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BEEspoke Data 44

FIELD OF THE INVENTION The present invention relates to a flexible, open-pored cleaning body having at least one scrubbing surface which is provided in at least one subregion with continuously formed, raised projecting ridges. BACKGROUND INFORMATION A cleaning body is described in German Utility Patent No. 7 612 130. In the patent, the ridges have an identical cross-section over their entire length; they are arranged close to one another and separated from each other by perpendicularly incised channels. They consist of the same material as the cleaning body and have a correspondingly high flexibility. When encountering adherent solid dirt laterally, a lateral buckling is often observed, which makes little contribution to detaching the dirt and subsequently removing it. Besides, the already detached dirt components which penetrate into the interspaces between the ridges have a tendency to become fixed therein. They are hard to remove. Another German Patent No. 27 30 266 describes cleaning bodies in which a plurality of isolated protuberances are arranged on a flat surface in close proximity to one another. Such cleaning bodies do not make it possible to wipe off a surface to be cleaned without leaving streaks. Further, the resistance of the protuberances to buckling decreases with increasing height. Thus, to remove adhering dirt, it is necessary to make the height of the protuberances very low. However, in so doing, an impairment of the dirt uptake capacity of the interspaces must be reckoned with. SUMMARY OF THE INVENTION An object of the present invention is to further develop a cleaning body in such a way that the mechanical removal of adhering dirt components can be achieved more satisfactorily than before. According to the present invention, this task is accomplished with a flexible, open-pored cleaning body having at least one scrubbing surface which is provided in at least one subregion with continuously formed, raised projecting ridges. It is provided for the cleaning body according to the present invention that the ridges are formed in a continuous manner and have regions of different heights in the direction of their extension. Here, the present invention is based on the recognition that, as a rule, the thickness of contaminations covering a surface to be cleaned is largely uniform. Their removal with the use of the cleaning body according to the invention is not intended to be done in a single step, but in such a way that the ridges attack the dirt only at the most protuberant sites of the cleaning body, which makes it possible to exert at these sites high specific contact pressures on the dirt through the ridges. In this way the breakup and removal of the dirt at isolated places and/or during the forward movement of the cleaning body in the course of isolated scraping is facilitated. It is advantageous that the raised sites of the ridges are connected with each other via zones which protrude to a lesser extent, and therefore in a position to carry out a supplementary windshield-wiper effect over their entire length. In this way, by moving the scrubbing agent to and fro in closely adjacent streaks over a surface to be cleaned and substantially transversely or obliquely to the direction of the ridges, complete removal of all dirt components adhering thereto is achieved within a short time. In addition, the areas of low height adjacent to the protuberances along the ridges provide said protuberances with static support against lateral buckling. As a result, the cleaning body is particularly suitable for use in the domestic or industrial sector. The ridges normally extend parallel to each other. They can be designed so that they have a straight-line, serpentine or zig-zag course. A design in which the adjacent ridges are arranged so as to fill gaps, at least with regard to their protuberances, is also possible and can improve the cleaning effect. In their course, the ridges can successively change direction in an irregular manner, or be self-enclosing and have the form e.g. of a ring or ellipse. With regard to its external shape, the cleaning body may be modified in various ways. For example, it is possible to give it the form of a cleaning cloth or a scrubbing sponge of parallelepiped shape. Many possibilities exist also with regard to the materials used for fabricating the cleaning bodies. Apart from open-cell foams, fiber-containing materials such as fleeces or laminated materials, which optionally contain both foams and fibers, can also be used. In that case the foams and fibers can have a blended structure or be imbedded in one another. If fibers are used, it is merely necessary to ensure that the titer of the fibers not be too low. Advantageously, the titer should be in the range of coarse staple fibers, at about 0.2 to 40 dtex, preferably between 1 and 6.7 dtex. A supplementary or alternative use of metallic fibers can also be included in the considerations. Used as foams are primarily soft, open-pored, polyurethane flexible foams having a density of from 15 to 200 kg/m 3 , preferably between 20 and 50 kg/m 3 . The use and preparation of the cleaning agent is particularly simple when the regions in which the ridges have a varying height regularly follow each other in a recurrent fashion. According to an advantageous embodiment of the present invention, the regions of varying height are designed so that they blend into one another in a uniform manner. In this way the formation of streaks when wiping smooth surfaces can be avoided in a particularly simple way. Ridges in which the regions of varying height follow each other in a sinusoidal form are preferred. To enable the cleaning body to be used in a way that is independent of the direction of the streaks during wiping processes, provision can be made for the ridges to cross one another. When a regular pattern is used, this offers the possibility of producing the ridges without any waste, in such a way that a thicker layer of the material forming the cleaning body is elastically deformed with the use of inflexible molding materials of relief-like structure, and then split into two identical cleaning bodies. The mechanical resistance of the ridges to a lateral buckling movement can be increased if they, viewed in the transverse direction, are delimited by inclined surfaces. Viewed in the transverse position, these surfaces can have a curvature and optionally a sinusoidally blending profile. The ridges are produced in one piece with the scrubbing agent made of the same material. Accordingly, in the case of unfavorable profiling, the mechanical strength under certain circumstances is very low. To improve this situation it has been found advantageous if the ratio between the distance of the midpoints of adjacent ridges and their maximum height is about 4 to 12, preferably from 6 to 9. Even with the use of relatively easily deformable materials, adherence to this ratio makes it possible to obtain an excellent wiping effect. The scrubbing surface can be provided with a flexible coating which improves the abrasion resistance. Examples of coatings are described in U.S. Pat. No. 4,264,337. Within the framework of the present invention, a two-component polyurethane is preferentially used, which is cross-linked by subsequent heating and then hardened. In this way, the penetration of the protuberances of the scrubbing surface into adherent dirt layers is further improved. Advantageously, such a coating is applied to or pressed into the scrubbing surface in the liquid state, and then hardened. Particles of a scrubbing agent, e.g. particles of a rubber granulate and/or an abrasive grain, may optionally be embedded therein. For speedy performance of cleaning processes it is highly advantageous if, during the cleaning process, the cleaning body can be used as a water-storing means and if it is possible to displace the water contained in the cleaning body e.g. by simple compression and then re-release it toward the front side of the scrubbing surface, or if it can be drawn away from it by suction. To meet this requirement, it has proved useful for the coating to be permeable to liquids and, e.g., be permeated by pores. When the ridges are arranged obliquely to the longitudinal direction of the cleaning body, a wiper effect is obtained when it is used as specified, which makes it possible to quickly remove liquids from large surface areas. Advantageously, the coating of the cleaning body is continuously applied to the scrubbing surface during an elastic deformation with the aid of a roll mill, pressed into it to an at least partial extent, and then hardened. In this way a particularly intimate bond results between the coating and the cleaning body, which improves the durability of the cleaning body. Found particularly advantageous has been a process for fabricating the cleaning body from open-pored foam, a process wherein a substantially flat foam mat is elastically deformed in a continuous manner between intermeshing projections of a pair of rolls, and, within the roll slit, is divided by a straight cut into two mat sections, which, on emerging from the roll slit, are delimited on the opposite sides by a corrugated surface, with the individual cleaning bodies obtained by being punched out from the mat sections. This process operates without waste, and is thus advantageous from both the economical point of view and with regard to avoidance of waste materials. In the aforementioned process a coating of liquid polymeric material, e.g. a solution of elastomeric polyurethane, is advantageously applied to the corrugated surface of the mat sections, and is then hardened. In this way, the coating still in the liquid state can be pressed into the mat section under continuous elastic deformation of said mat section. The application and pressing-in of the coating are most successful when the deformation is carried out with the aid of a roll mill, so that all surface zones of said mat section are included. By operating in this way, the coating surprisingly has a largely uniform layer density in all subregions of the corrugated surface of the cleaning body, even though rolls having a cylindrical surface can be used. The components of the coating situated in the region of protuberances and recesses of the scrubbing surface can thereby be mutually supported when transverse forces appear, a fact which improves the scrubbing effect and prevents detachment of the coating when abrasive stress is exerted on the protuberances. In general, the coating layer has a thickness of from 2 to 5 mm, of which only about 1 mm extends beyond the surface of the foamed body. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a view of the scrubbing surface of a typical cleaning body according to the present invention. FIG. 2 shows a scrubbing surface wherein the highest points of the ridges are marked with a star and the lowest points with a cross, and in which the position of the individual cutting planes according to FIGS. 3 to 5 are indicated. FIG. 3 shows the cleaning body according to FIG. 1 in sectional representation. FIG. 4 shows the cleaning body according to FIG. 1 in another sectional representation. FIG. 5 shows the cleaning body according to FIG. 1 in yet another sectional representation. FIG. 6 and FIG. 7 show a cleaning body in cross-sectional representation, and in a view of the scrubbing surface, wherein perpendicularly intersecting ridges are all arranged obliquely to the longitudinal direction of the scrubbing body. DETAILED DESCRIPTION OF THE INVENTION In the drawing, the scrubbing surface of a cleaning body shown by way of example is represented in top view. In the area of the scrubbing surface 2 (FIGS. 3 and 4), the cleaning body is comprised of a foam material 1 of open-pored polyurethane foam having a bulk density of between 20 and 50 kg/m 3 . On its top surface 4 (FIG. 3) continuous raised ridges 3 are arranged so as to form the scrubbing surface 2, said ridges forming two perpendicularly intersecting ridge clusters. The ridge clusters form a one-piece component of the foam material 1 forming the cleaning body in the region of the upper side. They are produced by a cutting process in a waste-free manner. Within both ridge clusters, the distance between opposite midpoints of adjacent ridges 3 is 30 mm, at a maximum height of 4 mm and a minimum height of 2 mm, in each case in terms of that site of the profile where the latter attains its greatest distance from an imaginary prolongation of the top surface 4. The spatial position of the top surface is indicated in FIG. 3. The dimensioning can be varied as a function of the specific use. In the longitudinal direction the height of the ridges 3 varies sinusoidally between sites of the greatest and smallest height C, D. Moreover in the transverse direction, the ridges 3 have the profile of a bell-shaped curve. This is delimited at its base by the lines shown in FIG. 1. These lines are not recognizable on the product, because the ridges 3 merge into the top surface 4 of the cleaning body by avoiding an abrupt change of direction and sharp edges. Furthermore, at the crossing points, the limiting surfaces of the ridges merge into one another in a rounded-off fashion. Thus, the regions of varying heights C, D of the ridges 3 again follow each other regularly in every direction, with the individual ridges 3 nevertheless enclosing bowl-shaped recesses 5 in the manner of a waffle pattern. The base of the recesses 5 determines the position of the top surface above which rise the ridges 3. The recesses 5 are suitable for taking up, in a largely pressure-free manner, relatively large amounts of dirt which are detached from a surface to be cleaned. Despite the exertion of considerable pressing forces, a rubbing-in action into the pore structure of the cleaning body is prevented, because these forces are absorbed predominantly by the ridges 3 and, particularly, by those parts of the ridges 3 in which they attain the greatest height C. Hence, after exceeding the lateral edge limit of the body to be cleaned, the detached dirt components readily fall out from the recesses 5, after which the original storage capacity is regained. In any case, a firm settling of such dirt components within the interior of the pore structure of the cleaning body is largely prevented. The scrubbing surface 2 is coated in its entirety with a layer of cross-linked elastomeric polyurethane, which is applied in the course of an impregnation process and is then hardened and bonded with the scrubbing surface 2 in an undetachable manner. In this way its mechanical strength and, in particular, its abrasion resistance is considerably increased. In the transverse direction the coating is permeated by pores. This results in a good water permeability in the direction of the surface to be worked, which allows the amounts of water stored in the open-pored structure of the cleaning body to be readily displaced toward the front side of the scrubbing surface 2 by pressure exerted on the cleaning body, or to draw them, together with the detached dirt components, out of the scrubbing surface 2 during a cleaning process when the pressure is released. Worked into the coating is an abrasive granulate which may consist of rubber particles and/or a scrubbing agent. In this way, even adhering dirt components can be eliminated from a surface to be cleaned without any difficulty. The cleaning body shown in the drawing is provided with ridges 3 of the type according to the invention only in the region of a scrubbing surface 2. As a result the reverse side can be used to dry the surfaces that are already cleaned. In the embodiment shown, this side is formed of a lining of viscous sponge 6, which is particularly well suited for these purposes. By contrast, it is possible, if necessary, to provide this surface, or even additional surfaces of the cleaning body, with correspondingly or differently formed ridges 3. In such embodiments, the scrubbing surface 2 which is not being used momentarily is again completely freed from adhering dirt components through the milling movements of the cleaning body with another scrubbing surface 2' which occur during the normal cleaning process, as well as through the pressure-free absorption and outflow of water through the pore structure of the unused scrubbing surface, and it is made suitable for a renewed application, without any special effort being required for this purpose. FIGS. 6 and 7 show a cleaning body in the form of a cleaning cloth made of foam which is produced homogeneously from a single foam block and is delimited on its lower side by a flat surface. The top side is formed of a scrubbing surface 2 which is structured analogously to the above-described surface, but whose perpendicularly intersecting ridge clusters are arranged obliquely to the longitudinal direction and at an angle of 45 degrees. Thus, the sites of greatest heights of the ridge 3, which follow one another in the longitudinal direction, are so disposed with respect to each other so that they fill up gaps. In this way, despite relatively great opposite distances between the sites of greatest height D of the ridges 3, a nearly gapless attack on the surface to be cleaned is attained in the operating direction which is transverse to the longitudinal direction. If the cleaning body according to FIGS. 6 and 7 does not move over the surface to be cleaned in a way that is exactly parallel to its longitudinal direction, but is more or less rotated away from that direction, then an automatic improvement of the extent of mutual covering of the strips cleaned through the sites of greatest height D takes place. On normal performance of a cleaning process, the thus oblique correlation of the longitudinal direction of the ridges 3 with the direction of movement is almost always satisfied. Hence, within the framework of the present invention, an arrangement and design of the ridges 3 in accordance with FIGS. 6 and 7 is preferred.

A flexible, open-pored cleaning body having at least one scouring surface (2) provided in at least one subregion with continuously formed, raised projecting ridges (3), wherein the ridges (3) have regions C,D of different heights in the direction of their extension.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to cooking apparatus, and in particular, to apparatus having adjustable walls. 2. Description of Related Art There is increased concern about cooking foods thoroughly to eliminate bacteria. At the same time, consumers are interested in reducing the fat content in the cooked food below the levels normally associated with frying. An efficient and popular method of cooking food is immersion in a heated liquid. A familiar cooker is a deep fryer where foodstuff is placed in a wire basket and lowered into a pot of hot oil. Food can also be cooked in a crock pot, which is typically a ceramic pot heated will electrical heater elements. When used properly, these devices can kill bacteria, but cannot be used readily for many food products. One difficulty with the foregoing cooking devices is that the food products are kept loose. Some food products such as hamburger patties cannot be easily cooked in quantity when loosely placed inside such a cooking device. For example, liquid turbulence may break up the patties. In U.S. Pat. No. 4,224,864 a number of horizontal, parallel plates are stacked together and slide on a number of posts. The plates are normally separated by springs but can be driven together by a cam lever to hold meat patties between the plates. Once secured, the patties can be immersed in a deep fry cooker. This reference does not allow a simple adjustment of the cooking space and will drive the plates against the food based on the force applied by the cam and spring. In U.S. Pat. No. 5,195,426 a number of parallel shelves are held together by a chain or other device. When hoisted, the shelves separate to admit cheese. When lowered, the shelves collapse to hold the cheese in place. This reference does not concern cooking and does not allow adjustment of the space between shelves. Instead the shelf to shelf spacing is always the same. See also U.S. Pat. No. 4,815,368. In U.S. Pat. No. 5,265,523 a hollow platform has a number of perforated dividers. Frozen food placed between the dividers can be defrosted by heating water that circulates through the dividers and past the frozen food. While vertical dividers are shown, the space between them is not adjustable. U.S. Pat. 4,508,027 shows a divider in the form of a grid that can be placed in a variety of positions inside a frying basket. While the size of compartments inside the basket can thus be adjusted, the reference does not disclose an assembly with a hinged floor member. See also U.S. Pat. No. 4,854,227. See also U.S. Pat. Nos. 474,446; 3,282,460; 3,552,297; 4,287,818; 4,297,942; 4,548,130; and 5,216,947. U.S. Pat. Nos. 4,472,448 and 4,851,241 show sauces for treating meat products. See also U.S. Pat. No. 5,567,466. Accordingly, there is a need for an improved cooking apparatus that can cook foodstuffs safely and efficiently in an adjustable cooking space. SUMMARY OF THE INVENTION In accordance with the illustrative embodiments demonstrating features and advantages of the present invention, there is provided an apparatus for cooking foodstuffs. The apparatus has a pot and at least one support assembly adapted to rest atop the pot. The support assembly has a floor and a pair of walls. Each of the walls is dependently mounted from the support assembly. The walls are spaced apart an adjustable amount. The floor is hinged to and spans the pair of walls. By employing apparatus of the foregoing type, improved equipment is achieved for thoroughly and efficiently cooking foodstuffs. In a preferred embodiment, one wall is affixed to a support assembly. Another, movable wall is suspended from a shaft whose outer ends slide in arcuate slots formed in blocks mounted on the support assembly. The bottom edges of these two walls are spanned by a floor that is hinged to the two walls. The hinging is such that as the walls move together or separate, they remain parallel, although the floor may change its angle of elevation. In this preferred embodiment, the support assemblies may be inserted or removed from bays in a lid that rests atop a pot containing a cooking fluid, such as a water-based sauce. Preferably, the pot contains electrical heating coils that are regulated by a thermostat to maintain a desired cooking temperature. The apparatus may be formed as a small home cooking unit or as a larger commercial unit with many cooking bays. In a top end commercial unit, each cooking assembly in each bay includes a timer for scheduling the cooking interval for each bay. This unit can include perches or shelves between the walls of the support assemblies to allow food products to be vertically stacked without placing the entire weight of the stack on the bottom product. With the preferred apparatus, food products such as hamburger patties, do not lose their shape, because the opposing walls of the assembly are in contact with the entire surface of the product. This contact is especially effective for embodiments where the walls are formed as a grid, as opposed to solid material. Moreover, the preferred embodiment is designed to hold the food products at a continuously adjustable range of thicknesses. Also, the food products need not be turned, and because they are separated, they do not stick together. Additionally, efficiency is greatly enhanced since the food products can be loaded at the same time, so they are ready at the same time. BRIEF DESCRIPTION OF THE DRAWINGS The above brief description as well as other objects, features and advantages of the present invention will be more fully appreciated by reference to the following detailed description of presently preferred but nonetheless illustrative embodiments in accordance with the present invention when taken in conjunction with the accompanying drawings, wherein: FIG. 1 is an axonometric view of cooking apparatus in accordance with principles of the present invention; FIG. 2 is a detailed, exploded view of a portion of the support assembly of FIG. 1; FIG. 3A is simplified, schematic, end view of the support assembly of FIG. 1 with the walls maximally separated; FIG. 3B is simplified, schematic, end view of the support assembly of FIG. 1 with the walls brought close together; FIG. 4 is a top view of a cooking apparatus that is an alternate to that of FIG. 1; and FIG. 5 is a front elevational view, partly in section, of the cooking apparatus of FIG. 4. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to FIGS. 1 and 2, the present apparatus is illustrated as a pot 10, which may be a double-walled assembly formed as an inner container for holding a cooking fluid and an outer container spaced therefrom to make the pot 10 safe to touch. In one embodiment the inner container is ceramic and the outer container is a metal or plastic shell, although other materials may be used in other embodiments. The pot has a pair of horizontal handles 12. In this embodiment pot 10 is 14 inches (35.5 cm) long, 12 inches (30.5 cm) wide and about 10 inches (25.4 cm) tall, although other sizes and proportions are contemplated, depending upon the desired capacity, number of cooking bays, the type and number of food products to be cooked, etc. As described further hereinafter, electrical heating coils may be placed between the inner container and the outer container. The electrical heating coils may be arranged in a conventional manner with a thermostat and manual controls to regulate the heating effect of these coils. The pot 10 is fitted with a lid 14 containing four parallel slots or bays 16, although a different number of slots may be employed in alternate embodiments. Lid 14 is shown with a pair of upright handles 18, although such handles may be eliminated in alternate embodiments. Lid 14 may be secured to the pot 10 by appropriate fasteners. It is preferred, however, that lid 14 can be lifted to allow access to the inside of pot 10 for cleaning. A support assembly is shown herein as including a plate 20 with an upright handle 22. In this embodiment, plate 20 is 12 inches (30.5 cm) long and 2 inches (5 cm) wide, although other dimensions and proportions can be used in other embodiments. Plate 20 is preferably metal that is clad with an external, thermally insulating layer making plate 20 safe to touch. It will be appreciated that other heat resistant materials may be used in alternate embodiments. A pair of walls 24 and 26 are shown supported by and depending from plate 20. Walls 24 and 26 are shown as stainless steel grids bordered by thicker stainless steel rods. A pair of members 28 and 30 are shown as slotted blocks, which are attached to the underside of plate 20 by welding or attachment with appropriate fasteners. Wall 24 has a rectangular outline and may be 11 inches (28 cm) wide and 8 inches (20 cm) tall, although other dimensions and proportions are anticipated for other embodiments. Wall 24 may be attached at its upper corners to the blocks 28 and 30 and, along its upper edge, to the underside of plate 20. For this reason, wall 24 has notches 25, allowing the wall to fit around the blocks 28 and 30. Wall 24 is attached in such a way to keep it fixed in position relative to plate 20 without shifting or swinging. Wall 26 also has a substantially rectangular outline with the same dimensions as wall 24, except for somewhat larger notches 34 located in the two upper corners of wall 26. The upper edge of wall 26 is attached to an upper peripheral rod 36. Rod 36 is a shaft having on each end an annular flange 38 bordering a threaded end portion 40. Threaded portion 40 is sized to slidably fit inside the arcuate slot 32 in block 28. Arcuate slot 32 essentially follows a quadrant of a circle extending between opposite corners of the block 28. The upper end of the arcuate slot 32 breaches a vertical edge of block 28 to allow removal of the threaded end 40 of the shaft 36. Accordingly, the shaft 36 can be moved up and away from (or down and toward) wall 24 by following arcuate slot 32. The shaft 36 can be clamped into a desired position along the arcuate slot 32 by a clamping means, shown herein as knob 42. Knob 42 may be a plastic handle with an internally threaded metal insert (not shown) sized to screw onto the threaded end 40 of shaft 36. By tightening knob 42, flange 38 can be pulled against the 10 inside surface of the block 28 (same effect at block 30). Thus knob 42 and flange 38 grab the block and hold shaft 36 in position. A floor 44 is shown hinged to the bottom edges of the walls 24 and 26. Floor 44 is shown as a sheet metal panel, preferably 11 inches (28 cm) long and 1 inch (2.5 cm) wide, although other dimensions and proportions are contemplated for other embodiments. Floor 44 has a plurality of tabs 46 that are rolled as shown to embrace the lower edge of walls 24 and 26. In other embodiments the floor 44 can be hinged to the walls by means of separate brackets or by conventional hinges. Referring to FIG. 3A, the wall 26 is shown clamped at an upper extreme position in arcuate slot 32. In this illustrated position, the wall 26 is in its highest position and spaced maximally from wall 24. Positioned in this fashion, the floor 44 is held substantially horizontal. The wall 26 can also be lowered to the position shown in FIG. 3B. In this illustrated position, the wall 26 is in its lowest position, closest to wall 24. Also, the floor 44 is shown tilted, forming an oblique angle with wall 24 and an acute angle with wall 26. By following slot 32, the upper edge of wall 26 stays at a fixed distance from the center 48 of the circle defining slot 32. Consequently, wall 26 acts as if it were hinged to a virtual panel that is hinged between center 48 and the upper edge of wall 26. Accordingly, walls 24 and 26 stay parallel and act as two opposite sides of parallelogram with the other two sides formed by floor 44 and the above mentioned virtual panel. The fixed wall 24 is shown in FIG. 3A fitted with a perch 50. Perch 50 may be a number of horizontal pins attached to wall 24. Perch 50 acts as a shelf so that food products 52 and 54 can be stacked vertically without unduly compressing the food product on the bottom of the stack. Perch 50 is aligned with openings in the grid of wall 26 to protrude through these openings when the walls 24 and 26 are brought together as shown in FIG. 3B. In this Figure thinner food products 56 and 58 are shown between the walls 24 and 26. Referring to FIGS. 4 and 5, a commercial cooking apparatus is illustrated, which is an alternate to that shown in FIGS. 1 and 2. The illustrated apparatus is substantially larger and has fourteen bays. This apparatus has an overall length of 30 inches (76 cm), an overall width of 15 inches (38 cm), and an overall height of 16 inches (40.6 cm). In this embodiment, components having structure or functions similar to that illustrated in FIGS. 1 and 2 have the same reference numerals but increased by one hundred. Here, pot 110 is in the form of a ceramic container mounted inside a sheet metal shell. The floor 111 of the ceramic container of pot 110 is slanted to drain towards outlet valve 160. Pot 110 has a lid 114 with an inlet 162 shown fitted with a funnel 164, for filling the pot 110. Lid 114 is attached to pot 110 by hinges 166. Thus, lid 114 can be swung about the hinges 166 by lifting lid 114, using handles 118. The front of pot 110 has an inspection window 168. This inspection window is relatively narrow and extends from the top of pot 110 down about one quarter the height of the pot. Window 168 is used to view the level 170 of the fluid inside pot 110. The fluid level 170 is shown sufficiently high to almost reach the underside of the blocks 148. Each of the fourteen bays of pot 110 is shown with a support assembly including a support plate 120 with a strap 122, which can connect to a lifting handle (not shown). As before, support plate 120 has mounted below it a block 148 with an arcuate slot to support a movable wall 126. Again, a fixed wall 124 is mounted between the blocks 148 to the underside of support plate 120. Fixed wall 124 is shown with a number of perches 150 to hold food products 172. Walls 124 and 126 are again designed to have a variable spacing that can be changed by clamping the upper edge of movable wall 126 in the block 148. In this embodiment, each of the support panels 120 has a timer 174. Each timer can be set for a predetermined time interval. This time interval is set depending upon the type of food being cooked. When the time interval elapses, a ready light 176 is illuminated. While individual timers and ready lights are illustrated, in alternate embodiments a single timer and ready light may be mounted on the lid 114 to serve all of the bays. Such an arrangement assumes that all the bays will be loaded and unloaded simultaneously. To facilitate an understanding of the principles associated with the foregoing apparatus, its operation will be briefly described in connection with the embodiment of FIGS. 1 and 2 (although the operation of the other embodiment will be similar). In operation, pot 10 will be first filled with a cooking fluid. Preferably, the pot 10 will be filled with a water-based sauce. This reduces the fat content of the food, in comparison to food that is cooked in an oil-based sauce. The internal heaters are then electrically powered to heat the sauce in pot 10. When the sauce is sufficiently hot (depending upon the type of food to be cooked) the support assemblies can be loaded with foodstuffs. The assembly in each of the bays 16 can be lifted by means of handle 22. Next the knobs 42 are loosened (but need not be removed) to free the wall 26 from the blocks 28. Consequently, wall 26 can be swung away from wall 24 to allow loading of foodstuffs. For example, hamburger patties may be loaded against wall 24 and then wall 26 can be swung into back into a closed position. Specifically, the threaded end 40 of shaft 36 (FIG. 2) can be slid back into arcuate slot 32. Shaft 36 is then pushed toward wall 24 to grip the foodstuffs between the walls with an appropriate amount of force. As shaft 36 is adjusted, the floor 44 swings as illustrated in FIGS. 3A and 3B. During this adjustment the walls 24 and 26 remain parallel. Once properly set, the knobs 42 are tightened to clamp shaft 36 in position. Once loaded, the support assemblies can be lifted by means of handles 22 and placed in the appropriate bay 16. This process is repeated for each of the bays until each is loaded with the food to be cooked. It will be appreciated that not all bays need be loaded with food in every cooking session. The user will allow an appropriate amount of time to elapse so that the food inside pot 10 will be sufficiently cooked. Because the food is immersed in very hot liquid, there will be thorough cooking and elimination of bacteria. Also, where the hot liquid inside pot 10 is water-based, the fat content of the foodstuffs between walls 24 and 26 will be reduced by the leaching of fat into the liquid inside pot 10. The food can be unloaded by lifting the support assemblies by means of the handles 22. The movable walls 26 can be freed by loosening the knobs 42. As before, the wall 26 can swing away from block 28 and wall 24 to allow the food to fall out of the assembly. The process can be completed by closing wall 26 (either with or without a new load of uncooked food) by sliding shaft 36 back into slot 32 of block 28 and clamping the shaft by tightening knob 42. Then the assembly can be replaced in the bay 16, again using handle 22. The operations with respect to the embodiment of FIGS. 4 and 5 are similar. This latter embodiment, however, has additional features such as the timer 174, which operates the ready light 176. Also, the temperature of the cooking fluid can be established by a thermostat regulating the heater coils 178. Moreover, since the walls 124 and 126 are taller, more foodstuffs can be placed between them. In this embodiment, two rows of perches 150 are employed to allow three rows of foodstuffs. In addition, the cooking fluid inside pot 110 can be quickly drained daily by opening drain valve 160. The following day, the cooking fluid can be quickly added by filling pot 110 through opening 162 using funnel 164. The filling can be controlled by observing level 170 through window 168. Window 168 can be examined periodically throughout the day to refill pot 110 if necessary due to evaporation or migration of cooking fluid into food products that are subsequently removed. It will be appreciated that various modifications may be implemented with respect to the above described, preferred embodiments. Instead of a threaded rod clamped by a knob, other embodiments may employ a series of notches for holding the shaft, or other types of holding mechanisms. While a grid is shown for the parallel walls, alternative walls may include sheet metal with perforations or slots. In still other embodiments, one of the walls may be imperforate. Also, the floor of the food supporting assembly may in some embodiments be perforated, be formed of a grid, or have some alternate structure. While keeping the walls that hold the food parallel is desirable, in some embodiments one may allow the walls to converge or diverge, especially for irregularly shaped food products. In some embodiments the cooking fluid may be heated by other means, such as a combustion source. Obviously, many modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described.

Apparatus can cook foodstuffs with a pot and at least one support assembly adapted to rest atop the pot. The support assembly has a pair of walls. Each of the walls is dependently mounted from the support assembly. The walls are spaced apart an adjustable amount. The support assembly also has a floor hinged to and spanning the pair of walls.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an ophthalmic apparatus, and more particularly to an ophthalmic apparatus usable as apparatus of battery type and of hand-held type. 2. Description of Related Art In general, the on-off control of electric power to cornea shape measuring apparatuses, fundus cameras and the like is performed by examiners using a manual switch. In the case where an examiner operates the apparatus with switches, however, if the examiner forgets to turn off the power supply after use, the life of electrical parts such as a lamp and the like is shortened and electric power is unnecessarily consumed. To overcome the above problems, some conventional apparatuses are provided with an auto-off function for automatically turning off the power supply if no operation is carried out for a prescribed time. However, in the conventional apparatus loaded with the auto-off function, the power supplied to a microcomputer circuit etc. is not turned off even when operation is not performed, so that the unnecessary consumption of electric power can not be prevented sufficiently. The resulting drawback is the need for frequent battery charges or replacement of the battery apparatus of battery driving type. To store sufficient electric power by one charge or change of battery in the battery type apparatus, the battery capacity thereof is required to be enlarged. As a result, the cost will increase and also the battery will be enlarged in size. This may be disadvantageous for apparatuses of hand-held type in particular. The apparatus provided with the auto-off function has further a problem that return to an active condition from an auto-off condition needs a switching operation, and therefore, it is a cause of trouble. SUMMARY OF THE INVENTION The present invention has been made in view of the above circumstances and has an object to overcome the above problems and to provide an ophthalmic apparatus capable of working with simple operation and less consumption of electric power. Additional objects and advantages of the invention will be set forth in part in the description which follows and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims. To achieve the objects and in accordance with the purpose of the invention, as embodied and broadly described herein, an ophthalmic apparatus of this invention comprises measuring means for measuring an eye of an examinee, detecting means for detecting whether the eye of the examinee is located within a predetermined area with respect to the apparatus, interval-time-signal-producing means for producing a prescribed interval time, power supply means for supplying power intermittently to the detecting means in accordance with the signals of the interval-time-signal-producing means, and means for generating a signal to initiate the supply of power required for driving the measuring means of the apparatus when said detecting means judges that the eye exists within the predetermined area. Further, in the second aspect of the present invention, an ophthalmic apparatus comprises a measuring index projecting optical system for projecting cornea-shape measuring indexes onto an eye of an examinee and a measuring index detecting optical system for detecting corneal reflection images of the indexes projected on the eye by the measuring index projecting optical system, measuring light sources disposed in said measuring index projecting optical system, and detecting means disposed in the measuring index detecting optical system, and cornea-reflection image-detecting judging means for turning on the measuring light sources, and for judging whether corneal reflection images are detected by the measuring index detecting optical system, and means for activating the judging means repeatedly to turn on the measuring light sources in said measuring index projecting optical system to judge repeatedly whether corneal reflection images are detected by the detecting means and for turning off the measuring light sources each time the judging means detects no corneal reflection images, each activation of the judging means occurring after a prescribed lapse of time following an absence of detection of corneal reflection images. According to the present invention, the apparatus is so constituted as to control automatically power supply and operation by detecting if an examinee's eye is located within a measurable range. Accordingly, the apparatus has the advantages that operation thereof can be simplified, an examiner may concentrate on observing and measuring the examinee's eye, and reduction of electric power can be attained. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of this specification illustrate an embodiment of the invention and, together with the description, serve to explain the objects, advantages and principles of the invention. In the drawings, FIG. 1(a) is a schematic front view of a measurement unit of an ophthalmic apparatus according to the present invention, which show the side facing an examiner; FIG. 1(b) is a schematic rear view of the measurement unit of FIG. 1(a); FIG. 2 is a schematic optical arrangement diagram of the ophthalmic apparatus in the first embodiment of the present invention; FIG. 3 is a schematic plan view of a battery charger and a printer unit of the ophthalmic apparatus in the first embodiment; FIG. 4 is a circuit block diagram of the ophthalmic apparatus in the first embodiment; FIG. 5 is a flow chart for explaining the operation of the apparatus in the first embodiment; FIG. 6 is a flow chart for explaining the operation of the apparatus in the first embodiment; and FIG. 7 is a flow chart for explaining the operation of the apparatus in the first embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A detailed description of a preferred embodiment of an ophthalmic apparatus embodying the present invention will now be given referring to the accompanying drawings. The ophthalmic apparatus in the present embodiment is a cornea-shape measurement apparatus of the hand-held type, which comprises generally a measurement unit internally provided with optical systems for measurement and observation and electric systems for control and calculation, a battery charger and a printer unit. (Measuring unit) FIG. 1(a) illustrates the front face, i.e., examiner's side, of a measurement unit 1 and FIG. 1(b) illustrates the or reverse face thereof. As shown in FIG. 1(a), the measurement unit 1 comprises an observation window 2 which allows an examiner to observe an examinee's eye for alignment, a liquid crystal display 3 on which measurement results and other information are displayed, a clear switch 4 to clear measured values stored in a memory, a transmission starting switch 5 to transmit measured data to a printer unit, and switches 6 and 7 to designate the right or left eye of an examinee's eye examined. The lower part of the measurement unit 1 is grip-shaped so that the measurement unit 1 may be held in one hand of the examiner, and a battery 10 is stored removably in the lower part of the grip. On the opposite face of the measurement unit 1 as shown in FIG. 1(b), numeral 11 identifies a contact for transmitting measured data to the printer unit on-line via a battery charger when the measurement unit 1 is set in the battery charger, numeral 12 identifies contacts for charging the battery 10. Numeral 13 identifies a light source for data transmission light which transmits the measured data to the printer unit using an optical signal, whereby data transmission can be achieved even when the measurement unit 1 is not set in the battery charger. FIG. 2 shows schematically an optical system of the measurement unit 1, which comprises a light source 23 of fixation index projecting light and a fixation index plate 24 having a spot aperture. Numeral 20 show an examinee's eye to be examined and numeral 21 shows an eye of an examiner who observes the examinee's eye 20 magnified through an observing lens 22. Light emitted by the light source 23 illuminates the index plate 24 to project image thereof on the fundus of the eye 20 through a concave lens 25, a dichroic mirror 27, a focusing lens 26 and a beam splitter 28. Then, the examiner is allowed to view fixedly the index plate 24. An index projecting optical system 29 which is to measure the shape of cornea comprises four optical sub-systems 29a-29d arranged apart from each other at a 90-degree angle in a circle about an optical path of observation light. Each of the sub-systems 29a-29d, wherein sub-systems 29c and 29d are not shown in FIG. 2, is constituted of a source 30 of measuring light such as a LED or the like which emits near-infrared light, a spot diaphragm 31 and a collimator lens 32. When detecting a working distance, the collimator lens 32 of the sub-system 29a will be removed out of the optical path of index projecting light of the sub-system 29a so as to form a finite index. Numeral 33 identifies a telecentric diaphragm and disposed at a focal position of the focusing lens 26. Numeral 34 identifies a two-dimensional CCD sensor for detecting the position of corneal reflection images being formed by the index projecting optical system 29, which is disposed in a position that is in a substantially conjugate relationship with respect to about an iris on which corneal reflection images are to be formed through the focusing lens 26. Numeral 35 are LEDs arranged apart from each other at a 30-degree angle in a circle about the optical path of observation light. Each of LEDs 35 is associated with a spot diaphragm 36 and a collimator lens 37. Corneal reflection images formed by the LEDs 35 in all will serve as mire-ring. (Charger and Printer Unit) FIG. 3 shows a plan view of a charger 40 and a printer unit 44. Charger 40 has a holder 41 in which the measurement unit 1 is to be set with the face shown in FIG. 1(b) downward, contacts 42 for battery charging and a contact 43 for data transmission. Simultaneously with being set in the holder 41, the measurement unit 1 is charged through the contacts 42. Numeral 44 is a printer unit which is provided with a light receiving section 45 which receives optical signals during data transmission. The charger 40 and the printer unit 44 are connected with each other through a cable, and which are supplied with power source through an AC adaptor. Operation of the thus constructed apparatus will be explained referring to FIG. 4 showing a circuit block diaphragm and FIGS. 5-7 showing flow charts. The measurement unit has three operational modes, namely, sleep mode, active mode and stand-by mode. Sleep mode is defined as a mode wherein power supply is cut off except for a timer circuit which produces interval time; active mode is defined as a mode wherein the corneal shape of an examinee's eye is measured successively; and stand-by mode is defined as a mode wherein, after measurement, measured data is memorized in a memory. While receiving the power supply, microcomputer circuit 53 monitors battery voltage through voltage monitor 60. When the battery voltage becomes close to a prescribed voltage at which the circuit can not operate, the microcomputer circuit 53 displays message marks on a liquid crystal display 3 through a display circuit 57 to urge charge or change of battery and, at the same time, sounds a buzzer 59 through a buzzer circuit 58 to give notice to the examiner with an alarm. When the battery voltage falls to an operational limit, the microcomputer circuit 53 writes the data in a fixed memory if measured data is being memorized in a memory, and then stops a timer circuit 51 and turns a power source circuit 52 off. After charge or change of battery by the examiner, electric power is supplied to the timer circuit 51 and the measurement unit 1 is put in a sleep mode. When the timer circuit 51 starts to operate, the microcomputer circuit 53 checks the fixed memory 61 at the time of the initial check on an examinee's eye. If finding measured data therein, the microcomputer 53 will read in the data. After that, the mode is shifted to a stand-by mode and the data are displayed on the display 3. When power is supplied to the battery 10, the measurement unit 1 is put in a sleep mode and then the power source is supplied to the timer circuit 51 to produce interval time. The timer circuit 51, after a predetermined time (for example, 2.5 seconds in the embodiment) has elapsed, transmits a start signal to the power source circuit 52. On receiving the signal, the power source circuit 52 is turned on to supply electric power to the microcomputer circuit 53. Then, the microcomputer circuit 53 drives a light source driving circuit 54 to turn on measuring light source 30 and, successively, drives a CCD sensor driving circuit 55 to operate a CCD sensor 34. The microcomputer circuit 53 checks through a signal detecting circuit 56 whether any signal, which is the corneal reflection image of the examinee's eye, is detected on the CCD sensor 34. In a case where the signal detecting circuit 56 can not detect any signal of corneal reflection image, the microcomputer circuit 53 judges that the examinee's eye is not located within a measurable area and turns off the power source circuit 52, so that power supply is cut off except to the timer circuit 51. The timer circuit 51 produces interval time. Then, the power source circuit 52 is turned on again after a predetermined time elapsed to similarly check whether the examinee's eye is detected within the measurable area. In a case where the signal detecting circuit 56 detects optical signals, microcomputer circuit 53 turns off the measuring light source 30. The signal detecting circuit 56 judges that the examinee's eye is located within or close to the measurable area if any optical signal has not been detected. In a case where similar signal is detected though the measuring light source 30 is being turned off, microcomputer circuit 53 judges the optical signal detected is not caused by reflection of cornea of the examinee's eye but caused by external disturbance light and turns the power source circuit 52 off, so that the mode is shifted to a sleep mode. At the same time, the timer circuit 51 starts timer operation. When judged that the examinee's eye is located within a measurable area, the microcomputer circuit 53 turns all the measuring light sources 30 on, the sleep mode being shifted to the active mode. The active mode can be achieved automatically, without needing manual operation by examiner, by only setting the measuring optical system of the measurement unit in a place where signal of images of the examinee's cornea can be obtained. It is possible to turn on any number of measuring light sources 30 for checking the existence of an examinee's eye in accordance with the interval signal of the timer circuit 51. It is preferable to turn on one of measuring light sources 30 in behalf of the power saving effect and increasing the life of measuring light sources, and is more preferable to change the measuring light source to be turned on one by one every time. When judged that the examinee's eye is located in a measurable area, the microcomputer circuit 53 turns all measuring light sources 30 on to measure the corneal shape of the examinee's eye. The examiner aligns the measuring optical system of the measurement unit with respect to the examinee's eye, so that signals of corneal reflection images come at a described proper location on the CCD sensor 34. Then, the microcomputer circuit 53 generates a trigger signal to start measurement of the shape of the cornea and processes in predetermined calculations to obtain measured data. Explanations of alignment between the examinee's eye and the measuring system and calculations of the shape of cornea have been described in U.S. patent application Ser. No. 08/098,786 (Japanese Patent Application No. 4-224896) and Japanese Patent Publication No. 1-19896, both which were filed by the same applicant as the present invention. Therefore, detail explanations are omitted herein. At the time of the active mode when the measuring light sources 30 all are being turned on, if a prescribed time (for example, 60 seconds in the embodiment) has elapsed or any signal of corneal reflection image come to be not detected on the CCD sensor 34, the microcomputer circuit 53 judges that the examiner stopped measurement and cuts the power source circuit 52 off to shift the active mode to the sleep mode. When measurement on the examinee's eye is completed after alignment of the eye, the microcomputer circuit 53 shifts the active mode to the stand-by mode and drives the display circuit 57 to display the measured data on the display 3. Next, the examiner presses either switch 6 marked "R" in FIGS. 1 and 4 or switch 7 marked "L" to designate whether the measured eye is right or left. On receiving a signal from the switch 6 or 7, the microcomputer circuit 53 stores the designation of the measured eye with measured data of the eye in an internal memory. If, in the stand-by mode where the measured data are being displayed on the display 3 after measurement, no switch operation has been performed for a prescribed time (for instance, 60 seconds), the microcomputer circuit 53 operates the display 3 to display a message to urge the next operation and also sounds the buzzer 59 through the buzzer driving circuit 58 to give notice to the examiner with an alarm. The microcomputer circuit 53 succeedingly checks the existence of examinee's eye in accordance with an interval signal of the timer circuit 51, and the other eye of the examines will be measured in the same process as above. After measurement, if requiring the measured data output, the examiner presses the print switch 5. When the print switch 5 is pressed, the microcomputer circuit 53 can transmit directly the measured data through the light source driving circuit 54 from the light source 13 for data transmission to the printer unit 44. When the measurement unit is set in the charger 40, the microcomputer circuit 53 transmits the measured data through a contact 11 for data transmission and a contact 43 of the charger 40 to the printer unit 44. The printer unit 44 receives a communication signal through optical communication or a contact and prints out the measured data thereof. On the other hand, if the measured data is unnecessary after measurement, the examiner presses the clear switch 4, so that the measured data stored in the internal memory of the microcomputer circuit 53 will be deleted. When the print switch 5 or the clear switch 4 is pressed by the examiner, the power source circuit 52 is cut off and the stand-by mode is shifted to the sleep mode. The present invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. For instance, it is effective to apply the present invention particularly to hand-held type apparatuses by battery drive, but it is not limited thereto, the present invention may also be applied to conventional installed-type apparatuses. In the above embodiment, though cornea reflection images formed by measurement light sources are utilized to check on the existence of an examinee's eye, another light source may be utilized and further different ways than optical detecting may be used. Further, by additionally providing a function capable of changing the interval time and the shifting time from the stand-by mode to the sleep mode and the like in the apparatus of the embodiment, it is possible to obtain effective apparatuses according to use conditions. The foregoing description of the preferred embodiment of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, and modifications and variations are possible in light of the above teachings or may be acquired from practice of the invention. The embodiment chosen and is in order to explain the principles of the invention and its practical application to enable one skilled in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims appended hereto, and their equivalents.

An ophthalmic apparatus for measuring an eye of an examinee, includes a device for detecting whether the eye is located within a predetermined area with respect to the apparatus, an interval time producing device for producing a prescribed interval time, a power supply device for supplying power intermittently to the detecting device in accordance with signals for the interval time producing device, and power supply signal generating device for generating a signal to supply a power required by the ophthalmic apparatus when the detecting device judges that the eye exists within the predetermined area.

FIELD OF THE INVENTION [0001] This invention relates generally to the field of articles worn by persons to reduce the likelihood, severity, or exacerbation of injury to the body, and more specifically to the field of braces worn on the knee. BACKGROUND OF THE INVENTION [0002] Flexible knee braces are used by athletes and other persons engaged in vigorous physical activity to protect the knee from injury and to avoid exacerbation of existing injury. The knee is one of the most heavily used joints of the body, as it is used in any activity that involves walking or running. The knee is also a common subject of injury, due to the relatively high levels of stress it must bear. During normal ambulation, in occupations involving physical labor, and especially during strenuous sports, the knee can undergo abnormal motions as a result of quick changes in direction, fatigue, uneven surfaces, or impacts. These abnormal motions can cause sprains or more serious injuries, including dislocation, stretching, or tearing of the tissues that make up the knee. [0003] Several different types of abnormal motion can cause injury to the knee. First, hyperextension of the knee joint can occur, wherein the knee flexes in its normal front to back fashion but beyond its normal range of motion. A second type of abnormal motion is axial rotation, wherein the lower leg is twisted rotationally relative to the thigh about the knee joint. A third type of abnormal motion is lateral flexure of the lower leg relative to the thigh, wherein the knee joint flexes from side to side instead of the normal front to back motion. In addition, abnormal motion of the patella (kneecap) can result in injuries such as chondromalacia patella, which is a softening or degeneration of the undersurface of the patella, and dislocation of the patella, also known as subluxation of the patella. [0004] Devices to protect the knee against abnormal motions have been used for many years, in a variety of specific embodiments which vary in their abilities to protect against the different types of abnormal motions. Besides protecting the knee against abnormal motions, the devices sometimes provide additional benefits such as insulating the knee to keep it warm, protecting the knee against impact, or compressing the knee to reduce discomfort. However, the protections afforded by these devices against abnormal motion are often accompanied by a reduction in range or ease of normal motion. These devices can also have other undesirable aspects such as added weight on the leg, potential for self-injury or injury to others caused by rigid components, difficulty of application and removal, cost, appearance, and irritation or chafing of the skin. [0005] For these reasons, there has long been motivation to find an improved knee brace which can protect the knee from abnormal motions without affecting the range or ease of normal motion, while avoiding the undesirable aspects of prior art devices. SUMMARY OF THE INVENTION [0006] A knee brace according to the present invention includes crossed support straps which are permanently fixed to the base of the brace. This eliminates any need to fasten the crossed support straps, thereby avoiding the possibility of error during application of the brace, and helps to ensure the proper fit at all times of the crossed support straps. Further, as the knee moves between flexion and extension positions, the straps self-adjust to the position of the knee. [0007] A knee brace according to the invention preferably includes both upper and lower crossed support straps, but this is not necessary. A knee brace according to the invention may include upper crossed straps without lower crossed support straps, or such a knee brace may include lower crossed straps without upper crossed support straps. The midpoints of the crossed straps may be fastened to each other, or to the base, although this is not required. [0008] According to another aspect of the invention, the knee brace may include one or more upright support members fastened to either or both sides of the base, although this is not required. The upright support members may be a resilient stay member, or a hinge, or other upright support members known in the art. The upright support member may be removable. [0009] According to another aspect of the invention, the knee brace may include a diamond shaped or round opening around the patella (kneecap), although other shapes could be used. A preferred embodiment includes a diamond-shaped opening which may conform to the shape of the patella particularly well. [0010] According to another aspect of the invention, the knee brace may include a circular opening over the popliteal area (the area at the rear of the knee). Such a popliteal opening can decrease the chance of irritation of the skin in that area. [0011] A knee brace according to the invention can protect against all forms of abnormal knee motion and provide patella support, while avoiding undue restriction of movement or bunching. It can provide therapeutic warming without undue moisture buildup. It is easy to adjust, fasten, and remove, and it can be used by a wide range of people with a variety of knee problems and knee sizes. [0012] Further objects, features, and advantages of the invention will be apparent from the following detailed description when taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0013] In the drawings: [0014] [0014]FIG. 1 is a front perspective view of a knee brace according to the invention fitted on the leg of a person; [0015] [0015]FIG. 2 is a side view of a knee brace according to the invention fitted on the leg of a person; [0016] [0016]FIG. 3 is a front view of a knee brace according to the invention laid flat; [0017] [0017]FIG. 4 is a rear view of a knee brace according to the invention laid flat; [0018] [0018]FIG. 5 is a side view of an exemplary resilient stay member; [0019] [0019]FIG. 6 is a front view of an exemplary resilient stay member; and [0020] [0020]FIG. 7 is a cross-sectional view of the knee brace of FIG. 1 taken along the line 7 - 7 thereof. DETAILED DESCRIPTION OF THE INVENTION [0021] Referring to the drawings, FIGS. 1-4 show a preferred embodiment of a knee brace according to the invention indicated generally at 20 . As normally worn by a person, the upper leg 21 extends from an opening at the top of the knee brace 20 , and the lower leg 22 extends from an opening at the bottom of the knee brace 20 . [0022] The knee brace 20 includes a base 28 , having a first side 29 and a second side 30 , which is preferably formed as a reclosable sleeve made from a sheet of elastic material which provides generalized support and compression to the knee area, along with therapeutic warming, but other materials may be used. The base 28 may also be formed, for example, of a tubular elastic sleeve shaped to fit snugly about the knee and adjacent leg portions. [0023] The base 28 may include a patella opening 31 which generally matches the size of the patella, such that the patella (kneecap) 23 of the wearer extends from the patella opening 31 when the brace 20 is worn, although this is not necessary. The patella opening 31 is preferably diamond-shaped, but this is not necessary and other shapes may be used. In addition to providing direct patella stabilization, the patella opening 31 may help to locate the brace 20 with respect to the patella 23 during application of the brace 20 . [0024] As best shown in FIGS. 3 and 4, the first side 29 and second side 30 of the base 28 are preferably each formed to terminate in upper fastening tabs 32 and lower fastening tabs 33 . When the base 28 of the knee brace 20 is wrapped about the leg of a person, the pair of upper fastening tabs 32 overlap at the rear of the leg where they may be detachably attached together in order to fasten the knee brace 20 about the upper leg 21 of the wearer. Similarly, the pair of lower fastening tabs 33 overlap at the rear of the leg where they may be detachably attached together in order to fasten the knee brace 20 about the lower leg 22 of the wearer. [0025] A gap 34 may be provided between the upper fastening tabs 32 and the lower fastening tabs 33 , so that when the knee brace 20 is fitted upon the leg the gaps on each side form a popliteal opening 35 at the rear of the knee, to avoid chafing, provide ventilation, and avoid bunching or undue restriction of movement, although this is not required. [0026] In a preferred embodiment, each pair of upper fastening tabs 32 and lower fastening tabs 33 may be detachably attached together, preferably using hook and loop material of the type which adheres when pressed together. Areas of hook type fastening material 36 may be fastened, for example by stitches 37 , onto one of the upper fastening tabs 32 and one of lower fastening tabs 33 . The other upper fastening tab 32 and the other lower fastening tab 33 (which do not bear areas of hook type fastening material 36 ) may be partially or entirely covered in loop type fastener material 38 . [0027] When the base 28 of the knee brace 20 is wrapped about the leg with the areas of hook type fastening material 36 on one upper fastening tab 32 and one lower fastening tab 33 overlapping and engaging the loop type fastening material 38 on the other upper fastening tab 32 and the other lower fastening tab 33 , each pair of upper fastening tabs 32 and lower fastening tabs 33 may be detachably attached by pressing them together, thereby fastening the brace about the leg of the wearer. [0028] As shown in FIG. 2 and as shown in cross-section in FIG. 7, one or more upright support members 45 may be provided on the first side 29 or second side 30 or on both sides of the base of the knee brace, to provide support and protect the knee against abnormal motions, although this is not required. In a preferred embodiment, the upright support members 45 may be formed, for example, by placing a resilient stay member 46 in an elongated side pocket 47 . As shown in FIGS. 5 and 6, the resilient stay members 46 are preferably comprised of a flattened spiral core of stainless steel or other flexible material of conventional construction commonly used in various types of braces. [0029] The elongate side pocket 47 may be formed, for example, between vertical sewn seams 48 that fix a side pocket cover strip 49 to the base 28 . The side pocket cover strip 49 may be made of the same elastic sheet material as the base 28 of the knee brace 20 , although this is not necessary. Edge binding 50 may be fastened to the edges of the side pocket cover strips 49 , for example using stitches 48 , although this is not necessary. [0030] As shown in FIGS. 1-4, a preferred embodiment of a knee brace according to the invention includes a first upper support strap 59 and a second upper support strap 60 , each upper support strap having an upper end 61 , a midpoint 62 , and a lower end 63 . The first upper support strap 59 and second upper support strap 60 are permanently fastened to the base 28 in a crossed fashion, by permanently fastening the upper end 61 of the first upper support strap 59 and the lower end 63 of the second upper support strap 60 to the first side 29 of the base and by permanently fastening the upper end 61 of the second upper support strap 60 and the lower end 63 of the first upper support strap 59 to the second side 30 of the base, preferably using the stitches 48 which secure the side pocket cover strips 49 to the base 28 . The midpoints 62 of the crossed first upper support strap 59 and second upper support strap 60 may also be permanently fastened together, or fastened to the base, preferably using stitches 64 . [0031] As shown in FIGS. 1-4, a preferred embodiment of a knee brace according to the invention may also include a first lower support strap 69 and a second lower support strap 70 , each lower support strap having an upper end 71 , a midpoint 72 , and a lower end 73 . The first lower support strap 69 and second lower support strap 70 are preferably permanently fastened to the base 28 in a crossed fashion, by permanently fastening the upper end 71 of the first lower support strap 69 and the lower end 73 of the second lower support strap 70 to the first side 29 of the base and by permanently fastening the upper end 71 of the second lower support strap 70 and the lower end 73 of the first lower support strap 69 to the second side 30 of the base, preferably using the stitches 48 which secure the side pocket cover strips 49 to the base 28 . The midpoints 72 of the crossed first lower support strap 69 and second lower support strap 70 may also be permanently fastened together, or fastened to the base 28 , preferably using stitches 74 . [0032] There are various possibilities with regard to alternative embodiments of a knee brace according to the invention. [0033] Although in a preferred embodiment the knee brace 20 includes a base 28 which is formed as a reclosable sleeve made from a sheet of elastic material, this is not required. For example, the base 28 may also be formed of a tubular elastic sleeve shaped to fit snugly about the knee and adjacent leg portions. The base 28 does not need to include a patella opening 31 , and the patella opening 31 , if present, could have a variety of shapes, e.g. circular, square, rectangular, elliptical, diamond, trapezoidal, or any substantial equivalent. All such alternative embodiments will be referred to herein as a base. [0034] Although in a preferred embodiment the first side 29 and second side 30 of the base each terminate in upper fastening tabs 32 and lower fastening tabs 33 , with a side gap 34 between the upper and lower fastening tabs, this is not required. For example, the first side 29 , or the second side 30 , or both sides of the base, or portions thereof, could be straight. [0035] Although in a preferred embodiment the base is detachably fastened about the leg of the wearer using hook and loop material of the type which adheres when pressed together, this is not required. For example, other fasteners such as buttons, clasps, buckles, pins, zippers, straps, buttons or other substantial equivalents may be substituted for the hook and loop type fastener material. [0036] Although in a preferred embodiment, various components are permanently fastened together using stitches, this is not required. For example, other means such as glue, thermal bonding, or other substantial equivalents could be used. [0037] Although in a preferred embodiment, two upright support members 45 (shown in cross-section in FIG. 7) are provided on the first side 29 and second side 30 of the base of the knee brace, this is not necessary, and the exact number, location, and construction of the upright support members 45 may vary. For example, there may be a single elongated side pocket 47 forming only one upright support member 45 , or there may be one or more elongated side pockets 47 on each side of the knee with a resilient stay 46 in each elongated side pocket 47 . The elongated side pockets 47 may be openable at one end to allow removal of the resilient stays 46 , so that the brace may be washed or so that different resilient stays 46 may be inserted to adjust the amount and type of support provided. The upright support members 45 may include mechanical hinges, plastic rods, metal rods, narrow strips of reinforcing sheet material, or other substantial equivalents, or a combination of these various alternatives. [0038] As shown in FIGS. 1-4, a preferred embodiment of a knee brace according to the invention may include crossed first upper support strap 59 and second upper support strap 60 and crossed first lower support strap 69 and second lower support strap 70 , wherein the ends of each pair of crossed support straps are permanently fastened to the base, although other arrangements are possible. For example, there may be a pair of crossed upper support straps which are permanently fastened to the base, without a pair of crossed lower support straps which are permanently fastened to the base, or with lower support straps arranged in a different configuration. Similarly, there may be a pair of crossed lower support straps which are permanently fastened to the base, without a pair of crossed upper support straps which are permanently fastened to the base, or with upper support straps arranged in a different configuration. [0039] It is understood that the invention is not confined to the embodiments set forth herein as illustrative, but embraces all such forms thereof that come within the scope of the following claims.

A knee brace for use by athletes or others requiring protection and support of the knee. The knee brace protects against abnormal motions of the knee, and provides direct and indirect patella stabilization. A base comprised of elastic material is configured to closely fit around portions of the knee and adjacent leg portions. Direct patella support is provided by upper crossed straps that are permanently fastened to the base and cross the front of the leg above the knee, or by lower crossed straps that are permanently fastened to the base and cross the front of the leg below the knee, or by both upper and lower crossed straps. Additional direct patella support may be provided by a patella opening. One or more generally upright lateral pockets containing semi-rigid stays may also be provided on the sides of the base for lateral support. A popliteal opening may be provided to reduce the possibility of chafing at the rear of the knee.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates generally to an exercising apparatus and more particularly to a pliable, mobile, exercise tool for accomplishing both dead (standard), dynamic, and progressive resistance exercises. Characteristics of this invention include being able to be used both inside and outside a gym and the ability to be transformed into a weight vest. [0003] 2. Brief Description of the Prior Art [0004] It has been known for some time that exercise contributes to the health of a person's heart and that consistent moderate exercise can prevent heart attacks. Studies have now proven that exercise also increases the body's ability to use oxygen. This VO2 maximum is a measure of fitness which normally begins to decline about age 20. There is some indication that strength training can help maintain a high VO2 and actually help to slow down the body's natural aging process. Regular exercise also increases the amount of blood supplied to the skin cells, removing waste products, bringing nourishment and, according to aging studies, decreasing the number of wrinkles. Exercise not only improves muscle tone, but appears to help reduce high blood pressure, thereby lowering blood-cholesterol levels and improving blood sugar levels in diabetics. It is recommended that a person exercise 30 to 60 minutes per day, with a minimum of 12 minutes of aerobic activity, while maintaining the heart rate in its “target zone” (75 to 80% of a person's maximum heart rate). [0005] Lifting free (dead) weights is one of the best methods for developing muscle endurance, strength, and size. Examples of free weights commonly include barbells, dumbbells, and kettle bells. However, free weights have basic limitations, one of these being that they do not provide proper variable resistance. According to Dr. Ellington Darden, Research Director of Nautilus, Inc., this is due to the “manner in which they function and because of their basic shape.” He also stated that to become stronger muscles should be subjected to “increasing resistance as they contract.” However, most barbell exercises do not provide this increase in resistance. In fact, during many free weight exercises, the resistance actually decreases as the muscle contracts due to increased mechanical advantage. [0006] Mechanical advantage occurs when levers and pivot points are employed so that a relatively small force may move a larger weight than normally possible without such leverage. In the human body, bones act as levers, joints act as pivots, and muscles provide the force. Unfortunately, this natural mechanical advantage can sometimes encourage muscular weakness during a particular range of motion or exercise. [0007] To reduce mechanical advantage during weight training, variable or progressive weight training was introduced. Besides decreasing mechanical advantage, merits of variable resistance include: the ability to target a specific range of motion, the development of better neuromuscular coordination, the cultivation of greater explosive muscle contractions, and a more functional, powerful body since most objects do not get heavier the further they are from the ground. [0008] Dynamic resistance is another beneficial consequence of lifting with progressive resistance. This occurs when the load or weight is unstable throughout a movement or exercise. Dynamic lifting's advantage is that it better simulates real world situations. It allows a person's strength training to more closely resemble what he will encounter when interacting with his surroundings, since very little in life comes fully equipped with perfectly formed hand holds or remains stable when forces are applied. [0009] Common forms of exercise equipment that incorporate the aspects mentioned above include the: Nautilus cam-based system, rubber bands, slosh tubes, and metal chains. There are disadvantages of each of these existing systems. For example, the Nautilus system is an effective source of progressive resistance, but it is expensive, stationary, and a very different machine is needed for each exercise. Rubber bands may be employed for progressive and dynamic movements, but they have a short shelf life, a sharp on/off loading period, and are not masculine in appearance. Moreover, the force necessary to lengthen the bands is difficult to equate to a physical weight that is encountered in natural surroundings. Similarly, slosh tubes are a great source for dynamic loads, but do nothing else. [0010] A metal chain, on the other hand, when used properly represents all three lifting characteristics: dynamic, progressive, and dead weight. As useful as a metal chain may be, its detractions typically keep it out of modern commercial and home gyms. Chains remain inaccessible or impractical for most people because there are downsides to this device. In particular it can be noisy, dirty, dangerous (grabbing hair, clothing, or an errant finger), difficult to manipulate (there is no easy way to carry it around), uncomfortable to use, and it can damage the floor upon which it is used. SUMMARY OF THE INVENTION [0011] The present invention, this Multifaceted Linear Training Device enables everyone to reap the benefits of weight training with chains without the oppressive noise, discomfort, danger, unknown weight amounts, poor mobility, or damage to their clothes/home/gym. The challenges of size, expense, longevity, and general lack of a user-friendly interface have been overcome. This invention has accomplished these benefits while retaining many of the advantages exhibited by the prior technology. DESCRIPTION OF THE DRAWINGS [0012] FIG. A, B, and C represent the predecessor to this current invention. Had a patent been pursued for this device, it would have centered and been limited to a system that properly secured a ‘silenced’ chain to a [0013] Olympic-type lifting bar. Its development allowed for the present instance of invention. [0014] FIG. A is the leading end, which has a welded metal ring that slips over any Olympic-type lifting bar; [0015] FIG. B is a cross-sectional view of the trailing end, this closed outer shell severely reduces noise and produces the ‘silenced’ effect; [0016] FIG. C is a representation of the test model as a whole (without detachable handles at either end, the ‘D’ rings at three points, buckles, nor integrated and detachable straps); [0017] FIG. 1 is a perspective of the instant of invention used by someone with basic progressive resistance knowledge—e.g., bench press; [0018] FIG. 2 is a cross section (lengthwise) of the unit in accordance with the present invention; [0019] FIG. 3 is the embodiment of the outer shell, which may be removed and cleaned; [0020] FIG. 4 is the embodiment of the inner shell, a two step process (this also may be removed and cleaned); [0021] FIG. 5 is the first step; [0022] FIG. 6 is the second step; [0023] FIG. 7 is a view of the standard detachable handle attached to each end; [0024] FIG. 8 is a detail of the standard detachable handle's pattern; [0025] FIG. 9 is a detail of the clasp's composition (this relates to all detachable handles); [0026] FIG. 10 is an alternate embodiment of the invention, a cross section (lengthwise) of the unit; [0027] FIG. 11 is the embodiment of the retention strap; [0028] FIG. 12 is an alternate detachable handle (A 1 ) for a person's ankle or wrist; [0029] FIG. 13 is a second view of this detachable handle (A 1 ) showing how it is tightened; [0030] FIG. 14 is an alternate detachable handle (A 2 ) specifically for the human hand; [0031] FIG. 15 is an alternate detachable handle (A 3 ) specifically for an Olympic-type lifting bar; [0032] FIG. 16 is a side view of this detachable handle (A 3 ); [0033] FIG. 17 is an embodiment of the instant of invention, setup as a vest (front); [0034] FIG. 18 is an embodiment of the instant of invention, setup as a vest (rear); [0035] FIG. 19 is an embodiment of the instant of invention, setup for a suitcase-style dead lift; [0036] FIG. 20 configuration (B 1 ), exercise—dips/triceps extensions; [0037] FIG. 21 configuration (B 2 ), exercise—dips/triceps extensions; [0038] FIG. 22 configuration (B 3 ), exercise—dips/triceps extensions; [0039] FIG. 23 sitting cross-legged, exercise—shoulder press; [0040] FIG. 24 seated exercise—shoulder press; [0041] FIG. 25 standing exercise—shoulder press; [0042] FIG. 26 standing exercise with additional weight—shoulder press; [0043] FIG. 27 standing exercise with additional weight and a second instant of invention—shoulder press; [0044] FIG. 28 standard behind the head press (this demonstrates the typical discomfort experienced during execution with shoulder impingement); [0045] FIG. 29 standard behind the head press (this demonstrates the freedom of movement experienced with this invention when all muscles and joints are allowed to move as their individual mechanics dictate); [0046] FIG. 30 standard front squat (this demonstrates the pain and discomfort experienced throughout the movement, with compression and abrasion of the flesh in and around the anterior deltoids/pectoralis major and stretched and torn ligaments in the wrists); [0047] FIG. 31 standard front squat (demonstrates the benefit of this invention, noting that all the benefits of the standard front squat are retained without the resulting discomfort and injury); and [0048] FIG. 32 is a side view of FIG. 31 . DETAILED DESCRIPTION OF THE INVENTION [0049] The device contains four handles, an adjustment strap, one or more locking bands, an inner sleeve, an outer sleeve, and a weighted portion. The weighted portion of the device is supported and protected by the surrounding inner and outer sleeves respectively—the former being heavily padded for personal protection, the latter, formulated to dampen sound and resist abrasion/dirt. It may be completely disassembled for cleaning and service. During use most of the invention is supported by the floor. Generally, as the exercise motion progresses, more of the weight section is removed or lifted from the floor, thus increasing the effective amount of weight being lifted. Often the user will wish to lift the device using both hands spaced apart and for such movements the invention will never touch the ground and the weight will not increase. It will, however, become unstable and thus challenge the muscles more. Often the user will wish to transform the invention into a weight vest; after it has been transformed, it will not touch the ground. Wearing it as a weight vest will increase personal weight and thus add strain on the muscles. [0050] To begin with FIG. 1 gives a basic understanding of how one might exercise with either the Prior Art or this assembled instant of invention (unit 3 combined with standard handle 4 ). FIG. 1 depicts a person developing their chest/triceps/core through a classic movement, the bench press. Beginning at position 1 and continuing on to position 2 , the weight will increase as this is a progressive style movement. While this progressive style movement is not exclusive to this instant of invention, the instability of the bar while in motion is. This invention produces the instability, resulting in additional muscle fiber recruitment and a higher level of fitness. Unit 3 may be 6-12 ft in length, but generally is 8 ft long. Unit 3 does come in various outside diameters to provide for a larger/heavier central mass. [0051] FIG. 2 illustrates a cross sectional view and a basic understanding of the internal components of the instant of invention. All but the weight unit 9 are made of flexible textiles. All but the weight unit 9 are easy to clean, sound dampening, and compressible. This compression is key as it makes for a more comfortable interface with the user. Strap 5 runs both perpendicular and horizontally. Weight unit 9 represents heavy anchor chain. This instant of invention is a means with which to turn ordinary items such as anchor chain into a wholly functional all encompassing workout device. [0052] FIGS. 3 , 4 , 5 , and 6 represent this invention's central mass's construction, unit 3 . FIG. 3 shows bands 5 and their general layout and unit 6 —a washable, sound dampening, flexible, sewable, non-abrasive, textile. Exercises may require an alternate means or a centrally located means with which to control the movement of unit 3 ; these secondary handles are produced by combining unit 10 , a rigid, light, plastic tube and bands 5 . Strap 13 is removable. Strap 13 and band 12 facilitate the invention's transformation into a weight vest. FIG. 4 shows unit 7 —a durable, flexible, sewable textile that will initially contain padding 8 and ultimately the bulk of the invention. FIG. 5 and FIG. 6 show this padding 8 . [0053] FIG. 10 illustrates an alternate cross-sectional view which is a similar construction until the weighted portion 20 , contained by unit 19 . Weighted portion 20 may be any small granular-like item, that when pressure is applied, it will slide past similar granular like items with limited resistance. Unit 19 may be any textile that is relatively impermeable and flexible, so as to prevent weighted portion 20 from escaping. Weighted portion 20 may be any suitable item; for example weighted portion 20 could be a series of large ball bearings which also would be contained within unit 19 . [0054] FIG. 7 illustrates how standard handles 4 are affixed to the central mass, unit 3 . FIG. 8 , a general layout of standard handle 4 ; unit 16 is built of coarse stretch-resistant, flexible, webbing. Standard handle 4 is designed not to limit a person's usage when the trajectory of a limb could become an issue with traditional exercise installations. Unit 11 is a Velcro type textile. FIG. 9 is a detailed drawing of standard handle 4 clasping mechanism. [0055] FIGS. 12 , 13 , and 14 show alternate handles. FIG. 12 may come in different lengths. Unit 21 is a standard rectangular metal ring. FIGS. 15 and 16 illustrate a metal ring assembly designed to facilitate interfacing with any Olympic-type bar, where a standard type handle 4 is not resilient enough. Device 22 is commonly known as a wire lock pin. [0056] FIGS. 17 and 18 show how this invention may be turned into a weight vest. This is appropriate when the individual decides to exercise where their hands must be free to perform other tasks, i.e. running, jumping, and pull-ups. Strap 13 puts tension on the vest to keep it snug. Band 12 combines with standard handle 4 to produce the rear portion. FIG. 19 shows a ‘suitcase dead lift’, and how band 12 and standard handle 4 may be once again combined, but this time to produce a progressive resistance tool with only a single interface. FIG. 20 through 22 illustrate three different ways with which to perform an exercise commonly known as a ‘dip’. The ‘dip’ is executed by suspending one's self between two parallel bars and carefully raising and lowering the body. It primarily works out the rear of the arm. The diversity represented here is made possible by the innovative nature of this invention, and how it may be incorporated into nearly any exercise in a number of ways. In FIG. 20 the user has decided to strictly increase the base resistance. In FIG. 21 the user has decided to increase the base resistance and incorporate an element of instability often found in the real world. In FIG. 22 , the individual has decided progressive resistance is best and attached a weight belt to the standard handle 4 . [0057] FIG. 23 through FIG. 27 represent not only the same muscle development, but also five ways with which to manipulate the resistance within this exercise, all without changing out the base invention. Common Prior Art does not allow for this variation. Again, the less mass in contact with the floor, the greater the progressive resistance. The resistance can be manipulated by simply sitting on the floor, a chair, or standing up. The incorporation of a dumbbell FIG. 26 , or the tandem operation on an Olympic-type lifting bar FIG. 27 will also provide other methods of manipulation. It is the pliable nature of standard handle 4 that allows for the flexibility of this invention. These represent five simple ways to either increase or decrease the amount of resistance a person manipulates. These options will be of particular importance to those who are in a limited training environment or struggling due to age, injury, or a debilitating handicap. [0058] FIG. 28 illustrates a ‘behind the head military press’. It is performed by holding onto an Olympic-type bar in an overhand grip and lifting it from behind the head to full extension above the head (muscles in both arms contract at the same time). Typically there will be a good deal of discomfort from this exercise and represented here by hash marks. This discomfort is due to a syndrome known as shoulder impingement and it can occur when there is too little room for the tendons to move properly. Without a full range of motion, the movement will often lead to injury. This causes most people to avoid any ‘behind the head military press’ exercises. The problem isn't with the exercise itself, but with all rigid bars that are associated with the movement. [0059] FIG. 29 illustrates how someone might avoid shoulder impingement entirely and still perform this elite exercise. In essence, the instant invention becomes a flexible bar, and the individual will benefit from a full range of motion. Additional weights may be hung from the standard handle 4 as needed. [0060] FIG. 30 shows an individual at the starting position of a ‘front squat’. The ‘front squat’ is performed by positioning one's self behind and slightly under an Olympic-type bar that is resting on a weight rack at chest height. Next, the individual will take hold of the bar in an overhand grip, and using only one's legs lift it from the rack. When standing erect in a neutral position, keeping one's elbows as far out in front as possible and allowing one's wrists and fingers to relax, the bar will come to rest on the individual's shoulders. This is the starting position, and raising and lowering one's self by means of one's legs will constitute a single repetition. ‘Front squats’ are considered to be one of the most effective weight training exercises, however, there is a great deal of physical pain associated with a ‘front squat’ (this discomfort is represented by the hash marks in FIG. 30 ). The discomfort comes from bruises or contusions to the shoulders and the hyperextension of the wrists and fingers. [0061] FIG. 31 demonstrates how someone can properly perform a ‘front squat’ and avoid the multiple contusions and hyperextensions. The weight rests in the same plane as before, but the arms and wrists retain a natural position. It is the essence of the instant of invention that permits this execution without the associated discomfort. FIG. 29 and FIG. 31 , 32 are also good examples of how someone might use the secondary handles.

The present invention, the Multifaceted Linear Training Device, is a pliable exercise device that allows the user to perform various resistance exercises. This exercise invention consists of a resilient pliable outer shell, a supple padded inner sheath, and a flexible weighted inner mass with a multitude of fastening straps and handles designed to enhance the strength training effectiveness of this device. These handles provide an ergonomic user interface for this resistance system and thus a unique method to exercise the entire body. When the straps and handles are combined, this innovative device may be transformed into a weight vest and worn during exercise. This multifaceted resistance system allows the user a choice of dead, dynamic, or progressive weight training options. This invention may also be integrated with free-weights and other traditional workout equipment to create new enhanced training exercises.

FIELD OF THE INVENTION [0001] This invention generally relates to a merchandising system that includes as a part of the system an improved gravity feed tray, which can be used for the storage, and gravity feed dispensing of bottles, cans, and other merchandise. BACKGROUND OF THE INVENTION [0002] Supermarkets and other retail settings typically utilize displays to store and dispense merchandise. Most of the display racks used in supermarkets and other retail stores are self-service displays. A common example of a self-service displays are found in supermarkets, convenience stores, and many other stores selling bottles or cans of soft drinks. Typically, the customer will select a bottle or can from the self-service display rack and then proceed to the checkout line without the help of store employees. [0003] Self-service display racks frequently implement a gravity feed configuration for the convenience of both the customer and store personnel. In typical gravity feed display racks, a shelf is tilted such that the rear edge of the shelf is above the front edge of the shelf thereby advancing items supported on the shelf toward the front edge due to gravity. In such a gravity feed configuration, the merchandise is readily accessible in a self-service manner to a customer in that it is positioned along the front edge of the shelf. This avoids the problem that it may be difficult for customers to reach bottles or merchandise on the rear or back of the shelf, particularly if the shelves are of significant depth or if several shelves are closely spaced together. [0004] Furthermore, typical gravity feed display racks are designed to automatically advance merchandise toward a front edge of the shelf after a customer has selected a product. This prevents the problem of having merchandise at the rear of the displays from being hidden from customers. [0005] Additionally, gravity feed display racks have proven to be advantageous when restocking merchandise. Gravity feed display racks allow store employees to readily ascertain whether the gravity feed tray needs to be restocked because if it was stocked the retail merchandise would be readily visible at the front edge of the gravity feed tray. Furthermore, if the merchandise on the gravity feed display rack needs to be restocked, the store employees can replenish the merchandise from the front edge or the rear edge because as the merchandise is added to the gravity feed display rack it will automatically advance toward the front edge of the shelf, which provides the additional advantage the employee restocking the merchandise will not need to keep rearranging the shelves as merchandise is added. [0006] One example of a conventional gravity feed tray includes a downwardly tilted planar support surface over which a feeder belt is arranged to slide. Such a gravity feed display shelf is disclosed and claimed in U.S. Pat. No. 4,128,177, which is herein incorporated by reference, issued Dec. 5, 1978. Another example of a conventional gravity feed tray is represented by U.S. Pat. No. 2,218,444, which is herein incorporated by reference, issued Oct. 15, 1940 which discloses a metal channel intended primarily for use in conjunction with milk bottles in refrigerators. This patent discloses alternative procedures for achieving the desired degree of tilt of the chute. [0007] Although, the conventional gravity feed trays described above have many advantages they are not without their faults. There are certain retail environments, such as commercial refrigerated cabinets or freezers, which have not been able to realistically incorporate conventional gravity feed trays. One reason for this is that conventional gravity feed trays fail to optimize the finite amount of space available in commercial refrigerators or freezer. As such, many retailers choose not to install conventional gravity feed trays in their freezers and refrigerators because they are unwilling to sacrifice valuable retail display space. [0008] Additionally, conventional gravity feed trays typically mount to shelving that is common in commercial refrigerated cabinets or freezers. The mounts of the conventional gravity feed systems typical couple with the retail shelving and the weight of the retail merchandise exerts a downward force on the mounts, which provides some prevention from having the mounts slide along the retail shelving. This design makes conventional gravity feed trays susceptible to dislodging. This is especially true when the conventional gravity feed trays are not fully stocked with retail merchandise and therefore there is little downward force being applied by the weight of the retail merchandise to keep the mounts of the gravity feed tray from dislodging from the retail shelving. A problem can occur if a mount dislodges before loading because it can cause the immediate collapse of the gravity feed tray. Likewise, if a conventional gravity feed system uses multiple mounts if one of them becomes dislodged or partially dislodged the weight of the retail merchandise will be applied to the non-dislodged mount which will cause excess strain on the non-dislodged mount. Over time, the strain on the non-dislodged mount can cause the non-dislodged mount to deform, in which case the retailor has to incur the cost of replacing the non-dislodged mount or the entire conventional gravity feed tray. In addition, the deformation of the mounts raises safety concerns for retailors due to the fact customers and employees routinely place their hands and arms below loaded gravity feed trays to restock or select retail merchandise. As a result, many retailers have not incorporated conventional gravity feed trays into their stores due to the financial and safety concerns raised above. [0009] Accordingly, there is a need in the art for a gravity feed tray that can be readily incorporated into a refrigerated cabinet or a freezer and maximize the limited amount of space available; is prevented from inadvertently dislodging from mount shelving; and remains in a cantilevered position even while holding heavy loads of retail merchandise for extended periods of time. [0010] The invention provides such a gravity feed tray. These and other advantages of the invention, as well as additional inventive features, will be apparent from the description of the invention provided herein. BRIEF SUMMARY OF THE INVENTION [0011] In one aspect, the invention provides a gravity feed tray. An embodiment of the gravity feed tray according to this aspect includes a first support and a second support structure in an opposed spaced relationship. The first support and the second support are coupled to a u-bracket. The first and second support structures having inwardly extending flanges and the first support structure having a first mount and the second support structure having a second mount. The first and second mounts being capable of coupling to a retail display bar to support the first and second support structures as cantilevered extensions. The gravity feed tray may include a bar lock located on the second support structure that prevents the inadvertent dislodging of the gravity feed tray from the retail display bar. The first support structure and the second support structure may act to define a merchandise channel where the inwardly extending flanges project into the merchandise channel. The bar lock on the first support structure may also be adjusted to accommodate for retail display bars of varying dimensions. The first mount and the second mount on the first and second support structures may take the form of hooks. [0012] In another aspect, the invention provides gravity feed tray. The gravity feed tray having a first support structure and a second support structure that can mount to a retail display. The first support and the second support act to define a merchandise channel and the first support having a first flange and the second support having a second flange that project inwardly into the merchandise channel and provide a retail display surface. The first support structure may have a first mount and the second support structure may have a second mount that couple to a retail display bar and support the first and second support structure as cantilevered extensions. In addition, the width of the merchandise channel may be adjustable. Furthermore, the gravity feed tray may have half of the volume of the retail merchandise displayed on the retail display surface be located below the retail display surface. The gravity feed tray may also include a bar lock that acts to prevent the inadvertent dislodging of the gravity feed tray from the retail display bar. In addition, the first and second mounts may include an adjustable aperture for receiving retail display bars of varying dimensions. The gravity feed tray may also have first and second mounts that have an aperture that is adjustable to accommodate for retail display bars having different height or width dimensions. [0013] In yet another aspect, the invention provides a gravity feed tray having a first support and a second support structure where the first support structure has a first mount and the second support structure has a second mount. The first support structure and the second support structure having inwardly extending flanges that project into a merchandise channel and provide a retail merchandise display surface. The gravity feed tray may have a bar lock having a first position and a second position where the first position allows the first and second mount to couple with a retail display bar and the second position prevents the first and second mount from decoupling with a retail display bar. The first and second support structures can have a first and second bar lock aperture where the first bar lock aperture is located above the second bar lock aperture on the first and second support structures. The bar lock being removable from the first bar lock aperture and capable of being inserted into the second bar lock aperture on the first and second support structures. The gravity feed tray having a contact surface area between the retail merchandise and the retail display surface is less than ten percent of the total surface area of the outside of the retail merchandise being displayed. The gravity feed tray capable of displaying retail merchandise having top portion, a middle portion, and a bottom portion where the top portion and bottom portion have a diameter that is greater than the diameter of the middle portion and only the middle portion of the retail merchandise has a contact surface area with the retail display surface. [0014] Other aspects, objectives and advantages of the invention will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0015] The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention and, together with the description, serve to explain the principles of the invention. In the drawings: [0016] FIG. 1 A is a perspective view of the gravity feed tray displaying merchandise in a retail setting according to one embodiment of the present invention; [0017] FIG. 1 B is a side view of the gravity feed tray displaying merchandise in a retailing setting illustrated in FIG. 1 A; [0018] FIG. 2 is a cross sectional perspective view of a gravity feed tray according to one embodiment of the present invention; [0019] FIG. 3 is a cross sectional perspective view of the gravity feed tray shown in FIG. 2 ; [0020] FIG. 4 is a top perspective view of a gravity feed tray according to one embodiment of the present invention; [0021] FIG. 5 is a bottom perspective view of the gravity feed tray of FIG. 4 ; [0022] FIG. 6 is a top view of the gravity feed tray of FIG. 4 ; [0023] FIG. 7 is a bottom view of the gravity feed tray of FIG. 4 ; [0024] FIG. 8 is a side-view of the gravity feed tray of FIG. 4 ; [0025] FIG. 9 is a side-view of the opposing side of the gravity feed tray illustrated in FIG. 8 ; [0026] FIG. 10 is an exploded view of a gravity feed tray according to one embodiment of the present application; [0027] FIG. 11 is a front view of the gravity feed tray of FIG. 4 ; [0028] FIG. 12 is a rear view of the gravity feed tray of FIG. 4 ; and [0029] FIG. 13 is a perspective view of a gravity feed tray according to one aspect of this invention in a retail environment illustrating a first piece of retail merchandise being selected from the gravity feed tray. [0030] While the invention will be described in connection with certain preferred embodiments, there is no intent to limit it to those embodiments. On the contrary, the intent is to cover all alternatives, modifications and equivalents as included within the spirit and scope of the invention as defined by the appended claims. DETAILED DESCRIPTION OF THE INVENTION [0031] FIG. 1A illustrate a gravity feed tray 10 according to one embodiment of the present invention. The first support structure 100 has a first support mount 114 and the second support structure 200 has a second support mount 214 , as best illustrated in FIGS. 2-3 . In use, a retail display bar 900 can be inserted into an aperture 116 of the first support mount 114 and an aperture 216 of second support mount 214 . The first and second support structures 100 and 200 then support the gravity feed tray 10 as it hangs as a cantilevered extension from the retail display bar 900 . The movement of the retail merchandise 930 , 940 , and 950 is from the rear edge 250 of the gravity feed tray 10 to the front edge 150 of the gravity feed tray is generally indicated at 20 . [0032] As the gravity feed tray 10 hangs as a cantilevered extension from the retail display bar 900 it can be loaded with retail merchandise, 930 , 940 , and 950 . In FIG. 1 A, the retail merchandise is represented by a first, second, and third soda bottle, 930 , 940 , and 950 respectively. Typically, soda bottles and other retail merchandise have a bottom portion 980 having a large diameter, a middle or neck portion 975 having a smaller diameter, and a top portion 970 having a diameter that is typically less than the bottom portion 980 , but larger than the middle or neck portion 975 diameter. This allows the gravity feed tray 10 to display soda bottles, water bottles, etc. while not taking up a great deal of space because the gravity feed tray 10 does not need to have a large contact area 955 (See FIG. 1B ) with the retail merchandise 930 , 940 , and 950 . In this manner the gravity feed tray 10 can display the retail merchandise 930 , 940 , and 950 while taking up a minimal amount of retail space until a self-service customer selects one of the pieces of retail merchandise 930 , 940 , and 950 for purchase. [0033] FIG. 1 B is a side view of the gravity feed tray 10 displaying retail merchandise 930 , 940 , and 950 in a retail environment. As illustrated, the gravity feed tray 10 is forwardly and downwardly inclined when couple with retail display bar 900 . The amount that the first and second support structures 100 and 200 (See FIG. 4 ) are forwardly and downwardly inclined is generally represented as θ. [0034] As will be appreciated by one of ordinary skill in the art the angle θ required by the first and second support structure 100 and 200 will depend on a number of factors, such as but not limited to, the weight of the retail merchandise 930 , 940 , and 950 , the contact area 955 between the retail merchandise 930 , 940 , and 950 , and the coarseness of the inwardly extending flanges 104 and 204 as well as the coarseness of the surface of the retail merchandise being displayed by the gravity feed tray 10 , etc. In one embodiment, the angle θ could be in the range between 5° and 45°. However, as will be understood by one of ordinary skill in the art the angle θ that the first and second support structures 100 and 200 extend from the retail display bar 900 are not limited to the range between the range of 5° and 45° and may be any angle θ selected by the user. [0035] Turning to FIG. 3 , which generally illustrates the first support structure 100 of the gravity feed tray 10 . As illustrated, the first support structure 100 has an inwardly extending flange 104 . The inwardly extending flange 104 runs the length of the first support structure 100 and has a rear upturned end 106 and a front upturned end 108 . [0036] Turning back to FIG. 2 , which generally illustrates the second support structure 200 of the gravity feed tray 10 . As illustrated, the second support structure 200 also has an inwardly extending flange indicated by 204 . The inwardly extending flange 204 runs the length of the second support structure 200 and has a rear upturned end 206 and front upturned end 208 . [0037] As will be appreciated by those of ordinary skill in the art the coarseness of the material selected for the first and second support structures 100 and 200 and in particular the inwardly extending flanges 104 and 204 is important because the gravity feed tray 10 relies on the force of gravity to shift the retail merchandise 930 , 940 , and 950 to the front edge 150 of the merchandise channel 30 when the first piece of retail merchandise 930 is selected by a customer. Therefore, if the material selected for the first and second support structures 100 and 200 and in particular the inwardly extending flanges 104 and 204 is too course the force of gravity may be unable to overcome the force of friction created between the inwardly extending flanges 104 and 204 and the contact surface area of the retail merchandise 970 . Therefore, as will be appreciated by those of ordinary skill in the art, one embodiment of the gravity feed tray 10 according to the application may incorporate a brushed metal for the first and second support structures 100 and 200 and the inwardly extending flanges 104 and 204 , such as, but not limited to brushed stainless steel, brushed aluminum, or brushed nickel. As will be understood by those of ordinary skill in the art brushed metals provide many advantages such as providing a surface that is relatively course, is mechanically strong, and is easy to clean and maintain. [0038] FIG. 2 also illustrates the bar lock 600 . In the illustrated embodiment the bar lock 600 is coupled to the second support structure 200 . However, as will be understood by those of ordinary skill in art other embodiments may have the bar lock 600 on the first support structure 100 or any other suitable component of the gravity feed tray 10 . For example, as best illustrated in FIG. 10 , the first support structure 100 has a bottom bar lock aperture 801 and top bar lock aperture 802 and the second support structure 200 also has a bottom bar lock aperture 803 and a top bar lock aperture 804 . As will be understood by those having ordinary skill in the art the bar lock 600 can be decoupled from any one of the bar lock apertures 801 , 802 , 803 , or 804 and be then be coupled to any one of the other bar lock apertures 801 , 802 , 803 , or 804 of the users choosing. As will readily be recognized by one of skill in the art the ability to couple and decouple the bar lock 600 from bar lock apertures 801 , 802 , 803 , and 804 that have different locations or positions on the gravity feed tray 10 allows the bar lock 600 to lock retail display bars 900 with varying dimensions. Furthermore, as will also be appreciated by those of ordinary skill in the art the bar lock apertures 801 , 802 , 803 , and 804 are not limited to their position or placement in the illustrated embodiment and those of skill in the art will readily recognize that bar lock apertures may be positioned on any suitable place of the gravity feed tray 10 that allows for the bar lock 600 to prevent the gravity feed tray 10 from inadvertently dislodging from the retail display bar 900 . [0039] As illustrated, a user will position the retail display bar 900 within the mount 214 of the second support structure 200 and the bracket 300 . Once the retail display bar 900 is positioned within the mount 214 and the bracket 300 the user can rotate the bar lock 600 until the triangular projection 602 of the bar lock is aligned flush with the bottom of the retail display bar 900 . After the bar lock 600 is rotated to have the triangular projection 602 aligned flush with the bottom edge 902 of the retail display bar 900 the user can tighten the fastener 700 , which will prevent further rotation of the bar lock 600 . Once the fastener 700 is tightened with the triangular projection 602 of the bar lock 600 flush with the bottom of the retail display bar 902 the mount 214 and the bracket 300 will not be able to be dislodged from the retail display bar 900 . As will be understood by those of ordinary skill in the art the user can remove the gravity feed tray 10 from the retail display bar 900 by untightening fastener 700 and rotating the bar lock 600 until it is no longer flush with the bottom edge 902 of the retail display bar 900 , which will provide clearance for the user to lift the mount 214 and bracket 300 from the retail display bar 900 . [0040] Turning to FIG. 4 and FIG. 5 , which respectively illustrate a top perspective view and a bottom perspective view of one embodiment of the gravity feed tray 10 according to the invention. As illustrated, the first and second support structures 100 and 200 are coupled to bracket 300 . As those of ordinary skill in the art will readily recognize bracket 300 performs the function of acting as an additional support to the first and second support structures 100 and 200 as well as acting as a spacer between the first and second support structure 100 and 200 to define the merchandise channel 30 . [0041] FIG. 4 and FIG. 5 also illustrate the flip scan and plate label holder 400 , where merchants can place information about the retail merchandise being displayed by the gravity feed tray 10 such as, but not limited to, the product name, price, bar code, QR code, etc., as best illustrated in FIG. 13 . The illustrated embodiment also shows label support 500 , which acts to secure the label holder 400 to the gravity feed tray 10 and supports the label holder 400 so that it faces towards potential customers, which allows the customers to easily view the information contained on the label holder 400 . Furthermore, as best illustrated in FIG. 12 , the flip scan and plate label holder 400 is movable in a vertical direction, such that when a customer selects a piece of retail merchandise 930 , 940 , and 950 from the merchandise channel 30 the flip scan and plate label holder can swing up vertically so that it does not interfere with the removal of the first piece of retail merchandise 930 and then swing back down to its original position to front face the next customer and provide that customer with the information the retailor has displayed on the flip scan and plate label holder 400 . [0042] FIG. 2 also illustrates the bar lock 600 . In the illustrated embodiment the bar lock 600 is coupled to the second support structure 200 . However, as will be understood by those of ordinary skill in art other embodiments may have the bar lock 600 on the first support structure 100 or any other suitable component of the gravity feed tray 10 . For example, as best illustrated in FIG. 10 , the first support structure 100 has a bottom bar lock aperture 801 and top bar lock aperture 802 and the second support structure 200 also has a bottom bar lock aperture 803 and a top bar lock aperture 804 . As will be understood by those having ordinary skill in the art the bar lock 600 can be decoupled from any one of the bar lock apertures 801 , 802 , 803 , or 804 and be then be coupled to any one of the other bar lock apertures 801 , 802 , 803 , or 804 of the users choosing. As will readily be recognized by one of skill in the art the ability to couple and decouple the bar lock 600 from bar lock apertures 801 , 802 , 803 , and 804 that have different locations or positions on the gravity feed tray 10 allows the bar lock 600 to lock retail display bars 900 with varying dimensions. Furthermore, as will also be appreciated by those of ordinary skill in the art the bar lock apertures 801 , 802 , 803 , and 804 are not limited to their position or placement in the illustrated embodiment and those of skill in the art will readily recognize that bar lock apertures may be positioned on any suitable place of the gravity feed tray 10 that allows for the bar lock 600 to prevent the gravity feed tray 10 from inadvertently dislodging from the retail display bar 900 . [0043] As illustrated, a user will position the retail display bar 900 within the mount 214 of the second support structure 200 and the bracket 300 . Once the retail display bar 900 is positioned within the mount 214 and the bracket 300 the user can rotate the bar lock 600 until the triangular projection 602 of the bar lock is aligned flush with the bottom of the retail display bar 900 . After the bar lock 600 is rotated to have the triangular projection 602 aligned flush with the bottom edge 902 of the retail display bar 900 the user can tighten the fastener 700 , which will prevent further rotation of the bar lock 600 . Once the fastener 700 is tightened with the triangular projection 602 of the bar lock 600 flush with the bottom of the retail display bar 902 the mount 214 and the bracket 300 will not be able to be dislodged from the retail display bar 900 . As will be understood by those of ordinary skill in the art the user can remove the gravity feed tray 10 from the retail display bar 900 by untightening fastener 700 and rotating the bar lock 600 until it is no longer flush with the bottom edge 902 of the retail display bar 900 , which will provide clearance for the user to lift the mount 214 and bracket 300 from the retail display bar 900 . [0044] Turning to FIG. 6 and FIG. 7 , which respectively illustrate a top-down and bottom-up view of the gravity feed tray 10 according to one embodiment of the invention. As illustrated, the merchandise channel 30 has a width 921 defined by the first and second support structures 100 and 200 . In one embodiment the merchandise channel 30 may have a width 921 between 3.40 and 5.75 cm. However, as will be readily recognized by those of ordinary skill in the art the merchandise channel 30 is not limited to this range and may be smaller than 3.40 cm or larger than 5.75 cm depending on the type of retail merchandise 930 , 940 , 950 , being displayed within the gravity feed tray 10 . [0045] Next, the inwardly extending flanged 104 and 204 form a support and display surface for the retail merchandise 930 , 940 , and 950 . In the illustrated embodiment the inwardly extending flanges 104 and 204 have a width 923 between 0.85 cm and 1.70 cm. However, as will be readily recognized by those of ordinary skill in the art the widths 923 of the inwardly extending flanges 104 and 204 are not limited to the range between 0.85 cm and 1.70 cm and can readily be made smaller than 0.85 cm or larger than 1.70 cm depending on the type of retail merchandise 930 , 940 , and 950 being displayed within the gravity feed tray 10 . Further, although the widths 923 of the inwardly extending flanges 104 and 204 are represented as being the same size in the illustrated embodiment the inwardly extending flanges 104 and 204 are not limited to being the same size and flange 104 could be larger than flange 204 and vice versa. [0046] Next, the distance between the inwardly extending flanges 104 and 204 defines a merchandise track gauge 922 . As illustrated, the merchandise track gauge 922 is between 1.70 cm and 3.38 cm. However, as will be readily recognized by those of ordinary skill in the art the merchandise track gauge 922 is not limited to this range and may be smaller than 1.70 cm or larger than 3.38 cm depending on the type of retail merchandise 930 , 940 , and 950 being displayed within the gravity feed tray 10 . [0047] As best illustrated in FIG. 10 , the first support structure 100 and the second support structure 200 are coupled to a bracket 300 . In the illustrated embodiment the first and second support 100 and 200 are coupled to the bracket 300 via mig weld. As will be appreciated by those having skill in the art a mig welding will provide a mechanically strong and relatively inexpensive coupling between the first and second support structures 100 and 200 and the bracket 300 . However, as will also be appreciated by those of ordinary skill in the art the first and second support 100 and 200 may be coupled to the bracket 300 by any means generally known in the art. Furthermore, those of ordinary skill in the art that the bracket 300 both provides structural support to the first and second support 100 and 200 and also acts as a spacer between the first and second support 100 and 200 and helps define the width 921 of the merchandise channel 30 . [0048] Furthermore, as best illustrated in FIGS. 2-3 and 6 , the gravity feed tray may also have a first half u-brace 110 located on the first support structure 100 and a second half u-brace 210 located on the second support structure. In the illustrated embodiment the first half u-brace 110 is incorporated into the first support structure 100 and the second half u-brace 210 is incorporated into the second support structure 200 . In some embodiments the first u-brace 110 and the second u-brace 210 can then be coupled together via mechanical means such as, but not limited to, mig welding. Although, the illustrated embodiment show the first half u-brace 110 being a part of the first support structure 100 and the second half u-brace 210 being part of the second support structure 200 those of ordinary skill in the art will understand that a u-brace does not have to be formed from two parts and can easily be formed from a single piece or a multitude of pieces that couple to the first support structure 100 and the second support structure 200 and provide structural support and act as a spacer between the first and second support structures 100 and 200 . [0049] Turning to FIG. 8 and FIG. 9 , which respectively represent a first side view of one embodiment of the gravity feed tray 10 and a second side view of the gravity feed tray 10 opposite the first side view. As illustrated, the length 920 of the gravity feed tray 10 is generally defined by the length of the first and second support structure 100 and 200 . In one embodiment the length 920 of the first and second support structure 100 and 200 can be in the range of 35.74 cm and 70.84 cm. However, as will be readily recognized by those of ordinary skill in the art the length 920 of the first and second support structure 100 and 200 is not limited to this range and may be smaller than 35.74 cm or larger than 70.84 cm depending on the type and amount of retail merchandise 930 , 940 , and 950 the user wants to display using the gravity feed tray 10 . [0050] FIGS. 8 and 9 also illustrate the first and second forward spacers 112 and 212 . As best illustrated in FIG. 1B . The first and second forward spacers 112 and 212 can act to support the label support 500 . In addition, as best illustrated in FIG. 13 the first and second forward spacers 112 and 212 provide front aperture 807 that allows a customer to remove a piece of retail merchandise 930 , 940 , or 950 from the gravity feed tray 10 . [0051] Next, the retail display mounts 114 and 214 of the first and second support structures are illustrated. The mounts 114 and 214 have respective apertures 116 and 216 to insert the retail display bar 900 . In the illustrated embodiment the apertures 116 and 216 have an opening between 2.21 cm and 4.40 cm. However, as will be readily recognized by those of ordinary skill in the art the apertures 116 and 216 are not limited to the range between 2.21 cm and 4.40 cm and can readily be made smaller than 2.21 cm or larger than 4.40 cm depending on the retail display bar 900 used to mount the gravity feed tray 10 . Further, although the apertures 116 and 216 are illustrated as having the same dimensions apertures 116 and 216 are not limited to having the same dimensions and aperture 116 could be larger or smaller than aperture 216 and vice versa. [0052] Turning to FIG. 11 , the front edge 150 of the gravity feed tray 10 is illustrated. As best illustrated in FIG. 11 , the first support structure 100 has a front upturned end 108 and the second support structure 200 has a second front upturned end 208 . In one embodiment the front upturned ends 108 and 208 can extend angularly upward from the inwardly extending flanges 104 and 204 at a height 928 between range of 2.55 cm and 5.07 cm. However, as will be understood by one of ordinary skill in the art the height 928 of the front upturned ends 106 and 206 is not limited to the above range and can be below 2.55 cm or above 5.07 cm as required by the user. The front upturned ends 106 and 206 act to prevent the second and third piece of retail merchandise 940 and 950 in the retail channel 30 from inadvertently dislodging from the merchandise channel 30 when the first piece of retail merchandise 930 is removed 930 from the retail merchandise display 30 and the second and third pieces of retail merchandise are shifted toward the front edge 998 of the retail merchandise channel 30 by gravitational force (See FIG. 13 ). [0053] Turning to FIG. 12 , the rear edge 250 of the gravity feed tray 10 is illustrated. FIG. 12 best illustrates that the first support structure 100 also has a first rear upturned end 106 and the second support structure 200 has a second rear upturned end 206 . In one embodiment the rear upturned ends 106 and 206 can extend angularly upward from the inwardly extending flanges 104 and 204 at a height 927 between the range of 0.85 cm and 1.69 cm. However, as will be understood by one of ordinary skill in the art the height 927 of the rear upturned ends 106 and 206 is not limited to the above range and can be below 0.85 cm or above 1.69 cm as required by the user. As will also be understood by those of ordinary skill in the art the rear upturned ends 106 and 206 will typically have a smaller angular height than the front upturned ends 108 and 208 because the front upturned ends 108 and 208 act to prevent the dislodging of the retail merchandise 930 , 940 , and 950 under the force of gravity. However, as will also be appreciated by one of ordinary skill in the art the rear upturned ends 106 and 206 can act to prevent retail merchandise 930 , 940 and 950 from dislodging from the rear edge 250 of the merchandise channel 30 when the retail merchandise 930 , 940 , and 950 is being stocked from the front edge 150 of the merchandise channel 30 . [0054] Turning to FIG. 12 , which illustrates a gravity feed tray 10 according to one aspect of this invention in a typical retail environment. As illustrated, the gravity feed tray 10 is displaying retail merchandise 930 , 940 , and 950 that are represented as typical soda bottles. In use, the user will position the first and second mount openings 116 and 216 to receive the retail display bar 900 . With the first and second mounts 114 and 214 now in contact with the retail display bar 900 the first and second support structures 100 and 200 support the gravity feed tray 10 as a cantilevered extension. Once in position and secured to the gravity feed tray 10 the gravity feed tray 10 can be loaded with retail merchandise 930 , 940 , and 950 . In FIG. 13 the retail merchandise 930 , 940 , and 950 is represented by soda bottles. [0055] After the gravity feed tray 10 is secured to the retail display bar 900 can then load retail merchandise 930 , 940 , and 950 into the merchandise channel 30 . Within the merchandise channel 30 the first and second support flanges 104 and 204 prevent the retail merchandise 930 , 940 , and 950 from falling from the merchandise channel 30 . The user may place the first piece of retail merchandise 930 into the merchandise channel 30 from the forward edge 150 or the rear edge 250 of the merchandise channel 30 . As the user releases the first piece of retail merchandise 930 into the merchandise channel 30 the downward angle of the first and second support flanges 104 and 204 cause the retail merchandise 930 , 940 , and 950 to slide forward until the retail merchandise reaches the front edge 150 of the merchandise channel 30 . [0056] After the gravity feed tray 10 has been loaded with retail merchandise 930 , 940 , and 950 a customer can select the first piece of retail merchandise 930 that is located at the front edge of the merchandise channel 30 . When the customer selects the first piece of retail merchandise 930 from the merchandise channel 30 it will be removed from the merchandise channel 30 at a slightly upward direction 999 . Once the first piece of retail merchandise 930 is selected from the merchandise channel 30 the second and third piece of retail merchandise 940 and 950 will shift forward by the force of gravity 998 until the second piece of retail merchandise 940 abuts the front edge 150 of the retail merchandise channel 30 and fills the space left vacant by the first piece of retail merchandise 930 that has been selected by the customer. Therefore, as long as the gravity feed tray 10 remains stocked with retail merchandise 930 , 940 , and 950 apiece of retail merchandise 930 , 940 , and 950 will always be at the front edge 150 of the merchandise channel 30 where it can easily be identified and selected by customers. [0057] All references, including publications, patent applications, and patents cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein. [0058] The use of the terms “a” and “an” and “the” and similar referents in the context of describing the invention (especially in the context of the following claims) is to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention. [0059] Preferred embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Variations of those preferred embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.

A gravity feed tray is provided for use as a component of a display device for retail merchandise such as bottled soft drinks or water in a retail setting. The gravity feed tray includes a first and second support structure that are forwardly and downwardly inclined when coupled to a retail display bar. The first and second support structures having inwardly extending flanges that project into a merchandise channel formed by the first and second support structures. The inwardly extending flanges provide a surface to display retail merchandise. The support surfaces being disposed downwardly and forwardly along a straight line so that rows of retail merchandise, such as bottles, may be stocked in the merchandise channel and supported by the inwardly extending flanges, whereby removal of the bottle at the front end of the merchandise channel causes a void that the remaining bottles fill by sliding via gravitational force.

RELATED APPLICATIONS [0001] This application is a continuation-in-part of U.S. patent application Ser. No. 12/276,068 filed on Nov. 21, 2008, and entitled “Systems and Method for Therapeutic Electrical Stimulation” and claims the benefit of U.S. Provisional Application No. 61/019,489 filed on Jan. 7, 2008 entitled “Systems and Method for Therapeutic Electrical Stimulation,” the entirety of which are hereby incorporated by reference. BACKGROUND [0002] Low-power electrical stimulation has been found to have various therapeutic uses. One example of low-power electrical stimulation is transcutaneous electrical nerve stimulation (“TENS”). TENS devices typically operate by generating low-power electrical impulses that are supplied to the skin of a patient through electrodes. The electrical impulses have been found to diminish or completely relieve pain previously felt by a patient. [0003] There are two primary theories for the effectiveness of TENS devices. The first theory is the Gate Control Theory. In this theory, the mild electrical stimulation is thought to relieve pain in a similar way as when an injured area is manually rubbed. Rubbing acts to mask the pain from the injury. Similarly, when electrical impulses pass through the skin they pass through portions of the peripheral nervous system. The electrical impulses reduce the transmission of pain messages, thereby diminishing or completely relieving pain. [0004] A second theory is the Endorphin Release Theory. This theory states that the electrical impulses from the TENS device cause mild to moderate muscle twitching in the body. The body responds to the muscle twitching by producing natural pain relievers called endorphins, thereby diminishing or completely relieving the pain. [0005] In addition to TENS, electrical stimulation has also been found to be useful for other therapies. Examples include edema reduction, wound healing, iontophoresis drug delivery, muscle stimulation, and interferential current therapy. [0006] Currently available TENS devices are subject to several drawbacks that impair their usability for a patient. For example, some devices are bulky and have many wires that get tangled or in the way of the user. The wiring and bulky housings of some current TENS devices can also be obtrusive and embarrassing for a user to wear in public. In addition, many devices are complex and lack a simple, user-friendly connection mechanism between controller and electrodes to allow a user to easily connect or disconnect the device. The drawbacks of current TENS devices prevent a user from seamlessly integrating electrical stimulation therapy into their everyday lives. SUMMARY [0007] In general terms, this disclosure is directed to therapeutic electrical stimulation and addresses various shortcomings with currently available electrical stimulation technologies. In one aspect, the systems, devices and methods disclosed herein provide improved usability of electrical stimulation devices. Certain embodiments of the present disclosure provide a therapeutic electrical stimulation device that is user friendly and easy to wear, comprising a controller for providing electrical signals for electrical stimulation of the patient and an electro mechanical intermediate connector arranged to convey the electrical signals from the controller to the patient. The controller includes a power source, an electrical signal generator, and a receptacle, wherein the electrical signal generator is electrically coupled to the power source, and wherein the electrical signal generator generates electrical signals that are provided to a conductor associated with the receptacle. In certain embodiments, the electro mechanical connector is an interconnecting patch. An exemplary patch includes a shoe, an insulating layer, and electrodes, wherein the shoe is removably mechanically connected to the controller at the receptacle, the shoe is electrically coupled to the conductor at the receptacle, and the electrodes are electrically coupled to the shoe. [0008] Another aspect is a more user friendly controller for a therapeutic electrical stimulation device, the controller comprising a power source including a rechargeable battery; an electrical signal generator powered by the power source and generating an electrical signal, and a receptacle including at least one conductor. The conductor is electrically coupled to the electrical signal generator to receive the electrical signal. The receptacle is arranged and configured to receive a portion of an electro mechanical interconnecting patch to electrically couple a portion of the patch with the conductor. [0009] Yet another aspect is a patch for a therapeutic electrical stimulation device, the patch comprising an insulating layer having a first side and a second side; a shoe connected to the first side of the patch and including at least two conductors, wherein the shoe is configured for insertion into a receptacle of a controller of the therapeutic electrical stimulation device; at least two electrodes adjacent the second side of the patch, wherein each conductor is electrically coupled to one of the electrodes; and an adhesive layer connected to the second side of the insulating layer. [0010] A further aspect is a method of connecting a patch with a controller of a therapeutic electrical stimulation device, the method comprising advancing the controller in a first direction toward that patch to insert a shoe of the patch into a receptacle of the controller; and advancing the controller in a second direction to cause the controller to engage with the shoe. [0011] Another aspect is a method of adjusting the operation of a therapeutic electrical stimulation device, the method comprising operating the therapeutic electrical stimulation device in a first mode by executing a first firmware algorithm; downloading a second firmware algorithm; installing the second firmware algorithm onto the therapeutic electrical stimulation device; and executing the second firmware algorithm to operate the therapeutic electrical stimulation device in a second mode. [0012] A further aspect is a docking station comprising a housing; a slot in the housing arranged and configured to receive a therapeutic electrical stimulation device; a power source for supplying power to a therapeutic electrical stimulation device to recharge a battery; and a data communication device for communicating between the therapeutic electrical stimulation device and a communication network. [0013] In one aspect a system is provided for delivering therapeutic electrical stimulation. The system includes a patient interface component, a controller component that provides signals for electrical stimulation, and an intermediate electro-mechanical connection component positioned between the patient interface component and the controller component. The intermediate component matingly engages with the controller component and includes conducting lines that interface with leads in the controller component to provide electrical communication between the patient interface and the controller component. Each component has a useful life that is determined either by the device supplier, government regulation, or by natural wear and tear of the component itself. In certain embodiments, the useful life of the component is predetermined prior to initial use or sale of the component, and it is replaced upon expiration of the useful life. In some implementations, the predetermined useful life coincides with a period established by regulatory or other administrative authority by paying for or reimbursing for such component. In some embodiments, such predetermined useful life is shorter than the period in which the component becomes physically worn out or inoperable. [0014] In certain embodiments, the patient interface component has a useful life that is shorter than the useful life of the intermediate component, and the intermediate component has a useful life that is shorter than that of the controller component. In certain embodiments, the controller component has a useful life of about five years, the intermediate component is a multiuse component having a useful life of about six months or less, and the interface component is a single use disposable. [0015] In one aspect, the system provides an electro-mechanical interface between the patient and an electro stimulation source. In certain embodiments, the interface has disposable and reusable component. In certain implementations, the electromechanical interface is formed from at least two disposable components, with each having a useful life of different length than that of the other. In some embodiments, the system provides a disposable patient contact layer, a disposable/reusable intermediate module, and a reusable controller. [0016] A further aspect is a garment that carries the components and is adapted to position the patient interface component against the patient. [0017] Yet another aspect is a controller component that has a receptacle with a least one conductor, the conductor is electrically coupled to an electrical signal generator to receive the electrical signal. The receptacle is configured to receive a portion of the intermediate component to electrically couple a portion of the intermediate component with the conductor. [0018] In another aspect, the intermediate component is a patch, the patch comprising a shoe connected to at least one insulating layer and including at least one conductor, wherein the shoe is configured for insertion into the receptacle of the controller component. [0019] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used in any way as to limit the scope of the claimed subject matter. DESCRIPTION OF THE DRAWINGS [0020] FIG. 1 is a perspective top view of an example therapeutic electrical stimulation device. [0021] FIG. 2 is a perspective top view of the controller of the therapeutic electrical stimulation device shown in FIG. 1 . [0022] FIG. 3 is a top plan view of the controller of the therapeutic electrical stimulation device shown in FIG. 1 . [0023] FIG. 4 is a front view of the controller of the therapeutic electrical stimulation device shown in FIG. 1 . [0024] FIG. 5 is an exploded perspective view of the controller of the therapeutic electrical stimulation device shown in FIG. 1 . [0025] FIG. 6 is a perspective top view of a shoe of the therapeutic electrical stimulation device shown in FIG. 1 . [0026] FIG. 7 is a side plan view of a shoe of the therapeutic electrical stimulation device shown in FIG. 1 . [0027] FIG. 8A is an exploded perspective view of a shoe of the therapeutic electrical stimulation device shown in FIG. 1 . [0028] FIG. 8B is a front view of a shoe of the therapeutic electrical stimulation device shown in FIG. 1 [0029] FIG. 9 is a perspective view of the therapeutic electrical stimulation device shown in FIG. 1 . [0030] FIG. 10A is a side cross-sectional view of the therapeutic electrical stimulation device before connection. [0031] FIG. 10B is a side cross-sectional view of the therapeutic electrical stimulation device shown in FIG. 9 after connection. [0032] FIG. 11 is a block diagram of an example shoe of the therapeutic electrical stimulation device shown in FIG. 1 attached to a generic structure. [0033] FIG. 12 is a perspective top view of another example therapeutic electrical stimulation device. [0034] FIG. 13 is an exploded perspective view of the therapeutic electrical stimulation device shown in FIG. 12 . [0035] FIG. 14 is a right side cross-sectional view of the device shown in FIG. 12 , including a controller that is disconnected from a patch. [0036] FIG. 15 is a right side cross-sectional view of the device shown in FIG. 14 with the controller being arranged over the patch. [0037] FIG. 16 is a right side cross-sectional view of the device shown in FIG. 14 with the controller being connected with the patch. [0038] FIG. 17 is a perspective top view of the device shown in FIG. 12 in a partially assembled configuration. [0039] FIG. 18 is a block diagram of an electrical schematic for the controller shown in FIG. 14 . [0040] FIG. 19 is an electrical schematic of an exemplary circuit for the controller shown in FIG. 14 . [0041] FIG. 20 is another block diagram of an electrical schematic for the controller shown in FIG. 14 . [0042] FIG. 21 is another electrical schematic of an exemplary circuit for the controller shown in FIG. 14 . [0043] FIG. 22 is a top perspective view of another embodiment of a patch. [0044] FIG. 23A is a schematic illustration of possible applications and configurations for the device shown in FIG. 12 and FIG. 1 . [0045] FIG. 23B is an exploded perspective view of an exemplary implementation of the devices shown in FIG. 23A . [0046] FIG. 23C is a side cross sectional view of a possible configuration for the devices shown in FIG. 23A . [0047] FIG. 23D is a perspective view of a possible configuration for the devices shown in FIG. 23A . [0048] FIG. 24 is a perspective view of an exemplary docking station. [0049] FIG. 25 is a block diagram of an exemplary system for communicating across a communication network including the device shown in FIG. 12 . DETAILED DESCRIPTION [0050] Various embodiments will be described in detail with reference to the drawings, wherein like reference numerals represent like parts and assemblies throughout the several views. Reference to various embodiments does not limit the scope of the claims attached hereto. Additionally, any examples set forth in this specification are not intended to be limiting and merely set forth some of the many possible embodiments for the appended claims. [0051] Referring now to FIG. 1 , an example therapeutic electrical stimulation device 10 is shown. In this example, device 10 is a transcutaneous electrical nerve stimulation (“TENS”) device. Device 10 includes controller 11 and an electro-mechanical connecting shoe 13 . Controller 11 generates electrical impulses and supplies the electrical impulses to shoe 13 . The connector shoe 13 receives the electrical impulses from controller 11 and supplies the electrical impulses to a conductive layer or directly to a therapeutic location, such as the skin of a patient. Examples of electrical signals which may be used by controller 11 are described in more detail in U.S. Pat. No. 4,922,908, the teachings of which are incorporated herein by reference. [0052] As shown in FIGS. 2-5 , controller 11 includes an outer protective shell formed of upper housing 12 and lower housing 14 . Upper and lower housings 12 , 14 are made of any suitable material such as plastic, metal, or the like. A lower edge of upper housing 12 is configured to be connected with an upper edge of lower housing 14 . In some embodiments, a fastener is used to connect upper housing 12 to lower housing 14 . Examples of suitable fasteners include adhesive, screws, latching mechanisms, and other known fasteners. In other embodiments, upper housing 12 is directly connected to lower housing 14 , such as by welding or over molding. [0053] Upper and lower housings 12 , 14 act together to enclose battery 26 and electrical circuitry 29 . As a result, upper and lower housings 12 , 14 provide protection to the enclosed components from contact with other objects that could otherwise damage the components. In some embodiments, upper and lower housings 12 , 14 are water resistant to protect enclosed components from water or other fluids. Some embodiments of upper and lower housing 12 , 14 are completely sealed to resist most or all fluid, gas, or particle intrusion. Some embodiments are hermetically sealed. [0054] Battery 26 is a power source that provides electrical power to controller 11 . In some embodiments, battery 26 is a rechargeable battery such as a lithium-ion battery. Battery 26 can be charged by connecting controller 11 to a battery charger, as described further below. One example of a battery charger is a docking station described in more detail herein. Inductive charging is used in some embodiments. In other embodiments, other rechargeable batteries are used, such as a nickel cadmium battery, a nickel metal hydride battery, or a rechargeable alkaline battery. Yet other embodiments include non-rechargeable, disposable batteries, such as alkaline batteries, or other known batteries. An alternate embodiment of controller 11 does not include battery 26 , but rather includes a different power source such as a capacitor. [0055] Lower housing 14 includes a controller receptacle 24 that is arranged and configured to receive a portion 42 of shoe 13 . In some embodiments, lower housing 14 and portions of electrical circuitry 28 are uniquely arranged and configured to mate with portion 42 and resist mating with other shoe configurations. In addition, a railway platform 28 is positioned within controller receptacle 24 to fit with complementary surfaces on portion 42 to matingly engage with receptacle 24 , as described more fully below. This mating engagement forms a keyed receptacle. One benefit of a keyed receptacle is that it can be used to resist connection with inappropriate patches or other devices, such as to resist connection with a patch that would be incompatible with controller 11 . On the other hand, the keyed receptacle is also used in some embodiments to allow connection of controller 11 with various types of patches or other devices if desired. [0056] In the example shown, the electrical circuitry 28 includes a PCB board 29 with a plurality of pins 31 extending therefrom. Pins 31 are sized to be received in receptacles formed in corresponding portion 42 of the shoe 13 to create an electrical connection between controller 11 and shoe 13 , as described below. [0057] Upper housing 12 includes a member 22 that moves into and out of controller receptacle 24 to capture and release corresponding structure 42 of the shoe 13 . As described further below, as portion 42 is inserted into controller receptacle 24 , and member 22 engages structure 56 on portion 42 to couple portion 42 to controller 11 . To release portion 42 , the user depresses member 22 to disengage member 22 from portion 56 . Portion 42 of shoe 13 can then be pulled out of controller receptacle 24 . [0058] In one embodiment, controller 11 includes an on-board user interface having a power button 20 and amplitude adjustment buttons 16 and 18 . When power button 20 is first depressed, the controller turns ON and begins generating therapeutic electrical signals. When power button 20 is depressed again, the controller turns OFF and stops generating the therapeutic electrical signals. [0059] While the controller 11 is ON, amplitude adjustment buttons 16 and 18 are used to adjust the amplitude of the generated therapeutic electrical signals accordingly. Amplitude adjustment button 16 provides an input to increase (“+”) the amplitude of the therapeutic electrical signals. Amplitude adjustment button 18 provides an input to decrease (“−”) the amplitude of the therapeutic electrical signals. [0060] Referring now to FIGS. 6-8B , the shoe 13 , with sides 42 a and 42 b , is shown in greater detail. In the example shown, shoe 13 includes upper portion 42 and a base 44 , having sides 44 a and 44 b . As shown, upper portion 42 a is mounted to base portion 44 a , and upper portion 442 b is mounted to base portion 44 b . Also typically included, but not shown, is an insulating layer (see, e.g., insulating layer 122 described below). During sliding insertion, portion 42 is configured to engage with a receptacle 24 (shown in FIGS. 9 and 10 ) of controller 11 , as previously described. Portion 42 is a plastic or other suitable structure used to physically and electrically connect shoe 13 with controller 11 . [0061] The shoe 13 includes two symmetric halves 13 a and 13 b that allow insertion of an electrical connector 51 inside, as shown in FIG. 8A . The electrical connector may be any suitable electrical connection device, such as a FCI connector. The electrical connector 51 fits snugly inside of shoe 13 within the two halves. The electrical connector 51 may be fastened inside of the shoe 13 using glue, ultrasonic welding, or other available techniques. [0062] One or more electrodes (such as electrodes 124 and 126 in FIG. 13 or electrodes 1502 in FIGS. 23B and 23D ) are connected to shoe 13 . When the electrodes are applied to a patient, they provide an electrical connection with the skin of the patient to supply electrical pulses to a desired therapeutic location, such as on the patient's skin. Exemplary electrodes are made of one or more sheets of electrically conductive material (e.g., conductive polymer or stainless steel). In some embodiments, the electrodes are generally disk-shaped to distribute the electrical signals across a relatively large area of skin. In other embodiments, the electrodes are of a variety of other shapes including ring-shaped, circular, elliptical, serpentine, comb-shaped, or other desired shape. [0063] In operation, the electrodes are connected to the shoe 13 and ultimately to the controller using electrode lead wires 46 , 48 , which extend from shoe 13 and connect to the electrical connector 51 . The connection of lead wires to the shoe and the electrodes is done using any appropriate connection mechanism (e.g., metal crimp, solder, etc.). [0064] In certain embodiments, lead wire 46 connects to the shoe 13 through electrical connector 51 and to signal pin 31 a in receptacle 50 a . Lead wire 48 connects to the shoe 13 through electrical connector 51 and to ground pin 31 b in receptacle 50 b . Lead wire 46 and 48 connect to separate electrodes so that during stimulation, a voltage potential is generated between the electrodes and current enters the skin through one electrode, passes through the skin, and then returns through the other electrode. [0065] A disposable, conducting adhesive layer (e.g., adhesive layer 128 and 1504 described below) is applied to one side of electrodes 124 , 126 and 1502 to allow the electrodes to be securely, yet removably, adhered to the skin and to permit the electrical signals to flow from the controller 11 to the patient. In some embodiments, adhesive layers 128 and 1504 are applied across an entire surface of electrodes 124 , 126 and 1502 . In other embodiments, adhesive layers 128 and 1504 are electrically connected to the shoe, but not to the regions of electrodes 124 , 126 and 1502 . Other adhesive layer arrangements are used in other embodiments. Exemplary adhesive layers are made of an electrically conductive material such as an electrogel or hydrogel (e.g., UltraStim Self-Adhering Neurostimulation Electrodes made by Axelgaard Manufacturing Co.). The adhesive layer is preferably disposed of after one use, but may reused for multiple applications. Some embodiments of shoe 13 include additional layers. [0066] During stimulation, controller 11 generates a voltage potential between electrode lead wires 46 , 48 such that the current enters the skin through one wire, passes through the skin, and then returns through the other wire. Some embodiments provide a plurality of electrodes. In some implementations, the polarity of the electrodes is alternated during a therapy. In some embodiments a skin preparation product, such as a conductive gel, is applied to the skin prior to application of shoe 13 . [0067] To make electrical connection between shoe 13 and controller 11 , portion 42 includes a plurality of receptacles 50 a - 50 c on a front face 52 of portion 42 . The receptacles are part of connector 51 (e.g., FCI connector) housed inside of shoe 13 . The three electrical receptacles 50 a - 50 c are assigned various functions such as providing an electrical signal, connection to ground, and battery charging connection. The electrical receptacles 50 a - 50 c are sized to receive pins 31 a - 31 c , respectively, of controller 11 when portion 42 is fully inserted into connector receptacle 24 (see FIGS. 9 and 10 ), and provide a location where the pins 31 a and 31 b connect with the lead wires 46 and 48 , respectively. As shown, pins 31 extend generally parallel to the railway platform 28 . [0068] Fitting pins 31 into receptacles 50 creates an electrical connection between controller 11 and shoe 13 and allows controller 11 to deliver electrical stimulation therapy through electrode lines 46 , 48 to the patient. In particular, as shown, receptacle 50 a receives the electrical signal pin 31 a and receptacle 50 b receives the ground pin 31 b , which combine to form the electrical connection between the shoe 13 and the controller 11 . Receptacle 50 c receives the battery charging pin 31 c . It will be appreciated that when the shoe 13 and the controller 11 are mated together for operation, the battery charging pin 31 c sits within the receptacle 50 c but does not electrically connect. As discussed below, the controller 11 may be disengaged from the shoe 13 after patient therapy and connected to a battery charging station. [0069] The mechanical connection between the shoe 13 and controller 11 is further shown in FIGS. 6-10B . With reference to FIG. 6 , shoe 13 includes portion 42 that defines a channel 54 sized to receive railway platform 28 of controller 11 when portion 42 is inserted into controller receptacle 24 . Railway platform 28 slides inside channel 54 below portion 42 and above the bottom surface defining channel 54 , fitting in a ‘U’ shape around portion 55 of shoe 13 . Also, portion 42 includes a clip member 56 sized to engage a detent or lip 23 of member 22 of controller 11 when portion 42 is fully inserted into controller receptacle 24 to retain portion 42 within receptacle 24 . In certain embodiments, when clip member 56 engages the lip 23 of member 22 the connection creates an affirmative “click” sound, indicating that shoe 13 is connected to controller 11 . In addition, the base 44 of the shoe includes two side flanges 44 a and 44 b . As the shoe 13 slides into connection with the controller 11 , the base flanges 44 a and 44 b slide under and at least partially abut respective side portions 8 a and 8 b of the controller 11 . [0070] Referring now to FIGS. 9 and 10B , the coupling between shoe 13 and controller 11 also occurs as pins 31 of controller 11 are inserted into receptacles 50 of portion 42 of shoe 13 . [0071] The process of connecting shoe 13 and controller 11 begins as shown in FIG. 10A which depicts the controller 11 and shoe 13 detached and in position to be coupled. By moving shoe 13 in the direction X (i.e., in the direction of the arrow toward controller 11 ), they can be coupled as shown in FIGS. 9 and 10B . [0072] When coupled, railway 28 of controller 11 is received in channel 54 of portion 42 and allows portion 42 to be slid along railway 28 as portion 42 is inserted into controller receptacle 24 . Additionally, railway 28 fits around portion 55 of shoe 13 . The engagement of railway 28 and channel 54 fixes the position of controller 11 and shoe 13 in a direction Y so that shoe 13 cannot be moved out of controller receptacle 24 in the direction Y. [0073] Further, lip 23 of member 22 of controller 11 is engaged by clip member 56 of portion 42 . The engagement of lip 23 and clip member 56 fixes the position of controller 11 and shoe 13 in a second dimension so that shoe 13 cannot be moved in a direction X out of controller receptacle 24 . When the user wants to remove portion 42 from controller receptacle 24 , the user depresses member 22 in the direction Y so that lip 23 clears clip member 56 . Portion 42 thereupon be slid along railway 28 in direction X out of receptacle 24 . Flanges 44 a and 44 b engage portions 8 a and 8 b , as described above. [0074] Other configurations can be used to maintain the portion 42 in the receptacle 24 . For example, in another embodiment, a knob or knurl can be formed on the portion 42 that engages or is seated with a detent within the receptacle when fully inserted. When the portion 42 is removed, the knob or knurl flexes slightly to bend away from the detent so that the portion can be removed. Other configurations are possible. [0075] In some examples described herein, shoe 13 is connected to a garment to deliver therapy to the user. The is made by stitching, gluing or embedding the shoe 13 in a laminate layer. In other examples, shoe 13 is connected to other structures to deliver therapy; charge controller 11 ; and/or program controller 11 . [0076] For example, referring now to FIG. 11 , shoe 13 is electrically connected to a structure 60 . As described below, shoe 13 can be connected to a plurality of different structures so that controller 11 can be coupled thereto. [0077] In some examples, structure 60 is an apparatus that can be used to deliver therapy to the user. For example, as described below, structure 60 can be a patch (e.g., patch 104 ) or an electrode that is attached to the skin to deliver therapy. In other examples, structure 60 is a garment such as a belt that is worn around certain anatomy of a patient, such as the waist, arm, or leg. One or more shoes 13 can be located along the belt so that one or more controllers 11 can be coupled to the shoes 13 to deliver therapy at desired locations along the belt. For example, the belt can include a single shoe 13 for one controller 11 , and can include a plurality of electrodes that are spaced along the belt to deliver therapy along an entire surface for the patient. FIG. 23D shows an example of a belt including a shoe 13 with base 44 electrically connected to electrodes 1502 . Electrodes 1502 may be placed in any position along the belt and in any pattern suitable to provide therapy to a user. There may be an array of four electrodes, as shown in FIG. 23D , or there may be more or fewer electrodes provided as necessary. In addition, multiple shoes 13 , may be placed on the belt of FIG. 23D . In other examples, structure 60 is a brace or cast (e.g., air cast, knee brace, or back brace) with built-in electrodes that allow controller 11 to be connected to the shoe and delivery therapy to the desired area. [0078] In some embodiments, structure 60 is electrical components that are used to provide power so that controller 11 can be connected to shoe 13 to charge battery 26 in controller 11 . For example, in one embodiment, structure 60 is a docking station, such as docking station 1300 described below. In other examples, structure 60 is an electrical power transformer that can be plugged into a typical wall outlet or an automobile outlet to provide power to charge battery 26 . In other examples, controller 11 can also include an auxiliary charging port, such as a USB or micro-USB port, which can be used to charge controller 11 . In yet other examples, controller 11 can include on-board recharge capabilities, such as solar panels or inductive coupling technologies. [0079] In yet other examples, structure 60 is electrical circuitry that can be used to program controller 11 . In some embodiments, controller 11 includes computer readable media, such as RAM or ROM. In one embodiment, controller 11 includes flash memory that can be rewritten with new therapy programs to enhance the functionality of controller 11 . [0080] In such examples, structure 60 can be a docking station, such as docking station 1300 described below. In other examples, structure 60 can be a component in a care giver's office that allows the care giver to modify or enhance the therapies that can be provided by controller 11 . In other examples structure 60 can be connected to a LAN or have an internet or phone connection. [0081] Referring now to FIG. 12 , another example therapeutic electrical stimulation device 100 is shown. Device 100 is similar to device 10 described above, except that device 100 is configured differently. In the example of FIG. 12 , device 100 is a transcutaneous electrical nerve stimulation (“TENS”) device. Device 100 includes controller 102 and patch 104 , similar to those described above. Controller 102 is a device that generates electrical impulses and supplies the electrical impulses to patch 104 . Patch 104 receives the electrical impulses from controller 102 and supplies the electrical impulses to a therapeutic location, such as the skin of a patient. [0082] In one embodiment, controller 102 includes a user interface having a power button 110 and amplitude adjustment buttons 112 and 114 . When power button 110 is first depressed, the controller turns ON and begins generating therapeutic electrical signals. When power button 110 is depressed again, the controller turns OFF and stops generating the therapeutic electrical signals. [0083] While the controller 102 is ON, amplitude adjustment buttons 112 and 114 are used to adjust the amplitude of the generated therapeutic electrical signals accordingly. Amplitude adjustment button 112 provides an input to increase the amplitude of the therapeutic electrical signals. Amplitude adjustment button 114 provides an input to decrease the amplitude of the therapeutic electrical signals. [0084] Patch 104 is typically applied to the skin of a patient. The electrical signals are conducted from the controller to the skin by patch 104 . Patch 104 includes a shoe 120 (shown in FIG. 13 ), an insulating layer 122 , and conductive electrodes 124 and 126 . Shoe 120 is connected to one side of insulating layer 122 , and is configured to engage with a receptacle (shown in FIG. 14 ) of controller 102 . Shoe 120 is a connector used to physically and electrically connect patch 104 with controller 102 . [0085] Electrodes 124 and 126 (shown more clearly in FIG. 13 ) are located adjacent insulating layer 122 on a side opposite shoe 120 . The electrodes are typically a sheet of electrically conductive material that, when applied to a patient, provides an electrical connection with the skin of the patient to supply electrical pulses to a desired therapeutic location. An adhesive layer 128 is typically applied to one side of patch 104 to allow patch 104 to be securely, yet removably, adhered to the skin. Some embodiments of patch 104 include additional layers. [0086] During stimulation, controller 102 typically generates a voltage potential between electrodes 124 and 126 such that current enters the skin through one electrode, passes through the skin, and then returns through the other electrode. Some embodiments alternate the polarity of the electrodes during a therapy. In some embodiments a skin preparation product, such as a conductive gel, is applied to the skin prior to application of patch 104 . [0087] In some embodiments, buttons 110 , 112 , and 114 are arranged with a unique tactile arrangement. For example, buttons 110 , 112 , and 114 are arranged at one end of controller 102 and protrude out from the housing of controller 102 . The tactile arrangement allows the device to be controlled by the patient or caregiver even if the device is hidden from view under clothing or in a non-visible location, such as on the back. If, for example, the device is located under a shirt on the patient's upper arm, the patient can feel controller 102 through the shirt and locate protruding buttons 110 , 112 , and 114 . Due to the unique arrangement of buttons 110 , 112 , and 114 , the user is able to identify each button, and select from them accordingly. Other embodiments include additional tactile elements. For example, in some embodiments buttons 110 , 112 , and 114 include an elevated identifier, such as a line, square, arrow, dot, circle, or Braille character. In other embodiments, buttons 110 , 112 , and 114 each include a unique shape, such as a square, triangle, circle, oval, rectangle, arrow, or other desired shape. In yet other embodiments, buttons are located on different locations of the housing, such as on the sides or bottom of the housing. [0088] FIG. 13 is an exploded perspective view exemplary therapeutic electrical stimulation device 100 . Device 100 includes controller 102 and patch 104 . Controller 102 includes upper housing 202 , battery 204 , user input devices 206 , electrical circuitry 208 , and lower housing 210 . Patch 104 includes shoe 120 , insulating layer 212 , electrodes 124 and 126 , and adhesive layer 128 . [0089] Controller 102 includes an outer protective shell formed of upper housing 202 and lower housing 210 . Upper and lower housings 202 and 210 are made of any suitable material such as plastic, metal, or the like. A lower edge of upper housing 202 is configured to be connected with an upper edge of lower housing 210 . In some embodiments, a fastener is used to connect upper housing 202 to lower housing 210 . Examples of suitable fasteners include adhesive, screws, latching mechanisms, and other known fasteners. In other embodiments, upper housing 202 is directly connected to lower housing 210 , such as by welding or over molding. [0090] Upper and lower housings 202 and 210 act together to enclose battery 204 and electrical circuitry 208 and to at least partially enclose user input devices 206 . As a result, upper and lower housings 202 and 210 provide protection to the enclosed components from contact with other objects that could otherwise damage the components. In some embodiments, upper and lower housings 202 and 210 are water resistant to protect enclosed components from water or other fluids. Some embodiments of upper and lower housing 202 and 210 are completely sealed to resist most or all fluid, gas, or particle intrusion. Some embodiments are hermetically sealed. [0091] Lower housing 210 includes a controller receptacle 211 that is arranged and configured to receive shoe 120 of patch 104 . In some embodiments, lower housing 210 and portions of electrical circuitry 208 are uniquely arranged and configured to mate with shoe 120 and resist mating with other shoe configurations. This is sometimes referred to as a keyed receptacle. One benefit of a keyed receptacle is that it can be used to resist connection with inappropriate patches or other devices, such as to resist connection with a patch that would be incompatible with controller 102 . On the other hand, the keyed receptacle is also used in some embodiments to allow connection of controller 102 with various types of patches or other devices if desired. [0092] Battery 204 is a power source that provides electrical power to controller 102 . In some embodiments, battery 204 is a rechargeable battery such as a lithium-ion battery. Battery 204 can be charged by connecting controller 102 to a battery charger. One example of a battery charger is a docking station described in more detail herein. Inductive charging is used in some embodiments. In other embodiments, other rechargeable batteries are used, such as a nickel cadmium battery, a nickel metal hydride battery, or a rechargeable alkaline battery. Yet other embodiments include non-rechargeable, disposable batteries, such as alkaline batteries, or other known batteries. An alternate embodiment of controller 102 does not include battery 204 , but rather includes a different power source such as a capacitor. [0093] User input devices 206 receive input from a user to cause controller 102 to adjust an operational mode of the device 100 . Different operational modes may be used to provide different types of therapy, such as therapy to treat edema or to provide drug delivery. A more thorough description of how operational modes work can be found in U.S. Pat. No. 5,961,542 which is incorporated herein by reference. User input devices 206 include power button 110 and amplitude adjustment buttons 112 and 114 . User input devices 206 are arranged such that a portion of buttons 110 , 112 , and 114 protrude through upper housing 202 . A user provides input to controller 102 by momentarily depressing one of buttons 110 , 112 , and 114 . When the button is depressed, the force is transferred through user input device 206 to a switch of electrical circuitry 208 . The switch closes to make an electrical connection and causes current flow within electrical circuitry 208 . The electrical circuitry 208 responds to adjust the appropriate operational mode of controller 102 . [0094] Electrical circuitry 208 typically includes a circuit board and a plurality of electrical circuits such as a power supply circuit, pulse generator circuit, and electrical contacts for electrical connection with conductors of shoe 120 . Examples of electrical circuitry 208 are described in more detail herein. In some embodiments, electrical circuitry 208 includes sensors that receive electrical signals from patch 104 . In some embodiments the electrical circuitry is activated between output pulses to monitor the patient. Some embodiments of controller 102 further include sensor electronics that monitor patch 104 to be sure that patch has not become partially or fully disconnected from the patient. If the patch does become disconnected, the electronics deactivate delivery of therapeutic electrical signals from controller 102 . A more detailed description of how a patch connection can be monitored is found in U.S. Patent Application Publication No. 2004/0015212, which is incorporated herein by reference. In some embodiments, the electronics monitor for changes in impedance between electrodes. In another embodiment, electrical circuitry 208 also includes activity monitoring, such as with an accelerometer. With activity monitoring, feedback control is used to increase electrical stimulation level in response to activity level. [0095] Patch 104 is a device that transfers electrical impulses from controller 102 to a therapeutic location on a patient, such as the patient's skin. Patch 104 includes shoe 120 , insulating layer 212 , electrodes 124 and 126 , and adhesive layer 128 . [0096] Shoe 120 is arranged and configured to engage with controller 102 , such as through controller receptacle 211 . In some embodiments, shoe 120 includes a unique configuration that is designed to mate only with controller receptacle 211 and to resist connection with other receptacles or devices. The unique configuration is sometimes referred to as a keyed shoe. One benefit of a keyed shoe is that it can be used to resist connection with inappropriate controllers or other devices, such as to resist connection with a controller that would be incompatible with patch 104 . This may be done by creating a unique shoe configuration with a particular two or three dimensional shape that fits snugly within controller receptacle 211 . Thus, controller receptacles and shoes that do not have a matching two or three dimensional shape cannot be connected. On the other hand, the keyed shoe is also used in some embodiments to allow patch 104 to be connected with various types of controller 102 . In this case, the shoe may be designed with a two or three dimensional shape that fits into multiple controller receptacles. Shoe 120 includes conductors that conduct electrical signals between controller 102 and electrodes 124 and 126 . [0097] Patch 104 includes insulating layer 212 . Insulating layer 212 is connected to patch 104 by any suitable fastening mechanism, such as adhesive, screws, nails, or other known fasteners. In other embodiments, insulating layer 212 and shoe 120 are formed of a unitary piece, such as by molding. Conductors from shoe 120 pass from shoe 120 , through insulating layer 212 , and are connected to electrodes 124 and 126 . [0098] In some embodiments, insulating layer 212 is a primary structural layer of patch 104 . Insulating layer 212 also electrically insulates a side of patch 104 . In this way, if insulating layer 212 comes into contact with a conductive object (e.g., the hand of the patient or another electronic device), insulating layer 212 prevents or at least resists the electrical conduction between electrodes 124 and 126 and the conductive object. Inadvertent electrical shocks and unintended electrical connections are thereby reduced or entirely prevented. [0099] Electrodes 124 and 126 are electrical conductors that are used to introduce electrical signals to a therapeutic location of a patient, such as on to the patient's skin. Electrodes 124 and 126 are electrically connected to conductors that pass through shoe 120 . In some embodiments electrodes 124 and 126 are generally disk-shaped to distribute the electrical signals across a relatively large area of skin. In other embodiments, electrodes 124 and 126 are of a variety of other shapes including ring-shaped, circular, elliptical, serpentine, comb-shaped, or other desired shape. [0100] Patch 104 is connected to the skin of a patient with adhesive layer 128 . In some embodiments, adhesive layer 128 is applied across an entire surface of patch 104 , including across electrodes 124 and 126 . In such embodiments, adhesive layer 128 is electrically conductive. In other embodiments, adhesive layer 128 is applied to the surface of patch 104 , but not on the regions of electrodes 124 and 126 . Other adhesive layer arrangements are used in other embodiments. [0101] FIGS. 14-16 illustrate an exemplary method of connecting a controller 102 to a patch 104 of a therapeutic electrical stimulation device 100 . FIGS. 14-16 are right side cross-sectional views of device 100 . FIG. 14 illustrates controller 102 disconnected from patch 104 . FIG. 15 illustrates controller 102 arranged in a first position over patch 104 . FIG. 16 illustrates controller 102 arranged in a second position and connected with patch 104 . A method of disconnecting controller 102 from patch 104 is the reverse of that described herein. [0102] Before connecting controller 102 with patch 104 , patch 104 is typically applied to a desired therapeutic location on the patient (not shown in FIG. 14 ) such that shoe 120 extends from patch 104 in a direction generally away from the therapeutic location. [0103] The process of connecting controller 102 with patch 104 begins as illustrated in FIG. 14 , such that controller 102 is arranged such that controller receptacle 211 is in line with shoe 120 . Controller 102 is also oriented such that rear side 301 of shoe 120 is facing toward the rear side 302 of receptacle 211 . In some embodiments, shoe 120 in receptacle 211 is shaped such that shoe 120 can only be inserted into receptacle 211 in a single orientation. In other embodiments, shoe 120 can be inserted within receptacle 211 in multiple orientations, but can only be fully engaged (as shown in FIG. 16 ) if shoe 120 and receptacle 211 are properly oriented. [0104] Once properly oriented, controller 102 is moved toward patch 104 in the direction of arrow A 1 , such that shoe 120 enters receptacle 211 as shown in FIG. 15 . Controller 102 is then advanced in the direction of arrow A 2 . This movement of controller 102 causes shoe 120 to engage with controller 102 as shown in FIG. 16 . In particular, electrical circuitry 208 makes electrical contact with conductors of shoe 120 to electrically connect electrodes of patch 104 with electrical circuitry 208 . [0105] Electrical connectors are used to electrically connect conductors of shoe 120 with electrical circuitry 208 . In one embodiment, male and female plug-type connectors are included as part of shoe 120 and electrical circuitry 208 . In another embodiment, surface conductors are used to connect with protruding electrical contacts, such as used in Universal Serial Bus (USB) connectors and for connecting memory cards with memory slots. Other electrical connectors are used in other embodiments. [0106] As described above, FIGS. 14-16 illustrate a two-step method of connecting patch 104 and controller 102 . The first step involves moving controller 102 in the direction of arrow A 1 , and the second step involves moving controller 102 in the direction of arrow A 2 . This method of connection is partially a result of the “L-shape” of shoe 120 . Shoe 120 has a first portion 304 that extends generally normal to a surface of insulating layer 212 , and a second portion 306 that extends at generally a right-angle to the first portion 304 . [0107] One of the benefits of this shape of shoe 120 is that it resists unintentional disengagement of controller 102 from patch 104 , once controller 102 is properly connected (as shown in FIG. 16 ). For example, if a force is applied to controller 102 in a direction opposite arrow A 1 , the second portion of shoe 120 resists disengagement of controller 102 from patch 104 . Sideways forces (e.g., forces normal to arrow A 1 and arrow A 2 ) are also resisted, as well as a force in the direction of arrow A 2 . A force in the direction opposite arrow A 2 will result in disconnection of shoe 120 from electrical circuitry 208 . However, shoe 120 will still provide support to receptacle 211 unless controller 102 is arranged vertically below patch 104 . This allows the user to manually grasp controller 102 before it becomes completely disconnected from patch 120 and reconnect controller 102 , if desired. If controller 102 is arranged vertically below patch 104 , then gravity will tend to pull controller 102 away from patch 104 . [0108] In another embodiment, shoe 120 has a generally linear shape (not shown in FIGS. 14-16 ), such that shoe 120 is plugged directly into controller 102 in a single step, namely the insertion of shoe 120 into receptacle 211 . In this embodiment, electrical circuitry 208 includes an electrical connector that is in line with the path of entry of shoe 120 into receptacle 211 or directly surrounds the point of entry. [0109] In another possible embodiment, shoe 120 has an “L-shape” but receptacle 211 is arranged on a side of controller 102 . In this embodiment, connection of controller 102 with patch 104 is accomplished in a single step—insertion of a second portion of shoe 104 into the side receptacle. [0110] Some embodiments of shoe 120 and receptacle 211 are arranged and configured to safely disconnect from each other upon the application of a sufficient force. If the user bumps device 100 on another object, for example, it is preferred that controller 102 electrically disconnects from patch 104 before patch 104 becomes disengaged from the patient. Shoe 120 and receptacle 211 are designed to remain connected unless a sufficient force is applied to controller 102 and before the force becomes large enough to disconnect patch 104 from the patient. [0111] FIG. 17 is a perspective top view of an exemplary embodiment of partially assembled device 100 . In this figure, upper housing 202 and battery 204 (shown in FIG. 13 ) are removed. Device 100 includes controller 102 and patch 104 . Controller 102 includes user input device 206 and electrical circuitry 208 . Electrical circuitry 208 includes circuit board 602 and electronic components 604 . Electrical components 604 include transformer 606 , status indicator 608 , and electrical connector 610 . [0112] In FIG. 17 , shoe 120 is shown in the fully connected position, such as shown in FIG. 16 . When in this position, electrical connectors of shoe 120 mate with electrical connectors 610 of electrical circuitry 208 . Circuit board traces on or within circuit board 602 communicate electrical signals between electrical components 604 and shoe 120 . [0113] Some embodiments of electrical circuitry 208 include transformer 606 . In some embodiments (such as shown in FIG. 13 ), the transformer is mounted on a surface of the circuit board. To reduce space consumed by transformer 606 , some embodiments include a hole in circuit board 602 . Transformer 606 is inserted within the hole to reduce the overall distance that transformer 606 extends above circuit board 602 . This allows upper and lower housing 202 and 210 to have a reduced profile. Some embodiments include a receptacle in the circuit board (e.g., circuit board 29 of FIG. 5 ) to accept a component such as portion 42 of shoe 13 . This allows the allows pins 31 of circuit board 29 to extend into the space created by connector receptacle 24 . [0114] Some embodiments include one or more status indicators 608 . Status indicators inform a user of the operational status of device 100 and can come in the form of visual, audible, and/or tactile indicators. Examples of suitable status indicators 608 include a light, an LED, a liquid crystal or other type of display, a speaker, a buzzer, and a vibrator. Status indicators 608 are used in some embodiments to show whether device 100 is ON or OFF. In other embodiments, status indicators 608 communicate an operational mode, such as a type of therapy being provided, or a change in operational mode, such as an increase or decrease in amplitude. In yet other embodiments, status indicators 608 are used to show battery power status (e.g., full power, percentage of full power, or low on power/in need of charge), or charging status (e.g., charging or fully charged). Other indicators are used in other possible embodiments. Speakers, buzzers, and vibrators are particularly useful for those with certain disabilities or impairments and also for communication when the device is located in an area that is not easily visible (e.g., on the back of a patient). [0115] FIG. 18 is a block diagram of an exemplary electrical schematic for controller 102 . Controller 102 includes power supply 700 , pulse generator 702 , power switch 704 , amplitude adjustment switches 706 , and output 708 . [0116] Power supply 700 provides electrical power to controller 102 . In some embodiments, power supply 700 includes a battery and also includes power filtering and/or voltage adjustment circuitry. Power supply 700 is electrically coupled to power switch 704 and to pulse generator 702 . Power switch 704 receives input from a user through power button 110 (e.g., shown in FIG. 12 ) and operates with power supply 700 to turn controller 1020 N or OFF. [0117] Pulse generator 702 generates therapeutic electrical signals. Pulse generator 702 is electrically coupled to output 708 and provides the electrical signals to output 708 . In turn, output 708 is electrically coupled to patch electrodes to deliver the electrical signals to the therapeutic location of the patient. Amplitude adjustment switches 706 are electrically coupled to pulse generator 702 and receive input from the user through amplitude adjustment buttons 112 and 114 (e.g., shown in FIG. 12 ). Amplitude adjustment switches 706 operate with pulse generator 702 to adjust the intensity of the electrical signals sent to output 708 . [0118] Some examples of suitable pulse generators are described in U.S. Pat. Nos. 4,887,603 and 4,922,908, both by Morawetz et al. and titled MEDICAL STIMULATOR WITH STIMULATION SIGNAL CHARACTERISTICS MODULATED AS A FUNCTION OF STIMULATION SIGNAL FREQUENCY, the disclosure of which is hereby incorporated by reference in its entirety. In some embodiments, the electrical signals generated by pulse generator 702 are simple modulated pulse (SMP) signals. Other configurations and electrical signals are possible. [0119] FIG. 19 is an electrical schematic of an exemplary circuit for controller 102 . Controller 102 includes power supply 800 , pulse generator 802 , power switch 804 , amplitude adjustment switch 806 , and output 808 . Power supply 800 includes battery 812 , thermistor 814 , step up converter 816 , and other electrical components. Power supply 800 is electrically coupled to supply power to pulse generator 802 . In addition, power supply 804 is electrically coupled to connector block 820 that is used to supply power to power supply 800 to charge battery 812 . [0120] In this example, battery 812 is a lithium-ion battery having a voltage of about 3.7 to 4.2 volts, although other battery types and voltages are used in other embodiments. Thermistor 814 is electrically coupled between battery 812 and connector block 820 and is used to detect the temperature of battery 812 to ensure that battery 812 is not overheated while recharging. Power switch 804 is used to turn controller 1020 N or OFF. Power switch 804 may be easily controlled, for example, by user control 110 . In one embodiment, switch 804 is a single pole double throw (SPDT) switch, as shown. Power supply 800 also includes step up converter 816 . Step up converter 816 operates to increase the voltage of power from battery 812 to a desired voltage. One suitable step up converter is the LTC3401 micropower synchronous boost converter that is distributed by Linear Technology Corporation, with headquarters in Milpitas, Calif. [0121] Pulse generator 802 receives power from power supply 700 and generates a therapeutic electrical signal. The therapeutic electrical signal is provided by pulse generator 802 to output 808 . Pulse generator 802 includes amplitude adjustment switch 806 . Amplitude adjustment switch 806 may be easily controlled, for example, by user controls 112 and 114 . In this embodiment, amplitude adjustment switch 806 is a potentiometer. When the potentiometer is adjusted, intensity of the electrical signal generated by pulse generator 802 is increased or decreased accordingly. [0122] In this example, pulse generator 802 includes first and second timers 830 and 832 as well as additional circuitry as shown. In one embodiment, both timers 830 and 832 are the TS556 low-power dual CMOS timer, distributed by STMicroelectronics, with headquarters in Geneva, Switzerland. [0123] Pulse generator 802 also includes output stage 840 . Output stage 840 includes MOSFET 842 and transformer 844 . Output stage 840 acts to increase the output voltage of the electrical signal before sending the electrical signal to output 808 . [0124] FIG. 20 is a block diagram of another exemplary electrical schematic for controller 102 . In this embodiment, controller 102 is formed from primarily digital circuitry. Controller 102 includes power supply 902 , battery 904 , controller processor 906 , power switch 108 , amplitude adjustment switches 910 , data communication device 912 , data storage device 914 , output stage 916 , and output 918 . Controller 102 is connected to external power source 920 , to charge battery 904 . In one embodiment, external power source 920 is a home or commercial power supply, such as available through an electrical power outlet. In another embodiment, external power source 920 is an vehicle power supply, such as accessible through a 12V receptacle. [0125] During normal operation, power supply 902 receives power from battery 904 . Power supply 902 converts the battery power to a desired voltage before supplying the power to other components of controller 102 . Power supply 902 also includes battery charger 930 . Battery charger 930 receives power from an external power supply and operates to recharge battery 904 . [0126] Control processor 906 controls the operation of controller 102 . Control processor 906 is powered by power supply 902 . Control processor 906 also generates electrical signals that are provided to output stage 916 . [0127] Control processor 906 is electrically coupled to power switch 908 and amplitude adjustment switches 910 . Control processor 906 monitors the state of power switch 908 . When control processor 906 detects that the state of power switch 908 has changed, control processor 906 turns controller 1020 N or OFF accordingly. Control processor 906 also monitors the state of amplitude adjustment switches 910 . When control processor 906 detects that the state of amplitude adjustment switches 910 has changed, control processor 906 increases or decreases the intensity of electrical signals provided to output stage 916 accordingly. [0128] Control processor 906 includes memory 932 . Firmware 934 is stored in memory 932 . Firmware 934 includes software commands and algorithms that are executed by control processor 906 and defines logical operations performed by control processor 906 . The software commands and algorithms in firmware 932 may be used to operate the electrical stimulation device in a desired mode, such as a mode that provides transcutaneous electrical nerve stimulation therapy. In certain embodiments, controller 102 includes a data communication device 912 . Data communication devices include wired or wireless communication devices, such as serial bus communication devices (e.g., a Universal Serial Bus communication devices), local area networking communication devices (e.g., an Ethernet communication device), a modem, a wireless area networking communication device (e.g., an 802.11x communication device), a wireless personal area networking device (e.g., a Bluetooth™ communication device), or other communication device. [0129] Data communication device 912 can be used to send and receive data with another device. For example, data communication device 912 can be used to download different firmware 934 to the controller 102 to alter the operation of control processor 906 , and operate the therapeutic electrical stimulation device in a desired mode, such as a mode that provides iontophoresis therapy. In certain embodiments, a firmware algorithm must be purchased before it can be downloaded by a user. In certain embodiments, the a user must access a patient interface of a web server or other similar interface before downloading a firmware algorithm. Data communication device 912 can also be used to upload data to another device. For example, control processor 906 stores a therapy log in data storage device 914 . The control processor 906 can be used to upload the therapy log to an external device by sending the data log to data communication device 912 . [0130] Data storage device is a device capable of storing data, such as a memory card or other known data storage device. In some embodiments, data storage device 914 is part of memory 932 . [0131] When controller 102 is ON, control processor 906 generates therapeutic electrical signals, and provides those signals to output stage 916 . Output stage 916 converts and filters the electrical signals, and then provides the electrical signals to output 918 . Output 918 is electrically coupled to a patch that delivers electrical signals to the patient. [0132] FIG. 21 is an electrical schematic of another exemplary circuit for controller 102 . In this embodiment, controller 102 includes a control processor 1006 that controls the operation of controller 102 . In this embodiment, controller 102 is made from primarily digital circuitry. Controller 102 includes power supply 1002 , battery 1004 , control processor 1006 , power switch 1008 , amplitude adjustment switches 1010 , output stage 1016 , and output 1018 . Controller 102 can also be connected to external power source 1020 , such as to charge battery 1004 . [0133] In this embodiment, power supply 1002 includes a lithium-ion charge management controller 1030 and a step up converter 1032 , as well as other electrical components as shown. An example of a suitable lithium-ion charge management controller 1030 is the MCP73833 stand-alone linear lithium-ion charge management controller manufactured by Microchip Technology Inc., of Chandler, Ariz. An example of a suitable step up converter is the LTC3401 micropower synchronous boost converter. [0134] Battery 1004 provides power to power supply 1002 . In this example, battery 1004 is a lithium-ion 3.7V battery. Power supply 1002 can also be connected to external power source 1020 , such as a 5V DC power source. External power source 1020 provides power to power supply 1002 that enables power supply 1002 to recharge battery 1004 . In some embodiments, battery 1004 includes a thermistor to monitor the temperature of battery 1004 during charging. [0135] Control processor 1006 controls the operation of controller 102 . One example of a suitable control processor 1006 is the ATtiny44 8-bit microcontroller manufactured by Amtel Corporation, located in San Jose, Calif. Alternatively, various other processing devices may also be used including other microprocessors, central processing units (CPUs), microcontrollers, programmable logic devices, field programmable gate arrays, digital signal processing (DSP) devices, and the like. Control processor 1006 may be of any general variety such as reduced instruction set computing (RISC) devices, complex instruction set computing devices (CISC), or specially designed processing devices such as an application-specific integrated circuit (ASIC) device. [0136] Control processor 1006 is electrically coupled to power switch 1008 and amplitude adjustment switches 1010 . Power switch 1008 provides signals to control processor 1006 that cause control processor 1006 to alternate controller 102 between ON and OFF states accordingly. Amplitude adjustment switches 1010 instruct control processor 1006 to adjust the intensity of the electrical signals generated by controller 102 . Electrical signals generated by control processor 1006 are passed to output stage 1016 . [0137] Output stage 1016 converts the electrical signals received from control processor 1006 to an appropriate form and then provides the electrical signals to output 1018 . In this example, output stage 1016 includes MOSFET 1042 and transformer 1044 . Other embodiments do not include transformer 1044 , but rather use a flyback converter or other converter to generate an appropriate output signal. [0138] FIG. 22 is a top perspective view of another exemplary embodiment of patch 104 . Patch 104 includes insulating layer 212 and shoe 120 . Shoe 120 is connected to a surface of insulating layer 212 . In this embodiment, shoe 120 includes wires 1101 and 1103 that are electrically coupled to conductors within shoe 120 . The wires 1101 and 1103 may be connected to conductors within shoe 120 using a metal crimp or other suitable method of electrical connection. Wires 1101 and 1103 are also connected at an opposite end to patches 1102 and 1104 . Patches 1102 and 1104 may include electrodes such as a conducting polymer material. Patch 104 may be used in a garment or medical device such as the belt depicted in FIGS. 23 A-D. [0139] In one embodiment, patch 104 includes one or more electrodes, such as shown in FIG. 13 , and an adhesive layer that allows patch 104 to be connected to a patient or other device. In another embodiment, patch 104 does not include an electrode, but rather passes electrical signals through wires 1101 and 1103 to separate patches 1102 and 1104 . Patches 1102 and 1104 include an insulating layer and one or more electrodes, but do not include a shoe. Instead, patches 1102 and 1104 receive electrical signals from the shoe included in patch 104 . Patches 1102 and 1104 can be adhered to the patient such as with an adhesive layer. The electrodes of patches 1102 and 1104 direct the electrical signals to desired therapeutic locations of the patient. [0140] Other embodiments include any number of wires 1101 and 1103 and any number of patches 1102 and 1104 (e.g., one patch, two patches, three patches, four patches, five patches, etc.) as desired for a particular therapy. Shoe 120 includes an appropriate number of electrical conductors that can provide multiple electrical conduction channels for communicating electrical signals between controller 102 (such as shown in FIG. 12 ) and the patches. In some embodiments, wires 1101 and 1103 are formed adjacent to or within insulating layers to provide additional protection to the wires from damage. In some embodiments, wires 1101 and 1103 are other types of electrical conductors. In other examples, multiple electrode sites can be positioned in a patch 104 . For example, a quad-patch can be formed with an insulating layer having four lobes, with each lobe having an electrode for delivery of therapy, as described below with respect to FIG. 23D . Other configurations are possible. [0141] In some embodiments, patches 104 , 1102 , and 1104 are held in place by a band, strap, brace, built, garment, active wear, or other suitable supporting object. For example, patches can be formed integral with a supporting object or inserted within a pocket or recess of a supporting object. Some embodiments include integrated hot or cold packs. The connection to a supporting object may be made by stitching, gluing, snapping, velcroing, embedding in a laminate layer or any other possible way to connect one or more of elements 1101 , 1103 , 1104 , 1102 and 1104 to a supporting material. In embodiments where one or more of elements 1101 , 1103 , 1104 , 1102 and 1104 are formed integral with a supporting object, they may be washed or cleaned (e.g., in a washing machine, soap and water, dry cleaned, etc.) along with the supporting object. Some further examples are illustrated in FIG. 23A . [0142] FIG. 23A schematically illustrates some of the possible applications and configurations of therapeutic electrical stimulation device 100 . FIG. 23A illustrates a patient 1200 including a front profile (left) and a rear profile (right). [0143] One application of device 100 is to reduce joint pain or to reduce swelling in a joint. For example, device 100 is integrated into elbow brace 1202 , hip support 1204 , knee braces 1206 and 1208 , shoulder brace 1210 , glove 1212 , back support 1214 , and sock 1216 to provide relief from pain or swelling at the respective location. This illustrates that device 100 can be used to treat symptoms at the patient's elbow, hip, knee, shoulder, wrist, hand, fingers, back, ankle, foot, or any other joint in the body. [0144] Alternatively, embodiments of device 100 are directly adhered to the desired therapeutic location, such as shoulder 1220 , as described herein. [0145] Another application of device 100 is to reduce muscle or other tissue pain at any desired therapeutic location on the body. For example, device 100 is adhered to thigh 1222 of patient 1200 . [0146] Another application of device 100 is to stimulate wound healing. For example, device 100 can be placed on or adjacent to wound 1224 (shown on the rear left thigh of patient 1200 ). Some embodiments of device 100 act as electronic adhesive bandage to promote wound healing and reduce pain associated with wound 1224 . Some embodiments of device 100 include controller 102 and patch 104 (such as shown in FIG. 12 ) as a single non-separable unit. [0147] Furthermore, alternate patch configurations (such as shown in FIG. 22 ) can be used to supply therapeutic electrical signals to multiple locations of the body (e.g., a back and hip) or to multiple regions of the same body part (e.g., opposite sides of the knee or top and bottom of the foot). [0148] FIGS. 23B and 23C show an example of how a therapeutic stimulation device, such as device 100 , may be configured to provide therapy to as user (e.g., as depicted in FIG. 23A ). In FIG. 23B , shoe 13 is attached to a garment 2602 . The shoe 13 may be attached to garment 2062 in a variety of ways, for example it may be stitched or glued to the garment or embedded in a laminate layer. [0149] The garment 2062 may be any type of garment or medical device such as clothing or elbow brace 1202 , hip support 1204 , knee braces 1206 and 1208 , shoulder brace 1210 , glove 1212 , back support 1214 , and sock 1216 . The garment 2602 is connected to one or more electrodes 1502 positioned adjacent the garment and electrically connected to lead wire 46 . One or more electrodes 1502 may be placed in various positions on the garment 2602 (e.g., the layout shown in FIG. 23D ). The electrodes 1502 may be wired and connected electrically in various patterns and orders and to one or more different shoes 13 . For example, two of the electrodes 1502 (right) of FIG. 23D are electrically connected to each other but not to the electrodes 1502 (left). The variance in electrode patterns and electrical connections allows for the ability to create various stimulation schemes for therapy. The electrodes are made of a conductive polymer, stainless steel or other suitable material, and may be integrated within the garment or connected to the outside of the garment by sewing, gluing, velcroing or other suitable attachment schemes. [0150] In certain embodiments, stainless steel snaps (male connector) are stamped through the garment and are thereby securely connected to the garment. The snaps are electrically conductive and allow for an electrode (female connector) to mechanically and electrically connect to the male snaps and become secured to the garment. The male snaps are connected to leads wires 46 and 48 , which are electrically connected to the shoe 13 . Snap connectors for electrodes are described in more detail in U.S. Pat. No. 6,438,428 which is incorporated herein by reference. [0151] As shown in FIGS. 23B and 23C , the base 44 of shoe 13 and one or more of the lead wires 46 are positioned between layers of the garment 2602 . This allows the wires 46 to be hidden and shielded from the user. The base 44 physically holds the shoe 13 within the garment to create a connection between the garment and the shoe. The top of shoe 13 is exposed on the outside of garment 2602 , to allow connection to controller 11 . In certain embodiments, shoe 13 , lead wires 46 , and electrode 1502 remain attached as a unit, while the controller 11 may be frequently detached and reused for other applications with other shoes or at a different times with the same shoe. In this example, the shoe 13 , lead wires 46 , and electrode 1502 elements may all be washed or cleaned together. Typically, the garment including the shoe, wire, and electrodes are used for about 6 months before being disposed and replaced. [0152] In certain embodiments, the electrode 1502 connects directly to a user 1506 by sitting directly on top of the skin. In other embodiments, an adhesive layer 1504 is affixed to electrode 1502 and the adhesive layer affixes the electrode to the patient. The adhesive layer 1504 is a conductor to allow current to pass from the electrode 1502 to the patient 1506 . The adhesive layer 1504 may be sticky on both sides so that a more reliable electrical and mechanical connection is made with the skin of a user. In certain embodiments only one side of the adhesive layer 1504 is sticky, and one side (e.g., the exposed side) of the electrode 1502 is sticky. Typically the adhesive layer 1504 is used only once before being disposed, though it may be reused multiple times. [0153] In some embodiments, multiple devices 100 are in data communication with each other to synchronize therapies provided by each respective device. For example, wireless communication devices (e.g., 912 shown in FIG. 20 ) are used to communicate between two or more devices 100 . [0154] In some embodiments, device 100 is configured to provide interferential therapy, such as to treat pain originating within tissues deeper within the body than a typical TENS device. [0155] Some embodiments of device 100 are configured for drug delivery. Such embodiments typically include a drug reservoir (such as absorbent pads) within patch 104 (e.g., shown in FIG. 13 ). Iontophoresis is then used to propel the drug (such as medication or bioactive-agents) transdermally by repulsive electromotive forces generated by controller 102 . An example of a suitable device for iontophoresis is described in U.S. Pat. No. 6,167,302 by Philippe Millot, titled DEVICE FOR TRANSCUTANEOUS ADMINISTRATION OF MEDICATIONS USING IONTOPHORESIS, the disclosure of which is hereby incorporated by reference in its entirety. [0156] Other therapies can also be delivered. For example, controller 100 can be programmed to deliver microcurrent. Such microcurrent can be a constant voltage that is delivered for wound healing purposes. Other therapies can be delivered to address pain, edema, drop-foot, and other abnormalities. [0157] The components of the therapeutic electrical stimulation devices, such as device 10 and garment 2602 , are manufactured to be disposable and replaced after the useful life of such components has expired. Useful life of a component can be defined, for example, by number of uses of the particular component, the lifetime of a component before wearing out, time established by the manufacturer, time available between reimbursements by Medicare or Medicaid (or other similar programs), or other similar standards. In certain embodiments, the controller is provided with a manufacturer-imposed useful life of about 5 years, such that upon the expiration of such 5 years, a replacement controller is made available to the patient. During its useful life, the controller may be reused for multiple applications on various different garments and with several different shoes 13 . In certain embodiments, the garment, such as shown in FIG. 23A-D , including shoe 13 and patch 104 , is provided with a manufacturer imposed useful life of about 6 months or less. In certain embodiments, the adhesive layer (e.g. adhesive layer 128 ) is provided with manufacturer imposed useful life of one application or use, though it may be reused multiple times. In certain embodiments, a user uses a certain number of adhesives (e.g., a package of 10) on a monthly basis. [0158] In certain embodiments, the useful life of the component is predetermined prior to initial use or sale of the component, and it is replaced upon expiration of the useful life. In some implementations, the predetermined useful life coincides with a period established by regulatory or other administrative authority by paying for or reimbursing for such component. In some embodiments, such predetermined useful life is shorter than the period in which the component becomes physically worn out or inoperable. [0159] FIG. 24 is a perspective view of an exemplary docking station 1300 . Docking station 1300 includes housing 1302 including multiple slots 1304 , 1306 , and 1308 and status indicators 1310 associated with each slot. [0160] Each slot of the docking station 1300 is arranged and configured to receive a controller 102 of a therapeutic electrical stimulation device 100 , such that multiple controllers 102 can be connected with docking station 1300 at any time. However, some embodiments of docking station 1300 include only a single slot 1304 or other port for connection to a single controller 102 . Other embodiments include any number of slots as desired. [0161] Docking station 1300 includes an electrical connector similar to connector 51 in shoe 13 , such as shown in FIGS. 8A and 8B . When device 100 is inserted into docking station 1300 , shoe 120 engages with receptacle 211 , such as described with respect to FIGS. 14-16 . When the shoe 120 engages with receptacle 211 , pins 31 a - 31 c combine with receptacle 211 to form an electrical connection. When device 100 is coupled with docking station 1300 , data is transferred through pin 31 a to the docking station 1300 through an abutting connector wire inside the station 1300 , similar to the connection formed when pin 31 a joins wire 46 , as shown in FIG. 10B . A ground connection is similarly made through pin 31 b , and the battery in controller 102 is charged through pin 31 c. [0162] In this example, docking station 1300 performs two primary functions. The first function of docking station 1300 is to recharge the battery of controller 102 . To do so, docking station 1300 is typically electrically coupled to a power source such as an electrical wall outlet. Docking station 1300 converts the power from the electrical wall outlet to an appropriate form and then provides the power to the power supply (e.g., 902 shown in FIG. 20 ) of controller 102 . [0163] The second function of docking station 1300 is to communicate data between controller 102 and a communication network. Controller 102 can send data to docking station 1300 and can receive data from docking station 1300 . This function is described in more detail with reference to FIG. 25 . [0164] Some embodiments of docking station 1300 provide only one of these functions. Other embodiments provide additional features and functionality. For example, some embodiments of docking station 1300 allow multiple devices 100 to communicate with each other when connected with docking station 1300 . In other examples, docking station 1300 is also configured to communicate with one or more computers accessible through a network, as described below. This allows for interactive data sharing between devices in order to promote, for example, greater efficiency in hospitals. Connection to the docking station 1300 allows nurses to keep a record of pain management for patients, and thereby increase the quality of care. [0165] Docking station 1300 includes status indicators 1310 associated with each slot of docking station 1300 . In this example, status indicators 1310 include a data communication indicator and a charging indicator. The data communication indicator is a light emitting diode (LED) that illuminates when the docking station 1300 is communicating with the respective controller 102 . The charging indicator is an LED that illuminates when docking station 1300 is charging the respective controller 102 . Other embodiments include additional status indicators 1310 . Other types of status indicators include audible status indicators (e.g., speakers, buzzers, alarms, and the like) and visible status indicators (e.g., lights, liquid crystal displays, display screens, and the like). [0166] Docking station 1300 is not limited to connection with a single type of controller 102 . Multiple types of controllers 102 can be connected with docking station 1300 at any one time, if desired. For example, controllers 102 include a TENS device, an iontophoresis device, a muscle stimulation device (e.g., a neuromuscular electrical stimulation (NMES) device), a wound healing device, an interferential device, or other devices. [0167] In some examples, docking station 1300 is configured to be used at a patient's home, such as in a bathroom or kitchen. Docking station 1300 can include multiple stations for charging different types of devices, as well as drawers and other conveniences that allow docking station 1300 to be used for multiple purposes. [0168] FIG. 25 is a block diagram of an exemplary system for communicating across communication network 1400 involving therapeutic electrical stimulation devices. The system includes devices 102 , 1402 , and 1404 . Devices 102 are in data communication with docking station 1300 , such as shown in FIG. 24 . Device 1402 includes a wireless communication device and device 1404 includes a wired network communication device. The system also includes server 1406 , caregiver computing system 1408 , and patient computing system 1410 . Server 1406 includes database 1412 and Web server 1414 . System also includes wireless router 1416 . [0169] Communication network 1400 is a data communication network that communicates data signals between devices. In this example, communication network 1400 is in data communication with docking station 1300 , device 1402 , device 1404 , server 1406 , caregiver computing system 1408 , patient computing system 1410 , and wireless router 1416 . Docking station 1300 is in data communication with devices 102 . Wireless router 1416 is in data communication with device 1404 . Examples of communication network 1400 include the Internet, a local area network, an intranet, and other communication networks. [0170] In some embodiments, devices 102 , 1402 , and 1404 store, in memory, data relating to therapy delivery or other operational characteristics of the respective devices. Communication network 1400 can be used to communicate that data to another device. For example, the data is transferred to patient computing system 1410 or to caregiver computing system 1408 . Once the data has been transferred to the computing system, the data is stored for review and analysis by the patient or the caregiver. Communication network 1400 can also be used to communicate data from devices 102 , 1402 , and 1404 to server 1406 . Server 1406 stores the data in patient record 1420 . [0171] In some embodiments, server 1406 includes Web server 1414 . Web server 1414 includes caregiver interface 1430 patient interface 1432 . Additional interfaces are provided in some embodiments to third parties, such as an insurance company. Web server 1414 generates web pages that are communicated across communication network 1400 using a standard communication protocol. An example of such a protocol is hypertext transfer protocol. The webpage data is arranged in a standard form, such as hypertext markup language. The webpage data is transferred across communication network 1400 and received by computing system 1408 and computing system 1410 . A browser operating on respective computing system reads the webpage data and displays the webpage to the user. [0172] Caregiver interface 1430 generates a webpage intended for use by a caregiver. The caregiver interface 1430 allows the caregiver to access patient records 1420 and generates reports or graphs to assist the caregiver in analyzing data from patient records 1420 . In addition, caregiver interface 1430 provides technical or medical suggestions to the caregiver. In some embodiments, caregiver interface 1430 also allows the caregiver to request adjustments to an operational mode of a device 102 , 1402 , or 1404 . The operational mode adjustments are then communicated from server 1406 to the device, and the device makes the appropriate mode adjustments. [0173] Patient interface 1432 generates a webpage intended for use by a patient. In one example, patient interface 1432 allows the patient to access patient records 1420 and generates reports or graphs that assist the patient in analyzing data from patient records 1420 . Patient interface 1432 provides instructions to assist the patient with uploading data from device 102 , 1402 , or 1404 to patient records 1420 . Instructions or other educational information is also provided by patient interface 1432 , if desired. [0174] In some embodiments, database 1412 includes firmware repository 1422 . Firmware repository 1422 includes data instructions that define the logical operation of a controller 102 (e.g. firmware 934 shown in FIG. 20 ). Firmware repository 1422 is used in some embodiments to store various versions of firmware. For example, when a new firmware version is created, the developer stores the new version of firmware in the firmware repository 1422 . The firmware is then communicated to the appropriate devices 102 , 1402 , or 1404 . The communication of new firmware versions can be either automatically distributed, or provided as an option to a patient or caregiver through interfaces 1430 and 1432 . In some embodiments, patient interface 1432 requires that a patient agree to pay for an upgraded firmware version before the firmware is made available for installation on a device. [0175] In another embodiment, firmware repository 1422 includes different firmware algorithms. Each firmware algorithm is specifically tailored to provide a specific therapy when executed by devices 102 , 1402 , 1404 or to be used with a particular hardware configuration. Examples of therapies defined by separate firmware algorithms include TENS, interferential therapy, edema therapy, muscle stimulation, iontophoresis therapy, and other therapies. A different firmware algorithm can also be specifically tailored for particular hardware configurations, such as for particular electrode numbers or configurations, for particular data communication devices, for different docking stations, or to accommodate other differences in hardware configuration. [0176] For example, a patient may first obtain a TENS device including a patch shown in FIG. 12 . The device includes a first firmware type that defines an algorithm appropriate for TENS therapy. Later, the patient desires to upgrade the device to cause the device to operate as an iontophoresis device. To do so, the patient uses patient computing system 1410 to access patient interface 1432 . The patient selects a new firmware algorithm that is designed for iontophoresis therapy. The patient purchases and downloads the firmware associated with the iontophoresis therapy and loads the firmware onto the device. If necessary, an appropriate patch can be purchased through patient interface 1432 and delivered to the patient. The patch is then connected to the device controller and the new firmware algorithm is executed. The firmware causes the device to provide the desired iontophoresis therapy. In this way, some embodiments of controller 102 are customizable to provide multiple different therapies. [0177] In another embodiment, firmware is specially tailored for providing a therapy to a particular part of the body. As a result, separate firmware algorithms are available for the treatment of separate body parts and conditions associated with those body parts. Such firmware algorithms can be obtained by downloaded, as described above. [0178] In some embodiments, controllers 11 , 100 include graphical user interfaces that allow the user to control the controllers 11 , 100 and the therapy provided thereby. For example, the controllers can include built-in displays that are used to present the user interfaces. The user interfaces have home pages that allow the user to control various aspects of the controller, such as turning the device on and off, the type of therapy provided, and the intensity of the therapy. [0179] In other examples, a separate device is used to control the controllers 11 , 100 . This device can communicate with the controllers 11 , 100 through wired or wireless means (e.g., Wifi, Bluetooth). For example, a docking station (e.g., docking station 1300 described above) can include a user interface that is programmed to control the therapy provided by controllers 11 , 100 . The docking station can communicate wirelessly with controllers 11 , 100 . [0180] In some examples, controllers 11 , 100 can include additional functionality, such as open lead detection. If a lead looses contact with a surface that is being delivered therapy, controllers 11 , 100 are programmed to detect the open lead and to modify therapy appropriately until the lead again makes contact. For example, controllers 11 , 100 can be programmed to shut down therapy that is delivered to the open lead and to issue an alarm so that the user can replace the lead. [0181] In other examples, controllers 11 , 100 are programmed to sense feedback from the user and modify therapy accordingly. For example, controllers 11 , 100 can be programmed to sense electromyographic biofeedback based on muscle activity and regulate therapy accordingly. In other examples, controllers 11 , 100 are programmed to sense impedance and deliver therapy accordingly. In other examples, other biofeedback such as heart rate or activity levels can also be monitored. Other configurations are possible. [0182] In some examples, the user can provide specific feedback as well. For example, the user can set pain thresholds that controllers 11 , 100 are programmed to remember. In other examples, the pain thresholds can be set automatically by controllers 11 , 100 by monitoring capacitance levels. [0183] In yet other examples, controllers 11 , 100 can include accelerometers and/or gyroscopes that can be used to measure orientation and activity level of the patient. For example, therapy can be adjusted based on the orientation of the patient (e.g., lying down or upright), as well as activity level. Controllers 11 , 100 can be programmed to adjust therapy over a specific time. In yet other examples, multiple controllers can be used, and the controllers can be programmed to communicate with each other to synchronize the therapy that is delivered to the user, thereby forming a body area network. This network can be formed through wireless communication and/or conductive communication through the patient's body. [0184] The number of delivery channels can be modified (e.g., 2 channel vs. 4 channel) to modify the type and intensity of therapy. Also, devices can be connected in series to deliver an increase in therapy intensity or increase the area treated. [0185] The various embodiments described above are provided by way of illustration only and should not be construed to limit the claims attached hereto. Those skilled in the art will readily recognize various modifications and changes that may be made without following the example embodiments and applications illustrated and described herein, and without departing from the true spirit and scope of the disclosure.

In various embodiments, the invention disclosed herein provides systems, devices and methods for providing electrical stimulation to a patient. An electrical mechanical interconnection is provided to facilitate user friendly systems and devices. Exemplary therapeutic electrical stimulation devices include a shoe connected mechanically and electrically to a conductor that provides signals for electrical stimulation.

FIELD OF THE INVENTION The present invention relates to methods and systems for altering the environment in closed chambers by the use of non-ionizing radiation that has been imprinted in water using a spectral region known as Terahertz Radiation. More particularly, there is provided a means for altering the environment so as to maintain the freshness of food products and retard the activity of bacteria associated with the food products. BACKGROUND OF THE INVENTION The use of magnets is known to create a magnetic field to energize water so as to permit the magnetized properties to dissipate to the surrounding areas. U.S. Pat. No. 6,164,332 discloses an apparatus to deliver water energized by a vortex flow of water through a magnetic field. U.S. Pat. No. 6,053,287 discloses a magnetic processing treatment facility for subjecting a fluid flow to magnetic energy that is integrated into an agricultural use to enhance activity in terms of crop growth and to increase the solubility of agricultural chemical agents to be used in a spray. U.S. Pat. No. 6,602,411 discloses a magnetic treatment apparatus to “energize” water using at least two magnetic fields and an electrical current. The water is used to condition potable water, gardening water and recycled water. U.S. Pat. No. 7,476,870 to Hopaluk et al, which is herein incorporated by reference, discloses a method of “energizing” water using reflected ultraviolet light. There exists an AquaCharge® system for “energizing” water using paramagnetic material and Organite to clear harmful energy signatures from water. The system passes water through a concentrated paramagnetic system combined with quartz crystals in combination with orgone to provide the water with positive frequencies. The article of Gerecht et al entitled “A Passive Heterodyne Hot Electron Bolometer Imager Operating at 850 GHz” in IEEE Transactions on Microwave Theory and Technoques , Vol 56, No. 5, May 2008, describes means for producing and detecting Tetrahertz radiation at a frequency of 720-930 GHz. Light rays produced by the sun comprise electric and magnetic vibrations which are vibrating in more than one plane that is referred to as unpolarized light. The spectrum of electromagnetic radiation striking the earth on a daily basis originates from the sun including for example commonly known spectra such as the visible and ultraviolet regions. The full spectrum is characterized by the term EOF representing the electro optical frequencies of solar radiation. The bands of these frequencies are characterized based upon wavelengths into nine general regions illustrated by the Solar Spectrum. These nine categories of increasing wavelength from 100 nm to 1 mm include Ultraviolet C, Ultraviolet B, Ultraviolet A, Visible light, Infrared A, Infrared B, Infrared C, FAR Infrared, and Extreme Far Infrared, the latter of which is part of the Terahertz spectrum. This special region known as Terahertz spectrum radiation or the “Terahertz Gap” falls between electromagnetic frequencies (measured with antennas) and optical frequencies (measured with optical detectors). There are currently no known natural sources of Terahertz radiation in the Extreme Far Infrared region. Terahertz radiation is a non-ionizing sub-millimeter radiation and shares with X-rays the capability to penetrate a wide variety of non conductive materials. Terahertz radiation can pass through clothing, paper, cardboard, wood, masonry and plastic. It can also penetrate fog and clouds, but cannot penetrate metal or water. It is possible to transform unpolarized light into polarized light. Polarized light waves are light waves in which the vibrations occur in a single plane. The process of transforming unpolarized light into polarized light is known as polarization. There are a variety of methods of polarizing light. The most common method of polarization involves the use of a Polaroid filter. Polaroid filters are made of a special material which is capable of blocking one of the two planes of vibration of an electromagnetic wave. A Polaroid serves as a device which filters out one-half of the vibrations upon transmission of the light through the filter. When unpolarized light is transmitted through a Polaroid filter, it emerges with one-half the intensity and with vibrations in a single plane; it emerges as polarized light. A Polaroid filter is able to polarize light because of the chemical composition of the filter material. The filter can be thought of as having long-chain molecules that are aligned within the filter in the same direction. During the fabrication of the filter, the long-chain molecules are stretched across the filter so that each molecule is aligned in the vertical direction. As unpolarized light strikes the filter, the portion of the waves vibrating in the vertical direction are absorbed by the filter. The general rule is that the electromagnetic vibrations which are in a direction parallel to the alignment of the molecules are absorbed. The alignment of these molecules gives the filter a polarization axis. This polarization axis extends across the length of the filter and only allows vibrations of the electromagnetic wave that are parallel to the axis to pass through. Any vibrations which are perpendicular to the polarization axis are blocked by the filter. Thus, a Polaroid filter with its long-chain molecules aligned horizontally will have a polarization axis aligned vertically. Such a filter will block all horizontal vibrations and allow the vertical vibrations to be transmitted. On the other hand, a Polaroid filter with its long-c chain molecules aligned vertically will have a polarization axis aligned horizontally; this filter will block all vertical vibrations and allow the horizontal vibrations to be transmitted. SUMMARY OF THE INVENTION The present invention relates to a method and means for altering the environment in a closed system by non-ionizing Terahertz radiation emitted from water imprinted with wavelengths of 100 micrometers to 1 micrometers or frequencies from 300 GHz to 3 THz so as to reduce the activity of pathogens and maintain the freshness of food products. More particularly, there is provided water which has been imprinted with Terahertz non-ionizing in a geometrically suitable transparent container which emits radiation at least at a frequency of 720-930 GHz, preferably at 850 GHz into a closed environment containing food products. Advantageously, the containers in which the food products are stored with the means for radiating the Terahertz non-ionizing radiation consists of refrigerators, coolers, food transports and the like. The container storing the “energized” water is preferably egg shaped. It is a general object of the invention to provide a means for generating non-ionizing radiation from a container to alter the environment in a storage container for foodstuff. It is another object of the invention to reduce the pathogens associated with food by the use of Terahertz radiation and thereby extending the shelf life of the product. It is yet another object of the invention to accelerate the conversion of glycogen in fruits and vegetables, such as apples and tomatoes, using Terahertz radiation. It is a still further object of the invention to reduce oxidation and retain the moisture of food in the refrigerator or pantry without using chemicals. It is a yet another object of the invention to provide a means for altering the environment in a closed chamber with Terahertz radiation so as to reduce pathogenic growth, mold and mildew. These and other objects will become apparent from the reading of the description of preferred embodiments and the drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a block diagram of a procedure for preparing a means for generating Terahertz radiation to imprint water. FIG. 2 represents a geometric container for storing the energized water of the process and emitting radiation in a closed chamber. DESCRIPTION OF THE PREFERRED EMBODIMENTS According to the present invention, there is provided a means for radiating in a closed chamber Terahertz radiation and imprinting water containing inorganic salts and/or minerals with wavelengths of about 100 micrometers to 1 micrometer or frequencies from 300 GHz to 3 THz, preferably radiation at a frequency of about 720 to 930 GHz, most preferably of about 850 GHz which is placed in a geometrically suitable transparent container to effect the environment in the chamber. Preferably, the chamber is environmentally controlled. As seen in FIG. 1 of the drawing, a source ( 10 ) of Terahertz radiation which generates the desired Terahertz radiation, such as disclosed in aforementioned IEEE Transactions on Microwave Theory and Techniques or naturally from the sun, is beamed to a metal reflector ( 11 ). The electro-optical frequencies generated are reflected onto a polarization filter ( 12 ). The polarized rays are then directed into a tank containing ionized water ( 22 ) which contains inorganic salts and/or minerals to absorb the polarized Terahertz radiation and store imprinted information. The tank of water contains a vortex generator ( 13 ) to create a spinning turbulent flow of water in the tank. The turbulence is produced for at least one hour in a tank containing about 125 liters of the polarized water. The irradiated polarized water is then rested for about one hour to allow imprinting of the Terahertz radiation. The vortex generated is preferably rotated in a counterclockwise direction. The imprinted water can then be placed in a geometrically acceptable transparent container ( 14 ), for example, an egg shaped transparent container, which when placed into an environmentally controlled chamber ( 15 ) transmits the desired Terahertz radiation. The container can also be placed in a non controlled environment such as an insulated container. When using sunlight as the source of Terahertz radiation, consideration is taken as to the amount of sunlight available. One of the properties of sunlight is its wave particle duality. The main property used in the process encompasses the particle aspect of the waves of sunlight. Using the high photonic energy of the unobstructed sunlight the polarized light has the ability to change the electromagnetic spin of the electrons in the water molecules containing the inorganic salts and/or minerals such as found in spring water. The process synchronizes the water molecules into certain formations allowing the water to absorb the Terahertz radiation, especially those in the Far Infrared end of the spectrum. As seen in FIG. 2 , proper geometrically shaped containers ( 20 ), for example, egg shaped transparent containers ( 21 ) containing the energized water ( 22 ) are placed on a stand ( 23 ). Proper geometrically shaped containers are well known to transmit various energies whereby the wavelengths do not interfere with each other. Containers which are egg shaped have this capability. Pyramid configurations are considered to channel energies in the proper direction as well. Tubular containers also permit the energizing properties of the water to dissipate therefrom in proper order. Use of the radiation emitting devices of the invention can reduce oxidation and retain moisture in food that are stored in chambers such as refrigerators, refrigeration vehicles, coolers, pantries and the like which causes odors and food spoilage. Example 1 A comparison study was made wherein three controlled environment chambers were used. One chamber contained 25 fresh picked Gala apples. A second chamber contained 25 fresh picked Gala apples treated with gaseous 1-methylcyclopropene (1-MCP) which is commercially available under the trademark Smart Fresh®. A third chamber contained 25 fresh picked Gala apples and the egg shaped device with the Terahertz radiation treated water of the invention. After 6 weeks the apples were tested to firmness, acid levels, color, taste and aroma. Results The non-treated apples had soft spots, brown spots when sliced, tasted as being stale and not fresh. The color was only slightly faded. The apples treated with 1-MCP were crunchy, fresh tasting and similar to the fresh picked apples. The apples from the third chamber had the same quality and characteristics as the apples from the second chamber. The terms and expressions which have been used are not limitations and there is no intention in the use of these terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but recognize that various modifications are possible within the scope of the invention claimed.

The present invention provides a method for imprinting water so as to emit Terahertz radiation and a method for maintaining the freshness of foodstuff with an article containing the imprinted water.

[0001] The present invention relates to combinations of compounds of the class having the formula (I) as defined below, for example compounds of the xanthenone acetic acid class having the formula (II) as defined below, such as 5,6-dimethylxanthenone-4-acetic acid (DMXAA), or a pharmaceutically acceptable salt, ester or prodrug thereof and EGFR signalling pathway inhibitors. For example, the present invention relates to synergistic combinations of compounds of the class having the formula (I) as defined below, for example compounds of the xanthenone acetic acid class having the formula (II) as defined below, such as 5,6-dimethylxanthenone-4-acetic acid (DMXAA), or a pharmaceutically acceptable salt, ester or prodrug thereof and EGFR signalling pathway inhibitors. More particularly, the invention is concerned with the use of such combinations in the treatment of cancer. The present invention also relates to pharmaceutical compositions containing such combinations. [0002] 5,6-dimethylxanthenone-4-acetic acid (DMXAA) is represented by the following formula: [0000] [0003] Three phase I clinical trials of DMXAA as a monotherapy have recently been completed, with dynamic MRI showing that it induces a significant reduction in tumour blood flow at well-tolerated doses. DMXAA is thus one of the first vascular disrupting agents (VDAs) for which activity (irreversible inhibition of tumour blood flow) has been documented in human tumours. These findings are in agreement with preclinical studies using syngeneic murine tumours or human tumour xenografts, which showed that its antivascular activity produced prolonged inhibition of tumour blood flow leading to extensive regions of haemorrhagic necrosis. [0004] However, in these phase I clinical trials of DMXAA there were very few tumour responses, demonstrating that DMXAA alone does not have significant potential in cancer treatment as a single agent. Therefore, there is a need to identify compounds that could have a synergistic effect with DMXAA. [0005] There is a new class of cancer drugs available that are not cytotoxics, but block the epidermal growth factor signalling pathways. Examples include Erbitux™ (cetuximab), a monoclonal antibody binding to epidermal growth factor receptor (EGFR) and Tarceva™ (erlotinib) and Iressa™ (gefitinib), small molecules that inhibit cell signalling in the EGFR pathway. We have surprisingly found that DMXAA may act synergistically with these new agents, enhancing their anti-cancer activity. EGFR Signalling Pathway Inhibitors [0006] Tumours have been found to overexpress certain growth factors that enable them to proliferate rapidly, one of which is EGF. Activation of EGFR by binding of EGF and formation of an active receptor dimer induces phosphorylation of the tyrosine kinase in the intracellular domain of the receptor. The ras protein initiates a cascade of phosphorylations which result in activation of mitogen activated protein kinase (MAPK). MAPK triggers events in the nucleus that result in cell division. As a result, overexpression of EGF, or of EGFR on the cell surface can result in uncontrolled cell division characteristic of cancer. Expression levels of EGF and EGFR are negatively correlated with prognosis and survival in cancer, and inhibiting the signalling pathway has been shown to improve survival. [0007] The EGFR pathway is targeted by Erbitux™ (cetuximab, a chimeric monoclonal antibody marketed for colorectal cancer by Imclone and Bristol-Myers Squibb in the US and Schering in Europe), which binds to EGF receptors, blocking EGF from binding to them. Tarceva™ (erlotinib, marketed by Genentech and OSI Pharmaceuticals in the US and Roche elsewhere) and Iressa™ (gefitinib, marketed by AstraZeneca), small molecules marketed for non-small cell lung cancer, inhibit phosphorylation of the intracellular tyrosine kinase, interfering with cell signalling. This limits the uncontrolled cell division caused by overstimulation of the EGFR signalling pathway. [0008] Of the EGFR signalling pathway inhibitors, only Tarceva™ has demonstrated a survival advantage in phase III trials, with both Erbitux™ and Iressa™ being approved based on tumour response rates. Since its approval Iressa™ has completed a number of phase III trials, which found that it did not extend median survival, despite the improvement in response rate over standard care. Previous EGFR Signalling Pathway Inhibitor Combination Studies [0009] Clinical trials of the EGFR signalling pathway inhibitors do not suggest that they are likely to show synergy with vascular targeting anti-cancer agents. Erbitux™ is approved for use as a monotherapy or in combination with irinotecan, a non-vascular targeting cytotoxic. [0010] Both Iressa™ and Tarceva™ have been tested with combinations that include paclitaxel, a compound known to have anti-angiogenic properties secondary to its cytotoxic activity, with no evidence of benefit. For both products, two trials failed to show a benefit of adding the EGFR signalling inhibitor to standard chemotherapy. Iressa™ is indicated only as a monotherapy because two large, controlled, randomised trials showed it to give no survival benefit when used first-line in combination with chemotherapy that included a platin and another agent, which could be paclitaxel. Tarceva™ has been similarly unsuccessful in demonstrating a survival benefit when combined with carboplatin/paclitaxel or cisplatin/gemcitabine. Tarceva™ has demonstrated a survival benefit in pancreatic cancer patients when combined with gemcitabine, a non-vascular targeting cytotoxic cancer drug. Previous DMXAA Combination Studies [0011] DMXAA has previously been demonstrated to have synergy with a number of agents in xenograft studies. These agents include widely used cytotoxic chemotherapies such as taxanes (paclitaxel and docetaxel), platins (cisplatin and carboplatin), vinca alkaloids (vincristine), antimetabolites (gemcitabine), topoisomerase II inhibitors (etoposide) and anthracyclines (doxorubicin). It is believed that the synergy arises because DMXAA causes necrosis in the centre of tumours, but seems to leave a viable rim of cancer cells. These are targeted by the cytotoxic agents which primarily act on rapidly proliferating cells. None of these chemotherapy agents are known to affect the EGFR signalling pathway. [0012] DMXAA is currently in two phase II trials examining its anti-tumour efficacy in combination with paclitaxel and carboplatin, and one trial combining it with docetaxel. The cytotoxic effect of the taxanes is caused by interference with tubulin, which prevents normal mitosis (cell division). A secondary effect is disruption of newly formed blood vessels, since the cells of the new vascular endothelium depend on tubulin to maintain their shape. However, the cytotoxic effect is overriding at higher doses, such as those used in chemotherapy. Any synergy between DMXAA and the taxanes is thought to be a result of the targeting of different parts of the tumour, as described above. [0013] Other agents have also been shown to enhance the activity of DMXAA in xenograft studies. Although the exact mechanism of action of DMXAA is not understood, it is believed to cause upregulation of various cytokines, and compounds with similar activity appear to enhance its effectiveness. These include tumour necrosis factor stimulating compounds and immunomodulatory compounds such as intracellular adhesion molecules (ICAMs). [0014] Diclofenac, an NSAID that has been shown to enhance the anti-tumour activity of DMXAA, is believed to affect the PK of DMXAA via competition for metabolic pathways. At a concentration of 100 μM, diclofenac has been shown to significantly inhibit glucoronidation (>70%) and 6-methylhydroxylation (>54%) of DMXAA in mouse and human liver microsomes. In vivo, diclofenac (100 mg/kg i.p.) has been shown to result in a 24% and 31% increase in the plasma DMXAA AUC (area under the plasma concentration-time curve) and a threefold increase in T 1/2 (P<0.05) in male and female mice respectively (see Zhou et al. (2001) Cancer Chemother. Pharmacol. 47, 319-326). Other NSAIDs have been shown to have a similar effect. [0015] Similarly to diclofenac, thalidomide, which is approved for erythema nodosum leprosum (ENL), seems to enhance the activity of DMXAA. Thalidomide is also known to have anti-angiogenic effects but the synergy is caused by effect on metabolism of DMXAA. It competes for glucuronidation, prolonging DMXAA's presence at therapeutic levels in tumour tissue. Thalidomide increases the AUC of DMXAA by 1.8 times in plasma, liver and spleen and by three times in tumour (see Kestell et al. (2000) Cancer Chemother. Pharmacol. 46(2), 135-41). DESCRIPTION OF THE INVENTION [0016] In a first aspect, the present invention provides a method for modulating neoplastic growth, which comprises administering to a mammal, including a human, in need of treatment an effective amount of formula (I): [0000] [0000] wherein: (a) R 4 and R 5 together with the carbon atoms to which they are joined, form a 6-membered aromatic ring having a substituent —R 3 and a radical —(B)—COOH where B is a linear or branched substituted or unsubstituted C 1 -C 6 alkyl radical, which is saturated or ethylenically unsaturated, and wherein R 1 , R 2 and R 3 are each independently selected from the group consisting of H, C 1 -C 6 alkyl, halogen, CF 3 , CN, NO 2 , NH 2 , OH, OR, NHCOR, NHSO 2 R, SR, SO 2 R or NHR, wherein each R is independently C 1 -C 6 alkyl optionally substituted with one or more substituents selected from hydroxy, amino and methoxy; or [0018] (b) one of R 4 and R 5 is H or a phenyl radical, and the other of R 4 and R 5 is H or a phenyl radical which may optionally be substituted, thenyl, furyl, naphthyl, a C 1 -C 6 alkyl, cycloalkyl, or aralkyl radical; R 1 is H or a C 1 -C 6 alkyl or C 1 -C 6 alkoxy radical; R 2 is the radical —(B)—COOH where B is a linear or branched substituted or unsubstituted C 1 -C 6 alkyl radical, which is saturated or ethylenically unsaturated, [0000] or a pharmaceutically acceptable salt, ester or prodrug thereof and concomitantly or sequentially administering an EGFR signalling pathway inhibitor. [0019] Where (B) in the radical —(B)—COOH is a substituted C 1 -C 6 alkylene radical, the substituents may be alkyl, for example methyl, ethyl, propyl or isopropyl, or halide such as fluoro, chloro or bromo groups. In one example the substituent is methyl. [0020] In one embodiment of the first aspect of the invention, the compound of the formula (I) as defined above may be a compound of the formula (II): [0000] [0000] where R 1 , R 4 , R 5 and B are as defined above for formula (I) in part (b). [0021] In a further embodiment of the first aspect of the invention, the compound of formula (I) as defined above may be a compound of the formula (III): [0000] [0000] wherein R 1 , R 2 and R 3 are each independently selected from the group consisting of H, C 1 -C 6 alkyl, halogen, CF 3 , CN, NO 2 , NH 2 , OH, OR, NHCOR, NHSO 2 R, SR, SO 2 R or NHR, wherein each R is independently C 1 -C 6 alkyl optionally substituted with one or more substituents selected from hydroxy, amino and methoxy; wherein B is as defined for formula (I) above; and wherein in each of the carbocyclic aromatic rings in formula (I), up to two of the methine (—CH═) groups may be replaced by an aza (—N═) group; and wherein any two of R 1 , R 2 and R 3 may additionally together represent the group —CH═CH—CH═CH—, such that this group, together with the carbon or nitrogen atoms to which it is attached, forms a fused 6-membered aromatic ring. [0022] For example, the compound of formula (III) may be a compound of the formula (IV): [0000] [0000] wherein R, R 1 , R 2 and R 3 are as defined for formula (III). [0023] In one embodiment of the compound of formula (IV), R 2 is H, one of R 1 and R 3 is selected from the group consisting of C 1 -C 6 alkyl, halogen, CF 3 , CN, NO 2 , NH 2 , OH, OR, NHCOR, NHSO 2 R, SR, SO 2 R or NHR, wherein each R is independently C 1 -C 6 alkyl optionally substituted with one or more substituents selected from hydroxy, amino and methoxy, and the other of R 1 and R 3 is H. [0024] For example, the compound of formula (IV) may be of the formula (V): [0000] [0000] wherein R, R 1 , R 2 and R 3 are as defined for formula (IV). [0025] The compound of formula (V) may be, for example, 5,6-dimethylxanthenone-4-acetic acid (DMXAA), or a pharmaceutically acceptable salt, ester or prodrug thereof. [0026] In one embodiment of the invention the EGFR signalling pathway inhibitor is a monoclonal antibody. [0027] In one embodiment of the invention the EGFR signalling pathway inhibitor is Erbitux™ (cetuximab). [0028] In one embodiment of the invention the EGFR signalling pathway inhibitor is a tyrosine kinase inhibitor. [0029] In one embodiment of the invention the EGFR signalling pathway inhibitor is Tarceva™ (erlotinib). [0030] In one embodiment of the invention the EGFR signalling pathway inhibitor is Iressa™ (gefitinib). [0031] In another aspect, the present invention provides the use of a EGFR signalling pathway inhibitor for the manufacture of a medicament (e.g. of a unit dose of a medicament), for simultaneous, separate or sequential administration with the compound of formula (I) as defined above or a pharmaceutically acceptable salt, ester or prodrug thereof (e.g. a unit dose of the compound of formula (I) as defined above or a pharmaceutically acceptable salt, ester or prodrug thereof), for the modulation of neoplastic growth. [0032] In another aspect, the present invention provides the use of the compound of formula (I) as defined above or a pharmaceutically acceptable salt, ester or prodrug thereof for the manufacture of a medicament (e.g. a unit dose of a medicament) for simultaneous, separate or sequential administration with the EGFR signalling pathway inhibitor (e.g. a unit dose of the EGFR signalling pathway inhibitor) for the modulation of neoplastic growth. [0033] According to one aspect, the neoplastic growth is a tumour and/or a cancer. [0034] In a further aspect, the neoplastic growth is one or more of ovarian, prostate, lung, pancreatic, colorectal, and head and neck cancer. [0035] In a further aspect, there is provided a pharmaceutical formulation comprising a combination of the compound of formula (I) as defined above or a pharmaceutically acceptable salt, ester or prodrug thereof (e.g. in a unit dose) and an EGFR signalling pathway inhibitor (e.g. in a unit dose). [0036] In one embodiment there is provided a compound according to formula (I) or a pharmaceutically acceptable salt, ester or prodrug thereof and an EGFR signalling pathway inhibitor for use (in combination) as a medicament for modulation of neoplastic growth. [0037] The invention further provides a process for the preparation of a pharmaceutical formulation which process comprises bringing into association a combination of the compound of formula (I) as defined above or a pharmaceutically acceptable salt, ester or prodrug thereof (e.g. a unit dose of the compound of formula (I) as defined above or a pharmaceutically acceptable salt, ester or prodrug thereof) and an EGFR signalling pathway inhibitor (e.g. a unit dose of the EGFR signalling pathway inhibitor), optionally with one or more pharmaceutically acceptable carriers therefor. For example, the pharmaceutical formulation may be in a unit dose. [0038] Pharmaceutical formulations comprise the active ingredients (that is, the combination of a compound of formula (I) as defined above or pharmaceutically acceptable salt, ester or prodrug thereof and the growth factor inhibitor, for example EGFR signalling pathway inhibitor), for example together with one or more pharmaceutically acceptable carriers therefor and optionally other therapeutic and/or prophylactic ingredients. The carrier(s) must be acceptable in the sense of being compatible with the other ingredients in the formulation and not deleterious to the recipient thereof. [0039] The compound of formula (I) as defined above or a pharmaceutically acceptable salt, ester or prodrug thereof and the EGFR signalling pathway inhibitor may be administered simultaneously, separately or sequentially. [0040] In one embodiment, the pharmaceutically acceptable salt is a sodium salt. [0041] The amount of a combination of a compound of formula (I) as defined above or pharmaceutically acceptable salt, ester or prodrug thereof and an EGFR signalling pathway inhibitor required to be effective as a modulator of neoplastic growth will, of course, vary and is ultimately at the discretion of the medical practitioner. The factors to be considered include the route of administration and nature of the formulation, the mammal's bodyweight, age and general condition and the nature and severity of the disease to be treated. [0042] A suitable effective dose of a compound of formula (I) as defined above, or a pharmaceutically acceptable salt thereof, for administration, simultaneously, separately or sequentially, with an EGFR signalling pathway inhibitor, for the treatment of cancer is in the range of 600 to 4900 mg/m 2 . For example from 2500 to 4000 mg/m 2 , from 1200 to 3500 mg/m 2 , more suitably from 2000 to 3000 mg/m 2 , particularly from 1200 to 2500 mg/m 2 , more particularly from 2500 to 3500 mg/m 2 , preferably from 2250 to 2750 mg/m 2 . [0043] It is of course also possible to base dosages upon the weight of a patient. For example, a dosage of a compound of formula (I) as defined above, or a pharmaceutically acceptable salt thereof, for administration, simultaneously, separately or sequentially, with an EGFR signalling pathway inhibitor, for the treatment of cancer may be in the range of 15 to 125 mg/kg body weight may be administered. More preferably, the dosage is from 30 to 80 mg/kg, or 30 to 70 mg/kg. [0044] In one embodiment the Erbitux™ may be administered in a loading dose of 250 to 500 mg/m 2 (e.g. about 400 mg/m 2 ) and then weekly doses of 150 to 350 mg/m 2 (e.g. about 250 mg/m 2 ). [0045] As above, the dosage for Erbitux™ may be based upon the weight of a patient. For example, Erbitux™ may be administered in a loading dose of 6 to 13 mg/kg (e.g. about 10 mg/kg) and then weekly doses of 4 to 9 mg/kg (e.g. about 6 mg/kg). [0046] In one embodiment the Iressa™ and Tarceva™ may be administered in an amount of one 100 to 350 mg tablet daily. For example, Iressa™ may be administered in an amount of one 250 mg tablet daily, and the Tarceva™ may be administered in an amount of one 150 mg tablet daily. [0047] The pharmaceutical formulation may be delivered intravenously (e.g. a formulation containing Erbitux™) or orally (e.g. a formulation containing Iressa™ or Tarceva™). The pharmaceutical composition for intravenous administration may be used in the form of sterile aqueous solutions or in an oleaginous vehicle which may contain other substances, for example, enough salts or glucose to make the solution isotonic with blood. The aqueous solutions may be buffered (e.g. to a pH from 3 to 9), if necessary. [0048] The pharmaceutical formulations (e.g. containing Iressa™ or Tarceva™) may, for example, be administered orally in one or more of the forms of tablets, capsules, ovules, elixirs, solutions or suspensions, which may contain flavouring or colouring agents, for immediate-, delayed-, modified-, sustained-, pulsed- or controlled-release applications. [0049] If the pharmaceutical formulation is a tablet, then the tablet may contain excipients such as microcrystalline cellulose, lactose, sodium citrate, calcium carbonate, dibasic calcium phosphate and glycine, disintegrants such as starch (preferably corn, potato or tapioca starch), sodium starch glycollate, croscarmellose sodium and certain complex silicates, and granulation binders such as polyvinylpyrrolidone, hydroxypropylmethylcellulose (HPMC), hydroxypropylcellulose (HPC), sucrose, gelatin and acacia. Additionally, lubricating agents such as magnesium stearate, stearic acid, glyceryl behenate and talc may be included. [0050] Solid formulations of a similar type may also be employed as fillers in gelatin capsules. Preferred excipients in this regard include lactose, starch, cellulose, milk sugar or high molecular weight polyethylene glycols. For aqueous suspensions and/or elixirs, the compound may be combined with various sweetening or flavouring agents, colouring matter or dyes, with emulsifying and/or suspending agents and with diluents such as water, ethanol, propylene glycol and glycerin, and combinations thereof. [0051] Pharmaceutical formulations suitable for oral administration may, where appropriate, be conveniently presented in discrete dosage units and may be prepared by any of the methods well known in the art of pharmacy. All methods include the step of bringing into association the active ingredients with liquid carriers or finely divided solid carriers or both and then, if necessary, shaping the product into the desired formulation. [0052] Pharmaceutical formulations suitable for oral administration wherein the carrier is a solid are most preferably presented as unit dose formulations such as boluses, capsules or tablets each containing a predetermined amount of the active ingredients. A tablet may be made by compression or moulding, optionally with one or more accessory ingredients. Compressed tablets may be prepared by compressing in a suitable machine the active compounds in a free-flowing form such as a powder or granules optionally mixed with a binder, lubricant, inert diluent, lubricating agent, surface-active agent or dispersing agent. Moulded tablets may be made by moulding an inert liquid diluent. Tablets may be optionally coated and, if uncoated, may optionally be scored. Capsules may be prepared by filling the active ingredients, either alone or in admixture with one or more accessory ingredients, into the capsule shells and then sealing them in the usual manner. Cachets are analogous to capsules wherein the active ingredients together with any accessory ingredient(s) are sealed in a rice paper envelope. The compound of formula (I) or a pharmaceutically acceptable salt or ester may also be formulated as dispersible granules, which may for example be suspended in water before administration, or sprinkled on food. The granules may be packaged e.g. in a sachet. [0053] The active ingredients may also be formulated as a solution or suspension for oral administration. Formulations suitable for oral administration wherein the carrier is a liquid may be presented as a solution or a suspension in an aqueous liquid or a non-aqueous liquid, or as an oil-in-water liquid emulsion. [0054] As used herein, the term “prodrug” includes entities that have certain protected group(s) and which may not possess pharmacological activity as such, but may, in certain instances, be administered (such as orally or parenterally) and thereafter metabolised in the body to form the agents which are pharmacologically active. [0055] Furthermore, the invention also provides a kit comprising in combination for simultaneous, separate or sequential use in modulating neoplastic growth, the compound according to formula (I) as defined above or a pharmaceutically acceptable salt, ester or prodrug thereof and an EGFR signalling pathway inhibitor. DESCRIPTION OF THE FIGURES [0056] FIG. 1 : shows the average tumour volume (relative to the average volume on the first day of treatment) for A549 (lung carcinoma) xenografts observed for an untreated control group of mice and for mice given (i.e. treated with) Erbitux™ (alone), DMXAA (alone), or a combination of Erbitux™ and DMXAA. [0057] FIG. 2 : is a representation of the same data used to generate FIG. 1 , but expressed in terms of the percentage of mice having tumour volume less than four times the volume measured on the first day of treatment. EXAMPLES Example 1 Method [0058] Xenografts for human lung cancer are set-up in groups of nude, athymic mice. The cell line selected was A549 (ATCC number CCL-185), a lung carcinoma. [0059] The A549 was selected as DMXAA has previously been shown to be effective in these cell lines when used in combination with paclitaxel or 5-FU in xenograft studies. [0000] Dose level Group Cell line Treatment (mg/kg) No. of mice 1 A549 Untreated control — 10 2 A549 DMXAA 21  10 3 A549 Erbitux ™ 33* 10 4 A549 Erbitux ™/DMXAA 33* & 21 10 *Calculated from dose of 1 mg/mouse. [0060] For this study, DMXAA is given twice in each of Weeks 1 and 4 of the study. Erbitux™ is given twice weekly for four weeks. [0061] Xenografts are measured two or three times per week and their absolute volume recorded; xenograft tumour volume relative to that recorded on Day 0 (V 0 ) is then calculated. The time taken to reach a relative tumour volume of 3×V 0 is used as a surrogate marker for survival. Results [0062] Tables 1 and 2 below, as well as FIGS. 1 and 2 show that the combination of Erbitux™ and DMXAA provides an unexpected synergistic effect in delaying tumour growth. [0000] TABLE 1 Results of studies with A549 xenografts. Dose Regression (mg/kg by Drug Median VQT Tumour Growth Duration b TTP c Group injection) deaths (Range; days) Delay a (Days) (Days) (Days) Erbitux ™ 33 d 0/10 44 12 0 4 DMXAA 21   2/10 48 16 0 16 Erbitux ™/ 33 d + 21 1/10 70 38 28 34 DMXAA a The difference in days for treated versus control tumours to quadruple in volume (control tumours quadrupled in 17 (14-23) days). b Tumour regression duration is the number of days that the tumour volume is less than the original treatment volume. c TTP: Median time to disease progression. d Calculated from dose of 1 mg/mouse. [0000] TABLE 2 Results of studies with A549 xenografts. Dose (mg/kg by Response e Group injection) PD PR SD CR Erbitux ™ 33 d 0/10 44 12 0 DMXAA 21   2/10 48 16 0 Erbitux ™/ 33 d + 21 1/10 70 38 28 DMXAA d Calculated from dose of 1 mg/mouse. e PD: Progressive Disease (≧50% increase in tumour size) PR: Partial Response (≧50% reduction in tumour size sustained over two weeks) SD: Stable Disease (does not satisfy criteria for PR or PD) CR: Complete Response (cure; undetectable tumour over two weeks) ABBREVIATIONS [0063] AUC=area under curve (plasma concentration vs. time) CR=Complete Response [0064] DMXAA=5,6-dimethylxanthenoneacetic acid EGF=endothelial growth factor EGFR=endothelial growth factor receptor ENL=erythema nodosum leprosum 5-FU=5-fluorouracil HPC=hydroxypropylcellulose HPMC=hydroxymethylcellulose ICAM=intracellular adhesion molecule i.p.=intraperitoneal MRI=magnetic resonance imaging PD=Progressive Disease [0065] PK=pharmacokinetics PR=Partial Response SD=Stable Disease [0066] TTP=median time to disease progression VDA=vascular disrupting agent VQT=(tumour) volume quadrupling time

The present invention relates to combinations of the xanthenone acetic acids class such as 5,6-dimethylxanthenone-4-acetic acid (DMXAA) and EGFR signalling pathway inhibitors. More particularly, the invention is concerned with the use of such combinations in the treatment of cancer and pharmaceutical compositions containing such combinations.

This application claims priority to U.S. Provisional Application No. 60/314,475 filed Aug. 23, 2001, the contents of which are incorporated herein in their entirety by this reference. FIELD OF THE INVENTION The present invention relates to instrumentation used for precision bone cutting. More specifically, the invention relates to a cutting guide apparatus for guiding a bone saw to allow for the surgical preparation of bone joint structures to facilitate the implantation of artificial joint prostheses. BACKGROUND OF THE INVENTION In total knee arthroplasty, a damaged knee joint is replaced with a prosthesis to reproduce natural knee function. Multiple faceted cuts are made on the femur and at least one cut is made to the tibia to prepare the bone surface for application of the knee replacement prosthesis. These cut surfaces are preferably precisely angularly aligned to each other and are planar to enable satisfactory mating with the prosthesis. In preparing the joint for a prosthesis, a series of cuts are made to the inferior end of the femur and the superior end of the tibia. Exemplary femoral cuts are depicted in FIG. 1 . Initially the femur is cut to create a flat surface (annotated “A” in the drawings) generally perpendicular to the longitudinal mechanical axis of the bone. Next, two flat cuts are made generally parallel to the longitudinal mechanical axis of the femur: one at the rear of the knee to remove the posterior femoral condyles B and another at the front of the knee C. Lastly, two chamfered cuts D, D′ are made at approximately a forty-five degree angle at the juncture of the perpendicular and the anterior and posterior planes (or “planed femoral surfaces”). The superior end of the tibia is cut off perpendicular to the longitudinal mechanical axis of the tibia in a fashion similar to femoral cut A. Skeletal joints are subject to high degrees of mechanical stress. The secure attachment of joint replacement structures to the bone is, therefore, critical in determining the long-term success of the surgical procedure. The accuracy with which the bone ends are shaped is essential to achieving a secure connection between the existing bone and an implanted prosthesis. A number of studies have documented the correlation between imprecise bonding surface preparation and later complications for joint replacement patients. Knee implant malpositioning due to deficient bone resecting technique contributes to poor long-term results by influencing a prosthesis' function, load distribution, wear and fixation. These discoveries have led researchers to propose standards that improve the likelihood of post-surgical success. Sandborn et al. recommended that the gap between the bone and a porous-coated knee implant not exceed 0.5 mm for optimal bone ingrowth. P. M. Sandborn et al., The Effect Of Surgical Fit On Bone Growth Into Porous Coated Implants , 12 Trans. Orthop. Res. Soc., 217 (1987). Cooke et al proposed a maximum cutting error of ±1 mm for proper bone fixation into a porous-coated prosthesis. T. D. Cooke et al., Universal Bone Cutting Device For Precision Knee Replacement Arthroplasty And Osteotomy . 7 J. Biomed. Eng. 45, 50 (1985). These levels of accuracy are currently difficult to achieve. Unfortunately, these currently exists as much as a ten-fold discrepancy between the precision of the implant manufacturing tolerances (±0.2 mm) and the bone cutting process. Bone cements are often used to fill the gap between resected bone tissue and the prosthesis. Even with the use of bone cement, however, an uneven cement mantle due to poor bone cutting can result in early prosthesis loosening. To aid the surgeon in making the precise multiple bone cuts required for this type of surgery, various guides and devices have been proposed. An initial group of devices are secured to the saw driver and to the patient and/or the surgical table. A second group includes cutting guides that guide the saw blade, typically within a close fitting slot. The first group includes, for example, U.S. Pat. No. 4,457,307, issued to Stillwell, which discloses a bone cutting device for total knee replacements that is secured to the femur throughout its use. With this device, cuts are made both to the femur and the tibia. The Stillwell design requires removal of a large amount of soft tissue and a substantial number of calculations and adjustments in order to make the cuts required for total knee replacement surgery. U.S. Pat. No. 4,574,794, issued to Cooke et al., discloses a guide for supporting a bone saw driver. The Cooke guide includes a complex system of parallel guide rods secured to the operating table as well as to the long bones of the leg and the bones of the foot. The device requires extensive fixation to the bone and numerous calculations to generate the desired cuts on the knee joint. U.S. Pat. No. 5,007,912, issued to Albrektsson et al., discloses a cutting device mounted to a frame. The frame is connected to the patient's femur and to the operating table. Similar to the Cooke device, this system requires extensive manipulation of the saw driver and the patient to create the required cuts. U.S. Pat. No. 5,092,869, issued to Waldron, discloses a surgical saw guide, including retractable guide pins mounted in guide pin holders which stabilize the saw for translational movement along a linear axis. U.S. Pat. Nos. 5,228,459 and 5,304,181, issued to Caspari et al., disclose an apparatus that is affixed to the tibia and the ankle that includes a rack and pinion mechanism to linearly advance a surgical milling device to make the appropriate surface cuts for total knee replacement surgery. The '181 patent discloses refinements to the device of the '459 patent. U.S. Pat. No. 5,653,714, issued to Dietz et al., discloses a multi-component assembly that slides and pivots a milling head in order to make the cuts required for knee replacement surgery. The second group of cutting guide systems includes devices such as that disclosed in U.S. Pat. No. 5,925,049, issued to Gustilo et al. The Gustilo patent discloses slotted cutting guides which are secured to the bone end by screws or other fixtures. Slotted cutting guides assist in orienting the blade of a surgical bone saw during the cutting process. Despite these efforts, there remains room for improvement in the creation of precise and accurate bone cuts with current cutting technologies. Devices that guide the saw body tend to be complex and cumbersome to set up, adjust and use. Orthopedic surgery is a physically demanding, labor intensive and time-consuming endeavor. Added instrument complexity tends to lead to longer procedures, which results in surgeon fatigue and a greater chance of surgical error. Surgical cutting guides tend to obstruct the surgeon's view of the cutting site. This increases the risk of inadvertent damage to surrounding tissue, and can reduce the accuracy of a cut. The oscillating saw used by orthopedic surgeons can be guided along a surgical cutting guide by hand. Some cutting guides utilize slots to provide a measure of blade control during surgery. There are numerous limitations with this cutting methodology. The very nature of resting an oscillating saw blade against another surface while the saw blade is in motion creates a certain degree of imprecision. Also, to allow clearance for the saw in the kerf, surgical bone saw teeth are set. That is, alternate teeth are offset from the center of the blade so that the resulting cut is slightly wider than the blade, to prevent the blade binding in the kerf. Consequently, the guide slot must be wide enough to receive the set of the teeth. This creates enough clearance for the blade to toggle within the slot and substantially reduce the precision of the cut. The surgeon's hand motions can cause the blade to toggle during the procedure and generate a non-planar bone surface. Vibrations generated by the oscillating saw driver are transmitted to the hands of the surgeon and to the cutting guide, affecting the quality of the resected bone surface. In addition, inadvertent blade contact with the inner slot surface of a cutting guide dulls the blade teeth and damages the guide slot. Contact between the blade and guide can also result in a temporary loss of blade control. Consequently, it is difficult to maintain the saw oriented in the desired plane and angle. Additionally, current cutting guide sets contain a large number of precision machined parts. These parts are expensive and their multiplicity creates both added expense and complexity. It would be preferable if the orthopedic surgeon had available a simpler cutting guide system with relatively few parts. Thus, there is a need for a surgical saw guide that allows for the precise faceting of bone ends to facilitate the implantation of orthopedic prostheses. The guide should be simple to set up and use while creating precision planar cuts in bone tissue. It is preferred that the guide minimize saw blade damage and wear and that the guide minimize vibrational energy transfer to the surgeon's hands and the patient's bone. It would be preferable to minimize the amount of visual obstruction presented by the cutting guide. SUMMARY OF THE INVENTION The present invention fulfills the above needs by providing a rotating track cutting guide system that maintains precise alignment of a bone saw with bone tissue. The rotating track cutting guide system generally includes a track subassembly and cutting guide subassemblies attachable to the bone that is to be cut. The track subassembly supports an oscillating surgical saw driver. The track subassembly is removably securable to cutting guide subassemblies which are attachable to the desired bone to facilitate a series of controlled cuts. The design of the track subassembly stabilizes the oscillating saw driver and enables it to both rotate in the plane of the saw blade and move linearly along the track. In conjunction with specially designed cutting guide subassemblies, use of the track subassembly enables a surgeon using the rotating track cutting guide system to perform all the necessary surgical cuts required for a knee replacement with great accuracy and precision. The rotating track cutting guide system is adaptable to an open frame design to improve visibility of the surgical site during resection. Although the rotating track cutting guide system will be described in the context of total knee arthroplasties, it should be understood that the invention may be applied to various other surgical procedures. The track subassembly includes a rotating driver carriage that supports an oscillating saw driver. The driver carriage rests upon a track that has an alignment member that enables the track to removably attach to various positioning and cutting guides. The alignment member allows immediate fixation of the track onto the cutting guide subassembly, while fastening members provide for ready attachment and removal. The use of a stabilizing track in conjunction with cutting and positioning guides results in a synergistic effect that enables the user to resect bone to great accuracy and precision along a plane. The present invention provides a cutting platform whereby the oscillating saw driver, the cutting guide and the bone to be cut are fixed relative to one another except in the plane in which the cut is being made. The stabilization of movement affords the surgeon excellent control and enables the physician to perform precise and accurate cuts. Further, the rotating track cutting guide system minimizes blade damage and wear caused by inadvertent contact between the blade and the cutting guide. The resulting retention of blade sharpness throughout the procedure produces a smoother, flatter, more precisely cut bone surface than is otherwise achievable. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 a is a perspective view of a resected distal femur showing facets created in preparation for placement of a knee prosthesis; FIG. 1 b is a profile view of a distal femur and a proximal tibia uncut; FIG. 1 c is a profile view of a resected distal femur and a proximal tibia as faceted for total knee arthroplasty; FIG. 2 is a side perspective view of a rotating track cutting guide system of the present invention positioned as attached to a femur, with phantom lines depicting a femur and a saw apparatus; FIG. 3 is a top perspective view of a track subassembly in accordance with the present invention; FIG. 3 a is a detail view of a second embodiment of the end of the track subassembly (taken at the position of 3 a of FIG. 3 ); FIG. 4 is a perspective view of the track subassembly as depicted in FIG. 2 , but with the subassembly inverted, phantom lines depicting a saw apparatus; FIG. 5 is an exploded top perspective view of a driver carriage used in accordance with the present invention; FIG. 6 is an exploded front perspective view of the distal femur and proximal tibia cutting guide subassembly and track in accordance with the present invention; FIG. 6 a is a perspective view of an alternative embodiment of a distal femur and proximal tibia cutting guide, attached to an intramedullary alignment system (depicted in phantom); FIG. 7 is rear perspective view of an anterior and posterior femoral cutting guide subassembly in accordance with the present invention; FIG. 8 is top perspective view of a posterior cutting guide in accordance with the present invention; FIG. 9 is a bottom perspective view of the posterior cutting guide in accordance with the present invention; FIG. 10 is a front perspective view of an anterior cutting guide in accordance with the present invention; FIG. 11 is rear perspective view of the anterior cutting guide in accordance with the present invention; FIG. 12 is an exploded, top perspective view of the anterior cutting guide with the detachable femoral anterior reference in accordance with the present invention; FIG. 13 is a bottom perspective view of the detachable anterior reference in accordance with the present invention; FIG. 14 is a top perspective view of a chamber cutting guide subassembly in accordance with the present invention; FIG. 15 is a cross-sectional view of the chamfer cutting guide subassembly of the present invention taken along line 15 — 15 of FIG. 14 ; FIG. 16 is a perspective view of an alternative embodiment of a distal femur and proximal tibia cutting guide and track in accordance with the present invention; FIG. 17 is a perspective view of a first alternative embodiment of the rotating track cutting guide system including a multipurpose cutting guide and multipurpose track, with phantom lines depicting a bone saw and a femur; FIG. 18 is a perspective view of the multipurpose cutting guide and multipurpose track of FIG. 17 assembled, with phantom lines depicting a bone saw and a femur; FIG. 19 is a perspective view of a second alternative embodiment of the multipurpose track subassembly in accordance with the present invention, with phantom lines depicting a bone saw and a femur; FIG. 20 is a graph summarizing experimental results for a precision comparison between the rotating track cutting guide and a prior art cutting system, each system cutting plastic-coated knees; FIG. 21 is a graph summarizing experimental results for a precision comparison between the rotating track cutting guide and a prior art system, each system cutting cadaver knees; FIG. 22 is a profile view of a third alternative embodiment of the rotating track cutting guide system engaged to a femur; and FIG. 23 is a perspective view of the embodiment of FIG. 22 with a bone saw and a femur depicted in phantom. DETAILED DESCRIPTION OF THE INVENTION The rotating track cutting guide system 30 of the present invention, as depicted in the drawings, generally includes a track subassembly 32 and a variety of bone cutting guides. Bone cutting guides include an anterior and posterior femoral (APF) cutting guide 36 , a distal femur and proximal tibia (DFPT) cutting guide 38 and a chamfer cutting guide 40 . Track subassembly 32 is adapted to be removably affixed to any of the bone cutting guides. Bone cutting guides are adapted to be removably affixed to bone structures via clamps (not shown), screws (not shown), pins (not shown), drill bits 33 or any other means known to those skilled in the orthopedic arts. Bone cutting guides may be adapted to receive handlebars 35 . Referring to FIGS. 2 , 3 and 4 , track subassembly 32 supports an oscillating saw driver 42 and is depicted attached to distal femur and proximal tibia cutting guide 38 which is, in turn, attached to femur 44 . Oscillating saw driver 42 drives saw blade 46 . Track subassembly 32 generally includes track 48 and driver carriage 50 . Driver carriage 50 is slidably carried on track 48 and is adapted to support oscillating saw driver 42 . Oscillating saw driver 42 may be, for example, a 3M oscillating head L120B in combination with a 3M Maxi Driver II L100. Track 48 is adapted to be removably attachable to any of cutting guides 36 , 38 , 40 . Referring to FIG. 5 , driver carriage 50 , includes superior driver brace 52 , inferior driver brace 54 and endcap 56 . Superior driver brace 52 presents counterbored holes 58 , 60 , 62 , 64 adapted to receive threaded fasteners 66 , 68 , 70 , 72 through top brace face 73 . Threaded fasteners 66 , 68 , 70 , 72 thread into fastening holes 74 , 76 , 78 , 80 in inferior driver brace 54 , to secure superior driver brace 52 to inferior driver brace 54 . Inner brace contact surfaces 77 , 79 of superior driver brace 52 and inferior driver brace 54 conform to oscillating saw driver 42 . Endcap 56 includes superior circular plate 81 , inferior circular plate 82 and cylindrical spacer 84 . Inferior circular plate 82 presents counterbored hole 86 adapted to receive threaded fastener 88 . Counterbored hole 86 is located proximate the center of inferior circular plate 82 . Threaded fastener 88 is receivable into threaded bore 90 located in inferior driver brace 54 . Referring particularly to FIG. 3 , track 48 presents track slot 92 , alignment peg 94 , and counterbored alignment hole 96 adapted to receive fastener 97 . Track 48 further presents superior track face 98 , inferior track face 100 , front track face 102 , back track face 104 , inner track face 106 and side track faces 108 . Track slot 92 , as defined by inner track faces 106 , is of appropriate width to slidably receive cylindrical spacer 84 . The thickness of track 48 , as defined as the distance between superior track face 98 and inferior track face 100 , is adapted to be received between superior circular plate 80 and inferior circular plate 82 . Front end 110 of track 48 is adapted to be secured to bone cutting guides 36 , 38 , 40 . Front end 110 includes alignment peg 94 and counterbored alignment hole 96 . Counterbored alignment hole 96 receives threaded fastener 97 . In another embodiment, depicted in FIG. 3 a , front end 110 ′ includes alignment pins 114 , recesses 116 and alignment clips 118 . Referring to FIG. 6 , distal femur and proximal tibia cutting guide 38 generally includes positioning guide 120 and cutting guide 122 . DFPT cutting guide 38 is adapted to receive track 48 . Positioning guide 120 presents attachment shelves 124 , 126 , peg holes 128 , 130 , track fastening holes 132 , 134 , pin holes 136 , 138 , diagonal pin holes 144 , 146 , handlebar holes 148 , 150 , and guide fastening holes 152 , 154 . Guide fastening holes 152 , 154 are adapted to receive guide fasteners 156 , 158 . Cutting guide 122 presents cutting slot 160 , intramedullary attachment holes 162 , 164 and counterbore guide holes 166 , 168 . Also shown in phantom in FIG. 6 a is intramedullary alignment system 170 . Intramedullary alignment system 170 includes intramedullary alignment rod 172 , bracket 174 and angle positioner 175 . Referring to FIG. 16 , another embodiment of DFPT cutting guide 38 ″ is shown. This embodiment of DFPT cutting guide 38 ″ presents attachment slots 176 , 178 , attachment bosses 180 , 182 , and attachment clip receivers 184 , 186 . This embodiment further presents diagonal pin holes 144 and handlebar holes 148 and slot 160 similar to the initial embodiment. Referring to FIG. 7 , APF cutting guide 36 generally includes posterior cutting guide 188 and anterior cutting guide 190 . Posterior cutting guide 188 generally includes body 192 and posterior condyle referencing paddles 194 , 196 . Referring particularly to FIGS. 8 and 9 , body 192 presents condyle cutting slots 198 , 200 , sizing slot 202 and notch 204 . Notch 204 is located between posterior condyle referencing paddles 194 , 196 . Attachment shelves 206 , 208 are located at the juncture between posterior condyle referencing paddles 194 , 196 and body 192 . Each attachment shelf 206 , 208 further includes fastening holes 210 and peg holes 212 . Attachment shelves 206 , 208 are adapted to receive track 48 . Sizing slot 202 includes inner sizing slot grooves 214 , 216 and inner sizing slot top face 218 . Inner sizing slot top face 218 presents a plurality of sizing holes 220 . Body 192 further presents handlebar attachments 222 , 224 and diagonal fixation pinholes 226 , 228 oriented diagonally inward therethrough. Referring to FIGS. 10 , 11 and 12 , anterior cutting guide 190 generally includes sizing ledge 230 and guide body 232 . Sizing ledge 230 generally includes sizing side ridges 234 , 236 , sizing ledge top face 238 and sizing ledge bottom face 240 . Sizing ledge top face 238 presents sizing holes 242 therethrough. Sizing ledge 230 is dimensioned so as to be slidably received into sizing slot 202 as depicted in FIGS. 8 and 9 . Guide body 232 includes inner ring 244 and attachment ledge 246 . In a first embodiment of anterior cutting guide 190 , inner ring 244 is cut entirely through the thickness of guide body 232 . In a second embodiment inner ring 244 is cut partially through the thickness of guide body 232 , and a cutting slot 248 is cut through the remaining thickness. In the second embodiment attachment buttress 250 is present. Attachment ledge 246 includes fastening hole 252 and peg hole 254 . Attachment ledge 246 is adapted to receive track 48 . Attachment ledge 246 is also adapted to receive detachable femoral reference 256 . Referring to FIG. 13 , detachable femoral reference 256 generally includes body 258 , L-bracket 260 and attachment slot 262 . Referring to FIGS. 14 and 15 , chamfer cutting guide 40 generally includes side plates 264 , 266 , attachment guide plates 268 , 270 and central guide plate 272 . Side plates 264 , 266 each present handlebar hole 274 and diagonal fixation hole 276 . Attachment guide plate 268 presents anterior fastening hole 278 and anterior peg hole 280 . Attachment guide plate 270 presents posterior fastening hole 282 and posterior peg hole 284 . Central guide plate 272 presents a plurality of guide positioning holes 286 . Attachment guide plate 268 and central guide plate 272 define anterior cutting slot 288 . Attachment guide plate 270 and central guide plate 272 define posterior cutting slot 290 . Bottom side attachment guide plates 268 , 270 and central guide plate 272 define bone contacting face 292 . Referring to FIGS. 17 and 18 , another embodiment of rotating track cutting guide system 30 is depicted. This embodiment generally includes multipurpose cutting guide 294 and multipurpose track 296 . Multipurpose cutting guide 294 is generally an open frame guide. Multipurpose cutting guide 294 includes perpendicular cut adaptor 300 and chamfer cut adaptors 302 . Multipurpose cutting guide 294 defines a plurality of alignment rod receivers 304 . Perpendicular cut adaptor 300 includes perpendicular rod receivers 306 . Chamfer cut adaptors 302 include chamfer rod receivers 308 . Multipurpose cutting guide 294 defines a window 310 . Window 310 has a superior edge 312 and an inferior edge 314 . Multipurpose track 296 is generally similar to track 48 except for the addition of a terminal block 316 secured at the end thereof. Terminal block 316 supports alignment rods 318 and presents upper edge 320 . In one embodiment, depicted in FIG. 19 terminal block 316 also is perforated by guide slot 322 . Guide slot 322 is sized to receive saw blade 46 . Referring to FIGS. 22 and 23 , an additional embodiment of the present invention includes curved track 324 . Driver carriage 50 is slidably and rotatably retained on curved track 324 . Otherwise this embodiment is similar in structure to the foregoing embodiments. In operation, rotating track cutting guide system 30 is assembled in concert with oscillating saw driver 42 . Referring to FIG. 5 , superior driving brace 52 and inferior driving brace 54 are separated and assembled to grip oscillating saw driver 42 as depicted in FIG. 4 . Saw blade 46 is attached to oscillating saw driver 42 . Track 48 may then be connected to any of bone cutting guides 36 , 38 , 40 . Referring particularly to FIGS. 2 and 6 , in preparing to make an initial cut on femur 44 , distal femur and proximal tibia cutting guide 38 is secured to femur 44 via clamps, screws, pins or drill bits or any other means known in the orthopedic arts. If desired, handle bars 35 may be secured to DFPT cutting guide 38 to allow an assistant to the surgeon to help support DFPT cutting guide 38 during the cutting process. Track 48 is secured to DFPT cutting guide 38 prior to cutting. Referring particularly to FIG. 6 , DFPT cutting guide 38 may be disassembled into positioning guide 120 and cutting guide 122 . For attachment, front end 110 of track 48 is inserted so that it rests on one of attachment shelves 124 , 126 and so that alignment peg 94 engages into peg hole 128 , 130 . Thereupon, a fastener 131 may be inserted through counterbored alignment hole 96 and threaded into track fastening hole 132 , 134 . Once fastener 131 is tightened in place, cutting guide 122 is assembled to positioning guide 120 . This is achieved by inserting fasteners 156 , 158 through cutting guide counterbored holes 166 , 168 on cutting guide 122 and tightening fasteners 156 , 158 against fastening holes 152 , 154 . Referring again to FIGS. 2 , 3 and 4 , oscillating saw driver 42 may then be moved linearly and rotationally in a fixed plane because of the interaction between driver carriage 50 and track 48 . End cap 56 is securely and slidably engaged to track slot 92 , thereby allowing driver carriage 50 , along with oscillating saw blade 46 , to move within a fixed plane aligned with cutting slot 160 if present. Oscillating saw driver 42 may then be advanced through cutting slot 160 in order to make an initial planar cut across the inferior end of femur 44 . Because of the interconnection of rotating track cutting guide system 30 to femur 44 , this cut will be planar and smooth. After this initial cut is made, distal femur and proximal tibia cutting guide 38 may be unfastened from femur 44 and removed. Making the initial femoral cut with the alternate embodiment of DFPT cutting guide 38 depicted in inset 3 a and FIG. 16 requires a slightly different procedure. In this embodiment, positioning guide 120 and cutting guide 122 are combined into a single unit. DFPT cutting guide 38 is secured to femur 44 by the insertion of drill bits 33 into fastening holes 136 , 138 . Track 48 is then inserted into attachment slot 176 , 178 , and alignment of track 48 is achieved through the interaction of attachment bosses 180 , 182 with recesses 116 . Upon insertion, alignment clips 118 engage attachment clip receivers 184 , 186 to secure track 48 to DFPT cutting guide 38 . Thereafter, the initial femoral cut is made as described above. Referring to FIGS. 7-12 , anterior and posterior femoral cutting guide 36 is adapted to be placed against the planar resected bone surface previously produced by the use of DFPT cutting guide 38 . To properly orient APF cutting guide 36 , body 192 is placed on the resected bone surface so that posterior condyle referencing paddles 194 , 196 are in contact with the condyles on femur 44 and notch 204 is aligned with the intercondylar notch on femur 44 . After properly orienting anterior and posterior femoral cutting guide 36 , the size of femur 44 may be measured using detachable femoral reference 256 . Detachable femoral reference 256 is placed so that attachment slot 262 engages attachment ledge 246 . The femur 44 may then be sized by pressing posterior condyle referencing paddles 194 , 196 against the femoral condyles and pressing L-bracket 260 of detachable femoral reference 256 against the anterior femoral surface. Thereafter, APF cutting guide 36 is secured to femur 44 by any means known to the orthopedic arts. If necessary, handlebars 35 may be secured to handlebar attachments 222 , 224 to enable an assistant to hold and restrain the motion of APF cutting guide 36 to provide additional stability during the cutting process. Resection of the anterior portion of femur 44 may then be accomplished. Track subassembly 32 is secured to attachment ledge 246 . Oscillating saw driver 42 may then be advanced along track 48 to make the appropriate cut to the anterior region of femur 44 . Resection of the posterior portion of the femoral condyles is accomplished by sequentially securing track subassembly 32 to attachment shelves 206 , 208 . Oscillating saw driver 42 may then be advanced and rotated along track 48 as needed to accomplish the required posterior femoral condyle cuts. Once the required resections are made, APF cutting guide 36 is removed from femur 44 . Next, referring to FIGS. 14 and 15 , anterior and posterior chamfer cuts may be made to femur 44 . Chamfer cutting guide 40 is secured to the resected surface of femur 44 by use of any means known to the orthopedic art such that bone contacting face 292 is flush with the resected femur surface A. Track subassembly 32 is then secured to one of attachment guide plates 268 , 270 . To make the posterior chamfer cut, track subassembly 32 is secured at anterior peg hole 280 and anterior fastening hole 278 . Oscillating saw driver 42 may then be advanced along track 48 and rotated as need be to make the required resection. The anterior chamfer cut is made in a similar fashion, attaching track subassembly 32 at posterior peg hole 284 and posterior fastening hole 282 . If desired, handlebars 35 may be secured at handlebar holes 274 in order to provide additional stabilization of chamfer cutting guide 40 . To effect resection of the proximal portion of the tibia, a procedure similar to that used for resecting the distal portion of femur 44 is followed. Referring to FIGS. 17 and 19 , to utilize multipurpose cutting guide 294 for the initial femoral cut, multipurpose cutting guide 294 is secured to the anterior surface of femur 44 by any means known to the orthopedic arts. Note that the presence of window 310 provides convenient visibility of the bone structure for the surgeon. Once multipurpose cutting guide 294 is in position, multipurpose track 296 may be engaged to multipurpose cutting guide 294 as depicted in FIG. 18 . Thereupon, oscillating saw driver 42 and saw blade 46 may be advanced along multipurpose track 296 in order to make the appropriate cuts. Note, referring to FIG. 18 , that when engaged, terminal block 316 and superior edge 312 combine to form an effective guide slot for saw blade 46 . In another alternate embodiment, depicted in FIG. 19 , terminal block 316 includes guide slot 322 to provide additional stabilization of saw blade 46 . After making the initial femoral cut, as depicted in FIG. 17 , multipurpose cutting guide 294 may be relocated to make anterior and posterior femoral cuts. This orientation is depicted in FIG. 18 . After multipurpose cutting guide 294 is secured to femur 44 at the location of the initial femoral cut, multipurpose track 296 may be engaged to make the anterior femoral cut. Once the anterior femoral cut is completed, multipurpose track 296 may be removed, rotated 180°, around the longitudinal axis of multipurpose track 296 and replaced on multipurpose cutting guide 294 in order to make the posterior femoral cut. After the posterior femoral cut is made, multipurpose track 296 may be removed and relocated so as to engage chamfer cut adaptor 302 in order to make a first chamfer cut. Thereafter, multipurpose track 296 may be located to the other chamfer cut adaptor 302 in order to make the second chamfer cut to this resected femur 44 . Note that when placed on chamfer cut adaptors 302 , upper edge 320 of terminal block 316 provides support for saw blade 46 and superior edge 312 or inferior edge 314 also provide support for saw blade 46 . This additional support serves to improve the planar quality of the cuts made. Multipurpose cutting guide 294 both reduces the number of parts necessary for the rotating track cutting guide system 30 and allows the anterior and posterior femoral cuts as well as the chamfer cuts to be made without the necessity of repositioning or replacing the cutting guide. EXAMPLES A quantitative assessment of the final design of the rotating track cutting guide system was performed to judge its effectiveness. Its capabilities were compared to cutting guides from a typical knee replacement system, the Exodus® System (Orthopaedic Innovations, Minneapolis, Minn.). Three experiments were performed to appraise the efficacy of the rotating track cutting guide system. The following experiments were performed: A. Precision Analysis: Evaluated the each system's capacity to reproducibly cut in the same plane. B. Blade Wear Analysis: Examined the cutting guides' success at reducing blade wear. C. Femoral Component Fit Analysis: Provided information on the amount of contact between prosthesis and the resected bone surface to determine the accuracy with which the cut bone fit the prosthesis. A. Precision Analysis The precision analysis evaluated a cutting guide's ability to cut consistently in the same plane. After distal femoral condyle resection in a simulated total knee arthroplasty, the angle between the lateral and medial femoral condylar planes was measured. The precision of the cut was defined as the absolute value of the angular difference between the two condylar planes. Methods for Experiment A1 Twelve 1145 urethane foam knees (Pacific Research Laboratories, Inc., Vashon, Wash.) were used. The rotating track cutting guide system and the Exodus® System were each tested with six knees and six new K-2000-25 3M Maxi-driver® blades (Komet Medical, Savannah, Ga.). After securing each cutting guide to a femur, the distal femoral condyles were resected. A Craftsman® Magnetic Universal Protractor (Sears, Hoffman Estates, Ill.) measured the angle of the lateral and medial condylar planes with respect to the ground. The protractor had an accuracy of ±0.5° and was maintained in a consistent orientation when placed on each condyle. When measuring the condylar plane orientation, the angle indicated by the protractor was read by two individuals to account for user error. Both individuals separately measured the angles associated with the resected medial and lateral condylar planes. Each individual then calculated the angular difference between the two condylar planes and these values from the two individuals were compared. If the angular difference values differed, then the angles associated with the resected medial and lateral condylar planes were re-measured by each individual. Methods for Experiment A2 The same procedure in Experiment A1 was performed, except that femora from twelve 1107-2 plastic-coated urethane foam knees were used. The 1107-2 urethane foam knees had a hard urethane elastomer cortex and were intended to model real bones more closely than the urethane foam bones. Methods for Experiment A3 The same procedure in Experiment A1 was performed, except that the femora from fresh-frozen cadaver knees were used. Analysis for the Precision Experiments For the precision analysis, the absolute value of the angular difference between the two condylar planes was computed. For all the knees, a Fisher's Exact Test of Independence was used. This analysis is two-tailed test using a 2×2 table and compared the rate of existence of a zero difference between the Exodus® System and the rotating track cutting guide system. The experimental hypothesis was that the rotating track cutting guide system would have a higher rate of zero angular difference than the Exodus® System. TABLE 1 Angular Difference (Degrees) Between the Condyles When Using the Exodus ® System and the Rotating Track Cutting Guide to Resect Foam Femora Exodus ® System Rotating Track Cutting Guide System Bone 1 0 0 Bone 2 0 0.5 Bone 3 0 0 Bone 4 0.5 0 Bone 5 0 0 Bone 6 0 — TABLE 2 Angular Difference (Degrees) Between the Condyles When Using the Exodus ® System and Rotating Track Cuffing Guide to Resect Plastic-coated Femora Exodus ® System Rotating Track Cutting Guide System Bone 1 0 0 Bone 2 0.5 0 Bone 3 0.5 0 Bone 4 1 0 Bone 5 0.5 0 Bone 6 0.5 0 TABLE 3 Angular Difference (Degrees) Between the Condyles When Using the Exodus ® System and Rotating Track Cutting Guide to Resect Cadaver Femora Exodus System Rotating Track Cutting Guide Bone 1 2.5 0 Bone 2 1.5 0 Bone 3 0 0.5 Bone 4 0 0 Bone 5 0.5 0 Bone 6 0 0 Discussion For the Precision Analysis using the foam femora and cadaver femora, no significant differences could be found between the performances of the two cutting systems. When the cadaver femora were resected, the largest indicator of the different levels of performance between the two cutting systems stemmed from the 2.5 degree angular difference between the resected medial condylar plane and the lateral condylar plane when using the Exodus® System. In our study, however, the sample size of six did not allow the results to be statistically significant. These results suggested that a larger sample size would be appropriate for a definitive statistical comparison. The Fisher's Exact Test of Independence for plastic-coated bones indicated that the rotating track cutting guide system had a significantly higher rate of zero angular difference than the Exodus® System (P=0.015). The better performance of the rotating track cutting guide system in our study suggested that the rotating track cutting guide system cuts more precisely than the Exodus® System. B. Blade Wear Analysis The investigators made an examination of the blade wear associated with total knee arthroplasty. Reduced blade wear reflects the cutting guides' effectiveness for minimizing blade damage. Retained blade sharpness results in the more precise cutting of bone and a smoother bone surface. Methods for Experiment B1 Two new K-2000-25 3M Maxi-driver® blades and 12 new 1145 urethane foam knees were obtained. One blade and six knees were randomly assigned to the cutting guides of the Exodus® System. The rotating track cutting guide system's cutting guides used the remaining blade and knees. The blades for the Exodus® and the rotating track cutting guide system's guides were weighed before their use. After performing all the femoral and tibial cuts in a simulated total knee arthroplasty, each blade was soaked overnight in acetone, dried and weighed. Repeated weighing of the blade ensured that a consistent blade weight value was obtained. A total of six simulated knee arthroplasties were performed using each blade and system, and the blade was weighed after each of the six procedures. The change in blade weight provided an indication of the average amount of blade wear associated with the use of each instrumentation system after one total knee arthroplasty. Methods for Experiment B2 This experiment was similar to Experiment B1, but required the use of 12 new 1107-2 plastic-coated urethane foam knees. For additional qualitative information on blade damage, scanning electron microscopy provided 20×images of the blade teeth. SEM images of each blade were taken before the first arthroplasty and after the sixth procedure. Providing descriptive rather than quantitative information on blade damage, the images depicted the cumulated blade wear associated with each instrumentation system. Analysis for the Blade Wear Experiments The mean blade wear loss for each cutting system was calculated from six total knee arthroplasties. For the foam and plastic-coated knees, a repeated measures ANOVA compared the performance between the two cutting systems. The hypothesis was that the rotating track cutting guide system would result in less blade weight loss compared with the Exodus® System. Results TABLE 4 Blade Weight Loss Comparison Between the Exodus ® System and the Rotating Track Cutting Guide System After Performing Total Knee Arthroplasty on Six Foam Knees Exodus ® System Rotating Track Cutting Guide System Trial 1 1.65 mg 0.125 mg  Trial 2  1.2 mg 0.125 mg  Trial 3 0.85 mg 0.07 mg Trial 4  2.5 mg 0.03 mg Trial 5  0.7 mg  0.2 mg Trial 6  1.6 mg  0.0 mg Total  8.5 mg 0.55 mg Mean 2.56 mg 0.16 mg TABLE 5 Blade Weight Loss Comparison Between the Exodus ® System and the Rotating Track Cutting Guide System After Performing Total Knee Arthroplasty on Six Plastic-coated Knees. Exodus System Rotating Track Cutting Guide System Trial 1 −2.7 mg    0.3 mg Trial 2 9.8 mg 1.55 mg Trial 3 1.5 mg   0 mg Trial 4 0.7 mg  0.2 mg Trial 5 0.4 mg   0 mg Trial 6 1.25 mg   0.1 mg Total  11 mg 2.15 mg Mean 4.1 mg 0.67 mg Blade damage was also qualitatively assessed by examining SEM images. The images with the Rotating track cutting guide system exhibited less cumulative blade damage than the Exodus® System. Discussion In the Blade Wear Analyses, a repeated measures ANOVA yielded a statistically significant difference in the blade wear between the rotating track cutting guide system and the Exodus® System (P=0.03). When resecting foam knees, there was often an order of magnitude difference in the blade weight loss between the rotating track cutting guide system and the Exodus® System. Use of the rotating track cutting guide system and the Exodus® System to resect plastic-coated knees showed a similar difference. There also existed a consistent wear pattern between each cutting system when resecting foam bones. The wear pattern, however, became less consistent when resecting plastic-coated bones. Additionally, the negative difference after the first blade wear trial for the Exodus® System was most likely due to plastic residue that remained on the blade after cleaning. Given the small sample size, more definitive conclusions can only be made after testing a larger number of blades. The SEM images provided visual information that the rotating track cutting guide system was more effective in the retention of blade teeth sharpness than the Exodus® System. For the blade used by the rotating track cutting guide system, there was no deformation of the teeth closest to the sides of the saw blade, unlike with the blade used by the Exodus® System. The blade used by the rotating track cutting guide system, however, did have one row of blade teeth that was significantly worn. This wear pattern was probably due to the interference of the saw blade with the posterior cutting guide slots on the anterior and posterior femoral cutting guide subassembly. The experimental design of the rotating track cutting guide system did not include a method to attach and use the track subassembly to help guide the saw blade to resect the posterior femoral condyles. Consequently, the row of damaged teeth probably occurred from the saw blade not being oriented and stabilized with a track. C. Femoral Component Fit Analysis This experiment indicated the effectiveness of the cutting instrumentation through a fit assessment of the femoral component onto the femur. Although the use of PMMA allows a surgeon a greater margin of error when cutting bone, an uneven cement mantle can result in early prosthesis loosening. For this analysis, Ultra Low Pressurex® film (Sensor Products, Inc., East Hanover, N.J.) provided an image of the contact between the underside of the femoral component and the resected femoral surface. Decreased cutting effectiveness during resection would result in reduced contact area. Methods for Experiment C1 In this experiment, 12 new plastic-coated femora and 12 new K-2000-25 3M blades were obtained. Six blades and femora were randomly selected and used with the Exodus cutting guides. The rotating track cutting guide system used the remaining blades and bones. Each system was used to perform the distal, anterior, posterior, anterior chamfer and posterior chamfer femoral cuts. The two halves of the Ultra Low Pressurex® film, the Transfer Sheet and the Developer Sheet, were individually cut into 3″×4.5″ rectangles and folded to conform to the distal portion of the resected femur and to each other. After the Transfer Sheet and the Developer Sheet were gently placed upon one another to avoid inadvertent film activation, the femoral component was placed onto the distal femur. The high sensitivity Pressurex® film was used so that film activation would not depend solely on the impact force applied by the surgeon when placing the femoral component onto the bone. Contact between the underside of the femoral component and the resected femoral surface broke the chemical-filled microcapsules on the Transfer Sheet. This chemical reacted with the color developing material on the Developer Sheet and generated a residual red stain at the regions where the prosthesis and bone contacted. Unstained Pressurex® film indicated the location of the gaps between the implant and the cut bone. Methods for Experiment C2 The same procedure as in experiment C1 was performed, except that fresh-frozen cadaver knees were used rather than plastic-coated knees. Analysis The contact area between the component and femur was calculated using SigmaScan® software. The data were normalized by dividing the contact area by the total area of the underside of the femoral component. After averaging the percent of contact data for the six femora with the two cutting systems, their means were compared. Plastic-coated knees required a two-sample t test for statistical analysis. The use of paired cadaver knees required a paired t-test for analysis. The hypothesis was that the rotating track cutting guide system would result in a higher percent of contact area than the Exodus® System Results Results of the femoral fit component fit analysis utilizing plastic coated femora and cadaver are summarized in graphs depicted as FIGS. 20 and 21 respectively. Discussion For the Femoral Component Fit Analysis using plastic-coated bones, use of the rotating track cutting guide system resulted in statistically significant increased contact between the underside of the femoral component and the resected femur than the Exodus® System (mean 42% vs. 28%, P=0.039). In the Femoral Component Fit Analysis with cadaver bones, use of the rotating track cutting guide system also resulted in statistically significant increased contact between the underside of the femoral component and the resected femur than the Exodus® System (mean 44% vs. 31%, P=0.021). Both results indicated that proper use of the rotating track cutting guide system resulted in greater contact between the resected bone surface and the prosthesis. The distribution of contact percentages between each system may be attributed to how the cutting systems were designed and manufactured. For the Exodus® System, the cutting guide must be manually adjusted to the appropriate size before performing the chamfer cuts. A millimeter of difference can influence whether the femoral component will fit onto the resected bone surface. Consequently, half a millimeter of difference in the sizing of the cutting guide may have caused the contact percentage to range from 20-40%. For the rotating track cutting guide system, one of the diagonal fixation holes of the medium chamfer cutting guide subassembly broke. This occurred as cadaver femur 3 was being resected. Consequently, the rotational motion of the medium chamfer cutting guide subassembly during the resecting process resulted in a low area contact percentage between the resected femoral surface and the prosthesis. The remaining variability in the performance of the rotating track cutting guide system was probably due to minor rotational motion of the large chamfer cutting guide subassembly during surgery. D. Experiment Summary The various analyses provided insight into the capabilities of the rotating track cutting guide system. The results of the Precision Analysis suggested that the rotating track cutting guide system resected the distal femur more precisely than a conventional cutting system. The Blade Wear Analysis proved a clearer suggestion that the rotating track cutting guide system produced statistically significant less blade wear on a saw blade than the Exodus® System. Use of the rotating track cutting guide system also resulted in statistical significant increased contact between the underside of the femoral component and the resected femur surface. The present invention may be embodied in other specific forms without departing from the spirit of any of the essential attributes thereof; therefore, the illustrated embodiments should be considered in all respects as illustrative and not restrictive, reference being made to the appended claims rather than to the foregoing description to indicate the scope of the invention.

The present invention is a rotating track cutting guide system that maintains precise alignment of a bone saw with bone tissue. The rotating track cutting guide generally includes a track subassembly and cutting guide subassemblies attachable to the bone that is to be cut. The track subassembly supports an oscillating surgical saw driver. The track subassembly is removably securable to cutting guide subassemblies which are attachable to the desired bone to facilitate a series of controlled cuts. The design of the track subassembly stabilizes the oscillating saw driver and enables it to both rotate in the plane of the saw blade and move linearly along the track.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application is a continuation of International Application No. PCT/EP02/11995 filed Oct. 26, 2002, the entire disclosure whereof is expressly incorporated by reference herein, which claims priority under 35 U.S.C. § 119 of German Patent Application No. 101 54 627.0, filed Nov. 7, 2001. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to cosmetic and dermatological tissues which are moistened with highly liquid cosmetic and dermatological impregnation solutions—in particular with highly liquid cosmetic and dermatological water-in-oil emulsions (W/O emulsions) which are long-term stable. In particular, the invention relates to cosmetic and dermatological impregnated, optionally surface-structured, care, cleansing and deodorant tissues, and impregnated tissues for the control and prevention of skin diseases (such as acne, sunburn etc.) and those which specifically care for the skin after sunbathing and decrease the after-reactions of the skin to the action of UV radiation. The present invention further relates to impregnation solutions which are suitable for the impregnation of tissues of this type. [0004] 2. Discussion of Background Information [0005] Impregnated tissues are widely used in all sorts of areas as articles of everyday necessity. Inter alia, they allow efficient and skin-caring cleansing and care, particularly also in the absence of (running) water. Here, the actual article of daily use consists of two components: a) a dry tissue, which is constructed from the materials such as paper and/or all sorts of mixtures of natural or synthetic fibers, and b) a low-viscosity impregnation solution. [0008] Cosmetic or dermatological tissues can consist either of water-soluble (e.g. such as toilet paper) or of water-insoluble materials. The tissues can further be smooth or alternatively surface-structured. Surface-structured tissues are produced, for example, based on cellulose and are used in particular as household tissues and for perianal cleansing. Their structure is produced by mechanical embossing by means of calendering rolls. Tissues of this type have a low resistance to tearing with at the same time great roughness and hardness. They are therefore only limitedly suitable for use on the human skin. [0009] Conventional impregnation solutions for water-insoluble nonwoven materials have hitherto had the deficiency of low long-term stability. Emulsions of this type are prone, in particular at high environmental temperature, to phase separation, which is a crucial disadvantage for the impregnation process and also for the final quality of the end product. [0010] The long-term stability of known impregnation solutions is in general guaranteed by the use of increased emulsifier concentrations and also high energy input—for example on repeated homogenization. [0011] It would be desirable to have available impregnation solutions which are stable long-term for application to water-insoluble nonwoven materials, which do not exhibit the disadvantages of the prior art and which are highly liquid emulsions which are stable long-term even at low emulsifier contents, which have to be homogenized only slightly and can contain more caring lipids and water-insoluble active ingredients. SUMMARY OF THE INVENTION [0012] The present invention provides a cosmetic or dermatological tissue which comprises a water-insoluble nonwoven which is impregnated and/or moistened with a cosmetic or dermatological W/O emulsion. This emulsion comprises (a) a water phase, (b) at least one oil phase which comprises one or more oils and/or one or more lipids and (c) an emulsifier system of (A) at least one O/W emulsifier having an HLB value of >10; (B) at least one silicone emulsifier (W/S) having an HLB value of ≦8, and/or (C) at least one W/O emulsifier having an HLB value of <7. The emulsion has a viscosity of less than 2,000 mPa·s and a silicone oil content of not more 25% by weight. [0017] In one aspect of the tissue, the weight ratio of the nonwoven and the W/O emulsion may be from 5:1 to 1:5. [0018] In another aspect, the nonwoven may comprise a structured nonwoven. [0019] In yet another aspect, the nonwoven may comprise an unstructured nonwoven. [0020] In a still further aspect of the tissue, the nonwoven may comprise a jet consolidated nonwoven and/or a water jet-embossed nonwoven. [0021] In another aspect, the nonwoven may have a thickness of from 0.4 mm to 1.5 mm and/or an area weight of from 35 to 120 g/m 2 . For example, the nonwoven may have a thickness of from 0.6 mm to 0.9 mm and an area weight of from 40 to 60 g/m 2 . [0022] In another aspect, the nonwoven may comprise fibers of a mixture of 70% by weight of viscose and 30% by weight of polyethylene terephthalate. [0023] In yet another aspect, the nonwoven may comprise fibers which have a water absorption rate of more than 60 mm/10 min and/or a water absorption capacity of more than 5 g/g, e.g., a water absorption rate of more than 80 mm/10 min and/or a water absorption capacity of more than 8 g/g. [0024] In another aspect of the present invention, the at least one silicone emulsifier B may comprise an alkylmethicone copolyol and/or an alkyl dimethicone copolyol. For example, the at least one silicone emulsifier B may comprise an emulsifier of the formula in which X and Y independently represent H, a branched or unbranched alkyl group, an acyl group and an alkoxy group having 1-24 carbon atoms, p is a number of from 0-200, q is a number of from 1-40, and r is a number of from 1-100. [0026] In a still further aspect of the issue of the present invention, the at least one W/O emulsifier C may comprise at least one polyglycerol emulsifier. [0027] In another aspect, the at least one O/W emulsifier A may comprise at an ethoxylated polysorbate and/or an ethoxylated stearate and/or a phosphate emulsifier and/or a sulfate emulsifier. [0028] In another aspect, the emulsion may comprise a total concentration of A, B and C of from 0.1% to 15% by weight, e.g., of from 0.5% to 10% by weight, or of from 2% to 10% by weight. [0029] In yet another aspect, the weight ratio A:B:C is expressed as a:b:c and a, b and c may be rational numbers of from 1 to 5, preferably of from 1 to 3. [0030] In another aspect, the emulsion may comprise from 0.5% to 5.0% by weight of the at least one silicone emulsifier B. [0031] In another aspect of the tissue of the present invention, the emulsion may comprise at least 2% by weight of one or more silicone oils which comprise a cyclic silicone and/or a linear silicone and/or a derivative thereof. [0032] In yet another aspect, the emulsion may comprise from 2% to 25% by weight of at least one silicone oil, e.g., from 5% to 20% by weight, or from 10% to 20% by weight of at least one silicone oil. [0033] In a still further aspect, the at least one oil phase may comprise a polar oil and/or a carboxylic acid ester, and/or a dialkyl ether and/or a dialkyl carbonate. For example, the at least one oil phase may comprise a C 12-15 alkyl benzoate. [0034] In another aspect, the emulsion may comprise from 1% to 90% by weight of the at least one oil phase, e.g., from 2.5% to 80% by weight, or from 5% to 70% by weight of the at least one oil phase. [0035] In another aspect, the emulsion may further comprise at least one light protection filter which is selected from oil-soluble and water-soluble light protection filters. The at least one light protection filter may comprise one or more UV filters, e.g., a triazine, a sulfonated UV filter, a UV filter which is liquid at room temperature, an inorganic pigment and/or a benzotriazole. Preferably, the one or more UV filters may comprise at least one of 2,4-bis{[4-(2-ethylhexyloxy)2-hydroxy]phenyl}-6-(4-methoxyphenyl)-1,3,5-triazine, dioctylbutylamidotriazine, 4,4′,4″-(1,3,5-triazine-2,4,6-triyltriimino)trisbenzoic acid tris(2-ethylhexyl ester), phenylene-1,4-bis(2-benzimidazyl)-3,3′,5,5′-tetrasulfonic acid bis sodium salt, 2-phenylbenzimidazole-5-sulfonic acid, terephthalidene dicamphorsulfonic acid, 4-methoxycinnamic acid (2-ethylhexyl)ester, 2-ethylhexyl-2-cyano-3,3-diphenyl acrylate, 2-ethylhexyl 2-hydroxy-benzoate, homomenthyl salicylate, TiO 2 , ZnO, 2,2′-methylenebis(6-(2H-benzotriazol-2-yl)-4-( 1,1,3,3-tetramethylbutyl)phenol, and 2-(2H-benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[1,3,3,3-tetramethyl[(trimethylsilyl)oxy]disiloxanyl]propyl]-phenol. [0036] In another aspect, the emulsion may further comprise an additive and an active ingredient. For example, the emulsion may further comprise a repellent, a self-tanning agent and/or a pigment. [0037] In another aspect, the emulsion may further comprise vitamin E and/or a derivative thereof and/or α-glycosylrutin and/or a derivative thereof. [0038] In yet another aspect, the emulsion may further comprise at least one component selected from moisturizers, waxes, surfactants, preservatives, antioxidants, dyes, plant extracts, deodorants, antiperspirants, dermatologically active ingredients, and perfumes. [0039] In a still further aspect, the emulsion may have a high water resistance. [0040] The present invention also provides various products which comprise the tissue of the present invention, e.g., a skin care product, an insect repellent, a self-tanning product, a sunscreen product, a product for the treatment or prophylaxis of light-related skin ageing, a skin moisturizing product, a baby care product and a skin cleansing product. [0041] The present invention also provides the above O/W emulsion for use in the production of the tissue of the present invention, including the various aspects thereof. [0042] The present invention further provides a process for manufacturing the tissue of the present invention. This process comprises providing a water-insoluble nonwoven and impregnating and/or moistening the nonwoven with the W/O emulsion of the present invention. [0043] It is surprising that cosmetic and dermatological tissues comprising a water-insoluble nonwoven which is impregnated or moistened with cosmetic and dermatological W/O impregnation emulsions, which in addition to further cosmetic/dermatological additives or excipients has an emulsifier system of A at least one O/W emulsifier having an HLB of >10, B at least one silicone emulsifier (W/S) having an HLB of ≦8 and/or C at least one W/O emulsifier having an HLB of <7 and a viscosity of less than 2000 mPa.s, a silicone oil content of not more than 25% by weight (based on the total weight of the preparation) and one or more oil phases comprising lipids and/or oils, may remedy the disadvantages of the prior art. [0048] The tissues according to the invention represent the combination of a soft, water-insoluble, nonwoven material with highly liquid cosmetic and dermatological W/O impregnation emulsions. They are extremely satisfactory in every respect and are accordingly very particularly suitable for use as a basis for preparation forms having a variety of application purposes. The tissues according to the invention exhibit very good sensory and cosmetic properties and are further distinguished by outstanding skin care data. [0049] The nonwoven material is preferably consolidated by jets of water in the production process as a spunlace material. The tissues according to the invention can be either structured or unstructured (“smooth”). If the material is to be the structured, the structuring is advantageously likewise carried out by means of jets of water. By means of this structuring, for example, a uniform sequence of elevations and depressions results in the material. [0050] In combination with suitable impregnation solutions, this structuring by means of its elevations makes possible both a better access to hollows in the human skin and by means of its structural valleys to an increased dirt absorption capacity. This leads overall to a markedly improved cleansing power. [0051] A better access to depressions in the human skin is moreover of particular importance for the control of skin diseases and skin irritations, and for the effective display of a deodorant action. [0052] Depending on the tissue employed, the weight ratio of the unimpregnated tissue to the W/O emulsion is may be in the range of from 5:1 to 1:5. By means of this, drip-free application of the impregnated tissue is guaranteed. [0053] In particular, structured cosmetic or dermatological tissues are therefore preferred according to the invention. [0054] The cosmetic and dermatological W/O impregnation emulsions with which the tissues according to the invention are moistened can be present in various forms. [0055] They are preferably highly liquid to sprayable and have, for example, a viscosity of less than 2000 mPa·s, in particular of less than 1500 mPa·s (measuring apparatus: Haake Viskotester VT-02 at 25° C.). [0056] The preparations according to the invention are extremely satisfactory preparations in every respect. In particular, it was surprising that the emulsions produced from the preparations according to the invention have a high solubility for UV filters from the group of the triazines and thus the achievement of a high UVA & UVB protection factor is possible. In addition, repellents and also self-tanning substances (e.g. dihydroxyacetone) can be stably incorporated in these novel W/O emulsions. [0057] Accordingly, preparations within the meaning of the present invention are very particularly suitable for use as a basis for product forms having a variety of application purposes. [0058] Impregnation emulsions according to the invention can also contain only one of the emulsifiers B and C—depending on the content of silicone oils and lipids—in addition to the O/W emulsifier A. [0059] According to the invention, the silicone emulsifiers B can advantageously be selected from the group of the alkylmethicone copolyols and/or alkyldimethicone copolyols, in particular from the group of compounds which are characterized by the following chemical structure: in which X and Y are chosen independently of one another from the group consisting of H (hydrogen), and the branched and unbranched alkyl groups, acyl groups and alkoxy groups having 1-24 carbon atoms, p is a number from 0-200, q is a number from 1-40, and r is a number from 1-100. [0061] An example of silicone emulsifiers to be used particularly advantageously within the meaning of the present invention are dimethicone copolyols which are marketed by the company Th. Goldschmidt AG under the trade names ABIL® B 8842, ABIL® B 8843, ABIL® B 8847, ABIL® B 8851, ABIL® B 8852, ABIL® B 8863, ABIL® B 8873 and ABIL® B 88183. [0062] A further example of interface-active substances to be used particularly advantageously within the meaning of the present invention is cetyl dimethicone copolyol which is marketed by the company Goldschmidt AG under the trade name ABIL® EM 90. [0063] A further example of interface-active substances to be used particularly advantageously within the meaning of the present invention is dimethicone copolyol cyclomethicone which is marketed by the company Goldschmidt AG under the trade name ABIL® EM 97. [0064] Furthermore, the emulsifier laurylmethicone copolyol which is obtainable under the trade name Dow Corning® 5200 Formulation Aid from the company Dow Corning Ltd. has turned out to be very particularly advantageous. [0065] A further advantageous silicone emulsifier is ‘Octyl Dimethicone Ethoxy Glucoside’ from Wacker. [0066] The total amount of silicone emulsifiers B used according to the invention in the cosmetic or dermatological preparations according to the invention is advantageously in the range of from 0.1-10.0% by weight, preferably 0.5-5.0% by weight, based on the total weight of the preparations. [0067] According to the invention, the W/O emulsifier(s) C are preferably chosen from the following group: sorbitan stearate, sorbitan oleate, lecithin, glyceryl lanolate, lanolin, microcrystalline wax (Cera microcristallina) as a mixture with paraffin oil (liquid paraffin), ozocerite, hydrogenated castor oil, glyceryl isostearate, polyglyceryl 3-oleate, wool wax acid mixtures, wool wax alcohol mixtures, pentaerithrityl isostearate, polyglyceryl 3-diiso-stearate, sorbitan oleate as a mixture with hydrogenated castor oil, beeswax (Cera alba) and stearic acid, sodium dihydroxycetyl phosphate as a mixture with isopropyl hydroxycetyl ether, methyl glucose dioleate, methyl diglucose dioleate as a mixture with hydroxystearate and beeswax, mineral oil as a mixture with petrolatum and ozocerite and glyceryl oleate and lanolin alcohol, petrolatum as a mixture with ozocerite and hydrogenated castor oil and glyceryl isostearate and polyglyceryl 3-oleate, PEG-7 hydrogenated castor oil, sorbitan oleate as a mixture with PEG-2 hydrogenated castor oil, ozocerite and hydrogenated castor oil, sorbitan isostearate as a mixture with PEG-2 hydrogenated castor oil, polyglyceryl 4-isostearate, polyglyceryl 4-isostearate, hexyl laurate, acrylate/C 10-30 -alkyl acrylate crosspolymer, sorbitan isostearate, poloxamer 101, polyglyceryl 2-dipolyhydroxystearate, polyglyceryl 3-diisostearate, polyglyceryl 4-dipolyhydroxystearate, PEG-30 dipolyhydroxystearate, diisostearoyl polyglyceryl 3-diisostearate, polyglyceryl 2-dipolyhydroxystearate, polyglyceryl 3-dipolyhydroxystearate, polyglyceryl 4-dipolyhydroxystearate, polyglyceryl 3-dioleate. [0068] According to the invention, the O/W emulsifier(s) A are preferably chosen from the following group: Glyceryl stearate as a mixture with ceteareth-20, ceteareth-25, ceteareth-6 as a mixture with stearyl alcohol, cetyl stearyl alcohol as a mixture with PEG-40 castor oil and sodium cetyl stearyl sulfate, triceteareth 4-phosphate, glyceryl stearate, sodium cetyl stearyl sulfate, lecithin trilaureth-4 phosphate, laureth-4 phosphate, stearic acid, propylene glycol stearate SE, PEG-25 hydrogenated castor oil, PEG-54 hydrogenated castor oil, PEG-6 caprylic acid/capric acid glycerides, glyceryl oleate as a mixture with propylene glycol, PEG-9 stearate, PEG-20 stearate, PEG-30 stearate, PEG-40 stearate, PEG-100 stearate, ceteth-2, ceteth-20, polysorbate-20, polysorbate-60, polysorbate-65, polysorbate-100, glyceryl stearate as a mixture with PEG-100 stearate, glyceryl myristate, glyceryl laurate, PEG-40 sorbitan peroleate, laureth-4, ceteareth-3, isostearyl glyceryl ether, cetyl stearyl alcohol as a mixture with sodium cetyl stearyl sulfate, laureth-23, steareth-2, glyceryl stearate as a mixture with PEG-30 stearate, PEG-40 stearate, glycol distearate, PEG-22 dodecyl glycol copolymer, polyglyceryl-2 PEG-4 stearate, ceteareth-12, ceteareth-20, ceteareth-30, methyl glucose sesquistearate, steareth-10, PEG-20 stearate, steareth-2 as a mixture with PEG-8 distearate, steareth-21, steareth-20, isosteareth-20, PEG-45/dodecyl glycol copolymer, methoxy-PEG-22/dodecyl glycol copolymer, PEG-40 sorbitan peroleate, PEG-40 sorbitan perisostearate, PEG-20 glyceryl stearate, PEG-20 glyceryl stearate, PEG-8 beeswax, polyglyceryl 2-laurate, isostearyl diglyceryl succinate, stearamidopropyl-PG dimonium chloride phosphate, glyceryl stearate SE, ceteth-20, triethyl citrate, PEG-20 methyl glucose sesquistearate, glyceryl stearate citrate, cetyl phosphate, cetearyl sulfate, sorbitan sesquioleate, triceteareth 4-phosphate, trilaureth 4-phosphate, polyglyceryl methylglucose distearate, potassium cetyl phosphate, isostearate-10, polyglyceryl 2-sesquiisostearate, ceteth-10, oleth-20, isoceteth-20, glyceryl stearate as a mixture with ceteareth-20, ceteareth-12, cetyl stearyl alcohol and cetyl palmitate, cetyl stearyl alcohol as a mixture with PEG-20 stearate, PEG-30 stearate, PEG-40 stearate, PEG-100 stearate. [0069] It is advantageous according to the invention to choose the weight ratios of coemulsifier A to emulsifier B to emulsifier C (A:B:C) as a:b:c, where a, b and c independently of one another can be rational numbers from 1 to 5, preferably from 1 to 3. A weight ratio of approximately 1:2:1 is particularly preferred. [0070] It is advantageous within the meaning of the present invention to choose the total amount of the emulsifiers A, B and C from the range from 0.1 to 15% by weight, advantageously from 0.5 to 10% by weight, in particular from 2 to 10% by weight, in each case based on the total weight of the formulation. [heading-0071] Silicone Oils [0072] It is preferred to choose the oil phase of the preparations according to the invention to at least 2.0% by weight, based on the total weight of the preparations, from the group of the cyclic and/or linear silicones, which in the context of the present disclosure are also designated as “silicone oils”. Such silicones or silicone oils can be present as monomers, which as a rule are characterized by structural elements as follows: [0073] Linear silicones to be employed advantageously according to the invention having a number of siloxyl units are in general characterized by the following structural element: where the silicon atoms can be substituted by identical or different alkyl radicals and/or aryl radicals, which are represented here in general terms by the radicals R 1 -R 4 (i.e., the number of the different radicals is not necessarily restricted to up to 4). m can in this case assume values from 2-200,000. [0075] Cyclic silicones to be employed advantageously according to the invention are in general characterized by the following structural element where the silicon atoms can be substituted by identical or different alkyl radicals and/or aryl radicals, which are represented here in general terms by the radicals R 1 -R 4 (i.e., the number of the different radicals is not necessarily restricted to up to 4). n can in this case assume values from 3/2 to 20. Fractional values for n take into consideration that odd-numbered numbers of siloxyl groups can be present in the cycle. [0077] Advantageously, phenyl trimethicone is chosen as the silicone oil. Other silicone oils, such as, for example, dimethicone, phenyl dimethicone, cyclomethicone (for example hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane, cyclopentasiloxane, cyclo-hexasiloxane, and mixtures of these components), polydimethylsiloxane, poly-(methylphenylsiloxane), cetyl dimethicone, behenoxy dimethicone can also be used advantageously within the meaning of the present invention. Mixtures of cyclo-methicone and isotridecyl isononanoate, and those of cyclomethicone and 2-ethyl-hexyl isostearate are furthermore advantageous. [0078] It is, however, also advantageous to choose silicone oils of similar constitution to the above-designated compounds, whose organic side chains are derivatized, for example polyethoxylated and/or polypropoxylated. These include, for example, polysiloxane-polyalkyl-polyether copolymers such as cetyl dimethicone copolyol, (cetyl dimethicone copolyol (and) polyglyceryl 4-isostearate (and) hexyl laurate). [0079] Advantageously, cyclomethicone is employed as the silicone oil to be used according to the invention. However, other silicone oils can also be used advantageously within the meaning of the present invention, for example dimethicone (polydimethyl-siloxane) and also phenyl trimethicone or combinations of the substances mentioned here. [0080] It is advantageous within the meaning of the present invention to restrict the total amount of the silicone oils to 2 to 25% by weight. According to the invention, a total amount of the silicone oils of 5 to 20% by weight and very particularly a total amount of 10 to 15% by weight—always based on the total amount—is particularly advantageous. [0081] Advantageously, the oil phase can further contain cyclic or linear silicone oils or consist completely of such oils, where, however, it is preferred to use, aside from the silicone oil or the silicone oils, an additional content of other oil-phase components. [heading-0082] Oil Phase/Lipids [0083] The oil phase of the formulations according to the invention is advantageously chosen from polar oils, for example from lecithins and fatty acid triglycerides, especially the triglycerol esters of saturated and/or unsaturated, branched and/or unbranched alkanecarboxylic acids of a chain length of 8 to 24, in particular 12 to 18, carbon atoms. The fatty acid triglycerides can, for example, be chosen advantageously from synthetic, semisynthetic and natural oils, such as, for example, coconut glyceride, olive oil, sunflower oil, soybean oil, peanut oil, rapeseed oil, almond oil, palm oil, coconut oil, castor oil, wheatgerm oil, grapeseed oil, thistle oil, evening primrose oil, macadamia nut oil and the like. [0084] Further advantageous polar oil components can be chosen within the meaning of the present invention further from the esters of saturated and/or unsaturated, branched and/or unbranched alkanecarboxylic acids of a chain length of 3 to 30 carbon atoms and saturated and/or unsaturated, branched and/or unbranched alcohols of a chain length of 3 to 30 carbon atoms, and from the esters of aromatic carboxylic acids and saturated and/or unsaturated, branched and/or unbranched alcohols of a chain length of 3 to 30 carbon atoms. Such ester oils can then advantageously be chosen from octyl palmitate, octyl cocoate, octyl isostearate, octyl dodecyl myristate, cetearyl isononanoate, isopropyl myristate, isopropyl palmitate, isopropyl stearate, isopropyl oleate, n-butyl stearate, n-hexyl laurate, n-decyl oleate, isooctyl stearate, isononyl stearate, isononyl isononanoate, 2-ethylhexyl palmitate, 2-ethylhexyl laurate, 2-hexyldecyl stearate, 2-octyldodecyl palmitate, stearoyl heptanoate, oleyl oleate, oleyl erucate, erucyl oleate, erucyl erucate, tridecyl stearate, tridecyl trimellitate, and also synthetic, semisynthetic and natural mixtures of such esters, such as, for example, jojoba oil. [0085] Furthermore, the oil phase can be advantageously chosen from dialkyl ethers and dialkyl carbonates; for example, dicaprylyl ether (Cetiol OE) and/or dicaprylyl carbonate, for example that obtainable under the trade name Cetiol CC from Cognis, are advantageous. [0086] It is further preferred the oil component(s) from isoeicosane, neopentyl glycol diheptanoate, propylene glycol dicaprylate/dicaprate, caprylic/capric/diglyceryl succinate, butylene glycol dicaprylate/dicaprate, C 12-13 -alkyl lactate, di-C 12-13 -alkyl tartrate, triisostearin, dipentaerithrityl hexacaprylate/hexa-caprate, propylene glycol monoisostearate, tricaprylin, dimethyl isosorbide. It is particularly advantageous if the oil phase of the formulations according to the invention contains C 12-15 -alkyl benzoate or consists completely of this. [0087] Any desired mixtures of such oil and wax components can also be employed advantageously within the meaning of the present invention. [0088] Furthermore, the oil phase can likewise advantageously also contain nonpolar oils, for example those which are chosen from branched and unbranched hydrocarbons and hydrocarbon waxes, in particular mineral oil, petroleum jelly (petrolatum), paraffin oil, squalane and squalene, polyolefins, hydrogenated polyisobutenes and isohexadecane. Among the polyolefins, polydecenes are the preferred substances. [0089] The lipid(s) are chosen according to the invention from the natural and/or synthetic lipids. The following are preferably used: C 12 -C 15 alkyl benzoate, capric/caprylic triglyceride, butylene glycol dicaprylate/dicaprate, octyl dodecanol, dicaprylyl carbonate, dicaprylyl carbonate, dicaprylyl ether, mineral oil, coconut glycerides. [0090] Mixtures of cyclomethicone, dicaprylyl carbonate and C 12-15 -alkyl benzoate and of cyclomethicone, dimethicone, butylene glycol dicaprylate/dicaprate, dicaprylyl carbonate and mineral oil are furthermore particularly advantageous. [0091] Advantageously, the content of the fatty phase is between 1 and 80% by weight, based on the total weight of the preparations, preferably 2.5-70% by weight, in particular 5-60% by weight. [heading-0092] Water Phase [0093] The aqueous phase of the preparations according to the invention optionally advantageously contains alcohols, diols or polyols of low carbon number, and also their ethers, preferably ethanol, isopropanol, propylene glycol, glycerol, butylene glycol, ethylene glycol, ethylhexyl glycerol, ethylene glycol monoethyl or monobutyl ether, propylene glycol monomethyl, monoethyl or monobutyl ether, diethylene glycol monomethyl or monoethyl ether and analogous products, furthermore alcohols of low carbon number, e.g. ethanol, isopropanol, 1,2-propanediol, glycerol and also in particular one or more thickening agents which can advantageously be chosen from the group consisting of silicon dioxide, aluminum silicates, polysaccharides and their derivatives, e.g. hyaluronic acid, xanthan gum, hydroxypropylmethylcellulose, particularly advantageously from the group consisting of the polyacrylates, preferably a polyacrylate from the group consisting of the “carbopols”, for example carbopols of the types 980, 981, 1382, 2984, 5984, in each case individually or in combination. [0094] Advantageous preservatives within the meaning of the present invention are, for example, formaldehyde-cleaving agents (such as, for example, DMDM hydantoin [e.g. Glydant®]), iodopropyl butylcarbamate (e.g. obtainable under the trade names Glycacil-L or Glycacil-L and Konkaben LMB from Lonza), parabens, phenoxy-ethanol, ethanol, benzoic acid and suchlike. Customarily, according to the invention the preservative system advantageously also contains preservation aids, such as, for example, ethylhexyloxyglycerol, Glycine soja etc. [0095] In addition, humectants or “moisturizers” can be present. [0096] Moisturizers are designated as substances or substance mixtures which impart to cosmetic or dermatological preparations the property, after the application to or dispersion on the skin surface, of reducing the release of moisture from the horny layer (also called trans-epidermal water loss (TEWL)) and/or of positively influencing the hydration of the horny layer. [0097] Advantageous moisturizers within the meaning of the present invention are, for example, glycerol, lactic acid, pyrrolidonecarboxylic acid and urea. Furthermore, it is particularly advantageous to use polymeric moisturizers from the group consisting of the polysaccharides which are water-soluble and/or swellable in water and/or gellable with the aid of water. Those particularly advantageous are, for example, hyaluronic acid, chitosan and/or a fucose-rich polysaccharide, which is deposited in the Chemical Abstracts under the registry number 178463-23-5 and is obtainable, for example, under the name Fucogel® 1000 from SOLABIA S.A. [0098] The cosmetic or dermatological preparations according to the invention can furthermore advantageously, even though not compulsorily, contain fillers which, for example, further improve the sensory and cosmetic properties of the formulations and, for example, produce or increase a velvety or silky skin sensation. Advantageous fillers within the meaning of the present invention are starch and starch derivatives (such as, for example, tapioca starch, distarch phosphate, aluminum or sodium starch octenylsuccinate and the like), pigments which have neither mainly UV filter nor coloring action (such as, for example, boron nitride etc.) and/or Aerosils® (CAS No. 7631-86-9). [heading-0099] Excipients [0100] The compositions according to the invention can further optionally contain additives customary in cosmetics, for example perfume, thickeners, deodorants, antimicrobial substances, refatting agents, complexing and sequestering agents (e.g. EDTA, imino disuccinic acid), pearl luster agents, plant extracts, vitamins, active ingredients, preservatives, bactericides, colorants, pigments which have a coloring action, thickening agents, moisturizing and/or humectant substances, fats, oils, waxes or other customary constituents of a cosmetic or dermatological formulation such as alcohols, polyols, polymers, foam stabilizers, electrolytes, organic solvents or silicone derivatives. [heading-0101] Dyes [0102] The cosmetic and dermatological preparations according to the invention can contain dyes and/or color pigments, in particular if they are present in the form of decorative cosmetics. The dyes and color pigments can be selected from the corresponding positive list of the Cosmetics Order or the EC list of cosmetic dyes. In most cases, they are identical to the dyes permitted for foodstuffs. [0103] Advantageous color pigments are, for example, titanium dioxide, mica, iron oxides (e.g. Fe 2 O 3 , Fe 3 O 4 , FeO(OH)) and/or tin oxide. [0104] Advantageous dyes are, for example, carmine, Prussian blue, chromic oxide green, ultramarine blue and/or manganese violet. It is particularly advantageous to choose the dyes and/or color pigments from the following list. The Colour Index numbers (CIN) are taken from the Rowe Colour Index, 3 rd edition, Society of Dyers and Colourists, Bradford, England, 1971. Chemical or other name CIN Colour Pigment Green 10006 green Acid Green 1 10020 green 2,4-Dinitrohydroxynaphthalene-7-sulfo acid 10316 yellow Pigment Yellow 1 11680 yellow Pigment Yellow 3 11710 yellow Pigment Orange 1 11725 orange 2,4-Dihydroxyazobenzene 11920 orange Solvent Red 3 12010 red 1-(2′-Chloro-4′-nitro-1′-phenylazo)-2-hydroxynaphthalene 12085 red Pigment Red 3 12120 red Ceresrot; Sudan Red; Fettrot G 12150 red Pigment Red 112 12370 red Pigment Red 7 12420 red Pigment Brown 1 12480 brown 4-(2′-Methoxy-5′-sulfo acid diethylamide-1′-phenylazo)-3- 12490 red hydroxy-5″-chloro-2″,4″-dimethoxy-2-naphthoic acid anilide Disperse Yellow 16 12700 yellow 1-(4-Sulfo-1-phenylazo)-4-aminobenzene-5-sulfo acid 13015 yellow 2,4-Dihydroxyazobenzene-4′-sulfo acid 14270 orange 2-(2,4-Dimethylphenylazo-5-sulfo acid)-1-hydroxynaphthalene- 14700 red 4-sulfo acid 2-(4-Sulfo-1-naphthylazo)-1-naphthol-4-sulfo acid 14720 red 2-(6-Sulfo-2,4-xylylazo)-1-naphthol-5-sulfo acid 14815 red 1-(4′-Sulfophenylazo)-2-hydroxynaphthalene 15510 orange 1-(2-Sulfo acid-4-chloro-5-carboxylic acid-1-phenylazo)- 15525 red 2-hydroxynaphthalene 1-(3-Methylphenylazo-4-sulfo acid)-2-hydroxynaphthalene 15580 red 1-(4′,(8′)-Sulfo acid naphthylazo)-2-hydroxynaphthalene 15620 red 2-Hydroxy-1,2′-azonaphthalene-1′-sulfo acid 15630 red 3-Hydroxy-4-phenylazo-2-naphthylcarboxylic acid 15800 red 1-(2-Sulfo-4-methyl-1-phenylazo)-2-naphthylcarboxylic acid 15850 red 1-(2-Sulfo-4-methyl-5-chloro-1-phenylazo)-2-hydroxy- 15865 red naphthalene-3-carboxylic acid 1-(2-Sulfo-1-naphthylazo)-2-hydroxynaphthalene-3-carboxylic 15880 red acid 1-(3-Sulfo-1-phenylazo)-2-naphthol-6-sulfo acid 15980 orange 1-(4-Sulfo-1-phenylazo)-2-naphthol-6-sulfo acid 15985 yellow Allura Red 16035 red 1-(4-Sulfo-1-naphthylazo)-2-naphthol-3,6-disulfo acid 16185 red Acid Orange 10 16230 orange 1-(4-Sulfo-1-naphthylazo)-2-naphthol-6,8-disulfo acid 16255 red 1-(4-Sulfo-1-naphthylazo)-2-naphthol-3,6,8-trisulfo acid 16290 red 8-Amino-2-phenylazo-1-naphthol-3,6-disulfo acid 17200 red Acid Red 1 18050 red Acid Red 155 18130 red Acid Yellow 121 18690 yellow Acid Red 180 18736 red Acid Yellow 11 18820 yellow Acid Yellow 17 18965 yellow 4-(4-Sulfo-1-phenylazo)-1-(4-sulfophenyl)-5-hydroxypyrazolone- 19140 yellow 3-carboxylic acid Pigment Yellow 16 20040 yellow 2,6-(4′-Sulfo-2″,4″-dimethyl)bisphenylazo)1,3-dihydroxy- 20170 orange benzene Acid Black 1 20470 black Pigment Yellow 13 21100 yellow Pigment Yellow 83 21108 yellow Solvent Yellow 21230 yellow Acid Red 163 24790 red Acid Red 73 27290 red 2-[4′-(4″-Sulfo-1″-phenylazo)-7′-sulfo-1′-naphthylazo]-1-hydroxy- 27755 black 7-aminonaphthalene-3,6-disulfo acid 4′-[(4″-Sulfo-1″-phenylazo)-7′-sulfo-1′-naphthylazo]-1-hydroxy-8- 28440 black acetylaminonaphthalene-3,5-disulfo acid Direct Orange 34, 39, 44, 46, 60 40215 orange Food Yellow 40800 orange trans-β-Apo-8′-carotenal (C 30 ) 40820 orange trans-Apo-8′-carotenic acid (C 30 )-ethyl ester 40825 orange Canthaxanthin 40850 orange Acid Blue 1 42045 blue 2,4-Disulfo-5-hydroxy-4′-4″-bis(diethylamino)triphenylcarbinol 42051 blue 4-[(-4-N-Ethyl-p-sulfobenzylamino)phenyl-(4-hydroxy-2-sulfo- 42053 green phenyl)(methylene)-1-(N-ethyl-N-p-sulfobenzyl)-2,5-cyclohexa- dienimine] Acid Blue 7 42080 blue (N-Ethyl-p-sulfobenzylamino)phenyl-(2-sulfophenyl)methylene- 42090 blue (N-ethyl-N-p-sulfo-benzyl)-Δ 2,5 -cyclohexadienimine Acid Green 9 42100 green Diethyldisulfobenzyldi-4-amino-2-chlorodi-2-methylfuchson- 42170 green immonium Basic Violet 14 42510 violet Basic Violet 2 42520 violet 2′-Methyl-4′-(N-ethyl-N-m-sulfobenzyl)amino-4″-(N-diethyl)- 42735 blue amino-2-methyl-N-ethyl-(N-m-sulfobenzylfuchsonimmonium 4′-(N-Dimethyl)amino-4″-(N-phenyl)aminonaphtho-N-dimethyl- 44045 blue fuchsonimmonium 2-Hydroxy-3,6-disulfo-4,4′-bis-dimethylaminonaphthofuchson- 44090 green immonium Acid Red 52 45100 red 3-(2′-Methylphenylamino)-6-(2′-methyl-4′-sulfophenylamino)- 45190 violet 9-(2″-carboxyphenyl)xanthenium salt Acid Red 50 45220 red Phenyl-2-oxyfluorone-2-carboxylic acid 45350 yellow 4,5-Dibromofluorescein 45370 orange 2,4,5,7-Tetrabromofluorescein 45380 red Solvent Dye 45396 orange Acid Red 98 45405 red 3′,4′,5′,6′-Tetrachloro-2,4,5,7-tetrabromofluorescein 45410 red 4,5-Diiodofluorescein 45425 red 2,4,5,7-Tetraiodofluorescein 45430 red Quinophthalone 47000 yellow Quinophthalone disulfo acid 47005 yellow Acid Violet 50 50325 violet Acid Black 2 50420 black Pigment Violet 23 51319 violet 1,2-Dioxyanthraquinone, calcium-aluminium complex 58000 red 3-Oxypyrene-5,8,10-sulfo acid 59040 green 1-Hydroxy-4-N-phenylaminoanthraquinone 60724 violet 1-Hydroxy-4-(4′-methylphenylamino)anthraquinone 60725 violet Acid Violet 23 60730 violet 1,4-Di(4′-methylphenylamino)anthraquinone 61565 green 1,4-Bis-(o-Sulfo-p-toluidino)anthraquinone 61570 green Acid Blue 80 61585 blue Acid Blue 62 62045 blue N,N′-Dihydro-1,2,1′,2′-anthraquinazine 69800 blue Vat Blue 6; Pigment Blue 64 69825 blue Vat Orange 7 71105 orange Indigo 73000 blue Indigo disulfo acid 73015 blue 4,4′-Dimethyl-6,6′-dichlorothioindigo 73360 red 5,5′-Dichloro-7,7′-dimethylthioindigo 73385 violet Quinacridone Violet 19 73900 violet Pigment Red 122 73915 red Pigment Blue 16 74100 blue Phthalocyanine 74160 blue Direct Blue 86 74180 blue Chlorinated phthalocyanine 74260 green Natural Yellow 6, 19; Natural Red 1 75100 yellow Bixin, norbixin 75120 orange Lycopene 75125 yellow trans-alpha-, beta- or gamma-Carotene 75130 orange Keto- and/or hydroxyl derivatives of Carotene 75135 yellow Guanine or pearl luster agent 75170 white 1,7-Bis-(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione 75300 yellow Complex salt (Na, Al, Ca) of carminic acid 75470 red Chlorophyll a and b; copper compounds of chlorophylls and 75810 green chlorophyllins Aluminum 77000 white Aluminum hydroxide 77002 white Water-containing aluminum silicates 77004 white Ultramarine 77007 blue Pigment Red 101 and 102 77015 red Barium sulfate 77120 white Bismuth oxychloride and its mixtures with mica 77163 white Calcium carbonate 77220 white Calcium sulfate 77231 white Carbon 77266 black Pigment Black 9 77267 black Carbo medicinalis vegetabilis 77268:1 black Chromic oxide 77288 green Chromic oxide; water-containing 77289 green Pigment Blue 28, Pigment Green 14 77346 green Pigment Metal 2 77400 brown Gold 77480 brown Iron oxides and hydroxides 77489 orange Iron oxide 77491 red Ferric hydroxide 77492 yellow Iron oxide 77499 black Mixtures of iron(II) and iron(III) hexacyanoferrate 77510 blue Pigment White 18 77713 white Manganese ammonium diphosphate 77742 violet Manganese phosphate; Mn 3 (PO 4 ) 2 · 7 H 2 O 77745 red Silver 77820 white Titanium dioxide and its mixtures with mica 77891 white Zinc oxide 77947 white 6,7-Dimethyl-9-(1′-D-ribityl)-isoalloxazine, lactoflavin yellow Caramel brown Capsanthin, capsorubicin orange Betanin red Benzopyrylium salts, anthocyans red Aluminum, zinc, magnesium and calcium stearate white Bromothymol blue blue Bromocresol green green Acid Red 195 red [0105] If the formulations according to the invention are present in the form of products which are applied to the face, it is convenient to use as a dye one or more substances from the following group: 2,4-dihydroxyazobenzene, 1-(2′-chloro-4′-nitro-1′-phenylazo)-2-hydroxynaphthalene, Ceresrot, 2-(4-sulfo-1-naphthylazo)-1-naphthyl-4-sulfo acid, calcium salt of 2-hydroxy-1,2′-azonaphthalene-1′-sulfo acid, calcium and barium salts of 1-(2-sulfo-4-methyl-1-phenylazo)-2-naphthylcarboxylic acid, calcium salt of 1-(2-sulfo-1-naphthylazo)-2-hydroxynaphthalene-3-carboxylic acid, aluminum salt of 1-(4-sulfo-1-phenylazo)-2-naphthol-6-sulfo acid, aluminum salt of 1-(4-sulfo-1-naphthylazo)-2-naphthol-3,6-disulfo acid, 1-(4-sulfo-1-naphthylazo)-2-naphthol-6,8-disulfo acid, aluminum salt of 4-(4-sulfo-1-phenylazo)-1-(4-sulfo-phenyl)-5-hydroxypyrazolone-3-carboxylic acid, aluminum and zirconium salts of 4,5-dibromofluorescein, aluminum and zirconium salts of 2,4,5,7-tetrabromofluorescein, 3′,4′,5′,6′-tetrachloro-2,4,5,7-tetrabromofluorescein and its aluminum salt, aluminum salt of 2,4,5,7-tetraiodofluorescein, aluminum salt of quinophthalonedisulfo acid, aluminum salt of indigo disulfo acid, red and black iron oxide (CIN: 77 491 (red) and 77 499 (black)), ferric hydroxide (CIN: 77 492), manganese ammonium diphosphate and titanium dioxide. [0106] Oil-soluble natural dyes, such as, for example, paprika extracts, β-carotene or cochineal are furthermore advantageous. [0107] Formulations containing pearl luster pigments are furthermore advantageous within the meaning of the invention. In particular, the types of pearl luster pigments listed below are preferred: 1. Natural pearl luster pigments, such as, for example “silver gray” (guanine/hypoxanthine mixed crystals from fish scales) and “mother of pearl” (ground mussel shells) 2. Monocrystalline pearl luster pigments such as, for example, bismuth oxychloride (BiOCl) 3. Layer substrate pigments: e.g. mica/metal oxide [0113] Powdered pigments or castor oil dispersions of bismuth oxychloride and/or titanium oxide, and bismuth oxychloride and/or titanium dioxide on mica, for example, are the basis for pearl luster pigments. The luster pigment listed under CIN 77163, for example, is particularly advantageous. [0114] The following pearl luster pigments based on mica/metal oxide, for example, are furthermore advantageous: Group Coating/layer thickness Color Silver-white pearl TiO 2 : 40-60 nm silver luster pigments Interference pigments TiO 2 : 60-80 nm yellow TiO 2 : 80-100 nm red TiO 2 : 100-140 nm blue TiO 2 : 120-160 nm green Color luster pigments Fe 2 O 3 bronze Fe 2 O 3 copper Fe 2 O 3 red Fe 2 O 3 red-violet Fe 2 O 3 red-green Fe 2 O 3 black Combination pigments TiO 2 /Fe 2 O 3 gold shades TiO 2 /Cr 2 O 3 green TiO 2 /Prussian blue deep blue TiO 2 /carmine red [0115] The pearl luster pigments obtainable from Merck under the trade names Timiron, Colorona or Dichrona, for example, are particularly preferred. [0116] The list of the pearl luster pigments mentioned is not intended, of course, to be limiting. Within the meaning of the present invention, advantageous pearl luster pigments are obtainable in numerous ways known per se. For example, other substrates aside from mica can also be coated with further metal oxides, such as, for example, silica and suchlike. SiO 2 particles coated with TiO 2 and Fe 2 O 3 (“Ronaspheres”), for example, which are marketed by Merck are advantageous and are particularly suitable for the visual reduction of fine lines. [0117] It can moreover be advantageous to dispense completely with a substrate such as mica. Iron pearl luster pigments which can be prepared without the use of mica are particularly preferred. Such pigments are obtainable from BASF, for example, under the trade names Sicopearl Kupfer 1000. [0118] Effect pigments which are obtainable under the trade name Metasomes standard/ glitter in various colors (yellow, red, green, blue) from Flora Tech are furthermore also particularly advantageous. The glitter particles are present here as mixtures with various excipients and dyes (such as, for example, the dyes having the Colour Index (CI) numbers 19140, 77007, 77289, 77491). [0119] The dyes and pigments can be present either individually or as a mixture, and can also be mutually coated with one another, in general various color effects being produced by means of different coating thicknesses. The total amount of the dyes and color-imparting pigments is advantageously chosen from the range from, for example, 0.1% by weight to 30% by weight, preferably from 0.5 to 15% by weight, in particular from 1.0 to 10% by weight, in each case based on the total weight of the preparations. [heading-0120] Active Ingredients [0121] Particularly advantageous preparations are further obtained if antioxidants are employed as additives or active ingredients. According to the invention, the preparations advantageously contain one or more antioxidants. As convenient antioxidants, which, however, are nevertheless to be used optionally, it is possible to use all antioxidants which are suitable or customary for cosmetic and/or dermatological applications. [0122] Advantageously, the antioxidants are chosen from amino acids (e.g. glycine, histidine, tyrosine, tryptophan) and their derivatives, imidazoles (e.g. urocaninic acid) and its derivatives, peptides such as D,L-carnosine, D-carnosine, L-carnosine and their derivatives (e.g. anserine), carotenoids, carotenes (e.g. α-carotene, β-carotene, lycopene) and their derivatives, lipoic acid and its derivatives (e.g. dihydrolipoic acid), aurothioglucose, propylthiouracil and other thiols (e.g. thioredoxin, glutathione, cysteine, cystine, cystamine and their glycosyl, N-acetyl, methyl, ethyl, propyl, amyl, butyl and lauryl, palmitoyl, oleyl, γ-linoleyl, cholesteryl and glyceryl esters), and their salts, dilauryl thiodipropionate, distearyl thiodipropionate, thiodipropionic acid and its derivatives (esters, ethers, peptides, lipids, nucleotides, nucleosides and salts), and sulfoximine compounds (e.g. buthionine sulfoximines, homocysteine sulfoximine, buthionine sulfones, penta-, hexa-, heptathionine sulfoximine) in very low tolerable doses (e.g. pmol to μmol/kg), furthermore (metal) chelators (e.g. α-hydroxy fatty acids, palmitic acid, phytic acid, lactoferrin), α-hydroxy acids (e.g. citric acid, lactic acid, malic acid), humic acid, bile acid, bile extracts, bilirubin, biliverdin, EDTA, EGTA and their derivatives, unsaturated fatty acids and their derivatives (e.g. γ-linolenic acid, linoleic acid, oleic acid), folic acid and its derivatives, ubiquinone and ubiquinol and their derivatives, vitamin C and derivatives (e.g. ascorbyl palmitate, Mg ascorbyl phosphate, ascorbyl acetate), tocopherols and derivatives (e.g. vitamin E acetate), vitamin A and derivatives (vitamin A palmitate), and coniferyl benzoate of benzoin resin, rutic acid and its derivatives, ferulic acid and its derivatives, butylhydroxytoluene, butylhydroxy-anisole, nordihydroguaiaretic acid, nordihydroguaiaretic acid, trihydroxy-butyrophenone, uric acid and its derivatives, mannose and its derivatives, zinc and its derivatives (e.g. ZnO, ZnSO 4 ), selenium and its derivatives (e.g. selenomethionine), stilbenes and their derivatives (e.g. stilbene oxide, trans-stilbene oxide) and the derivatives suitable according to the invention (salts, esters, ethers, sugars, nucleotides, nucleosides, peptides and lipids) of these mentioned active ingredients. [0123] Water-soluble antioxidants can be employed particularly advantageously within the meaning of the present invention, such as, for example, vitamins, e.g. ascorbic acid or tocopherol and their derivatives. [0124] A surprising property of the preparations according to the invention is that they are very good vehicles for cosmetic or dermatological active ingredients in the skin, preferred active ingredients being antioxidants which can protect the skin from oxidative stress. Preferred antioxidants are in this case vitamin E and its derivatives, and vitamin A and its derivatives. [0125] The amount of the antioxidants (one or more compounds) in the preparations is preferably 0.001 to 30% by weight, particularly preferably 0.05 to 20% by weight, in particular 0.1 to 10% by weight, based on the total weight of the preparation. [0126] If vitamin E and/or its derivatives is/are the antioxidant(s), it is advantageous to choose their respective concentrations from the range from 0.001 to 10% by weight, based on the total weight of the formulation. [0127] If vitamin A or vitamin A derivatives, or carotenes or their derivatives is/are the antioxidant (s), it is advantageous to choose their respective concentrations from the range from 0.001 to 10% by weight, based on the total weight of the formulation. [0128] According to the invention, the active ingredients (one or more compounds) can also very advantageously be chosen from lipophilic active ingredients, in particular from the following group: acetylsalicylic acid, atropine, azulene, hydrocortisone and its derivatives, e.g. hydrocortisone 17-valerate, vitamins of the B and D series, very favorably vitamin B 1 , vitamin B 12 , vitamin D 1 , but also bisabolol, unsaturated fatty acids, especially the essential fatty acids (often also called vitamin F), in particular gamma-linolenic acid, oleic acid, eicosapentaenoic acid, docosahexaenoic acid and their derivatives, chloramphenicol, caffeine, prostaglandins, thymine, camphor, extracts or other products of vegetable and animal origin, e.g. evening primrose oil, borage oil or currant pip oil, fish oils, cod-liver oil but also ceramides and ceramide-like compounds etc. [0129] It is also advantageous to choose the active ingredients from the group consisting of the refatting substances, for example purcellin oil, Eucerit® and Neocerit®. [0130] Particularly advantageously, the active ingredient(s) are further chosen from the group consisting of the NO synthase inhibitors, in particular if the preparations according to the invention are to be used for the treatment and prophylaxis of the symptoms of intrinsic and/or extrinsic skin ageing, and for the treatment and prophylaxis of the harmful effects of ultraviolet radiation on the skin. [0131] A preferred NO synthase inhibitor is nitroarginine. [0132] Additionally advantageously, the active ingredient(s) are chosen from the group which includes catechols and bile acid esters of catechols and aqueous or organic extracts of plants or plant parts which contain the catechols or bile acid esters of catechols, such as, for example, the leaves of the plant family Theaceae, in particular of the species Camellia sinensis (green tea). Their typical ingredients (such as, for example, polyphenols or catechols, caffeine, vitamins, sugars, minerals, amino acids, lipids) are particularly advantageous. [0133] Catechols are a group of compounds which are to be interpreted as hydrogenated flavones or anthocyanidines and derivatives of “catechol” (3,3′,4′,5,7-flavanpentaol, 2-(3,4-dihydroxyphenyl)chroman-3,5,7-triol). Epicatechol ((2R,3R)-3,3′,4′,5,7-flavan-pentaol) is also an advantageous active ingredient within the meaning of the present invention. [0134] Plant extracts containing catechols, in particular extracts of green tea, such as, for example, extracts of leaves of the plants of the species Camellia spec., very particularly of the tea species Camellia sinensis, C. assamica, C. taliensis or C. irrawadiensis and crossings of these with, for example, Camellia japonica are furthermore advantageous. [0135] Preferred active ingredients are furthermore polyphenols or catechols from the group consisting of (−)-catechol, (+)-catechol, (−)-catechol gallate, (−)-gallocatechol gallate, (+)-epicatechol, (−)-epicatechol, (−)-epicatechol gallate, (−)-epigallocatechol, (−)-epigallocatechol gallate. [0136] Flavone and its derivatives (often also collectively called “flavones”) are also advantageous active ingredients within the meaning of the present invention. They are characterized by the following basic structure (substitution positions indicated): [0137] Some of the more important flavones, which can also preferably be employed in the preparations according to the invention, are listed in the table below: OH substitution positions 3 5 7 8 2′ 3′ 4′ 5′ Flavone − − − − − − − − Flavonol + − − − − − − − Chrysin − + + − − − − − Galangin + + + − − − − − Apigenin − + + − − − + − Fisetin + − + − − + + − Luteolin − + + − − + + − Campherol + + + − − − + − Quercetin + + + − − + + − Morin + + + − + − + − Robinetin + − + − − + + + Gossypetin + + + + − + + − Myricetin + + + − − + + + [0138] In nature, flavones as a rule occur in glycosidated form. [0139] According to the invention, the flavonoids are preferably chosen from substances of the generic structural formula where Z 1 to Z 7 independently of one another are chosen from the group consisting of H, OH, alkoxy and hydroxyalkoxy groups, where the alkoxy or hydroxyalkoxy groups can be branched and unbranched and can have 1 to 18 carbon atoms, and where Gly is chosen from the group consisting of the mono- and oligoglycoside radicals. [0141] According to the invention, the flavonoids, however, can also advantageously be chosen from substances of the generic structural formula where Z 1 to Z 6 independently of one another are chosen from the group consisting of H, OH, alkoxy and hydroxyalkoxy groups, where the alkoxy or hydroxyalkoxy groups can be branched and unbranched and can have 1 to 18 carbon atoms, and where Gly is chosen from the group consisting of the mono- and oligoglycoside radicals. [0143] Preferably, such structures can be chosen from substances of the generic structural formula where Gly 1 , Gly 2 and Gly 3 independently of one another are monoglycoside radicals or. Gly 2 and Gly 3 can also individually or together be saturations by hydrogen atoms. [0145] Preferably, Gly 1 , Gly 2 and Gly 3 independently of one another are chosen from hexosyl radicals, in particular the rhamnosyl radicals and glucosyl radicals. However, other hexosyl radicals, for example allosyl, altrosyl, galactosyl, gulosyl, idosyl, mannosyl and talosyl can optionally also be used advantageously. It can also be advantageous according to the invention to use pentosyl radicals. [0146] Advantageously, Z 1 to Z 5 independently of one another are chosen from the group consisting of H, OH, methoxy, ethoxy and 2-hydroxyethoxy groups, and the flavone glycosides have the structure [0147] Particularly advantageously, the flavone glycosides according to the invention are from the group which are represented by the following structure: where Gly 1 , Gly 2 and Gly 3 independently of one another are monoglycoside radicals or. Gly 2 and Gly 3 can also individually or together be saturations by hydrogen atoms. [0149] Preferably, Gly 1 , Gly 2 and Gly 3 independently of one another are chosen from hexosyl radicals, in particular the rhamnosyl radicals and glucosyl radicals. However, other hexosyl radicals, for example allosyl, altrosyl, galactosyl, gulosyl, idosyl, mannosyl and talosyl can optionally also be used advantageously. It can also be advantageous according to the invention to use pentosyl radicals. [0150] It is particularly advantageous within the meaning of the present invention to choose the flavone glycoside(s) from α-glucosylrutin, α-glucosyl-myricetin, α-glucosylisoquercitrin, α-glucosylisoquercetin and α-glucosylquercitrin. [0151] α-Glucosylrutin is particularly preferred according to the invention. [0152] Naringin (aurantiin, naringenin 7-rhamnoglucoside), hesperidin (3′,5,7-trihydroxy-4′-methoxyflavanone 7-rutinoside, hesperidoside, hespereitin 7-O-rutinoside), rutin (3,3′,4′,5,7-pentahydroxyflyvone 3-rutinoside, quercetin 3-rutinoside, sophorin, Birutan, Rutabion, taurutin, phytomelin, melin), troxerutin (3,5-dihydroxy-3′,4′,7-tris(2-hydroxyethoxy)flavone 3-(6-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranoside)), monoxerutin (3,3′,4′,5-tetrahydroxy-7-(2-hydroxyethoxy)flavone-3-(6-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranoside)), dihydrorobinetin (3,3′,4′,5′,7-pentahydroxy-flavanone), taxifolin (3,3′,4′,5,7-pentahydroxyflavanone), eriodictyol 7-glucoside (3′,4′,5,7-tetrahydroxyflavanone 7-glucoside), flavanomarein (3′,4′,7,8-tetrahydroxy-flavanone 7-glucoside) and isoquercetin (3,3′,4′,5,7-pentahydroxyflavanone 3-(β-D-glucopyranoside) are also advantageous according to the invention. [0153] It is also advantageous to choose the active ingredient(s) from the group consisting of the ubiquinones and plastoquinones. [0154] Ubiquinones are distinguished by the structural formula and are the most widespread and thus the best investigated bioquinones. Depending on the number of the isoprene units linked in the side chain, ubiquinones are called Q-1, Q-2, Q-3, etc or according to the number of carbon atoms U-5, U-10, U-15 etc. They preferably occur with certain chain lengths, e.g. in some microorganisms and yeasts with n=6. Q 10 predominates in most mammals including man. [0156] Coenzyme Q10, which is characterized by the following structural formula is particularly advantageous. [0158] Plastoquinones have the general structural formula [0159] Plastoquinones are distinguished in the number n of the isoprene radicals and are named accordingly, e.g. PQ-9 (n=9). Other plastoquinones with different substituents on the quinone ring additionally exist. [0160] Creatine and/or creatine derivatives are also preferred active ingredients within the meaning of the present invention. Creatine is distinguished by the following structural formula: [0161] Preferred derivatives are creatine phosphate, and creatine sulfate, creatine acetate, creatine ascorbate and the derivatives esterified on the carboxyl group by mono- or polyfunctional alcohols. [0162] A further advantageous active ingredient is L-carnitine [3-hydroxy-4-(trimethyl-ammonio)butyric acid betaine]. Acylcarnitines, which are chosen from substances of the following general structural formula where R is chosen from the group consisting of the branched and unbranched alkyl radicals having up to 10 carbon atoms are advantageous active ingredients within the meaning of the present invention. Propionylcarnitine and in particular acetylcarnitine are preferred. Both enantiomers (D- and L-form) can be used advantageously within the meaning of the present invention. It can also be advantageous to use any desired mixture of enantiomers, for example a racemate of the D- and L-form. [0164] Further advantageous active ingredients are sericoside, pyridoxol, vitamin K, biotin and aromatic substances. [0165] The list of active ingredients or active ingredient combinations mentioned which can be used in the preparations according to the invention is not intended, of course, to be limiting. The active ingredients can be used individually or in any desired combinations with one another. [0166] Moreover, selected formulations according to the invention which, for example, contain known antiwrinkle active ingredients such as flavone glycosides (in particular α-glycosylrutin), coenzyme Q10, vitamin E and/or derivatives and the like, are particularly advantageously suitable for the prophylaxis and treatment of cosmetic or dermatological skin changes, such as occur, for example, on ageing of the skin. They are furthermore advantageous against the syndrome of dry or rough skin. [0167] Skin ageing is caused, for example, by endogenous, genetically determined factors. In the epidermidis and dermis, age-related disturbances, e.g. the following structural damage and functional disturbances occur, which can also come under the term “senile xerosis”: a) dryness, roughness and formation of (dryness) lines, b) itching and c) decreased refatting by sebaceous glands (e.g. after washing). [0171] Exogenous factors, such as UV light and chemical noxae, can have a cumulative action and, for example, accelerate the endogenous ageing processes or supplement them. In the epidermidis and dermis, the following structural damage and functional disturbances, for example, in particular occur in the skin due to exogenous factors, which extend beyond the extent and quality of the damage in the case of chronological ageing: d) visible vasodilatation (teleangiectasies, cuperosis); e) flabbiness and formation of lines; f) local hyper-, hypo- and malpigmentation (e.g. age spots) and g) increased susceptibility to mechanical stress (e.g. fissurability). [0176] In a particular embodiment, the present invention relates in particular to products for the care of naturally aged skin, and for the treatment of the subsequent damage due to light ageing, in particular the phenomena mentioned under a) to g). Specific Application [0177] The cosmetic and/or dermatological preparations according to the invention can have the customary composition and be used for cosmetic and/or dermatological light protection, further for the treatment, the care and the cleansing of the skin and/or the hair and as make-up products in decorative cosmetics. [0178] For application, the cosmetic and dermatological preparations according to the invention are applied to the skin and/or the hair in adequate amounts in the manner customary for cosmetics. [heading-0179] Protection Against the Sun [0180] A further advantageous embodiment of the present invention consists in products for protection against the sun. [0181] An addition of oil-soluble and/or water-soluble and/or pigmentary organic UV filters and/or inorganic pigments absorbing or reflecting UV radiation is particularly advantageous. [0182] It is also advantageous within the meaning of the present invention to make available cosmetic and dermatological preparations whose main aim is not protection from sunlight, but which, nevertheless, can contain UV protection substances. Thus UV-A or UV-B filter substances are usually incorporated, for example, into day creams or make-up products. The UV protection substances, just like antioxidants and, if desired, preservatives, also represent an effective protection of the preparations themselves against deterioration. Cosmetic and dermatological preparations which are present in the form of a sunscreen are furthermore favorable. [0183] The formulations can optionally, although not necessarily, also contain one or more organic and/or inorganic pigments as UV filter substances, which can be present in the water and/or the oil phase. [0184] Preferred inorganic pigments are metal oxides and/or other metal compounds which are poorly soluble or insoluble in water, in particular oxides of titanium (TiO 2 ), zinc (ZnO), iron (e.g. Fe 2 O 3 ), zirconium (ZrO 2 ), silicon (SiO 2 ), manganese (e.g. MnO), aluminum (Al 2 O 3 ), cerium (e.g. Ce 2 O 3 ), mixed oxides of the corresponding metals, and mixtures of such oxides. [0185] Within the meaning of the present invention, such pigments can advantageously be surface-treated (“coated”), where, for example, an amphiphilic or hydrophobic character is to be formed or retained. This surface treatment can consist in providing the pigments with a thin hydrophobic layer by processes known per se. [0186] The titanium dioxide pigments can be present both in the crystal modification rutile and anatase and can advantageously be surface-treated (“coated”) within the meaning of the present invention, where, for example, a hydrophilic, amphiphilic or hydrophobic character is to be formed or retained. This surface treatment can consist in treating the pigments with a thin hydrophilic and/or hydrophobic inorganic and/or or organic layer by processes known per se. The various surface coating can within the meaning of the present invention also contain water. [0187] Inorganic surface coatings within the meaning of the present invention can consist of aluminum oxide (Al 2 O 3 ), aluminum hydroxide Al(OH) 3 , or aluminum oxide hydrate (also: alumina CAS No.: 1333-84-2), sodium hexametaphosphate (NaPO 3 ) 6 , sodium metaphosphate (NaPO 3 ) n , silicon dioxide (SiO 2 ) (also: silica, CAS No.: 7631-86-9) or iron oxide (Fe 2 O 3 ). These inorganic surface coatings can occur on their own, in combination and/or in combination with organic coating materials. [0188] Organic surface coatings within the meaning of the present invention can consist of vegetable or animal aluminum stearate, vegetable or animal stearic acid, lauric acid, dimethylpolysiloxane (also: dimethicone), methylpolysiloxane (methicone), simethicone (a mixture of dimethylpoly-siloxane with an average chain length of 200 to 350 dimethylsiloxane units and silica gel) or alginic acid (algic acid). These organic surface coatings can occur on their own, in combination and/or in combination with inorganic coating materials. [0189] Within the meaning of the present invention, coated and uncoated titanium dioxides described can also be used in the form of commercially obtainable oily or aqueous predispersions. Dispersing aids and/or solubilizers can advantageously be added to these predispersions. [0190] Suitable titanium dioxide particles and predispersions of titanium dioxide particles within the meaning of the present invention are obtainable from the companies mentioned under the following trade names: Additional Coating/ constituents in Trade name surface coating predispersions Manufacturer MT-150W None — Tayca Corporation MT-150A None — Tayca Corporation MT-500B None — Tayca Corporation MT-600B None — Tayca Corporation MT-100TV Aluminum hydroxide — Tayca Stearic acid Corporation MT-100Z Aluminum hydroxide — Tayca Stearic acid Corporation MT-100T Aluminum hydroxide — Tayca Stearic acid Corporation MT-500T Aluminum hydroxide — Tayca Stearic acid Corporation MT-100S Aluminum hydroxide — Tayca Lauric acid Corporation MT-100F Stearic acid — Tayca Iron oxide Corporation MT-100SA Alumina — Tayca Silica Corporation MT-500SA Alumina — Tayca Silica Corporation MT-600SA Alumina — Tayca Silica Corporation MT-100SAS Alumina — Tayca Silica Corporation Silicone MT-500SAS Alumina — Tayca Silica Corporation Silicone MT-500 H Alumina — Tayca Corporation MT-100AQ Silica — Tayca Aluminum hydroxide Corporation Alginic acid Eusolex T Aqua — Merck KgaA Simethicone Eusolex Alumina — Merck KgaA T-2000 Simethicone Eusolex Silica C 12-15 alkyl- Merck KgaA T-Olio F Dimethylsilate benzoate Aqua Calcium poly- hydroxystearate Silica dimethyl- silate Eusolex Aqua Octyl palmitate Merck KgaA T-Olio P Simethicone PEG-7 hydrogenated castor oil Sorbitan oleate Hydrogenated castor oil Beeswax Stearic acid Eusolex Aqua Phenoxyethanol Merck KgaA T-Aqua Alumina Sodium Sodium meta- methylparabens phosphate Sodium meta- phosphates Eusolex Alumina Isononyl iso- Merck KgaA T-45D Simethicone nonanoate Polyglyceryl ricinoleate Kronos None — Kronos 1171 (titanium dioxide 171) Titanium None — Degussa dioxide P25 Titanium Octyltrimethyl- — Degussa dioxide silane T 805 (Uvinul TiO 2 ) UV-Titan Alumina — Kemira X610 Dimethicone UV-Titan Alumina — Kemira X170 Dimethicone UV-Titan Alumina — Kemira X161 Silica Stearic acid UV-Titan Alumina — Kemira M210 UV-Titan Alumina Glycerol Kemira M212 UV-Titan Alumina — Kemira M262 Silicone UV-Titan Alumina — Kemira M160 Silica Stearic acid Tioveil Alumina Aqua Solaveil AQ 10PG Silica Propylene glycol Uniquema Mirasun Alumina Aqua Rhone-Poulenc TiW 60 Silica [0191] Very particularly advantageous titanium dioxides are Eusolex T-2000 and Eusolex T-aqua from Merck, MT-100 TV and MT-100 Z from Tayca, titanium dioxide T 805 from Degussa and Tioveil AQ 10PG from Solaveil. [0192] A further advantageous coating of the inorganic pigments consists of dimethylpoly-siloxane (also: dimethicone), a mixture of fully methylated, linear siloxane polymers which are terminally blocked with trimethylsiloxy units. [0193] Suitable zinc oxide particles and predispersions of zinc oxide particles within the meaning of the present invention are obtainable from the companies mentioned under the following trade names: Trade name Manufacturer Coating Z-Cote HP1 BASF 2% dimethicone Z-Cote BASF / ZnO NDM H & R 5% dimethicone ZnO neutral H & R / MZ-300 Tayca / MZ-500 Tayca / MZ-700 Tayca / MZ-303S Tayca 3% methicone MZ-505S Tayca 5% methicone MZ-707S Tayca 7% methicone MZ-303M Tayca 3% dimethicone MZ-505M Tayca 5% dimethicone MZ-707M Tayca 7% dimethicone Z-Sperse Collaborative ZnO (>=56%)/ Ultra Laboratories dispersion in dimethicone/ cyclomethicone/ethylhexyl hydroxystearate benzoate Samt-UFZO- Miyoshi Kasei ZnO (60%)/ 450/D5 (60%) dispersion in cyclomethicone/ dimethicone [0194] Within the meaning of the invention, the zinc oxides Z-Cote and Z-Cote HP1 from BASF, zinc oxide NDM from Haarmann & Reimer, and MZ-505S from Tayca are particularly preferred. [0195] An advantageous organic pigment within the meaning of the present invention is 2,2′-methylenebis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol) [INCI: Bisoctyltriazole], which is characterized by the chemical structural formula and is obtainable from CIBA Chemikalien GmbH under the trade name Tinosorb® M. [0197] Advantageously, preparations according to the invention contain substances which absorb UV radiation in the UV-A and/or UV-B range, the total amount of the filter substances being, for example, 0.1% by weight to 30% by weight, preferably 0.5 to 20% by weight, in particular 1.0 to 15.0% by weight, based on the total weight of the preparations, in order to make available cosmetic preparations which protect the hair or the skin from the entire range of ultraviolet radiation. They can also be used as a sunscreen for the hair or the skin. [0198] Advantageous further UV-A filter substances within the meaning of the present invention are dibenzoylmethane derivatives, in particular 4-(tert-butyl)-4′-methoxydi-benzoylmethane (CAS No. 70356-09-1), which is marketed by Givaudan under the brand Parsol® 1789 and by Merck under the trade name Eusolex® 9020. [0199] Advantageous sulfonated, water-soluble UV filters within the meaning of the present invention are: phenylene-1,4-bis(2-benzimidazyl)-3,3′-5,5′-tetrasulfonic acid, which is distinguished by the following structure: and its salts, particularly the corresponding sodium, potassium or triethanol-ammonium salts, in particular phenylene-1,4-bis(2-benzimidazyl)-3,3′-5,5′-tetra-sulfonic acid bis sodium salt having the INCI name Bisimidazylate (CAS No.: 180898-37-7), which is obtainable from Haarmann & Reimer, for example, under the trade name Neo Heliopan AP. [0203] A further sulfonated UV filter within the meaning of the present invention are the salts of 2-phenylbenzimidazole-5-sulfonic acid, such as their sodium, potassium or their triethanol ammonium salts, and the sulfonic acid itself. having the INCI name Phenylbenzimidazole Sulfonic Acid CCAS No.: 27503-81-7), which is obtainable from Merck, for example, under the trade name Eusolex 232 or from Haarmann & Reimer under Neo Heliopan Hydro. [0205] A further advantageous sulfonated UV filter is 3,3′-(1,4-phenylenedimethylene)bis (7,7-dimethyl-2-oxobicyclo-[2.2.1 ]hept-1-ylmethane sulfonic acid, such as its sodium, potassium or its triethanolammonium salts, and the sulfonic acid itself: having the INCI name Terephthalidene Dicamphor Sulfonic Acid (CAS No.: 90457-82-2), which is obtainable, for example, from Chimex under the trade name Mexoryl SX. [0207] Further advantageous water-soluble UV-B and/or broadband filter substances are, for example: sulfonic acid derivatives of 3-benzylidenecamphor, such as, for example, 4-(2-oxo-3-bornylidenemethyl)benzenesulfonic acid, 2-methyl-5-(2-oxo-3-bornylidenemethyl)sulfonic acid and their salts. [0209] The total amount of one or more sulfonated UV filter substances in the finished cosmetic or dermatological preparations is advantageously chosen from the range 0.01% by weight to 20% by weight, preferably from 0.1 to 10% by weight, in each case based on the total weight of the preparations. [0210] Advantageous UV filter substances within the meaning of the present invention are furthermore “broadband filters”, i.e. filter substances which absorb both UV-A and UV-B radiation. [0211] Advantageous broadband filters or UV-B filter substances are, for example, bis-resorcinyltriazine derivatives having the following structure: where R 1 , R 2 and R 3 independently of one another are chosen from the group consisting of the branched and unbranched alkyl groups having 1 to 10 carbon atoms or an individual hydrogen atom. 2,4-Bis{[4-(2-ethylhexyloxy)-2-hydroxy]phenyl}-6-(4-methoxyphenyl)-1,3,5-triazine (INCI: Bisethylhexyloxyphenol Methoxyphenyl Triazine), which is obtainable from CIBA Chemikalien GmbH under the trade name Tinosorb® S, are particularly preferred. [0213] Particularly advantageous preparations within the meaning of the present invention, which are distinguished by a high or very high UV-A protection, contain, besides the filter substance(s) according to the invention, preferably further UV-A and/or broadband filters, in particular dibenzoylmethane derivatives [for example 4-(tert-butyl)-4′-methoxydibenzoylmethane], phenylene-1,4-bis(2-benzimidazyl)-3,3′-5,5′-tetrasulfonic acid and/or its salts, 2,2′-methylenebis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol), 1,4-di(2-oxo-10-sulfo-3-bornylidenemethyl)-benzene and/or its salts and/or 2,4-bis{[4-(2-ethylhexyloxy)-2-hydroxy]phenyl}-6-(4-methoxyphenyl)-1,3,5-triazine, in each case individually or in any desired combinations with one another. [0214] Other UV filter substances which have the structural motif are also advantageous UV filter substances within the meaning of the present invention, for example the s-triazine derivatives described in European laid-open specification EP 570 838 A1, whose chemical structure is represented by the generic formula where R is a branched or unbranched C 1 -C 18 -alkyl radical, a C 5 -C 12 -cycloalkyl radical, optionally substituted by one or more C 1 -C 4 -alkyl groups, X is an oxygen atom or an NH group, R 1 is a branched or unbranched C 1 -C 18 -alkyl radical, a C 5 -C 12 -cycloalkyl radical, optionally substituted by one or more C 1 -C 4 -alkyl groups, or a hydrogen atom, an alkali metal atom, an ammonium group or a group of the formula in which A is a branched or unbranched C 1 -C 18 -alkyl radical, a C 5 -C 12 -cycloalkyl or aryl radical, optionally substituted by one or more C 1 -C 4 -alkyl groups, R 3 is a hydrogen atom or a methyl group, n is a number from 1 to 10, R 2 is a branched or unbranched C 1 -C 18 -alkyl radical, a C 5 -C 12 -cycloalkyl radical, optionally substituted by one or more C 1 -C 4 -alkyl groups, if X is the NH group, and a branched or unbranched C 1 -C 18 -alkyl radical, a C 5 -C 12 -cycloalkyl radical, optionally substituted by one or more C 1 -C 4 -alkyl groups, or a hydrogen atom, an alkali metal atom, an ammonium group or a group of the formula in which A is a branched or unbranched C 1 -C 18 -alkyl radical, a C 5 -C 12 -cycloalkyl or aryl radical, optionally substituted by one or more C 1 -C 4 -alkyl groups, R 3 is a hydrogen atom or a methyl group, n is a number from 1 to 10, if X is an oxygen atom. [0231] A particularly preferred UV filter substance within the meaning of the present invention is furthermore an unsymmetrically substituted s-triazine, whose chemical structure is represented by the formula which is also designated as diethylhexylbutylamidotriazone (INCI: Diethylhexyl Butamidotriazone) below and is obtainable from Sigma 3V under the trade name UVASORB HEB. [0233] Also advantageous within the meaning of the present invention is a symmetrically substituted s-triazine, 4,4′,4″-(1,3,5-triazine-2,4,6-triyltriimino)trisbenzoic acid tris(2-ethylhexyl ester), synonym: 2,4,6-tris[anilino(p-carbo-2′-ethyl-1′-hexyloxy)]-1,3,5-triazine (INCI: Ethylhexyl Triazone), which is marketed by BASF Aktiengesellschaft under the trade name UVINUL® T 150. [0234] Also in European laid-open specification 775 698, bisresorcinyltriazine derivatives preferably to be employed are described, whose chemical structure is represented by the generic formula where R 1 , R 2 and A 1 represent all sorts of organic radicals. [0236] Furthermore advantageous within the meaning of the present invention are 2,4-bis-{[4-(3-sulfonato)-2-hydroxypropyloxy)-2-hydroxy]phenyl}-6-(4-methoxyphenyl)-1,3,5-triazine sodium salt, 2,4-bis-{[4-(3-(2-propyloxy)-2-hydroxypropyloxy)-2-hydroxy]phenyl}-6-(4-methoxyphenyl)-1,3,5-triazine, 2,4-bis{[4-(2-ethylhexyloxy)-2-hydroxy]phenyl}-6-[4-(2-methoxyethylcarboxyl)phenylamino]-1,3,5-triazine, 2,4-bis-{[4-(3-(2-propyloxy)-2-hydroxypropyloxy)-2-hydroxy]phenyl}-6-[4-(2-ethylcarboxyl)-phenylamino]-1,3,5-triazine, 2,4-bis-{[4-(2-ethylhexyloxy)-2-hydroxy]phenyl}-6-)1-methylpyrrol-2-yl)-1,3,5-triazine, 2,4-bis{[4-tris(trimethylsiloxysilylpropyloxy)-2-hydroxy]phenyl}-6-(4-methoxyphenyl)-1,3,5-triazine, 2,4-bis-{[4-(2″-methylpropenyl-oxy)-2-hydroxy]phenyl}-6-(4-methoxyphenyl)-1,3,5-triazine and 2,4-bis{[4-(1′,1′,1′,3′,5′,5′,5′-heptamethylsiloxy-2″-methylpropyloxy)-2-hydroxy]phenyl}-6-(4-methoxyphenyl)-1,3,5-triazine. [0237] Additionally advantageous, within the meaning of the invention, are the benzotriazole derivatives. Benzotriazoles are distinguished by the following structural formula: in which R 1 and R 2 independently of one another can be linear or branched, saturated or unsaturated, substituted (e.g. substituted by a phenyl radical) or unsubstituted alkyl radicals having 1 to 18 carbon atoms and/or polymeric radicals which do not absorb UV rays themselves (such as, for example, silicone radicals, acrylate radicals and suchlike), and R 3 is chosen from the group consisting of H or an alkyl radical having 1 to 18 carbon atoms. [0241] An advantageous benzotriazole within the meaning of the present invention is 2,2′-methylenebis(6-(2H-benzotriazol-2-yl)-4-( 1,1,3,3-tetramethylbutyl)phenol), a broadband filter, which is characterized by the chemical structural formula and is obtainable from CIBA Chemikalien GmbH under the trade name Tinosorb® M. [0243] An advantageous benzotriazole within the meaning of the present invention is furthermore 2-(2H-benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]disiloxanyl]propyl]phenol (CAS No.:155633-54-8) having the INCI name Drometrizole Trisiloxane, which is characterized by the chemical structural formula [0244] Further advantageous benzotriazoles within the meaning of the present invention are [2,4′-dihydroxy-3-(2H-benzotriazol-2-yl)-5-(1,1,3,3-tetramethylbutyl)-2′-n-octoxy-5′-benzoyl]diphenylmethane, 2,2′-methylenebis[6-(2H-benzotriazol-2-yl)-4-(methyl-phenol], 2,2′-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)-phenol], 2-(2′-hydroxy-5′-octylphenyl)benzotriazole, 2-(2′-hydroxy-3′,5′-di-t-amyl-phenyl)benzotriazole and 2-(2′-hydroxy-5′-methylphenyl)benzotriazole. [0245] According to the invention, cosmetic or dermatological preparations contain 0.1 to 20% by weight, advantageously 0.5 to 15% by weight, very particularly preferably 0.5 to 10% by weight, of one or more benzotriazoles. [0246] Liquid UV filter substances particularly advantageous at room temperature within the meaning of the present invention are homomenthyl salicylate, 2-ethylhexyl-2-cyano-3,3-diphenyl acrylate, 2-ethylhexyl 2-hydroxybenzoate and esters of cinnamic acid, preferably 4-methoxycinnamic acid (2-ethylhexyl) ester and 4-methoxycinnamic acid isopentyl ester. [0247] Homomenthyl salicylate (INCI: Homosalate) is distinguished by the following structure: [0248] 2-Ethylhexyl-2-cyano-3,3-diphenyl acrylate (INCI: Octocrylene) is obtainable from BASF under the name Uvinul® N 539 and is distinguished by the following structure: [0249] 2-Ethylhexyl 2-hydroxybenzoate (2-ethylhexyl salicylate, octyl salicylate, INCI: Octyl Salicylate) is obtainable, for example, from Haarmann & Reimer under the trade name Neo Helipan OS and is distinguished by the following structure: [0250] 4-Methoxycinnamic acid (2-ethylhexyl) ester (2-ethylhexyl 4-methoxycinnamate, INCI: Octyl Methoxycinnamate) is obtainable from Hoffmann-la Roche under the trade name Parsol MCX and is distinguished by the following structure: [0251] 4-Methoxycinnamic acid isopentyl ester (isopentyl 4-methoxycinnamate, INCI: Iso-amyl p-Methoxycinnamate) is obtainable, for example, from Haarmann & Reimer under the trade name Neo Helipan E 1000 and is distinguished by the following structure: [0252] A further advantageous UV filter substance within the meaning of the present invention, which is liquid at room temperature (3-(4-(2,2-bisethoxycarbonylvinyl)-phenoxy)propenyl)methylsiloxane/dimethylsiloxane copolymer, which is obtainable, for example, from Hoffmann-Ia Roche under the trade name Parsol SLX. [0253] The total amount of one or more UV filter substances which are liquid at room temperature in the finished cosmetic or dermatological preparations is advantageously chosen from the range 0.1% by weight to 30% by weight, preferably from 0.5 to 20% by weight, in each case based on the total weight of the preparations. [0254] It can also be a considerable advantage to use polymer-pound or polymeric UV filter substances in preparations according to the present invention, in particular those such as are described in WO-A-92/20690. [0255] The list of the UV filter substances mentioned which can be employed within the meaning of the present invention is not intended, of course, to be limiting. [0256] Advantageously, the preparations according to the invention contain the substances which absorb UV radiation in the UV-A and/or UV-B range in a total amount of, for example, 0.1% by weight to 30% by weight, preferably 0.5 to 25% by weight, in particular 1.0 to 20% by weight, in each case based on the total weight of the preparations in order to make cosmetic preparations available which protect the hair or the skin from the entire range of ultraviolet radiation. They can also be used as sunscreens for the hair or the skin. [0257] Furthermore, it can be advantageous to incorporate film-forming agents into the cosmetic or dermatological preparations according to the invention, for example in order to improve the water resistance of the preparations or to increase the UV protection power (UV-A and/or UV-B boosting). Both water-soluble and dispersible and also fat-soluble film-forming agents are suitable, in each case individually or in combination with one another. [0258] Advantageous water-soluble or dispersible film-forming agents are, for example, polyurethanes (e.g. the Avalure® types from Goodrich), Dimethicone Copolyol Poly-acrylate (Silsoft Surface® from the Witco Organo Silicones group), PVP/VA (VA=vinyl acetate) copolymer (Luviscol VA 64 powder from BASF) etc. [0259] Advantageous fat-soluble film-forming agents are, for example, the film-forming agents from the group consisting of the polymers based on polyvinylpyrrolidone (PVP) [0260] Copolymers of polyvinylpyrrolidone are particularly preferred, for example PVP hexadecene copolymer and PVP eicosene copolymer, which are obtainable under the trade names Antaron V216 and Antaron V220 from GAF Chemicals Cooperation, and Triacontyl PVP and suchlike. [heading-0261] Cleansing Agents [0262] According to the invention, these emulsions can be employed as cosmetic and dermatological preparations and as cleansing agents. [0263] Cosmetic preparations which are cosmetic cleansing preparations for the skin can be present in liquid or solid form. Besides active ingredient combinations according to the invention, they preferably contain at least one anionic, nonionic or amphoteric surface-active substance or mixtures thereof, if desired one or more electrolytes and excipients such as are customarily used therefor. The surface-active substance can be present in a concentration of between 1 and 94% by weight in the cleansing preparations, based on the total weight of the preparations. [heading-0264] Repellents—Insect-Repellent Agents [0265] A further advantageous embodiment of the present invention consists in insect-repellent agents. [0266] Advantageous active ingredients for repellents are low-melting or liquid amides, alcohols, esters and ethers having melting points of over 150° C., which evaporate only slowly at room temperature. [0267] The following active ingredients have proven particularly advantageous individually in combination with one another or with others: 3-(N-n-butyl-N-acetylamino)propionic acid ethyl ester (trade name: Insect Repellent 3535 obtainable from Merck), N,N-di-ethyl-3-methylbenzamide (DEET), dimethyl phthalate, ethylhexanediol, caprylic acid diethylamide and natural plant oils such as citronella oil, eucalyptus oil, lavender oil and oil of cloves. [heading-0268] Self-Tanning Agents [0269] A further advantageous embodiment of the present invention consists in self-tanning agents. [0270] Advantageous active ingredients for self-tanning agents are natural or synthetic ketols or aldols. Dihydroxyacetone (DHA), glycerolaldehyde, erythrulose, melanin, alloxan, hydroxy-methylglyoxal, γ-dialdehyde, 6-aldo-D-fructose, ninhydrin and meso-tartaric acid di-aldehyde have proven advantageous. [0271] Mixtures of the abovementioned active ingredients with one another or with muconic dialdehyde or/and naphthoquinones such as, for example, 5-hydroxy-1,4-naphthoquinone (juglone) have particularly advantageous. [heading-0272] Tissues [0273] According to the invention, in combination with the highly liquid cosmetic and dermatological W/O impregnation emulsions, tissues are employed which consist of a nonwoven which is in particular water jet-consolidated and/or water jet-embossed (spunlaced material). [0274] The macro embossing incorporated into the nonwoven can have any desired pattern. The choice to be made depends on on the one hand on the impregnation to be applied and on the other hand according to the field of use to which the future tissue is to be used. [0275] Large cavities in the nonwoven surface and in the nonwoven facilitate the absorption of dirt and impurities if the skin is run over with the impregnated tissue. The cleansing action is increased by a large amount compared with the unimpregnated tissues. [0276] Relative to the unembossed nonwoven, the thickness of the nonwoven with the high spots produced by embossing is advantageously approximately twice as high. In preferred embodiments, the embossed nonwoven is between 5% and 50%, very particularly preferably between 10% and 25%, thicker than the unembossed nonwoven. [0277] The embossed nonwoven additionally has particular properties which make possible the use as a carrier material for emulsions or other preparations. [0278] Thus the tensile strength is, in particular [N/50 mm] in the dry state machine direction >60, preferably >80 transverse direction >20, preferably >30 in the impregnated state machine direction >4, preferably >60 transverse direction >10, preferably >20 The stretchability of machine direction 15% to 100%, preferably the tissue is preferably 20% and 50% in the dry state transverse direction 40% to 120%, preferably 50% and 85% in the impregnated state machine direction 15% to 100%, preferably 20% and 40% transverse direction 40% to 120%, preferably 50% and 85% [0279] It has turned out to be advantageous for the tissue if it has a weight of 35 to 120 g/m 2 , preferably of 40 to 60 g/m 2 , (measured at 20° C.±2° C. and with a humidity of the room air of 65%±5% for 24 hours). [0280] The thickness of the nonwoven is preferably 0.4 mm to 1.5 mm, in particular 0.6 mm to 0.9 mm. [0281] Finally, it is particularly advantageous for the tissue to have a “surface Tinting” of less than 4 mg/1000 mm 2 , preferably less than 2 mg/1000 mm 2 . [0282] As starting materials for the nonwoven of the tissue, generally all organic and inorganic natural- and synthetic-based fibers can be used. Viscose, cotton, jute, hemp, sisal, silk, wool, polypropylene, polyester, polyethylene terephthalate (PET), aramid, nylon, polyvinyl derivatives, polyurethanes, polylactide, polyhydroxy-alkanoate, cellulose ester and/or polyethylene, and also mineral fibers such as glass fibers or carbon fibers can be mentioned. The present invention, however, is not restricted to the materials mentioned, but a multiplicity of further fibers can be employed for the formation of the nonwoven. [0283] In a particularly advantageous embodiment of the nonwoven, the fibers consist of a mixture of 70% of viscose and 30% of PET. [0284] Fibers of high-strength polymers such as polyamide, polyester and/or high-flex polyethylene are also particularly advantageous. [0285] Moreover, the fibers can also be dyed in order to emphasize and/or to increase the visual attractiveness of the nonwoven. The fibers can additionally contain UV stabilizers and/or preservatives. [0286] The fibers employed for the formation of the tissue preferably have a water absorption rate of more than 60 mm/[10 min] (measured using the EDANA test 10.1-72), in particular more than 80 mm/[10 min]. [0287] The fibers employed for the formation of the tissue preferably then have a water absorption power of more than 5 g/g (measured using the EDANA test 10.1-72), in particular more than 8 g/g. DETAILED DESCRIPTION OF THE INVENTION [0288] The following examples are intended to illustrate the impregnation solutions according to the invention without restricting them. The numerical values in the examples denote percentages by weight, based on the total weight of the respective preparations. EXAMPLES [0289] The following examples are intended to illustrate the present invention without restricting it. The numerical values in the examples denote percentages by weight, based on the total weight of the respective preparations. A. Impregnation medium: W/O sunscreen emulsions 1. Cetyl dimethicone copolyol 2 Polyglyceryl-2 dipolyhydroxy-stearate 2 Polysorbate-65 1 PEG-100 stearate 0.5 Cetyl phosphate 1 Cyclomethicone 10 Caprylyl methicone 5 Tinosorb ® S 2 Ethylhexyl triazone 4 Octocrylene 5 Ethylhexyl salicylate 5 Phenylbenzimidazole sulfonate 4 Titanium dioxide T 805 ® 3 Zinc oxide neutral 1 C 12-15 alkyl benzoate 2 Butylene glycol dicaprylate/dicaprate 5 Dicaprylyl carbonate 3 Dihexyl carbonate 5 Shea butter 0.75 PVP hexadecene copolymer 0.5 Silsoft Surface ® 1.0 Glycerol 10 Xanthan gum 0.1 Vitamin E acetate 1 EDTA 0.01 Magnesium sulfate 0.3 DMDM hydantoin 0.01 Ethanol 4 Dye q.s. Perfume q.s. Water to 100 2. Lauryl methicone copolyol 3 Polyglyceryl-3 diisostearate 2 Polysorbate-20 2 Cetearyl sulfate 0.7 Dimethicone 2 Phenyl trimethicone 5 Tinosorb ® S 3 4-Methylbenzylidene camphor 4 Ethylhexyl methoxycinnamate 10 Homosalate 7 Diethylhexyl butamidotriazone 2 Dimethico-diethylbenzal-malonate 3 MT-100 Z ® 2 Z-Cote HP1 3 Dicaprylyl ether 6 Butylene glycol dicaprylate/dicaprate 2 Mineral oil 7 PVP hexadecene copolymer 1.0 Glycerol 7.5 Vitamin E acetate 0.5 Magnesium sulfate 0.7 Konkaben LMB ® 0.12 Methylparaben 0.3 Phenoxyethanol 0.5 Dye q.s. Perfume q.s. Water to 100 3. Cetyl dimethicone copolyol 1.5 Lauryl methicone copolyol 0.7 Polyglyceryl-2 dipolyhydroxy-stearate 1.0 Polysorbate-65 1 PEG-100 stearate 1 Cyclomethicone 15 Neo Heliopan AP ® 2 Butyl methoxydibenzoyl-methane 1 Ethylhexyl triazone 2 4-methylbenzylidene camphor 4 Ethylhexyl salicylate 10 Phenylbenzimidazole sulfonate 1.5 C 12-15 alkyl benzoate 5 Dicaprylyl carbonate 4 Dihexyl carbonate 6 Shea butter 3 Silsoft Surface ® 0.50 Glycerol 5 Butylene glycol 5 Xanthan gum 0.3 Sodium chloride 1.2 Glycine soya 1.5 Ethanol 5 Dye q.s. Perfume q.s. Water to 100 4. Cetyl dimethicone copolyol 2.5 Isostearyl diglyceryl succinate 1.5 Cetyl phosphate 1.2 Dimethicone 3 Phenyl trimethicone 10 Tinosorb ® S 1 Tinosorb M ® 2 Ethylhexyl triazone 1.5 Ethylhexyl methoxycinnamate 5 Homosalate 7 Dimethicone diethylbenzal-malonate 0.5 Octyl cocoate 4 Mineral oil 5 Vitamin E acetate 0.3 α-Glucosylrutin 0.25 EDTA 0.2 Magnesium sulfate 1 Sodium chloride 0.1 Glycine soya 1 Ethanol 3 Dye q.s. Perfume q.s. Water to 100 5. Cetyl dimethicone copolyol 1.5 Polyglyceryl-2 dipolyhydroxy-stearate 2 Polysorbate-20 1 Cetearyl sulfate 0.5 Cyclomethicone 3 Neo Heliopan AP ® 0.5 Butyl methoxydibenzoyl-methane 1.5 Tinosorb M ® 2 Ethylhexyl salicylate 8 Dimethico-diethylbenzal-malonate 1 Z-Cote HP1 1.5 C 12-15 alkyl benzoate 7.5 Dicaprylyl carbonate 10 Glycerol 7.5 Vitamin E acetate 1.5 Sodium chloride 0.6 DMDM hydantoin 0.02 Methylparaben 0.4 Dye q.s. Perfume q.s. Water to 100 6. Cetyl dimethicone copolyol 3 Polyglyceryl-2 dipolyhydroxy-stearate 1 Isostearyl diglyceryl succinate 0.3 Polysorbate-65 1.5 Cetyl phosphate 0.7 Cetearyl sulfate 1 Dimethicone 2 Cyclomethicone 15 Tinosorb ® S 4 Ethylhexyl methoxycinnamate 10 Octocrylene 7.5 Ethylhexyl salicylate 6.5 Phenylbenzimidazole sulfonate 4 MT-100 Z ® 0.5 Zinc oxide neutral 4 Dicaprylyl carbonate 4 Dihexyl carbonate 6 Mineral oil 6 PVP hexadecene copolymer 0.4 Butylene glycol 7 α-Glucosylrutin 0.15 EDTA 0.15 Magnesium sulfate 1 Konkaben LMB ® 0.1 Phenoxyethanol 1 Repellent 3535 ® 10.0 Ethanol 1 Dye q.s. Perfume q.s. Water to 100 7. Cetyl dimethicone copolyol 1 Lauryl methicone copolyol 2.5 Isostearyl diglyceryl succinate 1 Polysorbate-20 1 Caprylyl methicone 5 Neo Heliopan AP ® 1 Tinosorb ® S 1 Butyl methoxydibenzoyl-methane 1 Tinosorb M ® 4 Ethylhexyl triazone 3 Ethylhexyl methoxycinnamate 10 Titanium dioxide T 805 ® 2.5 Z-Cote HP1 7 C 12-15 alkyl benzoate 5 Butylene glycol dicaprylate/ 3 dicaprate Octyl cocoate 7.5 Shea butter 3 Silsoft Surface ® 0.75 Glycerol 15 Xanthan gum 0.5 Vitamin E acetate 1.0 Magnesium sulfate 1 Konkaben LMB ® 0.2 Methylparaben 0.3 Dye q.s. Perfume q.s. Water to 100 8. Cetyl dimethicone copolyol 2.5 Lauryl methicone copolyol 0.7 Polyglyceryl-2 dipolyhydroxy-stearate 1.0 Polysorbate-65 1 PEG-100 stearate 1 Cyclomethicone 20 Tinosorb ® S 3 Butyl methoxydibenzoyl-methane 1.5 Tinosorb M ® 1 4-Methylbenzylidene camphor 1 Octocrylene 4 Ethylhexyl salicylate 8 Homosalate 2 Diethylhexyl butamidotriazone 2 Phenylbenzimidazole sulfonate 2 Titanium dioxide T 805 ® 5 PVP hexadecene copolymer 0.7 Butylene glycol 7.5 α-Glucosylrutin 0.5 Magnesium sulfate 0.7 DMDM hydantoin 0.01 Glycine soya 0.5 Dye q.s. Perfume q.s. Water to 100 9. Cetyl dimethicone copolyol 3 Polyglyceryl-2 dipolyhydroxy-stearate 2 Polysorbate-65 0.5 PEG-100 stearate 0.5 Cetyl phosphate 1 Dimethicone 5 Cyclomethicone 7 Caprylyl methicone 6 Neo Heliopan AP ® 2.5 Butyl methoxydibenzoyl-methane 2 Ethylhexyl triazone 2 Octocrylene 2.5 Dimethico-diethylbenzal-malonate 2 Dicaprylyl carbonate 5 Dihexyl carbonate 5 Mineral oil 15 Shea butter 2 Glycerol 4 Butylene glycol 5 Vitamin E acetate 0.75 Sodium chloride 0.75 Phenoxyethanol 1 Glycine soya 1 Dye q.s. Perfume q.s. Water to 100 10. Cetyl dimethicone copolyol 1.5 Polyglyceryl-3 diisostearate 2 Polysorbate-65 2 Cetearyl sulfate 0.75 Dimethicone 5 Cyclomethicone 5 Phenyl trimethicone 2 Neo Heliopan AP ® 1 Tinosorb ® S 2 Ethylhexyl triazone 3 Ethylhexyl methoxycinnamate 5 Dicaprylyl ether 8 Butylene glycol dicaprylate/dicaprate 8 Dicaprylyl carbonate 3 Glycerol 6 Butylene glycol 10 Sodium chloride 1 Methylparaben 0.2 Ethanol 7 Dye q.s. Perfume q.s. Water to 100 [0290] B. Impregnation medium: caring W/O emulsions 1 2 Cetyl dimethicone copolyol 2 Laurylmethicone copolyol 3 Polyglyceryl-2 dipolyhydroxystearate 1.5 Polyglyceryl-3 diisostearate 2 Polysorbate-65 1 Polysorbate-20 2 PEG-100 stearate 0.5 Trilaureth-4 phosphate 1.5 Cetearyl sulfate 0.7 Dimethicone 5 Cyclomethicone 5 15 Phenyl trimethicone 2 Caprylyl methicone 1 C 12-15 alkyl benzoate 4 Dicaprylyl ether 10 Octyldodecanol 3 Dicaprylyl carbonate 10 Octyl cocoate 2 Caprylic/capric triglyceride 2 Shea butter 0.5 Glycerol 10 7 Butylene glycol 10 Vitamin E acetate 1 0.5 α-Glycosylrutin 0.15 Magnesium sulfate 0.7 1.4 DMDM hydantoin 0.01 Konkaben LMB ® 0.1 Phenoxyethanol 1 0.4 Dihydroxyacetone 5 Dye q.s. q.s. Perfume q.s. q.s. Water to 100 to 100 3 4 Cetyl dimethicone copolyol 2.5 Laurylmethicone copolyol 1.5 Polyglyceryl-2 dipolyhydroxy- 2 stearate Polyglyceryl-3 diisostearate Isostearyl diglyceryl succinate 0.7 1.5 PEG-100 stearate 1 Trilaureth-4 phosphate 1.2 Dimethicone 1 Phenyl trimethicone 7 Caprylyl methicone 10 C 12-15 alkyl benzoate 8 Dicaprylyl carbonate 4 Caprylic/capric triglyceride 5 Isononyl octanoate 10 5 Dihexyl carbonate Mineral oil 10 Shea butter 1 Glycerol 15 Butylene glycol 5 Xanthan gum 0.2 Vitamin E acetate 1 α-Glycosylrutin 0.3 Coenzyme Q10 0.7 Sodium chloride 1 1.5 DMDM hydantoin Konkaben LMB ® 0.15 0.2 Methylparaben 0.3 Ethanol 2 Dye q.s. q.s. Perfume q.s. q.s. Water to 100 to 100 5 6 Cetyl dimethicone copolyol 1.5 3 Polyglyceryl-2 dipolyhydroxy-stearate 1.5 1 Isostearyl diglyceryl succinate 0.3 Polysorbate-65 1.5 Polysorbate-20 0.7 Cetearyl sulfate 1 Dimethicone 4 Cyclomethicone 20 Caprylyl methicone 8 C 12-15 alkyl benzoate 5 Dicaprylyl ether 5 Dicaprylyl carbonate 10 15 Isononyl octanoate 2 Dihexyl carbonate 6 Mineral oil 5 Shea butter 2 Glycerol 5 7.5 Butylene glycol 5 Xanthan gum 0.5 Vitamin E acetate 0.75 2 α-Glycosylrutin 0.2 Coenzyme Q10 Magnesium sulfate 0.2 1 Sodium chloride 0.5 Phenoxyethanol 0.3 Glycine soja 1 0.7 Ethanol 5 Dihydroxyacetone 7.5 Dye q.s. q.s. Perfume q.s. q.s. Water to 100 to 100 7 8 Cetyl dimethicone copolyol 1 1.5 Lauryl methicone copolyol 2.5 0.7 Polyglyceryl-2 dipolyhydroxy-stearate 1.0 Isostearyl diglyceryl succinate 1 Polysorbate-65 1 Polysorbate-20 1 PEG-100 stearate 1 Dimethicone 7 2 Cyclomethicone 20 Phenyl trimethicone 15 Dicaprylyl ether 10 Octyldodecanol 5 Dicaprylyl carbonate 7.5 Octyl cocoate 7 Caprylic/capric triglyceride 2 Glycerol 10 Butylene glycol 10 Vitamin E acetate 1.5 0.5 α-Glycosilrutin Coenzyme Q10 0.02 Magnesium sulfate 0.5 0.3 DMDM hydantoin 0.01 Methylparaben 0.2 Glycine soya 1.5 Ethanol 3 Dye q.s. q.s. Perfume q.s. q.s. Water to 100 to 100 9 10 Cetyl dimethicone copolyol 3 1.5 Polyglyceryl-3 diisostearate 1 2 Polysorbate-65 2 Trilaureth-4 phosphate 1 Cetearyl sulfate 0.75 Cyclomethicone 15 Phenyl trimethicone 4 Caprylyl methicone 5 C 12-15 alkyl benzoate 9 Dicaprylyl ether 5 Octyldodecanol Dicaprylyl carbonate 10 Octyl cocoate 15 Caprylic/capric triglyceride 10 Isononyl octanoate 4 Dihexyl carbonate 5 Mineral oil 15 Shea butter 4 Glycerol 7.5 5 Xanthan gum 0.1 Vitamin E acetate 0.3 0.2 Magnesium sulfate 0.7 Sodium chloride 0.5 Konkaben LMB ® 0.18 Methylparaben 0.1 Phenoxyethanol 1 1 Glycine soya 0.5 Dye q.s. q.s. Perfume q.s. q.s. Water to 100 to 100

A cosmetic or dermatological tissue comprising a water-insoluble nonwoven impregnated and/or moistened with a cosmetic or dermatological W/O emulsion comprising an emulsifier system of an O/W emulsifier having an HLB value of >10 and a silicone emulsifier (W/S) having an HLB value of <=8 and/or a W/O emulsifier having an HLB value of <7.

[0001] This application claims the benefit of U.S. Provisional Application No. 60/454,260, filed Mar. 12, 2003, the disclosure of which is hereby incorporated by reference in its entirety. FIELD OF THE INVENTION [0002] The present invention is directed to a process for preparing 2-aminomethyl-5-fluorobenzamides, which can be coupled with naphthyridine carboxylic acids or esters thereof to form naphthyridine carboxamides that are useful as HIV integrase inhibitors. BACKGROUND OF THE INVENTION [0003] The HIV retrovirus is the causative agent for AIDS. The HIV-1 retrovirus primarily uses the CD4 receptor (a 58 kDa transmembrane protein) to gain entry into cells, through high-affinity interactions between the viral envelope glycoprotein (gp 120) and a specific region of the CD4 molecule found in T-lymphocytes and CD4 (+) T-helper cells (Lasky L. A. et al., Cell 1987, 50: 975-985). HIV infection is characterized by an asymptomatic period immediately following infection that is devoid of clinical manifestations in the patient. Progressive HIV-induced destruction of the immune system then leads to increased susceptibility to opportunistic infections, which eventually produces a syndrome called ARC (AIDS-related complex) characterized by symptoms such as persistent generalized lymphadenopathy, fever, and weight loss, followed itself by full blown AIDS. [0004] After entry of the retrovirus into a cell, viral RNA is converted into DNA, which is then integrated into the host cell DNA. Integration of viral DNA is an essential step in the viral life cycle. Integration is believed to be mediated by integrase, a 32 kDa enzyme, in three steps: assembly of a stable nucleoprotein complex with viral DNA sequences; cleavage of two nucleotides from the 3′ termini of the linear proviral DNA; and covalent joining of the recessed 3′ OH termini of the proviral DNA at a staggered cut made at the host target site. The fourth step in the process, repair synthesis of the resultant gap, may be accomplished by cellular enzymes. [0005] Certain 8-hydroxy-1,6-naphthyridine-7-carboxamides constitute a class of inhibitors of HIV integrase and of HIV replication. Compounds of this class include, but are not limited to, compounds of Formula (A): [0006] and pharmaceutically acceptable salts thereof, wherein: [0007] each R* is independently H, alkyl, or cycloalkyl; [0008] Q is H, —C(═O)N(R X R Y ), —N(R X )SO 2 R Z , or 1,1-dioxido-1,2-thiazinan-2-yl; [0009] R X and R Y are each independently H, alkyl, or cycloalkyl; and [0010] R Z is alkyl or cycloalkyl. [0011] Exemplary of compounds of Formula (A) is the compound of formula: [0012] alternatively referred to herein as Compound 10. [0013] Compounds of Formula (A) can be prepared by coupling 8-hydroxy-naphthyridine-7-carboxylic acids (or acid derivatives such as acid halides or esters) with the appropriate 2-aminocarbonyl-4-fluorobenzylamine (typically and alternatively referred to herein as the 2-aminomethyl-5-fluorobenzamide or, more simply, as the benzamide side chain). The benzamide side chain can be prepared using the method exemplified in Scheme A below. [0014] Unfortunately, the process depicted in Scheme A has several disadvantages. The starting material A1 is quite expensive and not available in bulk quantitites, and the bromination in the first step of Scheme A results in the formation of significant dibromide byproduct, requiring chromatographic purification of the product A2. The fifth step of Scheme A is an aminocarbonylation that involves the use of carbon monoxide which presents a serious safety hazard. Careful handling of the CO and monitoring of CO levels is essential. In addition, the aminocarbonylation step has a relatively low yield of 6 (e.g., about 60%), and chromatographic purification of the product is required due to the formation of significant byproduct. The overall yield observed for the process of Scheme A is typically less than 30%, which is quite low especially for the production of benzamide side chain in bulk quantities. In summary, the Scheme A process is not well suited to the large scale production of benzamide side chain. [0015] The benzamide side chain can also be prepared using a variation of Scheme A, exemplified in Scheme B below. [0016] Scheme B requires fewer steps than Scheme A, but nonetheless still includes the aminocarbonylation step and its attendant disadvantages as described above. In addition, the reagent (BOC) 2 NH used in the first step to prepare di-BOC intermediate B3 is very expensive and not available in bulk quantities. Overall yields for Scheme B are no better than those for Scheme A; i.e., they are typically less than 30%. [0017] Accordingly, there is a need for more efficient methods for preparing the benzamide side chain. SUMMARY OF THE INVENTION [0018] The present invention is directed to a process for preparing 2-aminomethyl-5-fluorobenzamides that can be coupled to naphthyridine carboxylic acids or esters thereof to form naphthyridine carboxamide integrase inhibitors. More particularly, the present invention is a process for preparing a benzamide compound of Formula (VII): [0019] which comprises: [0020] (Y) reacting a benzoate compound of Formula (V): [0021] with an amine of formula R 1 R 2 NH in a solvent Y to obtain a benzamide compound of Formula (VI): [0022] (Z) treating the benzamide compound of Formula (VI) with an amine deprotecting agent to obtain the benzamide compound of Formula (VII); [0023] wherein: [0024] R 1 and R 2 are each independently: [0025] (1) —H, [0026] (2) —C 1-6 alkyl, optionally substituted with from 1 to 5 substituents each of which is independently —OH, —O—C 1-6 alkyl, —CN, —NO 2 , —N(R a )R b , —C(═O)N(R a )R b , —SO 2 N(R a )R b , —N(R a )C(═O)R b , —N(R a )CO 2 R c , —N(R a )SO 2 R c , —N(R a )SO 2 N(R a )R b , —OC(═O)N(R a )R b , or —N(R a )C(═O)N(R a )R b , [0027] (3) —C 3-6 cycloalkyl, optionally substituted with from 1 to 4 substituents each of which is independently —C 1-4 alkyl or —O—C 1-4 alkyl, or [0028] (4) aryl, optionally substituted with from 1 to 6 substituents each of which is independently halogen, —C 1-4 alkyl, —O—C 1-4 alkyl, —CN, —N(R a )R b , —C(═O)N(R a )R b , —SO 2 N(R a )R b , —N(R a )C(═O)R b , —N(R a )CO 2 R c , —N(R a )SO 2 R c , —(CH 2 ) 1-2 —O—C 1-4 alkyl, —(CH 2 ) 1-2 —CN, —(CH 2 ) 1-2 —N(R a )R b , —(CH 2 ) 1-2 —C(═O)N(R a )R b , —(CH 2 ) 1-2 —SO 2 N(R a )R b , —(CH 2 ) 1-2 —N(R a )C(═O)R b , —(CH 2 ) 1-2 —N(R a )CO 2 R c , —(CH 2 ) 1-2 —N(R a )SO 2 R c , phenyl, or —(CH 2 ) 1-2 -phenyl; [0029] R 3 is —C 1-6 alkyl, —C 1-6 alkyl-aryl, or aryl; [0030] P* is an amino protective group; [0031] each R a is independently —H, —C 1-6 alkyl, or —C 3-6 cycloalkyl; [0032] each R b is independently —H, —C 1-6 alkyl, or —C 3-6 cycloalkyl; and [0033] each R c is independently —C 1-6 alkyl or —C 3-6 cycloalkyl. [0034] The process of the present invention can provide the benzamide compound of Formula (VII) in a high yield with respect to the starting benzoate compound of Formula (V). For example, the process has typically resulted in an overall yield of at least about 90% of N-methyl 2-aminomethyl-5-fluorobenzene carboxamide (alternatively referred to herein as Compound 7) from methyl 2-t-butyloxycarbonylaminomethyl-5-fluorobenzoate (alternatively referred to herein as Compound 5). The efficiency of the process of the invention is surprising, because the process would be expected to form substantial or major amounts of lactam byproduct due to cyclization of the amino group with the ester in Compound V and with the amide in Compound VI. [0035] An embodiment of the invention is the process of the invention as set forth above, further comprising Steps U, V, W and X as described below, wherein compounds of Formula (V) are prepared starting from 5-fluoro-2-halobenzoic acids. The 5-fluoro-2-halobenzoic acids are either available commercially at relatively low cost or are typically easy to prepare in good yields or both. This multi-step process (i.e., Steps U, V, W, and X as described below plus Steps Y and Z as set forth above and more fully described below) can achieve yields of Compound VII of greater than 60%, a substantial improvement over the processes depicted in Schemes A and B above. In addition, this multi-step process does not include a carbonylation step and thus avoids the use of carbon monoxide, the use of which is a significant drawback to the processes of Schemes A and B. [0036] Other embodiments, aspects and features of the present invention are either further described in or will be apparent from the ensuing description, examples and appended claims. DETAILED DESCRIPTION OF THE INVENTION [0037] A benzamide compound of Formula (VII) is alternatively referred to herein more simply as “Compound VII” or “benzamide VII”. Similarly, a benzamide compound of Formula (VI) is alternatively referred to as “Compound VI” or “benzamide VI”, and a benzoate compound of Formula (V) is alternatively referred to as “Compound V” or “benzoate V”. Analogous nomenclature is employed for compounds of Formula (I) to (IV) set forth in the description below. [0038] The present invention is directed to processes for preparing 2-aminomethyl-5-fluorobenzamides, which are useful as the side chains of naphthyridine carboxamide integrase inhibitors. The present invention includes the process comprising Steps Y and Z as set forth above in the Summary of the Invention. [0039] An embodiment of the present invention is the process comprising Steps Y and Z as set forth above, wherein R 1 and R 2 in the definition of Compounds VI and VII are each independently —H, —C 1-6 alkyl, —C 3-6 cycloalkyl, or aryl. In an aspect of this embodiment, R 1 and R 2 are each independently —H, —C 1-4 alkyl, cyclopropyl, or phenyl. In another embodiment of the present invention, R 1 and R 2 are each independently —H or —C 1-6 alkyl. In an aspect of this embodiment, R 1 and R 2 are each independently —H or —C 1-3 alkyl. In still another embodiment, one of R 1 and R 2 is —H and the other of R 1 and R 2 is —C 1-6 alkyl. Other embodiments include the process comprising Steps Y and Z in which R 1 is —H and R 2 is —C 1-4 alkyl; or R1 is H and R2 is methyl, ethyl, n-propyl, or isopropyl; or R1 is H and R2 is methyl or ethyl; or R1 is H and R2 is methyl. [0040] Another embodiment of the present invention is the process comprising Steps Y and Z as set forth above, wherein R 3 is —C 1-6 alkyl, —CH 2 -aryl, or aryl. In another embodiment, R 3 is —C 1-4 alkyl, benzyl, or phenyl. Other embodiments include the process comprising Steps Y and Z in which R3 is —C 1-4 alkyl; or is methyl, ethyl, n-propyl, or isopropyl; or is methyl or ethyl; or is methyl. [0041] Another embodiment of the present invention is the process comprising Steps Y and Z as set forth above, wherein P* is [0042] (1) —C(═O)—O—C 1-6 alkyl, [0043] (2) —C(═O)—O—CH 2 -aryl, [0044] (3) —C(═O)—O—(CH 2 ) 0-1 —CH═CH 2 , [0045] wherein R s and R t are each independently —C 1-6 alkyl, —CH 2 -aryl, or aryl ; and [0046] R u and R v are each independently an aryl group. [0047] Aspects of this embodiment include P* as defined above, wherein R s and R t are each independently —C 1-4 alkyl, benzyl, or phenyl; or R s is the same as R t (i.e., R s and R t are both the same —C 1-6 alkyl group, the same —CH 2 -aryl, or the same aryl); or R s and R t are both phenyl, or both benzyl, or both the same —C 1-4 alkyl group (e.g., both methyl, both ethyl, both n-propyl, both isopropyl, both n-butyl, or both t-butyl). Other aspects of this embodiment include P* as defined above, wherein R u and R v are both the same aryl group; or R u and R v are both phenyl. [0048] Another embodiment of the present invention is the process comprising Steps Y and Z, wherein P* is selected from the group consisting of (C 1-4 alkyloxy)carbonyl, benzyloxycarbonyl (CBZ), allyloxycarbonyl (ALLOC), diphenylphosphinyl, di—(C 1-3 alkyl)phosphono, diphenylphosphono, and dibenzylphosphono. In another embodiment, P* is t-butyloxycarboxnyl (BOC), CBZ, or ALLOC. In still another embodiment, P* is BOC. [0049] Certain of the substituents set forth in the definitions of R 1 and R 2 herein include groups R a and R b . Each R a and R b is independently —H, —C 1-6 alkyl, or —C 3-6 cycloalkyl. In one embodiment, each R a and R b is independently —H or —C 1-4 alkyl. In another embodiment, each R a and R b is independently —H or —C 1-3 alkyl. In another embodiment, each R a and R b is independently —H, methyl, or ethyl. In still another embodiment, each R a and R b is independently —H or methyl. [0050] Certain of the substituents set forth in the definitions of R 1 and R 2 include the group R c . Each R c is independently a —C 1-6 alkyl or a —C 3-6 cycloalkyl. In one embodiment, each R c is independently a —C 1-4 alkyl. In another embodiment, each R c is independently a —C 1-3 alkyl. In another embodiment, each R c is independently methyl or ethyl. In still another embodiment, each R c is methyl. [0051] It is understood that any embodiment, aspect, or feature of any one of P*, R 1 , R 2 , R 3 , R a , R b , and R c can be combined with any embodiment, aspect of feature of any one or more of the others of P*, R 1 , R 2 , R 3 , R a , R b , and R c . Each such possible combination, when incorporated into the process of the invention as defined above, represents an embodiment of the process of the present invention. [0052] In Step Y an amine of formula R 1 R 2 NH is reacted (i.e., acylated) with benzoate compound V in a solvent Y to obtain benzamide compound VI. The solvent Y can suitably be selected from the group consisting of aromatic hydrocarbons, halogenated aliphatic hydrocarbons, alcohols, ethers, and nitriles. In one embodiment, the solvent Y is selected from the group consisting of C 6 -C 14 aromatic hydrocarbons, dialkyl ethers wherein each alkyl is independently a C 1 -C 6 alkyl, C 1 -C 6 linear and branched alkanes substituted with two —O—C 1 -C 6 alkyl groups (which are the same or different), C 4 -C 8 cyclic ethers and diethers, C 6 -C 8 aromatic ethers, and C 2 -C 6 aliphatic nitriles. Exemplary solvents for use in Step Y include benzene, toluene, o-, m-, and p-xylene (single or mixed isomers), ethylbenzene, carbon tetrachloride, chloroform, methylene chloride, 1,2-dichloroethane, 1,1,2-trichloroethane, 1,1,2,2-tetrachloroethane, methanol, ethanol, propanol, isopropanol, n-butanol, isobutanol, THF, DME, MTBE, di-n-butyl ether, dioxane, acetonitrile, and propionitrile. [0053] In another embodiment, the solvent Y is selected from aromatic hydrocarbons, alcohols, and ethers. In an aspect of the preceding embodiment, the solvent Y is selected from the group consisting of C 1 -C 6 alkyl alcohols, dialkyl ethers wherein each alkyl is independently a C 1 -C 4 alkyl, C 4 -C 5 cyclic ethers, and C 7 -C 8 aromatic hydrocarbons. In another aspect of the preceding embodiment, the solvent Y is methanol, ethanol, n-propanol, isopropanol, n-butanol, diethylether, THF, DME, toluene, or single or mixed isomers of xylene. In still another aspect of the preceding embodiment, solvent Y is toluene or single or mixed isomers of xylene. [0054] The amine of formula R 1 R 2 NH can be employed in Step Y in any proportion with respect to Compound V which will result in the formation of at least some of Compound V, but is typically employed in an amount that can optimize conversion of Compound V and formation of Compound VI. In one embodiment, the amine is employed in Step Y in an amount in a range of from about 1 to about 200 equivalents per equivalent of benzoate V. In another embodiment, the amine is employed in an amount in a range of from about 1 to about 50 (e.g., from about 1 to about 10) equivalents per equivalent of Compound V. In still another embodiment, the amine is employed in an amount in a range of from about 1 to about 5 (e.g., from about 1.5 to 5) equivalents per equivalent of Compound V. In still another embodiment, the amine is employed in an amount in a range of from about 2 to about 5 equivalents per equivalent of Compound V. [0055] Step Y can be conducted at any temperature at which the reaction (acylation) to form Compound VI can be detected. The temperature is suitably in a range of from about 50 to about 200° C., and the reaction is typically conducted at a temperature in a range of from about 75 to about 150° C. (e.g., from about 75 to about 125° C.). In one embodiment, the temperature is in a range of from about 75 to about 100° C. [0056] The Step Y reaction can be conducted by charging the solvent Y, the amine, and Compound V to a suitable reaction vessel, bringing the resulting mixture to reaction temperature, and maintaining the mixture at reaction temperature (optionally with agitation such as stirring) until the reaction is complete or the desired degree of conversion of the reactants is achieved. The order of addition of the reactants and reagents to the reaction vessel is typically not critical; i.e., they can be charged concurrently or sequentially in any order. For example, Compound V can first be dissolved in solvent Y, and the solution charged to the reaction vessel, followed by addition of the amine. When the amine is a gas (e.g., methylamine), the reaction can be conducted under pressure in a suitable reactor (e.g., a bomb). The reaction time can vary widely depending upon, inter alia, the reaction temperature and the choice and relative amounts of reactants, but the reaction time is typically in a range of from about 1 to about 96 hours. Compound VI can subsequently be isolated (alternatively referred to as recovered) from the reaction mixture using conventional procedures, such as by cooling and concentrating the post-reaction mixture to precipitate the desired product, then separating the product by filtration. [0057] In Step Z, the benzamide compound of Formula (VI) is treated with an amine deprotecting agent to obtain the benzamide compound of Formula (VII). The amino protective group P* in Compounds V and VI can be any amino protective group that is stable enough to survive the acylation of Step Y and labile enough to be removed (cleaved) from Compound VI via contact with a suitable amine deprotecting agent to form benzamide VII with little or no degradation of the amido group (e.g., little or no lactam formation). Suitable P* groups include alkyloxycarbonyls (e.g., BOC), arylmethyloxycarbonyls (e.g., CBZ), vinyloxycarbonyl, ALLOC, diarylphosphinyls, diarylphosphonos, and dialkylphosphonos, such as those defined and described earlier. These P* groups can be formed by treating the amine precursors of Compound V with amine protecting agents. Suitable amine protecting agents and treatment methods are described below in the discussion of Step X. In most instances the P* groups can be removed by treatment with acids including mineral acids, Lewis acids, and organic acids. Suitable mineral acids include hydrogen halides (HCl, HBr, and HF, as a gas or in aqueous solution), sulfuric acid, and nitric acid. Suitable organic acids include carboxylic acids, alkylsulfonic acids and arylsulfonic acids. Exemplary organic acids include trifluoroacetic acid (TFA), toluenesulfonic acid, benzenesulfonic acid, methanesulfonic acid, and trifluoromethanesulfonic acid. Suitable Lewis acids include BF 3 .Et 2 O, SnCl 4 , ZnBr 2 , Me 3 SiI, Me 3 SiCl, Me 3 SiOTf, and AlCl 3 . Cleavage conditions (e.g., temperature, choice and concentration of acid) can vary from mild to harsh depending upon the lability of the amino protective group. Although acid treatment is typically effective, other means can often be employed. Removal of CBZ or ALLOC, for example, is typically accomplished via hydrogenolysis (e.g., hydrogenation with a Pd catalyst). Further description of amine deprotecting agents and deprotection treatments suitable for use in Step Z can be found in Protective Groups in Organic Chemistry , edited by J. F. W. McOmie, Plenum Press, New York, 1973, pp. 43-74; and in T. W. Greene and P. G. M. Wuts, Protective Groups in Organic Synthesis , 2 nd edition, John Wiley, New York, 1991, pp. 309-385. [0058] An embodiment of the present invention is the process comprising Steps Y and Z as originally described above or as described in any of the preceding embodiments thereof, wherein P* is an amino protective group capable of being cleaved by an acid and the amine deprotecting agent in Step Z comprises an acid Z. In an aspect of this embodiment, the acid Z is a protonic acid (i.e., a proton-donating substance, also referred to in the art as a Lowry-Bronsted acid). In a feature of this aspect, the protonic acid is a mineral acid (e.g., HCl). [0059] The treatment in Step Z (e.g., hydrogenolysis, acid hydrolysis, etc.) can be conducted at any temperature at which the formation of Compound VI can be detected. The temperature is suitably in a range of from about −50 to about 150° C., and is typically in a range of from about −50 to about 100° C. When the deprotecting agent is an acid Z, the treatment in Step Z is more typically conducted at a temperature in a range of from about −20 to about 50° C. (e.g., from about −10 to about 30° C.). When the deprotecting agent is hydrogen (for hydrogenolysis), the treatment temperature is more typically in a range of from about 0 to about 50° C. (e.g., from about 5 to about 30° C.). [0060] When an acid Z is employed as the deprotecting agent in Step Z, it is suitably employed in an amount in a range of from about 0.1 to about 100 (e.g., from about 1 to about 50) equivalents per equivalent of benzamide VI, and is typically employed in an amount in a range of from about 0.5 to about 50 equivalents (e.g., from about 1 to 10) equivalents per equivalent of benzamide VI. In one embodiment, the acid is employed in an amount in a range of from about 1 to about 15 (e.g., from about 3 to about 15) equivalents per equivalent of benzamide VI. For hydrogenolyses, hydrogen is typically employed in an amount of at least about 1 equivalent per equivalent of benzamide VI. [0061] The treatment in Step Z is typically conducted in solvent, hereinafter alternatively referred to as solvent Z. When treatment is with an acid, suitable solvents include esters, alcohols, halogenated aliphatic hydrocarbons, ethers, and nitriles. Suitable and exemplary alcohols, halogenated aliphatic hydrocarbons, ethers, and nitriles for Step Z are the same as those described above for Step Y. Suitable esters include C 1 -C 6 alkyl esters of C 1 -C 6 alkylcarboxylic acids. In one embodiment, solvent Z is a C 1-4 alkyl acetate (e.g., ethyl acetate, isopropyl acetate, n-butyl acetate, or isobutyl acetate). When hydrogenolysis is employed, suitable solvents include the C 1 -C 6 alkyl alcohols, such as methanol, ethanol, n-propanol, and isopropanol. [0062] The Step Z reaction can be conducted by first charging a mixture of solvent and Compound VI to a suitable reaction vessel at low temperature, then adding the amine deprotecting agent (e.g., acid Z, either as a gas such as gaseous HCl or in aqueous solution), warming the mixture to reaction temperature, and maintaining the mixture at reaction temperature (optionally with agitation) until the reaction is complete or the desired degree of conversion is achieved. When hydrogenolysis is employed, the treatment is typically conducted in a pressurized reactor. Treatment times can vary widely depending upon, inter alia, the reaction temperature and the choice and relative amounts of amine deprotecting agent and Compound VI, but the reaction time is typically in a range of from about 0.5 to about 12 hours. Compound VII can be recovered using conventional means in the form of an acid salt (e.g., a hydrochloride salt) or as the free base. Either the salt or the free base can be employed in the preparation of naphthyridine carboxamide integrase inhibitors. The acid salt is typically more stable than the free base, and thus, if the product is to be stored before use, it is usually preferred to isolate the compound as a salt. [0063] The present invention includes a process for preparing a benzamide compound of Formula (VII) which comprises Steps Y and Z as described above and which further comprises: [0064] (X) treating a benzoate compound of Formula (IV): [0065] with an amine protecting agent containing the group P* in a solvent X to obtain the benzoate compound of Formula (V). [0066] Suitable amine protecting agents for use in Step X include: [0067] (i) compounds of formula P a* -Q, wherein Q is halide (e.g., chloride or bromide) and P a* is selected from the group consisting of: [0068] (1) —C(═O)—O—C 1-6 alkyl, [0069] (2) —C(═O)—O—CH 2 -aryl, [0070] (3) —C(═O)—O—(CH 2 ) 0-1 —CH═CH 2 , [0071] wherein R s and R t are each independently —C 1-6 alkyl, —CH 2 -aryl, or aryl; and [0072] R u and R v are each independently an aryl group; and [0073] (ii) anhydrides of formula (P b* ) 2 O, wherein P b* is BOC, CBz, or ALLOC. [0074] P a* and P b* represent sub-definitions of P*. [0075] A class of suitable amine protecting agents is selected from (i) compounds of formula P a* -Q, wherein P a* is selected from the group consisting of (C 1-4 alkyloxy)carbonyl, benzyloxycarbonyl (CBZ), allyloxycarbonyl (ALLOC), diphenylphosphinyl, di—(C 1-3 alkyl)phosphono, diphenylphosphono, and dibenzylphosphono and (ii) compounds of formula (P b* ) 2 O, wherein P b* is BOC, CBZ, or ALLOC. Representative examples of amine protecting agents in this class are Ph 2 P(═O)Cl, (i-PrO) 2 P(═O)Cl, (t-BuO) 2 P(═O)Cl, (BnO) 2 P(═O)Cl, BOC-Cl, CBZ-Cl, (CBZ) 2 O, (ALLOC) 2 O, allyl chloroformate, and (BOC) 2 O. A sub-class of this class consists of amine protecting agents selected from BOC-Q and (BOC) 2 O. [0076] Each of the aspects restricting the values of R s and R t and of R u and R v in the definition of P* as set forth in the above discussion of Steps Y and Z represent additional classes of suitable amine protecting agents of formula P a* -Q. [0077] Treating Compound IV with a compound of formula P a* -Q will result in the acylation, phosphonylation, or phosphinylation of the amino group to give the corresponding carbamate (i.e., —NH—P a* wherein P a* is one of groups (i)(1), (i)(2) or (i)(3)), phosphoramidate (—NH—P a* wherein P a* is group (i)(4)), or phosphinamide (—NH—P a* wherein P a* is group (i)(5)). Treatment with the anhydride (P b* ) 2 O results in the acylation of the amine group to form the carbamate —NH—P b* . Further description of these and other amine protecting agents suitable for use in Step X can be found in Protective Groups in Organic Chemistry , edited by J. F. W. McOmie, Plenum Press, New York, 1973, pp. 43-74; and in T. W. Greene and P. G. M. Wuts, Protective Groups in Organic Synthesis , 2 nd edition, John Wiley, New York, 1991, pp. 309-385; the disclosures of which are hereby incorporated by reference in their entireties. [0078] The amine protecting agent is typically employed in an amount that can optimize conversion of benzoate compound IV to benzoate compound V. The amine protecting agent is suitably employed in an amount in a range of from about 0.9 to about 10 equivalents per equivalent of benzoate compound IV, and is typically empoyed in an amount in a range of from about 0.9 to about 3 (e.g., from about 1.1 to about 3) equivalents per equivalent of benzoate compound IV. [0079] The treatment in Step X can be conducted at any temperature at which the reaction to form Compound V can be detected. The temperature is suitably in a range of from about −20 to about 60° C., and is typically in a range of from about −20 to about 50° C. (e.g., from about −5 to about 35° C.). [0080] Step X is conducted in solvent X. Suitable solvents include aromatic hydrocarbons, halogenated aliphatic hydrocarbons, alcohols, esters, ethers, and nitriles. Further description of these solvent classes is set forth above in the discussion of Steps Y and Z, is applicable here, and is incorporated herein by reference. Aliphatic hydrocarbons (e.g., C 3 -C 12 linear and branched alkanes) and alicyclic hydrocarbons (e.g., C 5 -C 7 cycloalkanes), not heretofore described, are also suitable for employment as solvent X. Exemplary solvents include hexane (pure and mixed isomers), cyclohexane, cycloheptane, toluene, single and mixed isomers of xylene, methylene chloride, DCE, chloroform, carbon tetrachloride, methanol, ethanol, isopropanol, n-butanol, t-butanol and iso-butanol, ethyl acetate, isopropyl acetate, isobutyl acetate, n-butyl acetate, THF, diethyl ether, di-n-butyl ether, MTBE, DME, acetonitrile, and propionitrile. [0081] An embodiment of the present invention is the process comprising Steps X, Y and Z, wherein the amine protecting agent in Step X is P a* -Q or (P b* ) 2 O as originally defined above or as defined in a class or sub-class thereof; the amine protecting agent is employed in an amount in a range of from about 0.9 to about 10 equivalents per equivalent of benzoate compound compound IV; the solvent X is selected from the group consisting of aromatic hydrocarbons, halogenated aliphatic hydrocarbons, alcohols, ethers, and acetates; and the treatment in Step X is conducted at a temperature in a range of from about −20 to about 60° C. In an aspect of this embodiment, the amine protecting agent is BOC-Q or (BOC) 2 O. [0082] The Step X treatment can be conducted by charging the solvent X, the amine protecting agent, and Compound IV to a suitable reaction vessel, bringing the resulting mixture to reaction temperature, and maintaining the mixture at reaction temperature (optionally with agitation such as stirring) until the reaction is complete or the desired degree of conversion of the reactants is achieved. Compound IV can be charged to the vessel in the form of an acid salt or free base. When charged as an acid salt, sufficient base is typically included in the reaction mixture to neutralize the salt. Suitable bases include tertiary alkyl amines (e.g., NMM and TEA), alkali metal carbonates (e.g., sodium carbonate and potassium carbonate), and alkali metal bicarbonates (e.g., sodium bicarbonate and potassium bicarbonate). The order of addition of the reactants and reagents to the reaction vessel is typically not critical; i.e., they can be charged concurrently or sequentially in any order. For example, Compound IV can first be dissolved in solvent X, and the solution charged to the reaction vessel, followed by addition of the amine protecting agent and, when Compound IV is employed as an acid salt, the base. The reaction time can vary widely depending upon, inter alia, the reaction temperature and the choice and relative amounts of reactants and reagents, but the reaction time is typically in a range of from about 1 to about 48 hours. Compound V can subsequently be recovered from the reaction mixture by conventional means. Alternatively, the reaction mixture of Compound V in solvent X, after suitable washing and other treatment to remove impurities and unreacted reagent, can be employed directly in Step Y. [0083] The present invention includes a process for preparing a benzamide compound of Formula (VII) which comprises Steps X, Y and Z as described above and which further comprises: [0084] (W) hydrogenating a benzonitrile of Formula (III): [0085] in a solvent W and in the presence of a transition metal catalyst to obtain the benzoate compound of Formula (IV). [0086] Solvent W can suitably be selected from the group consisting of alcohols, ethers, and esters. Further description of these solvent classes is set forth above in the discussion of other process steps, is applicable here, and is incorporated herein by reference. In one embodiment, solvent W is an alcohol. In an aspect of this embodiment, solvent W is a C 1 -C 6 alkyl alcohol. In another aspect of this embodiment, solvent W is a C 1 -C 4 alkyl alcohol (e.g., methanol, ethanol, n-propanol, isopropanol, or isobutanol). [0087] The hydrogenation of the benzonitrile III can be conducted over a wide range of temperatures, although the temperature is typically in the range of from about 0 to about 100° C. (e.g., from about 10 to about 100° C.). In one embodiment, the temperature is in the range of from about 15 to about 60° C. In another embodiment, the temperature is from about 25 to about 45° C. [0088] The pressure is not a critical aspect in Step W, although atmospheric and superatmospheric pressures tend to be expedient. In one embodiment, the pressure is at least about 2 psig (115 kPa). In another embodiment, the pressure is in the range of from about 10 psig (170 kPa) to about 1,000 psig (6996 kPa). [0089] The hydrogenation catalyst employed in Step W comprises a transition metal or a compound thereof, and is suitably a transition metal of Group VIII of the periodic table of the elements or a compound thereof. A class of suitable hydrogenation catalysts consists of catalysts selected from Pd, Ni, Pt, Rh, Ru and compounds thereof. A sub-class of suitable hydrogenation catalysts consists of catalysts selected from Pd, Pt, and compounds thereof. Exemplary of the catalysts in this sub-class are Pd, Pt, Pt halides (e.g., PtCl 2 ), Pd acetate, PdO, and PtO. The catalysts can be supported or unsupported. Another sub-class of suitable catalysts consists of supported and unsupported palladium catalysts. Suitable catalyst supports include carbon, silica, alumina, silicon carbide, aluminum fluoride, and calcium fluoride. Exemplary palladium catalysts include Pd black (i.e., fine metallic palladium particles) and Pd/C (i.e., palladium on a carbon support). Pd/C is a preferred catalyst. [0090] Another sub-class of suitable hydrogenation catalysts consists of nickel catalysts. Exemplary of the catalysts in this sub-class are Raney nickel and nickel boride. Raney nickel is a preferred catalyst. [0091] The hydrogen source is typically hydrogen gas, optionally in admixture with a carrier gas that is inert under the conditions employed in Step W (e.g., nitrogen or a noble gas such as helium or argon). [0092] The hydrogenation in Step W is typically conducted under acidic conditions in the presence of a protonic acid W, except when the catalyst is Raney nickel. Higher yields of Compound IV have been achieved in Step W when the hydrogenation is conducted (e.g., with a Pd catalyst) in the presence of a protonic acid relative to yields under neutral or basic conditions. While not wishing to be bound by any particular chemical theory or mechanism, it is believed that the presence of a protonic acid results in the protonation of the product amine IV, which prevents it from condensing with partially reduced imine to form a secondary amine side product. In addition, rapid cyclization of the unprotonated amine product IV is avoided by the use of protonic acid during Step W. Protonic acids suitable for use in Step W include mineral acids and organic acids, such as those described earlier in the discussion of amine deprotecting agents employed in Step Z. Particularly suitable protonic acids are the hydrogen halides, especially HCl. [0093] When the catalyst is Raney nickel, the hydrogenation is typically conducted under neutral or basic conditions. [0094] The hydrogenation can be carried out in a pressurized reactor (e.g., an autoclave equipped with a stirrer or rocker to agitate the mixture) in which the mixture of gas (i.e., hydrogen optionally mixed with an inert gas), solvent W, benzonitrile III, catalyst, and (optionally) protonic acid W is continuously agitated. The order of addition of benzonitrile III, solvent, acid, and hydrogenation catalyst to the reaction vessel is not critical. The reactants and reagents can, for example, be added concurrently, either together or separately, or they can be added sequentially in any order. In one embodiment, benzonitrile III pre-mixed with the solvent is charged to the reaction vessel followed by addition of acid and then the catalyst. The hydrogenation can then be conducted by charging hydrogen gas, optionally in admixture with one or more inert gases, to the vessel, and then agitating the mixture under reaction conditions. The reaction time can vary widely depending upon, inter alia, the reaction temperature and pressure, the choice and relative amounts of catalyst and benzonitrile reactant, but the reaction time is typically in a range of from about 1 to about 72 hours. [0095] Any amount of catalyst, hydrogen and protonic acid W can be employed that results in the formation of at least some of benzoate compound IV. Of course, the maximum conversion of Compound III and maximum yield of Compound IV is normally desired, and relative proportions of reactants and reagents suitable for this purpose are typically employed. [0096] The catalyst is suitably employed in Step W in an amount in a range of from about 0.001 to about 1 equivalent per equivalent of benzonitrile III, and is typically employed in an amount in a range of from about 0.01 to about 0.8 equivalent per equivalent of benzonitrile III. In one embodiment, the catalyst (e.g., Pd- or Pt-containing catalyst) is employed in an amount in a range of from about 0.02 to about 0.5 (e.g., from about 0.02 to about 0.2) equivalents per equivalent of benzonitrile III. In another embodiment, the catalyst is employed in an amount in a range of from about 0.02 to about 0.1 (e.g., from about 0.02 to about 0.08) equivalents per equivalent of benzonitrile III. [0097] The uptake of hydrogen is not a critical process parameter, although at least a stoichiometric amount of hydrogen gas is typically employed. [0098] When used in Step W, the protonic acid is suitably employed in an amount of at least about 1 equivalent per equivalent of benzonitrile III, and is typically employed in an amount in a range of from about 1.1 to about 5 (e.g., from about 1.1 to about 3) equivalents per equivalent of benzonitrile III. In one embodiment, the protonic acid is employed in an amount in a range of from about 1.5 to about 3 (e.g., from about 1.5 to about 2.5) equivalents per equivalent of benzonitrile III. [0099] The present invention includes a process for preparing a benzamide compound of Formula (VII) which comprises Steps W, X, Y and Z as described above and which further comprises: [0100] (V) reacting a halobenzoate compound of Formula (II): [0101] in an aprotic solvent V with a cyanide compound selected from the group consisting of CuCN and Zn(CN) 2 to obtain the benzonitrile of Formula (III); with the proviso that when the cyanide compound is Zn(CN) 2 , the reaction is conducted in the presence of a Pd compound and an activating ligand; wherein X is chloro, bromo, or iodo. In one embodiment of Step V, X is Br or Cl. In an aspect of this embodiment, X is Br. [0102] CuCN can be employed per se in the reaction, but Zn(CN) 2 is employed in the presence of a Pd compound such as with Pd 2 (dba) 3 or Pd(PPh 3 ) 4 , and an activating ligand such as dppf, PPh 3 , dppe, dppp, dppb, and BINAP. Although not required, the reaction with CuCN can also be conducted in the presence of a Pd compound and an activating ligand. [0103] Any amount of cyanide compound can be employed that results in the formation of at least some of benzonitrile compound III, but of course a high conversion of Compound II and a maximum yield of Compound III is normally desired, and a relative proportion of the cyanide compound to halobenzoate II suitable for this purpose is typically employed. The cyanide compound is suitably employed in an amount in a range of from about 0.5 to about 30 equivalents per equivalent of halobenzoate II, and is typically employed in an amount in a range of from about 0.5 to about 10 (e.g., from about 0.5 to about 5) equivalents per equivalent of halobenzoate II. In one embodiment, the cyanide compound is employed in an amount in a range of from about 0.9 to about 2 (e.g., from about 0.9 to about 1.5) equivalents per equivalent of halobenzoate II. [0104] When used, the Pd compound is suitably employed in an amount in a range of from about 0.00001 to about 0.2 equivalents per equivalent of halobenzoate II, and is typically employed in an amount in a range of from about 0.0005 to about 0.05 equivalents per equivalent of the cyanide compound. When used, a ligand is suitably employed in an amount in a range of from about 0.001 to about 0.2 equivalents per equivalent of halobenzoate II, and is typically employed in an amount in a range of from about 0.01 to about 0.1 equivalents per equivalent of halobenzoate II. [0105] The solvent employed in Step V is aprotic solvent V. Suitable aprotic solvents include nitriles, ethers, tertiary amides, tertiary amines, aliphatic hydrocarbons, aromatic hydrocarbons, and dialkylsulfoxides. Nitrile, ether, aliphatic hydrocarbon, and aromatic hydrocarbon solvents have been described in the discussion of previous process steps. This earlier discussion is applicable here and accordingly is incorporated herein by reference. Tertiary amide, tertiary amine and dialkylsulfoxide solvents have not been previously described. Suitable tertiary amide solvents include N,N-di-C 1 -C 6 alkyl tertiary amides of C 1 -C 6 alkylcarboxylic acids. Exemplary tertiary amide solvents include DMF and DMAC. Suitable tertiary amines include tri-(C 1 -C 6 alkyl)amines and N—C 1 -C 6 alkyl-cyclic amines. Exemplary tertiary amine solvents include TEA, DIPEA, N-methylpiperidine, and N-methylpyrrolidine. Other tertiary amine solvents suitable for use in Step V are NMM and NMP. A suitable dialkylsulfoxide solvent is DMSO. [0106] Step V can be conducted at any temperature at which the reaction (cyanation) to form benzonitrile III can be detected. The temperature is suitably in a range of from about 60 to about 200° C., and the reaction is typically conducted at a temperature in a range of from about 80 to about 150° C. (e.g., from about 90 to about 150° C.). [0107] The reaction (cyanation) of Step V can be conducted by charging the aprotic solvent V, the cyanide compound (plus the Pd compound and the activating ligand, as appropriate), and halobenzoate II to a suitable reaction vessel, bringing the resulting mixture to reaction temperature, and maintaining the mixture at reaction temperature (optionally with agitation such as stirring) until the reaction is complete or the desired degree of conversion of the reactants is achieved. The order of addition of the reactants and reagents to the reaction vessel is typically not critical; i.e., they can be charged concurrently or sequentially in any order. In one embodiment, halobenzoate II is first dissolved in aprotic solvent V, and the resulting solution charged to the reaction vessel, followed by addition of the cyanide compound slurried in another portion of solvent V. The reaction time can vary widely depending upon, inter alia, the reaction temperature and the choice and relative amounts of reactants, but the reaction time is typically in a range of from about 1 to about 24 hours. The benzonitrile III product can subsequently be isolated from the reaction mixture using conventional recovery procedures. In some cases the reaction mixture, after washing, filtration, and/or other treatment(s) to remove byproducts and/or unreacted substances, can be used directly in Step W. In other instances, the reaction mixture can be solvent switched (e.g., from a tertiary amide to an alcohol) for use in Step W. [0108] The present invention includes a process for preparing a benzamide compound of Formula (VII) which comprises Steps V, W, X, Y and Z as described above and which further comprises: [0109] (U) esterifying a benzoic acid of Formula (I): [0110] with an alcohol of formula R 3 —OH optionally in the presence of an acid U to obtain the halobenzoate compound of Formula (II). R 3 is as defined above. Any and all embodiments and aspects of the definition of R 3 set forth above in the discussion of Steps Y and Z apply here as well, and thereby provide embodiments and aspects of the definition of R 3 —OH and thusly embodiments and aspects of Step U and succeeding steps of the process of the invention. The alcohol R 3 —OH can be employed as the solvent as well as the reactant in Step U. When a separate solvent U is employed, the solvent can suitably be selected from the group consisting of aromatic hydrocarbons, halogenated aliphatic hydrocarbons, ethers and nitriles. These solvents have been described in the discussion of at least one previous process step, and the earlier discussion is applicable here and is accordingly incorporated herein by reference. [0111] The R 3 —OH alcohol is typically employed in an amount that will provide for an optimum conversion and yield of benzoic acid I and halobenzoate II respectively, and is suitably employed in an amount of at least about one equivalent (e.g., from about 1 to about 20 equivalents or from about 1.5 to about 10 equivalents) of alcohol per equivalent of benzoic acid I. When the alcohol performs the dual role of reactant and solvent, the alcohol is in essence automatically employed in an amount substantially in excess of that required to react with all of the benzoic acid. [0112] The acid U acts as a catalyst for the esterification reaction and is suitably employed in an amount in a range of from about 0.05 to about 50 equivalents per equivalent of benzoic acid I. The acid U is typically employed in an amount in a range of from about 0.05 to about 20 (e.g., from about 0.1 to about 5 or from about 0.1 to about 2) equivalents per equivalent of benzoic acid I. Acids suitable for use as acid U include the protonic acids described earlier in the discussion of Steps W and Z, including sulfuric acid, HCl, HBr, alkylsulfonic acids, arylsulfonic acids, nitric acid, and triflic acid. [0113] Step U can be conducted at any temperature at which the reaction (esterification) to form halobenzoate II can be detected. The temperature is suitably in a range of from about 20 to about 100° C. (e.g., from about 25 to about 90° C.), and the reaction is typically conducted at a temperature in a range of from about 30 to about 80° C. (e.g., from about 40 to about 80° C.). In one embodiment, the reaction is conducted at the reflux temperature of the reaction mixture. [0114] The esterification of Step U can be conducted by charging the alcohol reactant, optional solvent U, and benzoic acid I to a suitable reaction vessel, bringing the resulting mixture to reaction temperature, and maintaining the mixture at reaction temperature (optionally with agitation such as stirring) until the reaction is complete or the desired degree of conversion of the reactants is achieved. By-product water is typically removed (e.g., via molecular sieves) to favor formation of the desired ester product. Alternatively the reaction can be conducted at reflux temperature in the presence of the trialkyl orthoformate of formula (R 3 —O) 3 CH corresponding to the R 3 —OH alcohol reactant with concurrent removal (e.g., by distillation) of alkyl formate by-product to favor formation of the desired ester. The order of addition of the reactants and reagents to the reaction vessel is typically not critical; i.e., they can be charged concurrently or sequentially in any order. In one embodiment, the alcohol reactant (also serving as the solvent) is charged to the reaction vessel first, followed by addition of benzoic acid I and the orthoformate, and then by addition of the acid U. The reaction time can vary widely depending upon, inter alia, the reaction temperature and the choice and relative amounts of reactants, but the reaction time is typically in a range of from about 1 to about 24 hours. The halobenzoate II product can subsequently be isolated from the reaction mixture using conventional recovery procedures, such as by adjusting the reaction mixture to neutral pH by addition of an aqueous solution of base, and then separating, washing, and concentrating the organic layer. [0115] The present invention also includes a process for preparing a benzamide compound of Formula (VII) which comprises Steps Y and Z as described above wherein P* is BOC, ALLOC, or CBZ; and wherein the process further comprises: [0116] (XA) hydrogenating a benzonitrile of Formula (III): [0117] in a solvent XA, in the presence of (i) (BOC) 2 O, (ALLOC) 2 O, or (CBZ) 2 O and (ii) Raney nickel, and optionally in the presence of a base to obtain a benzoate compound of Formula (V): [0118] Solvent XA can suitably be selected from the group consisting of alcohols, ethers, and esters. Further description of these solvent classes is set forth above in the discussion of other process steps, is applicable here, and is incorporated herein by reference. In one embodiment, solvent XA is an ether. In an aspect of this embodiment, solvent W is a dialkyl ether wherein each alkyl is independently a C 1 -C 6 alkyl, a C 1 -C 6 linear or branched alkane substituted with two —O—C 1 -C 6 alkyl groups (which are the same or different), or a C 4 -C 8 cyclic ether or diether. In another aspect of this embodiment, solvent W is THF, dioxane, DME, MTBE, diethyl ether, or di-n-butyl ether. [0119] The hydrogenation of the benzonitrile III can be conducted over a wide range of temperatures, although the temperature is typically in the range of from about 0 to about 100° C. (e.g., from about 10 to about 100° C.). In one embodiment, the temperature is in the range of from about 20 to about 80° C. In another embodiment, the temperature is from about 25 to about 60° C. [0120] The pressure is not a critical aspect in Step XA, although atmospheric and superatmospheric pressures tend to be expedient. In one embodiment, the pressure is at least about 2 psig (115 kPa). In another embodiment, the pressure is in the range of from about 10 psig (170 kPa) to about 1,000 psig (6996 kPa). [0121] The hydrogen source is typically hydrogen gas, optionally in admixture with a carrier gas that is inert under the conditions employed in Step XA (e.g., nitrogen or a noble gas such as helium or argon). [0122] The hydrogenation in Step XA is typically conducted in the presence of a base (i.e., under basic conditions), because it has been observed that conducting the hydrogenation under basic conditions (versus acidic conditions) can result in a reduction of the amount of dimer byproduct. Suitable bases include alkali metal carbonates (Na 2 CO 3 or K 2 CO 3 ), bicarbonates (NaHCO 3 or KHCO 3 ), tertiary alkyl amines (TEA), tertiary cyclic amines (NMM or NMP), and pyridines. The base is suitably employed in an amount in a range of from about 0 to about 50 (e.g., from about 0.1 to about 50) equivalents per equivalent of benzonitrile III, and is typically employed in an amount in a range of from about 0.1 to about 20 (e.g., from about 0.25 to about 2 or from about 0.5 to about 1.5) equivalents per equivalent of benzonitrile III. [0123] The amine protecting agent (i.e., (BOC) 2 O, (ALLOC) 2 O, or (CBZ) 2 O) is typically employed in an amount sufficient to provide for the complete conversion of benzonitrile III. The amine protecting agent is suitably employed in an amount in a range of from about 1 to about 30 equivalents per equivalent of benzonitrile, and is typically employed in an amount in a range of from about 1 to 10 (e.g., from about 1 to about 5 or from about 1 to about 2) equivalents per equivalent of benzonitrile III. [0124] The Raney Ni catalyst is suitably employed in Step XA in an amount in a range of from about 0.001 to about 1 equivalent per equivalent of benzonitrile III, and is typically employed in an amount in a range of from about 0.01 to about 0.8 equivalent per equivalent of benzonitrile III. [0125] The uptake of hydrogen is not a critical process parameter, although at least a stoichiometric amount of hydrogen gas is typically employed. [0126] The hydrogenation can be carried out in a pressurized reactor (e.g., an autoclave equipped with a stirrer or rocker to agitate the mixture) in which the mixture of gas (i.e., hydrogen optionally mixed with an inert gas), solvent XA, benzonitrile III, Raney nickel catalyst, amine protecting agent, and (optionally) base is continuously agitated. The order of addition of benzonitrile III, solvent, catalyst, protecting agent and base to the reaction vessel is not critical. The reactants and reagents can, for example, be added concurrently, either together or separately, or they can be added sequentially in any order. In one embodiment, benzonitrile III pre-mixed with the solvent is charged to the reaction vessel followed by addition of the protecting agent (e.g., (BOC) 2 O), Raney Ni, and base. The hydrogenation can then be conducted by charging hydrogen gas, optionally in admixture with one or more inert gases, to the vessel, and then agitating the mixture under reaction conditions. The reaction time can vary widely depending upon, inter alia, the reaction temperature and pressure, the choice and relative amounts of catalyst, amine protecting agent and benzonitrile reactant, but the reaction time is typically in a range of from about 1 to about 48 hours. [0127] The present invention also includes a process for preparing a benzamide compound of Formula (VII) which comprises Steps XA, Y and Z as described above wherein P* is BOC, ALLOC, or CBZ; and wherein the process further comprises Step V for preparing a benzonitrile of Formula (III) from a halobenzoate of Formula (II); and optionally further comprises Step U for preparing halobenzoate II from a benzoic acid of Formula (I). [0128] The present invention also includes a process for preparing Compound 7: [0129] which comprises: [0130] (yy) reacting a benzoate compound of Formula (Va): [0131] with methylamine in a solvent yy to obtain Compound 6: [0132] and [0133]  (zz) treating the Compound 6 with an acid zz to obtain the Compound 7; wherein R 3a is —C 1-6 alkyl. [0134] An embodiment of this process is the process as just described, wherein the benzoate compound of Formula (Va) is Compound 5: [0135] Additional embodiments of the process comprising Steps yy and zz include the process as originally set forth or as set forth in the preceding embodiment incorporating any one or more of the following aspects: [0136] (yy-i) the reaction in Step yy is conducted at a temperature in the range of from about 50 to about 200° C. (e.g., from about 75 to about 150° C., or from about 75 to about 150° C.); [0137] (yy-ii) methylamine is employed in Step yy in an amount in a range of from about 1 to about 200 (e.g., from about 1 to about 50, from about 1 to about 10, from about 1 to about 5, from about 1.5 to about 5, or from about 2 to about 5) equivalents per equivalent of Compound Va; [0138] (yy-iii) the solvent yy is selected from the group consisting of alcohols, ethers, and aromatic hydrocarbons (e.g., solvent yy is selected from methanol, ethanol, n-propanol, isopropanol, n-butanol, xylene (single or mixed isomers), toluene, diethyl ether, TBF, DME and dioxane); [0139] (zz-i) the acid zz is a mineral acid, a Lewis acid, a carboxylic acid, an alkylsulfonic acid, or an arylsulfonic acid (e.g., the acid is HCl); [0140] (zz-ii) the acid zz is employed in Step zz in an amount in a range of from about 0.1 to about 100 (from about 0.5 to about 50, from about 1 to about 50, from about 1 to about 15, from about 1 to about 10, or from about 3 to about 15) equivalents per equivalent of Compound 6; or [0141] (zz-iii) the treatment in Step zz is conducted in a solvent zz which is a C 1-6 alkyl ester of a C 1-6 alkylcarboxylic acid (e.g., solvent zz is C 1-4 alkyl ester of a C 1-4 alkylcarboxylic acid, and is especially a C 1-4 alkyl acetate such as methyl, ethyl, n-propyl, or isopropyl acetate). [0142] The present invention includes a process for preparing Compound 7 which comprises Steps yy and zz as described above and which further comprises: [0143] (xx) treating a benzoate compound of Formula (IVa): [0144] with an amine protecting agent containing the BOC group in a solvent xx to obtain the benzoate compound of Formula (Va). [0145] In an embodiment of this process, the benzoate compound of Formula (IVa) is Compound 4: [0146] and the benzoate compound of Formula (Va) is Compound 5. [0147] Additional embodiments include processes comprising Steps xx, yy and zz, wherein Step xx is as originally set forth or as set forth in the preceding embodiment, and wherein either Step yy incorporates one or more of aspects (yy-i) to (yy-iii) or Step zz incorporates one or more of aspects (zz-i) to (zz-iii), or both Steps yy and zz incorporate one or more of aspects thereof. [0148] Additional embodiments of the process include processes comprising Step yy optionally incorporating any one or more of aspects (yy-i) to (yy-iii), Step zz optionally incorporating any one or more of aspects (zz-i) to (zz-iii), and Step xx as originally set forth or as set forth in the next to preceding paragraph incorporating any one or more of the following aspects: [0149] (xx-i) the amine protecting agent in Step xx is selected from the group consisting of BOC halides and (BOC) 2 O; [0150] (xx-ii) the solvent xx is selected from the group consisting of aromatic hydrocarbons, esters, and ethers (e.g., the solvent xx is toluene, xylene (single or mixed isomers), EtOAc, IPAc, isobutyl acetate, n-butyl acetate, THF, di-n-butyl ether, dioxane, or MTBE); [0151] (xx-iii) the treatment in Step xx is conducted at a temperature in a range of from about −20 to about 60° C. (e.g., from about −20 to about 50° C., or from about −5 to about 35° C.); or [0152] (xx-iv) the amine protecting agent is employed in an amount in a range of from about 0.9 to about 10 (e.g., from about 0.9 to about 3 or from about 1.1 to about 3) equivalents per equivalent of benzoate compound (IVa). [0153] The present invention includes a process for preparing Compound 7 which comprises Steps xx, yy and zz as described above and which further comprises: [0154] (ww) hydrogenating a benzonitrile of Formula (IIIa): [0155] in a solvent ww and in the presence of a catalyst to obtain the benzoate compound of Formula (IVa). [0156] In an embodiment of this process, the benzonitrile compound of Formula (IIIa) is Compound 3: [0157] and the benzoate compound of Formula (IVa) is Compound 4. [0158] Additional embodiments include processes comprising Steps ww, xx, yy and zz, wherein Step ww is as originally set forth or as set forth in the preceding embodiment, and wherein at least one of Steps xx, yy and zz incorporates one or more of aspects (xx-i) to (xx-iv), (yy-i) to (yy-iii), or (zz-i) to (zz-iii) respectively. [0159] Additional embodiments of the process include processes comprising Step xx optionally incorporating any one or more of aspects (xx-i) to (xx-iv), Step yy optionally incorporating any one or more of aspects (yy-i) to (yy-iii), Step zz optionally incorporating any one or more of aspects (zz-i) to (zz-iii), and Step ww as originally set forth or as set forth in the next to preceding paragraph incorporating any one or more of the following aspects: [0160] (ww-i) the catalyst employed in the hydrogenation in Step ww is supported or unsupported and is selected from the group consisting of Pd, Pt, and compounds thereof; [0161] (ww-ii) the hydrogenation in Step ww is conducted under acidic conditions in the presence of a protonic acid ww (e.g., the protonic acid ww is HCl); [0162] (ww-iii) the hydrogenation in Step ww is conducted at a temperature in a range of from about 0 to about 100° C. (e.g., from about 10 to 100° C., from about 15 to about 60° C., or from about 25 to about 45° C.); [0163] (ww-iv) the catalyst is employed in an amount in a range of from about 0.001 to 1 equivalent (e.g., from about 0.01 to about 0.8, from about 0.02 to about 0.5, from about 0.02 to about 0.10, or from about 0.02 to about 0.8) equivalents per equivalent of the benzonitrile of Formula (IIIa); or [0164] (ww-v) the solvent ww is an alcohol (e.g., solvent ww is a C 1 -C 4 alkyl alcohol, such as methanol, ethanol, n-propanol, isopropanol, or isobutanol). [0165] The present invention includes a process for preparing Compound 7 which comprises Steps ww, xx, yy and zz as described above and which further comprises: [0166] (vv) reacting a halobenzoate compound of Formula (IIa): [0167] in an aprotic solvent vv with a cyanide compound selected from the group consisting of CuCN and Zn(CN) 2 to obtain the benzonitrile of Formula (IIIa); with the proviso that when the cyanide compound is Zn(CN) 2 , the reaction is conducted in the presence of a Pd compound and an activating ligand; wherein X is chloro, bromo, or iodo. [0168] In an embodiment of this process, the halobenzoate compound of Formula (IIa) is Compound 2: [0169] and the benzonitrile compound of Formula (IIIa) is Compound 3. [0170] Additional embodiments include processes comprising Steps vv, ww, xx, yy and zz, wherein Step vv is as originally set forth or as set forth in the preceding embodiment, and wherein at least one of Steps ww, xx, yy and zz incorporates one or more of aspects (ww-i) to (ww-v), (xx-i) to (xx-iv), (yy-i) to (yy-iii), or (zz-i) to (zz-iii) respectively. [0171] Additional embodiments of the process include processes comprising Step ww optionally incorporating any one or more of aspects (ww-i) to (ww-v), Step xx optionally incorporating any one or more of aspects (xx-i) to (xx-iv), Step yy optionally incorporating any one or more of aspects (yy-i) to (yy-iii), Step zz optionally incorporating any one or more of aspects (zz-i) to (zz-iii), and Step vv as originally set forth or as set forth in the next to preceding paragraph incorporating any one or more of the following aspects: [0172] (vv-i) the aprotic solvent vv is a tertiary amide (e.g., the solvent is DMF or DMAC); [0173] (vv-ii) the reaction in Step vv is conducted at a temperature in a range of from about 60 to about 200° C. (e.g., from about 80 to about 150° C. or from about 90 to about 150° C.); [0174] (vv-iii) the cyanide compound is CuCN; or [0175] (vv-iv) the cyanide compound (e.g., CuCN) is employed in Step vv in an amount in a range of from about 0.5 to about 30 (e.g., from about 0.5 to about 10, from about 0.5 to about 5, from about 0.9 to about 2, or from about 0.9 to about 1.5) equivalents per equivalent of the halobenzoate compound of Formula (IIa). [0176] The present invention includes a process for preparing Compound 7 which comprises Steps vv, ww, xx, yy and zz as described above and which further comprises: [0177] (uu) esterifying a benzoic acid of Formula (I): [0178] with an alcohol of formula R 3a —OH optionally in the presence of an acid uu to obtain the halobenzoate compound of Formula (IIa). [0179] In an embodiment of this process, the benzoic acid of Formula (I) is Compound 1: [0180] and the halobenzoate compound of Formula (IIa) is Compound 2. [0181] Additional embodiments include processes comprising Steps uu, vv, ww, xx, yy and zz, wherein Step vv is as originally set forth or as set forth in the preceding embodiment, and wherein at least one of Steps vv, ww, xx, yy and zz incorporates one or more of aspects (vv-i) to (vv-iv), (ww-i) to (ww-v), (xx-i) to (xx-iv), (yy-i) to (yy-iii), or (zz-i) to (zz-iii) respectively. [0182] Additional embodiments of the process include processes comprising Step vv optionally incorporating any one or more of aspects (vv-i) to (vv-iv), Step ww optionally incorporating any one or more of aspects (ww-i) to (ww-v), Step xx optionally incorporating any one or more of aspects (xx-i) to (xx-iv), Step yy optionally incorporating any one or more of aspects (yy-i) to (yy-iii), Step zz optionally incorporating any one or more of aspects (zz-i) to (zz-iii), and Step uu as originally set forth or as set forth in the next to preceding paragraph incorporating any one or more of the following aspects: [0183] (uu-i) the alcohol of formula R 3a —OH acts as the solvent for Step uu (and thus is present in an amount substantially in excess of that which is required to react with benzoic acid I); [0184] (uu-ii) the acid uu is employed in an amount in a range of from about 0.05 to about 50 (e.g., from about 0.05 to about 20, from about 0.1 to about 5, or from about 0.1 to about 2) equivalents per equivalent of benzoic acid I; [0185] (uu-iii) the acid uu is a mineral acid (e.g., sulfuric acid); or [0186] (uu-iv) the esterification in Step uu is conducted at a temperature in a range of from about 20 to about 100° C. (e.g., from about 25 to about 90° C., from about 30 to about 80° C., or from about 40 to about 80° C.). [0187] The present invention includes a process for preparing Compound 7 which comprises Steps yy and zz as described above and which further comprises: [0188] (xxa) hydrogenating a benzonitrile of Formula (IIIa): [0189] in a solvent xxa, in the presence of (BOC) 2 O and Raney nickel, and optionally in the presence of a base to obtain a benzoate compound of Formula (Va): [0190] In an embodiment of this process, the benzonitrile of Formula (IIIa) is Compound 3; and the benzoate compound of Formula (Va) is Compound 5. [0191] Additional embodiments include processes comprising Steps xxa, yy and zz, wherein Step xxa is as originally set forth or as set forth in the preceding embodiment, and wherein at least one of Steps yy and zz incorporates one or more of aspects (yy-i) to (yy-iii) or (zz-i) to (zz-iii) respectively. [0192] Additional embodiments of the process include processes comprising Step yy optionally incorporating any one or more of aspects (yy-i) to (yy-iii), Step zz optionally incorporating any one or more of aspects (zz-i) to (zz-iii), and Step xxa as originally set forth or as set forth in the preceding paragraph incorporating any one or more of the following aspects: [0193] (xxa-i) the hydrogenation in Step xxa is conducted at a temperature in a range of from about 0 to about 100° C. (e.g., from about 10 to about 100° C., from about 20 to about 80° C., or from about 25 to about 60° C.); [0194] (xxa-ii) (BOC) 2 O is employed in Step xxa in an amount in a range of from about 1 to about 30 (e.g., from about 1 to about 10, from about 1 to about 5, or from about 1 to about 2) equivalents per equivalent of the benzonitrile IIIa; [0195] (xxa-iii) solvent xxa is selected from the group consisting of ethers and esters (e.g., solvent xxa is an ether, such as THF, dioxane, DME, MTBE, or di-n-butyl ether); [0196] (xxa-iv) the optional base in Step xxa is an alkali metal bicarbonate (e.g., NaHCO 3 or KHCO 3 ); [0197] (xxa-v) the amount of base employed in Step xxa is in a range of from about 0.1 to about 20 (from about 0.25 to about 2, from about 0.5 to about 1.5, or from about 1 to about 2) equivalents per equivalent of the benzonitrile IIIa; or [0198] (xxa-vi) Raney nickel is employed in an amount in a range of from about 0.001 to about 1 (e.g., from about 0.01 to about 0.8) equivalent per equivalent of benzonitrile IIIa. [0199] The present invention also includes a process for preparing Compound 7 which comprises Steps xxa, yy, and zz as described above wherein the process further comprises Step vv for preparing a benzonitrile of Formula (IIIa) from a halobenzoate of Formula (IIa); and optionally further comprises Step uu for preparing halobenzoate IIa from a benzoic acid of Formula I. [0200] The processes for preparing Compound 7 (i.e., those processes involving Steps xx and yy and optionally one or more other steps as described above) can be conducted using procedures the same or similar to those described earlier for the analogous processes for preparing Compound VII (i.e., those processes involving Steps X and Y and optionally one or more other steps as earlier described). [0201] Still other embodiments of the present invention include any of the processes as originally defined and described above and any embodiments or aspects thereof as heretofore defined, further comprising isolating (which may be alternatively referred to as recovering) the compound of interest (e.g., Compound VII or Compound 7, in the form of an acid salt or as the free base) from the reaction medium. [0202] The progress of any of the above-described reaction steps (i.e., Steps U, V, W, X, XA, Y and Z or Steps uu, vv, ww, xx, xxa, yy and zz) can be followed by monitoring the disappearance of a reactant (e.g., Compound V in Step Y) and/or the appearance of the product (e.g., Compound VII in Step Z) using such analytical techniques as TLC, HPLC, IR, NMR or GC. [0203] The present invention also includes a compound of Formula (IIIa), a compound of Formula (IVa) (or a salt thereof), and a compound of Formula (Va), all as defined and described above. [0204] The present invention also includes Compound 3, Compound 4 (or a salt thereof), and Compound 5, all as set forth above. [0205] As used herein, the term “C 1-6 alkyl” (or “C 1 -C 6 alkyl”) refers to a linear or branched chain alkyl group having from 1 to 6 carbon atoms and includes all of the hexyl alkyl and pentyl alkyl isomers as well as n-, iso-, sec- and t-butyl, n- and isopropyl, ethyl and methyl. “C 1-4 alkyl” refers to n-, iso-, sec- and t-butyl, n- and isopropyl, ethyl and methyl. “C 1-3 alkyl” refers to n- and isopropyl, ethyl and methyl. [0206] The term “C 3-6 cycloalkyl” (or “C 3 -C 6 cycloalkyl”) means a cyclic ring of an alkane having three to six total carbon atoms (i.e., cyclopropyl, cyclobutyl, cyclopentyl, or cyclohexyl). [0207] The term “C 1-6 alkyloxy” refers to a —O—C 1-6 alkyl in which the C 1-6 alkyl group is as defined above. “C 1-4 alkyloxy” has an analogous meaning. [0208] The term “halogen” (or “halo”) refers to fluorine, chlorine, bromine and iodine (alternatively referred to as fluoro, chloro, bromo, and iodo). [0209] The term “aryl” as used herein refers to an aromatic carbocyclic ring or an aromatic carbocyclic fused ring system. The fused ring system contains two or more carbocyclic rings in which each ring shares two adjacent carbon atoms with at least one other ring. The aryl group may be attached to the rest of the molecule at any carbon atom which results in a stable compound. A subset of aryl groups particularly suitable for use in the present invention includes those selected from phenyl, naphthyl, anthryl (also referred to as “anthracenyl”), and phenanthryl (or “phenanthrenyl”). Another particularly suitable subset of aryl groups is phenyl and naphthyl. Still another particularly suitable subset of aryl groups is phenyl per se. [0210] When any variable (e.g., R a , R b , or R c ) occurs more than one time in Formulas V to VII or in any other formula depicting and describing compounds employed in the process of the invention, its definition on each occurrence is independent of its definition at every other occurrence. Also, combinations of substituents and/or variables are permissible only if such combinations result in stable compounds. [0211] The term “substituted” (e.g., as in “aryl, optionally substituted with from 1 to 6 substituents . . . ”) includes mono- and poly-substitution by a named substituent to the extent such single and multiple substitution (including multiple substitution at the same site) is chemically allowed. [0212] The term “solvent” in reference to the solvent employed in a process step (e.g., solvents Y and Z employed in Steps Y and Z respectively) can be any organic compound which under the reaction conditions employed is in the liquid phase, is chemically inert (unless expressly stated to the contrary; e.g., the alcohol in Step U can be both reactant and solvent), and will dissolve, suspend, and/or disperse the reactants so as to bring the reactants into contact and permit the reaction to proceed. [0213] Unless expressly stated to the contrary, any range (e.g., a temperature range) cited herein is inclusive; i.e., the range includes the values for the upper and lower limits of the range as well as all values in between. [0214] Abbreviations used in the instant specification include the following: [0215] Ac=acetyl [0216] ALLOC=allyloxycarbonyl [0217] BINAP=2,2′-bis(diphenylphosphino)-1,1′-binaphthyl [0218] Bn=benzyl [0219] BOC or Boc=t-butyloxycarbonyl [0220] (BOC) 2 O (or BOC 2 O)=di-t-butyl carbonate [0221] CBZ or Cbz=carbobenzoxy (alternatively, benzyloxycarbonyl) [0222] dba=dibenzylideneacetone [0223] DCE=1,2-dichloroethane [0224] DIPEA=diisopropylethylamine (or Hunig&#39;s base) [0225] DMAC=N,N-dimethylacetamide [0226] DME=1,2-dimethoxyethane [0227] DMF=N,N-dimethylformamide [0228] dppb=1,4-bis(diphenylphosphino)butane [0229] dppe=1,2-bis(diphenylphosphino)ethane [0230] dppp=1,3-bis(diphenylphosphino)propane [0231] dppf=diphenylphosphinoferrocene [0232] EDC=1-ethyl-3-(3-dimethylaminopropyl) carbodiimide [0233] EtOAc=ethyl acetate [0234] HPLC=high performance liquid chromatography [0235] IPAc=isopropyl acetate [0236] IR=infrared spectroscopy [0237] KF=Karl Fisher titration for water [0238] Me=methyl [0239] MeOH=methanol [0240] MTBE=methyl tert-butyl ether [0241] NBS=N-bromonsuccinimide [0242] NMM=N-methylmorpholine [0243] NMP=N-methyl pyrrolidinone [0244] NMR=nuclear magnetic resonance [0245] Ph=phenyl [0246] Pr=propyl [0247] i-Pr=isopropyl [0248] TEA=triethylamine [0249] THF=tetrahydrofuran [0250] TLC=thin layer chromatography EXAMPLE 1 Potassium 5-(1,1-dioxido-1,2-thiazinan-2-yl)-7-[({4-fluoro-2-[(methylamino)-carbonyl]benzyl}amino)carbonyl]-1,6-naphthyridin-8-olate [0251] Step 1: Methyl 2-bromo-5-fluorobenzoate Material MW Amount Moles 2-bromo-5-fluorobenzoic acid 219.01 4.00 kg 18.3 methanol  32.04 18 L 296.3 (d = 0.791) trimethylorthoformate 106.12 3.88 kg 36.5 96% sulfuric acid  98.08 0.373 kg 3.65 2 M K 2 HPO 4 174.18 4.82 L 9.68 ethyl acetate 16 L 10% NaHCO 3  84.02  4 L 25% brine  4 L toluene 12 L DMF [0252] To a 72 L round bottom flask, equipped with an overhead stirrer, thermocouple, water-cooled condenser, and nitrogen inlet, was charged methanol (18 L). 2-Bromo-5-fluorobenzoic acid (4.00 kg), trimethyl orthoformate (3.876 kg), were then charged with stirring, followed by the addition 96% sulfuric acid (0.373 kg). The resulting solution was refluxed at 63° C. and aged for 10-16 hr, while the by-product (methyl formate) was removed during the reaction. The reaction mixture was monitored by HPLC (conversion was &gt;99%). The reaction mixture was concentrated, then diluted with ethyl acetate (16 L), and cooled to 20° C. 2 M potassium hydrogen phosphate (4.82 L) was then added to adjust the pH to 6.5-7. The mixture was then transferred to a 100 L nalgene extractor. After phase cut, the organic layer was washed with 10% NaHCO 3 (4 L), 25% brine (4 L), and then concentrated under reduced pressure. The residual oil was dissolved in toluene (6 L), and concentrated. This operation was done one more time. The remaining oil was dissolved in DMF (total vol. 9.2 L). The resulting solution was used for next step. [0253] HPLC conditions: column: Zorbax, Rx C 8 250×4.6 mm; temperature: 30° C.; detection: 210 nm; mobile phase: 0.1% aq H 3 PO 4 (A)/MeCN (B); gradient: 90:10 (A)/(B) to 10:90 over 15 min, 10:90 hold for 5 min, 10:90 to 90:10 (A)/(B) over 10 seconds; flow rate: 1 mL/min; retention time for the desired monoester; 13.6 min. [0254] Evaporation of a sample to dryness gave a colorless oil: 1 H NMR (400 MHz, CDCl 3 ) δ: 7.64 (dd, J=8.8, 5.0 Hz, 1H), 7.53 (dd, J=8.8, 3.1 Hz, 1H), 7.08 (td, J=8.8, 3.1 Hz, 1H), 3.95 (s, 3H); 13 C NMR (100 MHz, CDCl 3 ) δ: 165.4, 161.3 (d, J=240.0 Hz), 135.9, 133.4, 120.0 (d, J=20.0 Hz), 118.5 (d, J=20.0 Hz), 116.1, 52.7. [0255] Step 2: Methyl 2-nitrile-5-fluorobenzoate Material MW Amount Moles methyl 2-bromo-5-fluorobenzoate 233.03 18.3 in DMF copper(I) cyanide 89.56 1.60 kg 17.9 DMF 5 L + 4 L ethyl acetate 35 L + 17 L 10% NH 4 OH-20% NH 4 Cl 37 L 25% brine  8 L MeOH 33 L [0256] To a solution of methyl 2-bromo-5-fluorobenzoate (18.26 moles) in DMF (total vol. 9.2 L) was charged copper(I) cyanide (1.603 kg) in DMF (5 L) slurry and followed with a DMF flush (4 L). After being degassed, the reaction mixture was heated at 100° C. for 10-16 hours. The reaction mixture was monitored by HPLC (conversion was &gt;98%). After being cooled to 50° C.-60° C., ethyl acetate (20 L) was added, and then 10% NH 4 OH-20% NH 4 Cl (22 L). The mixture was then transferred to a 100 L nalgene extractor. The 72 L round bottom flask was washed with 15 L of EtOAc and 15 L of water and transferred to the 100 L extractor. After phase cut, the aqueous layer was back-extracted with EtOAc (17 L) one time. The combined organic layers were washed with 10% NH 4 OH/20% NH 4 Cl:water (1:1, 3×10 L), 16% brine (8 L), concentrated, and solvent switched to MeOH (total vol. 22 L, KF=152.6 μg/mL). The resulting solution was used for next step. [0257] HPLC conditions: column: Zorbax, Rx C 8 250×4.6 mm; temperature: 30° C.; detection at 210 nm; mobile phase: 0.1% aq H 3 PO 4 (A)/MeCN (B); gradient: 90:10 (A)/(B) to 10:90 over 15 min, 10:90 hold for 5 min, 10:90 to 90:10 (A)/(B) over 10 seconds; flow rate: 1 mL/min; retention time for the desired monoester: 11.7 min. [0258] Evaporation of a sample to dryness gave a light yellow solid: 1 H NMR (CDCl 3 ) δ: 7.86-7.80 (m, 2H), 7.37 (td, J=8.5, 2.6 H, 1H), 4.02 (s, 3H); 13 C NMR (100 MHz, CDCl 3 ) δ: 164.3 (d, J=260 Hz), 163.3, 137.1 (d, J=10.0 Hz), 135.2 (d, J=10.0 HZ), 120.2 (d, J=30.0 Hz), 118.8 (d, J=20.0 Hz), 116.6, 109.0, 53.1. [0259] Step 3: Methyl 2-aminomethyl-5-fluorobenzoate, HCl salt Material MW Amount Moles methyl 2-nitrile-5-fluorobenzoate 179.15 10.6 in MeOH 3.0 M HCl in MeOH (anhydrous) 36.46 7.10 L 21.22 10% Pd/C 0.475 kg solka floc 2.6 kg MeOH 3 × 10 L [0260] A degassed mixture of methyl 2-nitrile-5-fluorobenzoate (10.6 moles) in MeOH (total 10.0 L), 3.0 M HCl in MeOH (7.10 L), and 10% Pd/C (0.475 kg) was submitted to hydrogenation at 40° C. and 45 PSI for 48 hours. The reaction mixture was monitored by HPLC (conversion was &gt;97%). After being cooled to ambient temperature, the reaction mixture was then filtered by passing a short Solka Flock (2.6 kg), which was washed with MeOH (3×10 L). The combined filtrates were concentrated and solvent-switched to toluene in total volume (about 18 L, KF=154 μg/mL). The crystalline solid was filtered off and washed with toluene, dried under vacuum with nitrogen sweep to afford 2.02 kg of the title compound (87% isolated yield overall for the three steps, &gt;99A % purity, HPLC). [0261] HPLC conditions: column: Zorbax, Rx C 8 250×4.6 mm; temperature: 30° C.; detection at 210 nm; mobile phase: 0.1% aq H 3 PO 4 (A)/MeCN (B); gradient: 90:10 (A)/(B) to 10:90 over 15 min, 10:90 hold for 5 min, 10:90 to 90:10 (A)/(B) over 10 seconds; flow rate: 1 mL/min; retention time for the desired monoester: 5.78 min. [0262] [0262] 1 H NMR (CDCl 3 ) δ: 8.43 (brs, 3H), 7.74-7.65 (m, 2H), 7.55 (td, J=8.4, 2.8 Hz, 1H), 4.26 (q, J=5.5 Hz), 3.85 (s, 3H); 13 C NMR (100 MHz, CDCl 3 ) δ: 165.8, 162.1 (d, J=250 Hz), 134.8 (d, J=10.0 Hz), 131.9 (d, J=10.0 Hz), 131.7, 120.1 (d, J=20.0 Hz), 117.7 (d, J=30.0 Hz), 53.2, 40.3. [0263] Step 4: Methyl 2-t-butyloxycarbonylaminomethyl-5-fluorobenzoate Material MW Amount Moles ammonium salt 4 219.64 3.42 kg 15.6 (BOC) 2 O 218.25 3.73 kg 17.1 NMM 101.15 (d = 0.920) 1.73 kg 17.1 40 wt. % MeNH 2  31.06 1.21 kg 15.6 toluene 31 L 0.1 M EDTA Na sol&#39;n 6.2 L 25% brine 6.2 L [0264] To the ammonium salt 4 (3.42 kg) in toluene (31 L) was added (BOC) 2 O (3.73 kg), followed by NMM (1.73 kg), at 15° C.-20° C. over 1 hour. The reaction mixture was aged at room temperature for 15-24 hours (conversion as determined by HPLC was &gt;99%), followed by the addition of 40 wt % methylamine aqueous (1.21 kg) at 5° C.-10° C., after which the mixture was aged at the same temperature for 2 hours to quench the excess (BOC) 2 O. The reaction mixture was then worked up by charging water (12 L). After phase cut, the organic layer was washed with 0.1 M EDTA sodium solution (6.2 L), 25% brine (6.2 L), and concentrated to total volume (20 L), which was divided by two equal amount portions for amidation in two batches. [0265] HPLC conditions: column: Zorbax, Rx C 8 250×4.6 mm; temperature: 30° C.; detection at 210 nm; mobile phase: 0.1% aq H 3 PO 4 (A)/MeCN (B); gradient: 90:10 (A)/(B) to 10:90 over 15 min, 10:90 hold for 5 min, 10:90 to 90:10 (A)/(B) over 10 seconds; flow rate: 1 mL/min; retention time for the desired monoester: 14.5 min. [0266] Evaporation of a sample to dryness gave a colorless oil: 1 H NMR (CDCl 3 ) δ: 7.65 (dd, J=9.4, 2.4, 1H), 7.50 (dd, J=8.0, 5.7 Hz, 1H), 7.18 (dd, J=8.0, 2.8 Hz, 1H), 5.31 (brs, 1H), 4.47 (d, J=6.6 Hz, 1H), 3.91 (s, 3H), 1.41 (s, 9H); 13 C NMR (100 MHz, CDCl 3 ) δ: 166.5, 1.61.5 (d, J=250 Hz), 155.8, 137.0, 132.8 (d, J=10.0 Hz), 130.2 (d, J=10.0 Hz), 119.6 (d, J=30.0 Hz), 117.7 (d, J=20.0 Hz), 79.2, 52.4, 42.9, 28.4 (3C). [0267] Step 4a: Alternative to Steps 3-4 for the preparation of methyl 2-t-butyloxycarbonylaminomethyl-5-fluorobenzoate Material MW Amount Moles methyl 2-nitrile-5-fluorobenzoate 179.15 9.13 in THF (BOC) 2 O 218.25 2.191 kg 10.04 NaHCO3 84.01 0.8448 Kg 10.04 Raney Ni 0.409 Kg Solka floc 1 Kg THF 3 × 5 L Toluene 20 L methylamine 31.06 0.284 Kg  9.13 [0268] A degassed mixture of methyl 2-nitrile-5-fluorobenzoate (3, 9.13 moles), (BOC) 2 O (2.191 Kg), sodium bicarbonate (0.844 Kg), and Raney-Ni (0.409 Kg, anhydrous) in THF was hydrogenated at 50° C. for 24 hours. Conversion as determined by HPLC was &gt;99%. After cooling the reaction mixture to ambient temperature, the mixture was filtered through Solka Flock (1 Kg) which was then washed with THF (3×5 L). The combined filtrates were cooled to −20° C. and then methylamine (0.284 Kg) was added by bubbling to remove excess (BOC) 2 O. The reaction mixture was stirred at ambient temperature for 1 hour, after which the mixture was concentrated and solvent switched to toluene (total vol. 25 L). The resulting solution was washed with 0.1 M EDTA disodium salt (2×5 L), 10% NaHCO 3 :16% brine (1:4, 5 L), concentrated to a total volume (11 L). The solution was suitable for use in the next step. [0269] HPLC conditions: column: Zorbax, Rx C 8 250×4.6 mm; temperature: 30° C.; detection at 210 nm; mobile phase: 0.1% aq H 3 PO 4 (A)/MeCN (B); gradient: 90:10 (A)/(B) to 10:90 over 15 min, 10:90 hold for 5 min, 10:90 to 90:10 (A)/(B) over 10 seconds; flow rate: 1 mL/min; retention time for the desired monoester; 14.45 min [0270] Step 5: N-methyl 2-t-butyloxycarbonylaminomethyl-5-fluorobenzenecarboxamide Material MW Amount Moles methyl benzoate 5 283.30 7.77 in toluene methylamine 31.06 0.483 kg 15.6 toluene 5 L heptane 50 L + 25 L [0271] The crude methyl benzoate 5 in toluene (7.77 moles in 10 L) was cooled to −20° C. and methylamine (0.483 kg) gas was added. The mixture was then heated in an autoclave at 80-85° C. for 48 hours. The reaction was monitored by HPLC (conversion was &gt;98%). After cooling to about 50° C., the reaction mixture was transferred to a large round bottom flask for batch concentration. The solution was concentrated, producing a slurry, and solvent-switched to toluene (total vol. 12 L), after which heptane (50 L) was slowly charged to the slurry. The resulting slurry was aged at 0° C. for 1 hour. The white crystalline solid was filtered off, rinsed with heptane (25 L), and dried under vacuum with a nitrogen sweep to give methylamide 6 (1.92 kg, 83% overall yield for the two preceding steps after correcting to pure product). [0272] HPLC conditions: column: Zorbax, Rx C 8 250×4.6 mm; temperature: 30° C.; detection at 210 nm; mobile phase: 0.1% aq H 3 PO 4 (A)/MeCN (B); gradient: 90:10 (A)/(B) to 10:90 over 15 min, 10:90 hold for 5 min, 10:90 to 90:10 (A)/(B) over 10 seconds; flow rate: 1 mL/min; retention time for the desired product: 11.6 min. [0273] [0273] 1 H NMR (CDCl 3 ) δ: 7.43 (dd, J=8.4, 5.5 Hz, 1H), 7.15-7.07 (m, 2H), 6.52 (brs, 1H), 5.66 (brs, 1H), 4.28 (d, J=6.4 Hz, 2H), 3.10 (d, J=4.8 H, 3H), 1.42 (s, 9H); 13 C NMR (100 MHz, CDCl 3 ) δ: 169.0, 161.5 (d, J=250 Hz), 156.1, 137.3, 133.5, 132.0 (d, J=10.0 Hz), 117.2 (, d, J=20.0 Hz), 114.3 (d, J=20.0 Hz), 79.4, 42.2, 26.7. [0274] Step 6: N-methyl 2-aminomethyl-5-fluorobenzenecarboxamide, HCl salt Material MW Amount Moles N-methyl amide 6 282.31 3.14 kg 11.1 HCl (gas) 36.46 3.25 kg 89.0 EtOAc 21.4 L + 42.8 L + 30 L heptane 40 L [0275] HCl gas (3.25 Kg) was bubbled into ethyl acetate (21.4 L) at −20° C. N-Methyl amide 6 (3.14 kg) was charged to the HCl-EtOAc solution, and the reaction mixture was warmed to ambient temperature (17° C.) in about 3 hours and aged for 2-4 hours. The reaction was monitored by HPLC (conversion was &gt;99%). The reaction mixture was diluted with EtOAc (42.8 L), and the resulting slurry was aged at 0-5° C. for 0.5 hour. The crystalline solid was filtered off and washed with EtOAc (30 L), then with heptane (40 L), and then dried under vacuum with a nitrogen sweep to give the salt. The crystalline solid (2.434 kg) was recrystallized by dissolved in methanol (10.5 L) at 30° C. To the resulting solution was added EtOAc (64 L), producing a slurry that was aged at 0-5° C. for 1 hour. The white crystalline solid was filtered off and washed with EtOAc (30 L), dried under vacuum with nitrogen sweep to give the desired product (2.14 kg, 91% isolated yield corrected for starting material purity; &gt;99.5 A % purity). [0276] HPLC conditions: column: Zorbax, Rx C 8 250×4.6 mm; temperature: 30° C.; detection at 210 nm; mobile phase: 0.1% aq H 3 PO 4 (A)/MeCN (B); Gradient: 90:10 (A)/(B) to 10:90 over 15 min, 10:90 hold for 5 min, 10:90 to 90:10 (A)/(B) over 10 seconds; flow rate: 1 mL/min; retention time for the desired product: 3.33 min. [0277] [0277] 1 H NMR (CDCl 3 ) δ: 8.84 (brs, 1H), 8.05 (brs, 3H), 7.55 (dd, J=8.3, 5.8 Hz, 1H), 7.46-7.13 (m, 2H), 4.01 (s, 3H), 2.77 (d, J=4.6 Hz, 3H); 13 C NMR (100 MHz, CDCl 3 ) δ: 167.9, 162.0 (d, J=250 Hz), 157.9, 138.5 (d, J=10.0 Hz), 134.3 (d, J=10.0 Hz), 129.2, 117.6 (d, J=20.0 Hz), 115.5 (d, J=20.0 Hz), 40.7, 26.7. [0278] Step 7: 5-(1,1-Dioxido-1,2-thiazinan-2-yl)-8-hydroxy-1,6-naphthyridine-7-carboxylic acid Material MW Equivalents Amount Moles Tosylate 8 491.5 1.0 3.3 kg 6.7 2-propanol 4 L/kg 8 13.2 L water 4 L/kg 8 13.2 L LiOH · H 2 O 41.96 3.3 0.93 22.2 2 N HCl 2.6 8.7 L 17.5 Water 5 L/kg 8 4 × 4.3 L [0279] A 50-L flask equipped with a mechanical stirrer, temperature probe, addition funnel, and nitrogen inlet was charged with 2-propanol (13.2 L) and tosylate 8 (3.3 kg). The lithium hydroxide monohydrate (0.93 kg) was then charged as a solution in GMP water (13.2 L) at 20-25° C. The resulting suspension was warmed to 60° C. where a homogeneous yellow solution was obtained. The reaction was aged until complete conversion to 9 was reached as determined by HPLC assay (4-16 hours). The resulting yellow suspension was cooled to about 20° C. and diluted with 2 N HCl (8.7 L) over 0.5 hour. The pH was between 1.3-1.6 at 20° C. following HCl addition. The suspension was cooled to about 20° C., filtered, and the cake was washed with water (4×4.3 L) as displacement washes. The cake was dried on the filter pot under nitrogen and house vacuum until the water content was &lt;6 wt % by Karl Fisher titration. The purity of carboxylic acid phenol 9 was &gt;99.4 A % by HPLC assay. [0280] [0280] 1 H NMR (DMSO-d6, 400 MHz) δ 9.21 (1H, dd, J=4.3, 1.6 Hz), 8.62 (1H, dd, J=8.5, 1.6 Hz), 7.92 (1H, dd, J=8.5, 4.3 Hz), 3.91-3.78 (2H, m), 3.55-3.45 (2H, m), 2.28 (3H, m) and 1.64 (1H, m) ppm. [0281] Step 8: 5-(1,1-Dioxido-1,2-thiazinan-2-yl)-N-{4-fluoro-2-[(methylamino)carbonyl]benzyl}-8-hydroxy-1,6-naphthyridine-7-carboxamide Material MW Equivalents Amount Moles carboxylic acid 9 323.33 1.0 1.63 kg 5.04 DMF 10 L/kg 9 16.3 L amine 7 218.66 1.2 1.32 kg 6.05 HOBt 135.13 0.5 341 g 2.52 NMM 101.15 0.9 456 g 4.54 EDC · HCl 191.71 1.5 1.45 kg 7.56 water 10 L/kg 9 16.3 L [0282] A 50-L flask equipped with a mechanical stirrer, temperature probe, and nitrogen inlet was charged with the dry DMF (16.3 L), carboxylic acid 9 (1.73 kg gross, 1.63 assay kg, KF=6.0 wt % water), anhydrous HOBt (341 g), amine 7 (1.32 kg), and NMM (456 g, 500 mL). The suspension was agitated at 20° C. until a homogeneous solution was obtained and then cooled to 0-5° C. The EDC (1.45 kg) was added and the reaction aged until complete conversion of 9 was reached as determined by HPLC (&lt;0.5% 9, about 16 hours). The reaction was diluted with water (1.6 L) at 20° C., seeded (11 g), and aged for 0.5 hour. The batch was diluted with water (14.7 L) to give a 1:1 v/v ratio of water:DMF and then cooled to 0° C. The batch was then filtered and the cake washed with chilled 1:1 water:DMF (4×2.5 L) and chilled water (4×5.5 L) as displacement washes. The cake was then dried at ambient temperature under nitrogen tent/house vacuum to obtain the title product (2.16 kg, 88% isolated yield, purity: &gt;99.0 A % by HPLC assay). [0283] [0283] 1 H NMR (DMSO-d6, 400 MHz) δ 9.53 (1H, s), 9.19 (1H, s), 8.68 (1H, s), 8.58 (1H, d, J=8.0 Hz), 7.89 (1H, d, J=3.8 Hz), 7.53 (1H, m), 7.41-7.34 (2H, m), 4.64 (2H, d, J=5.7 Hz), 3.92-3.47 (4H, m), 2.83 (3H, d, J=3.8 Hz), 2.35 (3H, m), and 1.64 (1H, m) ppm. [0284] While the foregoing specification teaches the principles of the present invention, with examples provided for the purpose of illustration, the practice of the invention encompasses all of the usual variations, adaptations and/or modifications that come within the scope of the following claims.

Benzamide compounds of Formula VII are prepared by reacting a benzoate compound of Formula V with an amine to obtain a benzamide compound of Formula VI, and then treating the benzamide VI with an amine deprotecting agent to obtain the benzamide VII; wherein R 1 and R 2 are each independently H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, aryl, or substituted aryl; R 3 is alkyl, -alkylaryl, or aryl; and P* is an amino protective group. Embodiments of this preparative method include one or more of the following additional steps: obtaining the benzoate V having the N-protected ortho-aminomethyl substituent by treating the corresponding benzoate IV having a free aminomethyl substituent with an amine protecting agent, hydrogenating an ortho-cyanobenzoate III (also referred to as benzonitrile III) to obtain the benzoate IV, cyanating an ortho-halobenzoate II to obtain benzonitrile III, and esterifying an ortho-halobenzoic acid I to obtain ortho-halobenzoate II. The benzamides are Formula VII are useful as intermediates in the preparation of HIV integrase inhibitors.

BACKGROUND OF THE INVENTION The present invention relates to fitness apparatuses. More particularly, it relates to an improved Swiss ball or inflatable ball apparatus which includes a variable stabilizing base as well as variable resistance extension devices for working various muscle groups. STATEMENT OF THE PRIOR ART A Swiss ball or inflatable exercise ball is an inflatable exercise apparatus which is used primarily to promote core fitness as a way of, inter alia, increasing core (abdominal) strength and balance. The ball, being inherently unstable, is positioned between the user and a stable support surface such as a floor, the user typically having to use core muscles for stability as he performs various routines designed to isolate and target specific core muscles. The primary benefit of the exercise ball is to promote core strength and to exercise various muscle groups which are difficult or impossible to exercise using traditional weight training devices such as barbells, dumbbells, resistance training machines, and the like. It is known to incorporate various devices in, on, or around an exercise ball to allow for the implementation of various core strengthening exercises, the resultant apparatuses including pull handles, grasping handles, and the like allowing for limited arm and leg exercises while positioned on the ball. U.S. Design Pat. No. 503,756 issued to Chiang discloses one such device which has extended handles which apparently allow for flexibility training while positioned on the ball. U.S. Pat. No. 7,344,487 issued to Carter et al. discloses another such device having a central bore through which a flexible, adjustable tension cord with attached grasping portions extends. U.S. Pub. App. No. 2008/0176727 issued to Heitzman discloses a frame or partial enclosure positioned around an exercise ball to restrict lateral movement of the ball while the user is positioned thereon. The preceding devices suffer from serious drawbacks for a user attempting to achieve a full body workout or exercise regimen incorporating an exercise ball. First, the ball, being both compressible and laterally movable, presents a serious challenge to any user attempting to maintain a specific position while performing even the most routine exercises. Novice users, users engaging in physical therapy to recover from accidents or illnesses, or the elderly risk serious injury as a result from falls while attempting an exercise routine. Even more advanced users risk injury using the ball, which often requires a trainer to prevent injury from falls. The Heitzman device recognizes this problem but only provides a partial solution by providing some lateral restraint of the ball. Second, the user attempting to do a more strenuous exercise runs an even greater risk of injury both from falls and from the improper execution of specific routines as he/she attempts to maintain balance. Third, the prior art apparatuses must be used with an exercise ball. Fourth, the prior devices do not allow for varying the intensity of core building exercises. Finally, those apparatuses which do incorporate limited strength training peripherals do not allow for much variation in the applied resistance or for varying the positions from which the apparatus is used, and thus the user is limited to only a few upper body routines. None of the above inventions and patents, taken either singly or in combination, is seen to describe the instant invention as claimed. SUMMARY OF THE INVENTION The present invention overcomes the disadvantages of the prior art by providing a fitness apparatus which allows for simultaneous strength training and core muscle building/strengthening, the apparatus incorporating an inflatable exercise ball. The apparatus includes a base which allows for selectively controlling the lateral movement and effective compressibility of the ball while performing various exercise routines. Also incorporated in the base are adjustable resistance training devices which allow for a variety of strength training routines, the resistance training devices allowing routines ranging from very light to sufficiently strenuous to challenge advanced users. The apparatus is collapsible and stowable, and may be used without the exercise ball to facilitate both strength/flexibility training, as well as aerobics. Accordingly, it is a principal object of the invention to provide an improved fitness apparatus. It is an object of the invention to provide an improved fitness apparatus which selectively incorporates an inflatable exercise ball. It is an object of the invention to provide an improved fitness apparatus which allows for selectively restricting the lateral movement of an inflatable exercise ball. It is an object of the invention to provide an improved fitness apparatus which allows for selectively restricting the effective compressibility of an inflatable exercise ball. It is an object of the invention to provide an improved fitness apparatus which selectively incorporates an inflatable exercise ball in combination with adjustable, repositionable resistance training devices. It is an object of the invention to provide an improved fitness apparatus which is reconfigurable to allow for core building, aerobics, and strength training. It is an object of the invention to provide an improved fitness apparatus which is collapsible. Finally, it is a general object of the invention to provide improved elements and arrangements thereof in an apparatus for the purposes described which is dependable and fully effective in accomplishing its intended purposes. These and other objects of the present invention will become readily apparent upon further review of the following specification and drawings. BRIEF DESCRIPTION OF THE DRAWINGS Various other objects, features, and attendant advantages of the present invention will become more fully appreciated as the same becomes better understood when considered in conjunction with the accompanying drawings, in which like reference characters designate the same or similar parts throughout the several views, and wherein: FIG. 1 shows a front perspective view of the fitness apparatus of the invention. FIG. 2 shows a rear perspective view of the fitness apparatus of the invention with the exercise ball removed. FIG. 3 shows a rear perspective view of the apparatus. FIG. 4 shows a rear perspective view of the apparatus illustrating an alternative operational mode of the apparatus. FIG. 5 shows a perspective view of the interior of the base component of the apparatus illustrating the ball stability adjustment mechanism. FIG. 6 shows a perspective view of the housing for the resistance training component. FIG. 7A shows a side sectional view of the housing for the resistance training component. FIG. 7B shows a rear perspective view of the housing for the resistance training component. FIG. 8 shows a top sectional view of the housing viewed from line 8 - 8 of FIG. 6 for the resistance training component. FIG. 9 shows a detail of the control rod of the ball stability adjustment mechanism. FIG. 10 shows a user positioned to perform an upper body strength training routine. FIG. 11 shows a user positioned to perform a lower body strength training routine. FIG. 12 shows a user positioned to perform an aerobic training routine. FIG. 13 shows a user positioned to perform another upper body strength training routine. FIG. 14 shows a user positioned to perform an upper body strength routine while standing. DETAILED DESCRIPTION Referring now to FIGS. 1-14 , the fitness apparatus of the present invention, generally indicated by the numeral 10 is shown. The apparatus 10 can be operated in four distinct but selectively overlapping modes. First, it may be operated in core building mode. It may also be operated in strength training mode, with an emphasis on core stabilizing. It may be operated in strength training mode in the same manner as a conventional resistance training apparatus. Finally, it may be operated in aerobic mode. Reconfiguring the apparatus is facilitated by the modular nature of the various components, and the apparatus 10 is collapsible and stowable as will be discussed later. Referring now particularly to FIGS. 1 and 10 , the apparatus 10 is shown with a user positioned thereon and using the apparatus in strength training mode with an emphasis on core stabilizing, that is, with the user positioned on the exercise ball 20 and operating the resistance training component 22 . This is the primary mode of operation of the apparatus 10 , as it affords the user many different strength training routines, all of which are amplified in varying intensity, with respect to the core muscles, by the user&#39;s position on the ball 20 , and by adjustments to the stability of the ball 20 itself. It should be noted that the user may use the ball 20 in core building mode, that is, without using the various other components as described below, with the ball 20 on or off of the base 24 . The apparatus 10 can be seen to comprise three main components. Referring now to FIG. 2 in view of FIG. 1 , the three components are the base 24 , which serves to contain the ball 20 and anchor the resistance training component 22 and the ball 20 . The base 24 is seen to comprise a substantially frusto-conical main body 26 formed of heavy plastic or other durable material and having a hollow interior 28 which forms a recess defined by a substantially continuous annular interior sidewall 25 of the main body 26 and a bottom panel 29 , the main body including sloping exterior sidewalls 33 , the interior wall 25 also sloped. The base 24 may be vertically adjustable using any means as may be apparent to one of skill in the art, a vertically adjustable base 24 allowing for the performance of different routines, or for performing routines from different angles. For example a mat, as shown and described below, may be folded and placed beneath the base 24 . The effective depth of the interior 28 is adjustable via a ball 20 stability adjustment apparatus 30 , the hollow interior 28 facilitating storage of the apparatus 10 components as will be explained in more detail later. The base 24 must be sufficiently large to allow the ball 20 a few inches, e.g. 2 to 5 inches, of lateral movement, with an adjustment mechanism 30 as described below adjustably positionable to constrict lateral movement of the ball 20 . A pair of recesses 31 formed in the sloped exterior sidewalls 33 of the front portion of the base 24 allows for foot placement of the user nearer to the ball 20 while performing routines, and to ease user disengagement from the ball 20 . The adjustment mechanism 30 includes an operating handle 32 which allows the user to manipulate the mechanism 30 from a high position to a low position within the base 24 to affect stability of the ball 20 within the base 24 as can be seen in FIGS. 1-3 . Adjusting the mechanism 30 to a selected position within the base 24 is facilitated by several radially spaced rod-like projections 34 extending outwardly from the annular main body 38 of the mechanism 30 , each of the projections 34 positioned for sliding engagement with inclined surfaces 36 of respective guide members 37 . While shown as annular, the main body 38 of the adjustment mechanism 30 may be any shape which could fit about the lower end of an exercise ball 20 and restrict movement thereof. There is one guide member 37 for each projection 34 , with the inclined surface 36 of each of the guide members 37 terminating at its apex with a recess 39 within which projections 34 are seated ( FIG. 2 ) when the main body 38 of the adjustment mechanism 30 is positioned at its highest level within the base 24 . Guide members 37 are securely attached to the bottom panel 29 proximate the interior sidewall 25 of the base 24 . Thus it can be appreciated that the inclined surfaces 36 act as camming surfaces to translate rotational movement of the main body 38 into reciprocal movement between an upper and lower position. Handle 32 is secured to the annular main body 38 of the mechanism by a control or connecting rod 40 which extends through the sidewalls 25 , 33 at the rear of the base 24 via an angular slot 42 which has a length and slope corresponding to the length and slope of inclined surfaces 36 . Thus, mechanism 30 can be selectively raised or lowered by grasping handle 32 and moving it within the slot 42 between first and second positions as can be seen in FIGS. 1-3 . At the lowermost position, indicated as position 1 in FIG. 3 , adjustment mechanism 30 allows for some lateral movement and compression of the ball 20 at the lower end. Specifically, it can be seen that the ball 20 can roll freely limited only by the interior sidewall 25 of the base 24 , with the lower end of the ball 20 resting primarily upon the bottom panel 29 . When the adjustment mechanism 30 is at the highest position, indicated as position 2 in FIG. 3 , and shown with the ball 20 in place in FIG. 1 , virtually no lateral movement of the ball 20 is allowed as the annular main body 38 of the adjustment mechanism 30 confines and restricts lateral movement of the ball 20 , and deformation at the lower end 49 of the ball 20 is greatly restricted. To the user, the ball 20 is thus relatively stable when the adjustment mechanism 30 is at the highest level, effectively reducing the amount of effort required by the user to stabilize her position on the ball 20 , the result being a comparatively reduced core workout. The user may then progress to a more difficult core routine by adjusting (lowering) the vertical position of the adjustment mechanism 30 . A key aspect of the invention is to allow for selectively restricting the lateral translation and effective compressibility of the ball 20 in order to allow for varying the intensity of the core workout. As previously mentioned, an exercise ball 20 effectively strengthens core muscles by forcing the user to balance herself on the ball while performing an exercise routine. The need to maintain balance is a direct result of the fact that the ball 20 is inherently unstable, rolling and compressing with even the slightest shift in the user&#39;s balance. Therefore, the less the ball 20 rolls and compresses, the less the user must “recruit” core muscles to maintain his position on the ball 20 . Accordingly, with the handle 32 , and therefore the adjustment mechanism 30 at the highest position, indicated by the numeral 2 in FIG. 9 and shown in FIGS. 1 and 2 , the mechanism 30 affords maximum stability of the ball 20 , effectively reducing the intensity of the core workout for any routine done on the ball 20 . With the handle 32 at the lowest position, indicated by the numeral 1 in FIG. 9 and shown in FIGS. 3 , 5 , and 9 , there is a corresponding increase in core workout intensity as the ball 20 is allowed to compress and roll within the limits as discussed above. It should be noted that the adjustment mechanism 30 may be configured to allow for infinite adjustment, or to allow for stepped increments by providing additional recesses 39 , or by other modification as would be apparent to one of skill in the art. Also, the annular main body 38 and the base 24 are sized in accordance with the size of the ball 20 . The inner surface of the main body 38 should be sized so that only about ⅛ th to ¼ th of the ball 20 can fit through to ensure that the ball 20 is seated firmly within the main body 38 and cannot move laterally. The base 24 , adjustment mechanism 30 , and resistance component 22 , as well as all subcomponents may be made of any rigid durable material such as hard plastic, except as otherwise indicated. Referring now particularly to FIGS. 6-8 , the resistance training component 22 can be seen. At least two resistance components 22 are preferably provided, but more may be provided as necessary. A single resistance component 22 may be provided and used as described in detail below. Each resistance component 22 comprises a removable housing 60 , the housing 60 having an angled and contoured rear face 62 corresponding to the slope and contour of the exterior wall 33 of the base 20 to enable a flush engagement therewith. Extending from the rear face 62 is an elongated guide 63 which is sized for sliding engagement within a track 70 formed in the exterior wall 33 . A removable, spring loaded “pin” or connecting member 64 extends laterally through a bore 65 formed in the housing 60 from the front face 66 to the rear face 62 , the bore 65 terminating in an aperture 72 . The pin 64 is sized for insertion into one of a series of apertures 68 formed in the track 70 , the connecting member 64 in combination with angled rear face 62 and guide 63 serving to secure the housing 60 to the base 24 . The apertures 68 are formed in circumferential spaced relation within the track 70 to allow for repositioning of the components 22 as necessary to facilitate a full range of motion for a particular exercise routine. Indicia such as opposing arrows 71 or the like may be imprinted on the housing 60 and at points along the upper edge of the base 24 corresponding to the positions of the apertures 68 to allow for proper user alignment. The tip of the pin 64 is a spring loaded extension 74 biased in the extended position. Rotation of the pin 64 by grasping and twisting tab 76 causes retraction of the extension 74 within aperture 72 , disengaging the pin 64 from the aperture 68 allowing the component 22 to slide along track 70 . Repositioning of the component 22 is accomplished by twisting tab 76 until the extension is disengaged from the aperture 68 , sliding the component 22 along track 70 until arrow 71 imprinted thereon is aligned with a selected arrow 71 imprinted on the base 24 , and releasing the tab 76 allowing the extension 74 to engage within the selected aperture 68 . This type of pin or connecting member 64 is well known in the art. Guide member 63 has opposing flanges 77 which are sized for sliding engagement within grooves 78 formed in the track 70 , the grooves 78 extending along the track 70 from the front end 79 of the track 70 , terminating proximate the rear end 81 . The housing 60 may be disengaged from the track 70 at the point 81 where the grooves 78 terminate. An extension element 61 (see especially FIG. 13 detail) is operatively connected within the housing 60 to allow for variable resistance strength routines. Each extension element 61 comprises a handle 80 selectively connectable to an array of resistance members 82 positioned within housing 60 . A pair of connecting straps 84 extends from opposing ends of the handle 80 , the straps 84 joined together and connected to an elongated loop 86 made of durable material such as metal. A clasp or other releasable connector 92 (e.g., a lobster clasp) is connected to loop 86 , the clasp 92 sufficiently large to connect to any or all of the pull rings 98 which are connected to a length of extension cable 96 which is contained within the resistance members 82 . Resistance members 82 , of which there are may be one or more, but preferably at least two, may be spring reels 94 formed of a length of extension cable 96 terminating in pull ring 98 , the cable 96 wrapped around a groove formed in the reel 94 , which reels 94 are biased to retract the cable 96 by a coil spring as is well known in the art. The reels 94 may be conventional arbor reels encased in plastic cartridges, which may vary in effective resistance from about 5 pounds effective resistance up to 50 pounds or more. The resistance of the resistance member 82 is determined by, e.g., the spring constant of the spring (not shown) within the resistance member 82 . The force/work required to extend the handle 80 to the limit of travel provided by the cable 96 , can be varied from a few pounds up to 40 or 50 pounds or more. Accordingly, the resistance components 22 can be provided for users of all strength levels, with an array of light, medium, or heavy resistances available for each component 22 . Thus, for a user requiring a light resistance, a component 22 having four resistance members 82 offering resistance of 5, 7.5, 10, and 15 pounds may be provided. For a user requiring a more strenuous workout, the resistance members 80 may provide a resistance of, for example, 20, 30, 40, and 50 pounds. Of course, more or fewer resistance members 82 may be provided within housing 60 than the four shown, with four being optimal as it affords the user some flexibility and keeps the size and weight of the component 22 at a minimum to allow for enhanced portability. Each of the resistance members 82 are self contained cartridges 100 which slide into slots 102 provided in housing 60 . The cartridges 100 , which have a substantially rectangular geometry, with a sloped rearward portion corresponding to the slope of the base 24 , may be made of hard plastic or other durable material. A pin 103 , which may be a conventional pin having a tip with ball plungers as used with weight plates, extends horizontally through housing 60 and cartridges 100 , preventing unintended disengagement of the cartridge 100 due to torque loading as an exercise routine is performed. Apertures 105 , 107 formed in cartridges 100 and the lower end of the housing 60 respectively, are axially aligned when the cartridges 100 are properly seated within the housing 60 . Both the housing 60 and cartridges 100 have forward grasping areas 97 , 99 respectively to provide space for hand placement as the housing 60 rests primarily upon the floor which would otherwise interfere with manipulation of the housing 60 and cartridges 100 . The clasps 92 appended to the connecting straps 84 allow for selective engagement with the pull ring 98 of the resistance member 82 to allow the user flexibility with respect to the effective resistance provided to each extension member 61 . Thus, from the example above, the user may select cartridges 100 having a resistance of 5 and 7.5 pounds for an effective resistance of 12.5 pounds. With effective resistance member 82 resistances as discussed above then, the user may select from an effective resistance of between 5 and 37.5 pounds. If the cartridges 100 ranged from 10 to 50 pounds, the user could select from between 10 and 120 pounds effective resistance. Of course, the clasps 92 can be arranged to allow for simultaneous engagement with as many of the four pull rings 98 as desired. The apparatus 10 would be packaged with several cartridges 100 to allow for routines to be performed by users of all strength levels. The apparatus 10 thus provides for variable resistance training regimens by interchanging (replacing) cartridges 100 or by selectively attaching to cartridges 100 already in place. FIG. 4 shows the apparatus 10 reconfigured as an aerobic stepper. In this configuration, the user may step onto platform 110 which is held in place by a recessed annular shelf 112 formed in the upper portion of the base 24 . Platform 110 is essentially a rigid panel which may be formed of the same material as the base 24 , and may include friction material adhered thereto or formed integrally therefrom as by molding a roughened area. The platform 110 is held down by a locking mechanism such as a plurality of radially spaced ball plungers 116 formed in the base 24 proximate the shelf 112 . The ball plungers 116 allow for a snap fit engagement of the platform 110 within the shelf 112 , reducing the possibility of rotational or unintended displacement of the platform 110 . U-shaped cutouts 118 in the platform 110 allow for grasping and removal of the platform 110 . The ball 20 may be a standard exercise ball, inflatable and made from a resilient material such as rubber, and commonly sold as a Swiss ball made of rubber or plastic and sufficiently durable to withstand several hundred pounds of pressure. The ball 20 would preferably have handles 120 , the handles 120 preferably being of a unitary construction to reduce the possibility of unintended detachment, although any means of securely attaching the handles 120 may be employed. A ball 20 of about 26 inches in diameter may be used, but larger or smaller balls may be used, with the size of the base 24 made in accordance with the size of the ball 20 . The handles 120 are spaced to allow the user to support himself thereon while performing the routines as described in more detail below. Specifically, the handles 120 should be spaced slightly more than shoulder width, allowing the user to extend their hands from their core for balance or additional support. Thus handles 120 should be placed on opposing sides of the upper half of the ball 20 , the term upper half being relative with respect to the orientation of the ball 20 on the base 24 or a floor. Multiple handles 120 may also be positioned on the ball 20 . With handles 120 on the ball 20 as shown and discussed, the ball 20 may be used in standalone mode, with the handles 120 used to facilitate certain routines such as leg extensions or any routine where the uses positions her hands on the ball 20 . As previously stated, the apparatus 10 may be used in several modes. In a first mode the user is positioned on the ball 20 performing various routines. In a second mode, the user may stand on the base with the platform 110 secured in position on the base 24 and perform resistance training routines. In a third mode, the user may use the platform 110 secured on the base 24 as an aerobic step. Referring again to FIG. 10 , a user is shown positioned on the ball 20 performing a resistance training routine. The particular routine shown is a resistance training routine focusing primarily on the upper body and core muscles. Once the user has set the adjustment mechanism 30 as described, and attached the extension element 61 to a selected one of the resistance members 82 , a curling routine may be performed. Unlike traditional curling routines, the user must recruit core muscles in order to remain stably positioned on the ball 20 and perform the exercise using the proper form, i.e. pulling the extension element 61 via handle 80 upwards to the maximum extension possible, and releasing the extension member 61 downwards, with both upward and downward movement performed against the resistance provided by the resistance member 82 . The resistance training component 22 may be repositioned as desired in order to emphasize biceps primarily, i.e., by moving both resistance components 22 forward near the front (foot position 31 ) as would be apparent to one familiar to resistance training apparatuses. FIG. 11 shows a user performing a leg extension routine. It can be seen that this routine requires a foot holder or harness 130 be used in place of handle 80 on extension member 61 , the foot harness 130 being a conventional design used with resistance training devices. The user may grasp handles 120 , spaced as described above, for additional stability, while extending and retracting his legs as shown by arrow 131 . A mat 132 having a circular end portion corresponding to the size and shape of the base 24 , and an elongated forward extension may be placed under the base 24 to protect the primary support surface (i.e., the floor) from, e.g., scuff damage. FIG. 12 shows a user performing an aerobic stepping routine. The resistance training components 22 may be removed and stored in the interior 28 of the base while performing this routine, as may the mat 132 for storage of the apparatus 10 . The base 24 has sufficient volume to contain a deflated ball 20 so that the apparatus 10 may be broken down and stowed or transported as a single unit. FIG. 13 shows a user performing an upper body routine, specifically, a bench press routine performed lying on the ball 20 and extending and retracting the arms as shown. The routine is intensified by the instability of the ball 20 , less so when the adjustment mechanism 30 is positioned in the upper position as discussed. The user may adjust the weight by either attaching the clasp 92 to, for example, only one or two of the rings, or by replacing the cartridges 100 as desired to achieve a desired effective resistance. FIG. 14 shows a user performing a curling routine standing on the platform 110 . In this configuration, the apparatus functions as a standard resistance apparatus. It can be seen that only a single resistance component 22 is used with 2 pull handles attached, allowing for closer spacing of the hands. From the foregoing description, one skilled in the art can easily ascertain the essential characteristics of this invention and, without departing from the spirit and scope thereof, can make various changes and modifications of the invention to adapt it to various usages and conditions. It is to be understood that the present invention is not limited to the sole embodiment described above, but encompasses any and all embodiments within the scope of the following claims:

A fitness apparatus which allows for simultaneous strength training and core muscle building/strengthening, the apparatus incorporating an inflatable exercise ball. The apparatus includes a base which allows for selectively controlling the lateral movement and compressibility of the ball while performing various exercise routines. Also incorporated in the base are adjustable resistance training devices which allow for a variety of strength training, the resistance training devices allowing routines ranging from very light to sufficiently strenuous to challenge advanced users. The apparatus is collapsible and stowable, and may be used without the exercise ball to facilitate both strength/flexibility training, as well as aerobics.

TECHNICAL FIELD The present invention relates to snow skis or snow boards that are adapted to be ridden and which have bindings mounted thereon. In particular, the present invention relates to fiber reinforced skis such as those formed by the wet wrap or torsion box process wherein a wooden or foam plastic core is wrapped with a fiber-reinforced sheet impregnated with resin, and then cured under pressure in a mold with a base assembly. The term &#34;fiber reinforced&#34; is meant to include any high modulus fibrous materials such as glass, aramid fibers such as Kevlar™, graphite, metal wire, polyester, etc. BACKGROUND OF THE INVENTION High performance skis are carefully designed in order to give the user maximum control during skiing. This includes designing the skis to cleanly &#34;carve&#34; turns; that is, during the carving of a turn, every point on the edge of the ski is designed to pass over a single point on the snow. In order to accomplish this, skis are shaped with curved edges such that the waist portion of the ski is narrower than the shovel or tail portions of the ski. In addition to the exterior shape of the ski, the structural core of the ski is carefully tailored such that the ski has the ability to smoothly flex over its length during the carving of a turn. During skiing, a snow ski flexes continuously both in response to irregularities in the snow and in response to the user&#39;s movements, such as during turning. Flexing of a fiber-reinforced ski causes the various layers of fiberglass and other materials that make up the body of the ski to shear with respect to each other. Elements of the ski which effect the interlaminar shear of the materials that make up the ski affect the resulting flex of the ski. As discussed above, skis are designed to flex freely over their length and in accordance with certain desired flex patterns. Elements of the ski that interfere with such flex patterns undesirably affect the performance of the ski. Mounting ski bindings on the upper surface of skis and positioning relatively rigid boots within the bindings are known to interfere with the desired flex patterns of the ski. Ski bindings are typically mounted on the top surface of the narrowed waist portion of the ski through the use of screw-type fasteners that extend through the top surface of the ski downward into the core of the ski. A number of fasteners are typically used to hold both the toe piece and heel piece of the binding to the ski. Each of these fasteners pierce the layers of fiberglass and other materials positioned within the body of the ski. This compresses the layers of the ski together and reduces their ability to shear with respect to each other during flexing of the ski. Furthermore, the positioning of a rigid plastic ski boot between the toe and heel pieces of a ski binding tends to prevent the ski from flexing in the area beneath the ski boot, thus creating an inflexible &#34;flat&#34; spot in the ski. The introduction of a &#34;flat&#34; or relatively inflexible portion to the center of the ski reduces the ability of the ski to flex over its length, thus affecting the ski&#39;s ability to carve a smooth turn. A related problem is the tendency of screw-type fasteners, used to hold the bindings to the ski, to pull out of the ski under the significant stresses commonly encountered during skiing. Metal reinforcing plates, such as those shown in U.S. Pat. Nos. 3,498,626; 3,635,482; 3,671,054; 3,844,576; 3,861,699; 3,901,522; 3,917,298; 3,928,106; 4,349,212; 4,639,009; and 4,671,529, are commonly used to provide a base element within the body of the ski into which the fasteners may be screwed and held. This helps to solve the problem of fastener pullout but increases the problems related to ski flexing, due to the introduction of a very stiff element to the narrowed waist portion of the ski. A number of prior art patents attempt to deal with the problems associated with mounting bindings on a ski. U.S. Pat. No. 2,560,693 discloses a separate foot plate system for allowing a ski to flex uniformly over its entire length. This foot plate system is screwed directly into the body of the ski at its ends, consequently, the screws which mount the foot plate system to the skis compress the various layers that make up the body of the ski. Furthermore, the foot plate system raises the bindings and boots off of the upper surface of the ski, thus affecting the ski&#39;s performance. U.S. Pat. No. 4,141,570 discloses the use of an elevated platform to allow the ski to flex between platform supports. However, the platforms themselves are screwed into the body of the ski thus creating the same problems described above. U.S. Pat. No. 3,997,178 discloses a cross-country ski having a two-layer core with the uppermost layer of the core consisting of wood having a thickness of at least 1.5 mm at its thickest part. The wood upper layer stiffens and increases the resistance of the ski to bending and also acts to prevent the binding screws which extend through the plate into the core of the foam plastic ski from being torn out during skiing. Another system that attempts to reduce the problems caused by mounting bindings on a ski is the so-called &#34;Derby Flex&#34; system described in PCT Patent No. CH83/00039. This system comprises an aluminum plate overlying a hard rubber substrate. The aluminum plate spans the narrowed waist portion of a ski and allows ski bindings to be screwed directly through the aluminum plate and into the rubber substrate rather than directly into the core of the ski. The aluminum plate, however, is screwed directly into the ski at each end in order to attach the aluminum plate to the ski. Consequently, the screws mounting the aluminum plate compress the layers of material forming the body of the ski, thus interfering with the interlaminar shear between the layers of the ski. Furthermore, the Derby Flex system raises the bindings and ski boot away from the body of the ski, thus changing the profile and influencing the performance of the ski. In addition to flexing of the ski, vibrations in the ski affect both the performance and the comfort of the ski during use. A highly vibratory ski is not as responsive in precise turns, especially on icy slopes. In addition, high frequency vibrations in skis, approximately 150 Hz and above, tend to be transmitted through the binding to the ski boot and user. German Patent No. 3,934,888 discloses a system for reducing shock and vibration between a ski and a ski binding through the use of a damping plug recessed into a chamber in the body of the ski. German Patent No. 3,934,891 discloses the placement of a viscoelastic layer on the top surface of a ski in between the ski and binding. The binding screws extend through the viscoelastic layer and into the structural layers which make up the body of the ski. One goal of the present invention is to reduce the effects of the mounting of ski bindings and ski boots on a ski upon the flex patterns of the ski. A related goal is to reduce the transmission of shock and vibration between a ski and a ski binding and ski boot mounted thereon. The present invention achieves this goal without changing the side profile of the ski or adding additional mounting plates to the top of the ski. SUMMARY OF THE INVENTION The present invention provides a unique ski construction including an integral binding mounting plate having a thickness sufficient to fully encompass the depth of the binding mounting screws so that the screws do not pass into the body of the ski. A layer of viscoelastic material is positioned between the binding mounting plate and the body of the ski and bonded to each of these elements, whereby the binding mounting plate is both held in place and isolated from the ski body. The body of the ski of the present invention is designed to flex uniformly along its length to allow for the precise carving of turns. The mounting of ski bindings and boots on the isolated binding mounting plate reduces their interference with the flex patterns of the ski. An integral ski binding mounting plate is thus provided that helps to allow the ski to flex independently of the binding system. The binding mounting plate of the present system accepts most current bindings irrespective of size or shape. In one embodiment, the ski body is provided with a recess in its top surface adjacent to the narrowed waist portion of the ski. The binding mounting plate is correspondingly shaped to fill the recess in a manner such that the conventional smooth curved top surface of a ski is achieved. If desired, additional flexible reinforcing material such as fiberglass cloth or mat, or thin sheets of aluminum or steel, may be placed in the narrowed waist portion of the ski to locally strengthen the ski and ensure uniform flexing along its length. BRIEF DESCRIPTION OF THE DRAWINGS The foregoing aspects and many of the attendant advantages of this invention will become more readily appreciated as the same becomes better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein: FIG. 1 is a perspective view of a snow ski with an integral binding isolation mounting plate according to the present invention; FIG. 2 is a cross-sectional view of the binding isolation mounting plate and ski of FIG. 1; FIG. 3 is an enlarged exploded side elevational view of the binding isolation mounting plate of FIG. 1; FIG. 4 is an enlarged side elevational view of the binding isolation mounting plate of FIG. 1 after it has been attached to the body of the ski. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 illustrates a snow ski comprising a ski body 8 and an integral binding isolation system 9 according to the present invention. The ski body is formed with an upturned shovel portion 10 which prevents the front of the ski from digging into the snow. The body narrows as it progresses longitudinally along its length until it reaches a narrowed waist portion 12 at which point it extends longitudinally and widens into a tail portion 14. As described above, this exterior shape helps the ski carve a proper turn in which the ski turns around a single point in the snow. As illustrated in FIG. 2, the body of the ski comprises a structural but flexing core 40 which has been shaped to form the shovel portion, waist portion and tail portion of the ski. The core 40 can be formed of any suitable material commonly used in ski fabrication, including wood, a honeycomb metal structure, structural foam, etc. In order to strengthen and stiffen the core, it is desirable to wrap the core 40 with a fiber reinforced layer 42. The fiber reinforced layer could include a triaxially braided composite structure as described in U.S. Pat. No. 4,690,850 (Fezio), a fiber reinforced cloth, a filament wound structure, layers of unidirectional fiber reinforced prepreg or other suitable reinforcement materials. A number of high modulus fibrous materials can be used to form the reinforced layer 42, including glass, graphite, aramid fibers such as Kevlar™, metal wire and polyester to name a few. The reinforced layer 42 may be formed of a fibrous material that has been preimpregnated with a matrix system, or may be formed of dry fibers which are later impregnated with a matrix. Possible matrix systems include epoxy resins, other adhesive systems, thermoplastic matrix systems, or other suitable high strength, flexible matrix systems. The number of layers of material, fiber orientations in each layer, and thickness of each material used to reinforce the core 40 are carefully determined to ensure that the finished ski will have the proper structural characteristics. This includes designing the ski such that it has the proper vibration characteristics, can withstand the structural loads present in the application and can properly flex in order to give the ski the ability to cleanly carve a turn. In order to protect the core 40 and reinforced layer 42, and to cosmetically enhance the ski, protective side walls 44 and top layer 45 may be placed on the vertical side surfaces and top layer, respectively, of the combined core assembly. In the preferred embodiment, the side walls and top layer are formed of a durable protective material such as ABS or ABS/urethane. However, any suitable material that can withstand the harsh temperature environment and punishment experienced by a ski may be used, such as plastics or metals. In order to achieve high performance, the lower edges of a ski must be able to cut into the snow and ice to allow the skier to perform a turn. Therefore, it is desirable that the lower edges of the ski be formed of a material which can achieve this goal. In the preferred embodiment, two steel edges 46 are placed at the lower corners of the ski. The edges extend longitudinally along the length of the ski and can be formed of any material which creates a durable, sharp edge capable of cutting into snow and ice. The cutting edges 46 are typically formed of steel alloys capable of holding a sharp cutting edge. To increase performance, a smooth, slick running surface 48 is placed upon the lower surface of the core assembly. The running surface can be formed of any appropriate material which creates a smooth friction-free running surface that allows the ski to move freely over the snow and ice. In the preferred embodiment, sintered polyethylene is used to form the running surface, however other plastics or Teflon™ materials could also be used. According to the present invention, the body 8 of the ski is formed with an integral binding isolation system 9. The isolation system comprises a recess 32 located on the top surface of the ski in the narrowed waist portion 12 (FIGS. 3 and 4). A layer 60 of viscoelastic material is placed in the recess 32 between the body of the ski and a binding mounting plate 30. The recess 32, layer 60 and mounting plate 30 are formed such that they establish a smooth upper surface of the ski, i.e., the upper surface of the mounting plate forms a smooth continuation of the upper surface of the body of the ski at opposite ends of the recess. The term &#34;viscoelastic&#34; as used herein means any material capable of storing energy of deformation, and in which the application of a stress gives rise to a strain that approaches its equilibrium value slowly, an example of which is rubber. An adhesive material capable of bonding the layer 60 to the mounting plate and body of the ski is placed on both surfaces of the layer. The adhesive material could be any material capable of properly bonding the viscoelastic material used to the body of the ski and the binding plate, such adhesives could include epoxy resins, rubber cements or other adhesive systems. The layer 60 may be formed of any suitable viscoelastic material such as urethane or rubber, and the bonding adhesive may be an epoxy resin. The thickness of the viscoelastic layer 60 should be determined based upon two parameters. First, the thickness of the viscoelastic material should be determined such that the finished ski, complete with bindings and attached ski boot is capable of flexing in a desired manner over the entire length of the ski. Additionally, the thickness of the viscoelastic material should be determined such that, as the body of the ski flexes, the interlaminar stress present between the body of the ski, viscoelastic material, and binding plate are not so high as to destroy the bonds holding the separate parts of the ski together. In general, the thickness of the viscoelastic layer depends on the choice of material used and the amount of isolation and damping desired. In one preferred embodiment, the viscoelastic material is urethane having a thickness of 0.010 inches, but it should be understood that a layer having a thickness in the range of 0.005 to 0.05 inches would be satisfactory. The viscoelastic material allows the mounting plate 30 to be connected to the body of the ski such that the ski is free to flex without being rigidly restricted by the mounting plate 30. In this design, when the body of the ski flexes, the resulting deformation and interlaminar stress between the body of the ski and mounting plate are contained primarily within the viscoelastic material forming the layer 60. This allows the binding to be mounted to the ski such that it is not rigidly secured along its length to the body of the ski, and instead the body of the ski is free to flex independently of the binding and mounting plate 30. In alternate embodiments, not shown, some portions of the mounting plate 30 could extend through the viscoelastic layer 60 to provide added stability for the mounting plate 30 with respect to the body of the ski. However, in these embodiments, these portions of the mounting plate should not be rigidly connected to the body of the ski and should therefore ideally not be fixedly attached to the body of the ski. In order to strengthen the ski and for the body of the ski to flex over its length in a desired flex pattern, it may be beneficial to reinforce the narrowed waist portion of the ski containing the recess 32. The decreased cross-sectional area at the recess 32 could result in the ski being weaker and more flexible along the length of the recess than elsewhere along the length of the ski. This could result in the ski having an undesirable flex pattern and, consequently, poor ability to a turn. It may be beneficial, therefore, to reinforce the narrowed waist portion of the ski containing the recess 32 by placing a reinforcing layer 34 along the upper surface of the core and/or a reinforcing layer 36 along the lower surface of the core. The reinforcing layers 34 and 36 could be additional layers of fiberglass or other materials with the same stiffness as the rest of the layers 42, or the reinforcing layers 34 and 36 could be formed of a higher modulus material such as graphite. The thickness and materials used to reinforce the section of the ski containing the recess 32 should be selected such that the finished ski flexes in a continuous curve along its length during turning. The mounting plate 30 is formed similarly to the body of the ski. A center core 62 (FIG. 2) is formed to the proper shape and is then overlaid by a reinforcing layer 65. The reinforcing layer could be a triaxially braided composite structure, a fiber reinforced cloth, a filament wound structure, or layers of unidirectional fiber reinforced prepreg. To ensure that mounting screws do not pull out of the mounting plate 30, it could be advantageous to place an additional layer of material 64 between the core 62 and the reinforcing layer 65. This additional layer could be a chopped fiberglass mat, as in the preferred embodiment or a number of other materials such as fiberglass cloth, Kevlar™ cloth, a metal sheet, a plastic sheet, or other similar materials. In order to protect the interior structure and cosmetically enhance the ski, a protective side wall 68 and top surface 66 are then placed around the core and reinforcing layers. It will be understood that for cosmetic reasons, the top surface 66 will typically be formed of the same conventional material used to form the top surface of the shovel and tail of the ski, for example, ABS or ABS/urethane. After laying up the mounting plate 30, the combined assembly including the body of the ski, the viscoelastic material, and the mounting plate are then cured as a combined assembly under proper temperatures and pressures for the resins or adhesives used throughout the structure. In the preferred embodiment, the combined assembly is cured as one piece, however, the mounting plate and body of the ski could be cured separately and then bonded to the viscoelastic layer 60 using a suitable adhesive as described above. The recess 32 and mounting plate 30 are sized such that they are long enough to be used as a mounting plate for a conventional ski binding. In addition, the thickness of the mounting plate is sized such that it is thick enough to contain the fasteners 22, used to mount the ski bindings, within the depth of the mounting plate, thus preventing the fasteners from piercing the layer 60 or the body of the ski. The toe and heel bindings 16 and 18 are illustrated representations only and it is contemplated that the invention will be usable with all standard release bindings. As illustrated, both the toe binding 16 and the heel binding 18 are fixedly secured to the mounting plate 30 through the use of fasteners 22. The fasteners 22 could be any type of screw fastener capable of being secured within the mounting plate without piercing the layer 60 or the body of the ski. In the preferred embodiment, the mounting plate 30 is 9 millimeters thick and is intended to be used with conventional 8 millimeter long binding screws. The use of the mounting plate 30 allows a relatively stiff, structurally solid mounting surface to be used to mount the bindings to the ski. This prevents the fasteners from being pulled loose from the ski under the significant stresses commonly encountered during skiing. Furthermore, the use of a separate mounting plate 30 and viscoelastic layer 60 to isolate the bindings and ski boot from the ski body creates significant advantages. In a standard ski, the mounting of different brands and types of ski bindings upon the ski affects the flexing of the ski. Therefore, in order to ensure proper performance, a skier may have to try a number of different combinations of skis and bindings in order to get the characteristics desired. In the present invention, the bindings are isolated from the ski body, therefore selection of bindings does not significantly affect the flexing, or performance of the ski. In addition, the present invention allows the ski to flex over its entire length in the fashion for which it was designed. The effects of the flat or relatively inflexible portions of a ski created by prior binding mounting techniques are eliminated. Furthermore, the viscoelastic material serves to dampen high frequency vibrations that would otherwise be transmitted through the bindings to the skier. All these advantages are gained without the addition of unsightly plates mounted on top of the ski which change the side profile of the ski and affect the ski&#39;s performance. It will be understood that while the present invention finds its principal application in connection with snow skis, the concept disclosed may also be applied to snowboards, since snowboard bindings are also typically screwed into the body of the board with consequent reduction in edge control. While the preferred embodiment of the invention has been illustrated and described, it will be appreciated that various changes can be made therein without departing from the spirit and scope of the invention. As an example, the materials used to fabricate the body of the ski or the mounting plate could be changed. Similarly, the shape of the mounting plate or recess could be changed.

A snow ski has a main body with a recess located in the central portion of the top surface of the ski. The recess is adapted to receive a complementary shaped ski binding mounting plate which is bonded to an intermediate layer of viscoelastic material, which is, in turn, bonded to the main body of the ski. The ski binding mounting plate has a thickness such that the fasteners used to hold the ski binding thereon do not extend through the mounting plate into the body of the ski. The body of the ski may also include reinforcing material in the central portion of the ski containing the recess.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] Embodiments of the invention described herein pertain to the field of pest management and the monitoring of pest populations. More particularly, but not by way of limitation, one or more embodiments of the invention enable an easily disassembled navel orangeworm egg trap to facilitate cleaning, inspection, maintenance, reloading, and repair. [0003] 2. Description of the Related Art [0004] Navel orangeworm are the primary pest of pistachios and almonds and are a serious pest of walnuts. The larvae and pupae of navel orangeworm overwinter in old nuts left on the trees or on the ground after harvesting. The adults emerge in the spring, and the female adults lay their eggs on the nuts remaining on the trees or on twigs close to the old nuts. When the eggs hatch, the larvae of the navel orangeworm crawl to the inside of the nut and dig into the kernel of the nut. Navel orangeworm causes damage by feeding on nut kernels and increase processing costs. [0005] Monitoring the population of navel orangeworm is a critical part of a pest management program. Accurate predictions of navel orangeworm populations are necessary for timing insecticide sprays to maximize the control of the larvae. Accurate timing is particularly important for modern insecticides which are effective for shorter periods of time. [0006] The navel orangeworm egg trap is the primary tool nut growers use to monitor and control navel orangeworm populations. A conventional navel orangeworm egg trap typically is a narrow plastic vial with screened vents near the center of the vial. The vial is filled with an ovipositional bait attractant which draws the female navel orangeworm. Two end-caps attach to the ends of the plastic vial to seal the contents of the vial. [0007] Orchard workers place the navel orangeworm egg traps on tree branches throughout an orchard. Volatile compounds from the ovipositional bait attractant escapes through the vents of the egg traps, which lures the female navel orangeworm to the egg traps. The female navel orangeworm lay their eggs on the grooved sections of the trap. Workers routinely examine the egg traps and count and record the number of eggs laid on each egg trap. Workers then remove the eggs from each egg trap and return the egg traps to the tree branches. The egg count information is analyzed over time to provide growers with an estimation of the total navel orangeworm population in the orchard. Alternatively, workers can monitor the development of the eggs laid on the trap. This population information enables growers to accurately manage pest control activities such as determining the time to apply insecticides. [0008] One drawback of the commercially available traps is that they may be difficult to inspect, clean, and repair. Periodically, workers in the field are required to replace the attractant material and clean the navel orangeworm trap. Workers may remove the two end-caps from the trap, and then push the remaining attractant out of the trap. Inspection of the egg trap may be rendered difficult as the narrowness of the vial provides the workers with only an oblique view of the inner surfaces of the trap. Cleaning may be problematic as damage to the screens may result if workers attempt to aggressively clean the egg trap. Repair to the screens may also be difficult as workers are unable to directly access the inner surfaces of the trap. This inability to clearly see and directly access the inner surfaces of the vials may make inspection, cleaning, and repair problematic and time consuming. [0009] For at least the limitations described above, there is a need for a navel orangeworm egg trap that easily disassembles for easy inspection, cleaning and repair. BRIEF SUMMARY OF THE INVENTION [0010] One or more embodiments of the invention enable an easily disassembled navel orangeworm egg trap. One or more embodiments of the invention enable orchard workers in the field to easily disassemble, clean, refill the ovipositional bait attractant, and reassemble navel orangeworm egg traps. In one or more embodiments of the invention, the navel orangeworm egg trap may have two half-tubular sections that have a half-circle cross section. The two half-tubular sections may attach to each other through the use of multiple pins and blind-holes. Ovipositional bait attractant material that lures female navel orangeworms to lay their eggs on the egg trap may be placed within the attached half-tubular sections. The half-tubular sections may have multiple vents that allow the volatile compounds of the bait attractant to be released into the surrounding air. The outer surfaces of the half-tubular sections may have grooves to replicate the topography of a splitting hull or nut shell that encourages the female navel orangeworm to lay her eggs on this surface. The top and bottom of the connected half-tubular sections are enclosed with two end-caps that seal the attractant material inside the trap. The top end-cap may be attached to a hanger that allows the navel orangeworm egg trap to be hung from a tree branch in an orchard. Egg traps may be examined periodically for the number of eggs laid on the grooved surfaces and the development stages of the eggs to determine the overall population and development stages of navel orangeworm in the orchard and to accurately time the application of insecticides. [0011] In one or more sections of a chamber may be detachably coupled to form a chamber that holds an attractant but allows the volatile compounds of the attractant to permeate the environment where the trees are grown. These sections of the chamber may disassemble to expose the inner surfaces of the chamber for easy cleaning, inspection, and repair. In one or more embodiments of the invention, the outer surfaces of the chamber may have a surface topography on which female navel orangeworm may lay their eggs. [0012] In one or more embodiments of the invention, a plurality of chamber sections may be detachably connected along a longitudinal axis to form a trap chamber. A multi-dimensional surface topography may be formed on some portion of the outer surface of at least one of these chamber sections. At least one vent may be fixedly coupled to at least one of the chamber sections which permits air to pass through the chamber section. The trap chamber may be configured to contain a bait attractant. The vent allows the volatile compounds from the bait attractant to escape from the trap chamber. In one or more embodiments of the invention, a hanger may be coupled to the trap chamber so that the trap chamber may be supported by a physical structure. [0013] In one or more embodiments of the invention, orchard workers may periodically clean the navel orangeworm egg traps and place new attractant into the egg traps. A worker may remove the egg trap from the tree, and may disassemble the two end-caps from the chamber of the trap. The chamber may further disassemble into the two chamber sections. The worker may remove the attractant from the chamber sections and clean the exposed inner surfaces of the chamber sections with a brush. The worker may be able to inspect the vents, the screening materials, and the entire inner surface of the chamber sections. [0014] In one or more embodiments of the invention, workers may be able to repair the egg traps. Workers may be able to replace the screening material, reattach the screening material, repair the means through which the chamber section are detachably coupled, and repair damage to the integrity of the egg trap. [0015] In one or more embodiments of the invention, the chamber may have more than two chamber sections. In one or more embodiments of the invention, the chamber sections may be of any shape. In one or more embodiments of the invention, the chamber sections may be coupled to the other chamber sections with hinges that enable the chamber sections to disassemble and lay flat for easy cleaning and re-assembly. [0016] In one or more embodiments of the invention, the multiple chamber sections may be formed out of a single piece of semi-flexible material. Workers may be able to open up the chambers by bending back one chamber section with respect to another. After cleaning and inspection, the workers may close the chamber sections back onto the adjacent chamber sections. In one or more embodiments of the invention, the chambers may be made of plastic or soft metals. [0017] In one or more embodiments of the invention, the vents may be formed by a series of small holes or perforations in the chamber sections that are sufficiently small to prevent the solid attractant from escaping from the trap. The vents may be formed by holes upon which a meshed screening material is secured. The screening material may be made out of wire-mesh, polyester screening, or any other material that enables volatile compounds to escape to the surrounding environment. BRIEF DESCRIPTION OF THE DRAWINGS [0018] The above and other aspects, features and advantages of the invention will be more apparent from the following more particular description thereof, presented in conjunction with the following drawings wherein: [0019] FIG. 1 presents an exploded view of an embodiment of the invention. [0020] FIG. 2 presents a view of an embodiment of the invention that is fully assembled. [0021] FIG. 3 presents a view of an embodiment of the invention illustrating detachable chamber sections couple using a hinge. [0022] FIG. 4 presents a view of an embodiment of the invention in which the chamber sections are formed out of a single piece of material. [0023] FIG. 5 presents one or more embodiments of the invention that has a tongue and groove structure to detachably couple the chamber sections. [0024] FIGS. 6A and 6B present one or more embodiments in which the chamber sections are marked with surface features. DETAILED DESCRIPTION [0025] An easily disassembled navel orangeworm egg trap will now be described. In the following exemplary description, numerous specific details are set forth in order to provide a more thorough understanding of embodiments of the invention. It will be apparent, however, to an artisan of ordinary skill, that the present invention may be practiced without incorporating all aspects of the specific details described herein. In other instances, specific features, quantities, or measurements well known to those of ordinary skill in the art have not been described in detail so as not to obscure the invention. Readers should note that, although examples of the invention are set forth herein, the claims, and the full scope of any equivalents, are what define the metes and bounds of the invention. [0026] FIG. 1 presents an exploded view of an embodiment of the navel orangeworm egg trap apparatus, while FIG. 2 presents a view of one or more embodiments of the assembled egg trap. In one or more embodiments of the invention, an ovipositional bait attractant is placed within the inner volume of the chamber formed by first half tubular section 110 , second half tubular section 111 , top end-cap 160 , and bottom end-cap 161 . The ovipositional bait attractant may lure female navel orangeworm to lay their eggs on the egg trap. In one or more embodiments of the invention, a first half tubular section 110 may have a plurality of vents 130 and 133 . Second half tubular section 111 may have a plurality of vents 131 and 132 . In one or more embodiments of the invention, vents 130 , 131 , 132 , and 133 allow the volatile compounds of the attractant to permeate the air near where the trees are grown. Vents 130 , 131 , and 132 may be a series of openings that are sufficiently small to prevent the attractant from leaking out of the trap, or prevent an insect or animal from reaching or feeding on the attractant material. In one or more embodiments of the invention, a screened mesh may be secured behind or in front of the vent openings. The screening material may be made out of metal, fiber, plastic, wire, polyester screening, or any other material that enables volatile compounds to escape to the surrounding air. [0027] The ovipositional bait attractant releases volatile odors which lure female navel orangeworms to lay their eggs on the trap hosts. Ovipositional bait attractant may consist of a meal in the form of chicken feed, ground corn, rolled oats, or ground nuts. Almond oils, almond extracts, glycerol, and other substances may be added to the meal to aid in the effectiveness of the ovipositional bait attractant. [0028] Surface topographies 121 and 122 are formed on an outer surface of the first half tubular section 110 , and surface topographies 122 and 123 may be formed on an outer surface of the second half tubular section 111 . In one or more embodiments of the invention, the surface topographies 120 - 123 may simulate a surface where the navel orangeworm might preferably lay eggs. For example the surface topography may take the form of a crosshatch pattern or grooves that replicate a hull or shell split. In one or more embodiments of the invention, the grooves may be formed through an injection molding process, through a machining or milling process, through an etching process, through an engraving process, or through any process that results in a series of grooves on the surface. In one or more embodiments of the invention, the grooves may be nearly horizontal. In one or more embodiments of the invention, the grooves may be vertical. In one or more embodiments of the invention, one or more surfaces of the first half tubular section 110 and second half tubular section 111 and end-caps 160 and 161 may have crosshatch markings. In one or more embodiments of the invention, one or more of the end-caps 160 and 161 may have grooves or crosshatch marks on their surfaces. In one or more embodiments of the invention, the grooves or crosshatch marks are on a surface other than first half tubular section 110 and second half tubular section 111 . [0029] In one or more embodiments of the invention, the first half tubular section 111 is detachably coupled along the length or longitudinal axis to second half tubular section 111 to form a chamber. In one or more embodiments of the invention, the detachable coupling of first half tubular section 110 and second half tubular section 111 may be through the use of pins 140 - 143 (shown) and blind-holes 150 - 153 (not shown) respectively, and pins 144 and 145 (shown) and pins 146 and 147 (not shown) with blind hole 154 (shown) and blind-holes 155 - 157 (not shown). First half tubular section 110 and second half tubular section 111 are detachably coupled as the blind holes 150 - 157 receive the pins 140 - 147 . The diameter of the blind holes 150 - 157 and the pins 140 - 147 may be such that first half tubular section 110 and second half tubular section 111 remains coupled for the ordinary use of the egg trap but may be decoupled for cleaning, inspection, and repair. In one or more embodiments of the invention, first half tubular section 110 and second half tubular section 111 may attach using a tongue-in-groove, hinges, mechanical fasteners, tape, elastic bands, or any other attachment means that provide a detachable coupling. [0030] In one or more embodiments of the invention, and a bottom end-cap 161 may seal a bottom end of the said chamber formed by first half tubular section 110 coupled to second half tubular section 111 . In one or more embodiments of the invention, a bait attractant may be placed within the chamber formed by first half tubular section 110 , second half tubular section 111 , and bottom end-cap 161 . Top end-cap 160 may seal the top end of said chamber formed by first half tubular section 110 , second half tubular section 111 , and bottom end-cap 161 . The end-caps 160 and 161 may attach to the chamber formed by first half tubular section 110 and second half tubular section 111 through a compression fit, threads, tape, a mechanical fastener, an elastic band, or any other attachment method that provides for a detachable coupling. [0031] In one or more embodiments of the invention, hanger 170 may be coupled to the top end-cap 160 which supports the chamber from a physical structure. Hanger 170 may be attached to end-cap 160 which enable the entire egg trap apparatus to be hung from tree branches or other physical structures. In one or more embodiments of the invention, the hanger may be made of plastic, metal, carbon fiber, cardboard, fiberglass, or any other durable material. In one or more embodiments of the invention, the hanger 170 and the top end-cap 160 may form a one-piece assembly. In one or more embodiments of the invention, hanger 170 and top end-cap may be formed through an injection molding process or through a machining or milling process. [0032] In one or more embodiments of the invention, first half tubular section 110 and second half tubular section 111 and end-caps 160 and 161 may be formed in plastic, metal, carbon fiber, cardboard, fiberglass, or any other durable material. In one or more embodiments of the invention, first half tubular section 110 and second half tubular section 111 may be formed through the means of an injection molding process, a machining or milling process, or through an assembly process. [0033] In one or more embodiments of the invention, first half tubular section 110 and second half tubular section 111 , and the end-caps 160 and 161 may be painted or covered with a material that has a dark and less-reflective color. In one or more embodiments of the invention, first half tubular section 110 and second half tubular section 1 , and the end-caps 160 and 161 may be formed out of a material with a dark and less-reflective material. Examples of a suitable dark color may include black, dark green, dark blue, dark brown, and dark indigo. [0034] FIG. 3 is a view of one or more embodiments of the invention. In one or more embodiments of the invention, separate end-caps may be rendered unnecessary as chamber sections 310 and 311 are formed to include a top and bottom surface perpendicular to the length or longitudinal axis of the chamber sections 310 and 311 . In one or more embodiments of the invention, a bait attractant may be placed within the inner volume of chamber sections 310 and 311 . In one or more embodiments of the invention, chamber sections 310 and 311 may be formed by an injection molding process or by a machining and milling process. In one or more embodiments of the invention, hanger 370 may be coupled to chamber section 310 . In one or more embodiments of the invention, hanger 370 and chamber section 310 may be one piece. In one or more embodiments of the invention, the one-piece unit of hanger 370 and chamber section 310 may be formed by an injection molding process or by a machining and milling process. [0035] In one or more embodiments of the invention, chamber sections 310 and 311 may be coupled together with a hinge 380 that runs along the length or longitudinal axis of the chamber sections 310 and 311 . The use of a hinge 380 may enable an orchard worker in the field to easily re-assemble the navel orangeworm egg trap as pins 340 - 343 and blind-holes 350 - 353 may be automatically aligned as the chamber section 310 folds over and on top of chamber section 311 . In one or more embodiments of the invention, the chamber may have more than 2 chamber sections, where each chamber section is coupled to the adjacent chamber section through the use of hinges. [0036] In one or more embodiments of the invention, a second hinge forms another detachable coupling between chamber sections 310 and 311 and replaces the detachable coupling mechanism provided by the pins 340 - 343 and blind-holes 350 - 353 . In this configuration, a worker in the field may remove the pin from one of the hinges and opens up the chamber assembly about the other hinges. After cleaning and replacement of the attractant material, the worker may close the chamber sections together and replaces the pin in the hinge. [0037] In one or more embodiments of the invention, vents 330 - 333 may be formed in the chamber sections 310 and 311 . In one or more embodiments of the invention, vents 330 - 333 may be in the form of a series of small holes or perforations that allow for ventilation but otherwise contains the attractant material. In one or more embodiments of the invention, the vents may also be larger holes with a screen mesh attached to the chamber sections 310 and 311 . [0038] FIG. 4 is a view of an embodiment in which the chamber sections are formed out of a single piece. This approach potentially offers lower manufacturing costs. In one or more embodiments of the invention, chamber 410 may have an upper half-shell 411 and a lower half-shell 412 that is configured to couple detachably with each other. The inner surfaces of upper half-shell 411 and lower half-shell 412 may be configured to hold a bait attractant material, and chamber 410 is configured to release the volatile compounds of said attractant though vents 430 - 435 . Surface topographies 420 and 421 may be in the form of horizontal groove. Chamber 410 may be in the form of a cylinder that has a length that is parallel to the axis of the intersection of upper half-shell 411 and lower half-shell 412 . Chamber 410 is configured to disassemble along the length of the upper half-shell 411 and lower half-shell 412 . [0039] In one or more embodiments of the invention, upper half-shell 411 and lower half-shell 412 may open up to expose the inner surfaces for cleaning, repair, and inspection. In one or more embodiments of the invention, the area where the upper chamber and the lower chamber meet effectively forms a hinge so that the upper and chambers automatically align when the chamber 410 is closed. In one or more embodiments of the invention, the upper and lower sections of chamber 410 may close through any means for detachably coupling the two sections including pins and blind-holes, tongue and grooves, hinges, tape, or mechanical fasteners for example. [0040] In one or more embodiments, chamber 410 may be made out of a semi-flexible plastic such as polyethylene, polypropylene, nylon, flexible PVC, or out of rubber. Any type of flexible material is in keeping in spirit with the spirit of the invention. In one or more embodiments of the invention, chamber 410 may be formed through an injection molding process, through a stamping process, through a machining or milling process, or through a melting or fastening process. [0041] In one or more embodiments of the invention, vents 430 - 435 may be formed to allow the volatile compounds of the bait attractant to escape to the surrounding environment. A plurality of grooves 420 and 421 may be formed on chamber 410 to encourage navel orangeworm to lay their eggs on these grooves. Hanger 470 is coupled to chamber 410 to enable chamber 410 to be hung from tree branches. [0042] FIG. 5 presents one or more embodiments of the invention that may have a tongue 540 and groove 550 as the means for detachably coupling chamber section 510 to chamber section 511 . In one or more embodiments of the invention, a bait attractant may be placed within the inner volume of chamber section 510 and chamber section 511 . In one or more embodiments of the invention, the tongue 540 and groove 550 may be formed through an injection molding process, or through a milling or machining process. Chamber section 510 may rotate about hinge 580 so that the tongue 540 is automatically aligned with groove 550 . Vents 530 - 533 may allow the bait attractant to permeate the surrounding environment. Hanger 570 enables one or more embodiments of the invention to be hung from tree branches or other physical structures. [0043] FIGS. 6A and 6B present one or more embodiments in which the chamber sections 610 and 610 may be marked with surface features 620 and 621 , and 622 and 623 respectively. FIG. 6A presents one or more embodiments in which the surfaces 620 - 623 may have grooves or ridges in a vertical or nearly vertical orientation. FIG. 6A presents one or more embodiments of the invention in which the outer surfaces of other the top and or bottom end-cap may be marked with a cross-hatch of grooves or ridges. FIG. 6B presents one or more embodiments of the invention in which the surfaces 620 - 623 are marked with a cross-hatch pattern of grooves or ridges. FIG. 6B presents an embodiment of the invention in which the top and or bottom end-cap 660 and 661 respectively are marked with a plurality of grooves or ridges. Any combination or orientation of grooves, ridges, cross-hatch patterns, or any other two dimensional surface topography that will simulate the splitting of a nutshell or is otherwise attractive to a female navel orangeworm is in keeping with the spirit of the invention. In one or more embodiments of the invention, the grooves may be formed through an injection molding process, through a machining or milling process, through an etching process, through an engraving process, or through any process that results in a series of grooves on the surface. Vents 630 - 632 allow the volatile compounds of the bait attractant to permeate the surrounding environment, which lures female orangeworms to lay their eggs on the surface topography. Hanger 670 enables one or more embodiments of the invention to be hung from a tree branch or other physical structure. [0044] While the invention herein disclosed has been described by means of specific embodiments and applications thereof, numerous modifications and variations could be made thereto by those skilled in the art without departing from the scope of the invention set forth in the claims.

An easily disassembled navel orangeworm egg trap apparatus which facilitates easy cleaning, inspection, maintenance, reloading, and repair. One or more embodiments of the invention enable orchard workers in the field to easily disassemble a navel orangeworm egg trap for cleaning, inspection, and repair. In one or more embodiments of the invention, at least one chamber section that is detachably coupled along the length of the chamber section. The chamber disassembles along the length of the chamber sections, thus exposing the inner surfaces of the ovipositional bait attractant chamber. By offering an easily disassembled chamber that exposes the inner surface, navel orangeworm egg traps are easily cleaned and repaired in the field.

BACKGROUND OF THE INVENTION This invention generally relates to guiding members for vascular catheters useful in such procedures as angiography, angioplasty, valvuloplasty and the like. In typical percutaneous transluminal coronary angioplasty (PTCA) procedures, a guiding catheter having a preformed distal tip is percutaneously introduced into the cardiovascular system of a patient through the brachial or femoral arteries and advanced therein until the distal tip thereof is in the ostium of the desired coronary artery. A guidewire and a dilatation catheter having a balloon on the distal end thereof are introduced through the guiding catheter with the guidewire slidably disposed within an inner lumen of the dilatation catheter. The guidewire is first advanced into the patient&#39;s coronary vasculature until the distal end thereof crosses the lesion to be dilated and then the dilatation catheter is advanced over the previously introduced guidewire until the dilatation balloon is properly positioned across the lesion. Once in position across the lesion, the flexible, relatively inelastic balloon is inflated to radially compress atherosclerotic plaque against the inside of the artery wall to thereby dilate the lumen of the artery. The balloon is then deflated so that the dilatation catheter and the guidewire can be removed and blood flow resumed through the dilated artery. Guidewires for vascular use usually comprise an elongated core member which is tapered toward the distal end, a helical coil disposed about and secured to the tapered distal end of the core member and a rounded plug provided on the distal tip of the coil. Preferably, the plug and at least part of the coil are formed of highly radiopaque materials to facilitate fluoroscopic observation thereof. There are two general types of guidewire constructions. In the first type, the core member extends through the coil to the plug in the distal tip thereof. In the second type, the core member extends into the interior of the helical coil, but terminates short of the plug in the distal tip. A shaping ribbon is secured directly or indirectly to the core member and the ribbon is secured to the radiopaque plug as shown. Steerable dilatation catheters with built-in or fixed guidewires or guiding elements are used with greater frequency because the deflated profile of such catheters is generally smaller than conventional dilatation catheters with movable guidewires or elements having the same inflated balloon size. Further details of angioplasty procedures and the devices used in such procedures can be found in U.S. Pat. No. 4,332,254 (Lundquist); U.S. Pat. No. 4,323,071 (Simpson-Robert); U.S. Pat. No. 4,439,185 (Lundquist); U.S. Pat. No. 4,468,224 (Enzmann et al.) U.S. Pat. No. 4,516,972 (Samson); U.S. Pat. No. 4,538,622 (Samson et al.); U.S. Pat. No. 4,554,929 (Samson et al.); and U.S. Pat. No. 4,616,652 (Simpson). Each of the above references is incorporated herein in their entirety. Further details about guidewires can be found in U.S. Pat. No. 4,538,622 (Samson et al.); U.S. Pat. No. 4,554,929 (Samson et al.) U.S. Pat. No. 4,619,274 (Morrison); and U.S. Pat. No. 4,721,117 (Mar et al.). Further details of low-profile steerable dilatation catheters may be found in U.S. Pat. No. 4,582,181 (Samson); U.S. Pat. No. 4,619,263 (Frisbie et al.); U.S. Pat. No. 4,641,654 (Samson et al.); and U.S. Pat. No. 4,664,113 (Frisbie et al.). While the prior guidewires and guide members have for the most part performed well, there was always a need for increased flexibility and the increased torquability and pushability of the distal tip of the guidewire. With the prior devices, improvements in flexibility usually involved some loss of torquability and improvements in torquability usually involved some loss in flexibility. What has been needed and heretofore unavailable is some means to improve both the flexibility and torquability of the distal tip of the guidewire. The present invention satisfies that need. SUMMARY OF THE INVENTION This invention is directed to a guidewire or guiding member design having both improved flexibility and torquability, particularly in the distal portion thereof. The guiding member of the invention generally includes an elongated core member which preferably tapers toward the distal end thereof. A plurality of interfitting links are provided on the distal portion of the core member to facilitate improvements in flexibility and torquability. Means are provided on the proximal end of the core member to apply torque thereto which is transmitted through the core member to the distal portion thereof having a section of loosely interfitting links. In a presently preferred embodiment, the links comprise a relatively flat base and a plurality of vertically extending arms which fold inwardly in the upper portion thereof to engage the upper surface of the flat base of the adjacent link, with the length of the upwardly extending portion of the arms being chosen to provide a desirable amount of axial movement between the links. An opening, preferably centered, may be provided in the flat base of the link to receive the distal portion of the core member or a shaping ribbon which extends from the distal end of the core member to the distal tip of the flexible link section with a rounded plug formed in the distal end thereof. The ends of the arms which extend upwardly from the flat base and are bent inwardly between the arms of the adjacent link are preferably provided with an enlargement on the end thereof for interlocking the links and to thereby prevent their separation, particularly during vascular procedures. Lost motion or winding between the individual links can be minimized by minimizing the spacing between the interfitting arms of the links. The length of the interfitting links generally will assume the shape imposed on the shaping member or the distal end of the core which passes through the opening provided in the flat bases of the links. These and other advantages of the invention will become more apparent from the following detailed description thereof when taken in conjunction with the accompanying exemplary drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an elevation view partially in section of a steerable, fixed wire dilatation catheter embodying features of the invention; FIG. 2 is a perspective view of the distal portion of the dilatation catheter shown in FIG. 1; FIG. 3 is a perspective view of a link of a preferred embodiment; FIGS. 4 and 5 illustrate the interfitting of the links, such as shown in FIG. 3 to form the distal portion of the guiding member shown in FIGS. 1 and 2; FIG. 6 is a side elevation view of a guidewire embodying features of the invention; FIG. 7 is a plan view of an alternative link preform; FIG. 8 is a perspective view of the link preform shown in FIG. 7 finally formed; FIG. 9 is an elevation view of several links as shown in FIGS. 7 and 8 in an assembled condition; FIG. 10 is a plan view of an alternative link preform; FIG. 11 is a perspective view of the link preform shown in FIG. 10; and FIG. 12 is an elevation view of several links in an assembled condition. DETAILED DESCRIPTION OF THE INVENTION Reference is made to FIGS. 1 and 2 which illustrate a steerable dilatation catheter assembly 10 having a fixed guidewire or guiding member 11 therein embodying features of the invention. The catheter assembly 10 generally comprises an elongated tubular body 12 having a balloon member 13 on the distal portion thereof adjacent the distal end and a multi-arm adapter 14 on the proximal end of the tubular body 12. A core member 15 is disposed within an inner lumen 16 provided within the tubular body 12 with a tapered distal portion 17. A flexible section 20 of the catheter 10 includes a plurality of interfitting links 21 and is secured to the core member 15 at location 22 by means of welding, brazing, soldering, adhesives or the like. A shaping member or ribbon 23 extends through aperture 24 provided in the links 21 from the bond location 22 which secures the proximal end of the shaping member 23 to the core member 15 to the rounded plug 25 provided on the distal tip of the flexible link section 20. A torquing knob 26 is provided on the proximal end of the core member 15 in a conventional fashion to allow the manual rotation of the guiding member or guidewire 11 in a desired manner to guide the catheter assembly 10 through a patient&#39;s vasculature. The two-arm adapter 27 on the proximal end of tubular member 12 has an arm 28 for injecting inflation fluid through the lumen 16 to the interior of balloon 13. A preform 30 from which an individual link 21 can be made is shown in FIG. 3. As indicated, the preform 30 includes a base 31, preferably flat, having an aperture 24 and a plurality of projecting arms 32 extending radially outwardly from the base 31. However, as shown in FIGS. 4 and 5, the individual links 21 are interfitted by first placing one preform 30 on top of another, radially offsetting the upper preform so that the arms 32 of one of the preforms extend between the arms of the adjacent preform, as shown. The arms 32 of the lower preform 30 are folded upwardly at the junction thereof with the base 31 and then are folded inwardly again at an intermediate location 33, as shown in FIG. 5, so that the inwardly folded section 34 of the arms 32 limits the maximum axial displacement between adjacent links. Additional preforms are added in the same manner in order to form the flexible link section 20. The ends 35 of the inwardly folded arm section 32 are enlarged, preferably flaring outwardly, as shown, so that when the arm sections 34 are folded inwardly the links 21 interlock to thereby prevent the separation thereof during vascular procedures. The transverse dimension (i.e., the width) of the arms 32 controls the amount of relative axial rotation between adjacent links. The larger the width dimension, the less relative axial rotation is allowed between links 21 and thus the less lost motion from the proximal to the distal end of the flexible link section 20. The length of the shaping ribbon 23 extending between the bonding location 22 and the plug 25 at the distal tip of the flexible section 20 can determine the relative axial placement of the individual links 21 within the displacement allowed by the arms 32 of each link 21. FIG. 6 illustrates another embodiment of the invention involving a movable guidewire 40 for use within the inner lumen of a dilatation catheter, not shown. The guidewire 40 generally comprises a relatively thin core 41 with a short tapered distal portion 42. All or a substantial part of the guidewire 40 may be provided with a thin Teflon coating (not shown) of about 0.0005 to about 0.001 inch (0.013 to 0.025 mm) to facilitate the passage thereof through the central lumen of the dilatation catheter. The tapered distal portion 42 has two sections 43-45 of progressively smaller cross-sectional dimensions with gentle tapers 46-48 between the progressively smaller sections. This embodiment has a standard design wherein section 45 extends to the plug 52 and is flattened to allow shaping. A flexible link section 53 is disposed about the short tapered distal portion 42 of the guidewire 40. The proximal end of the section 53 is secured to the distal portion 42 by welding, brazing, soldering, or adhesive at location 51. The distal end of the flexible link section 53 is secured to the plug 52. If desired, the entire length of the link section 53 may be covered by a flexible protective sheath 54, such as rubber, elastomer or the like. The distal end of the core 41 could be provided with a distal section, as shown in FIG. 1, if desired. The link section 53 typically has a length from about 1 to about 3 cm and in one presently preferred embodiment, at least some of the links are fabricated from a sheet of radiopaque material, such as molybdenum, rhenium, palladium, platinum, tungsten, and alloys thereof to make the link section more visible under fluoroscopic examination. Alloys of molybdenum and rhenium have been found to be particularly suitable with a nominal composition of 50 percent molybdenum and 50 percent rhenium being preferred. The links may also be made of stainless steel and NITINOL. An alternative link embodiment is illustrated in FIGS. 7-9. The link preform 60, best shown in FIG. 7, has a pair of opposing discs 61 and a pair of opposing socket sections 62 which are secured to the base 63 which has an aperture 64 therein which is adapted to receive a guiding element (not shown). As depicted in FIGS. 8 and 9, the discs 61 are bent along lines 65 in one axial direction and the socket sections 62 are bent along lines 66 in an axial direction opposite to that of the discs 61. The discs 61 of one link interfit the recess or socket 67 in an axially adjacent link which, as shown in FIG. 9, allows limited movement between the links, yet facilitates the transmission of torque between the links. Preferably, the socket sections 62 and the discs 61 are curved so as to form a generally cylindrical shape. FIGS. 10-12 illustrate another alternative link design which is suitable for use in the present invention. The link preform 70 is best shown in FIG. 10, whereas the forming and operation of the links are best shown in FIGS. 11 and 12. The preform 70 has a pair of opposing arms 71 which have rounded enlarged ends 72, a pair of opposing socket sections 73 and 74, and a central aperture 75 in the base 76 which is adapted to receive a guiding element (not shown). The arms 71 are bent axially in one direction at fold lines 77 and socket sections 73 and 74 are bent in the same axial direction along fold lines 80 and 81, as shown in FIG. 11. The distal tip of the arms 71 are bent inwardly, as shown in FIG. 11, so as to fit within the socket 82 of an adjacent link and be locked therein by the enlarged end 72 when the socket sections 73 and 74 are bent into their final positions. This construction allows pivotal movement between the links as in the previously described embodiments and provides for the transmission of torque between the links. Generally, the size and materials of construction for the guidewire or guide element may be conventional, except as noted otherwise. Modifications and improvements can be made to the invention without departing from the scope thereof.

A guidewire or guiding element for vascular catheters, particularly balloon dilatation catheters having an elongated core member with a tapered distal portion with a flexible length of interfitting links on the tapered distal portion. The individual links generally comprise a base with an aperture therein and a plurality of upwardly extending arms with the ends of the arms bent inwardly toward the longitudinal axis of the flexible length to engage the base of an adjacent link. Improved flexibility and torquability are provided by the flexible length of interfitting links.

FIELD OF THE INVENTION The present invention generally relates to slide mechanisms for drawers slidable in articles of furniture. The invention specifically relates to a three-part heavy-duty miniature ball bearing drawer slide mechanism with offset outer channel members and a progression roller which assists closure and detent of the slide. BACKGROUND OF THE INVENTION To reduce friction and enable a drawer to withstand a heavy load, drawer slides for furniture in file cabinets and other furniture employ bearings to reduce wear, Professional furniture for medical, industrial, and engineering applications often requires thin drawers and thin drawer slides. Such applications also require a heavy-duty slide. Four sets of ball bearings are usually required to bear a typical load when full extension is required. However, the use of four separate sets of ball bearings poses obstacles to miniaturization of the slide. Furniture designers desire the cross-section profile of the slide to be thin in the horizontal direction, thereby enabling a drawer to be as wide as possible compared to the opening in which it slides. Moreover, designers want slides which are shallow in the vertical direction to keep the slide unobtrusive, and enable use with short drawers. In most drawer slides of the prior art, the four separate ball bearing assemblies are aligned in pairs on two spaced-apart vertical axes. To make a drawer slide thin in the horizontal direction, designers have focused on making the relative vertical separation of one pair of bearings narrower than the other. This enables the vertical axes of the bearing pairs to become nearly collinear, resulting in a thin slide. For example, U.S. Pat. No. 5,022,768 (Baxter) discloses, in FIG. 1, a prior art slide mechanism in which the ball bearing pairs are on nearly collinear vertical axes. FIGS. 3, 4, and 7 of U.S. Pat. No. 4,469,384 (Fler et al.) discloses a similar collinear axis slide. However, the cross-section profile of the resulting slide is not symmetrical, requiring the separate fabrication of a fixed cabinet member and a moving drawer member, each having a different cross-section. This increases manufacturing costs and increases the height profile of the slide. Thus, designers of drawer slides desire to provide a slide which is horizontally thin and vertically short to enable unobtrusive installation in a variety of furniture mounting arrangements. Designers of drawer slides also desire to provide a slide in which the central slide member is structurally stable. Another goal of slide design is smooth control of extension of the slide. U.S. Pat. No. 4,662,761 discloses a multi-part slide with a roller 18. This slide requires four outside channel members and separate plates 57, 58 to join the channels together. The bearings are arranged on a vertical collinear axis. The roller 18 has a horizontal axis of rotation and provides sequential motion rather than smooth progressive movement. U.S. Pat. No. 3,966,273 shows a slide with progressive movement control of a ball retainer using bands of material which impose friction. U.S. Pat. No. 3,901,564 shows a slide with a progression roller 38 having a horizontal axis of rotation. The roller imposes friction on the outer channel members of the slide. U.S. Pat. No. 3,857,618 shows control of a ball retainer using a rack and pinion arrangement best seen in FIG. 11. The pinion gear has a horizontal axis of rotation but requires clearance space at the bottom of the slide channel members, thereby increasing the overall height of the slide. Punched holes are required in the slide. U.S. Pat. No. 3,679,275 shows a drawer slide with four outer channel members and a roller 66 mounted on a vertical shaft 68. The roller has a knurled outer surface which imposes friction on the inside faces of outer plates 16, 36 which hold the four channel members together. This requires special preparation of the slide member surfaces, which leads to higher manufacturing costs and greater complexity of design. Also, the &#39;275 patent requires two separate sets of sliding components. Thus, the prior art fails to provide a drawer slide which is horizontally thin and vertically shallow or short, and also incorporates a progression roller system. The prior art also fails to provide a slide with a progression roller which can facilitate closure of the slide, act as a detent, and also release pressure on the roller when the slide is closed. A particular disadvantage of prior art slides with progression rollers is that when closed, the roller is in constant compression within the slide. This results in permanent flattening or deformation of the roller over time. This causes undesirable bumpy movement of the slide. SUMMARY OF INVENTION Accordingly, the present invention provides a thin profile drawer slide apparatus for slidably supporting a heavy drawer in an article of furniture, comprising symmetrical, identical fixed cabinet and moving members or channels for slidably attaching the apparatus to a drawer and an article of furniture, a plurality of bearings slidably retained in the channels by bearing retainers, and by an intermediate retaining means. The intermediate retaining means preferably comprises an intermediate slide member which is the unitarily formed combination of a generally vertical central wall, a first bearing raceway joined to an end of the central wall, and a second bearing raceway joined to an arcuate wall extending angularly outwardly from the first bearing raceway, whereby the first and second bearing raceways are vertically and angularly separated or offset. The central wall of the inner retaining means comprises a generally rectangular window with a progression roller mounted therein on a vertical axis of rotation. The roller exerts friction on the inner faces of the channels by compression against the interior faces when the roller is moved. The edges of the window act as a detent on the roller and also urge the slide closed when the slide is brought to rest with the roller against one of the edges. The window provides means for releasing compression tension on the roller when the slide is fully closed. Thus, the invention provides a horizontally thin, vertically short three-part slide with ball bearings arranged in four nearly collinear, slightly offset sets. Use of a single central member with raceways for four separate sets of bearings enables construction of a thin, strong drawer slide for carrying heavy loads. BRIEF DESCRIPTION OF DRAWINGS FIG. 1 is a cross-section view of a first embodiment of a three-part drawer slide with progression roller according to the invention; FIG. 2 is a cross-section view of a second embodiment of a drawer slide, with double-thickness intermediate member raceways, having no bearing retainers and showing fasteners for securing the slide; FIG. 3 is a cross-section view of a third embodiment of a drawer slide having no progression roller; FIG. 4 is a cross-section view of a fourth embodiment of a drawer slide according to the invention; FIG. 5 is a partial elevation view of a drawer assembly showing the slide of FIG. 1 secured to a drawer and an article of furniture; FIG. 6 is an elevation view of the drawer slide of FIG. 1, showing the slide in a fully closed position; FIG. 7 is a section view of the slide of FIGS. 1 and 6 taken on line 7--7 of FIG. 6; FIG. 8 is an elevation view of the drawer slide of FIG. 1, showing the slide in an open position; FIG. 9 is a section view of the slide of FIGS. 1 and 8 taken on line 9--9 of FIG. 8 with an exaggerated representation of a roller; FIG. 10 is a partial cross-section view of the slide of FIG. 1 in a nearly closed position; and FIG. 11 is a partial schematic view of the slide of FIG. 10 showing rotational stress on the roller. DETAILED DESCRIPTION In the following detailed description of the preferred embodiments, specific terminology is used for the sake of clarity. However, the invention is not limited to the specific terms selected, but includes all technical equivalents functioning in a substantially similar manner to achieve a substantially similar result. General construction details of three part drawer slides are well known in the art. Relevant disclosures, showing typical prior art slides, ball bearing retainers, channel members and stop mechanisms include U.S. Pat. Nos. 4,537,450 (Baxter); 4,991,981 (Baxter); and the patent references discussed above in the section entitled &#34;Background of the Invention.&#34; The reader is directed to these references for general construction details and configurations of three part drawer slides. FIG. 1 shows a cross-section view of a drawer slide 10 according to the invention. FIGS. 6 to 11 show elevation and plan views of the slide of FIG. 1. The drawer slide comprises an outer slide member or outer channel member 20 which in a first of two alternate orientations is affixed to an interior wall of a stationary article of furniture; an intermediate slide member 30 which is slidable in the outer member 20; and an inner slide or channel member 40 which can be affixed to an outer surface of a side wall of a movable drawer. A second alternate orientation is shown in FIG. 5 and described below. A first set of ball bearings 70 enable outer slide member 40 to telescope in and out of the intermediate slide member 30. Likewise, a second set of ball bearings 72 mounted between intermediate member 30 and outer member 20 enable the intermediate member to slide through the outer member. To be retained in the channel members the bearings are rotatably or rollably mounted in bearing retainers or ball spacers 74. The retainers axially retain the bearings so as to keep each set together, while the channel members and intermediate slide member retain the bearings. A stop (not shown) can be provided to prevent the drawer from being pulled entirely out of the article of furniture. The channel members 20, 40 preferably are symmetrically identical. The slide is mounted to the drawer and article of furniture via the channel members. The discussion below relates to details of the outer channel member 20 in FIG. 1, but the same parts are provided in symmetrically opposite locations on the inner channel member 40. The inner and outer channel members can be manufactured in identical form and assembled in opposite orientation and are elongated to any desired slide length. The channel members are preferably formed with a vertically elongated &#34;C&#34; shaped cross section using cold-rolled steel or other suitable material, and comprise a generally vertical or flat outer wall 22, upper and lower inwardly angled walls 26, and arcuate top and bottom walls 28. In this description, &#34;inwardly&#34; means toward a center axis of the intermediate slide member 30. The inner surfaces 29 of top and bottom walls 28 form raceways or trackways for the ball bearings 70, 72. The intermediate slide member 30 preferably is formed in a single piece of steel or other suitable material. The intermediate member can be roll-formed or solid extruded metal. The unitary construction adds structural stability and reduces manufacturing costs of the entire apparatus. Moreover, the central member is symmetrical and may be inverted or reversed without affecting the operation of the mechanism. For clarity, details of the intermediate member 30 of FIG. 1 are identified by reference numerals on FIG. 3. One of ordinary skill in the art will readily understand that the intermediate members of FIGS. 1 and 3 are identical, except that the intermediate member of FIG. 1 additionally comprises a progression roller as discussed below. As indicated in FIG. 3, the intermediate slide member 30 comprises a central vertical wall 32 unitarily formed with upper and lower short horizontal walls 34A, 34B. Preferably, the horizontal walls are joined at an approximately right angle to the central wall. Using a sharp or hair pin bend, the walls 34A, 34B are joined to upper and lower parallel arcuate raceway members 36A, 36B. Preferably, each of the raceway members includes an arcuate raceway surface 38A, 38B. The raceways provide a second trackway or bearing surface for ball bearings 70, 72. Thus, in operation, when the outer or inner channel members are moved axially in or out, the ball bearings 70, 72 will simultaneously rotate on the trackways formed by the inside face 29 of the outer and inner channel members and on the outward-facing raceways 38A, 38B on the intermediate slide member. Preferably, a central vertical axis of the central wall 32 forms a center of gravity of the slide, so that a downward-bearing load placed on the top of channel member 20 is directed down into the central wall. The intermediate member 30 further comprises angled arms 80A, 80B joined at one end to raceway members 36A, 36B. The opposite end of the angled arms 80A, 80B is joined to short vertical walls 82A, 82B. These vertical walls are joined at their upper ends to arcuate upper and lower raceways 84A, 84B. These upper and lower raceways provide a ball bearing trackway or raceway directly opposite raceways 29. This combination of elements provides an intermediate member enabling four sets of ball bearings to be arranged on nearly collinear axes, minimizing the horizontal thickness and the vertical height of the slide. The structure of the intermediate member also enables greater &#34;wrap&#34; around the ball bearings 70, 72. As is known in the art, &#34;wrap&#34; refers to the amount of perimeter surface of the bearing which is covered or guided by a raceway. A large amount of wrap is desirable to prevent lateral disembodiment (pulling apart) of the slide. As shown in FIGS. 1 and 3, the ball bearings 70, 72 are nearly encircled completely by raceways 29, 84A and arcuate member 28 and raceway 38A, 38B. The slide of FIG. 1 also comprises a progression roller 80 which can rotate on a vertical axis on axles 82, 84. Preferably the roller comprises a resilient material such as soft rubber with a steel core. The axles are formed in a window or cutout 86 of central wall 32 of intermediate member 30. When the slide is opened or closed, as discussed below, the perimeter surface 89 of the roller rolls against the interior faces 24, 44 of the channel members 20, 40. Friction caused by contact of the rubber roller with the metal channel members enables smooth, controlled, progressive opening and closing of the slide. Unlike the prior art, the central mounting location of the roller enables use of a progression roller in a horizontally thin and vertically short slide. Unlike two-part drawer slides, three-part drawer slides permit full outward extension of a drawer from a cabinet. The progression roller enables smooth and controlled extension of the slide without hitting noise. Three-part slides without progression rollers produce several &#34;clicks&#34; caused by the drawer slide members hitting together as the slide extends. Typically, when a drawer with a prior art slide is pulled out, the movable inner member first extends to its entire length. Inwardly protruding end tabs on the inner member strike the end of the intermediate member, causing &#34;pick up noise&#34; (a &#34;click&#34;) and pulling the intermediate member out. When the slide reaches full extension there is another &#34;click&#34; as end tabs on the intermediate member strike stop tabs on the stationary outer member. This phenomenon is well known in the art. It is also possible for the intermediate member to extend first, followed by the movable inner member, but the double click effect is the same. In contrast, in a slide of the present invention, when a drawer is pulled out of an article of furniture, the inner member extends and the intermediate slide member is also carried forward by the progression roller. As a result, both the movable inner member and the intermediate member extend from the stationary outer member at the same rate, preventing hitting noise or &#34;clicks.&#34; Operation of the progression roller in the slide of FIG. 1 is shown in FIGS. 6 to 11. FIGS. 6 and 7 show elevation and section views, respectively, of the slide of FIG. 1 in the closed position. At least one clearance window 120 is provided in the outer channel member 20. The window 120 preferably comprises a generally rectangular cutout in the outer channel member. The window has a leading edge 122 and a trailing edge 124. When the slide is closed, the roller 80 protrudes through the window, as shown in FIG. 7, and the perimeter surface of the roller rests against the leading and trailing edges 122, 124, 142, 144. Inner channel member 40 has a corresponding window or cutout 140 with a leading edge 142 and a trailing edge 144. When the slide is closed, the windows 120, 140 are opposite one another. In this closed position, the edges of the window act as a detent on the roller. Slight side-to-side pressure on the slide will not cause the slide to move since the protruding roller is abutted against edges 122, 124, 142, 144. However, firm pressure on the slidable members of the slide will cause the roller to compress inside the slide, moving under edges 124, 142 and assuming the deformed shape shown in exaggerated form in FIGS. 8 and 9. As shown in FIG. 8, when the slide is opened, the roller moves past the window 120 and is compressed between the interior surfaces 24, 44 of outer member 20 and inner member 40. The compression of the roller 80 exerts friction on the channel members, insuring that the slide parts extend smoothly and at a proportional rate. This eliminates the hitting phenomenon found in prior art slides. The progression roller feature also balances the load on the slide, thereby increasing life of the slide. The window 120 also acts as a decompression mechanism for the roller. In prior art slides with a roller located between outer and inner channel members of a slide, the roller is compressed even when the slide is completely closed. As a result, over time, constant compression of the roller can cause the roller to assume a distorted shape, or lose its compressive tension entirely. This is known in the art as &#34;taking a set&#34; and results in a malfunction of the roller. In the present invention, the windows 120, 140 enable the roller to release compressive tension when the slide and drawer are completely closed. The window prevents flat spots from forming on the roller when it is in continuous compression. This extends the life of the roller and improves its performance. The roller also provides a self-closing effect, as illustrated in FIGS. 10 and 11. FIG. 10 provides a section view of the slide of FIGS. 7 and 9, in which the slide channel members are almost closed. In this position, the windows 120, 140 are slightly offset, and the roller assumes an oval shape. Part of the perimeter surface of the roller extends into the windows 120, 140, and a portion of the roller remains compressed in the slide. In this position, rotational tension develops in the roller as indicated by arrows 200, 210 in FIG. 11. This tension urges the roller to rotate, thereby causing the slide to close completely. Thus, if the slide is closed part way, such as by a user pushing a drawer with insufficient pressure to close the drawer completely, the roller will tend to urge the slide (and the drawer) closed. This prevents slides and drawers from stopping in a slightly open position. In an alternative embodiment, the leading and trailing edges of the windows can be formed at an angle, or can be beveled, so as to enhance or retard detent action of the window. The roller additionally prevents &#34;creep&#34; of the slide. The friction exerted on the outer and inner channel members by the roller under compression increases the force required to move the slide. This causes the slide to remain in a desired position until sufficient force is exerted on the slide to overcome the friction exerted by the roller. In an alternate contemplated embodiment, the outer and inner channel members can be provided with multiple windows, thereby enabling use of the windows as detents or multiple stop positions for the slide. The roller can comprise any resilient material and can be synthetic. Referring to FIG. 2, an alternate embodiment slide is shown. Symmetrically identical left and right (outer and inner) channel members or channel means 20, 40 are provided for slidably attaching the slide to an article of furniture and a drawer. One or more holes 48 can be provided in the vertical wall to enable securement of the slide apparatus to a drawer or an article of furniture using a threaded fastener 50. Preferably, a #6 pan head screw is used for fastening the slide to furniture. 0f course, any suitable type of fastener can be used. The fasteners must be flush with the channel or member surface so as to ensure that the roller does not roll over or against the heads of the fasteners. The fasteners could comprise flat head counter sunk threaded screws or bayonets. Also, in the embodiment of FIG. 2, the raceway members 84A, 84B are joined by an additional hairpin bend to secondary raceway members 86A, 86B. These members provide double-thickness raceways for the intermediate member, thereby increasing the load which the slide can carry. In the embodiment of FIG. 3, the ball bearings 70 are retained in left and right bridge-type bearing retainers 60L, 60R. The ball bearing retainers are symmetrically identical, thereby reducing manufacturing costs by enabling a single type of retainer to be used on both sides of the apparatus. As is known in the art, each bridge type bearing retainer holds two sets of ball bearings to cause both sets to move synchronously. Both left and right retainers 60L, 60R include corresponding parts in a like arrangement. The left ball bearing retainer 60L includes a central vertical wall 62. The vertical wall 62 is joined using upper and lower angled walls 64A, 64B. Each angled wall has a plurality of spaced-apart holes or pockets (not shown) in which the ball bearings rotate. The general construction of ball bearing retainers is well-known in the art. For example, the ball bearing retainer disclosed in U.S. Pat. No. 4,991,981 (Baxter) is suitable for incorporation in the mechanism disclosed herein. Another alternate embodiment is shown in FIG. 4. In this embodiment, the intermediate member 30 does not comprise a vertical central wall 32. Instead, the intermediate member comprises a generally horizontal central wall 33 joined by a sharp bend to one end of two short vertical walls 35A, 35B. The opposite end of these walls is joined to the raceway members 36A, 36B. Use of a horizontal central wall 33 in place of the vertical central wall 32 enables the embodiment of FIG. 4 to be vertically shorter than the embodiments of FIGS. 1, 2, and 3. Preferably, the overall height of a side of FIG. 4 is approximately 32 millimeters, and its overall width is about 13 millimeters. The embodiment of FIG. 4 provides a high-strength, heavy-duty miniature drawer slide in which four sets of bearings are provided in a vertically and horizontally compact arrangement. As shown in FIG. 5, the offset positioning of the channel members facilitates attachment of a slide to a drawer and an article of furniture with the slide in the aforementioned second orientation. In the prior art, slide attachment brackets (not shown) are required to enable attachment of a drawer slide in the arrangement of FIG. 5. The offset channel arrangement of the present invention enables the top surface of the movable channel member 20 to act as a load-bearing member for the drawer. In this arrangement, a &#34;U&#34;-shaped bracket 90 is provided and secured to the channel member 40 using welding or with a suitable fastener, or using bayonets provided on the exterior surface of the channel member 40. The bracket can comprise a generally vertical wall 92, a horizontal bottom wall 94 joined at a right angle to the vertical wall, and an inner vertical wall 96 which can be joined to the slide. Preferably channel member 40 is welded to the vertical wall 96 or secured thereto using a fastener 105. The bracket can be affixed to an article of furniture using suitable fasteners such as screws 91. The drawer 100 comprises top and bottom walls 110, 108 which are spaced apart by an inner vertical wall 104. Storage space 106 is provided in the drawer. An inner vertical wall 102 is provided in spaced-apart relation to the vertical wall 104. Preferably channel member or drawer member 20 is fixed to the wall 102 using brackets or other fastening means (not shown). The drawer also comprises a load-bearing wall 114 which can be mounted directly on the arcuate wall 28 of the slide. This enables the outer channel member 20 to transfer load from the drawer to the intermediate member, thereby reducing shear load on whatever fastening means is used. A fascia panel 120 can be provided, to prevent the drawer slide from being visible when the drawer is open. The ball bearings may be constructed of steel, plastic, ceramic, or any suitable material, and the slide members can comprise steel, stainless steel, plastic, aluminum, or any similar suitable material. As indicated above, the present invention provides a novel and unique apparatus for facilitating support and smooth sliding of drawers in articles of furniture. A unitarily-formed central or intermediate slide member provides a plurality of raceways for four separate sets of ball bearings, with reduced manufacturing costs and simpler construction than the prior art. Drawer slides according to the invention may be used in a variety of nondrawer applications such as extendable writing surfaces of desks and other applications known in the art. The invention may be practiced in many ways other than as specifically disclosed herein. For example, the drawings are not rendered to scale and the size of the walls can be modified. In one contemplated embodiment, elongated plastic strips are affixed to the interior faces of the channel members, thereby increasing friction exerted by the progression roller. The plastic strip can be smooth or knurled. Positive progression can be provided by forming the strips as a rack and using a pinion gear instead of a smooth roller. Bayonet mounting tabs can be formed in the channel members to facilitate mounting the slide on metal furniture. Bayonets are preferred for the embodiment of FIG. 1 and FIG. 4 since use of fasteners protruding through the channel members is impractical with these embodiments. Thus, the scope of the invention should be determined from the appended claims.

A thin profile drawer slide apparatus for slidably supporting a heavy drawer in furniture, comprising symmetrical, identical channel members for slidably attaching the apparatus to a drawer and an article of furniture, a plurality of bearings slidably retained in the channel members by bearing retainers, and by an intermediate slide member. The intermediate slide member comprises the unitarily formed combination of a generally vertical central wall, a first bearing raceway joined to an end of the central wall, and a second bearing raceway joined to an arcuate wall extending angularly outwardly from the first bearing raceway, whereby the first and second bearing raceways are vertically and angularly separated. The ball bearings are arranged in four linear, slightly offset sets. Use of a single intermediate slide member with raceways for four separate sets of bearings provides a thin, strong drawer slide for carrying heavy loads. In an alternate embodiment, the central wall of the intermediate slide member comprises a generally rectangular window with a progression roller mounted therein on a vertical axis of rotation. The roller exerts friction on the inner faces of the channel members by compression against the inner faces when the roller is moved. Edges of window act as a detent on the roller and also urge the slide closed when the slide is brought to rest with the roller against one of the edges. The windows relieve compression of the roller when the slide is fully closed.

BACKGROUND OF THE INVENTION The invention relates to apparatus to prevent splash and spatter of bodily fluids on health care workers in dentistry and other medical fields. Prior art devices have either been uncomfortable, bulky, obtrusive, costly, difficult to adjust, or difficult to clean and sterilize. New OSHA regulations require that chin length face shields be used by those that may be exposed to the splash or spatter of bodily fluids as may occur in the dental or medical field. Extensive cleaning and sterilization procedures are required to prevent contamination that further increases the cost of health care. The use of disposable products in medical facilities is increasing because it is less expensive, in many cases, to replace a low cost product than incur the cost of labor for cleaning and sterilization. Frequently, a doctor may need to wear magnifying lens or other attachments to his glasses during certain procedures that interfere with conventional face shield use. This is a major design consideration. The prior art structures include U.S. Pat. No. 4,965,887 having a joint inventor that is the same as the present invention. While the apparatus described in that patent is useful for many applications it and other prior art suffers from the following disadvantages: 1. The clips are discarded with the shield which is wasteful and results in a poor use of natural resources. 2. The cost is very high because of the waste of material and the high labor content. 3. The present shields are limited in adjustment in their present form to horizontal adjustment along the temple members of a frame. 4. Each time a typical prior art shield is washed, sterilized and placed back on the wearer&#39;s glasses the mounting brackets have to be adjusted. This is particularly significant when the health care professional visits a number of patients. When the brackets are adjusted improperly, as could happen if the wearer were to hurry, the shield may be installed in a crooked position and may not provide proper protection. 5. The present face protection devices are very difficult to clean and sterilize when the user goes from patient to patient. The new OSHA guidelines for those exposed to bodily fluids such as might occur in dentistry and the medical field, require frequent changing of face shields. Disposable shields are being required in more and more medical procedures because of the high cost and time required for proper cleaning and sterilizing for contamination prevention between patients. 6. The present face shield devices are not practical to recycle as they contain combinations of different materials such as plastics and metal. 7. Prior art apparatus commonly uses head covers for added protection along with greater side protection at the eye area. Replacing head covers and face shields between patients creates an expensive practice with first cost, installation and adjustment cost, washing and sterilization cost and administration cost. 8. When magnifying lens, loops or other attachments are used with the doctors glasses, conventional face shields cannot be used. SUMMARY OF THE INVENTION It has now been found that these and other objects of the invention may be attained in a face protector apparatus for protecting the user&#39;s face including the eyes, nose, ears or mouth, which includes a web shaped substantially transparent plastic lens member; a frame for mounting on the face of a user including a brow member dimensioned and configured for extending across the face of a user and having first and second axial extremities. The brow member includes depending nose pads for engaging the nose of the user and the frame includes first and second temple members, each of the temple members cooperating with respective axial extremities of the brow member; first and second clips carried on respective temple members, each of the clips including first means for releasably engaging the lens member and independent second means for releasably engaging one of the temple members, the first means releasably engaging the lens without affecting the engagement between the second means and a temple member. In some forms of the invention each of the second means is slidable along the axial extent of one the temple members. The first means may grip the lens along an edge thereof and the first means may includes a slot for receiving the lens. The first means may include means for locking the lens in the slot and/or a lock screw. The second means may include a lock screw and an elongated slot dimensioned and configured to receive one of the temple members. In some forms of the invention the clamp is pivotally mounted on the clip and the lens includes a preformed support frame. In other forms of the invention the apparatus includes means for mounting on the face of a user including a brow member dimensioned and configured for extending across the face of a user and having first and second axial extremities, the brow member including depending nose pads for engaging the nose of the user, the frame including first and second temple members, each of the temple members cooperating with respective axial extremities of the brow member, which includes a web shaped substantially transparent plastic lens member; first and second clips carried on respective associated temple members, each of the clips including first means for releasably engaging the lens member and independent second means for releasably engaging one of the temple members, the first means releasably engaging the lens without affecting the engagement between the second means and a temple member. Each of the second means may be slidable along the axial extent of one of the temple members and the first means may grip the lens along an edge thereof. In some forms of the invention the first means includes a slot for receiving the lens and the first means includes means for locking the lens in the slot. The first means may include a lock screw and the second means may include a lock screw. The second means may include an elongated slot dimensioned and configured to receive one of the temple members and the second means includes a clamp. In other forms of the invention includes a preformed glassless frame. The frame includes first and second elongated temple members, the temple members each include a first and second axial extremities. The frame further includes a brow member dimensioned and configured to extend across the face of the user. The brow member may include means for engaging the nose of the user including depending first and second nose pads and means for cooperating with the first axial extremities of each of the temple members. The apparatus also includes a web shaped substantially transparent plastic lens member and first and second means each including means for engaging the frame and means for releasably engaging the lens. The means for releasably engaging the lens is independent of the means for engaging whereby the release of the lens does not affect the meas for engaging. The means for engaging may cooperate with one of the temple members and may be slidable along the axial extent thereof. BRIEF DESCRIPTION OF THE DRAWING The invention will be better understood by reference to the accompanying drawings in which: FIG. 1 is a view of one form of the invention showing the glassless support frames with two double clips and a clear plastic face shield lens on a human face. FIG. 2 is a side view showing the side of the frame, clip and lens. FIG. 2A is a cross-section view of the reusable double clip with a set screw locking feature. FIG. 2B is a plan or top view of the reusable double clip. FIG. 2C is an isometric view of the reusable double clip. FIG. 3 is a perspective view of the device in accordance with a second form of the invention that includes a double clip with a spring loaded press on clip for connection to the frame. FIG. 4 is a cross-section view of the second form of the reusable double clip showing a locking set screw pressed against the lens material and a rivet attachment that acts to secure the clip and to allow for partial rotation adjustment. FIG. 4A is a plan view of the spring loaded double clip. FIG. 4B is an inside view of the spring loaded double clip, shown in FIG. 4, secured to the temple frame. FIG. 4C is a side view of the spring loaded double clip as shown in FIG. 4 showing the locking set screw knob. FIG. 5 is a schematic view of a third form of the double clip that shows a screw type clamping action to lock onto the frame. FIG. 6 is a schematic view of fourth form of the double clip that shows a spring loaded clamping action to lock onto the temple frame. FIG. 7 is a schematic view of fifth form of the double clip that shows part of a frame having a round temple member that allows for rotation adjustment of the clip. FIG. 8 is a side view of a sixth form of the invention that includes a head cover attached to the face shield lens by means of a clamp device. FIG. 9A is a side view of a seventh form of the invention showing the face protector with a preformed support frame with clips, lens and head cover attached. FIG. 9B is a cross-section of the preformed support frame shown in FIG. 9A taken along the line 9B of FIG. 9A. FIG. 9C is a cross-section of the head cover material holder also shown in FIG. 9B. FIG. 9D is a side view of the inner face of the clip fastened to the support frame and which shows the structure of FIG. 9A in greater detail. FIG. 9E is a cross-section of the support frame of FIG. 9A with clip and head cover holder attached. FIG. 9F is an isometric view of the face protector of FIG. 9A with support frame and clips. FIG. 10A is a side view of one form of the invention showing the face protector with preformed and integrated support frame, interlocking clips and interlocking temple frames, with lens and head cover attached. FIG. 10B is a cross-section of the temple frame. FIG. 10C is a cross-section of a portion of the preformed temple frame with interlocking matching shape for clip engagement and fastening. FIG. 10D is a cross-section of the preformed support frame shown in FIG. 10A taken along the line 10C of FIG. 10A. This view shows interlocking of double clip to both the support frame and temple frame. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to FIGS. 1 and 2 a face protector 10 is shown that includes a frame that comprises temple members 21, 21 that are pivotally connected to brow member 23 in the manner of conventional glasses. In the usual form of the invention no optical lens or &#34;sunglass&#34; lens (other than the face shield lens 20) is carried on the frame. (Accordingly, the frames may be referred to herein as &#34;glassless&#34; frames.) Carried on the brow member 23 is a pair of nose rests 22. The protector 10 also includes reusable double clips 11, 11 and a clear plastic face shield lens 20. Those skilled in the art will recognize that each double clip 11 is the mirror image of the other. (In certain forms of the invention the cross-section of the temple members or frames 21 may have an interlocking shape for the clips 11.) One such clip 11 is shown in greater detail in FIGS. 2A, 2B, and 2C. The face shield lens 20 is inserted into a slot 11b until it abuts the end 11c of the slot 11b. A lens set screw 15 is shown tightened so that the end 15a of the set screw 15 presses against and slightly deforms the lens 20 and locks it into position. The temples 21 are disposed within respective channel slots 11d and locked in place by the end 17b of a temple set screw 17a. The slot 11d is dimensioned and configured so that each clip 11 can slide back and forth along the temple 21. The clear plastic face shield lens 20 is inserted into the thin slot 11b in the respective double clips 11 and then secured into position with set screws that lock the lens 20 to the clips 11. Once properly adjusted the clips 11 are then secured into position with set screws 17a that lock the clips onto the temple frames 21. With the clips 11 locked onto the temple frames 21 it is a quick and simple matter to remove and replace a soiled or contaminated face shield lens 20 without further adjustment being necessary. The face protector 10 may be adjusted to fit any size or any shape head and face. The unique feature of providing both vertical and horizontal adjustment with locking set screws assures a perfect fit every time a new face shield lens 20 is installed. The slot or groove 11d that clamps over the temple frame can be larger than the temple frame cross-section thereby allowing further rotation adjustment that allows the face shield lens 20 to be tilted slightly from the vertical position before being locked into position. The thin slot that the lens 20 is inserted into is tilted inward at the bottom. This causes the face shield to tilt in toward the sides of the chin, tapering down and in for a contoured look that more generally follows the natural tapering of ones head from wide at top to narrow at chin. The face protector 10, in one form of the invention, also allows for the clips 11, head cover and lens 20 to be attached to a common preformed support frame 5. Once the clips 11 are adjusted to the wearers face and secured to the temple frames 21 of the glassless frame no further adjustments are necessary. Replacement lens 20 are simply inserted in the slot 11b in the support frame 30 and secured with set screws 15. Replacement head covers are simply placed in a holder 31 that is slipped into a slot in the support frame 30 where it also is secured with set screws 32. This face protector 10 invention comprises a brow member 23, two temple members 21, 21 with two integral reusable double clips 11 and a clear plastic face shield lens 20. The double clips 11 can slide back and forth along the temple frames 21. The clear plastic face shield lens 20 is inserted into the thin slot in the double clips 11 and then secured into position with set screws 15 that lock the lens 20 to the clips 11. Once properly adjusted the clips 11 are then secured into position with set screws that lock them onto the temple frames 21. With the clips 11 locked onto the temple frames 21 it is a quick and simple matter to remove and replace a soiled or contaminated face shield lens 20 without further adjustment being necessary. The face protector 10 invention can be adjusted to fit any size or any shape head and face. The unique feature of providing both vertical and horizontal adjustment with locking set screws assures a perfect fit every time a face shield lens 20 is used. The slot or groove that clamps over the temple frame can be larger than the temple frame cross-section thereby allowing further rotation adjustment that allows the face shield lens 20 to be tilted slightly from the vertical position before being locked into position. The thin slot that the lens 20 is inserted into is tilted inward at the bottom. This causes the face shield to tilt in toward the sides of the chin tapering down and in for a contoured look that more generally follows the natural tapering of ones head from wide at top to narrow at chin. The face protector 10 can accommodate a wide range of different shape and thickness face shield lens 20 to suit the protection required for the medical procedure at hand. A full or partial head cover can be utilized with the face shield lens 20 thereby providing even further protection. The face protector 10 may be used for light duty face protection in a wide variety of applications. It can also act as a secondary protector when worn over safety glasses. The face protector 10, in one form of the invention, also allows for the clips 11, head cover and lens 20 to be attached to a common preformed support frame 30. Once the clips 11 are adjusted to the wearers face and secured to the temple frames 21 and the support frame 30 no further adjustments are necessary. Replacement lens 20 are simply inserted in the slot 11b in the support frame 30 and secured with set screws 15. Replacement head covers 24 are simply placed in a holder 31 that is slipped into a slot in the support frame where it also is secured with set screws. In another form of the invention, shown in FIGS. 3 and 4, a face protector 10 is shown as above except a clamp on double clip 11 is used. A cushioned grip 14 of the spring loaded clip 12 portion of the double clip 11 engages the temple 21. A rivet 16 allows for slight rotational adjustment of the spring loaded clip 12 portion. FIG. 5 shows another form of the double clip 11 with a screw type clamping feature. A set screw 17 provides the necessary clamping action. FIG. 6 shows another form of the double clip 11 that shows a spring loaded clamp 12 securing the temple frame 21. FIG. 7 shows another form of the double clip 11 with a round temple frame 21 that allows for rotation adjustment of the double clip 11 around the temple frame 21. FIG. 8 shows another form of the face protector 10 with a head cover 24 held in place with clamp 29 at support holder 26 that secures the head cover 24 to the face shield lens 20. This view also shows prescription or safety glasses 21A being used. FIG. 9A-9F shows another form of the face protector 10 with the clips 11 fastened to an integral preformed support frame 30 and the temple frames 21. In this form the clips 11 can slide along the support frame 30 that holds the lens 20 and head cover 24. The support frame 30 acts to hold and stiffen the lens 20 when the lens 20 material is of a thinner thickness or when the lens 20 is wider and extended out to cover the magnifying lens 21b. Such magnifying lens 21b are frequently used in front of glasses 21a. The support frame 30 being of lightweight plastic can easily deform to suit the head width of the wearer. FIGS. 10A-10D show still another form of the face protector 10 with the clips 11 interlocked and fastened to an integral preformed support frame 30 and the preformed temple frames 21. In this form, the temple frames 21 are of matching cross-sectional shape for interlocking with the clips 11. The clips 11 can then slide along both the support frame 30 and the temple frame 21 for extended adjustment and failsafe operation. A partial head cover 24, partial chin cover 32 and a safety strap 33, to prevent slipping, is also shown. IMPROVEMENT OVER PRIOR ART The face protector 10 is a substantial improvement over prior art for the following reasons: 1. Having the face protector 10 with reusable double clips 11 substantially reduces the cost of face protection. 2. The face protector 10 with reusable double clips 11 allow for adjustment of the clear plastic face shield lens 20 in both the vertical and horizontal direction and in certain forms may include a swivel feature thereby providing for infinite adjustment to fit any size head. 3. The two reusable double clips 11 can be securely clamped to the temple support frames 21 once they are adjusted for ideal fit. Then the two reusable double clips 11 and temple support frames 21 act as a face protector 10 ready to receive replacement face shield lens without loosing the ideal adjustment for ones own unique face. 4. This face protector 10 device speeds up lens replacement between patients for avoiding contamination problems. 5. The reusable double clips 11 clips in another form of the invention can be securely clamped to a clear face shield lens and used with ones safety glasses, prescription glasses or glassless supporting frames 21. 6. The two reusable double clips 11 devices can allow for various thickness face shield lens to be used. During certain procedures it may be desirable to use a thicker lens. Likewise a very lightweight lens may be used on low risk procedures. 7. The face protector 10 device provides such a simple, inexpensive, comfort able and easy to use face shield method that it will be used. 8. The reusable double clips 11 device allows for face shields with light ray shielding properties to be used during certain procedures. 9. The face protector 10 device can also be used with a shorter shield lens for use by the dental patient during certain procedures for protection from dropped instruments, splash or spray. 10. The face protector 10 device can be manufactured out of a lightweight high temperature resistant plastic or metal so that the entire assembly can be sterilized in an autoclave. 11. The face protector 10 device allows for the replacement face shield lens to be supplied in the flat stamped position so that a great quantity can be stacked for packaging and shipping. 12. The face protector 10 device can also be adjusted with the reusable double clips 11 in a forward position thereby allowing the use of loops, magnifying lens or other visual aids behind the face shield lens. This feature also keeps the complex and expensive magnifying lens equipment clean and free of splatter. These units are very difficult to clean and sterilize. The face protector 10 can protect these units from contamination as the doctor goes from patient to patient. 13. The face protector 10 device with glassless temple frames 21 can also be provided with reusable double clips 11 with a channel feature or prongs that allows for the face protector 10 to simply fit over regular glasses. 14. The face protector 10 device with the integral preformed support frame allows for the clips 11, head cover and lens to all be quickly and independently attached to a common support 30. The support frame 30 allows for further extension of a lighter and wider face shield lens as may be used when magnifying lens, as described in item 12 above, are used. The support frame 30 acts to hold and stiffen the wider and lighter weight lens and prevents it from swaying or shaking. The preformed support frame 30 is partially flattened from the round curvature in front so that glare is reduced at the lens 20, especially when in the extended position. The support frame 30 can thus support any width of thickness lens. The support frame 30 becomes a convenient universal support and may also be fitted with various attachments including magnifying lens, loops, light shielding lens, a clamp on light, a fan, a nose bridge support and temple frame extensions for resting on ones ears. The face protector 10 device with integral preformed support frame 30, preformed temple frames 21 and interlocking clips 11 can be adjusted to reduce the face protector weight on the bridge of the nose. When the clips 11 are slid back, toward the ears, the weight also shifts to the non-sensitive ear area. Very little weight, except for support stabilization then occurs at the sensitive bridge of the nose area and forehead area. FORMS AND VARIATIONS OF THE INVENTION The face protector 10 may be provided in a number of forms and variations including the following: 1. The face protector 10 may include a glassless support frame with two reusable double clips 11 attached to the temple frames 21. In this form of face protector 10 the face shield lens 20 can be simply attached or replaced without loosing adjustment. 2. The face protector 10 may include prescription, or safety glasses 21A with two reusable double clips 11 attached to the temple frames 21. In this form of the face protector 10 the face shield lens can also be simply attached without loosing adjustment, but in addition, the wearer has the added protection of his safety glasses 21A. The wearer also has the comfort of using his own comfortable frames. 3. The reusable double clips 11 may be made out of plastic with a thin slot to receive the thin face shield lens. A screw type fastener could be used to tighten against the lens material thereby locking it in place. An attached spring loaded clip 11 could be an integral part of the assembly. This clip portion would be used to clamp onto the temple members 21 of the users glasses. 4. The reusable double clips 11 may be plastic injected molded wherein a portion of the assembly is designed to allow a clamping action to occur so as to clamp onto the temple frames 21. 5. The reusable double clips 11 may be an integral or added part of the temple frames 21. This version may include greater adjustment, and easier manufacturing. This version may also have preformed partially rounded temple frames 21 that allow for partial rotation around frame 21. A swivel feature may also be provided allowing the clip and lens portion to be tilted from the vertical position. 6. The face protector 10 may also include additional clamps that can act to hold a head cover in place. 7. The reusable double clips 11 may be preformed and shaped to match the cross-section shape of the preformed temple frames 21. The clip 11 can then slide along the preformed temple frame 21 without the possibility of becoming disengaged. 8. The reusable double clips 11 may include an offset bracket and swivel that allows for the lens portion to be tilted upward when in the non-protection mode. 9. The reusable double clips 11 may include spring type clamps, press or friction fit clamps, screw type clamps or a wide variety of fastening or clamping devises to simultaneously secure both the face shield lens to ordinary or preformed temple frames 21 thereby forming a face protector 10. The variations of form, of materials and of methods may vary widely but these teachings include the method of a support frame 30 such as glasses or glassless support frames 21 so that the only point of contact is the temple or glassless frames resting on the ears and on the bridge of the nose. 10. The face protector 10 device may include a common preformed support frame 30 that allows for simple and quick attachment of the clips 11, head cover and face shield lens. In this form of the invention the clips 11 connect to the temple frames 21 and the support frame 30. The head cover and lens are secured to the support frame 30. This common support frame 30 may also allow for attachment of other devices. 11. The clips 11 will ordinarily be manufactured of metal or high temperature plastic to permit sterilization in an autoclave. Because sterilization may be achieved without an autoclave other materials may be used in other forms of the invention. In this form of the invention, a thin slot in the body of the support frame 30 can accept the insertion of a face shield lens 20; the lens is secured in place with set screws 15 that press against the lens material within the slot thereby locking the lens in place. An additional slot in the support frame 30 can accept the insertion of a head cover holder 31; the holder 31 is secured in place with set screws 32 that press against the holder 31 within the slot thereby locking the head cover 24 and holder 31 in place. An additional grooved slot in the support frame 30 can accept the clips 11 that secure to the temple frames 21; the clips 11 can then slide along the support frame 30 to obtain optimum adjustment, then lock in place with set screws. In this form the clips are very secure and slide along in a snug, fail proof fit. Once fitted and adjusted to a wearers face the lens and or head cover can quickly and easily be replaced without further adjustments being necessary. The invention has been described with reference to its illustrated preferred embodiment. Persons skilled in the art of such devices may upon exposure to the teachings herein, conceive other variations. Such variations are deemed to be encompassed by the disclosure, the invention being delimited only by the following claims.

A face protector for protecting the face against fluid splatter or splash of bodily fluids as occurs in the medical field, which includes a glassless temple frame support with two reusable double clips that are slid over the temple frames and clamped onto the ends of a disposable clear plastic face shield lens. The two reusable double clips are then carefully slid into position on the temple frames of the glassless supporting frames. Once the face protector is adjusted to fit ones face the reusable double clips are locked by set screws onto the temple frames where they can remain in place. The disposable face shield lens can simply be removed, discarded and quickly replaced without further adjustment being necessary. This device thereby provides for practical face shield protection. When soiled, scratched or contaminated the clear face shield lens may be removed and discarded. The support frames with (reusable double clips) attached then act as the structural support of the face protector ready to receive a new clean face shield lens. In another form of the invention the reusable double clips can be attached to the wearers own prescription glasses or safety glasses thereby converting the assembly into a face protector. In yet another form of the invention the clips, lens and head cover are attached to a preformed support frame.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates to a rehabilitation footwear, especially to a rehabilitation footwear that can fix bones of an injured foot and has adjustable functions according to different stages of recovery and rehabilitation. [0003] 2. Description of the Prior Art [0004] An injured person&#39;s foot after surgery, fracture, sprain or contusion needs to be fixed with plaster to fix soft tissues as well as bones in a right position. The purpose of using plaster is to prevent the soft tissues and the bones from shifting and causing a secondary injury and to enhance rehabilitation of the foot. To enhance rehabilitation of the soft tissues and the bones of the injured person, a rehabilitation footwear is available on the market. Conventional rehabilitation footwear includes an ankle rehabilitation footwear and a rehabilitation footwear. The ankle rehabilitation footwear is used for protecting a sole and an ankle of the foot. The high leg rehabilitation footwear is used for protecting a shank of the leg. The ankle rehabilitation footwear is restricted to rehabilitate an injured region of the sole and ankle of the foot. On the other hand, the high leg rehabilitation footwear is designed with an adjustable or nonadjustable height. The high leg rehabilitation footwear with adjustable height can be adjusted according to the injured region of the foot. However, the high leg rehabilitation footwear with adjustable height lacks a design for full cover protection and for different recovery stages of the foot. In other words, the conventional rehabilitation footwear lacks the adjustable function based on the recovery stages of the foot to enhance the recovery rate of the soft tissues as well as the bones of the injured person. [0005] To overcome the shortcomings, the present invention provides a rehabilitation footwear to mitigate or obviate the aforementioned problems. SUMMARY OF THE INVENTION [0006] The main objective of the invention is to provide a rehabilitation footwear with an adjustable function according to the recovery stages of an injured person&#39;s foot. [0007] The rehabilitation footwear in accordance with the present invention has a shoe body, multiple fasteners, a back guard pad, a front guard pad, two supporting frames and an encircling band. [0008] The shoe body comprises multiple buckles and two concave grooves. [0009] Each of the multiple fasteners comprises a buckle ring and a band ring. The buckle ring is fastened with one of the multiple buckles of the shoe body. [0010] The back guard pad comprises a lower back guard pad, a middle back guard pad, and an upper back guard pad. The lower back guard pad comprises two protrusion parts, multiple holes and multiple perforations. The two protrusion parts of the back guard pad are interlocked with the two concave grooves of the shoe body. The middle back guard pad comprises multiple buckles and multiple clasps. The multiple buckles of the middle back guard pass through the multiple holes of the lower back guard pad and are fastened with the buckle rings of the multiple fasteners. The multiple clasps of the middle back guard are clasped with the perforations of the lower back guard pad. The upper back guard pad comprises multiple buckles and multiple clasps. The multiple buckles of the upper back guard pad pass through the multiple holes of the lower back guard pad and are fastened with the buckle rings of the multiple fasteners. The multiple clasps of the upper back guard pad are clasped with the multiple perforations of the lower back guard pad. [0011] The front guard pad comprises a lower front guard pad, a middle front guard pad, and an upper front guard pad. The lower front guard pad comprises a clasp. The middle front guard pad comprises a perforation clasped with the clasp of the lower front guard pad. The upper front guard pad comprises a perforation clasped with the clasp of the lower front guard pad. [0012] Each of the two supporting frames comprises a protrusion part and multiple band rings. The protrusion part of each of the two supporting frames is interlocked with each of the two concave grooves of the shoe body. [0013] The encircling band passes through the multiple band rings of the two supporting frames that are positioned correspondingly to each other. [0014] A full-cover rehabilitation footwear is built up by combination of the shoe body, the lower back guard pad, the upper back guard pad, the lower front guard pad and the upper front guard pad, and fixed with the injured person&#39;s foot by the encircling band passing through the band rings of the multiple fasteners corresponding to each other. [0015] A supporting-type rehabilitation footwear is built up by combination of the shoe body, the lower back guard pad, the middle back guard pad, the lower front guard pad and the middle front guard pad, and fixed with the injured person&#39;s foot by the encircling band passing through the band rings of the multiple fasteners corresponding to each other. [0016] A frame-type rehabilitation footwear is built up by combination of the shoe body and the two supporting frames, and fixed with the injured person&#39;s foot by the encircling band passing through the multiple band rings of the two supporting frames corresponding to each other. BRIEF DESCRIPTION OF THE DRAWINGS [0017] FIG. 1 is a perspective exploded view of a rehabilitation footwear in accordance with the present invention; [0018] FIG. 2A is an enlarged view of a lower back guard pad of the rehabilitation footwear in FIG. 1 ; [0019] FIG. 2B is an enlarged view of an upper back guard pad of the rehabilitation footwear in FIG. 1 ; [0020] FIG. 3 is a side view of the rehabilitation footwear in FIG. 1 ; [0021] FIG. 4 is a perspective view of a first embodiment of the rehabilitation footwear in accordance with the present invention; [0022] FIG. 5 is a perspective view of a second embodiment of the rehabilitation footwear in accordance with the present invention; and [0023] FIG. 6 is a perspective view of a third embodiment of the rehabilitation footwear in accordance with the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The First Embodiment [0024] With reference to FIG. 1 , a first embodiment of a rehabilitation footwear in accordance with the present invention comprises a shoe body 10 , a back guard pad 1000 , a front guard pad 2000 , a first fastener 11 , a second fastener 12 , a third fastener 13 , a fourth fastener 14 , a fifth fastener 15 , a sixth fastener 16 , a seventh fastener 17 , an eighth fastener 18 , a first fill A and a second fill B. [0025] The shoe body 10 comprises two lateral sides and a back end respectively corresponding to bilateral sides and a heel of a human&#39;s foot. The two lateral sides and the back end of the shoe body 10 form a capacity space for accommodating the human&#39;s foot. The two lateral sides comprise a first buckle 111 , a second buckle 122 , a third buckle 133 , and a fourth buckle 144 . The back end of the shoe body 10 comprises a first concave groove 155 and a second concave groove 166 . [0026] The back guard pad 1000 comprises a lower back guard pad 20 and an upper back guard pad 30 . The lower back guard pad 20 comprises three lateral sides connected with each other at nearly right angle, allowing to be formed a lower capacity space for accommodating a back of a human&#39;s shank. The lower capacity space comprises a lower end and an upper end. Two of the lateral sides of the lower back guard pad 20 opposite each other and corresponding to the lower end of the lower capacity space extend and form a first protrusion part 201 and a second protrusion part 202 . The first protrusion part 201 and the second protrusion part 202 are respectively interlocked with the first concave groove 155 and the second concave groove 166 of the shoe body 10 , allowing the back guard pad 1000 to be fixed with the shoe body 10 . The two opposite lateral sides of the lower back guard pad 20 comprise a first hole 203 and a second hole 204 . The two lateral sides of the lower back guard pad 20 opposite each other and corresponding to the upper end of the capacity space extend outwards and form a small capacity space. [0027] With reference to FIG. 1 and FIG. 2A , the small capacity space corresponding to the two lateral sides of the lower back guard pad 20 opposite each other forms a third hole 205 , a fourth hole 206 , a fifth hole 207 , a sixth hole 208 , a first perforation 209 , a second perforation 210 , a third perforation 211 and a fourth perforation 212 . [0028] The upper back guard pad 30 comprises three lateral sides connected with each other at nearly right angle, allowing to be formed an upper capacity space for accommodating the back of the human&#39;s shank. The upper capacity space comprises a lower end and an upper end. Two of the lateral sides of the upper back guard pad 30 opposite each other and corresponding to the upper end of the upper capacity space comprise a first upper buckle 301 and a second upper buckle. The two lateral sides of the upper back guard pad 30 opposite each other and corresponding to the lower end of the upper capacity space comprise a third upper buckle 303 and a fourth upper buckle. The third upper buckle 303 and the fourth upper buckle respectively pass through the first hole 203 and the second hole 204 of the lower back guard pad 20 . [0029] With reference to FIG. 1 , FIG. 2A and FIG. 2B , the two lateral sides of the upper back guard pad 30 opposite each other and corresponding to the lower end of the upper capacity space extend outwards and form protrusion structures. One of the protrusion structures is a protrusion structure 30 A. The protrusion structure 30 A comprises a surrounding a recess, and the first fill A is placed in the recess of the protrusion structure 30 A. The protrusion structure 30 A is fitted into the small capacity space of the lower back guard pad 20 . The other one of the protrusion structures is identical to the protrusion structure 30 A and positioned oppositely to the protrusion structure 30 A of the upper back guard pad 30 . The other one of the protrusion structures comprises a surrounding wall having a recess, and the second fill B is placed in the recess of the other one of the protrusion structures. The protrusion structure 30 A and the second fill B are fit into the small capacity space of the two opposite lateral sides of the lower back guard pad 20 . The first fill A comprises a first bump A 1 and a second bump A 2 . The second fill B comprises a third bump B 1 and a fourth bump. The first bump A 1 passes through the third hole 205 of the lower back guard pad 20 , and the second bump A 2 passes through the fourth hole 206 of the lower back guard pad 20 . The third bump B 1 passes through the fifth hole 207 of the lower back guard pad 20 , and the fourth bump passes through the sixth hole 208 of the lower back guard pad 20 . [0030] Two lateral sides of the surrounding wall of the protrusion structure 30 A comprise a first clasp 305 and a second clasp 306 formed toward outside of the recess. The first clasp 305 passes through and is clasped with the first perforation 209 of the lower back guard pad 20 . The second clasp 306 passes through and is clasped with the second perforation 210 of the lower back guard pad 20 , allowing the lower back guard pad 20 to be fixed with the upper back guard pad 30 . [0031] With reference to FIG. 1 and FIG. 3 , the first fastener 11 , the second fastener 12 , the third fastener 13 , the fourth fastener 14 , the fifth fastener 15 , the sixth fastener 16 , the seventh fastener 17 and the eighth fastener 18 each comprises two ends. One end of each of the first fastener 11 , the second fastener 12 , the third fastener 13 , the fourth fastener 14 , the fifth fastener 15 , the sixth fastener 16 , the seventh fastener 17 and the eighth fastener 18 comprises a buckle ring respectively corresponding to the first buckle 111 , the second buckle 122 , the third buckle 133 , the fourth buckle 144 , and the first upper buckle 301 , the second upper buckle, the third upper buckle 303 and the fourth upper buckle of the upper back guard pad 30 . The other end of each of the first fastener 11 , the second fastener 12 , the third fastener 13 , the fourth fastener 14 , the fifth fastener 15 , the sixth fastener 16 , the seventh fastener 17 and the eighth fastener 18 comprises a band ring, allowing an encircling band 80 to be passed through. The encircling band 80 comprises a fabric hook and loop fastener. [0032] With reference to FIG. 1 and FIG. 3 , the front guard pad 2000 comprises a lower front guard pad 50 and an upper front guard pad 60 . The lower front guard pad 50 comprises a front end and a back end. The back end of the lower front guard pad 50 comprises a clasp 501 . The upper front guard pad 60 comprises a front end. The front end of the upper front guard pad 60 comprises a clasp 601 . [0033] With reference to FIG. 1 and FIG. 4 , a method for using the first embodiment comprises: [0034] (1) putting an injured person&#39;s foot wrapped in a rehabilitation strap 90 on a surface 10 A of the shoe body 10 , and placing the back of the injured person&#39;s shank in the lower capacity space of the lower back guard pad 20 and the upper capacity space of the upper back guard pad 30 . [0035] (2) fastening the first fastener 11 , the second fastener 12 , the third fastener 13 , and the fourth fastener 14 respectively with the first buckle 111 , the second buckle 122 , the third buckle 133 and the fourth buckle 144 . [0036] (3) placing the lower front guard pad 50 on an instep of the injured person&#39;s foot, such that the front end of the lower front guard pad 50 is corresponding to a tiptoe of the injured person&#39;s foot. [0037] (4) passing the encircling band 80 through the band rings of the first fastener 11 and the second fastener 12 , and the band rings of the third fastener 13 and the fourth fastener 14 , separately. [0038] (5) fixing the injured person&#39;s foot between the shoe body 10 and the lower front guard pad 50 by attaching the fabric hook and loop fastener of the encircling band 80 . [0039] (6) passing the third upper buckle 303 , the fourth upper buckle, the first clasp 305 and the second clasp 306 through the first hole 203 , the second hole 204 , the first perforation 209 and the second perforation 210 of the lower back guard pad 20 , respectively, allowing the first clasp 305 and the second clasp 306 to be clasped respectively with the first perforation 209 and the second perforation 210 of the lower back guard pad 20 . [0040] (7) fastening the buckle ring of the fifth fastener 15 , the sixth fastener 16 , the seventh fastener 17 and the eighth fastener 18 with the third upper buckle 303 , the fourth upper buckle, the first upper buckle 301 and the second buckle of the upper back guard pad 30 , respectively, allowing the lower back guard pad 20 to be fixed with the upper back guard pad 30 . [0041] (8) placing the upper front guard pad 60 on a front of the injured person&#39;s shank, and clasping the clasp 601 of the upper front guard pad 60 with the clasp 501 of the lower front guard pad 50 . [0042] (9) passing the encircling band 80 through the band rings of the fifth fastener 15 and the sixth fastener 16 , and the band rings of the seventh fastener 17 and the eighth fastener 18 , separately, allowing the injured person&#39;s shank to be fixed between the lower back guard pad 20 , the upper back guard pad 30 and the upper front guard pad 20 . [0043] The first embodiment allows soft tissues as well as bones of the injured person&#39;s foot to be protected by fixing in a full-cover rehabilitation footwear, and avoids shifting of the soft tissues and bones to enhance recovery. The Second Embodiment [0044] With reference to FIG. 1 and FIG. 5 , a second embodiment of the rehabilitation footwear in accordance with the present invention comprises a shoe body 10 , a back guard pad 1000 , a front guard pad 2000 , a first fastener 11 , a second fastener 12 , a third fastener 13 , a fourth fastener 14 , a fifth fastener 15 , a sixth fastener 16 , a first fill A and a second fill B. [0045] The shoe body 10 comprises two lateral sides and a back end corresponding to bilateral sides and a heel of a human&#39;s foot, respectively. The two lateral sides and the back end of the shoe body 10 form a capacity space for accommodating the human&#39;s foot. The two lateral sides comprise a first buckle 111 , a second buckle 122 , a third buckle 133 , and a fourth buckle 144 . The back end of the shoe body 10 comprises a first concave groove 155 and a second concave groove 166 . [0046] The back guard pad 1000 comprises a lower back guard pad 20 and a middle back guard pad 40 . The lower back guard pad 20 comprises three lateral sides connected with each other at nearly right angle, allowing to be formed a lower capacity space for accommodating the back of the human&#39;s shank. The lower capacity space comprises a lower end and an upper end. Two of the lateral sides of the lower back guard pad 20 opposite each other and corresponding to the lower end of the lower capacity space extend and form a first protrusion part 201 and a second protrusion part 202 . The first protrusion part 201 and the second protrusion part 202 are respectively interlocked with the first concave groove 155 and the second concave groove 166 of the shoe body 10 , allowing the back guard pad 1000 to be fixed with the shoe body 10 . The two opposite lateral sides of the lower back guard pad 20 comprise a first hole 203 and a second hole 204 . The two lateral sides of the lower back guard pad 20 opposite with each other and corresponding to the upper end of the capacity space extend outwards and form a second small capacity space. [0047] With reference to FIG. 1 and FIG. 2A , the second small capacity space corresponding to the two opposite lateral sides of the lower back guard pad 20 forms a third hole 205 , a fourth hole 206 , a fifth hole 207 , a sixth hole 208 , a first perforation 209 , a second perforation 210 , a third perforation 211 and a fourth perforation 212 . [0048] The middle back guard pad 40 is smaller than the upper back guard pad 30 and comprises three lateral sides connected with each other at nearly right angle, allowing to be formed a middle capacity space for accommodating the back of the human&#39;s shank. The middle capacity space comprises a lower end and an upper end. [0049] The two lateral sides of the middle back guard pad 40 opposite each other and corresponding to the lower end of the middle capacity space comprise a first middle buckle 401 and a second middle buckle. The first middle buckle 401 and the second middle buckle pass through the first hole 203 and the second hole 204 of the lower back guard pad 20 , respectively. [0050] Two of the lateral sides of the middle back guard pad 40 opposite each other and corresponding to the upper end of the middle capacity space extend outwards and form protrusion structures. One of the protrusion structures is a second protrusion structure 40 A. The second protrusion structure 40 A comprises a surrounding wall having a second recess, and the first fill A is placed in the second recess of the second protrusion structure 40 A. The second protrusion structure 40 A is fitted into the small capacity space of the lower back guard pad 20 . The other one of the protrusion structures is identical to the second protrusion structure 40 A and positioned oppositely to the second protrusion structure 40 A of the middle back guard pad 40 . The other one of the protrusion structures comprises a surrounding wall having a recess formed threin, and the second fill B is placed in the recess of the other one of the protrusion structures. The second protrusion structure 40 A and the second fill B are fit into the small capacity space of the two opposite lateral sides of the lower back guard pad 20 . The first fill A comprises a first bump A 1 and a second bump A 2 . The second fill B comprises a third bump B 1 and a fourth bump. The first bump A 1 passes through the third hole 205 of the lower back guard pad 20 , and the second bump A 2 passes through the fourth hole 206 of the lower back guard pad 20 . The third bump B 1 passes through the fifth hole 207 of the lower back guard pad 20 , and the fourth bump passes through the sixth hole 208 of the lower back guard pad 20 . [0051] Two lateral sides of the surrounding wall of the second protrusion structure 40 A comprise a third clasp 403 and a fourth clasp 404 formed toward outside of the recess. The third clasp 403 passes through and is clasped with the first perforation 209 of the lower back guard pad 20 . The fourth clasp 404 passes through and is clasped with the second perforation 210 of the lower back guard pad 20 , allowing the lower back guard pad 20 to be fixed with the middle back guard pad 40 . [0052] The first fastener 11 , the second fastener 12 , the third fastener 13 , the fourth fastener 14 , the fifth fastener 15 , the sixth fastener 16 , the seventh fastener 17 and the eighth fastener 18 each comprise two ends. One end of each of the first fastener 11 , the second fastener 12 , the third fastener 13 , the fourth fastener 14 , the fifth fastener 15 , the sixth fastener 16 , the seventh fastener 17 and the eighth fastener 18 comprises a buckle ring corresponding respectively to the first buckle 111 , the second buckle 122 , the third buckle 133 , the fourth buckle 144 , and the first middle buckle 401 , the second middle buckle of the middle back guard pad 40 . The other end of each of the first fastener 11 , the second fastener 12 , the third fastener 13 , the fourth fastener 14 , the fifth fastener 15 , and the sixth fastener 16 comprises a band ring, allowing an encircling band 80 to be passed through. The encircling band 80 comprises a fabric hook and loop fastener. [0053] With reference to FIG. 1 and FIG. 5 , the front guard pad 2000 comprises a lower front guard pad 50 and a middle front guard pad 70 . The lower front guard pad 50 comprises a front end and a back end. The back end of the lower front guard pad 50 comprises a clasp 501 . The middle front guard pad 70 comprises a front end. The front end of the middle front guard pad 70 comprises a clasp 701 . [0054] A method for using the first embodiment comprises: [0055] (1) putting an injured person&#39;s foot wrapped in the rehabilitation strap 90 on the surface 10 A of the shoe body 10 , and placing the back of the injured person&#39;s shank in the lower capacity space of the lower back guard pad 20 and the upper capacity space of the upper back guard pad 30 . [0056] (2) fastening the first fastener 11 , the second fastener 12 , the third fastener 13 , and the fourth fastener 14 respectively with the first buckle 111 , the second buckle 122 , the third buckle 133 and the fourth buckle 144 . [0057] (3) placing the lower front guard pad 50 on an instep of the injured person&#39;s foot, such that the front end of the lower front guard pad 50 is corresponding to a tiptoe of the injured person&#39;s foot. [0058] (4) passing the encircling band 80 through the band rings of the first fastener 11 and the second fastener 12 , and the band rings of the third fastener 13 and the fourth fastener 14 , separately. [0059] (5) fixing the injured person&#39;s foot between the shoe body 10 and the lower front guard pad 50 by attaching the fabric hook and loop fastener of the encircling band 80 . [0060] (6) passing the first middle buckle 401 , the second middle buckle, the third clasp 403 and the fourth clasp 404 through the first hole 203 , the second hole 204 , the first perforation 209 and the second perforation 210 of the lower back guard pad 20 , respectively, allowing the third clasp 403 and the fourth clasp 404 to be clasped respectively with the first perforation 209 and the second perforation 210 of the lower back guard pad 20 . [0061] (7) fastening the buckle rings of the fifth fastener 15 and the sixth fastener 16 with the first middle buckle 401 , the second middle buckle of the middle back guard pad 40 , respectively, allowing the lower back guard pad 20 to be fixed with the middle back guard pad 40 . [0062] (8) placing the middle front guard pad 70 on a front of the injured person&#39;s shank, and clasping the clasp 701 of the middle front guard pad 70 with the clasp 501 of the lower front guard pad 50 . [0063] (9) passing the encircling band 80 through the band rings of the fifth fastener 15 and the sixth fastener 16 , and the band rings of the seventh fastener 17 and the eighth fastener 18 , separately, allowing the injured person&#39;s shank to be fixed between the lower back guard pad 20 , the middle back guard pad 40 and the upper middle guard pad 70 . [0064] According to recovery of the injured person&#39;s foot, when ready for the next rehabilitation stage, the rehabilitation footwear of the fist embodiment can be replaced by the second embodiment. The rehabilitation footwear of the second embodiment allows the soft tissues as well as bones of the injured person&#39;s foot to be protected by fixing in a supporting-type rehabilitation footwear further for enhancing the rate of recovery. The Third Embodiment [0065] With reference to FIG. 1 , a third embodiment of the rehabilitation footwear in accordance with the present invention comprises a shoe body 10 , frames, a first fastener 11 , a second fastener 12 , a third fastener 13 , a fourth fastener 14 , a fifth fastener 15 and a sixth fastener 16 . [0066] The shoe body 10 comprises two lateral sides and a back end corresponding to bilateral sides and a heel of a human&#39;s foot, respectively. The two lateral sides and the back end of the shoe body 10 form a capacity space for accommodating the human&#39;s foot. The two lateral sides comprise a first buckle 111 , a second buckle 122 , a third buckle 133 , and a fourth buckle 144 . The back end of the shoe body 10 comprises a first concave groove 155 and a second concave groove 166 . [0067] The frames comprise a first supporting frame 100 and a second supporting frame 110 . Each of the first supporting frame 100 and the second supporting frame 110 comprises a lower end, a middle end, an upper end and two lateral sides. [0068] The lower ends of the first supporting frame 100 and the second supporting frame 110 extend and respectively form a first protrusion part 1001 and a second protrusion part 1101 . The first protrusion part 1001 of the first supporting frame 100 and the second protrusion part 1101 of the second supporting frame 110 are respectively interlocked with the first concave groove 155 and the second concave groove 166 of the shoe body 10 . The two lateral sides of the middle end of the first supporting frame 100 comprise a first band ring 1001 A and a second band ring 1001 B; the two lateral sides of the upper end of the first supporting frame 100 comprise a third band ring 1001 C and a fourth band ring 1001 D. The two lateral sides of the middle end of the second supporting frame 110 comprise a fifth band ring 1101 A and a sixth band ring 1101 B; the two lateral sides of the upper end of the second supporting frame 110 comprises a seventh band ring 1101 C and an eighth band ring 1101 D. [0069] The first fastener 11 , the second fastener 12 , the third fastener 13 , the fourth fastener 14 , the fifth fastener 15 and the sixth fastener 16 each comprise two ends. One end of each of the first fastener 11 , the second fastener 12 , the third fastener 13 , the fourth fastener 14 , the fifth fastener 15 and the sixth fastener 16 comprises a buckle ring corresponding respectively to the first buckle 111 , the second buckle 122 , the third buckle 133 , the fourth buckle 144 , allowing an encircling band 80 to be passed through. The encircling band 80 comprises a fabric hook and loop fastener. [0070] With reference to FIG. 1 and FIG. 6 , a method for using the first embodiment comprises: [0071] (1) wrapping an injured person&#39;s foot with the rehabilitation strap 90 and placing the injured person&#39;s foot on the surface 10 A of the shoe body 10 . [0072] (2) fastening the first fastener 11 , the second fastener 12 , the third fastener 13 , and the fourth fastener 14 respectively with the first buckle 111 , the second buckle 122 , the third buckle 133 and the fourth buckle 144 . [0073] (3) passing the encircling band 80 through the band rings of the first fastener 11 and the second fastener 12 , and the band rings of the third fastener 13 and the fourth fastener 14 , separately. [0074] (4) fixing the injured person&#39;s foot with the shoe body 10 by attaching the fabric hook and loop fastener of the encircling band 80 . [0075] (5) passing the encircling band 80 through the first band ring 1001 A of the first supporting frame 100 and the fifth band ring 1101 A of the second supporting frame 110 , separately; passing the encircling band 80 through the second band ring 1001 B of the first supporting frame 100 and the sixth band ring 1101 B of the second supporting frame 110 , separately; passing the encircling band 80 through the third band ring 1001 C of the first supporting frame 100 and the seventh band ring 1101 C of the second supporting frame 110 , separately; finally, passing the encircling band 80 through the fourth band ring 1001 D of the first supporting frame 100 and the eighth band ring 1101 D of the second supporting frame 110 , separately, allowing the injured person&#39;s shank to be fixed between the first supporting frame 100 and the second supporting frame 110 . [0076] According to recovery of the injured person&#39;s foot, when ready for next rehabilitation stage, the rehabilitation footwear of the second embodiment can be replaced by the third embodiment. The rehabilitation footwear of the second embodiment allows the soft tissues as well as bones of the injured person&#39;s foot to be protected by fixing in a frame-type rehabilitation footwear further for enhancing the rate of recovery.

A rehabilitation footwear comprises a shoe body, multiple fasteners, a lower back guard pad, an upper back guard pad, a lower front guard pad, an upper front guard pad, and two supporting frames. A full-cover rehabilitation footwear can be built up by combining the shoe body, the lower back guard pad, the upper back guard pad, the lower front guard pad, and the upper front guard pad together with the multiple fasteners. A supporting-type rehabilitation footwear can be built up by combining the shoe body, the lower back guard pad, the middle back guard pad, the lower front guard pad, and the middle front guard pad together with the multiple fasteners. A frame-type rehabilitation footwear can be built up by combining the shoe body and the two supporting frames together with the multiple fasteners. An adjustable rehabilitation footwear is provided.

BACKGROUND [0001] The present invention relates to a system, method and apparatus for ablating tissue under temperature control of each electrode to control lesion dimensions, and in particular for ablating myocardial tissue to treat Ventricular Tachycardia (VT) or atrial fibrillation/flutter (AF). [0002] Ventricular tachycardia is a disease of the heart which causes the heart chambers to beat excessively fast and usually degenerates to ventricular fibrillation where the heart chambers do not effectively pump blood through the body&#39;s system and hence leads to death. Ventricular tachycardia is the most common cause of cardiac arrest and sudden death. Typical features of patients with VT are (1) a history of myocardial infarction (heart attack), (2) significant left ventricular dysfunction (the main chamber effecting the pumping action), and (3) left ventricular aneurysm (dilation, thinning and stretching of the chamber). Detailed mapping studies of the electrical propagation within the myocardium during VT have shown that a re entrant pathway within and around the scarring (caused by infarction) is responsible for the arrhythmia, These studies have shown that the critical area of myocardium necessary to support reentry appears to be less than 2 to 4 cm 2 . [0003] Atrial fibrillation (AF) and atrial flutter are diseases of the heart which can cause the heart to beat excessively fast and frequently in an erratic manner. This usually results in distress for patients. This may also be associated with clot formation in the atria, which may become dislodged and cause strokes. AF is usually due to abnormal electrical activation of the atria. Preliminary investigations have shown that linear lesions in the atria using radiofrequency ablation can cure these arrhythmias. [0004] A number of conventional techniques using radio frequency (RF) energy have been used to treat VT or AF. Endocardial radio frequency catheter ablation has been used in the treatment of hemodynamically stable monomorphic ventricular tachycardia secondary to coronary artery disease. The resulting lesions caused in RF ablation using catheters however have been insufficient in volume to destroy the area of tissue causing the arrhythmia. [0005] Radiofrequency catheter ablation has been used for treatment of AF, but has been limited by the number of separate ablations required and the time required to perform the procedure. [0006] In accordance with one conventional technique, RF energy is delivered from an RF source, incorporating phase shift networks to enable potential differences and hence current flow between multiple, separate electrode structures. Also, multiple RF power sources have been used connected to such electrodes. The independent phases of the power source lead to multiple current paths. [0007] However, this conventional system lacks adequate temperature control because the multiphase RF ablation cannot function satisfactorily unless certain restrictions on the dimensions of the electrode are adhered to. The ablation temperature can only be maintained at an optimum predetermined level of approximately 80° C. This is a significant shortfall of the technique. SUMMARY [0008] The present invention is directed to improving the efficacy of producing radio frequency lesions using multiple temperature controlled delivery by splitting high frequency current from a single generator into a number of electrodes simultaneously. Further, the system accurately measures the temperatures of these electrodes which are then used as the feedback in the system, allowing appropriate control strategies to be performed to regulate the current to each electrode. [0009] In accordance with a first aspect of the invention, a system for ablating tissue comprises; [0010] a device for generating RF energy; [0011] a probe device comprising N separate electrodes, each having a corresponding device for sensing the temperature of the electrode; [0012] a splitter device for splitting the RF energy coupled to the generating device and the probe device, the splitter device having N separate channels each being coupled to a corresponding one of the N electrodes and temperature sensing device; and [0013] a device for controlling the splitter device, whereby the ablation of tissue at each electrode is independently controlled using closed loop feedback of the temperature of the electrode by independently regulating the amount of the RF energy delivered to each electrode. [0014] Preferably, the system comprises a plurality of the probe devices and the splitter devices, and the controlling device separately controls each of the probe devices and the corresponding splitter device. [0015] Preferably, the probe device has an elongated needle-like structure with one end adapted to puncture tissue and having sufficient rigidity to puncture the tissue, or a catheter which can be advanced into the heart. Bach of the electrodes may consist of a circular metal surface separated one from another by insulation. [0016] Preferably, the RF energy has a single phase. [0017] Preferably, the system further comprises a device for independently and continuously adjusting the RF energy delivered to each electrode in response to a control signal from the controlling device dependent on the temperature of the electrode. [0018] Preferably, the controlling device is programmable. [0019] Optionally, the probe device is a catheter probe device. [0020] Preferably, each of the temperature sensing devices is a thermocouple. Preferably, the splitter device comprises one or more devices for independently interrupting current from the RF energy generating device to a respective electrode. [0021] In accordance with a second aspect of the invention, a medical apparatus for treatment by radiofrequency ablation of tissue comprises: [0022] an RF energy generator; [0023] one or more probes each comprising a plurality of separate electrodes and corresponding temperature sensors for sensing the temperature of the electrodes, each temperature sensor connected to a respective one of the plurality of electrodes; [0024] a splitter for splitting the RF energy provided by the RF energy generator, the splitter having a plurality of separate channels, wherein each of the electrodes is coupled to a respective one of the plurality of channels; and [0025] a programmable controller coupled to the RF splitter for independently controlling the ablation of tissue at each electrode using closed loop feedback of the temperature of the electrode, whereby the amount of the RF energy delivered to each electrode is independently regulated by the programmable controller. [0026] In accordance with a third aspect of the invention, a radio frequency energy splitter for use with one or more probes in a system for RF ablation of tissue is provided. Each probe comprises a plurality of separate electrodes and corresponding temperature sensors for sensing the temperature of the electrode. The splitter comprises: [0027] an input device for receiving RF energy from an RF energy generator; [0028] a plurality of channel modules for separately delivering RP energy from the input device to a respective electrode of the plurality of electrodes of the one or more probes, each channel module comprising: [0029] a device for variably adjusting an amount of the RF energy delivered to the respective electrode in response to a control signal, the variable adjusting device being coupled between the input device and the respective electrode; [0030] a device for interrupting the RF energy delivered to the respective electrode: [0031] an output device coupled to the respective temperature sensor for providing a temperature signal; [0032] a device for determining if the temperature at the respective electrode exceeds a predetermined threshold and actuating the interrupting device if the threshold is exceeded, whereby the RF energy is interrupted from delivery to the respective electrode; [0033] wherein each channel module is capable of receiving the respective control signal from and providing the respective temperature signal to a programmable controller so that the amount of the RF energy delivered to each electrode can be independently regulated using closed loop feedback of the temperature of each electrode. [0034] Preferably, the variable adjusting device or circuit comprises a bridge rectifier including a fast-switching variable resistance for controlling operation of the bridge rectifier in response to the control signal. [0035] Preferably, the RF energy interrupting device comprises a circuit for interrupting a current through the RF energy interrupting device and a circuit for limiting the current. [0036] Preferably, the determining device compares the temperature signal with the predetermined threshold. [0037] In accordance with a fourth aspect of the invention, a method for ablating tissue comprises the steps of: [0038] generating RF energy; [0039] providing a probe device comprising N separate electrodes, each having a corresponding temperature sensing device; [0040] measuring the temperature of each electrode using the temperature sensing device of the electrode; [0041] splitting the RF energy to the probe device into N separate channels each being coupled to a corresponding one of the N electrodes and temperature sensing device; and [0042] controlling the splitting of the RF energy to the probe device, whereby the ablation of tissue at each electrode is independently controlled using closed loop feedback of the measured temperature of the electrode by independently regulating the amount of the RF energy delivered to each electrode. [0043] Preferably, the method comprises the step of separately controlling the splitting of the RF energy to a plurality of the probe device. [0044] Preferably, the probe device has an elongated needle-like structure with one end adapted to puncture tissue and having sufficient rigidity to puncture the tissue, wherein each of the electrodes consists of a metal substantially circular surface separated one from another by insulation. [0045] Preferably, the RF energy has a single phase. [0046] Preferably, the method further comprises the step of independently and continuously adjusting the RF energy delivered to each electrode in response to a control signal from a programmable controlling device dependent on the temperature of the electrode. [0047] In accordance with a fifth aspect of the invention, a method for treatment by radiofrequency (RF) ablation of tissue comprises the steps of: [0048] generating RF energy; [0049] providing one or more probes each comprising a plurality of separate electrodes and corresponding temperature sensors, each temperature sensor connected to a respective one of the plurality of electrodes; [0050] measuring the temperature of each electrode using the respective temperature sensor; [0051] splitting the RF energy into a plurality of separate channels, wherein each of the electrodes is coupled to a respective one of the plurality of channels; and [0052] programmably controlling the splitting of the RF energy so as to independently control the ablation of tissue at each electrode using closed loop feedback of the measured temperature of the electrode, whereby the amount of the RF energy delivered to each electrode is independently regulated. [0053] Preferably, the method involves using at least two probes, and comprises the step of programmably controlling each of the probes separately. [0054] In accordance with a sixth aspect of the invention, there is provided a method of splitting radio frequency energy delivered to one or more probes in a system for RF ablation of tissue. Each probe comprises a plurality of separate electrodes and corresponding temperature sensors for sensing the temperature of the electrode. The method comprises the steps of: [0055] receiving RF energy from an RF energy generator; [0056] providing a plurality of channel modules for separately delivering the RF energy to a respective electrode of the plurality of electrodes of the one or more probes, further comprising, for each channel module, the sub-steps of: [0057] variably adjusting an amount of the RF energy delivered to the respective electrode in response to a control signal; [0058] measuring the temperature of the respective electrode using the corresponding temperature sensor to provide a temperature signal; [0059] determining if the temperature at the respective electrode exceeds a predetermined threshold and interrupting delivery of the RF energy to the respective electrode if the threshold is exceeded; [0060] wherein each channel module is capable of receiving the respective control signal from and providing the respective temperature signal to a programmable controller so that the amount of the RF energy delivered to each electrode can be independently regulated using closed loop feedback of the temperature of each electrode. [0061] Preferably, the step of variably adjusting the RF energy comprises the step of changing the resistance of a fast-switching variable resistance incorporated in a bridge rectifier in response to the control signal. [0062] Preferably, the step of interrupting the RF energy comprises the steps of interrupting a current to the respective electrode and limiting the current. [0063] Preferably, the step of determining comprises the step of comparing the temperature signal with the predetermined threshold. BRIEF DESCRIPTION OF THE DRAWINGS [0064] Embodiments of the invention are described hereinafter with reference to the drawings, in which [0065] [0065]FIG. 1 is a block diagram of the RF ablation system according to one embodiment; [0066] [0066]FIG. 2. is a detailed schematic of a single channel of the system of FIG. 1; [0067] [0067]FIG. 3 is a detailed schematic of the system of FIG. 1, wherein N=4; and [0068] [0068]FIG. 4 is a detailed schematic of a single channel of an RF ablation system according to another embodiment. DETAILED DESCRIPTION [0069] First Embodiment [0070] The RF ablating system according to a first embodiment shown in FIG. 1 comprises a programmable controller 2 , an N-channel RF splitter 6 , an RF generator 8 , a large conductive, dispersive plate 12 , and an N-electrode probe 20 . RF generators for RF ablation of tissue are well known in the art. It will be appreciated by a person skilled in the art that the present invention can be practiced with any of a number of RF generators without departing from the scope and spirit of the invention. [0071] Preferably, the probe 20 has a needle-like structure wherein each of the electrodes 22 A to 22 D has a tubular or ring shape. The electrodes 22 A to 22 D are separated from each other by an intervening insulative portion. Such a probe structure is disclosed in International Publication No. WO 97/06727 published on Feb. 27, 1997 (International Application No. PCT/AU96/00489 by the Applicant) and incorporated herein by cross-reference. The structure of this probe 20 enables the electrodes 22 A to 22 D to be inserted into the myocardium for use in the present system. While this embodiment is described with reference to a single needle probe 20 , the system may be practiced with a plurality of such needle probes 20 and one or more corresponding N-channel RF splitters 6 that are controlled by the programmable controller 2 . It will be apparent to a person skilled in the art that the embodiment is not limited to the use of such needle-like probes but may be practiced with other types of ablating probes including catheters. [0072] Further, while this embodiment is discussed with reference to ablation of reentrant pathways in relation to ventricular tachycardia, the system is not limited to this particular application, and instead can practiced in relation to a number of other applications. For example, the system may be used to ablate tissue causing atrial fibrillation or flutter, tumors, or for coagulation treatment. [0073] The programmable controller 2 may be implemented using a general purpose computer executing a control algorithm to operate the RF splitter 8 in response to measured temperatures of the electrodes 22 A to 22 D, as described below. In this embodiment, the programmable controller 2 is preferably implemented using an AMLAB instrument emulator (published in International Publication No. WO92/15959 on Sep. 17, 1992; International Application No. PCT/AU92/00076), which comprises a general purpose computer having a digital signal processor subassembly that is configurable using a graphical compiler. The programmable controller 2 is connected to the N-channel RF splitter 6 via N output control signals 14 and N temperature signals 16 provided from the N-channel RF splitter 6 to the programmable controller 2 . The N-channel RF splitter 6 , the RF generator 8 , the RMS-to-DC converter 10 , the probe 20 , and the dispersive plate 12 , shown as module 4 , are provided so as to meet electrical isolation barrier requirements in accordance with IEC 601 and AS3200.1 type CF standards. [0074] The N-channel RF splitter 6 provides RF energy from the RE generator 8 coupled to the splitter 6 via N electrical connections 18 to the corresponding electrodes 22 A to 22 D of the probe 20 . In addition, the N electrical connections 18 are connected to corresponding thermocouples of each of the electrodes 22 A to 22 D. While thermocouples are preferably employed, other temperature transducers or sensing circuits/devices may be practiced without departing from the scope and spirit of the invention. For example, a temperature sensing device for a respective electrode of one or more electrodes could include a thermistor or other temperature transducer. The N temperature signals 16 provided to the programmable controller 2 are obtained from the temperature sensing devices of the electrodes 22 A to 22 D. The RF generator 8 is also connected to the dispersive electrode 12 via the RMS-to-DC converter 10 . [0075] This embodiment advantageously employs a single RF generator in which the N-channel RF splitter 6 independently controls the delivery of RF energy of a single phase to one or more of the electrodes 22 A to 22 D of the probe 20 . The temperature of each of the electrodes 22 A to 22 D is independently monitored by the programmable controller 2 , which in turn provides the control signals 14 to the N-channel RF splitter 6 to simultaneously control the amount of RF energy delivered to the corresponding electrode 22 A to 22 D. [0076] Using closed-loop feedback and independent, simultaneous control of each electrode, the system is able to advantageously regulate temperatures to occur at each electrode at the desired temperature. This produces optimum lesion size, and avoids charring and vaporisation associated with temperatures greater than 100° C. This is in marked contrast to the prior art, since the embodiment provides a margin of at least 20° C., highlighting the lack of temperature control of all of the electrodes in the conventional system. The prior art is able to affect only the temperature of the electrode being monitored. As lesions size is proportional to the temperature of the electrodes, the system according to this embodiment is able to controllably produce larger lesion. The ability to maintain all electrodes at a desired temperature simultaneously and independently enables contiguous uniform lesions, not as dependent on the size and contact area of each electrode. Conversely, if it is desired to deliver RF energy to only one particular electrode to minimise thermal damage to “good” tissue, the system according to this embodiment is able to ensure that adjacent electrodes have minimal current. That is, the system according to this embodiment has the ability to ensure precise temperature control of each electrode individually and simultaneously. [0077] [0077]FIG. 3 is a detailed schematic diagram of the system of FIG. 1. As shown in FIG. 3, the number of electrodes and separate channels N is preferably four (4). However, this embodiment may be practiced with a different number (e.g., N=3 or N=5) of electrodes and channels without departing from the scope and spirit of the present invention. Further, the splitter may be practiced with N channels and a number of separate probes where the total number of electrodes of the probes is less than or equal to N. A single electrode 22 A and corresponding channel of the N-channel RF splitter 6 is described hereinafter with reference to FIG. 2. While a single electrode 22 A and corresponding channel are described, it will be apparent to a person skilled in the art that the following description applies equally to the three remaining electrodes 22 B to 22 D and the corresponding channels of the splitter of FIG. 3. [0078] In FIG. 2, the control signal 14 A output by the programmable controller 2 is provided to an isolation amplifier 42 A which in turn is connected to a fast-switching, full bridge rectifier 34 A. In particular, the output of the isolation amplifier 42 A is connected to a fast-switching variable resistance 48 A used to control operation of the rectifier bridge 34 A. Preferably, the variable resistance 48 A is implemented using a power N-channel enhancement MOSFET. The programmable controller 2 receives a temperature signal 16 A from the output of another isolation amplifier 40 A. [0079] One terminal of the RF generator 8 is coupled via a decoupling capacitor 9 to the dispersive electrode 12 . The tissue (e.g., myocardium) which the probe 20 is to be applied to is generally represented by a block 15 between the dispersive plate 12 and an electrode 22 A of the needle probe 20 . In this embodiment, the needle probe is inserted into the tissue. The electrode 22 A is generally represented by a tubular or ring-like structure in accordance with the electrode structure employed in the needle probe 20 . However, again it will be appreciated that other electrode structures may be practised dependent on the probe type without departing from the scope and spirit of the invention. The other terminal of the RF generator 8 is connected via a fail-safe relay 38 A and a thermal fuse, current limiter 39 A to the rectifier bridge 34 A. The relay 38 A consists of a fail-safe relay contact 38 A′ and a fail-safe relay winding 38 A″. These circuits act as current interrupting and current limiting devices. [0080] The output terminal of the fast-switching, full bridge rectifier 34 A is coupled via a decoupling impedance matching capacitor 44 A to a stainless steel conductor 47 A, which is connected to the stainless steel electrode 22 A and a terminal of the thermocouple junction 36 A. The stainless steel conductor 47 A is also connected to a low pass filter 30 A, preferably composed of passive elements. A titanium conductor 46 A is also coupled to the stainless steel electrode 22 A and the other terminal of the thermocouple junction 36 A embedded in the electrode 22 A. The titanium conductor 46 A is further connected to the low-pass filter 30 A. However, other conductive materials may be used for the electrode 22 A and the conductors 46 A and 47 A without departing from the scope and spirit of the invention. The output of the low pass filter 30 A is provided to a thermocouple reference compensation amplifier and alarm 32 A. The amplifier 32 A also provides a control signal to the relay 38 A. The output of the amplifier 32 A is provided to the isolation amplifier 40 A, which in turn provides the temperature signal 16 A to the programmable controller 2 . Again, other temperature sensing devices and corresponding associated circuits to provide equivalent functionality may be practiced without departing from the scope and spirit of the invention. [0081] The thermocouple 36 A embedded in the electrode 22 A produces a temperature signal on conductors 46 A and 47 A in response to the heat produced by the delivery of RF energy to the myocardium tissue 15 . The signal produced by the thermocouple junction 36 A is low-pass filtered using the low-pass filter 30 A, the output of which is provided to the amplifier and alarm 32 A. The alarm and amplifier 32 A produces an amplified temperature signal that is provided to the isolation amplifier 40 A. In addition, the amplifier and alarm 32 A provides a control signal to operate the relay 38 A so as to interrupt the delivery of RF energy from the RF generator via the relay 38 A when the measured or sensed temperature exceeds a predetermined threshold level. [0082] The programmable controller 2 uses the temperature signal 16 A to produce a control signal 14 A that is provided to the variable resistance 48 A of the full bridge rectifier 34 A. This control signal 14 A is provided via the isolation amplifier 42 A. The control signal 14 A operates the full bridge rectifier so as to variably and continuously control the amount of RF energy delivered to the stainless steel electrode 22 A for ablation. Thus, this embodiment is able to precisely and independently control the electrodes 22 A to 22 D of the needle probe 20 . [0083] The heating in RF energy transfer occurs not from the electrode 22 A to 22 D itself but from a small volume of tissue in contact with the electrode 22 A to 22 D, This heating source is directly proportional to the electrode surface area in contact with the tissue, contact pressure and the electrical conductivity of the tissue. Therefore, the system according to this embodiment advantageously controls the RP energy in each electrode independently of each other. [0084] Thus, the system provides maximum control at each electrode 22 A to 22 D by minimising current flow between adjacent electrodes 22 A to 22 D. This is achieved by a single RF source (one phase) 8 using RF splitter 8 to regulate current flow to each electrode 22 A to 22 D as a function of the temperature of each electrode. [0085] The first embodiment illustrated in FIGS. 1 to 3 provides a system for simultaneous unipolar, multi-electrode ablation using simultaneous closed-loop control of temperature at each electrode 22 A to 22 D. This system advantageously enables multielectrode ablation for ablating ventricular tachycardia and atrial fibrillation. In contrast to conventional ablation systems which cut off current to any electrode during ablation if a temperature or impedance goes above a particular level and therefore cannot produce reliable lesions because the electrode-tissue interface surface area varies considerably during ablation, this embodiment is able to overcome this disadvantage of conventional systems. In this embodiment the control algorithm for generating the control signals and operating the system in response to the temperature of each of the electrodes is preferably implemented in software carried out using a general purpose computer. [0086] An experimental example of the use of the system is set forth below outlining the use of another system in accordance with that of this embodiment. ablation with simultaneous closed-loop temperature control of each electrode is the optimum method for simultaneous multi-electrode ablation. [0087] Second Embodiment [0088] Another embodiment of the invention is illustrated in FIG. 4, in which like elements of FIGS. I to 3 are indicated with the same reference numerals, For the purpose of brevity only, components of the second embodiment shared with the first embodiment are not repeated hereinafter. However, those aspects of the second embodiment will be readily understood by a person skilled in the art in view of the description with reference to FIGS. 1 to 3 . Instead, the description hereinafter describes those aspects of the second embodiment not set forth above. [0089] A single channel of the system according to the second embodiment is shown schematically in FIG. 4. The system comprises the programmable controller 2 and the module 4 ′, which comprises the like numbered elements of FIG. 2, a voltage/current sensing module 50 A and the corresponding isolation amplifier 52 A. Again, while the RF generator 8 is illustrated within the module 4 ′, it will be apparent to a person skilled in the art that the RP generator 8 can be equally applied to plural channels, as indicated in FIG. 3. [0090] The conductors 46 A and 47 A are also coupled to the input terminals of the voltage and/or current sensing module 50 A, which preferably detects the root-mean-square (RMS) voltage and/or current at the electrode 22 A. The detected or measured voltage and/or current signal is output by the sensing module 50 A and provided to isolation amplifier 52 A. In turn the output of the isolation amplifier 52 A is provided to the programmable controller 2 . [0091] The voltage and/or current sensing module 50 A measures the RMS voltage and current delivered to the electrode 22 A Thus, the average power and impedance of each electrode 22 A can be determined independently as well. Thus, the module 50 A independently senses at least one of following: the voltage, current, impedance and average power of each electrode. This is done to provide a corresponding measurement EXAMPLE [0092] A system in accordance with the first embodiment was implemented and tested to compare unipolar versus bipolar ablation and single electrode temperature control versus simultaneous multi-electrode temperature control during ablation. [0093] Two types of 21 gauge needles, each with 2 cylindrical electrodes were introduced from the epicardium at thoracotomy in 3 greyhounds, The proximal electrode measured 1 mm. The distal electrode measured 1 mm in one needle and 1.5 mm in the other. The inter electrode distance was 4 mm. Seventy four intramural RF ablations were performed for 60 seconds through both the electrodes of each needle simultaneously in an unipolar (Uni) or a bipolar (Bi) fashion. During ablations the temperature of only one electrode (proximal or distal) or both the electrodes simultaneously were maintained at 80° C. by closed loop control. Lesion sizes were measured histologically. [0094] The maximum±SD temperature (temp) measured at the proximal (P) and the distal (D) electrodes were (electrode controlled = electrode at which temperature was Controlled) Length of each electrode Uni Electrode Temp of P Temp of D in needle or Bi controlled electrode electrode p value P =   1 mm, Bi P(1 mm) 82 ± 1 82 ± 2 0.7 D =   1 mm P =   1 mm, Uni P(1 mm) 83 ± 1 82 ± 2 0.01 D =   1 mm P =   1 mm, Bi P(1 mm) 81 ± 1 60 ± 2 &lt;0.001 D = 1.5 mm P =   1 mm, Bi D(1.5 mm) 96 ± 2 80 ± 2 &lt;0.001 D = 1.5 mm P =   1 mm, Uni Both 82 ± 2 81 ± 1 0.24 D = 1.5 mm [0095] Simultaneous multi-electrode ablation without closed-loop temperature control of each electrode results in higher temperature at the smaller electrode-tissue interface and lower temperature at the larger electrode-tissue interface. This results in varying lesion sizes and potentially coagulum formation and impedance rises. Unipolar RF signal which can be used by the programmable controller so that additional safety features may be implemented in the system. This preferably provides an increased level of safety by enabling predetermined cut-off levels (eg, RMS voltage, RMS current, impedance and average power) to be used to shut-down the output of each electrode 22 A. This is preferably carried out by the programmable controller 2 which provides control signal 14 A dependent upon at least one of these criteria. Thus, the controller 2 generates the control signal 14 A to independently interrupt delivery of the RF energy to the respective electrode when the meaurement signal exceeds a predetermined threshold condition. Further control structures utilising RMS voltage and/or current may also be applied to enhance the control and safety performance of the system. [0096] Thus, the second embodiment provides, in addition to the advantages of the first embodiment, additional safety features. [0097] While only a small number of embodiments of the invention has been described, it will be apparent to a person skilled in the art that modifications and changes thereto can be made without departing from the scope and spirit of the present invention.

A system ( 2,4), method and splitter ( 6) for ablating tissue ( 15) using radiofrequency (RF) energy is disclosed. The system ( 2,4) ablates tissue ( 15) using unipolar RF energy simultaneously delivered to multiple electrodes ( 22 A- 22 D) in one or more probes ( 20). This is carried out by the multiple channel RF splitter ( 6) that can independently control the RF energy delivered through each channel ( 18) to a respective electrode ( 22 A- 22 D) in a continuous manner. Each electrode ( 22 A- 22 D) has a corresponding temperature sensor or transducer ( 36 A- 36 D) that is processed independently so that the amount of RF energy delivered to each electrode ( 22 A- 22 D) can be varied dependent on the temperature of the electrode ( 22 A- 22 D) so that the lesion size produced by each electrode ( 22 A- 22 D) can be accurately controlled. Preferably, each probe ( 20) has a needle-like structure with a number of electrodes ( 22 A- 22 D) separated by insulative material and is adapted to puncture tissue. Each channel ( 18) of the splitter ( 6) has circuitry for interrupting current delivered to the respective channel if a predetermined temperature or current level is exceeded.

BACKGROUND OF THE INVENTION This invention relates to a novel method for inhibiting microvascular thrombosis and, more particularly, to a method for reducing the thrombogenicity of microvascular anastomoses during microvascular reconstruction by the topical administration of a blood coagulation inhibitor known as lipoprotein-associated coagulation inhibitor (LACI) and alternatively as tissue factor pathway inhibitor (TFPI). Thrombosis of microvascular anastomoses, particularly in cases of extremity trauma in free flap reconstructions, is a significant problem for the reconstructive surgeon. A recent survey by Salemark, Microsurgery 12, 308-311 (1991), revealed that many centers routinely make use of systemic anticoagulation for replants and free flap transfers. However, the risk for generalized hemorrhage [Leung, Hand 12, 25-32 (1980); Hirsh, Semin. Thromb. Hemostas. 12, 21-32 (1980)], with compounding risks from blood transfusion products, leaves open the question of benefit from massive systemic circulatory alteration merely to preserve flow in a small vessel supplying blood to non-vital tissue. The concept of site-specific action by an antithrombotic agent, administered through simple topical application was proposed by Cooley and Gould, Microsurgery 12, 281-287 (1991). Since those vessels which are prone to thrombosis are exposed during the reconstructive effort, with ready access to the lumenal surface during the anastomotic repair, an agent could be applied through the course of normal vessel irrigation, potentially achieving a highly localized effect through surface binding to the thrombogenic site(s). In fact, Cooley et al. have described one possible agent, a peptide based on the platelet-binding and fibrin-polymerizing region of fibrinogen, and have shown its ability to reduce the occurrence of thrombotic occlusion in a rat model [6th Ann. Meeting, Amer. Soc. Reconstructive Microsurgery, Toronto, Canada. Sep. 21-23, 1990]. Thrombosis caused by vascular injury is at least partially if not predominantly initiated through the tissue-factor-mediated pathway of coagulation. Plasma contains a multivalent Kunitz-type inhibitor of coagulation, referred to herein as tissue factor pathway inhibitor (TFPI). This name has been accepted by the International Society on Thrombosis and Hemostasis, Jun. 30, 1991, Amsterdam. TFPI was first purified from a human hepatoma cell, Hep G2, as described by Broze and Miletich, Proc. Natl. Acad. Sci. USA 84, 1886-1890 (1987), and subsequently from human plasma as reported by Novotny et al., J. Biol. Chem. 264, 18832-18837 (1989); Chang liver and SK hepatoma cells as disclosed by Wun et al., J. Biol. Chem. 265, 16096-16101 (1990). TFPI cDNA have been isolated from placental and endothelial cDNA libraries as described by Wun et al., J. Biol. Chem. 263, 6001-6004 (1988); Girard et al., Thromb. Res. 55, 37-50 (1989). The primary amino acid sequence of TFPI, deduced from the cDNA sequence, shows that TFPI contains a highly negatively charged amino-terminus, three tandem Kunitz-type inhibitory domains, and a highly positively charged carboxyl terminus. The first Kunitz-domain of TFPI is needed for the inhibition of the factor VII a /tissue factor complex and the second Kunitz-domain of TFPI is responsible for the inhibition of factor X a according to Girard et al., Nature 328, 518-520 (1989), while the function of the third Kunitz-domain remains unknown. See also copending application Ser. No. 07/301,779, filed Jan. 26, 1989, now U.S. Pat. No. 5,106,833. TFPI is believed to function in vivo to limit the initiation of coagulation by forming an inert, quaternary factor X a : TFPI: factor VII a : tissue factor complex. Further background information on TFPI can be had by reference to the recent reviews by Rapaport, Blood 73, 359-365 (1989); Broze et al., Biochemistry 29, 7539-7546 (1990). Recombinant TFPI has been expressed as a glycosylated protein using mammalian cell hosts including mouse C127 cells as disclosed by Day et al., Blood 76, 1538-1545 (1990), baby hamster kidney cells as reported by Pedersen et al., J. Biol. Chem. 265, 16786-16793 (1990), Chinese hamster ovary cells and human SK hepatoma cells. The C127 TFPI has been used in animal studies and shown to be effective in the inhibition of tissue factor-induced intravascular coagulation in rabbits according to Day et al., supra, and in the prevention of arterial reocclusion after thrombolysis in dogs as described by Haskel et al., Circulation 84, 821-827 (1991). Recombinant TFPI also has been expressed as a non-glycosylated protein using E. coli host cells and obtaining a highly active TFPI by in vitro folding of the protein as described in co-pending application of Judy A. Diaz-Collier, Mark E. Gustafson and Tze-Chein Wun, on &#34;Method of Producing Tissue Factor Pathway Inhibitor&#34;, Ser. No. 07/844,297, filed Mar. 22, 1992, now U.S. Pat. No. 5,112,091, the disclosure of which is incorporated by reference herein. The cloning of the TFPI cDNA which encodes the 276 amino acid residue protein of TFPI is further described in Wun et al., U.S. Pat. No. 4,966,852, the disclosure of which is incorporated by reference herein. BRIEF DESCRIPTION OF THE INVENTION In accordance with the present invention a novel method is provided for inhibiting microvascular thrombosis. The method comprises topically administering to a warm blooded mammal at the site of microvascular anastomoses contemporaneously with microvascular reconstruction of a small, but effective amount of TFPI sufficient to reduce the thrombogenicity of microvascular anastomoses. The invention is illustrated herein by topical application of the TFPI to a rabbit ear artery model of crush/avulsion injury subjected to microvascular repair. In this illustrative topical application of TFPI, traumatized arteries treated through lumenal irrigation with normal saline vehicle (controls) achieved patency rates of 8% and 0% at 1 and 7 days postoperatively (p.o.), respectively. Heparin irrigation (10 units/ml) resulted in patencies of 40% at both evaluation times. In contrast, TFPI at a dose of 20 μg/ml (0.2 ml total volume; 10-minute exposure) yielded a 91% patency rate at 1 day, and 73% at 7 days p.o. (p&lt;0.0005 vs. controls). Systemic anticoagulation effect was checked with peripheral blood prothrombin time (PT) and activated partial thromboplastin time (APTT). These values were not altered after topical treatment with TFPI. Scanning electron microscopy revealed dramatically inhibited thrombogenesis upon the injured surfaces of TFPI-treated vessels. These results support the effectiveness of TFPI used as a topically-applied antithrombotic agent for the prevention of thrombosis in clinical microvascular surgery. It will be appreciated that the method of the invention is useful for other warm blooded mammals, e.g. humans, in a analogous manner. It is expressly adapted for microvascular reconstruction such as by free flap transfer or replantation surgery. As defined herein, TFPI can be either glycosylated or non-glycosylated. DETAILED DESCRIPTION OF THE INVENTION While the specification concludes with claims particularly pointing out and distinctly claiming the subject matter which is regarded as forming the present invention, it is believed that the invention will be better understood from the following detailed description of preferred embodiments taken in conjunction with the accompanying drawings in which: FIG. 1 is a bar graph that shows the patency rates achieved at 1 and 7 days postoperatively, for each of three treatment groups, in which topical administration of TFPI during microvascular repair of a vascular trauma in a rabbit ear model is compared with similar administration of heparin or the control vehicle (normal saline) without either TFPI or heparin. FIG. 2, in 3 parts, namely FIGS. 2A, 2B and 2C, shows the scanning electron micrographs at several magnifications of the lumenal surfaces of vessels one hour after reflow, following microvascular repair and topical administration of TFPI as in FIG. 1. FIG. 2A=30X; FIG. 2B=100X; FIG. 2C=2000X. FIG. 3, in 3 parts, namely FIGS. 3A, 3B and 3C, shows scanning electron micrographs at several magnifications of the lumenal surfaces one hour after reflow, following microvascular repair and topical administration of heparin as in FIG. 1. FIG. 3A=30X; FIG. 3B=100X; FIG. 3C=2000X. FIG. 4, in 3 parts, namely FIGS. 4A, 4B and 4C, shows scanning electron micrographs at several magnifications of the lumenal surfaces one hour after reflow, following microvascular repair and topical administration of the control vehicle without either TFPI or heparin as in FIG. 1. FIG. 4A=30X; FIG. 4B=100X; FIG. 4C=2000X. In order to illustrate the invention in greater detail, the following illustrative microsurgical repair of vascular trauma accompanied with administration of TFPI was carried out. It will be appreciated, however, that the invention is not limited to this exemplary work or to the specific details set forth in these examples. EXAMPLES Materials and Methods The NIH guidelines for the care and use of laboratory animals were followed throughout. New Zealand White rabbits (3-5 lbs) were anesthetized with intramuscular injection of ketamine (100 mg) and xylaaine (20 mg). Under sterile conditions, the central ear artery was exposed over a length of 20 mm. A modification of the crush-avulsion injury of Cooley and Hansen, Microsurgery 6, 46 48 (1985), was created as follows. Two Webster needleholders were clamped firmly upon the artery 2 mm from each other, then moved apart in proximal-distal directions, traumatically severing the artery. Temporary microvascular clamps were applied beyond the Webster crush sites, and the lumen was flushed with normal saline. The torn ends of the artery were minimally trimmed, preserving essentially the entire length of traumatized artery. An end-to-end anastomosis was next performed using 8-10 stitches of 10-0 nylon suture. Before tying the last stitch, 0.2 ml of a test solution was irrigated across the anastomosis and injured lumen, filling the vessel with the fluid. It was left in place for 10 minutes, then washed out with normal saline. One of three solutions was used per vessel on a blinded, randomized basis: TFPI at a concentration of 20 μg/ml in normal saline, heparin (10 units/ml) in normal saline, or normal saline (the control vehicle). The TFPI used in these Examples was obtained through recombinant DNA clones expressed in E. coli It is a 277 amino acid protein consisting of the 276 residue sequence described by Wun et al., J. Biol. Chem. 263, 6001-6004 (1988), and in U.S. Pat. No. 4,966,852, with an additional Alanine residue inserted at the N-terminus as further described in the aforesaid copending application of Diaz-Collier, Gustafson and Wun, Ser. No. 07/844,297, filed Mar. 22, 1992, now U.S. Pat. No. 5,212,091. It is &gt;95% homogeneous. Upon completion of the repair and irrigation of the lumen as described above, the temporary clamps were released. In 34 arteries (from 17 rabbits), the patency was followed for 1 hour, then the wound was closed Re-anesthetization was induced at 1 and 7 days post-operatively for re-evaluation of patency. In a separate series, 9 arteries (from 5 rabbits), were divided into 3 groups of 3 vessels each; TFPI, heparin or vehicle was administered to each as described above. The injured and repaired vessels were harvested after 1 hour of flow, fixed in buffered glutaraldehyde, and prepared for examination of the lumenal surfaces with a scanning electron microscope. Blood was drawn from a femoral vein branch before arterial injury and again one hour after reflow (before vessel harvest). Prothrombin (PT) and activated partial thromboplastin (APTT) times were determined on plasma samples using a standard, commercially available fibrometer. Results Patency rates for all groups are shown in FIG. 1. All vessels that were patent at 1 day had shown clear patency at 1 hour of reflow. Vessels found thrombosed at 1 day were still thrombosed at 7 days, for all groups. The patency rates for the control (vehicle-treated) arteries were 8% (1/13) at 1-day and 0% (0/13 at 7 days postoperatively. Heparin-treated vessels achieved 40% (4/10) patency at both 1 and 7 days, with a significant improvement noted at 7 days (p &lt;0.025; Fisher exact test). TFPI treatment resulted in 91% (10/11) and 73% (8/11) patency rates at 1 and 7 days, significantly better than controls for both time periods (p &lt;0.0005). The TFPI-treated vessels had a significantly higher patency than heparin-treated vessels at 1 day (p &lt;0.02), but not at 7 days (p &gt;0.1). Peripheral blood PT and APTT values for TFPI-treated rabbits were within the normal range (6-8.5 sec. for PT; 14-18 sec. for APTT). The times for each animal showed no differences between pre- and post-treatment values. Scanning electron microscopy at 15 KV of patent specimens harvested after 1 hour of flow showed at 30× magnification a suture line obscured by thrombus in control (FIG. 4A) and heparin-treated (FIG. 3A) vessels. In contrast, the suture line and surrounding vessel lumen was virtually clear of any sizable thrombotic accumulation in TFPI-treated vessels (FIG. 2A). At higher magnification (100× and 2000×), the controls displayed a mixed thrombus of fibrin strands and platelet aggregates. Heparin-treated vessels had dramatically less fibrin strand formation, with most of the thrombus composed of platelet aggregates and entrapped red blood cells (FIGS. 3B and C). TFPI-treated vessels showed very few organized thrombotic elements, leaving what appeared to be a surface relatively inert to thrombogenesis (FIGS. 2B and C). Relative to the problems encountered with large vessel, cerebral and coronary thrombosis, reconstructive microvascular surgery has the great advantage of easy and often necessary surgical access to the vessels that are most prone to thrombosis. During the microvascular repair, the surgeon is able to achieve direct exposure of the thrombogenic surface. The standard treatment for injured vessels has been to identify all traumatized portions, to resect and replace (with vein grafts) those considered too severely injured, and to administer systemic antithrombotic agents (heparin, aspirin, dipyridamole, and/or dextran most frequently) to prevent the occurrence of subsequent thrombosis. Several problems may exist, not all of which may be known to the surgeon: an apparently normal vessel surface may in fact have a significant thrombogenic capacity, due to endothelial denudation, fine medial tears, or possibly an activated coagulation pathway on the surface of an otherwise uninjured vessel; the extent of vessel injury may be beyond direct visibility to the surgeon, even with the aid of a microscope; vein grafts may be limited in availability or the selection may be less than ideal; the traumatic incident or an unsuspected systemic coagulopathy may augment the probability for localized or generalized hemorrhage, respectively. For these reasons, the development of an efficacious antithrombotic agent applied through intra-operative topical irrigation in accordance with the present invention is useful and very practical. Heparin has been shown to have a high affinity for endothelium in vivo. [Hiebert and Jaques, Thrombosis Res. 8, 195-204 (1976); Hiebert and Jaques, Artery 2, 26-37 (1976); Mahadoo et al., Thrombosis Res. 12, 79-90 (1977)]. A significant improvement in microvascular patency with topical heparin compared with unheparinized solutions has been shown experimentally. Reichel et al., J. Hand Suro. 13A, 33-36 (1988), using a rat crushed artery model of thrombosis, demonstrated that heparin, urokinase and other agents moderately enhanced patencies (up to 55%, compared to a control level of 10%) after topical administration only. A more dramatic improvement was noted by Cooley et al. using a 21-residue peptide homologue to the carboxy-terminus of the fibrinogen gamma chain (83% patent, compared with 17% for controls). [6th Ann. Meeting, Amer. Soc. Reconstructive Microsurgery, Toronto, Canada, Sep. 21-23 (1990)]. In accordance with the present invention, comparably high levels of success using a substantially different agent, TFPI. Recent studies with TFPI using in vitro assays have shown that it forms a complex with tissue factor, and Factors VIIA and Xa, rendering these key clotting cascade enzymes ineffective. [Broze et al., Blood 71, 335 (1988)]. In accordance with the present invention, topical application of TFPI to a traumatized vessel surface may allow it to complex with these enzymes which have been activated through the vascular injury. Following blood flow reestablishment, the capacity of the extrinsic pathway of coagulation at this site is substantially reduced. Since TFPI can be applied locally and in minute quantities, systemic effects are virtually non-existent, as was shown by the foregoing results. Topical administration of the TFPI can be carried out by conventional methods of administration of topically effective drugs which are well-known to persons skilled in the art. For example, the TFPI can be administered topically in the conventional manner whereby heparin is thus administered as a topical agent during microsurgery. See, e.g., Cooley and Gould, Microsurgerv 12, 281-287 (1991). For conventional methods of topical administration reference can also be had to the numerous texts and treatises in the field of drug administration, e.g., Remington&#39;s Pharmaceutical Sciences, Ed. Arthur Osol, 16th ed., 1980, Mack Publishing Co., Easton, PA. Preferably, the TFPI is carried in a physiologically acceptable vehicle or control such as normal saline or buffered saline such as with phosphate buffered saline or other such pharmaceutically acceptable buffers, e.g., HEPES. It can also be administered in a powder, salve or ointment form in conventional vehicles. The amount of TFPI administered to the site of the vascular trauma can be a very small amount, depending in part, on the degree and extent of the trauma. Doses of TFPI of from about 1 μg/ml to about 100 μg/ml applied in a volume of about 0.01 to about 1 ml volume over an exposure period of 1 to several minutes are suitable. Various other examples will be apparent to the person skilled in the art after reading the present disclosure without departing from the spirit and scope of the invention. It will be understood that all such other examples are included within the scope of the appended claims.

A method for reducing the thrombogenicity of microvascular anastomoses in a warm blooded mammal comprising administering to said mammal at the site of said microvascular anastomoses contemporaneously with microvascular reconstruction of a small but inhibitory effective amount of TFPI.

This application is a continuation of application Ser. No. 08/098,206, filed Jul. 28, 1993, abandoned. BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to radiodiagnostic agents and reagents for preparing such agents, and also methods for producing radiolabeled radiodiagnostic agents. Specifically, the invention relates to technetium-99m ( 99m Tc) labeled agents, methods and kits for making the agents, and methods for using the agents to image pathological sites, including sites of infection, inflammation, cancer and atherosclerosis in a mammalian body. Specifically the agents and reagents are derivatives of oligosaccharides, more specifically β-glucans. 2. Description of the Prior Art In the field of nuclear medicine, certain pathological conditions can be localized or the extent of such conditions determined by imaging the internal distribution of administered radioactively-labeled tracer compounds (i.e. radiotracers or radiopharmaceuticals) that accumulate specifically at the pathological site. This type of procedure is commonly known as radioimaging or scintigraphic imaging. Radioimaging has particular advantages over other methods of diagnosis in that it is essentially non-invasive, highly sensitive, highly specific, can be used to scan the entire body and is relatively cost-effective. A variety of radionuclides are known to be useful for radioimaging, including 67 Ga, 68 Ga, 99m Tc, 111 In, 123 I, 125 I or 201 Tl. There is a clinical need to be able to determine the location and/or extent of sites of focal or localized infection. In a substantial number of cases conventional methods of diagnosis (such as physical examination, x-ray, CT and ultrasonography) fail to identify such sites (e.g., an abscess). In some cases, biopsy may be resorted to, but is preferably avoided at least until it is necessary in order to identify the pathogen responsible for an abscess at a known location. Identifying the site of such &#34;occult&#34; infection is important because rapid localization of the problem is critical to effective therapeutic intervention. An abscess may be caused by any one of many possible pathogens, so that a radiotracer specific for a particular pathogen would have limited scope. On the other hand, infection is almost invariably accompanied by inflammation, which is a general response of the body to tissue injury. Therefore, a radiotracer specific for sites of inflammation would be expected to be useful in localizing sites of infection caused by any pathogen. One of the main phenomena associated with inflammation is the localization of leukocytes (white blood cells), including macrophages, monocytes and neutrophils, at the site of inflammation. A radiotracer specific for leukocytes would be useful in detecting leukocytes at the site of a localized infection. Currently approved nuclear medicine procedures for imaging sites of infection use either indium-111 labeled leukocytes ( 111 In-WBC) (see, e.g. Peters, 1992, J. Nucl. Med. 33: 65-67) or gallium-67 ( 67 Ga) citrate (see, e.g. Ebright et al., 1982, Arch. Int. Med. 142: 246-254). A major disadvantage of using 111 In-labeled WBCs is that the preparation of the radiotracer requires sterile removal of autologous blood, sterile isolation of the leukocytes from the blood, sterile labeling of the leukocytes using conditions that do not damage the cells (since damaged WBC are taken up by the reticuloendothelial system when re-injected) and return (re-injection) of the (now labeled) leukocytes to the patient. Furthermore, a delay of 12 to 48 hours between injection and imaging may be required for optimal images. While 99m Tc labeled leukocytes have been used to shorten this delay period (see, e.g. Vorne et al., 1989, J. Nucl. Med. 30: 1332-1336), ex-corporeal labeling is still required. A preferred radiotracer would be one that does not require removal and manipulation of autologous blood components. 67 Ga-citrate can be administered by intravenous injection. However, this compound is not specific for sites of infection or inflammation. Moreover, a delay of up to 72 hours is often required between injection of the radiotracer and imaging. In addition, the γ-(gamma) emission energies of 67 Ga are not well suited to conventional gamma cameras. Radiolabeled monoclonal and polyclonal antibodies raised against human leukocytes (including monocytes, neutrophils, granulocytes and others) have been developed. 99m Tc labeled antigranulocyte monoclonal antibodies (see, e.g. Lind et al., 1990, J. Nucl. Med. 31: 417-473) and 111 In-labeled non-specific human immunoglobulin (see, e.g. LaMuraglia et al., 1989, J. Vasc. Surg. 10: 20-28) have been tested for the detection of inflammation secondary to infection. 111 In-labeled IgG shares the disadvantages of 111 In-labeled WBC, in that 24-48 hours are required between injection and optimal imaging. In addition, antibodies are difficult to produce and are associated with safety concerns regarding potential contamination with biological pathogens (e.g. retroviruses). In addition, the effective treatment of cancer by surgery or radiation therapy requires knowledge of the localization and extent of the disease. A means of monitoring the progression/regression of tumors following or during any form of therapy is also highly desirable. Advances in high-resolution imaging modalities such as CT and MRI allow the detection of many neoplasms. However certain tumors and their metastases are small and difficult to localize by these methods. Nuclear medicine offers a potentially more sensitive alternative. A radiotracer that selectively binds to or localizes to any and all cancerous tissue, sufficiently to allow easy external detection, might be considered to be the ultimate goal of radiodiagnostic oncology. Also, despite remarkable advances in cardiology, coronary artery disease remains the leading cause of death in the U.S. The final event in this disease is usually fatal myocardial infarction caused by occlusive thrombosis of one or more coronary arteries usually at the site of a complicated atherosclerotic plaque. Therefore a means, preferably non-invasive, of determining the localization and/or extent of atherosclerotic plaque is highly desirable as an aid to selecting appropriate patient management. One of the most notable characteristics of atherosclerotic plaque is the accumulation of foam cells which are lipid-laden macrophages. β-Glucans are oligoglucosides, which comprise 1,3 and 1,6 linked β-D-glucose residues, originally discovered as components of yeast and fungal cell walls (Bartnicki-Garcia in Ann Rev Microbiol. 1968, 22, 87). Originally obtained in an insoluble form, β-glucans have since been obtained as soluble, low molecular weight oligomers (Janusz, Austen and Czop, J. Immunol. (1989), 142, (959-965). They have been shown to be active in enhancing the host defense mechanisms of mammals by activating the alternative complement pathway through their specific binding to receptors (called β-glucan receptors) found on the cell-surfaces of monocytes, macrophages and neutrophils (Czop and Kay, J. Exp. Med. (1991), 173, 1511-1520, Czop et al, Biochemistry of the Acute Allergic Reactions: Fifth International Symposium. (1989), 287-296 and J. K. Czop, Pathol. Immunopathol. Res (1986), 5, 286-296, Czop and Austen, J. Immunol. (1985), 134, 2588-2593). The in vivo administration of particulate β-glucans has been shown to provide protection from many pathogens including bacteria, viruses and fungi as well as reducing tumor growth (Czop et al, Biochemistry of the Acute Allergic Reactions: Fifth International Symposium. 1989, 287-296). The smallest active β-glucan reported so far is a heptaglucoside (Janusz et al, J Immunol 1989, 142, 959. Onderdonk and co-workers (Infection and Immunity, 1992, 60, 1642-1647) describe the antiinfective properties of this small β-glucan. The β-glucans have also been shown to exhibit an anti-tumor growth effect, believed to occur by increasing the number of macrophages localizing to tumors (Di Luzio in Pathophysiology of the Reticuloendothelial System (Eds Altruo and Saba), Raven Press, NY, pp209-224). Czop and Janusz, U.S. Pat. No. 5,057,503 (1991), claim a heptaglucoside capable of reacting with β-glucan receptors, their isolation and their therapeutic use. Jamas et al, PCT/US90/03440 claim β-glucans as drug delivery vehicles and as adjuvants. Jamas et al, PCT/US90/05022 claim a method of activating the immune system by administering β-glucans. Jamas et al, PCT/US90/05041 claim a method of producing a soluble β-glucan. Methods for preparing radiolabel-binding moieties and of labeling them with 99m Tc are disclosed in co-pending U.S. patent applications Ser. No. 07/653,012, now abandoned, which issued as U.S. Pat. No. 5,654,272; Ser. No. 07/757,470, now U.S. Pat. No. 5,225,180; Ser. No. 07/807,062, now U.S. Pat. No. 5,443,815; Ser. No. 07/851,074, now abandoned, which issued as U.S. Pat. No. 5,711,931; Ser. No. 07/871,282, a divisional of which issued as U.S. Pat. No. 5,720,934; Ser. No. 07/886,752, now abandoned, a continuation of which has been allowed as U.S. Ser. Nos. 08/273,274; 07/893,981, now U.S. Pat. No. 5,508,020; Ser. Nos. 07/955,466; 07/977,628, now U.S. Pat. No. 5,405,597; Ser. No. 08/019,525, now U.S. Pat. No. 5,552,525; Ser. No. 08/044,825, now abandoned, which issued as U.S. Pat. No. 5645,815; and Ser. No. 08/073,577, now U.S. Pat. No. 5,561,220; and PCT International Applications PCT/US92/00757, PCT/US92/10716, PCT/US93/02320, PCT/US93/03687, PCT/US93/04794, and PCT/US93/06029, which are hereby incorporated by reference. SUMMARY OF THE INVENTION The present invention provides scintigraphic imaging agents that are β-glucans which are radiolabeled with a radioisotope or are β-glucan-derived reagents radioactively-labeled with a radioisotope. The β-glucan-derived reagents of the invention are comprised of a β-glucan covalently linked to a radiolabel binding moiety. The scintigraphic imaging agents of this invention are useful for imaging pathological sites within a mammalian body including sites of infection, inflammation, cancer and atherosclerosis. A first aspect of the invention comprises reagents for preparing scintigraphic imaging agents for imaging sites within a mammalian body, said reagents comprising a β-glucan having a 1,3 and 1,6 linked D-glucoside sequence, of molecular weight of up to about 2,000 kDa and a radiolabel-binding moiety. In a second aspect, the scintigraphic imaging agent of the invention comprises a soluble β-glucan. In a third aspect, the scintigraphic imaging agent of the invention comprises the radioisotope 99m Tc. In another aspect of the invention the radiolabel-binding moiety is linked to the β-glucan via a 1-amino or 1-thio substituent. In yet another aspect, the reagents of the invention comprise a β-glucan and a radiolabel-binding moiety of formula Cp(aa)Cp I. wherein Cp is a protected cysteine residue and (aa) stands for an amino acid, and wherein the radiolabel-binding moiety is covalently linked to the β-glucan. In a preferred embodiment, the amino acid is glycine. In another preferred embodiment, the radiolabel-binding moiety is linked to the β-glucan via a linker which forms either an ether, thioether or amine bond to the β-glucan. In another aspect, the invention provides reagents comprising a radiolabel-binding moiety having the following structure: radioisotope complexing group comprising a single thiol moiety having the following structure A--CZ (B)-- C(R.sup.1 R.sup.2)!.sub.n --X II. wherein A is H, HOOC, H 2 NOC, (β-glucan)-(linker)-NHOC, (β-glucan)-(linker)-OOC or R 4 ; B is H, SH or --NHR 3 , --N(R 3 )-(linker)-(β-glucan) or R 4 ; X is SH or --NHR 3 , --N(R 3 )-(linker)-(β-glucan) or R 4 ; R 1 , R 2 , R 3 and R 4 are independently H or straight or branched chain or cyclic lower alkyl; n is 0, 1 or 2; and: (1) where B is --NHR 3 or --N(R 3 )-- (linker)-(β-glucan), X is SH and n is 1 or 2; (2) where X is --NHR 3 or --N(R 3 )-(linker)-(β-glucan), B is SH and n is 1 or 2; (3) where B is H or R 4 , A is HOOC, H 2 NOC, (β-glucan)-(linker)-NHOC or (β-glucan)-(linker)-OOC, X is SH and n is 0 or 1; (4) where A is H or R 4 , then where B is SH, X is --NHR 3 or --N(R 3 )-(linker)-(β-glucan) and where X is SH, B is --NHR 3 or --N(R 3 )-(linker)-(β-glucan); (5) where X is H or R 4 , A is HOOC, H 2 NOC, (β-glucan)-(linker)-NHOC or (β-glucan)-(linker)-OOC and B is SH; (6) where Z is methyl, X is methyl, A is HOOC, H 2 NOC, (β-glucan)-(linker)-NHOC or (β-glucan)-(linker)-OOC and B is SH and n is 0; and wherein the thiol moiety is in the reduced form. In yet another aspect, the present invention provides reagents comprising β-glucans covalently linked to a radiolabel-binding moiety having the following structure: ##STR1## For purposes of this invention, radiolabel-binding moieties having structure III will be referred to as picolinic acid (Pic)-based moieties; or ##STR2## For purposes of this invention, radiolabel-binding moieties having structure IV will be referred to as picolylamine (Pica)-based moieties; wherein X is H or a protecting group; (amino acid) is any amino acid. In a preferred embodiment, the amino acid is glycine and X is an acetamidomethyl protecting group. In yet another embodiment of the invention, reagents are provided for preparing scintigraphic imaging agents for imaging sites within a mammalian body, comprising a β-glucan and a bisamino bisthiol radiolabel-binding moiety covalently linked to the β-glucan. The bisamino bisthiol radiolabel-binding moiety in this embodiment of the invention has a formula selected from the group consisting of: ##STR3## wherein each R 5 can be independently H, CH 3 or C 2 H 5 ; each (pgp) S can be independently a thiol protecting group or H; m, n and p are independently 2 or 3; A is linear or cyclic lower alkyl, aryl, heterocyclyl, combinations or substituted derivatives thereof; and X is (linker)-β-glucan; ##STR4## wherein each R 5 is independently H, lower alkyl having 1 to 6 carbon atoms, phenyl, or phenyl substituted with lower alkyl or lower alkoxy; m, n and p are independently 1 or 2; A is linear or cyclic lower alkyl, aryl, heterocyclyl, combinations or substituted derivatives thereof; V is H or --CO-(linker)-β-glucan; R 6 is H or a (linker)-β-glucan; provided that when V is H, R 6 is a (linker)-β-glucan and when R 6 is H, V is a --CO-(linker)-β-glucan. For purposes of this invention, radiolabel-binding moieties having these structures will be referred to as &#34;BAT&#34; moieties. The invention comprises scintigraphic imaging agents that are complexes between β-glucans or the reagents of the invention and 99m Tc, and methods for radiolabeling the β-glucans and reagents of the invention with 99m Tc. Radiolabeled complexes provided by the invention may be formed by reacting β-glucans or the reagents of the invention with 99m Tc in the presence of a reducing agent. Preferred reducing agents include but are not limited to dithionite ion, stannous ion and ferrous ion. Complexes of the invention are also formed by labeling β-glucans or the reagents of the invention with 99m Tc by ligand exchange of a prereduced 99m Tc complex as provided herein. The invention also provides kits for preparing scintigraphic imaging agents that are β-glucans or the reagents of the invention radiolabeled with 99m Tc. Kits for labeling the β-glucans or the reagents provided by the invention with 99m Tc are comprised of a sealed vial containing a predetermined quantity of a β-glucan or a reagent of the invention and a sufficient amount of reducing agent to label the β-glucan or reagent with 99m Tc. This invention provides methods for using scintigraphic imaging agents that are radiolabeled β-glucans and reagents for imaging pathological sites, including infection, inflammation, cancer and atherosclerosis within a mammalian body by obtaining in vivo gamma scintigraphic images. These methods comprise administering an effective diagnostic amount of radiolabeled β-glucan or reagent of the invention and detecting the gamma radiation emitted by the radiolabel localized at the pathological site within the mammalian body. Specific preferred embodiments of the present invention will become evident from the following more detailed description of certain preferred embodiments and the claims. DETAILED DESCRIPTION OF THE INVENTION The β-glucans of this invention have linear or branched 1,3 and 1,6 linked D-glucoside sequences. They comprise both insoluble and soluble molecular entities having molecular weights of up to about 2,000 kDa. In a preferred embodiment, the β-glucan is soluble. Most preferably the soluble β-glucan is a poly-β1-6-glucotriosyl-β1-3-glucopyranose. In Cp(aa)Cp-containing β-glucan reagents, the Cp is a protected cysteine where the S-protecting groups are the same or different and may be but are not limited to: --CH 2 -aryl (aryl is phenyl or alkyl or alkyloxy substituted phenyl); --CH-(aryl) 2 , (aryl is phenyl or alkyl or alkyloxy substituted phenyl); --C-(aryl) 3 , (aryl is phenyl or alkyl or alkyloxy substituted phenyl); --CH 2 -(4-methoxyphenyl); --CH-(4-pyridyl)(phenyl) 2 ; --C(CH 3 ) 3 ; --9-phenylfluorenyl; --CH 2 NHCOR (R is unsubstituted or substituted alkyl or aryl); --CH 2 --NHCOOR (R is unsubstituted or substituted alkyl or aryl); --CONHR (R is unsubstituted or substituted alkyl or aryl); --CH 2 --S--CH 2 -phenyl The preferred protecting group has the formula --CH 2 --NHCOR wherein R is a lower alkyl having 1 and 8 carbon atoms, phenyl or phenyl-substituted with lower alkyl, hydroxyl, lower alkoxy, carboxy, or lower alkoxycarbonyl. β-Glucans of the present invention can be obtained from natural sources, such as yeast, by methods well known in the art (e.g. see Manners, Masson and Patterson in J. Gen. Microbiol. (1974), 80, 411-417). Small soluble β-glucans can be obtained from larger β-glucans by methods known in the art (e.g. as described by Janusz, Austen and Czop in J. Immunol. (1989),142, 959-965 and Jamas et al, PCT/US90/05041) or can be obtained by chemical synthesis. Preferred soluble β-glucans are poly-β1-6-glucotriosyl-β1-3-glucopyranoses including those that are heptaglucosides. The term soluble β-glucan is used herein to mean soluble in a physiologically compatible solution to about 10 mg/mL. The reagents of this invention comprise a β-glucan covalently attached to a radiolabel-binding moiety. The radiolabel binding moiety can be attached directly to the β-glucan or it can be attached via a linker. The direct attachment of the radiolabel-binding moiety may be advantageously made by a 1-thioether or 1-amino group, or via an ester or ether bond to any hydroxyl group of the β-glucan (see for example, Her, Santikarn and Reinhold, J. Carbohydrate Chemistry (1987), 6, 129-139 and Bogwald, Seljelid and Hoffman, Carbohydrate research (1986), 148, 101-107). The linker is normally a small entity, of less than about 500 Da formula weight and may advantageously be a small (up to about 10 carbon atoms) linear or branched chain divalent alkyl, alkaryl or aryl group, optionally comprising a multiplicity of hetero atoms, preferably oxygens, and optionally substituted, preferably with hydrophilic moieties. In forming a complex of radioactive technetium with the β-glucans and the reagents of this invention, the technetium complex, preferably a salt of 99m Tc pertechnetate, is reacted with the β-glucan or reagent in the presence of a reducing agent. Preferred reducing agents are dithionite, stannous and ferrous ions; the most preferred reducing agent is stannous chloride. Means for preparing such complexes are conveniently provided in a kit form comprising a sealed vial containing a predetermined quantity of a β-glucan or reagent of the invention to be labeled and a sufficient amount of reducing agent to label the reagent with 99m Tc. Alternatively, the complex may be formed by reacting a β-glucan or reagent of this invention with a pre-formed labile complex of technetium and another compound known as a transfer ligand. This process is known as ligand exchange and is well known to those skilled in the art. The labile complex may be formed using such transfer ligands as tartrate, citrate, gluconate or mannitol, for example. Among the 99m Tc pertechnetate salts useful with the present invention are included the alkali metal salts such as the sodium salt, or ammonium salts or lower alkyl ammonium salts. The reaction of β-glucans and reagents of this invention with Tc-pertechnetate or preformed 99m Tc labile complex can be carried out in an aqueous medium at room temperature or with heating for a short period (from 5 to about 60 minutes). When an anionic complex having a charge of -1! is formed in the aqueous medium in the form of a salt with a suitable cation such as sodium cation, ammonium cation, mono, di- or tri-lower alkyl amine cation, etc. Any conventional salt of the anionic complex with a pharmaceutically acceptable cation can be used in accordance with this invention. In a preferred embodiment of the invention, a kit for preparing 99m Tc-labeled β-glucans and β-glucan reagents is provided. An appropriate amount of the β-glucan or reagent is introduced into a vial containing a reducing agent, such as stannous chloride, in an amount sufficient to label the β-glucan or reagent with 99m Tc. An appropriate amount of a transfer ligand as described (such as tartrate, citrate, gluconate or mannitol, for example) can also be included. In forming the 99m Tc complexes, it is generally preferred to form radioactive complexes in solutions containing radioactivity at concentrations of from about 0.01 millicurie (mCi) to 100 mCi per ml. Scintigraphic imaging agents of this invention can also be prepared by incubating radiolabeled β-glucans or radiolabeled β-glucan reagents with leukocytes, wherein the leukocytes take up the radiolabeled species and can then be administered as radiolabeled leukocytes. The radiolabeled scintigraphic imaging agents provided by the present invention can be used for visualizing pathological sites including sites of inflammation and infection, including abscesses and sites of &#34;occult&#34; infection and inflammatory bowel disease. The imaging agents provided can also be used to image sites of atherosclerotic plaque and also tumors. In accordance with this invention, the scintigraphic imaging agents are administered in a single unit injectable dose. Any of the common carriers known to those with skill in the art, such as sterile saline solution or plasma, can be utilized after radiolabeling for preparing the injectable solution to diagnostically image various organs, tumors and the like in accordance with this invention. Generally, the unit dose to be administered has a radioactivity of about 0.01 mCi to about 100 mCi, preferably 1 mCi to 20 mCi. The solution to be injected at unit dosage is from about 0.01 ml to about 10 ml. After intravenous administration, imaging of the organ or tumor in vivo can take place in a matter of a few minutes. However, imaging can take place, if desired, in hours or even longer, after injecting into patients. In most instances, a sufficient amount of the administered dose will accumulate in the area to be imaged within about 0.1 of an hour to permit the taking of scintiphotos. Any conventional method of scintigraphic imaging for diagnostic purposes can be utilized in accordance with this invention. The scintigraphic imaging agents provided by the invention may be administered intravenously in any conventional medium for intravenous injection such as an aqueous saline medium, or in blood plasma medium. Such medium may also contain conventional pharmaceutical adjunct materials such as, for example, pharmaceutically acceptable salts to adjust the osmotic pressure, buffers, preservatives and the like. Among the preferred media are normal saline and plasma. The methods for making and labeling these compounds are more fully illustrated in the following Examples. These Examples illustrate certain aspects of the above-described method and advantageous results. These Examples are shown by way of illustration and not by way of limitation. EXAMPLE 1 Reagent Synthesis DMSO=dimethyl sulfoxide, DMF=N,N-dimethylformamide and DIEA=N,N-diisopropylethylamine. Poly-β1-6-glucotriosyl-P1-3-glucopyranose (PGG) is obtained using the procedures described by Jamas et al (PCT/US90/05041). N-α-Boc-lysyl-glycyl-(S-trityl)cysteine amide, glycyl-glycyl-(S-trityl)cysteine amide and chloroacetyl-(S,S&#39;-bis-acetamidomethyl)cysteinyl-glycyl-cysteine amide are prepared by solid phase or solution phase peptide synthesis and are purified by reverse phase HPLC. A conjugate with N 1 ,N 4 -bis(2-mercapto-2-methylpropyl)-1,4,10-triazadecane is obtained by reacting a β-glucan (e.g., PGG) at from about 1 to 100 mg/mL with about 1.5 mmol N 1 -(t-butoxycarbonyl)-N 1 ,N 4 -bis(2-methyl-2-triphenylmethylthiopropyl)-1,4,10-triazadecane in water, Cellosolve or mixtures thereof at approximately pH 7 at about 65° C. for from 1 to about 10 hours, followed by reduction with NaBH 3 CN followed by deprotection with trifluoroacetic acid. The product is purified by preparative HPLC. Similarly conjugates of α-(lysyl-glycyl-cysteine amide) and glycyl-glycyl-cysteine amide are prepared from N-α-Boc-lysyl-glycyl-(S-trityl)cysteine amide and glycyl-glycyl-(S-trityl)cysteine amide respectively. A conjugate of N 6 ,N 9 -bis(2-mercapto-2-methylpropyl)-6,9-diazanonanoic acid is prepared by reacting β-glucan (e.g. PGG) at from about 1 to 100 mg/mL in water, DMSO or DMF containing about 1.5 mmol DIEA and optionally containing about 0.15 mmol 4-dimethylaminopyridine, with about 1.5 mmol of the N-hydroxysuccinimide ester of N 9 -(t-butoxycarbonyl)--N 6 ,N 9 -bis(2-methyl-2-triphenylmethylthiopropyl)-6,9-diazanonanoic acid, at room temperature, followed by deprotection with TFA and purification by HPLC. A conjugate of (S,S&#39;-bis-acetamidomethyl)cysteinyl-glycyl-cysteine amide is prepared by reacting β-glucan (e.g. PGG) at from about 1 to 100 mg/mL in DMSO, with sodium methylsulfinylmethanide, or another suitable base, (approx. 1.6 mmol base/100 mg β-glucan) for from 1 to about 24 hours and reacting the resultant mixture with approx. 1.6 mmol chloroacetyl-(S,S&#39;-bis-acetamidomethyl)cysteinyl-glycyl-cysteine amide for about 1 to 5 hours at between 20° and 50° C., followed by purification by HPLC. EXAMPLE 2 A General Method for Radiolabeling with Tc-99m 1. About 0.1 mg of a β-glucan or a reagent prepared as in Example 1 is dissolved in 0.1 mL of water or 50/50 ethanol/water. Approximately 100 μg stannous salt as stannous chloride pre-dissolved in methanol, or stannous tartrate pre-dissolved in water is added followed by 1-10 mCi 99m Tc pertechnetate in approximately 0.1 mL. The mixture is allowed to stand for 15-30 minutes at room temperature or at 100° C. For soluble β-glucans the preparation is then filtered through a 0.2 μm filter and the Tc-99m labeled product purity is determined by HPLC. The purity of insoluble β-glucan products is assessed by ITLC developed in saline. 2. About 0.1 mg of β-glucan or reagent prepared as described in Example 1 is dissolved in 0.1 mL of water or 50/50 ethanol/water or phosphate-buffered saline or 50 mM potassium phosphate buffer (pH=5, 6 or 7.4). Tc-99m gluceptate was prepared by reconstituting a Glucoscan vial (E.I. DuPont de Nemours, Inc.) with 1.0 mL of Tc-99m sodium pertechnetate containing up to 200 mCi and allowed to stand for 15 minutes at room temperature. 25 μl of Tc-99m gluceptate was then added to the peptide and the reaction allowed to proceed at room temperature or at 100° C. for 15-30 min. For soluble β-glucans the preparation is then filtered through a 0.2 μm filter and the Tc-99m labeled product purity is determined by HPLC. The purity of insoluble β-glucan products is assessed by ITLC developed in saline.

This invention relates to radiodiagnostic agents and reagents for preparing such agents, and also methods for producing radiolabeled radiodiagnostic agents. Specifically, the invention relates to technetium-99m ( 99m Tc) labeled agents, methods and kits for making the agents, and methods for using the agents to image pathological sites, including sites of infection, inflammation, cancer and atherosclerosis in a mammalian body. Specifically the agents and reagents are derivatives of oligosaccharides, more specifically b-glucans.

CROSS-REFERENCES TO RELATED APPLICATIONS Not applicable STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not applicable BACKGROUND Air purification respirators (“APRs”), commonly referred to as “gas masks,” are in wide private and military use. APRs are wearable filtering devices used to create an envelope of clean air around at least a wearer&#39;s nose and mouth, providing protection to the wearer from the inhalation of undesired or harmful dust, fumes, vapors, or other gases. APRs have multiple applications, particularly in the industrial and military fields. APRs are used in industry to protect workers from airborne industrial hazards such as fumes, gasses, dust, and particulate matter. Representative industrial uses would include in paint booths, grain storage facilities, and laboratories. In the military, APRs are employed to protect personnel who may be exposed to attack by poison gas or other airborne toxins. APRs are generally manufactured in the form of a mask that covers at least the wearer&#39;s mouth and nose. APRs can include additional protective surfaces to guard the wearer&#39;s eyes, ears, facial skin, or even hair. When properly fitted and worn by a wearer, an APR creates an envelope of clean air within the APR by, in part, forming a seal between the APR and the wearer&#39;s face that substantially prohibits the entry of air from the outside environment. As a result, the air breathed by the wearer during use of the APR is, except for minimal leakage through the facial seal, the intake ports, or the exhalation valve, air that has been cleaned by filters connected to the APR intake ports or air that has been provided directly from a known clean air source such as an air tank. APRs generally have one or more intake ports, usually disposed towards the sides of the mask apparatus. A filter apparatus or canister can be fitted into the intake port, usually by a sealing threaded connection or a sealing press-fit connection. Both filter ports can be fitted with filter apparatuses, or one can be so fitted and the other sealed shut with a threaded cap. This general modularity allows filters to be changed quickly and conveniently, and allows different filtering apparatus to be installed to optimize an APR for different environments. The ability to quickly replace filters also reduces cost by allowing the same APR mask body to be re-used even if the filters have to be replaced or changed. Alternatively, one or both intake ports can be coupled to a hose leading to a known clean air source, such as an air take. APRs generally include a means to allow the wearer&#39;s exhaled breath to escape, most typically an outlet port disposed on a central portion of the mask. The outlet port of the APR typically comprises a port, generally round in shape, disposed over the area of the wearer&#39;s mouth. In many APRs in common use, this port includes one-way valve assembly, such as a flap valve, configured to allow air to escape from the APR during the wearer&#39;s exhalation, but which prevents air from the outside environment from entering the APR during inhalation. This one-way valve assembly is often removable via a sealing snap-on or sealing interference fit with the lip of the outlet port of the APR. In one common configuration, the outlet port of the APR includes a spoke-and-hub structures in which spokes support a donut-shaped hub in the center of the port opening. The hole in the center of the hub is sized to accept the stem of a mushroom-style membrane, which stem presses into the hole in the center of the hub and is there retained, with the membrane in general contact with the spokes of the spoke-and-hub structure and in generally sealed contact with a circumferential rim around the edge of the outlet port. The membrane is shaped and sized to cover the outlet port opening and a portion of this circumferential rim. When a wearer exhales, exhalation pushes the membrane away from the spoke-and-hub structure and from the rim, allowing the exhaled air to escape through the exhalation port. At other times, and particularly when a wearer inhales, the membrane is pulled by negative pressure against the spoke-and-hub structure and the circumferential rim, sealing the outlet port so that air from the outside environment (other than leakage in acceptable volumes, as would be known by one skilled in the art) does not enter the clean air envelope defined by the mask. APRs may be either positive pressure or negative pressure devices. A positive pressure APR typically includes an external pump or pressurized vessel that forces clean air into the APR through an intake port. Positive pressure creates a more positively sealed clean air envelope, since the pressure within the clean air envelope is higher than the pressure of the external air. Such positive pressure reduces the occurrence of seepage or leakage of air from the outside environment into the clean air envelope of the APR. A negative pressure APR is more common and less expensive, and uses the negative pressure generated by the wearer&#39;s inhalation to assist with sealing the APR to the wearer&#39;s face. A wearer&#39;s inhalation generates negative pressure inside the clean air envelope as it draws air into the APR through the intake ports. Filter apparatus attached to the intake ports clean air from the outside environment before it passes into the clean air envelope. The negative pressure generated by inhalation assists with maintaining the seal between the APR and the wearer&#39;s face and assists with maintaining the seal formed by the outlet port valve. One disadvantage common to APRs is impairment of the wearer&#39;s ability to speak clearly or audibly. Maintenance of a clean air envelope within the APR restricts the volume of air going into or out of the APR. Even exhaled air must pass through a one-way valve before it reaches the outside environment. As a result, the volume of sound generated by a wearer&#39;s speech or other vocalizations is notably diminished to listeners, and such vocalizations may be garbled and difficult to understand. This impairment to clear and audible speech is a detriment in many of the APRs typical applications, particularly in military and industrial contexts where clear and audible communication may be imperative. Several attempts to mitigate this impairment to a wearer&#39;s ability to speak and be heard clearly while wearing an APR are known to the art. Some APRs are equipped with a diaphragm element in proximity to the outlet port that acts as a mechanical emitter to more efficiently transmit vibrations created by the wearer&#39;s speech from the clean air envelope within the APR to the outside environment without allowing untreated air to pass into the APR. While diaphragms facilitate some improvement in sound transmission, they still result in speech that is largely muted, muffled, and difficult to understand. Alternate attempts to solve this problem are disclosed by, for example, U.S. Pat. No. 5,463,693. These solutions involve amplifiers, microphones, or both, adapted to fit either on the outlet or inlet port of an APR (externally mounted solutions) or within the clean air envelope (internally mounted solutions). These known solutions generally require substantial modification of the APR, which is a disadvantage if clear vocalization is desired as an optional, but not a mandatory feature, for the APR. The modification to the APR required by these solutions also risks compromise of the integrity of the clean air envelope seal and does not allow a standard APR to be adapted quickly to allow improved vocal transmission. Further, since externally mounted solutions attempt generally to amplify sound transmitted through the APR, they still result in muted and muffled speech. Internally mounted solutions also often require piercing of components of the APR for the passage of wires or other structures, threatening the integrity of the clean air envelope. It would be a decided advantage to have an enhanced speech transmission device that can be readily attached to an existing APR produced in large quantities, which places a microphone inside of the wearer&#39;s clean air envelope, but does not require piercing any portion of the APR, does not require substantial modification of the APR, and enables the wearer to transmit clear speech without substantial muting or muffling. SUMMARY Versions of the present invention are directed to an enhanced speech transmission device that can be readily attached to commonly-used APRs. Versions of the present invention are further directed to an enhanced speech transmission APR device. Versions of the present invention are further directed to methods of improving the audibility of the speech of an APR wearer. The present invention satisfies the need for a device that substantially enhances the volume and clarity of the speech of the wearer of an APR and can easily and quickly be attached to or removed from an APR without tools, without substantial modification of the APR, and without piercing any portion of the APR. BRIEF DESCRIPTION OF THE DRAWINGS These and other features, aspects, and advantages of the present invention will become better understood with regard to the following description and accompanying drawings, where: FIG. 1 shows a perspective view of a commonly-used APR suited for modification by an enhanced speech transmission device as described herein; FIG. 2 shows an exploded view of a commonly-used APR suited for modification by an enhanced speech transmission device as described herein; FIG. 3 shows a perspective view of one embodiment of an enhanced speech transmission device as described herein; FIG. 4 shows an exploded view of one embodiment of an enhanced speech transmission device as described herein; FIG. 5 shows a perspective view of one embodiment of an enhanced speech transmission device as described herein, installed on a APR; FIG. 6 shows an exploded view of one embodiment of an enhanced speech transmission device as described herein, installed on a APR. DETAILED DESCRIPTION Referring now to the specific embodiments shown above, FIGS. 1 and 2 show one commonly-used APR known to the art. In relevant part, this configuration of APR comprises a mask body ( 1 ), one or more APR intake ports ( 3 ), and an outlet port ( 5 ). The mask body ( 1 ) further comprises a gasket ( 7 ) shaped to seal to a wearer&#39;s face, and attachment pins ( 9 ). The APR outlet port includes an APR valve portion ( 11 ), in this case a mushroom-style valve membrane coupled to the hub-and-spoke structure within the APR outlet port ( 5 ) of the APR. In the embodiment shown in FIG. 1 , the outlet port ( 3 ) has a generally round protruding lip ( 13 ) to which a cover ( 2 ) can be attached, generally through a press fit. A typical APR further comprises a retaining member ( 15 ) that assists with keeping the APR in sealed connection with the wearer&#39;s face. In the APR shown in FIG. 1 , the retaining member ( 15 ) is a strap configured to wrap around the back of the wearer&#39;s head on one side, and, on the other side, connects to the APR through one or more attachment points ( 17 ) that attach to the APR attachment pins ( 9 ). It will be understood by one skilled in the art that while one form of commonly used APR is shown, the invention herein is not limited to the depicted APR and can be used with a variety of makes and types of APRs in a variety of configurations, including full masks, positive pressure APRs, APRs in other configurations, and APRs with other outlet port shapes or exhalation valve types. Referring now to FIGS. 3 and 4 , the enhanced speech transmission device of this invention comprises a main housing ( 19 ), an amplifier assembly ( 21 ), and a microphone ( 23 ). The main housing ( 19 ) comprises a battery housing portion ( 25 ), an amplifier housing portion ( 27 ), and an outlet port portion ( 29 ). The battery housing portion ( 25 ) comprises positive and negative connectors for an electric power supply. These connectors are operatively connected, such as through insulated wires, to the amplifier assembly ( 21 ). In the preferred embodiment depicted in FIGS. 3 and 4 , the power supply is two AAA size alkaline batteries, the battery housing portion ( 25 ) is shaped to house and secure those batteries, and the positive and negative connectors are metal tabs configured to operatively connect to the positive and negative terminals, respectively, of those batteries. In this preferred embodiment, the positive and negative connectors are operatively connected to at least the amplifier assembly by insulated wires. It will be appreciated by one skilled in the art that different battery sizes, different battery types, different battery configurations, different numbers of battery, and power sources other than alkaline batteries all may be used within the spirit and scope of this invention. It will be further appreciated by one skilled in the art that the device could be powered by a power source remote from the device. The main housing ( 19 ) further comprises an amplifier housing portion ( 27 ). In the preferred embodiment depicted in FIGS. 3 and 4 , the amplifier housing portion ( 27 ) houses an amplifier assembly that includes at least one amplifier circuit board ( 31 ). The amplifier housing portion ( 27 ), in this preferred embodiment, further houses at least one speaker ( 33 ). Optionally, the amplifier housing portion ( 27 ) may comprise a grill or mesh to more easily allow the transmission of sound from the speaker ( 33 ) to the outside environment. In the preferred embodiment shown in FIGS. 3 and 5 herein, the amplifier housing portion ( 27 ) is located above the outlet port portion ( 29 ). It will be appreciated by one skilled in the art that the amplifier housing portion ( 27 ) may assume a large variety of shapes and sizes other than those depicted in the preferred embodiment discussed herein. It will further be appreciated that the amplifier housing portion ( 27 ) may house an amplifier assembly and one or more speakers ( 33 ), may house only the amplifier assembly with all speakers ( 33 ) located outside of the amplifier housing portion ( 27 ), or may house an amplifier assembly and one or more speakers ( 33 ), with additional speakers ( 33 ) located outside of the amplifier housing portion ( 27 ). It will further be appreciated by one skilled in the art that the amplifier housing portion ( 27 ) is not limited to a specific location on the device, and may be placed in a large number of configurations with respect to the outlet port portion ( 29 ) and the battery housing portion ( 25 ). The main housing ( 19 ) further comprises an outlet port portion ( 29 ). The outlet port portion ( 29 ) comprises an extension body ( 35 ), a sealing member ( 37 ), a valve portion ( 39 ), and an aperture ( 41 ). Referring to the preferred embodiment shown in FIGS. 3 and 4 , the outlet port portion ( 29 ) is a structure that generally corresponds to and extends the outlet port ( 5 ) of the APR. In this embodiment, the outlet port portion ( 29 ) is generally round. It will be appreciated by one skilled in the art that virtually any overall shape, size, or configuration of outlet port portion ( 29 ) may be used, so long as it couples to the outlet port ( 5 ) of an APR and includes, either integrally or by coupling, a valve portion ( 39 ) permitting exhalation. The outlet port portion ( 29 ) further comprises an extension body ( 35 ). The extension body ( 35 ) has a first portion ( 43 ) that is shaped to form a removable sealing connection to the outlet port ( 5 ) of an APR, preferably after the valve ( 11 ) has been removed from the outlet port ( 5 ) of an APR. A sealing member ( 37 ) located on, and preferably circumscribing, the first portion ( 43 ) cooperates with the outlet port ( 5 ) of an APR to seal the connection between the outlet port portion ( 29 ) and the outlet port ( 5 ) of an APR. In the preferred embodiment shown in FIGS. 4 and 6 , the outlet port first portion ( 43 ) has a generally round profile corresponding to the generally round outlet port lip ( 13 ) of the outlet port ( 5 ) of an APR, the sealing member ( 37 ) is a gasket around the outer circumference of the first portion ( 43 ), and the first portion ( 43 ) forms a removable sealing connection to the round outlet port lip ( 13 ) of the outlet port ( 5 ) of an APR when the first portion ( 43 ) is pressed onto the outlet port lip ( 13 ) until the sealing member ( 37 ) engages the inner circumference of the outlet port lip ( 13 ). In a most preferred embodiment, tabs in the outlet portion ( 29 ) cooperate with recesses in the outlet port ( 5 ) of an APR to create an interference fit between the outlet port ( 5 ) of the APR and the device outlet portion ( 29 ) to assist with maintaining a sealed connection between the APR and the amplifier. The first portion ( 43 ) can have a variety of shapes and sizes, and can couple to the outlet port ( 5 ) of an APR in a variety of fashions within the scope and spirit of this invention, as will be appreciated by one skilled in the art, including through a press-on fit, a twist-in fit, a threaded fit, or an interference fit. The sealing member ( 37 ) ensures that the connection between the first portion ( 43 ) and the outlet port ( 5 ) of an APR is substantially sealed against infiltration of air from the outside environment into the clean air envelope defined by the mask and the device. The sealing member ( 37 ) may comprise one or more gaskets, o-rings, washers, grommets, molded seals, or other sealing structures, as will be appreciated by one skilled in the art. The sealing member ( 37 ) may be made of any material capable of cooperating with another material to form a substantially airtight seal, including plastic, rubber, elastomers, metal, overmolded metal, and other materials that will be apparent to one skilled in the art. In a preferred embodiment, as shown in FIGS. 4 and 6 herein, the sealing member ( 37 ) is a rubber gasket located around the outer circumference of the first portion ( 43 ) of the extension body ( 35 ) that forms a seal between the first portion ( 43 ) and the lip ( 13 ) of the outlet port ( 5 ) of an APR. Although a specific shape and material for the sealing member ( 37 ) are disclosed in the preferred embodiment hereof, it should be understood that the sealing member ( 37 ) may be any structure that cooperates with both the first portion ( 43 ) and the outlet port ( 5 ) of an APR to form a detachable sealed connection. Accordingly, a variety of seal types, structures, shapes, sizes, and materials may be used for the sealing member ( 37 ) within the scope and spirit of this invention. Further, the sealing member ( 37 ) may be integral to one or more of the first portion ( 43 ) or outlet port ( 5 ) of an APR. The extension body ( 35 ) further comprises a second portion ( 45 ) that may include a valve portion ( 39 ). The second portion ( 45 ) may comprise an integral valve portion, or it may be shaped to connect to a removable valve portion, including specifically a valve portion ( 39 ) that comprises a valve ( 11 ) removed from an APR. In the preferred embodiment shown in FIGS. 3, 4, and 6 , the second portion ( 45 ) comprises a spoke-and-hub structure that corresponds to the spoke-and-hub structure in the outlet port ( 5 ) of an APR with which the device is, in that embodiment, intended to be used. The second portion includes a central hub ( 47 ). A hole in the hub ( 47 ) is sized to receive and retain the stem ( 49 ) of a valve ( 11 ) removed from the APR, and the second portion ( 45 ) is sized and shaped to be sealed substantially in one direction by a valve ( 11 ) removed from the APR in generally the same fashion as the outlet port ( 5 ) of an APR was sealed by that same valve ( 11 ). It will, however, be appreciated by one skilled in the art that other sizes, shapes, and configurations may be used for the second portion ( 45 ) within the scope and spirit of this invention, so long as the second portion ( 45 ) includes (whether integrally or by coupling) a valve portion ( 39 ) that substantially permits air exhaled by the wearer to escape the clean air envelope and prohibits significant volumes of air from the outside environment from entering the clean air envelope defined by the APR and the device. The valve portion ( 39 ) is a one-way valve structure that allows air exhaled by the wearer to escape from the clean air envelope without allowing significant volumes of air from the outside environment to enter the clean air envelope defined by the APR and the device, particularly when the wearer inhales. The valve portion ( 39 ) may be of virtually any size or shape, so long as it cooperates with the second portion ( 45 ) to substantially permit air exhaled by the wearer to escape from the clean air envelope and prohibit any significant volumes of air from the outside environment from entering the clean air envelope defined by the APR and the device. Preferably, the second portion ( 45 ) and valve portion ( 39 ) will cooperate to prohibit air from the outside environment from entering the clean air envelope at any rate exceeding 30 milliliters per minute at a suction pressure of 25 mmH 2 O. Most preferably, the second portion ( 45 ) comprises a structure corresponding to the valve retention structure of the outlet port ( 5 ) of the APR with which the device is intended to be used, and the valve portion ( 39 ) comprises a valve ( 11 ) removed from that APR. The valve portion ( 39 ) may comprise one or more valves or valve assemblies shaped to couple to said second portion ( 45 ) or one or more valve membranes shaped to couple to said second portion ( 45 ). A membrane comprising a valve portion, in whole or in part, may be made of a variety of air-impermeable materials, including natural rubber, silicone rubber, or neoprene. The valve portion ( 39 ) may comprise virtually any style of exhalation valve used on a commercially available APR, including mushroom-style valves and their membranes sheet-style valves and their membranes. In the preferred embodiment shown in FIGS. 3 and 4 , the valve portion ( 39 ) is a mushroom-style valve membrane ( 11 ) removed from the outlet port ( 5 ) of an APR and reinserted by its stem ( 49 ) into a hub ( 47 ) located on the second portion ( 45 ). The extension body ( 35 ) further comprises an aperture ( 41 ). The aperture ( 41 ) is a void passing through a portion of the wall of the extension body ( 35 ) between the sealing member ( 37 ) and the valve portion ( 39 ), such that the aperture is located within the clean air envelope but does not substantially interfere with the sealed removable connection between the extension body first portion ( 43 ) and the outlet port ( 5 ) of an APR. The aperture ( 41 ) can be of any size or shape, but is preferably sized to accommodate electrical connections, preferably insulated wires, running from a microphone ( 23 ) to the amplifier assembly ( 21 ). In the preferred embodiment, shown in FIGS. 3 and 4 , the aperture ( 41 ) is located at the top of the extension body ( 35 ). Preferably, the aperture ( 41 ) is sealed around the electrical connections to prohibit excessive leakage of air from the outside environment to within the clean air envelope. The device further comprises an amplifier assembly. The amplifier assembly comprises one or more amplifier circuit boards ( 31 ). As will be appreciated by one skilled in the art, the amplifier circuit board ( 31 ) includes capacitors, resistors and other electrical components which cooperate to filter and amplify the signal received from the microphone ( 23 ). The one or more amplifier circuit boards ( 31 ) provide an amplified signal to one or more speakers ( 33 ), as will be appreciated by one skilled in the art. The amplifier circuit board ( 31 ) is operatively connected to a power source through the battery housing portion ( 25 ), and is further operatively connected to the microphone ( 23 ). In the preferred embodiment shown in FIGS. 3 and 4 , one amplifier circuit board ( 31 ) and one speaker ( 33 ) are contained within the amplifier housing portion ( 27 ). In this preferred embodiment, the amplifier circuit board ( 31 ) is operatively connected to two AAA-sized alkaline batteries located in the battery housing portion ( 25 ) by insulated wires, is further operatively connected to one speaker ( 33 ) located within the amplifier housing portion ( 27 ) by insulated wires, and is operatively connected to a microphone ( 23 ) located within the outlet port portion ( 29 ) by insulated wires running through the aperture ( 41 ), so that sound signals picked up by the microphone ( 23 ) are carried to the amplifier circuit board ( 31 ), are there filtered and amplified, and are projected in filtered and amplified form by a speaker ( 33 ) through a vent or grill in the amplifier housing portion ( 27 ). It will be understood by one skilled in the art that a large variety of amplifier circuit board types and speaker types may be used within the scope and spirit of this invention. It will further be understood that while the speaker is preferably located within the amplifier housing portion, one or more speakers may within the scope and spirit of this invention be located outside of the amplifier housing portion. Further, multiple amplifier circuit boards, or multiple speakers, or both, may be used within the scope and spirit of this invention. The device further comprises a microphone ( 23 ) located within the outlet port portion ( 29 ). Virtually any size, shape, and style of microphone may be used, provided the microphone ( 23 ) fits within the outlet port portion ( 29 ) and can be powered by one or more of the amplifier assembly or directly by a power source connected to the battery housing portion ( 25 ). The microphone ( 23 ) is operatively connected to the amplifier assembly, preferably by insulated wires running through the aperture ( 41 ). The microphone ( 23 ) may be powered by the amplifier assembly ( 21 ) or may optionally be directly operatively connected to a power source through the battery housing portion ( 25 ). In the preferred embodiment shown in FIGS. 3 and 4 , the microphone ( 23 ) is a button-type microphone seated in and secured by a fitted socket located on the interior face of the second portion ( 45 ) of the extension body ( 35 ). As will be appreciated by one skilled in the art, the microphone ( 23 ) may be located in virtually any location within the clean air envelope defined by the outlet port portion ( 29 ) and may be secured to the outlet port portion ( 29 ) by a variety of mechanical or chemical connection means, such as sockets, screws, brackets, staples, ledges, interference fits, or glues. Optionally, as shown in the preferred embodiment in FIGS. 5 and 6 , the main housing ( 19 ) may further comprise APR attachment points ( 17 ) configured to attach to APR attachment pins ( 9 ). In this preferred embodiment, an attachment point ( 17 ) is disposed on either side of the amplifier housing portion ( 27 ). When said attachment points ( 17 ) are coupled to the attachment pins ( 9 ) of an APR, they assist with holding the device in place on the APR, and specifically assist with maintaining a sealed connection between said outlet port portion ( 29 ) and the outlet port ( 5 ) of an APR. Further optionally, the main housing ( 19 ) may additionally comprise substitute attachment pins ( 53 ) for connection to a retaining member ( 15 ). In the preferred embodiment shown in FIGS. 5 and 6 , the substitute attachment pins ( 53 ) are coupled to the APR attachment points of a retaining member ( 15 ). The retaining member ( 15 ) optionally provides additional assistance and support in holding the APR in place on the wearer&#39;s face and in maintaining a sealed connection between said first portion ( 43 ) of said extension body ( 35 ) and the outlet port ( 5 ) of an APR. As will be appreciated by one skilled in the art, embodiments of the present device may be configured to be certified for intrinsic safety. Other embodiments of the present device may be configured to not be certified for intrinsic safety. Although the present invention has been described in considerable detail with reference to certain preferred versions thereof, other versions are possible. For example, other mask types, outlet port shapes, sealing member configurations, valve types, housing configurations, microphone types, speaker types, power sources, or amplification means than those disclosed herein may be used within the spirit and scope of this invention.

An electrical amplifier unit which removably attaches to a gas mask and includes a microphone for detecting voice sounds emitted by the wearer of the gas mask, circuitry for amplifying the detecting sound, and a loudspeaker for emitting the amplified sounds externally of the mask. The associated components are contained within a housing that attaches sealably to the outlet port of a gas mask. The amplifier unit is quickly and easily attachable to commercially available gas masks without additional hardware and does not affect the structural and functional integrity of the host mask.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. patent application Ser. No. 12/421,919, filed Apr. 10, 2009, which is a divisional of U.S. patent application Ser. No. 10/505,846, filed Aug. 26, 2004, which is the U.S. National Stage Application of International Patent Application No. PCT/FR03/00667, filed Feb. 28, 2003, which claims priority to FR 02/02587, filed Feb. 28, 2002. TECHNICAL FIELD OF THE INVENTION [0002] The present invention relates to a method and a device for placing dental implants. BACKGROUND OF THE INVENTION [0003] Esthetical considerations or therapeutic indications often lead to the replacement of missing teeth of a highly deteriorated denture of a patient by an implant. The most common prostheses are still the tooth or tissue borne prosthesis, while the placement of prostheses anchored in the mandible or the maxilla of the patient by way of one or more implants screwed into holes drilled in the boney tissue is being developed. [0004] Modern medical imaging techniques coupled to robotics make it possible to simulate on computer the placement of implants in three dimensions before any intervention is done, and to produce a drilling template that will guide the surgeon-dentist during the operation. The use of these techniques has considerably increased the rate of aesthetic success, while decreasing the risk of post-operative complications. [0005] Such a method and a device for determining the ideal placement of an implant and conceived for the exact placement thereof are described in U.S. Pat. No. 5,320,529, in the name of D. Pompa, published Jun. 14, 1994. [0006] A stereolithographic model of the jawbone is made starting from tomographic sections, allowing the practitioner to simulate on this model the placement of the prostheses. A surgical template is obtained by moulding of the bone model and radio-opaque models of the implants in place, armed with their fixture mounts. Drilling tubes with an inside diameter which corresponds to drills of different sizes are thereafter placed on the imprint of the fixture mounts. [0007] This method makes it possible to obtain a precise surgical template, but does not completely make use of the possibilities and the advantages of a computer simulation, as this template is obtained by recreating the implant simulation by moulding staring from a real bone model and not from a viral model. [0008] The drilling template described in international patent application WO 99/26540, in the name of M. Klein et al., published on Jun. 3, 1999, is based on the previously described principle of using drilling tubes of different diameters inserted into bore tubes of a single diameter, except for the fact that they are inserted into cylinders which are themselves placed in bore tubes drilled directly into the scannographic guide by a drilling machine under numerical control based on scanning data. [0009] The need for an additional moulding step is thus removed by proceeding in this manner. Nevertheless, the method and device described in application WO 99/26540 seem to be applicable only to tooth borne templates, and not to bone or tissue borne templates. Moreover, the drilling tubes are maintained in place in the cylinders by a flange and a clamping screw, which represents a major inconvenience. Besides the handling difficulties linked both to the placement and to the control of such a high number of elements in a patient&#39;s mouth, and to the instability of their fixation, the system of drilling tubes of varying diameter held by screws also compromises the safety of the intervention as it remains possible that one of the pieces is ingested. [0010] The drawings illustrating the publication (Practical Procedures &amp; Aesthetic Dentistry, Vol. 13, No. 2, March 2001, pages 165-9, M. Klein et al.) of the results obtained by the method and the device subject of application WO 99/26540 clearly illustrate the excessive bulkiness of the flange of the cylinder, and the difficulty to access the screw without grips with a hexagon socket in radial position. [0011] The method for producing models of parts of the human body based on digital images revealed by the company Materialise in Belgian patent BE-1.008.372, published on Apr. 2, 1996, and applied specifically to computer assisted implantology, provides an additional simplification by allowing the production by stereolithography, a rapid prototyping technique well known in plastification, of models of mandibles, maxillas and surgical templates corresponding to any required implant planning. [0012] The software derived from this patented method for the acquisition of scanner data, the computer simulation of the mandible or maxilla, the visualisation of the design of the implants and the template, as well as the guiding of the prototyping machine, is commercialised under the name of SurgiCase® and offers the practitioner a solution which is widely applicable. [0013] Starting from the scanner data, the implantologist using the software prepares a virtual implant planning and transmits the results to the service center charged with converting these data into actual drilling templates. During the operation, a template is positioned on the alveolar crest; due to the complexity of the forms of the jaws and the teeth, the position of the template is unique and stable. The templates contain cylinders in sinless steel that can be implanted, which make up the physical guides for the drills during surgery and allow to control the drilling axis in an optimal way. Several templates are made with cylinders of different diameters making it possible to take into account the specific drilling sequence for every implant, and to adapt appropriately to every individual case. When the site is ready, the implants are inserted in a usual way using fixture mounts. [0014] Nevertheless, the need to use a plurality of templates somewhat reduces the advantages of the simplification obtained by making use of the method of the company Materialise. [0015] It is thus clear from the documents cited above that different methods and devices for the placement of dental implants are known in the state of the art; nevertheless, these methods and devices do not entirely meet the needs of the practitioner, who is still limited by too many constraints in their use. DESCRIPTION OF THE INVENTION [0016] The present invention relates to a method and a device for the placement of dental implants which aims to eliminate the constraints related to the use of the methods and systems of the prior art. [0017] More specifically the object of the invention is a method of the type comprising following steps: a) placement in the mouth of the patient of a scannographic guide, b) acquisition by the computer of the scanner data of the guide, as well as of the mandible or the maxilla of the patient, c) simulation on the computer of the mandible or the maxilla starting from the scanner data, d) generation by the computer, under control of the practitioner, of implant planning parameters based on this simulation, e) control by computer based on the planning parameters of a device for the production of a template featuring bore tubes with predetermined inclinations and positions, f) securing in these bore tubes guiding cylinders of one single standard dimension predetermined in function of the type of implants, g) insertion into the guiding cylinders of tubes arranged so as to control the direction and the depth of insertion of drills, h) drilling, by means of drills that are used successively and through the drilling tubes, of holes in the mandible or maxilla which are intended to receive the implants, and i) placement of implants through the guiding cylinders in the holes by way of fixture mounts. [0027] The method for the placement of dental implants according to the invention consists in: pre-producing the drilling tubes having one single predetermined standard inside diameter in function of the type of implants, pre-producing a first set of drills consisting of staged drills of which the maximal standard diameter corresponds to the inside diameter of the drilling tubes, pre-producing a second set of drills consisting of calibration drills of which the nominal standard diameter corresponds to the inside diameter of the tubes, so as to ensure the drilling procedure specific for each implant while only using for each hole first one of the staged drills, and then one of the calibration drills, instead of having to subsequently use a plurality of drills and tubes of increasing diameters. [0032] The method of the invention is also of interest because the placement of the implants is guided by specific fixture mounts that glide into the cylinders of the template. [0033] The method for the placement of dental implants of the invention is also remarkable because of the fact that the implantation planning parameters contain the heights of the bore tubes calculated by computer or determined by the practitioner, so as to control without additional means the depth of penetration of the bores in the maxilla or mandible of the patient. [0034] Alternatively or simultaneously, according to a variation of the method for the placement of dental implants according to the invention, a set of rings with an inside diameter corresponding to the diameter of the bores is pre-produced. A first intermediate step of the method then consists of placing, or not, depending on the need thereof at least one of the rings on the bores so as to control the depth of penetration into the mandible or maxilla of the patient. [0035] The drilling operation draws an advantage of these two last particular characteristics of the method when only staged drills and calibration drills of one standard length predetermined in function of the type of implants are used, independent of the depth of the osteotomies to be obtained. [0036] The method according to the invention also has the advantage that a set of washers with inside diameters corresponding to the diameter of the fixture mounts can be pre-produced. When necessary, during a second intermediate stage, the placement of one or more of these washers on the fixture mounts allows to control the depth of penetration of the implants. [0037] In this latter case, the implant procedure is preferably performed with fixture mounts of one single standard length in function of the type of implants, independent of the height of the implants to be placed. [0038] One additional characteristic of the method is that the insertion of the tubes in the guiding cylinders is preferably achieved by screwing. Moreover, the fixation of the cylinders in the template is preferably done by pasting. [0039] The method for the placement of dental implants according to the invention is preferably performed by a device of the type comprising: a) a scannographic guide for being placed in the mouth of the patient, b) a first computer implemented acquisition system of the scanning data of the guide and of the mandible or maxilla of this patient, c) a second computerised data simulation system of the mandible or the maxilla based on the scanning data, d) a third computerised system for the generation of dental planning parameters based on this simulation, e) a fourth system for drilling template formation which can be computer controlled, f) a fifth system for computer control of this fourth system based on the planning parameters, g) bore tubes in the template at predetermined angles and positions, and armed with guiding cylinders of predetermined standard size in function of the type of implants, h) drilling bores coaxially placed in the upper part of the guiding cylinders, i) drills of which the diameters correspond to the inside diameter of the tubes, and j) fixture mounts. [0050] An essential characteristic of the device according to the present invention is that the drilling tubes all have one standard inside diameter predetermined in function of the type of implants and that the drills present a first set of staged drills and an second set of calibration drills of which, respectively, the maximal standard diameter and the nominal standard diameter correspond to the inside diameter of these tubes. [0051] Advantageously, each of these staged drills comprises, successively along its axis, staring from the pointed end to the other end: a first length of the drill having a section with a single standard diameter, predetermined in function of the type of implants, a second length of the drill, adjacent to the first length, with a single standard diameter pre-determined in function of the type of said implants and larger than the diameter of the first drill section, a smooth part with a single standard diameter predetermined in function of the type of the implants and corresponding to the inside diameter of the drilling tubes, a flange, and a standard blocking means for a handpiece. [0057] In a similar advantageous way, each of the calibration drills preferably present successively along its axis, starting from the pointed end to the other end: a first cutting section with a single standard diameter, pre-determined in function of the type of implants and corresponding to the standard inside diameter of the drilling-tubes, a second cutting section with a diameter significantly smaller than the diameter of the first cutting section, a smooth zone with a single diameter predetermined in function of the type of implants and corresponding to the unique inside diameter of the drilling tubes, a flange, a standard blocking means for a handpiece. [0063] The fixture mounts of the present invention are further advantageous when they each comprise, on the one hand, a mandrel which features, successively along its axis: a piece complementary to a handpiece-connector, a flange, a smooth section of a single standard external diameter predetermined in function of the type of implants and corresponding to the standard inside diameter of the guiding cylinders, and a piece complementary to the standard heads of the implants, and, on the other hand, a screw which passes through the mandrel and is screwed in the head of the implant. [0068] An additional feature of the device for the placement of dental implants according to the invention is that the bore tubes of the template have a variable height in order to limit, without any additional means, the insertion depth of the drills in the mandible or the maxilla of the patient during the operation. [0069] Alternatively or simultaneously, the device for the placement of dental implants according to the invention additionally comprises a set of rings with inside diameters corresponding to the diameter of the drills, said rings intended to be slid over the smooth drill section or smooth drill zone of each drill in order to control the penetration depth. [0070] In these latter two embodiments, the staged drills and the calibration drills of the device for the placement of dental implants according to the invention are all of a predetermined standard length pre-determined in function of the type of implants, independent of the depth of the holes to be made, thus representing “universal” drills. [0071] Advantageously, the device for the placement of dental implants according to the invention further comprises a set of washers with an inside diameter corresponding to the diameter of the fixture mounts, the washers intended to be slid over the smooth sections of each of the fixture mounts in order to control the depth of penetration of the implant. [0072] Fixture mounts of one single predetermined standard length in function of the type of implants, and thus functioning as “universal” fixture mounts, have advantage of this latter feature. [0073] Preferably, the cylinders and the drilling tubes of the device according to the invention respectively have an internal screw thread and an external screw thread featuring four helixes at a 90° angle with respect to each other. Most advantageously, each of the tubes of this device features a ring with a tangential slot. Alternatively or simultaneously, this ring contains four blind radial holes at 90° with respect to each other. [0074] According to an additional feature of the device for the placement of dental implants which is the subject of the present application, the rings and the washers which are intended for placement around the drills or the future mounts respectively, are made of a bio-compatible plastic material, preferably of polyoxymethacrylate (POM). [0075] As for the guiding cylinders in the template, these are preferably made of a titanium alloy, most preferably of TA6V, just as the mandrels of the future mounts, while the tubes are in steel, preferably in stainless steel INOX 316L. [0076] These few essential characteristics will make it clear to the skilled person what the advantages are of the method and device for the placement of dental implants according to the invention compared to those of the prior art. [0077] The detailed characteristics of the invention, and more specifically the examples illustrating advantageous selections of dimensional characteristics of the device are provided in the following description, accompanied by the enclosed Figures. It is to be noted that these Figures are but an illustration of the text of the description and should not be considered in any way to present a limitation to the scope of the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0078] FIG. 1 represents an overview of the different steps which make up the methods for the placement of dental implants known in the state of the art to which the present invention relates. [0079] FIG. 2 is an exploded view of part of the device according to the invention during the drilling step, featuring more particularly the drilling template, the guides and a staged drill and its ring. [0080] FIGS. 3 a and 3 b are respectively a sectional view (along A-A) and a top view of a guiding cylinder of the template. [0081] FIGS. 4 a and 4 b are respectively a front view and a top view of a drilling tube of the template [0082] FIGS. 5 a and 5 b are respectively a sectional view (along B-B) and a top view of a drilling ring used to limit the depth of penetration. [0083] FIGS. 6 and 7 are respectively a front view of a staged drill and a calibration drill. [0084] FIG. 8 is an exploded view of part of the device according to the invention during the step of placement of the implants, featuring more particularly the drilling template, an implant, a washer, a fixture mount and its screw. [0085] FIGS. 9 a and 9 b are respectively a front view and a top view of a fixture mount according to the invention. [0086] FIG. 10 is a front view of the corresponding screw of the fixture mount. [0087] FIG. 11 is a cross-sectional view of a template according to the invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION [0088] FIG. 1 is a schematic representation of the known succession of steps which lead to the placement of dental implants 1 in the mouth of a patient. [0089] In a preliminary step 2 , the practitioner having at his disposal a system of computer-assisted implantology, decides together with the patient on the placement of the implants 1 . This system is a complex set of methods and devices optimised in function of the goal to be achieved. As a consequence, the characteristics of each of the elements of this system are strongly interdependent, and lead to standards of facts, which result from the generalisation of certain proprietary systems commercialised by the most important producers of medical devices. The implantologist should thus have at his disposal right from the start the material (implants 1 , fixture mounts 3 , drills, 4 , 5 , etc.) adapted to the rest of the system which he intends to use. Of course it is of interest to both the patient and the practitioner that the system used is as simple and as reliable as possible. [0090] A scannographic guide is placed (step 6 ) into the mouth of the patient, after which he will undergo a scanner in the usual way. Such a scannographic guide comprises radio-opaque markers that make it possible to subsequently allow, by means of known methods, to have the reference markers of the radiologic images obtained by computer in this step 8 coincide with the points of markers of the actual prostheses. [0091] At the end of this examination, the scanner data of the guide and the jaw 7 of the patient are sent to a service centre, which converts these raw data and prepares them before forwarding them to the implantologist. [0092] The software which is at the disposal of the practitioner ensures a virtual reconstruction of the mandible 7 or the maxilla of his patient starting from the prepared scanner data. This computer driven simulation 9 allows to create an implant planning 10 , by visualising the location of the future implants 1 . The parameters of the planning 10 will be retransmitted to the service centre for the production 12 of the drilling template 11 . [0093] By a method which is known in the art, the service centre will in this production step make use of the received data to control a stereolithographic device, which has the advantage over a digital milling machine of being able to produce objects with closed cavities. [0094] The service centre glues (step 13 ) the guiding cylinders 14 to the interior of the bore tubes 15 of the template 11 and sends the latter, as well as an actual model of the jaw 7 to the implantologist. The cylinders 14 are of a standard size, chosen in function of the type of implants 1 that will be placed. [0095] During the next step 16 , i.e. during the surgical procedure of the placing of the implants 1 themselves, the practitioner uses the template 11 to drill the holes 17 intended to receive the implants 1 , each on the location wanted and in the right direction as determined in the planning 10 . [0096] In order to limit the heating of honey tissue 7 , a hole of a small diameter is first drilled, before switching to a larger diameter in order to obtain the nominal diameter. In the classical methods, five drills are used to prepare the implantation site. Given that the guiding cylinders 14 of the template 11 are of a given diameter, several templates 11 are thus usually necessary to obtain a drilling sequence, unless use is made of a series of adaptation tubes 18 inserted into the cylinders 14 . [0097] This latter method of working is retained in the method of the present invention, but, different from the prior art, in this step 16 , the drilling tubes 18 are of only one kind, the inside diameter being predetermined in function of the type of implant 1 . The handling of several drilling tubes 18 for every drilling is thus eliminated: the same standard tube 18 is screwed into the cylinder 14 for the entire duration of the drilling. [0098] This is made possible by using, during the drilling step 19 , only two drills 4 , 5 , of a particular type: one drill named “staged drill” 4 , and a second drill named “calibration drill” 5 . All of these elements will be described in detail in connection with FIGS. 2 , 3 , 4 , 6 , and 7 . [0099] The method for the placement of the implant 1 is completed by introduction of the latter by way of a fixture mount 3 in the osteotomy 17 which is obtained beforehand. During this final stage 20 , the implant 1 is correctly directed by a particular type of fixture mount 3 , characteristic to the method of the invention, which is guided by sliding movement into the cylinder 14 of the template 11 . [0100] The drilling templates 11 used will normally feature tubes 17 of a same height predetermined at the request of the practitioner in function of the type of implants 1 that he will be using (“Standard”, “Wide”, or “Zygomatic”). Every type of implant 1 exists in different lengths. In order to drill holes 17 of corresponding depths, the drills 4 , 5 thus have to be changed. [0101] The method according to the present invention suggests to retain only the longest drills 4 , 5 (“universal” drills for the type of implants 1 being considered) and to adapt their length by using the rings 21 of known thickness. These rings limit the depth of penetration of the drill 4 , 5 into the bone 7 by more or less filling up the free space between the top of the template 11 placed on the osseous crest and an axial stop 22 which appears on all of the drills 4 , 5 . [0102] The same principle is applied to the fixture mounts 3 : washers 23 inserted around the stem 24 are used to limit the depth of the screwing of the implant 1 . In this way the variability in the length of the fixture mounts 3 is limited to the only combination of the type of implants 1 and of the type “osseous” or mucous” of fixture mounts 3 . [0103] According to a variation of the method, to avoid the use of the rings 21 , the practitioner specifies the heights of the bore tubes 15 of the template 11 upon production. In this method it is then the height of the stereolithographic tube 17 which is variable and not the drill 4 , 5 . The deeper the stereolithographic tube, all the less deep the drilling will be, while using the same guiding cylinders 14 and drilling tubes 18 . This method has three advantages: first it makes use of only one length of drill 4 , 5 for all depths; secondly there is no need to control the depths at each drilling, as this is predetermined by the template 11 ; finally, in the case of tissue borne templates 11 , this allows to take into account the thickness of mucosa which is uneven in the different implantation zones, without having to perform any calculations or any adaptations. [0104] All of the elements of a computer-assisted implantology system adapted for performing the method which has been described in detail above will not be repeated here in detail. Only those parts of the device specific to the invention will be described hereafter. [0105] FIG. 2 clearly depicts the drilling template 11 fixed to the osseous crest of a mandible 7 , with the guiding cylinders 14 in position in the bore tubes 15 . This situation corresponds to the moment of step 16 when the practitioner has already screwed the drilling tubes 18 in the cylinders 14 (the tube 18 is here drawn on top of the cylinder 14 for the clarity of the representation), and is starting the operative step of drilling 19 . [0106] The “universal” staged drill 4 is provided with a ring 21 if the height of the bore tubes 15 is not sufficient to limit insertion thereof to a depth corresponding to the size of the implant 1 . The detailed characteristics of all elements of FIG. 2 are represented in FIGS. 3 to 7 . [0107] The guiding cylinder 14 seen in section in FIG. 3 a , and from above in FIG. 3 b , comprises an upper threaded part 25 extending over half of its length. The screw thread presents four recessed helices spaced apart by 90°, which facilitates the screwing and unscrewing. [0108] The cylinder 14 has a height of 4 mm. It has an inside diameter, with a dimensional tolerance H7, of 4.20 mm at the part which is not threaded. Its exterior diameter is 5.20 mm. These dimensions are suitable for implants 1 of a “standard” type, having an exterior diameter of 3.75 mm or 4.00 mm, which applies to 97% of the cases. Cylinders 14 of different sizes exist for implants of the “Wide” type with a diameter of 4.75 mm, 5 mm or 6 mm. [0109] The cylinders 14 are made of implantable metal, preferably of the titane alloy TAV6. [0110] The drilling tube 18 , seen from the front in FIG. 4 a and from above in FIG. 4 b , has an external pitch 26 which is close to the top end and complementary to the threaded part 25 of cylinder 14 . The four shifted relief pattern helixes allow the fixing of the tube 18 in its cylinder in a quarter of a turn only. [0111] The handling and the fixing/releasing of the drilling tube 18 using a tool are made easier by way of a ring 27 which surrounds its upper end, and featuring four radial blind holes 28 . A cylindrical tangential slot 29 allows the passing of a silk thread which serves as a parachute. [0112] The drilling tube 18 has a height of 5 mm and apart from the screw thread, has an external diameter of 4.20 mm with a dimensional tolerance g6, thus corresponding to the inside diameter of the cylinder 14 and adjusted to fit the most common cases. The external diameter of the ring 27 is 5.2 mm and its height 0.5 mm The inside diameter of the tube 18 is 3.20 mm for guiding drills 4 , 5 with a diameter of 3.15 mm. [0113] The drilling tubes 18 are produced in steel, preferably stainless steel INOX 316L. [0114] The ring depicted in FIGS. 5 a and 5 b does not feature any particular characteristics apart from its dimensions which are adapted to the system. Its external diameter corresponds to the common diameter of the ring 27 of the drilling tube 18 and of the flange 22 of the drills 4 , 5 in between which it is placed, thus being 5.2 mm. Its inside diameter of 3.10 mm is slightly smaller than the diameter of the drills 4 , 5 of 3.15 mm in order for it to adhere thereto. [0115] These rings 21 are produced in polyoxymethacrylate (POM). Rings 21 with a thickness of 0.5 mm are preferably in white coloured natural POM, while rings 21 with a thickness of 1.5 mm are preferably coloured black, so as to be more easily distinguishable from each other. [0116] The staged drill 4 represented in FIG. 6 allows the replacement of the ball drill, the drill of 2 mm and the pilot drill by one single drill. A staged drill 4 for an implant 1 having a length of 10 mm, but representative of the system when making use of standard implants 1 , typically features: a conical part with an opening angle of 120° followed by a first drill section 30 of 2 mm in diameter and which is 4 mm in length, a second drill section 31 of 3 mm in diameter and 6 mm in length, including the conical connection, having an opening angle of 120° with the first drill section 30 , a smooth section 32 of 3.15 mm in diameter and 5 mm length, including the conical connector, of an opening semi-angle of 10°, with the second drill section 31 , a flange 22 of 5.2 mm in diameter and 0.5 mm thickness, and a standard blocking means for a handpiece 33 with a total length of 14 mm. [0122] Staged drills 4 for implant lengths of 13, 15 or 18 mm also exist but, as has been explained, the longest drill 4 of the series can be used as a “universal” drill if used with rings 21 in POM or with a template 11 featuring bore tubes 15 of variable heights. [0123] The calibration drill 5 represented in FIG. 7 comprises an upper part 22 , 33 identical to that of the staged drill 4 . [0124] In case of a standard implant 1 with a length of 10 mm, the lower part of this drill 5 typically features: a conical part with an opening angle of 120° followed by a first drill section 34 of 3.15 mm in diameter and 4 mm in length, [0126] a second drill section 35 of 3.00 mm in diameter and 6 mm in length, a smooth section 36 of 3.15 mm in diameter and 5 mm in length, including the conical connection to the second drill section 35 with a semi-angle opening of 10°. [0128] The staged drills 4 as well as the calibration drills 5 are made of stainless steel, preferably of the type Z33C13. [0129] FIG. 8 represents an implant 1 , a fixture mount 3 and the template 11 during the placement step 20 of the implants 1 following the drilling step 19 (the elements have been dissociated here for the clarity of the representation). The cavities 17 drilled in the boney tissue 7 in the exact location foreseen by the implant planning 10 will receive the implants 1 . The guiding cylinders 14 of the template 11 , from which the drilling tubes 18 have been unscrewed, allow the precise guiding of the implants 1 by way of the specific fixture mounts 3 . [0130] Each of these fixture mounts 3 according to the invention comprises on the one hand a composite shape which forms a mandrel 37 and on the other hand a fixing screw 38 of the implant 1 . These two elements are represented respectively in FIGS. 9 and 10 . [0131] The mandrel 37 comprises an upper part 39 of a hexagonal section which forms a part which is complementary to an instrument-holder. This part 39 features an axial bore 40 and is linked to a smooth sleeve 24 by a flange 22 identical to that of the drills 4 , 5 . The base of the mandrel 37 comprises a cavity 41 which is hexagonal in cross-section complementary to the hexagonal head 42 of an implant 1 , armed with a threaded blind hole. The screw 38 which passes through the mandrel 37 is screwed by way of its threaded end 43 into the hexagonal head 42 so as to inseparably fit together the implant 1 and the fixture mount 3 . To achieve this, the head of the screw 38 of the fixture mount 3 is advantageously of a type having a hexagon socket 44 . [0132] The exterior diameter of the sleeve 24 of the mandrel 37 corresponds to the inside diameter of a guiding cylinder 14 . In this way, the implant 1 is guided when placed into position by the gliding of sleeve 24 into the cylinder 14 of the template 11 . The flange 22 going solid on the upper part of the cylinder 14 limits the insertion to the level desired by the surgeon. Thus, as has been set forth above, washers 23 in POM allow the precise control of this penetration depth. [0133] The fixture mounts 3 can be divided into two main types based on their length: the osseous fixture mounts, which are short, and the long fixture mounts, adapted for transmucosal placement. [0134] For the standard implants 1 , the external diameter of the sleeve 24 of a fixture mount 3 is 4.15 mm, which ensures a soft gliding in a cylinder 14 having an inside diameter of 4.20 mm The height of the sleeve 24 (height of the fixture mount under the flange) is 4.5 mm for the osseous fixture mounts, and 10.5 mm for the mucous fixture mounts. The total length of the screw 38 of the fixture mount 3 is respectively 13.5 mm and 19.5 mm In the case of a “universal” osseous fixture mount and the “universal” mucous fixture mount, the sleeve 24 is respectively 10.0 mm and 15.0 mm high, and the screw 38 is respectively 19.0 mm and 24.0 mm long. The hexagon sockets 41 of the base of the mandrel 24 and the screw thread M 2 43 of the screw 38 are compatible with most of the implants 1 on the market. [0135] The washers 23 of the fixture mounts 3 are of the same plastic bio-compatible material as the rings 21 of the drills 4 , 5 . [0136] In case of standard implants, their external diameter is the same as that of the flanges 22 , and their inside diameter is 4.10 mm, which is slightly inferior to the external diameter of the sleeve 24 . Their thickness is either 0.5 mm, or 1.5 mm. Preferably, the thinner ones are white and the thicker ones are black, so as to not to confuse one for the other. [0137] The whole of the characteristics provides to the method and to the device for the placement of dental implants according to the invention several noteworthy advantages over the prior art: only two drills are used (for every type of implant) instead of several drills of different lengths and different diameters, the specific template allows drilling without calculations and adjustments to the appropriate depth, one single model of drilling tubes is required (for every type of implant) instead of a series of tubes with increasing inside diameters, the handling of the tubes is made easier as their specific mechanical design allows them to be engaged in the guiding cylinders by simple screwing over a quarter of a turn, the security is increased by the tubes having a “parachute”, and the fixture mounts are guided precisely during the placement of the implant. [0144] The method and the device described above can in some cases be simplified so as not to make use of the rings 21 and/or the washers 23 to adapt the depth of penetration of the drills 4 , 5 and, respectively, of the fixture mounts 3 , independent of the depth of drilling, the thickness of the gums or how deep the implants are applied. [0145] It is known that the drills most frequently used have lengths of 10, 13, 15, 18 and 20 mm. [0146] Moreover, the lengths of the implants most frequently used are: 8.5; 10; 11.5; 13; 15; 18 and 20 mm. [0147] Knowing that X equals the length of the of the drill that is used or it can be used, minus the length of the implant to be placed, X must allow the use of an available fixture mount, without rings or washers, by choosing X+4 as the length of the fixture mount. [0148] Each time that this will be possible, the value of X will be chosen so that it can comply with the two prerequisites cited above while a drill of a specific length and a fixture mount of a similarly specific length are used. [0149] Thus, this value X will be independent of the insertion depth of the implant into the bone and of its position with regard to the osseous crest, but also independent of the operating method used (osseous guide or mucous guide), independent of the value of the thickness of the gums and independent of the determination of the surface of the osseous crest. [0150] In most cases, it will thus be possible to drill and then place an implant without having to use neither a ring 21 nor a washer 23 , or by having to use a ring but no washer or a washer but no ring. [0151] Lengths of the fixture mounts of 4, 5, 6, 7, 9, 10, 11, 12, 14 and 17 mm will in practice allow to respond to all hypothetical cases of the above-cited values, i.e. preventing the use of a ring and/or the use of a washer. [0152] It is of course understood that the invention is not limited only to the preferred embodiments described above. To the contrary, it encompasses all possible variant embodiments that would be in accordance with the concept of the present invention as defined by the following claims. [0000] We claim:

The invention relates to a method and device for placing implants using a surgical template which is made from tomographic cuts in the patient's jawbone. Step drills and calibrating drills, having a single standard diameter for each type of implant, are guided through drill bushings which are inserted into bores in the template in order to produce any drilling sequence corresponding to an implant plan. The penetration depth of the drills is controlled by the height of the bores or by the drill rings. The method limits the required number of drills and implant supports to the longest models only. The inventive method and device are particularly suitable for computer-assisted implantology systems.

CLAIM OF PRIORITY This application is a Continuation application claiming priority from Divisional application Ser. No. 13/933,388, filed on Jul. 2, 2013, which claims priority from U.S. patent application Ser. No. 12/335,505, filed on Dec. 15, 2008, now issued as U.S. Pat. No. 8,542,902, which claims priority from Provisional Application No. 61/014,427, entitled “D YNAMIC THREE-DIMENSIONAL OBJECT MAPPING FOR USER-DEFINED CONTROL DEVICE ”, filed on Dec. 17, 2007, which are herein incorporated by reference. BACKGROUND OF THE INVENTION Description of the Related Art The video game industry has seen many changes over the years. As computing power has expanded, developers of video games have likewise created game software that takes advantage of these increases in computing power. To this end, video game developers have been coding games that incorporate sophisticated operations and mathematics to produce a very realistic game experience. Example gaming platforms, may be the Sony Playstation, Sony Playstation2 (PS2), and Sony Playstation3 (PS3), each of which is sold in the form of a game console. As is well known, the game console is designed to connect to a monitor (usually a television) and enable user interaction through handheld controllers. The game console is designed with specialized processing hardware, including a CPU, a graphics synthesizer for processing intensive graphics operations, a vector unit for performing geometry transformations, and other glue hardware, firmware, and software. The game console is further designed with an optical disc tray for receiving game compact discs for local play through the game console. Online gaming is also possible, where a user can interactively play against or with other users over the Internet. As game complexity continues to intrigue players, game and hardware manufacturers have continued to innovate to enable additional interactivity and computer programs. The traditional way of interacting with a computer program or interactive game has remained relatively unchanged, even thought there have been great advances in processing power. For example, computer systems still require basic input objects, such a computer mouse, a keyboard, and possibly other specially manufactured objects/devices. In a similar manner, computer gaming consoles generally require some type of controller, to enable interaction with a game and/or console. All of these input objects, however, are specially manufactured with a predefined purpose and have special buttons, configurations and functionality that is predefined. Accordingly, traditional interfacing devices must be purchased, and used for the purpose defined by the manufacturer. It is within this context that embodiments of the invention arise. SUMMARY In one embodiment, a computer-implemented method to interactively capture and utilize a three-dimensional object as a controlling device for a computer system is disclosed. One operation of the method is capturing depth data of the three-dimensional object. In another operation, the depth data of the three-dimensional object undergoes processing to create geometric defining parameters for the three-dimensional object. The method can also include defining correlations between particular actions performed with the three-dimensional object and particular actions to be performed by the computer system. The method also includes an operation to save the geometric defining parameters of the three-dimensional object to a recognized object database. In another operation, the correlations between particular actions performed with the three-dimensional object and particular actions to be performed by the computer system in response to recognizing the particular actions are also saved to the recognized object database. In one embodiment, a system for initiating and using a three-dimensional object as a controlling device when interfacing with a computer system used for interactive video game play, is provided. The system includes an interface for receiving data from a capturing device of a three-dimensional space and storage coupled with computer system. The computer system provides data to a screen and receiving user input to obtain geometric parameters of the three-dimensional object and assign actions to be performed with the three-dimensional object when moved or placed in positions in front of the capture device during interactive video game play. The geometric parameters and the assigned actions being saved to a database on the storage for access during interactive video game play or future interactive sessions. In another embodiment, a computer-implemented method is disclosed to interactively capture and utilize a three-dimensional object to be a controlling device for a computer system. The method includes an operation for identifying the three-dimensional object. To identify the three-dimensional object, there are operations for capturing depth data of the three-dimensional object and processing captured depth data of the three-dimensional object to create geometric defining parameters for the three-dimensional object. There are also operations for defining correlations between particular actions performed with the three-dimensional object and particular actions to be performed by the computer system. Additionally, there are also operations for saving the geometric defining parameters of the three-dimensional object and correlations between particular actions performed with the three-dimensional object and particular actions to be performed by the computer system to a recognized object database. The method also includes operations for presenting the three-dimensional object to a camera and moving the presented three-dimensional object in front of the camera so as to trigger one or more of the particular actions to be performed by the computer system. In yet another embodiment, a system for using a three-dimensional object as a controlling device when interfacing with a computer system is disclosed. The system includes a camera interfaced with the computer system that is configured to capture data from a three-dimensional space. Also include in the system is storage that is linked to the computer system. The system can also include a display that can be coupled to the computer system. The display can be configured to display a plurality of graphical display screens to enable set-up of a capture session to obtain geometric parameters of an object. The capture session can also be used to assign actions to be performed with the object when moved in front of the camera during an interactive session. During the interactive session, the geometric parameters and the assigned actions can be saved to a database for access on the storage linked to the computer system. Wherein the assigned actions can be custom defined by a user for particular movements made by the user on the object when holding the object in front of the camera. Other aspects and advantages of the invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, illustrating by way of example the principles of the invention. BRIEF DESCRIPTION OF THE DRAWINGS The invention, together with further advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying drawings. FIG. 1 illustrates a scene 100 with a user 101 manipulating a generic three-dimensional object 102 to interact with a computer system 108 in accordance with one embodiment of the present invention. FIG. 2A is an exemplary flow chart illustrating various operation that can be performed to allow the computer system 108 to recognize the three-dimensional object 102 , in accordance with one embodiment of the present invention. FIG. 2B is another exemplary flow chart illustrating a procedure to define and use a three-dimensional object to control a computer system, in accordance with one embodiment of the present invention. FIGS. 3A-3G illustrate real-world and virtual-world views of various actions performed by users while holding the three-dimensional object 102 , in accordance with various embodiments of the present invention. FIGS. 4A-4D are examples where various three-dimensional objects can be recognized and used to control a variety of virtual devices based on the configuration of the three-dimensional object and the software being executed by the computer system, in accordance with one embodiment of the present invention. FIG. 5A and FIG. 5B illustrate movements of a three-dimensional object to perform pre-configured remote control operations, in accordance with one embodiment of the present invention. FIGS. 6A-6D illustrate capturing a three-dimensional object in various states of deformation, in accordance with one embodiment of the present invention. FIG. 7 is an exemplary flow chart illustrating operations to map geometric defining parameters of a three-dimensional object, in accordance with one embodiment of the present invention. FIG. 8 is an exemplary flow chart illustrating one method to configure an object to control virtual elements or the graphical user interface of the computer system, in accordance with one embodiment of the present invention. FIG. 9 is an exemplary flow chart illustrating operations to utilize an object that has been mapped and configured, in accordance with one embodiment of the present invention. FIG. 10 schematically illustrates the overall system architecture of the Sony® Playstation 3® entertainment device, a computer system capable of utilizing dynamic three-dimensional object mapping to create user-defined controllers in accordance with one embodiment of the present invention. DETAILED DESCRIPTION An invention is disclosed for capturing geometric identifying data for everyday objects and mapping controls to the everyday object to control a computer system. Broadly speaking, the computer system can be any type of system that takes input from a user, whether it be a general purpose computer (e.g., desktop, laptop, portable device, phone, etc.), or a special purpose computer like a game console. A camera capable of measuring depth data can be used to capture geometric data along with actions that can be correlated to controls for a variety of different programs. In one embodiment, a single camera is used, and in other embodiments, multiple cameras can be used to capture images from various locations or view perspectives. The correlated controls can be used to control aspects of a virtual object defined by a program executed by the computer system. The correlations between actions performed with the object and control of the virtual world element can be saved with the captured geometric identifying data of the object. Comparisons of real-time image data captured by the camera can be made to geometric identifying data that has been saved in order to recognize an object that is presented to the camera. Once recognized, the saved correlations can be loaded and the user can manipulate the object to control various aspects of a virtual object. Accordingly, the capturing sequences, methods and systems should be broadly understood to enable the capture of any real-world object, discern its geometric identifying data and enable mapping of various controls to the real-world object. Recognition of the object along with recognition of actions correlated to control of a program can improve user interaction with the computer system. As used herein, a three-dimensional object should include any physical or material thing that can be touched, held, moved, captured in an image, captured in a video, compared to other things to discern its size or relative size, or identified based on height, width, length, or depth, and the like. A virtual-world object shall be broadly construed to include a computer generated image or images that can be displayed on a screen. The screen can represent the virtual-world object as a two or three dimensional thing and can be animated to move, be placed, be interacted with, or be modified based on user interactivity. The interactivity can include commands provided by the user, using a three-dimensional object or other interface devices such as keyboards, computer mice, touch screens, gaming controllers, motion sensors, or, acoustic or audible sounds and combinations thereof. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It will be apparent, however, to one skilled in the art that the present invention may be practiced without some or all of these specific details. In other instances, well known process steps have not been described in detail in order not to unnecessarily obscure the present invention. FIG. 1 illustrates a scene 100 with a user 101 manipulating a generic three-dimensional object 102 to interact with a computer system 108 in accordance with one embodiment of the present invention. The computer system 108 can output video to a display 106 . In some embodiments the display 106 can be a computer monitor while in other embodiments the display 106 can be a television. While not shown in the scene 100 , the computer system 108 can also output audio. Associated with the computer system 108 is a camera 104 . The camera 104 can capture images and video that can be processed by the computer system 108 . The computer system 108 is shown wirelessly communicating with the camera 104 , but wired connections can also be used. The camera 104 can be configured to capture depth data, as shown by depth sensing lines 104 a . In some embodiments, the depth data from the camera 104 is transmitted to and processed by the computer system 108 . User input from a controller 110 is also transmitted to the computer system 108 . In various embodiments, the controller 110 transmits user input using wireless protocols such as, but not limited to, Bluetooth or WiFi. Thus, a controller with a wired connection to the computer system 108 can also be used. As will be discussed in greater detail below, a generic three-dimensional object 102 , recognized by the computer system 108 via images captured from the camera 104 can also be used to provide user input to the computer system 108 . The “U” shape of the three-dimensional object 102 should not be construed to be limiting, as the shape was chosen for illustrative clarity and simplicity. The term “three-dimensional object” is intended to describe any physical object capable of being held by a user. As such, the three-dimensional object 102 does not need to be specifically made to interface with the computer system 108 , but may have been a random object found in the home of user 101 . FIG. 2A is an exemplary flow chart illustrating various operations that can be performed to allow the computer system 108 to recognize the three-dimensional object 102 , in accordance with one embodiment of the present invention. The flow chart is shown with exemplary images displayed to the user from the user&#39;s perspective. Operation 200 shows a user manipulating an exemplary graphical user interface to initiate an object capture procedure. A variety of user interfaces including various menus can be used to display and interact with the computer system. In other embodiments, audible commands, gestures, or user input into a controller or previously captured three-dimensional object can be recognized to initiate the capture process shown in operation 200 . In operation 202 , the user presents the three-dimensional object 102 to the camera. For simplicity, the three-dimensional object 102 is shown as a blocky “U” shaped object. However, the three-dimensional object 102 can be any real-world object that can be manipulated by a person and perceived by the camera. Exemplary three-dimensional objects include items such as coffee mugs, drinking glasses, books, bottles, etc. Note that the previously discussed three-dimensional objects were intended to be exemplary and should not be construed as limiting. In operation 204 , the user is prompted to rotate the three-dimensional object 102 in front of the camera. As shown in FIG. 2 , the user can be prompted to rotate the three-dimensional object 102 is different directions to allow the camera can capture views necessary to recognize the three-dimensional object 102 . When the user rotates the three-dimensional object 102 , the camera and computer system can capture and process geometric defining parameters associated with the three-dimensional object 102 . In another embodiment, more than a single camera can be used, when placed in various locations to allow image mapping from various angles of the space. In one embodiment, the computer system uses depth data from the camera to measure ratios between various geometric defining parameters on the three-dimensional object. Geometric defining parameters can include, but are not restricted to recognizable features of a three-dimensional object such as points, planes, transitional surfaces, fillets, accent lines, and the like. In such an embodiment, recognizing ratios between geometric defining parameters can allow the computer system to more readily recognize the three-dimensional object if the three-dimensional object is presented to the camera for recognition at a different distance than when it was captured. Operation 206 informs the user when sufficient views of the three-dimensional object 102 have been presented so the computer system can recognize the three-dimensional object 102 based on the defined geometric parameters. In one embodiment, operation 206 displays a computer-generated model of the three-dimensional object 102 , as captured and modeled by the computer system. In another embodiment, operation 206 displays real-time video of the user holding the three-dimensional object 102 . Operation 206 allows a user to choose between saving the three-dimensional object 206 without configuration, or continue to configure the three-dimensional object 206 . Continuing with FIG. 2A , Operation 208 is an exemplary view of a screen prompting the user to save the geometric parameters associated with the three-dimensional object 102 . Operation 208 is an exemplary screen where users can choose to save the geometric parameters of the three-dimensional object 102 or to cancel the save procedure. If a user chooses to configure the three-dimensional object, operation 210 allows a user to choose between pre-configured or custom configurations. In either case, configuring the three-dimensional object 102 allows a user to define correlations between particular actions performed with the three-dimensional object 102 and particular actions to be performed by the computer system. In one embodiment, the user can select a pre-configured setting that enables control the computer system user interface with user-performed actions with the three-dimensional object 102 . For example, the pre-configured setting can correlate user-performed actions with the three-dimensional object to navigation and selection of menus within a graphical user interface. In other embodiments, the user can custom configure the three-dimensional object to control aspects of a game being executed by the computer system, as will be discussed below. FIG. 2B is another exemplary flow chart illustrating a procedure to define and use a three-dimensional object to control a computer system, in accordance with one embodiment of the present invention. The procedure beings with start operation 220 . In operation 222 , a user presents a three-dimensional object and depth data for the three-dimensional object is captured. As previously discussed, a single depth camera or multiple depth cameras can be used to capture depth data for the three-dimensional object. Operation 224 processing the captured depth data for the three-dimensional object to create geometric defining parameters. In one embodiment, the depth data can be used to create wire frame models of the three-dimensional object. In another embodiment, the depth data for the three-dimensional object can be processed to define particular features such as, but not limited to, length, height, and width. Operation 226 is where a user can define correlation between actions performed with the three-dimensional object and specific actions that are to be performed by the computer. The actions performed with the three-dimensional object can include moving and manipulating the three-dimensional object in a manner than can be detected by the depth camera or other sensors associated with the computer system. The computer system can capture a sequence of images and depth data of a user performing actions with the three-dimensional object and determine a relative position of the three-dimensional object throughout the action. For example, in one embodiment, a user can wave the three-dimensional object in a single plane or wave the three-dimensional object across multiple planes. Similarly, in another embodiment a user can create complex or simple gestures in a real-world three-dimensional space while holding the three-dimensional object. The user can associate or correlate particular real-world actions or gestures performed with the three-dimensional object to virtual world actions performed by the computer. Thus, when a user performs a particular gesture while holding the three-dimensional object, the computer system can perform a particular task or execute a particular instruction. In some embodiments, real-world actions performed with the three-dimensional object can be associated with particular virtual world motions such as swinging a virtual world golf club or tennis racquet. In other embodiments, real-world actions can be associated with user interface menu navigation. Operation 228 saves the geometric defining parameters for the three-dimensional object along with the correlations between user actions with the three-dimensional object and virtual world actions performed by the computer to a database. Once saved in the database, the computer system can perform real-time analysis on depth data to recognize geometric defining parameters within the database if a user picks up the corresponding real-world three-dimensional object. Furthermore, the computer system can perform real-time analysis on user actions while holding the recognized three-dimensional object to recognize when a user performs an action correlating to a virtual world action or command for the computer system. The procedure is terminated with end operation 230 . FIGS. 3A-3G illustrate real-world and virtual-world views of various actions performed by users while holding the three-dimensional object 102 , in accordance with various embodiments of the present invention. In the following examples, the three-dimensional object 102 has been configured to perform a particular function associated with various in-game actions. The following examples are exemplary and not intended to be limiting. Furthermore, it should be noted that a three-dimensional object could be recognized and configured to perform multiple functions for more for multiple different games. FIG. 3A illustrates a how a three dimensional object 102 can be configured to be used like a baseball bat, in accordance with one embodiment of the present invention. In the real-world view, the user 101 a is shown holding the three-dimensional object 102 and swinging it like a baseball bat. Accordingly, as shown in the in-game view of FIG. 3A , an in game character 101 b , representative of the user 101 a , swings a virtual baseball bat 300 in response to the real-world swing of the three-dimensional object 102 . In one embodiment, the in game character 101 b is a computer-generated likeness of a real-world professional baseball player swinging a virtual baseball bat 300 in response to the user 101 a swinging the three-dimensional object 102 . In another embodiment, the in game character 101 b is a user created avatar integrated into a virtual baseball stadium. In other embodiments, the in game character 101 b can be a combination of computer generated real-world characters and user generated avatars swinging a virtual baseball bat 300 in response to the real-world swing of the three-dimensional object 102 . FIG. 3B illustrates how different orientations of the three-dimensional object 102 can be configured to different actions of a virtual world light sword 302 a and 302 b , in accordance with one embodiment of the present invention. As illustrated in the real-world view, the user 101 is holding a three-dimensional object 102 a in a first orientation. In one embodiment, this first orientation 102 a is correlated to the virtual world light sword 302 a being turned “off”, as shown in the in-game view of FIG. 3B . Conversely, when the user 101 holds the three-dimensional object 102 b in a second orientation as shown in the real-world view, the virtual world light sword 302 b is shown in an “on” position, in the in-game view. Thus, when the user 101 is holding the three-dimensional as shown in orientation 102 b , the computer will display the in-game character with the light sword extended. Additionally, while held as three-dimensional object 102 b , in an “on” position, the camera and computer system can recognize movement of the three-dimensional object 102 b , and move the in-game light sword 302 b accordingly. FIGS. 3C-3G illustrate other virtual-world objects that can be controlled using the three-dimensional object 102 , in accordance with other embodiments of the present invention. For example, in FIG. 3C , the three-dimensional object 102 can be used to control the swing of a virtual golf club 304 . Similarly, in FIG. 3D , a virtual tennis racquet 306 can be controlled by a user swinging the three-dimensional object 102 . In FIG. 3E , the three-dimensional object 102 can be used to allow a user to control a virtual bowling ball 308 . In FIG. 3F , the three-dimensional object 102 can be used in a virtual game of pool or billiards to control a virtual cue 310 . Another example of where the orientation of the three-dimensional object may need to be detected is found in FIG. 3G where the three-dimensional object 102 is used to control a virtual steering wheel 312 . Orientation of the three-dimensional object 102 can be used to determine when the virtual steering wheel 312 returns to a centered position resulting in the virtual car traveling in a substantially straight direction. Accordingly, orientation of a three-dimensional object 102 when held by a user can also be applied to control of other virtual world objects or even control of the computer system interface. FIGS. 4A-4D are examples where various three-dimensional objects can be recognized and used to control a variety of virtual world devices based on the configuration of the three-dimensional object and the software being executed by the computer system, in accordance with one embodiment of the present invention. FIG. 4A shows a scene 400 with three-dimensional objects 102 , 402 , and 404 in front of a user 101 . In this example, three-dimensional objects 102 , 402 , and 404 have previously been captured by the computer system and can be recognized by the computer system when presented to the camera 104 . In FIG. 4B , the user 100 picks up a three-dimensional object 102 and software being executed on the computer system determines if the three-dimensional object controls a baseball bat 406 , a steering wheel 408 , or a remote control 410 . In one embodiment, if the computer system is executing a baseball simulation program, the three-dimensional object 102 is recognized and rendered as a virtual world baseball bat 406 . Thus, the computer system can attempt to recognize batting swing motions performed by the user 100 with the three-dimensional object 102 . Similarly, if the computer system is executing software to simulate a tennis simulation, the user 100 can control a virtual world tennis racquet 408 based on the real-world movement of the three-dimensional object 102 . In another embodiment, movements and interactions with the three-dimensional object 102 can be configured and recognized functions from a remote control 410 . This can allow a user to perform motions with the three-dimensional object 102 that result in, but not limited to, increasing/decreasing volume, accessing a channel guide, and paging up/down within the channel guide. In FIG. 4C , the user has picked up three-dimensional object 402 . The three-dimensional object 402 can be used as a remote control 410 . Alternatively, the three-dimensional object 402 can be used to control a virtual tennis racquet 412 , or a virtual bowling ball 414 . Similarly, in FIG. 4D , depending on the type of software being executed on the computer system, three-dimensional object 404 can be recognized as a virtual baseball bat 406 , a virtual golf club 416 or a remote control 410 . In some embodiments, where software executed on the computer system can recognize multiple virtual world counterparts associated with a three-dimensional object, the computer system can prompt the user to select which virtual world counterpart to control. In another embodiments, when a user picks up a three-dimensional object the computer system automatically recognizes the three-dimensional object as a user defined default virtual object. Thus, while executing the appropriate software, a user can configure the three-dimensional objects 102 , 402 and 404 to be associated respectively with the virtual baseball bat, the virtual bowling ball, and the virtual golf club. Thus, when object 102 is picked up, the on screen character is immediately shown holding a baseball bat. Likewise, when the user picks up three-dimensional object 402 , the on screen character is holding and has control of a virtual bowling ball. Similarly, the virtual golf club 416 is controlled by an on screen character when the user picks up three-dimensional object 404 . In another embodiment, the various three-dimensional objects 102 , 402 , 404 could be representative of different weapons that can be accessed by a character in a first-person shooter game. For example, object 102 can correspond to a knife, object 402 can correspond to a pistol, and object 404 can correspond to an assault rifle. Physically switching between real world three-dimensional objects can result in increase user interaction and enjoyment of the first person shooter game. FIG. 5A and FIG. 5B illustrate movements or deformations of a three-dimensional object 102 to perform pre-configured remote control operations, in accordance with one embodiment of the present invention. After capturing and mapping both un-deformed and deformed geometric defining parameters of the three-dimensional object 102 to basic television functions, the computer system can recognize changes made to the three-dimensional object 102 to control television functions such as changing the channel or changing the volume. In the embodiment shown in FIG. 5A , rotating the three-dimensional object 102 around the Y-axis, can result in changing the channel up or down. Likewise, in the embodiment shown in FIG. 5B , rotating the three-dimensional object about the X-axis can change the volume up or down. FIGS. 6A-6D illustrate capturing a three-dimensional object in various states of deformation, in accordance with one embodiment of the present invention. For example, the three-dimensional object can be twisted and bent to control various aspects of the software being executed on the computer system. In one embodiment, twisting the three-dimensional object from the original shape shown in FIG. 6A to the deformed shape in FIG. 6B can bring up a television schedule. Similarly, deforming the three-dimensional object as shown in FIG. 6C can be correlated to having the computer system display the next page of the television schedule. Conversely, deforming the three-dimensional object as shown in FIG. 6D can instruct the computer system to display the previous page of the television schedule. The deformation and corresponding actions used in FIGS. 6A-6D are intended to be exemplary and should not be considered limiting. In other embodiments, three-dimensional mechanical objects can be captured in various states to control various aspects of virtual world machines, virtual world objects, or graphical user interfaces. For example, scissors or a stapler can be captured in both the open and closed position. In one embodiment, a virtual world character can be standing when the stapler or scissors are closed, and crouched when the stapler or scissors are open. Alternatively, opening and closing the stapler or scissors can make an in-game character jump. FIG. 7 is an exemplary flow chart illustrating operations to map geometric defining parameters of a three-dimensional object for use to control a computer system, in accordance with one embodiment of the present invention. In operation 700 a user initiates the object capture system. In operation 702 , the user presents the object to the depth camera. The object can be any object discernable by the depth camera and the object does not need to be specifically configured to interface with the computer system. In operation 704 , the depth camera and computer system capture depth data from multiple viewing angles to define the object through geometric defining parameters. In some embodiments the geometric defining parameters can be associated with dimensions such as height, depth, and width. In other embodiments, ratios between particular features of the object can be used. In still other embodiments, a combination of dimensions and feature ratios can be used as geometric defining parameters. In operation 706 , it is determined whether the object can be deformed or manipulated into a different or alternate form. In one embodiment, this operation can be as performed by prompting the user to indicate whether the object is deformable or capable of having an alternate configuration. In yet another embodiment, the computer system can include basic generic object shapes that can be recognized as deformable. For example, the computer system may be able to recognize a generic pair of scissors or a stapler. As such, when a user presents scissors or a stapler, the computer system can automatically prompt the user to capture depth data for the deformed or alternate configuration. Operation 708 captures depth data for the manipulated or deformed object. In some embodiments, Operation 708 may require the user to present the object in the alternate form to the depth camera from multiple viewing angles, similar to the viewing angles in operation 704 . Operation 710 saves all of the depth data associated with the object, including any alternate or manipulated form of the object. FIG. 8 is an exemplary flow chart illustrating one method to configure an object to control virtual elements or the graphical user interface of the computer system, in accordance with one embodiment of the present invention. Operation 800 recalls saved depth data associated with an object. In some embodiments the recalled depth data is stored on local storage associated with the computer system such as a local hard drive or flash memory. In other embodiments, the depth data can be stored on a local network or in still further embodiments, on remote storage accessible via the internet. Operation 802 associates movement of the object with actions performed by the computer system. In other embodiments, operation 802 can associate actions performed with the object such as waving, shaking, or deforming the object with actions performed by the computer system. Operation 804 saves the associated movements and actions with the depth data associated with the object. The associated movements and actions can be saved to a local storage element such as a hard drive or other non-volatile memory. Alternatively, the associated movements and actions can be uploaded to network storage via the internet and publicly shared among friends. FIG. 9 is an exemplary flow chart illustrating operations to utilize an object that has been mapped and configured, in accordance with one embodiment of the present invention. In operation 900 a user presents an object to the depth camera for recognition. In operation 902 , the computer system performs real-time analysis of the depth camera data and recognizes the object from stored geometric parameters. Operation 902 also loads any associated movements and actions that are stored with the depth data associated with the object. In operation 904 , the camera and computer system perform real-time image processing of the user manipulating and moving the object and perform the desired actions when actions with the object are recognized. It is possible for a user to have multiple objects mapped and configured and the computer system is capable of recognizing and switching between configurations as different objects are presented to the depth camera. Furthermore, a single object can have multiple configurations and upon recognition, a default configuration is loaded. In one embodiment, the user can selectively load an alternate configuration. In other embodiments, the user is asked to confirm loading the default configuration when multiple configurations for one object are present. FIG. 10 schematically illustrates the overall system architecture of the Sony® Playstation 3® entertainment device, a computer system capable of utilizing dynamic three-dimensional object mapping to create user-defined controllers in accordance with one embodiment of the present invention. A system unit 1000 is provided, with various peripheral devices connectable to the system unit 1000 . The system unit 1000 comprises: a Cell processor 1028 ; a Rambus® dynamic random access memory (XDRAM) unit 1026 ; a Reality Synthesizer graphics unit 1030 with a dedicated video random access memory (VRAM) unit 1032 ; and an I/O bridge 1034 . The system unit 1000 also comprises a Blu Ray® Disk BD-ROM® optical disk reader 1040 for reading from a disk 1040 a and a removable slot-in hard disk drive (HDD) 1036 , accessible through the I/O bridge 1034 . Optionally the system unit 1000 also comprises a memory card reader 1038 for reading compact flash memory cards, Memory Stick® memory cards and the like, which is similarly accessible through the I/O bridge 1034 . The I/O bridge 1034 also connects to six Universal Serial Bus (USB) 2 . 0 ports 1024 ; a gigabit Ethernet port 1022 ; an IEEE 802.11b/g wireless network (Wi-Fi) port 1020 ; and a Bluetooth® wireless link port 1018 capable of supporting of up to seven Bluetooth connections. In operation the I/O bridge 1034 handles all wireless, USB and Ethernet data, including data from one or more game controllers 1002 . For example when a user is playing a game, the I/O bridge 1034 receives data from the game controller 1002 via a Bluetooth link and directs it to the Cell processor 1028 , which updates the current state of the game accordingly. The wireless, USB and Ethernet ports also provide connectivity for other peripheral devices in addition to game controllers 1002 , such as: a remote control 1004 ; a keyboard 1006 ; a mouse 1008 ; a portable entertainment device 1010 such as a Sony Playstation Portable® entertainment device; a video camera such as an EyeToy® video camera 1012 ; and a microphone headset 1014 . Such peripheral devices may therefore in principle be connected to the system unit 1000 wirelessly; for example the portable entertainment device 1010 may communicate via a Wi-Fi ad-hoc connection, whilst the microphone headset 1014 may communicate via a Bluetooth link. The provision of these interfaces means that the Playstation 3 device is also potentially compatible with other peripheral devices such as digital video recorders (DVRs), set-top boxes, digital cameras, portable media players, Voice over IP telephones, mobile telephones, printers and scanners. In addition, a legacy memory card reader 1016 may be connected to the system unit via a USB port 1024 , enabling the reading of memory cards 1048 of the kind used by the Playstation® or Playstation 2® devices. In the present embodiment, the game controller 1002 is operable to communicate wirelessly with the system unit 1000 via the Bluetooth link. However, the game controller 1002 can instead be connected to a USB port, thereby also providing power by which to charge the battery of the game controller 1002 . In addition to one or more analog joysticks and conventional control buttons, the game controller is sensitive to motion in six degrees of freedom, corresponding to translation and rotation in each axis. Consequently gestures and movements by the user of the game controller may be translated as inputs to a game in addition to or instead of conventional button or joystick commands. Optionally, other wirelessly enabled peripheral devices such as the Playstation Portable device may be used as a controller. In the case of the Playstation Portable device, additional game or control information (for example, control instructions or number of lives) may be provided on the screen of the device. Other alternative or supplementary control devices may also be used, such as a dance mat (not shown), a light gun (not shown), a steering wheel and pedals (not shown) or bespoke controllers, such as a single or several large buttons for a rapid-response quiz game (also not shown). The remote control 1004 is also operable to communicate wirelessly with the system unit 1000 via a Bluetooth link. The remote control 1004 comprises controls suitable for the operation of the Blu Ray Disk BD-ROM reader 1040 and for the navigation of disk content. The Blu Ray Disk BD-ROM reader 1040 is operable to read CD-ROMs compatible with the Playstation and PlayStation 2 devices, in addition to conventional pre-recorded and recordable CDs, and so-called Super Audio CDs. The reader 1040 is also operable to read DVD-ROMs compatible with the Playstation 2 and PlayStation 3 devices, in addition to conventional pre-recorded and recordable DVDs. The reader 1040 is further operable to read BD-ROMs compatible with the Playstation 3 device, as well as conventional pre-recorded and recordable Blu-Ray Disks. The system unit 1000 is operable to supply audio and video, either generated or decoded by the Playstation 3 device via the Reality Synthesizer graphics unit 1030 , through audio and video connectors to a display and sound output device 1042 such as a monitor or television set having a display 1044 and one or more loudspeakers 1046 . The audio connectors 1050 may include conventional analogue and digital outputs whilst the video connectors 1052 may variously include component video, S-video, composite video and one or more High Definition Multimedia Interface (HDMI) outputs. Consequently, video output may be in formats such as PAL or NTSC, or in 720p, 1080i or 1080p high definition. Audio processing (generation, decoding and so on) is performed by the Cell processor 1028 . The Playstation 3 device&#39;s operating system supports Dolby® 5.1 surround sound, Dolby® Theatre Surround (DTS), and the decoding of 7.1 surround sound from Blu-Ray® disks. In the present embodiment, the video camera 1012 comprises a single charge coupled device (CCD), an LED indicator, and hardware-based real-time data compression and encoding apparatus so that compressed video data may be transmitted in an appropriate format such as an intra-image based MPEG (motion picture expert group) standard for decoding by the system unit 1000 . The camera LED indicator is arranged to illuminate in response to appropriate control data from the system unit 1000 , for example to signify adverse lighting conditions. Embodiments of the video camera 1012 may variously connect to the system unit 1000 via a USB, Bluetooth or Wi-Fi communication port. Embodiments of the video camera may include one or more associated microphones that are also capable of transmitting audio data. In embodiments of the video camera, the CCD may have a resolution suitable for high-definition video capture. In use, images captured by the video camera may for example be incorporated within a game or interpreted as game control inputs. In general, in order for successful data communication to occur with a peripheral device such as a video camera or remote control via one of the communication ports of the system unit 1000 , an appropriate piece of software such as a device driver should be provided. Device driver technology is well-known and will not be described in detail here, except to say that the skilled man will be aware that a device driver or similar software interface may be required in the present embodiment described. Embodiments may include capturing depth data to better identify the real-world user and to direct activity of an avatar or scene. The object can be something the person is holding or can also be the person&#39;s hand. In this description, the terms “depth camera” and “three-dimensional camera” refer to any camera that is capable of obtaining distance or depth information as well as two-dimensional pixel information. For example, a depth camera can utilize controlled infrared lighting to obtain distance information. Another exemplary depth camera can be a stereo camera pair, which triangulates distance information using two standard cameras. Similarly, the term “depth sensing device” refers to any type of device that is capable of obtaining distance information as well as two-dimensional pixel information. Recent advances in three-dimensional imagery have opened the door for increased possibilities in real-time interactive computer animation. In particular, new “depth cameras” provide the ability to capture and map the third-dimension in addition to normal two-dimensional video imagery. With the new depth data, embodiments of the present invention allow the placement of computer-generated objects in various positions within a video scene in real-time, including behind other objects. Moreover, embodiments of the present invention provide real-time interactive gaming experiences for users. For example, users can interact with various computer-generated objects in real-time. Furthermore, video scenes can be altered in real-time to enhance the user&#39;s game experience. For example, computer generated costumes can be inserted over the user&#39;s clothing, and computer generated light sources can be utilized to project virtual shadows within a video scene. Hence, using the embodiments of the present invention and a depth camera, users can experience an interactive game environment within their own living room. Similar to normal cameras, a depth camera captures two-dimensional data for a plurality of pixels that comprise the video image. These values are color values for the pixels, generally red, green, and blue (RGB) values for each pixel. In this manner, objects captured by the camera appear as two-dimension objects on a monitor. Embodiments of the present invention also contemplate distributed image processing configurations. For example, the invention is not limited to the captured image and display image processing taking place in one or even two locations, such as in the CPU or in the CPU and one other element. For example, the input image processing can just as readily take place in an associated CPU, processor or device that can perform processing; essentially all of image processing can be distributed throughout the interconnected system. Thus, the present invention is not limited to any specific image processing hardware circuitry and/or software. The embodiments described herein are also not limited to any specific combination of general hardware circuitry and/or software, nor to any particular source for the instructions executed by processing components. With the above embodiments in mind, it should be understood that the invention may employ various computer-implemented operations involving data stored in computer systems. These operations include operations requiring physical manipulation of physical quantities. Usually, though not necessarily, these quantities take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. Further, the manipulations performed are often referred to in terms, such as producing, identifying, determining, or comparing. The above-described invention may be practiced with other computer system configurations including hand-held devices, microprocessor systems, microprocessor-based or programmable consumer electronics, minicomputers, mainframe computers and the like. The invention may also be practiced in distributing computing environments where tasks are performed by remote processing devices that are linked through a communications network. The invention can also be embodied as computer readable code on a computer readable medium. The computer readable medium is any data storage device that can store data that can be thereafter read by a computer system, including an electromagnetic wave carrier. Examples of the computer readable medium include hard drives, network attached storage (NAS), read-only memory, random-access memory, CD-ROMs, CD-Rs, CD-RWs, magnetic tapes, and other optical and non-optical data storage devices. The computer readable medium can also be distributed over a network coupled computer system so that the computer readable code is stored and executed in a distributed fashion. Although the foregoing invention has been described in some detail for purposes of clarity of understanding, it will be apparent that certain changes and modifications may be practiced within the scope of the appended claims. Accordingly, the present embodiments are to be considered as illustrative and not restrictive, and the invention is not to be limited to the details given herein, but may be modified within the scope and equivalents of the appended claims.

A system for initiating and using a three-dimensional object as a controlling device when interfacing with a computer system used for interactive video game play is provided. One example system includes an interface for receiving data from a capturing device of a three-dimensional space and storage coupled with computer system. The computer system provides data to a screen and receiving user input to obtain geometric parameters of the three-dimensional object and assign actions to be performed with the three-dimensional object when moved or placed in positions in front of the capture device during interactive video game play. The geometric parameters and the assigned actions being saved to a database on the storage for access during interactive video game play or future interactive sessions.

CROSS-REFERENCE TO RELATED APPLICATION This application is based upon and claims priority to German Patent Application 199 44 748.9 filed Sep. 17, 1999, which application is herein expressly incorporated by reference. BACKGROUND OF THE INVENTION The invention relates to a side strut for a lower steering arm of a tractor. Side struts are used to at least temporarily stabilize lateral pivotable lower steering arms of a tractor. Side struts prevent the lower steering arms from being pivoted. The side struts are designed such that, when an implement is lifted, the implement and the lower steering arms are automatically centered centrally relative to the longitudinal axis of the tractor. Furthermore, the side struts serve to hold the lower steering arms at a predetermined distance from one another in accordance with the category of the to be attached implement. This enables the implement to be coupled automatically from the driver&#39;s seat. DE 197 37 318 A1 discloses an assembly where one lower steering arm of a tractor attaching device is associated with a single-action, double-stage telescopic cylinder. The other lower steering arm is associated with a single-action, single-state hydraulic cylinder in the form of a side strut. The piston rod of the single-stage hydraulic cylinder includes a bore with a freely movable guiding rod. At its free end, the guiding rod or the piston rod of one of the two cylinders includes a thread to receive an attaching element to connect to the lower steering arm. The attaching element can be threaded over a shorter or longer distance. One stage of the double-stage telescopic cylinder serves to compensate for any play and to adapt to a certain category. A tension spring is arranged between the attaching means associated with the piston rod and the outside of the cylinder housing. The tension spring loads the pistons and the guiding rod to enable them to assume their moved-in positions. The tension spring is arranged eccentrically relative to the longitudinal axis of the side strut. In consequence, the spring is unprotected, so that the dimension of spread between the two lower steering arms changes if no implement is attached. In order to couple the implement, the correct dimension of spread has to be re-set. Furthermore, the effect of the spring may be adversely affected by rough operating conditions. DE-GM 19 749 38 describes side struts that are associated with the lower steering arms of a tractor. Each side strut has a tube with a first attaching means and an adjustable journal. The adjustment is limited by stops. A further attaching means is also provided. If the lower steering arms are connected to one another by a liftlink drawbar, the connection with the lower steering arms can be effected to ensure free lateral movability or that such movability is eliminated. In addition, any play can be compensated for by the play of the thread. A central setting effect from a certain lifted position of the lower steering arm onwards is not possible. DE 197 44 328 C1 describes a side strut which can be used for the lower steering arms of a tractor. The side strut has a single-action hydraulic cylinder with a piston and a cylinder housing. One end of a piston rod associated with the piston projects from the cylinder housing. The rod carries a first attaching means which is connected to a corresponding attaching means at the rear of the tractor. The cylinder housing is axially followed by a hollow cylinder. An adjustable rod-shaped setting element is arranged in the hollow cylinder. The setting element is guided in the hollow cylinder by two spaced guiding rings. A pressure spring is arranged between the guiding rings. The spring is loaded into a moved-in position in which the setting element, by means of one end face, is supported against the base of the cylinder housing. The piston and the setting element can be moved out in opposite directions. The end of the setting element projects from the hollow cylinder when the setting element is moved in. The setting element includes a threaded bore which is engaged by a threaded rod. The second attaching means is attached to the threaded rod and is connectable to the associated lower steering arm. The basic axial length resulting from arranging the cylinder housing, the hollow cylinder, and the setting device for the category setting means with the threaded bore and the threaded bar one behind the other is too great for the installation conditions prevailing in modern tractors. Thus, the pivoting path of the lower steering arm is restricted. SUMMARY OF THE INVENTION It is an object of the invention to provide a side strut which is as short as possible. Also, a side strut is provided where the position of the piston in the cylinder housing remains unaffected by the spring. In accordance with the invention, a side strut includes a single-action hydraulic cylinder. The single-action hydraulic cylinder has a cylinder housing, a piston including a hollow cylinder and a base closing one end of the hollow cylinder. The end of the piston with the base enters the cylinder housing. The hollow cylinder is guided out of the cylinder housing. The piston in the cylinder housing is movable along a longitudinal axis. The single-action hydraulic cylinder, further includes a first attaching means. The side strut further includes a setting means. The setting means includes a rod-shaped setting element arranged in the hollow cylinder. The rod-shaped element is co-axially arranged in the hollow cylinder and rotatable around the longitudinal axis. The rod-shaped element is also adjustable relative to the hollow cylinder between a first position, where it is moved into the hollow cylinder, and a second position, where it is moved out of the hollow cylinder. The setting element has a threaded bore arranged and centered on the longitudinal axis. The threaded bore starts from a second end face which projects from the open end of the hollow cylinder. The setting means further includes a spring means arranged in the hollow cylinder around the setting element. The spring means is effective between the piston and the setting element only. The spring means loads the setting element to enable the setting element to assume the moved-in position. The setting element, via a first end face, is in contact with the base face of the base of the piston in the moved-in position. The spring means allow the setting element to be adjusted in a direction which corresponds to the direction in which the piston is moved out of the cylinder housing. The setting means further include an actuating means to enable rotational displacement of the setting element. The setting means further includes a threaded rod connected to the second attaching means. The threaded rod is displacably received in the threaded bore of the setting element. The telescopic design achieves short lengths between the attaching means. As a result, when use is made of the lower steering arms of a tractor, the lower steering arms include a great lateral freedom of movement. In addition, because the piston and the setting element move in the same direction when they are moved out, a short buckling length is achieved. This is advantageous from a buckling strength viewpoint. It is also advantageous that the spring means is protected. Thus, when the setting element is in the moved-in condition, the spring means hold the setting element by a first end face in contact with the base face of the base of the piston. The thread enables an adjustment to a certain category and to eliminate play when the implement is coupled. The spring only serves to adjust the setting element. It has no influence on the position of the piston in the cylinder. According to a preferred embodiment, a setting element is guided through two guiding rings in the hollow cylinder. A first guiding ring and a second guiding ring are arranged on the outer face of the setting element. The compact arrangement is further improved by securing the first guiding ring in the hollow cylinder at the end removed from the cylinder housing in the moving-out direction of the setting element. The second guiding ring is secured at the end of the setting element, which faces the base of the piston, in a direction corresponding to the moving-in direction of the setting element. The spring means is arranged between the two guiding rings and between the outer face of the setting element and the inner face of the hollow cylinder. The spring means is in the form of a pressure element. The setting element is rotatably held in the two guiding rings. By rotating the setting element, the length between the attaching means is changed. To facilitate such rotation, the actuating means are provided by an actuating lever attached to the setting element end which projects from the hollow cylinder. The actuating lever can be secured to the holding means in order to prevent any unintentional adjustment. The first attaching means is preferably connected to the cylinder housing. A particularly compact design is achieved by arranging the threaded bore in the setting element such that, in the moved-in condition of the setting element, the setting element is at least partially positioned inside the hollow cylinder and thus inside the piston. Extremely short lengths are achieved so that a particularly advantageous short buckling length is also achieved. From the following detailed description, taken in conjunction with the drawings and subjoined claims, other objects and advantages of the present invention will become apparent to those skilled in the art. BRIEF DESCRIPTION OF THE DRAWINGS A preferred embodiment of the invention is illustrated in the drawings wherein: FIG. 1 is a diagrammatic plan view of the lower steering arms of a three-point attaching device of a tractor with the side struts associated with the lower steering arms. FIG. 2 is a longitudinal section view through a side strut. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 shows a diagrammatic plan view of two lower steering arms 1 , 1 ′ attached by suitable attaching means at the fixing points 3 , 3 ′ at the rear of the tractor. The arms 1 , 1 ′ are pivotable around a pivot axis 2 . The two fixing points 3 , 3 ′ are laterally offset from the longitudinal tractor axis 8 by equal amounts. The two lower steering arms 1 , 1 ′ are able to carry out both lateral and lifting movements. The arms pivot around the pivot axis upward and downward, out of and into the drawing plane. This is shown in FIG. 1 from the position shown in continuous lines into the position shown in dashed lines. Coupling hooks 4 are provided to prevent lateral movements of the two lower steering arms 1 , 1 ′. The coupling hooks 4 receive corresponding coupling means at the implement to pull the implement or to carry the implement in cooperation with an upper steering arm (not illustrated). The upper steering arm is normally centered on the longitudinal tractor axis 8 above the pivot axis 2 . The one end of the two side struts 5 are secured by a first attaching means 6 to a suitable fixing means at the rear of the tractor. The fixing means are centered on the pivot axis 2 . The side struts are laterally offset relative to the fixing points 3 , 3 ′. A second attaching means 7 , at the other ends of the side struts 5 , connects the side struts to a lower steering arm 1 , 1 ′. The attaching means 6 , 7 enable a pivot movement. Furthermore, as can be seen in FIG. 1, the pivot axes of the attaching means 7 are arranged at a radius R relative to the fixing points 3 , 3 ′. Thus, the attaching means 7 carry out a pivot movement with the radius R. If, with an attached implement, a side movement S occurs at the two lower steering arms 1 , 1 ′, with the two lower steering arms 1 , 1 ′ being displaced from the position shown in continuous lines into the position shown in dashed lines, a length change occurs for the two lower steering arms 1 , 1 ′. Starting from identical distances L 1 and L 2 between the pivot axes of the articulation points 6 , 7 , the dimension L is increased to L 1 ′, whereas the dimension L 2 is shortened to dimension L 2 ′. The changes in length vary with respect to magnitude. If the lower steering arms 1 , 1 ′ pivoted clockwise around the fixing points 3 , 3 ′, the length L 1 would be shortened and the length L 2 would be lengthened. When shortening takes place, care must be taken to ensure that the lower steering arm 1 ′, in its dashed position, does not hit the rear wheels. Furthermore, the two side struts 5 hold the attached implement centered on the longitudinal tractor axis 8 when the attached implement is in the lifted transport position. The same applies if no implement is attached and if the lower steering arms 1 , 1 ′ are in the transport position. In this condition, the two side struts ensure that the lower steering arms 1 , 1 ′ are held so that they cannot move sideways from the set dimension of spread A from the longitudinal tractor axis 8 outwardly towards the rear wheels. The dimension of spread A between the coupling hooks 4 of the two lower steering arms 1 , 1 ′ can be manually set. Here, a settable telescopic setting means is integrated into the side struts 5 if to be coupled implements are in a category that deviates from the set category. FIG. 2 shows an enlarged longitudinal section through a side strut 5 of FIG. 1 . The side strut 5 includes a single-action hydraulic cylinder with a cylinder housing 9 and a piston 16 . The cylinder housing 9 has a cylinder chamber 10 . At one end, the cylinder chamber 10 is closed by a base. At the other end, the cylinder chamber 10 includes a guiding bore 13 centered on the longitudinal axis 12 . An attaching bore 11 leads into the cylinder chamber 10 . A pressure agent line can be connected to the attaching bore 11 . The pressure agent line is either connected to the lifting mechanism of the tractor for the lower steering arms, or it is connected to a separate pressure source with incorporated control elements. The first attaching means 6 , in the form of a ball eye, is attached to the cylinder housing 9 . A stripper 14 and a seal 15 , one positioned behind the other, are arranged at the end of the guiding bore 13 , remote from the first attaching means 6 . The piston 16 has a hollow cylinder 17 . The hollow cylinder 17 is closed at one end by a base 18 . The base face 18 point towards the interior of the hollow cylinder. The outer face of the hollow cylinder 17 , toward the base 18 , includes a groove which is engaged by a stop ring 23 . The stop ring 23 delimits the outward movement of the piston 16 out of the cylinder housing 9 . FIG. 2 shows the piston 16 in its furthest moved-out position. The piston 16 is supported via the stop ring 23 against a corresponding face in the region of transition between the cylinder chamber 10 and the guiding bore 13 . A rod-shaped, especially tube-shaped setting element 20 , is received in the hollow cylinder 17 . The setting element 20 is adjustable along the longitudinal axis 12 . FIG. 2 shows the setting element 20 in its moved-in position relative to the piston 16 and the hollow cylinder 17 . The setting element 20 , via its first end face 21 , rests against the base face 19 . The setting element 20 is guided relative to the hollow cylinder 17 by two guiding rings 26 , 28 . The guiding rings 26 , 28 are positioned on the outer face 24 of the hollow cylinder 17 . The first guiding ring 26 is arranged near the end of the hollow cylinder 17 . The end is removed from the base 18 . The first guiding ring 26 is guided on the inner face 25 of the hollow cylinder 17 . The first guiding ring 26 is also in contact with a securing ring 27 secured in the hollow cylinder 17 . Thus, the first guiding ring 26 cannot be moved out of the hollow cylinder 17 . The second guiding ring 28 is arranged near the base 18 and secured to the outer face 24 of the setting element 20 towards the base 18 by a securing ring 29 . The second guiding ring 28 is guided on the inner face 25 of the hollow cylinder 17 . Spring means is arranged between the two guiding rings 26 , 28 . The spring means is in the form of a pressure spring 31 . The first end face 21 of the setting element is held by the pressure spring 31 in contact with the base face 19 . The pressure spring 31 is co-axially arranged around the setting element 20 and is arranged in the hollow cylinder 17 . The setting element 20 includes a continuous bore centered on the longitudinal axis 12 . Part of the bore, starting from the second end face 22 of the setting element 20 , includes a threaded bore 30 . A threaded rod 32 is adjustably received in the bore 30 . In the moved-in condition of the setting element 20 , the threaded bore 30 , relative to the hollow cylinder 17 , is arranged with part of its length in the hollow cylinder 17 . In the moved-in condition, a small part of the setting element 20 axially projects beyond the end of the hollow cylinder 17 , which end faces away from the base 18 . A holding device 35 is secured to the setting element near the second end. An actuating lever 33 is secured to the holding device 35 . The lever 33 is pivotable around the pivot axis 34 . In the inactive condition, which is shown in FIG. 2, the actuating lever 33 is positioned between two yoke arms of a first holding element 36 . The lever is held by the setting element 20 so as to be non-rotatable relative to the piston 16 . Thus, the setting element 20 cannot be rotated around the longitudinal axis 12 . Furthermore, the threaded rod 32 carries the second attaching means. The second attaching means 7 attaches to a lower steering arm. The telescopic design achieves an extremely short installation length. While the above detailed description describes the preferred embodiment of the present invention, the invention is susceptible to modification, variation and alteration without deviating from the scope and fair meaning of the subjoined claims.

A side strut ( 5) for a lower steering arm of a tractor has a single-action hydraulic cylinder with a cylinder housing ( 9) and a piston ( 16). The piston includes a hollow cylinder ( 17) with a base ( 18). In the hollow cylinder ( 17), a rod-shaped element ( 20) is adjustable against the force of a spring from a moved-in position into a moved-out position. Because the piston ( 16) and the setting element ( 20) move in the same direction, it is possible to achieve a telescopic design which leads to a short installation length which, in turn, results in a more advantageous buckling strength.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention discloses an animal trap that is particularly well-suited for destroying moles in their burrows. 2. Description of the Related Art Traps for destroying moles are well known in the art. Conventional traps include spring-loaded jaws and a trigger. Many traps are set so that the jaws are positioned on either side of a mole burrow or tunnel. A trigger is positioned on the ground above the burrow. When a mole travels between the jaws, vibrations caused by the mole&#39;s movement release the trigger so that the jaws close and destroy the mole. Representative examples of such traps are found in U.S. Pat. Nos. 472,038; 1,296,407; 1,923,039 and 2,525,383. Conventional spring-loaded traps can be unstable when placed in the ground. Particularly after a rain shower, a trap can settle and shift so that a jaw is exposed in the mole burrow, thereby minimizing the chance that a mole will pass between the jaws. Also, the trap may shift so that a mole can pass through the burrow without being caught by the trap. Furthermore, conventional traps can be pushed too far into the ground during installation, thereby decreasing the effectiveness of the trap. Oftentimes, the ground elevation at a mole burrow is rough and uneven. The effectiveness of conventional traps can be decreased as the ground settles away from the trigger. Consequently, a need exists for improvements in mole traps. It is desirable that a mole trap include an element to stabilize and prevent the trap from shifting after it has been set. It is also desirable that a trap include a trigger which is adjustable to accommodate all types of ground terrain. SUMMARY OF THE INVENTION The present invention includes a mole trap that is stabilized on the ground when the trap is set. A platform, connected to the trap, rests on the ground and prevents the trap from being pushed too far into the ground. The present trap also includes a trigger which can be adjusted to accommodate various ground elevations. Once set, the trap cannot be removed from the ground until it is released. The trap has a low profile and shields the trigger from accidental releases. The present mole trap is extremely effective, durable, inexpensive and easy to operate. In a preferred embodiment, the present invention includes a mole trap having a pair of spring-loaded jaws. A platform is connected to the jaws to limit the travel of the trap into the ground and to stabilize the trap on the ground when it is set. A lever assembly forces the jaws open and sets the trap when a lever reaches an off-center position. An adjustable trigger mechanism is positioned on the ground above a mole borrow. The vibration of a mole traveling beneath the trigger causes the lever assembly to move upwardly from the off-center position so that the jaws close and destroy the animal. Other features and advantages of the present invention will become more fully apparent from the following detailed description of the preferred embodiment, the appended claims and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a preferred embodiment of the mole trap of the present invention shown in the closed position. FIG. 2 is a side elevational view of the mole trap of FIG. 1 shown set in the ground adjacent a mole burrow. FIG. 3 is a side elevational view of the present mole trap after the trap has been released. FIG. 4 is a detailed view of a first embodiment of the adjustable trigger mechanism of the present mole trap. FIG. 5 is a detailed view of the trigger mechanism of FIG. 4 wherein the trigger rod is mounted on a support bar of the second lever. FIG. 6 is a detailed view of a second embodiment of the adjustable trigger mechanism. FIG. 7 is a detailed side elevational view of a first embodiment of a spring retainer. FIG. 8 is a detailed side elevational view of a second embodiment of a spring retainer. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS A preferred embodiment of the mole trap of the present invention, indicated generally at 10, is illustrated in FIGS. 1-3. The mole trap 10 includes a first angled member 12 and a second angled member 14. Angled member 12 terminates in a support end 12A and an opposite blade end 12B. Near the mid-point of the angled member 12, member 12 is angled or bent to form an angle greater than 90°. However, other angular configurations for angled member 12 are within the scope of the present invention. In a similar manner, angled member 14 includes a support end 14A and a blade end 14B. Angled members 12 and 14 are hinged together by fastener 20 to form a first jaw 15. Mole trap 10 also includes angled members 16 and 18 which are hinged together about fastener 22 to form a second jaw 19. A lever assembly 25 is connected to the support ends 12A, 14A, 16A, and 18A of the first and second jaws 15 and 19 to load and set the trap 10. The lever assembly 25 includes a first connecting rod 26 which is secured to support ends 12A and 16A. A second connecting rod 28 is secured to support ends 14A and 18A. A first lever 30 is pivotally connected at its first end 30A to the first connecting rod 26. A second lever 32 is pivotally connected at its first end 32A to the first connecting rod 28. A support bar 34 is pivotally connected to the first lever 30 near the second end 30B of the first lever 30. The second end 32B of the second lever is pivotally connected to the support bar 34. It is preferred that lock washers 33 be used to secure support bar 34 to the first lever 30. Coil springs 40 and 42 are secured to the first and second connecting rods 26 and 28 on opposite sides of the first and second levers 30 and 32. As illustrated in FIG. 1, spacers 44A through 44D are inserted between the springs 40 and 42 and the levers 30 and 32 to hold the springs 40 and 42 in place. A detailed view of the installation of spacer 44B is illustrated in FIG. 7, wherein spacer 44B is inserted between spring 40 and the first end 32A of the second lever 32. The springs 40 and 42 are selected so that they are not in tension when the first and second jaws 15 and 19 are closed. It is understood that other types of springs can be utilized with the present trap 10. Also, it is possible to incorporate only one spring with the trap 10. A trigger mechanism, indicated generally at 50, is pivotally connected to the support bar 34. Trigger mechanism 50 includes a trigger rod 52 pivotally connected at its upper end 52A to the support bar 34. As illustrated best in FIGS. 4 and 5, the lower end 52B of trigger rod 52 is threaded. A sleeve nut 54 is secured to a plate 56. As is described below, the sleeve nut 54 is adjusted on the threaded portion 52B of the trigger rod 52 so that the plate 56 rests on the ground. As described below, it is preferred that a loose fit be provided between the trigger rod 52 and the support bar 34. As illustrated in FIG. 5, it is preferred that an elongated slot 58 be provided in the second end 32B of the second lever 32. The slot 58 guides the trigger rod 52 when the trap 10 is set. An alternate embodiment of the trigger mechanism 50A is illustrated in FIG. 6. A trigger rod 59 includes a flattened, upper portion 59A pivotally connected to the support bar 34. Other elements of trigger mechanism 50A are the same as trigger mechanism 50. As illustrated, it is desirable that a loose fit be provided between the trigger rod 59 and the support bar 34. An alternate embodiment of securing spring 40 on connecting rod 28 is illustrated in FIG. 8. A groove 60 is provided in the outer surface of the connecting rod 28 near support end 14A. The end of the spring 40 is secured in groove 60. A cotter pin 62 is inserted in the connecting rod 28 to hold the first end 32A of the second lever 32 in place. Likewise, a second cotter pin (not shown) is placed along the opposite side of the lower end 32A of the second lever 32 to secure the lever 32 on the connecting pin 28. A platform, indicated generally at 70 is secured to the mole trap 10 by fasteners 20 and 22. A preferred embodiment of the platform 70 is a rectangular structure which includes a planar surface 72 and side elements 74A-74D, as illustrated in FIGS. 1-3. Each side element 74A-74D includes a vertical sidewall 75A-75D. In the embodiment illustrated in FIGS. 1-3, the planar surface 72B and 72D is provided only on side elements 74B and 74D, respectively. However, it is understood that the planar surface 72 can also be provided on side elements 74A and 74C, as desired. The planar surface 72 can extend any desired width so long as it does not interfere with the operation of the first and second jaws 15 and 19. Sidewalls 75A and 75C are flattened so as to form tops 76A and 76C, respectively. Top 76A and 76B are parallel to planar surfaces 74B and 72D. It will be understood that tops can also be provided on sidewalls 75B and 75D if desired. During installation, force can be applied only at tops 76A and 76C to position the trap 10. It is preferred that the platform 70 be pivotally connected to the first and second jaws. As illustrated in FIG. 1-3, fasteners 20 and 22 are inserted through sidewalls 75A and 75C. The fasteners 20 and 22 are snugly tighted, thereby permitting the platform 70 to pivot with respect to the remainder of the trap 10. The installation and operation of the mole trap 10 is illustrated in FIGS. 2 and 3. A force is applied on the second end 30B of the first lever 30 to open the first and second jaws 15 and 19. As a force is applied downwardly, the first and second levers 30 and 32 provide a lever action to force the connecting rods 26 and 28 away from each other against the force of springs 40 and 42. As the first lever 30 approaches an approximate horizontal orientation, the lever 30 is off-center and locks in place so that the first and second jaws 15 and 19 are opened. The jaws 15 and 19 are inserted into the ground 80 on either side of a mole burrow 82. As the trap 10 is inserted into the ground, the platform 70 prevents the trap 10 from being pushed too far into the ground, so that the hinge points 20 and 22 remain above the ground. The planar surfaces 72B and 72D provide a contact surface between the trap 10 and the ground. The platform 70 can be tilted about fasteners 20 and 22 to achieve a desired orientation. Furthermore, the platform 70 stabilizes the trap 10 and prevents the trap 10 from shifting when the trap 10 is set in the ground. Once the trap 10 is set into position, the sleeve nut 54 is adjusted so that the plate 56 comes into contact with the ground 80 above the mole burrow 82. The loose fit provided between the trigger rod 52 and the support bar 34 permits angular movement so that the plate 56 can be oriented to accommodate various ground terrains. When a mole travels in the mole burrow 82, vibrations are transmitted through the ground to the plate 56. As the plate 56 is nudged upwardly, the first and second levers 30 and 32 are forced upwardly and out of a locked position. Springs 40 and 42 immediately close the first and second jaws 15 and 19 to destroy the animal. In FIG. 3, the trap 10 is shown in a closed position in the mole burrow 82. When set (see FIG. 2), the trap 10 has a low profile close to the ground 80. When set in the ground 80, the trap 10 cannot be removed until the trap 10 is released since the blade ends 12B, 14B, 16B and 18B have pushed soil away from the burrow 82 but not above their locked position. The ground 80 above the blade ends 12B, 14B, 16B and 18B has not been distributed and prevents the trap 10 from being removed until the trap 10 is released. As illustrated in FIG. 2, the trigger mechanism 50 is shielded by support ends 12A, 14A, 16A and 18A and levers 30 and 32. Therefore, the upper construction of the trap prevents any accidental releases of the trap 10. It is preferred that a stop be provided on the angled members 12, 14, 16 and 18 to limit the range of motion when the jaws 15 and 19 are closed. A flange 66 is provided near the mid-point of angled member 12. In a similar manner, a flange 68 is provided on angled member 18. Flanges 66 and 68 are oriented so as to be perpendicular with angled members 14 and 16, respectively. When the jaws are not open, the range of closure is limited as flanges 66 and 68 engage angled members 14 and 16, respectively, thereby preventing injury to fingers or hands that are between support ends 12A, 14A, 16A and 18A. It is understood that flanges can be provided on angled members 14 and 16 in orientation so as to engage angled members 12 and 18, if desired. Also, it is understood that only one flange may be used if desired. It is preferred that the mole trap 10 be constructed from stainless steel to resist weather and corrosion. Furthermore, it is difficult for a mole to smell the stainless steel thereby making the animal unaware that the trap is set in place about its burrow. Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.

The present invention includes a mole trap having a pair of spring-loaded jaws. A platform is pivotally connected to the jaws to limit the travel of the trap into the ground and to stabilize the trap on the ground when it is set. A lever assembly forces the jaws open and sets the trap when the lever reaches an off-center position. An adjustable trigger mechanism is positioned on the ground above a mole borrow. The vibration of a mole traveling beneath the trigger causes the lever assembly to move upward from the off-center position and the jaws to close and destroy the animal.

CROSS REFERENCE The present invention is a continuation of U.S. patent application Ser. No. 11/139,908 filed 27 May 2005, now U.S. Pat. No. 7,632,265, issued 15 Dec. 2009, which claims priority to U.S. Provisional Application No. 60/575,741, filed 28 May 2004, both of which are incorporated by reference herein in its entirety. FIELD OF THE INVENTION The present invention relates generally to radio frequency ablation catheter systems and more particularly to an interactive and automated catheter for producing lesions to treat arrhythmias in the atrium of a patient&#39;s heart. BACKGROUND OF THE INVENTION Many atrial arrhythmias are caused by anatomical accessory pathways in the heart, which provide spurious conduction paths. Conduction of electrical depolarization&#39;s along these pathways within a chamber gives rise to arrhythmias. Although drugs have been used to treat such arrhythmias for many years, cardiac ablation, or destruction of localized regions of tissue, can provide a permanent cure for the patient. For this reason cardiac ablation is preferred in many instances. This treatment is especially preferred for patients that experience detrimental effects from drugs. Cardiac ablation has traditionally been a tedious procedure performed under fluoroscopy by a physician who sequentially maps the electrical potentials within the heart using a manually directed EP catheter. Once an appropriate site has been selected identified and selected for ablation, RF energy is delivered to the site. Ablation energy is typically delivered through the same catheter used to “map”. The purpose of the ablation is to destroy a small bolus of tissue at the location. This tissue lesion can no longer conduct and the arrhythmia is interrupted and the arrhythmia stops. One common intervention is ablation around the annulus or the ostium of the pulmonary vein that is located in the left atrium. However, navigating to this location reliably and sequentially and delivering electrical energy is an extremely tedious procedure requiring substantial amount of skill and time to complete successfully. For this reason there is a continuing need to improve catheter technology. SUMMARY OF THE INVENTION The present invention provides a system that allows for the automated rapid and successful ablation of cardiac tissue. The overall system interfaces with an Endocardial Solutions Ensite “work station” endocardial mapping system of the type sold by Endocardial Solutions, Inc. of St. Paul, Minn., or other equivalent devices. The “Ensite” system is preferred as it includes a “NavX” feature that allows the physician to see a representation of the physical location of his catheter in a presentation of an anatomic model of the patient&#39;s heart. The system includes a “servo catheter” and a servo catheter control system that are interfaced with the work station. The work station is the primary interface with the physician and it is anticipated that the servo catheter control software will run on the work station. The servo catheter will also be coupled to a conventional RF generator. In use the physician will locate site for ablation therapy and then he will confirm the location of the catheter which will automatically navigate to the lesion site desired by the physician. Once the catheter is located at that desired point or site the physician will activate the RF generator to deliver the therapy. BRIEF DESCRIPTION OF THE DRAWINGS Throughout the several drawings identical reference numerals indicate identical structure wherein: FIG. 1 is a schematic representation of the overall system; FIG. 2 is a schematic representation of a portion of the overall system; FIG. 3 is a schematic representation of an image displayed by the system; FIG. 4A is a flow chart representation of a method of the system; FIG. 4B is a flow chart representation of a method of the system; FIG. 5 is a representation of a servo catheter of the system; and, FIG. 6 is a representation of a servo catheter of the system. DETAILED DESCRIPTION Overview For purposes of this disclosure the NavX features of the Ensite system as sold by ESI of St Paul Minn., allows for the creation of a chamber geometry reflecting the chamber of interest within the heart. In a preferred embodiment a mapping catheter is swept around the chamber by the physician to create a geometry for the chamber. Next the physician will identify fiducial points in the physical heart that are used to create a base map of the heart model. This base map may be merged with a CT or MRI image to provide an extremely high resolution, highly detailed anatomic map image of the chamber of the heart. Or in the alternative the base map may be used for the method. The physician identifies regions of this model heart for ablation by interacting with a computer terminal and for example using a mouse to lay down a collection of target points which he intends to ablate with RF energy. In summary the servo catheter is also interfaced with the Ensite system and makes use of the NavX catheter navigation and visualization features of NavX. In operation the physician navigates the servo catheter to the approximate location of the therapy and a relatively complicated control system is invoked that navigates the servo catheter tip to various locations sequentially identified by the physician. Once in place and after its position is verified the physician will activate the RF generator to provide the ablation therapy. Servo Catheter The catheter has a number of attributes that permit the device to carry out this function. An illustrative and not limiting prototype version of the device is seen in FIG. 5 and FIG. 6 . The catheter 100 has been constructed with eight pull wires (of which 4 are shown for clarity) and two associated pull rings labeled 102 and 104 in the figures. The pull wires typified by pull wire 106 and 108 are manipulated by servo mechanisms, such as stepper or driven ball screw slides illustrated in FIG. 1 . These mechanisms displace the wire with respect to the catheter body 110 and under tension pull and shape the catheter in a particular direction. The use of multiple wires and multiple pull rings allows for very complex control over the catheter&#39;s position, shape and stiffness, all of which are important to carry out the ultimate therapy desired by the physician. Multiple pull rings and multiple individual wires permits control over the stiffness of the catheter which is used to conform the shape of the catheter so that the entire carriage may be advanced on a ball screw to move the catheter against the wall of the heart. At least one force transducer 112 is located within the catheter provide feedback to the control system to prevent perforation of the heart and to otherwise enhance the safety of the unit. Preferably the force transducer takes the form of a strain gauge 112 coupled to the control system via connection 120 . The catheter distal tip will carry an ablation electrode 124 coupled via a connection not shown to the RF generator as is known in the art. It is preferred to have a separate location electrode 126 for use by the Ensite system as is known in the art. Once again no connection is shown to simply the figure for clarity. As seen in FIG. 6 pulling on pull wire 108 deflects the distal tip while pulling on pull wire 106 deflects the body 110 of the catheter. Since each wire is independent of the others the computer system may control both the stiffness and deflection of the catheter in a way not achieved by physician control of the wires. In general the physician will use a joystick of other input device to control the catheter. However, this control system also invokes many of the automated procedures of the servo catheter and is not strictly a direct manipulator. Although robotic control has made great headway in surgery most conventional systems use a stereotactic frame to position the device and the coordinate systems with respect to the patient. One challenge of the current system is the fact that the target tissue is moving because the heart is beating and the catheter within the heart is displaced and moved by heart motion as well so that there is no permanently fixed relationship between the catheter and its coordinate system, the patient and its coordinate system, and the patient and its coordinate system at the target site. This issue is complicated by and exacerbated by the fact that the map may not be wholly accurate as well, so the end point or target point&#39;s location in space is not well resolved. Operation Overview Turning to FIG. 1 there is shown a patient&#39;s heart 10 in isolation. A series of patch electrodes are applied to the surface of the patient (not shown) typified by patch 12 . These are coupled to an Ensite catheter navigation system 14 which locates the tip of the Servo catheter 16 in the chamber 18 of the patient&#39;s heart. The Ensite system is capable of using this catheter or another catheter to create a map of the chamber of the heart shown as image 20 on monitor 22 of a computer system. In operation the physician interacts with the model image 20 and maps out and plans an RF ablation intervention that is applied to the Servo catheter 16 through its proximal connection to the Servo catheter interface box 24 . The interface box allows RF energy from generator 26 to enter the catheter upon the command of the physician and ablate tissue in the cardiac chamber. Critical to the operation of the servo catheter is the translation mechanism 28 , which provides a carriage for translating the catheter proximal end advancing or retracting the catheter from the chamber as indicated by motion arrow 30 . An additional group of sensors and actuators or other servo translation mechanism 32 are coupled to the proximal end of the catheter 16 to allow the device to be steered automatically by software running on the Ensite 14 workstation. Thus, in brief overview, the physician navigates the catheter into the chamber of interest, identifies locations of interest within that chamber which he desires to ablate, then the Servo mechanism moves the catheter to various locations requested by the physician and once in position the physician administers RF radiation to provide a therapeutic intervention. FIG. 2 shows the interaction of the physician with the heart model. The locations for ablation are shown on the map 20 as X&#39;s 32 which surround an anatomic structure that may be, for example, the pulmonary vein 34 . These locations are typically accessed on the map image through a mouse or other pointer device 36 so that the physician may act intuitively with the model. As is clear from the Ensite operation manual the catheter 16 may also be shown on the image to facilitate planning of the intervention. Turning to FIG. 3 the servo catheter 16 has been activated and the catheter has been retracted slightly as indicated by arrow 41 and has been manipulated to come into contact with the cardiac tissue at location 40 . In this instance the physician is in a position to perform his ablation. The control system to achieve this result is shown in FIG. 4A and FIG. 4B which are two panels of a software flow chart describing software executed by the Ensite work station. Turning to FIG. 4 a , initially the catheter is placed in the desired heart chamber as seen in FIG. 2 by the positioning of catheter 16 as represented on the Ensite work station within the chamber of the heart 20 . This process occurs after the creation of the chamber geometry. In block 202 the Ensite system determines the location of the location ring of catheter 16 in the chamber and in process 204 a small motion is initiated by the operation of the steppers 32 controlling the various pull wires of the catheter. The Ensite system tracks the motion of the location electrode and establishes a relationship between the operation of the various pull wires and motion in the chamber. It is important to note that this process eliminates the need to keep track of the X, Y, Z references of the body and the catheter. In process 206 the physician manipulates the joystick or other control mechanism and places the target location, for example target location 32 , around an anatomic feature of interest, for example the OS of the pulmonary vein. The user then activates a “go” command on the workstation and the catheter 16 automatically navigates to the location 32 by measuring the difference between its current position and the desired location position in block 210 . If it is within 0.5 millimeters or so, the process stops in block 212 . However, if the catheter is farther away from the target location than 0.5 millimeters, the process defaults to step 212 wherein a displacement vector is calculated in process 212 . In process 214 the displacement vector is scaled and in process 216 an actuation vector is computed to drive the catheter toward the location. In process 218 the actuation vector is applied to the pull wires 32 and to the carriage 28 to move the catheter tip toward the desired location. After a short incremental motion in process 220 a new location for the catheter is computed and the process repeats with comparison step 210 . It is expected that in most instances the algorithm will converge and the catheter will move smoothly and quickly to the desired location. However, after a certain number of tries if this result is not achieved it is expected that an error condition will be noted and the physician will reposition the catheter manually and then restart the automatic algorithm.

A system that interfaces with a workstation endocardial mapping system allows for the rapid and successful ablation of cardiac tissue. The system allows a physician to see a representation of the physical location of a catheter in a representation of an anatomic model of the patient's heart. The workstation is the primary interface with the physician. A servo catheter having pull wires and pull rings for guidance and a servo catheter control system are interfaced with the workstation. Servo catheter control software may run on the workstation. The servo catheter is coupled to an RF generator. The physician locates a site for ablation therapy and confirms the location of the catheter. Once the catheter is located at the desired ablation site, the physician activates the RF generator to deliver the therapy.

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of U.S. application Ser. No. 11/118,958, filed on Apr. 29, 2005 now abandoned. FIELD OF THE DISCLOSURE The present disclosure generally relates to oral hygiene products and methods and, more particularly, to such products and method adapted for children. BACKGROUND OF THE DISCLOSURE The teaching and motivation of toddlers and young children is a subject of much attention in patent and general literature. In particular, numerous writings, devices, techniques, aides, and kits have been proposed to assist children, parents (or other caregivers), or both, with learning and performing oral hygiene tasks. A common challenge for a caregiver is to teach the child to perform a complete oral hygiene task, particularly where the task requires several steps. At the outset, a caregiver will often provide at least some assistance and instruction on how to complete the task. The ultimate goal, however, is for the child to be able to execute the oral hygiene task unassisted. The age at which a child will practice an oral hygiene task on his or her own is dependent upon many factors, some of which are psychological, some physiological, and some unique to each individual child. Conventional oral hygiene products and methods are overly difficult for a child to use or perform. When performing tooth brushing, for example, current products typically require a child to simultaneously manipulate two separate items at some point in the process. When loading a brush with toothpaste, for example, the child must hold the toothbrush in one hand while dispensing toothpaste from a container with the other hand. Unfortunately, many children are unable to properly or efficiently perform this task, since they are at a stage of physiological development where muscle control and general coordination are limited. Consequently, oral hygiene apparatus and methods are needed that facilitate successful use by children. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a toothbrush adapted for use by children; FIG. 2 is a perspective view of a toothpaste dispenser adapted for use by children; FIG. 3 is a side elevation view, in cross-section, of the toothpaste dispenser of FIG. 2 ; FIG. 4 is a side elevation view of the toothbrush of FIG. 1 positioned to receive toothpaste from the toothpaste dispenser of FIG. 2 ; FIG. 5 is a perspective view of the toothpaste dispenser discharging toothpaste onto the toothbrush; FIGS. 6A and 6B are a perspective view and a side elevation view, respectively, of an alternative embodiment of a toothpaste dispenser for use with a toothbrush; FIGS. 7A-C illustrate a further toothpaste dispenser embodiment for use with a toothbrush; FIGS. 8A and 8B illustrate yet another embodiment of a toothpaste dispenser for use with a toothbrush; FIGS. 9A and 9B illustrate an additional embodiment of a toothpaste dispenser for use with a toothbrush; FIGS. 10A and 10B illustrate yet another embodiment of a toothpaste dispenser for use with a toothbrush; FIGS. 11A and 11B illustrate an additional embodiment of a toothpaste dispenser for use with a toothbrush; and FIGS. 12A and 12B illustrate a further embodiment of a toothpaste dispenser for use with a toothbrush. DETAILED DESCRIPTION Combinations of a toothbrush and a toothpaste dispenser, as well as methods for using such combinations, are disclosed that are particularly adapted for use by a child. Specifically, the combinations and methods allow a child to apply toothpaste to a toothbrush using a single hand. As used herein, the term “comprising” means that the various components, ingredients, or steps, can be conjointly employed in practicing the present invention. Accordingly, the term “comprising” is open-ended and encompasses the more restrictive terms “consisting essentially of” and “consisting of.” Other terms may be defined as they are discussed in greater detail herein. As used herein a “caregiver” means a person other than the child, such as, a parent, babysitter, family member, teacher, day care worker, or other person who is able to provide sufficient assistance to the child to complete a personal hygiene task. For purpose of style and simplicity, the term “parent” will be used in this specification to refer generally to any caregiver and the use of this term is in no way intended to limit the scope of the aides described and claimed. As used herein, a “compressing mechanism” includes any known manner of extracting toothpaste from a toothpaste container. Such compressing mechanisms may be manually or electrically operated. Known pump type compressing mechanisms include those disclosed in U.S. Pat. No. 6,345,731 to Bitton; U.S. Pat. No. 6,834,780 to Levy; U.S. Pat. No. 5,305,922 to Varon; U.S. Pat. No. 6,715,521 to Back, each of which is incorporated by reference herein. Known squeeze-type compressing mechanisms include those disclosed in U.S. Pat. No. 5,845,813 to Werner; U.S. Pat. No. 6,789,703 to Pierre-Louis; U.S. Pat. No. 6,474,509 to Prince et al.; U.S. Pat. No. 6,454,133 to Lopez et al; U.S. Pat. No. 5,810,205 to Kohen; and U.S. Pat. No. 5,897,030 to Stangle, each of which is incorporated herein by reference. Known types of electrically operated compressing mechanisms include those disclosed in U.S. Pat. No. 5,050,773 to Choi and U.S. Pat. No. 4,403,714, both of which are incorporated by reference herein. FIG. 1 illustrates a toothbrush 20 adapted for use by a child. The toothbrush 20 includes a handle 22 having a proximal end 24 and a distal end 26 . An enlarged base 28 is coupled to the proximal end 24 . Tooth cleaning structure, such as bristles 30 , are coupled to the distal end 26 to form a brush head 32 . The brush head 32 defines a toothpaste receiving surface 33 , which in the illustrated embodiment is oriented at an angle with respect to the proximal end of the handle 22 . In the illustrated embodiment, the handle 22 is contoured so that it may be comfortably gripped by a child. Accordingly, the handle 22 includes an enlarged section 34 and an angled portion 36 leading to the brush head 32 . In addition, the handle 22 and base 28 may carry graphics, icons, or other images to attract a child&#39;s attention. In the illustrated embodiment, the base 28 includes an image of a frog&#39;s hand 38 . The base 28 may be shaped and or eccentrically weighted to maintain the toothbrush 20 in an angular orientation illustrated in FIG. 4 . In the illustrated embodiment, the base 28 is formed substantially as a sphere. The sphere, by using internal voids, weights, or other means for introducing non-uniform mass, has a center of gravity CG that is spaced from a geometric center C of the sphere. In the illustrated embodiment, the center of gravity CG is spaced farther away from the handle proximal end 24 than the geometric center C. The sphere further has a mass sufficiently greater than the handle 22 and brush head 32 , so that the eccentrically located center of gravity CG forces the toothbrush to rotate about an exterior of the sphere to an equilibrium state, in which the handle 22 extends from the base 28 at an angle with respect to a plane defined by a support surface 40 on which the toothbrush 20 rests. In this position, the brush head 32 is held above the support surface 40 . The center of gravity CG is preferably located such that the toothbrush receiving surface 33 is automatically oriented generally towards the orifice 54 . The center of gravity CG may further be located, and or the outer surface of the enlarged base 28 may be appropriately shaped, such that the toothbrush 22 has a second equilibrium position, like the substantially vertical orientation illustrated in FIG. 1 . FIGS. 2 and 3 illustrate a toothpaste dispenser 50 adapted for use by a child. The dispenser 50 includes a housing 52 and a discharge orifice 54 extending therethrough. An activator 56 is positioned at a top of the housing 52 and is supported for reciprocating vertical motion between normal and actuated positions. A biasing element, such as spring 58 , extends between the housing 52 and a bottom of the activator 56 to apply a vertically upwardly directed biasing force to the activator 56 . A user may engage a top of the activator and apply a downward actuation force to overcome the bias force. A shroud 60 surrounds the spring 58 and extends between the housing 52 and the activator 56 to provide an attractive appearance. As best shown in FIG. 3 , a stem 62 is coupled to the activator 56 and extends into an interior of the housing 52 . The container 52 preferably includes a slip resistant base 64 to prevent movement of the dispenser along the support surface 40 during use. In the embodiment illustrated at FIG. 3 , a toothpaste cartridge 70 is received within the dispenser housing 52 . Toothpaste cartridge 70 and dispenser housing 52 may be adapted to provide lock-and-key functionality such that only certain toothpaste cartridges will work with certain dispenser housings. The incorporation of lock-and-key functionality may utilize a variety of technologies including, but not limited to, mechanical and/or electrical means. The cartridge 70 is similar to the cartridge construction disclosed in U.S. Pat. No. 5,158383, which issued to Glover et al. on Oct. 27, 1992, the entirety of which is incorporated by reference herein. Accordingly, the cartridge 70 includes a sidewall 72 , a sliding lower piston 74 , a sliding upper piston 76 , and a fixed upper wall 78 . The lower and upper pistons 74 , 76 sealingly engage an interior surface of the sidewall 72 to define an interior reservoir 80 for holding toothpaste. The lower piston 74 is adapted to move only in the upward direction, as is known in the art. The upper piston 76 may be releasably connected to the stem 62 , such as by mating threads, and is adapted to slide along the interior surface of the sidewall 72 . Accordingly, the upper piston 76 will move when an actuating force is applied or removed from the activator 56 . The fixed upper wall 78 includes a frustoconical portion 82 defining a spout 84 . The upper piston 76 includes a portion 86 that nests within the upper wall frustoconical portion 82 and extends across the spout opening to close the spout. The spout 84 fluidly communicates with the discharge orifice 54 . The activator 56 has a normal position which prevents toothpaste from passing through the orifice 54 , as best shown in FIG. 3 . In this position, the upper piston 76 is forced upward by the spring 58 (via the activator 56 and stem 62 ) so that it engages the fixed upper wall 78 . The portion 86 of the upper piston 76 is fully inserted into the frustoconical portion 82 of the upper wall 78 thereby to close off the spout and prevent toothpaste from flowing to the orifice. To dispense toothpaste, a user applies a downward actuation force to the activator 56 , as illustrated in FIG. 5 . The actuation force must be sufficient to overcome the spring bias force to allow the activator to move in a downward direction. The downward direction of the activator 56 also forces the stem 62 and upper piston 76 to move downward. The lower piston 74 resists downward movement to remain in the same position, and therefore the volume of the reservoir is reduced. Simultaneously, the portion 89 of the upper piston 86 disengages the frustoconical portion 82 of the upper wall 78 to open the spout 84 . As a result, toothpaste from the reservoir is forced through the spout toward the orifice 54 . When the activator 56 is subsequently released, it returns to the normal position under the force of the spring 58 . The stem 62 and upper piston 76 also move in an upward direction until the upper piston 76 again engages the upper wall 78 , thereby closing the spout 84 . The upward movement of the upper piston 76 draws toothpaste toward the piston 76 , which in turn pulls the lower piston 74 in an upward direction. With the lower piston 74 repositioned, the dispensing process may be repeated. The dispenser may be designed so that the actuation force required to operate the activator 56 is within a child&#39;s physical capabilities. Accordingly, the actuation force is less than approximately 50 Newtons, and more preferably less than 25 Newtons. When used together, the toothbrush 20 and dispenser 50 provide a combination particularly suited for use by children. As illustrated at FIG. 5 , the dispenser orifice 54 is positioned at an orifice height X above the support surface 40 . The enlarged base 28 supports the brush head 32 at a brush head height Y, which is above the support surface 40 but below the orifice height X, so that the head 32 remains adjacent and below the orifice 54 when the toothbrush 20 is released. The brush head height Y may be approximately 1 to 5 centimeters below the orifice height X to provide sufficient space for the discharged toothpaste. The passive positioning of the brush head 32 allows the child to focus on operating one oral hygiene article at a time, thereby simplifying the process of loading a toothbrush with toothpaste. The child may grasp the toothbrush 20 and position it on the support surface 40 in close proximity to the dispenser 50 . The child may then release the toothbrush 20 , so that the head 32 is raised above the support surface 40 . If necessary, minor adjustments to the position of the toothbrush 20 may be made to make sure the head 32 is vertically aligned with the orifice 54 . Additionally, one skilled in the art would appreciate that a variety of alignment techniques may be used to align head 32 and orifice 54 . One such example of an alignment technique includes the use of magnets 963 and 964 which may be located in head 32 and recess 965 , respectively. The activator 56 may then be operated to dispense toothpaste onto the head 32 . While a specific type of dispenser has been disclosed, it will be appreciated that various other types of dispensers may be used without departing from the scope of this disclosure. In general, the force that advances toothpaste to the orifice 54 may be supplied manually, electrically, pneumatically, or otherwise. Furthermore, if the toothpaste is provided in a flexible container, the dispenser may squeeze, roll, or otherwise compress the container to force the toothpaste from the container. The dispenser may be freestanding or mounted on a surface such as a wall. The following are specific alternative embodiments of the dispenser. FIGS. 6A and 6B illustrate a dispenser 100 adapted for mounting on a wall 102 . The dispenser includes a housing 104 carrying a flexible container 106 of toothpaste. The housing 104 further includes an orifice 108 in fluid communication with an interior of the flexible container 106 . The housing 104 may be positioned above the support surface 40 on which the toothbrush 20 lies, so that the brush head 32 is positioned below and proximate to an orifice 106 . In operation, a user may press the flexible container 106 inwardly to discharge toothpaste from the orifice 108 . FIGS. 7A-C illustrate a freestanding dispenser 110 that guides the toothbrush 20 to the appropriate position below an orifice. The dispenser 110 includes a base 112 defining a recess 113 sized to receive the brush head 32 and an orifice 114 positioned above the recess 113 . A hand pump/toothpaste cartridge 115 is releasably attached to the base 112 to place the toothpaste cartridge in fluid communication with the orifice 114 . In operation, the toothbrush 20 is guided by the recess 113 into position below the orifice 114 and the hand pump is subsequently operated to discharge toothpaste onto the brush head 32 . FIGS. 8A and 8B illustrate a wall-mounted dispenser 120 having a peristaltic type pump. The dispenser 120 includes a housing 121 for receiving a container 122 of toothpaste. The container 122 includes an elongate tube 123 extending to a discharge orifice 124 of the housing. A rotatable handle 125 is coupled to rollers 126 positioned to engages and squeeze the tube 123 when rotated. The rollers 126 produce a peristaltic effect that draws toothpaste from the container 122 for discharge from the orifice 124 . FIGS. 9A and 9B illustrate a freestanding dispenser 130 having a manual pump. The dispenser includes a housing 132 enclosing a flexible container of toothpaste. A depressible button 134 is provided that is movable between normal and depressed positions. The orifice further includes an orifice 136 in fluid communication with the container of toothpaste. In operation, the button 134 is depressed to compress the flexible container, thereby to discharge toothpaste from the orifice 136 . FIGS. 10A and 10B illustrate two related dispenser embodiments resembling a frog head. The dispenser 140 of FIG. 10A includes a flexible pouch 142 defining an orifice 144 . When compressed, the flexible pouch 142 forces toothpaste out the orifice 144 . In FIG. 10B , a dispenser 146 is actuated by placing the brush head 32 into a recess and cranking the toothbrush in a downward direction to advance toothpaste out an orifice 148 . FIGS. 1A and 1B illustrate a freestanding dispenser 150 . The dispenser 150 includes a base 152 defining an orifice 154 and a side receptacle 155 adapted to hold the toothbrush 20 . A flexible, ball-shaped container 156 of toothpaste is releasably coupled to the base 152 to place the orifice 154 in fluid communication with an interior of the container 156 . A user may directly engage and compress the container 156 to force toothpaste out the orifice 154 . FIGS. 12A and 12B illustrate a freestanding, manual pump style dispenser 160 . The dispenser 160 includes a toothpaste cartridge, such as a pump tube 162 , having a base 164 . As best shown in FIG. 12B , the tube 162 includes a reciprocating upper portion 165 for pressurizing and advancing toothpaste within the tube toward an orifice 166 . A pump shroud 167 is disposed over a top portion of the tube 162 . The shroud 167 defines a recess 168 sized to receive the brush head 32 . Downward force applied to the shroud 166 will compress the upper portion 165 to discharge toothpaste from the orifice 166 . While the foregoing examples illustrate manual compression mechanisms, it will be appreciated that dispensers having automatic or electrical compression mechanisms may be used without departing from the scope of this disclosure. Such electrical compression mechanisms may be similar to the prior art disclosures noted above. The toothbrushes and dispensers disclosed herein may include images such as character graphics to encourage and motivate a child to brush his or her teeth. The character graphic may provide a source of entertainment and reassurance for the child and a buddy, or friend, who reduces stress and can be related to in a non-competitive fashion during the tooth brush learning period. The character may also provide positive reinforcement and encouragement to the child while the child is learning new skills and behaviors to clean themselves in a non-competitive or threatening manner. Suitable character graphics can include animals, people, inanimate objects, natural phenomena, cartoon characters or the like, that may or may not be provided with human features such as arms, legs, facial features or the like. It may be desirable for the character graphic to be familiar to the child, such as an identifiable cartoon character. The character graphics should at least be a type that the child can relate to, examples of which could include animals, toys, licensed characters, or the like. Character graphics can be made more personable and friendly to the child by including human-like features, human-like expressions, apparel, abilities, or the like. In one optional embodiment it is desirable for a character to have a distinguishing feature or features, which in a pictograph can help in training, such as a frogs webbed hand. By way of illustration, an animal character graphic can be shown smiling, wearing clothing, playing sports, fishing, driving, playing with toys, or the like. In particular embodiments, the character graphic can desirably be created to project an appearance that could be described as friendly, positive, non-intimidating, silly, independent, inspirational, active, expressive, dauntless and/or persevering. In one optional embodiment the indicia may optionally include a character graphic which is associated with a line of children&#39;s consumer products, especially personal cleansing products and the like. The character may be one of a family, group, team, or the like, each member of which is designed to be associated with, for example, a consumer product, a personal hygiene activity such as brushing teeth, an age group, stage of infant development and the like. Alternatively, all of the characters of a family, group, team, or the like, may be designed to be associated with the entire range of consumer products. The association by the child of the character with the consumer product, hygiene activity etc., encourages and provides a way for the child to visualize through their imagination the character using the consumer product in the way intended. Furthermore, since this teaching is through the use of the child&#39;s imagination, there are none of the negative connotations associated with conventional parental instruction on how to use a consumer product. Instead of the child being subjected to parental nagging to do something the child really doesn&#39;t want to do, the child will actively use the consumer product as part of active learning play to interact with their new buddy, or friend, and imitate behavior. The interaction between the child and the character is only limited by the bounds of the child&#39;s imagination. The role of the caregiver or parent in then becomes one of actively encouraging imaginative play by the child with the character to use the consumer product correctly, instead of a being perceived by the child as a parent who stops play. Play is actively encouraged and new skills become part of play; “uninterrupted play”. Since the use of the product is essentially play, the child is eager to use the article of commerce and learn the skill. A family or group of character graphics can be used to progress a child through a system of consumer products, especially personal cleansing products and the like. In this embodiment each character of the family or group, would be tailored to appeal to different groups of children. These groups may be based on age, development stages, regions, etc. Alternatively, a single character may be tailored for one particular group consumer products of line of consumer products which are different for children at different ages, development stages, etc. In this case the character may, for example, be of a different age depending on the consumer product and by which group of children the product is intended to be used. The dispensers and toothbrushes illustrated herein include images depicting a frog character image. For example, the toothbrush 20 and dispenser 50 include frog hand images. Similarly, the dispensers 140 , 146 of FIGS. 10A and 10B , respectively, are shaped and include images that give the associated toothpaste containers the appearance of a frog head. While the graphics disclosed herein are related to a frog character graphic, it will be appreciated that other images may be provided, such as different animal character graphics, human character graphics, literary or popular character graphics, designs, or shapes, without departing from the scope of this disclosure. Alternatively, or in addition to, the appearance, the toothbrush and dispenser may interact in more than one way with the child&#39;s senses. For example, actuation of the dispenser may cause initiation of a signal that, for example, causes the appearance of dispenser to change (e.g., a change in color or actuation of a light) or causes origination of a sound. In one alternative embodiment, once initiated, the signal may be maintained for a predetermined time so as to provide reinforcement of a desired behavior. For example, the predetermined time may be the time required for the child to thoroughly brush his or her teeth. This embodiment is further illustrated by an audio assembly for generating a sound feature during or in response to certain operations, such as actuation of the activator or placement of the toothbrush near the orifice. As schematically illustrated in FIG. 5 , the dispenser housing 52 may include a speaker 170 connected to an audio circuit 172 . A sensor 174 may be adapted to detect movement of the activator 56 and/or stem 62 and forward a signal to initiate the audio circuit 172 , thereby causing speaker to generate the sound feature. For example, the activator 56 may be movable between extended and retracted positions, and the sensor 174 may be adapted to detect when the activator (or stem 62 ) is in a proximate position, which may generally correspond to the retracted position, and forward a signal to the audio circuit 172 to deliver sound. The audio assembly may be contained entirely within the dispenser to generate a sound feature whenever a certain activity is performed. Alternatively, the elements of the audio assembly may be provided in separate components that must be matched for the sound feature to be generated. For example, the dispenser housing 52 may carry the speaker 170 and sensor 174 while the toothpaste cartridge 70 provides the audio circuit 172 responsive to the sensor 174 . The audio feature may be particularly suited to a child and preferably promotes enthusiasm for using the toothbrush and/or dispenser. For example, the audio feature may provide a positive reinforcement upon successfully operating the dispenser, such as verbal or tonal encouragement. Additionally or alternatively, the audio feature may be a simulated animal sound or cartoon character voice. The audio feature may correspond to a visual feature provided on the toothbrush or dispenser. In the current embodiment, where the toothbrush and dispenser include frog character graphics, the audio feature may be a simulated “ribbit” or other noise typically associated with a frog. The audio feature need not match the frog character graphic, but may instead be provided as a simulated human voice, a series of notes, or other composition. Furthermore, the audio circuit may generate more than one type of sound which may be generated sequentially or randomly upon successful actuations of the activator or other activity, as desired. All documents cited in the Detailed Description are, in relevant part, incorporated herein by reference; the citation of any document is not to be construed as an admission that it is prior art with respect to the present disclosure. While particular embodiments of the present disclosure have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this disclosure.

A combination toothbrush and toothpaste dispenser, and method, are adapted for use by a child. The dispenser provides an easily actuatable activator that, when operated, discharges a predetermined amount of toothpaste from an orifice. The toothbrush is adapted to automatically lift the toothbrush head off of a support surface to a height near that of the dispenser orifice. As a result, a child may focus on manipulating one item at a time when loading a toothbrush with toothpaste.

The present invention relates to an apparatus for dental abrasive treatment of teeth, said apparatus having a chamber for mixing pressurised gas with abrasive particles. The invention also relates to an apparatus having both a chamber for mixing pressurised gas with abrasive particles and a hand piece with additional outlets apart from an orifice for the mixture of gas and particles. Finally, the invention also relates to an apparatus for dental abrasive treatment of teeth, said apparatus having a hand piece with additional outlets apart from an orifice for the mixture of gas and particles. BACKGROUND OF THE INVENTION U.S. Pat. No. 6,083,001 describes an apparatus for accurate control of particles flow with regard to feeding abrasive material to a surface of teeth during dental treatment. The apparatus comprises a compressor for establishing a flow of pressurised air, a chamber for mixing the pressurised air and the particles of abrasive material and a hand piece for letting out the mixture of pressurised air and abrasive material onto the surface of the teeth, which are to be treated. The chamber for mixing the pressurised air and the particles of abrasive material has an inlet for pressurised air, said inlet being situated in an outlet for the abrasive material at a level below a top level of abrasive material in the chamber. Thus, the mixing of pressurised air and particles of abrasive material takes place directly at the outlet of the abrasive material towards the hand piece. This, however, has the disadvantage that the mixing of the pressurised air and the particles of abrasive material only has very little time and very little space during which and in which the mixing can take place. This results in either an unsatisfactory mixing and/or a very uneven mixing of the pressurised air and the particles of abrasive material. U.S. Pat. No. 6,004,191 describes a hand piece where mixing of pressurised air and particles of abrasive material takes place in a chamber in the hand piece itself and where a fluidisation of the particles of abrasive material is established during mixing. The pressurised air is let into the chamber along a tube extending from one end towards another end of the chamber and with an orifice directed towards the other end. The mixed pressurised air and particles of abrasive material are let out of the chamber through another tube extending from a position in the middle of the chamber and towards and out through the other end of the chamber. This apparatus ensures a mixing which fluidises the particles of abrasive material. However, still the mixing may be unsatisfactory or may be very unequal due to the pressurised air being let towards the other end of the chamber. This results in the mixing being very dependent on the amount of particles of abrasive material which is present in the chamber, and also being very dependent on the inclination of the chamber and thus where in the chamber that the particles of abrasive material is situated. U.S. Pat. No. 4,482,322 describes a device for mixing an abradant with pressurised gas. The device comprises a reservoir for the abradant and a separate vortex chamber for mixing the abradant and the pressurised gas. An inlet in the vortex chamber is provided tangentially to the circumference of the chamber so that air flowing into the vortex chamber is swirled in a controlled manner. Thereby a favourable swirling of the abradant is obtained. An orifice is provided in the bottom of the reservoir, and the abradant is thus intended, by means of gravity, for trickling down into the vortex chamber through the orifice. The trickling down is provided by vibrating the reservoir. As mentioned, the device comprises a reservoir for containing the abradant and a separate vortex chamber for mixing the abradant with pressurised gas just before being used for surface treatment of teeth. For passing the abradant to the vortex chamber through the orifice, means has to be provided for vibrating the reservoir. This makes the device expensive and technically complicated and increases the need for regulation and adjustment means for obtaining correct dosage of the abradant and correct mixing of the abradant with the pressurised gas. It is an object of the present invention to provide an apparatus, which ensures not only a satisfactory mixing of pressurised air and particles of abrasive material, but which also ensures a very equal distribution of the particles in the air so that a thorough and uniform abrasive treatment of the surfaces of teeth may be obtained together with an apparatus not comprising technically complicated and economically cost increasing means. BRIEF DESCRIPTION OF THE INVENTION This object is obtained by one embodiment of the apparatus, where the apparatus comprises a hand piece, a means for establishing a flow of pressurised gas, and a chamber for mixing said pressurised gas with abrasive particles, said chamber having a circular cross-section and a bottom being intended for containing an amount of abrasive particles, and said chamber comprising a primary inlet for the pressurised gas, and an outlet for a mixture of pressurised gas and abrasive particles, and the inlet extending along a tube or a pipe from outside of the chamber into the interior of the chamber and having an orifice directed tangentially to the circular cross-section, and said chamber furthermore comprising an additional inlet for pressurised air. By combining a flow of gas, preferably a flow of air, which is directed tangentially to a cross-section of the chamber, and an additional inlet of pressurised air, the abrasive material is blown up into the chamber by means of the additional inlet and a vortex of gas and abrasive particles is established in the chamber by means of the primary inlet. Then a very uniform, but also thorough, mixing of the pressurised gas and the abrasive particles is accomplished. The effect is that not only is the dental treatment taking place in a very uniform and accurate way, but also the gas pressure needed for still obtaining this very satisfactory treatment is limited. Thus, the means for establishing the pressurised gas may be smaller than if not using the present invention. A smaller means for establishing the pressurised gas results in less noise which is environmentally desirable in a dental clinic, but which also reduces the fear of many people of visiting the dentist. The even and thorough mixing of the pressurised gas and the abrasive particles also reduces the amount of abrasive particles to be used. In a preferred embodiment the additional inlet for pressurised air is extending along a tube from outside of the chamber into the interior of the chamber and is having an orifice being situated in the amount of abrasive particles, and thus below the top surface of the amount of abrasive particles in the bottom of the chamber. By providing the additional inlet having an orifice in the amount of abrasive particles, the certainty is enhanced of particles being blown up into the void of the chamber, the void where the primary inlet is establishing a vortex. Thus, it is not the primary inlet itself, which has the task of both blowing the abrasive particles up into the chamber and also establishing the vortex of fluidised abrasive particles. Therefore, the task of establishing the vortex may be optimised by utilising the primary inlet, and the task of fluidising the abrasive particles may also be optimised by utilising the additional inlet. Thus, both the primary inlet and the additional inlet only have one task to perform, and which task therefore may be optimised without having to enter into compromises because of the need of multiple tasks. In another embodiment of the apparatus, the apparatus comprises a hand piece, a means for establishing a flow of pressurised gas, and a chamber for mixing said pressurised gas with abrasive particles, said hand piece having a nozzle with an outlet, and said outlet having an orifice providing a discharge opening for the mixture of pressurised gas and abrasive particles, said outlet furthermore being provided with a number of notches or a number of holes, and said number of notches or holes establishing additional discharge openings, apart from the orifice, for the mixture of pressurised gas and abrasive particles. It is has been discovered that the dental treatment not only depends on the correct, accurate and thorough mixing of the pressurised gas and abrasive particles, but is also very and perhaps even more dependent on the manual handling by the dentist of the hand piece of the apparatus. If the dentist holds the hand piece, and thus the orifice of the hand piece, far from the tooth surface to be treated, it may take longer time for the surface to be treated. This results in an increase in the amount of abrasive particles being used for treating the surface, but it also results in the patient having to endure a longer treatment. This is a disadvantage, but is also more costly, because the dentist cannot treat so many patients when each treatment takes a prolonged period of time. On the other hand, if the dentist holds the hand piece too near the tooth surface to be treated, it may take a shorter time to treat the surface, but the result is an increased risk of damaging the surface of the tooth and the neighbouring gum. Also, it may be more painful than necessary for the patient to be treated. Thus, holding the orifice of the hand piece closer to the tooth surface to be treated is also a disadvantage. By providing a number of notches or holes in the nozzle of the hand piece, and which number of notches or holes establishes additional discharge openings apart from the orifice of the nozzle, it is possible to let the orifice abut the tooth surface to be treated. By having the possibility of letting the orifice abut the tooth surface, the proper distance from the tooth surface to hold the orifice of the hand piece is easily obtained without having to think about whether the distance is too far or too near. Some of the mixture of pressurised gas and abrasive particles will be let out through the orifice for treating the tooth surface. However, the rest of the mixture of pressurised gas and abrasive particles will be let out through the additional discharge openings, and will not be used for treating the tooth surface. However, the discharge of superfluous mixture of pressurised gas and abrasive particles will reduce the risk of a “not proper” or a “too proper” treatment of the tooth surface. The correct and accurate dosage of pressurised gas and abrasive particles may be obtained by using a certain nozzle having a certain number of notches or holes and having a certain shape of the notches or holes. In a preferred embodiment the apparatus comprises a chamber having a primary inlet for the pressurised gas, and an outlet for a mixture of pressurised gas and abrasive particles, the inlet extending along a tube or a pipe from outside of the chamber into the interior of the chamber and having an orifice directed tangentially to the circular cross-section, and the apparatus also comprises a hand piece having a nozzle with an outlet, said outlet having an orifice providing a discharge opening for the mixture of pressurised gas and abrasive particles, said outlet furthermore being provided with a number of notches, and said number of notches establishing additional discharge openings, apart from the orifice, for the mixture of pressurised gas and abrasive particles. By combining the apparatus with a chamber according to the invention and with a hand piece according to the invention, a synergetic effect is obtained. Not only is mixture of pressurised gas and abrasive particles optimal, but also the discharge of the mixture is optimal. Accordingly, both the treating means for treating the tooth surface and the treatment itself are as good as can be obtained, and these two effects in combination result in the treatment at one and same time being as material-saving, as time-saving and as cost-saving as possible. BRIEF DESCRIPTION OF THE FIGURES The invention will now be described further with reference to the accompanying drawing, where FIG. 1 is a picture being a perspective view of an embodiment of inlets and an outlet in a top of a chamber for an apparatus according to the invention, FIG. 2 is a drawing being a cross-section of the embodiment of inlets and the outlet in the top of the chamber for the apparatus according to the invention, FIG. 3 is a drawing being a side plane view of the embodiment of inlets and the outlet in the top and the chamber itself for the apparatus according to the invention, FIG. 4 is a drawing being a bottom plane view of the embodiment of inlets and the outlet in the top of the chamber for the apparatus according to the invention, FIG. 5 is a cross-section of an outlet of a nozzle of a hand piece for an apparatus according to the invention, FIG. 6 is a bottom plane view of the outlet of the nozzle of the hand piece for the apparatus according to the invention, FIG. 7 is a picture being a perspective view of an embodiment of a nozzle of the hand piece for the apparatus according to the invention, and FIG. 8 is a picture being a perspective view of an embodiment of a hand piece with a handgrip and a nozzle and for an apparatus according to the invention, FIG. 9 is a longitudinal cross section of a possible embodiment of the nozzle, FIG. 10 is a longitudinal cross section of a further improved nozzle. DETAILED DESCRIPTION OF THE INVENTION FIGS. 1-4 are a picture and drawings showing a top 1 for a chamber and container 2 (see FIG. 3 ) for the chamber itself and to be utilised in an apparatus for dental abrasive treatment of teeth. The top is frusto-conical and is provided with an exterior inlet 3 and an exterior outlet 4 . The container 2 (see FIG. 3 ) enclosing the chamber is circular cylindrical at an upper part 5 of the container and is semi-spherically shaped at a lower part 6 of the container, said lower part constituting a bottom of the chamber. The lower part 6 of the container and thus of the chamber is intended for containing abrasive particles (not shown) to be used during the dental abrasive treatment of the teeth. The abrasive particles are preferably particles of aluminium oxide, but other particles suitable for the abrasive treatment may be used. The exterior inlet divides into an interior primary inlet 7 and an interior additional inlet 8 (see FIG. 2 ). The primary inlet 7 extends along a pipe from the top 1 towards the bottom of the chamber. An outer end 9 of the pipe is bent sideways and downwards and is having an orifice 10 directed tangentially to a circumference of the circular cross-section of the chamber. Due to the sideways bending of the primary inlet, a vortex is established when pressurised air is let into the chamber through the primary inlet 7 . Due to the downward bending, the vortex is established from a lower part of the chamber and upward towards the top of the chamber. The orifice 10 of the primary inlet 7 is arranged so that it falls into a level above an intended level of a top surface of the abrasive particles lying in the bottom of the chamber. However, alternatively it will be possible to let the orifice 10 fall into a level just beneath the top surface of the abrasive particles lying in the bottom of the chamber. The additional inlet 8 also extends along a pipe from the top 1 towards the bottom of the chamber. An outer end 11 of the pipe is directed downwards and is having an orifice 12 directed into a plane parallel to the circular cross-section of the chamber. The orifice of the additional inlet 8 is arranged so that it falls into a level beneath the intended level of a top surface of the abrasive particles lying in the bottom of the chamber. However, alternatively it will be possible to let the orifice fall into a level just above the top surface of the abrasive particles lying in the bottom of the chamber. The additional inlet 8 is optional and, as mentioned, is intended for blowing up the abrasive particles lying in the bottom of the chamber. Thus, the additional inlet 8 is fluidising the abrasive particles and the primary inlet 7 is creating a vortex of the fluidised abrasive particles in the pressurised air. An interior outlet 13 also extends along a pipe from a position in the middle of the chamber and to the top 1 of the chamber to the exterior outlet 4 of the chamber. An outer end 14 of the pipe is directed downwards and is having an orifice 15 directed into a plane parallel to the circular cross-section of the chamber. The orifice 15 of the outlet 13 is arranged so that it falls into a level above the intended level of a top surface of the abrasive particles lying in the bottom of the chamber. The pipe is arranged telescopically by providing an inner fixed pipe 16 with an outer displaceable sleeve 17 , so that the orifice 15 may be arranged in different levels within the chamber. Thus, it is possible to adjust where in the vortex of pressurised air and abrasive particles that the mixture of these two items is to be let out of the chamber. Accordingly, by sliding the outer sleeve 17 downwards or upwards in relation to the fixed pipe 16 , the orifice 15 of the outlet 13 will be positioned at a lower level or at a higher level, respectively, and the position in the vortex where the mixture is extracted from the chamber through the outlet 13 will alter accordingly. This may advantageously depend on the type of abrasive particles used, the particle size of the abrasive particles, the magnitude of pressure of the pressurised air, the remaining amount of abrasive particles in the bottom of the chamber and perhaps other factors influencing the vortex. However, alternatively it will be possible to let the orifice fall into a level just above the top surface of the abrasive particles lying in the bottom of the chamber. The container 2 constituting—together with the top 1 —the boundaries of the chamber are preferably made of glass or other transparent and abrasive resistant material. Thereby it is possible to visually determine the amount of abrasive particles left in the chamber. However, in order to ensure a proper wear resistant container without using glass, the container may be made of other materials, preferably metal, and the amount of abrasive particles have to be determined by de-mounting the container 2 from the top 1 of the chamber. The top 1 is preferably made of metal, and more preferably made of aluminium. As shown in FIG. 2 , in the top 1 of the chamber the exterior inlet 3 is divided into two interior initial inlets 18 , 19 , each leading to the primary inlet and the additional inlet, respectively, as mentioned above. The division into the two initial inlets 18 , 19 is taking place in the top 1 itself. The exterior inlet 3 is divided so that the amount of pressurised air being let to the exterior inlet 3 is divided equally between the two initial interior inlets 18 , 19 . This is accomplished by having the division shaped as a sort of fork as shown. Thereby, there is no risk of either the primary inlet 7 or the additional inlet 8 being provided with more pressurised air at the expense of the other inlet. Also, as shown in FIG. 2 , all the different parts in the top of the chamber, i.e. the exterior inlet 3 , the exterior outlet 4 , the interior inlets 7 , 8 , the interior outlet 13 and the top 1 itself are provided with threads. Thereby, each of the individual parts of the top 1 may be replaced if needed because of wear, failures or because of a need for any of these parts having other dimensions than the ones of the originally fitted parts. The exterior inlet 3 and the exterior outlet 4 are preferably provided with quick-fit couplings for connecting the inlet 3 and the outlet 4 with hoses or pipes from the means for establishing the pressurised air (not shown) and to the hand piece (see FIG. 8 ) of the apparatus, respectively. The exterior inlet 3 is preferably provided with a check valve 20 arranged between the means (not shown) for establishing the pressurised air and the exterior inlet 3 itself. Thus, there is no risk of abrasive particles accidentally being led backwards to the means for establishing the pressurised air and damaging this means. The dimensions of the individual parts may vary dependent on the intended capacity of the apparatus, the possible already available plant for establishing pressurised air and other specific factors which may influence the choice of dimensions. In the following a possible selection of dimensions which have proven to be efficient is listed. Inner diameter of primary inlet pipe  2.0 mm Inner diameter of additional inlet pipe  2.0 mm Inner diameter of outlet fixed pipe  4.0 mm Inner diameter of outlet sleeve  6.0 mm Inner diameter of chamber 49.0 mm Distance from centre of chamber to primary inlet 13.0 mm Distance from centre of chamber to additional inlet  7.5 mm Distance from centre of chamber to outlet  7.5 mm Distance from interior of top to interior of bottom 80.0 mm Distance from primary inlet orifice to bottom 25.0 mm Distance from additional inlet orifice to bottom 15.0 mm Distance (max.) from outlet orifice to bottom 54.0 mm Distance (min.) from outlet orifice to bottom 34.0 mm The pressure of the pressurised air being let to the exterior inlet is between 20 psi and 80 psi, preferably between 30 psi and 60 psi, more preferably between 40 psi and 50 psi, even more preferably 45 psi. These pressures have shown to provide adequate abrasive force to the treatments of the teeth, although these pressures are relatively low. FIGS. 5-6 are drawings showing a nozzle 21 for a hand-piece (see FIG. 8 ) for an apparatus according to the invention. FIG. 5 is a cross-sectional view along a longitudinal axis A of an embodiment of a nozzle 21 . FIG. 6 is a plane view seen from beneath of an outlet of the nozzle 21 . FIG. 7 is a picture showing a possible embodiment of an outlet of a nozzle. FIG. 8 is a picture showing a complete hand-piece 22 for an apparatus according to the invention. The hand-piece 22 consists of a distant end 23 for connecting the handpiece to pressurised air mixed with abrasive particles, a handgrip 24 and a nozzle 22 . The nozzle 21 consists of a pipe having an orifice 25 for letting out a mixture of pressurised air and abrasive particles. The nozzle 21 also has sidewalls 26 provided with notches 27 made in immediate vicinity of the orifice 25 . In FIG. 5 the notches 27 are shown as triangular shaped notches with the base of the triangle situated towards the orifice 25 . In other embodiments the notches may have other shapes such as rectangular, oval, partly circular, semicircular or even other shapes. In the embodiment shown in FIG. 5 , the notches extend along the same width w as the orifice itself, i.e. the nozzles 21 have the same lateral extension as an inner diameter d of the outlet of the nozzle 21 . However, in other embodiments the lateral extension of the notches may be greater or smaller than the inner diameter of the outlet. The notches constitute additional discharge openings apart from the orifice itself for the mixture of pressurised air and abrasive particles. The additional discharge openings constitute a kind of safety openings towards unintended too cautious or too violent treatment of the teeth. If the outlet of a common known nozzle is held in a position too far from a tooth surface to be treated, the treatment is too cautious. However, if the outlet of a common known nozzle is held in a position too near the tooth surface to be treated, the treatment is too violent. By providing notches, it is possible to let the outer lateral surfaces of the outlet, i.e. the surfaces surrounding the orifice, abut the tooth surface. Thereby, the position of the outlet is determined by a firm abutment with the tooth surface, so that the dentist does not have to worry about holding the outlet in the correct position. The notches constituting the additional discharge openings ensure that the treatment will not be too violent in respect of the actual treatment needed. By direct contact between the tooth surface and the outer end of the nozzle, the notches allow the dentist to work more precisely. FIG. 6 shows that the embodiment of the nozzle is provided with four notches arranged oppositely along diameters of the outlet. By providing an even number of notches arranged opposite each other in pairs, it is possible to easily manufacture the notches. A cutting tool may be employed and a mutual displacement towards each other of the nozzle and the cutting tool will provide the notches. In the case of triangular notches as the ones shown in FIG. 5 or oval or rectangular notches, the cutting tool may be a file. If the notches are partly circular such as semicircular (see FIG. 7 ) the cutting tool may be a drill or a milling tool. Below is a list of possible dimensions of the outlet of the nozzle and of the notches for individual uses. The individual dimensions depend on the pressure of the pressurised air, on the size of the abrasive particles such as either 50 μm or 25 μm and of the actual surface treatment of the teeth in question. Outer Inner diameter diameter Lateral width Vertical height Shape of notch of nozzle of nozzle of notch (max.) of notch (max.) Triangular 2.00 mm 0.65 mm 0.80 mm 0.80 mm 1.60 mm 0.40 mm 0.45 mm 0.45 mm Partly circular 2.00 mm 0.65 mm 0.70 mm 0.70 mm 1.60 mm 0.40 mm 0.40 mm 0.40 mm Alternatively to providing notches extending from the orifice and upward along the sidewalls of the nozzle, it will be possible to provide the sidewalls of the nozzle with holes instead. Thereby, the additional discharge openings will be situated further away from the orifice of the nozzle. The risk of abrasive particles discharged through the notches unintendedly assisting in the treatment of the tooth surface is eliminated. In the above tables, specific dimensions are stated. However, other dimensions may be employed fulfilling the same needs and demands for a proper and adequate dental abrasive treatment of teeth requiring a minimum of pressure and a minimum consumption of abrasive particles. For example, a specific embodiment has turned out to be highly effective for teeth treatment. In FIG. 9 an embodiment of the nozzle 21 is shown in a longidudinal cross-sectional view, where the nozzle 21 is provided with wedge shaped notches 27 , the angle v for the associated wedge is preferably 40-45 degrees. An improvement towards higher efficiency has been achieved by rounding the side walls 26 of the notches 27 in the direction towards the orifice 25 , which is illustrated in FIG. 10 a. The etches may, for example, be rounded by applying a drill, for example a diamond drill, with the rotational axis coinciding with the longitudinal axis of the nozzle 21 .

The invention relates to apparatuses for treating surfaces of teeth by using a mixture of pressurised gas, preferably pressurised air, and abrasive particles such as particles of aluminium oxide. A first apparatus comprises a chamber having at least a primary inlet and preferably an additional inlet and also having an outlet. The primary inlet establishes a vortex within the chamber and the additional inlet fluidises the abrasive particles lying in the bottom of the chamber. A second apparatus comprises a handpiece with a nozzle having an outlet provided with notches or holes. The notches or holes constitute additional discharge openings apart from an orifice in the nozzle. Both of the apparatuses ensure that the pressure needed for the treatment and the amount of abrasive particles for the treatment is minimised as much as possible.

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application is entitled to the benefit of, and claims priority to, provisional U.S. Patent Application Ser. No. 60/447,581 filed Feb. 14, 2003 and entitled “DEVICE AND METHOD FOR COLLECTION OF EXHALED ALVEOLAR BREATH CONDENSATE,” the entirety of which is incorporated herein by reference. BACKGROUND OF THE PRESENT INVENTION [0002] 1. Field of the Present Invention [0003] The present invention relates generally to breath condensate collection, and more particularly, to full-featured breath condensate collection apparatuses capable of separating the expired airway phase of mammalian exhalation from the alveolar phase. [0004] 2. Background [0005] As is well known, exhaled breath condensate contains water-soluble and water insoluble molecules, including dissolved gases, organic solutes, ions and proteins. Analysis of the molecular content of breath condensate can provide a method to diagnose and prognose certain diseases. (S. A. Kharitonov and P. J. Barnes, Exhaled markers of pulmonary disease, Am J Respir Crit Care Med 163:1693-1722, 2001.) However, the measurement of substances in exhaled condensate as a method to determine the presence of pathophysiologic. processes in the lung alveoli is degraded by contamination by substances arising from the mouth, nose, throat and the tracheobronchial tree. Using two dimensional gel electrophoresis, Griese and colleagues demonstrated distinctly different proteins in breath condensate collected from oral breathing, compared with nasal breathing (M. Griese, Proteomics 2:690-696, 2002.) This contamination can cause false positive testing. [0006] It is our hypothesis that a gating mechanism can be triggered from the measurement of the partial pressure of carbon dioxide in exhaled breath to open and close during the exhalation cycle in a manner to separate out the contaminant breath volume, generated during the expired airway phase of the exhalation cycle, from the alveolar volume generated during the alveolar phase of the cycle. The ability to selectively collect alveolar breath condensate rapidly and easily with a point-of-care device would improve the clinical utility of breath-based diagnosis for this purpose, particularly in the emergency department or clinic setting. The device described is designed to allow a patient to breath into a handheld disposable chamber to facilitate the collection of breath water vapor which can then be analyzed for biochemicals to detect the presence of specific diseases, including bacterial, chlamydial, mycoplasma, or fungal pulmonary infection, pulmonary embolism, pulmonary ischemia, systemic gram negative sepsis, fat embolism from sickle cell disease or after surgical fixation of fractures, carcinoma of the lung, asthmatic inflammation, and chronic obstructive pulmonary disease. Experimental History and Observations Leading to Conception of Invention [0007] An experimental pulmonary vascular occlusion (PVO), induced by venous infusion of polystyrene microspheres in rats, has been used to determine three major findings related to the device of the present invention. Using anesthetized, tracheostomized mechanically ventilated rats, exhaled breath condensate was collected in a pilot version of the present invention. The condensing chamber consisted of a sterile pipette within dry ice. As compared with control rats, increased concentrations of proteins, eicosinoid derivatives and peptides associated with fibrinolysis were found in the condensate of rats with PVO. (Nakos, Am J Resp Crit Care Med 1998, 158:1504.) The magnitude of the concentration of these vasoconstrictive agents correlated with the severity of hypoxemia and pulmonary hypertension in the subject rats. [0008] A variety of methods and apparatuses have been proposed for use in breath analysis, but none accomplish the needs and benefits of the present invention. Several of these, including U.S. Pat. Nos. 6,033,368 and 6,419,634 to Gaston et al., U.S. Pat. No. 6,585,661 to Hunt et al., U.S. Publication No. 2003/0208132 A1 to Baddour, Eur. Patent No. 0,759,169 B1 to Winsel et al., and PCT Patent App. No. 02/082977 to Vaughan et al., disclose breath condensate collection devices, but each has significant shortcomings. First, no known apparatus includes the use of a monitoring system in a breath condensate collection device as a mechanism to trigger a valve open and shut during the exhalation cycle for the purpose of collecting only one type of condensate—i.e., alveolar condensate or expired airway condensate. The former type of condensate is especially important in the use of a breath collection device to diagnose lower tract pulmonary infection, as it is necessary to eliminate contamination of the breath sample from the nasopharyngeal flora. Similarly, the latter type of condensate is especially important in diagnosing upper tract infection. [0009] Other devices or methods are known for separating the expired airway phase from the alveolar phase for such purposes as the detection of alcohol levels in a person&#39;s breath. For example, U.S. Pat. No. 3,613,665 to Gorsuch, U.S. Pat. No. 3,830,630 to Kiefer, U.S. Pat. No. 4,248,245 to Kempin, U.S. Pat. No. 5,327,901 to Delente, U.S. Pat. No. 5,376,555 to Forrester disclose methods and apparatuses for achieving such separation. Some, but not all, of these devices and methods use active mechanisms for providing such separation, while others use passive means. Unfortunately, all known devices and methods suffer drawbacks. For example, the Gorsuch device measures temperature with a heated thermistor and triggers a valve when the temperature differential indicates that the alveolar phase has been reached, while the Kempin device measures temperature differentials to determine when to divert exhaled breath into a measuring chamber. Temperature-based valve triggers may not be as reliable as desired. Neither the Kiefer device nor the methodology disclosed by Forrester is used to physically separate the alveolar phase breath from expired airway phase breath. Instead, the filament used in Kiefer is used merely to activate an alcohol-measuring section, while the Forrester methodology uses automated analysis of infrared profiles of the exhaled breath to identify the different phases thereof. Finally, the Delente device is passive, relying on a simple technique to retain in a collection chamber only the last portion of an exhaled breath, which is assumed to be alveolar phase rather than expired airway phase because it comes from the end of the exhaled breath. None of these devices or methods are thus suitable for use in breath condensate collection. [0010] Moreover, none of the known devices or methods for separating the expired airway phase from the alveolar phase have been applied to breath condensate collection devices. In fact, some of the devices, such as the Kempin device, takes steps or include features specifically to avoid condensation because it interferes with the measurement of the gases themselves. Finally, although the Forrester methodology uses infrared analysis of exhaled breath, none of the devices or methods use spectrometry methods to determine when the alveolar phase of an exhaled breath has been reached and to trigger a valve creating physical separation of the alveolar phase from the expired airway phase. [0011] A need exists for a specific condensation chamber designed to allow delivery of a sample of condensate to an analysis system that is separate from the machine in order to allow point-of-care immunoassay for certain antigens. In particular, a need exists for an immunoassay in the form of a small plastic cartridge, similar to a conventional home pregnancy test kit except that the antibodies in the matrix are directed against antigens that will help diagnose pulmonary embolism and pulmonary infection. Antibodies that will preferably be tested may include, but are not limited to, fibrinopeptide A, d-dimer, thromboxane (and its metabolites), leukotrienes, chemokines, interleukins, and bacterial, chlamydial, viral and mycoplasma antigens. Although the general intent of methodologies such as those disclosed in the Baddour and Vaughn patents may be somewhat similar to some of the purposes of the present invention, they fail to provide an apparatus for collecting condensate and then injecting approximately 50-500 μL of condensate from a tip into the immunoassay kit. In addition, a need exists for a device from which the condensate sample may be delivered to an arterial blood gas machine for analysis of pH, pCO 2 , pO 2 , lactate, urea, glucose and electrolytes. [0012] The Baddour device is designed to collect exhaled breath condensate from patients with asthma. The Baddour device does not describe a plunger that extrudes the sample, but describes a “duckbill” valve that appears to be an internal chamber for sample collection. This must be removed and requires additional steps before the sample can be analyzed. Baddour fails to disclose a tip which can be used to dispense the condensate onto the immunoassay filter, and fails to disclose a system of snaps to lock the handle of the plunger in its “closed” position. All of these features are very useful in facilitating simple breath condensate collection and analysis. Neither the specific objective of injecting the sample onto a port of an immunoassay, nor the objective of being able to use the condenser as a delivery unit to perform point-of-care pH, gas tension, lactate and urea measurements can be done with either the Baddour or Vaughn device. [0013] Although the Vaughn device appears to propose the use of an endothermic reaction to cool a condensing chamber, it does not disclose a means of packaging the reaction to make it easy to use at the patient&#39;s bedside. The Vaughn device also requires a complicated methodology for expressing collected condensate from a side port of the condensing chamber. A need exists for a simpler methodology. [0014] No prior art device uses a flow transducer to indicate when an adequate volume of breath has been collected, or provides visual or aural feedback as to the rate and completion percentage. A device having such features would be much more convenient to use than prior art devices. [0015] Further, no prior art device uses a high efficiency, miniature refrigeration unit, disposed within the breath collection device itself, to cool the breath condenser. Such a system would allow a new condensing chamber to be cooled rapidly without storing the chamber beforehand in a freezer and without resorting to means such as an endothermic reaction to provide a cooling effect. [0016] A need exists for a full-featured breath condensate collection apparatus for separating alveolar phase exhaled breath from expired airway phase exhaled breath, having improved cooling features, a housing that substantially encloses the various components in order to protect them, to protect the user from uncomfortable heat or cold produced thereby, to avoid contamination to or from the components, to provide greater convenience of use to the user, and to provide built-in analysis of the condensate collected therein. SUMMARY OF THE PRESENT INVENTION [0017] The device is designed to allow selective collection of breath condensate contained within the alveolar volume of expired breath. The device consists of port into which a patient breathes, connected in fluid series to a chamber with a port to allow transmission and measurement of percentage absorption of a light beam in the exhaled sample. In a preferred embodiment, when the concentration of CO 2 increases above a specified threshold, or increases at a specified rate, a rotary solenoid is actuated which is connected to a valve. This action causes the valve to rotate 90°, causing the exhaled breath to be diverted into a condensing chamber. [0018] Other general features include a built-in refrigeration system, a built-in analyzer, a flow transducer and microcontroller for measuring total volume of exhaled breath and signaling the user when a sufficient volume has been detected, and a housing in which the various components may be carried, including some disposable components and some reusable components. [0019] Broadly defined, the present invention according to one aspect is a method of diagnosing particular diseases based on expired breath from a mammalian subject, including: providing a breath condensate collection device having condensing chamber, a fluid inlet and a fluid outlet; cooling the condensing chamber; receiving, at the fluid inlet, at least one exhaled breath from a mammalian subject; separating the exhaled breath into an expired airway phase volume and an alveolar phase volume; condensing portions of either the expired airway phase portion of the exhaled breath or the alveolar phase volume of the exhaled breath, but not both, in the condensing chamber to produce condensate on the inner surfaces of the condensing chamber; removing the condensate from the condensing chamber; analyzing the condensate for markers indicative of respiratory disease; and rendering a diagnosis at least partly on the basis of whether the condensate being analyzed came from the expired airway phase portion of the exhaled breath or the alveolar phase volume of the exhaled breath. [0020] In features of this aspect, the separating takes place between the fluid inlet and the condensing chamber; the markers include biochemicals; the biochemicals include inorganic gases, volatile organic molecules, proteins, nucleic acids, lipids, lipid A, endotoxin and other impervious nonorganic exogenous materials; the markers include microbes; the microbes include viruses, fungi, mycoplasma, mycobacteria, bacteria, prions and protozoa; only the alveolar phase volume of the exhaled breath reaches the condensing chamber; alternatively, only the expired airway phase volume of the exhaled breath reaches the condensing chamber; the receiving, separating and condensing steps are repeated in order to increase the amount of condensate produced in the condensing chamber; and the method further includes expressing the condensate from the condensing chamber using a piston assembly. [0021] Broadly defined, the present invention according to another aspect is a method of collecting breath condensate from a portion of exhaled breath from a mammalian subject by separating the expired airway phase of the breath from the alveolar phase, including: providing a cartridge assembly and a condensing chamber, the cartridge assembly having a breathing port and at least two fluid outlets, at least one of which is in fluid communication with the condensing chamber; cooling the condensing chamber; receiving, at the breathing port in the cartridge assembly, at least one exhaled breath from a mammalian subject; monitoring, in the cartridge assembly, at least one characteristic of the exhaled breath, the characteristic generally capable of distinguishing the expired airway phase of the breath from the alveolar phase of the breath; based on the state of the monitored characteristic, diverting the flow of the exhaled breath through the cartridge assembly from one fluid outlet to the other fluid outlet; and upon receiving a diverted portion of the exhaled breath from the cartridge assembly, condensing portions of the exhaled breath to produce condensate on the inner surfaces of the condensing chamber. [0022] In features of this aspect, monitoring includes determining when the exhaled breath has transitioned from the expired airway phase to the alveolar phase, and diverting the flow of the exhaled breath based on the state of the monitored characteristic includes diverting the exhaled breath to the condensing chamber once it is determined that the alveolar phase of the exhaled breath has begun; cooling the condensing chamber includes cooling the condensing chamber to a temperature of less than 0° F.; the diverting step includes adjusting the state of a valve assembly to prevent the exhaled breath from passing into the condensing chamber until the alveolar phase of the exhaled breath has begun and to force the exhaled breath into the condensing chamber once the alveolar phase of the exhaled breath has begun; cooling the condensing chamber includes cooling the condensing chamber to a temperature of less than 0° C.; and the method further includes expressing the condensate from the condensing chamber using a piston assembly. [0023] In other features of this aspect, determining when the exhaled breath has transitioned from the expired airway phase to the alveolar phase includes determining when a predetermined level of a particular predetermined gas is reached; the particular predetermined gas is selected from the group consisting of CO 2 , O 2 , N 2 , CO and NO; the monitoring, diverting and condensing steps are repeated in order to increase the amount of condensate produced in the condensing chamber; the monitoring, diverting and condensing steps are repeated for a predetermined period of time; the monitoring, diverting and condensing steps are repeated until a predetermined volume of gas has passed into the condensing chamber; the monitoring and diverting steps are carried out automatically; and monitoring includes determining when the exhaled breath has transitioned from the expired airway phase to the alveolar phase, and diverting the flow of the exhaled breath based on the state of the monitored characteristic includes diverting the exhaled breath to the condensing chamber until it is determined that the alveolar phase of the exhaled breath has begun. [0024] Broadly defined, the present invention according to another aspect is breath condensate collection apparatus including: a cartridge assembly having a breathing port adapted to permit a mammalian subject to breathe in and out of the cartridge assembly, at least a first fluid outlet and a second fluid outlet, a monitoring system adapted to monitor at least one characteristic of a generally gaseous fluid passing through the cartridge assembly, the at least one characteristic generally capable of distinguishing the expired airway phase of an exhaled breath from the mammalian subject from the alveolar phase of the exhaled breath, and a valve assembly operable to divert the flow of fluid, received via the breathing port, to either the first fluid outlet or the second fluid outlet on the basis of the state of the monitored characteristic; and a condensing chamber having double side walls, including an inner side wall and an outer side wall in spaced relationship to one another, and first and second opposing ends, the condensing chamber being in fluid communication with at least one fluid outlet of the cartridge assembly. [0025] In features of this aspect, the condensing chamber includes an outlet and a one-way valve adapted to prevent gas from being drawn into the condensing chamber during an inhalation by the mammalian subject while permitting exhaled breath to be exhausted therethrough during an exhalation by the mammalian subject; the condensing chamber is cooled to a temperature of less than 0° F.; the condensing chamber is cooled to a temperature of less than 0° C.; the apparatus further includes a plunger assembly having a piston and a handle, the piston being slidably disposed in the interior of the condensing chamber in snug contact with the inner side wall and the handle extending from the first end of the condensing chamber so as to permit the piston to be moved within the central chamber; and in addition to the first one-way valve, the cartridge assembly further includes an inhalation port and a second one-way valve adapted to permit breathing gas to be drawn into the cartridge assembly during an inhalation by the mammalian subject, and the cartridge assembly further includes a third one-way valve in at least one of the at least two fluid outlets adapted to prevent gas from being drawn into the cartridge assembly during an inhalation by the mammalian subject while permitting exhaled breath to be exhausted therethrough during an exhalation by the mammalian subject. [0026] In other features of this aspect, the actuator device operates the valve assembly to divert the flow of fluid, received via the breathing port, to the second fluid outlet instead of to the first fluid outlet when a predetermined level of a particular predetermined gas is reached; the predetermined level is reached by the level of the predetermined gas rising to the predetermined level; the predetermined level is reached by the level of the predetermined gas dropping to the predetermined level; the particular predetermined gas is selected from the group consisting of CO 2 , O 2 , N 2 , CO and NO; the breathing port, the at least two fluid outlets and the valve assembly define a cartridge, and the apparatus further includes a housing adapted to carry the cartridge, the monitoring system and the condensing chamber; and the cartridge is adapted to be removable from the housing for disposal after a single use, while the monitoring system is adapted for repeated reuse. [0027] In still further features of this aspect, the actuator device operates the valve assembly to divert the flow of fluid, received via the breathing port, to the fluid outlet connected to the condensing chamber when the predetermined level of the particular predetermined gas is reached; the actuator device operates the valve assembly to divert the flow of fluid, received via the breathing port, away from the fluid outlet connected to the condensing chamber when the predetermined level of the particular predetermined gas is reached; the valve assembly includes a valve adjustable between at least two positions, such that in the first valve assembly state the valve is in a first position diverting fluid received at the breathing port to the first fluid outlet and away from the second fluid outlet, and in the second valve assembly state the valve is in a second position diverting fluid received at the breathing port to the second fluid outlet and away from the first fluid outlet; the valve is a directional flap; the actuator device is a rotary solenoid; and the valve assembly includes at least two valves. [0028] Broadly defined, the present invention according to another aspect is an apparatus for separating the expired airway phase of breath exhaled by a mammalian subject from the alveolar phase of the exhaled breath, including: a fluid inlet; at least a first fluid outlet and a second fluid outlet; a valve assembly adjustable between at least two states: a first state wherein fluid received at the fluid inlet is diverted to the first fluid outlet, and a second state wherein fluid received at the fluid inlet is diverted to the second fluid outlet; and a control system that adjusts the state of the valve assembly, having a spectrometer arranged to monitor at least one characteristic of a generally gaseous fluid passing through the separation apparatus, the characteristic generally capable of distinguishing the expired airway phase of an exhaled breath from a mammalian subject from the alveolar phase of the exhaled breath, and an actuator device, coupled to the spectrometer and the valve assembly, that adjusts the state of the valve assembly on the basis of the state of the monitored characteristic. [0029] In features of this aspect, the spectrometer is arranged to measure the partial pressure of a particular predetermined gas in the gaseous fluid passing through the separation apparatus; the actuator device adjusts the state of the valve assembly from its first state to its second state when the partial pressure of the particular predetermined gas reaches a predetermined level; the partial pressure reaches the predetermined level by rising to the predetermined level; the partial pressure reaches the predetermined level by dropping to the predetermined level; the particular predetermined gas is selected from the group consisting of CO 2 , O 2 , N 2 , CO and NO; the fluid inlet, the at least two fluid outlets and the valve assembly define a cartridge assembly, and the apparatus further includes a housing adapted to carry the cartridge assembly and the control system; and the cartridge assembly is adapted to be removable from the housing for disposal after a single use, while the control system is adapted for repeated reuse. [0030] In other features of this aspect, the apparatus further includes a chamber having an inlet connected in fluid communication with one of the at least two fluid outlets and adapted to collect at least a portion of the generally gaseous fluid passing through the separation apparatus; the chamber is a condensing chamber adapted to collect liquid condensed out of the generally gaseous fluid; the chamber is connected to the second fluid outlet, and the actuator device adjusts the valve assembly from the first state to the second state when the partial pressure reaches the predetermined level; the chamber is connected to the second fluid outlet, and the actuator device adjusts the valve assembly from the second state to the first state when the partial pressure reaches the predetermined level; the valve assembly includes a valve adjustable between at least two positions such that in the first valve assembly state the valve is in a first position diverting fluid received at the fluid inlet to the first fluid outlet and away from the second fluid outlet, and in the second valve assembly state the valve is in a second position diverting fluid received at the fluid inlet to the second fluid outlet and away from the first fluid outlet; the valve is a directional flap; the actuator device is a rotary solenoid; and the valve assembly includes at least two valves. [0031] Broadly defined, the present invention according to another aspect is a breath condensate collection apparatus including: a housing; a condensing chamber, carried by the housing, having an inlet that receives exhaled breaths from a mammalian subject and an outlet that permits a gaseous, non-condensed portion of the exhaled breaths to escape from the condensing chamber; and a built-in refrigeration system, carried by the housing, having a compressor, an expansion valve, an evaporator pipe arranged to cool the condensing chamber, and a condenser pipe arranged to dissipate heat away from the condensing chamber. [0032] In features of this aspect, the housing includes a cavity correspondingly shaped and sized to carry the condensing chamber, and the evaporator pipe is disposed generally around the cavity; when the condensing chamber is carried in the cavity, the condensing chamber makes contact with a substantial portion of the evaporator pipe; the condensing chamber has walls constructed from a good heat conducting material; the walls of the condensing chamber are constructed from aluminum; the apparatus further includes a ventilation system that dissipates heat generated by the refrigeration system; the ventilation system includes one or more vents in the housing; the ventilation system includes one or more fans; and the apparatus further includes a temperature gauge arranged to provide an indication of the temperature of the condensing chamber. [0033] Broadly defined, the present invention according to another aspect is a portable breath condensate collection apparatus including: a housing having at least one compartment adapted to receive and generally enclose a removable cartridge and a removable condensing chamber in fluid communication with one another; a removable, disposable cartridge, having at least one inlet, at least one outlet and a mouthpiece in fluid communication with at least one inlet, carried in the at least one compartment of the housing such that at least a portion of the mouthpiece is carried externally to the housing; and a removable condensing chamber, having an inlet and an outlet, carried in the at least one compartment of the housing such that the inlet is in fluid communication with at least one outlet of the cartridge and the outlet is open to the environment. [0034] In features of this aspect, the at least one compartment includes a compartment having a first section and a second section, the cartridge is carried in the first compartment section and the condensing chamber is carried in the second compartment section; alternatively, the at least one compartment includes at least a first compartment and a second compartment, the cartridge is carried in the first compartment and the condensing chamber is carried in the second compartment; the cartridge includes a valve assembly for alternately permitting or preventing the flow of fluids through the cartridge and into the condensing chamber; the apparatus further includes a control system, carried by and generally enclosed in the housing, for the valve assembly; and the control system is adapted to remain in the housing for repeated reuse while the cartridge and the condensing chamber are removed. [0035] In other features of this aspect, the apparatus further includes an analyzer, carried by and generally enclosed in the housing, adapted to provide information regarding the content of breath condensate received therein, and a conduit disposed in sealed fluid communication between the condensing chamber and the analyzer, adapted to guide breathe condensate from the condensing chamber to the analyzer; wherein the condensing chamber further includes a piston and a handle, the piston is slidably disposed in the interior of the condensing chamber in snug contact with the inside of the condensing chamber and the handle extends from the first end of the condensing chamber so as to permit the piston to be moved within the central chamber; and the piston is operable to force breath condensate collected in the condensing chamber to the conduit leading to the analyzer. [0036] Broadly defined, the present invention according to another aspect is a breath condensate collection apparatus including: a housing; a condensing chamber, carried by the housing; an inlet, carried by the housing, that receives exhaled breath from a mammalian subject; a conduit disposed in sealed fluid communication between the inlet and the condensing chamber; a gas flow measurement device, disposed in the conduit, that measures the flow of gas through the conduit; and a control system, coupled to the gas flow measurement device, that determines when a predetermined volume of gas has passed through the conduit. [0037] In features of this aspect, the conduit, the gas flow measurement device and the control system are carried by the housing; the apparatus further includes a signaling device that generates a user-identifiable indication that the predetermined volume of gas has passed through the conduit; the gas flow measurement device is a gas flow transducer and the control system includes a microcontroller that is electrically connected to the gas flow transducer; the signaling device includes a speaker that generates a user-audible signal; the user-audible signal changes, as a mammalian subject breathes through the apparatus, to provide an indication of progress toward reaching the predetermined volume of gas; the signaling device includes at least one user-visible light; and the at least one user-visible light includes a plurality of user-visible lights that light sequentially, as a mammalian subject breathes through the apparatus, to provide an indication of progress toward reaching the predetermined volume of gas. [0038] Broadly defined, the present invention according to another aspect is a breath condensate collection apparatus for separating the expired airway phase of breath exhaled by a mammalian subject from the alveolar phase of the exhaled breath, including: a housing; a cartridge assembly having a breathing port, at least two fluid outlets, a valve assembly adjustable between at least two states, including a first state wherein gas received at the breathing port is diverted to a first of the at least two fluid outlets, and a second state wherein gas received at the breathing port is diverted to a second of the at least two fluid outlets, a monitoring system arranged to monitor at least one characteristic of gas passing through the separation apparatus, the characteristic generally capable of distinguishing the expired airway phase of an exhaled breath from a mammalian subject from the alveolar phase of the exhaled breath, and an actuator device, coupled to the monitoring system and the valve assembly, that adjusts the valve assembly state on the basis of the state of the monitored characteristic; a condensing chamber, having an inlet and an outlet, carried by the housing such that the inlet is in fluid communication with at least one outlet of the cartridge assembly and the outlet is open to the environment; and a built-in refrigeration system, carried by the housing. [0039] In features of this aspect, the housing includes at least one compartment adapted to receive and generally enclose the cartridge assembly and the condensing chamber in fluid communication with one another; the condensing chamber is adapted to be removed from the housing after use and replaced by a previously-unused condensing chamber; the cartridge assembly is adapted to be removed from the housing after use and replaced by an unused cartridge assembly; the condensing chamber has double side walls and first and second opposing ends, and the double side walls include an inner side wall and an outer side wall in spaced relationship to one another; the built-in refrigeration system includes a compressor, an expansion valve, an evaporator pipe arranged to cool the condensing chamber, and a condenser pipe arranged to dissipate heat away from the condensing chamber; and the apparatus further includes a conduit disposed in sealed fluid communication between the valve assembly and the condensing chamber, a gas flow measurement device, disposed in the conduit, that measures the flow of gas through the conduit, and a control system, coupled to the gas flow measurement device, that determines when a predetermined volume of gas has passed through the conduit. BRIEF DESCRIPTION OF THE DRAWINGS [0040] Further features, embodiments, and advantages of the present invention will become apparent from the following detailed description with reference to the drawings, wherein: [0041] FIG. 1 is a side view of a device for collection of exhaled alveolar breath condensate in accordance with a preferred embodiment of the present invention; [0042] FIG. 2 is a front view of the device of FIG. 1 ; [0043] FIG. 3 is a top view of the housing of FIG. 1 with the cartridge lid removed to show the cartridge assembly; [0044] FIG. 4 is a top view of the housing of FIG. 1 with the cartridge assembly and the syringe removed; [0045] FIG. 5 is a side cross-sectional view of the device of FIG. 2 , taken along line 5 - 5 ; [0046] FIG. 6 is a schematic view of the cartridge assembly of FIG. 3 ; [0047] FIG. 7 is an enlarged perspective view of the cartridge of FIG. 1 ; [0048] FIG. 8 is a right side view of the cartridge of FIG. 7 ; [0049] FIG. 9 is a top view of the cartridge of FIG. 7 ; [0050] FIG. 10 is a rear view of the cartridge of FIG. 7 ; [0051] FIG. 11 is a side view of the directional flap of FIG. 7 ; [0052] FIG. 12 is a side perspective view of the directional flap of FIG. 7 ; [0053] FIG. 13 is a partially-schematic side cross-sectional view of the cartridge of FIG. 10 , taken along line 13 - 13 , showing the directional flap in a closed position; [0054] FIG. 14 is a partially-schematic side cross-sectional view of the cartridge of FIG. 10 , taken along line 13 - 13 , showing the directional flap in an open position; [0055] FIG. 15 is a left side view of the cartridge of FIG. 7 showing the attachment of a spring to the directional flap; [0056] FIG. 16 is a rear view of the cartridge assembly of FIG. 3 , shown removed from the housing; [0057] FIG. 17 is an enlarged perspective view of the rotary solenoid of FIG. 16 ; [0058] FIG. 18 is a side view of a first exemplary syringe for use in the device of FIG. 1 ; [0059] FIG. 19 is a front view of the syringe of FIG. 18 ; [0060] FIG. 20 is a side cross-sectional view of the syringe of FIG. 19 , taken along line 20 - 20 ; [0061] FIG. 21 is a side cross-sectional view of a device for collection of exhaled alveolar breath condensate in accordance with a second preferred embodiment of the present invention; [0062] FIG. 22 is a side cross-sectional view of a device for collection of exhaled alveolar breath condensate in accordance with a third preferred embodiment of the present invention; [0063] FIG. 23 is a side cross-sectional view of the device of FIG. 22 showing the plunger assembly in a fully inserted position; and [0064] FIG. 24 is a schematic view of an auxiliary control system for use with the device of FIGS. 1, 21 and 22 . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0065] Referring now to the drawings, in which like numerals represent like components throughout the several views, the preferred embodiments of the present invention are next described. The following description of the preferred embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. [0066] FIG. 1 is a side view of a device 10 for collection of exhaled alveolar breath condensate in accordance with a preferred embodiment of the present invention. The device 10 includes a housing 12 , a disposable mouthpiece 14 , a handle 16 , an intake cartridge assembly 20 and a syringe 80 . The size and shape of the housing 12 and the handle 16 are designed to permit the device 10 to be readily held by a patient, but the device 10 may also be mounted on the side of a hospital bed or gurney, attached to a rolling mobile stand, or the like, using suitable mounting hardware (not shown). [0067] FIG. 2 is a front view of the device 10 of FIG. 1 . The housing 12 is generally cylindrical and is designed to support the intake cartridge assembly 20 and the syringe 80 therein. The housing 12 includes a cartridge lid 13 secured to the remainder of the housing 12 by a hinge 11 . The cartridge lid 13 may thus be opened to facilitate access to the cartridge assembly 20 disposed inside the housing 12 . [0068] FIG. 3 is a top view of the housing 12 of FIG. 1 with the cartridge lid 13 removed to show the cartridge assembly 20 , FIG. 4 is a top view of the housing 12 of FIG. 1 with the cartridge assembly 20 and the syringe 80 removed, and FIG. 5 is a side cross-sectional view of the device 10 of FIG. 2 , taken along line 5 - 5 . As shown therein, the housing 12 may include a variety of compartments, recesses, pockets or the like for receiving the various components of the device 10 . In particular, one end of the housing 12 may be devoted to the components of the cartridge assembly 20 , while the other end houses the syringe 80 . The housing 10 includes a cartridge compartment, a two spectrometer pockets, an actuator pocket, and other pockets and recesses for various parts and functions described below. In addition, the housing 12 includes external openings through at each end as well as two openings in its bottom and an opening penetrating the cartridge lid 13 . The purpose of each of these openings will become apparent hereinbelow. [0069] FIG. 6 is a schematic view of the cartridge assembly 20 of FIG. 3 . The cartridge assembly 20 includes a disposable cartridge 22 and a control system 60 . The control system 60 is used to control a directional flap 36 in the cartridge 22 , which regulates the path of exhaled breath through the cartridge 22 . The operation of the control system 60 and the cartridge 22 will be more fully described hereinbelow. [0070] FIGS. 7-10 are perspective, right side, top and rear views of the cartridge 22 of FIGS. 5 and 6 . The cartridge 22 may be formed from polyethylene, polycarbonate, polyvinyl, plastic, glass or the like and includes a breathing port 24 , an inhalation port 26 , an absorption chamber 28 , a collection port 30 , an exhaust vent 32 , a pair of spectrometer windows 34 and a valve assembly that may include the directional flap 36 , a spring 50 and a pin or boss 52 protruding from an exterior surface of the cartridge 22 . The breathing port 24 is fluidly connected between the absorption chamber 28 and the mouthpiece 14 to permit a user to breathe in and out through the cartridge 22 . The inhalation port 26 includes a one-way valve 27 that permits ambient air to be drawn through the cartridge 22 during the user&#39;s inhalation cycle. The collection port 30 is in fluid communication with the syringe 80 and includes a one-way valve 31 to prevent gases in the syringe 80 from returning to the cartridge 22 . The exhaust vent 32 permits unwanted exhaled breath to be vented to the environment and includes a one-way valve 33 to prevent air from entering the cartridge 22 therethrough. It should be noted that although FIGS. 7 and 10 , and some of the other illustrations, show the exhaust vent 32 as being round, it may be preferable for the exhaust vent 32 to be rectangular or some other shape. The emitter and sensor units 64 , 66 of a spectrometer or other monitoring system 62 may be stationed adjacent the spectrometer windows 34 , as described below, in order to measure the content of gas contained in the absorption chamber 28 of the cartridge 22 . [0071] FIGS. 11 &amp; 12 are side and perspective views, respectively, of the directional flap 36 of FIG. 7 . The directional flap 36 includes a central shaft 37 , arranged around an axial pin 44 , from which a deflector plate 38 is supported by a pair of arms 39 , 41 . As illustrated in FIG. 8 , a pair of tabs 40 , 42 extend laterally from the ends of a flange 43 , supported by the central shaft 37 , for purposes made clear hereinbelow. The directional flap 36 may be adjusted to force the exhaled breath in the interior of the cartridge 22 to be exhausted either through the collection port 30 or the exhaust vent 32 . As perhaps best shown in FIGS. 8 and 9 , the flap 36 is supported in the interior if the cartridge 22 by the arms 39 , 41 , which extend through slots 45 in the sides of the cartridge 22 . [0072] FIGS. 13 and 14 are partially-schematic side cross-sectional views of the cartridge 22 of FIG. 10 , taken along line 13 - 13 , showing the directional flap 36 in a closed position and an open position, respectively. In the closed position shown in FIG. 13 , the deflector plate 38 blocks the air path to the collection port 30 that forms the portal between the cartridge 22 and the syringe 80 . This forces all expelled breath to be exhausted through the exhaust vent 32 . On the other hand, in the open position shown in FIG. 14 , the deflector plate 38 covers the exhaust vent 32 , forcing all expelled breath through the collection port 30 and into the syringe 80 . Preferably, gaskets 46 , 48 or other sealing devices and methods may be used to seal the deflector plate 38 and any other necessary surfaces of the directional flap 36 to the various internal structures of the cartridge 22 in order to ensure that gases of the wrong type are not passed through the wrong opening. [0073] FIG. 15 is a left side view of the cartridge 22 of FIG. 7 showing the attachment of the spring 50 to the directional flap 36 . The spring 50 or an equivalent device is preferably provided in order to bias the directional flap 36 in a normally-closed position. One purpose of this is to prevent gases and fluids collected in the syringe 80 from escaping back through the cartridge 22 . In one embodiment, the spring 50 is a simple coil spring that is interconnected between one of the tabs 42 on the directional flap 36 and the boss 52 on the exterior surface of the cartridge 22 , as perhaps best shown in FIGS. 9 and 10 . Other biasing devices and methods will be apparent to one of ordinary skill in the art. [0074] Moreover, it will be apparent that the valve assembly may take on any number of different constructions. For example, the directional flap 36 and the biasing device may be internalized within the cartridge 22 in order to provide better sealing, improve operation, or the like. Further, the valve assembly may include two flap-type valves operating in conjunction with each other instead of the single flap 36 disclosed and described herein, or the directional flap 36 may be replaced with a valve mechanism of any suitable alternative type, including but not limited to one rotary valve, a sliding door, a slip barrel, a plunger, or the like, with corresponding changes to the cartridge, biasing device, and the like being apparent to those of skill in the art. [0075] Returning to FIG. 6 , the control system 60 includes a monitoring system 62 , a control unit 67 and an actuator device 70 . The control unit 67 may include an amplifier/differentiator 68 and a monitoring system controller 69 . A variety of monitoring systems may be employed using different physical phenomena as triggers for the directional flap. One monitoring system 62 suitable for use in the preferred embodiments of the present invention is a spectrometer, which may be of any conventional type, including infrared (IR), laser, and the like, and includes a radiation source, or emitter unit 64 , disposed on one side of the absorption chamber 28 and a sensor unit 66 disposed on the opposite side, adjacent the spectrometer windows 34 . FIG. 16 is a rear view of the cartridge assembly 20 of FIG. 3 , shown removed from the housing 12 . In operation, radiation from the emitter unit 64 passes through the spectrometer window on one side of the cartridge 22 , through the absorption chamber 28 and through the absorption window 34 to the sensor unit 66 , where the received radiation is analyzed. [0076] IR spectrometers may use chopped IR light emission, where the emission is chopped at a frequency appropriate to distinguish absorbance of the gas of interest, such as CO 2 , from background absorbance. Alternatively, laser diode spectrometry can be used for detection of more than one gas for the purpose of actuating the directional flap and for the purpose of determining the presence of various pathophysiological processes that are specific to certain disease states. Lasers using AlGaAs, AlGaInP or a Vertical Cavity diodes operating in the near infrared or visible light spectrum at room temperature and ambient pressure in the 1-100 mW power range will be sufficient. The physical length between the emission and detection probe will be approximately 1-3 cm, but the apparent pathlength may be increased by light reflection using dielectrim mirrors to increase sensitivity. Detection wavelengths will be 1390 nm for CO 2 and 760 nm for O 2 , but other gases may be detected by the laser to assist in diagnosis of specific diseases, including lung ischemia, by the detection of the relative amounts of nitric oxide (NO) at 1800 nm and carbon monoxide (CO) at 1570 nm. It is anticipated that further research will reveal significance of laser-based quantification of other inorganic gases and volatile organic compounds to serve as adjuncts to the chemical analyses of the breath condensate in arriving at a final diagnosis of certain disease processes. [0077] Spectrometers are available from a variety of manufacturers, and the selection and implementation of one suitable for use with the present invention would be apparent to one of ordinary skill in the art. As is well known, the sensor unit 66 measures the percent transmission of the radiation to allow measurement of the partial pressure of certain gases in the absorption chamber 28 . Measured gases may include carbon dioxide, oxygen, nitrogen, nitrogen oxides, carbon monoxide, aliphatic and aromatic hydrocarbons, isoprostenoid derivatives, or amino acids dissolved in exhaled aerosolized droplets. [0078] One type of actuator device 70 suitable for use in the preferred embodiments of the present invention is a rotary solenoid: The rotary solenoid 70 utilizes a clutch mechanism to adjust or move the directional flap 36 back and forth between its open and closed positions. FIG. 17 is an enlarged perspective view of the rotary solenoid 70 of FIG. 16 . As illustrated therein, an actuator shaft 74 extends from the solenoid body 72 . A slot 76 in the end of the actuator shaft 74 may be firmly coupled to one of the tabs 40 on the directional flap 36 in order to provide rotational movement to the tab 40 and likewise rotating the directional flap 36 between its open and closed positions. If necessary, the directional flap tab 40 and the actuator shaft 74 of the rotary solenoid 70 may be disposed coaxially with the pin 44 of the directional flap in order to minimize wear on the components. Rotary solenoids 70 are available from a variety of manufacturers, and the selection and implementation of one suitable for use with the present invention would be apparent to one of ordinary skill in the art. It should also be apparent that other actuating devices and methods may be employed without departing from the scope of the present invention, including pulley mechanisms, magnetic actuation of a metallic valve, and the like, triggered from expired volume measured from a flow transducer rather than from light absorption technique. [0079] FIGS. 18 and 19 are side and front views, respectively, of a first exemplary syringe 80 for use in the device 80 of FIG. 1 . As illustrated therein, the syringe 80 includes an insulated condensing chamber 82 having a plunger assembly 84 , an inlet 86 and an exhaust port 88 . The condensing chamber 82 may be constructed of any suitable material, including, but not limited to, glass, plastic, polyethylene, polycarbonate, or polyvinyl or other synthetic polymer. [0080] FIG. 20 is a side cross-sectional view of the syringe 80 of FIG. 18 , taken along line 20 - 20 . As shown therein, the insulative effect of the condensing chamber 82 may be provided by any of a variety of materials either formed directly into the walls (not illustrated) of the condensing chamber or sandwiched between an inner wall 90 and an outer wall 92 . Arranged peripherally between the inner and outer walls 90 , 92 is a layer of a material 94 suitable for creating an endothermic reaction, such as NH 4 NO 3 , that has been vacuum-packed and sealed. The condensing chamber 82 is preferably provided with a needle port 96 or some other means for permitting the sealed material 94 to be hydrated or otherwise injected with a readily available catalyst in order to trigger an endothermic reaction when the syringe 80 is ready to be used. If NH 4 NO 3 is to be used, then the NH 4 NO 3 may be hydrated with water in a 1:4 molar ratio. Such a material is preferred because a user may trigger the reaction by injecting the NH 4 NO 3 material with a preset volume of tap water or saline via the needle port 96 , similar to the way a nurse would “flush” an IV line. However, other materials may likewise be used to create a suitable endothermic reaction. [0081] The inner surfaces of the condensing chamber 82 define a central cylinder in which is fitted the plunger assembly 84 . The plunger assembly 84 includes a piston 98 , a rubber gasket 100 , a handle 102 extending from one end of the condensing chamber 82 , and a clip assembly 104 disposed at the handle end of the condensing chamber 82 . The inlet 86 is preferably disposed at the opposite end of the condensing chamber 82 from the plunger assembly 84 and may be arranged in the form of a nipple. The exhaust port 88 is preferably disposed at the same end of the condensing chamber 82 as the handle 102 and is equipped with a one-way valve 106 to permit gases passing through the condensing chamber 82 to be exhausted therethrough while preventing ambient gases from entering the condensing chamber 82 . [0082] Although not shown herein, a second exemplary syringe suitable for use (with minor modifications) in the device 10 of FIG. 1 is a double-walled syringe of a type somewhat similar to one disclosed in the commonly-assigned U.S. Provisional Patent Application 60/434,916, filed Dec. 20, 2002. The construction of this syringe is similar to that of the first, except that the space between the inner and outer walls of the condensing chamber is filled with water, polyethylene glycol (“PEG”), or another suitable coolant material and the outer wall is then sealed to the inner wall to prevent leakage. A syringe of this type may be cooled by placing it in a standard freezer prior to use in order to lower the temperature of the syringe to less than 0° F., and preferably to less than 0° C. Details of this type of syringe are provided in the aforementioned provisional patent application. [0083] In operation, the housing lid 13 is opened and the cartridge assembly 20 is inserted into the housing 12 such that the various components are snapped into place in their respective compartments in the housing 12 . Next, a syringe 80 of one of the types described above is retrieved from storage and inserted into the open end of the housing 12 , nipple-shaped inlet 86 first, and pushed inward until the inlet 86 is coupled to the collection port 30 of the cartridge 22 . [0084] Depending on the syringe type, the syringe 80 may have been stored in a refrigeration device, such as a conventional household freezer, that is capable of lowering the temperature to less than 0° F., and preferably less than 0° C., in order to freeze the jacket of coolant material 94 contained between the inner and outer walls 90 , 92 of the condensing chamber 82 . Alternatively, syringes of the endothermic reaction type may merely be stored at an ambient temperature and then cooled to the desired temperature by triggering an endothermic reaction therein when ready for use. If the mouthpiece 14 is stored separately from the rest of the device 10 , then the mouthpiece 14 may be assembled to the cartridge assembly 20 . In some applications, such as when the device 10 is to be attached to a bed or to a rolling stand, it may be useful to connect the mouthpiece 14 to a longer tube (not shown) in sealed fluid communication with the breathing port 24 of the cartridge 22 . [0085] Once the device 10 is assembled, the patient positions the mouthpiece 14 in sealed relationship to his mouth area and inhales and exhales through the mouthpiece 14 . When the patient inhales, ambient air enters through the inhalation port 26 via the one-way valve 27 . The exhaled breath is guided into the absorption chamber 28 via the breathing port 24 . Under the control of the monitoring system controller 69 , the spectrometer 62 measures the partial pressure of certain gases in the absorption chamber 28 and delivers an analog current to the amplifier/differentiator 68 . For example, the magnitude of the analog signal may be proportional to the amount of CO 2 present in the absorption chamber 28 . [0086] At the beginning of an expiration by the patient, the patient&#39;s breath is dilute in carbon dioxide and rich in oxygen. In one preferred embodiment, the rotary solenoid 70 and the amplifier/differentiator 68 are calibrated such that the directional flap 36 remains in its resting state, wherein the flap 36 is held in its closed position by the spring 50 , and the airway deadspace is shunted out the exhaust vent 32 to the environment. As the patient&#39;s alveoli begin to empty during expiration, the partial pressure of CO 2 increases and the partial pressure of oxygen decreases. The resulting signal generated by the amplifier/differentiator 68 eventually activates the solenoid 70 , causing the directional flap 36 to open. At this point, the alveolar gas and associated water content are directed selectively to the syringe 80 . [0087] To maximize the efficiency of collection of breath condensate, the deadspace volume of the cartridge 22 should preferably be minimized to less than 20 mL. It will also be preferable for patients to exhale deeply through the device 10 in order to enhance the amount of condensation in the alveolar phase. Thermodynamic and kinetic modeling has suggested that forced exhalation will enhance the transfer of alveolar water into vapor and droplet phase. Thus the device 10 is preferably designed to impart a small resistance to exhaled flow. The outlet diameter and length of the collection port 30 , connected to the condensing chamber 82 , will be calibrated to provide a small amount of resistance to exhalation, which the patient should be able to detect, but which is not enough to cause exhalation to be excessively laborious. [0088] As portions of the expired breath pass into the syringe 80 , the moisture in the breath begins to condense on the inner surfaces of the condensing chamber 82 . Because of the depressed temperature of the condensing chamber 82 , condensate begins to collect and may immediately freeze on the inner surfaces thereof. Once the patient&#39;s breath has warmed the condensing chamber 82 sufficiently, the condensate will melt and may be expressed from the condensing chamber 82 . The construction of the condensing chamber 82 is preferably calibrated to provide a sufficient quantity of condensate (approximately 250 microliters) after a predetermined number of breaths. When sufficient condensate has been collected, the syringe 80 may be removed from the housing 12 and the plunger assembly 84 depressed to force the collected condensate from the nipple 86 as described previously. Finally, once the condensate has been collected and withdrawn, the mouthpiece 14 , the cartridge 22 (but preferably not the control system 60 , which is designed to remain uncontaminated and would be relatively expensive to replace after each use) and the syringe 80 may be disposed of according to conventional waste disposition procedures, and the collected condensate may be taken to a suitable analyzer for analysis. [0089] Because of the relatively small quantities of liquid condensate that may typically be collected using devices 10 of the present invention, it may be useful to include specialized features in the piston 98 and other components in order to maximize the amount of condensate that may be collected. For example, although not absolutely necessary, the piston 98 shown in the various illustrations includes a tip or protrusion 99 of dimensions and shape suitable for fitting snugly into the nipple-shaped inlet 86 when the plunger assembly 84 is fully depressed. This helps to ensure that as much condensate as possible is forced out of the inlet 86 . In addition, however, the protrusion 99 may, for example, include grooves, tunnels, or the like for guiding condensate from the condensing chamber 82 to the inlet 86 and out. Specialized pistons 98 such as these are more fully described in the aforementioned U.S. Provisional Patent Application 60/434,916. [0090] The analysis of the collected condensate may be carried out using any conventional analysis technique or system. The analysis may focus on identifying and quantifying the presence of a variety of markers of various respiratory diseases. The markers may include microbes such as viruses, fungi, mycoplasma, mycobacteria, bacteria, prions and protozoa, and biochemicals such as inorganic gases, volatile organic molecules, proteins, nucleic acids, lipids, lipid A, endotoxin and other impervious nonorganic exogenous materials such as inhaled particulate including asbestos, silicates, coal dust and the like. These markers and the analysis techniques and systems are well known to those of ordinary skill in the art. Once the analysis is complete, however, a more accurate diagnosis may be made by taking into account the exhalation cycle phase or phases in which the markers were found. [0091] FIG. 21 is a side cross-sectional view of a device 110 for collection of exhaled alveolar breath condensate in accordance with a second preferred embodiment of the present invention. In this alternative embodiment preferred for its completely self-contained nature, the device 110 includes a refrigeration system 120 built into its housing 112 . The refrigeration system 120 is generally of conventional design and includes a compressor 122 , an expansion valve (not shown), a distribution system 126 and an exhaust system 140 . However, it should be apparent that other types of cooling systems may likewise be utilized without departing from the scope of the present invention. For example, instead of a conventional refrigeration system 120 , the alternative device 110 may utilize a cooling jacket comprised of a layer of a liquid having a very low freezing point, such as PEG, in a bag made of rubber or the like, or may use an electric cooler making use of the thermoelectric effect, or other cooling methodologies. [0092] The device 110 may utilize an alternative syringe 180 having a single-walled condensing chamber 182 and a plunger assembly and other features as described herein. The distribution system 126 is a piping or tubing structure having a evaporator (cold) pipe or coil 128 and a condenser (hot) coil 130 . The evaporator coil 128 surrounds the recess into which the condensing chamber 182 is inserted. Although not shown herein, the evaporator coil 128 may even make direct contact with the wall of the condensing chamber 182 . Preferably, the walls of the condensing chamber 182 are formed of aluminum or another good heat conducting material, thus permitting the refrigeration system 120 to rapidly cool the condensing chamber 182 , thus facilitating breath condensate collection within seconds of inserting the syringe 180 therein. [0093] The condenser coil 130 may be cooled using convection cooling via the exhaust system 140 , which may include fans 142 and vents 144 such as those shown in the side and end, respectively, of the housing 112 in FIG. 21 . The exhausted heat should preferably be directed away from the patient. The compressor 122 may operate using standard 110 volt electrical power or using power supplied by a suitable battery pack. A temperature gauge (not shown) may be provided to indicate when the temperature of the condensing chamber 182 has been lowered sufficiently to allow breath condensation to occur with adequate efficiency, which may be important if the device 110 has not been used for an extended period of time. [0094] FIG. 22 is a side cross-sectional view of a device 210 for collection of exhaled alveolar breath condensate in accordance with a third preferred embodiment of the present invention. In this alternative embodiment preferred for its still greater functionality and convenience, the device 210 includes a built-in breath condensate analyzer 220 . The built-in analyzer feature may be combined with the built-in refrigeration system 120 described above, or may be utilized separately. In order to deliver the collected condensate to the analyzer 220 , a syringe 280 having a special condensing chamber 282 may be utilized. The condensing chamber 282 differs from previously-described condensing chambers 82 , 182 in that it includes a small side port 283 extending radially from the entry end of the condensing chamber 282 . This permits collected condensate to be expressed directly into the analyzer 220 . In addition, it should be noted that the plunger assembly 84 must include a tip or protrusion 99 of a type described previously (or a similar structure) in order to completely plug the nipple-shaped inlet 86 of the condensing chamber 282 , thereby preventing condensate from passing back into the cartridge 22 when the plunger assembly 84 is depressed. [0095] In use, a syringe 280 is first inserted into the housing 212 of the device 210 . A groove or channel may be provided in the recess of the housing 212 in order to guide the side port 283 into fluid communication with an inlet 221 for the analyzer 220 . If the device 210 is equipped with a built-in refrigeration system 120 as described previously, then the condensing chamber 282 may be cooled once it is in place in the housing 112 ; otherwise, the condensing chamber 282 should be cooled ahead of time. Condensate is then collected in a similar manner to that described hereinabove. When sufficient condensate has been collected, the plunger assembly 84 may be depressed until the plunger handle 102 snaps into place. FIG. 23 is a side cross-sectional view of the device of FIG. 22 showing the plunger assembly 84 in a fully inserted position. This forces the analyte out of the side port 283 and into the analyzer 220 , which may include an analysis matrix, such as an immunoassay screen, or permits it to be aspirated by vacuum into an analysis chamber contained within the housing 212 of the device 210 . [0096] FIG. 24 is a schematic view of an auxiliary control system 54 for use with the devices 10 , 110 , 210 of FIGS. 1, 21 and 22 . The auxiliary control system 54 includes a flow transducer 55 , a microcontroller or other computer device or electronic logic module 56 , and one or more signaling devices 57 , 58 . The flow transducer 55 may be installed anywhere along the flow path extending from the directional flap 36 in the cartridge 22 to the exhaust port 88 of the respective syringe 80 , 180 . 280 but is preferably installed at the collection port 30 of the cartridge 22 . The microcontroller 56 is interconnected between the flow transducer 55 and the signaling devices 57 , 58 . [0097] In operation, the flow transducer 55 measures the exhaled alveolar volume passing through the collection port 30 of the cartridge 22 and generates a corresponding analog signal that is monitored by the microcontroller 56 . The exhaled alveolar volume that is required in order to produce the volume of condensate needed for accurate chemical analyses can be preprogrammed, based upon experimental analysis, into the microcontroller 56 . When the microcontroller 56 determines that that volume has been reached, it transmits a suitable electronic signal to the signaling devices 57 , 58 , which may include a speaker, one or more LED&#39;s or other visual signal devices, or the like. Thus, when the speaker 57 sounds or the LED&#39;s 58 light, the operator of the respective device 10 , 110 , 210 is notified that the breath collection process has been completed. Alternatively, the microcontroller 56 may utilize a more complex signaling pattern, wherein the audible signal emitted by the speaker 57 rises in pitch or in intensity as the process progresses, or a series of LED&#39;s 58 are sequentially lit as the process progresses. This approach allows the patient and operator to know how much more breathing is required to complete condensation collection, which may be particularly advantageous for breath collection from children. [0098] It should be apparent that the devices 10 , 110 , 210 of various embodiments of the present invention may also be used to capture expired breath from the expired airway phase, rather than the alveolar phase, merely by reversing the triggering point for the solenoid 70 . This may be accomplished by calibrating the rotary solenoid 70 and the amplifier/differentiator 68 such that the directional flap 36 is initially held in its active state, wherein the flap 36 is held in its open position by the solenoid 70 . Alternatively, the spring 50 or other biasing means may be adjusted to bias the directional flap 36 in its open position, and the control system 60 may be adjusted such that when the solenoid 70 is activated, the flap 36 is closed. [0099] The operation of this variation is as follows. As described previously, at the beginning of an expiration by the patient, the patient&#39;s breath is dilute in carbon dioxide and rich in oxygen. Thus, when the flap 36 is open, the airway deadspace and associated water content are directed selectively to the syringe 80 . As the patient&#39;s alveoli begin to empty during expiration, the partial pressure of CO 2 increases and the partial pressure of oxygen decreases. The resulting signal generated by the amplifier/differentiator 68 eventually deactivates the solenoid 70 , causing the directional flap 36 to close. At this point, the alveolar gas is shunted out the exhaust vent 32 to the environment. The threshold concentration value for CO 2 is preferably set at approximately 4 torr, so that once the concentration of CO 2 exceeds that value, the actuator device 70 closes the flap 36 , thus preventing further exhaled breath from passing into the syringe 80 . [0100] Thus, this alternative arrangement may be used to provide specific separation of the expired airway phase from the alveolar phase. More specifically, this would allow selective spectrophotometric measurement of expired concentrations of inorganic gases and volatile organic compounds, as well as collection of expired condensate derived only from the airway phase of exhalation. Then, the condensing chamber 82 could be replaced and the triggering mechanism could be reset to alveolar collection mode, and the process repeated. Because the condensate collected during alveolar collection mode would be from the same subject as that collected during the expired airway mode, the cartridge 22 would not necessarily need to be replaced when changing modes; however, the cartridge 22 may likewise be replaced, if desired, in order to avoid contaminating the condensate collected in one mode with any residual condensate or remaining fluids still present in the cartridge 22 after operation in the first mode. [0101] The advantage of this differential sample collection would be the distinction of pathological processes affecting the lining of the bronchial tree versus processes primarily affecting the alveoli. The ability to distinguish lower airway disease (e.g., on the basis of differential measurement of inflammatory markers) from diseases affecting the conducting tract can have important ramifications on treatment. [0102] Based on the foregoing information, it is readily understood by those persons skilled in the art that the present invention is susceptible of broad utility and application. Many embodiments and adaptations of the present invention other than those specifically described herein, as well as many variations, modifications, and equivalent arrangements, will be apparent from or reasonably suggested by the present invention and the foregoing descriptions thereof, without departing from the substance or scope of the present invention. Accordingly, while the present invention has been described herein in detail in relation to its preferred embodiment, it is to be understood that this disclosure is only illustrative and exemplary of the present invention and is made merely for the purpose of providing a full and enabling disclosure of the invention. The foregoing disclosure is not intended to be construed to limit the present invention or otherwise exclude any such other embodiments, adaptations, variations, modifications or equivalent arrangements; the present invention being limited only by the claims appended hereto and the equivalents thereof. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for the purpose of limitation.

A diagnosis method for respiratory disease based on the separation of the expired airway phase in an exhaled breath from the alveolar phase, and a device to accomplish the method. The device includes a cartridge assembly and a disposable condensing chamber carried in a substantially enclosed housing. The cartridge assembly includes a disposable cartridge and a reusable control system that monitors a characteristic of gas passing through the cartridge to determine when to divert the exhaled breath to an exhaust outlet and when to divert the exhaled breath to the condensing chamber. The characteristic is selected as being representative of the transition from the expired airway phase to the alveolar phase. Also included are a refrigeration system, an auxiliary monitoring system for determining when a sufficient volume of gas has been produced, and a built-in analyzer.

BACKGROUND OF THE INVENTION [0001] This invention relates generally to medical imaging and, more particularly, to medical imaging using bowtie filters. [0002] At least some known bowties used in current Computed Tomographic (CT) scanners are designed for general uses. For example, a General Electric LightSpeed scanner commercially available from General Electric Medical Systems of Waukesha Wis. has a head bowtie for the head and pediatric applications and a body bowtie for adult body scans. The body bowtie was designed to provide a fairly uniform X-ray flux on the detector surface after the X-rays pass through the body, therefore providing relatively equivalent image quality (noise) for the whole imaging area. This, however, may not be necessary if one is only interested in specific organs, such as a heart, and may introduce extra surface dose to the patient that may not improve the image quality of the specific organs that one is interested in. BRIEF DESCRIPTION OF THE INVENTION [0003] In one aspect, a method for obtaining data includes scanning an organ with an imaging system emitting X-rays and modulating the emitted X-rays with an organ specific bowtie addition. [0004] In another aspect, a method for scanning an object with an imaging system having a bowtie filter is provided. The method includes positioning a bowtie addition in the imaging system, and scanning an object. [0005] In yet another aspect, a collimator assembly for an imaging system is provided. The collimator assembly includes a bowtie filter, and a bowtie addition positioned proximate the bowtie filter. [0006] In still another aspect, an imaging system is provided. The imaging system includes a radiation source, a radiation detector positioned to receive X-rays from the source, a bowtie filter positioned between the radiation source and the radiation detector, a bowtie addition positioned between the radiation source and the radiation detector, and a computer operationally coupled to the radiation source and the radiation detector, the computer is configured to scan objects. [0007] In another aspect, a Computed Tomography (CT) imaging system includes a radiation source, a radiation detector positioned to receive X-rays from the source, a bowtie filter positioned between the radiation source and the radiation detector, a bowtie addition positioned between the radiation source and the radiation detector, and a computer operationally coupled to the radiation source and the radiation detector, the computer is configured to perform CT scans. [0008] In one aspect, a Computed Tomography (CT) imaging system includes a radiation source, a radiation detector positioned to receive X-rays from the source, a bowtie filter positioned between the radiation source and the radiation detector, a bowtie addition comprising a plurality of thick sections interspersed with a plurality of thin sections positioned between the bowtie filter and the radiation detector, and a computer operationally coupled to the radiation source and the radiation detector, the computer is configured to perform CT scans of hearts. BRIEF DESCRIPTION OF THE DRAWINGS [0009] [0009]FIG. 1 is a pictorial view of a CT imaging system. [0010] [0010]FIG. 2 is a block schematic diagram of the system illustrated in FIG. 2. [0011] [0011]FIG. 3 is a more detailed view of the collimator assembly shown in FIG. 2. [0012] [0012]FIG. 4 illustrates an X-ray modulation 24 corresponding to the bowtie addition shown in FIGS. 2 and 3. [0013] [0013]FIG. 5 illustrates an image comparison from three different sets of data. DETAILED DESCRIPTION OF THE INVENTION [0014] In some known CT imaging system configurations, an x-ray source projects a fan-shaped beam which is collimated to lie within an X-Y plane of a Cartesian coordinate system and generally referred to as an “imaging plane”. The x-ray beam passes through an object being imaged, such as a patient. The beam, after being attenuated by the object, impinges upon an array of radiation detectors. The intensity of the attenuated radiation beam received at the detector array is dependent upon the attenuation of an x-ray beam by the object. Each detector element of the array produces a separate electrical signal that is a measurement of the beam intensity at the detector location. The intensity measurements from all the detectors are acquired separately to produce a transmission profile. [0015] In third generation CT systems, the x-ray source and the detector array are rotated with a gantry within the imaging plane and around the object to be imaged such that the angle at which the x-ray beam intersects the object constantly changes. A group of x-ray attenuation measurements, i.e., projection data, from the detector array at one gantry angle is referred to as a “view”. A “scan” of the object comprises a set of views made at different gantry angles, or view angles, during one revolution of the x-ray source and detector. [0016] In an axial scan, the projection data is processed to construct an image that corresponds to a two-dimensional slice taken through the object. One method for reconstructing an image from a set of projection data is referred to in the art as the filtered backprojection technique. This process converts the attenuation measurements from a scan into integers called “CT numbers” or “Hounsfield units” (HU), which are used to control the brightness of a corresponding pixel on a cathode ray tube display. [0017] To reduce the total scan time, a “helical” scan may be performed. To perform a “helical” scan, the patient is moved while the data for the prescribed number of slices is acquired. Such a system generates a single helix from a fan beam helical scan. The helix mapped out by the fan beam yields projection data from which images in each prescribed slice may be reconstructed. [0018] Reconstruction algorithms for helical scanning typically use helical weighing algorithms that weight the collected data as a function of view angle and detector channel index. Specifically, prior to a filtered backprojection process, the data is weighted according to a helical weighing factor, which is a function of both the gantry angle and detector angle. The weighted data is then processed to generate CT numbers and to construct an image that corresponds to a two-dimensional slice taken through the object. [0019] To further reduce the total acquisition time, multi-slice CT has been introduced. In multi-slice CT, multiple rows of projection data are acquired simultaneously at any time instant. When combined with helical scan mode, the system generates a single helix of cone beam projection data. Similar to the single slice helical, weighting scheme, a method can be derived to multiply the weight with the projection data prior to the filtered backprojection algorithm. [0020] As used herein, an element or step recited in the singular and proceeded with the word “a” or “an” should be understood as not excluding plural said elements or steps, unless such exclusion is explicitly recited. Furthermore, references to “one embodiment” of the present invention are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features. [0021] Also as used herein, the phrase “reconstructing an image” is not intended to exclude embodiments of the present invention in which data representing an image is generated but a viewable image is not. However, many embodiments generate (or are configured to generate) at least one viewable image. [0022] Referring to FIGS. 1 and 2, a multi-slice scanning imaging system, for example, a Computed Tomography (CT) imaging system 10 , is shown as including a gantry 12 representative of a “third generation” CT imaging system. Gantry 12 has an x-ray source 14 that projects a beam of x-rays 16 toward a detector array 18 on the opposite side of gantry 12 . Detector array 18 is formed by a plurality of detector rows (not shown) including a plurality of detector elements 20 which together sense the projected x-rays that pass through an object, such as a medical patient 22 between array 18 and source 14 . A collimator assembly 19 is positioned between array 18 and source 14 . Collimator assembly 19 includes a known bowtie filter 21 and a bowtie addition 23 . Bowtie addition 23 is fabricated from any material suitable for fabricating known bowtie filters. In one embodiment, bowtie addition 23 is positioned between bowtie filter 21 and array 18 . Alternatively, addition 23 is positioned between bowtie filter 21 and source 14 . Each detector element 20 produces an electrical signal that represents the intensity of an impinging x-ray beam and hence can be used to estimate the attenuation of the beam as it passes through object or patient 22 . During a scan to acquire x-ray projection data, gantry 12 and the components mounted therein rotate about a center of rotation 24 . FIG. 2 shows only a single row of detector elements 20 (i.e., a detector row). However, multi-slice detector array 18 includes a plurality of parallel detector rows of detector elements 20 such that projection data corresponding to a plurality of quasi-parallel or parallel slices can be acquired simultaneously during a scan. [0023] Rotation of components on gantry 12 and the operation of x-ray source 14 are governed by a control mechanism 26 of CT system 10 . Control mechanism 26 includes an x-ray controller 28 that provides power and timing signals to x-ray source 14 and a gantry motor controller 30 that controls the rotational speed and position of components on gantry 12 . A data acquisition system (DAS) 32 in control mechanism 26 samples analog data from detector elements 20 and converts the data to digital signals for subsequent processing. An image reconstructor 34 receives sampled and digitized x-ray data from DAS 32 and performs high-speed image reconstruction. The reconstructed image is applied as an input to a computer 36 , which stores the image in a storage device 38 . Image reconstructor 34 can be specialized hardware or computer programs executing on computer 36 . [0024] Computer 36 also receives commands and scanning parameters from an operator via console 40 that has a keyboard. An associated cathode ray tube display 42 allows the operator to observe the reconstructed image and other data from computer 36 . The operator supplied commands and parameters are used by computer 36 to provide control signals and information to DAS 32 , x-ray controller 28 , and gantry motor controller 30 . In addition, computer 36 operates a table motor controller 44 , which controls a motorized table 46 to position patient 22 in gantry 12 . Particularly, table 46 moves portions of patient 22 through gantry opening 48 . [0025] In one embodiment, computer 36 includes a device 50 , for example, a floppy disk drive, CD-ROM drive, DVD drive, magnetic optical disk (MOD) device, or any other digital device including a network connecting device such as an Ethernet device for reading instructions and/or data from a computer-readable medium 52 , such as a floppy disk, a CD-ROM, a DVD or an other digital source such as a network or the Internet, as well as yet to be developed digital means. In another embodiment, computer 36 executes instructions stored in firmware (not shown). Computer 36 is programmed to perform functions described herein, and as used herein, the term computer is not limited to just those integrated circuits referred to in the art as computers, but broadly refers to computers, processors, microcontrollers, microcomputers, programmable logic controllers, application specific integrated circuits, and other programmable circuits, and these terms are used interchangeably herein. Although the specific embodiment mentioned above refers to a third generation CT system, the methods described herein equally apply to fourth generation CT systems (stationary detector-rotating x-ray source) and fifth generation CT systems (stationary detector and x-ray source). Additionally, it is contemplated that the benefits of the invention accrue to imaging modalities other than CT. Additionally, although the herein described methods and apparatus are described in a medical setting, it is contemplated that the benefits of the invention accrue to non-medical imaging systems such as those systems typically employed in an industrial setting or a transportation setting, such as, for example, but not limited to, a baggage scanning system for an airport or other transportation center, and that addition 23 is used for objects other than organs. [0026] Herein are described novel methods and apparatus for use in imaging systems. In one aspect, the use of an organ-specific bowtie addition (e.g., bowtie addition 23 ) together with bowtie 21 for imaging specific organs results in the use of less dose but equal noise as with the use of bowtie 21 singularly. A set of organ-specific bowtie additions are made to modulate the X-ray flux coming out of the tube-bowtie assembly (e.g., collimator assembly 19 ) based on the specific organs that a physician is interested in. In one embodiment, the addition has a smooth surface and can be moved in and out of collimator assembly 19 easily by an operator. In an exemplary embodiment, bowtie addition 23 is mounted within collimator assembly 19 such that the operator can remove bowtie addition 23 without tools. Additionally, the operator can replace bowtie addition 23 with another bowtie addition without the use of tools. The additions maintain a majority of the x-ray flux coming out of bowtie 21 for the interested organ area while reducing X-ray flux for other areas, therefore reducing the whole body dose. Special bowtie additions may be made for, but certainly not limited to, the CT applications of cardiac, lung, and liver. [0027] As illustrated in FIG. 3, bowtie addition 23 is a specific example of a bowtie addition for cardiac imaging. Bowtie addition 23 has a smooth surface and is able to move in and out of collimator assembly 19 easily. For cardiac imaging, one can use a known head bowtie or a modified head bowtie that provides more attenuation of the X-ray towards the edge of the body than the current head bowtie. This modified head bowtie provides more X-ray flux than the current body bowtie near the center of the imaging field of view where the heart is located, while reducing the dose to the whole body by at least 20%. This modified head bowtie can also be used for the general head and pediatric scans. Combined with this modified head bowtie, a bowtie addition for cardiac imaging is also used such as bowtie addition 23 . Cardiac bowtie addition 23 is designed to account for the fact that the heart is not located exactly at the center of the imaging field of view, and that X-ray flux requirement for the lung area is substantially less. In the exemplary example of a cardiac bowtie addition as shown in FIG. 3 includes a plurality of thick sections 60 interspersed with a plurality of thin sections 62 . A middle thick section 64 is less thick than the other thick sections 60 . Although thick section 64 can be between one-third and two-thirds the thickness of other thick sections 60 , thick section 64 is always about one-half the thickness of the other thick sections 60 . In another example, bowtie addition 23 has more than 5 sections. In yet another example, bowtie addition 23 has 9 sections. In still another embodiment, bowtie addition 23 has 12 sections. In a further embodiment, bowtie addition 23 has at least one but less than 5 sections. In an additional embodiment, bowtie addition 23 has 4 sections. An X-ray modulation 24 is shown in FIG. 4. X-ray modulation 24 corresponds to bowtie addition 23 having 5 sections. [0028] Cardiac bowtie addition 23 has been evaluated using patient scans. Two sets of cardiac scans were obtained at both 320 mA and 200 mA for clinical evaluation. Lower dose scans (210 mA average) with the X-ray modulated according to the cardiac bowtie addition was simulated using a noise addition tool based on the original 320 mA scans. These three sets of scan data were reconstructed using the standard reconstruction algorithm. Image noises were measured at three different locations on three sets of images. FIG. 5 shows the image comparison from the three different sets of data. Also shown on the images are the noise measurements. The comparison indicates that (1) using the current body bowtie for cardiac imaging, the noise increases as the mA decreases. The discrepancies of the edge noise numbers were caused by the current fan beam reconstruction algorithm. After the two numbers were averaged, they still follow the inverse square root of the mA rule. And (2), with the use of bowtie addition 23 , the noise measurements in the heart area of the simulated lower dose scans were about the same as the original scans, even through the average mA (dose) has decreased by 30%. [0029] Exemplary embodiments of methods, systems, and assemblies for facilitating a reduction in patient dose are described above in detail. The methods, systems, and assemblies are not limited to the specific embodiments described herein, but rather, components of each methods, systems, and assemblies may be utilized independently and separately from other components described herein. In addition, each methods, systems, and assemblies component can also be used in combination with other components described herein. [0030] While the invention has been described in terms of various specific embodiments, those skilled in the art will recognize that the invention can be practiced with modification within the spirit and scope of the claims.

A method for obtaining data includes scanning an organ with an imaging system emitting X-rays and modulating the emitted X-rays with an organ specific bowtie addition.

BACKGROUND OF THE INVENTION [0001] Photodynamic therapy (PDT) is an effective local therapy based on a tumor localizing photosensitizer (PS) activated by long wavelength light directed at the treatment site. Current photosensitizers have high tumor selectivity, and light can be delivered almost anywhere in the body by thin, flexible optical fibers. [0002] Tetrapyrollic photosensitizers, e.g. porphyrins including chlorins, bacteriochlorins and other porphyrin based derivatives, including their analogs and derivatives, have recently found superior utility as photodynamic compounds for use in diagnosis and treatment of disease, especially certain cancers and other hyperproliferative diseases such as macular degeneration. These compounds have also found utility in treatment of psoriasis and papillomatosis. [0003] Such derivatives include dimers and trimers of these compounds. Permissible derivatives also include ring variations of these compounds; provided that, the central sixteen sided four nitrogen heterocycle of these compounds remains intact. Chlorophyllins, purpurins, pheophorbides, and their derivatives are, therefore, included within “porphyrins, chlorins, and bacteriochlorins and their derivatives and analogs”. Such derivatives include modifications of substituents upon these ring structures, e.g. pyropheophorbides. [0004] Numerous articles have been written on this subject, e.g. “Use of the Chlorophyll Derivative Purpurin-18, for Synthesis of Sensitizers for Use in Photodynamic Therapy”, Lee et al., J. Chem. Soc., 1993, (19) 2369-77; “Synthesis of New Bacteriochlorins And Their Antitumor Activity”, Pandey et al., Biology and Med. Chem. Letters, 1992; “Photosensitizing Properties of Bacteriochlorophyllin a and Bacteriochlorin a, Two Derivatives of Bacteriochlorophyll a”, Beems et al., Photochemistry and Photobiology, 1987, v. 46, 639-643; “Photoradiation Therapy. II. Cure of Animal Tumors With Hematoporphyrin and Light”, Dougherty et al., Journal of the National Cancer Institute, July 1975, v. 55, 115-119; “Photodynamic therapy of C3H mouse mammary carcinoma with hematoporphyrin di-esters as sensitizers”, Evensen et al., Br. J. Cancer, 1987, 55, 483-486; “Substituent Effects in Tetrapyrrole Subunit Reactivity and Pinacol-Pinacolone Rearrangements: VIC-Dihydroxychlorins and VIC-Dihydroxybacteriochlorins” Pandey et al., Tetrahedron Letters, 1992, v. 33, 7815-7818; “Photodynamic Sensitizers from Chlorophyll: Purpurin-18 and Chlorin p 6 “, Hoober et al., 1988, v.48, 579-582; “Structure/Activity Relationships Among Photosensitizers Related to Pheophorbides and Bacteriopheophorbides”, Pandey et al., Bioorganic and Medicinal Chemistry Letters, 1992, v 2, 491-496; “Photodynamic Therapy Mechanisms”, Pandey et al., Proceedings Society of Photo-Optical Instrumentation Engineers (SPIE), 1989, v 1065, 164-174; and “Fast Atom Bombardment Mass Spectral Analyses of Photofrin II® and its Synthetic Analogs”, Pandey et al., Biomedical and Environmental Mass Spectrometry, 1990, v. 19, 405-414. These articles are incorporated by reference herein as background art. [0005] Numerous patents in this area have been applied for and granted world wide on these photodynamic compounds. Reference may be had, for example to the following U.S. Patents which are incorporated herein by reference: U.S. Pat. Nos. 4,649,151; 4,866,168; 4,889,129; 4,932,934; 4,968,715; 5,002,962; 5,015,463; 5,028,621; 5,145,863; 5,198,460; 5,225,433; 5,314,905; 5,459,159; 5,498,710; and 5,591,847. [0006] One of these compounds “Photofrin®” has received approval for use in the United States, Canada and Japan. Others of these compounds have also received at least restricted approval, e.g. BPD for treatment of macular degeneration and others are in clinical trials or are being considered for such trials. [0007] The term “porphyrins, chlorins and bacteriochlorins” as used herein is intended to include their derivatives and analogs, as described above, and as described and illustrated by the foregoing articles and patents incorporated herein by reference as background art. [0008] Such compounds have been found to have the remarkable characteristic of preferentially accumulating in tumors rather than most normal cells and organs, excepting the liver and spleen. Furthermore, many such tumors can be killed because the compounds may be activated by light to become tumor toxic. [0009] Such compounds are preferentially absorbed into cancer cells, and destroy cancer cells upon being exposed to light at their preferential wavelength absorbance near infrared (NIR) absorption. Further such compounds emit radiation at longer wavelengths than the preferential absorption wavelength, such that light penetrates several centimeters of tissue. It is thus possible to sense and quantitate photosensitizer concentration in subsurface tissues from measurements of diffuse light propagation. [0010] However, for small, bulky, or buried lesions, it may be difficult to detect the malignancies and/or to properly place the optical fibers to illuminate the full extent of the tumor. Therefore the approach of guided therapy utilizing highly selective optical and radionuclide tumor imaging, allowing tumor visualization, image-guided placement of the optical fibers, and subsequent photodynamic destruction of the lesions would be extremely useful in cancer diagnosis and therapy. [0011] Optical imaging is a rapidly evolving field. Optical contrast agents can provide planar and tomographic images with high sensitivity. For small animals, planar images are adequate, but optical tomographic reconstruction of fluorescence images is becoming feasible. [0012] Most of the porphyrin-based photosensitizers (PS) fluoresce, and the fluorescence properties of these porphyrins in vivo has been exploited by several investigators for detection of early-stage cancers in the lung, bladder and various other sites, and to guide the activating light for treatment. However, PS are not optimal fluorophores for tumor detection or treatment guidance: (1) They have weak fluorescence compared to cyanine dyes. They have small Stokes shifts, making it difficult to separate the fluorescence from excitation light. [0013] Fluorescent cyanine dyes with NIR excitation and emission wavelengths can have high quantum yields and excitation coefficients, and appropriate Stokes shifts. They have high extinction coefficients and appropriate Stokes shifts. We have determined that such compounds coupled with photosensitizers can be used as “Bifunctional Agents” (i. e. tumor imaging and phototherapy). See e.g. copending PCT Patent Application PCT/US05/24782. [0014] Positron emission tomography (PET) predominately has been used to image and assay biochemical processes and circular function. However, there has been growing use of radiolabeled peptide ligands to target malignancies. Available isotope labels include 11 C (t 1/2 =20.4 min) 18 F (t 1/2 =110 min), (t 1/2 =12.8 h and 124 I (t 1/2 =4.2 days). For targeting photosensitizers, a long circulation time may be desired, as it can increase delivery of the agent into tumors. We have shown that I-124 labeled photosensitizers can be used for PET imaging and PDT. See e.g. copending U.S. patent application Ser. No. 11/353,626 filed Feb. 14, 2006. [0015] Integrins are heterodimeric transmembrane adhesion receptors that play an important role in cell-surface mediated signaling. There are at least 24 distinct integrin receptors identified, which are assembled from 18 α and 8 β subunits. αvβ3, α5β1, αvβ5, α4β1, α2β1 are known integrins expressed by tumor cells. As an example in accordance with the invention, integrin αvβ3 is used to illustrate the invention with binding to an RGD peptide, a small peptide containing an RGD sequence [arginine(Arg)-glycine(Gly)-aspartic acid(Asp) triamino acid sequence] It is understood that longer sequences, e.g. up to ten or more amino acids, may be used containing the RGD sequence and all such peptides are referred to herein as RGD peptides. As an example of non-peptide antagonists or ligands compounds containing a 4-{2-(3,4,5,6-tetrahydropyrimidin-2-ylamino)ethyloxy}-benzoyl]amino-2-(S)-aminoethylsulfonylamino (THPAB) group are used. We are initially focusing on the specific receptor, Integrin αvβ3, as an example of such Integrins expressed by tumor cells. Integrin αvβ3 is known for its high expression in tumor cells (3) and its binding with RGD peptides. [0016] Sequence analysis of integrin αv subunit from various organisms (human, mouse, bull, chicken, frog, zebrafish) using both T-Coffee and ClustalW multiple sequence alignment programs shows high degree of their conservations, especially among the mammals. Similar results are also observed from the sequence analysis of the integrin β3.subunit from various organisms (human, mouse, rat, chicken, frog, zebrafish). Strict conservation of the implicated ligand binding residues is clearly observed. [0017] As for 3D structures of integrins, several crystal structures are available at PDB. For Integrin β3 subunit, there are crystal structures of Integrin β3—Talin chimera complex (1MK7,1MK9), NMR structure of the Integrin β3 cytoplasmic domain (1S4X), as well as the Integrin αIIbβ3 receptor crystal (1TXV, 1TY3, 1TY5, 1TY6, 1TY7, 1TYE) and NMR (1M8O) structures. For the Integrin αvβ3 system, the structures of the extracellular domain of Integrin αvβ3 (1JV2) as well as its complex with Mn2+ (1M1X) and with the RGD ligand (1L5G) are available. In addition, recently the N-terminal PSI (plexin-semaphorin-integrin) domain of the β subunit structure has been reported in the context of the αvβ3 receptor (1U8C). We performed a pair-wise comparison of overall structure of integrin αvβ3 and αIIbβ3. It clearly shows the conservation of ion binding residues. [0018] Crystal structure of integrin αvβ3 RGD peptide complex was carefully examined. The RGD peptide binds at the interface of αv and β3 subunits where an intricate network of interactions involving 3 Mn cations plays an important role in recognition of RGD Asp residue (See FIGS. 1 and 2 ). [0019] Integrins are a major group of cell membrane receptors with both adhesive and signaling functions. They influence behavior of neoplastic cells by their interaction with the surrounding extracellular matrix, participating in tumor development. An increase in its expression is correlated with increased malignancy. Significant over expression of αvβ3 is reported in colon, lung, pancreas and breast carcinomas, and the expression of integrin was significantly higher in tumors of patients with metastases than in those without metastases. [0020] The following references are incorporated herein as background art. 1. Yihui Chen, Amy Gryshuk, Samuel Achilefu, Tymish Ohulchansky, William Potter, Tuoxiu Zhong, Janet Morgan, Britton Chance, Paras N. Prasad, Barbara W. Henderson, Allan Oseroff and Ravindra K. Pandey, A Novel Approach to a Bifunctional Photosentizer for Tumor Imaging and Phototherapy. Bioconjugate Chemistry, 2005, 16, 1264-1274. 2. Suresh K. Pandey, Amy L. Gryshuk, Munawwar Sajjad, Xiang Zheng, Yihui Chen, [0023] Mohei M. Abouzeid, Janet Morgan, Ivan Charamisinau, Hani A. Nabi, Allan Oseroff and Ravindra K. Pandey, Multiomodality Agents for Tumor Imaging (PET, Fluorescence) and Photodynamic Therapy: A Possible See and Treat Approach. J. Med. Chem. 2005, 48, 6286-6295. 3. Xiaoyuan C. et al. Integrin avb3-Targeted Imaging of Lung Cancer. Neoplasia, 2005, 7, 271-279. Yihui Chen, Amy Gryshuk, Samuel Achilefu, Tymish Ohulchansky, William Potter, Tuoxiu Zhong, Janet Morgan, Britton Chance, Paras N. Prasad, Barbara W. Henderson, Allan Oseroff and Ravindra K. Pandey, A Novel Approach to a Bifunctional Photosentizer for Tumor Imaging and Phototherapy. Bioconjugate Chemistry, 2005, 16, 1264-1274. 4. Suresh K. Pandey, Amy L. Gryshuk, Munawwar Sajjad, Xiang Zheng, Yihui Chen, Mohei M. Abouzeid, Janet Morgan, Ivan Charamisinau, Hani A. Nabi, Allan Oseroff and Ravindra K. Pandey, Multiomodality Agents for Tumor Imaging (PET, Fluorescence) and Photodynamic Therapy: A Possible See and Treat Approach. J. Med. Chem. 2005, 48, 6286-6295. 5. Xiaoyuan C. et al. Integrin avb3-Targeted Imaging of Lung Cancer. Neoplasia, 2005, 7, 271-279. BRIEF DESCRIPTION OF THE DRAWINGS [0027] FIG. 1 shows a crystal structure of integrin RGD peptide complex. A flat arrow indicates for β strand and a cylinder for a helix. White color is used for αv subunit and a porphyrin, chlorin or bacteriochlorin, e.g. pheophorbides and pyropheophorbides gray color for β3 subunit. Integrin RGD peptide, Arg-Gly-Asp-D-Phe-N-methyl Val is located between av and β3 subunits shown in ball and stick figure. The Mn ions located near the RGD peptide are shown as spheres. [0028] FIG. 2 shows how Asp interacts with residues from β3 subunit and Mn ions embedded in β3 subunit. Especially, the middle Mn ion is directly coordinated with Asp side chain (COO—) group. In turn, this Mn ion is coordinated by Ser 121, Ser 123, and Glu 220. These residues in turn are coordinated to two other Mn ions, which form additional coordination with other residues from β3 subunit. Asp side chain of RGD peptide also make a direct interaction with Asn 215. This network of interaction involving 3 Mn ions seems to be a very important stabilizing factor. BRIEF DESCRIPTION OF THE INVENTION [0029] The invention is a compound that is a conjugate of an antagonist to an integrin expressed by a tumor cell and at least one of a fluorescent dye, or a tumor avid tetrapyrollic photosensitizer, that may be complexed with an element X where X is a metal selected from the group consisting of Zn, In, Ga, Al, or Cu or a radioisotope labeled moiety wherein the radioisotope is selected from the group consisting of 11 C, 18 F, 64 Cu, 124 I, 99 Tc, 111 In and GdIII and its method of use for diagnosing, imaging and/or treating hyperproliferative tissue such as tumors and other uncontrolled growth tissues such as found in macular degeneration. [0030] In a preferred embodiment, the compound is a tumor avid tetrapyrollic photosensitizer compound conjugated with an antagonist for an integrin expressed by a tumor cell. Such compounds have extreme tumor avidity and can be used to inhibit or completely destroy the tumor by light absoption. The tetrapyrollic photosensitizer is usually a porphyrin, chlorin or bacteriochlorin including pheophorbides and pyropheophorbides and the integrin is usually an αvβ3, α5β1, αvβ5, α4β1, or α2β1 integrin. [0031] In a preferred embodiment, the antagonist is an RGD peptide or another antagonist that may be synthetic such as a 4-{2-(3,4,5,6-tetra-hydropyrimidin-2-ylamino)ethyloxy}-benzoyl]amino-2-(S)-aminoethyl-sulfonylamino group. The integrin is most commonly αvβ3. [0032] The antagonist may be combined with an imaging compound such as a fluorescent dye or a structure including an element X where X is a metal selected from the group consisting of Zn, In, Ga, Al, or Cu or a radioisotope labeled moiety wherein the radioisotope is selected from the group consisting of 11 C, 18 F, 64 Cu, 124 I, 99 Tc, 111 In. Such compounds provide tumor avidity and imaging ability thus permitting selective and clear tumor imaging. [0033] Objects of this invention include: [0000] 1. Efficient synthetic methodologies for the preparation of αvβ3 target-specific photosensitizers. (a) RGD conjugated photosensitizers (b) Integrin-antagonist conjugated photosensitizers. 2. Multimodality agents (photosensitizer-cyanine dye conjugates) with and without RGD peptide. 3. Target-specific PET/fluorescence imaging agent. DETAILED DESCRIPTION OF THE INVENTION [0036] As previously discussed, the invention is a compound that is a conjugate of an antagonist to an integrin expressed by a tumor cell and at least one of a fluorescent dye, and a tumor avid tetrapyrollic photosensitizer that may be complexed with an element X where X is a metal selected from the group consisting of Zn, In, Ga, Al, or Cu or a radioisotope labeled moiety wherein the radioisotope is selected from the group consisting of 11 C, 18 F, 64 Cu, 124 I, 99 TC, 111 In and GdIII and its method of use for diagnosing, imaging and/or treating hyperproliferative tissue such as tumors and other uncontrolled growth tissues such as found in macular degeneration. [0037] In the case of the presence of a tetrapyrollic photosensitizer, it usually has the structural formula: [0000] [0000] and its complexes with X where: R 1 is —CH═CH 2 , —CH 2 CH 3 , —CHO, —COOH, or [0000] where R 9 ═—OR 10 where R 10 is lower alkyl of 1 through 8 carbon atoms, —(CH 2 —O) n CH 3 , —(CH 2 ) 2 CO 2 CH 3 , —(CH 2 ) 2 CONHphenyleneCH 2 DTPA, —CH 2 CH 2 CONH(CONHphenyleneCH 2 DTPA) 2 , —CH 2 R 11 or [0000] [0000] or a fluorescent dye moiety; R 2 , R 2a , R 3 , R 3a , R 4 , R 5 , R 5a , R 7 , and R 7a are independently hydrogen, lower alkyl or substituted lower alkyl or two R 2 , R 2a , R 3 , R 3a , R 5 , R 5a , R 7 , and R 7a groups on adjacent carbon atoms may be taken together to form a covalent bond or two R 2 , R 2a , R 3 , R 3a , R 5 , R 5a , R 7 , and R 7a groups on the same carbon atom may form a double bond to a divalent pendant group; R 2 and R 3 may together form a 5 or 6 membered heterocyclic ring containing oxygen, nitrogen or sulfur; R 6 is —CH 2 —, —NR 11 — or a covalent bond; R 8 is —(CH 2 ) 2 CO 2 CH 3 , —(CH 2 ) 2 CONHphenyleneCH 2 DTPA, —CH 2 CH 2 CONH(CONHphenyleneCH 2 DTPA) 2 , —CH 2 R 11 or [0000] [0000] where R 11 is —CH 2 CONH—RGD-Phe-Lys, —CH 2 NHCO—RGD-Phe-Lys, a fluorescent dye moiety, or —CH 2 CONHCH 2 CH 2 SO 2 NHCH(CO 2 )CH 2 NHCOPhenylOCH 2 CH 2 NHcycloCNH(CH 2 ) 3 N; and polynuclide complexes thereof; provided that the compound contains at least one integrin antagonist selected from the group consisting of —CH 2 CONH—RGD-Phe-Lys, —CH 2 NHCO—RGD-Phe-Lys and —CH 2 CONHCH 2 CH 2 SO 2 NHCH(CO 2 )CH 2 NHCOPhenylOCH 2 CH 2 NHcycloCNH(CH 2 ) 3 N, where X is a metal selected from the group consisting of Zn, In, Ga, Al, or Cu or a radioisotope labeled moiety wherein the radioisotope is selected from the group consisting of 11 C, 18 F, 64 Cu, 124 I, 99 Tc, 111 In and GdIII. [0043] The complexes with X are readily made simply by heating the compound with a salt of X such as a chloride. The complex will form as a chelate of a -DTPA moiety, when present, or within the tetrapyrollic structure between the nitrogen atoms of the amine structure or both. Examples of such structures are: [0000] [0044] In the instance where a fluorescent dye is conjugated with the integrin antagonist (often a ligand), the fluorescent dye may be any non-toxic dye that causes the conjugate to preferentially emit (fluoresce) at a wave length of 800 to about 900 nm, e.g. indocyanine dyes. Such dyes usually have at least two resonant ring structures, often chromophores, connected together by an intermediate resonant structure of conjugated double bonds, aromatic carbon rings, resonant heterocylic rings, or combinations thereof. [0045] Examples of such dyes include bis indole dyes wherein two indole or modified indole ring structures are connected together at their 3 2 and 2 1 carbon atoms respectively by an intermediate resonant structure as previously described. Such dyes are commonly known as tricarboclyanine dyes. Such dyes almost always have at least one, and usually at least two, hydrophilic substituents making the dye water soluble. Such water solubility facilitates entry of the structure into an organism and its cellular structures and reduces the likelihood of toxicity because of reduced storage in fatty tissues and fast elimination from the system. The intermediate resonant structure usually contains a plurality of double bonded carbon atoms that are usually conjugated double bonds and may also contain unsaturated carboxylic or heterocyclic rings. Such rings permit conjugation to a porphyrin or other structure without significantly interfering with the resonance of the intermediate structure. A preferred dye is indocyanine green. [0046] When a radioisotope is combined with the integrin antagonist, it may be chemically combined by covalent or semi-ionic bonding or may be chelated into the compound. In such instances, the compound often includes known chelating structures such as DTPA. Preparation of 17 2 (17 5 -N-t-Bu-ethylene-diamido) Pyropheophorbide-a 2 [0047] [0048] Pyropheophorbide —a carboxylic acid 1 (200 mg) was obtained from spirolina algae by following the literature procedure. It was dissolved in dry dichloromethane (DCM) (5 ml), to this solution under N 2 were added in sequence triethylamine (0.3 ml), Boc-protected diethylamine (66.6 ul) and BOP (146 mg), after evacuation (2-3 times), reaction mixture was stirred at room temperature for overnight under N 2 . Reaction mixture was concentrated and chromatographed on silica (eluent: 4% Methanol in dichloromethane) and the desired compound 2 was isolated as the major product. Yield 90%. NMR (AMX400): (CDCl 3 , δ ppm): 9.35, 9.15 and 8.50 (each s, 1H, meso H); 7.80 (m, 1H CH═CH 2 ); 6.25, 6.1 (each d, 1H, CH—CH 2 ); 5.22(dd, 2H, —CH 2 exocyclic ring); 4.41(q, 1H,18H); 4.28 (d,1H, 17H); 3.75 (q,2H,CH 2 —CH 3 ); 3.62, 3.4, 3.25 (each s, 3H, ring —CH 3 ), 2.8-2.0 (several m, CH 2 —CH 2 —CO—NH—CH 2 —CH 2 —NH), 1.2 (s, 9H, Boc). Preparation of Pyropheophorbide-Cyclo(Lys-Arg-Gly-Asp-L-Phe) conjugate [0049] [0050] Pyropheophorbide 2 was treated with 90% trifluroacetic acid (TFA) to remove Boc group, TFA was removed on rotaevaporator and 3 was dried under high vaccum for further reaction. 3 (15 mg) was dissolved in dry DCM, to this solution were added under N 2 Cyclo(Lys-Arg-Gly-Asp-L-Phe) (20 mg) and EDCI (12 mg), reaction mixture was stirred at room temperature for overnight under N 2 . Reaction mixture was concentrated and chromatographed on preparative silica plate (eluent: 10% Methanol in dichloromethane). The isolated compound was further treated with 90% TFA/DCM for 3-4 hrs. to get the desired pyropheophorbide . . . 4. TFA was rotaevaporated and the compound was further purified on HPLC using C-18 column (eluent: gradient 90% MeOH in water to 100% MeOH in water, flow rate 0.5 ml/min). Yield 10 mg. Mass: m/z=1161 (M+H) + . Preparation of meso-Purpurinimide 6 [0051] [0052] Meso-purpurinimide (60 mg) and Boc-protected diethylamine (2.24 g) were dissolved in minimum amount of DCM and the reaction mixture was stirred for 48 hrs at room temperature under N 2 . UV-VIS showed the complete shift of absorbance from 685 nm to 651 nm. To this reaction mixture, freshly prepared diazomethane (200-400 mg) was added and the reaction was monitored by TLC (5% MeOH in DCM). After 10-min UV-VIS showed the complete disappearance of peak at 651 nm and the product peak at 695 nm. Reaction mixture was immediately washed with 2% acetic acid in water and then with water (×3), compound was dried on Na 2 SO 4 , concentrated and chromatographed on silica (eluent: 2-3% Methanol in dichloromethane), the isolated compound was further treated with 90% TFA/DCM for 3-4 hrs, TFA was rotaevaporated to get the desired compound 6 as the major product. Yield 90%. NMR (AMX400): 9.54 (s, 1H, 10H); 9.16 (s, 1H, 5H); 8.4 (s, 1H, 20H); 5.34 (m, 1H,17H), 4.67 (m, 2H, N—CH 2 ), 4.34(q, 1H, 18H), 3.78, 3.58, 3.23, 3.15 (each, 3H, 12CH 3 , 17 2 CH 3 , 2CH 3 , 7CH 3 resp.) 3.74 (q,2H, 8′CH 2 ), 3.605 ( CH 2 —CH 3 ), 2.71 (m, 1H, 1×17 2 ), 2.402 (m, 2H, 2×17 1 H), 2.0 (m,1H, 17 2 H), 1.76 (d, 3H, 18CH 3 ), 1.7-1.64 (8H, 8 2 CH 2 — CH 3 , N—CH-hd 2 — CH 3 —NH 2 ), 0.11-0.1 (2H, each s, —NH). Preparation of meso-Purpurinimide-Cyclo((Lys-Arg-Gly-Asp-L-Phe) conjugate 8 [0053] [0054] Meso- Purpurinimide 6 (17 mg) was dissolved in dry DCM, to this solution were added under N 2 Cyclo(Lys-Arg-Gly-Asp-L-Phe) (20 mg) and EDCI (12 mg), reaction mixture was stirred at room temperature for overnight under N 2 . Reaction mixture was concentrated and chromatographed on preparative silica plate (eluent: 10% Methanol in dichloromethane). The isolated compound was further treated with 90% TFA/DCM for 3-4 hrs. to get the desired meso-Purpurinimide-Cyclo((Lys-Arg-Gly-Asp-L-Phe) conjugate 8. TFA was rotaevaporated and the compound was dried under high vacuum. Yield 19 mg. Mass: m/z=1207 (M+H) + Preparation of Pyropheophorbide-Cyclo(Lys-Arg-Gly-Asp-D-Phe) conjugate 8 [0055] [0056] Pyropheophorbide —a carboxylic acid 7 (200 mg) was obtained from spirolina algae by following the literature procedure. 7(14 mg) was dissolved in dry DCM, to this solution were added under N 2 Cyclo(Lys-Arg-Gly-Asp-D-Phe) (20 mg), EDCI (12 mg) and DMAP (12 mg), reaction mixture was stirred at room temperature for overnight under N 2 . Reaction mixture was concentrated and chromatographed on preparative silica plate (eluent: 10% Methanol in dichloromethane). The isolated compound was further treated with 90% TFA/DCM for 3-4 hrs. and the solid product was washed with MeOH to get the desired pyropheophorbide-Cyclo(Lys-Arg-Gly-Asp-D-Phe) conjugate 8, TFA was rotaevaporated and the compound was dried under vacuum. Yield 10 mg. Mass: m/z=1119.6 (M+H) + Preparation of meso-Purpurinimide-glycine ester 10 [0057] [0058] 58 mg of purpurin-18 was dissolved in minimum amount of toluene, to this solution HCl salt of glycine-t-Bu ester and 10-15 drops of triethylamine were added, reaction was refluxed under N 2 , after 3 hrs UV-VIS showed the complete disappearance of peak at 696 nm of starting material and new peak at 705 nm, Reaction mixture was concentrated and chromatographed on silica (eluent: 2% Methanol in dichloromethane). and the desired meso- Purpurinimide-glycine ester 10 was isolated as the major product. Yield 90%. NMR (AMX400): 9.64 (s, 1H, 10H), 9.39 (s, 1H, 15H), 8.58 (s,1H, 20H), 7.84 (d, 1H, 3CH—CH 2 ), 6.16 (d,1H, 3CH═CH 2 ), 5.4(m,1H,17H), 4.46 (m, 2H, N—CH 2 — CH 2 —CO 2 H), 4.31 (q, 1H, 18H), 3.84 (s, 3H, 7CH 3 ); 2.68 and 2.39 (each m, 1H+2H, 2×17 1 H); 1.99 (m, 1H, 1×17 2 H); 1.74 (d, 3H, 18CH 3 ), 1.64 (t, 3H, 8 2 CH 3 ); 0.07 and −0.16 (each br, 1H, 2NH). Preparation of meso-Purpurinimide-glycine-Cyclo(Lys-Arg-Gly-Asp-D-Phe) conjugate 12 [0059] [0060] MMeso-Purpurinimide-glycine ester 10 (17 mg) was dissolved in dry DCM, to this solution were added under N 2 Cyclo(Lys-Arg-Gly-Asp-D-Phe) (20 mg), EDCI (12 mg) and DMAP (12 mg), reaction mixture was stirred at room temperature for overnight under N 2 . Reaction mixture was concentrated and the solid powder was washed with MeOH. The isolated compound was further treated with 90% TFA/DCM for 3-4 hrs. to get the desired meso- Purpurinimide-glycine-Cyclo(Lys-Arg-Gly-Asp-D-Phe) conjugate 12, TFA was rotaevaporated, washed with MeOH and dried under vaccum. Yield 20 mg. Mass: m/z=1220 (M+H) + . Preparation of Mono-I-Cypate [0061] [0062] Cypate 13 (260 mg, 0.4 mM) was dissolved in dry DMF (10-15 ml), to this solution were added under N 2 m-I-benzylamine (92 mg, 0.4 mM), EDCI (92 mg, 0.48 mM) and HoBt(64.75 mg, 0.48 mM), reaction mixture was stirred at room temperature for overnight under N 2 . After overnight reaction, DMF was removed under high vaccum, reaction mixture was washed with brine (×3) and water (×3), dried over Na 2 SO 4 and concentrated. Purification was done on Si column using MeOH/DCM as an eluant. Yield 57 mg (17%). Mass: m/z=839 (M+H) + . NMR (AMX400): 7.25-8.03 (m, 16H, aromatic), 6.28-6.80 (m, 4H, —CH), 2.47-3.0 (m, 10H, CH 2 ), 1.88 (s, 12H, CH 3 ). Preparation of Mono-I-Cypate-Cyclo(Lys-Arg-Gly-Asp-D-Phe) conjugate 16 [0063] [0064] Mono-I-Cypate(30 mg) was dissolved in dry DCM, to this solution were added under N 2 Cyclo(Lys-Arg-Gly-Asp-D-Phe) (20 mg), EDCI (12 mg) and DMAP (12 mg), reaction mixture was stirred at room temperature for overnight under N 2 . After overnight stirring, reaction mixture was concentrated and chromatographed on preparative silica plate (eluent: 13% Methanol in Dichloromethane). The isolated compound was further treated with 90% TFA/DCM for 3-4 hrs. and the oily product was further analyzed and purified on an HPLC (Waters, Delta 600 with 996 photodiode array detector) Ana. Column: Waters Symm-C-81, 4.6×150 mm, 5μ: Semiprep Column: Waters Symm- C-18, 7.8×150 mm, 7μ: using Acetinitrile/Water as an eluant (gradient: 30% to 100% ACN) to get the desired mono-I-Cypate-Cyclo(Lys-Arg-Gly-Asp-D-Phe) conjugate 16 , Yield 24 mg. Mass: m/z=1424 (M+H) + . Pyro-IA (methyl ester)(19) [0065] To a solution of Methyl 3-[4-{2-(3,4,5,6-tetrahydropyrimidin-2-ylamino)ethyloxy}-benzoyl]amino-2-(S)-aminoethylsulfonylaminopropionate (17) (47 mg, 0.1 mmol) and pyrocarboxylic acid (18) (60 mg, 0.11 mmol) in anhydrous DMF (5.0 mL) under nitrogen atmosphere, PyBOP (65 mg, 0.12 mmol) and anhydrous triethylamine (0.3 mL) was added and resultant reaction mixture was stirred for overnight at room temperature. Reaction mixture was then rotary evaporated down to dryness and desired product (19) was obtained after purifying crude reaction mixture first over prep silica TLC plate (eluant: 10% MeOH in CH2Cl2) followed by short silica column (eluant: 8% MeOH in CH2Cl2). Yield=50 mg (50%) [0066] 1 H-NMR(10% CD 3 OD in CDCl 3 ; 400 MHz): δ 9.39, 9.28 and 8.56(all s, 1H, meso-H); 7.95(dd, J=11.4, 18.2, 1H, 3-vinyl); 7.73(d, J=8.8, 2H, ArH); 6.84(d, J=8.8, 2H, ArH); 6.28(d, J=17.6, 1H, 3-vinyl); 6.18(d, J=11.6, 1H, 3-vinyl); 5.26(d, J=20, 1H, 13 2 -CH 2 ); 5.06(d, J=20, 1H, 13 2 -CH 2 ); 4.51(m, 1H, 18-H); 4.30-4.20(m, 2H, CH &amp; 17-H); 4.00(t, J=5.0, 2H, OCH 2 ); 3.85(m, 1H, CONHC H 2 ); 3.67 (s, 3H, ring CH 3 ); 3.62(m, 2H, 8-C H 2 CH 3 ); 3.60(m, 1H, CONHC H 2 ); 3.58(s, 3H, OCH 3 ); 3.42(t, J=5.0, 2H, SO 2 C H 2 ); 3.38(s, 3H, ring CH 3 ); 3.37-3.31(m, 6H, 3×NHC H 2 ); 3.19(s, 3H, ring CH 3 ); 3.14(m, 2H, 3×NCH 2 ); 2.66, 2.45, 2.28, 2.20 (all m, 4H, 17 1 and 17 2 -H); 1.93(t, J=5.6, 2H, CH 2 ); 1.80(d, J=7.2, 3H, 18-CH 3 ); 1.68(t, J=7.8, 3H, 8CH 2 C H 3 ). Mass for C 52 H 62 N 10 O 8 S: 986.45 (Calculated); 986.6 (Found, M + ). Pyro-Integrin Antagonist-IA (20) [0067] To a solution of Pyro-IA (methyl ester) (19)(40 mg) in dry THF (10 mL) under argon atmosphere, a solution of LiOH (80 mg, in 5+4 mL: H2O+MeOH respectively) was added and reaction mixture was stirred for 45 min. Reaction was then carefully neutralized with cation exchange resin. Resin was filtered out and reaction mixture was rotary evaporated down to dryness. No further attempt was made to purify the product. [0068] Yield=35 mg (90%). 1 H-NMR(25% CD 3 OD in CDCl 3 ; 400 MHz): δ 9.39, 9.28 and 8.56(all s, 1H, meso-H); 7.95(dd, J=11.4, 18.2, 1H, 3-vinyl); 7.73(d, J=8.8, 2H, ArH); 6.84(d, J=8.8, 2H, ArH); 6.28(d, J=17.6, 1H, 3-vinyl); 6.18(d, J=11.6, 1H, 3-vinyl); 5.26(d, J=20, 1H, 13 2 -CH 2 ); 5.06(d, J=20, 1H, 13 2 -CH 2 ); 4.51(m, 1H, 18-H); 4.30-4.20(m, 2H, CH &amp; 17-H); 4.00(t, J=5.0, 2H, OCH 2 ); 3.85(m, 1H, CONHC H 2 ); 3.67 (s, 3H, ring CH 3 ); 3.62(m, 2H, 8-C H 2 CH 3 ); 3.60(m, 1H, CONHC H 2 ); 3.42(t, J=5.0, 2H, SO 2 C H 2 ); 3.38(s, 3H, ring CH 3 ); 3.37-3.31(m, 6H, 3×NHC H 2 ); 3.19(s, 3H, ring CH 3 ); 3.14(m, 2H, 3×NCH 2 ); 2.66, 2.45, 2.28, 2.20 (all m, 4H, 17 1 and 17 2 -H); 1.93(t, J=5.6, 2H, CH 2 ); 1.80(d, J=7.2, 3H, 18-CH 3 ); 1.68(t, J=7.8, 3H, 8-CH 2 C H 3 ). Mass for C 52 H 62 N 10 O 8 S: 972.4 (Calculated); 972.6 (Found, M + ). Purpurinimide-Gly-IA (methyl ester)(22) [0069] To a solution of Methyl 3-[4-{2-(3,4,5,6-tetrahydropyrimidin-2-ylamino)ethyloxy}-benzoyl]amino-2-(S)-aminoethylsulfonylaminopropionate (17) (20 mg, 0.04 mmol) and glycine purpurinimide (21) (20 mg, 0.03 mmol) in anhydrous DMF (3.0 mL) under nitrogen atmosphere, PyBOP (20 mg, 0.04 mmol) and anhydrous triethylamine (0.1 mL) was added and resultant reaction mixture was stirred for overnight at room temperature. Reaction mixture was then rotary evaporated down to dryness and desired product (22) was obtained after purifying crude reaction mixture first over prep silica TLC plate (eluant: 10% MeOH in CH2Cl2) followed by short silica column (eluant: 8% MeOH in CH2Cl2). Yield=15 mg (45%) [0070] 1 H-NMR(10% CD 3 OD in CDCl 3 ; 400 MHz): δ 9.07, 8.94 and 8.58(all s, 1H, meso-H); 7.82(dd, J=11.4, 18.2, 1H, 3-vinyl); 7.70(d, J=8.8, 2H, ArH); 6.75(d, J=8.8, 2H, ArH); 6.26(d, J=17.6, 1H, 3-vinyl); 6.16(d, J=11.6, 1H, 3-vinyl); 5.25(d, J=7.2, 1H, 17-H); 5.10(dd, J=8.6, 16.0, 2H, NCH 2 ); 4.42(dd, J=4.4, 7.6, 1H, CH); 4.35(q, J=6.8, 1H, 18-H); 3.89(m, 2H, OCH 2 ); 3.85(m, 1H, CONHC H 2 ); 3.80 (m, 2H, NHC H 2 ); 3.72, 3.52, 3.36, 3.33 and 2.85(all s, all 3H, for 3×ring CH 3 &amp; 2×OCH 3 ); 3.67(m, 1H, CONHC H 2 ); 3.35(m, 4H, 2×NHC H 2 ); 3.26 (m, 4H, 8-C H 2 CH 3 and SO 2 C H 2 ); 3.15(m, 2H, NCH 2 ); 3.62(m, 2H, 8-C H 2 CH 3 ); 2.68, 2.38, 1.98 (all m, 4H, 17 1 and 17 2 -H); 1.83(t, J=5.6, 2H, CH 2 ); 1.80(d, J=7.2, 3H, 18-CH 3 ); 1.41(t, J=7.8, 3H, 8-CH 2 C H 3 ). Mass for C 55 H 65 N 11 O 11 S: 1087.46 (Calculated); 1087.8 (Found, M + ). Purpurinimide-Gly-IA (23) [0071] [0072] To a solution of Purpurinimide-Gly-IA (methyl ester)(22) (15 mg) in dry THF (7 mL) under argon atmosphere, a solution of LiOH (30 mg, in 4+3 mL: H 2 O+MeOH respectively) was added and reaction mixture was stirred for 45 min. Reaction was then carefully neutralized with cation exchange resin. Resin was filtered out and reaction mixture was rotary evaporated down to dryness. No further attempt was made to purify the product. Yield=12 mg (85%) [0073] 1 H-NMR(25% CD 3 OD in CDCl 3 ; 400 MHz): δ 9.07, 8.94 and 8.58(all s, 1H, meso-H); 7.82(dd, J=11.4, 18.2, 1H, 3-vinyl); 7.70(d, J=8.8, 2H, ArH); 6.75(d, J=8.8, 2H, ArH); 6.26(d, J=17.6, 1H, 3-vinyl); 6.16(d, J=11.6, 1H, 3-vinyl); 5.25(d, J=7.2, 1H, 17-H); 5.10(dd, J=8.6, 16.0, 2H, NCH 2 ); 4.42(dd, J=4.4, 7.6, 1H, CH); 4.35(q, J=6.8, 1H, 18-H); 3.89(m, 2H, OCH 2 ); 3.85(m, 1H, CONHC H 2 ); 3.80 (m, 2H, NHC H 2 ); 3.36, 3.33 and 2.85(all s, all 3H, for 3×ring CH 3 ); 3.67(m, 1H, CONHC H 2 ); 3.35(m, 4H, 2×NHC H 2 ); 3.26 (m, 4H, 8-C H CH 3 and SO 2 C H 2 ); 3.15(m, 2H, NCH 2 ); 3.62(m, 2H, 8-C H 2 CH 3 ); 2.68, 2.38, 1.98 (all m, 4H, 17 1 and 17 2 -H); 1.83(t, J=5.6, 2H, CH 2 ); 1.80(d, J=7.2, 3H, 18-CH 3 ); 1.41(t, J=7.8, 3H, 8-CH 2 C H 3 ). Mass for C 55 H 65 H 11 O 11 S: 1059.43 (Calculated); 1059.8 (Found, M + ).

A compound that is a conjugate of an antagonist to an integrin expressed by a tumor cell and at least one of a tumor avid tetrapyrollic photosensitizer, a fluorescent dye, and a radioisotope labeled moiety wherein the radioisotope is 11 C, 18 F, 64 Cu, 124 I, 99 Tc, 111 In or GdIII and its method of use for diagnosing, imaging and/or treating hyperproliferative tissue such as tumors. Preferably the photosensitizer is a tumor avid tetrapyrollic photosensitizer, e.g. A porphyrin, chlorin or bacteriochlorin, e.g. Pheophorbides and pyropheophorbides. Such conjugates have extreme tumor avidity and can be used to inhibit or completely destroy the tumor by light absoption. The integrin is usually avb3, a5b1, avb5, a4b1, or a2b1. Preferably, the antagonist is an RGD peptide or another antagonist that may be synthetic such as a 4-{2-(3,4,5,6-tetra-hydropyrimidin-2-ylamino)ethyloxy}-benzoyl]amino-2-(S)-amino-ethyl-sulfonylamino group. Such compounds provide tumor avidity and imaging ability thus permitting selective and clear tumor imaging.

CROSS REFERENCE TO RELATED APPLICATION Reference is made to U.S. Pat. application Ser. No. 08/055/989, now pending, entitled Barbed Tissue Connector, filed in the name of Gregory L. Ruff, on even date herewith. BACKGROUND OF INVENTION 1. Field of the Invention This invention relates to an inserting device for a barbed tissue connector, and more particularly, to such a device which can be used to quickly and effectively insert a number of connectors across a body wound. 2. Description of the Prior Art Human wounds are typically repaired with a filament introduced into the tissue by a needle attached to one end. After piercing the opposing faces of the wound, the needle is removed, and the ends of the suture are tied together with at least three overhand knots. Such a technique requires considerable time and expertise on the part of the surgeon. There are also a number of other drawbacks to repairing a wound in this manner. For example, it is very difficult to use sutures to repair wounds where there is insufficient space to properly manipulate the suture, especially those wounds repaired using fiber optic visualization. The suture forms a loop as it is tied, and this loop constricts blood flow to the tissue in its confines, promoting necrosis of the wound margins. Further, if the needle&#39;s passage was noncircular, the tissue will be distorted as it is secured by the suture. Alternatives to conventional sutures are known in the prior art. Staples, as shown, for example, in U.S. Pat. No. 4,994,073, to Green, are often used for approximating the superficial layer of the wound. Staples, however, are generally unsuitable for deeper layers of tissue. The patent to Alcamo, U.S. Pat. No. 3,123,077, discloses a roughened suture which can be passed through tissue in one direction, but resists movement in the opposite direction. The Alcamo suture, however, still must be sewn, as by a conventional technique, and the trailing end must be secured with knots. Thus, although there is less slippage of the suture in the wound, most of the disadvantages of sutures noted above are also found in the Alcamo suture. The patent to Tanner, U.S. Pat. No. 3,716,058, discloses a relatively rigid suture with one or more barbs on opposite ends of an arcuate body. The suture is inserted by means of a notched and slotted needle. One disadvantage of the Tanner suture is that the rigid barbs, which protrude from the needle as the suture is inserted, will lacerate tissue and prevent retrograde repositioning. Further, since the barbs are only located at the ends of the suture, the forces applied to the tissue by the barbs will be limited to a relatively small area; this substantially increases the pressure on the blood vessels ensnared by a barb and severely restricts blood flow to the area. It will be seen from the foregoing that there is a need for a tissue connector which can be placed more expeditiously than sutures, is self-retaining, obviates distortion of the tissue, can close tissue inaccessible to conventional procedures and which preserves blood flow by broadly distributing the retention force. SUMMARY OF THE INVENTION It is an object of the present invention to overcome the problems of known inserting devices for sutures and to provide an improved inserting device for use with a barbed tissue connector. In accordance with the present invention there is provided an inserting device for use with a barbed tissue connector, the connector comprising an elongated body and a plurality of axially spaced barbs projecting from the elongated body, the barbs being configured such that they are yieldable in the direction of the elongated body and are generally rigid in the opposite direction, the device comprising: a tubular body having an interior of a size sufficient to receive a barbed tissue connector, the tubular body having a leading end having an opening therein and a trailing end having an opening therein, and the opening in the leading end being sufficiently large to permit the connector to be extracted therefrom. In one embodiment of the present invention, the inserting device comprises a tubular body which is adapted to receive a barbed tissue connector therein with a pointed end of the connector protruding from an open leading end of the tubular body. The inserting device and the connector contained therein are positioned in tissue such that at least one of the barbs on the connector is engaging tissue, and the device is then retracted from the tissue, leaving the connector in place. The use of the inserting device of the present invention along with a barbed tissue connector permits a surgeon to rapidly and securely attach the edges of a wound in human tissue without the necessity of threading and tying numerous individual stitches or the use of a complicated or elaborate tool. The connector is bioabsorbable so that it does not require a painful and difficult removal by the surgeon after a wound is healed. The inserting device is configured to minimize distortion to tissue when inserted, is capable of insertion into the faces of a wound, can be used to connect tissue at the bottom of a deep wound, and can be used to connect tissue which is inaccessible to a staple. Finally, the inserting device can be used to quickly and accurately insert a connector when the surgeon only has access to tissue from a small opening or from only one direction, as, for example, during an endoscopic procedure. Other features and advantages will become apparent upon reference to the following description of the preferred embodiment when read in light of the attached drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side view of one embodiment of a barbed tissue connector for use with the present invention, with a section of the connector broken away to show an end of the connector; FIG. 2 is an end view of the connector shown in FIG. 1; FIG. 3 is a side view of another embodiment of a connector for use with the present invention, with sections of the connector broken away to show the ends of the connector; FIG. 4 is a side view of another embodiment of a connector for use with the present invention; FIG. 5 is a side view of another embodiment of a connector for use with the present invention; FIG. 6 is a side view of another embodiment of a connector for use with the present invention; FIG. 7 is a sectional view taken along the line 7--7 in FIG. 6; FIG. 8 is a side view of another embodiment of a connector for use with the present invention; FIG. 9 is a sectional view taken along the line 9--9 in FIG. 8; FIG. 10 is a perspective view of the inserting device of the present invention; and FIG. 11 is a view showing the inserting device and connector in a wound. DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention allows a surgeon to rapidly and securely attach the edges of a wound in human tissue without the necessity for threading and tying numerous individual stitches or for using a complicated or elaborate tool. As used herein, the term &#34;wound&#34; means an incision, laceration, cut, or other condition where suturing, stapling, or the use of another tissue connecting device might be required. With reference to FIGS. 1 and 2, there is shown a barbed tissue connector 2 for use with the present invention. Connector 2 includes a body 4 which is generally circular in cross section and a plurality of closely-spaced barbs 6 which extend around the periphery of the body 4. A pointed end 9 is formed on the body 4 to facilitate penetration of the connector 2 into tissue. The body 4 preferably has sufficient dimensional stability to assume a substantially rigid configuration during use and is sufficiently resilient to return to a predetermined shape after deflection therefrom. In some applications, it may be desirable for the body 4 to be flexible and substantially nonresilient so that the shape of an inserted connector will be determined by surrounding tissue. Barbs 6 serve to hold the connector in tissue and resist retraction of the connector from the tissue. The barbs 6 can be arranged in any suitable pattern, for example, in a helical pattern as shown in FIG. 1. In a helical pattern of barbs 6, it is preferable that the number of barbs occupying one revolution not be an integer, thereby avoiding parallel axial rows of barbs; such an arrangement provides a more uniform distribution of forces on the tissue and lessens the tendency of an inserted connector 2 to cut through tissue. If the number of barbs in one revolution is not an integer, the barbs in successive revolutions will be offset, as shown in FIG. 2, and the amount of offset will determine which barbs are in axial alignment. For example, if the barbs in successive revolutions are offset by 1/2 barb, the barbs in every second revolution will be in axial alignment, and by extension, if the barbs in each successive revolution are offset by 1/x barb, the barbs in every x revolution will be in axial alignment. As shown in FIG. 1, each barb 6 includes a first side 8 which forms an obtuse angle alpha with the body 4 and a second side 10 which forms an acute angle beta with the body 4. Each barb 6 tapers to a point 7, and the amount of difference between the angle alpha of side 8 and angle beta of side 10 will control the amount of taper in the barb 6. A barb 6 which tapers from a broad base to a narrow tip can be effective in resisting retraction, yet will yield toward the body 4 during insertion to reduce the effort and tissue damage associated with insertion of the connector 2. The barbs 6 can be generally conical, as shown in FIG. 1, or the barbs 6 can be any other shape which will function in substantially the same manner as the conical barbs 6. The configuration of barbs 6 and the surface area of the barbs can vary depending upon the tissue in which the connector 2 is used. The proportions of the barbs 6 can remain relatively constant while the overall length of the barbs and the spacing of the barbs are determined by the tissue being connected. For example, if the connector 2 is intended to be used to connect the edges of a wound in skin or tendon, each barb 6 can be made relatively short to facilitate entry into this rather firm tissue. If the connector 2 is intended for use in fatty tissue, which is relatively soft, the barbs can be made longer and spaced farther apart to increase the holding ability in the soft tissue. As shown in FIG. 1, the barbs 6 on connector 2 have a uniform unidirectional configuration, that is, the barbs 6 are uniformly spaced on body 4 and all the sides 8 are oriented in the same direction, facing pointed end 9. Connector 2 can be inserted into tissue with the sides 8 of each barb 6 facing in the direction of motion. Connector 2 will prevent movement of tissue in the direction in which it was inserted. A pair of connectors 2 inserted adjacent to each other and in opposite directions will prevent movement of tissue in either direction across a wound. Connector 2 can be formed of a material sufficiently hard for point 9 to pierce tissue and enable the connector to be inserted in tissue when a substantially axial force is applied to body 4. Connector 2 is preferably composed of a bioabsorbable compound, such as a polyglycolic acid or polylactic acid polymer or copolymer. The use of a bioabsorbable material eliminates the necessity of removing the connector from the patient, which can be a painful and possibly dangerous process. Connector 2 can be formed, for example, by injection molding. In one representative example of connector 2 for use in muscular tissue, the body 4 is formed from polyglycolic acid, has a length of 1 to 5 cm, and a diameter of about 1 mm. The diameter of a circle extending around points 7 of barbs 6 will be about 3 mm, and the barbs are spaced apart from each other on body 4 by a distance of 1 mm. Side 8 forms an angle of 135 degrees with the body 4 and side 10 forms an angle of 75 degrees with the body 4. In FIG. 3, there is shown a second embodiment of the present invention in which barbs 16 are arranged in a uniform bidirectional configuration on a barbed tissue connector 12. Barbs 16 are constructed in the same manner as barbs 6 on connector 2. A first set of barbs 15 on connector 12 are arranged in a helical pattern and face a pointed end 20, and a second set of barbs 16 on connector 12 are arranged in a helical pattern and face a pointed end 21. Each of the pointed ends 20, 21 should be sufficiently hard and sharp to easily penetrate tissue in which the connector is to be used. Connector 12 is particularly suitable for applications where the edges of a wound are prone to separate. Connector 12 can be used by inserting one of the ends, for example end 20, into a first side of a wound (not shown), spreading the wound slightly to expose the second side of the wound, inserting the end 21 of the connector 12 into the second side of the wound, and then pressing the edges of the wound together. The barbs 15 and 16 on the ends of the connector 12 will grasp the tissue on each side of the wound and prevent the edges of the wound from spreading. With reference to FIG. 4, there is shown another embodiment of the present invention in which a barbed tissue connector 22 has a nonuniform bidirectional configuration. Connector 22 comprises a pointed end 23 and one or more barbs 26 facing a first direction which alternate with one or more barbs 27 facing a second direction. At each axial location, there can be a number, e.g. 4-9, of circumferentially-spaced barbs 26 or 27. To insert connector 22 into tissue, the surgeon would use an inserting device 80 as described below. The barbs 26 and 27 on connector 22 are arranged to prevent any localized movement of tissue relative to the connector in an axial direction. With reference to FIG. 5, there is shown another embodiment of the present invention in which a barbed tissue connector 32 has a uniform bidirectional configuration. Connector 32 comprises a body 34 having pointed ends 33 and 35. A plurality of axially-spaced barbs 36 adjacent pointed end 33 face toward end 35, and a plurality of axially-spaced barbs 37 adjacent pointed end 35 face toward end 33. Barbs 36 and 37 can be circumferentially-spaced around body 34 at each axial location, or the barbs 36 and 37 can be of the same construction and arranged in the same pattern as barbs 6 on connector 2. To insert a connector 32, the surgeon would use an inserting device 80 as described below. If the body 34 of the connector 32 is sufficiently rigid, the connector 32 would prevent tissue retained by the barbs 36 from moving toward end 35 and tissue retained by barbs 37 from moving toward end 33. It will be apparent that only one end of connector 32 needs to be pointed; two pointed ends are preferable, however, so that the surgeon does not have to take the time to insure that connector 32 is oriented in the inserting device 80 with a pointed end protruding from the inserting device. With reference to FIGS. 6 and 7, there is shown another embodiment of the present invention in which a barbed tissue connector 42 comprises a body 44 having a pointed end 45 for penetration into tissue. A head 47 is formed on an opposite end of body 44. A plurality of circumferentially-spaced barbs 46 are formed on body 44 at each of a number of axial locations. As shown in FIG. 7, three barbs 46 are formed at each axial location; however, more or less than three barbs 46 could be used for certain applications. Barbs 46 include a first side 48 formed at an obtuse angle to the body 44 and a second side 49 which projects from body 44 at an acute angle. The connector 42 can be forced into tissue by applying a force to the head 47. The connector 42 can be applied by hand, or it can be inserted using an inserting device 80 as described below. The connector 42 can be formed entirely of a bioabsorbable material, or the head 47 and the body 44 can be composed of different materials. For example, the body 44 can be composed of a bioabsorbable material, and the head 47 can be composed of metal for superior strength and to facilitate insertion of the connector 42. Head 47 can be made flat, as shown in FIG. 6, or the head can be formed by a single ring of barbs (not shown) facing in a direction opposite to that of the barbs 46. In use, a series of connectors 42 can be inserted into tissue, such as along the edges and in the field of a skin graft. After an adequate amount of time has passed for the wound to heal, the tissue beneath each head 47 could be depressed slightly to permit the head 47 to be cut from the body 44. The tissue would then rise up over the cut end of the body. Such a process would reduce scarring which could result from a long-term projection of the body 44 through tissue and would eliminate the necessity to remove connectors 42 from the patient. With reference to FIGS. 8 and 9, there is shown another embodiment of the present invention in which a barbed tissue connector 52 has a uniform unidirectional configuration. Connector 52 comprises a body 54 having a non-circular cross-sectional shape. Body 54 includes a plurality of barbs 56 which are generally triangular in cross section and are equally spaced around the periphery of the body at a series of axial locations. Each of the barbs 56 includes a first side 58 disposed at an obtuse angle to body 54 and a second side 60 disposed at an acute angle to the body. Body 54 includes a pointed end 53 to facilitate entry in tissue. Use of a non-circular cross-sectional shape increases the surface area of the connector 52 and facilitates the formation of the multiple barbs on the connector. For example, barbs 56 can be formed on a piece of stock having a triangular cross section by removing material at successive axial locations from the three edges of the stock. It will be apparent that a similar process could be used to form barbs on stock of a different cross section (not shown), for example, a rectangular or hexagonal cross section. In the use of the disclosed connectors, such as connectors 2 and 42, the surgeon can grip the connector in one hand and push the connector into the tissue. As an alternative to directly inserting the connectors into the tissue, the surgeon can use an inserting device 80 as shown in FIGS. 10 and 11. The inserting device 80 comprises a circular tubular body 82. The tubular body 82 can be generally arcuate in an axial direction, and the body 82 is sufficiently long to contain at least a portion of a barbed tissue connector C. Device 80 has an inwardly tapered leading end 84 and an outwardly tapered, or flared, trailing end 86. A handle 83 is provided on body 82 adjacent trailing end 86 to enable the surgeon to manipulate the inserting device 80. In order to facilitate entry of the connector C and the device 80 into tissue, a connector C is positioned in tubular body 82 with a pointed end P of the connector C extending from leading end 84. In a preferred embodiment, the interior diameter of the body 82 is made slightly smaller than the outside diameter of the connector C so that the barbs B of a connector C in the body 82 will press against the body 82; as a result, the connector C will be retained in the body 82 during insertion in tissue with the point P properly positioned outside of the body 82. The connector can also be positioned in body 82 with a barb B outside of body 82 to insure that the connector C will not be pushed back in the body 82 during insertion. In one application of device 80, the surgeon inserts the body 82 having connector C therein into the patient&#39;s tissue 87 until the connector C reaches a desired position, for example, the position shown in FIG. 11. Device 80 is then withdrawn in the direction of arrow 90, and a barb, or barbs, B on the connector C penetrates and catches the tissue 87 to hold the connector C in the inserted position. Use of the inserting device 80 is particularly recommended when the connector C includes multiple barbs facing more than one direction, such as connectors 22 and 32, or when the connector is too flexible for insertion without additional support. While the present invention has been described with respect to certain preferred embodiments thereof, it is to be understood that numerous variations in the details of construction, the arrangement and combination of parts, and the type of materials used may be made without departing from the spirit and scope of the invention.

An inserting device is disclosed for positioning a barbed tissue connector in tissue to close a wound. The barbed tissue connector is of a type which includes a generally rigid elongated body having a pointed leading end and a plurality of axially spaced barbs on the elongated body. The inserting device comprises a tubular body which is adapted to receive the connector therein with the pointed leading end of the connector protruding from an open leading end of the tubular body. The inserting device and the connector contained therein are positioned in tissue such that at least one of the barbs on the connector is engaging tissue, and the device is then retracted from the tissue, leaving the connector in place.

BACKGROUND OF INVENTION [0001] 1. Field of Invention [0002] The invention relates to a bone chisel, and a method for working a tibia head. [0003] 2. Brief Description of Related Art [0004] The tibia head is the upper thickened end of the human shin bone. It forms the lower part of the knee joint, the upper part of which joint is comprised of the lower end of the femur, which lower end bears two condyles which rest on the tibia head (and on the menisci disposed between the tibia head and the lower end of the femur). [0005] When the knee joint suffers severe injury, a knee endoprosthesis is employed which in its customary form has a tibia plate on its side facing the tibia, which tibia plate is fixed to the tibia head, for which purpose part of the tibia head is excised, e.g. by means of a bone saw, leaving a smooth flat surface. [0006] When this relatively simple surgery is performed, care must be taken to avoid tearing the cruciate ligaments which extend from the middle of the upper side of the tibia head. This would result in their undesirable removal. In the absence of the cruciate ligaments, the patient would subsequently experience disadvantageous weakness of the knee, and disadvantageous sensory deficiencies due to absence of important proprioceptors in the cruciate ligaments. [0007] A knee endoprosthesis which preserves the cruciate ligaments is described in US 2011/0190898 A1. To prepare for application of the tibia plate, the region around the tibia head surface bearing the cruciate ligament connections is excised, leaving this region in the form of a projection (protrusion) on the upper side of the tibia head, the remainder of which tibia head is now removed. A tibia plate is employed which has a U-shaped recess to accommodate the described projection. [0008] The working of the upper part of the tibia head to produce this projection is attended by appreciable risks. Parts of the tibia head immediately adjoining the projection which one desires to leave undisturbed are removed, e.g. by operations of milling, chiseling, sawing, or the like. A small error may suffice to injure the projection which bears the cruciate ligaments, and to injure the cruciate ligaments themselves. [0009] The underlying problem of the present invention was to provide the surgeon with means of reducing these risks. [0010] This problem is solved with the bone chisel and method for working a tibia head as disclosed herein. BRIEF SUMMARY OF THE INVENTION [0011] According to the invention, a bone chisel is provided which is used in the excision to prepare the projection. The chisel has a thin U-shaped blade member which is applied so as to generally surround the projection, whereby it (its cutting edge) can be driven into the tibia head, in the longitudinal direction of the tibia. This results in stamping-out of a projection which exactly matches the tibia plate which will later be applied. It further facilitates excision of the material around the projection, with minimal risk, and in particular without injury to the projection or to the cruciate ligaments, which are protected by the blade member. Because the U-shaped blade member is open on one side, it may be applied with this opening directed posteriorly. Thus it can be applied between the tibia head and the femur, in a manner such that it generally surrounds the cruciate ligaments, whereby the cruciate ligaments are undamaged during the entire operation. The manner in which the bone chisel is guided during the driving process ensures the exact proper configuration of the result, with a simple manner of functioning, and in particular provides optimal protection of the cruciate ligaments. [0012] The U-shaped blade member may be in the form of a rounded U shape, but advantageously it may have right angles. With such a configuration of the blade member, the tibia plate may also have a right-angled recess. [0013] The inventive bone chisel may be struck with a hammer on its rear thin edge. However, advantageously the blade member may be formed on a solid shaft body which may have appreciable mass and which provides a suitable impact surface. The shaft body may also serve to facilitate guiding of the blade member with the user&#39;s other hand. [0014] Advantageously, the shaft body may be attached to a flange which is formed on the edge of the blade member which is opposite to the cutting edge. [0015] Advantageously, the shaft body has a bent configuration. This allows the positioning of the impact surface of the bone chisel in a region which is readily accessible to a hammer. [0016] Advantageously, the flange may have a sloped configuration, to facilitate its insertion into the narrow (indeed narrowed) region between the femur and the tibia. [0017] A method for working a tibia head using an inventive bone chisel is set forth below. BRIEF DESCRIPTION OF THE INVENTION [0018] The invention is illustrated schematically in the drawings, by way of example. [0019] FIG. 1 is an anterior view of an un-worked tibia head; [0020] FIG. 2 is a cross section through line 2 - 2 of FIG. 1 ; [0021] FIG. 3 is a view corresponding to FIG. 1 , of a tibia head which has been worked in the area of the cruciate ligaments; [0022] FIG. 4 is a cross section through line 4 - 4 of FIG. 3 ; [0023] FIG. 5 is a perspective view of a tibia plate; [0024] FIG. 6 is a view corresponding to FIG. 3 , with a tibia plate applied; [0025] FIG. 7 is a cross section through line 7 - 7 of FIG. 6 ; [0026] FIG. 8 is a cross section through line 8 - 8 of FIG. 7 ; [0027] FIG. 9 is a view corresponding to FIG. 3 , with the bone chisel inserted; [0028] FIG. 10 is a cross section through line 10 - 10 of FIG. 9 ; [0029] FIG. 11 is a cross section through line 11 - 11 of FIG. 10 , showing a cross section of the bone chisel; [0030] FIG. 12 is a perspective view of the bone chisel illustrated in FIG. 11 ; [0031] FIG. 13 is a perspective view of a different embodiment of a bone chisel; [0032] FIG. 14 is a lateral view of a bone chisel provided with longitudinal guide means; and [0033] FIG. 15 is a lateral view of a variant embodiment from that illustrated in FIG. 14 . DETAILED DESCRIPTION OF THE INVENTION [0034] FIG. 1 is an anterior view of the upper region of the tibia 1 , thus the shin bone of a man, with the tibia head 2 adjoining the tibia 1 at the top end of the latter. The anterior cruciate ligament 4 and the posterior cruciate ligament 5 are disposed on the upper side 3 of the tibia head 2 (also illustrated in FIG. 2 which is a top view of the upper side 3 ). [0035] For the sake of clarity, in FIG. 2 the generally used position designations “anterior” and “posterior” are indicated, surrounded by borders. [0036] In the surgical method described in the patent cited earlier in the Specification, for installing a knee endoprosthesis, the tibia head 2 must be worked in the manner shown in FIGS. 3 and 4 . The region of the tibia head 2 lying above the dashed line 6 in FIG. 1 is excised, e.g. with a saw. In the process, as illustrated in FIGS. 3 and 4 , a projection (protrusion) 7 , bearing the cruciate ligaments 4 and 5 , is not excised. The cut surface 8 disposed around the projection 7 should be as flat as possible. To achieve this, it is necessary to employ sharp tools around the projection 7 , e.g. milling cutters, saws, chisels, or the like. [0037] FIG. 5 illustrates a tibia plate 9 suitable for this surgical method, having a U-shaped recess 10 . The periphery of the tibia plate 9 corresponds to the periphery of the cut surface 8 as appears from FIG. 2 . The recess 10 corresponds to the periphery of the projection 7 . Accordingly, the tibia plate 9 fits on the tibia head 2 which has been excised according to FIG. 3 , and can be attached to the cut surface 8 as illustrated in FIG. 6 . The attachment may be achieved, e.g., by cementing. The bottom side of the tibia plate 9 may also bear projections (not shown) which may be driven into the tibia head 2 for purposes of attachment. Screws or the like may also be employed in achieving the attachment. [0038] FIGS. 7 and 8 illustrate the arrangement shown in FIG. 6 , in a lateral view and a top view. FIG. 8 shows how the recess 10 of the tibia plate 9 fits around the projection 7 . [0039] In the process of producing the projection 7 and providing a cut surface 8 which is as flat as possible, sharp tools are employed in the immediate vicinity of the projection 7 and the cruciate ligaments 4 and 5 . With such tools, there is a possibility that damage can be caused to the projection 7 and even to the cruciate ligaments 4 and 5 . Therefore, according to the present invention, a bone chisel as illustrated in a first embodiment in FIGS. 9 to 12 (bone chisel 11 ) is employed. [0040] The bone chisel 11 has a peripheral U-shaped blade member 12 which in this embodiment of the bone chisel 11 has a right-angle configuration, as may be seen in particular from FIGS. 11 and 12 . FIG. 12 shows that the blade member is thin and comprises a sharp cutting edge 13 which extends around the U shape. A U-shaped peripheral thickened flange 14 is disposed at the upper edge above the cutting edge 13 , which flange provides better load-bearing characteristics when the upper edge of the blade member 12 is struck by a hammer. This flange 14 serves also for stabilizing the U shape, but it is possible to omit it. [0041] FIG. 11 , which is a cross sectional view through line 11 - 11 in FIG. 10 , shows that the bone chisel 11 illustrated in FIGS. 9-15 generally surrounds a U-shaped region, wherewith its blade member 12 is comprised of a transverse wall 22 and two parallel side walls 23 and 24 , and has an opening 21 . [0042] In the use of the bone chisel 11 , the chisel is applied from above with its U-shaped cutting edge 13 being applied against the upper side 3 of the tibia head 2 , wherewith it is positioned and oriented such that it is aligned in correspondence with the edge of the cut surface 10 illustrated in FIG. 8 . In FIG. 8 the reference lines 21 and 22 are shown as dashed lines for purposes of illustration. [0043] The bone chisel is now driven in with a hammer, until, as illustrated in FIGS. 9 and 10 , its cutting edge 13 is at a height corresponding to the (future) cut surface 8 . The blade member 12 now surrounds the projection 7 , whereby the walls 22 , 23 , and 24 of the blade member 12 protect the sides of projection 7 which are at substantial hazard ( FIGS. 9 and 10 ). Now means such as the tool 15 ( FIG. 9 ) may now be used to remove all of the material located around the bone chisel 11 which has been driven into the tibia head 2 , and above the intended cut surface 8 , wherewith the tool 15 may also be employed, e.g., to smooth off the cut surface 8 . If by accident during this process the sharp cutting edge of the tool 15 approaches the projection 7 , it cannot proceed into the projection 7 , because the latter is protected by the blade member 12 . [0044] FIG. 13 illustrates a second embodiment of a bone chisel 11 ′. In the region of the cutting edge 13 , the blade member 12 , and the flange 14 ′, the bone chisel 11 ′ completely corresponds with the above-described bone chisel 11 . However, a massive shaft body 16 is disposed on the flange 14 ′, having an impact surface 17 which can be struck by a hammer, e.g. the hammer 21 illustrated in FIG. 14 . [0045] FIG. 14 illustrates a third embodiment of a bone chisel 11 ″. Here again the cutting edge 13 and blade member 12 are identical to the corresponding elements of bone chisels 11 and 11 ′. However here the flange 14 ″ is elongated in the anterior direction, thus beyond the transverse wall 22 , and on its elongation it bears a guide rod 18 which is guided in a guiding head 19 in the direction of the double arrow, namely the longitudinal direction of the tibia 1 , so as to be movable longitudinally in said direction. The guiding head is fixed to the tibia head 2 by means of the illustrated screws 20 . If a hammer 21 is caused to strike the flange 14 ″, it will drive the bone chisel 11 ″ from above into the tibia head 2 . In the process, the direction and exact positioning of the application of the bone chisel will be ensured by the guiding of the guide rod 18 in the guiding head 19 . The guiding head 19 has been fixed to the tibia head 2 in advance, so as to be precisely oriented. [0046] In the Figures the embodiments of the bone chisel 11 have a blade member 12 and a cutting edge 13 with a U-shaped configuration with right angle corners. However, the U-shape may be a rounded U-shape (not shown). [0047] FIG. 15 illustrates the knee shown in FIG. 14 , including the associated femur 25 to which the cruciate ligaments 4 and 5 are fixed. In a manner typical of surgeries of this type, the upper leg with the femur 25 is raised as far as possible and is oriented at an angle, so that the blade member 12 of a bone chisel 11 ′″ can be inserted between the femur 25 and the tibia head 2 , as illustrated in FIG. 15 . [0048] With this configuration, the blade member 12 surrounds the cruciate ligaments 4 and 5 in a correct protective disposition. However, the normal impact path of the hammer 21 is blocked by the femur 25 , which cannot be shifted laterally any farther without tearing the cruciate ligaments 4 and 5 . [0049] Therefore, the impact surface 17 of the bone chisel 11 ′″ in this embodiment is connected to the blade member 12 via a bent piece 26 the bent region of which extends anteriorly around the relevant region of the femur 25 , and transmits impact forces from the impact surface 17 to the blade member 12 . [0050] The flange 14 ′″ of the bent piece 26 , corresponding to the flange piece 14 ″ of FIG. 14 , is configured so as to be progressively thicker with progression from the opening 21 to the transverse wall 22 of the blade member 12 . This improves the stability, while reducing the thickness in the region of the opening 21 , while at that location still providing sufficient play (free space) above the flange 14 ′″ with respect to the femur 25 . The femur 25 has two condyles on its knee-side end region which allow passage of the parts 12 and 14 ′″ of the chisel 11 ″ without causing damage. [0051] At this point, a method for working a tibia head 2 with the bone chisel 11 ″ according to FIG. 15 will be described. [0052] First, the knee is exposed without disturbance of the cruciate ligaments 4 and 5 , and the femur 25 is inclined maximally with respect to the tibia 1 , until the position illustrated in FIG. 15 is achieved. [0053] Then the bone chisel 11 ″ with its U-shaped blade member 12 and at least the end region of the flange 14 ″ which adjoins the opening 21 is inserted, from the anterior side, between the tibia head 2 and the femur 25 . The blade member 12 is now brought into a position in which it can protect the cruciate ligaments 4 and 5 on all sides, as it surrounds the cruciate ligaments 4 and 5 , wherewith the transverse wall 22 of the blade member is directed anteriorly. [0054] Then the bone chisel 11 ″ with its U-shaped blade member 12 is pounded into the tibia head 2 and is thereby fixed to the tibia head. At this point, the distal end region of the tibia head 2 can be excised outside the walls 22 , 23 , and 24 of the blade member 12 , using a cutting tool 15 as per FIG. 9 .

A bone chisel for creating a protrusion bearing cruciate ligament attachments from an upper side of a tibia head, which has a blade that encloses an area of a projection in a U-shape to a front with a transverse wall and to a side with side walls, and which has a cutter. A guide rod extended parallel to a driving direction of the bone chisel is mounted on a side of the bone chisel formed by the transverse wall, which guide rod is displaceably mounted in a direction of the guide rod in a guide head, which can be affixed on a front side of the tibia head.

CROSS REFERENCE TO RELATED APPLICATION [0001] This application is a continuation of U.S. Ser. No. 10/055,417 filed January 22, 2002 which in turn is a continuation of U.S. Ser. No. 09/052,826, filed Mar. 31, 1998 which in turn claimed benefit from provisional application Ser. No. 60/042,144, filed Mar. 31, 1997, each of which is incorporated by reference. WO 98/43621 is also hereby incorporated by reference. BACKGROUND OF THE INVENTION [0002] This application is in the general field of treating diseases characterized by apoptosis. [0003] Apoptosis is a programmed cell death which occurs not only in natural development but also in disorders of many tissues incident to certain insults, such as growth factor deprivation and exposure to reactive oxygen species. Apoptosis is implicated, for example in chronic neurodegenerative disorders such as Huntington&#39;s disease, amyotrophic lateral sclerosis, Alzheimer&#39;s disease, and AIDS dementia, as well as in the penumbra of acute focal cerebral infarcts and after spinal chord injury or other forms of central nervous system trauma. Schwartz and Milligan, Trends in Neurosci. 19: 555-562 (1996). [0004] The family of cysteine proteases related to interleukin 1β-converting enzyme (ICE) has been generally found to be essential to apoptosis. Patel et al. FASEB. J. 10: 587-797 (1996); Schwartz and Milligan, Trends in Neurosci. 19: 555-562 (1996); Troy et al., Proc. Nat&#39;l Acad. Sci . ( USA ) 93: 5635-5640 (1996). The term caspase is now generally used to designate this ICE family of enzymes. Alnemri et al. Cell 87: 171 (1996). A conserved cysteine-containing sequence characteristic of caspases is essential for their activity. Patel et al. FASEB. J. 10: 587-797 (1996). For all known caspase enzymes, this sequence is QACRG (SEQ ID NO:1). Patel et al. FASEB. J. 10: 587-797 (1996). An apoptotic-like neuronal cell death process induced by growth factor deprivation or reactive oxygen species exposure of a neuronal-like cell line (PC12.cells) can be ameliorated by a pseudo-caspase enzyme, a fragment of the natural substrate IQACRG (SEQ ID NO:2) which contains that critical sequence and is believed to complex with and thus protect the natural substrates from degradation by caspases. Troy et al., Proc. Nat&#39;l. Acad. Sci. (USA) 93: 5635-5640 (1996). SUMMARY OF THE INVENTION [0005] S-nitrosylation (reaction of nitric oxide [NO] species with critical cysteine sulfhydryl groups of a caspase [RS] to form RS—NO) inhibits caspase activity and thereby ameliorates apoptosis. Such inhibition takes place throughout the body, in both neuronal and non-neuronal tissue and in opthalmological and non-opthalmological tissues. Accordingly, one aspect of the invention features methods of treating diseases characterized by apoptosis, by administering an S-nitrosylating compound to the patient in an amount effective. to reduce caspase activity. [0006] Another aspect of the invention features the use of caspase pseudo-enzymes to treat all apoptotic indications, neurological, opthalmological, and others. Specifically, apoptotic-like neuronal cell death of cerebrocortical neurons induced by mild excitotoxic injury [see, Bonfoco et al. Proc. Nat&#39;l Acad. Sci. (USA) 92: 7162-7166 (1995)] can be ameliorated by caspase substrate binding agent—peptides containing the sequence QACRG (SEQ ID NO:1), particularly those containing IQACRG (SEQ ID NO:2) and most particularly, IQACRG (SEQ ID NO:2) itself. These peptides may be linked. to an antennapedia sequence (see Troy et al., cited above, which is hereby incorporated by reference) or they may be incorporated into liposomes to enhance transport across the blood-brain barrier and/or entry into neurons. [0007] Finally the two approaches (nitrosylating therapies and caspase substrate binding agent) may be combined to treat apoptotic indications. [0008] Other features and advantages will be apparent from the following description of the Preferred Embodiments and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS [0009] FIG. 1 is a bar graph depicting inhibition of caspase-induced opoptosis by endogenous NO (See Example 1). [0010] FIG. 2 is a bar graph depicting the results of an experiment (Example 2) in which V-ICE inh decreases apoptosis induced by N-methyl-D-aspartate (NMDA). DESCRIPTION OF THE PREFERRED EMBODIMENTS [0011] Among the non-neuronal medical indications that can be treated according to the invention are: autoimmune diseases, including diseases of lymphocytes, systemic lupus erythematosus (SLE), synovial cells of rheumatoid arthritis (RA), fibroblasts (scleroderma), defective hematopoiesis, atherosclerosis, gastrointestinal diseases associated with cell death, including hepatobiliary disease, cell-mediated cytotoxicity, drug and chemical toxicity, carcinogenesis, viral disease, T-cell depletion associated with AIDS, oxidative stress, glomerulonephritis, cystic renal disease, renal tubular injury, atherosclerosis, myocardial ischemia or infarction, diabetic nephropathies, Chagas&#39; disease polycystic kidney disease, glomerulonephritis, hypocellular end-stage kidney disease, kidney disease associated with diabetes mellitus, Sjögren&#39;s syndrome, fulminant hepatitis (hepatitis B and C), red cell pathology; polycythemia, thalassemia, deficiencies in folate, vitamin B12, iron, glucose-6-phosphate dehydrogenase abnormalities, bone marrow failure, myelodysplasia, and chronic inflammatory disease. [0012] Neuronal medical indications include Parkinson&#39;s disease, Alzheimer&#39;s disease, Amyotrophic lateral sclerosis, autoimmune inflammation of the nervous system, multiple sclerosis, demyelinating diseases, autoimmune encephalomyelitis, status epilepticus and other seizure disorders, neurological mechanical trauma, hypoxia hypoglycemia, and ischemia, optic neuropathies, glaucoma, AIDS dementia, stroke, neuropathic pain, Huntington&#39;s disease, metabolic disorders (including homocyst(e)inemia) Tourette&#39;s syndrome, and withdrawal from drug addiction, drug tolerance or drug dependency. [0013] The S-nitrosylating therapeutics that can be used to effect treatment according to the invention include any compound which produces a sufficient amount of NO (most probably a related redox species such as an NO + equivalent or NO − donor) upon administration to a mammal to decrease apoptotic damage or injury. For convenience, I have also used the less precise term “NO-generating compound” to include compounds that produce the above described NO-related redox species (e.g., RS—NO, an NO + equivalent, or NO − ) or a physiologically acceptable salt thereof. [0014] Verification that a particular compound nitrosylates a caspase can be accomplished by the experiments provided below. [0015] The two preferred compounds (nitroglycerin and sodium nitroprusside) provide the advantage of a proven record of safe human administration (i.e., for treatment for cardiovascular disorders). Other nitroso-compounds that can be used in the method of the invention include: isosorbide dinitrate (isordil); S-nitroso captopril (SNOCAP); Serum albumin coupled to nitric oxide (“SA-NO”); Cathepsin coupled to nitric oxide (cathepsin —NO); tissue plasminogen activator coupled to NO (tPA-NO); SIN-1 (or molsidomine) cation-nitrosyl complexes, including Fe 2+ -nitrosyl complexes; Nicorandil; S-nitrosoglutathione; NO coupled to an adamantine derivative, such as memantine (see U.S. Pat. No. 5,614,650 hereby incorporated by reference); S-nitrosothiols including S-nitrosocysteine; quinones, including pyrroloquinoline quinone (PQQ), ester derivatives of PQQ, or ubiquinone; sydnonimines or NONOates having the formula X—[N(O)NO] − where X is any nucleophile including an amine; and agents which generate an oxidizing cascade similar to that generated by NO such as α-lipoic acid (thioctic acid and its enantiomers); dihydrolipoate; glutathione; ascorbate; or vitamin E. Alternatively, the NO donor can be a nitroxyl (NO − ) generator such as Piloty&#39;s acid, Angeli&#39;s salt (Oxi-NO), or sulfi-NO. See generally the list of NO compounds described in Chapter 7 of Feelisch and Stamler, Methods in Nitric Oxide Research, Wiley and Sons, Chichester, UK, (1996), pp 71-115, which is hereby incorporated by reference. Without wishing to be bound to a specific theory, the NO group in various redox forms can be transferred or react with the critical cysteine at the active site of caspases to decrease enzymatic function and thus provide protection against apoptosis. [0016] Any of the above described nitroso-compounds may be combined with other redox compounds that facilitate production and maintenance of NO. For example, direct NO-generators can be combined with pyroloquinoline quinone (PQQ) (see U.S. Pat. No. 5,091,391), or PQQ&#39;s derivative esters, or other quinones such as ubiquinone. [0017] The ability of NO to be transported to and cross cell membranes facilitates therapies according to the invention. [0018] My earlier U.S. Pat. No. 5,455,279 discloses that it is possible to build tolerance to undesired cardiovascular side effects of NO compounds (e.g., hypotension), without losing the desired protective effect. Accordingly, nitroso compounds capable of protecting against apoptosis can be administered continuously over an extended period with gradually escalating dosage, beginning at a dosage level which does not substantially reduce the patient&#39;s blood pressure, and, later, increasing gradually to higher dosage levels desirable for achieving the anti-apoptotic effect. The later dosage level is high enough to substantially reduce a naive patient&#39;s blood pressure, but, due to the tolerance that has been achieved in the patient, the compound&#39;s blood-pressure lowering effect is reduced to tolerable levels. [0019] An alternative way to offset the hypotensive effects of NO donors such as nitroglycerin is to co-administer with the NO-donating compounds, agents such as phenylephrine, dopamine, or yohimbine. See, e.g., Ma et al. Cardiovasc. Pharmacol. 20: 826-836 (1992). These agents may be given parenterally (e.g. IV) or orally depending on the drug. [0020] Nitroglycerin may be administered by transdermal patch as described in detail in my U.S. Pat. No. 5,455,279, referenced above. Alternatively, a long-lasting nitrate formulation, such as isosorbide dinitrate SR tablets which are usually administered every 8-12 hours, are administered more frequently (e.g., every 4 hours) to induce cardiovascular tolerance but preserve their effect on nitrosylation of caspases. It is also useful to administer superoxide dismutase (SOD), catalase, or both, to limit toxicity by decreasing the formation of peroxynitrite from the reaction of NO · with superoxide anion (O 2 ·− ) [0021] The compound may be included in a pharmaceutical preparation, using a pharmaceutical carrier (e.g., physiological saline); the exact formulation of the therapeutic mixture depends upon the route of administration. Preferably, the compound is administered orally or intravenously, but it may also be administered sublingually, by nasal spray, by transdermal patch, subcutaneously, intraventricularly, intravitreally, or by ointment. The preferred compounds, nitroglycerin or their derivatives (including all those preparations commercially available, e.g., those listed in the Physician&#39;s Desk Reference (1997) under coronary vasodilators or under nitroglycerin or nitroglycerin intravenous and including isosorbide mononitrate, isosorbide dinitrate, nitroglycerin sublingual, Minitran, NT-1, Niotrocor, Nitroderm, Nitrodisc, Nitro-dur, Nitro-Dur II, Nitrofilm, Nitrogard, Nitroglin, Nitropen, Tridil, and 6-chloro-2-pyridylmethyl nitrate) are administered at 0.01 mg-60 gm/day, in divided doses. Sodium nitroprusside—Na 2 [Fe(CN) 5 NO]-2H 2 O (from Elkins-Sinn, Inc., Cherry Hill N.J.), Nipride (from Roche, Nutley, N.J.), or other preparations—are administered intravenously at 0.5-10 pg/min. [0022] Compounds determined to be effective protective agents by the assays described herein are administered as above at a dosage suitable to reduce cellular damage. Generally, such compounds are administered in dosages ranging from 0.01 mg -60 gm/day, more preferably in dosage of 0.1-5 mg/day. [0023] Those skilled in the art will understand that there are other factors which aid in determining optimum dosage. For example, for NO-conjugated drugs, the dosage used for the unconjugated drug (e.g. tPA a dosage of 0.35-1.08 mg/kg and generally ≦0.9 mg/kg) is predictive of useful NO-conjugate dosage. Dosages may be divided. It is desirable to maintain levels of NO or related redox species in the brain of 1 nM to 500 μM. Treatment may be repeated as necessary. [0024] Regarding neuronal therapies, polyethylene glycol (PEG) is used to enhance absorption into the central nervous system (CNS) and efficacy of SOD and/or catalase. An SOD mimic, the protein-bound polysaccharide of Coriolus versicolor QUEL, termed “PS-K”, may also be effective by parenteral or oral routes of administration, especially with PEG to enhance CNS absorption, and such mimics may be substituted for SOD in this aspect of the invention. See Kariya et al., Mol. Biother. 4: 40-46 (1992); and Liu et al., (1989) Am. J. Physiol. 256: 589-593.” EXAMPLES Example 1 [0025] We have shown that S-nitrosylation of caspases [e.g., CPP32 (caspase-3, Alnemri et al.) and ICE (caspase-1)] inhibit their ability to cleave the substrate PARP [poly(ADP-ribose)polymerase]. Fluorogenic assays of caspase activity in neuronal and other cellular cultures revealed that S-nitrosylation by either exogenous or endogenous NO species inhibited enzyme activity and therefore prevented apoptosis. [0026] Nitrosylation of the critical cysteine in caspases (which is present in the peptide ICARG) (SEQ ID NO:3) can be verified by the Saville reaction, well known to those skilled the art. Feelish and Stamler, cited above, Ch. 36, p. 527. [0027] In cell toxicity experiments we demonstrate inhibition of caspase-induced apoptosis by endogenous NO in HEK-293-nNOS cells. HEK-293 cells [Bredt et al., Nature 351: 714-719 (199)] overexpressing nNOS were transiently transfected with mICE-lacZ (containing the caspase-1 construct [Miura et al., Cell 75: 653-660 (1993)] or control placZ using the calcium phosphate precipitation method. Following transfection, cells were incubated in absence (0 μM) or presence of 6 μM 4-Br-A23187 for 48 h. Cells were then permeabilized, fixed, and stained with propidium iodide. Apoptotic nuclei were counted in ≧12 fields and results expressed as a percentage of total nuclei. The results are shown in FIG. 1 . Values are the mean ± SEM for n≧3 from at least two experiments. A Fisher&#39;s protected least significance difference post-hoc test indicated a highly significant decrease in apoptosis of HEK-293-nNOS cells after caspase-1 transfection and 4-Br-A23187 exposure to increase Ca 2+ and thus activate the nNOS to produce NO (p≦0.007). Example 2 [0028] FIG. 2 depicts the results of one specific experiment in which the pseudo-caspase enzyme IQACRG (“ICE inh ”) demonstrably decreases the apoptosis induced by the excitotoxin N-methyl-D-aspartate (NMDA) plus glycine (an NMDA receptor co-agonist.) Note that ICE inh &#39;s entry into cells is facilitated by coupling the antennapedia peptide (a signal sequence allowing translocation across cell membranes, the conjugate being termed V-ICE inh ). Note also that the NMDA receptor is a subtype of glutamate receptor, which, when overexcited, causes neuronal damage. The reduction in NMDA-induced (300 μM NMDA/5 μM glycine) neuronal apoptosis effected by 200 nM VICE is significant. [0029] These findings support my conclusion that S-nitrosylation of caspase inhibits apoptosis. The pseudo-enzyme IQACRG (SEQ ID NO:2) containing the caspase active site also prevents apoptosis. The combination of the two is synergistic.

Compounds that inhibit caspase activity, particularly those that bind a caspase substrate and protect it, are combined with a vector such as liposomes or an antennapeida peptide to treat glaucoma.

FIELD OF THE INVENTION This application is a continuation-in-part of application Ser. No. 763,406, filed on Jan. 28, 1977 U.S. Pat. No. 4,153,574. This invention relates to compositions containing a dispersed form of a trialkyltin fluoride. More particularly, this invention relates to stable dispersions of trialkyltin fluorides which are capable of being stored for extended periods of time without any significant increase in viscosity. A number of trialkyltin fluorides, particularly tri-n-butyltin fluoride, effectively inhibit the attachment and growth of barnacles and other organisms responsible for fouling of submerged surfaces such as the hulls of sea-going vessels and the pilings of docks and other facilities exposed to salt water. The trialkyltin fluorides are, therefore, useful as the toxicant for antifouling coatings. A typical antifouling coating contains the toxicant, one or more pigments and a film-forming polymer. All of these components are dissolved or dispersed in an organic solvent such as xylene or toluene, optionally in combination with a ketone such as 2-butanone. Up until now, acceptable coatings containing trialkyltin fluorides, which are solid materials at ambient temperatures, have been difficult to prepare. Dispersions of trialkyltin fluorides in organic solvents exhibit a strong tendency to agglomerate in the form of large particles. These materials therefore cannot be dispersed in coating compositions or organic solvents by mixing at high speeds. This unusual behavior can be explained in terms of a difference between the electronegativities of tin and fluoride. This difference results in a relatively weak attractive force between the tin atom on one molecule and the fluoride atom on an adjacent molecule, resulting in a structure resembling that of a linear polymer molecule. Regardless of the cause, the agglomeration is undesirable, since it makes it difficult or impossible to prepare a useful coating formulation wherein the maximum particle size is 45 microns or less. This degree of fineness cannot be achieved without grinding the formulation in a pebble mill or a ball mill, a tedious, time-consuming operation. Even following such a grinding procedure, there may still be a number of hard agglomerates present in the formulation. These agglomerates must be removed manually to obtain a useful coating composition. It is, therefore, an objective of this invention to obtain stable dispersions of trialkyltin fluorides which can be readily dispersed in coating compositions without the need for grinding to achieve the desired particle size. Surprisingly, it has now been found that the presence of certain inorganic compounds enable trialkyltin fluorides such as tri-n-butyltin fluoride to be dispersed in a specified class of organic solvents without agglomeration to yield stable compositions. The resultant compositions remain stable for extended periods of time and can readily be incorporated into coating compositions, including paints. Japanese Patent Publication No. 7338847 discloses heating tri-n-butyltin fluoride at 40° to 60° C. in a liquid hydrocarbon or halogenated hydrocarbon that boils from 50° to 200° C. The resultant slurry hardens upon standing for any appreciable length of time, and hence is not practical for incorporation into antifouling coatings. Even after being ground the resultant particles do not yield a dispersion of adequate &#34;fineness&#34;. SUMMARY OF THE INVENTION This invention provides a stable, thixotropic dispersion of a trialkyltin fluoride, said dispersion consisting essentially of: (1) from 40 to 70% by weight of a trialkyltin fluoride of the formula R 3 SnF, wherein R is alkyl containing from 2 to 12 carbon atoms; (2) from 20 to 60% by weight of at least one organic liquid having a kauri butanol value of 96 or less and selected from the group consisting of alcohols containing from 4 to 12 carbon atoms, aliphatic hydrocarbons containing from 5 to 12 carbon atoms, aromatic hydrocarbons; (3) from 0.5 to 10% by weight of a compound selected from the group consisting of: (a) lithium and sodium salts of p-toluenesulfonic, phenylphosphonic and silicic acids; (b) nitric acid salts of calcium, magnesium, sodium, lithium, iron and zinc; (c) salts of p-toluenesulfonic or phenylphosphonic acid and an element selected from the group consisting of magnesium, calcium, strontium and barium; (d) the chlorides of metallic elements selected from the group consisting of divalent copper, silver, gold and the elements in Groups II-A, II-B, IV-A, IV-B, V-A, VI-B, VII-B and VIII of the periodic table, and (e) carboxylic acid salts of lead, manganese, zirconium, barium and strontium, wherein said carboxylic acid contains from 2 to 12 carbon atoms. DETAILED DESCRIPTION OF THE INVENTION The novel feature of the present trialkyltin fluoride compositions resides in the presence, in relatively small amounts, of compounds derived from one of the metallic elements. These compounds stabilize the dispersion by preventing agglomeration of the trialkyltin fluoride particles. The accompanying examples demonstrate that many members of this class of compounds are not suitable stabilizers, and it is therefore difficult to predict without experimentation which compounds are operable. For example, while sodium compounds are generally useful, the only effective potassium compound is the hydroxide. The liquid medium is also a critical factor with respect to stability of the dispersion. The cationic portion of those compounds found to be effective dispersion stabilizers is derived from one of a number of specified metallic elements, and includes members from groups I-A, I-B, II-A, II-B, IV-A, IV-B, V-A, VI-B, VII-B and VIII of the periodic table. The anionic portion of the molecule is a residue of an inorganic acid such as nitric or silicic acid, or an organic acid such as p-toluenesulfonic acid, phenylphosphonic acid or a carboxylic acid containing from 2 to 12 carbon atoms. Representative carboxylic acids include acetic, propionic, butyric, hexoic, heptanoic, cyclohexanecarboxylic and benzoic acids. Chlorides of polyvalent metallic elements are also effective dispersion stabilizers. By comparison, a dispersion containing sodium chloride solidifies upon standing. With the exception of potassium hydroxide, this is also true for dispersions containing the potassium analogs of the sodium compounds disclosed in this application and in copending application Ser. No. 763,406, of which the present application is a continuation-in-part. In addition to choice of the proper inorganic dispersion stabilizer, the organic liquid used as a dispersion vehicle is also critical to obtaining a non-coagulating dispersion of a trialkyltin fluoride. Suitable organic liquids include aliphatic hydrocarbons and aromatic hydrocarbons having a kauri butanol value of 96 or less. The kauri butanol value of a hydrocarbon solvent is equal to the volume in cubic centimeters (measured to 25° C.) of a given solvent that will produce a specified degree of turbidity when added to 20 g of a standard solution of kauri resin in normal butanol. The test method is published by the American Society for Testing and Materials as ASTM Test No. 01133-61 (reapproved in 1973). The pertinent portions of this testing procedure are hereby incorporated by reference. Representative useful liquid hydrocarbons include the aliphatic hydrocarbons. These hydrocarbons can be used individually or in mixtures that are commercially available as mineral spirits, petroleum ether and naphtha. The class of aromatic hydrocarbons includes xylene. Toluene has a kauri butanol value of 105, and is therefore not a suitable medium for the present dispersions, however, it can be used in mixtures with aliphatic hydrocarbons. Other useful liquid media include alcohols containing 1, 2 or 4 carbon atoms, such as methanol, ethanol and butanol. Surprisingly, a stable dispersion cannot be prepared in n-propanol. The trialkyltin fluorides that can be employed in the stable dispersions of this invention are of the general formula R 3 SnF, wherein R is alkyl and contains from 3 to 6 carbon atoms. If the dispersion is to be incorporated into a coating material intended to inhibit fouling by barnacles and other organisms on ship hulls and other normally submerged structures, R is preferably n-butyl. Using the dispersion stabilizers and organic liquids disclosed in the preceding specification and accompanying claims, it is possible to prepare compsitions containing from about 10% up to about 70% by weight of a trialkyltin fluoride. It has heretofore not been possible to incorporate more than about 40% by weight of a trialkyltin fluoride such as tri-n-butyltin fluoride in a dispersion. The maximum amount of fluoride that can be dispersed will, of course, be dependent upon the particular dispersion stabilizer and organic liquid selected. The physical forms of the present dispersions vary from viscous liquids to semi-solid pastes, depending upon the concentration of the trialkyltin fluoride. One important advantage of these compositions is that they exhibit thixotropy, and can therefore be easily blended by stirring the composition together with other ingredients conventionally used in paints and other coating compositions. These additional ingredients include natural or synthetic film-forming polymers such as rosin and copolymers of vinyl chloride with one or more ethylenically unsaturated monomers such as vinyl acetate, pigments such as titanium dioxide and iron oxide, viscosity modifiers, particularly clays such as bentonite, and one or more organic solvents. Typical antifouling coatings that can be prepared using the present dispersed form of trialkyltin fluoride contain from 1.0 to 20.0 of the trialkyltin flouride composition, including one or more of the aforementioned salts and organic liquids, from 10 to 50% by weight of pigments, typically titanium oxide or zinc oxide alone or in combination with colored pigments such as ferric oxide, from 10 to 50% by weight of at least one film-forming component, which typically includes vinyl chloride homopolymers and copolymers, rosin and chlorinated rubbers such as polychloroprene, and from 20 to 60% by weight of one or more organic solvents, including xylene, cyclohexanone, 2-butanone and mixtures of hydrocarbons commonly referred to as &#34;aliphatic naphtha&#34; and &#34;high flash naphtha&#34;. A small amount of a viscosity modifier such as a bentonite clay is usually included to impart thixotropy to the final coating composition. The preparation of a particularly preferred coating formulation is described in one of the accompanying examples. Incorporating tri-n-butyltin fluoride into a paint formulation has heretofore been a lengthy, time-consuming procedure due to the tendency of the flouride to agglomerate. The resultant paint usually must be ground for several hours in a pebble or sand mill to obtain a fineness of 4 to 5 on the Hegman N.S. Scale of 0 (no grind) to 10 (excellent grind). A rating of 4 to 5 on this scale is equivalent to an average particle size of from 40 to 70 microns. Similar problems resulting from agglomeration are encountered if an attempt is made to disperse the trialkyltin flouride in an organic solvent prior to incorporating it into a paint formulation. In addition, once a dispersion of the desired particle size is obtained, it cannot be stored for any length of time, since it rapidly hardens to a waxy solid. The accompanying examples disclose preferred embodiments of the present compositions and should not be interpretted as limiting the scope of the accompanying claims. In the examples all parts and percentages are by weight unless otherwise indicated. EXAMPLE 1 Dispersions of tri-n-butyltin flouride were prepared by blending 60 parts of this compound, 5 parts of the inorganic stabilizer and 35 parts of a mixture containing 64% special naphthalite (a mixture of liquid hydrocarbons containing less than 8% of aromatic hydrocarbons), 12% ethyl benzene, 9% n-butyl acetate, 5% iso-butyl acetate and 10% n-butanol. The flash point of the mixture is 14.4° C., the kauri butanol number is 36 and the boiling range is from 123° to 145° C. One hundred grams of the resultant mixture were placed in a cylindrical container measuring two inches (5.1 cm) in diameter and 4.5 inches (11.4 cm) in height. Into the same container were also placed 250 grams of stainless steel spheres measuring 4.7 millimeters in diameter. The container was then sealed and shaken vigorously for twenty minutes, after which the contents of the container were emptied onto a large mesh wire screen. Dispersions which solidified during milling and crumbled when prodded with a spatula were considered unacceptable and were not tested further. Acceptable materials were either viscous liquids or homogeneous, coherent semi-solids which could be forced through the openings of the screen using a spatula. Those materials which passed through the screen were collected and maintained under ambient conditions for two days. At the end of the period, they were examined to determine whether any changes in their physical form had occurred during this interval. Those materials which had solidified and could no longer be stirred with a spatula were considered unacceptable. All of the acceptable materials were thixotropic semi-solids or viscous liquids that exhibited a significant viscosity reduction under shear. Some of the materials appeared to be coherent solids yet could readily be stirred by hand with a spatula using only a minimal amount of force. Inorganic compounds yielding acceptable dispersions included: Sodium p-toluenesulfonate Calcium di-(p-toluenesulfonate) Sodium Phenylphosphonate Calcium Phenylphosphonate Barium Acetate Strontium Acetate Zirconium Acetate Manganous Acetate Lead Acetate Calcium Nitrate Ferrous Nitrate Ferric Nitrate Zinc Nitrate Sodium Silicate Magnesium Chloride Calcium Chloride Manganous Chloride Ferrous Chloride Ferric Chloride Cupric Chloride Stannous Chloride Bismuth Chloride Compounds which did not yield acceptable dispersions included: Potassium p-toluenesulfonate Potassium Phenylphosphonate Potassium Acetate Nickel(ous) Acetate Cuprous Acetate Cupric Acetate Cadmium Acetate Potassium Nitrate Barium Nitrate Nickel(ous) Nitrate Magnesium Silicate The chlorides of sodium, potassium &amp; monovalent Copper Calcium Fluoride It is believed that an effective stabilizer will interfere with the formation of strong bonds between the fluorine atoms on one molecule and tin atoms on adjacent molecules. This bond formation is believed responsible for the agglomeration which almost always occurs when a trialkyltin fluoride is dispersed into an organic solvent in the absence of one of the present inorganic compounds. EXAMPLE 2 The effect of vaarious organic liquids or diluents on the stability of a dispersion containing 60% by weight of tri-n-butyltin fluoride, 5% of calcium carbonate and 35% of the organic liquid was determined by preparing a dispersion as described in the preceding example. Those dispersions which could be classified as viscous liquids or coherent semi-solids following the initial milling operation were stored for one week under ambient conditions and then examined to determine whether the original thixotropic character had been retained. The organic liquids evaluated included a mixture of aromatic hydrocarbons available as Solvesso® 150 from the Exxon Company and typically having a flash point from 145° to 150° F. (63° to 65° C.), VM&amp;P naphtha [a mixture of aliphatic hydrocarbons typically having a flash point of 6.7° C. (tag closed cup) and a boiling range from 118° to 139° C.]; mineral spirits [a mixture of aliphatic hydrocarbons typically having a flash point of 42.2° C. (tag closed cup) and a boiling range from 160° to 196° C.]; ethyl benzene, amyl acetate, a mixture (A) containing 33.3% of VM&amp;P naptha, 28.9% cyclohexane and 37.8% amyl acetate and a second mixture (B) containing 34.2% mineral spirits, 4.4% Solvesso® 150, 12.2% ethyl benzene and 49.2% amyl acetate. Also included in the evaluation were cyclohexane, xylene, 2-butanone, n-butyl acetate, isobutyl acetate, n-butanol, ethylene glycol, n-propanol, octanol, Cellosolve® acetate (ethylene glycol monomethyl ether monoacetate) and toluene. Of the solvents evaluated, the two mixtures (A&amp;B), VM&amp;P naphtha, Solvesso® 150, mineral spirits, xylene, n-butanol and octanol produced acceptable dispersions. Dispersions prepared using the other solvents hardened during the one week storage period or were two stiff and gum-like for use in a paint formulation. EXAMPLE 3 A dispersion containing 60% by weight of tri-n-butyltin fluoride (TBTF) prepared as described in the preceding Example 1 using calcium chloride as the stabilizer, can be incorporated into a conventional paint formulation of the following composition: ______________________________________ Parts______________________________________Titanium dioxide 15.12Talc (magnesium silicate) 11.22Zinc oxide 7.08A vinyl chloride - vinyl acetate 11.16copolymer (VAGH)Rosin 3.732-butanone 20.31Xylene 18.84Bentonite clay 0.51Methanol (95%) 0.15TBTF.sup.1 dispersion As Required______________________________________ .sup.1 trin-butyltin fluoride The solvent employed to prepare the dispersions is a mixture containing 64% special naphthalite, 12% ethyl benzene, 9% n-butyl acetate, 5% isobutyl acetate and 10% n-butanol. Special naphthalite is described in the preceding Example 1. The amount of tri-n-butyltin fluoride dispersion employed is equivalent to 12% by weight of the compound in the formulation. The dispersion was blended together with the other components of the formulation to achieve a homogeneous mixture. The paint can be evaluated using a Hegman N.S. gauge to determine &#34;fineness&#34; of the grind. A 0.003 inch (0.0076 cm)-thick film is applied to a metal surface using a draw-down blade and the texture of the resultant film is evaluated using the following scale: 1. Rough surface easily detected by rubbing a hand over the surface of the coating 2. 10-20 observable lumps uniformly distributed on paint surface 3. Several lumps visible 4. Smooth The data from a typical paint evaluation are recorded in the following table. A Hegman fineness of 4 or 5 is considered acceptable. ______________________________________% CaCl.sub.2 Hegman Grind No. Film Rating______________________________________10 -- 45 -- 42.5 4 41 4-5 3-40.5 4-5 1-2______________________________________ The film prepared using a dispersion containing 0.5% by weight of calcium chloride and 60% tri-n-butyltin fluoride may be too rough in texture to be considered acceptable, however, this level of calcium chloride would be sufficient to stabilize dispersions containing less than 60% of the trialkyltin compound, for example about 50% by weight. EXAMPLE 4 A typical red formulation suitable for use with the present dispersed form of tri-n-butyltin fluoride can be prepared using the following procedure: ______________________________________1. Combine the following ingredients using a high speed stirrer to obtain a uniform dispersion: Rosin (70% by weight in xylene) 4.89 parts A mixture containing bentonite clay 0.47 part and methanol 0.14 part2. Combine the mixture of (1) with cyclohexane 12.00 parts3. Add the pigments Red iron oxide 13.90 parts Talc 10.30 parts Zinc oxide 6.05 parts4. Add the film-forming polymer vinyl chloride/partially hydrolyzed vinyl acetate copolymer (available as VAGH from Union Carbide Corporation) as a 3% by weight solution in a 2-butanone-xylene mixture. 34.13 parts5. Add a dispersed form of tri-n- butyltin fluoride as described in the preceding Example 1. 17.65 parts6. Stir the mixture at high speed until the composition exhibits a fineness of 4 to 5 on the Hegman N.S. scale.______________________________________ EXAMPLE 5 A dispersion containing 50% by weight of TBTF prepared as described in the preceding Example 1 using calcium chloride as the stabilizer can be incorporated into a conventional paint formulation wherein the film-forming component is a chlorinated rubber. ______________________________________INGREDIENT PARTS______________________________________Red iron oxide 17.24Zinc oxide 8.09Talc (magnesium silicate) 7.30Bentonite Clay.sup.1 0.59Methanol 0.18Chlorinated natural rubber.sup.2 8.9Rosin 8.9Xylene 21.9TBTF dispersion 26.9 100.00______________________________________ Notes:? .sup.1 Bentone® 27, supplied by NL Industries. .sup.2 64-65% by weight of chlorine, viscosity = 17-25 cps, measured usin a 20% by weight solution in toluene at 25° C.? The paint was prepared using the following procedure 1. Combine bentonite clay and methanol, mix thoroughly and combine with rosin; mix until homogeneous; 2. Add solvent (xylene) with the pigments to achieve the desired viscosity during dispersion; 3. Charge the pigments in order indicated and disperse to a 5 grind on the Hegman N.S. Scale: Red Iron Oxide: 17.24 Zinc Oxide: 8.09 Talc: 7.03; 4. Charge the chlorinated rubber slowly with agitation until dissolved; and 5. Add the TBTF dispersion and mix to achieve a 4-5 grind on the Hegman N.S. Scale.

The tendency of dispersions containing trialkyltin fluorides in organic liquids to agglomerate is avoided by using as the dispersion medium specified organic liquids in combination with from 0.5 to 10%, based on the weight of the dispersion, of specified inorganic compounds. The choice of both organic liquid and inorganic compounds is critical to achieving long-term stability of the resultant dispersion.

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 61/855,066, which was filed on 7 May 2013 and is incorporated herein by reference. BACKGROUND The present disclosure relates generally to equipment for exercising. More particularly, this disclosure relates to a device that can be used by a mobility-impaired user, such as user of a wheelchair. Various exercises have been utilized to develop and train various areas of the body. Exercises have historically been performed with resistance provided by free weights, such as barbells or machines, or even using a user&#39;s body as resistance. Many exercise devices contain adjustment features allowing a user to adapt the exercise devices for a particular exercises. Many of the adjustment features are not accessible to users with impaired mobility. Further, many areas of the assembly will not accommodate devices, such as wheelchairs, frequently utilized by users with impaired mobility. Thus, a mobility-impaired user cannot effectively train on many exercise devices. SUMMARY An apparatus according to an exemplary aspect of the present disclosure includes, among other things, an exercise device providing an exercise area configured to receive a wheelchair, at least one primary handle moveable by a first user in the wheelchair from a first position to a second position, and a resistance assembly that opposes movement of the at least one primary handle. At least one spotter handle is coupled to move together with the at least one primary handle. The at least one spotter handle is accessible by a second user from a position outside the exercise area. In another example of the foregoing apparatus, the primary handle comprises a first primary handle to be positioned on a first lateral side of the first user and a second primary handle to be positioned on an opposing, second lateral side of the first user. The spotter handle comprises a first spotter handle to be positioned on the first lateral side and a second spotter handle to be positioned on the second lateral side. In another example of any of the foregoing apparatus, the apparatus further comprises a wheelchair guide to position the wheelchair within the exercise area. In another example of any of the foregoing apparatus, the apparatus further comprises a link coupling movement of the at least one primary handle together with movement of the at least one spotter handle. The wheelchair guide is positioned between the link and the exercise area. In another example of any of the foregoing apparatus, the apparatus further comprises a second exercise area that is separate and distinct from the first exercise area, and a pick accessible from the second exercise area. Exercises using the pick are resisted with the resistance assembly. In another example of any of the foregoing apparatus, the resistance assembly comprises a weight stack. In another example of any of the foregoing apparatus, the apparatus further comprises a lap pad configured to stabilize a user between the lap pad and the wheelchair when the user is utilizing the pick. In another example of any of the foregoing apparatus, the lap pad is pivotable back and forth between a first position where the lap pad extends substantially vertically and a second position where the lap pad extends substantially horizontally. An exercise device for a user in a wheelchair according to another exemplary aspect of the present disclosure includes, among other things, an automatically adjustable pick. In another example of the foregoing exercise device, a belt is secured to the pick. The belt is configured to be driven to move the pick. In another example of any of the foregoing exercise devices, the belt is looped such that opposing ends of the belt are secured to the pick. In another example of any of the foregoing exercise devices, the belt is clamped to the pick. In another example of any of the foregoing exercise devices, the belt is a toothed belt. In another example of any of the foregoing exercise devices, the device comprises a sprocket to drive the belt to move the pick. In another example of any of the foregoing exercise devices, the pick is configured to adjust between a first position that is vertically above a head of a user during use, and a second position that is vertically below a knee of the user during use. In another example of any of the foregoing exercise devices, the pick is configured to be infinitely adjustable between the first position and the second position. In another example of any of the foregoing exercise devices, a lap pad is configured to stabilize a user between the lap pad and a wheelchair. In another example of any of the foregoing exercise devices, the lap pad is pivotable back and forth between a first position where the lap pad extends substantially vertically and a second position where the lap pad extends substantially horizontally. In another example of any of the foregoing exercise devices, the lap pad is pivotable about a pivot location on a first side of the user to a selectively engage a support on a second side of the user that is opposite the first side. An exercise device for a user in a wheelchair according to yet another exemplary aspect of the present disclosure includes, among other things, a pivotable lap pad configured to stabilize a user between the lap pad and a wheelchair. In another example of the foregoing exercise device, the lap pad is pivotable back and forth between a first position where the lap pad extends substantially vertically and a second position where the lap pad extends substantially horizontally. In another example of any of the foregoing exercise devices, the lap pad is pivotable about a pivot location on a first side of the user to a selectively engage a support on a second side of the user that is opposite the first side. A method of exercising when positioned within a wheelchair includes, among other things, positioning a user and the wheelchair within an exercise area of an exercise device, and moving a primary handle of an exercise device. The moving of the primary handle is resisted by a resistance device. The method includes moving a spotter handle to assist the moving of the primary handle. The spotter handle is coupled in movement together with the primary handle. In another example of the foregoing method, the moving of the primary handle is a pivoting movement around a first axis, and the moving of the spotter handle is a pivoting movement around a second axis spaced from the first axis. In another example of the any of the foregoing methods, the method comprises moving to another exercise area and automatically adjusting a height of a pick. In another example of the any of the foregoing methods, the method comprises pivoting a lap pad from a first position where the lap pad extends substantially vertically and a second position where the lap pad extends substantially horizontally, stabilizing the user between the lap pad and a wheelchair, and exercising using the pick. The embodiments, examples and alternatives of the preceding paragraphs, the claims, or the following description and drawings, including any of their various aspects or respective individual features, may be taken independently or in any combination. Features described in connection with one embodiment are applicable to all embodiments, unless such features are incompatible. BRIEF DESCRIPTION OF THE DRAWINGS The various features and advantages of the disclosed examples will become apparent to those skilled in the art from the detailed description. The figures that accompany the detailed description can be briefly described as follows: FIG. 1 shows a perspective view of an example wheelchair accessible exercise device. FIG. 2 shows another perspective view of the FIG. 1 device. FIG. 3 shows a user utilizing a row exercise portion of the device of FIG. 1 . FIG. 4 shows the user making an adjustment to the device of FIG. 1 . FIG. 5 shows the user making another adjustment to the device of FIG. 1 . FIG. 6 shows the user utilizing a forward press portion of the device of FIG. 1 . FIG. 7 shows a handle of the forward press portion of FIG. 6 in a first position. FIG. 8 shows the handle of FIG. 7 in a second position. FIG. 9 shows the user utilizing an overhead press portion of the device of FIG. 1 . FIG. 10 shows the user positioning a lap pad of the device of FIG. 1 . FIG. 11 shows the user positioning a lap pad support arm of the device of FIG. 1 . FIG. 12 shows the user engaging the lap pad with the lap pad support arm. FIG. 13 shows the user automatically adjusting a pick location of the device of FIG. 1 . FIG. 14 shows a button on the lap pad support arm utilized to adjust the pick position. FIG. 15 shows the user performing an overhead cable pull. FIG. 16 shows the user performing a chest cable pull. FIG. 17 shows the user performing a bicep curl with the lap pad in an engaged position. FIG. 18 shows the user performing a bicep curl with the lap pad in a disengaged position. FIG. 19 shows a perspective view of an adjustable pick and rail of the device of FIG. 1 . FIG. 20 shows a perspective view of an adjustable pick and rail of the device of FIG. 1 . FIG. 21 shows a perspective view of an adjustable pick and rail of the device of FIG. 1 . DETAILED DESCRIPTION Referring to FIGS. 1 and 2 , an example exercise device 10 includes, generally, a first exercise area 14 and a second exercise area 18 . The first exercise area 14 is used for exercises, such as rows, chest presses, overhead presses, etc. The second exercise area 18 is used for exercises that involve an adjustable pick 22 , such as cable-based pulls, curls, etc. Notably, the user may remain seated in a wheelchair 26 when performing exercises within the first exercise area 14 and the second exercise area 18 . Exercise, in this disclosure, encompasses training, therapy, drills, calisthenics, and other pursuits requiring physical effort. Referring now to FIGS. 3 to 5 , during a row exercise, the user grasps rowing handles 30 extending from row bars 32 . To start a row, a chest of a user presses against a pad 34 as the user is seated in the wheelchair 26 . The user then presses the rowing handles 30 away from their chest, which pivots the row bars 32 about a rowing pivot R p . The rowing handles 30 are user handles in this example since the exercising user grasps these handles when exercising. The row bars 32 are coupled to chest press bars 40 via a linking member 42 . The chest press bars 40 are attached to a weight stack 44 via a belt 46 . When the user pivots the row bars 32 about the pivot R p , the linking member 42 pulls the chest press bars 40 causing the chest press bars 40 to pivot about a chest press pivot C p . The weight stack 44 provides resistance to the rowing exercise through the belt 46 , the chest press bars 40 , the linking member 42 , and the row bars 32 . Notably, a trainer (not shown) may press and pull on the chest press bars 40 to assist or “spot” the user during the rowing exercise as needed. This assistance can be provided in an area clear from the wheelchair 26 and outside the exercise area 18 . When used for spotting, the chest press bars 40 are considered spotter handles. The user may adjust the position of the pad 34 via a pin and socket type attachment to place the rowing handles 30 at a desired location relative to the user when the user&#39;s chest is pressed against the pad 34 . Referring to FIGS. 5 to 8 with continuing reference to FIGS. 3 and 4 , during a forward press exercise, the user in the wheelchair may position their back (or a back of the wheelchair 26 ) against the pad 34 . The user in the wheelchair may then adjust resistance of the press by increasing or decreasing the resistance by moving a pin 48 within the weight stack 44 to cause more or less weight to be during the press. When performing the chest press, the user grasps chest press handles 43 extending from the chest press bars 40 . The pivoting movement of the chest press bars 40 as the user pushes the chest press handles 43 forward pulls the row bars 32 forward via the linking member 42 . Forward movement of the chest press handles 43 and chest press bars 40 is resisted by the weight stack 44 , which, again, is coupled to the chest press bar 40 via the belt 46 . The trainer may manipulate the position of the rowing handles 30 to assist the user when performing the chest press. During this exercise, the chest press handles 43 act as user handles, and the rowing handles 30 act a spotter handles. The chest press handles 43 are moveable between the retracted position of FIG. 7 and the extended position of FIG. 8 . Other handles of the device 10 may be similarly moveable. Referring to FIG. 9 , an additional exercise performed by the user within the first exercise area 14 is an overhead press. During such an exercise, the user pivots overhead press bars 50 about an overhead press axis O p by repositioning overhead press handles 52 . Rotation of the overhead press bars 50 is resisted by the weight stack 44 , which is coupled to the overhead press bars via a belt 54 . The first exercise area 14 may include guides 56 to help position the user, and the user&#39;s wheelchair, within the first exercise area 14 . The guides 56 also prevent the wheelchair 26 from interfering with the moveable linking member 42 and other moveable structures. Many exercises are possible within the first exercise area 14 . These exercises are accessible to the user confined to a wheelchair. Referring now to FIGS. 10 to 18 , the wheelchair accessible exercise device 10 provides further exercises within the second exercise area 18 . The second exercise area 18 includes a pair of supports 58 , 58 ′ extending generally horizontally from a tower 60 of the device 10 . The supports 58 , 58 ′ define an open area therebetween, which can receive the wheelchair 26 . One of the supports 58 ′ is hingably secured to the tower 60 . The user may pivot the support 58 ′ by moving the handles 62 . The user may pivot the support 58 ′ when entering or leaving the second exercise area 18 . In other examples, both supports 58 , 58 ′ may pivot relative to the tower 60 . Handles 62 extend vertically upward from the supports 58 , 58 ′. A lap pad 68 is hingably connected to the supports 58 . The lap pad 68 can be rotated to lift the lap pad 68 vertically. This allows user to enter the second exercise area 18 . When the wheelchair 26 and user are properly positioned within the second exercise area 18 , the user rotates the lap pad 68 from the position in FIG. 10 to the position in FIG. 11 , where the lap pad 68 rests on a lap of the user (or knees) of the user in the wheelchair 26 . The user then rotates the support 58 in a direction S ( FIG. 12 ) such that a bar 70 of the lap pad 68 is received within an aperture 72 defined within a plate 76 of the support 58 ′. The plate 76 limits movement of the lap pad 68 so that the lap pad 68 provides a suitable support during exercises within the second exercise area 18 . Notably, no support structure extends between the user&#39;s legs, such structure could potentially interfere with the wheelchair 26 entering the second exercise area 18 . If a vertical height adjustment of the lap pad 68 is required, the supports 58 , 58 ′ may be adjusted between one of several positions on the tower 60 by selectively engaging with one of several apertures 74 . After the user has appropriately positioned themselves within the second exercise area 18 , the user may adjust a location of the adjustable pick 22 . In this example, the user presses one of two buttons 78 positioned on each of the supports 58 , 58 ′ to adjust the vertical height of the adjustable pick 22 . Actuating the button 78 causes a motor 84 to rotate and move a belt 80 (see FIGS. 19 to 21 ). Opposing ends of the belt 80 are attached to the adjustable pick 22 . Rotating the belt 80 causes the adjustable pick 22 to move vertically up and down along a track or rail 86 . The adjustable pick 22 is effectively infinitely adjustable between a lowest position that is, in this example, below the knees of the user (see FIG. 17 ) to a vertically highest position that is well above a head of the user (see FIG. 16 ). Notably, the user is not required to stand or get out of the wheelchair 26 when adjusting the adjustable pick 22 to a desired position, even if that position is well above the head of the user. As can be appreciated, various exercises may be performed using a cable 88 that is attached to the weight stack 44 . Example exercises include the overhead rope pull shown in FIG. 15 and the chest pull shown in FIG. 16 . During the overhead rope pull of FIG. 15 , a back of the wheelchair 26 may be positioned against the lap pad 68 to stabilize the user. Other example exercises include the bicep curl shown in FIG. 17 and the bicep curl shown in FIG. 18 . The bicep curl of FIG. 18 does not require the lap pad 68 to be engaged within the plate 76 of the handles 62 . Other exercise may not require the lap pad 68 to be engaged with the plate 76 . The adjustable pick 22 rides along the rail 86 when moved by the motor 84 and the adjustment belt 80 . The example belt 80 is a toothed belt, which helps avoid slippage of the motor 84 on the rail 86 . The motor 84 turns a sprocket 82 to drive the belt 80 . The cable 88 loops over the top of the belt 80 through two horizontally spaced guide pulleys 90 . Features of the disclosed examples include an automatically, infinitely adjustable pick point location. Also, two primary belts and a single weight stack are used for effectively three machines—a row, chest press, and overhead press. The adjustable pick exercises are also off of the same weight stack. A single user, such as a user seated within a wheelchair, can complete an effective workout, including making desired adjustments to weights and positions, without requiring a spotter or training partner. The preceding description is exemplary rather than limiting in nature. Variations and modifications to the disclosed examples may become apparent to those skilled in the art that do not necessarily depart from the essence of this disclosure. Thus, the scope of legal protection given to this disclosure can only be determined by studying the following claims.

An example apparatus for a user in a wheelchair includes an exercise device providing an exercise area configured to receive a wheelchair. A primary handle is moveable by a first user in the wheelchair from a first position to a second position. A resistance assembly opposes movement of the at least one primary handle. A spotter handle is coupled to move together with the at least one primary handle. The spotter handle accessible by a second user from a position outside the exercise area. An example exercise device for a user in a wheelchair includes an automatically adjustable pick.

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application claims the priority benefit of U.S. Provisional Patent Application 62/169,097 filed Jun. 1, 2015, which is hereby incorporated herein by reference. BACKGROUND [0002] In slaughtering poultry, it is common to first stun the poultry, then kill the stunned poultry, and then to process the killed poultry. In stunning the poultry, it is desirable to avoid damaging the poultry tissue and to minimize movement of the poultry. [0003] In known prior stunner systems, a pulsating low DC voltage has been applied. The pulsating DC voltage, usually in the 10-14 volt range for chickens, 14-18 volts for small turkeys, and 30-35 volts for larger turkeys, works well for most poultry processors. However such pulsating DC voltages are not acceptable for those localities requiring a so-called “stun-to-kill” approach. [0004] In general, most stunners used outside North America are based upon a design developed in Western Europe. These European stunners operate as “water bath” stunners. This means that the birds&#39; heads and necks are dragged through a tank of electrically charged water. This results in a very inconsistent stun, and, when combined with European style killing machines which cut only one side of the bird&#39;s neck, results in birds still being alive when reaching the scalder. This is the main reason that many European countries now require the “stun-to-kill” practice. [0005] However, when a bird is killed in a stunner with electrical current, there is a very strong possibility of causing damage to the carcass, such as broken bones and hemorrhaging of blood vessels. Poultry processors have been looking for alternative stunning methods to improve the “stun-to-kill” procedure so that the birds can be stunned with less resulting product damage. [0006] U.S. Pa. No. 6,019,674 of Simmons provided a step forward in the art. As described in his patent, a saline solution is contained in an elongated trough, which is mounted at the end portions of four non-electronically conducting posts. The trough is filled with saline solution. The trough has an ingress funnel arrangement designed to control the thrashing of to-be-electrically stunned birds and an elongated grid having a portion immersed in the solution and a downstream portion out of the solution. The four posts extend upwardly and terminate in threaded portions. A frame carriage is provided which has four corners, and at the four corners are suitably mounted driven gears with internal bores and threads adapted to engagingly rotate about the threaded portions of the ports. The carriage is suitably affixed to a conventional I-beam to which is movingly mounted a conventional endless cable and space shackle system for conveying birds in an upside down manner. The four mounted gears are rotatable in unison by a chain drive which may be manual, hydraulic, pneumatic or electric, whereby the trough may be selectively moved upwardly or downwardly as found necessary to vary the distance between the said I-beam and said trough to accommodate different sized shackles and/or birds. [0007] The trough has a short extension bolted there onto to provide a first section and a second section. Both sections include a grate through which and across the top there of the bird&#39;s head is dragged. [0008] In the first section, a pulsating DC current operating at a relatively low voltage (9-30 volts) is applied via an electrical connection, such that electricity is applied to a grate in each section. The overhead shackle line carrying the birds is at a polarity which is opposite to the polarity of electricity being supplied to the stainless steel surface submerged in saline solution and the trough. In the second section, a low AC current operating at about 30 volts is applied via the electrical connection between the shackles and the trough. The second section of the extension is electrically isolated from the first section of the main or first section of the trough. The speed of the conveyer is such that the poultry are subjected to the low voltage AC current in the extension for a period of only about two to three seconds. [0009] While the apparatus and method described in U.S. Pat. No. 6,019,674 are effective to stun a bird such that it is unconscious, the bird is likely to still exhibit undesirable involuntary motion. SUMMARY OF THE INVENTION [0010] According to an illustrative embodiment, a DC voltage/current is applied for initial stunning, followed by an AC voltage/current to immobilize poultry and to further relax the muscles of the stunned poultry, such that the poultry does not exhibit involuntary motions, while at the same time avoiding or minimizing damage to the poultry tissue. [0011] In one example embodiment, an apparatus comprises a poultry stunning apparatus, including an electrical control module configured to apply a DC current to the poultry at a voltage sufficient to stun the poultry and to apply AC current to the stunned poultry at a voltage and for a period of time sufficient to immobilize and relax the muscles of the stunned poultry, while at the same time avoiding or minimizing damage to the poultry tissue. [0012] Optionally, the AC current is applied at a medium voltage of between about 60 and 250 VAC. Preferably, the AC current is applied at a voltage of between about 60 and 130 VAC. Most preferably, the AC current is applied at a voltage of between about 70-90 VAC. [0013] Preferably, the AC voltage/current is applied with a dwell time between about 2 and 5 seconds. [0014] Optionally, the AC voltage/current is applied at a frequency of about 50-60 Hz. [0015] In another example embodiment, the invention relates to a method for stunning poultry, including the steps of applying a DC current to poultry at a voltage sufficient to stun the poultry; and applying an AC current to the stunned poultry at a voltage and for a period of time sufficient to immobilize and relax the muscles of the stunned poultry, while at the same time avoiding or minimizing damage to the poultry tissue. BRIEF DESCRIPTION OF THE DRAWINGS [0016] FIG. 1 is a top view of a stunning apparatus according to an example embodiment of the present invention. [0017] FIG. 2 is a side view of a stunning apparatus according to FIG. 1 . [0018] FIG. 3 is an end view of a stunning apparatus of FIG. 1 . [0019] FIG. 4 is a perspective view of a stunning apparatus according to an example embodiment. [0020] FIG. 5 is a perspective view of a stunning apparatus of FIG. 4 . [0021] FIG. 6A is a perspective view of an electronics housing portion of the stunning apparatus of FIG. 1 and contents thereof. [0022] FIG. 6B is a schematic view of a wiring diagram of the electronics housing and contents thereof of FIG. 6A . [0023] FIG. 7 is a schematic flow chart of a method of operation of the stunning apparatus of FIG. 1 . DETAILED DESCRIPTION [0024] With reference now to the drawing figures, wherein like reference numbers represent corresponding parts throughout the several views, FIGS. 1-5 show a direct current/alternating current poultry stunning and immobilizing apparatus 10 according to an example embodiment of the present invention. The device generally includes a stunner cabinet 11 , an overhead support frame 12 , and kill line shackles 13 attached to a pre-existing overhead track 14 . Such an overhead track 14 is a common feature in many poultry processing plants. [0025] According to an illustrative embodiment, an apparatus and method are provided for applying a low voltage DC current to poultry to stun the poultry and then applying an AC current to the poultry at a sufficient voltage and for a sufficient period of time to immobilize the poultry without damaging the tissue. [0026] Referring to FIGS. 1 and 2 , which show a top and side view of the poultry stunning device 10 , show the stunner cabinet 11 which forms an elongated U-shaped basin (see FIGS. 3-5 ). The stunner cabinet 11 is open at each end to allow poultry to enter the cabinet 11 at a first end and exit at the second end. The cabinet 11 includes a DC stunner portion 17 , situated near the first end of the cabinet, and an AC stunner portion 27 , situated near the second end of the cabinet. The DC stunner portion 17 includes a recessed area capable of retaining water. The DC stunner portion 17 also includes a DC stunner contact grate 18 . In example embodiments, the DC stunner grate 18 is positioned at the bottom of the recessed area of the DC stunner portion 17 . The AC stunner portion 27 likewise includes an AC stunner contact grate 28 . The DC stunner grate 18 and the AC stunner grate 28 are made of electrically conductive material, such as stainless steel. The DC stunner contact grate 18 and the AC stunner contact grate 28 are electrically isolated from each other. The power supplies coupled to the DC stunner contact grate 18 and the AC stunner contact grate 28 are protected, for example, by a NEMA 4x stainless steel enclosure. [0027] The stunner cabinet 11 also includes a salt water injection system 31 located in the DC stunner portion 17 . The salt water injection system 31 is designed to fill and maintain a level of salt water in the recessed area of the DC stunner portion 17 . The salt water injection system 31 can include an optional electronic control to ensure the salt water contains the proper saline level for delivering electric current. The cabinet 11 can include an optional pneumatic adjustment system to adjust the height of the cabinet 11 such that it can accommodate a variety of types and sizes of poultry. [0028] The apparatus 10 also includes an overhead support frame 12 to support an existing overhead track. The overhead support frame 12 supports an overhead conveying track to which kill line shackles 13 are connected, as shown in FIGS. 2 and 3 . The kill shackles 13 are made of electrically conductive material and are designed to support poultry in an inverted position so that the bird hangs upside down with the bird&#39;s head oriented toward the bottom of the stunner cabinet 11 . The overhead support frame 12 and overhead track 14 are suitably affixed to a guide bar system 15 , which is movingly mounted to a conventional endless cable and space shackle system for conveying birds in an upside down manner in a manner understood by those skilled in the art. Optionally, an insulated rump bar and breast bar can also be used to support and hold poultry in an inverted position. In other embodiments, the apparatus can include an optional guide bar kit for accommodating plastic shackles. [0029] The apparatus 10 can be of a modular construction which allows for additional sections to be added without replacing the entire system. The apparatus can also include a digital display and/or a voltage data logger. [0030] As shown in FIGS. 6A and 6B , the stunner control panel consists of a NEMA 4X stainless steel enclosure containing (2) Simmons DC power packs and (1) Simmons AC power pack. Also included in the panel is (1) power conditioner and (1) primary/secondary DC power pack selector switch. [0031] The DC power pack operates by converting standard AC voltage (115-120 VAC) to low voltage high frequency DCV. The DC voltage and amperage are displayed through a digital display located on the face of the DC power pack enclosure. The DC power pack also includes a variable transformer to raise or lower the voltage going to the DC stunner grate and an on/off switch. The AC power pack uses standard AC voltage as an input (115-120 VAC). The applied voltage is displayed through a digital display located on the face of the AC power pack enclosure. The AC power pack also includes a variable transformer to raise or lower the voltage going to the AC stunner grate and an on/off switch. [0032] The stunner controller operates to control the DC and AC voltages applied to the bird, as described herein. [0033] In operation, the legs of poultry are connected to the kill line shackles 13 , and the poultry is conveyed upside down along the overhead track 14 from the DC stunner contact grate 18 towards the AC stunner contact grate 28 . The salt water injection system 31 injects a sufficient amount of salt water into the DC stunner section 17 of the stunner cabinet 11 such that, as the poultry is conveyed along the overhead track 14 , the head of the poultry is sufficiently submerged in the salt water to cause an electrical connection for a pulsating DC current to flow from the DC stunner grate 18 to the kill shackles 13 . This electrical connection enables the pulsating DC current to flow through the poultry such that the poultry is stunned effectively. [0034] According to an illustrative embodiment, as the poultry is conveyed toward the AC stunner contact grate 28 , the head of the poultry emerges from the salt water solution. As the head of the poultry comes into contact with the AC stunner contact grate 28 , the head of the poultry is damp enough to create an electrical pathway through the poultry for the AC current to flow from the AC stunner grate 28 to the kill shackles 13 , such that the poultry is immobilized. [0035] The strength (voltage) of the DC current, the strength (voltage) of the AC current, and the dwell time of the AC current may be varied depending upon, e.g., the size of the poultry, etc. For example, the DC current may be applied as a pulsating square wave with peaks between zero volts and about 60 volts (0 VDC and 60 VDC). Preferably, the DC voltage is cycled as a square wave with a frequency of about 500 Hz (cycles per second), with a duty cycle of about 25%, resulting in an average DC voltage of about 15 VDC. [0036] Optionally, the AC current is applied at a medium voltage of between about 60 and 250 VAC. Preferably, the AC current is applied at a voltage of between about 60 and 130 VAC. Most preferably, the AC current is applied at a voltage of between about 70-90 VAC. [0037] Ideally, the lowest AC current is about 70 VAC. It should be appreciated that lower AC currents may also work to immobilize the poultry, but not as effectively. Preferably, the dwell time (time of application of the AC current) is between about 2 and 10 seconds, and most preferably is between about 2 and 5 seconds. Preferably, the AC current is provided at a frequency of about 50-60 Hz. [0038] According to an illustrative embodiment, the application of DC current followed by AC current in the manner described above is effective to stun and then immobilize poultry and to relax the muscles of the stunned poultry, while at the same time avoiding or minimizing damage to the poultry tissue. This results in a generally “irreversible stun” from which poultry would not normally recover. [0039] In a preferred form, the present invention relates to a method 50 as shown in FIG. 7 , in which according to a first step 51 the bird is passed through the stunner apparatus. In the second step 52 , the DC voltage is applied to stun the bird. In the third step 53 , the AC voltage is applied to immobilize the bird. And in the fourth step 54 , the bird exits the stunner apparatus.

A poultry stunning apparatus and method, the apparatus including an electrical control module configured to apply a DC current to the poultry at a voltage sufficient to stun the poultry and to apply AC current to the stunned poultry at a voltage and for a period of time sufficient to immobilize and relax the muscles of the stunned poultry, while at the same time avoiding or minimizing damage to the poultry tissue. In the method, DC voltage/current is applied for initial stunning, followed by an AC voltage/current to immobilize poultry and to further relax the muscles of the stunned poultry, such that the poultry does not exhibit involuntary motions, while at the same time avoiding or minimizing damage to the poultry tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS N/A BACKGROUND OF THE INVENTION 1. The Field of the Invention The present invention is generally related to puzzles, brain teasers, mind bogglers or benders, magic tricks, or the like. In particular, the present invention provides a device configured to give the illusion that a rubber band or other elastic apparatus is hooked or otherwise captured within a housing device, wherein the operation of hooking or catching the rubber band is virtually and/or conceptually impossible. 2. Background and Related Art While the invention is subject to a wide range of applications, it is especially suited for use as a puzzle, brainteaser, mind boggler or bender, magic trick, or the like, and will be particularly described in these contexts. In the area of entertainment, there is always a need for new devices that the public might find intriguing. For example, magicians are always looking to find new tricks to add to their repertoire and/or people are continually entertained with new puzzles or mind boggling devices. For such novelty items, simple use and inexpensive manufacturing costs are always a concern. Accordingly, it is an object of the present invention to provide an illusion device that is simple to use. Further, it is an object of the present invention to provide an illusion device that is inexpensive to manufacture. BRIEF SUMMARY OF THE INVENTION In order to meet the above-identified objectives, the present invention provides a method and device that give the illusion that a rubber band or other elastic apparatus is hooked from within a base unit using a rod, wherein actually hooking the elastic apparatus within the base unit is virtually and/or conceptually impossible. For example, in a first example embodiment an opposite end of the rod is inserted at least partway into the hole of a base unit using the handle end of the rod. The base unit gives the appearance that the elastic device is attached to and extending within the hole thereof. The inserted opposite end of the rod is then pulled partially out of the base unit using a handle end of the rod. Next, before the opposite end of the rod is exposed in viewable sight, at least two of a user&#39;s fingers are pressed together on substantially opposing sides of the handle end of the rod in order to forcibly snap the rod back into the base unit giving the illusion that the rod slipped from the user&#39;s fingers due to an opposing force from the elastic apparatus pulling on the opposite end of the rod from within the base unit. In another exemplary embodiment, a device for use in creating the illusion as if a rod has hooked an elastic apparatus from within a hole of a base unit is provided, wherein the actual hooking of the elastic apparatus within the base unit is virtually impossible. The device comprises an elongated base unit with a hole therein running substantially parallel to its length. Further, an elastic apparatus having the appearance that it extends at least partway into the hole of the base unit and is attached thereto is provided. Moreover, the device comprises a rod with a handle end and an opposite end. The handle end is used to insert the opposite end at least partway into the hole of the base unit and also used to partially extract the opposite end from the hole, wherein the handle end of the base unit is formed such that when a user&#39;s fingers apply pressure on substantially opposite ends thereof, the rod slips from the user&#39;s fingers and forcibly snaps into the base unit giving the illusion that the rod slipped from the user&#39;s fingers due to an opposing force from the elastic apparatus pulling on the opposite end of the rod from within the base unit. Additional features and advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the invention. The features and advantages of the invention may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS In order to describe the manner in which the above-recited and other advantages and features of the invention can be obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: FIG. 1 illustrates an example illusory snap puzzle or device that can be used in accordance with exemplary embodiments of the present invention; FIGS. 2A-2D illustrate a method of using the illusory snap puzzle or device in accordance with exemplary embodiments of the present invention; and FIG. 3 illustrates another example illusory snap puzzle or device in accordance with exemplary embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention extends to methods and/or devices for creating the illusion as if a rod has hooked an elastic apparatus within the hole of a base unit, even though the hooking of the elastic apparatus is virtually and/or conceptually impossible. FIG. 1 illustrates an example of a puzzle or device 100 that may used to perform the above described illusion in accordance with exemplary embodiments of the present invention. The puzzle or device 100 includes a base unit 125 that has an elongated hole 120 running substantially parallel to the base unit&#39;s length. It should be noted, that although the present invention describes the base unit 125 as elongated and the relationship of the hole 120 in accordance therewith, the present invention is not restricted to any shape and/or relative size of the base unit 125 with relationship to the hole 120 . For example, the base 125 , rather than a rectangular block as shown in FIG. 1 , may be a square cube with the hole 120 running substantially parallel along on of the sides. Accordingly, any specific shape and/or relative size of the base unit 125 in relationship to the hole 120 therein is used for illustrative purposes only and is not meant to limit or otherwise narrow the scope of the present invention unless explicitly claimed. Regardless of the shape and/or relative size of the base unit 125 and the relationship of the hole 120 thereto, an elastic apparatus 130 is also provided that extends at least partway into the hole 120 of the base unit 125 , as shown in FIG. 1 . In this example, the material used to make the base unit is a nontransparent material such as wood, metal, ceramic, stone, fiberglass, or other similar nontransparent material. Accordingly, a portion of the elastic apparatus, e.g., a rubber band, should extending from the hole 120 outside of the base unit 125 in order to give the illusion that the elastic apparatus 130 extends within the hole 120 of base unit 125 . Because in this example embodiment the inside of the hole 120 in the base unit 125 for nontransparent materials cannot be viewed by the naked eye, whether or not the elastic apparatus 130 actually extends fully within the hole 120 of the base unit 125 is not of critical concern. Accordingly, in this embodiment, it is sufficient to give the illusion as if the elastic apparatus 130 extends fully within the hole 120 . In any event, as will be described in greater detail below, if the elastic apparatus 130 actually extends fully within the hole 120 of the base unit 125 , the device 100 should be configured such that the elastic apparatus 130 cannot be hooked using the rod 105 of the puzzle or device 100 described below. The rod 105 has a handle end 110 and an opposite or insertion end 115 . The handle end 110 is used to insert the rod 105 (and in particular the opposite or insertion end 115 ) into hole 120 of the base unit 125 . The opposing or insertion end 115 of the rod 105 will typically be formed in the shape of a hook. This enhances the illusion that the rod 105 is actually capable of hooking the elastic apparatus 130 within the base unit 125 . Note, however, that the present invention is not limited to any specific shape or form of the opposite or insertion end 115 . For example, the insertion end may be flat, for boggling or intriguing the mind even more as to how such a device could actually hook a rubber band or elastic apparatus 130 . Accordingly, any specific shape of the opposite or insertion end 115 as described herein is used for illustrative purposes only and is not meant to limit or otherwise narrow the scope of the present invention unless explicitly claimed. It should be noted that typically the diameter of the hole 120 will be just slightly larger than the diameter of the rod 105 . The present invention, however, is not limited to any specific hole 120 diameter relative to shaft 107 and/or opposite end 115 of the rod 105 diameter. Further, the present invention is not limited in the shape of shaft 107 and/or hole 120 (e.g., the shape of the shaft 107 and/or hole 120 may be triangular); however, the shaft 107 , opposite or insertion end 115 , and/or hole 120 should be of such shape and/or relative sizes such that the shaft 107 of the rod 105 can be sufficiently inserted into the hole 120 of the base unit. An important aspect to note, however, is that regardless of the shape and/or sizes of the shaft 107 , opposite or insertion end 115 , and/or hole 120 , any portion of the elastic apparatus 130 that extends within the base unit hole 120 should be virtually impossible to hook with the rod 105 ; otherwise the illusion described below no longer exists. For example, if the elastic apparatus 130 fully extends into the hole 120 and the shaft 107 of the rod 105 is long enough such that the opposite or insertion end 115 of the rod 105 can come into actual contact with the elastic apparatus 130 , the opposite or insertion end 115 of rod 105 should be large enough in diameter such that when inserted within the hole 120 of the base unit 125 the insertion end 115 pushes the elastic unit 130 down into the base unit 125 . In other words, the diameter of the opposite or insertion end 115 should be sufficiently larger to ensure that the opposite or insertion end 115 is not actually capable of hooking the elastic unit 130 , for this would frustrate the overall illusion. Alternatively, if only a small or unsubstantial portion of the elastic apparatus 130 extends within the hole 120 of the base unit 125 —and/or if the length of the shaft 107 is short in length—such that the opposite or insertion end 115 never comes into actual contact with the elastic apparatus 130 —then the size of the opposite or insertion end 115 of the rod 105 and/or shaft 107 relative to the hole 120 should not make a significant difference in performing the illusion of the present invention. Accordingly, as one would recognize, there are a wide variety of shapes and/or sizes for the hole 120 , the shaft 107 of the rod 105 , the opposite or insertion end 115 of the rod 105 , relative to each other. Furthermore, the placement of the hole 120 and shaft 107 of the rod 105 relative to base unit 125 and handle 110 , respectively, may also vary. In accordance with one embodiment, and as shown in FIG. 1 , the hole 120 and shaft 107 of the rod 105 are off center of the base unit 125 and handle end 110 , respectively. Accordingly, this has the added benefit of giving the illusion that a particular way of twisting the handle end 110 , as described in greater detail below with regard to FIGS. 2A-2D , relative to the base unit 125 actually causes the elastic apparatus 130 rubber band to be hooked. Note, however, that any particular placement of the hole 120 and/or shaft 107 relative to the base unit 125 and/or handle 110 , respectively, are used herein for illustrative purposes only and are not meant to limit or otherwise narrow the scope of the present invention unless explicitly claimed. Regardless of the shapes, sizes, and/or offsets or positions of the handle, shaft 105 , opposite or insertion end, 115 , and/or hole 120 , the handle end 110 should be formed (e.g., the pyramid shape shown in FIG. 1 ) such that when a user&#39;s fingers apply pressure on opposing or substantially opposing sides of the handle 110 , the handle 110 slips from the fingers forcing the rod 105 into the hole 120 of the base unit 125 . Note, however, that the present invention is not limited to any specific shape for the handle 110 . For example, rather than the pyramid shape shown in FIG. 1 , the handle end 110 of the rod 105 may be in the form of many shapes such as spherical, conical (e.g., circular cone, frustum circular cone, general cone, etc.), wedge shaped, substantially square, cylindrical, etc. It should be noted, however, for best results the handle should be formed such that (as described in greater detail below) the rod easily slips from the fingers of a user when pressure is applied to opposing ends of the handle. FIGS. 2A-2D illustrate a method of giving the illusion that an elastic apparatus is hooked using a rod inserted into a base unit as described above. As shown in FIG. 2A , the base unit 225 is retangular in shape and has a hole (not shown) that extends substantially parallel to its length within the base unit 225 . An elastic apparatus (for example, a rubber band) has the appearance of extending within the hole of the base unit 225 (or may actually extend within the hole of the base unit 225 as previously described). The left (or right) hand of a user 225 firmly grips the base unit 225 . The rod 205 has an opposite or insertion end 215 and a handle end 210 . In this example, the handle end is the shape of a pyramid for ease in slipping from the fingers, as described below. A user&#39;s right (or left) hand 240 grips the handle end 210 using at least two fingers (shown here as the index and thumb fingers) the user then inserts the rod 205 into the base unit as shown by arrow 235 . Once the user has inserted the rod 205 at least partway into the hole of the base unit 225 , the user may then make motions with the hands such as a rotation and/or slight up and down movement of the rod 205 or handle end 210 relative to the base unit 225 . This has the added effect of giving the illusion that some manipulation of the rod 205 can be performed to actually hook the elastic apparatus 230 . As previously mentioned, this feature may be enhanced when the hole in the base unit 225 and the shaft of the rod 205 are slightly off center of the base unit 225 and handle end 210 , respectively. Regardless of whether the above manipulation operation is performed, after inserting the rod 235 at least partway into the base unit 225 using the handle end 210 , the user then begins to extract the rod 205 from the base unit 255 as shown by arrow 255 in FIG. 2B . For optimum illusory results, this extraction motion 255 should slow down the further the rod is extracted from the base unit 225 . Before the opposite or insertion end 215 can be visibly seen, the user then applies pressure, as shown in FIG. 2C , on opposing ends or substantially opposing ends of the handle end 210 of the rod 205 , as indicated by the arrows 250 . The force of the pressure should be sufficient such that, as shown in FIG. 2D , the handle end 210 slips from the fingers forcing the rod into the base unit 225 —as indicated by arrow 265 —snapping 260 the handle end 210 against the base unit 225 . Accordingly, this gives the illusion as if it was the elastic apparatus 230 was hooked to the opposite or insertion end 215 of the rod and the opposing force of the elastic apparatus 230 caused the handle end 110 of the rod 205 to slip from the user&#39;s fingers 240 and force the rod 205 into the base unit 225 . FIG. 3 illustrates an alternative embodiment wherein at least the base unit 325 of illusory snap device 300 is made from a translucent or partially transparent material such as glass, plastic, or other similar transparent or partially transparent material. In this embodiment, the elastic apparatus 330 does not necessarily need to extend beyond the end of the base unit 325 . Instead, because the elastic apparatus 330 can clearly or partially be seen within the hole 320 of the base unit 325 , it is not necessary for the end thereof to extend beyond the base unit 325 . It may be important, however, to give the appearance that the elastic apparatus 330 is securely fastened within the base unit 325 . For example, a portion 335 of the elastic apparatus 330 may be formed beyond the base 340 of the hole 320 , such that the end 335 of the elastic apparatus 330 is formed and secured by the base unit 325 . Of course, other means for securing the elastic unit within the transparent base unit are also available to the present invention. For example, the hole 320 may be extended all the way through the base unit 325 , as was shown with regards to FIG. 1 . In such instance, a plug or other device may be used to secure the rubber band to the base unit 325 , and a portion of the elastic apparatus 330 may extend beyond the base unit 325 . Accordingly, any method or means for giving the appearance that elastic apparatus 330 is secured to the base unit 325 is used herein for illustrative purposes only and is not meant to limit or otherwise narrow the scope of the present invention unless explicitly claimed. In this embodiment, as in other embodiments, the handle end 310 , shaft 307 , and/or opposite or insertion end 315 of the rod 305 may or may not be made of a similar transparent or semi translucent material as the base unit 325 . It should be noted, however, that when such transparent or semi translucent base unit 325 is used, that in order for the illusion to appropriately be applied, the user should take special care in covering that portion of the base unit 325 that the rod 305 is inserted into during the above illusion performance. For example, the user may use her/his hand to cover up that portion of the base unit 325 that the opposite or insertion end 315 is inserted into. Alternatively, the user may cover the base unit 325 with a nontransparent sleeve (not shown) or other device to cover the view of the opposite or insertion end 315 such that one cannot see that the elastic apparatus 330 is not actually hooked by the rod 305 as previously described. The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

The present invention provides the illusion that an elastic apparatus is hooked from within a base unit, wherein actually hooking the elastic apparatus is virtually impossible. An opposite end of a rod is inserted at least partway into a hole of a base unit using the handle end of the rod. The base unit gives the appearance that the elastic device is attached to and extending within the hole thereof. The inserted opposite end of the rod is then pulled partially out of the base unit. But before the opposite end of the rod is exposed in viewable sight, two of a user's fingers are pressed together on substantially opposing sides of the handle end in order to forcibly snap the rod back into the base unit giving the illusion that the rod slipped from the user's fingers due to an opposing force from the elastic apparatus.

CROSS-REFERENCE TO RELATED APPLICATIONS This document, filed under 35 USC 111 and 37 CFR 1.53(b) as a continuation of the United States Patent Application that was filed on Sep. 11, 2008, bearing the title of REFRESHMENT TOWEL AND APPLIED SOLUTION, assigned Ser. No. 12/208,944 and issued as U.S. Pat. No. 8,182,826 on May 22, 2012, which patent claims the benefit of the filing date of the United States Provisional Application for Patent that was filed on Sep. 11, 2007 and assigned Ser. No. 60/971,436 BACKGROUND OF THE INVENTION It&#39;s hot, dang hot! Africa hot! Tarzan couldn&#39;t take this kind of heat! This paraphrase of probably the only memorable quote from the movie Biloxi Blues needs no explanation, especially if you have ever tried to accomplish anything outdoors in a southern state in the middle of the summer heat. We have all experienced moments where this quote could be used. Whether on the golf course, sitting in a baseball stadium, sitting on the sidelines while your child is playing soccer, mowing the grass, an outdoor wedding, changing a flat tire, or the like, there are just times that are almost unbearable. However, if you are an outdoors type of person and you refuse to be imprisoned in your nice air-conditioned home by the summer heat, you most likely have had, and will have, moments when you simply need some relief. People have found themselves in these situations time and time again. Hence, a typical scene in western movies is a sweat drenched, dusty cowboy dunking his head into the horse trough to cool down. This may seem like a refreshing step but, if you have ever raised horses, you will appreciate that a horse trough is certainly no place to be sticking your head. In fact, choosing between the options of a heat stroke or sticking your face into the slimy, grime that floats around in a horse trough is a tough call. Other, less dramatic techniques have also been employed such as, seeking the shade of a tree, building a fan by folding a piece of paper, putting a cold beverage to your forehead, running through the water sprinklers, retreating to an air-conditioned room, stepping in front of a fan, or wetting a towel to put over the back of your neck. The human body also has its own solution—sweat glands (or if you are a lady, glow glands). It is well known that as a liquid evaporates, it helps to eradicate heat. This is the purpose of your sweat—it helps to keep your body cool. As sweat evaporates from the surface of your skin, excess heat is removed and as a result, you are cooled. This phenomenon is based on the principle in physics which basically states that a certain amount of heat needs to be applied to a liquid in order for that liquid to evaporate—pass from a liquid form to a vaporous or gaseous form. This amount of heat is referred to as the heat of vaporization. The basis of this principle is that as the heat energy increases the speed of the water molecules also increase. Once the speed of the water molecules reaches a certain speed, they can escape into the air. The heat energy for this process is provided by your body. Thus, the heat used to evaporate sweat is then used up which in turn operates to cool your body down. This all works quite well in a nice dry environment, however, when you are in a highly humid environment, things begin to break down. First of all, the air in a highly humid environment is already near saturation and thus, cannot absorb much additional water vapor. Thus, the sweat cannot evaporate and you remain hot, and now, a sweaty mess. The troubles one finds in the heat of the summer don&#39;t stop there. First of all, as bacteria on your skin mixes with your sweat, you begin to emit noxious odors. Furthermore, the bugs and insects that once would hit and bounce off of you now have a tendency to hit and stick. Trying to stay in such conditions is not only a matter of comfort. As salt and sodium exits your body in your sweat, you can quickly dehydrate which can lead to circulatory problems and heat stroke. It is important to ensure that you do not overheat, especially in hot humid environments. Thus, there is a need in the art for a device to assist in the cooling down of an individual. Because many of the activities that occur outside are athletic in nature, it is not convenient to carry around products typically necessary to help a person stay cool, such as fans, ice, etc. Thus, there is a need in the art for a device that is compact, easy to carry and assists in the cooling down of an individual. Further, corporate and promotional events are often centered around outdoor activities such as a golf tournament, a concert, or a resort. Consequently, there is a need for corporate sponsors to offer their invitees an inexpensive, sanitary, and convenient way to cool off, repel insects, and stay productive while capitalizing on the opportunity to build and enhance brand awareness through a simultaneous dissemination of a trademark, banner, or logo. Other issues that arise in the summer outdoors can also be a nuisance. For instance, if you go too far south in the state of Georgia, you cross the well known Gnat Line. Below the Gnat Line one is constantly attacked by what some refer to as the Confederate Air Force designed to keep the Yankees away. The fact of the matter is, however, that in the southern states, insects are more prevalent. And to further exasperate matters, most insects, especially gnats, are attracted to moisture. As a result, your sweaty face gets bombarded by a host of gnats. It would be of great benefit to have a device that not only cools a person down but that also could help to alleviate the nuisance from insects. Moreover, while gnats are truly annoying, a device with an insect repellant property is even more desirable when one considers the need to keep more sinister insects at bay, such as mosquitoes, which are prone to carrying and transmitting disease. In addition, as the world gets educated on the dangers of exposing your skin to the ultraviolet light of the sun, products with an associated Sun Protection Factor (SPF) have grown in popularity. Applying SPF rated products to the skin is imperative if you are working outdoors and prone to getting sunburns. Thus, it would be beneficial for a cooling device to also provide the application of an SPF rated product to the skin. Part of feeling refreshed obviously includes smelling fresh. Thus, it would be beneficial for a cooling device to also provide a fresh scent to an individual. Also, because many people have skin prone to drying and cracking, it would be beneficial for a cooling device to provide a means of skin rehydrating and softening. The various embodiments, features and aspects of the present invention, either by themselves or in conjunction with each other, address each of these needs in the art, as well as other needs in the art as described herein. BRIEF SUMMARY OF EMBODIMENTS OF THE INVENTION A refreshment towel with applied solution is an apparatus consisting of a carrying agent, most likely a high quality cotton towel or towelette, that has been saturated with an aqueous solution comprised of various ingredients. The resulting saturated towel can be rubbed on a user&#39;s skin such that the aqueous solution that has been absorbed by the towel is transferred. The aqueous solution is specially formulated so that desired sensory results take place when the towel comes in contact with the skin. One aspect of embodiments of the present invention is the aqueous solution, or the specific combinations thereof. In a preferred embodiment, the specially formulated aqueous solution contains, among other ingredients, a concentration of menthol and alcohol. The presence of the menthol and alcohol creates a cooling sensation to the user when it is applied to the skin. Additionally, menthol and alcohol are well documented as sterilization agents having anti-bacterial properties. Advantageously, a towel soaked in such a solution provides a means of cooling off without having to douse oneself with water, go inside where the air is conditioned, or just shed clothes. Further, the optional inclusion of essential oils and additives, in addition to the menthol and alcohol, can offer additional desirable properties such as sanitation, skin softening and moisturizing, fragrance, invigoration, alertness, relaxation, etc. Moreover, a quality towel can be weaved, stitched or embroidered to include a logo or other similar decorative items for the purpose of marketing and promotional giveaways. Additionally, embodiments of the invention can be easily packaged and stored until ready for use, after which the remainder is a useful towel or cloth product suited for everyday use. The uses for the various embodiments of the present invention are virtually limitless and quite varied. Almost universally, anybody in need of physically cooling off can make use of an embodiment of the present invention. Whether a person is just passing the time sitting on the back porch during a hot, balmy summer night, or dug in deep in a foxhole somewhere in the blistering Middle East while serving this great country, the present invention affords a convenient, compact, safe and sanitary way to get some relief from the heat, improve hygiene, or stay alert. Women suffering from “hot flashes” or in the throws of labor, hospital patients in need of physical comfort, missionaries spreading the Gospel in the hot, remote, bug infested corners of the earth, government workers and volunteers working to rebuild disaster areas, men and women of the armed forces exposed to the elements while selflessly defending our freedom, all can benefit from various embodiments of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a three dimensional block diagram intended to represent an exploded view of the components making up an exemplary embodiment of the present invention. FIG. 2 is a block flow chart diagram depicting an exemplary method of manufacture for a typical embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION The present invention, as well as features and aspects thereof, is directed towards providing a towel, or towelette, that is moistened with a solution which when applied to the body, can help to cool the body, warm the body, refresh the body and provide other beneficial effects as well. In general, embodiments of the present invention operate to help a subject, such as a person or animal, to stay cool, alert, relaxed, refreshed, and free from, or at least less bothered by, the pestering and biting of insects. In addition, some embodiments of the present invention can be used as promotional items for organizations and businesses to build brand awareness and loyalty by putting their customized logo on the embodiments of the invention, or the packaging thereof, and giving them away after different events and as gifts-awards. Furthermore, embodiments of the present invention have the added benefit of being suitable for other purposes after providing refreshment and cooling to the subject. More specifically, an exemplary embodiment of the present invention is in the form of a towel or other form of cloth that is soaked in a natural solution. The natural solution includes various ingredients to meet various needs or alleviate various problems. For instance, one embodiment of the present invention may include a carrying agent that is cloth-like in nature and fabricated from natural fibers including, but not limited to, 100% cotton, bamboo fabric, or even a nonwoven material, and saturated or moistened with a specially formulated aqueous solution containing natural products. It should be appreciated that one skilled in the art may choose any material capable of absorbing the aqueous solution, for the purpose of acting as a carrying agent. Once the cloth, or carrying agent, has been saturated with the aforementioned solution, the solution can be applied to a user by simply rubbing the cloth on the skin. Depending on the particular formulation of the aqueous solution, application to the user&#39;s skin can operate to perform one or more of the functions in the following non-limiting list: removing heat calories from the body; cooling the body down; providing a refreshing feeling; soothing a person; helping to awaken or keep a person alert; opening skin pores to enable the body to breathe better and cool more quickly; preventing insects from biting and pestering; moisturizing the skin so that it does not dry out; leaving a fresh scent; cleaning body parts; and/or sanitizing body parts or surfaces. Preferred embodiments of the present invention employ cotton towels as the carrying agent for the specially formulated aqueous solution. Cotton is a desirable natural fiber for use as the carrying agent because it is readily attainable, all natural, hypoallergenic, absorbent and recyclable. Further, a cotton carrying agent can be kept cool, cold, or frozen. It holds an aqueous solution extremely well and has long term holding ability without degradation. Further, a cotton carrying agent, such as a towel, potentially has long term appeal for usability by an end user as it may be employed for other uses once the aqueous solution it carries has been exhausted. Alternative uses for the towel after its initial purpose is a benefit for such a product when used for promotional purposes. For instance, the towel could be used as a golf towel, a wash cloth, dry towel, etc. Thus, it should be clear that embodiments that use a quality towel actually provide a dual use. As an alternative to cotton, bamboo fiber is used as a carrying agent in some embodiments of the present invention. One aspect of the present invention when using bamboo fiber as a carrying agent is the added benefit of enhanced absorption capacity. Bamboo has on the order of four times the absorption capacity of cotton and, therefore, is capable of carrying larger quantities of the aqueous solution. Consequently, a carrying agent made of bamboo fiber performs longer for its intended purpose as a carrying agent of the aqueous solution. Further, benefits of bamboo fiber as a carrying agent include the aspect that bamboo fiber has natural anti-bacterial agents useful for sanitation purposes. Also, bamboo affords a user natural UV protection. Advantageously, it is softer than cotton and is comparable in feel to cashmere or silk. In addition, similar to cotton, bamboo is environmentally friendly and a renewable resource. It can be kept cool or frozen. It holds an aqueous solution very well and has long term holding power without degradation. Finally, like cotton, a carrying agent made of bamboo fiber has long term appeal for usability by the end user. A towel made from natural fibers is the preferred carrying agent for a specially formulated aqueous solution that, when applied to an end user, can operate to impart a desirable sensation or condition. It should be noted that the present invention is not limited to the particular carrying agent, although the particular carrying agent may be considered novel in and of itself. For instance, the carrying agent may even include a nonwoven material, a squeeze bottle, a roll-on type bottle, a moisture stick delivery system such as a deodorant stick, or a spray-on bottle. One aspect of embodiments of the present invention is the essential oils and liquid mixture, herein called a specially formulated aqueous solution, coupled with a convenient delivery system, that benefit the user wishing to transfer or apply a solution to the skin. The present invention makes use of a standard foundational mixture from which various embodiments of the specially formulated aqueous solution may be achieved based on subsequent additions of essential oils and other ingredients. The foundational mixture common to most embodiments of the specially formulated aqueous solution is comprised of the following ingredients: Purified Water 70% to 95% Polysorbate 20 (CAS #9005-64-5) as solubiliser from 3% to 0.005% L-Menthol (CAS #89-78-1) as cooling agent from 4% to 0.005% Ethyl Alcohol (CAS #64-17-5) as solubiliser/cooling agent from 3% to 0.005% Isopropyl Alcohol (CAS #200-661-7) as Denaturant for ethyl alcohol from 3% to 0.005% Peg-6 Caprylic/Capric Glycedires (CAS #127281-18-9) Co-Solubiliser 1.5% to 0.005% Glycerine (CAS #56-81-5) Moisturizer 3% to 0.005% Phenagon PDI (Phenoxyethanol+DMDM Hydantoin+Iodoprophyl Butylcarbamat) Preservative 2.5% to 0.002% Or Phenonip (Phenoxyethanol+Methylparabens+Ethylparabens+Prophylparabens+Butylparabens) Preservative 3% to 0.002% The variations in percent concentrations for the ingredients of the foundational mixture to the aqueous solution are necessary to accommodate choices of subsequent custom additions and carrying agent characteristics. Advantageously, one ingredient of the foundational mixture is a natural moisturizer, glycerine, and serves to offset possible drying effects stemming from the presence of alcohols and menthols used to create cooling sensations or alleviate bacteria. Further, another standard ingredient found in the foundational mixture of the aqueous solution that is a component of the present invention, is a preservative used, advantageously, to give the invention a minimum two year shelf life when stored per the manufacturer&#39;s instructions. Once the foundational mixture has been formulated, additional ingredients are added in order to concoct an aqueous solution designed to deliver specific sensations to an end user. An exemplary formula of these subsequent additions to the foundational mixture includes the following elements: Lemon Grass Oil (CAS #8007-02-1) Essential oil (insect repellant, and refreshing) 5% to 0.005% Citronella Oil (CAS #8000-29-1) Essential oil (insect repellant, and refreshing) 5% to 0.005% Bergamot Oil (CAS #8000-75-8) Essential oil (invigorating and refreshing) 5% to 0.005% Grapefruit Oil (CAS #8016-20-4) Essential oil (refreshing, cleaning, &amp; fragrance) 5% to 0.003% The four additional ingredients in the exemplary additive solution outlined immediately above are dissolved in the foundational mixture described prior in order to create a specially formulated aqueous solution. The particular exemplary solution described thus far operates to not only cool an individual when applied to his or her skin (menthol and alcohol), but also to moisturize the skin (glycerine), generate a pleasant fragrance (Lemon Grass Oil, Citronella Oil, Bergamot Oil, Grapefruit Oil), and provide a degree of protection of insects (Lemon Grass Oil, Citronella Oil). Another aspect of embodiments of the present invention is the relative ease and safety of the application process whereby the specially formulized aqueous solution is transferred from the carrying agent to the skin of the user. Such an aspect is particularly beneficial when considered in light of the exemplary specially formulized aqueous solution described above, which contains elements included as a result of the insect repellent properties. More specifically, because the present invention affords the means to wipe insect repellent on the skin in a targeted fashion, these embodiments of the present invention avoid the need to use c spray-based delivery systems. Advantageously, natural ingredients with insect repellent properties that are used by the present invention can be safely applied to the face in a careful, targeted manner, unlike spray or squirt-based applicators that can cause insect repellent formulas to get into the eyes, ears, nose, and mouth. However, the various aqueous solutions may also be formulated for placement into a spray bottle or other delivery mechanisms if so desired. Other exemplary mixtures of additive ingredients combined with the foundational formula can create a specially formulated aqueous solution capable of treating a wide number of conditions or providing desirable effects including, but not limited to, relief from hot flashes, relief from sweat flashes, mitigation of foul odor, cleansing and sanitization of skin, changing of mood, and relief from stress. Further, various embodiments of the present invention may employ aqueous solution combinations designed to relax, calm, invigorate, raise awareness, heighten focus, or combat fatigue. Various combinations of the specially formulated aqueous solution component of the present invention may include any one, or a combination of, the elements listed below in addition to the elements outlined in the exemplary formula above: Peppermint Oil (CAS #68917-18-0) Essential Oil (refreshing and fragrance), 5% to 0.003% Tangerine Oil (CAS #8008-31-9) Essential oil (refreshing, cleaning, &amp; fragrance), 5% to 0.003% Lime Oil (CAS #8008-26-2) Essential oil (refreshing, cleaning, &amp; fragrance), 5% to 0.003% Eucalyptus Citriodora Oil (CAS #8000-48-4) Essential Oil (refreshing, winter time, and fragrance), 4% to 0.003% Eucalyptus Chinese Oil (CAS #68917-18-0 Essential Oil (refreshing, winter time, and fragrance), 4% to 0.003% Grapefruit Oil (CAS #8016-20-4) Essential oil (refreshing, cleaning, &amp; fragrance), 5% to 0.003% Lavender Oil (CAS#008000-28-0) Essential oil (refreshing &amp; fragrance), 5% to 0.002% Lemon Oil (CAS #84929-31-7) Essential oil (refreshing, cleaning, &amp; fragrance), 5% to 0.003% Orange Oil (CAS #8028-48-6) Essential Oil (refreshing, cleaning, &amp; fragrance), 5% to 0.003% Tea Tree Oil (CAS #85085-48-9) Essential oil (refreshing, invigorating &amp; fragrance), 5% to 0.003% Vanilla Oil Essential oil (CAS#008024-06-4) (refreshing, invigorating &amp; fragrance), 5% to 0.003% Green Tea Oil Essential oil (CAS#999999-34-7) (refreshing, invigorating &amp; fragrance), 5% to 0.003% Geranium Oil (CAS #8000-46-2) Essential Oil (refreshing and fragrance), 4% to 0.003% Spearmint Oil (CAS #8007-02-1) Essential oil (refreshing and fragrance), 5% to 0.005% Mandarin Oil (CAS #8008-31-9) Essential oil (refreshing, cleaning, &amp; fragrance), 5% to 0.003% Coconut oil monoglycerides, ethoxylated (CAS#068553-03-7) Synonyms: Glycerides, coco mono-, ethoxylated; Coconut oil monoglycerides, ethoxylated, 5% to 0.003% Coconut diethylamide (CAS #068603-42-9) Synonyms: Coconut diethylamide; Coconut diethanolamide (1); Aldanolamide; Amides, coco, N,N-bis(2-hydroxyethyl); Coconut oil acid diethanolamine, 5% to 0.003% Coconut fatty acids (CAS#061788-47-4) Synonyms: Acids, coconut; Coco fatty acid; Coconut acid; Coconut fatty acids; Coconut oil acids; Fatty acids, coco, 5% to 0.003% Cocoamidopropylbetaine (CAS#061789-40-0) Synonyms: Cocoamidopropyl betaine; N-(Coco alkyl) amido propyl dimethyl betaine; Coconut oil amidopropyl betaine; Quaternary ammonium compounds, (carboxymethyl)3-cocoamidopropyl) dimethyl, hydroxides, inner salts; 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., inner salts, 5% to 0.003% Cucumber extract (CAS#089998-01-6) Synonyms: Cucumber extract; Cucumis sativus extract, 5% to 0.003% Vanilla oil/extract (CAS#008024-06-4) Synonyms: Protovanol; Oils, vanilla; Vanilla extract, 5% to 0.003% Green tea (CAS#999999-34-7), 5% to 0.003% Lavender oil (CAS#008000-28-0) Synonyms: Lavender oil; Lavandula officinalis oil; Lavender flowers oil; Oil of lavender; Oils, lavender, 5% to 0.003% Coconut oil, diethanolamine condensate (Surfactant) (CAS#008051-30-7) Synonyms: Surfactants (2); Coconut oil diethanolamine condensate; Coconut oil, reaction products with diethanolamine, 5% to 0.003% Yet another embodiment of the present invention may include an aqueous solution formulation that contains an ingredient with an associated Sun Protection Factor (SPF) designed to protect a user&#39;s skin against UVA and UVB radiation. Because an advantage of the present invention is to cool the body when applied to the skin, it is logical that typical users of the present invention may often be exposed to hot, sunny outdoor conditions. Advantageously, a formulation of the aqueous solution component of the present invention that contains an ingredient with an associated SPF, in addition to the cooling agents, would provide an added bonus of a much needed additional level of protection. Turning now to the figures in which like references refer to like elements throughout the several views, various aspects and embodiments of the present invention are further described. FIG. 1 is a three dimensional block diagram intended to represent an exploded view of the present invention in a typical embodiment. As described above, the specially formulized aqueous solution 10 is a combination of the previously outlined foundation mixture in conjunction with additional additives present for desired effects including, but not limited to, insect repellent, SPF quality, and fragrance. The specially formulized aqueous solution 10 is applied to a carrying agent 20 until the carrying agent 20 reaches a point of saturation. Once saturated with the specially formulized aqueous solution 10 , the carrying agent 20 is hermetically sealed in a packaging solution 30 capable of preventing the specially formulized aqueous solution 10 from evaporating out of the carrying agent 20 . In an exemplary embodiment, this packaging can be of superior quality to ensure resistance against evaporation, introduction of bacteria and mold, and operates to provide an extended shelf life. The carrying agent 20 in the preferred embodiment depicted in the figure may be a cloth-like structure constructed of any number of natural fibers including, but not limited to, cellulose, cotton, bamboo, wood products, grass products, or even spray bottles, squeeze bottles, etc. Further, the carrying agent 20 may be of a nonwoven form, a knitted form, a woven form, or any other form known to those skilled in the art of cloth manufacture. It must be appreciated that depending upon the particular formulation of the aqueous solution 10 , the size of the carrying agent 20 , the material of construction for the carrying agent 20 and other specific embodiment factors, the optimum carrying agent 20 gram weight may vary. For example, the preferred range of cloth weight for a woven carrying agent 20 made of cotton and used as a component in the present invention is 22 to 55 grams for a one square foot cloth. The ideal weight, within that range, for the same carrying agent 20 would be roughly 30 grams+/−10%. To further the example, a carrying agent 20 made of cotton that was of a knitted construction and measuring two and a quarter square feet ideally has a weight range of 70 to 85 grams. Moving now to FIG. 2 , the method of manufacture for the present invention is depicted via a block flow chart. As described prior, typical embodiments of the specially formulated aqueous solutions 10 contain a foundational mixture containing a measure of purified water, polysorbate, 1-menthol, ethyl alcohol, isopropyl alcohol, a moisturizer and preservatives. The preparation 40 of the specially formulated aqueous solution 10 entails combining the foundational mixture with at least one of the essential oils or additives listed prior in this specification. Components in the foundational mixture serve as solvents for the essential oils or additives and enable the creation of the homogenous mixture that is the aqueous solution 10 . Once the aqueous solution 10 has been prepared 40 , it is impregnated 50 into a fibrous cloth carrying agent 20 until the cloth is saturated with the solution 10 . After impregnation 50 of the carrying agent 20 is complete, the product is then sealed 60 in a waterproof package 30 that prevents evaporation of the aqueous solution 10 . The presence of preservatives in the foundational mixture of the aqueous solution 10 combined with the sealed, waterproof packaging 30 provide a means by which the product can be stored for up to two years without degradation of quality. The method is complete when the product is removed 70 from the packaging 30 and applied to the user. The present invention has been described using detailed descriptions of embodiments thereof that are provided by way of example and are not intended to limit the scope of the invention. The described embodiments comprise different features, not all of which are required in all embodiments of the invention. Some embodiments of the present invention utilize only some of the features or possible combinations of the features. Variations of embodiments of the present invention that are described and embodiments of the present invention comprising different combinations of features noted in the described embodiments will occur to persons of the art. Further, it will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described herein above. Rather, the scope of the invention is defined by the claims that follow.

A refreshment towel with applied solution is an apparatus consisting of a carrying agent, most likely a high quality cotton towel or towelette, that has been saturated with an aqueous solution comprised of various ingredients. The resulting saturated towel can be rubbed on a user's skin such that the aqueous solution that has been absorbed by the towel is transferred. The aqueous solution is compounded specifically to provide cooling, insect repellant, sun protection, freshness, cleansing and other uses. More specifically, the aqueous solution is specially formulated so that desired sensory results take place when the towel comes in contact with the skin.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates in general to an apparatus for forming impressions of a patient&#39;s teeth, gums and oral cavity and particularly relates to a dental tray having a rigid frame supporting a thin mesh or membrane for simultaneously making accurate impressions of a patient&#39;s upper and lower teeth as well as the bite registration therebetween. 2. Description of Prior Developments Dental impression trays have long been used by dentists to form impressions of various portions of a patient&#39;s mouth and teeth. Such impressions are typically used to produce dental replacement components and dental assemblies such as crowns, teeth, bridgework, dentures and other oral prostheses. One common type of dental impression tray is used to take an impression of either an upper or lower portion of the teeth and mouth by pressing a tray filled with impression material against that area of the mouth requiring repair or reconstruction. Another type of dental impression tray, referred to herein as a multiple impression tray, is used to take impressions of both upper and lower portions of a patient&#39;s teeth and mouth and to concurrently provide an impression of the relative positions of the upper and lower teeth during a bite. The upper impression corresponds to an impression section of maxilla, the lower impression corresponds to a complimentary section of mandible and the two complimentary impressions jointly provide an impression of the bite relationship of mandible to maxilla. A typical multiple impression tray includes an upper trough and a bottom trough, each filled with impression material such as a setable rubber base material. The tray is placed in a patient&#39;s mouth and the patient is instructed to bite into the impression material until the patient&#39;s upper and lower teeth substantially abut one another. During this procedure, the impression material is displaced and extruded between portions of the tray and the patient&#39;s teeth and gums. The forces developed during this displacement and extrusion of the impression material have resulted in the formation of inaccurate and distorted impressions. That is, as the impression material is pressurized during biting, it presses against the frame of the multiple impression tray causing it to flex, bend and distort in shape. If the frame does not fully recover or if it takes a permanent set, for instance during manipulation for removal from mouth or in lab production (preparation and stone moldings) an inaccurate impression will likely result. This problem is particularly noticeable with those multiple impression trays formed of highly flexible material such as plastic or thin wire. When a dental impression is taken with such a prior art impression tray, the bending and flexing of the frame can be further exacerbated as the tray is removed from the patient&#39;s mouth. Due to the forces required to free the patient&#39;s teeth from the impression material, the tray is again flexed and often spread open and twisted causing deformation and distortion of the impressions. Even after an impression has been made, it may be subject to additional distortion in the laboratory. As a technician manipulates the impression tray while producing a mold, the tray is often again flexed or bent thereby causing the movement and relative displacement of the impression material. Although some dental impression trays have been made of metal, the particular metal used has been in the form of easily deformed wire or easily flexed sheets which provide minimal rigidity against deformation and flexing. Moreover, such trays have been known to take a permanent set once they have been bent out of shape and therefore fail to return to their original shape. In this case, the impressions taken tend to be held in a deformed condition thereby yielding unsuitable impressions. Another problem particularly applicable to multiple impression trays is the inability, in some cases, of the patient to bring the upper and lower teeth into full abutting contact due to the presence of an intervening layer of material which defines upper and lower troughs for receiving impression material. This intervening layer or membrane is required to support and hold the impression material in the upper and lower troughs of the impression tray. The presence of this intervening material, even though it may be quite thin, can prevent the required contact between the upper and lower teeth and thereby prevent an accurate impression and reproduction of the patient&#39;s bite registration. The thicker the intervening material, the less likely will be the reproduction of an accurate bite registration between maxilla and mandible. An example of such prior art support material is a gauze or a meshed material which provides support for the impression material yet also allows the impression material to flow across and through it, preferably from the upper trough to the lower or bottom trough. Even though this mesh or gauze material is relatively thin, it still can prevent the upper and lower teeth from meeting. One prior conventional approach to solving this problem has been to use mesh material having wide spacings between adjacent filaments or strands. This wide spacing allows the teeth to spread the filaments apart and thereby meet between the filaments. This in turn allows full penetration of the impression material and accurate bite registration. Another approach to solving this problem relies on the use of a nonwoven fabric material to support the impression material. This nonwoven fabric material is formed of staple fibers having predetermined lengths. As such, it is generally thick and dense and must be penetrated and pierced by the teeth. When this material is pierced and sheared, its cut ends, which are taut, can fold into the impression cavity adjacent and between the teeth. These ends then extend into the impression cavity after removal from the patient&#39;s mouth and act as foreign objects in the resulting mold. This can result in a defective, deformed or substandard prosthetic molding. Accordingly, a need exists for a dental impression tray which includes a rigid structure resistant to deflection, deformation and twisting during and after the formation of a dental impression. A further need exists for a dental multiple impression tray which is formed of a rigid material and which resists plastic deformation during the forming of dental impressions. A further need exists for a dental multiple impression tray which adequately supports a layer of impression material in both its upper and lower troughs, yet allows substantially free abutting contact between a patient&#39;s upper and lower teeth during the formation of a dental impression. Still a further need exists for a dental multiple impression tray which substantially eliminates the need for piercing an intervening layer of material which supports impression material in the upper and lower troughs of the tray. Yet a further need exists for a dental multiple impression tray which eliminates the presence of sheared filaments or strands extending into a dental impression cavity carried by the tray. SUMMARY OF THE INVENTION The present invention has been developed to fulfill the needs noted above and therefore has as an object the provision of a dental tray formed of a rigid material which resists deflection, deformation, flexing, bending and twisting during the formation of a dental impression. Another object of the invention is the provision of a dental impression tray which resists bending, flexing and deformation during its removal from a patient&#39;s mouth and during subsequent handling during laboratory work. Another object of the invention is the provision of a dental impression tray having a rigid frame which resists flexure and which also resists plastic deformation. Another object of the invention is the provision of a dental impression tray which adequately supports a layer of impression material in its upper and lower troughs, yet which also allows virtually free unobstructed contact between a patient&#39;s upper and lower teeth. Still another object of the invention is the provision of a dental impression tray which substantially eliminates the need for the piercing or shearing of an intervening layer of material during the formation of a bite registration impression. Yet another object of the invention is the provision of a dental impression tray which provides accurate dental impressions free from deformities caused by flexure, twisting or bending of the frame which supports the impression material. In order to carry out the objects noted above, a dental impression tray is constructed according to the present invention so as to limit its flexure and bending during and after the formation of a dental impression. Flexure and bending, as well as twisting and deformation of the tray, are controlled by constructing the frame of the tray with a relatively rigid material such as steel. In particular, a rigid material such as steel is selected within a specified range of elastic moduli and yield strengths so as to control and limit the flexure of the impression tray, yet prevent the occurrence of plastic deformation. Even if some elastic deformation of the simultaneous impression tray takes place, for instance during the manipulation for removal from mouth or in lab production (stone molding and preparation) the rigid frame will quickly return to its original free state thereby preventing the distortion of the impression material adjacent a patient&#39;s teeth. The cross sectional shape of the steel frame may be configured so as to maximize its resistance to flexure in a preferential direction. That is, the steel frame may be formed with a rectangular or elliptical section having a major dimension or axis extending within a plane within which the maximum bending force will be applied during bite registration. The rigid frame may be provided in the form of a high elastic modulus core rod encapsulated in a plastic material. The plastic material not only adds to the aesthetics of the impression tray but also provides a softer contact surface for engagement with a patient&#39;s mouth and teeth. Additional rigidity can be provided to the impression tray by molding a plastic support structure around the rigid core. This plastic support structure can include a pair of side walls which support and control the flow of impression material. The side walls can be shaped with grooves for receiving and anchoring the impression material within the tray. Additional rigidity may be provided in the form of plastic molded stiffening ribs. In order to minimize the interference between the impression tray and the patient&#39;s teeth during the formation of a bite registration impression, the present invention adopts in one embodiment a spun-bonded, nonwoven fabric material for supporting the impression material within the upper and lower troughs of the impression tray. This spun-bonded fabric material is formed from multiple continuous filaments having average diameters less than about 0.0007 inch and loosely spread apart. As a result, it is typically not as dense and thick as fabrics made by other methods such as weaving, knitting, warpknitting and staple nonwovens, but yet still as strong. Thus, when a patient bites through the impression material and into the spun-bonded filaments, it is less likely that the filaments will be sheared because of their smaller diameter and looser and easier spreading than nonwoven materials based on staple fibers. This spreading action prevents the formation of loose cut ends and thereby prevents such ends from causing nonconformities within the impression cavities. The presence of loose cut ends can be further reduced by mounting the filamentary fabric of spun-bonded material to the frame of the impression tray in a loose or untensioned manner. In this case, even if a filament fiber is sheared, it will not be taut as in the case of a woven knitted or warp knitted material. Rather, the sheared end will be loose and untensioned and unable to project into the impression cavity. Although a spun-bonded, continuous filament membrane functions well in this application, other membrane materials may be used provided they are selected within predetermined thickness limits. For example, a thin foil of silicone could be used, or a sheet of perforated or meshed tin, or metal foil, or individual threads oriented in a predetermined direction on the multiple tray frame. The term membrane, as used to describe the support layer between the upper and lower troughs includes foils, fabrics and individual threads. Foils include metals such as tin and plastics such as silicone. Fabrics include nonwoven materials, woven, knitted and warp knitted material. Nonwoven materials include spun-bond materials, such as synthetics, and staple fibers which include natural and synthetic fibers. Threads suitable for use as membrane 30 include continuous filaments such as monofilaments and preferably multifilaments. Examples of such multifilaments are man-made synthetic fibers. Other less suitable threads may be derived from staples which are fibers having a typical length of about 1 to 21/2 inches. Staple fibers include natural fibers, synthetic fibers and blends of the two. Woven materials are not preferred for membrane 30. Grooves provided for anchoring the impression material within the multiple impression tray are formed in such a manner that they do not extend across the full height of the sidewalls. Rather, the grooves extend toward the rigid core from the top and bottom portions of the sidewalls and end short of the core so as to define a plastic reinforcing rib surrounding the rigid core. This rib can extend partially or completely around the rigid core to resist flexure and twisting of the tray. The aforementioned objects, features and advantages of the invention will, in part, be pointed out with particularity, and will, in part, become obvious from the following more detailed description of the invention, taken in conjunction with the accompanying drawings, which form an integral part thereof. BRIEF DESCRIPTION OF THE DRAWINGS In the drawings: FIG. 1 is a top plan view of a posterior dental impression tray according to the invention; FIG. 2 is a view in partial section taken along line 2--2 of FIG. 1; FIG. 3 is a view in section taken along line 3--3 of FIG. 1; FIG. 4 is a right side elevation view of FIG. 1; FIG. 5 is a left side elevation view of FIG. 1; FIG. 6 is a view in partial section taken along line 6--6 of FIG. 1; FIG. 7 is a view in partial section taken along line 7--7 of FIG. 1; FIGS. 8(a), 8(b), 8(c), 8(d), 8(e) and 8(f) are views in cross section through various embodiments of a core rod according to the invention; FIG. 9 is a view similar to FIG. 2 showing an alternate embodiment of the invention; FIG. 10 is a top plan view of another embodiment of the invention in the form of a full arch multiple impression tray; FIG. 11 is a perspective view of an alternate embodiment of the invention; and FIG. 12 is an end view of FIG. 11 taken along line 12--12 thereof. In the various figures of the drawings, like reference characters designate like parts. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will now be described in conjunction with the drawings, beginning with FIG. 1 which depicts a dental impression tray 20 constructed in accordance with the invention. Tray 20 is adapted to simultaneously form an impression of at least a portion of a patient&#39;s upper teeth or maxilla and an impression of a complimentary portion of the patient&#39;s lower teeth or mandible. At the same time, the relative position or alignment of these upper and lower mating portions is established. The relative alignment between the upper and lower teeth is known as bite registration. Since three useful measurements are provided during a single impression procedure, this type of dental impression tray is referred to as a simultaneous impression tray. As further shown in FIGS. 1 and 2, tray 20 includes a composite frame 22 having a somewhat U-shaped configuration and formed of a relatively rigid central core rod 24 surrounded at least in part by a softer encapsulating material 26. Material 26, which may be a hard rubber or plastic material, is molded around core 24. Handle 28 (FIG. 1) may be molded from plastic material 26 at the same time that the material is molded around the central core 24. In addition, membrane 30 may be mounted to frame 22 during and by this molding operation by insert molding continuously around the membrane periphery. The frame 22 includes at least a pair of legs 21,23 connected by an arcuate end portion 25 which together define a plane within which membrane 30 is supported. As discussed further below, frame 22 is designed so as to minimize deflection of legs 21 and 23 toward and away from one another within the above-noted plane. Membrane 30 is shown in FIG. 2 as being molded to the lower face of core 24, however, any suitable connection between membrane 30 and frame 22 is contemplated in accordance with the invention. Handle 28 may be molded with a pair of opposed recesses 32,34 as shown in FIG. 3 so as to provide a convenient grip between a dentist&#39;s thumb and index finger. Frame 22 and membrane 30 define an upper trough 36 and a lower trough 38 for receiving and containing dental impression material 40 as shown in phantom in FIG. 2. The impression material 40 is coated over first and second opposed sidewalls 42,44 and membrane 30. Sidewalls are also molded from the plastic material 26 during the molding of frame 22. Although sidewalls are generally preferred, they are not always required for carrying out the invention. Each sidewall 42,44 respectively includes an inner face 46,48 having a plurality of cavities or recesses 50 formed therein. For the particular posterior form of simultaneous impression tray shown in FIGS. 1 through 7, and as best seen in FIGS. 4, 5 and 6, the first or inner sidewall 42 is both shorter in its length L and its height H than the corresponding length and height of the second or outer sidewall 44. The first or inner sidewall 42 is bordered along its upper edge by a generally arcuate top wall 52 and along its lower edge by a generally arcuate bottom wall 54. In a similar fashion, the second or outer sidewall 44 is bordered along its upper edge by a generally arcuate top wall 56 and along its lower edge by a generally arcuate bottom wall 58. Walls 52 and 54 of sidewall 42 are disposed generally symmetrically about core 24 as are walls 56 and 58 of sidewall 44. A series of longitudinally spaced cavities or recesses 50 extends from top wall 52 of inner sidewall 42 along its inner face 46 and from bottom wall 54 of inner sidewall 42 along its inner face 46 in general mutual alignment toward core 24. In similar fashion, a series of cavities 50 extends from top wall 56 of outer sidewall 44 along its inner face 48 and from bottom wall 58 of outer sidewall 44 along its inner face 48 in general mutual alignment. As seen in FIG. 2, cavities 50 do not extend completely across the respective sidewall inner faces 46,48 but rather terminate before reaching the central core 24. In this manner, a first longitudinally extending rib 60 is defined along inner face 46 and a second longitudinally extending rib 62 is defined along inner face 48. Central ribs 60 and 62 extend over and along the inner faces of core 24 which border the upper and lower troughs 36,38 in order to provide added rigidity and resistance against flexure and deformation of frame 22. Although semi-cylindrical cavities 50 are shown in the drawings as defining the central ribs 60,62 any form of recess may be used. Recesses 50 assist in the retention of the impression material 40 on the multiple impression tray 20 during the formation of a simultaneous impression and during removal of the triple tray from a patient&#39;s mouth. A particularly significant aspect of the invention is the choice of material for core 24. Core 24 is designed so that it is essentially rigid at all times yet allows for a limited amount of elastic deformation during the formation of a simultaneous impression. It is important, however, to avoid any plastic deformation of the core and frame insofar as such plastic deformation will likely result in inaccurate and defective impressions. The invention therefore provides a careful balance between the forces applied to the multiple impression tray during manipulation from removal from the mouth or in lab production (stone molding and preparation), and the elastic modulus and yield strength of the core material. In this manner, minor elastic deflection of the frame may take place with complete elastic recovery so as to maintain the impression material in close contact with the patient&#39;s teeth and gums without distortion or separation of the impression material from the patient&#39;s oral impression surfaces. It has been found that the material of core 24 should be selected with an elastic modulus of at least 10 million pounds per square inch and a yield strength of at least 50 thousand pounds per square inch. Various metals such as steel alloys are particularly well suited for this application, such as stainless steel Type 301,302 and 304, for example. Steel alloys having elastic moduli of at least 28 million pounds per square inch are readily available and particularly suited for fabricating core rod 24. Other metals, such as alloys of titanium and aluminum may be used for core 24. Moreover, core 24 may be fabricated from reinforced fiber materials such as carbon-carbon and aramid fibers. In order to provide even greater rigidity and structural integrity to the impression tray, the cross section of core 24 is designed to provide the greatest resistance to bending and flexure in the plane defined by membrane 30. That is, core 24 is designed in such a manner so as to resist the relative movement of sidewalls 42 and 44 toward and away from one another so as to prevent distortion of the impression material during the formation of an impression. This in turn minimizes the flexure of the frame 22 toward and partially away from the sides of a patient&#39;s teeth during bite registration. Referring again to FIG. 2, as well as to FIGS. 6 and 7, and particularly to FIG. 8(a), core 24 may be formed with a rectangular cross section having its major dimension or largest pair of sides extending generally parallel to a plane defined by the intersection of membrane 30 with frame 22. Stated another way, the major dimension of core 24 extends transverse to the sidewalls in a direction generally parallel and coplanar with a plane which separates the upper trough 36 from the lower trough 38 symmetrically with respect to frame 22 and core 24. The minor dimension of core 24 extends generally transverse to the plane of the membrane between the upper and lower troughs. In this manner, the minor dimension or shortest sides of core 24 face one another across the gap between sidewalls 42,44 which define the sides of troughs 36,38. This orientation of the short sides or minor dimension extends generally transverse to the above-noted plane and membrane. This orientation of core 24 provides the greatest resistance to transverse bending of frame 22 toward and away from the sides of a patient&#39;s teeth during bite registration and reduces the chance of forming an inaccurate or distorted dental impression. Alternate cross sections for core 24 taken for example through arcuate end portion 25, are shown in FIGS. 8(b), 8(c), 8(d), 8(e) and 8(f). FIG. 8(b) depicts a rectangular core 24 with chamfered edges. FIG. 8(c) depicts an oval or elliptical core 24 and FIG. 8(d) depicts a core with flat upper and lower surfaces interconnected by semi-circular sides. Other sections are of course possible. In some cases, even a round section is possible as shown in FIG. 8(e) if the limits on deflection and elasticity can be maintained. Although FIGS. 8(a) through 8(e) all depict the arcuate end portion 25 of core rod 24 as being encapsulated or coated by a thin layer of plastic or elastomeric material 26, it is possible to leave the arcuate portion 25 uncoated except for its inner edge 63 which borders membrane 30, as shown in FIG. 8(f). Edge 63 of core rod 24 may be recessed or grooved to form an interlock between material 26 and core rod 24, with material 26 serving as an intermediary bonding member for securing membrane 30 to the core rod. To add further rigidity to the multiple impression tray, a pair of external ribs may be molded to core 24 along the outer faces 64,66 of the inner and outer sidewalls 42,44. As seen in FIGS. 1, 2, 4 and 5, a first outer external rib 68 is molded around core 24 along outer face 64 of sidewall 42 and a second outer external rib 70 is molded around core 24 along outer face 66 of sidewall 44. Another significant aspect of the invention is the selection of an appropriate material for membrane 30. As noted above, membrane 30 should provide adequate support for carrying a layer of impression material, yet present little or no obstacle to contact between a patient&#39;s teeth during bite registration. One suitable material for membrane 30 is a fabric made from nonwoven spun-bonded filaments. Such a fabric will function well if its overall or average thickness is maintained at or below about 0.003 inch as it forms membrane 30. Average thickness of fabrics chosen for membrane 30 should be measured according to ASTM-D-1777-64 standards. This spun-bonded filament may be advantageously maintained within a weight to area ratio of no greater than 0.4 ounce per square yard as it extends between sidewalls 42,44. In order to ensure an adequate spacing between the fibers of the filament, its air permeability between the upper and lower troughs 36,38 should be greater than about 1100 cubic feet per minute per square foot as measured according to ASTM-D-737-75 standards. When membrane 30 is constructed of such a material, it resembles a fine gauze-like, translucent, gossamer membrane. Examples of suitable fabrics include two CEREX fabrics respectively having fabric weights of 0.3 and 0.4 ounce per square yard, average thicknesses of 2.6 and 2.9 mils, burst strengths of 9 and 12 psi, and air permeabilities of 1330 and 1110 cubic feet per minute per square foot according to standard ASTM-D-737-75. Although the spun-bonded filamentary membrane which forms membrane 30 in FIGS. 1 through 7 is held on frame 22 in a somewhat flattened state, it may also be loosely held on frame 22 as shown in FIG. 9. By loosely mounting membrane 30 to frame 22 in the manner of a loose net, membrane 30 will present virtually no resistance to deformation between the interengaged surfaces of a patient&#39;s teeth during bite registration. FIG. 9 also depicts a modification to the inner faces 46 and 48 of sidewalls 42 and 44 in that these faces diverge outwardly from frame 22. This facilitates bite registration by guiding or wedging the teeth toward membrane 30. Another possible construction of membrane 30 is an array of yarn in the form of continuous filaments spanning across the multiple impression tray. An example of such an arrangement is shown in FIG. 10 in the context of a full arch multiple impression tray 20(a). A series of parallel spaced multifilament yarns 72 is strung across frame 22(a). Twenty to forty strands may be used in the embodiment of FIG. 10 and ten to twenty strands with the embodiment of FIG. 1. Threads 72 are preferably chosen as multifilament with all the filaments together having a value of less than about 2.0 tex wherein 1.0 tex equals one gram per one thousand meters in length. A pre-oriented yarn with a draw ratio of 1:1.3 to 1:3.5 has proven effective. Instead of filaments, a perforated or continuous sheet of silicone-based film having an average thickness of about 0.001 inch to 0.002 inch may be used to form membrane 30. Alternatively, a foil of highly malleable metal, either continuous or perforated, having a thickness of about 0.0005 inch to 0.001 inch may be used to form membrane 30. An example of such a perforated silicone sheet or perforated metal foil is shown in FIG. 11 wherein membrane 30 is mounted to a posterior tray 20(b) virtually identical to tray 20 of FIG. 1. FIG. 12 provides additional details of trays 20 and 20(b). There has been disclosed heretofore the best embodiment of the invention presently contemplated. However, it is to be understood that various changes and modifications may be made thereto without departing from the spirit of the invention.

The modulus of elasticity and yield strength of a rigid core rod are set within predetermined limits as to limit the elastic deformation and prevent plastic deformation of a dental tray during multiple impression taking, bite registration and subsequent handling. The tray is formed with a frame which provides a positive recovery force when it is flexed. The cross section of the core rod may be optimized to further limit deflection in a predetermined plane. Various preferred materials including nonwoven spun-bonded filaments are selected for supporting impression material on the tray while minimizing the likelihood of obstructing a patient's teeth during full occlusion.

FIELD OF THE INVENTION This invention relates to the general field of biochemistry and medical sciences, and specifically to a method of lyophilizing and reconstituting mammalian sperm cells. BACKGROUND OF THE INVENTION The presently used method of long term storage of mammalian sperm cells, required for human sperm banks and for livestock breeding, is by maintenance at liquid nitrogen temperatures. The length of time that the cells can be stored under these conditions is therefore cost-limited since at some point during the storage period the cost of consumption of liquid nitrogen makes further storage economically unfeasible. There is a need, therefore, for a method for storing sperm cells for prolonged periods of time in a cost efficient manner, while still maintaining the cells morphologically intact to be useful for in vitro or in vivo fertilization. It is therefore an object of the present invention to provide a method for lyophilizing mammalian sperm cells which permits prolonged storage times at ambient temperatures and which still allows for reconstitution of the cells in a morphologically intact form. SUMMARY OF THE INVENTION The present invention provides a method for lyophilizing mammalian sperm cells by mixing the sperm cells with a buffered solution comprising a carbohydrate and a polymer or mixture of polymers having a number average molecular weight in the range of about 1K to 600K, then drying the cells by sublimation of water. If desired, the sperm cells may be diluted with an extender prior to lyophilization. The lyophilized cells may be maintained for prolonged periods under ambient temperatures and then restored using reconstitution buffers containing polymers, phosphate buffered saline containing glucose and adenine and/or other cell metabolites such as ATP or NAD. DETAILED DESCRIPTION OF THE INVENTION The sperm cells treated according to the present invention may be used in a neat form or diluted with an extender such as egg yolk. Preferably if an extender is used, the concentration of the sperm cells in the extender will be in the range of about 10% to 50% by volume. The preferred sperm cells are those for commercial livestock fertilization such as porcine or bovine sperm cells, however the present invention may also be applicable for the preservation of human sperm cells. The lyophilization buffer according to the present invention will contain a carbohydrate, typically in the concentration of about 0.1 to 2.6 molar. Preferably the carbohydrate may be selected from the group consisting of monosaccharides and disaccharides but monosaccharides are preferred, particularly glucose. Other monosaccharides such as xylose, ribose, mannose and fructose may also be employed. The lyophilization buffer will also contain a polymer or a mixture of polymers having a number average molecular weight in the range of about 1K to 600K, preferably in the range of about 1K to 350K. These polymers are preferably amphipathic. While not intending to be bound by any theory, the amphipathic properties of the polymers are believed to allow them to bind to the cell membrane while protecting the membrane&#39;s surface by extension of the hydrophilic portion into the aqueous environment. This may alleviate the damage to the cell membrane. The preferred polymers are selected from the group consisting of polyvinylpyrrolidone (PVP) and polyvinylpyrrolidone derivatives, dextran and dextran derivatives, hydroxyethyl starch and poloxamers. Most preferred is a polyvinylpyrrolidone of an average molecular weight in the range of about 10K to 40K, preferably about 30K in a concentration range of about 10% to 30% weight/volume in the lyophilization buffer prior to lyophilization. Amino acid based polymers (proteins), dextrans or hydroxyethyl starch are also useful as are other amphipathic polymers such as poloxamers in any of their various forms. The term lyophilization is broadly defined as freezing a substance and then reducing the concentration of one of the solvents, namely water, by sublimation and desorption, to levels which will no longer support biological or chemical reactions. This is usually accomplished by a drying step in a high vacuum. The lyophilization buffer will be buffered in the range of about pH 7.0 to 7.4, preferably by a phosphate-buffered saline solution. A typical phosphate-buffered saline solution will comprise mono- and di-basic sodium phosphate, sodium chloride and potassium chloride, in amounts which typically maintain the pH at around 7.2. Upon lyophilization by conventional techniques, the lyophilized sperm cells may be maintained under vacuum in vacuum type containers or under nitrogen or other inert gas at room temperatures for extended periods of time in the absence of or without significant degradation of their desirable morphological properties when reconstituted for use. It is a particular advantage of the present invention that the lyophilized sperm cells may be stored at room temperature for extended periods of time. It is a further advantage of the present invention that the lyophilized sperm cells may be reconstituted at normal temperatures, i.e., greater than about 17° C. up to about 37° C., and preferably at about room temperature, 22° C. A preferred reconstitution medium is a solution comprising a polymer or mixture of polymers as described above, preferably having a number average molecular weight in the range of about 1K to 30K, preferably about 15K and phosphate-buffered saline containing glucose and adenine (PBSGA). The reconstitution solution will also preferably contain typical cell metabolites such as ATP and NAD. The polymer used may be the same polymer utilized to lyophilize the sperm cells as described above. Hence the polymers polyvinylpyrrolidone, hydroxyethyl starch, dextran or other amphipathic polymers are particularly preferred with the most preferred being polyvinylpyrrolidone. The reconstitution solution will be typically buffered by phosphate-buffered saline solution containing adenine and glucose to maintain the pH in the range of about 7.0 to 7.4. The most particularly preferred polymer is polyvinylpyrrolidone of an average number molecular weight of about 15K. The reconstitution buffer may also optionally contain a monosaccharide such as xylose, glucose, ribose, mannose, and fructose (in addition to the glucose in the PBSGA solution). A typical monosaccharide concentration would be about 1 molar in the reconstitution buffer. A 1 molar fructose concentration is particularly useful. In the most preferred embodiment, lyophilized sperm cells are reconstituted by mixing with an equal volume of reconstitution buffer at ambient temperature and mixed until fully hydrated. By equal it is meant that the volume is the same as the starting volume prior to lyophilization. After reconstitution, the cells may be used for in vitro fertilization. The lyophilized sperm cells are advantageously restorable at ambient atmospheric temperatures (usually about 20° to 30° C.) and can be reconstituted to morphologically intact states having intact DNA in the heads and intact tails. By intact tails it is noted that by and large the flagella of the cells are intact. These cells may be used for in vitro fertilization and it is contemplated that upon mixing with appropriate cofactors, motility may be induced for potential in vivo use as well. Having described the preferred embodiments of the present invention, the following examples are provided by way of illustration but are not intended to limit the invention in any way. EXAMPLE Various samples of boar and bull sperm were collected and used either in neat form or diluted 1:1 with an extender (egg yolk). A basic lyophilization buffer was prepared containing 3.1 mM potassium chloride, 1.5 mM potassium hydrogen phosphate, 91.9 mM sodium chloride, 4.3 mM disodium hydrogen phosphate, 2.6M of glucose and 26% w/v Plasdone C-30 (PVP,MW30K). This was called lyophilization Buffer A. A second lyophilization buffer was prepared containing the same components except that 16% Plasdone C-30 was used in 1.6M glucose. This was called lyophilization Buffer B. A third lyophilization buffer was used containing 16% Plasdone C-30, 1.6M glucose containing egg yolk extender. This was called lyophilization Buffer C. Six preparations containing boar sperm were prepared containing, respectively, 50% neat sperm, 10% neat sperm and 10% neat sperm in Buffers A, B and C, and 50% of 1:1 ratio sperm in extender, 10% of 1:1 mixture and 10% of 1:1 mixture in Buffers A, B and C. Five preparations containing bull sperm were prepared containing, respectively, 10% neat sperm in Buffer B and 10% neat sperm in Buffer C, 50% 1:1 sperm and extender in Buffer A, 10% 1:1 sperm and extender in Buffer B and 10% 1:1 sperm and extender in Buffer C. All eleven samples were lyophilized and reconstituted in four different buffers as follows: Buffer 1: 19% Plasdone C-15. Buffer 2: 19% Plasdone C-15/5 mM ATP/0.47 mM NAD. Buffer 3: PBSGA. Buffer 4: PBSGA/5 mM ATP/0.47 mM NAD. After reconstitution the morphology and motility of the sperm cells were observed under a microscope. In all cases morphologically the cells were intact with no broken flagella. The sperm cells were non-motile but would apparently be useful for in vitro fertilization. The cells were then incubated in PBSGA with 1M fructose at 37° C. (or alternatively at room temperature) for 30 minutes. The sperm morphology was not altered, but no motility was observed. From the foregoing description, one skilled in the art can readily ascertain the essential characteristics of the invention and, without departing from the spirit and scope thereof, can adapt the invention to various usages and conditions. Changes in form and substitution of equivalents are contemplated as circumstances may suggest or render expedient, and although specific terms have been employed herein, they are intended in a descriptive sense and not for purposes of limitation.

A method is provided for the lyophilization of mammalian sperm cells which can be stored and reconstituted to provide morphologically intact cells. The method is advantageous in that the sperm cells may be stored at ambient temperatures for extended periods of time and recovered morphologically intact with DNA-containing heads and intact flagella. The lyophilization medium comprises a carbohydrate and a polymer selected from PVP, HES, dextran and poloxamers or mixtures thereof.

CROSS-REFERENCE TO RELATED APPLICATIONS This is a National Phase Filing Under 35 U.S.C. 371, of International Application No. PCT/US04/27893, filed Aug. 27, 2004, which claims priority to U.S. Provisional Patent Application Ser. No. 60/498,742, filed Aug. 28, 2003, both of which are incorporated herein by reference. BACKGROUND OF THE INVENTION 1. Technical Field Generally, the present invention relates to inverse treatment planning. More specifically, the present invention relates to an artificial intelligence method for guiding inverse treatment planning. 2. Description of the Related Art Modern day radiation therapy of tumors has two goals: eradication of the tumor and avoidance of damage to healthy tissue and organs present near the tumor. It is known that a vast majority of tumors can be eradicated completely if a sufficient radiation dose is delivered to the tumor; however, complications may result from use of the necessary effective radiation dose. Most complications are due to damage to healthy tissue that surrounds the tumor or to other healthy body organs located close to the tumor. The goal of conformal radiation therapy is to confine the delivered radiation dose to only the tumor volume defined by the outer surfaces of the tumor, while minimizing the dose of radiation applied to surrounding healthy tissue or adjacent healthy organs. Conformal radiation therapy has been traditionally approached through a range of techniques and typically uses a linear accelerator (“LINAC”) as the source of the radiation beam used to treat the tumor. The linear accelerator typically has a radiation beam source that is rotated about the patient and directs the radiation beam toward the tumor to be treated. The beam intensity of the radiation beam has a predetermined, constant beam intensity. Multileaf collimators, which have multiple leaf or finger projections that can be moved individually into and out of the path of the radiation beam, can be programmed to follow the spatial contour of the tumor as seen by the radiation beam as it passes through the tumor, or the “beam&#39;s eye view” of the tumor during the rotation of the radiation beam source, which is mounted on a rotatable gantry of the linear accelerator. The multiple leaves of the multileaf collimator form an outline of the tumor shape, as presented by the tumor volume in the direction of the path of travel of the radiation beam, and thus block the transmission of radiation to tissue disposed outside the tumor&#39;s spatial outline as presented to the radiation beam, dependent upon the beam&#39;s particular radial orientation with respect to the tumor volume. Another approach to conformal radiation therapy involves the use of independently controlled collimator jaws that can scan a slit field across a stationary patient at the same time that a separate set of collimator jaws follows the target volume as the gantry of the linear accelerator rotates. An additional approach has been the use of attachments for LINACs that allow a slit to be scanned across the patient, the intensity of the radiation beam in the entire slit being modified as the slit is being scanned. A further approach for conformal radiation therapy treatment has been the use of a narrow pencil beam of high energy photons, with energy that can be varied, and the beam is scanned over the tumor target volume so as to deliver the best possible radiation dose distribution in each orientation of the gantry upon which the photon beam source is mounted. A major problem associated with such prior art methods of conformal radiation therapy are that if the tumor volume has concave borders, or surfaces, varying the spatial configuration, or contour, of the radiation beam, the therapy is only successful part of the time. In particular, when the convolutions, or outer surfaces, of a tumor are re-entrant, or concave, in a plane parallel to the path of the radiation treatment beam, healthy tissue or organs may be disposed within the concavities formed by the outer tumor concave surfaces, as well as the fact that the thickness of the tumor varies along the path of the radiation beam. In order to be able to treat tumors having concave borders, it is necessary to vary the intensity of the radiation beam across the surface of the tumor, as well as vary the outer configuration of the beam to conform to the shape of the tumor presented to the radiation beam. The beam intensity of each radiation beam segment should be able to be modulated to have a beam intensity related to the thickness of the portion of the tumor through which the radiation beam passes. For example, where the radiation beam is to pass through a thick section of a tumor, the beam intensity should be higher than when the radiation beam passes through a thin section of the tumor. Dedicated scanning beam therapy machines have been developed wherein beam intensity modulation can be accomplished through the use of a scanning pencil beam of high-energy photons. The beam intensity of this device is modulated by increasing the power of its electron gun generating the beam. The power increase is directed under computer control as the gun is steered around the tumor by moving the gantry upon which it is mounted and the table upon which the patient lies. The effect is one of progressively “painting” the target with the thickness, or intensity, of the paint, or radiation beam intensity, being varied by the amount of paint on the brush, or how much power is applied to the electron gun, as the electron gun moves over the tumor. Such dedicated scanning beam therapy machines, which utilize direct beam energy modulation, are expensive and quite time consuming in their use and operation, and are believed to have associated with them a significant patient liability due to concerns over the computer control of the treatment beam itself. Other methods and apparatus for conformal radiation therapy have been developed that spatially modulate the beam intensity of a radiation beam across a volume of tissue in accordance with the thickness of the tumor in the volume of tissue by utilizing a plurality of radiation beam segments. Such methods and apparatus utilize attenuating leaves, or shutters, in a rack positioned within the radiation beam before the beam enters the patient. The tumor is exposed to radiation in slices, each slice being selectively segmented by the shutters. However, a minor disadvantage of that method and apparatus results from the fact that only two slices of tissue volume may be treated with one rotation of the gantry of the linear accelerator. Although the slices may be of arbitrary thickness, greater resolution is accomplished by selecting slices for treatment that are as thin as possible. As the thickness of the treatment slices decreases, the time it takes to treat the patient increases because more treatment slices are required in order to treat the entire tumor volume. The foregoing methods and apparatus are designed to minimize the portion of the structures being exposed to radiation. However, because exposure to surrounding structures cannot be completely prevented, treatment plans are desired that are optimized to eradicate the tumor volume while minimizing the amounts of radiation delivered to the surrounding structures. Existing methods and apparatus for optimizing treatment plans use a computer to rate possible plans based on score functions, which simulate a physician&#39;s assessment of a treatment plan. However, existing methods and apparatus have proven to be insufficient. Existing methods and apparatus utilize a computational method of establishing optimized treatment plans based on an objective cost function that attributes costs of radiation of various portions of both the tumor and surrounding tissues, or structures. One such computational method is known in the art as simulated annealing. Existing simulated annealing methods utilize cost functions that consider the costs of under-exposure of tumor volumes relative to over-exposure of surrounding structures. However, the cost functions used in existing methods do not account for the structure volumes as a whole, relying merely on costs related to discrete points within the structure, and further do not account for the relative importance of varying surrounding structure types. For example, certain structure types are redundant in their function and substantial portions of the structure volume can be completely eradicated while retaining their function. Other structure types lose their function if any of the structure is completely eradicated. Therefore, the more sensitive structure volumes can receive a measured dose of radiation so long as no portion of the structure is subjected to a lethal dose. Existing cost functions utilized in the optimization of treatment plans do not account for such varying costs associated with the different types of structures. After the treatment plan is optimized, the physician currently must evaluate each computed treatment plan for compliance with the desired treatment objective. If the computed treatment plan does not successfully meet the treatment objectives, the optimization process is repeated until a treatment plan can be computed that meets the physician&#39;s treatment objectives for both the tumor volume and the surrounding structures. Further, existing methods and apparatus do not allow the physician to utilize the familiar Cumulative Dose Volume Histogram (“CDVH”) curves in establishing the desired dose distributions. Recent studies indicated that conformal dose distribution could be effectively achieved with the treatment technique called intensity-modulated radiation therapy (IMRT). Several promising delivery devices have also become available, such as static or dynamic MLC and tomotherapy to deliver conformal radiation dose. The basic concept of IMRT is that a dedicated delivery device with an intensity-variable modulates a uniform intensity in a traditional treatment field. However, it is still a very challenging issue in terms of how to generate an effective and optimal intensity spectrum and how to verify modulated radiation delivery. The first issue is also related to the problem of inverse treatment planning (or treatment planning optimization). An inverse planning method describes a specific treatment planning procedure in which, differing from traditional approach, both dose and volume are given first. Then a set of modulated beams is generated through a computer-aided optimization process in order to satisfy the prescription. The process is extremely important if the shapes of the target and critical organs are complicated, especially when the target has concavity and a critical organ lies in the hollow of the concavity. Typically, inverse treatment planning for intensity modulated radiation therapy involves the selection of an objective function and method of optimization. For a given objective function, an optimal treatment plan usually requires the optimization of beam intensity elements, a prescription method, and beam number and orientation. One of the most challenging problems in the optimization of treatment planning is how to construct a model by which the aim of radiation therapy can be fulfilled. The models that have been studied in the past can be classified as either physical or biological. There have been detailed discussions in recent literature concerning the merits and limitations of these two types of models. While biological models may be able to directly measure the clinical outcome, they still remain in the formative stages and suffer from controversy concerning the validity of the radiobiological response data used (such as, tumor control probability (TCP) and normal tissue complication probability (NTCP)). On the other hand, the physical dosimetric prescription has been well established as the clinical norm. In the traditional physical models, one optimizes an objective function that is the measure of closeness of the calculated dose distribution to the prescribed dose distribution. The crucial problem here is how to give the optimal dose value for the normal tissue so that the two objectives, delivering the desired dose to the target volume and minimizing the dose to normal tissues, can be achieved accordingly. A quadratic model has typically being used in inverse treatment planning. The model is widely discussed and has two major limitations, no direct biological information and no minimal constraints to normal tissues. Linguistically, the purpose of radiotherapy may be stated as (a) delivering a desired tumor dose and zero dose outside the target volume; (b) delivering a high dose to the target volume and a low dose to the normal tissue. The statement (a) and (b) may be served as absolute linguistic prescription (ALP) and relative linguistic prescription (RLP), respectively. Although the ALP is ideal, it is clearly impossible to deliver due to the laws of nature. On the other hand, RLP clinically describes the strategy of radiation therapy. The words ‘high’ and ‘low’ used here are vague terms that are associated with the limitation of making precise definition. The complexity of treatment planning optimization is evident from the need to formulate some kinds of clinical goals to be optimized since there is no unique treatment plan which is clinically feasible and fulfills the two conflicting objectives: maximizing dose in the target volume while minimizing dose in normal tissues. Recently, several researchers have paid attention to the analysis of uncertainties in radiation treatment planning optimization. The tolerance of normal tissues has been discussed. Spirou et al., developed an inverse planning algorithm with soft constraints. The method allows acceptable doses of maximum and minimum as well as dose-volume constraints to the tissues of interest. The search for the optimal beams usually can be interpreted to be an optimization problem. Thus, the searching problem is converted to find the extremum of a given objective function. Several methods and algorithms have been investigated for inverse planning. Some examples are simulated annealing iterative approaches, as well as filtered back-projection and Fourier transformation. Although these methods are very promising, there are some aspects that can be further improved upon. The simulated annealing method may require long computation time due to the nature of random search. Most iterative approaches are parameter-dependent. The convergence and the quality of convergence may be affected by these parameters that are often determined by try-and-error. The filtered back-projection and direct Fourier transformation may have limitations on dose prescription and kernel selection. Inverse treatment planning is still at its early stage and many important aspects require be to further improved. Additionally, Starkschall proposed an approach that removed the necessity of defining a “best” treatment plan, and incorporated the dose-volume constraints into a system to search for a feasible plan that could satisfy the constraints. If no calculated doses satisfy the treatment goal, the planner provides a guide about how the dose-volume constraints may be modified to achieve a feasible result. This approach is only applied to the conventional three-dimensional (3D) treatment planning. Wu and Mohan developed an optimization system, which employed both dose- and dose-volume-based objective functions. In the system, the optimal plan is selected by calculating the cost of the objective function, or “plan score” (the lower the score, the better the plan). Xing et al. presented a method that employed a second stage evaluation function to compute the differences between the calculated and the ideal dose volume histograms. Based on the results of the evaluation function, the weighting factors in the objective function are adjusted. The procedure minimizes both the objective and evaluation functions in a round-robin manner. Later, further improvement is achieved by using a statistical measure called preference function, which is constructed based on the empirical judgment. The problem of the selection of weighting factor still exists because it translated to the problem of how to specify the parameters in the evaluation or preference function. A similar method was also proposed by Wu et al. using a genetic algorithm to optimize the weighting factors and beam weights in the conventional 3D treatment planning. Li and Yin introduced fuzzy logic into the inverse planning system to adjust the weighting factors for normal tissue. The result was promising. However, optimizing the parameters for the target and critical organ were not included in the system. Also, the weighting factors initialized by the fuzzy functions still need to be modified by the trial-and-error approach. It would therefore be useful to develop a method or apparatus for conformal radiation therapy, for use with a radiation beam having a predetermined, constant beam intensity for treatment of a tumor, which is simple and economical to use, has a high safety factor for patient safety, computes an optimal treatment plan to meet conflicting, pre-determined, treatment objectives of a physician, accounting for objectives in both the target tumor volume and multiple structure types, and provides the desired dose distributions for each target tumor volume and tissue and structure types. SUMMARY OF THE INVENTION According to the present invention, there is provided a fuzzy inference system for use in modulating radiation treatment including a fuzzifier for inputting imaging data, an inference device operatively connected to the fuzzifier, the inference device being used for analyzing the imaging data and determining radiation treatment target from non-treatment target, and a defuzzifier for modulating radiation treatment pursuant to the analysis from inference device. Also provided is a method of modulating radiation treatment by inputting patient data into the fuzzy inference system disclosed above and modulating radiation treatment pursuant to data obtained from the fuzzy inference system. An apparatus for producing modulating radiation therapy in patients including an imaging device for creating and storing image data of relevant tissue and organ parts and a fuzzy inference system operatively connected to the imaging device for modulating radiation treatment is provided. A fuzzy inference system for use in modulating radiation treatment including a fuzzifier for inputting imaging data, an inference device operatively connected to the fuzzifier, the inference device being used for analyzing the imaging data and determining strength of radiation treatment, and a defuzzifier for modulating radiation treatment pursuant to the analysis from the inference device is also provided. BRIEF DESCRIPTION OF THE DRAWINGS Other advantages of the present invention are readily appreciated as the same becomes better understood by reference to the following detailed description, when considered in connection with the accompanying drawings wherein: FIG. 1 shows the schematic illustration of the fuzzy inference system (FIS) used for modification of the weighting factors; FIGS. 2A-D are illustrations of membership functions used in FIS; FIG. 2A shows the membership functions “High” and “Low” defined for input variable C TV ; FIG. 2B shows the membership functions “High” and “Low” defined for input variable C CO ; FIG. 2C shows the membership functions “High” and “Low” defined for input variable C NT ; FIG. 2D shows the membership functions “Decrease”, “No change”, and “Increase” defined for the output variable ΔW TV ; FIG. 3 shows the demonstration of the inference procedure including the following steps: Step 1: Inputs fuzzification; and Step 2: Degree of support; Step 3: Fuzzy inference (implication operation); Step 4: Aggregation operation; and Step 5: Output defuzzification; FIG. 4 shows the flow chart of the fuzzy logic guided inverse treatment planning system; FIGS. 5A and B show the central slices for ( FIG. 5A ) a simulated case and ( FIG. 5B ) a clinical case, wherein TV, CO and NT represent the target volume, the critical organ and the normal tissue, respectively and arrows pointed to the target volume indicate the beam directions; FIGS. 6A and B show the variations of ( FIG. 6A ) characteristic doses and ( FIG. 6B ) weighting factors versus the iteration number in the simulated case for the dose prescription [100%, 30%, 50%], the initial weighting factors [1,1,1] were normalized to [0.58,0.58,0.58] using formula (4); FIGS. 7A-C show the dose-volume histograms of the calculated doses in the simulated case for ( FIG. 7A ) the target volume, ( FIG. 7B ) the critical organ, and ( FIG. 7C ) the normal tissue for four sets of dose prescriptions; FIGS. 8A-D show the dose distributions in the central slice of simulated case for four sets of dose prescriptions ( FIG. 8A ) [100%, 20%, 50%], ( FIG. 8B ) [100%, 30%, 50%], ( FIG. 8C ) [100%, 40%, 50%], ( FIG. 8D ) [100%, 50%, 50%]; FIGS. 9A and B show the variations of ( FIG. 9A ) characteristic doses and ( FIG. 9B ) weighting factors versus iteration number in the clinical case for the dose prescription [100%, 30%, 50%] and the initial weighting factors [1,1,1] were normalized to [0.58, 0.58, 0.58] using formula (4); FIGS. 10A-E show the dose-volume histograms of calculated dose distributions for five involved organs: ( FIG. 10A ) the target volume, ( FIG. 10B ) the normal tissue, ( FIG. 10C ) the critical organ 1 , ( FIG. 10D ) the critical organ 2 , and ( FIG. 10E ) the critical organ 3 at iteration 5 , 10 , and 15 , respectively; and FIGS. 11A-C show the dose distributions in the clinical case at ( FIG. 11A ) Iteration 5 , ( FIG. 11B ) Iteration 10 , and ( FIG. 11C ) Iteration 15 . DESCRIPTION OF THE INVENTION The present invention provides a method of using fuzzy logic to optimize treatments of patients. More specifically, the present invention uses a fuzzy inference system (FIS) that uses three modules: a Fuzzifier, an Inference engine that includes fuzzy rules, and a Defuzzifier. During the process of fuzzification, a single input value is compared to the membership functions as defined for that input variable. If the membership functions have a nonzero output, it will take effect in the final results of the FIS. The Fuzzifier calculates the response of rules for the input values and the inference engine modifies the consequent rules in response to input values. The Defuzzifier generates a final output based on the result of the inference engine. The artificial intelligence (AI) method, fuzzy logic, is applied to optimize parameters in the inverse treatment planning for intensity-modulated radiation therapy (IMRT). With the capability of fuzzy inference, the parameter modification of the objective function is guided by physician&#39;s treatment intention and experience. For the different parameters involving inverse planning, the corresponding fuzzy inference systems (FISs) are developed in order to accomplish the treatment requirement. With the function of fuzzy inference, the efficiency and quality of inverse planning can be substantially improved. The system operates in a specifically preferred manner on the basis of the so-called fuzzy-set theory approach: thus, the rules are subject to some uncertainty. The fuzzy-set theory is concerned with “fuzzy sets” whose elements belong to individual sets in different ways. While in the classical theory of sets a specific element does or does not belong to a set, the fuzzy-set theory pertains to elements that only belong to a set to a certain degree. The degree of belonging is indicated by a function for the individual elements of a set. With the approach, it is possible to make decisions based on incomplete knowledge and in the absence of exactly measured input values. Fuzzy systems are capable of operating in a stable manner even in the case of contradictory individual rules. A fuzzy approach is developed to optimize the prescription of normal tissue. The presented method is based on the theory of fuzzy sets, and attempts to sufficiently use uncertain information under the tolerance. The method contains two types of optimizations: intensity-modulated beam optimization and normal tissue prescription optimization. The former employs the fast-monotonic descent (FMD) technique. In this technique, a new iteration method is being developed in which the update scheme is analytically determined to avoid defected convergence. The present invention is beneficial because the heuristic and practical experience (from physician, physicist, planner) can be used to optimize the parameters of inverse planning in order to improve the dose distribution. Additionally, the conformity of target dose distribution can be improved and high target dose improves the quality of inverse planning. The time spent on trial-and-error testing can be significantly reduced and the planner can be free from this time-consuming task, thereby improving the efficiency of inverse planning. Execution of an IMRT conformal plan using a dedicated delivery system requires accurate patient positioning. If patient is not correctly positioned, conformal radiation beams may be delivered to normal tissues rather than the planned target. Therefore, patient mis-positioning can limit the applicability of dose escalation that is the key for IMRT. A conventional radiation field is documented by use of a portal film in a two-dimensional version. Information included in this image may not be sufficient for IMRT procedure, because the leaf position is not stationary during treatment for each field. Most quality assurance procedures for IMRT are performed in phantom. It is therefore important to find a way to verify both anatomically and dosimetrically for IMRT treatment. It has been noted that monitoring actual dose delivered in IMRT using megavoltage computed tomography (MVCT) and portal imaging taken together with transit dosimetric method grows in great importance. At present, a rapid and cost-effective method of verifying conformal IMRT radiotherapy based on limited number of fields is currently unavailable in clinical practice. A combined method was developed to perform three-dimensional verification of patient setup and to document dose distribution treated using limited number of static IMRT fields. In this method, a megavoltage CT reconstruction technique was developed based on Multilevel Scheme Algebraic Reconstruction Technique (MLS-ART) using a megavoltage x-ray imaging device. By combining the transmitted treatment beams with the regular CT imaging projection beams, both patient geometry at treatment position and actual dose distribution can be reconstructed. The geometry and dose can be compared to the patient, setup position and prescribed dose, which are used to correct subsequent beam placement or dose delivery accordingly. Portal CT and portal dose reconstruction is a novel verification technique in radiation therapy (especially in IMRT) with several advantages. It is online and allows direct verification of IMRT for both patient position and dose delivery. Moreover, mega-voltage CT-based technology can replace conventional patient simulation that uses kilo-voltage simulator or diagnostic x-ray CT and mega-voltage CT-based images can be used for treatment planning. The optimization of intensity-modulated beams (IMBs) consists of two main tasks: modeling (selection of objective function) and optimization (method of minimizing objective function). In this context, modeling means that the construction of a model in which knowledge (physical, biological, and clinical) about the irradiated structure&#39;s response to radiation is expressed by an objective function. The task of optimization is to develop a method by which one can obtain the optimal solution of minimizing the objective function. For multilateral optimization of radiation treatment planning, improving computation efficiency is an important topic. In the method of the present invention, an optimal step-length, the key parameter in the update scheme for iteration, and an optimal solution to the problem of negative intensity are analytically derived. Therefore, the convergence to global minimum is not only guaranteed, but also fast and monotonic descent. The method is called the fast-monotonic descent (FMD) method, which can provide an optimal solution to the intensity-modulated beams either when the intensity value is greater than zero or when a negative solution is encountered. More specifically, the method functions as follows. Let x=(x 1 , x 2 , . . . , x N ) be an intensity vector; x n is the nth component of intensity vector x. For each dose point (i,j,k), let P ijk represent the prescribed dose, and D ijk denote the calculated dose D ijk = ∑ n = 1 N ⁢ ⁢ A n , ijk ⁢ x n , ( 1 ) where A n,ijk is a non-negative constant coefficient that can be directly calculated. The weight w ijk ≧0 is used to indicate the importance of matching prescription and calculation. A quadratic objective function is therefore defined by f ⁡ ( x ) = ∑ i ⁢ ⁢ ∑ j ⁢ ⁢ ∑ k ⁢ ⁢ w ijk ⁡ ( P ijk - D ijk ) 2 . ( 2 ) In the case of an optimization problem having an objective function of Equation (2), the minimum cost problem is that of finding an admissible intensity vector such that objective function is minimized. This constrained optimization problem can be written as minimize ( x ) ⁢ { f ⁡ ( x ) } ( 3 ⁢ a ) subject ⁢ ⁢ to ⁢ ⁢ x n ≥ 0 ⁢ ⁢ ∀ n . ( 3 ⁢ b ) Now consider an unsynchronous updating scheme used in iteration method. For an arbitrary evolution time l, when l→l+1, x n ⁡ ( l + 1 ) = { x n ⁡ ( l ) + Δ ⁢ ⁢ x n if ⁢ ⁢ n = m x n ⁡ ( l ) otherwise ( 4 ) and f ( x ( l ))→ f ( x ( l+ 1)), where m is one of (1, 2, . . . , n, . . . , N). The updating scheme (4) says that, for each evolution time l, only one variable is adjusted. If each of variables is adjusted one time, then it is called one cycle. Based on the theory of classical minimum, the necessary and sufficient condition of descent for/is that the iterative rule satisfies: for each n Δ ⁢ ⁢ x n = - λ n ⁢ ∂ f ⁡ ( x ⁡ ( l ) ) ∂ x n , ( 5 ) where λ n , is a small positive number and called step-length. Note that the iteration sequence generated by Equations (4) and (5) is not guaranteed to converge to the minimum of f. This convergence is always dependent upon the choice of λ n . Adequate selection of this parameter is critical for the success of iteration method. Generally, the choice of λ n is a craft that is problem-specific. For a quadratic function, the parameter can be analytically derived and f will converge rapidly and monotonically to the minimum with the following condition: ∂ f ⁡ ( x ⁡ ( l + 1 ) ) ∂ x n = 0 ⁢ ⁢ ∀ n . ( 6 ) Parameter λ n can then be derived from the condition listed above. λ m = 1 2 ⁢ ∑ i ⁢ ⁢ ∑ j ⁢ ⁢ ∑ k ⁢ ⁢ w ijk ⁢ A m , ijk 2 . ( 11 ) W/th these two conditions (Eqns (5) and (6)), f descends rapidly to the global minimum if for each m (l≦m≦N) x m ⁡ ( l + 1 ) = { x m ⁡ ( l ) + ∑ n = 1 N ⁢ ⁢ B mn ⁢ x n ⁡ ( l ) + C m if ⁢ ⁢ x m ⁡ ( l + 1 ) &gt; 0 , 0 otherwise ; ( 7 ) where / denotes the l-th iteration, B mn = - ∑ i ⁢ ⁢ ∑ j ⁢ ⁢ ∑ k ⁢ ⁢ w ijk ⁢ A m , ijk ⁢ A n , ijk ∑ i ⁢ ⁢ ∑ j ⁢ ⁢ ∑ k ⁢ ⁢ w ijk ⁢ A m , ijk 2 , ⁢ and C m = ∑ i ⁢ ⁢ ∑ j ⁢ ⁢ ∑ k ⁢ ⁢ w ijk ⁢ A m , ijk ⁢ P ijk ∑ i ⁢ ⁢ ∑ j ⁢ ⁢ ∑ k ⁢ ⁢ w ijk ⁢ A m , ijk 2 . The FMD algorithm can be summarized as follows: 1) Fix the maximum number of iterations L, weights {w ijk }, and termination criterion ε&gt;0. 2) Initialize x(0)=(x 1 (0), x 2 (0), . . . , x N (0)), and x≧0 for each n. 3) For l=1, 2, . . . , L; a. Update intensity vector using Equation (4). b. Compute E l = max { n } ⁢  x n ⁡ ( l + 1 ) - x n ⁡ ( l )  . c. IF E l ≦ε stop; ELSE next l. 4) Compute dose distribution using Equation (1). f is a constrained quadratic objective function. A set of values x 1 , x 2 , . . . , xN that satisfies the non-negative constraints expressed by Equation (3b) is called an admissible vector, and the admissible vector that minimizes the objective function is called the optimal admissible vector. An optimal admissible vector can fail to exist for two reasons. There are no admissible vectors (i.e., the given constrains are incompatible) or there is no minimum (i.e., there exists a direction in N space where one or more of the variables can be taken to negative infinity while still satisfying the constraints). Fortunately, neither of them is satisfied in the problem of intensity-modulated beam optimization. First, it is clear that, the sets in Equation (3b) are convex, and the intersection consists of many points. Therefore, the non-negative constraints in Equation (3b) are compatible. The second reason is also false, since the intensity variables are non-negative. There is one important parameter {W ijk } in Equation (2) that has not been addressed above. Typically, the prescribed dose for the target volume and the upper limit for the sensitive organ is known. The prescription for the normal tissue is usually not given. Therefore, the optimization result varies with the prescription selected for the normal tissue. An intuitive strategy for finding the optimal normal tissue prescription would be to compare values of objective function calculated by using different prescribed doses and then to choose the minimum. In this way, w n , the weight for the normal tissue, is a function of p n , the prescribed dose for the normal tissue. Here, the subscript n represents a point (i, j, k) inside the normal tissue. The difficulty of using this strategy is how to formulate the relationship between weight w n and prescribed dose p n . Generally, all that is known is a plausible relationship between them: w n is the least when p n approaches to zero and w n is the greatest when p n approaches to the upper limit. A dynamic weight function is used to express this fuzzy relationship. An optimal prescription dose for normal tissue is then determined by a validity function. A quadratic objective function, as shown in Equation 2, with fuzzy weight as P ijk = { p t , if ⁢ ⁢ i , j , k ∈ Ω t p s , if ⁢ ⁢ i , j , k ∈ Ω s p n ; if ⁢ ⁢ i , j , k ∈ Ω n ⁢ ⁢ and ⁢ ⁢ w ijk = { w t , if ⁢ ⁢ i , j , k ∈ Ω t w s , if ⁢ ⁢ i , j , k ∈ Ω s w n . if ⁢ ⁢ i , j , k ∈ Ω n p t , p s and p n denote the prescribed doses for the target volume, the sensitive organ and the normal tissue, respectively Ω t , Ω s and Ω n represent regions of these three corresponding structures. W ijk ε[0,1] is called fuzzy weight function that is used to emphasize the importance of matching the prescribed dose and the calculated dose for the point (i, j, k). Instead of fixing {P ijk } and {w ijk } in the hard inverse planning (HIP), p n is defined as a variable and w n is represented by a function of p n in fuzzy inverse planning (FIP). Also, it is assumed that p t = P t , p s = P s , w t = w s = 1 ⁢ ⁢ and ⁢ ⁢ w n = { 1 , if ⁢ p n &gt; P n g ⁡ ( p n ) , otherwise ( 9 ) where P t represents the prescribed dose in the target volume, P s is the tolerance dose in the sensitive organ, and P n , is the tolerance dose in the normal tissue. g(p n ) is a continuous function that increases with p n . g(p n )=1 when p n is equal to the tolerance dose P n . Here g(p n ) is called fuzzy weight function. Regarding the function g(•), one has only some vague knowledge that can be stated by the following two fuzzy rules: 1) the closer p n is to P n , the closer w n is to one (w n =1 means the most important); 2) the closer p n is to zero, the closer w n is to zero (w n =0 means the least important). Fuzzy technology is used to express the vague knowledge and to achieve an optimal solution. The form of fuzzy weight function can be obtained from a planner&#39;s experience. As will be seen below, however, it is effective to use the following function: g ⁡ ( p n ) = ( p n P n ) K , ⁢ 0 ≤ p n ≤ P n ( 10 ) where K is a positive constant that controls the pattern of g(•). These functions are shown in FIG. 1 . Obviously, any function with a K value of equal to or greater than 1 can be selected to express the mathematical meaning of the following linguistic prescription. For the normal tissue, the closer the prescribed dose p n is to the tolerance dose, the greater the importance of the dose (i.e., the difference between the tolerance dose and the prescribed dose). Fuzzy inverse planning allows many feasible solutions to occur for a specific clinic problem. Selection of a specific treatment plan is determined by evaluating planning validity. Note that Equation (8) cannot be served as a validity function since the objective of radiation therapy optimization for non-target volume cannot be expressed by a quadratic function. To measure the validity of radiation treatment, a validity function is introduced, v({P ijk };x), which is written as v ⁡ ( { P ijk } ; x ) = ∑ i , j , k ∈ Ω t ⁢ ⁢  P ijk - D ijk  + ∑ i , j , k ∉ Ω t ⁢ ⁢ D ijk . ( 11 ) where, the first term represents the degree of dose uniformity for the target volume, and the second term represents the grade of protection of the non-target volume. For prescription validity, the ideal dose distribution can be achieved by minimizing v({P ijk };x) under the tolerance of normal tissues: minimize{ v ({ P ijk };x )}.  (12) With the introduction of this validity function, the fuzzy inverse planning (FIP) algorithm can be summarized as follows. Fix the maximum number of trial dose prescriptions T for normal tissue, the maximum number of iterations L, and the termination criterion s&gt;0. Choose fuzzy weight function g(•). Initialize x(0)=x 1 (0), x 2 (0), . . . , x N (0)), and x n ≧0 for each n. Then, for t=1, 2, . . . , T, given p n (usually p n increases with t on the interval (0, P n ), calculate w n using Equation (9), for l=1, 2, . . . , L and update intensity vector using Equation (7), compute E l = max { n } ⁢  x n ⁡ ( l + 1 ) - x n ⁡ ( l )  . if E/≦ε, calculate v using Equation (11), otherwise next l. IF v t+1 &gt;v t stop, otherwise next t. The dose distribution can then be computed using Equation (1). Preferably, a computer is utilized to automatically calculate this in response to the input of data, however, a human can also calculate the same using the formula. The invention is further described in detail by reference to the following experimental examples. These examples are provided for the purpose of illustration only, and are not intended to be limiting unless otherwise specified. Thus, the invention should in no way be construed as being limited to the following examples, but rather, should be construed to encompass any and all variations which become evident as a result of the teaching provided herein. The FIP is evaluated by two artificial examples. Dose-volume histograms (DVH) of the target volume (TV) and the sensitive organs (SO) are used as a primary tool for presenting and comparing dose distributions. EXAMPLES Example 1 This is a simulated cylindroid object and its central slice is illustrated in FIG. 2 . The geometry of this slice is similar to a CT head axial cut with two sensitive organs (analog to eyes) that are very close to the target volume. The prescription was given as follows: 100 dose units to the target volume, 20 dose units to the sensitive organs, and upper limit of 60 dose units to the normal tissue. Seven fan beams as shown in FIG. 2 were uniformly arranged between 0-2 π. Based on the primary-only model, the dose at depth is estimated by means of the percent depth dose data that were measured from a field size of 4×4 cm with 6 MV photon beams. However, beam divergence was included. In order to show the convergence and fastness of FMD method, the FMD algorithm was run using three different values of the step-length: λ n =0.01, λ n =λ opt and λ n =0.001 (n=1, 2, . . . , N). Here λ opt is the optimal step-length. FIG. 3 shows the differences of convergence behavior between λ n =λ opt and λ n =0.001, and between λ n =λ opt and λ n =0.01 (n=1, 2, . . . , N). The result indicates that the effectiveness of iteration methods is dependent upon the choice of step-length. The optimal step-length λ opt derived here, however, provides an optimal performance in both the speed of convergence and the quality of convergence. FIG. 4 shows that FMD can provide a satisfactory result after 10 cycles. Effect of Normal Tissue Dose In the study, a validity function is introduced to judge the optimal normal tissue prescription. Variation of validity function v versus prescribed normal tissue dose is plotted in FIG. 5 . The data in FIG. 5 indicated that p n =25 dose units appear to be the optimal prescription for normal tissue. Table 1 shows the fuzzy inverse planning (FIP) performance as a function of the normal tissue prescription dose with K=5 and L=100. Here p n =0 means no normal tissue is considered in the FMD optimization algorithm, i.e., w n =0 and w s =w t =1. Although statistic indices for the target volume in the case of p n =0 are better than others, the average dose of 52.6 dose units and the standard deviation of 33.8 dose units for the normal tissue far exceed the upper limit of 60 dose units. The data listed in Table 1 show that the optimal balance between objectives of high target dose and low normal tissue dose is achieved when p n =25 dose units. FIG. 6 shows corresponding dose-volume histograms for the target volume ( FIG. 6( a )), the sensitive organs ( FIG. 6( b )) and the normal tissue ( FIG. 6( c )). The improvement of performance is evident with the optimization of normal tissue dose prescription. Comparison of FIP and HIP Methods The case described above, with a normal tissue dose prescription of 25 units, can be considered an optimal result for the FIP algorithm: In this section the result obtained by the FIP method is compared to that obtained by the hard inverse planning (HIP) method. HIP means that only the FMD algorithm is applied. For the HIP method, two extreme prescriptions are selected: (a) no normal tissue is considered in the optimization algorithm, i.e., w n =0 and w s =w t =1; (b) the prescribed normal tissue dose is fixed, i.e., p n =P n =60 and w n =w s =w t =1. Dose-volume histograms are calculated and illustrated in FIG. 7( a ) for the target volume obtained using FIP, HIP(a), and HIP(b), respectively. Corresponding dose-volume histograms for the sensitive organs and the normal tissue are illustrated in FIG. 7( b ) and FIG. 7( c ). Table 2 provides the relevant statistical parameters. It has been shown that the overall results obtained by optimizing prescription of normal tissue dose (FIP method) are better than those obtained by HIP(a) and HIP(b). Effect of Parameter K As discussed in Section III, validity function g(•) is considered to be adequate if K=1. The effect of the parameter K in Equation (10) on the performance of FIP method is evaluated by using values of K=1, 2, . . . , 5. Dose-volume histograms obtained using different K values for the target volume ( FIG. 8( a )), the sensitive organs ( FIG. 8( b )), and the normal tissue ( FIG. 8( c )) are calculated and compared. Results indicated that the uniformity of dose for the target volume is improved as K increases. At the same time, the control of dose for the sensitive organ is stronger as K increases. However, the control of dose for the normal tissue is weaker as K increases. Therefore, the result of K=5 is more desirable than those of others are. If K is greater than 5, the performance of normal tissue would be less desirable despite of dose improvement in other structures. Example 2 The central slice of the phantom geometry in Example 2 is illustrated in FIG. 9 . Similar to Example 1, seven fan beams are arranged at 0, 2 π/7, 4 π/7, 6 π/7, 8 π/7, 10 π/7, and 12 π/7, respectively. The prescribed doses were set: 100 dose units for the target volume, 20 dose units for the sensitive organs and the upper limit dose of 60 dose units for the normal tissue. The other parameters were L=100 and K=5. FIG. 10 shows dose-volume histograms obtained by using FIIP, HIP(a) and HIP(b) methods for the example 2. FIG. 10( a ) corresponds to the target volume, FIG. 10( b ) to the sensitive organs, and FIG. 10( c ) to the normal tissue. Table 3 indicates the relevant statistical parameters: means, standard deviations for the three structures in Example 2. The performance patterns of the FIP algorithm in Example 2 is consistent with the results obtained in Example 1. However, the optimal normal tissue value p n here is equal to 30. Note that in this example one can also obtain a desirable result without considering normal tissue, i.e., FIP has similar result as HIP(a). Megavoltage CT Image Using Limited Number of Projections The use of a fluorescent/CCD-based EPID, coupled with a novel Multilevel Scheme Algebraic Reconstruction Technique (MLS-ART), was analyzed for a feasibility study of portal CT reconstruction (Ying 1990, Wong 1990, Yin 1994, Zhu 1995). An EPID set it to work at the linear dynamic range and collimated 6 MV photons from a linear accelerator to a slit beam of 1 cm wide and 25 cm long was used. Scans were performed under a total of 200 MUs for several phantoms in which the number of projections and the MUs per projection were varied. The reconstructed images demonstrated that using the new MLS-ART technique, megavoltage portal CT with a total of 200 MIUs can achieve a contrast detectability of 2.5% for an object of size 5 mm×5 mm and a spatial resolution of 2.5 cm. Using a Csl(T1) transparent scintillator x-ray detector together with the multi-level scheme algebraic reconstruction technique (MLS-ART) for megavoltage computed tomography (CT) reconstructions. The reconstructed CT images can be useful for positional verification in radiotherapy. The Csl(T1) imaging system consists of a scintillator screen coupled to a liquid-nitrogen-cooled slow-scan CCD-TV camera. The system provides better contrast resolution than the standard electronic portal imaging system (EPID), which is especially useful given the low number of projections used. The geometry of the imaging system has also been optimized to achieve high spatial resolution (1 lp/mm) in spite of the thickness of the screen. The reconstructed images were presented using a pediatric head phantom using a total of 99 projections, and a combined phantom using 50 projections. Image reconstruction was carried out using the MLS-ART technique. The CT images obtained using the back projection technique for comparison purposes were also presented. In addition, the use of the kinestatic charge detector (KCD) combined with the multi-level scheme algebraic reconstruction technique (MLS-ART) for x-ray computer tomography (CT) reconstruction was also investigated. The KCD offers excellent detective quantum efficiency and contrast resolution. These characteristics are especially helpful for applications in which a limited number of projections are used. In addition, the MLS-ART algorithm offers better contrast resolution than does the conventional convolution backprojection (CBP) technique when the number of projections is limited. Here the images of a Rando head phantom that was reconstructed by using the KCD and MLS-ART were presented. Also presented, for comparison, the images reconstructed by using the CBP technique. The combination of MLS-ART and the KCD yielded satisfactory images after just one or two iterations. The advantages of MLS-ART applied to conformal radiotherapy are following: a. The MLS-ART outperforms the conventional CBP technique for low contrast detection given a limited number of projections and it is especially useful for megavoltage CT reconstruction since in radiotherapy one cannot rotate the linear accelerator gantry to acquire a large number of projections in a reasonably short of time. Contrast detectability is strongly dose-dependent, and for some situations in x-ray imaging, high contrast resolution is not as important as the ability to provide excellent image contrast (Yaffe and Rowlands 1997). Such is the case with megavoltage CT imaging for radiation treatment verification. The high-energy x-ray photons experience inherently low attenuation in tissues. In addition, attenuation of radiation by tissues in the energy range is mainly due to Compton scattering that depends on electron density but not the atomic number. The two factors combined resulted in poor differentiation between various tissues (Johns and Cunningham 1983). Further, the detective quantum efficiency (DQE) of current megavoltage imaging devices is at least one order lower than those of detector for diagnostic x-ray CT. Therefore, megavoltage portal CT requires an efficient reconstruction technique like the MLS-ART, especially the one that is optimal for situations of low-contrast detectability. Better contrast detectability also helps for more accurate dose reconstruction since spatial resolution imposed on dose is even more relaxed. b. MLS-ART can be used for CT reconstruction using the radiation treatment beams in addition to the regular CT projection beams. Such a 2-step reconstruction produces much better reconstruction accuracy than simply using the treatment beams themselves because the latter is a case of incomplete data (although even for this case, MLS-ART itself works better than CBP.) In this way, the patient position can be directly and continuously monitored and even corrected during the treatment. c. Doing conformal radiotherapy using intensity modulated beams and portal CT is complicated by the tumor irregularity. Depending on the target shapes and sparing of critical organs, select treatment beam orientations to be orthogonal or close to orthogonal are important. The orientations must yield small geometrical correlations (less dose overlap) and most complementary dose distribution information. One can select the beam orientations following the MLS ordering, or in combination with methods known to those of skill in the art, such as the methods used by Gokhale, Soderstrom, Bortfeld. d. MLS-AIRT can be used for dose reconstruction. It is more accurate than the analytical method given a limited number of beams because for any analytical dose integration method, there is an implicit assumption that an infinite number of projections were used. But the integration method fails if the angles between beams are large unless special techniques like arc therapy for tomotherapy are used. Reconstruction of IMRT Beams for Dose Distribution Methods: Inverse Treatment Planning Algorithm for IMRT: Research Method: First, it should been pointed out that the definition of fuzzy weight function as shown in Equation (10) is not a unique form. Different functions can be used to achieve different goals. The Gaussian function was tested instead of Equation (10) and it was found that the result obtained using Equation (10) is better than that obtained using a Gaussian function. Second, in the present study two loss functions are introduced. One is the objective function as shown in Equation (8) and the other is the validity function as shown in Equation (11). The former is used to optimize beam intensity. The latter is employed to evaluate the prescription of normal tissue. The objective function as shown in Equation (8) cannot replace the validity function as shown in Equation (11). For example, it is equal important in terms of loss value when the calculated dose in normal tissue is either 10 below or 10 above the prescribed dose. Therefore, Equation (8) does not completely express the objectives of radiotherapy, and a validity function as shown in Equation (11) is necessary. In addition, it is clear that Equation (11) is an unbiased measure function since the loss for the non-target volume is calculated from zero. In the present study there is described a fuzzy inverse planning (FTP) method for solving the problem of uncertain prescription optimization in radiation therapy. The study is concerned only with the optimization of normal tissue prescription. The dose prescription in the sensitive organs is fixed. Typically, the upper limit dose for the sensitive organ is less than that for the normal tissue. It is difficult to control the calculated dose less than the upper limit for the sensitive organ (except for those cases in which the sensitive organs are far from the target volume). Typically, the mean dose in the sensitive organs is greater than the upper limit dose. The importance of matching the calculated dose and the prescribed dose for the target volume is equal to that for the sensitive organ, i.e., w t =w s =1. Clinically, it means that the importance of protecting the sensitive organ is the same as that of controlling the tumor. However, different weighting factors can be chosen by radiation oncologists for a specific clinical case to fulfill a special objective. A fuzzy inverse treatment-planning algorithm has been developed. The method provides an alternative to soft optimization for treatment planning. The main advantages have two folds. (a) The developed FMD has the fastest convergence speed in the stage of optimizing the beam intensity and the algorithm is simple to use in which no parameter is problem-specific. And (b) the FIP technique can use uncertain information in inverse treatment planning to achieve the optimal balance between the objectives of matching the calculated dose and the prescribed dose for the target volume and minimizing the dose in normal tissue. The presented technique optimizes not only beam intensity distribution but also normal tissue prescription. The performance of the new algorithm has been compared to that of the hard, inverse planning methods for two treatment geometries. The calculation time is less than 2 minutes on PC machine (333 mHz, 64 MB RAM) for 10 slices with a matrix size of 256×256. At the present, it is difficult to compare between different approaches due to difference in test cases, dose calculation and other factors. Inverse planning method involves two key components: objective function to define the goal for the optimization, and optimization method to find the optimal solution for a given objective function. The optimization algorithm developed here may be also applicable to resolve objective functions based on biological model. f ⁡ ( x ) = ∑ i ⁢ ⁢ ∑ j ⁢ ⁢ ∑ k ⁢ ⁢ w ijk ⁡ ( P ijk - D ijk ) 2 The physical meaning of W ijk , P ijk , and D ijk are as described above. Optimization Method Compared to some existing iteration techniques, there are several unique characteristics of FMD technique. (1) The key parameter, step-length, used in update scheme is analytically calculated so that no trial-and-error is involved. Choice of update scheme is critical for fast convergence and optimal results. Inappropriate selection of the step-length may lead to poor convergence or even non-convergence. (2) Fast and monotonically convergence guarantees the global minimum of the optimization algorithm. (3) The problem of negative beam intensities is effectively eliminated. (4) The algorithm is simple to understand and implement for clinical applications. Fuzzy Representation of Vague Prescription The concept for a logistic plan is to deliver full dose to the target region while keeping the dose below the maximum tolerance for normal tissues. The quadratic model in the above section is not sufficient to address the upper limits for normal tissue prescription. A fuzzy function was introduced to represent vague normal tissue prescription. The theory of fuzzy set is a mathematical tool used to represent uncertain or partial knowledge. In inverse treatment planning, one only knows the upper limits for normal structures but is not certain what is the optimal prescription, especially the prescription for normal tissue and critical organs. Therefore, the category of problem can be represented by the theory of fuzzy set. The objective function can be divided into three terms. The first term relates to the target volume that is expected to receive uniform prescription dose. The second term relates to the critical organs that are sensitive to radiation damage and a tolerance dose will be set. The third term relates to the normal tissues except critical organs in which dose is expected to be as low as possible. To achieve these goals, the weight factors in the objective function can be redefined as follows: W ijk in target volume wt=tt, where tt is a constant and is used to indicate the importance of matching target dose. Typically, tt=1. W ijk in critical organs w c =cc*h(p c ,P c ), where cc is a constant and is used to indicate the importance of matching prescription for each critical organ. W ijk in critical organs w n =nn*g(p n ,P n ), where nn is a constant and is used to indicate the importance of matching prescription for normal tissues. Here both g and h are two fuzzy functions. The fundamental of constructing a fuzzy function is to find proper weighting factors in the objective functions. Linguistically, the closer the prescribed dose is to the tolerance dose, the greater the importance of the dose (i.e., the difference between the tolerance dose and the prescribed dose). Mathematically, it can be described by a following function: g ⁢ ( p ⁢ n ) = ( ⁢ p n ⁢ P n ) K , 0 ≤ p n ≤ P n ( 10 ) h ⁡ ( p ⁢ c ) = ( ⁢ p c ⁢ P c ) K , 0 ≤ p c ≤ P c ( 10 ) where K is a positive constant that controls the patterns of g(•) and h(•) These functions are shown in FIG. 1 . Obviously, any function with a K value of equal to or greater than 1 can be selected to express the mathematical meaning of the following linguistic prescription. Penalty of Optimization Method Fuzzy inverse planning allows many feasible solutions to occur for a specific clinic problem. Selection of a specific treatment plan is determined by evaluating planning validity. Note that Equation (8) cannot be served as a validity function since the objective of radiation therapy optimization for non-target volume cannot be expressed by a quadratic function. For example, when the calculated dose is greater than (but closer to) the prescribed dose, the objective function will not able to penalize such a situation. To measure the validity of radiation treatment, a validity function is introduces, say v({P ijk };x), which is written as ∑ ⁢ v ⁡ ( { P ijk } ; x ) = tt ⁢ ∑ i , j , k ∈ Ω t ⁢ ⁢  P ijk - D ijk  + nn ⁢ ∑ i , j , k ∉ Ω t ⁢ ⁢ D ijk + cc ⁢ ∑ i , j , k ∉ Ω t ⁢ ⁢ D ijk ( 11 ) The importance of requiring the quadratic function is that it is proved that the global minimum does exist and is unique. Here tt, nn, and cc are used to indicate the importance of matching each term. The parameters can be determined by the planner based on the clinical needs for each individual patient. When an equal importance is reached, tt, nn, and cc are equal to 1. If DVH is used to judge the results, tt, nn, and cc can be used changed to reach final plan. Evaluation of Inverse Planning Method: Phantom Test The developed inverse planning method was tested with three cylindrical, phantoms: brain, head and neck, and pelvis. Each geometry has both complicated target volume and critical organs around it. The primary beam was acquired from TMR data for 4×4 cm field size of 6 MV photon beam. Patient Case Test IMRT Experiment Clinical implementation was based on step-and-shot approach including the following: a. patient CT image; b. input to Pinnacle 3-D planning system; c. contour target and critical structure and external edges; d. export contours and CT images to inverse planning algorithm; e. generate IMRT intensities for each beam; f. segment each beam for step-and-shot; g. import segmented field to Pinnacle 3-D system; and h. calculate MIUs for each segment. Three-Dimensional Reconstruction of Dose Distribution With the patient at the treatment position, the same projection data for the geometry reconstruction was used to estimate the true dose delivered to the patient. A scheme for 3-D dose verification was developed, which requires overlaying the reconstructed patient geometry at treatment with the distribution of the delivered dose. This serves as a verification tool to the initial treatment planning. In the current megavoltage CT imaging, a uniform beam was used for both the calibration runs and the projection measurements. For the EMIRT, the x-ray beam from each projection was modulated in intensity, i.e., non-uniform. Therefore, the IMRT beams were measured before the patient is placed in the treatment room to get the entrance intensity distribution. An alternative way was to download the distribution from the IMRT delivery files; however, this option is less direct than measurement. Without these entrance beam intensity, one would be unable to decide whether any exit intensity change is due to the entrance intensity change or different attenuation within the patient geometry. Image reconstructions using the intensity-modulated beam can be tested initially using simply compensator or wedge. Different patient dose calculation methods can be used based on the measured transmission x-rays (most of the detected x-rays are primary components for that there is a 50 cm air gap between the patient exit surface and the detector. The scatter fraction for a 20×20 field size, 17 cm thick water and 30 cm air-gap is 10% [Jaffray et al., 1994]). The first two methods are based on the primary photon fluences at the point of dose calculation. These are called the convolution-superposition and the superposition-convolution method. In the first method, the x-ray fluence at the detector surface is ray-traced back to inside the patient&#39;s geometry. The fluence can be convoled inside the patient with an appropriate energy deposition kernel (dose spread array) to obtain the dose distribution. By superimposing all the distributions over the reconstructed patient geometry, one can obtain the total dose distribution. In the second method, first, the x-ray fluences of all the beams at the detector surface are ray traced back and superimposed together to get the total primary x-ray fluence distribution inside the patient. Then one can convolve the total fluence distribution with a rotation dose spread kernel to get the total dose distribution. In both methods, normalization (calibration) is needed. The third method is based on the primary photon distribution attenuated inside the patient. The overall primary attenuation distribution in the patient, which is different from the total primary fluence ray traced back from the detected x-rays, can also be reconstructed, using the similar methods for the emission tomographic reconstructions such as PET and SPECT. (For each beam the attenuation profile was obtained by subtracting the penetrated primary from the entrance beam.) Then, the overall attenuation distribution was convolved with a special rotation dose kernel (which is calculated based on the photon numbers rather than the photon fluence) to get the dose distribution. MLS-ART can be applied for such a photon attenuation reconstruction (with some modification) based on the experiences of Herman [1993], but not the conventional CBP technique due to the limited beam numbers. Further, the homogeneity corrections can be directly calculated based on the geometric reconstructions. Compared to the first two methods, the third method is more direct, accurate and convenient. It is also easier for the intensity-modulated beams. With faster and growing computation technology including hardware specifically designed for MLS-ART and FFT, one can achieve faster and more accurate on-line verification. To be more accurate, one needs to calculate the primary fluence on the detector&#39;s surface by deconvolving the projection data (measured during treatment session, therefore no additional dose to the patient) using the “EPIID kernel” (the point spread function of EPD). One can also use some portal dosimetry methods to model the exit dose distribution and to compare it to the calculation results. It can also be used to model the absorbed dose inside the treatment volume (actually the dose along the beam path) based on the treatment geometry as reconstructed using the MLS-ART. The results were compared to some other dose modeling and verification methods such as the portal dose imaging (PDI) technique [Wong et al., 1990], the superposition/convolution method [McNutt et al., 1996a &amp; b], and the inverse filtered (convolution) back-projection method of Holmes and Mackie [1994]. The other advantage of using the C51(T1) detector for dose modeling and verification throughout the treatment volume is that compared to commercial EPID which overrespond to low energy x-rays for dosimetry studies, the detector is more tissue equivalent. If a-Si detector is used, a more active way to reduce over-response is to use organic scintillators (low-Z plastic materials) on the detector so that detector response will be more tissue equivalent. One way is to use a low-Z screen with a buildup phantom such as the solid water. Then the photons undergo interactions in the buildup material. The secondary electrons are mainly absorbed in the organic screen, and the visible photons are emitted toward the a-Si photodiode sensor. The merit of using such an organic screen is that the dose deposition by electrons inside the tissue can be exactly modeled by using the tissue-equivalent organic material. The screen needs to be fabricated by a medical imaging company because the currently available screen has poor surface smoothness. For clinical application of megavoltage portal CT, improving the accuracy of reconstruction rests on more efficient detectors and optimized reconstruction algorithms to most effectively use the available dose. In the study, three interrelated specific goals can be analyzed. (1) Adapt an efficient x-ray detector to carry out the study. There are 3 options: a) use Varian Portal Vision Electronic Portal Imaging Device (EPD), which tested to be the best commercial EPID system; b) use the amorphous silicon system; and c) use a C5I(T1) CCD system which was specifically designed for megavoltage imaging. The Csl(T1) system is one of the best megavoltage imaging systems, providing both good contrast and spatial resolution. (2) Image reconstruction. The MLS-ART technique can be used for this specific application, in which a limited number of cone beam projections (dosage close to that in diagnostic CT) are used to get megavoltage CT reconstruction for patient geometry. Then the treatment beams can be used to further modify the reconstruction. The two-step reconstruction has three important purposes: 1. the second stage locally improves the CT image quality inside the tumor; 2. the second stage also determines the placement of treatment beams inside the patient geometry obtained by the first step; and 3. the treatment (dose covered) area can be visualized from the final CT images. MLS-ART can easily perform the reconstruction. However, it is impossible for the conventional convolution backprojection (CBP) technique. (3) Dose reconstruction and verification. From the portal image taken at the treatment portal, one can obtain the portal (transit) dosimetry and convert the portal dose information to photon fluence. The fluence can be traced back to the patient and one can determine the fluence inside the target. The convolution-superposition or superposition-convolution or other methods can then be used to calculate the dose inside the patient use the fluence. Such a 3D dose distribution can be overlaid onto the patient geometry to verify the treatment plan. Any major discrepancy between the prescribed and actual dose can be corrected by modification of the treatment setup. Example 3 Materials and Methods For a given dose prescription, conventional inverse treatment planning consists of two steps: (1) finding the suitable weighting factors for involved organs and (2) optimizing the intensity spectrum based on the given weighting factors. As there are a large number of choices for weighting factors, finding the desired ones for a given objective function is difficult. The involved organs in this system are categorized as the target volume (TV), the critical organs (CO), and the normal tissue (NT). The Principle of the Fuzzy Inference System The flow chart of FIS is illustrated in FIG. 1 . It consists of three main modules: the Fuzzifier, the Inference Engine (consisting of fuzzy rules) and the Defuzzifier. For each variable input to the fuzzy inference system, a number of fuzzy sets are defined with appropriate membership functions. These membership functions are labeled with linguistic tags frequently used by humans (such as “High” dose). During the process of fuzzification (corresponding to the module of Fuzzifier), the single input value is compared to the membership functions defined for that input variable. If the membership functions have a non-zero output, it will take effect on the final result of the FIS. Generally, the fuzzifier calculates the response of rules for the input values, and the inference engine modifies the consequent of rules in response to the input values and the defuzzifier generates the final output based on the result of the inference engine. The inputs to this system are defined as the characteristic doses [C TV , C CO , C NT ] which consist of the mean dose (Mean i , i=TV, CO, NT) and its standard deviation (STD i ,il=TV, CO, NT). For the target volume, C TV =Mean TV −STD TV . For the critical organs and normal tissue, CCO=Mean CO +STD CO and C NT =Mean NT +STD NT . The outputs of FIS [ΔW TV , ΔW CO , ΔW NT ] are defined as the adjustment of the weighting factors for each involved organs. For each input variable, two fuzzy sets, “High (H)” and “Low (L)”, are defined with membership functions [f i H (x), f i L (x), i=TV, CO, NT], as shown in FIGS. 2 a - 2 c . For each output variable, three fuzzy sets, “Increase (I)”, “No change (N)”, and “Decrease (D)”, are defined with membership functions [g i I (x), g i N (x), g i D (x), i=TV, CO, NT]. For the target volume, these three membership functions are shown in FIG. 2 d . Similar membership functions are defined for critical organ and normal tissues for the same adjustment strategy. Based on the input and output variables defined above, fuzzy rules are established for the fuzzy inference engine. Eight rules are employed in the system. In each rule, the “if” part of rule is called antecedent and the “then” part of rule is called consequent. Two of them (Rule 5 and Rule 8 ) are used to demonstrate the procedure of fuzzy inference as shown in FIG. 3 . Note that the input (output) variables are labeled using the bold fonts and their corresponding linguistic tags are labeled using the italic fonts in each rule. According to the linguistic tags, the corresponding membership functions for the input fuzzification are specified as shown in Step 1 of FIG. 3 . Such as the input variable C TV , the membership function f H TV is specified in Rule 5 by the linguistic tag “High”. For each rule, the outputs of the fuzzification are [D 5 TV , D 5 CO , D 5 NT ] and [D 8 TV , D 8 CO , D 8 NT ], respectively. Based on these outputs of fuzzification, the degree of support (D SUPPORT ) for each rule is achieved by a logic operator “Min”, such as D 5 support =Min (D 5 TV , D 5 CO , D 5 NT ) and D 8 support =Min (D 8 TV , D 8 CO , D 8 NT ), as shown in Step 2 of FIG. 3 . The degree of support represents the applicability of the rule&#39;s antecedent for given inputs. Based on the degree of supports, the fuzzy inference is performed by a standard implication method, which is accomplished by a logic operator “Min”. For example in Step 3, the membership function g N TV (x) in Rule 5 is modified as g N,D5 TV (x)=Min (D 5 support , g N TV (x)). The modified membership functions became [g N,D5 TV (x), g N,D5 CO (x), g N,D5 NT (x)] and [g N,D8 TV (x), g N,D8 CO (x), g N,D8 NT (x)] for Rule 5 and Rule 8 , respectively. As there are two sets of modified membership functions obtained, it is necessary to combine them to produce a single one. In Step 4, the functions were aggregated into one set by a logic operator “Max”, i.e., [ g TV ( x ), g CO ( x ), g NT ( x )]=[Max( g TV N,D 5 ( x ), g TV N,D 8 ( x )], Max( g CO N,D 5 ( x ), g CO N,D 8 ( x )), Max( g NT N,D 5 ( x ), g NT N,D 8 ( x ))]. The aggregated functions represent the combined consequent from all the rules. Finally, the aggregated functions are defuzzified to a single value by the centroid method in Step 5. The x-coordinate of the centroid (represented by sign “⊕”) for each aggregated function was the final output, the adjustment amount of weighting factors. The Fuzzy Logic Guided Inverse Planning Algorithm The flow chart of the FLGIP system is schematically illustrated in FIG. 4 . First, the dose prescription and weighting factors are set to their initial values. Then, an iterative gradient algorithm is used to calculate the intensity spectrum x. In the study, the objective function is defined as follows: f ⁡ ( x ) = ∑ i ⁢ ⁢ ∑ j ⁢ ⁢ ∑ k ⁢ ⁢ w ijk ⁡ ( p ijk - d ijk ) 2 , ⁢ Where ⁢ ⁢ d ijk = ∑ n = 1 N ⁢ ⁢ A n , ijk ⁢ x n ( 1 ) is the calculated dose for each voxel, A n,ijk is the relative dose coefficient, or dose per unit intensity of pencil beam. P ijk is the dose prescription and w ijk is the weighting factor defined as follows: p ijk = { P TV , if ⁢ ⁢ ( i , j , k ) ∈ Ω TV P CO , if ⁢ ⁢ ( i , j , k ) ∈ Ω CO P NT , if ⁢ ⁢ ( i , j , k ) ∈ Ω NT , ⁢ w ijk = { W TV , if ⁢ ⁢ ( i , j , k ) ∈ Ω TV W CO , if ⁢ ⁢ ( i , j , k ) ∈ Ω CO W NT , if ⁢ ⁢ ( i , j , k ) ∈ Ω NT . Ωw TV , Ωw CO and Ωw NT denote the target volume, the critical organ volume, and the normal tissue volume, respectively. The minimization of the objective function under the constraint of x n ≧0 can be written as a problem of min x ⁢ { f ⁡ ( x ) } ⁢ ⁢ subject ⁢ ⁢ to ⁢ ⁢ x n ≥ 0 , ⁢ ∀ n . ( 2 ) Equation 2 can be solved by the fast-monotonic-descent (FMD) method developed by Li and Yin, which is an optimized iterative gradient technique for the quadratic function. Based on the optimized intensity spectrum, the characteristic doses are calculated and then input to the FIS. Using fuzzy inference, the adjustment amounts of weighting factors [ΔW TV , ΔW CO , ΔW NT ] are obtained. Then, the weighing factors for the next iteration are modified as follows: W i ( n +1)= W i ( n )[1 +ΔW]iε{TV,CO,NT}, ΔWε[− 1,1].  (3) As the weighting factors affect the output of inverse planning by their relative values rather than the absolute values, they are re-normalized to [0, 1] by the following formula: W i * ⁡ ( n + 1 ) = W i ⁡ ( n + 1 ) W TV ⁡ ( n + 1 ) 2 + W CO ⁡ ( n + 1 ) 2 + W NT ⁡ ( n + 1 ) 2 ⁢ ⁢ i ∈ { TV , CO , NT } . ( 4 ) This updating procedure repeats until the following convergence criterion (5) is satisfied: [ C TV ⁡ ( n + 1 ) - C TV ⁡ ( n ) ] 2 + [ C CO ⁡ ( n + 1 ) - C CO ⁡ ( n ) ] 2 + [ C NT ⁡ ( n + 1 ) - C NT ⁡ ( n ) ] 2 C TV ⁡ ( n ) 2 + C CO ⁡ ( n ) 2 + C NT ⁡ ( n ) 2 &lt; T . ( 5 ) where T is a small threshold number, such as 0.01. Results The performance of FLGIP system was examined using two cases (one simulated and one clinical). Dose-volume histograms (DVHs), plus the variation of characteristic doses and weighting factors versus the iteration number, are used as the primary tools to evaluate the performance of this system. Pencil beams of 6 MV were used. For simplicity, the primary-only dose at depth is used in the calculation. The initial weighting factors [W TV , W CO , W NT ] are set to [1,1,1] (after re-normalization using formula (4), they became [0.58, 0.58, 0.58]) and the convergence constant T was set to 0.01. The Simulated Case The central slice of this case is illustrated in FIG. 5 a . The layout on this slice simulates the spinal cord with a target volume surrounding it. Seven treatment beams are uniformly arranged between 360 degrees. The configuration is typical in spinal radiosurgery using IMRT. The FLGIP system was tested using four sets of different dose prescriptions: [100%, 20%, 50%], [100%, 30%, 50%], [100%, 40%, 50%], [100%, 50%, 50%]. FIG. 6 shows the variation of (a) characteristic doses and (b) weighting factors versus the iteration number for dose prescription [100%, 30%, 50%]. The results indicate that for the target volume and critical organ, the characteristic doses monotonieally converge to the prescribed doses (the normal tissue dose also converges, but at a much less rate due to its large volume.) The results shown in Table 1 demonstrate that the high target dose and low critical organ dose are achieved simultaneously and both meet the prescribed doses. The corresponding DVHs for (a) the target volume, (b) the critical organ, and (c) the normal tissue are shown in FIG. 7 . The final results also depend on the provided dose prescriptions. For each set of dose prescriptions, the corresponding isodose distributions are shown in FIG. 8 . The effect of initial weighting factors on the final characteristic doses was examined by using eight sets of initial values with the same dose prescriptions [100%, 30%, 50%]. The characteristic doses for each set converged within 50 iterations. The final results and the standard deviations are shown in Table 2. The results indicate that the achieved characteristic doses by different sets of initial weighting factors are comparable. The final eight sets of weighting factors were averaged. The mean weighting factors and their standard deviations are 0.139±0.113 for the target volume, 0.985±0.025 for the critical organ, and 0.004±0.003 for the normal tissue. The Clinical Case The central slice for the present study is illustrated in FIG. 5 b . Eleven beams are arranged at 0°, 33°, 66°, 90°, 120°, 150°, 210°, 240°, 270°, 300°, 330°. The configuration represents a complicated IMRT case. The dose prescription is set to [100%, 30%, 50%]. The variations of the characteristic doses and weighting factors versus the iteration number are shown in FIG. 9 a and FIG. 9 b , respectively. The characteristic dose C TV monotonically converges to its prescribed dose 100% while the characteristic doses C CO and C NT monotonically converges to the doses below their prescribed values, 30% and 50% respectively. The DVHs of the calculated doses for different organs at three iterations 5 , 10 , 15 are shown in FIG. 10 . The results indicate that the gap between the DVHs of target volume ( FIG. 10 a ) and critical organs ( FIG. 10 c ) increases with increased iteration number. The substantial improvements of isodose distributions around the critical organ CO 1 , (the one closet to target volume) in different iterations can be easily identified from FIG. 11 . Discussion A fuzzy inference system was developed to automatically modify the weighting factors in inverse treatment planning in order to achieve the dose distributions best matching the treatment requirements. The fundamental inference mechanism is demonstrated by a mini system consisted of rules as shown in FIG. 3 . Among the eight rules, Rule 5 plays the primary role to drive the system toward the convergence while Rule 8 (plus the other six rules) drives the inputs toward its prescribed ones. For example, when the inputs for critical organ and normal tissue are much higher than their prescribed doses, the output of FIS can mainly be determined by the adjustment of Rule 8 . Once the inputs approach their prescribed ones to better match the antecedent of Rule 5 (usually after several iterations), the consequent of Rule 5 takes more effect on the output of FIS and drives the system towards convergence. The other six rules are used to process different scenarios of mismatching between characteristic doses and prescribed doses of different organs. The details of the adjustment process are shown in FIG. 6 and FIG. 9 . At the first several iterations, the weighting factor for the target volume decreases and the weighting factor for the critical organs increases quickly. After a few iterations, as the characteristic doses approach the prescribed ones, the adjustments of weighting factors gradually reduce. The characteristic doses for the target and critical organs in the last iteration satisfy their dose prescriptions. For the normal tissue, however, the final characteristic dose is appreciably lower than its prescribed dose due to its large volume. Although some rules seemingly take less effect on or are seldom used in these two cases, these rules are necessary for the more complicated cases. In addition, the results shown in FIG. 7 indicate that using different dose prescriptions can result in different dose distributions. Potentially, the fuzzy inference technique can also be used to optimize other parameters in inverse planning such as the beam orientation, the dose prescription, etc. As the configuration of FIS is flexible, it provides a wide space to customize the configuration for different applications. In the system, the input characteristic doses are chosen as the mean dose combined with its standard deviation. For target, the lower than mean input dose helps the FIS to drive the target dose to be higher toward the prescribed one in the next iteration. Similarly, for critical organ and normal tissue, the higher than mean input dose drives critical and normal tissue doses to be lower toward the prescribed ones in the next iteration. In this way, both high target dose and lower critical organ (and normal tissue) doses can be easier to achieve. For output variables, they are simply defined as the relative adjustment of the weighting factors, which are between −1 and 1. For the selection of inference rules, it is primarily determined by the clinical experience. The general treatment intention can be described as: If the target dose is low, its weighting factor should be increased. If the critical organ and normal tissue doses are high, their weighting factors should be increased. In the system of the present invention, such treatment intention is expressed by eight rules, which is a complete combination of linguistic tags for three kinds of involved organs. The option can avoid any unpredicted input values. As for the selection of membership functions, the Gaussian function is adopted due to its simplicity and popularity for most of the engineering applications. In some circumstances, part of the Gaussian function is used, such as those shown in FIG. 2 a - 2 c. CONCLUSION A fuzzy logic guided inverse planning system has been developed. The system provides an effective and efficient approach to optimize the parameters used in inverse planning. The main advantage of using FIS is that it can perform the sophisticated inference formerly done by trial-and-error approach. Relying on the planner&#39;s experience and knowledge on how to compromise parameters among different organs involved, the optimization of weighting factors can be easily accomplished by encoded rules. As demonstrated by the result of two cases, the fuzzy inference system can undertake the very complex task of parameter optimization in inverse planning. Throughout the application, author and year and patents by number reference various publications, including United States patents. Full citations for the publications are listed below. The disclosures of these publications and patents in their entireties are hereby incorporated by reference into this application in order to more fully describe the state of the art to which this invention pertains. The invention has been described in an illustrative manner, and it is to be understood that the terminology that has been used is intended to be in the nature of words of description rather than of limitation. Obviously, many modifications and variations of the present invention are possible in light of the above teachings. It is, therefore, to be understood that within the scope of the appended claims, the invention can be practiced otherwise than as specifically described. TABLE I Comparison of results by using different sets of dose prescriptions. Calculated dose (%) Dose prescription (%) Target Critical Normal Target Critical Normal volume organ tissue volume organ tissue Mean STD Mean STD Mean STD 100 20 50 102.1 6.3 20.5 2.4 26.2 18.9 100 30 50 102.3 5.3 31.1 2.1 26.6 19.1 100 40 50 102.3 4.6 40.2 1.8 26.9 18.7 100 50 50 102.4 4.1 50.3 2.0 27.2 18.6 TABLE II Comparison of results by using different sets of initial weighting factors. Calculated dose (%) Weighting factor Target Critical Normal Target Critical Normal volume organ tissue volume organ tissue Mean STD Mean STD Mean STD 0.1 0.1 0.1 100.8 5.6 30.2 0.8 25.8 18.8 0.1 0.1 1.0 101.0 5.9 30.0 0.2 25.7 19.1 0.1 1.0 0.1 101.1 6.0 30.0 0.2 25.7 19.1 1.0 0.1 0.1 100.3 4.5 30.8 3.0 25.3 18.5 1.0 1.0 1.0 100.8 5.6 30.2 0.8 25.8 18.8 1.0 1.0 0.1 100.5 5.1 30.4 1.5 25.5 18.6 1.0 0.1 1.0 100.4 5.2 30.3 1.3 25.3 18.7 0.1 1.0 1.0 100.7 6.0 30.0 0.1 26.6 22.5

A fuzzy inference system for use in modulating radiation treatment includes a fuzzifer for inputting imaging data, and inference device operatively to the fuzzifer for analyzing the imaging data and determining radiation treatment target from non-treatment target, and a defuzzifier for modulating radiation treatment pursuant to the analysis from the inference device.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention concerns a mounting device for the head of a golf club on the handle. 2. Description of Background and Other Information A golf club is conventionally made of a metal handle, and the head is connected to it by an upward extension called the &#34;neck&#34;. The assembly of the head and the handle generally occurs by fitting and bonding, particularly by gluing, of the handle on the neck. The head of the golf club constitutes the official hitting component. For the hit to be correct, it is necessary that this head rest completely flat on the ground, the handle of the club then forming the angle in relation to the horizontal plane of the ground, this angle constituting the angle called the &#34;lie&#34; of the handle. It can be easily conceived that the angle of lie of a golf club varies as a function of the player and essentially depends on his playing position and height. In the case of a club such as a &#34;putter&#34;, the three angles of lie are generally defined corresponding to three positions of the golf player, namely, a median position and two extreme positions obtained by a shift of about 2° from the axis of the handle on either side of the median position. It is attempted, particularly in the case of the precision clubs such as &#34;putters&#34;, to be able to easily modify the angle of lie in a manner to adjust it to the playing position of the player. Different solutions have been proposed to resolve this problem, and particularly that consisting of deforming the neck after assembling the golf club. In the case of traditional &#34;putters&#34;, that is &#34;putters&#34; in which the upper part of the head supporting the neck possesses a certain malleability in relation to the head, strictly speaking, the deformation occurs at the level of this upper part and is progressively distributed along the length of it. On the contrary, in certain &#34;putters&#34; called &#34;swan neck&#34;, the upper part of the head has a structure which gives it a rigidity so that it cannot bend. In this case, the bending stress is supported by the neck and is exercised on it at the level of the connection zone between the base and the upper part of the head. However, this zone is particularly narrow so that the bending stress often leads to a break in the base of the neck or an abrupt break in the alignment between it and the handle. It has also been proposed to adjust the angle of lie to the desired value by using a system of shims provided on the neck and/or on the inside of the handle, whose relative thicknesses are combined to pass incrementally from a median value of the angle of lie to the upper or lower values, as disclosed in commonly owned French Application No. 88.06187 filed on Jun. 2, 1988. SUMMARY OF THE INVENTION The goal of the present invention is a device to remedy these drawbacks, allowing for the adjustment in exact and progressive fashion of the angle of lie without the risk of damaging the golf club. To this end, the object of the present invention is a golf club with a head provided, on its upper part, with a neck on which is attached the lower part of the handle, by mutual fitting of the neck and the handle, characterized in that the base of the contact surface between the external side of the neck (or the handle) and the internal side of the handle (or neck) is distant from the base of the neck by which it connects to the upper part of the head, by a predetermined length equal to the length which will eventually be bent. Thus, according to the invention, the bending effort applied on the neck is distributed along a given length of it, and it is easily adjustable as a function of the material used. The present invention thus permits, in considering the length of the neck subject to bending as a function of the material constituting the head of the golf club, regulation of the stress inside the neck such that it occurs beyond the elastic limit and within the rupture limit of the material. In a variation, the length of the neck subject to bending is determined by a ring, made of a compressible or ductile material, around the neck between its base and the lower end of the golf club handle, the thickness of this ring determining the length of the neck subject to bending. In this manner, on the one hand the separation is determined in an exact and easy fashion, and on the other, during the bending exercised by the handle of the club on the neck, the lower end of the handle compresses the ring, permitting one to obtain a precise adjustment between it and the upper part of the head of the club. In an interesting variation on the invention, an intermediary compressible ring is used to assure the seal during the gluing operation between the handle and the neck of the head of the golf club, necessary so that the glue does not overflow. BRIEF DESCRIPTION OF THE DRAWING The above and additional objects, characteristics, and advantages of the present invention will become apparent in the following detailed description of preferred embodiments, with reference to the accompanying drawing which is presented as a non-limiting example, in which: FIG. 1 is a vertical cross-section of the head and the lower part of the golf club handle according to the state of the art; FIG. 2 is a partial cross-section on a larger scale of the junction between the upper part of the head and the lower part of the golf club handle in FIG. 1, after adjusting the angle of lie; FIGS. 3 and 4 are partial cross-sections of a golf club according to the invention, before and after adjusting the angle of lie, respectively; and FIGS. 5-10 are partial cross-sections of different variations on the construction of the invention. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS In these figures we have, for reasons of clarity, illustrated only the elements of the head and the golf club handle which are part of the assembly. In FIGS. 1 and 2 a golf club, more precisely a &#34;putter&#34; of the &#34;swan neck&#34; type, with a head 1 whose lower flat side 2 rests on the horizontal ground plane P, and whose upper part 5 is extended by a tapered neck 7 on which is attached by gluing the lower part of a tubular handle or shaft 9 fitted onto the neck. A lengthwise axis xx&#39; of the assembly constituted by the neck 7 and the handle 9 forms, in the position illustrated in FIG. 1, an angle a called &#34;the angle of lie&#34; with the horizontal ground plane P. When one wishes to modify the angle of lie a, a bending pressure is exerted on the handle 9, for example towards the front of the head 1 as indicated by arrow F1 in FIG. 2; when one wishes to increase the angle of lie, to move the axis xx&#39; of handle 9 from the position AA&#39; where it possesses the angle of lie a, to position BB&#39; (FIG. 2) where it possesses an angle of lie b greater than angle a We can determine that during this pressure the stress exerted by the bending force F1 on the handle 9 is applied at the level of a juncture between the base 7a of the neck 7, by which the latter connects to the upper part of the head 1, and the lower end of the handle 9. This pressure is thus concentrated in a short region, horizontally and longitudinally, in the direction of axis xx&#39;, leading to the generation of significant stress in the material used, and can lead in certain cases, according to the nature of the material used, to the beginning of a fracture 8, or a break, pure and simple. In FIGS. 3 and 4 of the upper part 24 of the head of the golf club is extended upward by a tapered neck 26. The neck 26 is engaged in the lower end part of a tubular handle 28 whose lower end 28c rests against the upper part 24 of the head. The base 26a of the tapered neck 26 is encircled by a ring groove 30 hollowed in the upper surface of the upper part 24 of the head of the golf club. The lower part of the internal side of the handle 28 is hollowed out along a length d from its lower end by a shallow internal ring-shaped recess 32 of essentially constant depth. As a result, below a lower end of the contact area between the internal surface of the handle and the external surface of the neck, the lower part of the internal side of the handle is no longer in contact with the neck 26 along the length d. Consequently, as in FIG. 4, when a bending pressure is exerted on the handle 28 in a given direction, for example in the direction of arrow F2 if one wants to increase the angle of lie, the bending pressure applied during this movement is exerted from this point along the entire length d of the neck 26 which is not in contact with the internal side of the handle 28. In this manner, the bending pressure is distributed along the portion of the neck of length d, and no longer concentrated in a particular section, and the resulting deformation of the neck is, as a consequence, progressive. The stress is thus less than it was when it was concentrated in the base 26a of the neck 26. As a function of the material used to make the head of the golf club, one can, by varying the length d in an appropriate manner, limit the stress rate inside the material such that it occurs within a determined range of values, especially beyond the elastic limit of the material, such that the latter retains the deformation applied to it, and within the rupture limit, in order to avoid breaking the neck 26. During the deformation of the neck 26 by the action of force F2 tending to increase the angle of lie, the part 28a of the handle 28 situated on the side towards which the pressure F2 is exerted, approaches the base 26a of the neck 26, which is possible because of the presence of the ring groove 30, receiving its lower end 28c, while the part 28b of the handle 28 which is situated on the opposite side moves away from the base 26a of the neck 26, as seen in FIG. 4. In FIG. 5, the neck 35 connects to the upper part of the head of the club by a flared part 37. The internal side of the tubular handle 28 has, at a distance from its lower end 28c, a ring-shaped shoulder 39 coming in contact with the upper end 40 of the neck 35, in a way which provides a space of length d1 between the base 35a of the neck 35 and the lower end 28c of the handle. As in FIGS. 3 and 4, the internal side of the lower part of the handle 28 is hollowed along a length d2 from its lower end by an interior ring-shaped recess 41 allowing for the provision in this spot between the external side of the neck 35 and the internal side of the handle 28, of a ring-shaped space along the length d2. Thus, the base 35b of the contact surface between the external side of the neck 35 and the internal side of the handle 28 is at a distance of d=d1+d2 from the base 35a of the neck 35, representing the length of a neck submitted to bending. The recess 41 also permits the lower part of the handle 28 to shift in relation to the neck 35 at the beginning of the bending operation. In the variation represented in FIG. 6, a ring 42 made of a compressible material, of thickness d, is placed on the neck 44 of the head of a golf club between the upper part 45 of this head, around the base 44a of the neck 44 and the lower end of the handle 47. In this way, during a movement causing the handle 47 to bend in the direction F3, the part 47a of the handle 47 which is located on the side towards which the pressure F3 is exerted can penetrate, at its lower end, the interior of the compressible ring 42, while the part 47b of the handle which is situated on the opposite side moves out of this ring. In order to avoid the creation of an unesthetic space after the bending operation, before this occurs one can, during the assembly and before gluing, place an axial pressure on the handle 47, in order to make it penetrate into the interior of the elastic ring, so that after bending, the part of the handle 47b does not come out of the ring 42. In the variation illustrated in FIG. 7, an elastic ring 50 is placed on the neck 52 of the head of a golf club and its upper part is hollowed by a coaxial cylindrical cavity 54 of a larger diameter receiving the lower part of the handle 56 of the club. A bottom 58 of this cavity, which constitutes a stop for the lower end of the handle 56, is at a distance d from the base 52a of the neck 52, representing the length of the latter when bent. In this construction form, the opposing end parts 56a, 56b of the handle 56 can shift inside the elastic ring 50 without the resulting deformations being visible from the exterior, which permits the achievement of a juncture surface between the neck of the club and the handle which is esthically satisfactory. In addition, the elastic ring 50 plays the role of a sealing joint during the assembly operation, since it constitutes an elastic blocking system preventing the glue put between the neck and the internal periphery of the handle to come back out, which avoids delicate cleaning operations. One can, of course, modify the details of the operation, without going beyond the framework of the invention. Thus, as shown in FIG. 8, the ring-shaped recess 72 of length d existing between the external side of the neck 70 and the internal side of the handle 74 can be made by hollowing out this recess in the neck 70 where it connects to the upper part 24 of the head of the golf club, starting at the base 70a of the neck. In the variation of construction represented in FIG. 9, the lower end part 76a of the handle 76 of the golf club is solid and tightly fitted in an axial direction into the tubular-shaped neck 78, open at its upper end. This lower end part of the handle 76 has a diameter less than that of the rest of the handle and is equal to the internal diameter of the tubular neck 78 and its length is less than the value d of the length of the tubular neck 78. The handle 76 is pressed against the upper end of the tubular neck 78 by the intermediary of a shoulder 80 which is formed in the connecting zone of the two parts of different diameters. Because of this arrangement, the lower end 76b of the handle 76 is maintained at a distance d from the base 78a of the neck 78, with a free space between the lower end 76b of the handle 76 and the base 78a of the neck 78. In the variation of construction represented in FIG. 10, the lower part of the handle 82 is made of a solid rod whose diameter is equal to the internal diameter of the tubular neck 78, and which is engaged in this neck. The lower end 82a of the handle 82 is maintained at a distance d from the base 78a of the neck 78 by a block 84 of thickness d, in a compressible and possibly elastic material. In the case of the two forms of construction described above, referring to FIGS. 9 and 10, the stress to which the tubular neck 78 is subjected when a bending force is exerted on the handle 76, 82 distributed along the entire length of the lower section of the tubular neck 78 which is left free between the lower end of the handle and the base 78a of the neck 78.

A golf club with a head provided, on its upper part, with a neck on which is affixed the lower part of a handle by the neck and the handle fitting into each other. The base of the contact surface of the golf club, between the external side of the neck and the internal side of the handle, is distant from the base of the neck, by which the latter connects to the upper part of the head, at a predetermined length which is equal to that which will eventually be subjected to bending.

This application claims priority from a Provisional Application, Ser. No. 60/470,711, filed May 15, 2003. FIELD OF THE INVENTION The present invention relates to medical equipment, and, more particularly, to machines for powering pneumatic ventricular assist devices. BACKGROUND Ventricular assist devices (“VAD”) are used to help supplement the heart&#39;s pumping action both during and after certain kinds of surgery, in situations where a complete cardiopulmonary bypass (using a heart-lung machine) is neither needed nor advisable in light of the serious side effects associated therewith. Ventricular assist devices typically comprise a pair of cannulae or other tubing and some sort of pump operably connected to the cannulae. In use, the cannulae are attached to either the left side of the heart (a left ventricular assist device) or to the right side of the heart (a right ventricular assist device) “in parallel,” i.e., the pump supplements the heart&#39;s pumping action but does not completely bypass it, and the pump is activated. Alternatively, a pump may be directly implanted into the body. Originally, ventricular assist devices were air powered, wherein fluctuating air pressure, provided by a simple mechanical air pump machine, was applied to a bladder-like sac. The bladder had input and output valves, so that blood would enter the bladder through the input valve when the pressure on the bladder was low, and exit the bladder through the output valve when the pressure on the bladder was high. Unfortunately, these pneumatic ventricular assist devices were complicated, and used expensive mechanical valves that were prone to failure, subject to “clogging,” and that caused blood trauma or damage because of hard, metal edges and the like. To overcome these problems, smaller, more reliable ventricular assist devices have been in use and/or development. These include axial flow pumps for temporary insertion directly into the heart, and peristaltic or centrifugal pumps. The former are based on the Archymides&#39; Principle, where a rod with helical blades is rotated inside a tube to displace liquid. In use, a catheter-mounted, miniature axial flow pump is appropriately positioned inside the heart, and is caused to operate via some sort of external magnetic drive or other appropriate mechanism. With high enough RPM&#39;s, a significant amount of blood can be pumped. In the case of peristaltic pumps, blood is moved by the action of a rapidly rotating impeller (spinning cone or the like), which causes the blood to accelerate out an exit. Both of these categories of ventricular assist devices are generally reliable and implantable, but are very expensive, not particularly durable, and are not useful in situations where a patient needs a true pulsating blood supply. Specifically, axial and peristaltic pumps are typically left on in a continuous operation mode, where a steady stream of blood is supplied on a continuous basis, as opposed to the natural rhythm of the heart, which acts on a periodic, pulse-producing basis. In addition, such pumps are still largely in the developmental or trial phase. Because of the inherent performance limitations of these ventricular assist devices, pneumatic devices would seem to be a good choice for providing pulsing pulmonary augmentation. However, as mentioned above, pneumatic ventricular assist devices are prone to failure and can cause blood damage and clotting. Moreover, the driver units for operating the pneumatic ventricular assist devices are motor-based (therefore, generally mechanically unreliable), and can only offer a simple cyclical pressure mode of operation, i.e., a repeating minimum and maximum pressure applied to the VAD bladder, which cannot be adjusted for particular patient conditions. Accordingly, a primary object of the present invention is to provide a driver for pneumatic ventricular assist devices that is more reliable, that has no electrical pump or motor, and that provides a greater degree of operational flexibility and customization. SUMMARY A gas powered driver or driver means for a pneumatic ventricular assist device (VAD) is powered by pressurized air, oxygen or any other gas commonly available in hospital rooms, intensive care units and operating rooms. The driver can provide both blood-ejecting pressure (systole) and blood-filling vacuum (diastole) to the VAD. The driver is controlled by a computer/digital controller by means of pressure and volume sensors, and electromechanical, computer-controlled valves. Ventricular pumping is performed by a single spring-loaded piston or bellows inside a pump cylinder. The computer can actively regulate maximum systolic ventricular pressure, maximum diastolic vacuum, cycling rate and/or ejection volume (depending on the operating mode). The driver is also capable of automatically and periodically venting the drive line to eliminate condensation and foul air. The absence of a motor or electrical pump make the device small, reliable, easy to handle, and inexpensive. BRIEF DESCRIPTION OF THE DRAWINGS These and other features, aspects, and advantages of the present invention will become better understood with respect to the following description, appended claims, and accompanying drawings, in which: FIG. 1 is a schematic diagram of an air-pressure powered driver for pneumatic ventricular assist devices, according to the present invention; FIGS. 2A &amp; 2B are schematic diagrams of a portion of the air-pressure powered driver in operation; and FIGS. 3A–3C are various views of the air-pressure powered driver as implemented as a wheeled, portable cart. DETAILED DESCRIPTION With reference to FIG. 1 , a preferred embodiment of a gas pressure powered driver or driver means 10 for driving a pneumatic ventricular assist device 12 (VAD) includes a console unit 14 and a pressurized air/gas unit 16 , which includes one or more backup tanks (e.g., 18 a , 18 b ) of pressurized gas (preferably air) and a gas input connector 20 that attaches to a facility-wide pressurized air line 22 . The console unit 14 includes a computer or other electronic controller 24 , a pump cylinder or positive-displacement pump (i.e., piston or bellows) 26 with a sealed, gas moveable member 28 (i.e., piston or bellows), an inlet pressure valve 30 , and a cylinder venting valve 32 , both of which are attached to the pressurized air source 16 and the source (or input) end of the pump cylinder 26 . A tubular outlet “driveline” (i.e., a line that can be pressurized to drive a device) 34 is connected to the discharge or output of the pump 26 . The driveline, in turn, is attached to the ventricular assist device 12 . In use, at the beginning of a cycle, the computer 24 opens the inlet pressure valve 30 to compress the bellows and spring 28 and raise the systolic pressure in the VAD 12 (active systole). Once the maximum desired driveline pressure is achieved, as measured by a driveline pressure sensor 36 electrically connected to the computer 24 , the inlet pressure valve 30 is closed and the computer 24 waits (passive systole) until the desired blood volume is ejected from the VAD (volume-limited mode) or the systolic time has elapsed (frequency-limited mode). Diastole begins by opening the cylinder venting valve 32 . The compressed spring inside the bellows 28 then creates a vacuum for the blood-filling phase of the cycle (i.e., as the spring pushes the bellows outwards, the gas pressure in the driveline 34 , connected to the VAD 12 , decreases). Once the desired vacuum level is reached, as measured by the driveline pressure sensor 36 , a vacuum regulating valve 38 (attached to the driveline 34 ) opens to let air into the VAD/inner piston space/driveline 34 insuring that the desired vacuum level is not exceeded. The computer 24 then waits for the desired blood volume to fill the VAD 12 (volume-limited mode) or until the diastolic time has elapsed (frequency-limited mode). As noted above, the preferred driver means 10 utilizes controlled pressurized air for operating the VAD 12 , as supplied to the console 14 from the pressurized air unit 16 , and not a motor-driven pump or the like. The pressurized air unit 16 may be separate from the console 14 , or attached thereto, e.g., as part of a mobile cart or the like (see FIGS. 3A–3C ). The primary source of pressurized air is the pressurized air, oxygen or other gas supply 22 found in most hospital rooms, intensive care units, and operating rooms, which is connected to the unit 16 by the connector 20 . The inlet pressure needs to be several times greater than the maximum systolic pressure desired, which is about 5 psi. Standard hospital oxygen and air supplies are regulated for fifty psi of pressure, which may be regulated by a regulator/alarm unit 40 positioned between the console 14 and the tanks 18 and supply line 22 . The tanks 18 a , 18 b are provided as a backup in case the main supply line 22 is shut off, or where portability is needed. A selector valve 42 , either computer-controlled or manual, is provided for selecting between the supply line 22 and tanks 18 a , 18 b . The regulator/alarm unit 40 may be configured to emit an alarm if the input pressure into the regulator/alarm unit 40 , i.e., the line pressure or tank pressure, falls or drops below a certain level. An inlet pressure sensor 44 , in fluid communication with the console&#39;s pressurized air input line 46 and electrically connected to the computer 24 , may be provided to issue a signal to the computer 24 to warn the user if the inlet pressure drops due to a supply failure. The computer 24 can be of any appropriate design or configuration. In one exemplary embodiment, the computer 24 comprises a microcontroller or microprocessor 50 and associated standard components (RAM, I/O bus, etc.), a video controller 52 and display 54 operably connected to the microcontroller 50 , a communications bus or port 56 (e.g., USB, Ethernet) for external access to the microcontroller, and an A/D and D/A converter 58 or other sensor/valve interface or control unit. The computer 24 also includes a speaker 60 for sounding alarms or the like. Remaining components will be described with respect to the operation of the air-pressure powered driver 10 . Pneumatic ventricular assist devices work by applying air pressure to a bladder or sac effectively attached in parallel to a patient&#39;s heart. Specifically, when pressure is applied to the sac, blood in the sac is ejected. When the air pressure against the sac is reduced, the sac expands, causing blood to enter the sac. When appropriate directional valves are employed, this creates a pulsing or cyclical blood flow. According to the present invention, with reference to FIGS. 2A and 2B , this action is accomplished using computer-controlled valves, a source of pressurized air, and the pump cylinder with spring-loaded bellows or piston. As shown in FIG. 2A , at the beginning of a cycle, the computer 24 opens the inlet pressure valve 30 . This causes air to enter into the inlet side (i.e., intake chamber or input chamber) of the pump cylinder 26 , which compresses the bellows and spring 28 (it should be noted that the intake chamber of the cylinder is sealed or separate from the outlet side or discharge chamber). Compressing the bellows 28 causes the pressure of the air/gas in the driveline 34 to increase, which in turn compresses the VAD bladder or sac 70 , forcing blood out of the sac, through a VAD outlet valve 72 , and into the patient&#39;s bloodstream. Once the maximum desired pressure in the driveline 34 is achieved, as measured by the driveline pressure sensor 36 , the inlet pressure valve 30 is closed and the computer 24 waits (passive systole) until the desired blood volume is ejected from the VAD 12 (volume-limited mode) or the systolic time has elapsed (frequency-limited mode). If the diastolic vacuum has not been established or is below the desired level (i.e., the driveline pressure is above the desired diastolic vacuum level), the computer 24 causes the vacuum regulating valve 38 to open momentarily to let a small amount of air escape the driveline 34 at the end of the systolic period. As shown in FIG. 2B , diastole begins by opening the cylinder venting valve 32 . The compressed spring inside the piston cylinder or bellows will then create a vacuum for the blood-filling phase of the cycle. Specifically, as pressurized air is let out of the cylinder 26 , there is no longer enough pressure to counteract the spring in the bellows 28 . The spring forces the bellows/piston 28 outwards, increasing the effective volume of the driveline 34 and reducing the air pressure therein. This causes the VAD bladder 70 to expand, drawing in blood through a one-way VAD inlet valve 74 . Once the desired vacuum level is reached, as measured by the driveline pressure sensor 36 , the vacuum regulating valve 38 is opened to let air into the driveline 34 insuring that the desired vacuum level is not exceeded. If the desired vacuum level is not reached then it will be adjusted for the next cycle by opening the vacuum regulating valve 38 as discussed above. The computer 24 then waits for the desired blood volume to fill the VAD (volume-limited mode) or until the diastolic time has elapsed (frequency-limited mode). The blood volume in the VAD 12 can be measured directly by a sensor in the VAD chamber (not shown). The blood volume in the VAD blood sac need not be measured directly, however, allowing for a simpler VAD design, but can be indirectly calculated by the computer 24 (calibrated to the VAD and driveline deadspace) by using Boyle&#39;s law (assuming a constant temperature, P 1 ·V 1 =P 2 ·V 2 ) and measuring the displaced volume in the pump cylinder 26 and driveline and barometric pressures. The barometric pressure and displaced volume can be measured by having, respectively: (i) a barometric pressure sensor 80 operably attached to the computer 24 ; and (ii) a distance sensor 82 (LED, other optical sensor, or the like) in the pump cylinder 26 and operably connected to the computer 24 , that measures the distance from one end of the pump cylinder to the bellows (or another appropriate measurement). A safety pressure relief valve 84 is attached to the driveline 34 to insure that maximum VAD/driveline pressure (e.g., 5 psi) is never exceeded, which could lead to air leaks in the VAD 12 . Periodically or at user selected times, the driver 10 has the capability of venting the driveline 34 to prevent excess condensation and remove fouled air. This is accomplished at the end of the diastolic period by opening a driveline venting valve 86 , positioned between the driveline 34 and the pressurized air input line 46 , for a short time. The VAD/inner-cylinder/driveline space 34 is pressurized with fresh air. Excess pressure is vented by the pressure relief valve 84 . Then the vacuum regulating valve 38 is opened to vent the system. The computer 24 is an electronic controllinf means for regulating maximum systolic ventricular pressure and maximum from a patient&#39;s heart, through the amount of gas selectively supplied to the pump&#39;s intake and exhaust chambers, wherein the computer 24 has the capability of controlling the entire process (mentioned in the paragraphs above) according to user selectable or manufacturer&#39;s preset parameters such as desired stroke volume, rate, VAD output, systolic to diastolic ratio, maximum diastolic volume, minimum systolic volume, maximum systolic pressure, and/or maximum diastolic vacuum. The computer, through its sensors, also has self diagnostic capabilities and can trigger warnings and alarms to the user. Finally, the computer may also have the capability of storing or relaying the operational status and performance of the driver to remote locations (nurses&#39; station, doctor&#39;s office) via network or wireless communications 56 . Although the VAD pumping action is primarily effectuated using pressurized air, the computer, valves, and sensors are electrically powered, via a standard power supply (attached to a wall outlet), generator, battery power system, or the like (not shown). Silencers or mufflers 88 may be attached to the outputs of the valves 32 , 38 , for minimizing noise as pressurized air is periodically let out of the driver&#39;s air lines. An emergency foot pump or bellows 90 may be operably attached to the driveline 34 , via a manual selector valve 92 and/or connector 94 . In an emergency (i.e., complete loss of pressurized air and/or electrical power), the foot bellows 90 are pumped manually, causing a variable pressure to be applied to the VAD 12 . Preferably, the air volume displaced by the bellows 90 is configured to generally match the displacement volume required for operating the VAD pumping sac 70 . FIGS. 3A–3C show how the air-pressure powered driver 10 can be implemented as a portable cart. Although the air-pressure powered driver has been described as having separate air inlet and pump venting valves 30 , 32 , respectively, a unitary air distribution device could be used instead, i.e., a computer-controlled device with three states: (i) “closed;” (ii) open to ambient (possibly through a muffler); and (iii) open to air input line 46 . This is also the case for the valves 38 , 84 , 86 on the driveline 34 . Thus, the term “air distribution device,” as used herein, refers both to: stand-alone, discreet valves; multi-state valves; or a combination of the two. Although the air-pressure powered driver has been illustrated as having a spring-loaded bellows or piston in the pump, a different biasing mechanism other than a spring could be used instead (polymer members, motor units, constructing the bellows out of a deformable material with a material memory, etc.). Accordingly, the term “biased air movement member” incorporates any bellows, pistons, or the like biased with a spring or other suitable device. Since certain changes may be made in the above-described air-pressure powered driver for pneumatic ventricular assist devices, without departing from the spirit and scope of the invention herein involved, it is intended that all of the subject matter of the above description or shown in the accompanying drawings shall be interpreted merely as examples illustrating the inventive concept herein and shall not be construed as limiting the invention.

A driver for a pneumatic ventricular assist device (VAD) is powered by pressurized air, oxygen or any other gas commonly available in hospital rooms, intensive care units and operating rooms. The driver can provide both blood-ejecting pressure (systole) and blood-filling vacuum (diastole) to the VAD. The driver is controlled by a computer/digital controller by means of pressure and volume sensors, and electromechanical valves. Ventricular pumping is performed by a single spring-loaded piston or bellows. The computer can actively regulate maximum systolic ventricular pressure, maximum diastolic vacuum, cycling rate and/or ejection volume (depending on the operating mode). The driver is also capable of automatically and periodically venting the drive line to eliminate condensation and foul air. The absence of a motor or electrical pump make the device small, reliable, easy to handle, and less expensive.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The invention relates to a valve arrangement of the type having a valve housing with an inlet and an outlet and with a flow regulator which is arranged in the housing so that a movement of the housing relative to the flow regulator can be performed, so a proportional variation of the flow is achieved. [0003] 2. Description of the Prior Art [0004] In U.S. Pat. No. 5,845,633, a valve arrangement of the above type is described. The object of that valve arrangement is to dose small amounts of nitric oxide to a breathing gas, the gas being supplied to a patient for medical purposes. The valve housing is here a tube-shaped container in which the flow regulator in the form of a tube-shaped membrane is arranged, with the container and the end side of the membrane which being turned towards the breathing gas being made of a material which does not allow nitric oxide to pass through. The membrane is connected via a gas tube with a source for nitric oxide. The tube-shaped membrane is made using a material which allows nitric oxide through, e.g. TeFlon®. The tube-shaped membrane is also removably arranged in the container. The nitric oxide source is suitably regulated so that a constant pressure is prevalent in the membrane tube. This results in a constant difference in partial pressure for nitrogen oxide on the in- and out-side of the membrane tube. Diffusion from the inside of the membrane tube to the breathing gas, which depends on the size of the membrane tube&#39;s diffusion surface, is obtained. The dosing is regulated by exposing a suitable portion of the total diffusion surface. The exposure of the diffusion surface occurs by taking a suitable part of the surface out of the container. This described ventilator arrangement is only related to dosing of nitrogen oxide. SUMMARY OF THE INVENTION [0005] An object of the invention is to provide a valve arrangement of the type described above which is related to regulating the micro-flow for different sorts of gases as well as different sorts of liquids. [0006] The above object is achieved in accordance with the invention by a flow regulator having a porous body to block the flow between the inlet and the outlet except for through the porous body wherein, through relative movement, a progressive variation of an outer surface of the porous body is obtained, the outer surface being in flow-contact with the outlet. By organizing the valve according to the invention, and particularly because of the porous body through which a gas or a liquid can pass, a universal valve is obtained for micro-flows, that allows such flows can to be easily be dosed. [0007] In an embodiment of the valve arrangement according to the invention, the valve housing has a first part containing the inlet, the first part having a sealing surface towards which at least a part of the porous body&#39;s outer surface lies, and a second part having the outlet, wherein the second part&#39;s inner diameter is larger than the body&#39;s outer diameter, and the relative movement is a displacement of the body between the first and the second part. By a gradual displacement of the porous body within the second part of the valve housing, the dosing of gas or liquid is increased. [0008] In another further embodiment of the valve arrangement according to the present invention, the porous body has a first non-porous end part, which is turned towards the second part of the ventilator housing, and that the first part is dimensioned so that the non-porous end part can be placed in the first part of the ventilator housing. In this way, when the porous body has been displaced to a location where the non-porous end part is placed in the first part of the valve housing, the body&#39;s entire outer surface lies towards the sealing surface in the first part, so the valve arrangement is closed. [0009] In Another embodiment of the valve arrangement according to the invention, the porous body is provided with at least one channel, the opening of which lies in the body&#39;s second end part which is turned towards the inlet. In this way gas or liquid can more quickly reach the porous body&#39;s interior and so have shorter routes through the pores to the outer surface of the body. DESCRIPTION OF THE DRAWINGS [0010] FIG. 1 is a longitudinal section through a valve arrangement according to the invention, in a closed position. [0011] FIG. 2 shows the valve arrangement of FIG. 1 in a partially opened position. [0012] FIG. 3 shows the valve arrangement of FIGS. 1 and 2 in a completely opened position. [0013] FIG. 4 is a longitudinal section through a further embodiment of a valve arrangement according to the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0014] In FIG. 1 , a valve arrangement 1 is shown in longitudinal section which is designed to regulate micro-flows for different sorts of gases. The valve arrangement 1 has a valve housing 2 with an inlet 3 , one or more outlets 4 and a flow regulator 5 in the form of a porous body which is displaceably arranged in the housing 2 along a central axis 8 . [0015] With this valve arrangement, gas can flow through the inlet 3 into the valve housing 2 and to reach the porous body 5 . The gas then passes over pores 20 in the body 5 to the outer surface 9 of the body 5 , so gas can be emitted through the outlets 4 . This will be described in detail below. [0016] The valve housing 2 can be divided into a first part 6 and a second part. The inlet 3 is arranged in the first part 6 . The inner diameter of the first part 6 of the housing 2 is dimensioned so that the outer surface 9 of the porous body 5 lies tight to the inner wall 10 of the housing 2 , the inner wall 10 here serves serving as a sealing surface. [0017] In the second part 7 of the ventilator housing 2 , the outlets 4 are arranged. The inner diameter of the second part 7 is larger than the outer diameter of the porous body 5 . The porous body 5 has a first non-porous end part 11 , which is turned towards the second part 7 of the housing 2 . The porous body 5 is provided with a channel 12 , the opening of which lies in the second end part 14 of the porous body 5 , which end part 14 is turned towards the inlet 3 . [0018] The end side 16 of the second part 7 of the housing 2 is provided with a through-passage opening 17 , through which an actuator 15 in the form of a straight peg extends, the opening 17 preferably being arranged so that the actuator 15 is displaceable along the central axis 8 . [0019] A spring 19 is placed between the second end part 14 of the porous body 5 and the inner wall 18 in the first part 6 of the housing 2 , which is turned towards the end part 14 . [0020] In FIG. 1 , the porous body 5 , with help of the actuator 15 pushing towards the body&#39;s non-porous end part 11 , has been displaced in the ventilator housing 2 along the central axis 8 so that the entire body 5 is placed in the first part 6 of the housing 2 , the spring 19 in this position being compressed. Because of the inner wall 10 that seals against the entire jacket surface 9 of the body 5 , and because of the first non-porous end part 11 of the body 5 which has an axial sealing function, the valve in this position is closed [0021] In FIG. 2 , it is shown that the porous body 5 by the action of the spring 19 and the actuator 15 has been displaced in the direction towards the second part 7 of the housing 2 , so a part of the jacket surface 9 of the body 5 has been exposed between, as earlier described, the inner diameter of the second part 7 of the housing 2 is larger than the outer diameter of the body 5 . In this way, gas comes from pores 20 in the body 5 which results in the exposed jacket surface 9 being in flow-contact with the outlets 4 . [0022] In FIG. 3 , it is shown that the porous body 5 has been displaced to a position where the valve arrangement 1 is completely open. In this position a maximum jacket surface 9 of the body 5 is exposed. In this way, a maximum number of pores 20 , resulting in the exposed jacket surface 9 of the body, have flow-contact with the outlets 4 . Only a few pores 20 have been depicted in the Figures. [0023] The channel 12 described in connection with FIG. 1 serves to easily and quickly distribute the gas in the porous body 5 . [0024] In FIG. 4 , a further example of a valve arrangement 21 for regulating micro-flows for gases is shown in longitudinal section. In the description of this valve arrangement 21 , the same reference numerals as in FIGS. 1-3 have been used as much as possible. [0025] The valve arrangement 21 has a valve housing 2 with an inlet 3 and an outlet 4 , and a flow regulator 5 in the form of a porous body. The interior of the housing 2 is dimensioned so that the body 5 can only rotate around the central axis 8 by the action of the actuator 15 , which is solidly fixed to the body 5 . The outer surface 9 of the body 5 is for the most part provided with a coating which serves as sealing layer for gases. Only a smaller surface 23 is exposed. The inner wall 10 of the housing 2 has in connection with the outlet 4 a recess 22 which extends along part of the outer surface of the body 5 . By turning the body 5 so that the surface 23 is in front of or partially in front of the recess 22 , the pores 20 resulting in this surface have more or less flow-contact with the outlet 4 . When the body 5 has been turned to a position where the sealing layer completely covers the recess 22 , the valve arrangement 21 is closed. Even this valve arrangement 21 can preferably be provided with a channel 12 in the porous body 5 , the benefits of which have been described above. [0026] Due to the relative movement between the housing 2 and the porous body 5 , described in connection with FIGS. 2, 3 and 4 , a progressive variation of the outer surface of the porous body 5 is achieved, which surface is in flow-contact with the outlets 4 , so an extremely careful micro-dosing of gas can be achieved. [0027] The valve arrangements according to the invention described herein can also regulate micro-flows for liquids. [0028] The valve arrangements described can also be used in connection with anaesthetic systems. In this way, an anaesthetic liquid can be supplied to the valve housing, the liquid being vaporized in the porous body, with the body preferably being heated so that the liquid will more easily be vaporized. [0029] Although modifications and changes may be suggested by those skilled in the art, it is the invention of the inventor to embody within the patent warranted heron all changes and modifications as reasonably and properly come within the scope of his contribution to the art.

A valve arrangement has a valve housing with an inlet and an outlet and a flow regulator including a porous body that is displaceable in the valve housing between the inlet and the outlet. The porous body blocks flow between the inlet and the outlet except for flow through the porous body. The displacement of the porous body between the inlet and the outlet proportionally varies a size of an outer surface of the porous body that is exposed to the outlet, thereby regulating fluid flow between the inlet and the outlet.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This Application claims priority under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 60/662,957 filed on Mar. 18, 2005. FIELD OF THE INVENTION [0002] The present invention relates to intravascular devices used in medical treatment and procedures. More specifically, the present invention relates to a new class of organic high intensity X-ray contrast agents suitable for enhancing the imaging of medical devices, particularly polymeric medical devices and polymeric coatings being fabricated from a polymer with the contrast agent dispersed within, conjugated at one or both ends of the polymers, as well as the method of manufacture of such materials and devices. DISCUSSION OF THE RELATED ART [0003] Recently, transluminal prostheses have been widely used in the medical arts for implantation in blood vessels, biliary ducts, or other similar organs of living body. These prostheses are commonly known as stents and are used to maintain, open, or dilate tubular structures. An example of a commonly used stent is given in U.S. Pat. No. 4,733,665 filed by Palmaz on Nov. 7, 1985, which is hereby incorporated herein by reference. Such stents are often referred to as balloon expandable stents. Typically the stent is made from a solid tube of stainless steel, although other metallic materials have been utilized. Thereafter, a series of cuts are made in the wall of the stent. The stent has a first smaller diameter, which permits the stent to be delivered through the human vasculature by being crimped onto a balloon catheter. The stent also has a second, expanded diameter, upon application of a radially, outwardly directed force, by the balloon catheter, from the interior of the tubular shaped member. [0004] However, one concern with such stents is that they are often impractical for use in some vessels such as the carotid artery. The carotid artery is easily accessible from the exterior of the human body, and is close to the surface of the skin. A patient having a balloon expandable stent made from stainless steel or the like, placed in their carotid artery, might be Susceptible to severe injury through day-to-day activity. A sufficient force placed on the patient&#39;s neck could cause the stent to collapse, resulting in injury to the patient. In order to prevent this, self-expanding stents have been proposed for use in such vessels. Self-expanding stents act like springs and will recover to their expanded or implanted configuration after being crushed. [0005] One type of self-expanding stent is disclosed in U.S. Pat. No. 4,655,771, which stent has a radially and axially flexible, elastic tubular body with a predetermined diameter that is variable tinder axial movement of the ends of the body relative to each other and which is composed of a plurality of individually rigid but flexible and elastic thread elements defining a radially self-expanding helix. This type of stent is known in the art as a “braided stent” and is so designated herein. Placement of such stents in a body vessel can be achieved by a device that comprises an outer catheter for holding the stent at its distal end, and an inner piston that pushes the stent forward once it is in position. [0006] However, braided stents have many disadvantages. They typically do not have the necessary radial strength to effectively hold open a diseased vessel. In addition, the plurality of wires or fibers used to make such stents could become dangerous if separated from the body of the stent, where they could pierce through the vessel. Therefore, there has been a-desire to have a self-expanding stent that is cut from a tube of metal, which is the common manufacturing method for many commercially available balloon-expandable stents. In order to manufacture a self-expanding stent cut from a tube, the alloy used would preferably exhibit superelastic or psuedoelastic characteristics at body temperature, so that it is crush recoverable. [0007] The prior art makes reference to the use of alloys such as Nitinol (Ni—Ti alloy), which have shape memory and/or superelastic characteristics, in medical devices that are designed to be inserted into a patient&#39;s body. The shape memory characteristics allow the devices to be deformed to facilitate their insertion into a body lumen or cavity and then be heated within the body so that the device returns to its original shape. Superelastic characteristics, on the other hand, generally allow the metal to be deformed and restrained in the deformed condition to facilitate the insertion of the medical device containing the metal into a patient&#39;s body, with such deformation causing the phase transformation. Once within the body lumen, the restraint on the superelastic member can be removed, thereby reducing the stress therein so that the superelastic member can return to its original un-deformed shape by the transformation back to the original phase. [0008] Alloys having shape memory/superelastic characteristics generally have at least two phases. These phases are a martensite phase, which has a relatively low tensile strength and which is stable at relatively low temperatures, and an austenite phase, which has a relatively high tensile strength and which is stable at temperatures higher than the martensite phase. [0009] Shape memory characteristics are imparted to the alloy by heating the metal at a temperature above which the transformation from the martensite phase to the austenite phase is complete, i.e. a temperature above which the austenite phase is stable (the Af temperature). The shape of the metal during this heat treatment is the shape “remembered.” The heat-treated metal is cooled to a temperature at which the martensite phase is stable, causing the austenite phase to transform to the martensite phase. The metal in the martensite phase is then plastically deformed, e.g. to facilitate the entry thereof into a patient&#39;s body. Subsequent heating of the deformed martensite phase to a temperature above the martensite to austenite transformation temperature causes the deformed martensite phase to transform to the austenite phase, and during this phase transformation the metal reverts back to its original shape if unrestrained. If restrained, the metal will remain martensitic until the restraint is removed. [0010] Methods of using the shape memory characteristics of these alloys in medical devices intended to be placed within a patient&#39;s body present operational difficulties. For example, with shape memory alloys having a stable martensite temperature below body temperature, it is frequently difficult to maintain the temperature of the medical device containing such an alloy sufficiently below body temperature to prevent the transformation of the martensite phase to the austenite phase when the device was being inserted into a patient&#39;s body. With intravascular devices formed of shape memory alloys having martensite-to-austenite transformation temperatures well above body temperature, the devices can be introduced into a patient&#39;s body with little or no problem, but they must be heated to the martensite-to-austenite transformation temperature, which is frequently high enough to cause tissue damage. [0011] When stress is applied to a specimen of a metal such as Nitinol exhibiting superelastic characteristics at a temperature above which the austenite is stable (i.e. the temperature at which the transformation of martensite phase to the austenite phase is complete), the specimen deforms elastically until it reaches a particular stress level where the alloy then undergoes a stress-induced phase transformation from the austenite phase to the martensite phase. As the phase transformation proceeds, the alloy undergoes significant increases in strain but with little or no corresponding increases in stress. The strain increases while the stress remains essentially constant until the transformation of the austenite phase to the martensite phase is complete. Thereafter, further increases in stress are necessary to cause further deformation. The martensitic metal first deforms elastically upon the application of additional stress and then plastically with permanent residual deformation. [0012] If the load on the specimen is removed before any permanent deformation has occurred, the martensitic specimen will elastically recover and transform back to the austenite phase. The reduction in stress first causes a decrease in strain. As stress reduction reaches the level at which the martensite phase transforms back into the austenite phase, the stress level in the specimen will remain essentially constant (but substantially less than the constant stress level at which the austenite transforms to the martensite) until the transformation back to the austenite phase is complete, i.e. there is significant recovery in strain with only negligible corresponding stress reduction. After the transformation back to austenite is complete, further stress reduction results in elastic strain reduction. This ability to incur significant strain at relatively constant stress upon the application of a load, and to recover from the deformation upon the removal of the load, is commonly referred to as superelasticity or pseudoelasticity. It is this property of the material which makes it useful in manufacturing tube cut self-expanding stents. [0013] The prior art makes reference to the use of metal alloys having superelastic characteristics in medical devices that are intended to be inserted or otherwise used within a patient&#39;s body. See for example, U.S. Pat. No. 4,665,905 (Jervis) and U.S. Pat. No. 4,925,445 (Sakamoto et al.). However, the prior art has yet to disclose any suitable tube-cut self-expanding stents. In addition, many of the prior art stents lacked the necessary rigidity,or hoop strength to keep the body vessel open. In addition, many of the prior art stents have large openings at their expanded diameter. The smaller the openings are on an expanded stent, the more plaque or other deposits it can trap between the stent and the vessel wall. Trapping these deposits is important to the continuing health of the patient in that it helps prevent plaque prolapse into the vessel, restenosis of the vessel it is implanted into, and strokes caused by the release of embolic particles into the bloodstream. [0014] One additional concern with stents, and with other medical devices, is that they may exhibit reduced radiopacity under X-ray fluoroscopy. To overcome this problem, it is common practice to attach markers made from highly radiopaque materials to the stent, or to use radiopaque materials in plating or coating processes. Those materials are typically gold, platinum, or tantalum. The prior art makes reference to these markers or processes in U.S. Pat. No. 5,632,771 (Boatman et al), U.S. Pat. No. 6,022,374 (Imran), U.S. Pat. No. 5,741,327 (Frantzen), U.S. Pat. No. 5,725,572 (Lam et al), and U.S. Pat. No. 5,800,526 (Anderson et al). However, due to the relative position of these materials in the galvanic series versus the position of the base metal of the stent in the galvanic series, there is a certain challenge to overcome; namely, that of galvanic corrosion. [0015] In addition, biodegradable stents and stents fabricated from polymeric materials that avoid the use of metallic materials must still be able to be visualized under X-ray fluoroscopy. For these types of devices a major challenge exists in how to impart/increase the radiopacity of these devices with out the use of radiopaque markers or coatings. The prior art makes reference to one such method in U.S. Pat. No. 4,935,019 (Papp), in which a radiopaque, polymeric composition suitable for printing onto surgical fabrics provides an X-ray detectable marker, said marker is obtained by dispersing a heavy metal salt such as barium sulfate in a liquid polymer carrier. In Papp, the barium sulfate has an average particle size greater than about 5 microns and is present in an amount of from about 15 to 90% by weight of total solids of said composition. Papp indicates that barium sulfate comprising from about 60 to 90% by weight of solids of said composition is preferred. However addition of barium sulfate in large percentage quantities such as this may affect the integrity of the base material, reducing strength, and adversely affecting other mechanical properties and characteristics. In biodegradable polymers, the impact of radiopaque additives may also affect properties such as degradation rates of bioabsorbable polymers, elasticity, while potentially adding the presence of stress risers in and around-any localized concentration of barium sulfate particles within the material. Furthermore, inorganic contrast agents such as barium sulfate and zirconium oxide do not readily dissolve or do not easily disperse in organic solvents, which are commonly used to dissolve non-degradable and biodegradable polymers. [0016] Accordingly, there is a need for a radiopaque material or agent that can be easily added to biostable polymeric and biodegradable polymeric materials which readily dissolves into the polymer so that the resulting composite material is adequately radiopaque and which will not adversely affect the material or mechanical properties of the material one desires to make radiopaque. BRIEF SUMMARY OF THE INVENTION [0017] The high intensity X-ray contrast agent in accordance with the present invention overcomes the disadvantages and shortcomings of what is currently available and satisfies the unmet needs of imaging medical devices, particularly non-metallic medical devices by maximizing the intensity of the x-ray contrast agent both through primary and secondary effects. Primary effects include incorporating the radiopaque element and maximizing the content of this element in the contrast agent through chemistry, while secondary effects include optimizing the location of the radiopaque element within the polymer. Essentially by selectively maximizing and incorporating the iodine content within and dispersed throughout the polymer one can tune the radiopacity of polymeric materials to levels previously not available. Moreover, the creation and optimization of this contrast agent allows for improved processing characteristics when combined with polymeric materials and as such may further reduce manufacturing costs while providing a polymeric material with improved high intensity radiopacity with a satisfactory degradation profile. [0018] The present invention relates to a high intensity dendritic or starshaped contrast agent suitable for use with implantable polymeric medical devices or for a polymeric coating of an implantable medical device. Multivalent hydroxyl or amine containing organic compounds such as pentaerythritol, bis-pentaerythritol glycerol, polyhydric mono- and di-saccharides, etc., can be used to react with an iodine containing aromatic compounds such as 2,3,5-triiodobenzoic acid to form such high iodine containing compounds. Each such compound may contain a multiple of three (3) iodine atoms, greatly intensifying the x-ray image of a medical device fabricated from a material containing such a compound. The iodine content in such a high intensity dendritic contrast agent may be as high as 85% using commercially available dendritic polyamine precursors. [0019] In an exemplary embodiment of the present invention, the contrast agent may contain a multiplicity of iodine atoms or bromine atoms or a combination of both in a single molecule in order to enhance the x-ray image produced by dispersing the agent throughout the material that either the device will be fabricated from or applied as a coating to the device. In accordance with the present invention, the contrast agent can be constructed from any core of dendrimer containing free functional groups such as amine, hydroxyl, sulfhydryl, isocyante, and result in a molecule containing a multiple of three (3) iodine or bromine or a combination of both atoms with each additional conjugation of small iodine or bromine containing building block, such as triiodobenzoic acid or as triiodobenzoic acid chloride. When constructed in this fashion, the contrast agent may be substantially soluble in common organic solvent such as acetone, dimethylacetamide (DMA), dimethylsulfoxide (DMSO), acetone, THF, 1,4-dioxane, DCM etc. and also has substantially good miscibility with common organic polymers such as PLGA, PLA etc. The contrast agent in accordance with the present invention can form a solid solution with a polymer matrix that can then form the basis of a medical device. The contrast agent in accordance with the present invention is substantially biocompatible and can be added to polymer or polymer mixtures, and/or inorganic/organic composite materials to enhance its X-ray image quality. [0020] In another exemplary embodiment of the present invention, the contrast agent may be mixed with the bulk material by various means such as solvent casting, injection and/or compression molding in order to form a medical device or a coating for a medical device. The bulk form can then be processed to final size and shape by traditional fabrication methods. Alternatively, the polymeric coating with the contrast agent included can be applied to the surface of an implantable medical device employing traditional coating methods [0021] In yet another exemplary embodiment of the present invention, selective incorporation of the contrast agent to a polymeric structure can be accomplished in a number of ways. By ensuring placement of the contrast agent in certain areas of the polymer structure and not in other areas, additional secondary improvements in radiopacity can be realized without affecting material and/or mechanical properties. One such example is incorporation of the contrast agent at the proximal and distal ends of the polymer chain. By utilizing methods such as orientrusion, which may provide for a high degree of molecular orientation of the polymer chains within the polymer, one can create a polymeric material with high intensity radiopacity at the select portions of the bulk material which would be significantly more radiopaque than the surrounding areas where the contrast agent was not present. Like wise the selective placement of the contrast agents in the coating material can provide one with secondary benefits similar to those obtained with selective placement of the contrast agents in the bulk material. [0022] In yet another exemplary embodiment of the present invention, selective incorporation of the contrast agent to a polymeric structure can be accomplished through a covalent conjugation process at either of the distal and proximal end, or both ends of a biostable and/or biodegradable polymer chain. Such polymers with inherent radiopacity can be used to either build implantable devices or as a coating for an implantable medical device. [0023] Furthermore the incorporation or application of biological and/or pharmaceutical agents with or onto the material can provide additional benefits when used in combination with the present invention, and as such is a further object of this invention. Compounds such as those identified below may be applied as coatings on these devices or incorporated within the polymer and may be used to deliver therapeutic and pharmaceutical agents which may include: anti-proliferative/antimitotic agents including natural products such as vinca alkaloids (i.e. vinblastine, vincristine, and vinorelbine), paclitaxel, epidipodophyllotoxins (i.e. etoposide, teniposide), antibiotics (dactinomycin (actinomycin D) daunorubicin, doxorubicin and idarubicin), anthracyclines, mitoxantrone, bleomycins, plicamycin (mithramycin) and mitomycin, enzymes (L-asparaginase which systemically metabolizes L-asparagine and deprives cells which do not have the capacity to synthesize their own asparagine); antiplatelet agents such as G(GP) II b /III a inhibitors and vitronectin receptor antagonists; anti-proliferative/antimitotic alkylating agents such as nitrogen mustards (mechlorethamine, cyclophosphamide and analogs, melphalan, chlorambucil), ethylenimines and methyl melamines (hexamethylmelamine and thiotepa), alkyl sulfonates-busulfan, nirtosoureas (carmustine (BCNU) and analogs, streptozocin), trazenes-dacarbazinine (DTIC); anti-proliferative/antimitotic antimetabolites such as folic acid analogs (methotrexate), pyrirnidine analogs (fluorouracil, floxuridine, and cytarabine), purine analogs and related inhibitors (mercaptopurine, thioguanine, pentostatin and 2-chlorodeoxyadenosine {cladribine}); platinum coordination complexes (cisplatin, carboplatin), procarbazine, hydroxyurea, nitotane, aminoglutethimide; hormones (i.e. estrogen); anti-coagulants (heparin, synthetic heparin salts and other inhibitors of thrombin); fibrinolytic agents (such as tissue plasminogen activator, streptokinase and urokinase), aspirin, dipyridamole, ticlopidine, clopidogrel, abciximab; antimigratory; antisecretory (breveldin); anti-inflammatory: such as adrenocortical steroids (cortisol, cortisone, fludrocortisone, prednisone, prednisolone, 6α-methylprednisolone, triamcinolone, betamethasone, and dexamethasone), non-steroidal agents (salicylic acid derivatives i.e. aspirin; para-aminophenol derivatives i.e. acetaminophen; indole and indene acetic acids (indomethacin, sulindac, and etodalac), heteroaryl acetic acids (tolmetin, diclofenac, and ketorolac), arylpropionic acids (ibuprofen and derivatives), anthranilic acids (mefenamic acid, and meclofenamic acid), enolic acids (piroxicam, tenoxicam, phenylbutazone, and oxyphenthatrazone), nabumetone, gold compounds (auranofin, aurothioglucose, gold sodium thiomalate); immunosuppressives: (cyclosporine, tacrolimus (FK-506), sirolimus (rapamycin), azathioprine, mycophenolate mofetil); angiogenic agents: vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF); angiotensin receptor blockers; nitric oxide donors; antisense oligionucleotides and combinations thereof; cell cycle inhibitors, mTOR inhibitors, and growth factor receptor signal transduction kinase inhibitors; retenoids; cyclin/CDK inhibitors; HMG co-enzyme reductase inhibitors (statins); and protease inhibitors. [0024] The use of compounds in conjunction with the present invention can provide distinct clinical advantages over existing therapies and/or devices. More specifically, compounds that are capable of causing lysis or degradation of the embolic debris can be incorporated into the filtering portion of the present invention. A factor to consider in the selection of such a compound is the origin of the debris be it thrombus, plaque, atheroma, or any other form representing an embolus. As the mesh and or pore size of the filtering aspect of the present invention decreases, more embolic material may become trapped in the filtering mechanism of the present invention, thereby increasing the load on the filtering portion. While small emboli (typically smaller than 100 microns) are not a major concern because of the body&#39;s natural ability to enzymatically degrade, digest or lyse the emboli, the embolic load on the filter itself can be overloaded and result in formation of a thrombus if the blood flow is significantly slowed to the point which allows for a thrombus formation. In this situation the incorporation or application of compounds, which can degrade trapped emboli, can be beneficial. Some exemplary suitable compounds may include: Tissue Plasminogen activator (TPA); Streptokinase(SK); Reteplase; Tenecteplase; Urokinase; Lanoteplase; Staphylokinase; and/or Nadroparin(anti-factor Xa). In addition, the filtering portion of the present invention may incorporate an antithrombotic and/or antithrombogenic agent to prevent the formation of a thrombus. Some exemplary compounds may include: Heparin; Fragmin (dalteparin, low MW Heparin); a monoclonal antibody such as ReoPro™ (abciximab, antiplatelet antibodies) Acenocoumarol; Anisindione; Dicumarol; Warfarin; Enoxaparin (Lovenox); Anagrelide (Agrylin); Indomethacin (Indocin); Dipyridamole; Clopidogrel; Aggrenox; and/or Coumadin. Furthermore, an affinity-binding compound may also be incorporated with the filtering aspect of the present invention by itself or in combination with other compounds. Affinity-binding compounds can promote the binding and/or adhesion of embolic material thus facilitating entrapment of embolic material and subsequent removal from the blood stream. Whether incorporated into the strut or membrane by methods such as chemical surface treatments, bombardment, placement into reservoirs, or in the case of polymeric struts and membranes, blended with the material itself, or by application of a coating to the struts and/or membranes with a compound, any identified compound or combination of identified compounds may be used. Furthermore any number of compounds may suggest themselves to one who is skilled in the art and may be utilized in connection with the present invention alone or in combination with other compounds. [0025] The foregoing exemplary embodiments of the present invention provide a high intensity radiopaque contrast agent which may be used independently, for example as a coating or may be incorporated within a polymeric material to be subsequently fabricated into medical devices in accordance with the present invention. Moreover, the incorporation of drugs and/or agents may be combined with the high intensity contrast agent to realize additional synergistic benefits. As noted above, the incorporation of biological and/or pharmaceutically active agents with the present invention can be utilized for the additional purposes of preventing thrombus formation, promotion of binding, and degradation of thrombus, all of which provide a patient benefit. BRIEF DESCRIPTION OF THE DRAWINGS [0026] Aspects of the present invention as well as the preceding information may best be understood with reference to the subsequent detailed description taken in conjunction with the accompanying exemplary drawings in which: [0027] FIG. 1 shows the chemical reaction products wherein, SOCl 2 is the catalyst or activating agent, and THF/Hexane is the reaction medium or solvent for the reaction. [0028] FIG. 2 shows the chemical structure of a level 4 dendritic polyamine as well as showing levels 1 through 3 superimposed on the structure. [0029] FIG. 3 shows the chemical structure of a level 4 dendritic polyamine derived high intensity contrast agent. [0030] FIG. 4 shows the chemical structure of a commercially available water soluble contrast agent known in the art under the trade name Ultravist®. [0031] FIG. 5 shows the chemical reaction wherein the high iodine content contrast agent is synthesized through the reaction between a pentaerythritol and three 2,3,5-triiodobenzoic acid molecules. [0032] FIG. 6 shows the reaction depicting the deprotection of the protected initiators. [0033] FIG. 7 shows the synthesis reaction of iodine containing end-capping groups. [0034] FIG. 8 shows the reaction resulting in a ring opening of a bioabsorbable polymer and end-capping iodine containing functional group. [0035] FIGS. 9A and 9B show schematically the random orientation of polymer strands/chains in a matrix ( 9 A) and the aligned orientation of polymer strands/chains in a polymer that has undergone orientrusion ( 9 B). [0036] FIG. 10 shows the chemical structure of exemplary dimers used for making bioabsorable polymers and/or copolymers. [0037] FIG. 11 shows the reaction resulting in a ring opening of bioabsorbable polyglycolide (PGA) and end-capping reaction with an iodine containing functional moiety. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0038] As shown in FIG. 1 , when reacting pentaerythritol ( 100 ) with triiodobenzoic acid ( 200 ) in the presence of SOCl 2 (the catalyst) and THF/Hexane (the reaction medium), the resulting contrast agent ( 300 ) may have a high iodine content of 85%, almost twice as high as commercially available agents ( 50 ) such as those under the tradename Ultravist®. In the reaction shown, triiodobenzoic acid ( 200 ) is the equivalent of a level 1 dendrimer, SOCl 2 is the catalyst, and THF/Hexane is the reaction medium for the reaction (scheme 1 ). Accordingly, higher level dendrimers can be used. FIG. 2 shows the chemical structure of a level 4 dendritic polyamine ( 400 ), wherein the total number of amine group ( 401 ) is 2 n . Each amine group ( 401 ) shown may be potentially conjugated to a triiodobenzoic moiety ( 200 ) for enhanced contrasting intensity. For example, for the level 4 dendritic polyamine ( 400 ) shown when the triiodobenzoic group ( 200 ) containing three iodine atoms is conjugated as shown in FIG. 3 , the result is a structure ( 500 ) containing 48 iodine atoms resulting in a high intensity contrast agent. The number of iodine atoms or other suitable atom exhibiting radiopaque properties may be expressed as up to 2 n ×3, where n is the level number of the dendritic precursor ( 400 ) used in the reaction. Similarly dendrimers containing other functional groups such as carboxyl, hydroxyl, sulfhydryl groups can also be used as the building blocks of high intensity contrast agents in accordance with this invention. As shown for the chemical structure of Ultravist®, each such molecule contains 3 iodine atoms covalently linked to the core benzene ring. The I—C bonds are demonstrated to be stable under physiological and irradiation conditions. The compound is mainly eliminated through renal dialysis. [0039] FIG. 4 shows a commercially available contrast agent ( 50 ), known under the trade name Ultravist®. A feature of this Iopromide compound is that it has multiple hydroxyl groups that make it soluble in water. Although the water solubility of this agent makes it suitable for use as an injectable contrast agent, it may not perform as well when used as a radiopaque coating or as a radiopaque additive in a polymer matrix. Such increase of side group makes the weight percentage of iodine in the molecule relatively low. In contrast, in accordance with the present invention, the linking of a multiple triiodobenzene ring structure to a core dendritic structure so the iodine content in each molecule is maximized can create a high intensity contrast agent suitable as an radiopaque additive as both a coating and an additive to a polymer matrix as well as other uses known to those skilled in the art. As shown in FIG. 5 , the simplest form of such a high iodine content contrast agent is synthesized through the reaction between a Fmoc-protected 1-amino-2,2-dihydroxymethyl-3-propanol ( 110 ) and three 2,3,5-triiodobenzoic acid chloride ( 210 ). The resulting contrast agent ( 310 ) has an iodine content of about 74%, much higher than Ultravist&#39;s 48% ( 50 ). Additional advantages of a contrast agent in accordance with the present invention are that all raw materials are readily available and the coupling reactions generally have high yield. Multiple layers of dendrimer cores may increase the cost, but this may be offset by ever-higher iodine content and reduced amount of the required agent in the medical device to achieve adequate image contrast. Increased molecule weight also reduces the mobility and potential of the contrast agent to leach out of the medical device. [0040] Reacting a hydroxyl- or an amine-group containing compound and an iodine containing aromatic carboxylic acid or carboxylic acid chloride compound with a catalyst may be used to synthesize an iodine containing contrast agent. In accordance with the present invention this reaction is expanded further by using a bi-, tri- or tetra-hydroxyl containing compounds such as ethylene glycol, propylene glycol, glycerol, and pentaerythritol, bis-pentaerythritol to a single reactive contrast agent with a multiple number of iodine atoms, which may result in maximizing the radio-opacity of the molecule. [0041] In-house research has showed that commercially available injectable contrast agents such as those under the trade name Ultravist® ( 50 ) (Ultravist is a Registered Trademark of Schering AG) (iopromide containing 3 iodine atoms in each Ultravist molecule) demonstrated comparable x-ray contrast to barium sulfate. The contrast agents in accordance with the present invention have up to two times (2×) more iodine atoms per unit weight of contrast agent, which may provide up to an estimated four times (4×) sharper contrast image quality. In addition, the proposed contrast agent is sparingly water-soluble and would not swell the polymer matrix of the medical device and thus better maintain the mechanical properties of a medical device. In addition to limiting the swelling, the leaching of the agent is also minimized. [0042] In accordance with the present invention, multiple iodine molecules are built into a single contrast agent resulting in maximizing the radio-opacity of the contrast agent. Moreover, because good solubility of the contrast agent is present in common organic solvents, good miscibility may result with common polymers or polymer blends to form solid solutions. Enhanced mechanical strength of the bulk materials is maintained due to the elimination of crystalline additives which may result in stress risers, while relatively low water solubility ensures long residence time and degradation rate of the bulk material. [0043] Additional modifications in accordance with the present invention such as use of various hydroxyl or amine containing functional molecules in the reaction may be beneficial. Typical examples include, ethylene glycol, propylene glycol, glycerol, pentaerythritol. Other functional group containing compounds such as carboxyl groups, may be used for the synthesis of the high intensity contrast agent compounds and naturally derived amine or polyhydric alcohols such as sorbitol, trehelose etc. may be used to construct such a contrast agent and in addition may provide good biocompatibility. As previously indicated, various processing methods such as solvent casting, dip coating, injection molding etc. may be used to mix the contrast agent and a bulk material. [0044] In accordance with the present invention, compositions of a new class of polymeric high intensity x-ray contrast agents suitable for imaging implanted medical devices such as a drug eluting stent are formulated. Protected polyhydric alcohol or amine containing organic compounds commonly used in the synthesis of dendrimers may be used to react with an iodine containing aromatic compounds such as 2,3,5-triiodobenzoic acid to form such high iodine containing initiators. Each such initiator may contain a multiple of three (3) iodine atoms. Upon deprotection, as shown in FIG. 6 , these iodine rich compounds can serve an initiator for the ring opening reaction of cyclic dilactones such as lactide, glycolide etc. to form a bioabsorbable polymers. Other functional dimers such as a dilactam, mixed dilactone, mixed cyclophosphoester, may also be used in the reaction. Optionally as shown in FIGS. 7 and 8 , the synthetic bioabsorbable polymer can be end-capped by a derivative of initiator ( 330 ), doubling the iodine atoms per polymer, further enhancing the x-ray image contrast. Similarly di-functional iodine rich compounds can be used in building other types of polymers such as polyurethanes and polyureas. The specific advantages of such a compound include but are not limited to: iodine containing bioabsorbable polymers which behave like bioabsorbable polymers used to make the matrices of a medical device such as a drug eluting stent; these compounds are soluble in common organic solvents; the molecular weight and other properties of such iodine containing bioabsorbable polymers can be adjusted to vary the degradation time, mechanical strength, and contrast intensity per polymer; the iodine-containing polymers in accordance with the present invention are miscible with the bulk materials used to construct a medical device, avoiding the change of degradation time and mechanical strength, and are not water-soluble and do not leach out during the manufacturing processes and initial implantation period. [0045] FIGS. 9A and 9B show the orientation of polymer strands in a polymer matrix. Although the normal orientation of polymer chains in a polymer matrix ( 10 ) is random, one can impart a forces and/or processing conditions to create an alignment of the polymer chains within the structure ( 11 ) that may result in anisotropic material properties and may lead to improved material and/or mechanical properties. In accordance with the present invention, the polymers having high intensity contrast properties can be similarly processed to achieve the desired mechanical properties. [0046] Similarly, other commonly used dimers as shown in FIG. 10 , for ring openting reactions such as glycolide (GA), caprolactone (CL), p-Dioxanone (DO), trimethylcarbonate (TMC) can all be used in the polymerizations. Such dimers alone such as in FIG. 11 showing an ring opening reaction of a bioabsorbable polyglycolide (PGA), and end capping reaction with an iodine containing functional moiety, or in combination with each other can also be used to adjust the physical and chemical properties of the final copolymers. Additional embodiments and/or modifications include a series of functional iodine or bromine containing initiators used to initiate the ring opening reactions of a bioabsorbable polymer such as lactide, glycolide, caprolactone, or the mixture therein. Difunctional iodine or bromine rich compounds may serve as a building block of non-degradable polymers such as polyurethanes and polyureas. These polymeric structures can be further modified by having a biodegradable and/or biostable polymer containing multiple iodine atoms at one end or both ends of the polymer chains. This is accomplished by utilizing a process in accordance with the present invention for end capping an iodine or bromine containing biodegradable and/or biostable polymer at the end of the reaction to double the iodine atoms in the polymer chain. Moreover this process in accordance with the present invention may be used to form X-ray visible bulk material of a medical device using such iodine or bromine containing bioabsorbable polymers providing the necessary radiopacity. Alternately this process, in accordance with the present invention, for adding such iodine or bromine containing bioabsorbable polymers may be used to enhance the X-ray contrast intensity of the bulk of the medical device. Furthermore one is not limited to bioabsorbable polymers as this process, in accordance with the present invention, for using such iodine or bromine containing non-degradable or biostable polymers may be utilized to form X-ray visible bulk material of a medical device. The process in accordance with the present invention may also enhance the X-ray contrast intensity of the bulk of the medical device by adding such iodine or bromine containing nondegradable or biostable polymers to the bulk of the medical device. [0047] A simple calculation of iodine content may show that with an iodine rich compound one has an iodine content of 72.7%. When incorporated into the final polymer with a degree of polymerization (DP) of 200 (molecular weight is ca. 30 KD), the iodine content in the final polymer is approximately 3.81%, which is adequate for visibility under normal x-ray operating conditions. If the final end-capping step in accordance with the present invention is used, the iodine content in the final polymer may be doubled to 7.25%, achieving a value much higher than 3.0% to 5.0% iodine content needed for acceptable x-ray opacity. Alternatively, the Molecular weight of the polymer may be doubled to around 60 Kilo Daltons (KD) without adversely affecting the radiopacity since the polymer would still have adequate X-ray opacity with the end-capping process of the present invention. [0048] The method for introducing iodine or bromine atoms into each repeating monomer as disclosed in U.S. Pat. No. 6,475,477, (which is hereby incorporated by reference) may cause the property of bulk polymer to change as a result of iodine or bromine introduction which is distributed throughout the polymeric material. This series of patents were also limited to iodine or bromine containing polycarbonates. In comparison, the current method in accordance with the present invention clusters iodine atoms and/or selectively locates the atoms at one end or both ends of a polymer chain, leaving the bulk of the polymer chains intact for its role as a medical device and thereby not producing a change in the properties of the bulk material which may affect device performance. [0049] This disclosed invention applies to both degradable and bioabsorbable polymer synthesis as well as non-degradable/biostable polymers. The x-ray opaque polymers may be further processed into different forms and shapes as medical devices providing the bulk material from which the end product or device is formed. The polymers may also be used as a polymeric coating or a drug release barrier for device drug combination products or to simply enhance the radiopacity of the device for which the material is coated upon or incorporated within. [0050] The reaction between a hydroxyl group containing compound and an iodine containing aromatic compound may be processed for synthesizing an iodine containing contrast agent. This invention expands the concept further and used a protected bi-, tri- or tetra-hydroxyl containing compounds to make a functional initiator. Upon deprotection of Fmoc (9-fluorenylmethoxycarbonyl) as shown in FIG. 6 , the initiator can be used to initiate a ring opening reaction of cyclic lactones such as lactide, glycolide to form an iodine-containing polymer. Other commonly used protecting groups for amine and hydroxyl groups, other than Fmoc, such as Boc-, Z-, Ddz-, tert.-Butyl, Cbz, may be expressly used to substitute for Fmoc as a suittable protecting group in the reaction. The ring opening reaction is well researched and used in production of other biocompatible materials such as resorbable sutures. The final end-capping step as shown in FIG. 8 is a variation of regular end capping of a methanol, to impart more iodine content of the bioabsorbable polymer. [0051] In accordance with the present invention, multiple iodine molecules are built into a single initiator of a ring opening reaction. A bioabsorbable polymer contains a large number of iodine atoms without sacrificing the mechanical properties of the bulk materials, for example, such a bioabsorbable polymer may contain twice the number of iodine atoms by end capping with a derivative of the iodine containing functional initiator. Such iodine containing bioabsorbable polymer can be blended with regular bulk materials to form a medical device with much enhanced x-ray contrast and is non-leachable during the processing and initial period of implantation, ensuring desired degradation and biocompatibility. Furthermore, the contrast intensity of the medical device can be adjusted by varying the molecular weight and the percentage of the iodine-containing polymer in the matrices. This iodine introduction method may be used for synthesis of radiopaque non-degradable polymer as well in accordance with the present invention. [0052] Modifications include use of various hydroxyl or amine containing functional molecules, which upon proper protection, can be used in the synthesis of the functional initiator. Upon deprotection, these functional initiators can be transformed into corresponding end capping iodine containing functional compounds. Any commonly monomers for bioabsorbable polymers such as lactide, glycolide, caprolactone, dioxanone, trimethylene carbonate, etc., or the combination of these monomers, can be used to construct the iodine-containing degradable polymers. Nondegradable polymers such as polyurethanes or polyureas may also be made more radiopaque using the same or similar chemistry. [0053] Although what has been shown and described is what is believed to be the most practical and preferred embodiment of the present invention, other forms of, and departures from the specific designs described and shown, will suggest themselves to those skilled in the art and may be used without departing from the spirit, scope- or essential characteristics of the present invention. The present invention is not restricted or limited to the foregoing described embodiments, but rather should be constructed to cohere with all variations, combinations, and modifications that may fall within the scope of the appended claims.

In accordance with the present invention, a high intensity radiopaque contrast agent is disclosed. The agent may be coated on or incorporated within bulk material which may then be subsequently utilized to fabricate a radiopaque medical device. Primary effects through chemistry include higher radiopaque concentrations per unit weight of the radiopaque element or agent. Secondary effects include selective placement of the radiopaque elements which may further enhance the radiopacity of the device with reduced requirements of the radiopaque agent. Such a radiopaque contrast agent may be produced in various forms such as a dendrimer and/or incorporated as the end groups of polymeric chain. In addition one can incorporate biological and/or pharmaceutical agents in combination with the present invention.

CROSS REFERENCE TO RELATED APPLICATION [0001] This application claims the benefit of U.S. Provisional Patent Application No. 62,257,744, filed on Nov. 20, 2015. FIELD OF INVENTION [0002] The invention relates to techniques for measuring activity on a flexible mat of a trampoline with a wireless enabled electronic processor that includes at least one sensor to measure the deflection of the jumping mat relative to the plane formed by the undeformed mat, and a smart handheld device which connects to the processor for data communication. The wireless communication enabled electronic processor manipulates the data and determines the height of the bounce based on user&#39;s profile, while ignoring any sensor noise and false bounces. The processor transfers bounce data to the smart handheld device for purposes including but not limited to entertainment and exercise. Furthermore, the bounce data can be displayed through a graphical user interface (GUI) on handhold device to illustrate user&#39;s activities and provide user interaction. This interface can be used to play games on the handheld device which use input from both the processor and the user to determine outcomes. The program running on handheld devices being able to exchange data with a cloud service through internet, thus turning a local trampoline bounce sequence into to an internet trampoline game with social features. BACKGROUND [0003] Canadian patent publication CA 2,772,801 to Yjip Inc. and U.S. patent publication US2015/0321039 to John Robert Howe have described different methods to measure activities on the trampolines. They invented a trampoline including a frame and a jumping mat assembly that is supported by the frame to allow at least one user to bounce on the jumping mat. The trampoline also includes a sensor system that includes a plurality of sensors supported by the frame and/or the jumping mat assembly. The sensors are used to determine the status of a user or users on the trampoline. The main purpose of these inventions is to ensure the safety of the bouncers. [0004] The previous inventions did not adequately solve the issue of differentiating between the two situations when a person is walking on the mat versus when the user is jumping on the mat. This lack of differentiation can result in false bounce detection by the sensor arrangement. Deflection of the jumping mat caused by walking on the trampoline should not be registered as a valid jump. This walking activity can be defined as a bounce of insufficient height. The insufficient bounce is a noise signal and should be filtered and ignored by the sensing unit. In another scenario, these patents failed to identify deflection of the jumping mat resulting from jumpers with different profiles, including user weight and trampoline size. For example, the deflection registered on the jumping mat from jumper weighing 100 lbs is quite different from that of a jumper weighing 200 lbs. [0005] Personal communication, productivity, and entertainment devices such as tablets, smart phones, c-books, handheld game player or game controllers, portable media/email device, iPads, Netbooks, etc. (all referred to hereafter as “smart devices”) are known to include features such as graphical user interfaces (GUI), touch screens, wireless connectivity, etc. These devices also are known to provide support for ancillary applications (referred to as “APP” thereafter), such as calendars, email, maps, navigation, or other user defined functions. Ancillary applications may be pre-installed in a smart device or may be made available for download by a user. After initial installation and configuration of such a smart device APP, a GUI may be provided by means of which a user may be enabled to issue operational commands to a user configured hardware. Disclosed herein are user-friendly and convenient GUI methods for facilitating command input/output for a smart trampoline mat. [0006] From technology point of view, the previous inventions did not include smart handheld device and APP program to interactively work with the bouncers. None of the former inventions have combined a trampoline bounce event effectively with bounce height calculations and energy consumption calculations coupled with entertainment gaming. Most importantly, none of the prior art has included an internet-enabled cloud service technology which can turn a local trampoline game to an internet game with social features. None of the former inventions discuss the ability to upload or download user&#39;s historical data to a cloud service for global distribution of game data, or for an individual&#39;s personal activity tracking. This invention breaks the limitation of physical localization of trampoline and brings fan to users all over the world. [0007] It is an object of preferred embodiments of the present invention to address some of the aforementioned disadvantages. An additional or alternative object is to at least provide the public with a useful choice, and make the previous invention useful. SUMMARY OF THE INVENTION [0008] A smart trampoline jumping mat system is provided which has a jumping mat, a sensor or set of bounce sensors, an electronic processor with communication unit, a handheld device with communication unit and an APP program running on the handheld device. The sensor or set of bounce sensors can be used for sensing activity of a person or an object on the bounce mat through deflection measurement. Sensor data is collected and sent to the local processor unit for calculation. The local process filters the data, removing sensor noise and calculating sufficient and insufficient jumps using jump height as a selection criteria. The local processor then sends data to the handheld device. The handheld device may then display the data, update and potential game scenario with the data, and/or upload the data to a cloud service for further processing and storage. [0009] Using the data acquired, the local processor calculates user bounce data, such as bounce count, bounce frequency, bounce period, bounce time, and bounce height. The processor communication unit is the link between the local processor and the handheld device. An APP program running on the smart devices displays user calorie dissipation by using bounce data received and displays user profile, bounce data, game guidance, activities, etc., on the visual display of the smart device. The APP is also capable of registering single or multiple user&#39;s profile, storing all users&#39; profile and personal history of bounce data locally in the memory of the smart device. Furthermore, the APP upload and download personal profile and bouncing activities to and from a cloud service. In the APP, a user can compare a pair of chosen user&#39;s bouncing action to start a competition. The APP applies cloud calculation to compare user&#39;s bouncing activity among other users so long as the users registered themselves through the APP or this APP&#39;s website. This invention turns a local trampoline to an open game over the interne and one of a social tool. This effectively brings more fun and exercise to any user from a local trampoline. BRIEF DESCRIPTION OF THE DRAWINGS [0010] The drawings described in this section are for illustrative purposes only and are to clarify and improve understanding of the embodiment of this invention. The drawings and figure listed are not all possible implementations of the current invention and thus not intended to limit the scope of the present disclosure [0011] FIG. 1 is a outline view of prior art of trampoline which is applied for this embodiment. [0012] FIG. 2 is an illustration of one embodiment of the present invention. [0013] FIG. 3 is one design of the bouncing sensor unit diagram. [0014] FIG. 4 is the APP block function illustration which runs in a smart device. [0015] FIG. 5 is the program flowchart of the bouncing sensor unit which measures deflection of the jumping mat and exchange data with smart handheld device. [0016] FIG. 6 is illustration of deflection aroused by jumper when standing still on the trampoline vs jumping on the trampoline. [0017] FIG. 7 is a typical embodiment of deflection measured from trampoline mat while jumping. [0018] FIG. 8 is a simplified deflection segment of one jump in time domain. [0019] FIG. 9 is a sketch of identifying valid jump from invalid jump by threshold value. LEGAL WORDING DEFINITIONS [0020] As used herein, “comprising,” “including,” “containing,” “is,” “are,” “characterized by,” and grammatical equivalents thereof are inclusive or open-ended terms that do not exclude additional unrecited elements or method steps. “Comprising” is to be interpreted as including the more restrictive terms “consisting of” and “consisting essentially of.” DETAILED DESCRIPTION OF THE INVENTION [0021] Referring to prior art FIG. 1 , there is illustrated one embodiment of a conventional trampoline 22 , which includes a trampoline frame 34 , to support the basic structure thereof. There is mounted to the frame 34 , a jumping bed 31 , a plurality of coil springs 32 , and a plurality of upright legs 36 . The legs 36 are adapted to be disposed uprightly on a ground surface and vertically coupled to the frame 34 in a spaced relationship to each other. The frame 34 shape, circular in this embodiment, defines a bed mounting space 37 or opening. The jumping bed 31 , is mounted in the space 37 , and includes a trampoline mat member 39 with a peripheral spring attachment portion 33 . There is a plurality of coupling members 35 , like grommets, peripherally mounted to the attachment portion 33 , and designed to releasably couple to one end of the coil springs 32 respectively. A second opposite end of each spring 32 is designed to be releasably coupled to a plurality of frame mounting members 30 , like a hook, ring or eye design, which are peripherally mounted in a spaced apart manner to the inner circumference of the frame 34 . Thus, the jumping bed is resiliently suspended off the ground and held in the mounting space 37 by the frame 34 and the springs 32 to allow users to jump thereon without hitting the ground. [0022] As shown in FIG. 2 , the trampoline mat 39 , the bounce sensor 50 , the local electronic processor (bounce sensor unit) 11 , the handheld device 51 , the cloud service 52 , the wireless/internet port 53 , the Bluetooth port 54 , and the Application program 55 comprised the smart trampoline system and provide a variety of functionality and entertainment to the game of trampoline. [0023] A trampoline mat has at least one bounce sensor unit 50 that are mounted on the mat or under the mat, illustrated in FIG. 3 . The bounce sensor unit measure deflection of the flexible mat relative to the plane formed by the undeformed mat, thus to measure activity of the bouncer on the jumping mat. A bounce sensor unit 50 includes sensor module 60 , power switch 62 , power module 63 , microprocessor 66 , wireless communication module 65 , LED indicators 61 , and audio module 64 . The MCU process communication and measurement procedures. The bouncing sensor unit measurement program flowchart is displayed in FIG. 5 . [0024] The bouncing sensor unit or units 50 are configured to measure value corresponding to deflection of the jumping mat as a person moves on the mat. The term deflection as used in this claim is related to a mat deflection signal or value measured relative to the plane of the undeformed mat. [0025] There are several suitable techniques for fixed or removable mounting the sensors in association with the trampoline. These preferred methods of mounting will be further described below. [0026] As sketched in FIG. 6 , when a person is standing on the jumping mat, the initial deflection value is defined as A, while a person jumps on the mat, the deflection value will be registered as a bigger value, called B in this scenario. The difference deflection between B and A, i.e., equation B-A, is possibly a valid deflection caused by the bouncing activity. [0027] For any jump to be considered a valid bounce, the deflection registered by this jump minus the initial deflection must be bigger than a threshold value B 0 , that is: [0000] ( B−A )&gt;B 0 , [0000] where the threshold B 0 , is not only related to jumping mat and springs&#39; elasticity, but also related to jumper&#39;s weight m and trampoline size D. For a predefined trampoline, the weight becomes the only parameter to affect the threshold value. [0028] A typical dynamic deflection curve 80 measured from bouncing sensor unit is printed in FIG. 7 . For simplicity, a typical jump can be represented by FIG. 8 , where a n can be acceleration, force or impact amplitude of the nth jump and t n the period of this jump. The deflection of the jumping mat is related to jump impact/force/acceleration a, weight of the jumper m, and period of the jump t, as described by the equation: [0000] B=μ mat [0000] where, a is value measured by the bouncing sensor unit, m is a fixed value for each jumper and t can be measured by analyzing the output curve shape of each jump measured by sensor. μ is a constant can be normalized using least square method and statistics method by a vast variety of experiment from different jumper at a wide range of weight μ is also related to size of trampoline. [0029] Deflection on jumping mat can be categorized to different levels (B k ), starting from minimum measurable deflection B 0 , notation k is grade of deflection. If a is the acceleration measured on the jumping spot, then deflection of mat is simplified to: [0000] D =μft [0000] therefore, the deflection is a linear function of pseudo-impact of jumper f*t. Here we call this pseudo-impact since the period t is not the time of contact but time of whole jump period. This equation complies with trampoline physics: 1. The longer time the jumper in the air, the bigger the jump, and vice versa; 2. The higher the deflection, the higher the jump, and vice versa; 3. The bigger the jump, the more moment or acceleration or impact on the trampoline mat, thus generating higher value of deflection; 4. The more impact on the trampoline, the bigger the deflection of the jumping mat; 5. For same height of jump, heavier person generating higher deflection value. [0035] From above, it is safely to conclude that deflection is a function of jumper&#39;s weight, jump period, and force/acceleration measured on trampoline mat, for a predefined stiffness of trampoline mat and springs. [0036] The lowest grade of deflection (B 0 ) can be decided by experiment of the minimal detectable jump. As shown in the FIG. 9 , any deflection measured above the dashed line 100 considered a valid jump 101 ; other than that, the jump is not considered valid 102 . [0037] Preferably the smart device has a processor, a memory unit, a display, and a user input facility. The user input facility includes a touch screen, a keyboard etc. A processor of the smart device 51 is included as control core of the system. The communication device may be in forms of Bluetooth or radio frequency (RF) or infrared radiation (IR) 54 to talk with electronic handheld device and APP program 55 installed on a smart device. The function block of the APP 55 running in the smart device is detail described in FIG. 4 . The APP program includes functions of pair with Bluetooth/RF/IR of sensor unit 70 , player list management 71 , player registration 72 , setup or change sensor parameter 73 , receive bouncing data from bouncing sensor unit 74 , player current data and history data analysis 75 , Exchange data and information with cloud service 76 , and game center with multiple games 77 , as described in FIG. 4 . [0038] The APP program is installed on a smart device with touch screen or sets of keys which could slide or push to interacts with the users. A user can register individual profile in the APP and the APP will upload the user&#39;s profile to cloud service. The user&#39;s profile may include but is not limited to, user&#39;s name, weight, gender, age, height, address, phone, email, etc. [0039] The sensor and processor installed on the trampoline will apply measured dynamics of the user on the trampoline to calculate bouncing time, bounce frequency, bouncing count, bounce height. Furthermore, by interacting with the APP program, the system is capable of calculating user&#39;s calorie dissipation. [0040] To add more fun to the game of trampoline, this invention also includes interne competition along with local trampoline completion. As we know, when a group of users jump at one trampoline one by one in sequence, they can start a competition game in sequence to find out the winner. For example, the winner is the one who bounce the most count in a 3 minute, but each bounce has to be over 1 meter&#39;s height to be counted as a valid jump. Or the winner is the one who finishes 100 jumps in shortest time, in condition that each jump being over 1 meter. Of course, the set height can be some other number as agreed by the jumper. In the APP, this function is distributed via cloud service worldwide, i.e., the jumpers are not limited to a physically one location trampoline, they can jump on their own trampoline and upload their jumping data and parameter to the cloud service, thus being involved with the competition. Jumpers can invite their friends or other cloud service members to start a set rules of competition. [0041] The APP program running on the handheld device is capable of, but not limited to: 1. Provide a set of game for users to choose; 2. Provide rules for users to choose, 3. Provide interface for user to customize their own game or sequence of actions and upload to their circle. 4. Upload their jumping video and data to Facebook, Twitter, Google Circle, WeChat, or other social platform to show to their friends. 5. Provide interface for any user to initiate a public game or sequence of action which allows other users to joining. [0047] The APP program is capable of recording local user&#39;s jumping data and parameter; and save the data and jumping parameter to local drive and/or uploading to cloud service. The APP program displays local user&#39;s jumping data on the handheld screen, such as count of bouncing, frequency of bouncing, bouncing time, bouncing height, etc. User can choose information to be displayed on the screen by setting. [0048] The APP is capable of alerting the user of the closest trampoline they can use to participate in cloud games if those trampolines are registered in the cloud service. [0049] The APP is capable of acting as a local game center which provides users a set of games to choose to play alone or with others from local area or remote cloud service. The followings is an example of a possible game: [0050] Game 1: In a set time, the winner is who finish the most jumps, all jumps has to be over a set height. [0051] Games in the game centers of the APP is not limited to the above mentioned. CITATIONS [0052] US20110034300A1, 26 Jun. 2012, David Hall, Sensor, control and virtual reality system for a trampoline [0053] US20100190608A1, Jul. 29, 2010, Jumpsport, Inc., Trampoline system [0054] US20020137598A1, Sep. 26, 2002, Mark Publicover, Jon Greiner, J. Publicover, Byron Bertsch, Trampoline or the like with enclosure [0055] U.S. Pat. No. 5,921,899A, Jul. 13, 1999, Amelia T. Rose, Pneumatic exerciser [0056] US20040077975A1, Apr. 22, 2004, Zimmerman Jeffrey C., Systems and methods for motion analysis and feedback [0057] US20090111670A1, Apr. 30, 2009, Julian D Williams, Walk simulation apparatus for exercise and virtual reality [0058] U.S. Pat. No. 7,297,089B2, Nov. 20, 2007, Samuel Chen, Lighted trampoline [0059] US20150321039A1, Nov. 12, 2015, John Robert Howe, Board &amp; Batten International Inc., Method and System of Measuring an Activity of a Person on a Flexible Mat of a Trampoline [0060] US 20120295763A1, Nov. 22, 2012, YJIP, Inc., Trampoline with feedback system

A smart trampoline jumping mat system is designed that has a jumping mat, a sensor or a set of sensors, a processor with wireless communication unit, and a handheld device with an application program running from the smart handheld device. The sensor or set of sensors can be used for sensing activity of a person or an object on the bounce members. The processor is used to acquire deflection data from the sensor or sensor group. Deflection data is then manipulated by the processor prior to being sent to the handheld device. The handheld device may include a processor, graphical user interfaces (GUI) to show the move meat of the juniper, and a speaker to generate audible feedback. A method to compute the height of a bounce is also presented. The deflection value is combined with data based on jumper's weight, jump period, and size of trampoline mat to determine the height of a bounce.

CROSS-REFERENCE TO RELATED APPLICATIONS STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0001] Not Applicable. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] This invention relates to beds and bed frames which have metal or wooden bed rails and to metal adjustable cross bars with legs for supporting the cross bars. While this invention is particularly applicable to full, queen, California king and king size beds which require legs on the cross bars to support -the extra width and weight of such beds and bedding, it also is applicable to twin size beds where legs may be desired. [0004] Specifically, this invention is related to adjustable angle iron cross bars for bed rails and frames designed for use with various sized beds and to a fastener for connecting the parts of the adjustable angle iron cross bars together, which fastener has a support leg fastened thereto. [0005] 2. Description of the Prior Art [0006] Conventional beds and bed rails require longitudinally spaced, transversely extending wooden or metal slats extending between the side rails. The side rails tend to warp, twist outwardly or deflect under the weight of the box spring and other bedding components, which causes the box spring to sag. This especially is a problem with wider span beds and bedding, such as, queen size and king size widths, since the wider bedding is heavier as well as being wider and longer. Slats setting on angle iron or wood rails not only push the rails downwardly, but also push the rails outwardly when weight or torquing of these rails frequently cause the bed legs to split when the slot in the legs of the beds is too close to the outside edge of the leg, or cause the bed legs to split away from the end board. These slats are normally 1″ thick or less and create a sway in the box spring between one slat and the next, thereby weakening the frame of the box spring. [0007] Prior U.S. Pat. No. 4,080,674 issued Jan. 3, 1977 discloses metal bed rails for queen size beds which eliminate the use of transverse slats and are interconnected by a centrally located angle iron rigid cross member with legs and adjustable glides. By extending the threaded glides to contact the floor they prevent the box spring from sagging and eliminate undue stress on the side rails and bed legs. [0008] U.S. Pat. No. 5,203,039 discloses an adjustable cross bar and foldable adjustable legs. U.S. Pat. No. 5,502,852 is an improvement on the adjustable leg structure of U.S. Pat. No. 5,203,039. U.S. Pat. No. 6,209,155 is an improvement on the adjustable cross bar shown in U.S. Pat. No. 5,203,039 and U.S. Pat. No. 6,397,413 is an improvement on U.S. Pat. No. 6,209,155 in that it provides for the installation of the leg on the fastener which holds the cross bar members together. [0009] U.S. Pat. Nos. 5,203,039; 5,502,852; 6,209,155; and 6,397,413 are owned by the assignee of this application. The present invention is an improvement on the support legs shown in the aforementioned patents in that it provides for the leg being riveted to the fastener which is a relatively inexpensive fastening technique compared to the spot welding required in U.S. Pat. No. 6,397,413. It also is fabricated at the factory and does not require assembly in the field, saving on installation costs by the installer. BRIEF SUMMARY OF THE INVENTION [0010] It is a primary object of the present invention to provide a cross bar construction, especially for full, king, California king, and queen size beds, which is adjustable in width and height, and which is easily and inexpensively fabricated at the factory. [0011] Another object is to provide an adjustable cross bar construction for bed frames in which a leg is riveted to the bracket which slidingly retains the free ends of the cross bar members. These and other objects will become apparent hereinafter. [0012] This invention comprises a bed frame cross bar having relatively expandable members and a locking bracket for retaining the expandable members in a fixed position with a leg riveted to the locking member by a relatively inexpensive and accurate technique at the place of fabrication. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0013] In the drawings wherein like numbers refers to like parts wherever they occur: [0014] [0014]FIG. 1 is a perspective view of the leg and locking member which is the subject of this invention; [0015] [0015]FIG. 2 is an end elevational view of this invention applied to two relatively slidable cross bar members; [0016] [0016]FIG. 3 is a fragmentary front elevation view of this invention as shown in FIG. 2; [0017] [0017]FIG. 4 is a front elevational view of the cross bar shown in FIG. 1; [0018] [0018]FIG. 5 is a plan view of the connecting member shown in FIG. 1; [0019] [0019]FIG. 6 is a vertical sectional view taken on line 6 - 6 of FIG. 3; and [0020] [0020]FIG. 7 is a sectional view taken on line 7 - 7 of FIG. 3. DETAILED DESCRIPTION OF THE INVENTION [0021] The following detailed description illustrates the invention by way of example and not by way of limitation. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what we presently believe is the best mode of carrying out the invention. [0022] This invention is an improvement on the adjustable cross bar connector shown in detail in FIG. 4 of U.S. Pat. No. 5,203,039 and identified by numerals 20 - 25 of that patent and on the connector identified by the numerals 100 et. seq. in U.S. Pat. Nos. 6,209,155 and 6,397,413. The structures of U.S. Pat. Nos. 5,203,039, 5,502,852, 6,209,155 and 6,397,413 are herein incorporated by reference to the extent necessary to define background for a completion of the present disclosure. [0023] [0023]FIG. 3 shows a cross-bar 100 which comprises a main cross bar member 101 and an adjustable cross bar member 102 . [0024] The main cross bar member 101 is an “L” angle, which has a horizontal flange or web 103 and a right angle vertical flange or web 104 . The vertical flange 104 terminates at 105 inwardly from the outboard edge 106 of the horizontal flange 103 . This defines a cut-out area which engages the inside of side rail 107 while the horizontal flange 103 has an opening 108 which overlaps the lip 107 a of the side rail 107 and accommodates a screw 108 a or other suitable means for fastening the main cross member 101 to the side rail 107 . The adjustable cross bar member 102 likewise has a vertical flange 109 and a horizontal flange 110 . The flanges 103 , 110 and 104 , 109 are of approximately equal size. The outboard end 111 of the adjustable cross member 102 is of similar construction to the outboard edge 106 of the main flange 101 and includes an opening 108 to accommodate a screw 108 a or other suitable fastener to attach the cross bar 102 to the side rail lip 107 a. When the side rails 107 and lips 107 a are wood, screws are used to fasten the cross bars members 101 , 102 to the lips 107 a. When the side rails 107 and lips 107 a are metal, bolts and nuts are used. [0025] The novel bracket 10 of this invention is used to tie the cross bar members 101 and 102 together at their inboard or free ends 112 and 113 . The bracket 10 preferably is about five inches in length for a bed cross bar, but can be any length for other applications as long as it is sufficiently long to provide rigidity and strength to the extended cross bar. [0026] The horizontal flange 103 of the cross bar member 101 has a longitudinal free edge 115 while the vertical flange 104 has a longitudinal free edge 116 . The horizontal flange 110 of the adjustable cross bar member 102 has a longitudinal free edge 117 and the vertical flange 109 has a longitudinal free edge 118 . This is more clearly shown in FIG. 2. [0027] As seen more clearly in FIG. 1, the bracket 10 comprises right angular flanges 11 and 12 . The flange 11 is horizontal and the flange 12 depends therefrom at a right angle. The free edges of the flanges 11 and 12 are turned backwardly over the outer surfaces 11 a, 12 a of the flanges 11 , 12 to form a horizontal track 13 and a vertical track 14 , respectively. The track 13 embraces the free ends 115 and 117 of the cross bar flange members 103 , 110 and the track 14 braces the free ends 116 , 118 of the cross bar flange members 104 , 109 , respectively. This is seen in FIG. 2. This allows the members 101 , 102 to be relatively movable through the tracks 13 , 14 , thus allowing the members 101 , 102 to be sized to fit the distance between the side rails 107 . [0028] An adjustable locking mechanism 20 is incorporated into the bracket 10 (FIG. 6) and is positioned adjacent to the flange inside surfaces 11 b and 12 b. A boss or gusset 21 is formed in the flange 12 on the inside surface 12 b thereof. The boss 21 has a rectangular base 21 a and triangular sides 21 b (FIG. 1). An opening 22 is formed in the base 21 a of the boss 21 and a Tinnerman nut 23 is positioned over the base 21 a and frictionally engages the front and backsides thereof. The Tinnerman nut 23 has legs 24 , 25 provided with openings 24 a and 25 a. The openings 24 a, 25 a are sized to mate with the boss opening 22 . The leg 25 has outwardly flared edges around the opening 25 a which act as a lock nut for an L-shaped threaded bolt or elbow 26 which is positioned through the openings 22 a, 24 a, 25 a. When the elbow 26 is tightened its end 27 engages the inside surface of the cross bar member 101 to lock the cross bar members 101 , 102 into frictional engagement with the bracket 10 . [0029] The tracks 13 and 14 are sized to accommodate the cross bar members 101 and 102 in a relatively sliding arrangement. [0030] When the cross bar member ends are firmly seated against the inside edges of the bed rails 107 and attached by the screws 108 a, they will resist rotation or other movement. An important aspect of this invention is that the bracket horizontal flange 11 and the cross bar member horizontal flanges 103 , 110 are aligned so that the weight of the spring, mattress and users urges them into frictional engagement and strengthens the grip of the elbow 26 against the inner surface 112 of the cross member flange 103 . [0031] An important improvement of this application is the way the leg 30 is attached to the fastening bracket 10 . In U.S. Pat. No. 6,397,413, the leg is welded to the fastening member in any of several different ways. Spot welding is an expensive way of attaching metal parts together and requires considerable time and skill on the part of the welder. In the present application, the leg 30 is riveted to the bracket 10 . Riveting is less costly and requires less skill and is more easily automated. [0032] The leg 30 is formed of hot rolled steel and has right angular flanges 31 and 32 . The flange 31 has rivets 33 applied to fasten the leg 30 to the leg bracket flange 12 . The rivets 33 have heads 34 which are positioned on the outside of the flange 31 and the inside of the vertical bracket flange 12 , i.e., between the flange 12 and the inside cross bar member 112 . To provide ease of engagement the rivet heads 34 and the cross bar member 112 , protrusions or dimples 35 are formed in the bracket flange 12 b. The dimples 35 are deeper than the thickness of the rivet heads 34 and therefore the cross bar members 101 , 112 slide on the tops of the dimples 35 and do not hang up on the wide flat rivet heads 34 (FIG. 7). [0033] To facilitate securing the leg 30 to the bracket 10 , an opening 40 is formed in the bracket vertical flange track 14 (FIG. 4). It is aligned with the rivet heads 34 . The opening 40 allows access to the rivet heads 34 on the bracket 10 to facilitate the riveting process. An opening 41 is formed in the bracket horizontal flange 11 and a downwardly depending stabilizing flange 42 (FIG. 1) is formed which tends to prevent leg deformation if lateral load is applied to the leg 30 , e.g.,by dragging the leg 30 across a floor. [0034] To facilitate installation of the Tinnerman nut 23 , an opening 45 is formed in the bracket horizontal track 13 . The opening 45 is aligned with the boss 21 . An opening 46 is formed in the horizontal flange 11 aligned with the boss 21 to also facilitate installation of the Tinnerman nut 23 . [0035] The free end of the leg 30 has a square bracket 50 which retains a threaded plastic nut 51 which holds an extensible foot 52 which is threaded to move in and out to thereby change the length of the leg 30 and provide firm support for the cross bar. [0036] In view of the above, it will be seen that the several objects and advantages of the present invention have been achieved and other advantageous results have been obtained. [0037] As various changes could be made in the above constructions without departing from the scope of the invention, it is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

An adjustable locking mechanism incorporated in a bracket embracing laterially slidable first and second members,. Said mechanism being incorporated in the bracket and having a first element engaged with the bracket and a second element engaged with the first element and movable through both the first element and the bracket into engagement with the first member to force the first member into engagement with the second member to hold said first and second members in fixed lateral relationship to each other.

CROSS REFERENCE TO RELATED APPLICATION This application claims the priority right from the U.S. provisional patent application No. 61/695,540 that was filed on Aug. 31, 2012, the content of which is herewith incorporated in its entirety by reference. FIELD OF THE INVENTION The present invention generally relates to cyanocobalamin containing medications that are placed in the mouth, dissolved and swallowed for the prevention and treatment of headaches and body pains in humans and for enhancing the normal functioning of the human body by boosting the human defense against headaches and body pains. BACKGROUND OF THE INVENTION Human brains are one fiftieth of our body&#39;s weight, and yet consume up to one fifth of the body&#39;s energy. Two thirds of the brain&#39;s energy consumption goes into making nerve cells fire, and one third into cell maintenance. Most of the brain&#39;s energy is chemical energy manufactured in the mitochondria and stored in the form of ATP. Mitochondria live as organelles within cells, including brain cells. The number of mitochondria per cell can range from one to thousands, depending on the energy needs of the cell. Energy-hungry brain cells contain thousands of mitochondria. Once inside the body cyanocobalamin is converted to adenosylcobalamin and methylcobalamin. Adenosylcobalamin is critical to the health and functioning of the brain&#39;s mitochondria while methylcobalamin is critical to the health and functioning of the rest of the brain&#39;s and body&#39;s cells. Muscle cells have a large energy demand and require lots of ATP. Muscle cells also have a correspondingly high number of mitochondria, and are often the site of the body&#39;s soreness and pain. The current invention focuses on musculoskeletal pain. The current invention discloses novel approaches to prevent and treat the malfunctioning or underperformance of the body&#39;s mitochondria and cells with methylcobalamin, and adenosylcobalamin, and their chemical precursor, cyanocobalamin, especially in the central and peripheral nervous systems. The inventor of the current invention puts forth the theory that by providing cyanocobalamin, methylcobalamin, and/or adenosylcobalamin in therapeutic doses to headache and body pain sufferers that their mitochondria will attain sufficient therapeutic concentrations of these essential micronutrients to survive, increase in number and function properly, thereby not creating the symptoms of certain types of headache and body pain. The current invention differs substantially from prior uses of cobalamins, such as hydroxycobalamin to take up excess nitric oxide, or cobalamins to prevent IgE-mediated allergic diseases, neurogenic inflammation or cobalamins to repair nerve cell-insulating myelin sheath. Cyanocobalamin, methylcobalamin, adenosylcobalamin and hydroxocobalamin each contain a biologically rare cobalt metal atom as a central feature. Around that cobalt is the active part of each molecule (i.e. the moiety) which is the location responsible for the unique type of chemical reactions that molecule causes to make happen. Attached to their central cobalt atoms; cyanocobalamin has a cyano group, methylcobalamin has a methyl group, adenosylcobalamin has an adeno group, and hydroxocobalamin has a hydroxyl (OH) group. Because of these distinct electromagnetic properties, each of these compounds plays a distinct biochemical role. Cyanocobalamin, methylcobalamin, and adenosylcobalamin (the three chemicals pertaining to the current patent) differ in some important ways from hydroxocobalamin (which does not pertain to the current patent). Once inside the body cyanocobalamin is converted to methylcobalamin and adenosylcobalamin, but not to hydroxocobalamin. Hydroxocobalamin is known to scavenge nitric oxide (NO) which is associated with migraine. Hydroxocobalamin does this scavenging by trading its OH group connected to its central cobalt with the nitric oxide molecule. Because neither cyanocobalamin, nor methylcobalamin, nor adenosylcobalamin have the ability to scavenge nitric oxide, their ability to lessen the frequency and severity of headaches cannot be ascribed to nitric oxide scavenging. In 1999 Merkus disclosed in U.S. Pat. No. 5,925,625 a method and composition for the prophylaxis and treatment of headaches using intranasal hydroxocobalamin. The current invention can be distinguished from Merkus&#39; patent because the current invention discloses the use of different chemical entities, namely cyanocobalamin, methylcobalamin, and adenosylcobalamin. The current invention can be distinguished from Merkus&#39; patent because Merkus describes a short-term treatment while the current patent describes a long-term treatment. The current invention can be further distinguished from U.S. Pat. No. 5,925,625 because Merkus states that “Oral, sublingual as well as nasal administration of vitamin B12 appeared to be ineffective treatments . . . ” while the current patent teaches away from Merkus because the current patent discloses that buccal and sublingual administration do indeed yield effective treatments for headache. In 2001 Ernest T. Armstrong (the inventor of the current invention) disclosed in U.S. Pat. No. 6,255,294 a method to treat allergy using cobalamins. However, in U.S. Pat. No. 6,255,294 there is no mention of headache or migraine. In U.S. Pat. No. 6,255,294 the invention relied on a method for treating Immunoglobulin E (IgE) mediated atopic disease including allergic rhinitis and asthma. Such atopic diseases are a completely different class of disease and human condition with different causations and modes of action than the headaches and body pains disclosed in the current invention. The claims of U.S. Pat. No. 6,255,294 were approved with cyanocobalamin, methylcobalamin, and hydroxocobalamin, but not with adenosylcobalamin. In 2002 van der Kuy showed in an unblinded, open-label study on 19 migraine patients that intranasal hydroxocobalamin can have an effect on migraine. The authors of the van der Kuy study hypothesize that hydroxocobalamin might be effective in migraine because of its nitric oxide-scavenging activity. Flaws in the van der Kuy study include the lack of a placebo group as a comparator, and the lack of any follow up after the last day the subjects received their last dose of medication which could have demonstrated (or not demonstrated) a persistence of effect. The current invention can be distinguished from van der Kuy&#39;s research because van der Kuy used hydroxocobalamin while the current invention discloses the distinct chemical entities of cyanocobalamin, methylcobalamin, and adenosylcobalamin. The current invention can be distinguished from van der Kuy&#39;s research because van der Kuy&#39;s treatment has a short-term persistence of effect while the current invention has a long-term effect. The current invention can be distinguished from van der Kuy&#39;s research because for all subjects van der Kuy showed essentially no reduction in severity (mean of 2.2 at baseline versus 2.1 at the end of the study, on a 0-3 scale). The current invention can be further distinguished from van der Kuy&#39;s research because van der Kuy&#39;s mechanism of action describes hydroxocobalamin as a nitric oxide (NO) scavenger. Nitric oxide is created and excreted by the body within a matter of hours. The important distinguishing point is that the current invention&#39;s mechanism of action most certainly is different than that of van der Kuy&#39;s invention because the scavenging of nitric oxide lasts only hours while the current invention has a persistence of effect lasts weeks, and perhaps months or years. (Van der Kuy, H et al. Hydroxocobalamin, a nitric oxide scavenger, in the prophylaxis of migraine: an open, pilot study. Cephalalgia, 2002, 22, 513-519.) Dalsgaard-Nielsen performed a double-blind, placebo-controlled study on 29 patients (active n=15 and placebo n=14). During two months every two weeks 2 mg of cyanocobalamin were administered intramuscularly. The patients reported a: “Good result” active n=4 versus placebo n=2, and “Considerable improvement” active n=2 versus placebo n=5. The authors concluded that no therapeutic effect attributable to cyanocobalamin was demonstrated. (Dalsgaard-Nielsen A T, Trautmann J. Profylaktisk behandling of migraene med vitamin B12. Almindelige Danske Laegeforening 1970; 132:339-41.) The authors of the van der Kuy study also hypothesize that since cyanocobalamin has no nitric oxide-scavenging activity, in contrast to hydroxocobalamin, it is not surprising that in the Dalsgaard-Nielsen trials on cyanocobalamin no effect was seen in migraine patients. Van der Kuy was correct about the lack of cyanocobalamin&#39;s nitric oxide-scavenging activity, but they missed another flaw in the Dalsgaard-Nielsen trials: Dalsgaard-Nielsen administered cyanocobalamin only once every two weeks. Based on the current inventor&#39;s original clinical research, the current invention teaches away from Dalsgaard-Nielsen and discloses a particularly preferred embodiment of daily administration of cyanocobalamin, with repeated delivery ranging from about 15 days to about 60 days. The non-obviousness of the instant claims can be established by considering that oral (buccal) dissolving strip, sublingual lozenges and other disclosed means of introducing the headache and body pain opposing medications orally provide significant improvements over the prior art in that the dissolving strip are more convenient for the headache patient than a series of injections, or a nasal spray. Compared to an injection, or nasal spray, a dissolving strip or a sublingual lozenge is much more convenient because it takes from between one minute and five minutes to inject oneself or to administer a nasal spray. These few minutes may not seem like much, but to the headache patient, time is of the essence. Another advantage is that people in pain do not want something stuffed up their nose or an injection in the body. Among the surprising advantages of the dissolving strip and sublingual lozenge over the injection and nasal spray is that the headache patient would not be further irritated by a painful injection process or by a nasal spray up a sensitive nostril. This is an important aspect of the oral strip which comes in an easy to use soft plastic container because headache patients are often hypersensitive to bright lights (photophobia), shrill sounds (phonophobia), smells (osmophobia), and metallic objects touching the body. Such extraneous irritations are the last thing a headache sufferer would want at the time he or she is experiencing an episode of headache, thus the strips and sublingual lozenge differ in a significant way. The significance of the difference between the oral dissolving medication and other delivery means becomes apparent when one examines the large numbers of people and money involved. There are between 30 and 50 million headache sufferers in the United States, thus if only ten percent can be provided an improvement, then some 3 to 5 million people will be helped. According the American Academy of Pain Medicine, pain affects more Americans than does diabetes, heart disease, and cancer combined. Back pain problems in the United States are reported to cost more than $100,000,000,000 annually. Many large pharmaceutical companies have spent millions of dollars over many years investigating new medications for headache sufferers, but none of them have developed any medication with the safety profile, efficacy and ease of use afforded by the current invention. EXAMPLE 1 This clinical study was designed and directed by the inventor of the current patent. Methods: 162 human subjects with demonstrated seasonal allergic rhinitis (hay fever) in the Pacific Northwest region of the United States were split into two groups with approximately 50 percent in the active group and 50 percent in the placebo group. Subjects were given their study medication, either Cyanocobalamin, USP or placebo in the a.m. and p.m. every day for 21 consecutive days. Data on adverse events including headache was captured throughout the ten-week duration of the study. Week One was a baseline during which time no medication was administered; Weeks Two, Three and Four were the weeks during which time the subjects received their study medication; and Weeks Five through Ten were a post-treatment period during which time no medication was administered but observations of symptoms and adverse events were documented. Each time a subject felt a “Headache”, he or she reported its occurrence. Results: The subjects&#39; post-treatment reports of “Headache” decreased from baseline in the following surprising and unexpected results: Week Five −1.4 active vs. −0.9 placebo, Week Six −1.6 active vs. −2.0 placebo, Week Seven −1.4 active vs. −0.1 placebo, Week Eight −2.1 active vs. −1.2 placebo, Week Nine −3.4 active vs. −1.8 placebo, and Week Ten −3.2 active vs. −0.3 placebo. The results also demonstrated a persistence of effect of at least six weeks after finishing the treatment. The results also demonstrated that there was a greater reduction in the frequency of headache in the active group versus placebo in five out of six post-treatment weeks. Additionally, almost one year later a follow-up questionnaire was completed by 43 active and 49 placebo subjects, the results of which suggest a persistence of effect lasting almost one year. EXAMPLE 2 This clinical study was designed and directed by the inventor of the current patent. A large, multi-center, Phase 3, randomized, placebo-controlled clinical study on 1,551 patients was designed and directed by the inventor of the current patent. Methods: The study was titled: “A Phase 3, randomized, double-blind, placebo-controlled, parallel group study of the safety and efficacy of pre-seasonal sublingual cyanocobalamin lozenges on moderate to moderately severe seasonal allergic rhinitis in humans”. The study took place before and during the ragweed pollen season at 23 study sites in the Midwest, Northeast and Central Texas regions of the United States. Essentially all of the 23 investigators were Board Certified in Allergy/Immunology. Qualified subjects were randomized into an active or placebo group (approximately 50% and 50%) using an interactive voice recognition system (IVRS). All subjects (or their guardians) signed an Informed Consent form approved by the IRB. Each subject had three visits to the clinic. At Visit 1 and at Visit 3, they were given a physical exam (HEENT, chest, lungs, heart, vital signs, height and weight); and donated blood and urine samples for laboratory analysis. CBC and chemistry panels were run for safety analyses. The blood samples were analyzed by chemiluminescent immunoassay for the presence of ragweed specific immunoglobulin epsilon (IgE), and were assayed for cobalamins (cyanocobalamin, methylcobalamin and adenosylcobalamin) levels. Subjects self-rated the severity their allergy symptoms in the morning (a.m.) and in the evening (p.m.) by entering a numeric score in a keypad of a telephone (IVRS) or in a computer connected via the Internet to a database. Subjects were given their study medication, either 3.3 mg Cyanocobalamin, USP or placebo in the a.m. and p.m. Subjects were instructed to let the study drug “dissolve completely in your mouth, especially under your tongue, then swallow.”. Subjects self-administered the study medications for six consecutive weeks. For the next four weeks subjects did not take any study medications. Any adverse event (AE) or serious adverse event (SAE) was documented by the subject in a paper diary and then transcribed to the appropriate case report form (CRF) page. All SAEs were attended to by the investigator, and reported to the FDA by the sponsor. All sites were monitored multiple times by qualified monitors. Results: There was a total enrollment of 1,551 subjects (RA5555 n=763 and RA3333 n=788). The total number of doses possible was 84 doses. Over 50 percent (n=766) of the 1474 subjects who reported taking at least one dose, took at least 80 doses of study medication. The allergy symptom scores were derived by summing and averaging all a.m. plus all p.m. scores for the symptoms of sneezing, runny nose, nasal congestion, nasal itch and eye itch. The primary comparison of interest was the scores across Weeks 4, 5 and 6 (i.e. during the pollen season). All randomized subjects who took at least one dose were included in this intent-to-treat (ITT) analysis. The reduction in symptom severity from baseline was greater for the active group than the placebo group for all five composite symptoms: sneezing, runny nose, nasal congestion, nasal itch and eye itch. In terms of safety, the active study medication was well tolerated. As per the laboratory results, a significant average increase of more than 250 percent in post-treatment blood serum cobalamin (cyanocobalamin, methylcobalamin and adenosylcobalamin) levels was reported in the cyanocobalamin-treated subject groups compared with essentially no increase in placebo-treated subjects. The following types of headaches were self-diagnosed and documented by subjects in the study: tension headache, headache, migraine, increased frequency of headaches, worsening sinus migraine headache, increased headache, headache worsening, worsening of migraine, sinus headache, severe sinus headache, and sinus pressure headache. The following types of body pains and myasthenia were self-diagnosed and documented by subjects in the study: ear pain, earache, sore throat, sore muscles, leg cramps, myalgia, back pain, sprained ankle, ache, toothache, hip pain, finger pain, knee pain, pulled back muscle, shoulder pain, pulled hamstring, neck pain, femur pain, gum pain, sore muscle, toenail pain, sore foot, and pulled neck muscle. Of the 294 documented reports of some type of headache and of body pain, the study yielded the following surprising and unexpected frequencies demonstrating positive results: 137 reports in the active group compared to 157 reports in the placebo group. The severities of those headaches and body pains were rated in the following surprising and unexpected intensities: “Mild” 63 reports (or 46.0%) in the active group versus 71 reports (or 45.2%) in the placebo group; “Moderate” 68 reports (or 49.6%) in the active group versus 68 reports (or 43.3%) in the placebo group; and “Severe” 6 reports (or 4.4%) in the active group versus 18 reports (or 11.5%) in the placebo group. EXAMPLE 3 The current invention was successfully tested in humans with a history of headache and/or body pains in a variety of formulas. These formulas comprised dissolving medications containing combinations of cyanocobalamin, methylcobalamin, adenosylcobalamin, magnesium, coenzyme Q10, L-carnitine, and riboflavin. Formula 1 was a dissolving medication with 3.3 mg of cyanocobalamin. Formula 2 was a dissolving medication with 6.6 mg of cyanocobalamin. Formula 3 was a dissolving medication with 3.3 mg of methylcobalamin. Formula 4 was a dissolving medication with 3.3 mg of adenosylcobalamin. Formula 5 was a dissolving medication with 2.2 mg of cyanocobalamin, 2.2 mg of methylcobalamin, and 2.2 mg of adenosylcobalamin. Formula 6 was a dissolving medication with 3.3 mg of adenosylcobalamin. Formula 7 was a dissolving medication with 5.6 mg of cyanocobalamin, 0.5 mg of methylcobalamin, and 0.5 mg of adenosylcobalamin. Formula 8 was a dissolving medication with 1.1 mg of cyanocobalamin, 1.1 mg of methylcobalamin, and 1.1 mg of adenosylcobalamin. Formula 9 was a dissolving medication with 2.2 mg of cyanocobalamin, 2.2 mg of methylcobalamin, 2.2 mg of adenosylcobalamin, 15 mg of coenzyme Q10, and 2.1 mg of riboflavin. Formula 10 was a dissolving medication with 1.1 mg of cyanocobalamin, 1.1 mg of methylcobalamin, 1.1 mg of adenosylcobalamin, 18 mg of coenzyme Q10, and 2.1 mg of riboflavin. Formula 11 was a dissolving medication with 1.1 mg of cyanocobalamin, 1.1 mg of methylcobalamin, 1.1 mg of adenosylcobalamin, 5 mg magnesium, 9 mg of coenzyme Q10, 5 mg L-carnitine, and 2.1 mg of riboflavin. Formula 12 was a dissolving medication with 5.6 mg of cyanocobalamin, 0.5 mg of methylcobalamin, 0.5 mg of adenosylcobalamin, 15 mg of coenzyme Q10, and 1 mg of riboflavin. Formula 13 was a dissolving medication with 5.6 mg of cyanocobalamin, 0.5 mg of methylcobalamin, 0.5 mg of adenosylcobalamin, 5 mg magnesium, 10 mg of coenzyme Q10, and 2.1 mg of riboflavin. Formula 14 was a dissolving medication with 5.6 mg of cyanocobalamin, 0.5 mg of methylcobalamin, 0.5 mg of adenosylcobalamin, 10 mg of coenzyme Q10, and 1 mg of riboflavin. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Headaches, such as tension headache and sinus headache, are painful and can rob individuals of quality of life. Headache symptoms include a pounding headache, nausea, vomiting, and light sensitivity. Body soreness is a pain in the body. Conventional headache and body pain remedies include various types of pain relievers, pain killers, and analgesics, including COX-1, COX-2, opioids, and NSAIDs; none are without side-effects, including drug addiction, liver damage and cardiovascular events; and none get to the truly underlying causes of pain and neurological health, as does the current invention. The International Classification of Headache Disorders (ICHD) is a classification of headaches published by the International Headache Society. The current patent applies to primary headaches which the ICHD-2 classification defines as migraines, tension-type headaches, cluster headache and other trigeminal autonomic cephalalgias stabbing headaches, headaches due to cough, exertion and sexual activity (coital cephalalgia), continuous headache on one side of the head (hemicrania continua), paroxysmal hemicrania, daily-persistent headaches along with the hypnic headache and thunderclap headaches. Vitamin B12 or simply B12 are unspecific terms often used casually for a variety of cobalamins, including cyanocobalamin, methylcobalamin, and adenosylcobalamin. All other headache remedies with adequate research proving their efficacy have safety profiles that contrast sharply with cyanocobalamin, methylcobalamin, and adenosylcobalamin which are considered by the nutritionists and the FDA to have excellent safety profiles, they are so safe and vital to health, that—like exceedingly few other products—they are recommended to women who are pregnant and lactating! The metal cobalt plays a central role in these molecules with its unique electrochemical bounding abilities. These molecules are the only molecules in the human body to utilize these special properties of cobalt, are difficult to absorb from food, and cannot be manufactured by the body. Cyanocobalamin (also known as CNCbI, or 5,6-dimethylbenzimidazolyl cyanocobamide) has the molecular formula C63H88CoN14O14P. Cyanocobalamin is a manufactured commercial form of a cobalamin, and not native to the human body. Once inside the body cyanocobalamin is converted to methylcobalamin and adenosylcobalamin, but not to hydroxocobalamin. Methylcobalamin (also known as mecobalamin, or MeCbl) has the molecular formula C63H91CoN13O14P and is notable as a rare example of an enzyme that contains metal-alkyl bonds. Methylation is the donation of a methyl group to a substrate, and methylcobalamin can function as the donor molecule. Proper DNA replication and cell division require methylation. For this reason, and others, the current invention includes cyanocobalamin and methylcobalamin. Adenosylcobalamin (also known as cobamamide, AdCbl, or dibencozide) comprises more than 70 percent of the cobalamins in the brain. Adenosylcobalamin functions in reactions in which hydrogen groups and organic groups exchange places. Adenosylcobalamin is the major form in cellular tissues, especially energy-hungry muscles, where it is retained in the mitochondria. Adenosylcobalamin is the coenzyme for the mitochondrial enzyme methylmalonyl CoA mutase. Problems with methylmalonyl CoA mutase can lead to methylmalonic aciduria and dysfunction of the mitochondria. In one preferred embodiment of the current invention, adenosylcobalamin is included to prevent dysfunction of the mitochondria in the brain. The mitochondrion (plural mitochondria) is the “cell&#39;s powerhouse”. Most of the organism&#39;s stored energy is converted into a usable chemical energy known as adenosine triphosphate (ATP) in the mitochondria. The citric acid cycle or Krebs cycle generates GTP which becomes ATP. Problems with the mitochondria can cause them to die. Problems with the mitochondria, which are also involved in cell signaling, cell death, and cell differentiation, can disrupt the functioning of the cell, tissue and organ in which they survive. It is an organelle with its own strand of DNA, distinct from DNA in the nucleus. Mitochondria are found inside most animal cells. Populations of mitochondria per cell range from one to thousands. Mitochondria living in our cells may be hitch-hiking, symbiotic descendants of bacteria that provided some benefits to us, indeed mitochondrial DNA resembles bacterial DNA. We certainly provided a safe living cell as home with all the warmth and nutrients to these bacteria. When one realizes that the basic chemical structure of cobalamins can only be synthesized by bacteria, it is not hard to see a critical connection and history between mitochondria and cobalamins. Consistent with the idea that certain types of headache are a result of insufficient energy production by the mitochondria are reports of headache remedies that lessen the brain&#39;s demand for energy including relaxation techniques, meditation, and calming affirmations while hypnotized. Also consistent are reports that providing more oxygen to an individual can ameliorate headaches, such treatments include repeated deep breathing and hyperbaric oxygen. Other consistent findings are that regular exercise can both prevent headaches and that exercise can increase the number of mitochondria in the brain. Conversely, strenuous physical activity by people who are not accustomed to it can reduce oxygen concentrations in the brain and have been reported to trigger a benign exertion headache. Likewise carbon monoxide (which binds up hemoglobin) and tobacco smoke can reduce oxygen and are associated with headache. Brain scans called fMRI detect where there is increased blood flow in the brain, which is a surrogate indicator for where there is increased brain activity. Such fMRI scans show that three of the highest energy demanding functional areas of our brains are those areas which process vision, smell and hearing. Accordingly the mitochondrial dysfunction theory of headache is consistent with the hypersensitivity of headache sufferers to bright lights, bad smells, and loud noises. Indeed, visual disturbances known as aura can occur an hour or so prior to the onset of a headache. The brain&#39;s electrical activity correlates to changes in cerebral blood flow and cerebral metabolic rate of oxygen. Rises in cerebral metabolic rate of oxygen are controlled by the ATP turnover, which depends on the energy used for the Na, K-ATPase to re-establish ionic gradients, while cerebral blood flow responses are controlled by mechanisms that depend on Ca(2+) rises in neurons. (Lauritzen M, Neuroimage, 2012 Aug. 15; 62(62(2):1040-50.) Caffeine acts as a stimulant because it constricts the brain&#39;s blood vessels and many analgesics contain caffeine to fight headaches, especially vascular headaches including migraines. Other products, such as adenosine, have the opposite effect because they dilate blood vessels in the brain and the increased blood flow can lead to a headache. Vasodilation may be part of a headache, yet it is not required for migraine symptoms to manifest. Vasodilation and the brief vasoconstriction that generally precedes it are not the root causes of vascular headaches, as once believed. The current invention teaches away from the prior art in its findings. The seemingly contradictory idea that headaches are caused by insufficient metabolism of oxygen in the mitochondria, and that increasing blood flow is also a cause of headaches can be reconciled as follows: Blood vessels over essentially all of the brain are normally constricted in a resting, non-headache state, and it is only at the local functional area(s) in the brain where current neurological processing is taking place that momentary vasodilation of the blood vessels (i.e. increases in local cerebral blood flow) occur. (This increased local blood flow can be seen in fMRI images that detect the iron in hemoglobin being fed to the high activity locations.) This local spike in cerebral blood flow delivers a quick, just-in-time oxygen supply to permit a local increase in the cerebral metabolic rate of oxygen. Ameliorating headaches by restricting blood flow all over the brain (increasing mean arterial pressure) is analogous to keeping all the fire hydrants in a city sealed shut except that one hydrant in front of a burning building where opening just that one hydrant provides sufficient pressure to blast the water out. Hours or days prior to the onset (aura) of a migraine attack, a headache sufferer often experiences a set of symptoms known as prodrome consistent with the current invention&#39;s teachings of mitochondrial dysfunction or underperformance in the brain and muscles. Prodrome&#39;s symptoms include mood changes, muscle stiffness, yawning (which is a call for more oxygen), fatigue and food (nutrition) cravings. The current inventor contends that the root cause of many headaches and body pains is inadequate energy (ATP) production in the mitochondria needed to fuel the energy-hungry brain and muscle cells (and not the inflammatory response as per conventional wisdom), and that surprisingly the current invention can provide the micronutrients needed as raw materials to permit the optional functioning of mitochondria. A non-obvious mechanism of action disclosed in the current invention is that increased mitochondrial concentrations of adenosylcobalamin (and also coenzyme Q10, magnesium, L-carnitine, and riboflavin) prevent or lessen the severity of a cellular energy crisis in which mitochondrial function declines. Such a decline can be due to alternating inner membrane potential, imbalanced trans-membrane ion-transport, and an overproduction of free radicals. (Zhuo M L, Huang Y, Liu D P, Liang C C (April 2005). “KATP channel: relation with cell metabolism and role in the cardiovascular system”. Int. J. Biochem. Cell Biol. 37 (4): 751-64.) In such a situation, mitochondrial K(ATP) channels open and close to regulate both internal Ca2+ concentration and the degree of membrane swelling. This helps restore proper membrane potential, allowing further H+ outflow, which continues to provide the proton gradient necessary for mitochondrial ATP synthesis. Without aid from the potassium channels, the depletion of high energy phosphate would outpace the rate at which ATP could be created against an unfavorable electrochemical gradient. (Xu M, Wang Y, Ayub A, Ashraf M (September 2001). “Mitochondrial K(ATP) channel activation reduces anoxic injury by restoring mitochondrial membrane potential”. Am. J. Physiol. Heart Circ. Physiol. 281 (3): H1295-303.) An ATP-sensitive potassium channel is a type of potassium channel that is gated by ATP. Simply stated, levels of ATP influence constriction and dilation of blood vessels which have receptors for ATP known as P2x-R. Many vascular headaches, including migraine, begin with a brief vasoconstriction immediately followed by vasodilation, resulting in a throbbing headache. The current invention therefore surprisingly prevents headaches by providing the micronutrients needed for the mitochondria to function properly. Any shortage or deficiency of adenosylcobalamin and/or the other micronutrients disclosed in the current invention will impair or inhibit mitochondrial functioning. Additionally, increasing amounts of adenosylcobalamin and/or the other micronutrients disclosed herein will accelerate the chemical reactions in the mitochondria, thereby permitting the mitochondria to metabolize more chemical energy over a given period of time. One example of the utility of the current invention is its amelioration of mitochondrial dysfunction in the hypothalamus, a hormone secreting region of the brain which is associated with cluster headaches. One especially preferred embodiment of the current invention is a once-daily dissolving that is placed on the tongue and swallowed, and contains combinations of cyanocobalamin, methylcobalamin, and adenosylcobalamin in amounts that are effective in defending the individual against headache and body pain; and the current invention also includes one or more of the following substances or metabolites and salts thereof: magnesium, coenzyme Q10, L-carnitine, and riboflavin. Magnesium ions are important to the production of nucleic acid, DNA, and RNA, and the catalytic action of many enzymes. Of special relevance to the current invention are the magnesium-dependant enzymes associated with the conversion of adenosine triphosphate (ATP) into adenosine diphosphate (ADP) in the mitochondria. Phosporylation is an important process that occurs in the mitochondria. For this reason, one particularly preferred embodiment of the current invention includes elemental magnesium, magnesium oxide, magnesium gluconate, magnesium citrate, magnesium oxide, magnesium orotate, magnesium malate, and combinations thereof in the formulation in amounts ranging from about 10 mg to about 500 mg per portion. Proper functioning of the mitochondria requires coenzyme Q10 (CoQ10), also known as ubiquinone or 1-4-benzoquinone. In one preferred embodiment, coenzyme Q10 is included in the formulation in amounts ranging from about 10 mg to about 500 mg per portion. Riboflavin (vitamin B2) has an important function in energy metabolism. Flavin mononucleotide (FMN) and flavin adenine dinucleotide (FAD) function as coenzymes for a wide variety of oxidative enzymes and remain bound to the enzymes during the oxidation-reduction reactions. Reduction of isoalloxazine ring (FAD, FMN oxidized form) yields the reduced forms of the flavoproteins (FMNH2 and FADH2). For this reason, one particularly preferred embodiment of the current invention includes riboflavin in the formulation in amounts ranging from about 0.1 mg to about 300 mg per portion. Levocarnitine (or L-carnitine) plays an important role in energy metabolism by helping the transport of fatty acids from the cytosol into the mitochondria. Also, it helps remove toxic chemical byproducts from the mitochondria so they do not accumulate. In one preferred embodiment of the current invention, L-carnitine, acetyl-L-carnitine (L-acetylcarnitine), L-propionyl carnitine, or L-carnitine fumarate, and combinations thereof is included in doses between 1 mg and 400 mg per portion. One especially preferred embodiment of the current invention is a once-daily dissolving medication that is placed on the tongue and swallowed, and contains combinations of cyanocobalamin, methylcobalamin, adenosylcobalamin, magnesium, coenzyme Q10, and riboflavin in amounts that are effective in defending the individual against headache and body pain. One particularly preferred embodiment of the current invention is a once- or twice-daily dissolving that is placed on the tongue and swallowed. Each dosage&#39;s approximate contains are: 1.1 mg of cyanocobalamin, 1.1 mg of methylcobalamin, 1.1 mg of adenosylcobalamin, 5 mg of coenzyme Q10, and 1.2 mg of riboflavin. In one preferred embodiment, the current invention includes one or more of the following plants or extracts thereof: feverfew ( Tanacetum parthenium, Chrysanthemum parthenium, Pyrethrum parthenium ), kudzu ( Pueraria lobata ), capsicum ( solanaceae ), butterbur ( Petasites hybridus ), ginger ( zingiber officinale ) and ginko ( ginko biloba ). In the current invention, formulation of dissolving medication can employ hydrophilic polymers that rapidly dissolve in the mouth, preferably on top of the tongue. The cyanocobalamin, methylcobalamin, and adenosylcobalamin permeate the skin of the mouth and, in a certain percentage, are ingested for absorption by the gut, especially the ileum. In one preferred embodiment of the current invention, formulation of dissolving medication involves the application of both aesthetic and performance characteristics such as polymers, plasticizers, active pharmaceutical ingredients, sweetening agents, saliva stimulating agents, flavoring agents, coloring agents, stabilizing and thickening agents. In the current invention, formulation of dissolving medication can employ polymers such as maltodextrin, microcrystalline cellulose and piroxicam made with a hot extrusion technique. To make the medication more flexible; plasticizer excipients such as propylene glycol, glycerol, dimethyl phthalate, diethyl phthalate, dibutyl phthalate, triacrtin, castor oil, triethyl citrate, tributyl citrate, acetyl citrate in the current invention. In one preferred embodiment of the current invention Stevia (steviol glycoside) is used to sweeten the medications. In one particularly preferred embodiment, the headache medication is delivered to the headache sufferer in a dissolving medication placed in the mouth. The dissolving medication is a thin film delivery technology, and is also referred to as a dissolving film or an oral strip. The current invention defines a dissolving strip as a thin film delivery means to administer active agent(s) via absorption in the mouth. This absorption can be in the mouth as a whole (buccally) on top of the tongue (supralingually), or under the tongue (sublingually) followed up by swallowing. The skin, including the surface of the tongue, provides a physical barrier that can interfere with the absorption of active drug ingredients. Although cyanocobalamin, methylcobalamin, and adenosylcobalamin are known to permeate the skin in the mouth, a penetration enhancer can increase their transdermal delivery in one preferred embodiment. Penetration enhancers that can increase transdermal delivery and can be used preferably in various embodiments of the current invention include but are not limited to: dimethyl isosorbide, alpha bisobola, sulphoxides (e.g. dimethylsulphoxide), azones (e.g. laurocapram), pyrrolidones (e.g. 2-pyrrolidone), alcohols and alkanols (e.g. ethanol and decanol), glycols (e.g. propylene glycol), surfactants, terpenes, fatty acids, fatty acid esters, fatty alcohols, fatty alcohol esters, biologics, enzymes, amines, amides, complexing agents, macrocyclics, classical surfactants and the like. Gels and creams with a Lamellar or liquid crystal structure also enhance penetration of active ingredients. When considering the various embodiments of the invention described herein, those knowledgeable in the art will appreciate that these are illustrative only. Such embodiments do not limit the scope of the invention. Those knowledgeable in the art involved will appreciate that many variations, substitutions, equivalents, and like modifications may be made within the scope of the present invention. SUMMARY OF THE INVENTION Consistent with original study findings on almost 2,000 people, most of whom were in a Phase III placebo-controlled clinical study, the present invention is directed to safe and effective cyanocobalamin, methylcobalamin, and/or adenosylcobalamin containing, orally-dissolving medications to reduce the frequency and severity of pains in the head and body in humans and for enhancing the normal functioning of the human body by boosting the human defense against headaches and body pains. A non-obvious mechanism of action disclosed in the current invention is that higher concentrations of adenosylcobalamin (and other disclosed compounds) in the mitochondria prevent or lessen the severity of a cellular energy crisis in which mitochondrial function declines. Mitochondria convert sugars into chemical energy the cell can use called ATP. Levels of ATP also function to constrict and dilate blood vessels. Many vascular headaches, including migraine, begin with a brief narrowing of the blood vessels (vasoconstriction) followed by an opening up blood vessels resulting in a throbbing headache. The current invention therefore surprisingly prevents headaches by providing the micronutrients needed for the mitochondria to function properly.

The current invention discloses novel approaches to help individuals defend against headaches and body pains with orally-delivered cyanocobalamin, methylcobalamin, adenosylcobalamin, and combinations thereof. Original clinical research conducted by the inventor on almost 2,000 humans yielded surprising and unexpected results showing differences in the frequency and severity of pains in the head and the body favoring cyanocobalamin patients over placebo. In one FDA-approved Phase III study on 1,551 patients, 4.4 percent of headaches and body pains were rated as "Severe" in the cyanocobalamin, group versus 11.5 percent in the placebo group. Once inside the body, cyanocobalamin is converted to methylcobalamin and adenosylcobalamin, but not to hydroxocobalamin. The current invention provides the patient's mitochondria with sufficient concentrations of essential micronutrients to survive, increase in number and manufacture the chemical energy (ATP) that is required to prevent the brief vasoconstriction followed by vasodilation associated with headache and body pain.

RELATED APPLICATIONS This application is a Continuation of International Application No. PCT/IL2007/001317, filed on Oct. 30, 2007, which in turn claims the benefit under 35 USC 119(e) of U.S. Provisional Application No. 60/855,143, filed on Oct. 30, 2006, both of which are incorporated herein by reference in their entirety. FIELD OF THE INVENTION The present invention relates to a system and method for in vivo measurement of biological parameters of a subject. BACKGROUND OF THE INVENTION Near infrared spectroscopy (NIRS) is a well-established non-invasive technique which allows for the determination of tissue and blood analytes conditions based on spectrophotometric measurements in the visible and near-infrared regions of the spectrum of light. According to this technique, incident light penetrates the examined skin, and reflected and/or transmitted light is/are measured. In order to quantify any blood analyte, light of at least two different wavelengths is required. Optical plethysmography, pulse oximetry, and occlusion spectroscopy are the most prominent examples of usage of the NIR spectroscopy in medicine and physiological studies. Visible or near infrared light is commonly used to track the optical manifestation of some time-dependent physiological processes. Such prolonged measurement of light response as a function of time can provide clinician with valuable information about time-dependent physiological processes. For example, the measured light response of a natural heart beat pulsation is varied with each pulse. The signal is then measured at one point of the pulse wave and compared with the signal at another point. The difference between the values is due to arterial blood alone. In the pulse-oximetry, this phenomenon is utilized for the determination of oxy-hemoglobin saturation. In the case of occlusion spectroscopy, the optical time-dependent signal is originated by light scattering changes associated with the red blood cells (RBC) aggregation process. In this case, the optical signal changes are utilized for the hemoglobin or glucose measurement. Yet another known method enables to generate the required changes is the application of a periodic or non-periodic local pressure variation, resulting in blood volume fluctuations. These fluctuations are used to measure different blood parameters, like hemoglobin or glucose. The major underlying assumption in the processing of all kind of the time-dependent signals is that the measured optical variation is originated solely by blood related components. In pulse oximetry, for example, it&#39;s commonly accepted that arterial blood volume changes are the only responsible factor staying behind the optical signal modulation. However, a more complex physical analysis shows that even if the only changes in the system are ascribed to the blood, the measured optical response of these changes is a convolution of absorption and scattering properties of blood and surrounding media. While carrying out any algorithmic modeling and signal processing procedure of these measured optical signals, the tissue related effects can not be disregarded. Therefore, the common denominator of all time-dependent signal related optical methods relies on the measurement of optical responses originated by the blood dynamics or hemorheological status changes. It should be noted that the accuracy of time-dependent methods depends on the ability to identify the hemorheological component of the blood. For example, in the particular case of pulse-oximetry, the heart beats modulate the hemorheological status of circulating blood, resulting in the fluctuation of RBC velocity, which is associated with the shear forces changes. The variation of the hemorheological blood parameters enables to optically distinguish the pulse-related changes of the signal. Therefore, the decreased accuracy in the determination of hemorheological properties leads to a lower accuracy in the determination of the sought blood parameter. Among the blood parameters which can be derived from the hemorheological changes are hemoglobin oxygen saturation, carohyhemoglobin (percentage of HbCO out of total hemoglobin), hemoglobin blood concentration and/or glucose. Moreover, the arterial blood pressure is another physiological parameter, which is commonly derived from the hemorheological related variations. The systolic blood pressure can be determined with assistance of inflating cuff which induces hemorheological variations artificially. When a pressure beyond the systolic pressure is applied, no pulsatile waveform appears at the down-flow. The diastolic point of the pressure is frequently measured by using Korotkoff&#39;s sounds. The source of these sounds is associated with abrupt changes in hemorheological properties of blood, occurring due to deflation of cuff from the systolic point. These hemorheological changes, in the vicinity of the diastolic point, result in a very typical pattern of sound, which can be detected by a stethoscope or by other acoustic device. However, the sound related method is very sensitive to different motion artifacts and therefore in automatic blood pressure devices, commonly used for the self-monitoring, the accuracy of blood pressure reading is impaired. SUMMARY OF THE INVENTION There is a need in the art in facilitating in vivo measurements of rheological parameters of a subject, by providing a novel measurement technique. This is associated with the two major problems related to time-dependent optical methods for the measurement of hemorheological processes. Firstly, the method of detecting hemorheological changes optically has a quite restricted sensitivity. Since the currently used method of optical measurement detects only scattering or absorption related changes of the signal, when the aggregation factor not vary, the scattering and absorption remain unchanged and hemorheological fluctuations remain unmeasured. For example, the measured optical signal has few ranges of low sensitivity with respect to the blood velocity changes. The limitation comes into force where the blood flow value is very high and, consequently, RBC aggregation process is prevented by very strong shear forces. Moreover, when the blood flow is very weak and the RBCs have already aggregated, the blood flow changes can not affect the aggregation status. Secondly, in the currently used technique, there is a problem in the reduction of motion artifacts. Most of the motion artifacts interfering with time-dependent measurements are removed based on fact that the characteristic time constants are different from slow, motion related interferences. When the motion artifacts characteristic appearance is in the close vicinity to the signal appearance (for example, 1 Hz of the heart beat interference with 1.1 Hz of the bounce of the running person), the hemorheological signal is almost undistinguishable from the artifact. The novel technique of the present invention enables to differentiate clearly between the blood-originated and tissue-related signals, reduce the problem of motion artifacts, determine at least one desired parameter or condition of a subject such as hemorheological (blood rheology) related parameters, for example apparent blood and blood plasma viscosity, red blood cells (RBC) aggregation, blood flow or blood coagulation properties, and based on these rheological parameters to determine chemical parameters of blood, such as oxygen saturation, hemoglobin, or glucose concentrations and physiological system parameters, like blood pressure and blood flow. Moreover, there is a need in performing an accurate blood pressure measurement by measuring hemorheological properties changes optically, using more robust and noise resistant method. As indicated above, the conventional techniques remove most of the motion artifacts interfering with pulse measurements, using characteristic time constants of heart beats which are different from slow motion related interferences. However, other types of motion artifacts interfering with pulse measurements, such as patient shivering, can not be removed by such techniques. This type of artifact is indistinguishable from the signal generated by pulse, due to the analogous characteristic time constants shared between pulse frequency and the frequency of the body shivering. Another example of indistinguishable motion artifact is associated with walking or running activities, where the characteristic frequencies of the motion pattern may overlap the heart rate frequency ranges. The last fact is considered as a great obstacle in utilization of the photoplethysmography or like for the heart rate measurements during the sport or walking activities. The present invention solves the above problems by providing a novel optical technique suitable for the in vivo measurement in a subject utilizing dynamic light scattering (DLS) approach. More specifically, the present invention utilizes the effect of DLS for the measurement of variety of blood related parameters, like viscosity of the blood and blood plasma, blood flow, arterial blood pressure and other blood chemistry and rheology related parameters such as concentration of analyte (e.g. glucose, hemoglobin, etc.), oxygen saturation etc. DLS is a well-established technique to provide data on the size and shape of particles from temporal speckle analysis. When a coherent light beam (laser beam, for example) is incident on a scattering (rough) surface, a time-dependent fluctuation in the scattering property of the surface and thus in the scattering intensity (transmission and/or reflection) from the surface is observed. These fluctuations are due to the fact that the particles are undergoing Brownian or regular flow motion and so the distance between the particles is constantly changing with time. This scattered light then undergoes either constructive or destructive interference by the surrounding particles and within this intensity fluctuation information is contained about the time scale of movement of the particles. The scattered light is in the form of speckles pattern, being detected in the far diffraction zone. The laser speckle is an interference pattern produced by the light reflected or scattered from different parts of an illuminated surface. When an area is illuminated by laser light and is imaged onto a camera, a granular or speckle pattern is produced. If the scattered particles are moving, a time-varying speckle pattern is generated at each pixel in the image. The intensity variations of this pattern contain information about the scattered particles. The detected signal is amplified and digitized for further analysis by using the autocorrelation function (ACF) technique. The technique is applicable either by heterodyne or by a homodyne DLS setup. According to one broad aspect of the invention, it provides a system for use in non-invasive determination of at least one desired parameter or condition of a subject having a scattering medium in a target region. The system comprises an illuminating system including at least one source of partially or entirely coherent light to be applied to the target region in said subject to cause a light response signal from the illuminated region; a detection system including at least one light detection unit configured for detecting time-dependent fluctuations of the intensity of the light response and generating data indicative of the a dynamic light scattering (DLS) measurement; and, a control system configured and operable to receive analyze the data indicative of the DLS measurement to determine the at least one desired parameter or condition, and generate output data indicative thereof. The data generated by the detection system is indicative of fluctuation dependent speckle pattern of the light response over a predetermined frequency interval. In some embodiments, the control system is configured and operable for analyzing the received data by using temporal autocorrelation intensity analyzing or power spectrum analyzing. The control system may be configured and operable analyze the received data, to reject low frequency component of the received data, and process high frequency components of the received data, thereby enabling elimination of motion artifacts. The control system comprises: a data acquisition utility responsive to the generated data coming from the detection system; a modulating utility associated with the illuminating system; a data processing and analyzing utility for analyzing data from the data acquisition utility and determine at least one hemorheological and blood chemical parameter; a memory utility for storing coefficients required to perform predetermined calculation by the data processing and analyzing utility, and an external information exchange utility configured to enable downloading of the processed information to an external user or to display it. According to some embodiments of the invention, the system comprises a controllably operated pressurizing assembly configured and operable to affect a change in a blow flow, the control system comprising a control utility associated with the pressurizing assembly. The system may comprise fiber optics for collecting the light response signal and delivering it to the detection system. According to some embodiments of the invention, the system having at least two light sources operable at different wavelength ranges. The illuminating system is adapted to produce light of red and near infrared spectral regions, enabling assessment of the arterial blood oxygen saturation and/or in blood hemoglobin determination. The system may be configured and operable to create an intermittent blood stasis state by applying over systolic blood pressure to the subject, thereby enabling the determination of red blood cell (RBC) aggregation. In some embodiments, at least one light source of the illumination system is coupled with a polarization unit enabling to create polarized electromagnetic signal in one preferable direction. An entrance of at least one of detection units of the detection system is also coupled with a polarization unit, such that the polarization unit enables only certain direction of pre-selected polarized radiation to be detected increasing the signal to noise ratio. According to another broad aspect of the invention, the present invention provides medical tool for carrying out non-invasive measurement and/or treatment on a patient&#39;s body. The medical tool comprises an illuminating system generating partially or entirely coherent light to be focused on a target region in the body, and a detection system configured for detecting time-dependent fluctuations of the intensity of the light response and generating data indicative of a dynamic light scattering (DLS) measurement. According to yet another aspect of the invention, the present invention provides an optical method for use in determining in vivo hemorheological chemical and physiological parameters of a subject. The method comprises generating a partially or entirely coherent light; applying the light to a target region in the subject; detecting fluctuation dependent speckle pattern of the light response over a predetermined frequency interval and generating data indicative thereof, processing the detected data by using the temporal autocorrelation intensity analyzing or the power spectrum analyzing; and, determining at least one desired parameter or condition of the subject from the time-fluctuation of a dynamic light scattering (DLS) signal. In some embodiments, the method comprises rejecting low frequency component of the detected DLS signal by using high-pass filters; and processing high frequency components to eliminate motion artifacts. The chemical parameter comprises at least one of the following: a blood viscosity, an average size of RBC aggregates, and blood coagulation properties. In some other embodiments, the method comprises creating temporal blood flow cessation at the measurement region to measure a post-occlusion signal. The method comprises analyzing the measured post-occlusion signal to determine blood plasma viscosity and a rate of RBC aggregation. In some other embodiments, the method comprises illuminating the target region with light of red and near infrared spectra, thereby enabling for measuring simultaneously the DLS signal at two or more wavelengths to determine at least one of the following: arterial blood oxygen saturation, blood hemoglobin concentration, and glucose concentration. According to yet another aspect of the invention, the present invention provides an optical method for determining in vivo arterial blood pressure of a subject. The method comprises applying partially or entirely coherent light to a target region in the subject to cause a light response signal from the target region; applying a controllable pressure to the subject so as to induce hemorheological variations artificially; detecting fluctuation dependent speckle pattern of the light response signal over a predetermined frequency interval and generating data indicative thereof, processing the detected data by using temporal autocorrelation intensity analyzing or power spectrum analyzing; and, determining systolic and diastolic arterial blood pressure values from the time-fluctuation of the DLS signal. According to yet another aspect of the invention, the present invention provides an optical method for determining in vivo heart pulse rate of a subject. The method comprises applying a partially or entirely coherent light to a target region in the subject to cause a light response signal from the target region; detecting fluctuation dependent speckle pattern of the light response over a predetermined frequency interval, and generating data indicative thereof; processing the detected data by using temporal autocorrelation intensity analyzing or power spectrum analyzing; and, determining the heart rate pulsation from the heart beat time fluctuation of the DLS related parameter. The above and other features of the invention including various novel details of construction and combinations of parts, and other advantages, will now be more particularly described with reference to the accompanying drawings and pointed out in the claims. It will be understood that the particular method and device embodying the invention are shown by way of illustration and not as a limitation of the invention. The principles and features of this invention may be employed in various and numerous embodiments without departing from the scope of the invention. BRIEF DESCRIPTION OF THE DRAWINGS In the accompanying drawings, reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale; emphasis has instead been placed upon illustrating the principles of the invention. Of the drawings: FIG. 1 is an illustration of a DLS measurement based system according to the teachings of the present invention; FIG. 2 is a schematic illustration of a simultaneous measurement of the transmission signal using photodetector D 2 and of the reflection signal using photodetector D 1 ; FIG. 3 is a schematic illustration of the use of an optical fiber-based system; FIG. 4 is a graphical illustration of a raw data of pulse being collected and measured from the finger tip by the DLS system; FIG. 5 is a graphical illustration of a change of a normalized function at measurement onset (0.5 sec) and after 20 sec of over systolic occlusion as measured on the finger tip by the DLS; FIG. 6 is a logarithmic scale graphical presentation of the same; FIG. 7 is a graphical presentation of the power spectrum used to process the measured signal by using a standard Fast Fourier Transformation (FFT) digital signal processing algorithm; FIG. 8 is a graphical presentation of the time variation of the full integral of the power spectrum during an 80 sec duration measurement section, which is presented in terms of the energy power spectrum; FIG. 9 is a graphical presentation of the time variation of the full integral of the power spectrum during the first 10 seconds of the pulsatile signal; FIG. 10 is a graphical presentation of the power spectrum integral upon the frequency interval [0-550 Hz]; FIG. 11 a - b are graphical presentations of the power spectrum integral upon the frequency interval [2700-10000 Hz]; FIG. 12 is a graphical presentation of the power spectrum integral upon the frequency interval [1-1.6 KHz]; FIG. 13 a is a graphical presentation of the power spectrum integral in the post-occlusion pulsatile sessions (80-86 sec) upon the frequency interval [0-2150 Hz]; FIG. 13 b is a graphical presentation of the power spectrum integral in the post-occlusion pulsatile sessions (80-86 sec) upon the frequency interval [2700-10000 Hz]; FIG. 14 is a graphical presentation of the pulsatile and post occlusion signals presented in terms of A(tn) and B(tn) of polynomial coefficients; FIG. 15 is a graphical presentation of a DLS related parameter (d(ln(G)/dt)) utilized for the determination of systolic and diastolic blood pressure; FIG. 16 is an imaging of a laser temporal speckle contrast K t inside occluded blood vessels; FIG. 17 is an imaging of a laser temporal speckle contrast K t inside occluded blood vessels and laser irradiation; FIG. 18 is a graphical presentation of a DLS measurement utilized for the determination of the oxygen saturation changes; and, FIG. 19 is a graphical presentation of the measured pulsatile component of the blood in terms of d(ln(AUT)/dτ. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Reference is made to FIG. 1 illustrating a DLS measurement based system 100 implementing the present invention. System 100 includes a light source unit 10 (e.g. laser) for generating at least partially coherent light; optical arrangement (not shown) including focusing optics and possibly also collecting optics; and a detection unit 16 . A focused beam of light 12 produced by laser 10 (e.g., a He—Ne laser) is used as a localized light source. In a non-limiting example, a light source unit 10 may be a laser diode (650 nm, 5 mW) or VCSEL (vertical cavity surface emitting laser). The light response i.e. the reflected and/or transmitted light returned from the localized region of the subject&#39;s surface 14 (patient&#39;s finger in the present example) illuminated with the localized light source 10 , can be collected in a determined distance L (in a non-limiting example, L=100 mm) either directly by a detector or via multimode fiber optics. In a non-limiting example, the multimode fiber optics may be a bifurcated randomized optical fiber where one optical entrance is connected to the detector and another one is optically coupled with the laser diode. In particular, as shown in FIG. 1 , system 100 includes at least one laser diode 10 and at least one photodetector (photodiodes) 16 appropriately positioned in the reflection-mode measurement set-up. As exemplified in FIG. 2 , the system may be operable to implement simultaneous measurement of the transmission signal using photodetector D 2 and reflection signal using photodetector D 1 . This can be used for a relatively transparent (for the respective wavelength range) subject (i.e. like through a subject&#39;s finger tip 14 ). It should be noted that generally, the system may be operable in either one of transmission and reflection modes or both of them. FIG. 3 exemplifies the use of an optical fiber-based system 200 having a somewhat different configuration. One of the advantages of optical fiber-based system 200 lies in the maximum flexibility of such system for non-invasive measurement of subjects. The use of randomized optical fiber secured geometric stability and the small effective distance between light source 10 and detector 16 is responsible for a high signal to noise ratio. It should be noted that the same fiber optic bundle 36 can be used for both the collection of the signal from the measured subject and the delivery of the coherent radiation towards the subject to be measured. Further provided is a control system having an electronic unit 32 and a data processor and analyzer (CPU) 34 . The electronic unit 32 is configured and operable to reject a low frequency component of the detected signal by using high-pass analog filters, and process only high frequency components to strongly amplify them, digitize them, and pass to the control unit (CPU) 34 for further digital processing. This approach enables the required sensitivity and dynamic range to be increased which is essential to account for only DLS related component of the measured signal. In a non-limiting example, the data is collected at 22 KHz sampling rate and 16-bit resolution. The kinetics of optical manifestations of two kinds of physiological signals is measured in vivo: the pulsatile signal associated with heart beats and the post-occlusion optical signal which is induced by an artificially generated blood flow cessation. The light transmission and/or reflection signals are used as a control of the physiological response. This kind of control measurement can be carried out simultaneously with the DLS reflection measurement. The mutual correspondence between DLS and standard optical signals is subject to a comparison analysis. The following is an example of analysis of pulsatile and post-occlusion signals. Reference is made to FIG. 4 showing an example of raw data of pulse (AC signal variation with time) which is collected and measured from a finger tip by DLS system 100 . The low frequency components of the signal are rejected by an analog filter of electronic box 32 . Subsequently, the signal is amplified and digitized for further analysis. Generally, two standard approaches are commonly applicable to an analysis of DLS signals. The first approach uses the temporal autocorrelation of the intensity, and the second approach entails the analysis of the power spectrum P(w) of the detected signal. According to the first approach, the formula for the correlation function G(τ) of temporal intensity fluctuations of light scattered by moving particles is given by: G ⁡ ( τ ) = 〈 I ⁡ ( t ) · I ⁡ ( t + τ ) 〉 〈 I ⁡ ( t ) 〉 2 [ 1 ] where I(t) is the intensity at time t and &lt; . . . &gt; denotes an ensemble average. It has to be taken into consideration that for preferable configuration of measurement system 100 , the intensity of the signal I(t) already lacks zero and low frequencies components of the signal (0-100 Hz), which are already removed by the high-pass analog filter of the electronic box 32 . When the measured signal is converted from an analog to digital form, the autocorrelation function is calculated by using a summation, averaging over N sampling points given by the following expression: 〈 G ⁡ ( τ ) 〉 = ( 1 / N ) ⁢ ∑ i = k k + N ⁢ I ⁡ ( k ) ⋆ I ⁡ ( k + i ) / ∑ I ⁡ ( k ) 2 [ 2 ] FIG. 5 shows a typical example of a normalized function G(τ) change as function of time and over systolic occlusion (20 sec occlusion vs 0.5 sec onset) as measured on the finger tip by DLS system 100 . For the purpose of the present application, the term “over systolic occlusion” refers to an application of over systolic pressure to create a temporary blood flow cessation state at the measurement location. The first measurement onset (T=0.5 sec) displays a more fast decrease of G(t) in initial measurement stage (0-0.001 sec) comparatively to second measurement (T=20 sec) occlusion data. More moderate time-dependent decrease of G(t) is noticed for both experiments in more advanced stage (&gt;0.001 sec) The logarithmic scale presentation of the same represented in FIG. 6 reveals a quasi-exponential nature of function G(τ). According to the second approach, the power spectrum presentation is used to process the detected signal. The power spectrum of the measured signal can be constructed by using a standard Fast Fourier Transformation (FFT) digital signal processing algorithm. FIG. 7 shows an example of the FFT of such a signal. The highest spectral frequency in the FFT presentation is defined by the number of the sampling points and the overall measurement time interval. The total energy of a power spectrum PwS[f1,f2] is bounded in the frequencies interval (f1, f2) and can be evaluated by a simple summation. This value can be used as a measure of changes which occurs during any physiological processes during the blood flow or during the blood flow cessation. FIG. 8 shows the time variation of the full integral of the power spectrum (i.e. energy power spectrum) during an 80 sec duration measurement section of the pulsatile signal. Each point of the power spectrum PwS[f1,f2] is calculated for a pre-set time interval. In this particular example, the interval is 0.0454 sec. The calculated value is normalized: PwS ⁡ [ f ⁢ ⁢ 1 , f ⁢ ⁢ 2 ] = ∑ f ⁢ ⁢ 1 f ⁢ ⁢ 2 ⁢ PwS ⁡ ( f ) / ∑ 0 f ⁢ ⁢ max ⁢ PwS ⁡ ( f ) [ 3 ] FIG. 9 shows the time variation of the full integral of the power spectrum during the first 10 seconds of the pulsatile signal. The characteristic behavior of the power spectrum PwS depends upon the frequency interval f1,f2. For example, referring to FIGS. 10 and 11 a - b , the function defined by PwS [0,550 Hz] (t) for the frequency window [0,550 Hz], behaves differently as compared to PwS [2700, 10000 Hz] ( FIG. 11 a - b ). Strong dependence of PwS function upon the chosen frequencies parameters is confirmed for the pulsatile phase, as illustrated in FIG. 11 a and FIG. 11 b . At a predetermined a frequency interval, PwS behaves as a very weak function of ongoing physiological scattering changes, as illustrated in FIG. 12 . In this particular example, this interval is identified as being located at approximately the frequency interval [1-1.6 kHz]. This interval is defined as the critical frequency point (CFP), which can be related to the parameters of the autocorrelation function. According to the statements of the Wiener-Khinchin theorem, PwS density of a wide-sense-stationary random process is the Fourier Transform of the corresponding autocorrelation function. Since the autocorrelation function is an even function, the classic Fourier integral is reduced to: P ⁡ ( ω , t ) ≈ ∫ 0 ∞ ⁢ 〈 I 〉 2 2 ⋆ π ⁢ cos ⁡ ( ω ⋆ τ ) ⋆ [ g 2 ⁡ ( τ , t ) - 1 ] ⋆ ⁢ ⅆ τ [ 4 ] For a very simple case, the normalized intensity correlation function can be approximated to: g 2 (τ)≈exp(−α*τ), where α is a factor proportional to the diffusion parameter D. After the integration of the expression, [4] reduces to: P ≈ α α 2 + ω 2 [ 5 ] In order to find the minimum point of P, the differentiation of g with respect to α is taken: d ⁡ ( P ) = ( - 2 ⁢ ⁢ α 2 ( α 2 + ω 2 ) 2 + 1 α 2 + ω 2 ) ⋆ d ⁢ ⁢ α [ 6 ] Therefore, for P ( t )=0,ω=α  [7] According to this expression, CFP can be used to evaluate the diffusion parameter D. The post-occlusion pulsatile sessions (80-86 sec) are represented for the frequency window [0, 2150 Hz] in FIG. 13 a , and for the frequency window [2700, 10000 Hz] in FIG. 13 b. Thus, the invented technique provides for using DLS for measurement of various parameters of a subject, particularly blood analytes. In this connection, it should be noted that the multiple scattering predominates the light propagation through the blood and tissue. This is why the transport approximation is considered to be a more appropriate approach for the invented technique. In the case of DLS, the measured parameter is autocorrelation function g 1 . For an infinite medium with a point source, this parameter can be approximated by: g 1 (τ)=exp(−√{square root over ( k 0 2 *&lt;Δr 2 (τ)&gt;+3μ α l )}*( r sd /l )  [8] where &lt;r 2 (τ)&gt;=6Dτ is the mean squared displacement of the scattered particles, l is mean free path of light and D is the diffusion coefficient given by Stoke-Einstein relation. D = kT 3 ⋆ πη ⁢ ⁢ d [ 9 ] Substitution of K and D into [8] gives: g 1 ⁡ ( τ , λ ) = exp ( - ( 2 ⁢ ⁢ π ⁢ ⁢ n / λ ) 2 ⋆ kT 3 ⋆ πη ⁢ ⁢ d + 3 ⁢ μ a ⋆ l ⋆ ( r sd / l ) [ 10 ] It should be pointed out that μ α is a function of light absorption dependent on the hemoglobin concentration and blood oxygen saturation level in blood. This expression can be used to process the DLS measurement of aggregation driven post-occlusion measurement where the Brownian motion takes over. The value g 1 relates to the measured autocorrelation function by the Segert relation: g 2 (τ)=1+β*| g 1 | 2   [11] In the case of a free pulsatile signal, the blood flow related phenomena are dominated by fluctuations of blood cells with a major contribution of red blood cells (RBC). The autocorrelation function decay is governed by the velocity variations measured across the blood vessels. If V(L) is the standard deviation of velocity difference across the source width L, then decay time is defined by: τ c ≈ 1 dV ⁡ ( L ) [ 12 ] The velocity difference of flowing blood is a function of its shear rate. This rate depends on variety of rheological parameters, such as blood viscosity or the actual size of flowing particles. Single RBC tends to form aggregates that can reversibly disaggregate under the influence of shear forces; RBC aggregation is a major determinant of the shear-thinning property of blood. In a vessel of radius R, axisymmetric velocity profiles v(r,t) can be described in cylindrical coordinates by the empirical relationship: v ( r,t )≈ v max *(1−( r/R ) ξ )* f ( t )  [13] where −1&lt;(r/R)&lt;1,f(t) is a periodic function of heart beat frequency, which is driven by systolic pressure wave and it is time phase-shifted with respect to the cardiac cycle, and ξ represents the degree of blunting. For example, in 30 micron arterioles, there is a range of ξ2.4-4 at normal flow rates. If ξ=2, a parabolic velocity distribution is obtained. Blunting would occur even in larger arterioles at low flow rates. By using the expression for d(v(r,t)) the standard deviation d(v) can be calculated by: rms ⁡ ( dV ) = v max ⋆ f ⁡ ( t ) ⁢ ∫ dv ⁡ ( r ) ⋆ r 2 ⋆ ⅆ r ∫ dv ⁡ ( r ) ⋆ ⅆ r = ξ ⋆ R 2 2 + ξ ⋆ v max ⋆ f ⁡ ( t ) [ 14 ] For small arterials (around 20 microns), the fluctuation of velocity from systolic to diastolic phases ranges from 1.5 mm/s to 2.5 mm/s. This results in a very significant fluctuation of standard deviation (rms) during the systolic-diastolic cycle. Pulsatile signal, therefore, can be used for calculation of hemorheological parameters. The DLS related pulsatile signal is advantageous over regular pulse measurement where the motion artifacts are prevalent. In addition, it should be noted that hemorheological changes can be extracted optically even if the scattering or absorption related changes are negligible. Therefore two major benefits are achieved: first, the pulsatile or other hemorheological change can be measured optically by using DLS-related technique; secondly, due to the process of only high frequency components in the DLS approach, low frequency interference is therefore eliminated, also eliminating motion artifacts. Another hemorheological parameter relates to the blood plasma viscosity. The post-occlusion signal (which is achieved during the stasis stage) can be utilized to evaluate blood plasma viscosity. In this case, the particles are displaced in the blood by Brownian motion according to the Stoke-Einstein equation [9]. It is clear that for the post-occlusion signal, the observed changes in the DLS signal are driven by the growth rate of d(t), following the growth of RBC aggregate size. The rate of RBC aggregate growth can be defined by calculating the change of autocorrelation function occurring during the stage of blood flow cessation (post-occlusion stage). Therefore the rate of RBC aggregation can be measured by using this technique. If the DLS signal is measured simultaneously at two or more wavelengths, then by using equation [10] or other such equations, the most influential scattering or absorption related parameters, such as oxygen blood saturation, hemoglobin or glucose can be determined since absorption properties of the scattering particles affect the DLS related parameters [10]. If the measurement system (e.g. system 100 ) includes a controllable pressurizing assembly, then the DLS effect can be used for measurement of arterial blood pressure. The point of systolic pressure is easily identified as a point of disappearance of the pulsatile signal, which is monitored either in terms of autocorrelation parameters or in terms of power spectrum. When the arterial pressure exceeds the cuff pressure, blood squirts through the partially occluded artery and creates turbulence, which creates the well-known Korotkoff sounds. Effect of turbulence results in dramatic change in fluctuation dependent speckle pattern which is expressed in an instant change of DLS parameters. In many applications ln(G(τ)) can be approximated by a polynomial form: G (τ)= A·τ 2 +B·τ+C   [15] FIG. 14 illustrates how the pulsatile and post occlusion signals can be presented in terms of polynomial coefficients A and B being defined in terms of autocorrelation analysis. In this example, the measurement session includes few physiological stages: a) an initial pulsatile signal session, b) an arterial blood occlusion session, and c) a pulsatile signal session after release of the over systolic (occlusion) session, all over the measurement duration of 80 seconds. FIG. 15 shows the behavior of a DLS related parameter (d(ln(G)/dt)) utilized for the determination of systolic and diastolic blood pressure. In this experiment, the pressurizing cuff is inflated up to over systolic pressure of 200 mm Hg during the first 5 seconds. Thereafter, for the next 75 seconds, the air pressure in the cuff is gradually reduced. Simultaneously, the DLS measurement is carried out at the area beneath the cuff. It is clearly seen in FIG. 15 , that the parameter d(Ln(G))/dt reaches its minimum point when the pressure measured in the cuff gets equal to the systolic pressure, as was defined previously by doing a standard blood pressure measurement test. Moreover, at the moment where the pressure in the cuff exceeds previously defined systolic pressure point, exactly at this point the value of parameter d(Ln(G))/dt starts to increase gradually. Therefore, by identifying these two extreme points on the curve of d(Ln(G))/dt, both systolic and diastolic blood pressure can be measured optically. Naturally, all other functions mathematically related to autocorrelation parameters, can be used for blood pressure measurement. This very unique sensitivity of DLS related parameters to the blood flow can be used for identification of blood flow disturbances or even for blood stasis identification and verification. To this end, any kind of a medical tool such as intro-vascular catheter (e.g. used for angioplasty) can be linked with DLS equipped optical fiber. Such a system is very efficient for identification of plugs and blood vessels abnormalities disturbing the normal blood flow. Moreover, blood circulation parameters measured by DLS technique can by embedded as an inherent part of new emerging technology of biofeedback. Based upon the biofeedback technique, different body parameters including the blood flow that can be beneficial to control emotional status, cardiovascular training, rehabilitation and other purposes can be controlled. For example, such a system can be used for the control of blood flow during recovery from heart failure. In the biofeedback applications, DLS based measurement system can be combined with facilities affecting the mental status of a subject. For example, a method of binaural beats can be used. The binaural beats are resulted from the interaction of two different auditory impulses, originating in opposite ears. The binaural beat is not heard but is perceived as an auditory beat and theoretically can be used to entrain specific neural rhythms through the frequency-following response (FFR), i.e. the tendency for cortical potentials to entrain to or resonate at the frequency of an external stimulus. Thus, a consciousness management technique can be utilized to entrain a specific induction of sympathetic and parasympathetic system. More specifically, biofeedback system based on the methods of binaural beats can be governed by the parameters of flowing blood measured by means of DLS. There is also provided a method to select appropriate frequencies characteristics of the binaural beats, according to the optimization curve of peripheral blood parameters, which are tightly associated with a stage of maximum relaxation. EXAMPLES Various examples were carried out to prove the embodiments claimed in the present invention. Some of these experiments are referred hereinafter. The examples describe the manner and process of the present invention and set forth the best mode contemplated by the inventors for carrying out the invention, but are not to be construed as limiting the invention. Example 1 To develop an optimized experimental approach for noninvasive visualization of blood clotting in vivo, an experimental protocol which allows visualizing fine changes in RBC motion at high spatial and temporal resolution, deep inside the tissue was established. The experiments were performed on occluded blood vessels and detection was carried out by modification of DLS described above. Anesthetized animal (nude mice) were placed on the stage of a setup for intravital microscopy. Temporal over systolic occlusion was created by using a mechanical occluder which produces local mechanical pressure on the area of visibly large arteries within the mouse ear. The duration of the occlusion did not exceed 10 minutes. In the first set of experiments, the illuminated area was imaged via a microscope by a CCD camera. The exposure time T of the CCD was 50 ms. Images were acquired through easy-control software at 20 Hz. The optical design of the system allowed for simultaneous laser irradiation and observation of a process of blood clotting via usage of a short pass optical filter (450 nm) placed in front of the CCD camera. It was observed that mechanical occlusion of major blood vessels never leads to complete blood flow stasis in microvessels. Even after maximal occlusion, RBCs continued to move and the character of such motions was not stochastic. RBCs were moving for up to 1 hour after animals were euthanatized. Therefore the absence of RBC motion in an occluded vessel can be a sign of blood clotting in vivo since polymerized fibrin can prevent even minimal movements of RBCs. Example 2 In order to monitor the blood clotting process, as well as to solve the problem of light scattering by skin and tissue, DLS from laser light was used for imaging the fine changes in RBC motion inside occluded vessels through the skin of the mouse ear. Particularly in the second set of experiments, the same animal model and procedures for animal care as described above were used. A diode laser (670 nm, 10 mW) was coupled with a diffuser, which was adjusted to illuminate the area of a mouse ear. The illuminated area was imaged through a zoom stereo microscope by a CCD camera. The exposure time T of the CCD was 50 ms. Images were acquired through easy-control software at 20 Hz. DLS imaging of RBC motion in occluded microvessels was based on the temporal contrast of intensity fluctuations produced from laser speckles that reflected from mouse tissue. The temporal statistics of time integrated speckles was utilized in order to obtain a two-dimensional velocity map which represents blood vessels under flow and no-flow conditions. The value of the laser temporal contrast K t at pixel (x,y) was calculated based on the following formula: K t ( x,y )=σ x,y / I x,y Where I x,y (n) is the CCD counts at pixel (x,y) in the n th laser speckle image, N is the number of images acquired and I x,y is the mean value of CCD counts at pixel (x,y) over the N images. Temporal mechanical blood occlusion in the observed area was applied, as described before, to ensure blood flow cessation. Referring to FIG. 16 , the laser temporal speckle contrast K t was higher (intensity scale 0-1 in the right side of the image refers the value of laser speckle temporal contrast) inside occluded blood vessels in which RBC motion can be detected. These vessels are represented by “white” pattern while the darker areas are referred to the blood vessels in which RBC motion was low or negligible. In addition, two minutes after occlusion, the beam of a Diode Pumped Solid State (DPSS) laser module, (Laser-Glow, Canada, 532 nm, 100 mW) was directed (at an angle of 45 degrees or less) onto the ear of an anesthetized mouse. The laser was focused in order to create a pinpoint injury on the mouse ear (200 μm). The injury was induced with a short high intensity laser burst and laser injury was induced at the area indicated by white arrows in frames 15 s and 20 s . The “white” pattern of blood vessels during DLS imaging, as illustrated in FIG. 17 of occluded blood vessels in the mouse ear can be related to remaining RBC motion. Conversely, relative changes in the intensity of K t upon clotting can be caused by elevation of blood/plasma viscosity as a result of blood clotting. In the experiments, two elements of Virchow&#39;s triad were used to induce the process of clotting in vivo and to assess it optically. Both changes in the vessel wall, as well as in the pattern of blood flow, predispose the area to vascular thrombosis and blood clotting. Thus, DLS images generated by RBC motion inside occluded blood vessels as a marker of the blood clotting process in vivo were used. Example 3 In order to monitor the change of oxygen saturation, a DLS system having two light sources was used. The light sources have respectively a wavelength of 650 nm and 810 nm. Absorption at these wavelengths differs significantly between oxyhemoglobin and its deoxygenated form, therefore from the ratio of the absorption of the red and infrared light the oxy/deoxyhemoglobin ratio can be calculated. The ratio of the two autocorrelation parameter (R 1 , R 2 ) for each wavelength was measured. The patient was asked to hold hit breath for approximately 30 seconds. As illustrated in FIG. 18 , the oxygen saturation drops. Then, the breath was reactivated, illustrated by a restoration of the oxygen saturation. The graph demonstrates the behavior of ratio of R 1 /R 2 during this experiment and reveals good correspondence between the ratio and the induced change of oxygen saturation. Example 4 By using the DLS related technique of the present invention, heart rate can also be measured. In this experiment, the method was tested on an upper wrist. This particular area is considered as a hardly available area for the commonly used photoplethysmographic method of pulse measurement. The pulsatile component in the wrist area is very weak and therefore is not used nor for heart rate measurement neither for pulse oximetry. A special probe including a coherent light source (VCSEL (vertical cavity surface emitting laser) of 820 nm), a detection unit, a laser driver and a preamplifier probe was constructed. The detection unit was located in close vicinity of the light source. All this system was encapsulated in the enclosure having a wristwatch form. This “wristwatch” was closely attached to the wrist and the measurement has been carried out. The DLS signal reflected from the skin area has been detected, amplified and digitized at the rate of 40 KHz. The obtained results have been processed. The auto-correlation function (AUT) was determined and averaged over 0.05 sec and the slope of the logarithm of AUT as a function of τ (sampling rate) was calculated. (d(ln(AUT)/dτ)). FIG. 19 represents the measured pulsatile component of the blood in terms of d(ln(AUT)/dτ. Heart rate is extracted from the obtained signal by utilizing any of commonly used methods such as FFT method. While this invention has been particularly shown and described with references to preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims.

A system, method and medical tool are presented for use in non-invasive in vivo determination of at least one desired parameter or condition of a subject having a scattering medium in a target region. The measurement system comprises an illuminating system, a detection system, and a control system. The illumination system comprises at least one light source configured for generating partially or entirely coherent light to be applied to the target region to cause a light response signal from the illuminated region. The detection system comprises at least one light detection unit configured for detecting time-dependent fluctuations of the intensity of the light response and generating data indicative of a dynamic light scattering (DLS) measurement. The control system is configured and operable to receive and analyze the data indicative of the DLS measurement to determine the at least one desired parameter or condition, and generate output data indicative thereof.

BACKGROUND OF THE INVENTION This invention relates to automatic machines for making pancakes on a rotating cooking drum whose surface can be smooth or can have a relief section depending upon the shape to be given to the pancakes. Prior Art Various means for applying pancake mix to a cooking surface of this kind have already been proposed, including periodic immersion of the cylindrical surface in the pancake mix to a substantially constant depth, depositing the paste by stripping an applicator roll which, as it rotates, dips to a substantially constant depth into a tank containing the pancake mix, free flow of the mix accommodated in a variable-opening hopper, etc. All these systems are attended by various disadvantages: heating of the mix, which only enables the machine to operate for a short period of time, machining difficulties and the need to install control systems which increases the cost of the machines to such an extent that their retail price is incompatible with marketing on a large scale. Object of the Invention The object of the present invention is to obviate these various disadvantages, namely to reduce heating of the pancake mix to a considerable extent, to simplify the design of the machine in such a way that there is no longer any need for complex adjustments to be made by the domestic or professional user, to control the temperature of the cooking drum automatically by reducing the input of calories when the machine moves from its working position to its waiting position. BRIEF SUMMARY OF THE INVENTION The invention relates to a method of applying a cooking mix to the cooking drum of an automatic machine for making pancakes or other similar products by means of a continuously rotating entraining roller partly immersed to a substantially constant drpth in a tank accommodating the mix, distinguished by the fact that the film of mix entrained by adhesion on the surface of said roller comes into contact before the cooking surface with mobile means for partly retaining this film which results in the formation of a &#34;bead&#34; of mix which touches gently upon and coats the surface of the cooking drum with continuous return of the excess mix to the tank, the controlled mobility of these means enabling formation of the bead to be interrupted at any required moment to stop coating of the drum. Further Features of the Invention As will be seen in the following, the film-retaining means can vary, although Applicant prefers the following arrangement. Since the two smooth, rotating surfaces of the drum and roller converge towards one another, a stripper bar is arranged immediately after the zone where the two surfaces are at their closest to one another, and is dimensioned in its cross-section in such a way that the bead flows over it during coating, the cooking drum being provided at one end with a projection which acts periodically on a pivot arm of the bar so that the bar is momentarily lifted in the radial direction and coating of the cooking drum interrupted while the bar is raised. Various arrangements for carrying out the coating method according to the invention will be briefly described hereinafter, followed by a detailed description of a preferred embodiment of the invention, in which the coating system, essentially comprising a constant-level tank of mix with a feed reservoir and the drive roller equipped with its stripping bar, forms a separate unit of the machine. According to another aspect of the invention, this separable unit can occupy two positions, namely a working position and a waiting position, the movement of the unit from one position to the other producing, through the connection or disconnection of a resistance, a corresponding variation in the input of calories to the cooking drum which is designed and arranged in such a way that the necessary regulation of temperature is made by balancing the input of calories with the natural losses of the drum. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawing diagrammatically illustrates various embodiments of the arrangements which can be used for carrying out the coating method according to the invention, together with one complete, detailed embodiment of an automatic machine for making pancakes equipped with one of these arrangements, with electrical circuit diagrams, in particular for heating the cooking drum. In the accompanying drawings: FIG. 1 is a diagrammatic cross-section through a symmetrical arrangement with a second roller rotating tangentially in the opposite direction to the driving roller. FIG. 2 is the same view of an arrangement with two tangential rollers, except that in this case the two rollers are offset relative to a vertical diametral plane of the cooking drum. FIG. 3 is a similar diagrammatic view in which the second roller is replaced by a fixed bar or scraper. FIG. 4 is the same as FIG. 3, except that the bar is arranged in such a way that it can be radially displaced relative to the coating roller. FIG. 5 is a diagrammatic cross-section through the cooking drum with the complete coating system designed as shown in FIG. 4. FIG. 6 is the same as FIG. 5, except that the bar is assumed to have been raised, thus interrupting coating of the drum. FIG. 7 is a perspective view of the arrangement shown in FIGS. 5 and 6 showing the paths followed by the strands of mix around the driving roller. FIG. 8 is a more detailed version of FIG. 5 in the form of a cross-section through a complete machine equipped with this variant of the coating system for a smoothsurface cooking drum. FIG. 9 is an elevation taken from the left-hand side of the machine with the cover removed. FIG. 10 is an elevation taken from the right-hand machine with the cover removed. FIGS. 11a and 11b are a cross-section through the machine, 11a the left-hand half-view being taken on the line XI--XI of FIG. 9, and 11b the right-hand half-view of the lines XI&#39;--XI&#39; of FIG. 10. FIG. 12 is a perspective view of the machine without its coating system but with the conveyor for cooked folded pancakes. FIG. 13 is a perspective view of the machine ready for use. FIGS. 14 and 16 show the various position which the coating tank can assume during its use. FIG. 17 is a section through the reservoir on a vertical axial plane of the driving roller. FIG. 18 is a section on the line XVIII--XVIII of FIG. 10. FIGS. 19 to 21 are variants of the circuit diagrams for regulating heating of the cooking drum with a synchronous motor for controlling the machine. FIG. 22 is another variant, but with electronic regulation using a triac. FIG. 23 is another variant of the electrical control system using a d.c. motor for controlling the machine. FIGS. 24 and 25 are two modified circuit diagrams completed to enable the surface of the cooking drum to be cleaned by pyrolysis. FIGS. 26 and 27 are two variants of the surface geometry of the cooking drum. FIG. 28 is a view of a mechanism for automatically taking up play to enable the cooking drum to be driven by smooth rollers. FIG. 29 is a variant of FIG. 14 in which the reservoir is in two halves which can be taken apart to facilitate its cleaning. DESCRIPTION OF EMBODIMENTS As shown in FIG. 1, a certain quantity of cooking mix is kept at a substantially constant level 2 in a tank 1: 4 is the driving roller against which a second identical roller 3 is tangentially applied, the two rollers being partly immersed in the mix and rotating in the arrowed directions. The mix adhering to the rollers at 5 and 5&#39; accumulates at 6 between the two rollers above their contact point and returns to the tank by flowing over the ascending film of mix, shown here at 7 and 7&#39;. If a cooking drum 8 heated to a suitable temperature is positioned above this arrangement, the paste situated at the top of the bead 6 comes into contact with and remains adhering to the hot surface. The quantity of mix 7 and 7&#39; returning to the tank decreases. However, it is essential for the mix to return to the tank without the level of the bead being decreased by an inadequate supply, which would give rise to &#34;deficits&#34; on the surface of the cooking drum. If the driving rollers 3 and 4 are moved apart whilst at the same time kept rotating, the bead 6 disappears, which stops coating of the cooking drum. Coating recommences when the rollers are brought together again. This arrangement under the cooking drum is hardly practical for designing an automatic machine in which it would be necessary to release and convey the product outside the machine. Accordingly, it is of advantage to arrange the coating system at the side of the cooking drum. FIG. 2 illustrates one embodiment of such an arrangement. This embodiment again comprises the driving roller 4, the second roller 3 of larger diameter and the formation of a bead of mix 6. This arrangement is not altogether satisfactory because the bead 6 is not stable. However, the roller 3 does not have to be rotated, which leads to the arrangement illustrated in FIG. 3, where the roller is replaced by a fixed bar 9 which stops the ascending film of mix and also produces the formation of bead in front of the bar 9. In another more advantageous arrangement, the driving roller is rotated in the opposite direction, as shown in FIG. 4, whilst the bar 9 is positioned in the immediate vicinity of the top of said roller. In this case, the bar is perfectly stable. In addition, the bar is exposed to less infrared radiation from the cooking drum. It can readily be lifted to make the bead disappear and, hence, to stop coating. A phenomenon due to the molecular entrainment of the mix by rotation of the roller is somewhat troublesome in this arrangement. In the arrangement illustrated in FIG. 3, the level of mix at 10 tends to drop with the result that the tank below the cooking drum is barely used. By contrast, in the arrangement shown in FIG. 4, the level at 11 rises to a point where it overflows. This disadvantage is obviated by creating a sufficiently large space between the walls of the tank and the driving roller to promote return of the mix below the roller, as shown here by the arrow 12. A coating system for a smooth cooking drum and for square pancakes, as illustrated in simplified form in FIGS. 5 to 7, can be made up from this more advantageous design illustrated in FIG. 4. The mix tank 13 is an integral part of the mix reservoir 14. The driving roller 15 is mounted in the sides 16 of the tank. The bar 17 rests freely on the drive roller and is pivotally connected at 18 to the sides of the tank. The pivotal arm 19 is extended by a lever 20 which can be actuated by a projection 21 arranged at the end of the cooking drum 22. The mix tank is introduced into the machine by engaging the forks 23 around studs 24 fixed to the frame supporting the cooking drum, and by pivoting the handles 25 which ultimately rest on the metal framework of the conveyor (not shown). Lowering of the handles 25 into the position illustrated in FIG. 5 rotates the tank/reservoir block towards the front, with the result that the pinion 26 integral with the shaft of the drive roller 15 meshes with a driving pinion (not shown). Since the cooking drum 22 rotates permanently, as does the aforementioned drive pinion, the drive roller begins to rotate as soon as it engages the drive pinion. A film of mix adhering to the drive roller is then formed by the bead 28 which, as soon as it has become sufficiently coherent, touches lightly upon the hot surface of the cooking drum. A layer of mix remains adhering to the cooking drum where it forms a band of mix. During each revolution, the projection 21 engages the end of the lever 20, the immediate effect of which is to allow the bead of paste to flow towards the tank (FIG. 6). Coating of the cooking cylinder then stops, starting again when the bar 17 is lowered. In order to stop making pancakes, it is sufficient either to keep the bar 17 raised or to release the tank by folding the handles 25 underneath the tank. The bead then moves away from the surface of the cooking drum. If the arrangement which has just been described is to function satisfactorily, the bar 17 should be of limited thickness. For example, a round wire of stainless steel 2 mm in diameter is suitable for a drive roller 24 mm in diameter rotating at a speed of 20 rpm in front of an aluminum cooking drum heated to 220°C and rotating at 15 rpm. The permanent overflow promotes the uniformity of the bead along the bar. FIG. 7 illustrates the phenomenon which occurs. Towards the ends of the drive roller, the mix, instead of forming a bead by accumulating in front of the bar, permanently escapes at the side of the roller in the direction of the arrow 28 and the flow 29. If the bar is sufficiently limited in thickness, a flow of mix is established in the central zone 30 above said bar to the detriment of the flow 28. Although smaller, the bead remains sufficiently large to continue performing its coating function, and remains substantially uniform in thickness up to the ends of the drive roller. The heating which the mix can undergo in coming into contact with the cooking drum is considerably reduced by this permanent return of mix to the reserve of fresh mix accommodated in the tank. The heated mix is permanently recycled by the drive roller whilst, as it is consumed, fresh paste coming from the reservoir 14 keeps the temperature at an acceptable level. In addition to working satisfactorily, the system illustrated in FIGS. 5 to 7 is advantageous in terms of domestic application, because it does not impose any strict tolerances on the manufacturing side, neither is any delicate mechanism required to start or stop coating. A complete machine equipped with this system will now be described in detail with reference in particular to FIGS. 8 to 11. As shown in FIGS. 11a and 11b, the frame of the machine consists of a stainless steel baseplate 101, to the ends of which are fixed two side plates 102 and 103 made of a thermoplastic plastics material or of aluminum, moulded with all the projections and orifices required, for example, the vents 106 and 107 are the anchoring points for a scraper blade or wire (not shown) by which the pancakes cooked on the cooking drum 22 are removed. Each side plate receives the grooved shafts 104 on which are mounted toothed wheels 105 which engage in the internally toothed rings 111 and 112 provided at each end of the cooking drum 22 made of injected aluminum. This internal arrangement of the rollers protects them, with the result that their rotation is always uniform. At the right-hand end, rotation of the drum 22 is obtained by one of the toothed wheels 113 from a mechanical transmission as will be explained hereinafter. At the left-hand end, there is a moulded projection 21 whose function it is to lift the scraper bar 17 with each revolution by acting on the lever 20. The mounting between each internally toothed ring 111, 112 and the toothed wheels 105 (including the wheel 113) of each end is made without any play, i.e. during heating, and even in the event of overheating, a functional clearance is established through a slight increase in the original diameter of the rings, which enables the cooking drum to rotate freely. A bore moulded in the drum 22 receives the shaft 117 of refractory steel on which is mounted a heating element in the form of two end steatite cylinders 118 and 119, between which are fitted tubular bars 120 also of steatite, the bars receiving coils 121 of nickel-chrome wire (held in position by passing them through openings 122 in the cylinders. This heating circuit will be discussed again hereinafter. Axial displacement is limited by the tube sections 125, 125&#39;, 126, 126&#39; and the washer 127, this washer being designed to fit against the bore, the arrangement being vented by openings formed in the tube sections and the washer. The tube section 125 is spot-welded to the shaft 117 and fixed at its left-hand end by a nut 32 screwed onto the threaded end of the shaft 117, the other right-hand end of the shaft being able to expand freely in the tube sections 126, 126&#39;. A temperature limiter 33 is held at the left-hand end of the shaft 117 between the nuts 34 and 32, the temperature transmitted to this limiter being proportional to the temperature of the cooking drum 22, i.e. it detects an &#34;image&#34; of this temperature. The cooking drum 22 is made in such a way that the mass of insulating material is low in relation to the heat-conductive mass. At the bottom of FIG. 8 can be seen the conveyor onto which the cooked pancakes are dropped by gravity, being removed at the lower end of the cooking drum 22 by the separator or release wire. This conveyor is mounted on the drive roller 35 (shown in axial section at the bottom of FIG. 11) and on two tension bars 36 and 37 arranged on either side of this drive roller at different levels (FIG. 8). Two sets of rubber rings 38 and 39 are stretched reciprocally between the drive roller and each of the tension bars. The rubber rings are identical so as to facilitate their supply and repositioning in the event of dismantling. The rear bar 36 is engaged in slots 40 directed in the stretching direction which are formed during the moulding of the side plates 102 and 103. Accordingly, they can be readily dismantled. The front bar 37 is an integral part of a reinforcement of stainless steel wire folded in a certain configuration comprising supporting feet 41, arms 42 and loops 43. The loops 43 are pivotally connected to the end of the drive roller 35, which enables the front section of the conveyor to be lifted as shown in FIG. 12. FIG. 13 shows the conveyor in its working position. The drive roller is arranged in position by engaging a stud formed at each of its ends (FIG. 11) in the hollow part of the drive shaft 45 equipped with a toothed drive pinion 46 and designed to retract into the side plate and to reassume its position under the effect of the leaf spring 47 (see also FIG. 10). After having lowered the drive shaft 45, the other end of the drive roller is brought in front of the cavity 48, the spring 47 being allowed to act in such a way that the stud 45&#39; engages in said cavity 48 (FIG. 11). If care has been taken to arrange the rings 39 on the bar 37 and to engage the ends of the roller 35 in the loops 43, it is sufficient to pass the bar 36 through the other rings 38 and to position said bar 36 in the slots 40, after which the conveyor is fully mounted. By virtue of the foregoing preliminary description, it will readily be possible to understand in the following the structure of the coating system for the cooking drum, its positioning and its use in the machine. The spindles 49, see FIG. 8, of the roller 15 entraining the mix engage in open bearings 50 whose opening is directed in such a way that the spindles remain in place in the positions which the coating tank is capable of assuming and under the reactive engaging force to which it is subjected during its driving. The two open bearings 50 are formed at the ends of the tank 13 surmounted by the reservoir 14. These latter two components are assembled by ultrasonic welding at the level 53 the front face 54 of the reservoir 14 dips into the tank to the level 55 at which the mix is to be kept. This same front face 54 is moulded with an antispill surface 56. The sides of the tank section extend downwards at 57 and terminate in flat surfaces 58 designed to fit the arms 42 of the conveyor. The flanks 57 also carry a framework of stainless steel wire articulated at 59 constituting the handles 25 with a right-angled bend 61. The handles can thus assume two stable positions, one indicated by the dotted line 25&#39; and the other by the solid line 25. At the end of the flanks 57, studs 62 can bear along grooves 63 moulded in the side plates 102 and 103. These grooves are hook-shaped as shown at 64 so that the studs 62 can engage in them. Outside the machine, the reservoir-tank can assume the three positions shown in FIGS. 13, 14 and 15. At rest, it is in the equilibrium position shown in FIG. 14. To fill it, it is placed on its back as shown in FIG. 15, the mix being poured onto the antispill plate 56. The mix then flows into the reservoir, as shown. By turning the reservoir tank through a quarter of a revolution according to the position shown in FIG. 16, the reservoir tank takes up a balanced position on the supporting surfaces 58 and the mix fills the tank. It stabilises at the level 55, the lower part of the front face 54 preventing air from entering above the mix remaining in the reservoir. The roller 15 for entraining the mix can be placed in any position that can be occupied by the reservoir-tank. The tank-reservoir, as described above, can be difficult to clean so that, in a modified embodiment, it is made in two separable halves, the reservoir and the tank as shown in FIG. 29. The reservoir 128 made of a transparent or translucent plastics material has a peripheral edge formed with two lips 129 and 130 which, in free form, are separated from one another, as can be seen from the left-hand part of the reservoir in the Figure, the tank has a groove 131 in its rear and lateral surfaces to receive the lips of the reservoir. The reservoir/tank assembly is sealed by the inner lip 129 which bears elastically against the side of the groove 131, this assembly of the two components is locked by means of the bead 132 of the lip 130 which engages in a complementary space formed in the groove 131. In order to fill the reservoir, it is separated from the tank and rested on its base. After filling, it is reassembled with the tank and the lips snapped into the groove by hand pressure. The assembly is returned by rotating it in such a direction that the mix accommodated in the reservoir flows progressively into the tank, the antispill plate 56 is thus eliminated, but this is the only appreciable modification made to the design of the tank-reservoir in a single assembly. In order to introduce the coater into the machine, the supporting surfaces 57 are placed on the arms 42 of the conveyor (FIG. 8), the studs 62 resting on the rib 63. It is sufficient to push the coater onto the arms of the conveyor until the studs come into contact with the ends of the ribs 63, and then to pivot the handles 25. The handles rest on the arms of the conveyor, the coater tends to pivot and assume the stable position shown in FIG. 8. In its rotating movement about the points 62, a toothed pinion 65 situated at the end of the drive roller engages with the toothed wheel 60 integral with the wheel 113 (FIGS. 11 and 17). When the stud 62&#39; drops into the hook 64&#39; (cf. left-hand side of FIG. 11), it presses down a plate 67 integral with a microswitch 68 whose functions will be described hereinafter. This microswitch 68 is held in position by riveting to a bracket 69 fitted onto a dummy leaf switch depending from an energy doser 70 which itself is held in position against the side plate 102 by the pressure of the cover 108 on the bracket 69. In order to lift the coater, it is sufficient first of all to fold the handles back into the position 25&#39; which releases the studs 62 and 62&#39; from the hooks 64 and 64&#39;, and lifts the plate 67 off the microswitch 68. The assembly is then drawn towards the rear in order to release and remove the coater. This system of introduction on tracks slightly different from that shown in FIGS. 5 and 6 has the advantage of enabling the coater to be placed exactly in position without calling for any particular attentiveness on the part of the user. In addition, a deviation of ± 1 mm in the flatness of the support of the machine at the level of the feet 41 of the conveyor (FIG. 8) does not adversely affect the operation of the coating system. The motor/mechanical transmission assembly of the machine is situated on the right-hand side of FIG. 11 (between the side plate 103 and the cover 109) with a side view in FIG. 10 and a section in FIG. 18 on the line XVIII--XVIII of FIG. 10. A synchronous electric motor 71 is fixed to two supports 72 and 73 moulded with the side plate 103 through a stirrup 74. The drive pinion 75 meshes with the stepped gearwheel 76 mounted for free rotation on the spindle 77. This spindle which extends through the side plate 103 via the bearing 78 is held radially by the stirrup 74. The pinion 76 meshes with the stepped gearwheel 79 mounted for free rotation on the fixed spindle 80. The pinion 79 meshes with the gearwheel 81 which is coupled to the spindle 77 by the engagement of two metal flats engaged in two grooves formed in the bore of this wheel. Finally, the spindle 77 is forced into the stepped gearwheel 113 - 66 which drives the entraining roller of the coating system and the cooking drum. The wheel 81 meshes with two stepped pinions 82 and 83, the latter driving the sliding pinion 46 which actuates the drive roller 35 of the conveyor. FIG. 19 is a diagram showing the electrical connections in the machine, the resistances 121 wound onto the steatite bars 120 of the cooking roller are denoted by the references R 1 to R 6 . The motor 71 is shed (220V) through a general circuit breaker C 1 and the bimetallic energy doser 70 with the heating resistance R 7 . At rest, i.e. when the tank/reservoir is not yet in position, the initially high power is reduced through the intervention of the temperature limiter 33 which opens the shunting of R 1 and R 2 when the temperature at the end of the rod 117 reaches a certain value, in the present case 110°C. This reduction in power corresponds exactly to the natural heat losses of the drum. The temperature of 110°C is the &#34;image&#34; at this moment of the actual temperature of the drum, i.e. around 205°C. Due to the thermal inertia of the infrared resistance elements 121, the temmperature of the drum rises to around 210°C following activation of the temperature limiter. Positioning of the tank/reservoir in the machine closes the microswitch 68 and increases power again by reshunting R 1 and R 2 . Since the pancake mix covers the drum in a semi-continuous manner, the heat loss increases and still corresponds to the energy supplied by the group of resistances under voltage. Removal of the tank restores power to its expected level by opening the shunt, i.e. the microswitch 68. It should be noted, that, in the event of an accidental drop in the mains voltage, the heat of the energy doser 70 remains proportional to the input voltage so that the average power delivered to the resistances 121 remains constant. Accordingly, temperature is regulated without any need to use a thermostat accommodated in the drum, which is incompatible with any compact, inexpensive domestic appliance. The heating cycle of the energy doser 70 can be modified, as shown in FIG. 19, by adding a resistance R 8 in series with R 7 . However, for varying the mean power delivered to the resistances 121 whilst at the same time maintaining the same values for the expected power and the cooking power (for example 240W and 570W, respectively), it is preferred to adopt the circuit illustrated in FIG. 20 with the resistances R 7 and R 8 to vary the cycle of the energy doser 70. The cooking drum is heated by the resistances R 3 to R 6 . FIG. 21 is the diagram of a third circuit which can be used for controlling heating. In this case, the resistances 121 are connected in parallel in two groups R 1 , R 2 , R 3 and R 4 , R 5 , R 6 , and change over is carried out by applying voltage to or by removing voltage from the first group. The six resistances 121 each have the same value. The additional resistance R 8 , for varying the cycle of the energy doser 70, is then shunted by two complementary circuit breakers C 3 and C 4 operating inversely to the microswitch 68 and to the temperature limiter 33, respectively, by reciprocal connection therewith. It would also be possible to envisage, still with two groups of resistances in parallel on the drum, an electronic circuit arrangement which regularises the mean power delivered to these resistances by all or nothing control, as illustrated in the circuit diagram in FIG. 22, in which the resistances are fed as follows through a triac 84. To enable the triac 84 to allow a complete sinusoid to pass for a time t 1 , it must be triggered with each zero-axis crossing of the mains voltage. For this purpose, an impulse is applied to the trigger of the triac 84 through the gate 85 and the impulse amplifier 86 at a moment determined by the zero voltage detector 87, that is to say each time the mains voltage disappears. A circuit breaker 89 in its closed position enables the gate 85 to apply the impulse to the trigger of the triac 84 via the impulse amplifier 86. The triac is triggered with each zero axis crossing of the mains voltage which is wholly applied to the heating resistances R 1 to R 6 . The circuit breaker in its open position prevents the gate from applying the impulse to the trigger of the triac which is blocked for a time t 2 and the resistances are no longer fed. Control of the circuit breaker 89 closes the circuit breaker 88 for a time t 1 and opens it for a time t 2 . The cycle of duration t 1 + t 2 is repetitive and the values of the times t 1 and t 2 are governed by the effective mains voltage. In order to shunt the group of resistances R 1 , R 2 , R 3 , it is necessary to use the temperature limiter 33 and the microswitch 68 controlling introduction of the coater of the machine. A more elaborate embodiment can be obtained by using a single group of non-shuntable resistances and by replacing the temperature limiter with a thermistor acting on the cycle t 1 + t 2 and/or by replacing the microswitch with a photoresistance also acting on the cycle t 1 + t 2 . This new value of the cycle t 1 + t 2 defines the standby power. Unlike the energy doser described above, which produces an all or nothing feed whose cycle extends over several seconds, the power regulator described above has a very short working cycle of less than 1 second and which is only effective for a few alternations. The machine described thus far is driven by a synchronous motor which generates a constant speed because it is in synchronism with the frequency of the network. In order to vary this speed, i.e. the cooking time, it is necessary inter alia to use a d.c. motor fed through a variable resistance. It is of advantage to use a low-voltage micromotor incorporating in permanent magnet. For this embodiment the current source is derived from the resistances heating the cooking drum. The junction between the resistances R 3 and R 4 , which, as has already been seen, is outside the heating cage is replaced in the circuit diagram shown in FIG. 23 by a connection of resistance wire r 3 and r 4 , see FIG. 24, forming a dropping resistance. Non-resistant copper connections L 1 and L 2 are connected at the ends of the resistances R 3 and R 4 and, on the other hand, to diodes D 1 and D 2 through which the motor 71 is fed. Its speed can be regulated by varying the variable resistance R 9 . By contrast, when the circuit is on standby (33 and 68 open) the voltage derived at L 1 L 2 is too low to feed the motor 71 under normal voltage, with the result that the motor stops. Although the face that the motor is no longer rotating when the coater is introduced, and is stopped when the coater is removed, constitutes an advantage, it then becomes impossible to release the last pancake coated onto the drum because there is a delay of one revolution of the cooking drum between coating and separation of one and the same pancake. In order to obviate this disadvantage, it is sufficient to only partly to fold the handles 25 back under the coater and to maintain the coater in such a position that the bead of mix formed on the entraining roller no longer comes into contact with the cooking drum. Once the last pancake has been released, the handles can be completely folded down for standby heating. In an alternative procedure, illustrated in FIG. 8, the arm 19 is extended by a lever 50 provided with a key 91 so that, by applying pressure to this key, the stripping bar 17 allows the bead of mix normally accumulating in front of it to flow through. Coating can thus be stopped. However, it is essential to remove the coater as soon as the last pancake has been removed, otherwise the cooking drum will become overheated in the absence of cold mix. It is apparent from the foregoing description of the machine that all the components coming into contact with the mix can be removed without any need for tools in order to be cleaned or replaced; this is the case with the coater and with the conveyor. So far as the cooking drum is concerned the brown-coloured calamine adhering firmly to it can be automatically removed by pyrolysis. To this end, it is sufficient to leave all or part of the resistance heating circuit of the cooking drum under voltage. The temperature of the drum settles at an equilibrium temperature defined by the calories applied by the resistances and the natural losses of the cylinder. In the form in which it has been described, with the circuit described with reference to FIG. 19, tests with the machine have shown that the temperature settles naturally at 300°C during cooking, which is the pyrolysis temperature. Several solutions can be adopted for obtaining an adequate pyrolysis temperature; for example: a. the circuit illustrated in FIG. 19 is completed as shown in FIG. 24. An auxiliary circuit breaker S 1 S 2 shunts, on the one hand, the temperature limiter 33 which prevents transfer to the standby circuit (S 1 ), and on the other hand breaks the feed circuit of the motor (S 2 ) to prevent the machine from being used at high temperature; b. alternatively, this same FIG. 19 is completed as shown in FIG. 25 a resistance R 10 normally shunted by a circuit breaker S 3 is brought into operation for pyrolysis, whilst the motor circuit is cut (S 4 ). The new heating rate of 70 allows the cooking drum to be overheated inspite of the action of 33; c. same arrangement as b), but for the diagram in FIG. 20, the additional resistance R 10 (not shown) being placed in series with R 8 ; d. adding an auxiliary resistance included in the heating cage and placed under voltage independently of the resistances R 1 to R 6 . In view of the temperatures reached during pyrolysis, the machine has to be equipped with a safety system in particular the essential need to dismantle the conveyor and to prevent use of the coater. These safety measures can readily be obtained by means of microswitches placed in series, for example with S 1 (FIG. 24) and actuated by the presence of the aforementioned components. All the possible mechanical and electrical features of the machine according to the invention have just been described. However, certain structural modifications can be made to this machine without departing from the scope of the invention. Thus, it has been assumed throughout the foregoing description that the cooking drum has a smooth, continuous surface. However, as shown in FIG. 26, it is possible to use a cylinder 22 with a longitudinal groove 92 sufficiently deep for the top of the bead of mix not to be able to adhere to the bottom of said groove; the groove has a sharp longitudinal edge 92a to stop coating in a clean line, whilst the inclination of the surface 92b is regulated so as not to interfere with the action of the bar or wire by which the cooked pancakes are removed from the drum. Square pancakes are obtained by interrupting the deposition of mix without using a mechanism for lifting the bar 17. As a variant illustrated in FIG. 27, for making round pancakes, the part 93 of the smooth cylindrical surface can be covered with a layer of antistick material, such as PTFE, so as to leave a smooth disc 94 on which the pancakes are cooked. In addition, it has already been seen, in reference to FIG. 11, that the cooking drum rotates via internally toothed wheels 105 and 113. In order to avoid excessive stressing of the insides of these wheels, the drum can be mounted on smooth wheels with a mechanism for automatically taking up play on the driving side. This mechanism will be described hereinafter with reference to FIG. 28. A curved arm 95 is mounted on a spindle 96 about which the smooth roller 97 rotates. This curved arm 95 is designed to oscillate through a certain angle (arrows 98 1 , 98 2 ), a short lever 99 riveted to the end of the spindle 86 is permanently under the action of a spring 100 so that the arm tends only to be displaced in the direction of the arrow 98 1 . The free end of the arm 95 carries the spindle 114 about which rotates a second smooth wheel 115. Since the drive pinion 113 rotates in the direction of the arrow f, the cooking drum is driven in the direction of the arrow F which tends to apply the path of rotation of the drum to the wheel 97 and, hence, to allow the arm 95 to act in the required direction of the arrow 98 1 . The arm 95, the spindle 114 and the smooth idle wheel 115 rotating on a path formed in an end zone of the inner wall of the cooking drum are shown in a circle and in axial section at the top and on the right-hand side of FIG. 11. Finally, in cases where it is desired to vary the length of the pancakes on the machine as essentially described in the foregoing, instead of controlling lifting of the bar 17 by means of the projection 21 arranged at the end of the cooking drum it is necessary to replace this projection by a mehanism acting, for example, every one and a half revolutions or every three quarters of a revolution. This mechanism is only suitable for compact machines and could consists of a disc turning somewhat more slowly or quickly than the cooking drum, this disc carrying a pin periodically engaging the bar 17 to lift it.

Method and apparatus for applying a cooking mix to the rotary cooking drum of an automatic machine for making pancakes or the like by means of a continuously rotating paste-entraining roller partly immersed to a substantially constant depth in a mix tank, the film of mix being entrained by adhesion on the surface of the roller and contacting movable means for partly retaining this film, resulting in the formation of a bead of mix which touches lightly upon the surface of the cooking drum and thus coats it.

CROSS-REFERENCE TO RELATED APPLICATION This is a continuation-in-part (CIP) application of U.S. patent application Ser. No. 08/411,620 filed Apr. 5, 1995, now abandoned. FIELD OF THE INVENTION The present invention relates to new pharmaceutical formulations of spiramycin. It relates more particularly to new formulations intended to be administered orally. BACKGROUND OF THE INVENTION Spiramycin has been commercially available for nearly twenty-five years. However, spiramycin has proven very difficult to administer to man and, more particularly, to children in the form of a solution, suspension or dispersible granule because its bitterness is extremely difficult to mask. Attempts to mask this bitterness include the formulation described in French published patent application number FR 2,669,533, which discloses spiramycin encapsulated by albumin by a technique which requires the use of organic solvents, such as isooctane, and their removal at the end of the process. This technique, although very efficient at taste-masking, is very expensive because it only allows the manufacture of small quantities of pharmaceutical composition and it necessitates stages of solvent recycling which are long and costly. SUMMARY OF THE INVENTION The present invention has made it possible to prepare spiramycin formulations having an enhanced taste without using solvent for its preparation. This enhanced taste masks the bitterness of spiramycin without adversely affecting bioavailability or stability of the spiramycin. The formulation comprises spiramycin and acesulfame, particularly potassium acesulfame. The new pharmaceutical forms of spiramycin according to the present invention, which may also include flavoring agents, are intended to take the form of doses (sachets, bottles or packs with a measure, for example) containing a granulated powder to be dissolved or to be dispersed in water prior to administration to the patient. This new granulated form, which can be suspended in water immediately before use, offers the following advantages: ease of use during ambulatory treatment accuracy of the unit dosage easy suspension or dissolution in water easy absorption. Numerous various formulation trials attempting to mask the bitterness have been undertaken. None of them gave satisfactory results as regards the taste of the aqueous suspension obtained or as regards the bioavailability of the spiramycin after absorption. However, the association between potassium acesulfame and spiramycin according to the present invention surprisingly has made it possible to achieve this objective. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS New granulated pharmaceutical forms of spiramycin for oral administration according to the present invention are prepared by wet granulation of the spiramycin and sucrose, preferably in a weight ratio of about 1/1 to about 1/9, followed by preparing in a dry state a mixture of the granules previously obtained, acesulfame, flavorings and any remaining sucrose. The new formulations according to the invention preferably comprise about 100,000 to about 5,000,000 IU spiramycin, about 10 to about 20 mg potassium acesulfame, about 20 to about 200 mg flavorings and about qs 1 to about 10 g sucrose. According to one preferred embodiment, such formulations comprise 375,000 IU spiramycin, about 10 to about 20 mg potassium acesulfame, 60 mg flavorings and about qs 3 g sucrose. These formulations are preferred. One of ordinary skill in the art will appreciate that the formulations of the present invention may be adapted according to the desired masking of the bitterness of the active ingredient by adding more or less potassium acesulfame. The flavorings may also be adapted to the taste and to the age of the child. These formulations may be presented either in the form of doses as mentioned above or in the form of a solution or suspension prepared immediately before use. The invention will be described more fully with the aid of the following examples, which should not be considered as limiting the invention. COMPARATIVE EXAMPLE 1 ______________________________________spiramycin 86.190 mg (375,000 IU)Eudragit E 100 ® 70.00 mgmannitol qs 950.00 mgsodium saccharinate 25.00 mgstrawberry flavoring 40.00 mganhydrous colloidal silica 12.50 mgcellulose (microcrystalline) 25.00 mgpolyvidone 100.00 mgsucrose 97.50 mg 1250.00 mg______________________________________ Trials with this type of formula were stopped, in spite of the success of the taste masking, because of poor bioavailability. COMPARATIVE EXAMPLE 2 Development of a simple and rational formula by preparation of a granule (concentrated) composed of sugar and spiramycin; and flavoring of the primary granule by the addition, in an external phase, of sweeteners and flavorings simply by mixing. The manufacture of the primary granule is performed in a Turbosphere mixer-granulator-drier and the preparation of the final mixture in a gravity mixer. Theoretical unit formula: ______________________________________spiramycin base 81.156 mg (375,000 IU)sucrose qs 1000.00 mg sucrose (Alveo sugar) 1960.00 mg externalbanana flavoring 40.00 mg phase 3000.00 mg______________________________________ A bioavailability study demonstrated the bioequivalence of the granule of comparative trial 2 and of commercial syrup; however, the taste acceptability tests showed that the flavoring of the product requires improvements. COMPARATIVE EXAMPLES 3 AND 4 The sweeteners commonly used (sodium saccharinate, sodium cyclamate) could not be selected because of the insufficient organoleptic effects. An acceptability test was carried out on two of these formulations (one with sodium saccharinate (Example 4) and one with aspartame (Example 3)). The general formulations and results are indicated in Table 1 below. For aspartame, the taste acceptability test is satisfactory but the product interacts with spiramycin, thereby making its use impossible. COMPARATIVE EXAMPLE 5 An attempt to mask the bitterness of spiramycin by association with xanthan gum. The general formulation is shown in Table 1. Results of taste testing were inconclusive but low. EXAMPLE 6 The manufacture of sachets is carried out in 3 phases: (a) Preparation of a concentrated primary granule (165 mg per sachet of 3 g containing 375,000 IU of spiramycin) in a Moritz mixer-granulator-drier: ______________________________________per sachet of 3 g______________________________________spiramycin base 84.081 mg (375,000 IU)sucrose (superfine sugar) qs 165.00 mgwater about 5% by mass______________________________________ During the granulation, the product is heated with the aid of a jacket up to about 55° C. The stirring is carried out at about 100 revolutions/minute for 30 minutes. For the drying, the stirring is carried out at about 20 revolutions/minute while the temperature is maintained but while the pressure is reduced to between 6 and 20 KPa for 60 minutes. The product is then cooled to room temperature over about 30 minutes. The granule is sieved on a screen with a mesh of 0.71 mm. (b) Preparation of the final granule in a cubic gravity mixer ______________________________________primary granule 165.00 mgpotassium acesulfame 10.00 mgpowdered strawberry flavoring 30.00 mgpowdered raspberry flavoring 30.00 mgsucrose* qs 3000.00 mg______________________________________ *superfine sugar and Alveosugar in a 1/1 ratio approximately. (c) Distribution of the final mixture in an amount of: 3 g for the 375,000 IU dosage 6 g for the 750,000 IU dosage 12 g for the 1,500,000 IU dosage per sachet of paper/aluminum/polyethylene complex. EXAMPLE 7 The procedures of Example 6 are repeated using qs 1 g sucrose in phase (a) per sachet of 3 g and 20 mg potassium acesulfame in phase (b). The preparations described above (Examples 2-7) were submitted to taste testing and rated on a scale of 1 to 20 where 20 was the highest score. The results are set forth in Table 1. TABLE 1______________________________________COMPARATIVE EXAMPLES 2 TO 5 INVENTIONC.sub.5 C.sub.2 C.sub.4 C.sub.3 7 6______________________________________spira- 375,000 375,000 375,000 375,000 375,000 375,000mycin(IU)sucrose qs 1 g qs 1 g qs 1 g qs 165 mgstarch 3.5 mgxanthan 15 mggumPVP 100 mgK ace- 20 mg 10 mgsulfameaspartame 10 mgsacchari- 25 mgnateEudragit 70 mgE ®mannitol 800 mgflavorings 20 mg 40 mg 40 mg 20 mg 60 mg 60 mgsucrose qs 2.5 g qs 3 g qs 1.25 qs 3 g qs 3 g qs 3 gscore out 6.25 poor 14 15 accept-of 20 non-bio inter- ableremarks equiva- action lent between spiramycin and aspartame______________________________________ The formulations according to the present invention (Examples 6 and 7) show a marked improvement compared with the prior art formulations regarding masking of the taste and aftertaste of spiramycin. The present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof and, accordingly, reference should be made to the appended claims, rather than the specification, as indicating the scope of the invention.

New formulations of spiramycin suitable for oral administration, particularly for children, comprise spiramycin and potassium acesulfame. These formulations mask the bitterness of spiramycin without adversely affecting the bioavailability or stability of the spiramycin. Preparation by wet granulation followed by dry state mixing is also disclosed.

CROSS-REFERENCES TO RELATED APPLICATIONS This is a continuation-in-part of U.S. Pat. application No. 217,997, now abandoned, filed Jan. 14, 1972 by the same inventors in Group Art Unit 172 for Food Resembling Cheese and Process For Making Same. BACKGROUND OF THE INVENTION The field of art to which the invention pertains is a food product resembling cheese or, in other words, imitation cheese. The particular cheeses that are resembled are the pasta filata and cheddar types. Applicants understand there are certain imitation cream cheeses on the market and know that imitation cream cheeses are described in U.S. Pat. No. 3,397,994 issued Aug. 20, 1968, entitled &#34;Imitation Cream Cheese Spread Containing Polyunsaturated Fat&#34;, and in U.S. Pat. No. 3,397,995 also issued Aug. 20, 1968, and entitled &#34;Edible Dietary Spread and Method of Making Same&#34;. However, Applicants were not aware of any imitation pasta filata or cheddar type cheese at the time of filing the parent application No. 217,997. SUMMARY OF THE INVENTION It is a general object of the present invention to provide a food resembling pasta filata or cheddar type cheese and the process of making the same. A more particular object of the present invention is to provide such a food which is less expensive than real pasta filata or cheddar type cheese. The imitation cheeses of the present invention are particularly suitable for use in such dishes as enchiladas, pizzas, tacos, sandwiches, sauces and other prepared foods in place of ordinary cheese. Other and further objects, features and advantages will be apparent from the following description of the invention given for the purpose of disclosure. The present invention is based upon the discovery that a food resembling pasta filata or cheddar type cheese can be economically produced by forming a substantially gas-free homogeneous blend of (a) an emulsion of water with a fat having a Wiley melting point between about 90° and 110° F., the fat being about 12 to 35% of the food, (b) about 15 to 33% calcium caseinate, preferably about 25%, (c) up to about 5% ungelatinized flour, and (d) about 0.5 to 1.8% adipic, lactic, citric, or malic acid, or combinations of such acids, the food having a pH of about 4.8 to 5.7 and including appropriate coloring and flavoring materials. In some instances, the ungelatinized flour may be omitted. In imitation cheddar-type cheese, there is normally included up to about 2% emulsifying salts, such as disodium phosphate and sodium aluminum phosphate. &#34;Substantially gas-free&#34;, as used herein, means that the product does not have air holes. In practicing the method of the present invention, the fat is melted and then an emulsion of the fat with water is formed under subatmospheric conditions to remove air from the emulsion. The dry ingredients, which include the calcium caseinate, are blended with the emulsion under high shear mixing, a subatmospheric condition and at a temperature above the melting point of the fat to form a substantially gas-free homogeneous blend of the dry ingredients and the emulsion. The purpose of the subatmospheric condition is to prevent the inclusion of gas in the product. The mixing is done under high shear conditions so that the blending of the dry ingredients with the emulsion takes place completely and quickly. If thorough mixing does not take place quickly, at least two harmful effects are created. One is that the dry ingredients will form lumps surrounded by an oily film which are extremely difficult to break down. The second is that the emulsion will break down and the product will take on a &#34;curdy&#34; appearance rather than a homogeneous blend resembling a pasta filata or cheddar type cheese. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a sectional side view of the Littleford-Lodige Model FM130D mixer identified later herein. FIG. 2 is an end view of the structure of FIG. 1. DESCRIPTION OF THE PREFERRED EMBODIMENTS The fat may be any of the edible fats used in shortenings or margarine having a melting point between 90° and 110° F. The preferred fat is refined, bleached and deodorized soybean oil hydrogenated to a melting point of about 95° F. and present in an amount equal to about 22 to 24% of the product. The preferred ungelatinized flour is tapioca flour. A product to properly resemble cheddar-type cheese must have proper melt-down characteristics, and to resemble pasta filata-type cheese, for example mozzarella, must also have acceptable stringiness and/or breakdown. Both imitation cheeses need acceptable eating characteristics in cooked and uncooked conditions. To obtain the characteristics of both the pasta filata and cheddar type cheeses, it is necessary in the process of the present invention that, in addition to the fat and water emulsion, there also be included the calcium caseinate, the ungelatinized flour, the particular acid or acids, and the pH must be controlled within the ranges specified. In some instances, if a non-stringy pasta filata-type cheese with greater breakdown tendencies is desired, the ungelatinized flour may be omitted. The ungelatinized flour is used to promote stringiness and also to aid in the firmness of the product which affects its sliceability and shredability. When ungelatinized flour is included, the amount used is preferably between about 1 and 5% of the food. Either adipic, lactic, citric or malic acids, or combinations of those acids must be included, but the exact chemical reason for this is not fully understood. Their function is to assist in the control of the pH range and to give proper firmness and melting qualities of the product when used on such materials as pizzas. The pH affects the flavor and the stringiness. If the pH is too high or too low, the food will not be stringy, and pasta filata-type cheese normally should be stringy. Also, the slightly acidic condition gives a desirable tart taste to the product. The preferred acid is adipic acid. The preferred amount of adipic acid in a mozzarella-type cheese is about 1.3% and in cheddar-type cheese is about 0.8%. The acid next most preferable to adipic is lactic acid. Imitation cheese made with lactic acid, when compared to the same product made using adipic acid, has about the same flavor, but has more tendency to crust and burn, has slightly inferior melting properties, has a greater tendency to curdiness, and is not as reliable in reproducability. Imitation cheese made with citric or malic acid, when compared to the same products made with adipic or lactic acid, have a generally satisfactory flavor, but their other properties are not nearly as favorable, that is, there is much more tendency to crust and burn, more inferior melting properties, greater tendency to curdiness, and less reliability in producability. This requirement of 0.5 to 1.8% of the use of either adipic, lactic, citric, malic, or combinations thereof, is required, and Applicants are not aware of any other acid that can be substituted. For example, phosphoric, succinic and fumaric acids have been tried and found to be quite unsatisfactory. For mozzarella-type imitation cheese, the pH of the product should be about 5.1 to 5.5, with about 5.1 being preferred. With a food resembling cheddar cheese, the pH should be about 4.8 to 5.7, with 5.1 being preferred. In cheddar cheese, the inclusion of an effective amount, up to about 2%, of emulsifying salts to give desired characteristics of melting, shredding and matting. Particularly, they assist in the desirable flow of the melt of the cheese when it is heated on other foods. Preferably about 0.85% disodium phosphate is used. In making the emulsion of fat and water, the preferred amount of water is approximately 46 or 47% of the weight of the final product. Water content depends on desired firmness of the final product and normally is between about 46 and 52%. Of course, conventional oil and water emulsifiers used in food products may be included. The most satisfactory apparatus known to Applicants to carry out the high shear mixing of the fat and water emulsion with dry ingredients including the calcium caseinate is a Littleford-Lodige high shear mixing vessel sold by Littlefore Brothers, Inc., Cincinnati, Ohio, U.S.A. The desired high shear mixing can be carried out with this equipment in less than four minutes, and preferably within two to three minutes. Referring now to the drawing, the Littleford-Lodige Model FM130D mixer includes a steam-jacketed cylindrical vessel 10 forming a generally horizontal cylindrical chamber 12 which is closed at both ends. A loading door 14 is on the top of the vessel and a discharging door 15 is at the bottom of the vessel 10 in line with the loading door 14. A vacuum line 16 communicates with the chamber 12 near the loading door 14 and a steam connection 20 is provided to admit steam to the steam jacket 21. An axle 22 extends along the axis of the chamber 12. Extending radially from the axle 22 are a series of arms 24 on the outer end of each of which is a plow-shaped impeller (or mixing element) 26 contoured to fit the inner surface of the chamber 12. These plow-shaped impellers project material being mixed away from the inner surface of the chamber 12 and hurl it toward the axis of the chamber. Protruding from the lower wall of the vessel 10 and into the chamber 12 is a high speed blending chopper driven by a motor 30. The chopper rotates at high speeds of approximately 3,600 r.p.m. to break up agglomerates. The following are examples of the present invention. EXAMPLE 1 An imitation mozzarella cheese was prepared from the following ingredients: ______________________________________Dry Ingredients PercentCalcium caseinate 24.55Tapioca flour 3.00Salt (NaCl) 2.16Adipic acid 0.60Vitamins and minerals 1.47Sorbid acid 0.10Artificial cheese flavor 0.50Fat-Color BlendSoybean oil hydrogenated to aWiley melting point of about95° F. 21.29Lactylated monoglycerideemulsifier 0.05Red-orange coloring 0.011Liquid-Flavor BlendVarious cream, cheese, starterand butter flavors 0.23Water-Color BlendColoring 0.05Water q.s. to 100%______________________________________ It is not necessary that there be coloring in both the fat-color blend and in the water-color blend. Similarly, the flavors need not all be in the liquid-flavor blend. For example, some of the flavoring could be in the dry ingredients and preferably a small amount of imitation cheese flavor is included in the dry ingredients. The particular set of ingredients or blend in which the flavoring or coloring material is placed depends upon the choice of the operator and the characteristics of the particular flavor or coloring material. If desired, especially to facilitate processing, a portion of the fat can be included in the dry ingredient mix. The sorbic acid is used to inhibit mold growth when the product is stored under exposure to air. In this example, the dry ingredients were formed into a dry blend mixture by mixing them in a large Hobart mixer Model M280 at No.2 speed for two minutes. The water-color mixture was prepared at 180° F. and put into a Littleford-Lodige Model FM130D mixer and held at that temperature by the stream jacket on the mixer. The fat-color blend was prepared at 160° and to this was added the liquid-flavor blend which, because of its small amount, need only be prepared at room temperature. This mixture was added to the contents of the Littleford-Lodige mixer and a vacuum of 20 inches of mercury was drawn on the mixer to remove the air entrapped in its contents. After about one minute of mixing at 180° F., the fat and water emulsion was formed. The vacuum was released and the dry blended mixture added to the mixer. A vacuum was again drawn to 20 inches of mercury and held during mixing at about 170° F. After about three minutes of mixing under these high shear conditions, the product, which had a pH of 5.3, was removed from the mixing vessel and packaged. After 3 days&#39; storage at 40° F., it was sufficiently firm to shred or slice properly. EXAMPLE 2 Using the process of Example 1, an imitation mozzarella cheese having a pH of about 5.1 was prepared from the following ingredients which did not include ungelatinized flour. ______________________________________Dry Ingredients PercentCalcium caseinate 24.65Salt (NaCl) 2.50Adipic acid 1.30Vitamins and minerals 1.47Sorbic acid 0.10Artificial cheese flavor 0.60Fat-Color BlendSoybean oil hydrogenated to aWiley melting point of about95° F. 22.7Red-orange coloring 0.007Liquid-Flavor BlendVarious cream, cheese, starterand butter flavors 0.26Water-Color BlendColoring 0.05Water q.s. to 100%______________________________________ EXAMPLE 3 Using the process of Example 1, an imitation cheddar cheese was prepared from the following ingredients: ______________________________________Dry Ingredients PercentCalcium caseinate 24.55Tapioca flour 0.20Salt (NaCl) 1.50Adipic acid 0.80Sorbic acid 0.10Cheese flavor 0.45Disodium phosphate 0.85Vitamins and minerals 1.47FatHydrogenated soybean oil havinga Wiley melting point of about95° F. 23.70Color-Flavor BlendApocarotenal color 0.005Various cream, cheese, starterand butter flavors 0.39Water q.s. to 100%______________________________________ This particular variety of imitation cheddar cheese had a pH of 5.1 and resembled natural current cheddar cheese often used in Mexican food dishes. It shredded properly without matting, making the product easy to use. It also melted properly when used in enchiladas which were heated at about 500° F. for three minutes. The melting was sufficient to enhance the eating properties but was not excessive. EXAMPLE 4 This is an example using a mixture of citric and adipic acids. In this instance, the imitation cheese had 49.2% water, 22.5% calcium caseinate, 3% tapioca flour, 2% modified whey protein, 2% salt, 0.75% citric acid, 0.25% adipic acid, 20% hydrogenated soybean oil and various flavoring agents. The imitation cheese had good slicing and shredability characteristics and on pizzas it performed very well, having a good appearance, no crust and excellent flavor. EXAMPLE 5 Here, citric acid was used without combining it with adipic, lactic or malic acid. In this example, the imitation cheese had 51.63% water, 1% vegetable gum, 24% calcium caseinate, 1% citric acid, 2.12% salt, 20% hydrogenated vegetable oil, and various artificial flavors. The finished product had good shredability, and when used on pizzas, had good string, very slight curd and a satisfactory appearance. EXAMPLE 6 Here, lactic acid was used without combining it with adipic, citric or malic acid. In this example, the imitation cheese was comprised of 24.185% calcium caseinate, 3.0% tapioca flour, 0.5% modified whey protein, 2.15% salt, 0.1% sorbic acid, 0.5% artificial flavors, 0.75% lactic acid, 47.0% water and 21.5% hydrogenated vegetable oil, together with various artificial colors. The finished product had good melt, good string and good appearance on pizzas. The flavor was satisfactory although it was not as preferable as a cheese made with adipic acid. EXAMPLE 7 This is an example using malic acid. This example is the same as Example 6 except that 1.3% malic acid was used in place of the lactic acid. The finished product had fairly good characteristics of sliceability and texture. It melted fairly well on pizzas and had a good appearance and breakdown with only a slight amount of curdiness, but in general was not as acceptable as an adipic acid control sample. From the foregoing discussion, examples and description of the invention, it is apparent that the objects set forth herein as well as others have been achieved. Those skilled in the art will recognize that the principles of this invention may be applied in several ways, only a few of which have been exemplified here specifically.

A food resembling pasta filata cheese or cheddar cheese is produced by forming a substantially gas-free homogeneous blend of fat, water, calcium caseinate, ungelatinized flour and certain acids. The blend is formed under high shear mixing at subatmospheric conditions.

REFERENCE TO RELATED APPLICATION This application is a continuation of International Application Number PCT/US2004/023304 filed Jul. 19, 2004 which claims the benefit under 35 U.S.C. §119(e) of Provisional Application No. 60/488,332 filed Jul. 18, 2003, the contents of which are incorporated herein in their entirety. FIELD OF THE INVENTION This is directed to methods and devices for altering gaseous flow within a lung to improve the expiration cycle of an individual, particularly individuals having chronic obstructive pulmonary disease. The methods and devices create channels in lung tissue and maintain the patency of these surgically created channels in tissue. Maintaining the patency of the channels allows air to pass directly out of the lung tissue which facilitates the exchange of oxygen ultimately into the blood and/or decompresses hyper-inflated lungs. BACKGROUND OF THE INVENTION The American Lung Association (ALA) estimates that nearly 16 million Americans suffer from chronic obstructive pulmonary disease (COPD) which includes diseases such as chronic bronchitis, emphysema, and some types of asthma. The ALA estimated that COPD was the fourth-ranking cause of death in the U.S. The ALA estimates that about 14 million and 2 million Americans suffer from emphysema and chronic bronchitis respectively. Those inflicted with COPD face disabilities due to the limited pulmonary functions. Usually, individuals afflicted by COPD also face loss in muscle strength and an inability to perform common daily activities. Often, those patients desiring treatment for COPD seek a physician at a point where the disease is advanced. Since the damage to the lungs is irreversible, there is little hope of recovery. Most times, the physician cannot reverse the effects of the disease but can only offer treatment and advice to halt the progression of the disease. To understand the detrimental effects of COPD, the workings of the lungs requires a cursory discussion. The primary function of the lungs is to permit the exchange of two gasses by removing carbon dioxide from arterial blood and replacing it with oxygen. Thus, to facilitate this exchange, the lungs provide a blood gas interface. The oxygen and carbon dioxide move between the gas (air) and blood by diffusion. This diffusion is possible since the blood is delivered to one side of the blood-gas interface via small blood vessels (capillaries). The capillaries are wrapped around numerous air sacs called alveoli which function as the blood-gas interface. A typical human lung contains about 300 million alveoli. The air is brought to the other side of this blood-gas interface by a natural respiratory airway, hereafter referred to as a natural airway or airway, consisting of branching tubes which become narrower, shorter, and more numerous as they penetrate deeper into the lung. Specifically, the airway begins with the trachea which branches into the left and right bronchi which divide into lobar, then segmental bronchi. Ultimately, the branching continues down to the terminal bronchioles which lead to the alveoli. Plates of cartilage may be found as part of the walls throughout most of the airway from the trachea to the bronchi. The cartilage plates become less prevalent as the airways branch. Eventually, in the last generations of the bronchi, the cartilage plates are found only at the branching points. The bronchi and bronchioles may be distinguished as the bronchi lie proximal to the last plate of cartilage found along the airway, while the bronchiole lies distal to the last plate of cartilage. The bronchioles are the smallest airways that do not contain alveoli. The function of the bronchi and bronchioles is to provide conducting airways that lead air to and from the gas-blood interface. However, these conducting airways do not take part in gas exchange because they do not contain alveoli. Rather, the gas exchange takes place in the alveoli which are found in the distal most end of the airways. The mechanics of breathing include the lungs, the rib cage, the diaphragm and abdominal wall. During inspiration, inspiratory muscles contract increasing the volume of the chest cavity. As a result of the expansion of the chest cavity, the pleural pressure, the pressure within the chest cavity, becomes sub-atmospheric. Consequently, air flows into the lungs and the lungs expand. During unforced expiration, the inspiratory muscles relax and the lungs begin to recoil and reduce in size. The lungs recoil because they contain elastic fibers that allow for expansion, as the lungs inflate, and relaxation, as the lungs deflate, with each breath. This characteristic is called elastic recoil. The recoil of the lungs causes alveolar pressure to exceed atmospheric pressure causing air to flow out of the lungs and deflate the lungs. ‘If the lungs’ ability to recoil is damaged, the lungs cannot contract and reduce in size from their inflated state. As a result, the lungs cannot evacuate all of the inspired air. In addition to elastic recoil, the lung&#39;s elastic fibers also assist in keeping small airways open during the exhalation cycle. This effect is also known as “tethering” of the airways. Tethering is desirable since small airways do not contain cartilage that would otherwise provide structural rigidity for these airways. Without tethering, and in the absence of structural rigidity, the small airways collapse during exhalation and prevent air from exiting thereby trapping air within the lung. Emphysema is characterized by irreversible biochemical destruction of the alveolar walls that contain the elastic fibers, called elastin, described above. The destruction of the alveolar walls results in a dual problem of reduction of elastic recoil and the loss of tethering of the airways. Unfortunately for the individual suffering from emphysema, these two problems combine to result in extreme hyperinflation (air trapping) of the lung and an inability of the person to exhale. In this situation, the individual will be debilitated since the lungs are unable to perform gas exchange at a satisfactory rate. One further aspect of alveolar wall destruction is that the airflow between neighboring air sacs, known as collateral ventilation or collateral air flow, is markedly increased as when compared to a healthy lung. While alveolar wall destruction decreases resistance to collateral ventilation, the resulting increased collateral ventilation does not benefit the individual since air is still unable to flow into and out of the lungs. Hence, because this trapped air is rich in CO 2 , it is of little or no benefit to the individual. Chronic bronchitis is characterized by excessive mucus production in the bronchial tree. Usually there is a general increase in bulk (hypertrophy) of the large bronchi and chronic inflammatory changes in the small airways. Excessive amounts of mucus are found in the airways and semisolid plugs of this mucus may occlude some small bronchi. Also, the small airways are usually narrowed and show inflammatory changes. Currently, although there is no cure for COPD, treatment includes bronchodilator drugs, and lung reduction surgery. The bronchodilator drugs relax and widen the air passages thereby reducing the residual volume and increasing gas flow permitting more oxygen to enter the lungs. Yet, bronchodilator drugs are only effective for a short period of time and require repeated application. Moreover, the bronchodilator drugs are only effective in a certain percentage of the population of those diagnosed with COPD. In some cases, patients suffering from COPD are given supplemental oxygen to assist in breathing. Unfortunately, aside from the impracticalities of needing to maintain and transport a source of oxygen for everyday activities, the oxygen is only partially functional and does not eliminate the effects of the COPD. Moreover, patients requiring a supplemental source of oxygen are usually never able to return to functioning without the oxygen. Lung volume reduction surgery is a procedure which removes portions of the lung that are over-inflated. The portion of the lung that remains has relatively better elastic recoil, providing reduced airway obstruction. The reduced lung volume also improves the efficiency of the respiratory muscles. However, lung reduction surgery is an extremely traumatic procedure which involves opening the chest and thoracic cavity to remove a portion of the lung. As such, the procedure involves an extended recovery period. Hence, the long term benefits of this surgery are still being evaluated. In any case, it is thought that lung reduction surgery is sought in those cases of emphysema where only a portion of the lung is emphysematous as opposed to the case where the entire lung is emphysematous. In cases where the lung is only partially emphysematous, removal of a portion of emphysematous lung which was compressing healthier portions of the lung allows the healthier portions to expand, increasing the overall efficiency of the lung. If the entire lung is emphysematous, however, removal of a portion of the lung removes gas exchanging alveolar surfaces, reducing the overall efficiency of the lung. Lung volume reduction surgery is thus not a practical solution for treatment of emphysema where the entire lung is diseased. Both bronchodilator drugs and lung reduction surgery fail to capitalize on the increased collateral ventilation taking place in the diseased lung. There remains a need for a medical procedure that can alleviate some of the problems caused by COPD. There is also a need for a medical procedure that alleviates some of the problems caused by COPD irrespective of whether a portion of the lung, or the entire lung is emphysematous. The production and maintenance of collateral openings through an airway wall allows air to pass directly out of the lung tissue responsible for gas exchange. These collateral openings serve to decompress hyper inflated lungs and/or facilitate an exchange of oxygen into the blood. It was found that creation of collateral channels in COPD patients allowed expired air to pass out of the lungs and decompressed hyper-inflated lungs. Such methods and devices for creating and maintaining collateral channels are discussed in U.S. patent application Ser. No. 09/633,651, filed on Aug. 7, 2000; U.S. patent application Ser. Nos. 09/947,144, 09/946,706, and 09/947,126 all filed on Sep. 4, 2001; U.S. Provisional Application No. 60/317,338 filed on Sep. 4, 2001; U.S. Provisional Application No. 60/334,642 filed on Nov. 29, 2001; U.S. Provisional Application No. 60/367,436 filed on Mar. 20, 2002; and U.S. Provisional Application No. 60/374,022 filed on Apr. 19, 2002 each of which is incorporated by reference herein in its entirety. It was found that creating an opening/channel through an airway wall overcomes the shortcomings associated with bronchodilator drugs and lung volume reduction surgery. To further improve the benefit provided by the channel a need further remains to extend the duration of which the channel remains open (e.g., patency of the opening). Surgically creating a hole in tissue triggers a healing cascade. The body&#39;s natural healing response sets into motion, amongst other things, cell proliferation which can result in a build-up of scar tissue. This tissue overgrowth can occlude or otherwise close the surgically created opening. Additionally, in the event an implant is deployed in the surgically created opening to maintain the patency of the opening, the implant may become encapsulated or filled with tissue thereby occluding the channel. Drug eluting coronary-type stents are not known to overcome the above mentioned events because these stents are often substantially cylindrical (or otherwise have a shape that conforms to the shape of a tubular blood vessel). Hence, they may slide and eject from surgically created openings in an airway wall leading to rapid closure of any channel. Additionally, the design and structure of the coronary-type stents reflect the fact that these stents operate in an environment that contains different tissues when compared to the airways not to mention an environment where there is a constant flow of blood against the stent. Moreover, the design of coronary stents also acknowledges the need to avoid partial re-stenosis of the vessel after stent placement. In view of the above, implants suited for placement in the coronary are often designed to account for factors that may be insignificant when considering a device for the airways. Not surprisingly, experiments in animal models found that placement of a paclitaxel drug eluting vascular stent into the opening did not yield positive results in maintaining the patency of the opening. The shortcomings were both in the physical structure of the stent along with the failure to control the healing cascade caused by creation of the channel. An understanding of the distinctions between the healing response in the coronary versus the airways may explain this outcome. For purposes of our discussion, the healing response in both the coronary and the lungs may be divided into approximately four stages as measured relative to the time of the injury: 1) acute phase; 2) sub-chronic phase; 3) chronic phase; and 4) late phase. In the coronary, after trauma caused by the placement of a coronary stent, the healing process begins in the acute phase with thrombus and acute inflammation. During the sub-chronic phase, there is an organization of the thrombus, an acute/chronic inflammation and early neointima hyperplasia. In the following chronic phase, there is a proliferation of smooth muscle cells along with chronic inflammation and adventitial thickening. In the late stage of the healing process there is chronic inflammation, neointimal remodeling, medial hypertrophy and adventitial thickening. Based upon the observations in a rabbit model, the healing response in the airway begins with a fibrinous clot, edema hemorrhage, and fibrin deposition. In the sub-chronic phase there is re-epithelialization, mucosal hypertrophy, squamous metaplasia, fibroplasias and fibrosus. In the chronic phase, while the epithelium is intact and there is less mucosal hypertrophy, there is still fibroplasia and fibrosis. In the late stage the respiratory epithelium is intact and there is evidence of a scar. In view of the above, a need remains to create channels in airways of COPD patients. A need also remains for methods and devices for creating the channels and placing conduits therein such that the patency of the opening is extended. SUMMARY OF THE INVENTION The invention includes methods and devices for treating a lung suspected of having chronic obstructive pulmonary disease through the creation of collateral channels. The invention also includes extending the duration during which these channels remain open (e.g., maintaining patency.) In one variation, the invention includes a method comprising selecting a treatment site in an airway of the lung, creating a hole in an airway wall of the airway; and expanding the hole in the airway wall. Selecting the treatment site may include visual inspection of the site or inspection for the presence or absence of a blood vessel underneath the surface of the airway wall. Selection of the site may be performed or aided by non-invasive imaging. Such imaging may include x-ray, ultrasound, Doppler, acoustic, MRI, PET, and computed tomography (CT) scans. Furthermore, a substance may be administered into the lungs to assist in the selection of the treatment site. For example, the substance may comprise a hyperpolarized gas, a thermochromatic dye, a regular dye, and/or a contrast agent. Variations of the invention include the use of a less-traumatic holemaker for creation of the channel (note that a channel includes a hole that is created and subsequently expanded.) The less traumatic holemaker may include a piercing member (e.g., a needle, a cannula, a blade, a tube, a rod or other similar structure). The less traumatic holemaker may also include devices which minimize the collateral damage to tissue (e.g., low temperature RF devices, pulsating RF, low temperature laser, ultrasound, high pressure water, etc.) In particular, the devices and methods prevent closure of the channel such that air may flow through the channel and into the airway. Such channels may be made by a variety of methods as discussed in the patents incorporated by reference above. For example, the channel may be made via a surgical incision, a needle, a rotary coring device, etc. Furthermore, the channel may be made by an energy based device, e.g., RF device, laser, etc. However, it has been noted that use of low temperature devices, e.g., mechanical devices, to create the channel result in less trauma to surrounding tissue and thereby minimize the healing response of the tissue. Accordingly, such modes of creating the channel often result in less occlusion of the channel. The method includes expanding the hole by inserting a conduit into the hole. Furthermore, the method may comprise partially expanding the hole by deploying the conduit in the hole, and then fully expanding the hole by expanding the conduit within the hole. Preventing closure may be performed using various approaches including, but not limited to, biochemical, electrical, thermal, irradiation, or mechanical approaches (or any combination thereof). The method may also include delivering a bio-active composition, as described herein, to maintain patency of the channel or conduit. The bio-active composition may be delivered to the airway wall prior to creation of the channel, subsequent to creation of the channel, and/or after insertion and deployment of the conduit. The bio-active composition may also be delivered through a drug eluting process, either through a composition placed on the conduit, or via delivery of a separate eluting substance. Biochemical approaches include delivery of medicines that inhibit closure of the surgically created channel. The medicines may be delivered locally or systematically. In one variation, a delivery catheter includes a dispense lumen that sends a drug to the target site. Also, bioactive substances may be delivered to the channel tissue using various delivery vehicles such as a conduit. The bioactive substance may be disposed on an exterior surface of the conduit such that it interacts with the channel tissue when the conduit is placed at the injury site. Also, bioactive substances may be delivered to the channel tissue before or after the conduit is positioned in the channel. The bioactive agent may also be delivered to the target site alone. That is, a medicine may be sent to the surgically created channel as the sole mechanism for maintaining the patency of the channel. Also, systematic delivery of medicines may be carried out through digestion, injection, inhalation, etc. Systematic delivery of medicines may be provided alone or in combination with other techniques described herein. For example, a patient having undergone the procedures described herein may be prescribed steroids and/or COX-2 inhibitors in an attempt to prolong the effects of the treatment. Any of the conduits discussed herein may also include at least one visualization feature disposed on a portion of the tissue barrier. The visualization feature may be a stripe circumferentially disposed about at least a portion of the center section. The visualization feature serves to aid in placement or deployment of the conduit in a target site. Another conduit for maintaining the patency of a channel created in tissue comprises a radially expandable center section and extension members as described above. A bioactive substance is disposed on at least a portion of a surface of the conduit. Also, when the conduit is radially expanded it has an overall length and an inner diameter such that a ratio of the overall length to the inner diameter ranges from 1/6 to 2/1. The conduit may also be provided such that this ratio ranges from 1/4 to 1/1 and perhaps, 1/4 to 1/2. A tissue barrier may be disposed on at least a portion of the exterior surface corresponding to the center section. The tissue barrier may be comprised of various materials including but not limited to polymers and elastomers. An example of a material which may be used for the tissue barrier is silicone. Additional matrixes of biodegradable polymer and medicines may be associated with the tissue barrier such that controlled doses of medicines are delivered to the tissue opening. The invention includes a hole-making catheter for creating and dilating an opening within tissue, the catheter comprising an elongate shaft having a proximal portion and a distal portion, and at least one lumen extending through the proximal end; a balloon having an interior in fluid communication with the lumen, the balloon located on the distal portion of the elongate shaft, the balloon having an uninflated state and an inflated state; a piercing member located at the distal portion of the elongate shaft, the piercing member being extendable and retractable within the elongate shaft; and a depth limiter stop located on the exterior of the distal portion of the elongate shaft, proximal to the balloon and larger in working diameter than the uninflated balloon, which limits the maximum penetration of the catheter into tissue. The piercing member may include a body portion having a lumen extending therethrough. The lumen of the piercing member may be in fluid communication with a central lumen of the elongate shaft. In some variations of the invention an obturator is used within the device, where the obturator is slidably located within the lumen of the elongate body and piercing member. The elongate body and/or piercing member may have multiple lumens. For example, they may be constructed from multi-lumen tubing. In some variations, the piercing member is retractable within the elongate shaft. The balloon member may consist of a distensible balloon or a non-distendsible balloon. For either type of balloon, the working diameter may closely match the outer diameter of the piercing member. The invention may also include an implant located about the balloon of the device. In use, the piercing member would create a channel within the tissue, the device is then further advanced until the implant is located within the channel. Inflation of the balloon then deploys the implant within the channel thereby improving the patency of the channel. Implants for the present invention include, but are not limited to, a stent, conduit, grommet, valve, graft, anchor, etc. It should be noted that since the device must often access airways deep within the lung, the elongate shaft may be comprised of a flexible material. In particular, the elongate shaft may be sufficiently flexible to pass through a fully articulated bronchoscope. The piercing member of the current invention may also be used to deliver bio-active agents to the site of the collateral channel. As described herein, such agents may increase the duration of patency of the channels and/or implants. The invention includes a balloon catheter for deploying a device within an opening in tissue, the balloon catheter comprising an elongate shaft having a proximal portion, a distal portion, a proximal end, a distal end; and at least one lumen extending through the proximal end, a balloon having an interior in fluid communication with the lumen, the balloon located on the distal end portion of the elongate shaft, a guide member extending distally from the distal end of the elongate shaft, the guide member comprising a rounded surface at an end opposite to the elongate shaft, where the guide member has sufficient column strength to penetrate the opening in tissue, the guide member further comprising at least one resistance surface a such that when the body enters the opening, the resistance surface exerts resistance against tissue upon removal of the guide member from the opening. The resistance surface may have an increased diameter greater to provide resistance upon removal from tissue. It may alternatively, or in combination, comprise a rough surface to provide added friction upon removal of the device. The guide member may be tapered, rounded, partially-spherical, elliptical, prolate, cone-shaped, triangular, or any similar shape. It is contemplated that there may be more than one resistance surface on the guide body. Moreover, the guide body may have a wavy/variable diameter shape providing several resistance surfaces on the areas of increased diameter. The device may also be used with an implant that may be located about the balloon where upon expansion of the balloon, the implant deploys. The implant may be selected from a stent, conduit, grommet, valve, graft, and anchor. In another variation of the invention, the balloon catheter may further comprise a dilating member located distally of the balloon. The dilating member may be is located on the distal portion of the shaft between the distal end and the balloon and may comprise a tapered section, a second balloon, or other similar structure. In some variations of the invention, the dilating member may be retractable within the elongate shaft. The device may also include a needle assembly moveably located in the instrument lumen, where the needle assembly is advanceable through a hole-making lumen and out of the opening in the rounded surface. The balloon catheter may be constructed to be sufficient flexibility to advance through a fully articulated bronchoscope. The balloon catheter may also be configured to deliver bio-active substances (e.g., drugs, medicines, compounds, etc.) to the tissue, either via the elongate tube or the guide member. Furthermore, the device may be adapted to provide suction to clear the target site. The invention includes a hole-making catheter for creating and dilating an opening within tissue, the catheter comprising; an elongate shaft having a proximal portion and a distal portion, and at least one lumen extending through the proximal end; a nondistensible balloon having an interior in fluid communication with the lumen, the nondistensible balloon located on the distal portion of the elongate shaft; and a piercing member located at the distal portion of the elongate shaft, the piercing member being extendable and retractable within the elongate shaft. The invention includes an implant delivery system for deploying the implant within a wall of tissue, the system comprising; an elongate shaft having a distal portion, a proximal end, a distal end, at least one lumen extending through the proximal end; a balloon member having an interior in fluid communication with the lumen, the balloon member located on the distal portion of the elongate shaft; a piercing member distally located to the distal end of the elongate shaft within the second lumen, the solid piercing member having a sharpened distal end adapted to penetrate tissue; and an expandable implant located about the balloon member. The preceding illustrations are examples of the invention described herein. It is contemplated that, where possible, combinations of features/aspects of specific embodiments or combinations of the specific embodiments themselves are within the scope of this disclosure. This application is also related to the following applications 60/420,440 filed Oct. 21, 2002; 60/387,163 filed Jun. 7, 2002; Ser. No. 10/235,240 filed Sep. 4, 2002; Ser. No. 09/947,144 filed Sep. 4, 2001; Ser. No. 09/908,177 filed Jul. 18, 2001; Ser. No. 09/633,651 filed Aug. 7, 2000; and 60/176,141 filed Jan. 14, 2000; Ser. No. 10/080,344 filed Feb. 21, 202; Ser. No. 10/079,605 filed Feb. 21, 2002; Ser. No. 10/280,851 filed Oct. 25, 2002; and Ser. No. 10/458,085 filed Jun. 9, 2003. Each of which is incorporated by reference herein. BRIEF DESCRIPTION OF THE DRAWINGS FIGS. 1A-1C illustrate various states of the natural airways and the blood-gas interface. FIG. 1D illustrates a schematic of a lung demonstrating a principle of the invention described herein. FIG. 2A illustrates a side view of a conduit in an undeployed state. FIG. 2B illustrates a side view of the conduit of FIG. 2A shown in a deployed shape. FIG. 2C illustrates a front view of the conduit shown in FIG. 2B . FIG. 2D is a cylindrical projection of the undeployed conduit shown in FIG. 2A . FIG. 2E illustrates a side view of another variation of a conduit in an undeployed shape. FIG. 2F illustrates a side view of the conduit of FIG. 2E in a deployed state. FIG. 2G is a cylindrical projection of the undeployed conduit shown in FIG. 2E . FIG. 3A illustrates a side view of a conduit having a tissue barrier in a deployed state. FIG. 3B illustrates a side view of a conduit having a tissue barrier. FIG. 3C is a front view of the conduit shown in FIG. 3B . FIG. 3D illustrates a conduit positioned in a channel created in a tissue wall. FIG. 3E is a cross sectional view of the conduit shown in FIG. 3B taken along line 3 E- 3 E. FIGS. 3F-3G depict another conduit including a membrane that supports a bioactive substance; the bioactive substance may be coated on the membrane. FIGS. 4A-4C a variation of selecting a site, creating a channel at the site using a less traumatic hole-maker, and expanding the channel. FIGS. 4D-4K illustrate variations of piercing members for creating collateral channels. FIGS. 5A-5C illustrate a method for deploying a conduit. FIGS. 5D-5E illustrate a method for deploying a conduit within another implant. FIGS. 6A-6B illustrate a method for deploying a conduit at an angle. FIGS. 7A-7B illustrate placement of a conduit within a channel by using a guide member. FIGS. 8A-8F illustrate additional variations of guide bodies for use with catheters of the present invention. FIGS. 9A-9B illustrate additional features for use with guide bodies of the present invention. DETAILED DESCRIPTION OF THE INVENTION Described herein are devices (and methods) for improving the gas exchange in the lung. In particular, methods and devices are described that serve to maintain collateral openings or channels through an airway wall so that air is able to pass directly out of the lung tissue and into the airways. This facilitates exchange of oxygen into the blood and decompresses hyper inflated lungs. By “channel” it is meant to include, but not be limited to, any opening, hole, slit, channel or passage created in the tissue wall (e.g., airway wall). The channel may be created in tissue having a discrete wall thickness and the channel may extend all the way through the wall. Also, a channel may extend through lung tissue which does not have well defined boundaries such as, for example, parenchymal tissue. The channels may be maintained by preventing or inhibiting tissue from growing into or otherwise blocking the channel. Chemical, electrical, light, mechanical, or a combination of any two or more of these approaches may be performed to maintain the channel openings. For example, the channel walls may be treated with a bioactive agent which inhibits tissue growth. The bioactive agent may be delivered locally or systematically. Also, the channels may be treated with rf energy, heat, electrical energy, or radiation to inhibit tissue overgrowth. These treatments may be performed once, periodically, or in response to the severity of the channel blockage. For example, the tissue blockage may be periodically removed with a laser or another tissue-removal tool. Also, mechanical devices and instruments may be deployed in the channel to prevent tissue growth from blocking the channel. Mechanical devices include without limitation conduits, valves, sponges, etc. These mechanical devices may be deployed permanently or temporarily. If deployed temporarily, the devices are preferably left in the channel for a sufficient amount of time such that the channel tissue heals coaxially around the device. FIGS. 1A-1C are simplified illustrations of various states of a natural airway and a blood gas interface found at a distal end of those airways. FIG. 1A shows a natural airway 100 which eventually branches to a blood gas interface 102 . Although not shown, the airway comprises an internal layer of epithelial pseudostratified columnar or cuboidal cells. Mucous secreting goblet cells are also found in this layer and cilia may be present on the free surface of the epithelial lining of the upper respiratory airways. Supporting the epithelium is a loose fibrous, glandular, vascular lamina propria including mobile fibroblasts. Deep in this connective tissue layer is supportive cartilage for the bronchi and smooth muscle for the bronchi and bronchioles. FIG. 1B illustrates an airway 100 and blood gas interface 102 in an individual having COPD. The obstructions 104 impair the passage of gas between the airways 100 and the interface 102 . FIG. 1C illustrates a portion of an emphysematous lung where the blood gas interface 102 expands due to the loss of the interface walls 106 which have deteriorated due to a bio-chemical breakdown of the walls 106 . Also depicted is a constriction 108 of the airway 100 . It is generally understood that there is usually a combination of the phenomena depicted in FIGS. 1A-1C . Often, the states of the lung depicted in FIGS. 1B and 1C may be found in the same lung. FIG. 1D illustrates airflow in a lung 118 when conduits 200 are placed in collateral channels 112 . As shown, collateral channels 112 (located in an airway wall) place lung tissue 116 in fluid communication with airways 100 allowing air to pass directly out of the airways 100 whereas constricted airways 108 may ordinarily prevent air from exiting the lung tissue 116 . While the invention is not limited to the number of collateral channels which may be created, it is to be understood that 1 or 2 channels may be placed per lobe of the lung and perhaps, 2-12 channels per individual patient. However, as stated above, the invention includes the creation of any number of collateral channels in the lung. This number may vary on a case by case basis. For instance, in some cases in an emphysematous lung, it may be desirable to place 3 or more collateral channels in one or more lobes of the lung. Although FIG. 1D depicts a mechanical approach to maintaining channels in the airway walls, the channel openings may be maintained using a variety of approaches or combinations of approaches. As shown in FIGS. 2A-2G , the conduits described herein generally include a center section 208 and at least one extension member (or finger) 202 extending from each end of the center section. The extension members, as will be discussed in more detail below, are capable of deflecting or outwardly bending to secure the conduit in an opening created in an airway wall thereby maintaining the patency of the opening. The extension members may deflect such that opposing extension members may form a V, U or other type of shape when viewed from the side. Additionally, the conduits shown in FIGS. 2A-2G include a center-control segment 235 , 256 which restricts or limits radial expansion of the center section. The center-control segments are adapted to straighten as the center section is radially expanded. Once the center-control segments become straight or nearly straight, radial expansion of the conduit is prevented. In this manner, the radial expansion of the conduit may be self controlled. It is understood that the conduits discussed herein are not limited to those shown in the figures. Instead, conduits of various configurations may be used as described herein. Such conduits are described in the following patent applications Ser. No. 09/908,177 filed Jul. 18, 2001; PCT/US03/12323 filed Apr. 21, 2003; Ser. No. 09/947,144 filed Sep. 4, 2001; Ser. No. 10/235,240 filed Sep. 4, 2002; and Ser. No. 10/458,085 filed Jun. 9, 2003 the entirety of each of which is hereby incorporated by reference. Conduit States The conduits described herein may have various states (configurations or profiles) including but not limited to (1.) an undeployed state and (2.) a deployed state. The undeployed state is the configuration of the conduit when it is not secured in an opening in an airway wall and, in particular, when its extension members (or fingers) are not outwardly deflected to engage the airway wall. FIG. 2A is a side view of a conduit 200 in an undeployed state. As shown in this figure, extension members 202 A, 202 B extend straight from the ends 210 , 212 respectively of center section 208 . The extension members shown in this example are parallel. However, the invention is not so limited and the extension members need not be parallel. The deployed state is the configuration of the conduit when it is secured in a channel created in an airway wall and, in particular, when its extension members are outwardly bent to engage the airway wall such that the conduit is fixed in the opening. An example of a conduit in its deployed configuration is shown in FIGS. 2B and 2C . FIG. 2B is a side view of a conduit in its deployed state and FIG. 2C shows a front view of the conduit of FIG. 2B . Center Section of the Conduit As shown in FIGS. 2A-2D , the conduit includes a center section 208 having a short passageway. This center section may be a tubular-shaped open-frame (or mesh) structure having a plurality of ribs. Also, as explained in more detail below, the center section may be a sheet of material. The axial length of the center section or passageway may be relatively short. In FIGS. 2A-2D , the passageway&#39;s length is about equal to the width of a wire segment or rib. Here, the center section serves as a bridge or junction for the extension members and it is not required to be long. The axial length of the passageway may therefore be less than 1 mm and even approach 0 mm. In one example, the length of the center section is less than twice the square root of a cross sectional area of the center section. However, the center section may also have passageways which have lengths greater than 1 mm. The overall length (L) of the conduit may be distinguished from the length of the center section because the overall length includes the lengths of the extension members. Further, the overall length (L) is dependent on which state the conduit is in. The overall length of the conduit will typically be shorter when it is in a deployed state as shown in FIG. 2B than when it is in an undeployed state as shown in FIG. 2A . The overall length (L) for a deployed conduit may be less than 6 mm and perhaps, between 1 and 20 mm. FIG. 2C shows a front view of the conduit 200 shown in FIG. 2B . FIG. 2C shows the passageway having a hexagonal (or circular) cross section. The cross-section, however, is not so limited. The cross section may be circular, oval, rectangular, elliptical, or any other multi-faceted or curved shape. The inner diameter (D 1 ) of the center section, when deployed, may range from 1 to 10 mm and perhaps, from 2 to 5 mm. Moreover, in some variations, the cross-sectional area of the passageway, when deployed, may be between 0.2 mm 2 to 300 mm 2 and perhaps between 3 mm 2 and 20 mm 2 . The diameter of the center section, when deployed, thus may be significantly larger than the passageway&#39;s axial length (e.g., a 3 mm diameter and an axial length of less than 1 mm). This ratio of the center section length to diameter (D 1 ) may range from about 0:10 to 10:1, 0.1:6 to 2:1 and perhaps from 1:2 to 1:1. The diameter of the center section, when deployed, may also be nearly equal to the overall length (L) of the conduit 200 . This overall length (L) to diameter (D 1 ) ratio may range from 1:10 to 10:1, 1:6 to 2:1, and perhaps from 1:4 to 1:1. However, the invention is not limited to any particular dimensions or ratio unless so indicated in the appended claims. Rather, the conduit should have a center section such that it can maintain the patency of a collateral channel in an airway wall. The dimensions of the center section (and the conduit as a whole) may be chosen based on the tissue dimensions. When the channel is long in its axial length, for example, the length of the center section may likewise be long or identical to the channel&#39;s length. Extension Members of the Conduit As mentioned above, extending from the ends of the center section 208 are extension members 202 A, 202 B which, when the conduit is deployed, form angles A 1 , A 2 with a central axis of the passageway. When viewed from the side such as in FIG. 2B , opposing extension members may have a V, U, or other shape. The extension members 202 A, 202 B may thus outwardly rotate until they sandwich tissue (not shown) between opposing extension members. The angles A 1 , A 2 may vary and may range from, for example, 30 to 150 degrees, 45 to 135 degrees and perhaps from 30 to 90 degrees. Opposing extension members may thus form angles A 1 and A 2 of less than 90 degrees when the conduit is deployed in a channel. For example, angles A 1 and A 2 may range from 30 to 60 degrees when the conduit is deployed. The conduits of the present invention are effective and may maintain a surgically created opening despite not substantially sandwiching tissue between opposing extension members as described above. Additionally, it is not necessary for the conduits of the present invention to prevent air from flowing along the exterior of the conduit. That is, air may move into (and through) spaces between the exterior of the conduit and the interior wall of the tissue channel. Thus, fluidly sealing the edges of the conduit to prevent side flow or leakage around the conduit is not crucial for the conduits to be effective. However, the conduits of the present invention are not so limited and may reduce or eliminate side flow by, for example, increasing the angles A 1 and A 2 and adding sealant around the exterior of the conduit. Moreover, the angle A 1 may be different than angle A 2 . Accordingly, the conduit may include proximal extension members which are parallel (or not parallel) to the distal extension members. Additionally, the angle corresponding to each proximal extension member may be different or identical to that of another proximal extension member. Likewise, the angle corresponding to each distal extension member may be different or identical to that of another distal extension member. The extension members may have a length between 1 and 20 mm and perhaps, between 2 and 6 mm. Also, with reference to FIG. 2C , the outer diameter (D 2 ) of a circle formed by the free ends of the extension members may range from 2 to 20 and perhaps, 3 to 10 mm. However, the invention is not limited to the dimensions disclosed above. Furthermore, the length of the distal extension members may be different than the length of the proximal extension members. The length of the distal extension members may be, for example, longer than that of the proximal extension members. Also, the lengths of each proximal extension member may be different or identical to that of the other proximal extension members. Likewise, the lengths of each distal extension member may be different or identical to that of the other distal extension members. The number of extension members on each end of the center section may also vary. The number of extension members on each end may range from 2-10 and perhaps, 3-6. Also, the number of proximal extension members may differ from the number of distal extension members for a particular conduit. Moreover, the extension members may be symmetrical or non-symmetrical about the center section. The proximal and distal extension members may also be arranged in an in-line pattern or an alternating pattern. The extension members or the center section may also contain barbs or other similar configurations to increase adhesion between the conduit and the tissue. The extension members may also have openings to permit tissue ingrowth for improved retention. The shape of the extension members may also vary. They may be open-framed and somewhat petal-shaped as shown in FIGS. 2A-2D . In these figures, the extension members 202 A, 202 B comprise wire segments or ribs that define openings or spaces between the members. However, the invention is not so limited and the extension members may have other shapes. The extension members may, for example, be solid or they may be filled. In another variation the conduit is constructed to have a delivery state. The delivery state is the configuration of the conduit when it is being delivered through a working channel of a bronchoscope, endoscope, airway or other delivery tool. The maximum outer diameter of the conduit in its delivery state must therefore be such that it may fit within the delivery tool, instrument, or airway. In one variation, the conduit is radially expandable such that it may be delivered in a smaller working channel of a scope while maximizing the diameter to which the conduit may expand upon deployment. For example, sizing a conduit for insertion into a bronchoscope having a 2 mm or larger working channel may be desirable. Upon deployment, the conduit may be expanded to have an increased internal diameter (e.g., 3 mm.) However, the invention is not limited to such dimensions. It is contemplated that the conduits 200 may have center sections that are expanded into a larger profile from a reduced profile, or, the center sections may be restrained in a reduced profile, and upon release of the restraint, return to an expanded profile. Additionally, the conduit need not have a smaller delivery state. In variations where the center section is not able to assume a second smaller delivery profile, a maximum diameter of the first or deployed profile will be sufficiently small such that the conduit may be placed and advanced within an airway or a working channel of a bronchoscope or endoscope. Also, in cases where the conduit is self-expanding, the deployed shape may be identical to the shape of the conduit when the conduit is at rest or when it is completely unrestrained. Additionally the conduit may be partially expanded in its proximal region in the delivery state, as shown in figure X. The partially expanded portion would still me sized small enough to fit within the working channel of the bronchoscope, but would be significantly larger (e.g., 0.5-2 mm) larger that the distal portion of the conduit. This partial expansion allows for easy placement of the conduit by providing a physical stop for the conduit within the airway wall. After the conduit is placed the entire conduit can be expanded to its intended expanded shape. The partial expansion state can also be achieved by partially inflating the proximal section of the conduit with a separate balloon on the delivery device. Another possible method is to design the conduit to preferentially expand the proximal section before the distal section, thereby partially expanding the conduit to create the size differential, placing the stent inside the airway wall with the aid of the stop, and then fully expanding the conduit. Control Members The conduit 200 shown in FIGS. 2A-2D also includes diametric-control segments, tethers, or leashes 235 to control and limit the expansion of the center section 208 when deployed. This center-control segment 235 typically is shaped such that when the conduit radially expands, the center-control segment bends until it is substantially straight or no longer slack. Such a center-control segment 235 may be circular or annular shaped. However, its shape may vary widely and it may have, for example, an arcuate, semi-circular, V, or other type of shape which limits the expansion of the conduit. Typically, one end of the center-control segment is attached or joined to the center section at one location (e.g., a first rib) and the other end of the center-control segment is connected to the center section at a second location (e.g., a rib adjacent or opposite to the first rib). However, the center-control segments may have other constructs. For example, the center-control segments may connect adjacent or non-adjacent center section members. Further, each center-control segment may connect one or more ribs together. The center-control segments may further be doubled up or reinforced with ancillary control segments to provide added control over the expansion of the center section. The ancillary control segments may be different or identical to the primary control segments. FIG. 2B illustrates the conduit 200 in its deployed configuration. As discussed above, the center-control segments 235 may bend or otherwise deform until they maximize their length (i.e., become substantially straight) such as the center-control segments 235 shown in FIG. 2B . However, as discussed above, the invention is not so limited and other types of center-control segments may be employed. As shown in FIGS. 2E-2G , control segments 252 may also be used to join and limit the expansion of the extension members 254 or the control segments may be placed elsewhere on the conduit to limit movement of certain features to a maximum dimension. By controlling the length of the control segments, the shape of the deployed conduit may be controlled. In the conduit shown in FIGS. 2E-2G , the conduit includes both center-control segments 256 and distal control segments 252 . The center-control segments are arcuate shaped and join adjacent rib sections of the center section and the distal-control segments are arcuate and join adjacent distal extension members. FIG. 2F illustrates the conduit in a deployed configuration and shows the various control members straightening as the extension members and center section deploy. The proximal extension members, however, are not restricted by a control member and consequently may be deflected to a greater degree than the distal extension members. Accordingly, a conduit having control members connecting, for example, regions of the center section and having additional control segments connecting extension members, may precisely limit the maximum profile of a conduit when it is deployed. This is desirable where overexpansion of the conduit is hazardous. This also serves to control the deployed shape of the conduit by, for instance, forcing angle A 1 to differ from angle A 2 . Using control segments in this manner can provide for cone-shaped conduits if the various types of control-segments have different lengths. For example, providing longer proximal-control segments than distal-control segments can make angle A 1 larger than angle A 2 . Additionally, cylindrical-shaped conduits may be provided if the center-control segments and the extension-control segments are sized similarly such that angle A 1 equals angle A 2 . Again, the control segments straighten as the conduit expands and the conduit is thus prevented from expanding past a predetermined amount. The control segments, as with other components of the conduit, may be added or mounted to the center section or alternatively, they may be integral with the center section. That is, the control segments may be part of the conduit rather than separately joined to the conduit with adhesives or welding, for example. The control segments may also be mounted exteriorly or interiorly to the members to be linked. Additionally, sections of the conduit may be removed to allow areas of the conduit to deform more readily. These weakened areas provide another approach to control the final shape of the deployed conduit. Details for creating and utilizing weakened sections to control the final shape of the deployed conduit may be found in U.S. patent Ser. No. 09/947,144 filed on Sep. 4, 2001. Manufacture and Materials The conduit described herein may be manufactured by a variety of manufacturing processes including but not limited to laser cutting, chemical etching, punching, stamping, etc. For example, the conduit may be formed from a tube that is slit to form extension members and a center section between the members. One variation of the conduit may be constructed from a metal tube, such as stainless steel, 316L stainless steel, titanium, titanium alloy, nitinol, MP35N (a nickel-cobalt-chromium-molybdenum alloy), etc. Also, the conduit may be formed from a rigid or elastomeric material that is formable into the configurations described herein. Also, the conduit may be formed from a cylinder with the passageway being formed through the conduit. The conduit may also be formed from a sheet of material in which a specific pattern is cut. The cut sheet may then be rolled and formed into a tube. The materials used for the conduit can be those described above as well as a polymeric material, a biostable or implantable material, a material with rigid properties, a material with elastomeric properties, or a combination thereof. If the conduit is a polymeric elastic tube (e.g. a thermoplastic elastomer), the conduit may be extruded and cut to size, injection molded, or otherwise formed. Additionally, the conduits described herein may be comprised of a shape memory alloy, a super-elastic alloy (e.g., a NiTi alloy), a shape memory polymer, or a shape memory composite material. The conduit may be constructed to have a natural self-assuming deployed configuration, but is restrained in a pre-deployed configuration. As such, removal of the restraints (e.g., a sheath) causes the conduit to assume the deployed configuration. A conduit of this type could be, but is not limited to being, comprised from an elastic polymeric material, or shape memory material such as a shape memory alloy. It is also contemplated that the conduit could comprise a shape memory alloy such that, upon reaching a particular temperature (e.g., 98.5° F.), it assumes a deployed configuration. Also, the conduit described herein may be formed of a plastically deformable material such that the conduit is expanded and plastically deforms into a deployed configuration. The conduit may be expanded into its expanded state by a variety of devices such as, for example, a balloon catheter. The conduit&#39;s surface may be modified to affect tissue growth or adhesion. For example, an implant may comprise a smooth surface finish in the range of 0.1 micrometer to 0.01 micrometer. Such a finish may serve to prevent the conduit from being ejected or occluded by tissue overgrowth. On the other hand, the surface may be roughened or porous. The conduit may also comprise various coatings and tissue barriers as discussed below. Tissure Barrier FIG. 3A illustrates another variation of a conduit 200 having a tissue barrier 240 . The tissue barrier 240 prevents tissue ingrowth from occluding the collateral channel or passage of the conduit 200 . The tissue barrier 240 may coaxially cover the center section from one end to the other or it may only cover one or more regions of the conduit 200 . The tissue barrier may completely or partially cover the conduit so long as the ends are at least partially open. Moreover, the tissue barrier may only be placed on the center section of the conduit. The tissue barrier 240 may be located about an exterior of the conduit&#39;s surface, about an interior of the conduit&#39;s surface, or the tissue barrier 240 may be located within openings in the wall of the conduit&#39;s surface. Furthermore, in some variations of the invention, the center section 208 itself may provide an effective barrier to tissue ingrowth. The tissue barrier, of course, should not cover or block the entrance and exit of the passageway such that air is prevented from passing through the conduit&#39;s passageway. However, in some constructs, the tissue barrier may partially block the entrance or exit of the passageway so long as air may continue to pass through the conduit&#39;s passageway. The tissue barrier may be formed from a material, mesh, sleeve, or coating that is a polymer or an elastomer such as, for example, silicone, fluorosilicone, polyurethane, PET, PTFE, or expanded PTFE. Other biocompatible materials will work, such as a thin foil of metal, etc. The coatings may be applied, for example, by either dip coating, molding, spin-coating, transfer molding or liquid injection molding. Alternatively, the tissue barrier may be a tube of a material and the tube is placed either over and/or within the conduit. The tissue barrier may then be bonded, crimped, heated, melted, shrink fitted or fused to the conduit. The tissue barrier may also be tied to the conduit with a filament of, for example, a suture material. Still other techniques for attaching the tissue barrier include: solvent swelling applications and extrusion processes; wrapping a sheet of material about the conduit, or placing a tube of the material about the conduit and securing the tube to the conduit. The tissue barrier may be secured on the interior of the conduit by positioning a sheet or tube of material on the inside of the center section and securing the material therein. The tissue barrier may also be formed of a fine mesh with a porosity or treatment such that tissue may not penetrate the pores. For example, a ChronoFlex™ DACRON® or TEFLON® mesh having a pore size of 100-300 microns may be saturated with collagen or another biocompatible substance. This construct may form a suitable tissue barrier. The mesh may be coaxially attached to a frame such as the open frame structures disclosed above. Still other suitable frames include a continuous spiral metallic or polymeric element. Given the mesh&#39;s radial strength or lack thereof, the use of a reinforcement element serves to prevent the implant from collapsing. Also, as described below, other substances may be applied to the exterior surface of the conduit to control elution of various medicines. FIGS. 3B and 3C respectively illustrate a side view and a front view of another conduit 300 having a partial tissue barrier coating. The conduit 300 includes a center section 310 , a plurality of extension members 320 , and a partial tissue barrier 330 . The conduit 300 is thus different than that shown in FIG. 3A in that the center section is longer and that the tissue barrier 330 only partially covers the extension members 320 . In particular, the center section 310 shown in FIGS. 3B-3C is cylindrical or tubular-shaped. This shape may be advantageous when a relatively long passageway is desired. Also, it is to be understood that the overall (or three dimensional) shape of the center section, when deployed, is not limited to the shape shown here. Rather, it may have various shapes such as, for example, rectangular, tubular, conical, hour-glass, hemi-toroidal, etc. Additionally, the tissue barrier 330 covers only a first region 350 of the extension members and leaves a second region 340 of the extension members uncovered. The second or free region 340 of the extension members 320 is shown as being open-framed. However, the invention is not so limited. The second region of the extension members may be solid and it may include indentations, grooves, and recesses for tissue ingrowth. Also, the extension members may include small holes for tissue ingrowth. For example, the second region of the extension members may have a dense array of small holes. In any event, the conduits described herein may include at least one region or surface which is susceptible to tissue ingrowth or is otherwise adherent to the tissue. Accordingly, tissue ingrowth at the second region 340 of the extension members is facilitated while tissue growth into the passageway 325 is thwarted. As shown in FIG. 3D , tissue growth 360 into the uncovered region 340 further secures the extension members to the tissue wall 370 . Free region 340 of the extension members may also include tissue growth substances such as epithelial growth factors or agents to encourage tissue ingrowth. Accordingly, conduit 300 may be configured to engage the tissue wall 370 as well as to allow tissue to grow into predetermined regions of the conduit. Visualization Feature The conduit shown in FIG. 3A also includes a visualization ring or marker 242 . The marker 242 is visually apparent during a procedure. The marker is observed as the conduit is placed in a collateral channel and, when the marker is even with the opening of the channel, the conduit may be deployed. In this manner, the visualization feature facilitates alignment and deployment of the conduits into collateral channels. The visualization ring or mark may be a biocompatible polymer and have a color such as white. Also, the visualization feature may protrude from the center section or it may be an indentation(s). The visualization mark may also be a ring, groove or any other physical feature on the conduit. Moreover, the visualization feature may be continuous or comprise discrete segments (e.g., dots or line segments). The visualization feature may be made using a number of techniques. In one example, the mark is a ring formed of silicone and is white. The polymeric ring may be spun onto the tissue barrier. For example, a clear silicone barrier may be coated onto the conduit such that it coaxially covers the extension members and the center section as shown in FIG. 3A . Next, a thin ring of white material such as a metal oxide suspended in clear silicone may be spun onto the silicone coating. Finally, another coating of clear silicone may be applied to coat the white layer. The conduit thus may include upwards of 1-3 layers including a tissue barrier, a visualization mark layer, and a clear outer covering. The shape of the visualization mark is not limited to a thin ring. The visualization mark may be large, for example, and cover an entire half of the conduit as shown in FIG. 3B . The visualization mark may, for example, be a white coating disposed on the proximal or distal half of the conduit. The visualization mark thus may extend from an end of the extension members to the center section of the conduit. As explained in more detail below, when such a device is deposited into a channel created in lung tissue, the physician may observe when one-half of the conduit extends into the channel. This allows the physician to properly actuate or deploy the conduit to secure the conduit in the tissue wall. Accordingly, the visualization member is made visually apparent for use with, for example, an endoscope. The visualization feature, however, may also be made of other vision-enhancing materials such as radio-opaque metals used in x-ray detection. It is also contemplated that other elements of the conduit can include visualization features such as but not limited to the extension members, tissue barrier, control segments, etc. In some variations of the invention, it was found that incorporation of a bioactive, as discussed herein, or other substance into the coating caused a coloration effect in the composition layer (e.g., the polymer turns white). This coloration obscures the support member structure in the layer making it difficult to identify the edges and center of the support member or implant. As discussed herein, placement of the implant may depend upon positioning the center of the implant within the opening in tissue. If the support member structure is identifiable, then one is able to visually identify the center of the implant. When the composition colors obscures the support member or renders the implant otherwise opaque, it may become difficult to properly place the device. This may be especially true when the composition layer extends continuously over the support member. Additionally, the coloration may render the visualization mark difficult to identify especially under direct visualization (e.g., using a scope) In some cases it was undesirable to simply add additional substances on or in the composition layer for marking because such substances could possibly interfere with the implant&#39;s ability to deliver the substance as desired. To address these issues, a variation of the invention includes a delivery device for delivering an expandable implant (such as those described herein and in the cases referenced herein), where the delivery device includes an expandable member having an expandable implant located about the expandable member. Where the implant and the expandable member are of different visually identifiable colors or shades such that they distinction is easy to identify under endoscopic or bronchoscopic viewing. In one example, as shown in FIG. 9C , a balloon catheter has a colored sleeve 306 located about the balloon. The sleeve 306 comprises a visually identifiable color where selection of the colors should ease identification of the implant an endoscopic visualization system (e.g., blue or a similar color that is not naturally occurring within the body.) The implant is placed about the sleeve 306 where the proximal and distal areas of the implant would be identifiable by the difference in color. Such a system allows a medical practitioner to place the implant 200 properly by using the boundary of the implant 200 to guide placement in the tissue wall. The sleeve 306 may be fashioned from any expandable material, such as a polymer. Optionally, the sleeve 306 may also provide an elastic force to return the balloon to a reduced profile after expansion of the balloon. Such a system allows for identification without affecting the properties of the implant. It should be noted that variations of the invention include coloring the balloon itself, or other expandable member, a color that meets the above criteria. In another variation, the visualization mark may comprise providing a contrast between the implant and a delivery catheter. In one example the implant is appears mostly white and while mounted on a contrasting color inflation balloon. In this example the implant would be placed over a blue deflated balloon catheter. The proximal and distal areas of the implant would be flanked by the deflated blue balloon, thus giving the appearance of a distinct distal and proximal end of the implant. This would allow a physician to place the implant properly by using the blue flanks as a guide for placing the central white portion in the tissue wall. Similarly, a colored flexible sheath covering the balloon would also suffice. It is noted that while the visualization features described above are suitable for use with the implants described herein, the inventive features are not limited as such. The features may be incorporated into any system where placement of an implant under direct visualization requires clear identification of the implant regardless of whether the implant is opaque or colored. Bioactive Agents As discussed above, the bio-active substance or combination of bioactive substances is selected to assists in modifying the healing response as a result of the trauma to the lung tissue resulting from creation of the collateral channel. As noted above, the term lung tissue is intended to include the tissue lining the airway, the tissue beneath the lining, and the tissue within the lung but exterior to the airway (e.g., lung parenchyma.) The purpose of modifying the healing response is to further extend the patency of the channel or implant to increase the duration which trapped gasses may exit through the implant into the airways. The term antiproliferative agent is intended to include those bioactive substances that directly modify the healing response described herein. The bioactive substances are intended to interact with the tissue of the surgically created channels and in particular, lung tissue. These substances may interact with the tissue in a number of ways. They may, for example, 1.) accelerate cell proliferation or wound healing to epithelialize or scar the walls of the surgically-created channel to maintain its patent shape or 2.) the substances may inhibit or halt tissue growth when a channel is surgically created through an airway wall such that occlusion of the channel due to tissue overgrowth is prevented. Additionally, other bioactive agents may inhibit wound healing such that the injury site (e.g., the channel or opening) does not heal leaving the injury site open and/or inhibit infection (e.g., reduce bacteria) such that excessive wound healing does not occur which may lead to excessive tissue growth at the channel thereby blocking the passageway. A variety of bioactive substances may be used alone or in combination with the devices described herein. Examples of bioactive substances include, but are not limited to, antimetabolites, antithrobotics, anticoagulants, antiplatelet agents, thorombolytics, antiproliferatives, antinflammatories, agents that inhibit hyperplasia and in particular restenosis, smooth muscle cell inhibitors, growth factors, growth factor inhibitors, cell adhesion inhibitors, cell adhesion promoters and drugs that may enhance the formation of healthy neointimal tissue, including endothelial cell regeneration. The positive action may come from inhibiting particular cells (e.g., smooth muscle cells) or tissue formation (e.g., fibromuscular tissue) while encouraging different cell migration (e.g., endothelium, epithelium) and tissue formation (neointimal tissue). Still other bioactive agents include but are not limited to analgesics, anticonvulsives, anti-infectives (e.g., antibiotics, antimicrobials), antineoplastics, H2 antagonists (Histamine 2 antagonists), steroids, non-steroidal anti-inflammatories, hormones, immunomodulators, mast cell stabilizers, nucleoside analogues, respiratory agents, antihypertensives, antihistamines, ACE inhibitors, cell growth factors, nerve growth factors, anti-angiogenic agents or angiogenesis inhibitors (e.g., endostatins or angiostatins), tissue irritants (e.g., a compound comprising talc), poisons (e.g., arsenic), cytotoxic agents (e.g., a compound that can cause cell death), various metals (silver, aluminum, zinc, platinum, arsenic, etc.), epithelial growth factors or a combination of any of the agents disclosed herein. Examples of agents include pyrolitic carbon, titanium-nitride-oxide, taxanes, fibrinogen, collagen, thrombin, phosphorylcholine, heparin, rapamycin, radioactive 188Re and 32P, silver nitrate, dactinomycin, sirolimus, everolimus, Abt-578, tacrolimus, camptothecin, etoposide, vincristine, mitomycin, fluorouracil, or cell adhesion peptides. Taxanes include, for example, paclitaxel, 10-deacetyltaxol, 7-epi-10-deacetyltaxol, 7-xylosyl-10-deacetyltaxol, 7-epi-taxol, cephalomannine, baccatin III, baccatin V, 10-deacetylbaccatin III, 7-epi-10-deacetylbaccatin III, docetaxel. Of course, bioactive materials having other functions can also be successfully delivered in accordance with the present invention. For example, an antiproliferative agent such as methotrexate will inhibit over-proliferation of smooth muscle cells and thus inhibit restenosis. The antiproliferative is desirably supplied for this purpose until the tissue has properly healed. Additionally, localized delivery of an antiproliferative agent is also useful for the treatment of a variety of malignant conditions characterized by highly vascular growth. In such cases, an implant such as a implant could be placed in the surgically created channel to provide a means of delivering a relatively high dose of the antiproliferative agent directly to the target area. A vasodilator such as a calcium channel blocker or a nitrate may also be delivered to the target site. The agent may further be a curative, a pre-operative debulker reducing the size of the growth, or a palliative which eases the symptoms of the disease. For example, tamoxifen citrate, Taxol® or derivatives thereof Proscar®, Hytrin®, or Eulexin® may be applied to the target site as described herein. Variations of the invention may also include fibrinolytics such as tPA, streptokinase, or urokinase, etc. Such fibrinolytics prevent or reduce the accumulation of fibrin within the opening. Accumulation of fibrin in the opening may result from inflammation of the tissue. The fibrin may form a structure which makes it easier for tissue to grow into the opening using the fibrin structure as a framework. Use of fibrinolytics, either topically, locally, or on the implant, serves to remove or hinder the network of fibrin from forming within the opening (or implant) and therefore aids in modifying the healing response. In the event that poisonous and toxic compounds are delivered, they should be controlled so that inadvertent death of tissue does not occur. The poisonous agent should be delivered locally or only be effective locally. One method for delivering the bioactive agent locally is to associate the bioactive agent with an implant. For example, the implants described herein may include a bioactive substance or medicine deposited onto the interior, the exterior, or both the interior and exterior surfaces of the implant. The bioactive substance may remain on the implant so that it does not leach. Cells that grow into the surgically created channel contact the poison and die. Alternatively, the bioactive agent may be configured to gradually elute as discussed below. When used in the lungs, the implant modifies the healing response of the lung tissue (e.g., at the site of newly created hole/channel) for a sufficient time until the healing response of the lung tissue subsides or reduces such that the hole/channel becomes a persistent air path. For example, the implant and bioactive substance will modify the healing response for a sufficient time until the healing response is reduced and, from a visual observation, the body treats the opening essentially as a natural airway passage rather than as an injury to the airway wall. In one variation of the invention which modifies the healing response as describe above, the implant provides a steady release rate of bio-active substance as well as has a sufficient amount of available bio-active substance to modify the healing response of the lung tissue. As noted herein, the term lung tissue is intended to include the tissue lining the airway, the tissue beneath the lining, and the tissue within the lung but exterior to the airway (e.g., lung parenchyma.) Such a delivery profile allows for a concentration gradient of drug to build in these tissues adjacent to the delivery site of the implant. It is believed that forming the concentration gradient affects the healing response of the lung tissue so that the implant does not become occluded as a result of the healing response. Because the implant is often placed in the airway wall it is exposed to the healing process of the multiple tissues. Providing a sufficient amount of bio-active substance allows for the formation of a concentration of the bio-active substance across these various tissues. In one variation of the invention it is believed that the fluids from these tissues enter into the composition layer of the device. The fluids then combine with the bio-active substances and migrate out of the composition layer to settle into the lung tissue. A concentration gradient forms when the drug ‘saturates’ local tissue and migrates beyond the saturated tissues. Furthermore, by providing a sufficient delivery rate, the healing response may be affected or suppressed during the critical time immediately after the wounding caused by creation of the collateral channel when the healing response is greatest. To select a proper combination of drug and polymer, it is believed that the solubility parameter of the polymer must be matched with the bio-active substance to provide an acceptable slow elution rate from the polymer. Next, the polymer itself must be selected to have the proper attributes, such as a proper diffusion coefficient (to slow fluid entering and departing from the implant), and proper mechanical expansion properties (to allow for the significant expansion of the polymer to accommodate formation of the grommet shape.) The solubility parameter is defined as the square root of the cohesive energy of the molecules in a compound. The level of control that a polymer has over the elution of a drug is the difference between the solubility parameters of the polymer and the solubility parameter of the drug. To select a polymer with the approximate diffusion a polymer with a high internal density could be selected to be less permeable to a complex molecule such as paclitaxel. Using a polymer with high internal density also accommodated the significant expansion required of the polymer to form the structure necessary to grommet about the airway wall. An example of the polymer selection is found below. It is also important to note that paclitaxel is a taxane that is regarded as a microtubule stabilizer. The benefits of a microtubule stabilizing substance for use in vascular drug eluting stents is discussed, for example, in U.S. Pat. No. 5,616,608 to Kinsella et al. This type of drug operates to enhance microtubule polymerization which inhibits cell replication by stabilizing microtubules in spindles which block cell division. In contrast to the vascular applications, the implant for use in the present invention may use microtubule stabilizing substances such as taxanes (e.g., paclitaxel) as well as those microtubule destabilizing substances that are believed to promote microtubule disassembly in preventing cell replication. Such destabilizing substances include, but are not limited to vincristine, vinblastine, podophylotoxin, estramustine, noscapine, griseofulvin, dicoumarol, a vinca alkaloid, and a combination thereof. Additionally, the exterior surface of the implant may be treated via etching processes or with electrical charge to encourage binding of the bioactive substances to the implant. The exterior surface may also be roughened to enhance binding of the medicine to the surface as discussed in U.S. Patent Application Publication No. 2002/0098278. See also U.S. Patent Application Publication Nos. 2002/0071902, 2002/0127327 and U.S. Pat. No. 5,824,048 which discuss various techniques for coating medical implants. Although the implant may comprise a frame or body with a bioactive matrix disposed or otherwise associated therewith, the invention is not so limited. In one variation, the support member is formed from a polymer and the composition is joined to the polymeric support member. Alternatively, the bioactive substances may be placed directly onto the polymeric support member. Various additional substances may be used incorporated into the device to reduce an adverse reaction resulting from possible contact with the implant and the airway wall. Adverse reactions include, but are not limited to, granulation, swelling, and mucus overproduction. These substance may may also be inhaled, injected, orally applied, topically applied, or carried by the implant. These substances may include anti-inflammatory, infection-fighting substances, steroids, mucalytics, enzymes, and wound healing-accelerating substances. Examples of these substances include but are not limited to, acetylcysteine, albuterol sulfate, ipratropium bromide, dornase alfa, and corticosteroids. As noted above, conventional vascular drug eluting devices are not designed for exposure multiple tissue environments. Moreover, those devices are placed in an environment where a constant flow of blood creates an environment requiring a different delivery mechanism and rate. As noted herein, experiments with conventional coronary drug eluting implants demonstrated that such devices were unsuitable. Channel Creation Devices and Methods As discussed above, the use of low temperature devices, (e.g., mechanical devices, newer generation RF-type devices, etc.) to create the channel may result in less trauma to surrounding tissue and minimize the healing response of the tissue. FIGS. 4A-4C illustrates creation of the collateral channel and selecting a treatment site in the airway 100 . As will be discussed in more detail below, a single device may be used to select the site and create the channel. Moreover, another variation of the invention includes using such a device to deploy the conduit at the target site. However, the invention also contemplates using separate devices to perform each step or a combination of steps. As shown in FIG. 4A , a device 602 is advanced, for example, via a bronchoscope 404 , into the airway 100 . A potential treatment site is then inspected to determine whether or not a blood vessel is in proximity to the site. Naturally, if a blood vessel is detected, the surgeon has the option of selecting a different site. The device 602 may be a Doppler ultrasound device, a thermal device, an imaging device, etc. FIG. 4B illustrates another variation of selecting a site for a channel. In this variation, a piercing member (e.g., a blade affixed to a shaft, a needle, cannula, sharpened tube or rod, etc.,) 604 is advanced into the airway wall. Once the piercing member 604 is inserted into the airway wall, the surgeon may inspect the area for blood to determine whether the device punctured a blood vessel. After the opening is created the surgeon may also remove collect a biopsy of material behind the airway wall. If the opening is large enough as created by a balloon, as described herein, the surgeon may use forceps to visually obtain the sample. This may preferable to a blind method of obtaining biopsies, considering that the risk of bleeding may be reduced because the area has been scanned for blood vessels. The piercing member 604 may have a lumen and may be open at a distal end or closed. In those cases where the piercing member 604 is hollow and has an opening at or near the distal end, the surgeon may aspirate the site using the piercing member 604 to determine whether a blood vessel is present and/or penetrated. For example, flashback catheters contain chambers which will fill with blood upon the penetration of a vessel by the distal tip of the catheter. The piercing member may be incorporated to have a flashback chamber to detect the presence of blood flow from a penetrated vessel. Using these approaches, a target site may not be selected until after a hole is made in the airway 100 wall. It should be noted that a piercing member may be of a diameter which results in closure of the puncture site upon removal of the piercing member. Alternatively, the piercing member may be of a sufficient size or construction that the hole remains open upon removal of the piercing member. In any case, the piercing member or another device may be used to mark the site of the opening (e.g., via ink, dye, physical marker, via application of electrical energy, etc.) Furthermore, the invention includes use of both a detecting device as described above in combination with a piercing member. For example, the site may be inspected by the detecting device prior to insertion of a piercing member. The piercing member lumen may also used to deliver therapeutic fluids to the lungs. For example, in case of bleeding after channel creation the physician may apply epinephrine or saline the lungs. Alternatively the physician may use the piercing member to apply epinephrine to the airway wall prior to creation of the channel, to prevent bleeding. This may be done by injecting directly into the airway wall at or about the site of passage creation; singly or in a surrounding pattern of multiple applications. The physician may also use the piercing member lumen to apply any of the bioactive agents discussed herein, before or after passage creation. Because it may be desirable to reach remote airways within the lung, it may be necessary to fully articulate the scope 404 to access and inspect a desirable site. Therefore, to inspect the site and create an opening, it may be desirable to maintain the scope 404 in a fixed position and simply advance/retract various components of the scope or devices in the scope. Accordingly, a piercing member may be selected to have a length that will sufficiently pass through the airway wall, while being small enough that it will also pass through a fully articulated bronchoscope. Furthermore, the piercing member may have sections of varying stiffness where a distal portion, (that is sufficient stiff to penetrate the tissue) may be of a length such that it is able to advance through a fully articulated bronchoscope. For example, the piercing member may comprised of a sharpened cannula which has a length from between 2 mm to 30 mm. The diameter may range between 16 Ga to 25 Ga or larger. The cannula may be affixed to a catheter having a relatively flexible proximal portion. In any case, the length of the piecing member 604 may vary as needed. The piercing member is not limited to a cannula, it may be of solid construction, such as a sharpened rod or wire. Additionally the piercing member may be adapted with an elongate member, such as a wire, rod, or tube, which extends throughout the device. The purpose of the elongate member is to provide column strength to the piercing member and necessary bending resistance to the catheter, because it has been found that the device must have high column strength to effectively pierce the airway wall, otherwise the device will deflect and not create a passageway. The elongate member may be utilized to expose and retract the piercing member within the catheter, as the elongate member may extend throughout the device to a user interface. The elongate member and piercing member may also be constructed from one piece of material, thereby making them one part. Alternatively the elongate member may be a separate part welded, bonded, mechanically attached, or a combination thereof, to the piercing member. However, it is understood, that the current invention is not limited to any particular length of the piercing member. Furthermore, the piercing member may be comprised of a resilient polymer, a polymer with a reinforced structure (e.g., a braid, coil, etc.), a super-elastic alloy, a metallic material with sufficient resilience, etc, such that it may navigate through a fully articulated bronchoscope yet return to its original profile upon exiting the working channel of the scope. In some variations of the invention, the piercing member of the device may be retractable within a lumen of an elongate shaft so as to prevent damage to the bronchoscope or to tissue as the device advances to the target site. Additionally the piercing member may be retracted after the initial piercing of the airway wall, and blunt trauma may be used to further push the remaining portion of the catheter into the airway wall. This technique may help avoid additional bleeding and pneumothoraxes from an exposed piercing member. The catheter may be advanced to tortuous locations, therefore the device may incorporate low friction materials to make it easier to reach the treatment site. The materials may be selected from a group of low friction polymers, for example PTFE. Low friction materials may also be applied as a coating onto the pierced member or elongate member, for example PTFE or titanium nitride. Reducing the contact surface area between the members may also help to reduce friction. Adding or removing material from the surfaces of members is one way to reduce contact surface area. For example attaching a closed coiled spring around the piercing member or elongate member, effectively reduces the surface area contacted between the elongate member and lumen because only the peaks of the coils contact the lumen. In additional variations of the invention, as shown in FIG. 4C , a balloon catheter may be configured with a piercing member 604 . In this variation the balloon 614 advances into the opening created by the piercing member (in which case the piercing member either retracts into the catheter or advances with the catheter.) The balloon 614 would then deploy to dilate the opening for ease of later inserting a conduit. Alternatively, a conduit may be located on the balloon itself and deployed on inflation of the balloon. Examples of variations of such a balloon catheter may be found below. Furthermore, the needle may be affixed to a tapered introducer type device which is able to dilate the opening. The piercing member 604 may also be used to deliver bioactive substances (as described herein) to the site of the opening. In such a case, the piercing member 604 may deliver the bioactive substance during creation of the opening (e.g., see FIG. 4B ) or after dilation of the opening (see e.g., FIG. 4C ). In another variation of the invention, the piercing member 604 may be have a multi-lumen cross-section with different lumens being reserved, for example, for inflating the balloon, aspirating the site for blood, drug delivery, and suction of mucous/fluids at the site. In any of the variations described herein, an obturator (not shown) may be used to fill a lumen during advancement of the piercing member into tissue so that the lumen does not become blocked with tissue or other debris. The obturator may be a guide-wire, polymeric column of material, etc. FIG. 4D illustrates a variation of a balloon catheter 606 having a piercing member 604 . In this variation, the balloon catheter 606 comprises two lumens 608 , 610 . One lumen 608 is fluidly coupled to the interior of the balloon 614 while the second lumen 610 extends through the piercing member 604 . It is understood that the device 606 may be configured to have any number of lumens as required. As discussed above, the piercing member 604 may either be fixedly attached to the distal end of the balloon catheter 606 . Alternatively, the piercing member 604 may be retractable into the balloon catheter 606 so that it does not cause damage to lung parenchyma when the catheter 606 is inserted into the airway 100 wall. As illustrated, the balloon catheter 606 may have a tapered section 612 between the piercing member 604 and the balloon 614 to assist in insertion of the balloon 614 into the opening 112 . FIG. 4E illustrates an additional variation of a piercing member 604 according the present invention. As illustrated, the piercing member 604 may have a number of ports 616 (e.g., openings, holes, etc.). The ports 616 may allow for either aspiration of blood or delivery of bio-active substances as described herein. Furthermore, although the piercing members 604 shown herein are configured with a beveled tip, it is contemplated that the tip may be any type of tip sufficient to penetrate the airway wall. For instance, the tip may be non-beveled with sharpened edges, the tip may be a trocar tipped needle, or any other available needle tip configuration. The piercing member 604 of FIG. 4E is also shown with an obturator placed therein. In this configuration, the obturator 618 blocks the lumen of the piercing member 604 at the distal end. Moreover, as shown, a portion of the obturator 618 may be sized such that it is smaller than a lumen of the piercing member 604 to allow for delivery of substances or aspiration through the ports 616 . FIG. 4F illustrates yet another variation of a balloon catheter 606 having a piercing member 604 . In this variation, as indicated by the arrow, the piercing member 604 is capable of being retracted into the catheter 606 . The ability to retract the piercing member 604 into the catheter 606 reduces the possibility of the piercing member 604 causing damage to any lung tissue that is behind the airway wall. Clearly, this variation combines the channel-making step with the conduit deployment step. Also, as shown in the figure, the catheter 606 may have a conduit 202 placed over the balloon 614 . Such a variation may create the opening or channel and then deploy the conduit 200 with a single device. FIG. 4G illustrates another variation of a balloon catheter 606 where the piercing member 604 is slidably located within the catheter 606 . In this variation, the catheter 606 contains an outer and inner sheaths 620 , 622 which define two lumens. The lumen defined by the inner sheath 622 extends to the distal end of the catheter 606 and may be used to deliver bioactive substances, for suction, or for irrigation. It is also contemplated that variations of the invention include a piercing member which is affixed to the catheter. Alternatively, the piercing member could have a flexible body that extends through the catheter to a proximal hub which is able to be coupled to a vacuum source, a source of medication, etc. Furthermore, either the piercing member and/or balloon catheter may be “pre-loaded” with a bioactive substance. Such a feature allows improves the precision of amount of substance delivered to the desired site. As mentioned above, the piercing member 604 may be of a sufficient size or construction that the hole remains open upon removal of the piercing member. Once variation of this as shown in FIG. 4H , where the device has a conical tip 658 with a lumen extending through out. A piercing member 604 is extendable past the distal tip to pierce the airway wall, after the initial opening is made, the rest of the device can be driven into the airway wall, gradually expanding the hole to a desirable diameter which allows the conduit to be subsequently placed. The makeup of airway tissue may require a considerable amount of force to create a channel with the piercing device. Therefore, it will generally be easier to create a channel if the device has sufficient column strength to avoid bending of the device when applying a force at the proximal end of the device. Additional variations of the invention may incorporate a nondistensible balloon to overcome the toughness of the airway tissue. Nondistensible balloons are generally made up of relatively inelastic materials consisting of PET, nylons, polyurethanes, polyolefins, PVC, and other crosslinked polymers. The makeup of airway tissue may be very tough and resist radial expansions. Therefore it will be generally easier to expand the channel in the airway wall using high pressure nondistensible balloons (&gt;6 atm), which generally inflate in a uniform shape. Nondistensible balloons will occupy a greater mass than distensible balloons because they in an inelastic predetermined form. Too much balloon mass will have too large of a working diameter, which in turn will hinder entry into a channel. Working diameter is the smallest effective diameter opening the uninflated nondistensible balloon can be inserted into. Therefore it is desirable to have the uninflated nondistensible balloon to have a working diameter close to the diameter of the piercing device 604 . This can be attained by using a thin walled balloon, using a balloon with a small distal profile, by using a balloon with a distal end which is close in actual diameter to the diameter of the piercing member or by using a balloon which folds into a low profile state, or a combination of these. As shown in FIG. 4I , a device of insufficient sharpness will “tent” the airway wall 450 . Tenting occurs when a device is placed against an airway wall with significant force but with no puncturing of the airway wall. The airway wall will deflect and become displaced until the device is withdrawn. If the tissue becomes tented there remains a significant amount of potential energy placed by the device onto the airway wall. The potential energy may unexpectedly becomes realized, when the device eventually punctures the airway, which may cause the device to suddenly plunge into the parenchyma to an unintended depth. Plunging may in turn cause unintended damage to the patient. A depth limiting feature 654 may overcome this problem. Variations of the invention include a depth limiting feature that may prevent inadvertent advancement of the device when creating the channel. One example of this may be a circular tube 654 placed over the device and set at a fixed distance (e.g. 10 mm) from the distal tip of the piercing member, proximal to the balloon, as shown in FIG. 4J . If the device does tent and plunge into the airway wall the front face of the tube may halt the plunging effect by acting as a barrier. Another example would be a secondary balloon, proximal to the channel expansion balloon, placed in a similar position to the circular tube as described above. Another example would be a folding basket formed from the outer lumen of the device, or constructed from wire. As shown in FIG. 4K , variations of the invention may include a distal collar 650 on the distal portion of the piercing member 604 to precisely limit the maximum extension and retraction of the piercing member 604 . The distal collar 650 would be attached to the piercing member and travel between two set collar stops 652 which are attached to the lumen 656 the piercing member travels in. This feature has multiple benefits; first, it has the safety setting a maximum distance for the piercing member to extend, around 2-3 mm has been found to be sufficient in most cases. Thus, the maximum penetration of the piercing member 604 is limited which may prevent unintentional damage to the lung tissue. The collar 650 protects the bronchoscope by preventing deflection of the distal tip. Deflection can take place when there is a significant amount of gap between the inner sheath 622 and the distal tip of the piercing member in the retracted mode. When the device is being maneuvered through a bronchoscope in a torturous configuration, the lumen 656 can deflect while the stiffer piercing member will not, and thus the piercing member may pierce through the deflected lumen 656 and subsequently into the bronchoscope. By setting a small gap (e.g. &lt;1 mm) this deflection may be eliminated, and the scope protected. The collar 650 also allows the piercing member to be reliably extended. It was found that when a similar feature was placed at the proximal section of the device the piercing member could not reliably be extended to a set distance beyond the distal tip. This is because when in a torturous configuration the outer sheath 620 of the device may have a tendency to stretch or compress. As a result the tubing may stretch to such a degree that when the piercing member is fully extended it still may not fully extend past the distal tip of the lumen 656 . By locating the collar 650 in the distal portion of the lumen 656 (e.g. less than 2 inches from the distal tip) the stretching or compression is minimized or eliminated. Conduit Deployment Devices and Methods FIGS. 5A-5C illustrate a way to deploy a conduit in a channel. Referring to FIG. 5A , a delivery device 400 is loaded with a conduit 200 . An access scope-type device 404 (e.g., an endoscope, a bronchoscope, or other device) may optionally be used to place the delivery device 400 into a collateral channel 112 . A guide wire 402 may be used to place the delivery device 400 into the collateral channel 112 . The guide wire 402 may be a conventional guide-wire or it may simply be comprised of a super-elastic material. The use of a guide wire is optional as the invention contemplates placement of the conduit 200 using only the delivery device 400 . FIG. 5A also illustrates articulation (or bending) of the deliver device 400 to access the collateral channel 112 . However, the invention also contemplates articulation of the access device 404 . The access device 404 may be articulated such that the delivery device 400 may advance straight into the collateral channel 112 . Accordingly, the delivery device 400 may exit straight from the access device 404 or it may be articulated into the opening. FIG. 5B illustrates deployment of the conduit 200 . In particular, balloon member 406 is shown in an expanded state resulting in (1) the conduit&#39;s center section being radially expanded and (2) the conduit&#39;s extension members being outwardly deflected such that opposing extension members sandwich portions of the tissue wall 422 . Diametric-control members 424 are also shown in this figure. The diametric or center-control segments limit the center section&#39;s radial expansion. In this manner, conduit 200 is securely placed in the channel to maintain a passageway through the airway wall 422 . FIG. 5C illustrates the deployed conduit 200 once the delivery device 400 is removed from the site. It should be noted that dilation of the collateral channel or opening 112 may be performed by mere insertion of the conduit 200 and/or delivery device 400 . It should be noted that deployment of conduits is not limited to that shown in FIGS. 5A-5C , instead, other means may be used to deploy the conduit. For example, spring-loaded or shape memory features may be actuated by mechanical or thermal release and unlocking methods. Additionally, mechanical wedges, lever-type devices, scissors-jack devices, open chest surgical placement and other techniques may be used to deploy the conduit. Again, the conduit 200 may be comprised of an elastic or super-elastic material which is restrained in a reduced profile for deployment and expands to its deployed state upon mechanical actuator or release. In one additional variation of the invention, as shown in FIGS. 5D , a conduit 201 may be deployed within a second structure such as a second conduit or stent. Such an approach may be used to increase retention of the conduits within the channel as well as prevent closing of the channel. For example, an initial conduit 200 or stent may be deployed within the channel 112 . This first conduit or stent may have certain properties that make it more acceptable to implantation within the body without generating an aggressive tissue healing response. For instance, the stent may be a drug eluting stent, or the conduit may be constructed from a bio-compatible metal without any additional tissue barrier. Once the initial stent or conduit is placed within the channel 112 a second conduit may be deployed within the first conduit. As shown in FIG. 5D , a first conduit 200 (or stent) is placed within the channel 112 . FIG. 5D illustrates a second conduit 201 advanced towards the first conduit 200 . FIG. 5E illustrates the second conduit 201 deployed within the first conduit 200 . The second conduit 201 may have additional properties that permit the channel to remain patent. For example, the second conduit 201 my have a tissue barrier as discussed above, or other construction that generates an aggressive healing response within the lung. Therefore, the first conduit 200 , being more conducive to implantation, will serve to anchor both conduits 200 , 201 as the tissue either does not grow, or it grows around the outer conduit 200 . The second conduit, for example, may have a tissue barrier placed thereon. Once the second conduit 201 is deployed within the first conduit 200 , the tissue barrier of the second conduit 201 will prevent tissue from growing through the stent structure. It should be noted that the structure of a conduit within a conduit may be incorporated into a single composite structure. In use, the conduit 200 is deployed with the distal side towards the parenchymal tissue 460 while the proximal side remains adjacent or in the airway 450 . Of course, where the proximal and distal extension members are identical, the conduit may be deployed with either side towards the parenchymal tissue. FIGS. 6A-6B illustrate another example of deploying a conduit 500 in a channel 510 (or opening) created in a tissue wall 520 . Referring to FIG. 6A , a delivery tool 530 carrying a deployable conduit 500 is inserted into the channel 510 . The delivery tool 530 is extended straight from an access catheter 540 such that the delivery tool forms an angle with the tissue wall 520 . It is to be understood that while the tissue wall of airway 522 is shown as being thin and well defined, the present invention may be utilized to maintain the patency of channels and openings which have less well defined boundaries. The delivery tool is further manipulated until the conduit is properly positioned which is determined by, for example, observing the position of a visualization mark 552 on the conduit relative to the opening of the channel 510 . FIG. 6B illustrates enlarging and securing the conduit in the channel using an expandable member or balloon 560 . The balloon 560 may be radially expanded using fluid (gas or liquid) pressure to deploy the conduit 500 . The balloon may have a cylindrical shape (or another shape such as an hourglass shape) when expanded to 1.) expand the center section and 2.) deflect the proximal and distal sections of the conduit such that the conduit is secured to the tissue wall 520 . During this deployment step, the tissue wall 520 may distort or bend to some degree but when the delivery tool is removed, the elasticity of the tissue tends to return the tissue wall to its initial shape. Accordingly, the conduits disclosed herein may be deployed either perpendicular to (or non-perpendicular to) the tissue wall. FIG. 7A illustrates another variation of deploying a conduit 200 into an opening 112 . In some variations of the invention, prior to deployment of the conduit 200 , the channel 112 may have a diameter or size that may require an additional dilation or expansion of the channel 112 for proper deployment of the conduit 200 . For example, the channel 112 may be created by a piercing member, as described above, where the channel 112 nearly closes upon removal of the piercing member. However, the devices and method described herein are not limited to channels 112 of any particular size. The channels may in fact be larger than a diameter of the conduit 200 in its un-deployed state. In any case, after creation of the channel 112 the surgeon may advance a balloon catheter 630 containing a conduit 200 towards the site of the opening 112 . The variation of the balloon catheter 630 depicted in the figure also includes a guide body 632 . Because the opening 112 may be difficult to locate, the guide body 632 may serve various functions to assist in locating the opening 112 and placing the conduit 200 . For example, as shown in FIG. 7A , the guide body 632 may have a rounded front surface. This allows probing of the catheter 630 against the airway 100 wall to more easily locate the opening 112 . The rounded surface of the guide body 632 will not drag on the airway tissue. As shown in FIG. 7B , once inserted into the opening 112 , the guide body 632 provides an additional function of temporarily anchoring the device 630 within the opening 112 . The ability to temporarily anchor the device 630 into the opening 112 may be desirable due to the natural tidal motion of the lung during breathing. The increased surface area of the guide body 632 requires increased resistance upon remove the guide body 632 from the opening 112 . Such a feature lessens the occurrence of unintended removal of the device from the site as the lung tissue moves. As shown in FIG. 7B , after insertion into the airway 100 wall, a portion of the guide body 632 serves as a resistance surface to provide the temporary anchoring function. Additional variations of the guide body 632 are shown below. FIGS. 8A-8F illustrate additional variations of guide bodies 632 for use with the present invention. As shown, the guide body 632 is located on the distal end of the balloon catheter 630 . The guide body 632 will have a front surface 634 that is preferably smooth such that it can easily be moved over the airway wall. Proximal to the front surface 634 , the guide body 632 will have at least one resistance surface 636 which is defined as an area that causes increased resistance upon removal of the guide body 634 from the airway wall. As shown, the resistance surface 636 will be adjacent to an area of reduced diameter 638 to which allows the guide body 632 to nest within the opening 112 in the airway wall. The guide body 632 may have any number of shapes as shown in the figures. FIG. 8F illustrates another variation of a guide body 632 having a resistance surface 636 which comprises an area of increased surface roughness such that the surface will drag upon the airway wall or tissue surrounding the channel 112 . Such a feature may be combined with the variations of the guide members provided above. The balloon catheters 630 of the present invention may include a dilating member between the guide body 632 and balloon 614 . In the variation shown in FIG. 8A , the dilating member comprises a tapered section. However, the invention is not limited as such. For example, the dilating member may comprise a second inflatable balloon, or other expanding device. The dilating members may also be retractable within the elongate shaft. FIGS. 9A and 9B depict cross sections of examples of a balloon catheter 630 having a guide body 632 that includes a lumen 642 which terminates at a surface of the guide body 632 . The lumen 642 may be used for suction, irrigation, or deliver bio-active substances, etc. The catheter 630 may also have an additional lumens 646 , 646 , 648 as shown, for inflation of the balloon 614 and for additional suction 644 , and for communication with the guide body lumen 642 . As shown in FIG. 8B , the lumen may also be used to advance a piercing member 604 to the airway wall to create the channel 112 . Any of the balloons described herein may be distensible balloons (e.g., they assume a predetermined shape upon expansion) or elastic balloons (e.g., simply expand). Use of a distensible balloon permits control in dilating the opening 112 or placement of the conduit. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. To the extent there is a conflict in a meaning of a term, or otherwise, the present application will control. Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it will be readily apparent to those of ordinary skill in the art in light of the teachings of this invention that certain changes and modifications may be made thereto without departing from the spirit or scope of the appended claims. It is also contemplated that combinations of the above described embodiments/variations or combinations of the specific aspects of the above described embodiments/variations are within the scope of this disclosure. EXAMPLE Implant Implants comprising stainless steel mesh frame fully encapsulated with a composition comprising silicone (as described below) and paclitaxel were implanted in several canine models. Visual observation indicated that, on average, the passage through the implants of the present invention remained unobstructed and were associated with significantly reduced fibrotic and inflammatory responses, in canine models, at a considerably higher rate than an implant without any drug adjunct or coronary drug eluting stents (as shown in FIG. 12 ). The composition comprised approximately a 9% paclitaxel to silicone ratio with approximately 400 micrograms of paclitaxel per implant. Measurements found that approximately 30% of the paclitaxel released after 60 days. In general, for implants with the paclitaxel/silicone composition, observations of chronic inflammation, epithelial metaplasia and fibrosis were all very mild. For paclitaxel as the bioactive substance, polymers with solubility parameters between 5-25 (MPa) ^½ were believed to provide sufficient elution rates. The polymer used in the example device has good diffusivity for lipophilic drug (such as paclitaxel) because the side methyl group on the silicone may be substituted with more lipophilic hydrocarbon molecules containing vinyl group or groups in addition polymerization by platinum catalyst. The composition for the example may be as follow: polymer part: polydimethylsiloxane, vinyldimethyl terminated, any viscosity; and/or polydimethylsiloxane, vinylmonomethyl terminated, any viscosity. The cross-linker part: polydimethylsiloxane, any viscosity; and or polymonomethylsiloxane, any viscosity. Platinum catalyst part and/or cross-linker part: platinum; and/or platinum-divinyltetramethyldisiloxane complex in xylene, 2-3% Pt; and/or platinum-divinyltetramethyldisiloxane complex in vinyl terminated polydimethylsiloxane, 2-3% Pt; and/or platinum-divinyltetramethyldisiloxane complex in vinyl terminated polydimethylsiloxane, ˜1% Pt; platinum-Cyclovinylmethylsiloxane complex, 2-3% Pt in cyclic vinyl methyl siloxane. These components may be combined in different ratios to make the polymer. The hydrocarbon side chain off the silicone back bone makes this polymer system unique and may result in a “zero-order”-like release profile. The amount of vinyl siloxane cross-linker may determine the rate of the drug release and diffusivity of the polymer to the drug. There are other types of polydimethylsiloxanes such as: trimethylsiloxy terminated polydimethylsiloxane in various viscosities, (48-96%) dimethyl (4-52%) diphenylsiloxane copolymer in various viscosities, dimethylsiloxane-ethylene oxide copolymer, dimethyl diphenylsiloxane copolymer, polymethylhydrosiloxane, trimethylsilyl terminated at various viscosities, (30-55%) methyldro-(45-70%) dimethylsiloxane copolymer at various viscosities, polymethylphenylsiloxane, polydimethylsiloxane silanol terminated at various viscosities, polydimethylsiloxane aminopropyldimethyl terminated at various viscosities. For paclitaxel a release profile was found to be acceptable with a polymer system consisting of polydimethylsiloxane vinyl terminated at various viscosity and a range of platinum-mono, di, tri and/or tetramethyldisiloxane complex.

Devices and methods for altering gaseous flow within a lung to improve the expiration cycle of an individual, particularly individuals having chronic obstructive pulmonary disease. The methods and devices create channels in lung tissue and maintain the patency of these surgically created channels in tissue. Maintaining the patency of the channels allows air to pass directly out of the lung tissue which facilitates the exchange of oxygen ultimately into the blood and/or decompresses hyper-inflated lungs.

This is a Continuation-in-Part of prior U.S. application Ser. No. 640,525 Filing Date: Jan. 11, 1991, now U.S. Pat. No. 5,231,980 which in turn is a continuation of application Ser. No. 162,450 Filing Date Mar. 1, 1988 now abandoned. FIELD OF THE INVENTION This invention relates to the recovery of halogenated hydrocarbons from a gas stream and recovery thereof for reuse. BACKGROUND OF THE INVENTION Halogenated hydrocarbon compounds include the family of compounds of bromo-, fluoro- and/or chloroethers, fluorinated alkyl ethers, chlorofluorocarbons and chlorofluoro ethers and their derivatives. This family of compounds are typically used as solvents, refrigerants, anesthetic gases, aerosol propellants, blowing agents and the like. Many of these compounds are widely used and normally discharged into the atmosphere. However, if these compounds could be recovered and re-used there would be a considerable cost saving and reduction in environmental pollution. In view of the possible effects of released anesthetic gases, attempts have already been made to recover such gases. An example of anesthetic gas removal, is with regard to patient exhalent to ensure that the environment in the operating theatre does not contain anesthetic gases which can have a long term effect on the professionals conducting the operation. Commonly, anesthetic gases are removed from patient exhalent by use of various types of disposable absorbers, such as that disclosed in U.S. Pat. Nos. 3,867,936 and 3,941,573. In the United States patent to Kelley, U.S. Pat. No. 3,867,936, an absorber unit is in the shape of a hollow drum filled with activated carbon to absorb anesthetic gases exhaled by the patient. When the weight of the absorber unit increases to a predetermined value, the unit is replaced with a fresh one. In Chapel, U.S. Pat. No. 3,941,573, a molecular sieve is used in combination with the activated carbon in a disposable cartridge. The cartridge is included in the patient anesthetic administration breathing system to absorb on both the activated carbon and the molecular sieve materials the exhaled anesthetic gases. It is common to dispose of the absorber units used to absorb anesthetic gases. However, in view of the rising costs of the anesthetic gases, attempts are being made to recover them. For example, in U.S. Pat. No. 3,592,191, a system is provided for recovering exhausted anesthetic gases from patient exhalent by removing water vapor from the collected gases by their condensation thereof or with a hygroscopic material. This treated gas then has the anesthetic agent extracted therefrom by a cryogenic process in which the vapors of the anesthetic gases are condensed to liquid phase, or by removal on an absorbent material which is processed later to remove the anesthetic agents. The collected anesthetic liquids are then reintroduced directly into the anesthetic system. Such approach has little if any facility to control bacterial contamination and recycle of harmful microorganisms to the patient. Another approach in the recapture of anesthetic gases is disclosed in Czechoslovakian patent 185,876. An absorbent material is used to absorb halogenous inhalant anesthetics from the patient exhalent. When the adsorbent material is saturated, it is removed in an appropriate container and placed in a regeneration system. A purging gas, such as steam, is used to remove the anesthetic agents from the adsorbent material. The purged gas is then collected with water removed therefrom and the separated anesthetic agents are subjected to fractionation to separate out the individual anesthetic agents from the supply of anesthetic gases from various operating theatres. The use of molecular sieves to adsorb gaseous components is exemplified in U.S. Pat. No. 3,729,902. Carbon dioxide is adsorbed on a molecular sieve which is regenerated with heated steam to remove the carbon dioxide from the adsorbent material. Another example of the use of molecular sieves to adsorb organic materials is disclosed in Canadian patent 1,195,258. In this instance, a hydrophobic molecular sieve is used to adsorb organic species from a gas stream containing moisture. The hydrophobic molecular sieve selectively adsorbs the organic molecular species into the adsorbent material, while preventing the collection of water vapor from the gas stream on the adsorbing material. The temperature and pressure at which the system is operated is such to prevent capillary condensation of the water in the gas stream onto the adsorbing material. By removing the adsorbing material from the system, the adsorbing material is essentially free of water yet has absorbed thereon the desired organic molecular species. The organic molecular species are then recovered from the adsorbent material by purging. Particularly desirable types of anesthetic gases are commonly sold under the trade marks ETHRANE and FORANE, as disclosed in U.S. Pat. Nos. 3,469,011; 3,527,813; 3,535,388; and 3,535,425. These types of anesthetic gases are particularly expensive; hence an effective method of recovering them from patient exhalent for reuse would be economically advantageous. SUMMARY OF THE INVENTION According to an aspect of the invention, a process for the recovery of halogenated hydrocarbons from a gas stream is provided. The process comprises passing the gas stream through a bed of hydrophobic molecular sieve adsorbents having pore diameters large enough to permit molecules of the halogenated hydrocarbon to pass therethrough and be adsorbed in the large internal cavities of the crystal framework, whereby the halogenated hydrocarbons are removed from the gas stream. The gas stream is passed through the bed of adsorbent material at least until just prior to breakthrough of an essentially saturated halogenated hydrocarbon absorption front. The adsorbent material containing the adsorbed phase is regenerated by exposing it to an inert purging gas stream whereby the halogenated hydrocarbons are desorbed into the purging gas stream. The halogenated hydrocarbons are removed from the purging gas stream and are purified to a purity suitable for reuse. According to another aspect of the invention, a canister is provided for use in adsorbing halogenated hydrocarbons from a gas stream passed through the canister. The canister has a peripheral side wall, a first end wall with an inlet port and a second end wall with an outlet port. A first fine mesh screen is spaced from the first end wall and closes off the first canister end. A second fine mesh screen is spaced from the second end wall and closes off the second canister end. Hydrophobic molecular sieve granular adsorbents are packed in the canister between the first and second screens. The sieve adsorbents have pore diameters large enough to permit molecules of the halogenated hydrocarbons to pass therethrough and be adsorbed in the large internal cavities of the crystal framework, whereby the halogenated hydrocarbons are removed from the gas stream. The first and second screens have a mesh sizing to retain the granular material in the canister. A means is provided for resiliently urging one of the first or second screens towards the other to compress such granular material between the screens. According to another aspect of the invention, an anesthetic machine is provided having an inlet port of the canister connected to an exhaust port of the machine thereby passing patient exhalent from the anesthetic machine to the canister to absorb anesthetic gases. According to another aspect of the invention, an apparatus is provided for regenerating the canister of adsorbent as connected to an anesthetic machine comprising means for connecting an incoming line of nitrogen gas to the inlet. A means is provided to heat the canister and optionally the nitrogen gas in the incoming line to a temperature in the range of 30° C. to 150° C. Means is provided for connecting an outgoing line to the canister outlet and for measuring temperature of nitrogen gas enriched with the desorbed anesthetic in the outgoing line. Regeneration is ceased shortly after the temperature of the nitrogen gas in the outgoing line is at a level of the temperature of the nitrogen gas in the incoming line. BRIEF DESCRIPTION OF THE DRAWINGS Preferred embodiments of the invention are shown in the drawings wherein: FIG. 1 is a schematic of an anesthetic machine with canister connected thereto for removing anesthetics from the patient exhalent; FIG. 2 is a section through the canister of FIG. 1; FIG. 3 is a schematic of the apparatus used to regenerate the adsorbent material in the canister of FIG. 2; FIG. 4 is a schematic of the multi-stage fractional distillation system for separating components of the anesthetic absorbed by the canister coupled to the anesthetic machine. FIG. 5 is a plot of the inlet and outlet concentrations versus time for an airstream saturated with isoflurane passed into a canister of adsorbent material. FIG. 6 is a plot of the net amounts of isoflurane evaporated, exhausted and retained in the canister versus time. FIG. 7 is a plot of the concentration versus time of concentration of isoflurane in the purging gas stream exiting from the recovery system and; FIG. 8 is a plot versus time of the net volume of isoflurane lost in the regenerative gas stream exiting the recovery system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS According to the invention, a system is provided which can recover a variety of halogenated hydrocarbons and purify the recovered compounds. Typical halogenated hydrocarbons include bromo-, chloro- and/or fluoroethers, fluorinated alkyl ethers, chlorofluorohydrocarbons, chlorofluoroethers and their derivatives. Anesthetic gases are well known types of halogenated hydrocarbons which include isoflurane, enflurane, halthane, and methoxyflurane. Other well known halogenated hydrocarbons include the variety of Freons (trade mark) such as trichlorofluromethane, and dichlorodifluoromethane. This family of halogenated hydrocarbon compounds which include, for example, an alkyl group or ether group substituted with one or more of chloro, fluoro and bromo groups are readily absorbed on the high silica zeolite adsorbent and can be readily desorbed from the adsorbent. A preferred aspect of the invention is described with respect to the recovery of various anesthetic gases. It is appreciated that the principles of the invention which are demonstrated by the following embodiments are equally applicable to the recovery of other types of halogenated hydrocarbons. A variety of organic based anesthetics are used in patient surgery. Common forms of anesthetics are those sold under the trade marks ETHRANE and FORANE by (ANAQUEST of Quebec, Canada). The respective chemical formulae for these anesthetics are as follows: 1,1,2-trifluoro-2-chloroethyl difluoromethyl ether and 1-chloro-2,2,2-trifluoroethyl difluoromethyl ether. Other types of anesthetics are, for example, Halothane (trade mark) of the formula bromochlorotrifluoroethane and Penthrane (trade mark) of the formula 2,2-dichloro-1,1-difluoroethyl methyl ether which are readily available from various suppliers, such as, Hoechst, Ayerst, Abbott, etc. By way of an anesthetic machine, these anesthetics either singularly or in combination are delivered to the patient in combination with oxygen, nitrous oxide and/or air. As the patient breathes the gas stream containing the anesthetic, a desired degree of unconsciousness is achieved and monitored by an anesthetist. Not all of the anesthetic inhaled by the patient is absorbed into the blood system. In fact, very little of the anesthetic is absorbed. During procedures, the gas flow rate to the patient may be in the range of 0.5 to 7 liters per minute, where the concentration by volume of the anesthetic may be in the range of 0.3% to 2.5%. Normally, the patient exhalent is not recycled via the anesthetic machine. Instead, it is exhausted to the atmosphere by way of appropriate ducting. It is very important to ensure that the patient exhalent is not exhausted into the operating theatre, because the presence of the anesthetics can have a long term effect on the people in the operating room. It is appreciated that the use of the term patient is in a general sense. It is understood that anesthesia is practiced on a variety of mammals not only including humans but also animals such as horses, cattle and other forms of livestock, domestic pets and the like. As shown in FIG. 1, the patient represented at 10 is connected to a mask 12 having a gas line 14 communicating therewith. The desired mixture of anesthetic gas is delivered in line 14 to the patient 10. The patient exhalent is delivered in line 16 to the anesthetic machine 18. The anesthetic machine 18, which is supplied with oxygen, a source of anesthetic and air in lines 20, 22 and 24, is operated to introduce the desired mixture in line 14. The patient exhalent in line 16 is discharged via line 26. Normally line 26 leads to external ducting for exhausting the anesthetics to atmosphere. In accordance with this invention, a canister 28 having an inlet 30 and an outlet 32 is interposed in line 26 at a position sufficiently downstream of the machine so as to have no or minimal effect on its operation. The patient exhalent in line 26, therefore, flows through the canister 28 before exhausting to atmosphere at 34. The canister 28 is charged with a hydrophobic molecular sieve granular material of silicalite which adsorbs from the patient exhalent stream the organic gaseous anesthetic. Hence, the stream discharge at 34 is free of the anesthetic gases. An anesthetic sensor 36 may be provided in the exhaust line 38 to sense the presence of anesthetics exiting from the canister 28. It is appreciated that the adsorption front of the adsorbed anesthetics, in the bed of adsorbent travels along the bed towards the canister outlet. Such adsorption front will usually have a curved profile across the canister as it approaches the outlet. The curved profile normally assumes an elongated &#34;S&#34; shape. The sensor will sense when any portion of that front has broken through the adsorbent into the outlet. Replacement of the canister is normally required at this time though the bed of adsorbent is not entirely saturated with organic anesthetic. The sensor 36 may be connected via signal line 40 to the anesthetic machine 18. The anesthetic machine may be equipped with a light and/or audible alarm 42 which is actuated when the sensor 36 senses anesthetic gases in line 38. This indicates to the anesthetist that the canister 28 should be replaced so that continued recovery of anesthetics is achieved. It is appreciated that a bypass 44 controlled by valve 46 may be provided to route the patient exhalent past the canister 28 during replacement thereof. In this instance, a valve 48 is provided in line 26 to shut off the supply to canister 28 during replacement of the canister. The canister may be charged with any of a variety of adsorbents. However, according to an aspect of this invention, the molecular sieve adsorbent utilized has an adsorptive preference for the less polar organic materials with respect to water, i.e., be hydrophobic. In the case of zeolitic molecular sieves, as a general rule the more siliceous the zeolite, the stronger the preference for non-polar adsorbate species. Such preference is usually observable when the framework molar SiO 2 /Al 2 O 3 ratio is at least 12, and is clearly evident in those zeolite species having SiO 2 /Al 2 O 3 ratios of greater than 50. A wide variety of zeolites can now be directly synthesized to have SiO 2 /Al 2 O 3 ratios greater than 50, and still others Which cannot at present be directly synthesized at these high ratios can be subjected to dealumination techniques which result in organophilic zeolite products. High temperature steaming procedures involving zeolite Y which result in hydrophobic product forms are reported by P. K. Maher et al., &#34;Molecular Sieve Zeolites&#34;, Advan. Chem. Ser., 101, American Chemical Society, Washington, D.C., 1971, p. 266. A more recently reported procedure applicable to zeolitic species generally involves dealumination and the substitution of silicon into the dealuminated lattice site. This process is disclosed in U.S. Pat. No. 4,503,023 issued Mar. 5, 1985 to Skeels et al. Many of the synthetic zeolites prepared using organic templating agents are readily prepared in a highly siliceous form--some even from reaction mixtures which have no intentionally added aluminum. These zeolites are markedly organophilic and include ZSM-5 (U.S. Pat. No. 3,702,886); ZSM-11 (U.S. Pat. No. 3,709,979); ZSM-12 (U.S. Pat. No. 3,832,449) and ZSM-35 (U.S. Pat. No. 4,016,245) to name only a few. It has been found that the silica polymorphs known as silicalite, F-silicalite and TEA-silicalite are particularly suitable for use in the present invention and are thus preferred, though not, strictly speaking, zeolites, because of a lack of ion-exchange capacity, these molecular sieve materials are included within the terms zeolite or zeolitic molecular sieve as used herein. These materials are disclosed in U.S. Pat. No. 4,061,724; U.S. Pat. No. 4,073,865 and U.S. Pat. No. 4,104,294, respectively. As shown in FIG. 2, the canister 28, which may be cylindrical in shape, has a side wall 50 with a first end 52 having an inlet 30. A second end 54 has the outlet 32. It is appreciated that the canister 28 may be disassembled by having releasable fasteners 56 about the perimeter of the side wall 28 to clip respectively the first and second end walls 52 and 54 to the side wall 50. Within the canister 28, the hydrophobic molecular sieve granular material of silicalite 58 is contained. At the second end of the canister, a fine mesh screen 60 is positioned to close off the second end defined by flange 62. The fine mesh screen 60 conforms to the interior shape of the canister side wall 50 which, in this instance, is circular and abuts the flange 62. A coiled spring 64, as spaced between the wall 54 and the fine mesh screen 60, holds the screen in place against the flange 62. With the other end 52 and the fine mesh screen 66 removed, the silicalite material 58 may be charged into the canister 28. Once the silicalite material has achieved a level indicated by arrow 68, the screen 66 is placed in the canister. A spring 70 is positioned between the wall 52 and the screen 66. When the clips 56 are clamped in position, the spring pushes the fine mesh screen 66 against the silicalite material 58 to compress and hold the silicalite material in place in the canister 28. This ensures that the silicalite material remains relatively fixed in the canister during use. The patient exhalent in line 26 from the anesthetic machine 18 of FIG. 1 is naturally moist. This has presented significant problems in the past in attempting to recover organic anesthetics from the moist patient exhalent. It has been discovered that the use of a hydrophobic molecular sieve granular material of silicalite overcomes those problems. The silicalite material has a pore diameter which permits the material to selectively adsorb and remove the organic gaseous anesthetic from the humid patient exhalent and which minimizes coadsorption of water molecules in the patient exhalent. The benefits in using silicalite adsorbents is that there is no bacterial growth on the adsorbents which can become a problem because of the presence of bacteria in the patient exhalent. The adsorbent is non-flammable in the presence of oxygen. This is a significant drawback with organic forms of adsorbents since for certain concentrations of oxygen, the organic adsorbents are at least flammable if not explosive. The silicalite adsorbent is inert so that minimal if any decomposition of the anesthetic agent is induced whereas with organic adsorbents, such as activated carbon, hydrochloric acid can be produced in the presence of iron by way of decomposition of the halogenated anesthetics. The inert silicalite adsorbents are readily re-sterilized using ozone, steam, peroxide or other disinfectants without in any way affecting the adsorptive reuse characteristics of the adsorbent. The silicalite adsorbents are found to be microwave transparent. Therefore, regeneration can be accomplished using microwave heating. A preferred form of silicalite is that manufactured and sold by Union Carbide under the trade mark &#34;S-115 Silicalite&#34;. The chemical properties of S-115 Silicalite are as follows: Chemical properties (greater than) 99% SiO 2 (less than) 1% aluminum oxide. The Silicalite has the following physical properties: ______________________________________Free apertureZig-zag channels 5.4 AStraight channels 5.75 × 5.15 APore volume 0.19 cc/gmPore size approx. 6 angstroms in diameterCrystal density 1.76 gm/ccLargest molecule adsorbed BenzeneForm Powder, Bonded Bead or Pellet______________________________________ By use of a silicalite material having those properties, it has been discovered that the organic anesthetics are adsorbed by the silicalite while other components of the patient exhalent, including moisture, pass through. Hence, a minimum of moisture is retained in the canister. Supplemental heating of the canister 28, as shown in FIG. 1, may be provided by control 72 for heater 74. The purpose of the heat is to ensure that the canister 28, during use on the anesthetic machine, remains at a temperature which prevents the moisture in the patient exhalent condensing on the silicalite material in the canister and also on the canister surfaces. Once it has been determined that the silicalite material in the canister is saturated with adsorbed organic anesthetic, or that the adsorption front has broken through to the outlet, the canister has to be replaced in the manner discussed. To regenerate the silicalite material in the canister 28 and to recover the anesthetic components for reuse, a silicalite regeneration system 76 is shown in FIG. 3. The system permits interposing canister 28 in lines 78 and 80 by couplings 82 and 84 which connect to the inlet and outlet 30 and 32 of the canister 28. The canister may be optionally heated within a conventional oven 85. An inert purging gas is passed through the silicalite material of the canister 28 to desorb the organic anesthetics from the silicalite granular material. In accordance with a preferred aspect of this invention, nitrogen gas or air is used as the purging gas. To enhance the desorption of the adsorbed organic anesthetics, the silicalite material is preferably heated to a temperature range of 30° C. to 150° C. It is appreciated that with other types of halogenated hydrocarbons, different temperature ranges may be necessary to effect desorption of the compounds. In order to heat the silicalite material within the canister to this temperature the oven 85 having heating coils 87 surrounded by insulating material 89 is controlled on the basis of prior experimentation in a manner to ensure that the silicalite is in this temperature range for passing of the purging gas through the canister. It is understood that in view of the transparency of the silicalite adsorbent to microwaves, then a microwave oven may be substituted for the conventional oven 85. The silicalite material in canister 28 during regeneration may either be heated by direct application of heat to the canister or by heating the nitrogen gas or air purging stream. In accordance with the embodiment shown in FIG. 3, the nitrogen gas from the source 86 may also be heated in heater 88 to a desired temperature in the range of 30° to 150° C. The purging gas passes through the silicalite material of the canister 28 where the fine mesh screen, as shown in FIG. 2, serve to retain the silicalite material in the canister. Hence any desired flow rate of purging gas may be used. The purging gas exits the canister 28 through line 80 and passes through a temperature sensor 90. Temperature sensor 90 provides an indication of the temperature of the purging gas in line 80. When the temperature of the purging gas in the exit line achieves a temperature nearing that of the temperature in the entrance lines 78, it has been determined that the silicalite material is at a temperature approximating the inlet temperature and that most of the organic anesthetic is desorbed. The system is then run for a desired period of time beyond that point to complete desorption. That aspect of the process may be automated and a temperature sensor 92 may be included in the inlet side to measure the temperature of the incoming stream. By way of suitable microprocessor, the signals from temperature sensors 90 and 92 may be fed to a control system 94 which compares the temperatures and actuates a signal 96 to indicate that canister regeneration is complete. It is appreciated, that regeneration of the silicalite adsorbent may take place at lower temperatures outside of the preferred range. For example, regeneration of absorbent can be achieved at temperatures as low as 25° C. where the time for regeneration is thereby extended. It is appreciated that in the alternative, silicalite adsorbent carrying anesthetic compounds may be removed from the canister and placed with adsorbent removed from other canisters. The collected adsorbent may then be regenerated in a separate vessel in a manner as discussed with respect to a single canister. The purging gas continues in line 80 through condenser 98. The purpose of the condenser is to remove, in liquid form, the organic anesthetics from the purging gas. Liquid nitrogen at a cryogenic temperature is fed through the condenser 98 via its inlet 100 and exit 102. This provides sufficiently cool temperatures in the line 104 of the condenser to cause the organic anesthetics to condense and permits collection in vessel 106 of liquid form anesthetics 108. To assist in the condensing of the organic anesthetics, a partial vacuum is drawn in line 104 by vacuum pump 110 connected to line 104 via line 112. The condensed liquid 108 then consists primarily of the organic anesthetics. In the course of one day, several operations may be conducted involving the same anesthetic machine 18. It may require many operations to saturate the canister 28 with anesthetics from the patient exhalent. During the different operations, it is appreciated that different anesthetics may be used. For example, Forane (trade mark) or Ethrane (trade mark) may be used separately or in combination with or without Halothane (trade mark). When the canister is saturated, two or more gases may be present inside. Hence, liquid 108 will correspondingly consist of a mixture of anesthetic components. Regardless of the composition of the liquid 108, it is important to purify it before reuse. In accordance with standard practice, anesthetics must have a high purity level normally in excess of 90% providing remaining impurities are non-toxic. To achieve that purity, the liquid 108 is subjected to fractional distillation. A preferred system is shown in FIG. 4 consisting of a multi-stage fractional distillation comprising three columns 114, 116 and 118. The liquid 108 is fed to column 114 via line 120. Sufficient heat is applied to the bottom of column 114 to cause the liquid 108 to boil and provide a vapor take-off in line 122. The vapor 122 is fed to column 116 where heat is applied to cause boiling of the vapor 122 as it condenses in column 116. The bottoms of columns 116 are removed via line 124 for recycle with new product into column 114. The vapors removed from column 116 via line 126 are fed to column 118. The vapors in line 126 condense in column 118 and with heat supplied thereto, cause boiling resulting in a take-off of two fractions, one in vapor phase in line 128 and secondly in liquid phase in line 130. Assuming that two anesthetics are in the liquid 108, the system of FIG. 4 separates them to provide desired purities in the lines 128 and 130. For example, with Forane and Ethrane, there is a difference in boiling points of approximately 8° C. which is sufficient to provide separation of the Ethrane from the Forane. Bacteria is present in the patient exhalent. It has been found, however, that a bacteria in the patient exhalent is not adsorbed on the silicalite material to any appreciable extent. Hence, the anesthetic produced by fractional distillation and particularly as provided in lines 128 and 130 is not contaminated and is ready for reuse. In accordance with this invention, an inexpensive process and apparatus is provided for what in essence is the manufacture of anesthetic gases from mixtures which are normally discharged to the atmosphere. Significant economic advantages are realized. Without limiting the scope of the appended claims, the following examples exemplify preferred aspects of the inventive process. EXAMPLE 1 A canister of the type shown in FIG. 2 was subjected to a known flow rate of air with a known concentration of the anesthetic isoflurane while monitoring the inlet and outlet concentration of isoflurane in the canister outlet until saturation of the adsorbent in the canister was detected by breakthrough of the adsorption front. The apparatus was set up to generate a constant concentration of isoflurane in the air stream. The source of air was from a cylinder of &#34;Zero&#34; grade air a portion of the air metered through a flow meter was passed through two midget impingers each containing 15 ml of the anesthetic isoflurane. A third impinger prevented droplets of the isoflurane from being carried over and into the air stream. The isoflurane saturated air was then mixed with the zero air. The total flowrate was measured with a second flow meter. A dry gas meter was installed at the canister outlet to provide confirmation of the flow rate indicated by the upstream flow meter. The outlets and inlets were sampled periodically throughout the tests by way of a Miran (trade mark) 1A infrared analyzer. This instrument is a variable wavelength, variable pathlink analyzer capable of measuring isoflurane to concentrations well below 1 ppm. The instrument was calibrated before use to provide accurate readouts of the inlet and outlet concentrations of the canister. FIG. 5 is a plot of the inlet and outlet concentrations versus time at the canister. The inlet concentration was about 0.77% by volume for most of the program and the average flow rate was approximately 5.2 meters per minute. Breakthrough started to occur after about 30 minutes. The canister appeared to be fully saturated after about 100 minutes. At that point the outlet value for isoflurane concentration was only slightly less than the inlet value. The inlet value dropped because most of the isoflurane had been evaporated. There were 8 ml of isoflurane remaining in the impingers at the end program. FIG. 6 is a plot of the net amounts of isoflurane evaporated, exhausted and retained versus time as calculated from the measured flow of isoflurane concentrations. The figure shows that about 19.5 ml were evaporated and about 12.7 ml were expected to have been adsorbed by the adsorbent in the canister at the end of the test run. The canister of adsorbent was regenerated by use of an apparatus of the type shown in FIG. 3. The canister was heated in an oven to a temperature of approximately 140° C. The nitrogen gas passed through the canister was at a flow rate of approximately 1.3 liters per minute during regeneration. During such regeneration the nitrogen gas emerging from the coal trap was monitored for isoflurane. FIG. 7 is a plot of the concentration versus time for the monitored isoflurane concentration in the emerging nitrogen gas stream. FIG. 8 is a plot of the net volume of isoflurane lost versus time based on a flow rate of the 1.3 liters per minute of the regeneration gas. The volume of isoflurane recovered from the flow trap was 11 ml. The amount expected was 12.7 ml.-1.5 ml.=11.2 mls. No water was recovered as expected since dry air was used. Furthermore, the adsorbent is principally hydrophobic. The results of the tests are therefore summarized in the following Table 1. TABLE 1______________________________________Laboratory Test Results - Summary______________________________________Average inlet concentration 0.76%Amount of Isoflurane in impinger 30.0 mlsAmount remaining 8.0 mlsCalculated isoflurane entering canister 19.5 mlsIsoflurane exhausted 6.7 mlsAmount of isoflurane expected 12.7 mlsAmount lost during desorption 1.5 mlsNet amount expected from recovery 11.2 mlsActual amount recovered 11.0 mls______________________________________ Approximately 90% of the isoflurane was recovered by thermal desorption using a low purge flow rate for the purging gas. According to this particular set up the canister capacity for isoflurane is approximately 13 mls or 18 grams of the isoflurane. The volume of adsorptive material in the canister was approximately 185 grams of the SR-115 high silica zeolite adsorbent material. EXAMPLE 2 The procedure of Example 1 was repeated with a view to establishing what the effect of the presence of water vapour in the gas stream had on the adsorption of the anesthetic gases. An impinger, containing water, was used to add moisture to the gas stream carrying the anesthetic gases. The average absolute humidity of 2.2% v/v was established. The inlet concentration of isoflurane was 0.84% by volume and the average flowrate was 5.2 liters per minute. Breakthrough occurred in approximately 25 minutes and the canister was completely saturated after approximately 78 minutes. Approximately 12.1 mls of isoflurane was adsorbed in the canister which is similar to the amount adsorbed in Example 1 under similar flowrate conditions. Hence the presence of moisture did not appreciably affect the adsorption of isoflurane. The procedure of Example 1 was followed to desorb the isoflurane from the canister. Similar volume of isoflurane was recovered along with a minimal volume of water. Fractional distillation was used to separate the isoflurane from the water. EXAMPLE 3 As the canister approaches saturation with adsorbed isoflurane continued passage of the gas stream through the canister has the potential for stripping isoflurane from the canister. The following procedure was established to determine if stripping could occur. A canister with 185 grams of silicalite was saturated with isoflurane. Air was then passed through the canister at a rate of about 6 liters per minute. The air at the exit of the canister was monitored for isoflurane using the Miran (trade mark) analyzer. At the beginning of the passage of the air stream, approximately 1.5 ml of isoflurane was removed from the saturated canister. Thereafter there was a nearly constant but extremely low concentration of isoflurane detected at the exit of the canister. This low concentration could not be accurately measured but was estimated to be at about 0.01 to 0.02% v/v for approximately 0.2 ml of liquid isoflurane per hour. Stripping of isoflurane from saturated or partially saturated canisters is therefore avoided and does not have a significant impact on the net amount of isoflurane that can be recovered from a gas stream. EXAMPLE 4 Several canisters were used in a &#34;real&#34; situation by coupling the individual canisters to anesthetic machines which were in use at the Toronto General Hospital. Recovery of isoflurane from these canisters by thermal desorption in accordance with the procedure of Example 1 revealed that certain impurities were appearing in the recovered mixture. To determine the extent of impurities the following procedure was followed. A new canister was loaded with 185 grams silicalite and regenerated at 120 degrees centigrade before use. The clean canister was coupled to a new anesthetic machine which was then put into use. After saturation of the canister it was then subjected to the procedure of Example 1 for recovery of the isoflurane. Recovery was carried out a desorption temperature of 120 degrees centigrade. The impurities identified in the recovered mixture were as follows: 1. 1-1-1-trifluoro-2-chloroethane; 2. bromochloro-1-1-difluoroethylene; 3. ethanal; 4. ethylene oxide; 5. trichlorofluoromethane; 6. dichlorodifluoromethane; 7. isopropyl alcohol; 8. 2-2-2 trifluoroethanol. The fact that the above impurities appeared as desorbed from the adsorbent indicates that the high silica zeolite, adsorbent is capable of absorbing a variety of halogenated hydrocarbons and in turn desorbing such compounds at suitable desorption temperatures. It is thought that impurity #8 is the result of the degradation of the isoflurane. Impurity #2 is thought to be a breakdown product of halothane, ethanol (acetaldehyde) is possibly present as a patient exhalent, ethylene oxide and isopropyl alcohol are common chemicals used as disinfectants in the hospital. Impurities 5 and 6 are commonly known as Freon 11 (trade mark) and Freon 12 (trade mark). It is believed these compounds were present in the new anesthetic machine as potential filler gases, however, the presence of such gases indicate that these types of halogenated hydrocarbons are adsorbed onto the adsorbent of the canister and can be subsequently desorbed by temperature desorption. Although the use of this canister has been demonstrated in association with an anesthetic machine, it is appreciated that the canister may be used in other systems to adsorb other types of halogenated hydrocarbons such as those commonly used as solvents, blowing agents, refrigerants, aerosol propellants and the like. Suitable systems may be set up to collect the vapours of these various agents and direct them through canisters which function in the same manner as the canisters specifically exemplified. Canisters can then be subjected to temperature desorption to provide for recovery and subsequent purification of the adsorbed halogenated hydrocarbons. Although preferred embodiments of the invention have been described herein in detail, it will be understood by those skilled in the art that variations may be made thereto without departing from the spirit of the invention or the scope of the appended claims.

A process for the recovery of halogenated hydrocarbons from a gas stream comprises passing the gas stream through a bed of hydrophobic molecular sieve adsorbent, preferably of the high silica zeolite type. Such adsorbent has pore diameters large enough to permit molecules of the halogenated hydrocarbons to pass therethrough and be selectively adsorbed in the large internal cavities of the crystal framework, whereby the halogenated hydrocarbons are removed. The gas is continued to be passed through the bed of adsorbent material until the material is saturated to the extent that breakthrough of the hydrocarbons is determined. The adsorbent material with adsorb phase of halogenated hydrocarbons is removed from the machine and regenerated by exposing the saturated material to an inert purging gas stream under conditions which desorb the halogenated hydrocarbons from the adsorbent material into the purging gas stream. The halogenated hydrocarbons are then removed from the purging gas stream and purified to a purity for reuse of the recovered halogenated hydrocarbons.

CROSS-REFERENCE TO RELATED APPLICATION This application claims priority to and the benefit of Korean Utility Model Application No. 20-2012-0002350 filed in the Korean Intellectual Property Office on Mar. 23, 2012, the entire contents of which are incorporated herein by reference. BACKGROUND (a) Field Embodiments of the present invention relate to a dish having a display element installed therein and a charging device of the same. (b) Description of the Related Art People buying a food dish or food plate may be more interested in designs of the dishes, such as prints on the surface of the dishes, than in functions such as durability and thermal conductivity. In addition, dishes might be used not only for serving the food, but may also be used for ornamental purposes. The dishes may be designed by changing their shapes, or by printing images or patterns on the dish. However, such a design cannot be modified once it is applied to the dish. An organic light emitting diode display includes a hole injection electrode, an electron injection electrode, and an organic emission layer formed between the hole and electron injection elements, and emits light as holes injected from an anode and, electrons injected from a cathode are recombined to cancel each other at the organic light emission layer. The OLED display device, having high quality properties such as low power consumption, high luminance, a high reaction speed, and the like, can be manufactured to be slim, and can be used in various devices including a portable electron device because of its flexible feature. The above information disclosed in this Background section is only for enhancement of understanding of the background of embodiments of the invention, and may therefore contain information that does not form the prior art that is already known in this country to a person of ordinary skill in the art. SUMMARY Embodiments of the present invention provide a dish having a display element therein that is capable of changing a design in the dish by displaying various images and providing various functions. A dish having a display element installed therein according to an exemplary embodiment of the present invention includes a dish main body including a display element including a display portion and a circuit portion, a first side including a transparent material, and a second side, and a battery portion at the second side for supplying power to the display element. The dish main body may include a center area for accommodating food and including the display portion of the display element, and a periphery area around the center area, rising from the center area, and including the circuit portion of the display element. The display element may include a flexible material, and an upper side of the dish main body may be concave. The dish may further include a bottom side protection pad at a bottom side of the dish main body for sealing the battery portion. The bottom side protection pad may include an impact cushioning member. The dish may further include a battery terminal coupled to the battery portion and exposed through the bottom side protection pad, and a capping portion for sealing the battery terminal. The battery portion may be configured to be charged using a wireless charging method or a solar light charging method. The dish may further include an antenna portion using BLUETOOTH® wireless communication at an edge of the dish main body. The dish may further include a touch screen for enabling control of the display element. The dish may further include a detachable protection film for covering at least a portion of an upper side of the dish main body. The dish may further include a controller coupled to the display element for controlling power to the display element and for controlling image displaying of the display element. A charging device according to an exemplary embodiment of the present invention can charge the dish having the display element installed therein, and the charging device includes a base for supporting the charging device, a plurality of supports extended upward from the base, and a plurality of dish mounting portions, each including a supporting portion coupling adjacent ones of the supports, a stand for supporting the dish, the stand extending from and perpendicular to the support, a fixing supporting portion extending from the stand and configured to affix the dish to the dish mounting portion, and a charging terminal for charging the battery portion of the dish. A position of the supporting portion may be adjustable with respect to the supports. According to exemplary embodiments of the present invention, a design of the dish can be changed depending on the food served in the dish by displaying various images, and the dish can emit light so that it can be used for ornamental purposes. In addition, according to exemplary embodiment of the present invention, the dish can perform various functions using the display element installed therein. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a dish having a display element installed therein according to an exemplary embodiment of the present invention. FIG. 2 is an exploded perspective view of the dish having the display element installed therein according to the exemplary embodiment of the present invention shown in FIG. 1 . FIG. 3 is a cross-sectional side view of the dish having the display element installed therein according to the exemplary embodiment of the present invention shown in FIG. 1 . FIG. 4 is a perspective view of a charging device of the dish having the display element installed therein according to the exemplary embodiment of the present invention shown in FIG. 1 . FIG. 5 is a view of the dish having the display element installed therein in the state of being charged by the charging device. DETAILED DESCRIPTION Hereinafter, a dish having a display element installed therein, and a charging device thereof, will be described in detail with reference to the drawings. Embodiments of the present invention may, however, be embodied in many different forms, and should not be construed as being limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. In the drawings, same reference numerals will be used throughout to designate same or like components. In addition, unless explicitly described to the contrary, the word “comprise” and variations such as “comprises” or “comprising”, will be understood to imply the inclusion of stated elements but not the exclusion of other elements. It will be understood that when an element such as a layer, film, region, or plate is referred to as being “on” another element, it can be directly on the other element, or one or more intervening elements may be present. FIG. 1 is a perspective view of a dish having a display element installed therein, and FIG. 2 is an exploded perspective view of the dish having the display element installed therein, according to an exemplary embodiment of the present invention. Referring to the drawings, the present embodiment includes a dish having a display element installed therein 10 , a dish main body 100 , a display element 110 ( FIG. 3 ), and a battery portion 120 . The dish main body 100 is formed in the shape of a plate so that food can be put on an upper side thereof. The dish main body 100 is in the shape of a circular plate in the present exemplary embodiment, but may be formed in other shapes, such as the shape of a polygon like a triangle or a square, or may be a curved plate having the shape of, for example, a leaf or a water droplet. In addition, the upper side of the dish main body 100 may be flat or concave downward. As shown in FIG. 2 , the dish main body 100 may include a center area 100 a where food may be placed, and a periphery area 100 b that is higher than the center area 100 a (e.g., uplifted from, or rising from, the center area 100 a ) while surrounding the center area 100 a . Since the peripheral area 100 b is higher than the center area 100 a , food can be prevented from moving outside of the dish main body 100 . Since the display element 110 is installed in the dish main body 100 to display an image or emit light, the upper side of the dish main body 100 may be at least partially formed of a transparent material. The dish main body 100 may further include a protection film 140 covering the upper side of the dish main body 100 , and capable of being detached from the dish main body 100 . The protection film 140 can prevent, or reduce the likelihood of, an image displayed in the display element 110 from being unclear due to scratches caused by a fork or a knife, or scratches in the dish main body 100 resulting from washing. Since the protection film 140 is attachable/detachable, the protection film 140 may be attached during meal time, and the protection film 140 may be detached when the dish 10 is used for ornamental purposes. In addition, when scratches are generated in the protection film 140 , the scratched protection film 140 can be replaced with another protection film 140 . The protection film 140 may be a film used for surface protection, such as polyethylene terephthalate (PET) or polyethylene, although the present invention is not restricted to these materials. Various protection films formed of various components that are known to a person skilled in the art, which are not harmful to humans, can be used as the protection film. FIG. 3 is a cross-sectional side view of the dish having the display element installed therein according to the present exemplary embodiment of the present invention. The battery portion 120 is connected with the display element 110 to supply power to the display element 110 , and is disposed in a bottom side of the dish main body 110 . The battery portion 120 is formed in the shape of a plate and is disposed in the bottom side of the dish main body 110 , and in the present exemplary embodiment, the battery portion 120 is formed in the shape of a square plate having a hole therein, although the present invention is not restricted to the battery portion 120 of the present embodiment. The battery portion 120 can have any shape that allows it to be connected with the display element 120 and supply power to the display element 110 . The battery portion 120 may be charged by a wireless charging method or a solar charging method. When the battery portion 120 is charged by the wireless charging method, it may be charged through an antenna portion 150 , and when the battery portion 120 is charged by the solar charging method, a solar light panel may be partially provided in an upper or bottom side of the dish main body 100 in a manner that will be understood by one of ordinary skill in the art. The battery portion 120 may further include a bottom side protection pad 130 at a bottom side 120 of the dish main body 100 to seal the battery portion 120 . Permeation of moisture into the battery portion 120 can be reduced or prevented by sealing the battery portion 120 . The bottom side protection pad 130 is also provided as an impact cushioning member that can absorb impact, and thus not only the battery portion 120 but also the dish 10 can be protected from external impact. The impact cushioning material may be elastic rubber or urethane, but it is not limited thereto. Any material having elastic force to absorb external impact can be used. When the bottom side protection pad 130 is provided, as shown in FIG. 3 , a battery terminal (e.g., a charging terminal of the battery portion) 122 is connected to one side of the battery portion 120 and is exposed through the bottom side protection pad 130 , and a capping portion 124 sealing the exposed battery terminal 122 may be further provided. The battery portion 120 may be connected with an external power source through the externally exposed battery terminal 122 , and thus the battery portion 120 can be charged. In addition, the capping portion 124 seals the exposed battery terminal 122 to prevent the battery terminal 122 from being exposed to moisture and the like. The antenna portion 150 of the present embodiment may, for example, wirelessly connect the display element 110 with an external device using BLUETOOTH® wireless communication (BLUETOOTH® is a registered trademark of Bluetooth SIG. Inc., Kirkland, Wash.). The antenna portion 150 of the present embodiment is formed along the edge of the dish main body 100 . For example, when the dish main body 150 is formed in the shape of a circle, the antenna portion 150 is formed in the shape of a circular ring. The antenna portion 150 may also wireless charge the battery portion 120 . When the display element 110 is connected with the external device using BLUETOOTH® wireless communication, the display element 110 may receive a signal of an image stored in the external device, and may display the corresponding image, or may be controlled by the external device. In the present embodiment, a touch sensor formed as a touch film, a touch sheet, or a touch pad is provided in the upper side of the dish main body 100 where the display portion of the display element 110 is located to sense touch such that the display element 10 can be driven by a touch screen method. The display element 110 may include a controller (not shown) provided at the bottom side of the dish main body 100 and connected with the display element 100 , and the controller may turn on and turn off the power of the display element 110 . In addition, as shown in (a) and (b) of FIG. 1 , the controller may change an image displayed in the display element 110 . In the above-description, an additional coupling member is provided for coupling or access between different elements or access. In addition, an additional sealant may be further provided to reduce or prevent leakage in an accessing portion. Further, a protrusion or groove may be formed in a fitted manner for convenience in a coupling process and reduction or prevention of a leak. Hereinafter, a charging device 20 that charges the dish of the present embodiment will be described with reference to the drawing. FIG. 4 is a perspective view of the charging device 20 of the dish having the display element installed therein according to an exemplary embodiment of the present invention. Referring to FIG. 4 , the charging device 20 according to the exemplary embodiment of the present invention includes a bracket (e.g., a base) 210 , a support 220 , and a dish mounting portion 230 . The bracket 210 acts as a base of the charging device 20 , and may be coupled to the ground, and may have a flat-plate shaped bottom side to stably support the charging device 20 . A cross-section of the bracket 210 of the present exemplary embodiment may be rectangularly-shaped, although the present invention is not limited thereto. The bottom side of the bracket 210 may be realized in various shapes. In addition, an inner space of the bracket 210 may have a space (e.g., a predetermined space) to install devices and wires for charging. Further, a plurality of supports 220 extended upward from the bracket 210 are formed at an upper side of the bracket 210 . The support 220 is supported by the bracket 210 , and the plurality of supports 220 may be formed in the shape of a plurality of parallel bars. In the present exemplary embodiment, three supports 220 are provided, but a different number of supports 220 (e.g., two or more) may be selected and provided according to the number of dishes 10 to be mounted and/or charged. In addition, the support 200 may have a space (e.g., a predetermined space) for installation of charging-related wires along the inner space. The dish mounting portion 230 for mounting and charging the dish 10 having the display element installed therein includes a supporting portion 232 , a stand 234 , and a fixing support portion 236 , and a charging terminal 238 that charges the dish 10 having the display element installed therein is formed in one side of the dish mounting portion 230 . The dish mounting portion 230 is provided as a plurality of separate dish mounting portions 230 to mount a plurality of dishes 10 , each having a display element installed therein. The supporting portion 232 functions to fix, or provide additional stability to, the supports 220 by connecting adjacent supports 220 . In the present exemplary embodiment, the supporting portion 232 is formed in the shape of a bar connecting bar-shaped supports 220 extended upward in a vertical direction. The stand 234 at least partially protrudes outwardly from the supporting bar 232 to support the dish 10 having the display element installed therein. In the present exemplary embodiment, the stand 234 is extended downward in the supporting bar 232 , and ends of the stand 234 are formed into two parts such that the ends may protrude to a direction crossing the up and down direction. In addition, the fixing support portion 236 is formed protruding from an end of the stand 234 and affixes the dish 10 (e.g., affixes the dish 10 to the fixing support portion 236 or to the dish mounting portion 230 ) such that an upper side of the dish 10 faces frontward. The inner space of the dish mounting portion 230 preferably has a predetermined space for installation of charging-related wires along the inner space. The height of the dish mounting portion 230 may be controlled by lifting or lowering the supporting bar 232 that connects between the supports 220 . As shown in FIG. 4 , the dish mounting portion 230 may be alternately disposed with an adjacent dish mounting portion 230 in the horizontal direction, and may be disposed in a row direction with the dish mounting portion 230 adjacent thereto in the horizontal direction by controlling the height thereof. In addition, a gap between adjacent dish mounting portions 230 may be adjusted as the dish mounting portions 230 are moved in the up and down direction depending on the size of the dish 10 having the display element installed therein. The dish 10 having the display element installed therein may be mounted to the dish mounting portion 230 , and may be charged through the charging terminal 238 formed in one side of the dish mounting portion 230 . The dish mounting portion 230 may be charged by combination of the charging terminal 238 of the dish mounting portion 230 and the battery terminal 122 of the battery portion 120 of the dish 10 having the display element installed therein. In addition, the bracket 210 , the support 220 , and the dish mounting portion 230 can install configuration such as charging-related devices such as a charging adapter and wires connecting the charging-related device and the charging terminal therein, and therefore space utilization can be simplified and a good appearance can be provided. FIG. 5 is a view illustrating a state in which the dish 10 having the display element installed therein is mounted to the charging device 10 to be charged. The dish 10 having the display element installed therein may be charged while being mounted to the dish mounting portion 230 , and, as shown in FIG. 5 , the upper side of the dish 10 faces frontward, the bottom side of the dish 10 is leaned on the dish mounting portion 232 , and the edge of the dish 10 is fixed by the fixing support portion 236 . The dish 10 having the display element installed therein can be mounted to the charging device 20 , allowing external power to be connected through contact of the charging devices 122 and 128 , and the dish 10 can be used as an ornament. While this invention has been described in connection with what is presently considered to be practical exemplary embodiments, it is to be understood that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims, and their equivalents. DESCRIPTION OF SOME OF THE REFERENCE CHARACTERS 100 : dish main body 110 : display element 120 : battery portion 130 : bottom side protection portion 140 : protection film 150 : antenna portion

A dish having a display element installed therein includes a dish main body including a display element including a display portion and a circuit portion, a first side including a transparent material, and a second side, and a battery portion at the second side for supplying power to the display element.

RELATIONSHIP TO OTHER APPLICATION This application claims priority to and benefits of the following: U.S. Provisional Patent Application No. US60/127,588, filed 13 May 2008, entitled “Fluorescence Detection And Deactivation Of Poison Oak Oil”, which is herein incorporated by reference in its entirety for all purposes. This invention was made partly using funds from United States National Science Foundation (NSF) research grant No. CHE-0453126. The U.S. Federal Government has certain rights to this invention. FIELD OF THE INVENTION The invention provides compositions, kits, and methods of using the compositions and kits for detecting, deactivating, degrading, immunogenic compounds from poison oak and poison ivy. BACKGROUND Urushiol-induced allergic contact dermatitis in the United States most commonly results from unexpected exposure to oils from plants in the sumac Family Anacardiaceae. Approximately 10 to 50 million Americans suffer from rashes resulting from exposure every year. In particular, the genus Toxicodendron species (which include Western and Eastern poison oak T. diversilobum , poison ivy T. radicans , and poison sumac or dogwood T. vernix ) are distributed widely across North America. Other sources of urushiol include poison wood (in Florida and the Bahamas), and the sap (kiurushi) of the Asian lacquer tree ( Toxicodendron verniciflua ) used as a varnish in Japanese lacquer ware, and cashew nut shells. (See, for example, Tucker and Swan (1998) NEJM, 339(4): 235.) Reaction to urushiol is an immunological response to the bio-oxidized form of urushiol (the ortho-quinone). Approximately 50-70% of the U.S. population is either allergic to urushiol, or will become allergic to it upon sensitization by repeated exposure. Symptoms of allergic contact dermatitis from urushiol exposure (often referred to as Rhus dermatitis) vary from a mild annoyance to weeks of irritation and pain. Occasionally, exposure can lead to nephropathy and even to fatal systemic anaphylaxis. The monetary cost due to worker disability from urushiol-induced injuries is substantive: in the states of California, Washington and Oregon, it has been estimated that up to one third of forestry workers are temporarily disabled by poison oak dermatitis each year. In California, the medical costs associated with poison oak injuries accounts for up to 1% of the annual workers&#39; compensation budget. It has been estimated that Toxicodendron dermatitis is responsible for 10% of the total U.S. Forest Services lost-time injuries. In 1988, NIOSH estimated that 1.07-1.65 million occupational skin injuries occurred yearly, with an estimated annual rate of 1.4 to 2.2 cases per 100 workers (8) the costs attributable to lost productivity, medical payments, and disability payments are very high. (See U.S. Centers for Disease Control; Leading work-related diseases and injuries—United States. MMWR, 1986 335:561-563). Chemically, urushiol is a name given to a collection of related compounds that are 3-substituted catechols (1,2-benenediols), in which the long hydrophobic chain is a linear C 15 or C 17 alkyl chain containing 0-4 degrees of cis unsaturation ( FIG. 1 ). The catechols with two, three, and four carbon-carbon double bonds (2-4 degrees of unsaturation) seem to be the most virulent in eliciting an allergic response. Each of the different members of the Toxicodendron species contain mixtures of the C 15 or C 17 alkyl chains, with various degrees of unsaturation. They all share the catechol functionality in common, and a long, greasy alkyl chain that facilitates migration into the skin. In addition to direct contact with the toxic plants, exposure commonly occurs by transfer from animal fur, contaminated clothing, garden tools, fire-fighting equipment, forestry and sports equipment. There are a few commercially available products that can be applied prophylactically to protect the skin by creating a physical barrier using organoclays (for example, a lotion containing quaternium-18 bentonite is commercially available as IVYBLOCK from Enviroderm Pharmaceuticals, Inc.). However, the success of this strategy requires advanced planning. By far the majority of allergic contact dermatitis cases from urushiol result from unexpected exposure. A number of methods to treat poison ivy or poison oak have been investigated, including hyposensitization, but this process is involved and can have unfavorable side effects. Studies towards an immunological approach to desensitization have been pursued, but have not yet reached a level of practical application. The best treatment to date is to avoid contact with urushiol. As most patients are unaware that they have had contact with urushiol, a low cost, quick and inexpensive method of detection is warranted. There are many recommended methods to remove urushiol after recent contact, including water, soapy water, organic solvents, and a variety of commercially available solubilizing mixtures including TECHNU, IVYCLEANSE, ALL-STOP, ZANFEL (comprising fatty acid, alcohol, and the surfactant sodium lauroyl sarcosinate), and even DIAL ultra dishwashing soap. Thus the ability to detect urushiol before it transverses the skin will be extremely valuable in mitigating the suffering caused by contact with the various Toxicodendron species. In addition, continued re-exposure (chronic exposure) from repeated introduction of the oil to the patient (from door handles, shoelaces, etc.) is a considerable problem. As little as 0.001 mg of urushiol is enough to cause allergic contact dermatitis. Treatment of the contact dermatitis usually involves a course of topical and/or enteric treatments with hydrocortisones, β-methasone, and other similar corticosteroids. Repeated exposure to either the original allergen or to a similar allergen can result in a severe hypersensitive immunoreaction, that is often extremely painful and, occasionally, fatal. There is therefore a particular need in the art for compounds and methods of treatment that can remove the allergen(s) prior to induction of an immune and/or allergic response, that can prevent the binding of the allergen(s) to an immunoglobulin or a cell-surface receptor, and/or that can be used to rapidly detect the presence of such allergen(s) so that other precautions may be used to remove the allergen(s) from the area of contact. There is therefore a need in the art to provide for compositions and methods for detecting the presence of urushiol, inactivating urushiol, and removing urushiol from substrates (including, for example, skin and clothing). BRIEF DESCRIPTION OF THE INVENTION The invention is drawn to novel methods, kits, sprays (including aerosol sparays) and compositions for detecting active compounds present in oils that are found in poison oak, poison ivy, poison sumac, cashew nut, and related plants. The methods disclosed herein may also be used to detect other catechols, both synthetic and those found in nature. The invention also is drawn to compositions that may be used to detect said active compounds using fluorescence. In one embodiment the methods of the invention may be used to detect catechols and alkyl-substituted catechols, such as, for example, urushiol, catechin, epicatechin, gallocatechin, epigallocatechin, epigallocatechin-3-gallate, and the like; and chatecholamines, such as, for example, epinephrine, norepinephrine, dopamine, dihydroxyphenylalanine (DOPA), and the like. The invention provides methods for detecting, treating, and deactivating the antigenic and/or allergenic compounds that induce urushiol-induced contact dermatitis. In one embodiment the method may be used for treating, deactivating, and/or detecting alk(en)yl catechols, and/or alk(en)yl resorcinols. The invention may be used by clinicians, nursing staff, paramedics, emergency rescue team members, the military, firefighters, forestry personnel, lumberworkers, hunters, mountaineers, hikers, anglers, and the like. In one embodiment, the invention is a kit comprising the elements disclosed herein and a set of instructions of how to use the kit, wherein the kit is used for detecting, treating, and/or deactivating a catechol. The kit can be used, for example, in the home, in the field, in a camp, in a clinic, in a hospital, in an emergency room, and the like. The invention provides a kit for detecting a catechol, the kit comprising a vessel, the vessel shaped and adapted for confining a composition, the composition further comprising a boron composition, a first nitroxide, and a second nitoxide, and an applicator. In one embodiment the boron composition comprises a hydrophobic alkyl group. In another embodiment the second nitroxide is a profluorescent nitroxide. In a preferred embodiment the applicator is a spray applicator. In a most preferred embodiment the catechol is urushiol. In one alternative embodiment, the kit can also comprise an aerosol propellant. In another embodiment the kit comprises a lamp. In a preferred embodiment, the invention provides a method for detecting a catechol in a sample, the method comprising the steps of (i) contacting a boron composition and a nitroxide with the sample (ii) allowing the boron composition to react with the catechol in the sample thereby creating a catecholborane; (iii) allowing a first nitroxide to react with the catecholborane thereby generating an alkyl radical and a nitroxide-catecholborane complex; (iv) allowing the alkyl radical to react with a second nitroxide thereby creating an alkoxyamine; (v) measuring the amount of alkoxyamine, nitroxide-catecholborane complex, or an alkoxyamine hydrolysis product so created; the method resulting in detecting the catechol in the sample. In one embodiment the boron composition comprises a hydrophobic alkyl group. In a preferred embodiment, the catecholborane is a B-alkyl catecholborane. In another preferred embodiment the alkyl group is selected from the group consisting of a hydrophobic alkyl group and a hydrophilic alkyl group. In a yet alternative embodiment the nitroxide is a profluorescent nitroxide. More preferably, the nitroxide is tetramethylpiperidinyloxy (TEMPO). In a more preferred embodiment the profluorescent nitroxide is dansyl amino-TEMPO. In another preferred embodiment the sample is selected from the group consisting of an area of a subject&#39;s skin, clothing, boots, pets, camping gear, tools, and other outdoor equipment. In another preferred embodiment the sample is selected from the group consisting of a plant tissue, a plant extract, a plant tissue extract, an animal tissue, an animal extract, an animal tissue extract, and an animal fluid. In a more preferred embodiment the plant tissue is from a plant selected from the group consisting of poison oak, poison ivy, poison sumac, mango, cashew nut, and lac tree. The invention further provides the methods as disclosed herein wherein the nitroxide further comprises a fluorescent compound, the fluorescent compound selected from the group consisting of a hydrophobic fluorescent organic molecule, a hydrophilic fluorescent organic molecule, and a fluorescent quantum-dot nanoparticle. In one embodiment the method comprises the measuring the amount of alkoxyamine so created using a photon source that results in fluorescence of the alkoxyamine and the nitroxide-catecholborane complex, wherein the fluorescence is visible to the naked eye. In a preferred embodiment the measuring of the amount of alkoxyamine so created is performed using a photon source that induces fluorescence of the alkoxyamine and the nitroxide-catecholborane complex, wherein the fluorescence is detected by a photometer. In a more preferred embodiment the fluorescence comprises photons having a wavelength of between about 250 and 600 nm. In one embodiment the photon source is a lamp. In a preferred embodiment the lamp is a hand-held lamp. In an alternative embodiment the photon source is the sun. The method may also further comprise measuring hydroxylamine complexed with boron or free hydroxylamine created by hydrolysis. In a preferred embodiment of the invention the catechol is selected from the group consisting of urushiol, catechin, epicatechin, gallocatechin, epigallocatechin, epigallocatechin-3-gallate, and catecholamines epinephrine, norepinephrine, dopamine, and dihydroxyphenylalanine (DOPA). In a more preferred embodiment the catechol is urushiol. The method may further comprise the step of reacting the alkyl radical with a profluorescent nitroxide having a fluorescent tag, wherein the fluorescent tag is selected from the group consisting of an organic fluorophore and Cd—Se nanoparticle. In another embodiment the method may further comprise the step of measuring the amount of the nitroxide-catecholborane complex. In another embodiment the method further comprises the step of measuring the amount of hydroxylamine hydrolysis product. In a yet other embodiment the method further comprises the step of measuring the amount of alkoxyamine product. The invention also provides for a method for deactivating a catechol in a sample, the method comprising the steps of (i) contacting a boron composition and an oxygen-containing molecule with the sample (ii) allowing the boron composition to react with the catechol in the sample thereby creating a catecholborane; the method resulting in deactivating the catechol in the sample. In one embodiment the boron composition comprises a hydrophobic alkyl group. In a preferred embodiment, the catecholborane is a B-alkyl catecholborane. In another preferred embodiment the alkyl group is selected from the group consisting of a hydrophobic alkyl group and a hydrophilic alkyl group. In a yet alternative embodiment the nitroxide is a profluorescent nitroxide. More preferably, the nitroxide is tetramethylpiperidinyloxy (TEMPO). In a more preferred embodiment the profluorescent nitroxide is dansyl amino-TEMPO. In another preferred embodiment the sample is selected from the group consisting of an area of a subject&#39;s skin, clothing, boots, pets, camping gear, tools, and other outdoor equipment. In another preferred embodiment the sample is selected from the group consisting of a plant tissue, a plant extract, a plant tissue extract, an animal tissue, an animal extract, an animal tissue extract, and an animal fluid. In a more preferred embodiment the plant tissue is from a plant selected from the group consisting of poison oak, poison ivy, poison sumac, mango, cashew nut, and lac tree. In one preferred embodiment the oxygen-containing molecule comprises a nitroxide. The invention further provides the methods as disclosed herein wherein the nitroxide further optionally comprises a fluorescent compound, the fluorescent compound selected from the group consisting of a hydrophobic fluorescent organic molecule, a hydrophilic fluorescent organic molecule, and a fluorescent quantum-dot nanoparticle. In one embodiment the method comprises the measuring the amount of alkoxyamine so created using a photon source that results in fluorescence of the alkoxyamine and the nitroxide-catecholborane complex, wherein the fluorescence is visible to the naked eye. In a preferred embodiment the measuring of the amount of alkoxyamine so created is performed using a photon source that induces fluorescence of the alkoxyamine and the nitroxide-catecholborane complex, wherein the fluorescence is detected by a photometer. In a more preferred embodiment the fluorescence comprises photons having a wavelength of between about 250 and 600 nm. The method may also further comprise measuring hydroxylamine complexed with boron or free hydroxylamine created by hydrolysis. In a preferred embodiment of the invention the catechol is selected from the group consisting of urushiol, catechin, epicatechin, gallocatechin, epigallocatechin, epigallocatechin-3-gallate, and catecholamines epinephrine, norepinephrine, dopamine, and dihydroxyphenylalanine (DOPA). In a more preferred embodiment the catechol is urushiol. The invention also provides for a boron composition, the boron composition comprising a reactive moiety that reacts with a catechol with a rate constant, k, of at least 0.2 M −1 s −1 and wherein the reaction produces a stable chatecholborane. The invention provides for a pharmaceutical composition, the pharmaceutical composition comprising a boron composition, wherein the boron composition comprises a hydrophobic alkyl group. In one embodiment the alkyl group is selected from the group consisting of a hydrophobic alkyl group and a hydrophilic alkyl group. In another embodiment the pharmaceutical composition comprises a boron composition in an effective amount for the treatment of poison oak oil-induced contact dermatitis. In a preferred embodiment the poison oak oil comprises a catechol. In a more preferred embodiment the catechol is urushiol. The invention provide a topical composition, the topical composition comprising an effective amount of a boron composition and a suitable excipient, carrier, or combination thereof, the boron composition comprising an alkylboronic acid having the general formula R—B(OH) 2 . In one alternative embodiment the boron composition optionally comprises at least one B-alkyl boronic acid derivative. In another embodiment the topical composition optionally containing xanthan gum or gellan gum. In a more preferred embodiment the boron composition is present in an amount selected from the group consisting of from about 99.5% to about 0.001%, from about 95% to about 0.1%, and from about 90% to about 0.5%, by weight, based on the total combined weight of the boron composition thereof, not including other excipient, carrier, or combination thereof. In a most preferred embodiment the topical composition comprises a boron composition in an effective amount for the detection of a catechol in poison oak oil. The invention further provides a topical medicament, the topical medicament comprising a boron composition, the boron composition comprising an alkylboronic acid having the general formula R—B(OH) 2 , a nitroxide, and a suitable excipient, carrier, or combination thereof, and where R is selected from the group consisting of a hydrophobic alkyl group and a hydrophilic alkyl group. In an alternative embodiment the boron composition optionally comprises at least one B-alkyl boronic acid derivative. In a more preferred embodiment the nitroxide is a profluorescent nitroxide. In a more preferred embodiment the topical medicament comprises a boron composition in an effective amount for the detection of a catechol in poison oak oil to avoid induced contact dermatitis. In another more preferred embodiment the topical medicament comprises a boron composition in an effective amount for the treatment of poison oak oil-induced contact dermatitis. In one embodiment, the invention provides a method for detecting, treating, and deactivating alk(en)yl catechols, and/or alk(en)yl resorcinols using a boron compound bearing a hydrophobic alkyl group and an at least one equivalent of profluorescent nitroxide are that are mixed in solution or on a substrate. In one preferred embodiment, the profluorescent nitroxide is a nitroxide with a short tether to a fluorescent dye, wherein the dye is quenched in the presence of the free nitroxide. In an alternative embodiment the boron compound further comprises an alkyl boronic acid or alkyl boronic acid derivative. In another alternative embodiment the boron compound further comprises at least one leaving group. In yet another alternative embodiment, the boron compound further comprises two leaving groups. In one embodiment the invention provides a method for detecting, treating, and deactivating alk(en)yl catechols, and/or alk(en)yl resorcinols, wherein the method results in producing a fluorescent compound that fluoresces when illuminated and wherein the fluorescence is induced by photons having a wavelength of between about 250 and 600 nm. In one embodiment the fluorescence can be, for example, between 250 and 300 nm, between 300 and 350 nm, between 350 and 400 nm, between 450 and 500 nm, between 500 and 550 nm, and between 550 and 600 nm. In the alternative, the method results in producing a fluorescent compound that fluoresces when illuminated with light in the visible spectrum and wherein the fluorescence is induced by photons having a wavelength of between about 600 and 750 nm. In one embodiment the fluorescence can be, for example, between 600 and 650 nm, between 650 and 700 nm, and between 700 and 750 nm. In another alternative embodiment, the nitroxide can comprise a fluorescent tag such as, for example, a fluorescent organic compound, such as dansyl, 3-hydroxy-2-methyl-4-quinolinecarboxylic ester, a coumarin, a xanthene, a cyanine, a pyrene, a borapolyazaindacene, an oxazine, bimane, 4-acetamido-4′-isothiocyanatostilbene-2,2′-disulfonic acid (SITS) and related stilbene derivatives, and the isothiocyanate of pyrenetrisulfonic acid, fluorescein, acryoldan, rhodamine, dipyrrometheneboron difluoride (BODIPY), acridine orange, eosin, acridine orange, 1-(3-(succinimidyloxycarbonyl)benzyl)-4-(5-(4-methoxyphenyl)oxazol-2-yl)pyridinium bromide (PyMPO), alexa-fluor 488, alexa fluor 532, alexa fluor 546, alexa fluor 568, alexa fluor 594, alexa fluor 555, alexa fluor 633, alexa fluor 647, alexa fluor 660 and alexa fluor 680, or the like, or a quantum-dot nanoparticle. In the present invention, a non-limited list of quantum dot nanoparticles includes cadmium sulfide (CdS), cadmium selenide (CdSe), zinc sulfide (ZnS), zinc oxide (ZnO), lead sulfide (PbS), zinc selenide (ZnSe), GaAS, and InP. (Lakowicz et al., Anal. Biochem., 2000, 280: 128-136. The invention further provides use of a composition comprising a boron composition for the manufacture of a composition for detecting a catechol. In one embodiment the boron composition comprises an alkylboronic acid having the general formula R—B(OH) 2 , a nitroxide, and a suitable excipient, carrier, or combination thereof, and where R is selected from the group consisting of a hydrophobic alkyl group and a hydrophilic alkyl group. In one alternative embodiment the boron composition optionally comprises at least one B-alkyl boronic acid derivative. In a preferred embodiment the nitroxide is a profluorescent nitroxide. In another preferred embodiment the composition comprises a boron composition in an effective amount for the detection of a catechol in poison oak oil. The invention can be used in a variety of embodiments, for example, for use as chemical sensors and molecular specific deactivating agents. The invention can be used in phototherapy for treatment of an inflammatory response and other disorders. The invention can also be used as a sensor that detects molecules. The invention is of particular use in the fields of clinical diagnosis, clinical therapy, clinical treatment, and clinical evaluation of various diseases and disorders, in the field of consumer goods, for example, over-the-counter medications, balms, ointments, etc., and diagnostic kits, manufacture of compositions for use in the treatment of various diseases and disorders, for use in molecular biology, structural biology, cell biology, molecular switches, molecular circuits, and molecular computational devices, and the manufacture thereof. In one embodiment, the composition comprises a surface stabilizer. In another alternative embodiment the composition comprises at least two surface stabilizers. In a preferred embodiment, the surface stabilizer is selected from the group consisting of an anionic surface stabilizer, a cationic surface stabilizer, a zwitterionic surface stabilizer, and an ionic surface stabilizer. In another preferred embodiment, the surface stabilizer is selected from the group consisting of cetyl pyridinium chloride, gelatin, casein, phosphatides, dextran, glycerol, gum acacia, cholesterol, tragacanth, stearic acid, benzalkonium chloride, calcium stearate, glycerol monostearate, cetostearyl alcohol, cetomacrogol emulsifying wax, sorbitan esters, polyoxyethylene alkyl ethers, polyoxyethylene castor oil derivatives, polyoxyethylene sorbitan fatty acid esters, polyethylene glycols, dodecyl trimethyl ammonium bromide, polyoxyethylene stearates, colloidal silicon dioxide, phosphates, sodium dodecylsulfate, carboxymethylcellulose calcium, hydroxypropyl celluloses, hypromellose, carboxymethylcellulose sodium, methylcellulose, hydroxyethylcellulose, hypromellose phthalate, noncrystalline cellulose, magnesium aluminum silicate, triethanolamine, polyvinyl alcohol, polyvinylpyrrolidone, 4-(1,1,3,3-tetramethylbutyl)-phenol polymer with ethylene oxide and formaldehyde, poloxamines, a charged phospholipid, dioctylsulfosuccinate, dialkylesters of sodium sulfosuccinic acid, sodium lauryl sulfate, alkyl aryl polyether sulfonates, mixtures of sucrose stearate and sucrose distearate, p-isononylphenoxypoly-(glycidol), decanoyl-N-methylglucamide; n-decyl β-D-glucopyranoside; n-decyl β-D-maltopyranoside; n-dodecyl β-D-glucopyranoside; n-dodecyl β-D-maltoside; heptanoyl-N-methylglucamide; n-heptyl-β-D-glucopyranoside; n-heptyl β-D-thioglucoside; n-hexyl β-D-glucopyranoside; nonanoyl-N-methylglucamide; n-noyl β-D-glucopyranoside; octanoyl-N-methylglucamide; n-octyl-β-D-glucopyranoside; octyl β-D-thioglucopyranoside; lysozyme, PEG-phospholipid, PEG-cholesterol, PEG-cholesterol derivative, and PEG-vitamin A. In another alternative embodiment, the cationic surface stabilizer is selected from the group consisting of a polymer, a biopolymer, a polysaccharide, a cellulosic, an alginate, a nonpolymeric compound, and a phospholipid. In another alternative embodiment, the surface stabilizer is selected from the group consisting of cationic lipids, polymethylmethacrylate trimethylammonium bromide, sulfonium compounds, polyvinylpyrrolidone-2-dimethylaminoethyl methacrylate dimethyl sulfate, hexadecyltrimethyl ammonium bromide, phosphonium compounds, quarternary ammonium compounds, benzyl-di(2-chloroethyl)ethylammonium bromide, coconut trimethyl ammonium chloride, coconut trimethyl ammonium bromide, coconut methyl dihydroxyethyl ammonium chloride, coconut methyl dihydroxyethyl ammonium bromide, decyl triethyl ammonium chloride, decyl dimethyl hydroxyethyl ammonium chloride, decyl dimethyl hydroxyethyl ammonium chloride bromide, C 12-15 dimethyl hydroxyethyl ammonium chloride, C 12-15 -dimethyl hydroxyethyl ammonium chloride bromide, coconut dimethyl hydroxyethyl ammonium chloride, coconut dimethyl hydroxyethyl ammonium bromide, myristyl trimethyl ammonium methyl sulphate, lauryl dimethyl benzyl ammonium chloride, lauryl dimethyl benzyl ammonium bromide, lauryl dimethyl (ethenoxy)4 ammonium chloride, lauryl dimethyl (ethenoxy) 4 ammonium bromide, N-alkyl (C 12-18 )dimethylbenzyl ammonium chloride, N-alkyl (C 14-18 )dimethyl-benzyl ammonium chloride, N-tetradecylidmethylbenzy-1 ammonium chloride monohydrate, dimethyl didecyl ammonium chloride, N-alkyl and (C 12-14 ) dimethyl 1-napthylmethyl ammonium chloride, trimethylammonium halide, alkyl-trimethylammonium salts, dialkyl-dimethylammonium salts, lauryl trimethyl ammonium chloride, ethoxylated alkyamidoalkyldialkylammonium salt, an ethoxylated trialkyl ammonium salt, dialkylbenzene dialkylammonium chloride, N-didecyldimethyl ammonium chloride, N-tetradecyldimethylbenzyl ammonium, chloride monohydrate, N-alkyl (C 12-14 ) dimethyl 1-naphthylmethyl ammonium chloride, dodecyldimethylbenzyl ammonium chloride, dialkyl benzenealkyl ammoniumchloride, lauryl trimethyl ammonium chloride, alkylbenzyl methyl ammonium chloride, alkyl benzyl dimethyl ammonium bromide, C 12 trimethyl ammonium bromides, C 15 trimethyl ammonium bromides, C 17 trimethyl ammonium bromides, dodecylbenzyl triethyl ammonium chloride, poly-diallyldimethylammonium chloride (DADMAC), dimethyl ammonium chlorides, alkyldimethylammonium halogenides, tricetyl methyl ammonium chloride, decyltrimethylammonium bromide, dodecyltriethylammonium bromide, tetradecyltrimethylammonium bromide, methyl trioctylammonium chloride, polyquaternium 10, tetrabutylammonium bromide, benzyl trimethylammonium bromide, choline esters, benzalkonium chloride, stearalkonium chloride compounds, cetyl pyridinium bromide, cetyl pyridinium chloride, halide salts of quaternized polyoxyethylalkylamines, quaternized ammonium salt polymers, alkyl pyridinium salts; amines, amine salts, amine oxides, imide azolinium salts, protonated quaternary acrylamides, methylated quaternary polymers, and cationic guar. The invention also provides for a chemical spray that can be used in the field to allow the detection of urushiol in conjunction with the use of a fluorescent lamp. In one embodiment the amount of urushiol detected is in the range of between about 0.1-100 μg. In a preferred embodiment, the amount of urushiol detected is in the range of between about 1-10 μg. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates the chemical formulae of chatechol and exemplary urushiols. FIG. 2 illustrates how B-alkyl catechol borane species react with oxygen radicals to expel alkyl radicals (adapted from Darency and Renaud, 2006, Top. Curr. Chem., 263: 71-106; Cadot et al. 2002, JOC, 67: 7193-7202; Baban et al. 1986, J. Chem. Soc., Perkin Trans. 2: 157). FIG. 3 illustrates a modified Brown and Negishi reaction that may comprise chain transfers with PTOC-OMe for radical acceptors (Brown and Negishi, 1971, J. Am. Chem. Soc. 93: 3777; Suzuki et al. 1969, J. Chem. Soc., Chem. Commun., 17: 1009; Forster 1999, PhD Thesis, University de Fribourg, Switzerland, Diss Nr. 1242; Ollivier and Renaud 1999, Chem. Eur. J., 5: 1468; Kumli and Renaud, 2006, Org. Lett. 8: 5861; Olivier and Renaud, 2000, Angew. Chem. Int. Ed. 39: 925). FIG. 4 illustrates novel methods for detecting poison oak oil (including poison ivy, sumac oil, and lac tree extracts) that are present upon a substrate by chemical generation of fluorescence. FIG. 5 illustrates an exemplary reaction between a nitroxide (for example, TEMPO) and a catechol that results in a nitroxide-catecholborane. FIG. 6 illustrates an exemplary reaction between a profluorescent nitroxide and a catechol that results in a fluorescent nitroxide-catecholborane. FIG. 7A illustrates details of another exemplary reaction between either a borane compound (top), a catecholborane (middle and bottom), and a nitroxide or profluorescent nitroxide that results in no reaction (top), production of a nitroxide-catecholborane (middle), or production of a fluorescent nitroxide-catecholborane (bottom). FIG. 7B illustrates details of how a reaction between a profluorescent nitroxide in the presence of phenylhydrazine results in production of a fluorescent compound. FIG. 8 illustrates that addition of an oxygen radical to an alkylcatecholborane forms a perboryl radical 5, visible by ESR FIG. 9 illustrates that addition of nitroxide to an alkylcatecholborane forms a perboryl radical 6, which fragments to generate an alkyl radical. A second equivalent of nitroxide reacts with the alkyl radical to form alkoxyamine 8. FIG. 10 shows exemplary profluorescent nitroxides: the free nitroxide quenches fluorescence of a closely tethered fluorophore; fluorescence is restored upon reaction to from the alkoxyamine or hydroxylamine. FIG. 11 illustrates a reaction sequence that may detect catechol using profluorescent nitroxide addition to alkylcatecholborane 13. FIG. 12 illustrates use of profluorescent Dansyl amino-TEMPO: preparation, reduction, and formation of radical trapping product 17. FIG. 13 shows an exemplary reaction of a model alkyl-catecholborane 19 with two equivalents of nitroxide: both alkoxyamine 20 and hydroxylamine 21 were isolated from the reaction mixture. FIG. 14 illustrates reaction of profluorescent Dansyl amino-TEMPO 16 with n-butylcatecholborane 19 in toluene to give fluorescent n-butylalkoxyamine 22 (A): paper towel spot test shows fluorescence of alkoxyamine 22 (B). FIG. 15 shows the in situ formation of n-butylcatecholborane 19 and subsequent reaction to form fluorescent 22 (A) in one pot (B). FIG. 16 illustrates common classes of readily synthesized stable nitroxides. FIG. 17 illustrates a general synthesis pioneered by Hideg and Keana for the preparation of proxyl nitroxides 42. FIG. 18 shows the synthesis of the pyrene proxyl profluorescent nitroxide 44. FIG. 19 illustrates a few representative known profluorescent nitroxides. FIG. 20 illustrates the excitation and emission spectra of profluorescent nitroxide 12 and fluorescent N-alkoxyamine 28 in DMSO. FIG. 21 shows a hydroboration route to prepare n-alkylboronic acids 25 FIG. 22 illustrates representative pyrogallols and catechols commonly found in foods such as red wine, tea, and chocolate: note that compounds 48 and 49 are polyols, and are thus aqueous rather than organic soluble. FIG. 23 illustrates a slow reduction of nitroxide by catechol; rapid reoxidation of the hydroxylamine to the nitroxide with PbO 2 . FIG. 24 illustrates fluorescence quenching and recovery upon addition of catechol to profluorescent nitroxide 12, with and without addition of PbO 2 as a reoxidant. FIG. 25 illustrates how exemplary mild oxidants can rapidly oxidize hydroxylamine to nitroxide but that do not oxidize catechol to quinone. FIG. 26 illustrates detection of urushiol on leaves of poison oak. A: Fresh Poison Oak triad of leaves; B: Print of the same leaves on a paper towel after treatment with Fl-NitO•, nBuB(OH) 2 and catalytic PbO 2 in acetone. DETAILED DESCRIPTION OF THE INVENTION In order to develop a system to selectively detect catechols in the presence of other alcohols and diols (such as sugars), a reaction that takes place with catechols but not with other alcohols was required. In the field of organic free radical chemistry, alkylcatecholboranes have been used to selectively generate alkyl radicals upon reaction with oxygen radicals. The efficacy of this oxygen radical addition specifically to alkylcatecholboranes is due to de-localization of the unpaired electron of the perboryl species 5 into the aromatic ring ( FIG. 8 ). Direct ESR evidence for this delocalized perboryl radical 5 below 270 K was observed by Roberts (Baban et al., J. Chem. Soc. Perkin Transact. 1986, 2(1): 157-161). A number of very useful synthetic methodologies have been developed from this chemistry. Key to this proposal is the work by Renaud, in which addition of two equivalents of the oxygen radical TEMPO 7, a commercially available persistent nitroxide radical, results in formation of the carbon radical trapping product, alkoxyamine 8 ( FIG. 9 ). In order to design a visual indicator of the reaction of nitroxides with alkylcatecholboranes, profluorescent nitroxides are used. Profluorescent nitroxides 10 (sometimes referred to as “pre-fluorescent nitroxides”) are nitroxides bearing a short covalent tether to a fluorophore. The free nitroxide quenches the fluorescence. Upon reaction of the nitroxide moiety to form an alkoxyamine 11 or a hydroxylamine (or any other non-nitroxide product), the fluorescence is no longer quenched, restoring fluorescence to the product ( FIG. 10 ). Profluorescent nitroxides have been utilized as sensors of nitric oxide, antioxidants, reactive oxygen species, carbon radicals, cationic metals, viscosity probes, as a chemical logic gate, and in the development of photomagnetic materials. (See Ivan, M. G.; Scaiano, J. C., Photochemistry and Photobiology 2003, 78, (4), 416-419; Hornig, F. S.; Korth, H. G.; Rauen, U.; de Groot, H.; Sustmann, R., Helvetica Chimica Acta 2006, 89, (10), 2281-2296; Lozinsky, E. M.; Martina, L. V.; Shames, A. I.; Uzlaner, N.; Masarwa, A.; Likhtenshtein, G. I.; Meyerstein, D.; Martin, V. V.; Priel, Z., Analytical Biochemistry 2004, 326, (2), 139-145; Meineke, P.; Rauen, U.; de Groot, H.; Korth, H. G.; Sustmann, R., Chemistry—a European Journal 1999, 5, (6), 1738-1747; Meineke, P.; Rauen, U.; de Groot, H.; Korth, H. G.; Sustmann, R., Biological Chemistry 2000, 381, (7), 575-582; Blough, N. V.; Simpson, D. J., Journal of the American Chemical Society 1988, 110, (6), 1915-1917; Lozinsky, E.; Martin, V. V.; Berezina, T. A.; Shames, A. I.; Weis, A. L.; Likhtenshtein, G. I., Journal of Biochemical and Biophysical Methods 1999, 38, (1), 29-42; Tang, Y. L.; He, F.; Yu, M. H.; Wang, S.; Li, Y. L.; Zhu, D. B., Chemistry of Materials 2006, 18, (16), 3605-3610; Hideg, E.; Kalai, T.; Kos, P. B.; Asada, K.; Hideg, K., Photochemistry and Photobiology 2006, 82, (5), 1211-1218; Aspee, A.; Garcia, O.; Maretti, L.; Sastre, R.; Scaiano, J. C., Free radical reactions in poly(methyl methacrylate) films monitored using a prefluorescent quinoline-TEMPO sensor. Macromolecules 2003, 36, (10), 3550-3556; Aspee, A.; Maretti, L.; Scaiano, J. C., Photochemical &amp; Photobiological Sciences 2003, 2, (11), 1125-1129; Ballesteros, O. G.; Maretti, L.; Sastre, R.; Scaiano, J. C., Macromolecules 2001, 34, (18), 6184-6187; Blinco, J. P.; McMurtrie, J. C.; Bottle, S. E., European Journal of Organic Chemistry 2007, 4638-4641; Coenjarts, C.; Garcia, O.; Llauger, L.; Palfreyman, J.; Vinette, A. L.; Scaiano, J. C., Journal of the American Chemical Society 2003, 125, (3), 620-621; Dang, Y. M.; Guo, X. Q., Applied Spectroscopy 2006, 60, (2), 203-207; Fairfull-Smith, K. E.; Blinco, J. P.; Keddie, D. J.; George, G. A.; Bottle, S. E., Macromolecules 2008, 41, 1577-1580; Gerlock, J. L.; Zacmanidis, P. J.; Bauer, D. R.; Simpson, D. J.; Blough, N. V.; Salmeen, I. T., Free Radical Research Communications 1990, 10, (1-2), 119-121; Johnson, C. G.; Caron, S.; Blough, N. V., Analytical Chemistry 1996, 68, (5), 867-872; Maurel, V.; Laferriere, M.; Billone, P.; Godin, R.; Scaiano, J. C., Journal of Physical Chemistry B 2006, 110, (33), 16353-16358; Micallef, A. S.; Blinco, J. P.; George, G. A.; Reid, D. A.; Rizzardo, E.; Thang, S. H.; Bottle, S. E., Polymer Degradation and Stability 2005, 89, (3), 427-435; Nagy, V. Y.; Bystryak, I. M.; Kotelnikov, A. I.; Likhtenshtein, G. I.; Petrukhin, O. M.; Zolotov, Y. A.; Volodarskii, L. B., Analyst 1990, 115, (6), 839-841; Arye, P. P.-B.; Strashnikova, N.; Likhtenshtein, G. I., Journal of Biochemical and Biophysical Methods 2002, 51, (1), 1-15; and Wang, H. M.; Zhang, D. Q.; Guo, X. F.; Zhu, L. Y.; Shuai, Z. G.; Zhu, D. B., Chemical Communications 2004, (6), 670-671.) The use of a profluorescent nitroxide with an alkylboronic acid derivative 12 is envisioned to react with catechols (such as, but not limited to, for example, urushiol) to form alkylboronate 13: nitroxide addition, radical 14 generation, and nitroxide trapping will generate the fluorescent signal of alkoxyamine 15. Other alkylboronic acid derivatives will be apparent to those of skill in the art. Catechols are a group of compounds well-known to those of skill in the art having diverse biological activities, whilst at the same time being structurally conservative. The invention contemplates that the compositions and methods disclosed herein may be used to detect, inactivate, or bind to any biologically-active catechol composition. In particular the invention contemplates a catechol selected from the group consisting of urushiol, catechin, epicatechin, gallocatechin, epigallocatechin, epigallocatechin-3-gallate, and catecholamines epinephrine, norepinephrine, dopamine, and dihydroxyphenylalanine (DOPA). One of skill in the art would consider that the structures of catechols are sufficiently similar that they are a well-known chemical class of compounds. Profluorescent nitroxide is sometimes referred to as a pre-fluorescent nitroxide. In the presence of a catechol such as urushiol and an B-alkylboronic acid derivative, a B-alkyl catecholborionate is formed. Addition of the nitroxide to the catecholborane results in expulsion of an alkyl radical, which is trapped by a second nitroxide, forming two fluorescent species: an alkoxyamine with a fluorescent tag, and fluorescently tagged nitroxide-catecholborane complex. In addition, the nitroxide-catecholborane may degrade to hydroxylamine that is also a fluorescent compound. Use of a hand-held fluorescent lamp shows fluorescence when a catechol such as urushiol is present. This can be used as a method to detect the presence of urushiol. As a treatment, binding of the urushiol into a catecholborane complex will prevent transfer through the skin, preventing oxidation of the catechol and elicitation of an immune response, thus preventing contact dermatitis. For detecting aqueous soluble catechols such as dopamine, epinephrine, and norepinephrine, a water-soluble alkyl group is preferred on the initial boron compound rather than a hydrophobic alkyl group. Examples of profluorescent nitroxides may be found in the following non-exhaustive list of publications: Blough, 1988, JACS, 110: 1915; Bottle, 2005, Polym. Degrad. &amp; Stability, 89: 427-435; Sciano, 2001, Macromol. 34: 6184; Ibid., 2003, JACS, 125: 620; Ibid., 2003, Photochem. Photobiol. 78: 416; Turro, 2001, Macromol., 34: 8187; Koth, 2000, Biological Chem., 381(7): 575-582; Ibid., 1999, Chem. Eur. J. 5(6): 1738-1747; Ibid., 1997, Ang. IEE, 36: 1501-1503; Ibid., 2006, Hely. Chim. Acta, 89: 2281-2296; Hideg 2006, Photochem. Photobiol. 82: 1211; Want, 2006, Chem. Mater., 18: 3605; and Dang and Guo, 2006, Appl. Spectrosc. 60: 203-207, In the present invention, a non-limited list of quantum dot nanoparticles includes cadmium sulfide (CdS), cadmium selenide (CdSe), zinc sulfide (ZnS), zinc oxide (ZnO), lead sulfide (PbS), zinc selenide (ZnSe), GaAS, and InP. (Lakowicz et al. Analytical Biochemistry, 2000, 280: 128-136). Alternative suitable donor fluorophores will be apparent to those of ordinary skill without undue experimentation. For example, nitroxides tethered to such a quantum dot will quench any fluorescence; when the nitroxides react with a catechol boronate complex, the quenching effect is removed and fluorescence can occur under appropriate conditions. Use of the Compositions for Detection of Urushiol A composition prepared according to the present invention may be formulated as an aerosol spray, a topical cream, ointment, medicament, or a solution. An aerosol containing approximately 0.005% to about 5.0% (w/w) each of the boron composition and nitroxide according to the present invention is prepared by dissolving the compositions in absolute alcohol. The resulting solution is then diluted in an organic solvent or purified water, depending upon the hydrophobicity of the compound. Routine experimentation by those having skill in the art can be used to determine an effective amount for detecting a catechol in a sample. There are several biologically very important catechols: the catecholamines (including epinephrine, norepinephrine, and dopamine), in addition to epicatechin (common in tea). All of these are water-soluble. Because boron species undergo dynamic exchange of alcohol ligands via their anionic “-ate” species in water, it is likely that this methodology may be extrapolated to detect catechols in an aqueous environment. The key reaction sequence of nitroxide reacting with alkylcatecholborane is well established in non-polar organic solvents. Extension to aqueous conditions would provide a very powerful detection method for catecholamines: success would depend on the lifetimes of the tricoordinate borane species compared to the predominate tetracoordinate boronate species. Water-soluble nitroxides and fluorophores are widely known; nitroxides have been used extensively as an EPR probe in biology. The detection of biologically important catecholamines (including epinephrine, norepinephrine, and dopamine) in aqueous environments could lead to powerful new methods in biomedicine. Contact dermatitis from exposure of skin to urushiol causes agony and suffering for tens of millions of Americans each year, making this an important human health issue in North America. Urushiol can be effectively removed from skin, clothes and equipment, but only if it is known where this invisible contamination is located. The invention comprises a fluorescence detection method: a spray containing a profluorescent nitroxide and an alkylboronate derivative in an organic solvent will react selectively with urushiol to form a fluorescent N-alkoxyamine. An inexpensive UV light can then be used to pinpoint the presence of urushiol, to prevent or mitigate exposure to skin. Preliminary results with catechol confirm that the key reaction works as expected, and that a highly fluorescent signal is generated. Optimization of the profluorescent nitroxide (both the fluorophore and nitroxide structures), solvent and fine-tuning of the alkyl group on the boronic acid are undertaken. The invention provides a clear benefit to society, including private outdoors enthusiasts, forestry workers, emergency rescue personnel, military personnel, and others who come in contact with poison oak, poison ivy, or sumac. The invention also may be used to deactivate a chatechol, such as urushiol, using the methods disclosed herein. In certain case the product, such as B-alkyl catecholboronate or alkycatecholborane, may be chemically unstable and the composition may hydrolyse to the products, chatechol and the alkylboronate derivative, for example. It is contemplated that such hydrolysis may be impeded or decelerated in the presence of environmental modulators, such as a hydrophobic composition, a hydrophilic composition, a buffer composition, or the like. Such environmental modulators can be sugars, carbohydrates, proteins, peptides, glycopeptides, glycolipids, and glycophospholipids; organic compositions, such as organic acids, organic salts, organic bases, or the like, lipids, phospholipids, or fatty acids; chemical stabilizers, or the like, or any combination thereof. Such compositions may be used to formulate a topical medicament or topical composition that is used to reduce or eliminate the effects of poison oak oil-induced contact dermatitis. In addition, the formulation or aerosol can comprise a solvent, the solvent comprising a polar organic solvent, a non-polar organic solvent, an aqueous solvent, or a non-aqueous solvent. The invention will be more readily understood by reference to the following examples, which are included merely for purposes of illustration of certain aspects and embodiments of the present invention and not as limitations. EXAMPLES Example I Preparation and Testing of Fluorescent Compounds We have prepared the known profluorescent nitroxide Dansyl amino-TEMPO 16. As reported, the free nitroxide quenches fluorescence; the insert of FIG. 12 shows the reaction of the nitroxide to form either the hydroxylamine 17 (vial shown) or the n-butylalkoxyamine 18 (not shown) restores the fluorescence to the naked eye upon irradiation with a long wave-length UV lamp at 366 nm. (A hand-held UV lamp typically used for viewing thin layer chromatography plates was utilized in these photographs). As an initial model, B-n-butylcatecholborane 19 was pre-formed using Dean Stark conditions, and then allowed to react with two equivalents of TEMPO 7 ( FIG. 13 ). The expected N-n-butyloxyamine 20 was formed as a mixture with the hydroxylamine 21, confirming the chemistry developed by Renaud. Hydroxylamine 21 is presumably formed by hydrolysis of the nitroxide boronic ester complex. This reaction was repeated with the profluorescent Dansyl amino-TEMPO 16 ( FIG. 14A ). The reaction mixture was strongly fluorescent in which a drop of solution was put on a paper towel; illumination with a thin layer chromatography (TLC) long-wavelength lamp clearly showed a strong fluorescent signal for the alkoxyamine 28 (see FIG. 14B ). Similar drops of solution containing the profluorescent nitroxide 16 and a control mixture of the profluorescent nitroxide mixed with n-butylboronic acid gave no detectible signal. Isolation and characterization of the fluorescent n-butylalkoxyamine 22 confirmed that the reaction had occurred as predicted. Example II Fluorescence Detection of Catechol In order to form alkylcatecholborane 13 from free catechol under ambient conditions, we initially believed it would be necessary to convert the hydroxyl groups on an alkylboronic acid to better leaving groups. However, early work by Brown indicated that alkylboronic acids react reversibly with catechol in organic, nonpolar solvents to form the desired catecholboranes. It was determined that the reaction sequence shown in FIG. 15A worked: alkylcatecholborane 19 formed from free catechol and an alkylboroinic acid in situ, and reacted with profluorescent nitroxide 16 in one pot to form 22 with a strongly fluorescent signal ( FIG. 15B ). This was an unexpectedly superior result. FIG. 26 shows a successful field test of this detection system. The composition was applied onto the surface of poison oak leaves. A paper towel was applied to the surface of the leaves and the paper towel was illuminated using a UV-lamp. As shown in FIG. 26 , the fluorescence was clearly visible to the naked eye. It has also been observed that the reaction works well in a variety of polar and nonpolar solvents. Example III Synthesis and Development of the Components of the Fluorescence-Generation Method: Optimize the Structure of the Nitroxide, Fluorophore, Tether and Alkylboronic Acid The chemical design of the profluorescent nitroxide is explored, entailing the choice of the optimum nitroxide, fluorescent tag, and tether to prepare a robust, soluble and effective component for this detection system. As fluorescence is a very sensitive method of detection, only very small amounts need react to give a signal visible to the naked eye using an inexpensive hand-held fluorescent lamp. The six-membered ring TEMPO is by far the most common nitroxide scaffold, however there are a number of other common stable nitroxide classes. Considerations in optimization of the nitroxide structure include ease and cost of synthesis, versatility in designing and optimizing the tether between the fluorophore and the nitroxide, stability and solubility. Common stable nitroxide classes include TEMPO (tetramethylpiperidinyl-1-oxyl), proxyl (pyrrolidine analogues), nitronyl, imino and doxyl nitroxides ( FIG. 16 ). The inventor and the inventor&#39;s research laboratory has been engaged in the synthesis and applications of nitroxides for over a decade, thus has extensive experience in the synthesis of new nitroxides. In addition, a large number of commercially nitroxides are available from Toronto Research Chemicals, Inc. (North York, Canada). Recent work by Lozinsky et al. (2004) indicates that profluorescent nitronyl nitroxides quench fluorescence by a different mechanism involving nonbonding electrons of nitrogen and oxygen rather than to the unpaired electron. Thus the fluorescence does not increase upon reduction to the hydroxylamine (and also presumably from the formation of alkoxyamines), making them unsuitable for this study. Given the simple synthetic access ( FIG. 17 ) to proxyl nitroxides following the large body of work pioneered by Hideg, Keana, and many others, proxyl nitroxides 42 are particularly attractive. The fluorophore can be easily introduced late in the synthetic sequence, encouraging synthetic diversity without having to start the sequence from the beginning. For an example, a Grignard reagent 43 prepared from 1-bromopyrene gives the proxyl nitroxide 44 with a very short tether between the fluorophore and the nitroxide ( FIG. 18 ). Example IV Use of Fluorescence Detection With regard to the choice of fluorophore, preliminary data and results focused on Dansyl amino-TEMPO 12, a well-developed profluorescent nitroxide. One advantage of this compound is that sulfonamides are resistant to hydrolysis, thus minimizing the possibility of hydrolysis to give a free fluorophore and thus a false positive signal. Scaiano (Aliaga et al., Organic Lett., 2003, 5(22): 4145-4148) has developed 4-(3-hydroxy-2-methyl-4-quinolinoyloxy)-TEMPO 45, which shows significantly enhanced fluorescence upon reaction of the nitroxide compared to Dansyl amino-TEMPO 12 (but contains a more easily hydrolyzed ester linkage) ( FIG. 19 ). Bottle (Micallef et al., Polymer Degrad. Stabil., 2005, 89(3): 427-435) has developed the profluorescent nitroxide TMDBIO 46, containing a phenanthrene fluorophore covalently fused into the structure of the nitroxide, making hydrolysis an impossibility. Other fluorophores such as pyrene 47 and coumarins have been utilized, and many more are possible. The use of fluorophores observable in the visible range is also explored. The intensity, wavelength dependence, cost, stability and ease of synthesis will all be taken into consideration in selecting the best fluorophore. Efficient quenching requires a short tether between the fluorophore and the nitroxide moiety; rotational freedom and flexibility also influence the quenching efficiency. Thus the 5-membered ring nitroxides may provide an advantage in holding the fluorophore in a closer geometry to the nitroxide as compared to the 6-membered ring framework of TEMPO. Example V Quenching of Fluorophore Dansyl amino TEMPO 12 does show a small amount of residual fluorescence, as shown in FIG. 20 . Other profluorescent nitroxides may be even more effective at quenching the fluorescence in the free nitroxide state. The wavelength of excitation and emission can be tuned by selection of the fluorophore. Example VI Effect of Charge Upon Fluorescence Detection Since urushiol is very hydrophobic, apolar organic solvents are investigated for the key reaction sequence, including toluene, hexanes, acetone, ethers, etc. The linear hydrophobic “tail” is optimized for both reactivity with catechol and solubility to match that of the hydrophobic urushiol. B-alkylpinacolboranes 24 are conveniently prepared by iridium-catalyzed hydroboration 78 of the corresponding terminal alkenes using commercially available pinacolborane 23 ( FIG. 21 ). Hydrolysis provides easy access to alkylboronic acids with a variety of chain lengths. Commercially available C 12 -C 17 linear terminal olefins are available, with the C 14 and C 16 being particularly inexpensive. Upon testing with actual urushiol, there may be an advantage to having an odd or even number of carbons in the sidechain, or the exact carbon count may prove to be inconsequential. The stability of the boronic acid is also a consideration. Tertiary alkyl boronic acids are prone to decomposition upon exposure with air. In our preliminary studies, we have used primary n-butyl boronic acid. The sample has remained stable for over a year without taking any precautions to avoid exposure to air. We have determined that aryl boronic acids (very stable, and commercially available) do not take part in the radical reaction sequence, presumably due to failure of the fragmentation step due to the instability of aryl radicals. Thus primary alkyl boronic acids seem to be ideal: they react in the desired radical reaction sequence, but are stable to storage. Example VII Optimizing the Detection System with Regard to Stoichiometry, Solvent, Concentration, Reaction Time, and Avoidance of False Positives Calibration of the fluorescence signal as a function of the concentration of the catechol, boron reagent and nitroxide is carried out. As exposure to 0.001 mg of urushiol can elicit allergic contact dermatitis, very small amounts of urushiol should to be detectable to make this method effective. The optimal stoichiometry to obtain a short reaction time is studied. It is expected that two nitroxides are needed for every boron complex, although one equivalent may be sufficient if the nitroxide catecholboronate complex is hydrolytically unstable. If the fluorescent signal is extremely strong, it may be possible to economize by using a mixture of regular nitroxide mixed with some small percentage of profluorescent nitroxide. The specificity of this system for catechols is explored. As controls, phenols, resorcinols (1,3-benenediols), alcohols and diols (for example, sugars) are not expected to participate in the key reaction sequence, as no delocalized perboryl radical intermediate similar to 6 will be formed. Reaction with these various alcohols are tested to ensure that this method is indeed selective for catechols. Pyrogallols (1,2,3-benenetriols, for example gallocatechins (ex. 48) and epigallocatechins ( FIG. 22 ) found in red wine, tea and chocolate) are expected to participate in the reaction, depending upon their solubility in the solvents. Likewise, the closely related catechins (ex. 49) and epicatechins (found in foods along with gallocatechins) are true catechols: reaction are again be limited by solubility. Possible sources of false positives are examined. It is well known that nitroxides react rapidly with ascorbic acid to form hydroxylamines. Our research group has used ascorbate reduction of nitroxide to aid in chromatographic separation of alkoxyamine from unreacted nitroxide. Blough was the first to show profluorescent nitroxides react with ascorbic acid to generate a fluorescent signal. Lozinsky has utilized profluorescent nitroxides to assay the amount of vitamin C in fruit juices, and Wang has used a fluorescent conductive charged polymer nitroxide salt as a sensor for ascorbate and for trolox (a vitamin E mimic). Another side reaction that may interfere with the selective detection of urushiol by this boron catechol sequence is the simple reduction of nitroxides by phenols. Scaiano has studied the kinetics of hydrogen transfer from phenol to nitroxide using a profluorescent nitroxide. The rate constants are very slow: k=0.003 M −1 s −1 in protic solvent for gallic acid and BHT, and k=0.2 M −1 s −1 for TROLOX. Scaiano did not investigate reduction by catechol. In preliminary experiments ( FIG. 23 ), we have shown that addition of catechol to Dansyl amino-TEMPO 12 in toluene does produce a weak fluorescent signal, however this is suppressed by addition of a mild oxidant (PbO 2 ) to convert the tiny amount of hydroxylamine to nitroxide. This removes the false positive from phenol ( FIG. 24 ). The use of other mild oxidants that will rapidly oxidize hydroxylamine to nitroxide in organic solvents, but not oxidize catechol to quinone, are investigated (See FIG. 25 ). Particularly attractive are Fe (III) salts as less toxic alternatives to lead. We have determined that OXONE is too strong of an oxidizing agent: the nitroxide is oxidized to the oxammonium salt. Interestingly, Bottle has shown that pyrrolidine nitroxides (cyclic 5-membered rings) have higher reduction potentials than piperidine (6-membered ring) nitroxides. Thus use of a pyrrolidine profluorescent nitroxide may inhibit the false positive signal arising from reduction by phenols. REFERENCES Addition of Nitroxides to Catecholboranes: Schaffner and Renaud (2004) Eur. J. Org. Chem. 2291-2298. Darmency and Renaud, (2006) Top. Curr. Chem. 263: 71-106. Cadot et al., (2002) J. Org. Chem., 67; 7193-7202. Ollivert et al. (1999) Synlett. 6: 807-809. Attempted Addition of Nitroxides to Trialkylboranes: Braslau and Anderson, in Radicals in Organic Synthesis , vol. 2 (Eds. P. Renaud, M. P. Sibi), Wiley-VCH, Weinheim, 2001, p. 129. Addition of Oxygen Radicals to Catecholboranes: Baban et al. (1986) J. Chem. Soc., Perkin Trans 2: 157. Suzuki et al. (1969) J. Chem. Soc., Chem. Commun. 1009. Brown and Negishi (1971) J. Am. Chem. Soc. 93: 3777. Forster (1999) PhD Thesis, Université de Fribourg, Switzerland, Diss. Nr. 1242. Ollivier and Renaud (1999) Chem. Eur. J. 5: 1468. Kumli et al. (2006) Organic Lett. 8(25): 5861-5864. Ollivier and Renaud (2000) Angew. Chem. Int. Ed. Eng. 39: 925. Profluorescent Nitroxides: Blough (1988) J. Am. Chem. Soc. 110: 1915. Blough (1990) Free Rad. Res. Comm. 10: 119-121. Blough (1996) Anal. Chem. 68: 867-872. Micallef A S et al. (2005) Polym Degrad. &amp; Stability 89: 427-435. Foitzik et al. (2008) Macromolecules 41: 1577-1580. Blinco et al. E. J. Org. Chem. 28: 4638-4641. Sciano (2001) Macromol. 34: 6184. Coenjarts et al. (2003) J. Am. Chem. Soc 125: 620-621. Ivan et al. (2003) Photochem. Photobiol. 78: 416. Aspee et al. (2007) Photochem. Photobiol. 83(3): 481-485. Maurel et al. (2006) J. Phys. Chem. B, 110(33): 16353-16358. Laferriere et al. (2006) Chem. Comm. (3): 257-259. Aspee et al. (2003) Photochem. Photobiol. Sci. 2(11): 1125-1129. Aspee et al. (2003) Macromolecules, 36(10): 3550-3556. Korth (2000) Biol. Chem. 381(7): 575-582; ibid (1999) Chem. Eur. J. 5(6): 1738-1747; ibid (1997) Angew. Chem. Int. Ed. Eng. 36: 1501-1503; ibid (2006) Hely. Chim. Acta 89: 2281-2296. Zhang and Zhu (2004) Chem. Commun. 670. Hideg (2006) Photochem. Photobiol. 82: 1211. Wang (2006) Chem. Mater. 18: 3605-3610. Dang and Guo (2006) Appl. Spectrosc. 60: 203-207. Likhtenstein et al. (2007) Photochem. Photobiol. 83: 871-881. Lozinsky, et al. (2004) Anal. Biochem. 326: 139-145. Likhtenstein (2002) Biochem. Biophys. Meth. 51: 1-15. Likhtenstein (1990) Analyst 115: 839. Likhtenstein (1999) Biochem. Biophys. Meth. 38: 29-42. Those skilled in the art will appreciate that various adaptations and modifications of the just-described embodiments can be configured without departing from the scope and spirit of the invention. Other suitable techniques and methods known in the art can be applied in numerous specific modalities by one skilled in the art and in light of the description of the present invention described herein. Therefore, it is to be understood that the invention can be practiced other than as specifically described herein. The above description is intended to be illustrative, and not restrictive. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

The invention herein disclosed provides for compositions, methods for synthesizing said compositions, and methods for using said compositions, wherein the compositions and methods may be used to bind to and/or deactivate a poison oak oil, such as urushiol. The compositions and methods can be used to treat and/or reduce an inflammatory reaction and/or hypersensitivity to natural compounds found in poison oak, poison ivy, poison sumac, mango, lac tree, and cashew nut.

CROSS REFERENCE TO RELATED APPLICATION [0001] This application is a divisional of U.S. application Ser. No. 11/165,163, filed Jun. 24, 2005, which is a continuation (and claims the benefit of priority under 35 USC 120) of U.S. application Ser. No. 10/151,812, filed May 22, 2002. The disclosure of the prior applications are considered part of (and are incorporated by reference in) the disclosure of this application. TECHNICAL FIELD [0002] This invention relates to suture passing surgical instruments, and more particularly, to a surgical instrument and method for single-handedly passing suture through tissue. BACKGROUND [0003] Suture is passed through tissue many ways including, for example, cannulated needles and instruments and needle passing instruments, which in general, require the use of multiple portal entry points in order to transfer the suture through tissue or require the use of additional instruments or devices to facilitate the passage of suture. As described in U.S. Pat. No. 5,935,149, it is known to place the suture at a desired site to be sutured by passing a needle attached to the suture from a first member of a suture passing forceps to a second member of the forceps. The suture is secured at the site by passing the needle through a suture receiving passage in an outer member of a suture securing device to position a portion of the suture therein and inserting an inner member of the suture securing device into the passage to secure the portion of the suture between the inner and outer members. The needle is passed through the passage by threading the needle through a suture threader disposed in the passage and pulling the threader from the passage. The suture threader has one end terminating in the needled suture and an opposite end terminating in a suture receiving loop. SUMMARY [0004] In one general aspect of the invention, a surgical instrument includes first and second members configured to receive tissue therebetween. The first member is adapted to receive suture, the second member is coupled to the first member, and a grasper is coupled to the second member for engaging the suture received by the first member. [0005] Embodiments of this aspect of the invention may include one or more of the following features. The grasper is coupled to the second member for movement between a retracted position and a suture engaging position. The second member defines a slot for receiving suture from the first member, and the grasper is configured to trap suture within the slot. The first member is configured to move relative to the second member between an open position and a closed, tissue piercing position. The second member defines a passageway for receiving a portion of the first member. The second member defines a slot for receiving suture from the first member. The slot opens into the passageway. [0006] The first member includes a needle for piercing tissue. The needle defines an eyelet for receiving suture. The eyelet includes a hole. Alternatively, the eyelet includes two holes. In another alternative, the eyelet includes a cutout. [0007] The surgical instrument also includes a handle that controls movement of the first member. The handle includes an articulating handle and a stationary handle. [0008] The second member includes a passageway that receives a portion of the first member. The second member includes at least one suture slot that is disposed in a lengthwise side of the passageway. Also, the at least one suture slot opens to the passageway. [0009] The first member includes a jaw and a needle arm extending from a distal end of the surgical instrument. The needle arm is adapted to receive suture. The jaw defines a passageway that receives a portion of the needle arm. The second member defines a passageway that receives a second portion of the needle arm. The second member defines at least one suture slot that is disposed in a lengthwise side of the passageway and opens to the passageway. The suture grasper engages the suture and holds the suture in the at least one suture slot. [0010] The grasper is disposed on a portion of the second member. The grasper includes a hook. Alternatively, the grasper includes a wedge. In another alternative, the grasper includes a set of jaws. In another alternative, the grasper includes a U-shaped cup. [0011] The surgical instrument includes a trigger that controls the grasper. The trigger is a paddle. Alternatively, the trigger is a lever. In another alternative, the trigger is a button. The surgical instrument also includes a grasper guide that is disposed on a portion of the second member. The trigger moves the grasper distally under the grasper guide to engage the suture. [0012] A portion of the first member is serrated. A portion of the second member is serrated. [0013] In another general aspect of the invention, a method of passing suture includes loading suture into a first member of a suture passing surgical instrument, stabilizing tissue between the first member and a second member of the surgical instrument, passing suture through tissue via the first member of the surgical instrument, holding the passed suture via a suture grasper of the surgical instrument, and removing the first member from the tissue. [0014] Embodiments of this aspect of the invention may include one or more of the following features. After loading suture, the surgical instrument is passed through a cannula. The method also includes removing the surgical instrument from the surgical site. [0015] Loading suture includes loading suture from a side of the surgical instrument. Loading suture further includes loading suture from the side of the surgical instrument on which the suture grasper is located. [0016] The method includes stabilizing tissue and passing suture through tissue simultaneously. [0017] The method includes passing suture multiple times. Passing suture multiple times includes loading suture into the first member of the suture passing surgical instrument, and passing suture through tissue via the first member of the suture passing instrument. [0018] Conventional instruments and methods for passing suture generally require multiple portal entry points and/or supplemental instruments to facilitate passage of suture. The surgical instrument of this invention overcomes these difficulties. In particular, the instrument and method provide a surgeon with the ability to single-handedly pass suture through tissue. As a result, only one portal and one instrument are required. [0019] The details of one or more implementations are set forth in the accompanying drawings and the description below. Other features and objects will be apparent from the description and drawings, and from the claims. DESCRIPTION OF DRAWINGS [0020] FIG. 1 is a partial cross-sectional view of an exemplary suture passing surgical instrument. [0021] FIG. 2 is a partial cross-sectional view of a distal portion of the surgical instrument of FIG. 1 in which an articulating jaw is closed. [0022] FIG. 3A is a side view and FIG. 3B is a perspective view of a push/pull rod for the articulating jaw of the surgical instrument of FIG. 1 . [0023] FIG. 3C is a top view of an elongated shaft of the surgical instrument of FIG. 1 . [0024] FIG. 3D is a partial cross-sectional view of a proximal portion of the surgical instrument of FIG. 1 . [0025] FIG. 4A is a top view of a distal portion of the surgical instrument of FIG. 1 showing a suture grasper capturing the suture and FIG. 4B is a perspective view of the distal portion of the surgical instrument of FIG. 1 showing the eyelet of the needle in line with the suture slots of the passageway. [0026] FIG. 5A is an exemplary tip of a suture capture device of the suture grasper and FIG. 5B is an exemplary arm of the suture capture device of the suture grasper of the surgical instrument of FIG. 1 . [0027] FIG. 6A is a partial cutaway top view of a trigger portion for the suture grasper shown in an open position and FIG. 6B is a partial cutaway top view of the trigger portion for the suture grasper shown in a closed position. [0028] FIGS. 7A-7O illustrate use of the surgical instrument of FIG. 1 . [0029] FIGS. 8A-8H illustrate alternative configurations of a suture eyelet of a needle of the surgical instrument of FIG. 1 . [0030] FIG. 9 shows a suture threaded through the suture eyelet of the needle of the surgical instrument of FIG. 1 . [0031] FIG. 10 shows a suture attached to an exemplary soft tissue attachment device. [0032] FIG. 11 is a detailed side view of an articulating jaw of the surgical instrument of FIG. 1 showing serrations. [0033] FIG. 12 is a detailed side view of a tissue platform of the surgical instrument of FIG. 1 showing serrations. [0034] FIG. 13A is a side view of an alternate implementation of the suture grasper. [0035] FIG. 13B is a detailed view of the suture capture device of suture grasper of FIG. 13A . [0036] FIG. 13C is a top view of an alternate implementation of the tissue platform provided with the suture grasper of FIG. 13A . [0037] FIGS. 14A-14H are top views of alternative implementations of the suture capture device of the suture grasper. [0038] FIG. 15A is a side view of the alternative implementation of the trigger. [0039] FIG. 15B is an exploded view of the trigger and a locking mechanism of FIG. 15A . [0040] FIG. 15C is a side view of another alternative implementation of the trigger. [0041] FIG. 15D is a detailed view of a locking mechanism of the trigger of FIG. 15C . [0042] FIGS. 16A-16E are top views of alternative implementations of push/pull rods of the suture grasper. [0043] FIG. 17A is a side view of an alternate implementation of the suture passing surgical instrument. [0044] FIG. 17B is a perspective view of the push-pull rod of the cross-sectional view of a proximal portion of the surgical instrument of FIG. 17A . [0045] FIG. 17C is a detailed cross-sectional view of a proximal portion of the surgical instrument of FIG. 17A . [0046] FIG. 17D is a perspective view of a needle arm of the surgical instrument of FIG. 17A . [0047] FIG. 17E is a partial cross-sectional view of a distal portion of the surgical instrument of FIG. 17A . [0048] FIG. 17F is a perspective view of a first jaw of the surgical instrument of FIG. 17A . [0049] FIG. 17G is a perspective view of a second jaw of the surgical instrument of FIG. 17A . [0050] FIG. 17H is a view of the suture grasper push rod that can be used in the surgical instrument of FIG. 17A [0051] FIGS. 18A-18E illustrate use of the surgical instrument of FIG. 17 . [0052] Like reference symbols in the various drawings indicate like elements. DETAILED DESCRIPTION [0053] Referring to FIG. 1 , a single-handed suture passing surgical instrument 100 passes suture 101 through tissue and holds the passed suture such that the instrument can be rethreaded to pass suture through tissue multiple times. An operator actuates a handle 190 to close an articulating jaw 110 through which suture is threaded to pass the suture through tissue, and thereafter actuates a trigger portion 150 to advance a suture grasper 130 along a tissue platform 120 to engage the suture with the suture grasper 130 . The jaw 110 is then opened and the instrument 100 removed with the suture remaining in the tissue and held by the suture grasper 130 . The instrument 100 can be rethreaded and reinserted to the surgical site to pass suture multiple times, for instance, as with a Mason-Allen Stitch. [0054] Suture passing surgical instrument 100 includes an elongated shaft 140 with a distal portion 105 and a proximal portion 145 . Located at the proximal port 145 of the elongated shaft 140 are handle 190 and trigger portion 150 . Located at the distal end 105 are articulating jaw 110 , tissue platform 120 , and suture grasper 130 . [0055] The articulating jaw 110 is pivotally attached to the tissue platform 120 , and movement of the articulating jaw 110 is controlled by the handle 190 . In use, distal portion 105 is positioned such that when jaw 110 is closed, tissue is held between an upper surface of the articulating jaw 110 and a lower surface of the tissue platform 120 . The handle 190 includes an articulating handle 191 and a stationary handle 192 . As the articulating handle 191 is moved away from and towards the stationary handle 192 , the articulating jaw 110 is opened and then closed, respectively. The articulating handle 191 is attached to a push/pull rod 128 , which moves along a groove 140 A in the elongated shaft 140 . The rod 128 is attached to the articulating jaw 110 by a pivot hinge assembly 165 , described further below. [0056] The suture grasper 130 is controlled by the trigger portion 150 and is located on the tissue platform 120 . Tissue platform 120 is the distal portion of shaft 140 . Generally, the suture grasper 130 is designed to advance forward and hold the suture. The trigger portion 150 includes a trigger mechanism 139 and a rod 138 (see FIG. 5B ). The trigger mechanism 139 is attached to rod 138 , which runs along the elongated shaft 140 , to control movement of the suture grasper 130 . [0057] Referring to FIG. 2 , the articulating jaw 110 is attached at its proximal end 119 to the tissue platform 120 by the pivot hinge assembly 165 . The pivot hinge assembly 165 includes two pins 166 , 168 and a hinge connector 167 . The hinge connector 167 is part of the jaw 110 and is attached to the tissue platform 120 by the pin 166 such that the articulating jaw 110 pivots about the pin 166 as the jaw 110 articulates. The rod 128 is attached to the hinge connector 167 by the pin 168 such that forward and backward motion of the rod 128 causes the jaw 110 to pivot about the pin 166 . [0058] Referring to FIGS. 3A-3D , the push/pull rod 128 includes two tabs 128 A, 128 B at its proximal end 129 B. Rod 128 is an elongated square-shaped shaft. At its distal end 129 A, rod 128 slopes away from its axis. Rod 128 includes this slope in order to articulate the jaw 110 in relation to the action of the handle 190 . [0059] The rod 128 reciprocates within groove 140 A in the instrument shaft 140 as the articulating handle 191 is moved away from and then towards the stationary handle 192 to open and close the articulating jaw 110 . The instrument shaft 140 also includes a limiting groove 140 B in which tab 128 A is located. The axial movement of tab 128 A in limiting groove 140 B limits movement of the rod 128 in the axial direction because axial movement of tab 128 A within the groove 140 B is constrained by the proximal and distal sides of groove 140 B. The articulating handle 191 defines a handle slot 140 C in which tab 128 B is located providing coupling between the rod 128 and the articulating handle 191 such that as the handle 191 is moved, the rod 128 moves to actuate jaw 110 . [0060] Referring again to FIG. 2 , the articulating jaw 110 includes a needle 115 . Generally, the needle 115 is sickle-shaped with a sharp point 113 and is formed of hardened stainless steel or similar material. The needle 115 is formed integral to the articulating jaw 110 and extends from the articulating jaw 110 toward the tissue platform 120 . Needle 115 includes a suture eyelet 111 disposed proximate to the tip 113 of the needle 115 . The needle 115 is sized such that when the articulating jaw 110 is closed, the instrument can fit within a predetermined sized cannula. Thus, the length of the needle 115 varies with different sized cannulas. [0061] Referring to FIGS. 4A and 4B , the tissue platform 120 has an U-shaped end 122 C defining a passageway 122 . The passageway 122 includes two suture slots 121 X, 121 Y. The suture slots 121 X, 121 Y are positioned such that when the needle passes through passageway 122 , the needle eyelet 111 is aligned with the slots when the portion of the needle defining the eyelet is within the passageway 122 to consistently place the suture 101 that is threaded through the eyelet in the suture slots 121 X, 121 Y (see FIG. 4B ). The suture rests in one of the suture slots 121 X, 121 Y after the needle 115 has passed through the tissue. The slots 121 X, 121 Y are provided in each of the lengthwise sides 122 A, 122 B of the passageway 122 . Suture grasper 130 acts to move the suture away from the needle 115 and holds the suture, for example, in slot 121 X against surface 121 A. Additionally, as the suture grasper 130 holds the suture against the wall 121 a of the suture slot 121 , the suture grasper 130 also closes the opening in side 122 A to capture the suture in the suture slot 121 X, as explained in more detail below. [0062] Referring to FIGS. 1 , 2 , 5 A, and 5 B, the suture grasper 130 is located on the tissue platform 120 and is attached to rod 138 . The suture grasper 130 includes a suture capture device 132 in the form of an arm 133 with an U-shaped tip 134 . The suture grasper 130 is shown to one side of the passageway 122 (the left side as viewed in FIG. 4A ). However, the suture grasper 130 can be located on either side, e.g., right or left, of the passageway 122 . To minimize possible damage to the suture, the suture is threaded through the eyelet 111 from the same side on which the suture grasper 130 is located. Rod 138 is formed as a pair of parallel rods 138 A, 138 B that terminate at their proximal end at a spring plate 137 A. [0063] The suture grasper 130 is activated by the trigger portion 150 to capture and hold the suture. The arm 133 of the suture capture device 132 of the suture grasper 130 advances forward to hold the suture in the U-shaped tip 134 against the distal wall 121 A of suture slot 121 X ( FIG. 4A ). The tissue platform 120 includes a grasper guide 170 under which the suture grasper 130 moves. The grasper guide 170 , for example, is formed like a bridge such that as the suture grasper 130 moves forward to hold the suture in suture slot 121 X, the suture grasper 130 follows a direct path towards the distal end 105 of the instrument 100 . [0064] The tip 113 of the needle 115 on the articulating jaw 110 passes through the passageway 122 when the articulating jaw 110 is closed. The passageway 122 is slightly wider than the needle 115 . The needle 115 pivots about pin 166 along an arc 110 a (see FIG. 2 ). The needle 115 is shaped with an arch, which corresponds to the radius of the arc 110 a . Thus, when the needle 115 extends through the passageway 122 , it arches over the suture grasper 130 . The arch of the needle 115 limits possible tearing of the tissue as the needle passes through the tissue. [0065] Referring to FIGS. 6A and 6B , the trigger portion 150 for moving the suture grasper 130 includes the trigger mechanism 139 , for example, shaped like a paddle, and the push/pull rod 138 . The trigger mechanism 139 rotates about an axis X. The trigger mechanism 139 is attached to the push/pull rod 138 that ends in the U-shaped suture capture device 132 . The trigger portion 150 also includes a rigid pin 139 A that follows a J-shaped groove 139 B in the trigger mechanism 139 and a spring 137 . [0066] In its resting position, the suture grasper 130 is in an open, locked position with pin 139 A located in the hook side 139 B 1 of the J-shaped groove 139 B, as shown in FIG. 6A . To create the forward movement of the suture grasper 130 necessary to capture the suture, the trigger mechanism 139 is rotated counter-clockwise (looking from the proximal end 190 down the shaft 140 ) to move the pin 139 A from the hook side 139 B 1 of the J-shaped groove 139 B to the long side 139 B 2 of the J-groove 139 B, as shown in FIG. 6B . The movement of the pin 139 A within the groove 139 B forces the push/pull rod 138 forward and the trigger mechanism 139 proximally and then distally against the spring 137 . The forward movement of the suture grasper 130 is created as the spring 137 moves forward against a spring plate 137 A and back against a spring brake or spring plate 137 B. To return the suture grasper 130 to its resting position, the trigger mechanism 139 A is rotated clockwise, e.g., moved from the long side 139 B 2 of the J-shaped groove 139 B back to the hook side 139 B 1 of the J-shaped groove 139 B. [0067] Referring to FIGS. 7A-7K , an operator uses the suture passing surgical instrument as follows. As shown in FIGS. 7A (top view) and 7 B (side view), an operator opens the articulating jaw 110 , i.e., articulating the jaw 110 away from tissue platform 120 , by moving handle 190 and loads suture into the suture eyelet 111 of the needle 115 . As shown in FIG. 7C (top view), the operator moves handle 190 to close articulating jaw 110 to hold the suture in the eyelet 111 . [0068] Then, as shown in FIG. 7D (side view), the operator passes the instrument 100 down a cannula to the surgical site. As seen in FIG. 7E (side view), after placing the instrument 100 in the surgical site, the operator moves handle 190 to open articulating jaw 110 to place the needle 115 under the targeted tissue. As shown in FIGS. 7F (side view) and 7 G (top view), the operator moves handle 190 to close articulated jaw 110 to capture the targeted tissue between the jaw 110 and the tissue platform 120 . The needle 115 on the articulating jaw 110 pierces the tissue as the tissue is grasped between the tissue platform 120 and the articulating jaw 110 , carrying the suture through the tissue. [0069] Next, as shown in FIGS. 7H (side view) and 7 I (top view), the operator moves trigger portion 150 to advance suture grasper 130 forward to hold suture in the suture slot 121 Y. As shown in FIGS. 7J (side view) and 7 K (top view), the suture passed through the tissue is trapped on the proximal side of the tissue. [0070] As shown in FIGS. 7L (side view) and 7 M (top view), the operator moves handle 190 to open articulating jaw 110 to release the tissue. As the jaw 110 is opened, the suture grasper 130 holds the suture against wall 121 A of suture slot 121 X. As the operator begins to withdraw the instrument 100 from the surgical site, the free end of the suture slides out of eyelet 111 of needle 115 . As shown in FIGS. 7N (side view) and 7 O (top view), the free end 101 A of the suture 101 (the end that was threaded through the eyelet 111 ) remains above the tissue platform 120 . The other end of the suture is located in suture slot 121 X and passes through the tissue. The operator moves handle 190 to close jaw 110 to withdraw instrument 100 through the cannula (not shown). The instrument may be rethreaded and reinserted through the cannula to the surgical site in order to pass suture multiple times. For instance, where most tendon tissue are fibrous bundles, a repair that can be less prone to tearing along the fibrous bundle structure can be possible when the suture is secured perpendicular to the bundle cord with multiple passes of the suture. By passing suture through different tissue bundle, the suture/tendon interface can be improved. [0071] Numerous alternative implementations or configurations of elements of the surgical instrument are possible. For instance, referring to FIGS. 8A-8H , the suture eyelet disposed proximate to the tip of the needle can have a variety of shapes and/or orientations. For example, FIG. 8A shows a rounded hole 211 as the suture eyelet, whereas FIG. 8B shows an oval or oblong hole 311 as the suture eyelet. In an alternative implementation, there can be more than one hole 411 , as shown in FIG. 8C . Or, the suture eyelet can be a cutout in the side of the needle proximate to the tip. For example, FIGS. 8D and 8E show cutouts 511 , 611 that extend into the needle, toward the jaw 110 . Alternatively, FIG. 8F shows a cutout 711 disposed below the tip 713 of the needle 715 that extends in both toward the tip 713 and toward the jaw 110 . Or, the eyelet can be located on the rounded side of the needle, as shown in FIGS. 8G and 8H (e.g., cutouts 811 , 911 ). [0072] The various positions and shapes of the suture eyelets affect a surgeon&#39;s ability to load/unload suture, to penetrate tissue, and to minimize procedure length. For instance, the suture may be threaded through the rounded hole or closed eyelet type of suture eyelets, as shown, for example, in FIG. 9 . While loading suture requires a bit more skill, the closed eyelet type of suture needle penetrates tissue more easily and accurately. Additionally, for example, the double eyelet needle shown in FIG. 8C may be used to pass two sutures simultaneously to form a mattress stitch with one pass hence, reduce surgical time. With the cutout-type of suture eyelet, the suture is easier to load/unload, but tissue is more difficult to penetrate. Regardless of type or orientation of suture eyelet, suture is loaded on the same side that the suture grasper is located. [0073] The various embodiments discussed can include “free” suture or suture attached to a soft tissue attachment device. As shown in FIG. 9 , the “free” suture (suture not attached to an external device) is threaded through the suture eyelet 111 of the needle 115 . The ability to use “free” suture with the suture passing surgical instrument provides a surgeon with the flexibility to use intricate weaving (suture) patterns without the demand of visualizing each suture transfer. Alternatively, referring to FIG. 10 , suture is attached to a soft tissue attachment device, e.g., an anchor, prior to being threaded through the suture eyelet 111 . [0074] Referring to FIG. 11 , the surface 117 of the horizontal portion of the articulating jaw 110 (the surface facing the tissue platform 120 ) includes serrations 124 (see also FIG. 2 ). The serrations 124 , for example, are “V” shaped and provide an increased surface area against which to hold the tissue. The shape, number, and length of the serrations 124 can, for instance, vary. The serrations 124 can be, for example, grooves, ribs, or ridges. Alternatively, the surface 117 is smooth, i.e., without serrations, as shown in FIGS. 8A-8H . [0075] Referring to FIG. 12 , the surface 127 of the tissue platform 120 (the surface that faces the articulating jaw 110 ) includes serrations 123 (see also FIG. 2 ). The serrations 123 of the tissue platform 120 are, for instance, V-shaped and provide a larger surface against which to hold the tissue after the needle 115 has penetrated the tissue. The shape, number and length of the serrations 123 can vary. For example, the serrations 123 can be grooves, ribs, or ridges. A surgeon may want to move the tissue after it has been grabbed to ensure that the tissue will reach the attachment site. Or, if the detached tissue creates adhesions to other tissue surfaces, by pulling on the held tissue, the surgeon can determine if it is necessary to release or cut those adhesions free. [0076] Referring to FIGS. 13A-13C , an alternative implementation of the suture grasper 230 includes a suture capture device 232 having two opposing jaws 233 , 234 that, when advanced forward, flex outward to open around the suture and then spring shut to enclose the suture between the two jaws 233 , 234 . The suture grasper 230 is moved forward by activation of a push-pull rod 238 by an alternative implementation of the trigger mechanism 339 , a thumb push plate. The opposing jaws 233 , 234 of the suture grasper 230 initially contact an expansion pin 280 , which causes the jaws 233 , 234 to open. The jaws 233 , 234 of the suture capture device 232 include a plurality of grasping teeth 233 a , 234 a on their facing surfaces for holding the suture. The suture grasper 230 continues to move forward until the expansion pin 280 enters the expansion pin release slot 285 , at which point the opposing jaws 233 , 234 of the grasper 230 close on the suture. [0077] A grasper guide 270 provides directional guidance for suture grasper 230 as the grasper moves forward along shaft 140 to capture the suture from the needle (not shown). The grasper guide 270 is a raised structure, e.g., a bridge, under which the suture grasper 230 moves. In this implementation of the guide 270 , the expansion pin 280 is located between the grasper guide 270 and the tissue platform 120 . [0078] Other implementations or configurations of a suture capture device include, for example, a hook or pick that advances forward or moves backward, pushes the suture away from the needle, and captures the suture. For example, the hook may be a forward-moving hook 332 , as shown in FIG. 14A ; a backward-moving hook 432 , 632 , as shown in FIGS. 14B and 14D ; a forward-moving wedge 532 , 732 , as shown in FIGS. 14C and 14E ; or a forward- or backward-moving hook 1032 , as shown in FIG. 14H . Alternatively, as shown in FIGS. 14F and 14G , the cup-shape of the suture capture device can have sides of different lengths ( FIG. 14F ) 832 or a flat base of the cup ( FIG. 14G ) 932 . As illustrated, for example, in FIGS. 14D-14H , the suture capture device alternatives are shown located on the left side of the tissue platform. However, the suture capture device can be located on the right side of the tissue platform, for example, as in FIGS. 14A-14C , if the suture were loaded from a different direction. [0079] Referring to FIGS. 15A and 15B , in an alternate implementation, the trigger portion 250 includes a trigger mechanism 239 , which is a hinged lever 239 attached to a push-pull rod 238 that ends in, e.g., one of the suture capture devices of FIGS. 14A-14H . A locking mechanism 236 , such as a spring or ratchet-type lock is used to hold the suture capture device, e.g., suture pick or hook, in a retracted position and to retain the suture capture device in a suture holding position. After the needle 115 has passed through the tissue, the lever 239 is pulled towards the handle 190 by the surgeon&#39;s finger. This action advances the push/pull rod 238 forward. The suture capture device then captures the suture from the needle and holds it in the suture slot. When the surgeon releases lever 239 , the locking mechanism acts to hold the suture capture device in its suture holding position. To release the suture, the lever 239 is actuated again to advance the push/pull rod 238 and release the suture. [0080] Referring to FIGS. 15C and 15D , in another alternative implementation, the trigger portion 350 includes a trigger mechanism 339 in the form of a button 339 , and a push rod 338 . The thumb-operated button 339 activates the push rod 338 , which moves the suture grasper 130 in a forward direction to capture the suture with the suture capture device, e.g., suture capture device 232 , after the articulating jaw 110 is closed and the suture needle 115 has penetrated the tissue. The button 339 is attached to the push rod 338 and the push rod 338 runs through a single or a series of rings 336 that direct the suture grasper 130 forward to grasp the suture. The articulating jaw 110 is then opened and removed from the tissue. [0081] A locking mechanism 336 for the suture grasper 130 is provided to secure the suture grasper 130 in position once the suture grasper 130 has been activated to hold the suture in the suture slot 121 . The locking mechanism can be a spring type mechanism that holds the suture capture device in a retracted position and retains the suture capture device in a suture holding position. Alternatively, as shown, the locking mechanism includes a plurality of teeth 336 A that mate with a latch 336 B, for example, within ring 335 (see FIG. 15D ) or on the instrument handle 190 (not shown), in order to lock the suture grasper 130 in place. To release, the locking mechanism 336 , button 339 is pushed away from the handle 190 to separate teeth 336 A and latch 336 B. [0082] Refernng to FIGS. 16A-16E , other implementations of the push/pull rod of the suture grasper include, for example, a dual split rod configuration 438 or a single rod configuration 538 , 638 , 738 , 838 . In the single rod configurations, the rod can have locking teeth 736 , 836 , as shown, for example, in FIGS. 16D and 16E . In each implementation, the rod is attached at its proximal end to a thumb-plate, for example, the button 339 of FIG. 15B or an articulating lever, for example, lever 239 of FIG. 15A . [0083] Referring to FIGS. 17A-17H , an alternate implementation of a suture passing surgical instrument 1700 includes an elongated shaft 1740 with a distal portion 1705 and a proximal portion 1745 . At the proximal end of the elongated shaft, there is a handle 1790 , a control 30 arm 1712 , and a trigger portion 1750 . At the distal end, there is a set of jaws 1718 , 1720 , a suture grasper 1730 , and a moveable needle arm 1710 . [0084] The jaw 1718 is controlled by the handle 1790 and attached to the elongated shaft 1740 by a pivot hinge assembly 1765 , as described above in relation to articulating jaw 110 . [0085] The needle arm 1710 is attached to a push/pull rod 1712 A and includes a needle 1715 at its distal end. The push/pull rod 1712 A runs along the elongated shaft 1740 and is actuated by a lever 1712 attached to the handle 1790 . The surgeon activates the lever 1712 with his finger to move the needle arm 1710 forward and backward. [0086] The suture grasper 1730 is controlled by the trigger portion 1750 and disposed on jaw 1720 , which is similar to the tissue platform 120 described above. The trigger portion 1750 includes a trigger mechanism 1739 , e.g., a thumb-operated button, and a rod 1738 . The thumb-operated button 1739 is attached to the rod 1738 , which runs along the elongated shaft 1740 to control the movement of the suture grasper 1730 , as described above. [0087] The trigger portion 1750 permits the surgeon to control when the surgeon captures the suture from the needle 1715 , after the needle 1715 and the suture have been passed through the tissue and are exposed above the jaw 1720 . As described above, the surgeon activates the button 1739 with his thumb to move the suture grasper 1730 forward to grasp the suture. The trigger portion may have similar alternatives and variations as previously described. [0088] Referring to FIG. 17B , the push/pull rod 1728 includes two tabs 1728 A, 1728 B at its proximal end and moves along a groove 1740 A of the instrument shaft 1740 , as described above. [0089] Referring to FIGS. 17C and 17D , the needle 1715 on the needle arm 1710 is shaped like a tapered rectangle that ends in a sharp tip 1713 . The needle 1715 is formed of nitinol, hardened stainless steel, or similar materials. The needle 1715 optionally is formed integral to the needle arm 1710 or separately and then rigidly attached (i.e., welded or mounted) to the needle arm 1710 . [0090] The needle 1715 initially extends from the needle arm 1710 , which is parallel to the pair of jaws 1718 , 1720 , and has a suture eyelet 1711 disposed therein. Needle arm 1710 is attached to push/pull rod 1712 at pivot 1710 A. The suture eyelet 1711 is disposed proximate to the tip 1713 of the needle 1715 . As described above, the suture eyelet 1711 can, for example, open to the front or side attic needle and have various alternative shapes. [0091] An operator moves the needle arm 1710 to articulate away from the set of jaws 1718 , 1720 in order for suture to be threaded onto the needle 1715 . A “free” suture (not attached to anything) or suture attached to a soft tissue attachment device, e.g., an anchor is threaded through the suture eyelet 1711 of the needle 1715 . The ability to use “free” suture with the suture passing surgical instrument provides a surgeon with the flexibility to use intricate weaving (suture) patterns without the demand of visualizing each suture transfer. [0092] After suture is threaded through the needle 1715 , an operator moves lever 1712 to return the needle arm 1710 parallel to the set of jaws 1718 , 1720 . Movement of the push/pull rod 1712 A distally causes the needle arm 1710 to move distally until tip 1713 of needle 1715 contacts deflector 1718 A of jaw 1718 . Contact with deflector 1718 A by needle 1715 causes needle 1715 to pivot towards jaw 1720 about pivot 1715 A such that needle 1715 passes through passageway 1722 B of jaw 1718 and passageway 1722 A of jaw 1720 . [0093] Referring to FIG. 17E , the surface 1728 of the jaw 1720 (the surface that faces the jaw 1718 ) and the surface 1717 of the horizontal portion of the jaw 1718 (the surface facing the jaw 1720 ) can be smooth and/or serrated. The serrations 1723 , 1724 , respectively, can vary in shape, number, and length, as described above. [0094] Referring to FIGS. 17F and 17G , the set of jaws 1718 , 1720 (shown in these figures without grooves for clarity) includes passageways 1722 A, 1722 B through which the needle 1715 of the needle arm 1710 passes. Each passageway 1722 A, 1722 B is slightly wider than the needle 1715 . [0095] The passageway 1722 A of the jaw 1720 includes two suture slots or grooves 1721 X, 1721 Y in which the suture rests after the needle 1715 has passed through the tissue. In this implementation, the grooves 1721 X, 1721 Y are provided in each lengthwise side 1722 A 1 , 1722 A 2 of the passageway 1722 A. The suture capture device 1732 moves the suture away from the needle 1715 and holds the suture for example in the suture slot 1721 X against surface 1721 A as described above. [0096] Jaw 1718 includes passageway 1722 B, which is defined by a central rectangular cutout. The Jaw 1718 can have similar grooves, as described above in relation to jaw 1720 . [0097] Jaw 1720 includes a U-shaped end 1720 A defining passageway 1722 A. A grasper guide 1770 , as described above, is located on the jaw 1720 . [0098] Referring to FIGS. 17A and 17H , suture grasper 1730 is disposed on jaw 1720 and has similar alternatives as those described above. [0099] Referring to FIGS. 18A-18E , an operator uses the suture passing surgical instrument 1700 of FIG. 17A as follows. From the position of instrument 1700 as shown in FIG. 18A , the operator moves lever 1712 to move moveable needle arm 1710 of the suture passing surgical instrument 1700 away from the set of jaws 1718 , 1720 to load suture through eyelet 1711 . Then, the operator moves lever 1712 to return needle arm 1710 parallel to the set of jaws 1718 , 1720 , as shown in FIGS. 18B and 18D . [0100] The operator places instrument 1700 in the surgical site through a cannula (not shown) to the surgical site. The operator moves handle 1790 to articulate jaw 1718 of the set of jaws 1718 , 1720 such that the jaws 1718 , 1720 open and close to grasp tissue therebetween. [0101] The operator moves lever 1712 moveable needle arm 1710 distally toward the deflector 1718 A of jaw 1718 . Upon contacting deflector 1718 A, moveable needle arm 1710 pivots about pivot 1715 A toward jaw 1720 and pierces the tissue held by the jaws 1718 , 1720 through passageway 1722 A, 1722 B. [0102] Next, the operator activates trigger portion 1750 to advance suture grasper 1730 distally to hold the suture in suture slot 1721 X. The operator moves lever 1712 to move needle arm 1710 back out of the set of jaws 1718 , 1720 . The needle 1715 moves out of the tissue through passageway 1722 A, 1722 B. The operator then moves the lever 1712 to return the needle arm 1710 parallel to the set of jaws 1718 , 1720 , as shown in FIG. 18C and 18E . [0103] The operator moves handle 1790 to open the set of jaws 1718 , 1720 to release the tissue and then the operator moves handle 1790 to close the jaws 1718 , 1720 . The free end of the suture remains above the jaw 1720 . The other end of the suture is located in the suture slot 1721 X and through the tissue. The operator removes instrument 1700 from the surgical site. The instrument may be rethreaded and reinserted through the cannula to the surgical site in order to pass suture multiple times. [0104] A number of implementations have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope. For example, the tissue platform may include one suture slot or the needle may pass through tissue to either side of the articulating jaw or set of jaws. Alternatively, the passageway may be offset to accommodate orientation of the needle or suture eyelet. The suture capture device may be or may include a latch or a cutout. The trigger portion may include a button or other mechanism is activate movement of the suture grasper. The needle may be formed separately from the jaw and then rigidly attached, e.g., welded or mounted to the jaw. The eyelet of the needle may open to the front of the needle or to the inside of the needle. [0105] Additionally, the instrument can be used in many surgical environments, including, for example, open, mini-open, and endoscopic, and with visualization, limited visualization, or no visualization of the suture grasper. Also, other devices for attaching tissue to bone or tissue to tissue will work with device and can be carried into the operative site and attached or secured by the device. The type of material used, i.e., material construction, braided or monofilament or combinations of construction and material type, synthetic, natural, permanent or reabsorbable, can vary, and a variety of material diameters are possible. Loose or highly mobile tissue can be translocated as desired by the surgeon. Also, the same suture strand can be passed through tissue multiple times and in various directions. Accordingly, other implementations are within the scope of the following claims.

A surgical instrument includes first and second members configured to receive tissue therebetween. The first member is adapted to receive suture, the second member is coupled to the first member, and a grasper coupled to the second member engages the suture received by the first member. A method of passing suture includes loading suture into a first member of a suture passing surgical instrument, stabilizing tissue between the first member and a second member of the surgical instrument, passing suture through tissue via the first member of the surgical instrument, holding the passed suture via suture grasper of the surgical instrument, and removing the first member from the tissue.

BACKGROUND [0001] In the rearing of animals, such as companion animals and livestock, ectoparasites cause enormous losses, including economic losses, particularly because many ectoparasites can act as disease vectors. [0002] The control of animal ectoparasites is an ongoing challenge. For example, numerous strains of ticks have developed resistance to a wide range of pesticides such as arsenic, hexachlorohexane, camphechlor, DDT, pyrethrines, carbamates and organophosphorous compounds despite the fact that these compounds have varied modes of action and several distinct primary sites of attack in the ectoparasite. It is therefore generally accepted that it is highly desirable to develop and commercialize additional active agents with new modes of action for ectoparasite control. [0003] Compounds harboring a quinazole, pyrazole or pyrimidine core are well known for their fungicidal, insecticidal and miticidal use in the crop chemistry applications (e.g., U.S. Pat. No. 5,411,963). However several reports have indicated that fenazaquin and tebufenpyrad have limited spectrum of activity against insect pests as well as relatively low toxicity to beneficial mite species under normal use ( Pest Manag Sci 2005 61(2):103-10). SUMMARY [0004] Described herein are methods for preventing and/or repressing ectoparasites of animals. The methods include the application to the animal of an effective amount of a composition that includes: 4-tert-butylphenethyl quinazolin-4-yl ether (fenazaquin), 4chloro-5-ethyl-2-methyl-N-[(4-tert-butylphenyl)methyl]pyrazole-3-carboxamide (tebufenpyrad), 5-chloro-N-[2-[4-(2-ethoxethyl)-2,3-dimethylphenoxy]ethyl]-6-ethyl-4-pyrimidinamine (pyrimidifen). Fenazaquin, tebufenpyrad and pyrimidifen are thought to affect metabolism by inhibiting the mitochondrial electron transport chain by binding with Complex I at co-enzyme Q 0 and represent a novel mode of action for ectoparasite control in animal health. [0005] The unexpected anti-tick and anti-flea properties of certain mitochondrial electron transport inhibitors are of considerable significance since there are relatively few agriculture pesticides that can be effectively be used against ectoparasites of animals. [0006] Compositions and processes for controlling ectoparasites of animals are described herein. The methods entail the use of compositions that include: 4tert-butylphenethyl quinazolin-4-yl ether (Formula I), 4-chloro-5-ethyl-2-methyl-N-[(4-tert-butylphenyl)methyl]pyrazole-3carboxamide (Formula II), 5-chloro-N-[2-[4-(2-ethoxyethyl)-2,3-dimethylphenoxy]ethyl]-6-ethyl-4-pyrimidinamine disclosed as formula III, to control ticks, mites, fleas, flies, and lice that infest animals. [0000] [0007] The compounds in Formula I, Formula II and Formula III are suitable for controlling arthropods which attack agricultural livestock such as, for example, cattle sheep, goats, horses, pigs, donkeys, camels, buffaloes, rabbits, chickens, turkeys, ducks, geese, other domestic animals such as, for example, dogs, cats, caged birds, aquarium fish and so-called experimental animals such as, for example, hamsters, guinea pigs, rats, and mice. By controlling these anthropods, cases of death and reductions in productivity (for meat, milk, wool, hides, eggs, and the like) can be lessened, so that more economical and simpler animal husbandry is possible. [0008] The details of one or more embodiments of the invention are set forth in the accompanying description below. Other features, objects, and advantages of the invention will be apparent from the description and from the claims. DETAILED DESCRIPTION [0009] Several compounds having activity as mitochondrial complex 1 inhibitors were commercialized in the 1990s for the purpose of protecting crops and other plants from predation by plant pests such as spider mites (e.g., two spotted spider mite) or rust mites (e.g., apple rust mite). These compounds include fenazaquin (4-tert-butylphenyl quinazolin-4-yl ether), tebufenpyrad (4-chloro-5-ethyl-2-methyl-N-[(4-tert-butylphenethyl)methyl]pyrazole-3-carboxamide), pyrimidifen (5-chloro-N-[2-[4-(2-ethoxyethyl)-2,3-dimethylphenoxy]ethyl]-6-ethyl-4-pyrimidinamine), fenpyroximate (tert-butyl 4-[[(1,3-dimethyl-5-phenoxy-pyrazol-4-yl)methylideneamino]oxymethyl]benzoate), pyridaben (4-chloro-2-tert-butyl-5-[(4-tert-butylphenyl)methylsulfanyl]pyridazin-3-one) and tolfenpyrad (4-chloro-3-ethyl-1-methyl-N-[4-(p-tolyloxy)benzyl]pyrazole-5-carboximide). [0000] [0010] Despite acting at a conserved site (coenzyme Q 0 of Complex I) and interfering with an essential process (mitochondrial electron transport) these pesticides nonetheless show surprising and unpredictable species selectivity. Although used primarily as acaricides against plant parasitic mites, fenazaquin, fempyroximate, pyridaben and tebufenpyrad have minimal impact on predatory mites and many beneficial insects under field conditions ( Pest Manag Sci 2005 61(2):103-10). [0011] A specific example of the large spades dependent differences in potency of complex I inhibitors is seen for fenazaquin in a study by Hackler et al. Fenazaquin is highly active against cotton aphids (LC 50 of 2.6 ppm) and against mosquito larvae of (LC 50 of 0725 ppm) but has low potency against the against cabbage looper (LC 50 188 ppm) and greater than 400 ppm activity against both southern corn rootworm and tobacco budworm (Hackler et al. 1998 Development of broad-spectrum insecticide activity from a miticide. In: Synthesis and Chemistry of Agrochemicals V (Bakeret al.; eds), American Chemical Society, Washington D.C., pp. 147-150). These species sensitivity differences could be due to intrinsic activity differences (i.e., active site changes), metabolism differences and/or penetration differences. For example, fenazaquin is extensively metabolized by the tobacco bud worm, which may explain the poor efficacy against this species. Additionally fenazaquin is degraded more extensively by rat liver microsomes than by trout liver microsomes which may partially explain the higher toxicity of the compound to fish than to mammals. At present, these species-dependent differences in the interactions of the compounds with the active sites, or metabolism or penetration differences are impossible to predict a priori. [0012] Surprisingly we have found that fenazquin (4-tert-butylphenethyl quinazolin-4-yl ether) and contain other mitochondrial complex I inhibitors are active on fleas and ticks, two distantly related groups of arthropods that are both commercially important ectoparasites in animal husbandry. [0013] The compounds 4-tert-butylphenethyl quinazolin-4-yl ether, 4-chloro-5-ethyl-2-methyl-N-[(4-tert-butylphenyl)methyl]pyrazole-3-carboxamide, and 5-chloro-N-[2- [4-(2-ethoxyethyl)-2,3-dimethylphenoxy]ethyl]-6-ethyl-4-pyrimidinamine, are contemplated to be active against animal parasites (ectoparasites) such as hard ticks, soft ticks, mange mites, harvest mites, lice, hair lice, bird lice and fleas. These parasites include the ectoparasites of the order Acari of the family Ixodidae, e.g., the cattle ticks such as Boophilus spp e.g. Boophilus microplus, Boophilus decoloratus and Boophilus annulatus; Rhipicephalus spp such as Rhipicephalus sanguineus, Rhipicephalus appendiculatus, Rhipicephalus pulchellus and Rhipicephalus evertsi; Hyalomma spp such as Hyalomma truncatum, Hyalomma rufipes, Hyalomma detritum, Hyalomma marginatum, Hyalomma dromedaril and Hyalomma anatolicum excavatum; Dermacentor species such as Dermacentor variabilis and Dermacentor andersoni; Amblyomma spp such as Amblyomma variegatum, Amblyomma herbraeum, Amblyomma pomposum, Amblyomma americanum, Amblyomma cayennenese, Amblyomma maculatum, Amblyomma gemma and Amblyomma lepidhon; of the family Argasidae, e.g., Otobius spp such as Otobius megnini and Ornithodores spp such as Ornithodoros savignyi, Ornithodoros lahorensis and Ornithodoros tholozani; of the family Psoroptidae, e.g., Psoroptes ovis and Psoroptes equi; and of the family Sarcopidae e.g. Sarcoptes bovis or Sarcoptes scabici; ectoprasites of the order Diptera, which includes biting and sucking flies; ectoparasites of the order Phthiraptera, which includes sucking and chewing lice; and ectoparasites of the order Siphonaptera, including but not limited to the cat flea ( Ctenocephalides felis ) and the dog flea ( Ctenocephalides canis ). [0014] The active compounds can be enterally administered in the form of, for example, tablets, capsules, potions, drenches, granules, pastes, boluses, the feed-through method, suppositories. The compounds can be parenterally administered such as, for example, by injections (intramuscularly, subcutaneously, intravenously, intraperitoneally and the like). The compounds can also be administered as implants, by nasal administration, by dermal administration in the form of, for example, immersing or dipping, spraying, pouring-on, spotting-on, washing, dusting, and with the aid of active-compound-comprising molded articles such as collars, ear tags, tail tags, limb bands, halters, marking devices and the like. [0015] The active compound content of the use forms prepared from the commercially available formulations can vary within wide limits. The active compound concentration of the use forms can be from 0.0000001 to 95% by weight of active compound, preferably between 0.0001 and 10% by weight. [0016] When used for cattle, poultry, domestic animals and the like, the active compound combinations can be applied as formulations (for example powders, emulsions, flowables) comprising the active compounds in an amount of 1 to 80% by weight, either directly or after 100- to 10,000-fold dilution or they may be used as a chemical dip. [0017] The compound of formula I, II and III are applied to the ectoparasites of the order Acari, in free base form or in agriculturally acceptable acid addition salt form, e.g., as hydrochloride or acetate, by topical treatment of the animals, e.g., by dusting, by dipping or by spray treatments with dilute aqueous form. The compound of formula I, II and III are preferably used in free base form. The degree of dilution may vary although preferably a concentration in the range of 0.01 to 5.0%, particularly of 0.02 to 0.1%, by weight of the active agent is employed. The treatment is preferably repeated at intervals of between 7 to 21 days. [0018] The active agent can be conveniently formulated as a dust, dust concentrate, wettable powder, emulsifiable concentrate or as a solution, with conventional solid or liquid adjuvants. Particularly preferred compositions of the invention are liquid concentrates, especially those containing preferably 3.0 to 50% by weight of active agent, to be diluted with water before use. Such liquid concentrate preferably includes an emulsifying agent such as a polyglycolether derived from a high molecular weight alcohol, mercaptan or alkyl phenol with an alkylene oxide as well as a diluent such as a liquid aromatic hydrocarbon or mineral oil. [0019] Suitable solid carriers are for example ammonium salts and ground natural minerals such as kaolins, clays, talc, chalk, quartz, attapulgite, montmorillonite or diatomaceous earth, and ground synthetic materials such as highly-disperse silica, alumina and silicates; suitable solid carriers for granules are: for example crushed and fractioned natural rocks such as calcite, marble, pumice, sepiolite and dolomite, or else synthetic granules of inorganic and organic meals, and granules of organic material such as sawdust, coconut shells, maize cobs and tobacco stalks; suitable emulsifiers and/or foam formers are: for example nonionic and anionic emulsifiers such as polyoxyethylene fatty acid esters, polyoxyethylene fatty alcohol ethers, for example alkylaryl polyglycol ethers, alkylsulphonates, alkyl sulphates, arylsulphonates, or else protein hydrolysates; suitable dispersants are: for example lignin-sulphite waste liquors and methylcellulose. [0020] Carboxymethylcellulose and natural and synthetic polymers in the form of powders, granules or latices, such as gum arabic, polyvinyl alcohol and polyvinyl acetate, or else natural phosopholipids such us cephalins and lecithins and synthetic phospholipids can be used in the formulations, Other additives can be mineral and vegetable oils. It is possible to use colorants such inorganic pigments, for example iron oxide, titanium oxide and Prussian Blue, and organic colorants such alizarin colorants, azo colorants and metal phthalocyanine colorants, and trace nutrients such as salts of iron, manganese, boron, copper, cobalt, molybdenum and zine. [0021] The formulations generally comprise between 0.1 and 95% by weight of active compound, preferably between 0.5 and 90%. [0022] The action of the compounds in Formula I, II and III against animal ectoparasites can be seen from the examples which follow. The examples are to be construed as merely illustrative, and not limitative of the remainder of the disclosure in any whatsoever. All of the publications cited herein are hereby incorporated by reference in their entirety. EXAMPLE 1 Activity Against A. Americanum Larvae in a Dip Survival Assay [0023] Compound 1 from a dimethyl sulfoxide (DMSO) stock or 2% DMSO alone is dispensed into a round-bottom 96-well plate and mixed with aqueous buffer containing 1% ethanol, 0.2% Triton X100. The final DMSO concentration does not exceed 2%. Larval-stage lone star ticks ( Amblyomma americanum ) are dispensed into the wells containing the Compound and submerged for 30 minutes. The ticks are subsequently dispensed into a tissue biopsy bag, which is allowed to dry for 1 hour. After drying, the bags are incubated at 25° with 95% humidity for 24 hours and the number of live or dead larvae are enumerated. The observations made illustrated in the following table. [0000] 0.05% 0.01% 2% DMSO Formula I Formula I Number of 43/2 0/48 0/52 live/dead A. americanum larvae 24 hours after treatment

Disclosed is a method of controlling ectoparasites that infest companion and livestock animals by applying to the animal an effective amount of 4 -tert-butylphenethyl quinazolin- 4 -yl either or 4 -chloro- 5 -ethyl- 2 -methyl-N-[( 4 -tert-butylphenyl)methyl]pyrazole- 3 -carboxamide or 5 -chloro-N-[ 2 -[ 4 ( 2 -ethoxyethyl)- 2,3 -dimethylphenoxy]ethyl]- 6 -ethyl- 4 -pyrimidinamine.

CROSS-REFERENCE TO RELATED U.S. PATENT This invention relates to patient support surfaces of the general type described in U.S. Pat. No. 5,003,654, dated Apr. 2, 1991, in the name of John H. Vrzalik, which has been assigned to Kinetic Concepts, Inc. The specification of that &#39;654 patent is hereby incorporated by reference into this present application, as though set forth in its entirety. BACKGROUND OF THE INVENTION 1. Field Of The Invention The present invention relates to a method and apparatus for positioning a patient during oscillating therapy, particularly for use with patient supports having inflatable air bags or the like adapted for rotating the patient from side to side. More particularly, it relates to a covering or sheet having thoracic supports (positioned between the torso and arms of a patient) and means for constraining the patient between the supports, such as by a VELCRO strap which connects from one support to the other in a manner which maximizes the therapeutic benefits of such an oscillating air support. 2. Background References Air supports utilizing inflatable cushions for supporting patients are old in the art. One air support of that general type is described and disclosed in Applicants said &#39;654 patent. Other such supports are well known in the prior art. Others have referenced patient positioning straps in connection with support surfaces disclosed for turning patients. For instance, the Fountain patent (U.S. Pat. No. 3,485,240) discloses inflatable straps to help keep the legs of a patient apart while turning the patient. U.S. Pat. No. 3,783,863 dated Jan. 8, 1974 discloses a patient immobilizing apparatus comprising a patient supporting table unit on which a patient lies. The patient is covered by an imperforate sheet of film-like material which forms a seal between the patient&#39;s body and the table. The region between the table top, the patient and the sheet is evacuated so that differential pressure forces secure the patient on the table. U.S. Pat. No. 3,339,544 dated Sep. 5, 1967 discloses a mattress which includes means for correcting pedal deformities in children, which is incorporated in the top surface of the mattress. That reference, more particularly, shows conical and tubular members which are inflated to help correct deformities in the legs of the patient. The disclosure also shows, in FIG. 3, a flexible foot constraint which may be snapped into position within a recess on the mattress. U.S. Pat. No. 28,916 reissue date Jul. 27, 1976 discloses an inflatable aquatic rescue board providing particular advantage in rescuing persons who have sustained injuries while swimming or diving, and who frequently must be held rigid to prevent further injuries while being removed from the water. Prior to inflation, the rescue board is quite flexible, permitting it to be rolled into a compact bundle for storage. Then, upon activation of a self-contained compressed gas supply, the rescue board quickly becomes stiff and buoyant to form an ideal aquatic stretcher. The board comprises a planar structure having two impervious parallel broad faces constrained to a maximum separation by internal members extending there between. Transverse reinforcements provide additional rigidity and two longitudinally extending flat springs facilitate unrolling of the rescue board under water during rescue. Strategically placed straps are provided for securing an injured person to the board and handles are placed for maximum ease of removal from water and transportation to competent medical treatment. U.S. Pat. No. 4,286,344 dated Sep. 1981 discloses a mattress including a pair of ridges made of elastomeric material and disposed respectively on both sides of an elastomeric layer which is laid on the top of a spring unit and covered with an outer covering, the ridges protruding from the elastomeric layer. Each ridge partially or fully extends in the longitudinal direction of the elastomeric layers. A user lying on the mattress is prevented from falling from the mattress by the ridges. U.S. Pat. No. 4,607,402 dated Aug. 16, 1986 discloses a retainer sheet which includes an array of pockets in which cylindrically shaped foam members are removably inserted to define a retainer structure enclosing a sleeping area. The foam units can be removed for laundering and can be positioned in abutting relationship to form a self-locking configuration. U.S. Pat. No. 4,754,509 dated Jul. 5, 1988 discloses a retainer sheet including an array of pockets in which cylindrically shaped form members are removably inserted to define a retainer structure enclosing a sleeping area. The foam units can be removed for laundering and can be positioned in abutting relationship to from a self-locking configuration. U.S. Pat. No. 4,871,228 dated Oct. 10, 1989 discloses a bed guard for temporary use to reduce the risk of falling out of bed comprising of at least one elongated bolster operatively assembled on top of a conventional mattress and releasably held in operative position along one side of the bed by a conventional bedsheet covering the mattress and the bolster and tucked under the mattress. A plurality of bolsters may be used on each side of the bed for additional protection. U.S. Pat. 4,873,710 dated Oct. 10, 1989 discloses a patient support including a support surface and structure positioned about the support surface for lifting selected portions of the patient&#39;s body from the support surface so as to permit the insertion of an x-ray cassette beneath the selected portion of the patient&#39;s body. The structure for lifting preferably includes a plurality of inflatable runners. Structure for placing the inflatable runners in fluid connection with fluid supply means is provided such that the runners can be inflated. The runners are spaced apart from one another and adapted when inflated to lift and adjacent portion of the patient so as to permit the insertion of an x-ray cassette between adjacent runners and beneath the patient. U.S. Pat. No. 4,873,734 dated Oct. 17, 1989 discloses a bumper sheet including an array of pockets in which relatively soft yet form-retaining inserts (such as foam plastic cylinders or inflatable bladders) are removably fitted to define a bumper area enclosing a sleeping or rest area within the confines of a cribbed rails or the like. U.S. Pat. No. 4,934,002 dated Jun. 19, 1990 discloses a mat assembly constructed so it may be tilted about a longitudinal axis by means of a pair of inflatable air bags. The mat assembly has an upper air cushion sheet provided upon the underside of the frame, and a pair of air bags disposed upon the underside of the lower air cushion sheet at right and left thereof as viewed in the longitudinal direction. By supplying air to a bag upon one side and by discharging air from the bag upon the other side, the mat assembly is titled. SUMMARY OF THE INVENTION The present invention represents an improved and novel apparatus over the prior art. It is characterized by a number of advantages which increase its utility over the prior art devices, including its flexibility of use, its ability to reduce the risks of sliding of the patient on a cover sheet prevention of the patient frand ease of accessibility to the patient for administrative purposes. A primary object of this present invention is to provide a covering or sheet that can be used to advantage by the prevention of a sliding movement by the patient from side-to-side. As mentioned above, other devices are known which are directed to constraining a patient, but these devices suffer from several problems. It is, moreover, an object of the present invention to provide a constraining apparatus comprising a sheet, removable supports to be located on both sides of the torso and a VELCRO strap connected to each of the supports thereby providing means of retaining the patient between the supports to prevent sliding. Another object of the present invention is to provide a constraining device for the legs of the patient in addition to the torso of the patient comprising a sheet, removable supports positioned between the torso and each arm of the patient, removable supports positioned on both sides of each leg, and a VELCRO strap connected to each set of supports to provide means for retaining the patient&#39;s torso and legs between each set of supports. Another object of the present invention is to provide a constraining device for children comprising a sheet, removable supports to be located on each side of the torso, additional removable supports to be located on the outside of each arm, and a VELCRO strap connected to each set of supports to provide means for retaining the patient&#39;s torso and arms between each set of supports. It is a further object of the present invention to provide inexpensive removable supports to be connected to the sheet to ease accessibility to the patient during administrative purposes. Another object of the present invention is to provide VELCRO straps which eliminates the need for fasteners and provides quick assemble/disassemble of the retaining device. Another object of the present invention is to provide a retaining sheet which is readily adaptable and transferable to different beds. These objects and advantages are accomplished in the present invention by providing a sheet with removable supports connected thereon. The supports are strategically connected to be located between the torso and the arms of the patient. Each support is capable of being removed to allow complete access to the patient. VELCRO straps are connected to each support providing a means for retaining the patient between the supports to prevent sliding movements. Also provided is a constraining apparatus comprising a sheet with removable supports connected thereon, to be located on each side of the torso, and supports to be located on each side of each leg. VELCRO straps are connected to each set of supports providing a means for retaining the patients torso and legs to prevent sliding movements. Also provided is a constraining apparatus for children comprising a sheet with removable supports connected thereon, to be strategically located on each side of the child&#39;s torso, and supports to be located on each side of each arm. VELCRO straps are connected to each set of supports providing a means for retaining the child&#39;s torso and arms to prevent sliding movements. Also provided is a constraining apparatus for large persons comprising a sheet with removable supports connected there, to be strategically located on each side of the torso between the torso and each arm. VELCRO straps are connected to each support to provide a means for retaining the large person&#39;s torso to prevent sliding movements. Many other features, objects and advantages of the invention will be clear to those skilled in the art from the foregoing and following more detailed descriptions, particularly when viewed in light of the prior art and in conjunction with the accompanying drawings and appended claims. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an overview of a first embodiment of the overlay sheet 510 of the present invention, as operatively employed with a patient 512 lying on overlay sheet 510. FIG. 2 is a partially-schematic end view of the first embodiment, depicting the sheet 510 on the top surface of an oscillating air support system 514. FIG. 2A is a partially-schematic cross-sectional view of a modification 510&#39; of the first embodiment of the present invention, viewed from an angle similar to that of FIG. 2. FIG. 3 is an exaggerated perspective view of the support pocket 504 of FIG. 1 showing the foam insert 531 positioned for operative insertion into pocket 504. FIG. 4 is a cut-away perspective view of the support pocket 503 of FIG. 1 showing the distinctions between pocket 503 and pocket 504, which is shown in FIG. 3. FIG. 5 is an alternative embodiment 520 of the sheet 510 including supports for the legs and torso of a patient. FIG. 6 is an alternative embodiment used for the constraint of children depicting support pockets for the arms and torso of the child. FIG. 7 is a cross-sectional view of the support pockets of the alternative embodiment used for the constraint of children taken along lines 7--7 in FIG. 6. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Referring to FIG. 1, there is shown an overlay sheet 510 constructed according to the teachings of the present invention. Overlay sheet 510 comprises thoracic support pockets 503 and 504 and a VELCRO strap 513 which are used to retain a patient 512 in a preferred position. Aside from those elements 503, 504 and 513, the sheet 510 is a conventional low air loss bed overlay sheet (or &#34;cover sheet&#34;) such as that currently employed by Kinetic Concepts, Inc. (San Antonio) on its commercially available Biodyne bed product. As depicted in FIG. 2, sheet 510 is positioned on an oscillating air support system 514. The support system 514 (although only shown schematically in FIGS. 2 and 2A) preferably is that support system described in much more detail in said &#39;654 patent, the description of which is incorporated herein by reference. Although that system is presently considered the most ideal, other types of static and oscillatory air supports, of course, could be substituted for that described in said &#39;654 patent while still enjoying the benefit of many aspects of the present invention. In operation, the cover sheet 510 fits over the alternately sloped air sacs 514a and 514b and is secured around its perimeter to the frame 514c of system 514 by anchor straps 518 and 519 in a conventional manner. Anchor straps 518 and 519 are spaced around and stitched to cover sheet 510 around its perimeter. As is conventional, anchor straps 518 and 519 are provided with Velcro connectors near their distal ends for easy connection to frame 514c in slots, loops and the like. The support pockets 503 and 504 are stitched to sheet 510 in the preferred embodiment, although alternative methods of forming them will be evident to those of skill in the art in view of this disclosure. Pockets 503 and 504, preferably are substantially parallel and are spaced eighteen inches apart at their connections to sheet 510. Such configuration (as is more completely illustrated in FIG. 1) allows for ready positioning of the support pockets 503 and 504 between the torso and arms of the patient 512. Referring to FIG. 2A, a second embodiment of the support pockets 503&#39; and 504&#39; are shown in a manner which tends to be more flexible than that of FIG. 2. Similar reference numerals are used to reference similar or related components of the embodiments shown in FIGS. 2 and 2A, although a prime (&#39;) designation is used where the similar components are distinguished in any respect. As is better viewed in FIGS. 3 and 4, pockets 503 and 504 are stitched to sheet 510 with a plurality of seams that preferably circumscribe its rectangular cross section. Pockets 503&#39; and 504&#39; on the other hand, are stitched along a single seam to sheet 510&#39;. The latter connection tends to provide greater movement for the pockets 503&#39; and 504&#39; which may be desired in certain circumstances, whereas the former tends to bias the pockets 503 and 504 upright when used in conjunction with a patient. Many other alternative methods of connecting the pockets will be evident to those of skill in the art in view of this disclosure. The Velcro straps 513, 527 and 537 in the various embodiments provide releasable means for releasably constraining a patient relative to the respective pockets 503, 504 and the like. Because each of the straps 513, 527 and 537 are essentially of the same construction except where otherwise specified herein, they can each be understood with reference to strap 513. The strap is preferably made of slightly elastic material with Velcro connectors sewn thereon, although the fabric itself could be Velcro compatible. One end of the VELCRO strap 513 is sewn or otherwise secured to the pocket 503 while its opposite (or distal) end is free to adjustably connect with the opposite pocket 504. The connection of its first, secure end to pocket 503 is preferably to a strip of material 508 which in turn is sewn to a surface (preferably the top surface) of support pocket 503. The distal end is provided with Velcro connecting material in the preferred embodiment, although ordinarily skilled individuals will recognize that certain other known connectors may also serve the same purposes. The strap 513 extends over the torso of the patient 512, interfaces with a strip of material 507 which is sewn to form a loop (like a belt loop) on the top surface of support pocket 507. After passing through that loop, the distal end can be wrapped back and connected with itself (as pictured in FIG. 2), thereby positioning the patient 512 in a defined position relative to the cover sheet 510. Referring again to FIG. 3, the support pocket 504 is shown in more detail. The support pocket 504 is comprised of the pocket 504 adapted for receiving a foam support insert 531 to provide shape and support to help hold the patient in position. Pocket 504 also has a strip of material 507 which is sewn to the top surface of the pocket 504 to form a loop. That loop is for receiving the VELCRO strap 513 as shown in FIG. 1. The pocket 504 is made from durable material (preferably GoreTex fabric, as is sheet 510) and is formed of sufficient size to accept the seven inch by twelve inch foam support insert 531. Further, the pocket 504 is sewn closed on all edges except the front edges, which open to accept the foam insert 531. The front face of the pocket 504 is comprised of two sides 532 and 533 which fasten to each other by means of a VELCRO connector. A strip of VELCRO hooks 535 is fastened to side 533 and a strip of VELCRO loops 534 are fastened to side 532. Connection of the VELCRO strips 534 and 535 retains the foam insert 531 in the pocket 504. The pocket 504 is connected to the sheet 510 by means of sewing the two side and rear end of the pocket 504 to the sheet 510. The inserts 531 are conventional foam rubber material thinly formed or cut substantially rectangular to fit between the body and arms of a patient in the preferred embodiment. The support pocket 503, depicted in FIG. 1, is fabricated identically as support pocket 504 with the exception of the strip of material 508 sewn to the top surface of the pocket 503 (see FIG. 4). One end of the VELCRO strip 513 is depicted in FIG. I and 4 is sewn to the top surface of the strip 508. The VELCRO strip 513 is comprised of an elastic strip, approximately thirty-one inches long by two inch square VELCRO loops. The hooks and loops are sewn to the elastic strip in an alternating pattern with a two inch space between each square. In an alternate embodiment used to retain larger patients, the support pockets 503 and 504 are nine inches by sixteen inches and are spaced two inches apart. All other features of the alternative embodiment are identical. Referring to FIG. 5, there is shown an alternative embodiment comprising an overlay sheet 520, support pockets 521 and 522 including a VELCRO strap 527 to retain the torso of a patient in a preferred position, and support pockets 523, 524, 525 and 526 including VELCRO straps 528 and 529 to retain the legs of a patient. The construction of the support pocket 522 is identical to support pocket 504 depicted in FIG. 3 and the support pocket 521 is identical to support pocket 503 (see FIG. 4). Support pockets 521 and 522 are to be spaced eighteen inches apart. The support pockets 523 and 525, which are used to retain the legs of the patient in the alternative embodiment shown in FIG. 5, are identical in construction to support pockets 503, shown in FIG. 4, with the exception of the size of the support pockets which are four inches by twelve inches. The support pockets 524 and 526, also used to retain the legs of the patient of FIG. 5, are identical in construction to support pocket 4, shown in FIG. 3, with the exception of the size of pockets which are four inches by twelve inches. The pockets 521 and 522 of FIG. 5 are spaced roughly eighteen inches apart and are sewn to the sheet 520 such that the torso of the patient is retained. The pockets 523 and 524, as well as the pockets 525 and 526, are spaced eight inches apart, in parallel to each other. Pockets 524 and 525 of FIG. 4 are sewn to the sheet 520 such that the spacing is: distance between Point A of pocket 524 and Point B of pocket 525 is three inches; distance between Point C of pocket 524 and Point D of pocket 525 is five inches; distance between Point E of pocket 524 and point F of pocket 525 is eight inches; and distance between point G of pocket 524 and point H of pocket 525 is eleven inches. These measurements are preferable but are not essential to most aspects of the invention. The VELCRO straps 527, 528, and 529 of FIG. 5 are identical in construction with the VELCRO strap 513 of FIG. 1. Referring to FIG. 6, three is shown an alternative embodiment for the retention of child in a preferred position comprising a sheet 530, support pockets 531, 532, 533 and 534 for the retention of the child&#39;s torso and for each arm, and straps 535 used to secure the sheet 530 to the bed (see FIG. 2). Support pockets 532 and 533 are sewn to sheet 530, six inches apart, such that the pockets 532 and 533 are positioned between the torso and arms of the child. Further, pockets 531 and 534 are positioned outside of pockets 532 and 533, respectively, such as to retain the arms in a preferred position. A VELCRO strap 537 is fastened to pocket 533 in a manner similar to FIG. 4 and interfaces with pocket 532 in a manner similar to FIG. 3 to retain the torso in a preferred position. Likewise, VELCRO straps are fastened to pockets 531 and 533 and interface with pockets 532 and 534 to retain the arms in a preferred position. Support pockets 531 and 533 are similar in construction to the pockets shown in FIG. 2A, except for the specific manner of connecting a single Velcro strap 537 through two loops 538 and 539 before securing its free end to a Velcro connector on the outside surface of pocket 531. As an alternative, strap 537 is substituted with a plurality of shorter straps with separate connectors. Likewise, support pockets 532 and 534 are similar in construction. The configuration of pockets 533 and 534 are shown in FIG. 7. Similar to the construction of pocket 504 in FIG. 3, all edges of pockets 533 and 534 are sewn closed except for the front surface shown in FIG. 7. The front surface opens into two sides to allow foam supports to be inserted into the pockets 533 and 534. Each front surface has a VELCRO connector, one side having VELCRO hooks, the other side has VELCRO loops. Although the present invention has been described in terms of the foregoing preferred embodiments, this description has been provided by way of explanation only and is not to be construed as a limitation of the invention, the scope of which is limited only by the following claims.

An overlay sheet and a related method for positioning a bedridden patient on an oscillating air support system for maximum safety and maximum therapeutic benefit. An overlay sheet which positions the patient is provided including the sheet, the supports which are located between the patient's arms and torso, and a retaining VELCRO strap. The patient is positioned between the supports and retained by the VELCRO straps, thus, ideally positioned and prevented from sliding side-to-side during oscillation of the air support system.

BACKGROUND OF THE INVENTION [0001] The invention relates to an anchor element for knotless fixing of tissue to a bone by means of at least one suture threaded through the anchor element. [0002] Generally, such anchor elements, also called suture anchors, are used in the medical field to ensure that tissues, mostly tendons, that have become detached from a bone can be fixed back onto the bone. [0003] For this purpose, the anchor element and a suture connected to the anchor element are driven firmly into the bone. The protruding suture ends are connected to the detached tissue, by which means the detached tissue is fixed to the bone. [0004] In a first operating technique, known in particular from U.S. Pat. No. 5,690,676, the anchor element is designed such that it has an approximately cylindrical body on whose outer face there are projections that prevent removal of the anchor element after it has been inserted into the bone. These projections can be designed as barb-like elements, for example if the anchor element is driven into the bone, or they can also be designed as an outer thread if the anchor element is turned into the bone in the manner of a screw. The suture is threaded through the transverse bore extending through the body, and the two suture ends are placed in outer longitudinal grooves on the body and guided in the proximal direction. A device called a driver is engaged on the proximal end of the anchor element, and it is usually mounted onto the proximal end of the anchor element. The two suture ends are guided along the driver device and are wound there onto radially projecting stubs for the driving-in procedure. [0005] After the anchor element has been driven into the bone and the driver device has been removed, the two free suture ends are used to secure the detached tissue. To do so, the two suture ends are knotted onto the detached tissue, for example a tendon, lying closely on the bone. [0006] The anchor element anchored in the bone, and the bone itself, form the force/abutment points between which the tissue is fixed. [0007] A disadvantage of this operating technique is that the knotting requires considerable experience and dexterity on the part of the operating surgeon. Such knots can come undone, or soft-tissue bridges can form around the knot because the knot is arranged on the outside of the operating site. [0008] In a development of this operating technique, so-called knotless anchors were developed, which are known for example from US 2004/0138706 A1 and which form the subject matter of the present invention. [0009] This anchor element has a body on whose outer face there are projections that prevent removal of the anchor element inserted in the bone. A transverse bore is arranged in the distal end area of the body and extends through the latter. A suture is threaded transversely through the body. A clamp element is provided which is moveable along the body and is used to clamp the suture. The clamp element is designed as an outer axially moveable sleeve. [0010] In this operating technique too, the suture is first threaded through the anchor element. One of the free suture ends is pushed, mostly with the aid of a needle, through the tissue to be fixed, and the pushed-through end is then threaded back in the opposite direction through the transverse bore in the anchor element. The connection between the anchor element and the tissue to be fixed takes the form of a suture loop. The anchor element can now be introduced into the bone, together with the suture after which the free suture ends are pulled so that the protruding loop of the suture, connected to the tissue, is drawn toward the fixing location. [0011] The relative position between the suture and tissue connected to it, and the anchor element is now fixed not by forming a knot, but instead by moving a clamp element through which the suture is fixed or as it were clamped in a defined position on the anchor element. In this way, the loop holding the tissue is also fixed. The protruding free ends can then be cut off, for example, and there is no need to apply a knot. [0012] In the US 2004/0138706 A1, the clamp element is designed as a sleeve which is mounted on the outside of the body of the anchor element. The sleeve and body are displaceable relative to one another. [0013] In one position of displacement of the sleeve, the suture threaded through the body is freely movable, for example so that the tissue pierced by the suture can be drawn onto the bone and fixed in its position. The sleeve is then moved in order to clamp the suture and fix it in its relative position. [0014] As can be seen in particular from moving from FIG. 4 to FIG. 5 of US 2004/0138706 A1, there are several relatively sharp-edged clamp points between which the suture is squeezed. This results in relatively high shearing forces, which means that damage to the suture, and therefore tearing-off of the suture, cannot reliably be ruled out. [0015] In addition, the outer sleeve is a very complicated structural part which, in order to exert a clamping force, has to be slightly spread open by the anchor element. For this purpose, suitable lock-type bridges are needed between the outer face of the body of the anchor element and the inner face of the sleeve, which make release from this locked position difficult or impossible. For this reason, corrective measures, for example during temporary release of the clamping connection, can only be carried out with difficulty, if at all. [0016] It should be borne in mind that the dimensions of such clamp elements involve lengths in the range of several centimeters and diameters of several millimeters. [0017] Therefore, not only is the production of such parts extremely complex, their handling is also very difficult and, in particular, their stability in respect of the holding or fixing force is extremely problematic. [0018] If a tendon subjected to high loading, for example a tendon from the shoulder area or the knee area, is fixed, it is evident that considerable tensile forces from the tendon act on the assembled structure introduced into the bone and composed of body, clamp element and clamped suture. [0019] If one considers the aforementioned dimensions, it will be evident that the wall thickness of the outer sleeve may at best be in the range of fractions of millimeters, although it is this structural part that is intended to provide the clamping force for holding the suture. [0020] Since the sleeve, because of its construction, covers a certain proportion of the outer face of the body of the anchor element, but this anchor element serves to hold the whole assembly in the bone via the projections present on its outer face, suitable structural measures have to be taken to ensure that the body of the anchor element as such can in fact be safely anchored in the bone. [0021] This leads to additional and considerable outlay in terms of construction. [0022] It is an object of the present invention to provide an anchor element for knotless fixing a tissue, which is of simple construction, ensures effective anchoring of the anchor element and, at the same time, allows the suture to be fixed efficiently and without damaging it. SUMMARY OF THE INVENTION [0023] The object is achieved by an anchor element having a body with an outer surface, which has projections projecting from said outer face for preventing removal of said anchor element when inserted in a bone. A transverse bore is arranged in a distal end section of said body, said transverse bore extending through that body. The transverse bore serves for threading said at least one suture transversely through that body A clamp element is provided for clamping said suture threaded transversely through said bore. Said clamping element having a portion arranged within said body, said clamping element being arranged moveable within said body and being moveable towards said transverse bore for clamping said suture in said transverse bore. [0024] An important advantage of arranging a portion of the displaceable clamp element in the inside of the body is that the outside of the body is not covered by this clamp element, such that the outside of the body of the clamp element is available fully for anchoring to the bone. When the portion of the clamp element arranged in the inside is moved away from the transverse bore, the suture threaded through the transverse bore can be freely moved. By moving the inner portion of the clamp element in the direction of the transverse bore, the portion of the suture received in the transverse bore can then be clamped. [0025] This can be done directly by the clamp element itself, or the clamp element can squeeze a further element, for example a clamping aid received in the transverse bore. Since the outside of the anchor element does not have to be covered during these movements, these maneuvers can be performed in the inside of the body after the anchor element has already been driven into the bone. In this way, it is also possible, for example, to correct the lie of the suture when the anchor element is already inserted, without the anchor element as such having to be moved relative to the bone for this purpose. [0026] The maneuvering of the clamp element in the inside of the body can be done from the proximal end of the anchor element, for which purpose the clamp element could also protrude at the proximal end. As regards its outer structural features, the body of the anchor element can be constructed exactly like an anchor element that works with knotting. The inside of the body simply has to be provided with a suitable cavity, which is very easy to produce and into which the inner portion of the clamp element can be introduced. This inner portion of the clamp element can be made solid in order to be able to exert the sufficient clamping force on the suture received in the transverse bore. [0027] The existing inner wall of the transverse bore is available as an abutment for the clamping by the clamp element. This wall provides the suture with a sufficiently large contact surface on which the suture to be clamped can be applied or fixed by the displaced clamp element. In other words, the suture can wedge itself on the inner wall of the transverse bore, such that the clamping forces are distributed over a relatively large surface area, with the result that the danger of damage and shearing of the suture is greatly reduced. [0028] In an embodiment of the invention, the body of the anchor element has an axially extending inner bore for receiving said clamping element. [0029] This measure allows to securely receive at least said portion of the clamping element arranged within the axially extending inner bore. [0030] In a further embodiment of the invention said inner bore opens into said transverse bore. [0031] This measure has the advantage that the portion of the clamping element arranged within the body can be guided securely into the transverse bore for clamping the suture therein. [0032] In another embodiment of the invention, a distal end of the clamp element is rounded. [0033] This measure has the advantage that the aforementioned pressing on the suture in the transverse opening can be exerted with low shear force and without damaging the suture. [0034] In a further embodiment of the invention, a gentle hollow is provided in said transverse bore opposite to said rounded distal end of said clamping element. The gentle hollow approximately corresponds to the rounded distal end. [0035] This method has advantage that parts of the suture can be pressed or squeezed into the gentle hollow enhancing the clamping of the suture between clamping element and transverse bore. [0036] In another embodiment of the invention, the portion of the clamp element arranged inside the body is designed as a pin. [0037] This measure has the advantage that this geometry permits a compact, stable clamp element which is able to transmit the necessary clamping force, even when the overall dimensions of the anchor element are very small. [0038] In another embodiment of the invention, the pin is designed as a headless screw. [0039] This measure has the advantage that a very compact clamp element is provided which is easy to control and which, by simple turning, can be moved to and fro within the body of the anchor element. [0040] In another embodiment of the invention, the clamp element is received completely in the body. [0041] This measure has the considerable advantage that the outer contour of the anchor element is not in any way impaired by the provision of the clamp element, that is to say the entire outer contour of the anchor element can be used for the actual function, namely that of anchoring in the bone. Seen from the outside, an anchor element according to the invention can appear, structurally, like an anchor element of the kind known for example from U.S. Pat. No. 5,690,676, but now used in the knottless technique. With the latter, there is already sufficient experience regarding the structural designs that provide a sufficient anchoring force, and this wealth of experience can be exploited here. [0042] In another embodiment of the invention, the clamp element is designed as a conical element. [0043] This measure has the advantage that such an element is very easy to produce and simply has to be driven forward in the inside of the body in order to fix the suture. By suitable choice of the cone angle and of the length of the inner portion, the sufficient holding force or clamping force can be exerted. [0044] In another embodiment of the invention, the clamp element has an assembly feature onto which a tool of a driver device for the anchor element can be attached. [0045] This measure then has the considerable advantage that the same tool with which the anchor element is driven in can also be used to control the clamp element, in other words to move it in the direction of the transverse bore for clamping the suture. [0046] As regards production and handling, this measure has the advantage that it is not necessary to provide two tools, one for driving in the anchor and one for moving the clamp element. The insertion of the anchor element and the displacement of the clamp element can be carried out in succession using one tool. [0047] This is especially of help to the operating surgeon and facilitates this operating technique. [0048] The materials used for the structural elements can, depending on the requirements, be metals, in particular titanium, or said structural elements can be made of bioabsorbable materials, if so desired. [0049] It will be appreciated that the aforementioned features and the features still to be explained below can be used not only in the cited combinations, but also in other combinations or singly, without departing from the scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS [0050] The invention is described and explained in more detail below on the basis of a number of selected illustrative embodiments and with reference to the attached drawings, in which: [0051] FIG. 1 shows an exploded view of an anchor element according to the invention and its clamp element, and with the maneuvering tool for fitting the anchor element into the bone being depicted at the lower end, [0052] FIG. 2 shows a longitudinal section through the anchor element from FIG. 1 with the clamp element inserted, with the maneuvering tool applied, and with a suture threaded through the anchor element but still freely movable, [0053] FIG. 3 shows a snapshot of the operating technique for fitting the anchor element, in which view the assembly shown in FIG. 2 can be seen, with the threaded suture having already been connected to a tissue and having been threaded back through the transverse bore, [0054] FIG. 4 shows a cross section after the anchor element has been fitted and the tendon has been fixed by means of the suture, and the suture has been fixed in the bone by means of the clamp element, and DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0055] An anchor element shown in FIGS. 1 to 4 is designated in its entirety by reference number 10 . [0056] The anchor element 10 has an elongate, roughly cylindrical body 12 from whose outer face 14 a number of projections 16 to 16 ′″ protrude. The projections 16 to 16 ′″ are designed as protruding annular flanges which, viewed in the distal direction, each merge with the next annular flange via approximately conically tapering portions. A distal end area 18 of the body 12 is provided with a rounded tip 20 . A proximal end 22 is formed by the cross-sectional surface area of the last projection 16 ′″. [0057] In the distal end area 18 of the body 12 , a transverse bore 24 is arranged extending through the latter. Starting from the mouth of the transverse bore 24 , two diametrically opposite longitudinal grooves 25 , cut into the projections 16 ′ to 16 ′″, extend proximally along the longitudinal axis 26 of the body 12 . [0058] The transverse bore is used for threading a suture 60 through the body 12 , as shown in FIG. 2 . The suture portions protruding from both ends of the transverse bore 24 can be placed into the longitudinal grooves 25 , such that these suture portions can be guided proximally from the direction of the transverse bore 24 while bearing closely on the body 12 . [0059] From the proximal direction, an axial bore 28 is formed centrally within the body 12 (see FIG. 2 ) and opens at the distal end into the transverse bore 24 . [0060] An inner thread 30 is cut in the axial bore 28 . [0061] This axial bore 28 is used for receiving a clamp element 32 . [0062] The clamp element 32 is composed of a pin 34 on whose outer face there is an outer thread 36 , which meshes with the inner thread 30 of the axial bore 28 . [0063] Formed at the proximal end of the pin 34 , there is a recess 38 , here in the form of a diametrical incision, whose purpose will be explained below. At the distal end 40 , the clamp element 32 is provided with a rounded part 42 . With that design, the pin 34 is a headless screw. [0064] A device referred to as a driver 50 , with which the anchor element 10 is maneuvered, is shown at the bottom end of FIG. 1 . [0065] The driver device 50 comprises a rod 52 from whose distal end face 54 a tool 56 projects which is designed such that it can be inserted with a form-fit into the recess 38 of the clamp element 32 . The end face 54 of the driver device 50 is moreover designed such that it can be placed on the proximal end 22 of the body 12 of the anchor element 10 . [0066] At a distance axially from its end face 54 , the driver device 50 is provided with two diametrically protruding stubs 58 , 59 around which the two protruding suture ends can be wound. At the proximal end, the rod 52 ends in a handpiece (not shown here) via which the driver device 50 can be gripped by hand by the person operating it. [0067] FIG. 2 now shows a situation in which the clamp element 32 is received in the inside of the body 12 , with the outer thread 36 inserted into the inner thread 30 , specifically such that the suture 60 guided through the transverse bore 24 is freely movable, as indicated by the double arrows. [0068] The proximal end 22 of the body 12 sits on the end face 54 of the driver device 50 , of which the tool 56 engages in the recess 38 of the clamp element 32 . [0069] As has been mentioned above, the longitudinal grooves 25 on the outer face 14 of the body 12 allow the suture ends to be guided in the proximal direction while bearing closely on the body 12 . Correspondingly, grooves 62 are cut into the rod 52 of the driver device 50 in order to guide these suture ends as far as the diametrically protruding stubs 58 , 59 around which they are wound. [0070] As will be evident in particular from the cross-sectional view in FIG. 2 , turning the driver device 50 about the longitudinal axis 26 of the assembled structure causes the clamp element 32 to turn in the inside of the anchor element 10 , as a result of which the clamp element 32 is moved in the direction toward the transverse bore 24 and into the latter. The portion of the suture 60 received in the transverse bore 24 is applied, by the rounded part 42 , against the opposite inner wall of the transverse bore 24 and, when driven further forward, correspondingly clamped. [0071] By means of the round and gentle profile of the rounded part 42 of the clamp element 32 and the corresponding profile of the inner wall of the transverse bore 24 , the clamping force on the suture can be distributed across a relatively large surface area, as a result of which a squeezing or shearing off of the fixed suture 60 in the transverse bore 24 can be avoided. [0072] It will be evident from the cross-sectional view in FIG. 2 that, on the distal side of the transverse bore 24 , the axial bore 28 is continued in the form of a gentle hollow 29 which corresponds approximately to the contour of the rounded part 42 , such that the suture 60 can be fixed particularly gently, but still securely between hollow 29 and rounded part 42 . [0073] As will be seen from FIG. 2 , the anchor element 10 bearing on the end face 54 of the driver device 50 can be driven into a bone by means of the latter, for example with a hammer. [0074] The length of the tool 56 and the depth of the recess 38 in the clamp element 32 are chosen such that the clamp element 32 is not damaged in this process, but such that there is sufficient engagement between these two structural elements to be able to subsequently turn the clamp element 32 and thus produce the clamping action. [0075] FIG. 3 shows a snapshot of an operating technique in which an anchor element 10 according to the invention is fitted. [0076] Part of a tissue 74 , for example a tendon, has become detached from a bone 70 and is now to be fixed back onto the bone 70 . [0077] In the illustrative embodiment shown, an opening 72 , for example a bore, has been formed in the bone 70 in the area of tissue detachment, the internal diameter of the opening 72 being slightly smaller than the external diameter of the projections 16 on the body 12 of the anchor element 10 . The assembly made up of the anchor element 10 , and clamp element 32 received therein, and of the driver device 50 is brought to the operating site, and the suture 60 is threaded once through the transverse bore 24 , as shown in FIG. 2 . One of the free ends is pushed, if appropriate with the aid of a needle, through a detached portion of the tissue 74 , the resulting cut 76 being shown in cross section in FIG. 3 . The suture portion emerging through the cut 76 is guided once again through the transverse bore 24 , specifically in the opposite direction to the previous one. [0078] As can be seen from FIG. 3 , this creates a loop 61 via which the tissue 74 is connected to the clamp element 10 . The two free suture ends are now guided closely along the surface of the structure composed of driver device 50 and anchor element 10 to the stubs 58 , 59 and are threaded around these. [0079] The anchor element 10 is then driven into the opening 72 of the bone 70 by means of the driver device 50 . By pulling on the free ends of the suture 60 , the detached tissue portion 74 can be brought into the desired position relative to the bone and to the anchor element. By turning the driver device 50 , the clamp element 32 is now moved into the transverse bore 24 and clamps the two suture portions received in the transverse bore. The driver device 50 is removed, and the protruding suture portions can be cut off. [0080] It is still entirely possible here to make certain corrections to the lie of the suture, even with the anchor element 10 already fitted, by means of slightly loosening the clamp element 32 again. After the driver device 50 has been removed, the tissue 74 to be fixed lies once again on the bone 70 , as shown in FIG. 4 . Only the loop 61 of the suture 60 is visible, and there is therefore no bulky knot. In the inside of the body 12 , the portions of the suture 60 received in the transverse bore 24 are fixed in position by the rotated clamp element 32 .

An anchor element serves for knotless fixing of a tissue to a bone by at least one suture threaded through the anchor element. A body of that anchor element has an outer surface with projections. A transverse bore is arranged in a distal end section of the body for receiving a threading passing therethrough. A clamp element serves for clamping the suture threaded transversely through the bore. The clamping element has a portion arranged within the body and is movable within the body towards that transverse bore.

BACKGROUND OF THE INVENTION This invention relates to a process for the production of an evaporated milk product containing fats. Evaporated milk or cream is prepared from whole milk or cream by partial elimination of the water which it contains. The effect of this concentration is to bring together the fatty globules which can cause the fats to rise during storage. Finally, evaporated milk has to be sterilized because it is intended for prolonged storage. When sterilization is carried out by a thermal appertization treatment after packing, for example in cans, there is an increased risk of destabilization of the liquid phase by the heat applied due to the disturbance of the caseinate/calcium phosphate system after concentration. During storage, the milk thus treated can thicken and then gel. A typical method of overcoming this particular disadvantage is to add stabilizing salts, such as for example disodium phosphate or trisodium citrate. However, these additives are being contested to an increasing extent by food legislation. One alternative to sterilization by appertization is aseptic packing of the evaporated milk which has been sterilized on-line, for example by ultra-high temperature or high temperature short-time. The latter process does not prevent harmful crystallization of the calcium citrate or even gelling during storage. SUMMARY OF THE INVENTION The object of the present invention is to provide a process for the production of an evaporated milk product free from non-lactic additives which is stable in storage and which is not affected by the acidity of coffee. Accordingly, the present invention relates to a process for the production of an evaporated milk product containing fats which is stable in storage and free from non-lactic additives, in which a milk product having a ratio by weight of fats to non-fat dry matter of 0.1:1 to 1.2:1 is heat-treated and then concentrated to a dry matter content of 20 to 40% by weight and the concentrate is sterilized. The problem addressed by the invention is solved by the fact that the milk product is homogenized or the milk product is mixed with a natural lactic emulsifier, the homogenizate or mixture is heat-treated before being concentrated and the concentrate is heat-treated and then homogenized before being sterilized. The evaporated milk product obtained in accordance with the invention is stable in storage in the same way as conventional products containing stabilizing salts. In addition, it can be sterilized without these additives which, hitherto, have been considered essential for avoiding gelling and/or coagulation during sterilization. In addition, it is totally unaffected by the acidity of a hot aqueous coffee extract and does not produce any flocculation when added to such an extract. DETAILED DESCRIPTION OF THE INVENTION To carry out the process, the whole milk is standardized where necessary, i.e., the respective quantities by weight of fats and non-fat solids are adjusted to the desired values by the addition as required of, for example, skimmed milk, cream or butter oil (anhydrous lactic fats). In a first embodiment of the process, the milk product is preheated to 50°-100° C. after the standardization step and is then homogenized under intensified conditions. The object of the homogenization step is to increase the surface of the fatty globules in order more firmly to bind the proteins and thus to compensate the relative deficiency of membranal lipids. In the context of the invention, intensified homogenization is understood to mean that the product is treated by one or more passes through a homogenizer comprising one or more stages under pressures ranging from 50 to 500 bar, preferably by a single pass in two stages under a pressure of 200 to 300 bar for the first and then under a pressure of approximately 50 bar for the second. In this way, the dimensions of the fatty globules are reduced and homogeneously distributed. The homogenizate is then heat-treated to stabilize the bonds between the proteins so that they remain intact after the concentration step. This heat treatment can be carried out by direct or indirect heating in any standard apparatus which enables the liquid to be kept at 80° to 150° C. for 1 to 1,200 s. The upper temperature limit naturally corresponds to the lower time limit. It is thus possible, for example, to combine a plate-type exchanger with a holding tube and a controlled counter-pressure valve, two plate-type exchangers connected by a holding tube or even a plate-type heat exchanger associated with a controlled counter-pressure valve and a thermostatically controlled holding tank. After this heat treatment, the liquid is concentrated by evaporation with expansion to a dry matter content of 20 to 40% and preferably 24 to 35% by weight in a falling float evaporator of the single-effect or, preferably, multiple-effect type. After concentration, the liquid is rehomogenized, preferably by a single pass through a two-stage homogenizer under a pressure of 75 to 175 bar in the first stage and approximately 25 bar in the second stage. The object of this second homogenization is to break up the clusters of fatty globules which have formed during the concentration step and, where necessary, further to reduce the size of these fatty globules. After the second homogenization, the homogenized concentrate may be directly heat-treated or may be temporarily stored. In the first case, the dry matter content of the concentrate is optionally adjusted to the desired value for the end product, for example 24 to 33% by weight, by addition of water. In the second case, the concentrate is cooled to 1° to 10° C. and preferably to 4° to 8° C. and, after adjustment of its dry matter content in the same way as above, it is left standing for 1 to 24 h. The second heat treatment may even be carried out directly, i.e., without temporary storage. The second heat treatment may be carried out in the same way as described above for the first heat treatment, i.e., by direct or indirect heating to 50° to 150° C. by injection of steam and, after a holding time of 1 to 600 s, by expansion in a vessel which results in cooling to 50° to 100° C. During this second heat treatment, the proteins bound by partial denaturing are stabilized. The bonds thus strengthened are sufficiently firm to ensure that the proteins no longer coagulate during subsequent sterilization. Another homogenization step is then carried out under similar conditions to the second homogenization mentioned above and with the same objective, namely to break up the clusters of fatty globules formed. The homogenizate is then cooled to 0° to 20° C. and preferably to 4° to 8° C. and its dry matter content is adjusted where necessary to the desired value of the end product by the addition of water. Finally, the milk product is sterilized, if necessary after intermediate storage. In a first embodiment of this sterilization step, the milk product is packed in containers, for example metal cans, glass bottles or heat-resistant plastic bottles, which are then hermetically sealed and then treated in a sterilizer for 30 s to 60 mins. at 95° to 135° C., the upper temperature limit corresponding to the shortest time, either in a single stage or in successive temperature stages. A variant of the sterilization step comprises on-line sterilization followed by aseptic filling. To this end, the concentrate is preheated to 50° to 90° C., sterilized online by indirect or direct heating, for example at 105° to 150° C. for 2 s to 1 h, the upper temperture limit corresponding to the lower time limit, and preferably by high temperature short-time or by ultra-high temperature. The milk product is then cooled to 50° to 90° C., if necessary by expansion, and subsequently homogenized by one or more passes and in one or two stages under a pressure of 50 to 300 bar, preferably by a single pass under a pressure of 200 to 250 bar in the first stage and then under a pressure of approximately 50 bar in the second stage. Finally, the milk product is cooled to 4° to 30° C. and preferably to approximately 20° C. and packed in containers, for example metal cans or cartons. The oeprations following sterilization are of course carried out under aseptic conditions. In a second embodiment of the process, the first homogenization step is replaced by the addition of a natural lactic emulsifier to the starting mixture, all the other steps following the first homogenization step remaining unchanged. In the context of the invention, a natural lactic emulsifier is understood to be a milk derivative containing the majority of the milk phospholipids or polar lipids. The natural lactic emulsifier is characterized in that it is a sweet buttermilk, or a buttermilk from production of butter oil or from production of anhydrous lactic fats, or a sweet buttermilk fraction freed from casein and lactose, or a fraction of buttermilk of anhydrous lactic fats freed from lactose, or mixtures thereof, or a whey fraction from the production of cooked cheeses, or a whey fraction from cooked curd cheese enriched with polar lipids. An emulsifier of this type may be selected from the following milk derivatives: a sweet buttermilk consisting of the aqueous phase remaining after the separation of butter from cream, a buttermilk consisting of the aqueous phase obtained from melted butter during the production of butter oil or anhydrous lactic fats, a fraction of either of the preceding buttermilks which has been freed from proteins, partly or completely freed from lactose and/or freed from butter; for example by separation of the casein and ultrafiltration to remove the lactose; by centrifugation to remove the non-polar lipids, a mixture of the preceding buttermilks or buttermilk fractions, a whey fraction from the production of cooked cheeses, for example Parmesan, obtained by successive separations of the fatty phase by centrifugation to collect the polar lipids, the preceding emulsifiers dried in powder form, if necessary after concentration. The natural lactic emulsifier is preferably added in the form of a dispersion in an aqueous medium, for example produced by premixing in a colloid mill. Alternatively, the emulsifier may be added to the concentrate after evaporation and before the subsequent homogenization step. The natural lactic emulsifier may be added in such a quantity that, depending on its phospholipid content, 0.1 to 1% by weight, preferably 0.15 to 0.35% by weight and, more preferably, approximately 0.20% by weight phospholipids are present in the final evaporated milk, for example with approximately 0.18% added phospholipids and approximately 0.07% phospholipids naturally present in the evaporated milk, for example with 30% solids and 10% fats. The invention is illustrated by the following Examples in conjunction with the accompanying drawings. In the Examples, parts and percentages are by weight, unless otherwise indicated. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 schematically illustrates a first embodiment of the process according to the invention. FIG. 2 schematically illustrates a first variant of the first heat treatment comprised between the dotted lines I and II in FIG. 1. FIG. 3 schematically illustrates a second variant of the first heat treatment comprised between the dotted lines I and II in FIG. 1. FIG. 4 schematically illustrates a third variant of the first heat treatment comprised between the dotted lines I and II in FIG. 1. FIG. 5 schematically illustrates a second embodiment of the process according to the invention as far as the dotted line II in FIG. 1. EXAMPLES In Examples 10 to 14, the milk phospholipid content of the emulsifier is determined by analysis of the phosphorus in the fats in accordance with R. Walstra et al., Neth. Milk &amp; Dairy J. 16 (1962). EXAMPLE 1 In this Example, the process is described with reference to FIG. 1. 255 kg of untreated whole milk containing 3.8% fats and 9% non-fat milk solids (1) and 0.86 kg cream containing 36% fats and 5.7% non-fat milk solids (2) are mixed in the tank 3. The mixture is passed by a centrifugal pump 4 through the plate-type heat exchanger 5 in which it is preheated to 80° C. and then through the homogenizer 6 in which it is homogenized in two stages, first under a pressure of 250 bar and then under a pressure of 50 bar. The mixture then passes into the plate-type heat exchanger 7, in which it is heated to 118° C., and is then cooled by expansion to 96° C. by means of the controlled valve 8, being kept at that temperature for 8 minutes in the tank 9. The rotary piston pump 10 then delivers the mixture via the controlled valve 11 to the double-effect falling-float evaporator 12 in which it is concentrated to a dry matter content of 35% by expansion in vacuo. It is then delivered by the pumps 13 into the buffer tank 14 and, from there, by the centrifugal pump 15 to the plate-type heat exchanger 16 in which it is heated to 65° C. It then passes through the homogenizer 17 in which it is homogenized in two stages, first under a pressure of 75 bar and then under a pressure of 25 bar, cooled to 40° C. in the plate-type heat exchanger 18 and then left standing at that temperature for 12 h in the buffer tank 19. During this period, the dry matter content is adjusted to 33% by addition of water. The concentrate is then taken up by the centrifugal pump 20, after which it is pumped by the piston pump 21 through the plate-type heat exchanger 22, in which it is preheated to 80° C., and then into the tube 23 in which it is heated to 135° C. by direct injection of steam at 24 and in which it is kept at that temperature for 5 s and, finally, into an expansion vessel 25 where its temperature falls to 78° C. At the bottom of the expansion vessel, the centrifugal pump 26 takes up the concentrate and delivers it to the homogenizer 27 in which it is homogenized in two stages, first under a pressure of 75 bar and then under a pressure of 25 bar, and then to the plate-type heat exchanger 28, in which it is cooled to 4° C., and finally to the tank 29 to await filling. 100 kg evaporated milk containing 10% lactic fats and 23% non-fat milk solids are obtained. After packing in cans and crimping of the cans, the product is sterilized for 12 minutes at 118.3° C. (these operations have not been shown). The product has the same stability in storage at ambient temperature as an evaporated milk stabilized with phosphate salts. EXAMPLE 2 The procedure is as in Example 1, except that 243.87 kg untreated whole milk containing 4.1% fats and 8.9% nonfat milk solids and 14.4 kg skimmed milk containing 0.01% fats and 9% non-fat milk solids are used. 100 kg evaporated milk containing 10% lactic fats and 23% non-fat milk solids are thus obtained. The product has the same stability in storage at ambient temperature as an evaporated milk stabilized with phosphate salts. EXAMPLES 3-9 The procedure is as in Example 1, the milk and the cream being mixed to obtain the proportions indicated under the operating conditions indicated in Table 1 below. In Table 1, the parameters of the various stages of the several variants of the process are indicated by reference to the apparatus designated by their respective reference numerals in FIGS. 1 to 4. Thus, Examples 3, 4 and 5 correspond to a heat treatment before evaporation using the plate-type heat exchangers 7 and 30 and then the holding tube 31 (FIG. 2). Examples 5 and 6 comprise a heat treatment before evaporation similar to that of Example 1 using the controlled valve 8 and the tank 9 (FIG. 1). Example 7 uses the holding tube 32 between the plate-type heat exchangers 7 and 30 (FIG. 3) for the heat treatment before evaporation. In Example 8, the valve 11 is controlled in such a way that the temperature in the holding tube 31 is the same as at the exit of the plate-type heat exchanger 7 (FIG. 4). TABLE 1__________________________________________________________________________Example 3 4 5 6 7 8 9__________________________________________________________________________Dry matter % 31 33 33 33 30 30 24Ratio of fats to 10/21 10/23 10/23 10/23 15/15 15/15 4/20non-fat solids%/%Parameters of the process according to FIGS. 1, 2, 3 and 4Reference numeral5 (°C.) 80 80 60 80 90 80 806 (bar) 250 + 50 250 + 50 225 + 50 300 + 50 200 + 50 250 + 50 250 + 507 (°C.) 118 118 118 118 118 120 1189 (°C./s) -- -- 95/480 95/480 -- -- --32, 30 (s/°C.) -- -- -- -- 120/95 120/120 --30, 31 (°C/s) 95/480 95/480 -- -- -- -- 95/48016 (°C.) 65 65 65 65 65 65 6517 (bar) 75 + 25 75 + 25 75 + 25 125 + 25 75 + 25 175 + 25 75 + 2522 (°C.) 80 80 80 80 80 80 8023, 24 (°C.) 115 135 128 130 118 130 11523 (s) 120 5 5 10 240 5 12025 (°C.) 78 78 78 78 78 78 7827 (bar) 75 + 25 75 + 25 75 + 25 125 + 25 75 + 25 200 + 50 75 + 2528 (°C.) 4 4 4 4 4 4 4Sterilization in 118/12 120/10 118/12 118/12 118/12 118/12 118/12cans °C./min.__________________________________________________________________________ The product has the same stability in storage at ambient temperature as an evaporated milk stabilized with phosphate salts. EXAMPLE 10 In this Example, the process is described with reference to FIGS. 1 and 5. In FIG. 5, 228.86 kg untreated whole milk (33) containing 4% fats and 9% non-fat milk solids, 0.39 kg cream (34) containing 36% fats and 5.7% non-fat milk solids and a 10% dispersion of 4.72 kg commercial buttermilk powder (35) containing 14.72% fats, 82.35% non-fat milk solids and 3.81% milk lecithin (milk phospholipids determined by analysis of the phosphorus in the fats) are mixed in water (36). The dispersion is prepared by premixing in the tank 37, taken up by the centrifugal pump 38 and delivered to the colloid mill 39 before being mixed with the milk and cream in the tank 40. The centrifugal pump 41 then delivers the mixture to the plate-type heat exchangers 42 and 43 in which it is heated to 118° C. The mixture is then treated as in Example 1, but under the different operating conditions shown in Table 2 below with reference to FIG. 1: TABLE 2______________________________________FIG. 1, reference numeral Conditions______________________________________16 (°C.) 70-7517 (bar) 100 + 2523, 24 (°C.) 145-15023 (s) 327 (bar) 100 + 25Sterilization in cans 95/15 + 118/12°C./mins.______________________________________ The product has the same stability in storage at ambient temperature as an evaporated milk stabilized with phosphate salts. EXAMPLE 11 The procedure is as in Example 10, except that the milk lecithin is added to the tank 14 (FIG. 1) after the concentration by evaporation. EXAMPLE 12 The procedure is as in Example 10 using a buttermilk powder enriched with milk phospholipids giving 0.18% milk phospholipids in the final evaporated milk. To prepare the buttermilk powder, melted butter is centrifuged in an opening bowl separator and the aqueous phase consisting of buttermilk of anhydrous lactic fats containing 15.23% dry matter, including 7.63% fats and 3.85% lactose, pH 6.65, is collected. The aqueous phase thus collected is pasteurized for 15 s at 73° C. in a scraped-surface heat exchanger and subsequently cooled to 50° C. in this heat exchanger. It is then subjected to ultrafiltration in a 9 m 2 ultrafiltration module of which the membranes have a cutoff zone of 20,000 daltons. The retentate is collected and spray-dried in a spray-drying tower. The powder contains 14% milk phospholipids (as measured by analysis of the phosphorus in the fats). EXAMPLE 13 The procedure is as in Example 10 using a buttermilk powder enriched with milk phospholipids giving 0.18% milk phospholipids in the final evaporated milk. To prepare the buttermilk powder, a skimmed sweet buttermilk containing 7% dry matter and 0.8% fats and 3.3% lactose, pH 6.81, is used. It is pasteurized for 15 s at 75° C. in a plate-type heat exchanger, cooled to 40° C. in a plate-type heat exchanger and then acidified to pH 4.6 with a 20% citric acid solution to precipitate the casein. The casein is separated in a centrifuge and a serum containing 5.58% dry matter is collected. After neutralization to pH 6.7 with a 1N aqueous sodium hydroxide solution, the serum is pasteurized for 15 s at 80° C. in a scraped-surface heat exchanger and then cooled to 50° C. in this heat exchanger. It is then subjected to ultrafiltration in a 9 m 2 ultra-filtration module of which the membranes have a cutoff zone of 20,000 daltons. The retentate is collected, concentrated to 28-32% dry matter in a double-effect evaporator and then spray-dried in a spray-drying tower. The powder contains 14% milk phospholipids (as measured by analysis of the phosphorus in the fats). EXAMPLE 14 The procedure is as in Example 10 using a natural lactic emulsifier from the production of cooked cheeses which gives 0.18% milk phospholipids in the final evaporated milk. A fatty phase is collected by centrifugation of whey from the production of Parmesan at 2,000 r.p.m./50° C. The fatty phase is then heated to a temperature of 75° C. in a scraped-surface heat exchanger and then treated by two passes through a centrifugal decanter. The aqueous phases, pH 4.4-4.6, are then combined into a single phase of which the pH is adjusted to 6.1 by addition of a 1N aqueous sodium hydroxide solution, subsequently pasteurized for 5 s at 95° C. in a scraped-surface heat exchanger, concentrated to a dry matter content of 18 to 20% in a falling float evaporator and, finally, spray-dried in a tower. The powder obtained contains 5% milk phospholipids (as measured by analysis of the phosphorus in the fats). EXAMPLE 15 The procedure is as in Example 1 up to the sterilization step. To carry out sterilization, the concentrate coming from the tank 29 is preheated to 80° C. in a platetype heat exchanger, sterilized at 120° C. in a plate-type heat exchanger and then kept at that temperature for 7 minutes in a holding tube. It is then expanded in a vessel, in which its temperature falls to 78° C., and homogenized in two stages, first under a pressure of 200 bar and then under a pressure of 50 bar, the homogenizate is cooled to 20° C. in a plate-type heat exchanger and then packed in cans which are hermetically sealed. Expansion, homogenization, cooling and packing are all carried out under aseptic conditions. The product has the same stability in storage at ambient temperature as an evaporated milk stabilized with phosphate salts. EXAMPLE 16 The procedure is as in Example 3 up to the sterilization step. To carry out sterilization, the concentrate coming from the tank 29 is preheated to 75° C. in a plate-type heat exchanger, sterilized at 140° C. by direct injection of steam and kept at that temperature for 10 s in a tube (ultra-high temperature sterilization). After cooling to 73° C. in a plate-type heat exchanger, it is homogenized in two stages, first under a pressure of 250 bar and then under a pressure of 50 bar, the homogenizate is cooled to 20° C. in a plate-type heat exchanger and then packed in cartons which are hermetically sealed. All the steps following sterilization are carried out under aseptic conditions. The product has the same stability in storage at ambient temperature as an evaporated milk stabilized with phosphate salts. By way of comparison, an evaporated milk treated in the same way, but without the steps of homogenization of the starting prod.uct, heat treatment of the homogenizate before concentration, heat treatment and homogenization of the concentrate described in detail in Example 3, gelled rapidly after an ultra-high temperature sterilization treatment.

Evaporated milk which is stable in storage without the addition of stabilizing salts is prepared by homogenizing a milk product, heat-treating the homogenized milk, evaporatively concentrating the milk, heat-treating the concentrate, homogenizing the heat-treated concentrate and then sterilizing the heat-treated concentrate. Alternatively, a lactic product containing phospholipids derived from milk is mixed with a milk product, the mixture is heat-treated, the heat-treated mixture is evaporatively concentrated, the concentrate is heat-treated, the heat-treated concentrate is homogenized, and then the homogenized heat-treated concentrate is sterilized. Further, alternatively, the milk product is first heat-treated and then evaporatively concentrated, a lactic product containing phospholipids derived from milk is mixed with the concentrate, the mixture is heat-treated, then homogenized and then sterilized.

RELATED APPLICATIONS This application is a divisional application of a U.S. patent application Ser. No. 12/815,144 filed Jun. 14, 2010 now U.S. Pat. No. 8,092,487, which is a divisional application of U.S. patent application Ser. No. 10/772,782, filed Feb. 5, 2004 now U.S. Pat. No. 7,758,606, which patent application is a continuation of U.S. patent application Ser. No. 09/896,258, filed Jun. 29, 2001 now U.S. Pat. No. 6,692,513 which &#39;258 cation claimed the benefit of prior U.S. Provisional Patent Application Ser. No. 60/215,542, filed Jun. 30, 2000 by Richard B. Streeter et al. for INTRAVASCULAR FILTER WITH DEBRIS ENTRAPMENT MECHANISM, which patent application is hereby incorporated herein by reference, and of prior U.S. Provisional Patent Application Ser. No. 60/231,101, filed Sep. 8, 2000 by Richard B. Streeter et al, for INTRAVASCULAR FILTER WITH DEBRIS ENTRAPMENT MECHANISM, which patent application is hereby incorporated herein by reference. FIELD OF THE INVENTION This invention relates to intravascular filtering apparatus and methods in general, and more particularly to apparatus and methods for filtering and irreversibly entrapping embolic debris from the vascular system during an intravascular or intracardiac procedure. BACKGROUND OF THE INVENTION Intracardiac and intravascular procedures, whether performed percutaneously or in an open, surgical, fashion, may liberate particulate debris. Such debris, once free in the vascular system, may cause complications including vascular occlusion, end-organ ischemia, stroke, and heart attack. Ideally, this debris is filtered from the vascular system before it can travel to distal organ beds. Using known filter mechanisms deployed in the arterial system, debris is captured during systole. There is a danger, however, that such debris may escape the filter mechanism during diastole or during filter removal. Apparatus and methods to reduce debris escape during diastole or during filter removal may be desirable to reduce embolic complications SUMMARY OF THE INVENTION An object of the invention is to provide a filtering mechanism that irreversibly entraps debris therein. Another object of the invention is to provide a filtering mechanism that permanently captures debris from the intravascular system of a patient. A further object of the invention is to provide a filtering mechanism with greater ability to collect debris in the intravascular system of a patient to decrease the number of complications attributable to such debris. Another further object of this invention is to provide a filter holding mechanism suitable to be secured to a retractor used to create access to the heart and surrounding structures during heart surgery procedures. A still further object is to provide a method for using a filtering mechanism in the intravascular system of a patient to permanently capture debris therefrom. Another still further object of the present invention is to provide a method for introducing a filtering device in the aorta downstream of the aortic valve to restrict the passage of emboli while allowing blood to flow through the aorta during cardiovascular procedures, and to entrap debris collected in the filter so as to prevent its escape during cardiac diastole or during manipulation, repositioning or removal of the device from the aorta. With the above and other objects in view, as will hereinafter appear, there is provided apparatus for debris removal from the vascular system of a patient, said apparatus comprising: a filtering device having a proximal side and a distal side said filter being sized to allow blood flow therethrough and to restrict debris therethrough and said filter having a first given perimeter, wherein blood flow in a first direction passes from the proximal side to the distal side of the filtering device; an entrapment mechanism having a proximal side and a distal side, the entrapment mechanism forming a selective opening to allow debris and blood flow passage in the first direction from the proximal side to the distal side therethrough, the selective opening having a restriction mechanism to debris passage in a second direction opposite to said first direction the selective opening having a second given perimeter, the first given perimeter and the second given perimeter being deployed within the vascular system so as to form a chamber between the distal side of the entrapment mechanism and the proximal side of the filtering device, wherein the entrapment mechanism allows blood flow and debris to pass therethrough in the first direction, the filtering device allows blood flow to pass therethrough in the first direction, the restriction mechanism prevents debris from passing back through said selective opening in a second direction opposite to the first direction and the chamber contains the debris received through the entrapment mechanism so as to prevent the escape of the debris therein by said filtering device in the first direction and said restriction mechanism in said second direction. In accordance with another further feature of the invention there is provided a method for filtering and entrapping debris from the vascular system of a patient, the method comprising: providing apparatus for filtering and entrapping debris from the vascular system of a patient, the apparatus comprising: a filter device being sized to allow blood flow therethrough and to restrict passage of debris therethrough, and the filter device having a first given perimeter, a proximal side and a distal side; and wherein the filtering device captures debris carried in a first direction of blood flow from the proximal side to the distal side thereof on the proximal side of the filter device; an entrapment mechanism having a proximal side and a distal side, the entrapment mechanist including a selective opening to allow passage of blood and debris therethrough, the selective opening being configured to allow passage of blood and debris carried therein therethrough in the first direction of blood flow from the proximal side to the distal side of the entrapment mechanism, the selective opening having a restriction mechanism to prevent debris passage from the distal side to the proximal side of the entrapment mechanism in a second direction opposite to the first direction, the selective opening forming a second given perimeter, and the first given perimeter and the second given perimeter being deployed within the vascular system so as to form a chamber between the distal side of the entrapment mechanism and the proximal side of the filtering device; wherein the entrapment mechanism allows blood and debris carried therein therethrough in the first direction of blood flow, the filtering device allows blood therethrough in the first direction of blood flow, and the restriction mechanism prevents debris back through the selective opening in the second direction of blood flow opposite to the first direction of blood flow such that the chamber entraps the filtered debris received therein for debris removal from the vascular system of the patient; inserting said apparatus into the vascular system of the patient; allowing blood and debris carried therein to flow through the entrapment mechanism, and into the chamber; and removing the apparatus from the vascular system of the patient. The above and other features of the invention, including various novel details of construction and combinations of parts and method steps will now be more particularly described with reference to the accompanying drawings and pointed out in the claims. It will be understood that the particular devices and method steps embodying the invention are shown by way of illustration only and not as limitations of the invention. The principles and features of this invention may be employed in various and numerous embodiments without departing from the scope of the invention. BRIEF DESCRIPTION OF THE DRAWINGS These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiments of the invention, which are to be considered together with the accompanying drawings wherein like numbers refer to like parts, and further wherein: FIG. 1A is a perspective view of a deployable entrapment filtering device for debris removal showing the filtering device in its fully deployed shape as released from its cannula into the blood stream of a patient; FIG. 1B is an exploded perspective view of the deployable entrapment filtering device of FIG. 1A showing the components thereof; FIG. 1C is a schematic cross-sectional illustration depicting the deployable entrapment filtering device of FIGS. 1A and 1B during cardiac systole; FIG. 1D is a schematic cross-sectional illustration depicting the deployable entrapment filtering device of FIGS. 1A and 1B during cardiac diastole; FIG. 2A is an exploded perspective view of a deployable entrapment filtering device for debris removal showing the components thereof including a set of filter mesh entrapment leaflets; FIG. 2B is a schematic cross-sectional illustration depicting the deployable entrapment filtering device of FIG. 2A during cardiac systole; FIGS. 3A-3D are a series of schematic illustrations depicting a method of using the deployable entrapment filtering device of FIGS. 2A and 2B ; FIG. 4A is an exploded perspective view of a deployable entrapment filtering device for debris removal showing the components thereof including a set of non-porous valve leaflets; FIG. 4B is a schematic cross-sectional illustration depicting the deployable entrapment filtering device of FIG. 4A during cardiac systole; FIGS. 5A-5D are a series of schematic illustrations depicting a method of using the deployable entrapment filtering device of FIGS. 4A and 4B ; and FIGS. 6A-6D are schematic illustrations depicting an orthogonally deployable valve/filter apparatus. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A filtration and entrapment apparatus 5 is shown in FIGS. 1A-5D for debris removal from the vascular system of a patient. Filtration and entrapment apparatus 5 generally includes a filter device 10 and an entrapment mechanism 15 . Filtration and entrapment apparatus 5 can be used to filter emboli during a variety of intravascular or intracardiac procedures, including, but not limited to, the following procedures: vascular diagnostic procedures, angioplasty, stenting, angioplasty and stenting, endovascular stent-graft and surgical procedures for aneurysm repairs, coronary artery bypass procedures, cardiac valve replacement and repair procedures, and carotid endardarectomy procedures. Now looking at FIGS. 1A-1D , a preferred embodiment of the present invention is shown with filtration and entrapment apparatus 5 as described herein below. FIG. 1A depicts the profile of filtration and entrapment apparatus 5 in its fully deployed shape, with filter device 10 and entrapment mechanism 15 released from cannula 20 into the blood stream (not shown). Prior to deployment, filter device 10 and entrapment mechanism 15 are collapsed within cannula 20 , e.g., by moving the proximal end 25 A proximally along center post 50 . FIG. 1B depicts the primary components of filtration and entrapment apparatus 5 comprising filter device 10 and entrapment mechanism 15 in attachment to deployable frame 25 . In the present embodiment of the invention, filter device 10 comprises a filter mesh bag 30 , and entrapment mechanism 15 comprises a piece of coarse mesh 35 and a set of entrapment flaps 40 . FIG. 1C depicts filtration and entrapment apparatus 5 deployed within an aorta 45 during cardiac systole. Blood and debris flow through opened deployable frame 25 , across course mesh 35 , between and through entrapment flaps 40 and into the end of the filter mesh bag 30 . Entrapment flaps 40 ensure unidirectional flow of blood and debris into filter mesh bag 30 . FIG. 10 depicts filtration and entrapment apparatus 5 within the aorta 45 responding to any retrograde flow of blood and/or back pressure within the aorta 45 during cardiac diastole. The back flow of blood and/or back pressure causes filter mesh bag 30 to partially deform and entrapment flaps 40 to close against coarse mesh 35 . Coarse mesh 35 is of a structure adequate to permit the free flow of blood and debris through it and into filter mesh bag 30 , and serves as a supporting structure against which entrapment flaps 40 can close and remain in a closed position to prevent the escape of embolic debris. Still looking at FIGS. 1A-1D , it should also be appreciated that the entrapment flaps 40 may be attached to structures other than deployable frame 25 , e.g., the entrapment flaps 40 may be attached to a center post 50 , or to coarse mesh 35 , etc. Furthermore, if desired, entrapment flaps 40 may be biased closed or biased open. In addition, entrapment mechanism 15 may consist of one or more flaps 55 , and have a configuration including, but not limited to, a single disk diaphragm (not shown), a semi-lunar configuration (not shown), a gill slit configuration (not shown), a multi-leaflet flap configuration (not shown), etc. It should also be appreciated that, while in the foregoing description the apparatus shown in FIGS. 1A-1D has been described in the context of functioning as a filter, it may also function as a one-way check valve. To the extent that the apparatus shown in FIGS. 1A-1D is intended to function primarily as a one-way check valve, filter mesh bag 30 (see FIG. 1B ) may be retained or it may be omitted. Looking next at FIGS. 2A and 2B , there is shown an alternative form of the present invention as a bidirectional flow filtration and entrapment apparatus 105 . Bidirectional flow filtration and entrapment apparatus 105 of FIGS. 2A and 2B generally comprises a filter device 110 and an entrapment mechanism 115 delivered by a cannula 120 to the interior of a vascular structure 122 (see FIGS. 3A-3D ); a deployable filter frame 125 ; a filter bag 130 attached to the perimeter of deployable filter frame 125 ; a compliant, soft outer cuff 135 (preferably formed out of a biologically inert material such as Teflon, Dacron, Silastic, etc.) for sealing filtration and entrapment apparatus 105 against the inner wall of vascular structure 122 when deployable filter frame 125 is expanded; entrapment leaflets 140 , preferably in the form of a fine filter mesh; a center post 150 (preferably formed out of steel or the equivalent) passing across the interior of the deployable filter frame 125 ; a hinge line 155 on entrapment leaflets 140 , connected to center post 150 , for permitting the entrapment leaflets 140 to open and close; co-aptation strands 160 extending across the interior of deployable filter frame 125 and providing a seat against which entrapment leaflets 140 may close during diastole; and a perimeter seal 165 (preferably formed out of expanded Teflon or the like). Perimeter seal 165 acts like a step to help support entrapment leaflets 140 during diastole. In addition, it should also be appreciated that soft outer cuff 135 may comprise a radially expandable mechanism (e.g., a balloon, a decompressed sponge, a spring loaded leaflet, etc.) for sealing filtration and entrapment apparatus 105 against the inner wall of vascular structure 122 . As noted above, entrapment leaflets 140 are preferably formed out of a fine filter mesh. This filter mesh is sized so that it will pass blood therethrough but not debris. Furthermore, this filter mesh is sized so that it will provide a modest resistance to blood flow, such that the entrapment leaflets will open during systole and close during diastole. By way of example but not limitation, the filter mesh may have a pore size of between about 40 microns and about 300 microns. FIGS. 3A-3D illustrate operation of bidirectional flow filtration and entrapment apparatus 105 shown in FIGS. 2A and 2B . More particularly, cannula 120 of deployable filtration and entrapment apparatus 105 is first inserted through a small incision 170 in the wall of the vascular structure 122 (see FIG. 3A ). Then deployable filter frame 125 is deployed (see FIG. 3B ). Thereafter, during systole (see FIG. 3C ), blood flows through deployable filter from 125 , forcing entrapment leaflets 140 open, and proceeds through filter bag 130 . Any debris contained in the blood is captured by filter bag 130 and thereby prevented from moving downstream past bidirectional flow filtration and entrapment apparatus 105 . During diastole (see FIG. 3D ), when the blood flow momentarily reverses direction, entrapment leaflets 140 (shown in FIGS. 2A and 2B ) close, seating against co-aptation strands 160 (shown in FIGS. 2A and 2B ) extending across the interior of deployable filter frame 140 (shown in FIGS. 2A and 2B ). The blood passes through the fine mesh of entrapment leaflets 140 (shown in FIGS. 2A and 2B ), being filtered as it passes, thus permitting coronary profusion to take place during the diastolic phase. The fine mesh of entrapment leaflets 140 (shown in FIGS. 2A and 2B ) prevents debris from passing back through bidirectional flow filtration and entrapment apparatus 105 . It should also be appreciated that with bidirectional flow filtration and entrapment apparatus 105 of FIGS. 2A , 2 B and 3 A- 3 D, entrapment leaflets 140 may be attached to structures other than center post 150 , e.g., they may be attached to co-aptation strands 160 , or to deployable filter frame 125 , etc. Furthermore, if desired, entrapment leaflets 140 may be biased closed, or biased open. In addition, entrapment mechanism 15 may consist of one or more flaps (not shown), and have a configuration including, but not limited to, a single disk diaphragm (not shown), a semi-lunar configuration (not shown), a gill slit configuration (not shown), a multi-leaflet flap configuration (not shown), etc. Looking next at FIGS. 4A and 4B , there is shown a deployable valve/filter apparatus 205 . Deployable valve/filter apparatus 205 of FIGS. 4A and 4B generally comprises a filter device 210 and a valve entrapment mechanism 215 delivered by a cannula 220 to the interior of the vascular structure 222 ; a deployable valve/filter frame 225 ; a filter bag 230 attached to the perimeter of deployable valve/filter frame 225 ; a compliant, soft outer cuff 235 (preferably formed out of a biologically inert material such as Teflon, Dacron, Silastic, etc.) for sealing the filter device 210 against the inner wall of vascular structure 222 when deployable valve/filter frame 225 is expanded; valve leaflets 240 , preferably in the form of a blood-impervious material; a center post 250 (preferably formed out of steel or the equivalent) passing across the interior of deployable valve/filter frame 225 ; a hinge line 255 on valve leaflets 240 , connected to center post 250 , for permitting valve leaflets 240 to open and close; co-aptation strands 260 extending across the interior of deployable valve/filter frame 225 and providing a seat against which valve leaflets 240 may close during diastole; and a perimeter seal 265 (preferably formed out of expanded Teflon or the like). Perimeter seal 265 acts like a step to help support valve leaflets 240 during diastole. In addition, it should also be appreciated that soft outer cuff 235 may comprise a radially expandable mechanism (e.g., a balloon, a decompressed sponge, a spring loaded leaflet, etc.) for sealing deployable valve/filter apparatus 205 against the inner wall of vascular structure 222 . FIGS. 5A-5D illustrate operation of deployable valve/filter apparatus 205 of FIGS. 4A and 4B . More particularly, valve/filter apparatus 205 is first inserted through a small incision 270 in the wall of the vascular structure 222 (see FIG. 5A ). Then deployable valve/filter frame 225 is deployed (see FIG. 5B ). Thereafter, during systole (see FIG. 5C ), blood flows through deployable valve/filter frame 225 , forcing valve leaflets 240 open, and proceeds through filter bag 230 . Any debris contained in the blood is captured by filter bag 230 and thereby prevented from moving downstream past valve/filter apparatus 205 . During diastole (see FIG. 5D ), when the blood flow momentarily reverses direction, valve leaflets 240 (shown in FIGS. 4A and 4B ) close, seating against co-aptation strands 260 (shown in FIGS. 4A and 4B ) across the interior of deployable valve/filter frame 225 (shown in FIGS. 4A and 4B ). The closed leaflets 240 (shown in FIGS. 4A and 4B ) prevent blood from passing back through the valve/filter frame 225 (shown in FIGS. 4A and 4B ). It should also be appreciated that with valve/filter apparatus 205 shown in FIGS. 4A , 4 B and 5 A- 5 D, valve leaflets 240 may be attached to structures other than center post 250 , e.g., they may be attached to co-aptation strands 260 , or to deployable valve filter frame 225 , etc. Furthermore, if desired, valve leaflets 240 may be biased closed, or biased open. In addition, valve entrapment mechanism 215 may consist of one or more flaps (not shown), and have a configuration including, but not limited to, a single disk diaphragm (not shown), a semi-lunar configuration (not shown), a gill slit configuration (not shown), a multi-leaflet flap configuration (not shown), etc. Looking next at FIGS. 6A-6B , there is shown an orthogonally deployable valve/filter apparatus 305 . Orthogonally deployable valve/filter apparatus 305 of FIGS. 6A-6D generally comprises a filter device 310 and a valve entrapment mechanism 315 deployed at an angle substantially orthogonal to an axis 318 of a cannula 320 , such as a catheter introduced to the vascular system at a location which may be remote from the point of operation, in the interior of a vascular structure 322 ; a deployable valve/filter frame 325 ; a filter bag 330 attached to the perimeter of deployable valve/filter frame 325 ; a compliant, soft outer cuff 335 (preferably formed out of a biologically inert material such as Teflon, Dacron, Silastic, etc.) for sealing the filter device 310 against the inner wall of vascular structure 322 when deployable valve/filter frame 325 is expanded; valve leaflets 340 , preferably in the form of a blood-impervious material, having a first portion 350 in attachment to deployable valve/filter frame 325 , and a second portion 355 separable from deployable valve/filter frame 325 , so as to allow valve leaflets 340 to open and close; and a mesh material 360 extending across the interior of deployable valve/filter frame 325 and providing a seat against which valve leaflets 340 may close during diastole. In addition, it should be appreciated that mesh material 360 may comprise coaptation strands such as coaptation strands 160 as first shown in FIG. 2A . In addition, it should also be appreciated that soft outer cuff 335 may comprise a radially expandable mechanism (e.g., a balloon, a decompressed sponge, a spring loaded leaflet, etc.) for sealing orthogonally deployable valve/filter apparatus 305 against the inner wall of vascular structure 322 . In addition, it should also be appreciated that valve entrapment mechanism 315 may be mounted for blood flow in either direction within vascular structure 322 . FIGS. 6A-6D illustrate operation of deployable valve/filter apparatus 305 . More particularly, deployable valve/filter apparatus 305 is first inserted through the interior of vascular structure 322 to a desired location (see FIG. 6C ). Then deployable valve/filter frame 325 is deployed (see FIG. 6D ). Thereafter, during systole (see FIG. 6A ), blood flows through deployable valve/filter frame 325 , forcing valve leaflets 340 open, and proceeds through filter bag 330 . Any debris contained in the blood is captured by filter bag 330 and thereby prevented from moving downstream past deployable valve/filter apparatus 305 . During diastole (see FIG. 6B ), when the blood flow momentarily reverses direction, valve leaflets 340 close, seating against mesh material 360 across the interior of deployable filter frame 340 . The closed leaflets 340 prevent blood from passing back through the valve/filter frame 325 . It should also be appreciated that with valve/filter apparatus 305 shown in FIGS. 6A-6D , valve leaflets 340 may be attached to structures other than deployable valve/filter frame 325 , e.g., they may be attached to mesh material 260 , or to cannula 320 , etc. Furthermore, if desired, valve leaflets 340 may be biased closed, or biased open. In addition, valve entrapment mechanism 315 may consist of one or more flaps (not shown), and have a configuration including, but not limited to, a single disk diaphragm (not shown), a semi-lunar configuration (not shown), a gill slit configuration (not shown), a multi-leaflet flap configuration (not shown) etc. The filter design as described herein to prevent the escape of captured debris during diastole or filter removal may also be applied to all intravascular filters. Such a filter design may comprise a one-way valve and a filtering mesh in series. Liberated debris may pass through the one-way valve and come to rest in the filtering mesh. The one-way valve ensures permanent entrapment of debris. Potential applications of such an apparatus extend to all percutaneous and surgical procedures on the heart and vascular system, including open heart surgery, balloon dilatation of cardiac valves and arteries, deployment of stents in arteries, diagnostic catheterizations, and other cardiac and vascular procedures. Advantages of such a system include more complete collection of liberated debris, with a resulting decrease in the complications attributable to such debris.

Apparatus for filtering and entrapping debris in the vascular system of a patient, the apparatus including a filter to allow blood to flow therethrough and to restrict passage of debris, wherein the filter captures debris carried in a first direction of blood flow. The apparatus further includes an entrapment mechanism which allows passage of debris and blood therethrough, in the first direction of blood flow and prevents debris passage in a second direction. The entrapment mechanism and filter allow blood and debris therethrough in the first direction of blood flow. The entrapment mechanism prevents debris flow in the second direction of blood flow. A method for filtering and entrapping debris in the vascular system includes inserting the apparatus into the vascular system, allowing blood and debris carried therein to flow through the entrapment mechanism, and removing the apparatus and accumulated debris from the vascular system.

REFERENCE TO PENDING PRIOR PATENT APPLICATION [0001] This patent application claims benefit of pending prior U.S. Provisional Patent Application Ser. No. 62/160,503, filed May 12, 2015 by Diagnosys LLC and Bruce Doran et al. for COMBINED STIMULATOR AND BIPOLAR ELECTRODE ASSEMBLY FOR MOUSE ELECTRORETINOGRAPHY (ERG) (Attorney&#39;s Docket No. DIAGNOSYS- 1 PROV), which patent application is hereby incorporated herein by reference. FIELD OF THE INVENTION [0002] This invention relates generally to apparatus and methods for the assessment of electrophysiological signals, and more particularly to apparatus and methods for the assessment of ophthalmic physiological signals. BACKGROUND OF THE INVENTION [0003] Full-field ophthalmic electrophysiology generally involves flashing a light from a large “bowl” into the eye of the subject, and then measuring the response from the retina of the subject using electrodes, i.e., an active electrode which contacts the eye of the subject and other electrodes (reference and ground electrodes) which contact other portions of the subject. This procedure is sometimes referred to as electroretinography (ERG). [0004] Clinically, the hardest part of performing ophthalmic electrophysiology is properly connecting the electrodes to the subject and, more particularly, properly connecting the active electrode to the eye of the subject. [0005] In some cases the ophthalmic electrophysiology must be conducted on humans. In other cases the ophthalmic electrophysiology must be conducted on small rodents of the sort commonly used in laboratory experiments, e.g., mice and rats (for the purposes of the present invention, such animals will generally be referred to herein as “mice”, however, it should be appreciated that such term is meant to be exemplary and not limiting). It will be appreciated that conducting electrophysiology on mice can present issues which may be different from the issues which might arise when conducting electrophysiology on humans. [0006] In present configurations for performing ophthalmic electrophysiology on mice, e.g., with an ERG dome such as that offered by Diagnosys LLC of Lowell, Mass., the anesthetized mouse is placed on a heated platform that maintains its body temperature during the test. At least three electrodes must be attached to the mouse: (i) a ground electrode; (ii) a reference electrode; and (iii) a corneal (active) electrode. In best current practice, all three electrodes are made out of platinum or silver/silver chloride and consist of two needles and a wire. One of the needles is used as a ground electrode and is easy to attach to the mouse because its position is not critical—anywhere in the haunch or tail of the mouse will do. Placement of the other two electrodes (i.e., the reference and active electrodes) requires much more care. The remaining needle electrode is the reference electrode. It must be inserted very precisely into the mouse, either at the midline of the scalp, in the mouth, or in the cheek. Mispositioning of the reference electrode will cause imbalances in the readings between the two eyes of the mouse. The last electrode, the wire electrode, is the corneal (active) electrode. It too must be placed in just the right position on the eye in order to avoid biasing the recording: too close to the center of the eye and the wire will block light; too far to the periphery of the eye and the wire will record lower voltages than if placed nearer to the center of the eye. If both eyes of the animal are to be tested, a second corneal wire must be placed in a homologous position to the first corneal wire. An added complication is that, usually, all this must be done in a room only dimly illuminated by deep red light. [0007] After the three electrodes have been placed on the mouse, the ERG dome is either moved into position over the mouse or the platform supporting the mouse is moved into the dome. Either movement may disturb the electrodes placed on the mouse, which would then require that the electrodes be repositioned. Since the mouse is hidden by the dome, it sometimes wakes up and escapes under cover of darkness. [0008] FIG. 1 shows the current Diagnosys mouse ERG dome platform in its open position. [0009] FIG. 2 shows the same Diagnosys mouse ERG dome platform in its closed position. [0010] It will be appreciated that conducting ophthalmic electrophysiology on a mouse is time-consuming and requires personnel with special skills. For this reason, ophthalmic electrophysiology is sometimes not performed on mice even where the results of performing ophthalmic electrophysiology could be beneficial. By way of example but not limitation, NIH has an impending campaign to phenotype more than 300,000 mutated mice. Among other things, the mice are being tested for deficits analogous to human eye disease. Although some of these deficits can only be detected using ophthalmic electrophysiology, electrophysiology was initially excluded from the testing protocols because existing techniques for performing ophthalmic electrophysiology on mice are too time-consuming and require personnel with rare skills. [0011] Ophthalmic electrophysiology would be significantly easier to perform on mice if there were a way to rapidly and automatically position the active and reference electrodes on the mouse. There is an existing device (a “contact lens bipolar corneal electrode”) that does this effectively for humans, but in its present state the contact lens bipolar corneal electrode is not practical for widespread use with mice. [0012] More particularly, a contact lens bipolar corneal electrode consists of a lid-retracting speculum with a reference electrode embedded in its outer circumference. A contact lens ringed by the corneal electrode is suspended by a spring from the inner part of the speculum. Since both active and reference electrodes are built into the device, the two electrodes occupy the same position on every eye (which is easily adjusted during manufacture to be at the correct position on the eye of the subject). As a result, the contact lens bipolar corneal electrode provides highly reliable positioning of the active and reference electrodes, and hence provides highly reliable results. A further advantage of the contact lens bipolar corneal electrode is that both electrodes (active and reference) touch the tear film, making excellent electrical contact with the subject without special preparation. [0013] FIG. 3 shows a human contact lens bipolar corneal electrode which was introduced by Diagnosys in 1986 . [0014] FIG. 4 shows another human contact lens bipolar corneal electrode sold by Hansen Ophthalmic Development Laboratories of Coralville, Iowa (hereinafter “Hansen Labs”). [0015] As noted above, human contact lens bipolar corneal electrodes work effectively, but mouse contact lens bipolar corneal electrodes are impractical for widespread use with mice. More particularly, a mouse contact lens bipolar corneal electrode is available from Hansen Labs, but the mouse contact lens bipolar corneal electrode is impractically delicate, expensive, and hard to make. The basic problem with the mouse contact lens bipolar corneal electrode sold by Hansen Labs is that the manufacturer does not know how its customers are going to use the lens—they may have an application that needs the animal to view an image—and so the manufacturer has to start by wrapping a corneal electrode around an optically “good”, zero-power mouse contact lens, and this is a challenging task. [0016] Another problem with mouse contact lens bipolar corneal electrodes is that, if anything, they slow the testing process down rather than speed it up. The mouse contact lens bipolar corneal electrodes are so delicate and sensitive that they require great care and skill in order to place them properly on the eye of the mouse—by way of example but not limitation, it is very easy to accidentally cover the mouse contact lens bipolar corneal electrodes with saline solution which shorts them out, and they often break during handling. In any case, mouse contact lens bipolar corneal electrodes are so hard to make that they are usually now offered only in monopolar versions, which means that the problem of placing the reference electrode on the mouse is still left to the user. The only real advantage of current mouse contact lens bipolar corneal electrodes over current wire electrodes is that the mouse contact lens bipolar corneal electrodes cover the cornea and prevent the formation of cataracts in the mouse due to drying. [0017] FIG. 5 shows the mouse contact lens bipolar corneal electrode sold by Hansen Labs. [0018] Thus there is a need for a new and improved approach for quickly and easily performing ophthalmic electrophysiology on mice. SUMMARY OF THE INVENTION [0019] The present invention comprises the provision and use of a new and improved method and apparatus for quickly and easily performing ophthalmic electrophysiology on mice. [0020] In one form of the present invention, there is provided apparatus for evoking and sensing ophthalmic physiological signals in an eye, the apparatus comprising: [0021] an elongated tubular light pipe having a longitudinal axis, a distal end and a proximal end, the distal end terminating in a spheroid recess; [0022] an active electrode having a distal end and a proximal end, the active electrode being mounted to the elongated tubular light pipe and extending proximally along the elongated tubular light pipe so that the distal end of the active electrode terminates at the spheroid recess at the distal end of the elongated tubular light pipe; and [0023] a reference electrode having a distal end and a proximal end, the reference electrode being mounted to the elongated tubular light pipe and extending proximally along the elongated tubular light pipe so that the distal end of the reference electrode terminates at the spheroid recess at the distal end of the elongated tubular light pipe; [0024] wherein the distal end of the active electrode is located closer to the longitudinal axis of the elongated tubular light pipe than the distal end of the reference electrode. [0025] In another form of the present invention, there is provided a method for evoking and sensing ophthalmic physiological signals in an eye, the method comprising: [0026] providing apparatus comprising: an elongated tubular light pipe having a longitudinal axis, a distal end and a proximal end, the distal end terminating in a spheroid recess; an active electrode having a distal end and a proximal end, the active electrode being mounted to the elongated tubular light pipe and extending proximally along the elongated tubular light pipe so that the distal end of the active electrode terminates at the spheroid recess at the distal end of the elongated tubular light pipe; and a reference electrode having a distal end and a proximal end, the reference electrode being mounted to the elongated tubular light pipe and extending proximally along the elongated tubular light pipe so that the distal end of the reference electrode terminates at the spheroid recess at the distal end of the elongated tubular light pipe; wherein the distal end of the active electrode is located closer to the longitudinal axis of the elongated tubular light pipe than the distal end of the reference electrode; [0031] positioning the elongated tubular light pipe against the eye of a test subject; and [0032] introducing light into the proximal end of the elongated tubular light pipe. BRIEF DESCRIPTION OF THE DRAWINGS [0033] These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiments of the invention, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts, and further wherein: [0034] FIGS. 1 and 2 are schematic views of a prior art rodent table for the ColorDome Stimulator of Diagnosys LLC; [0035] FIG. 3 is a schematic view of a prior art GoldLens Corneal Electrode; [0036] FIG. 4 are schematic views showing prior art Burian speculum type electrodes and prior art cotton wick electrodes; [0037] FIG. 5 is a schematic view showing a prior art mouse ERG electrode; [0038] FIGS. 6-12 are schematic views showing novel apparatus formed in accordance with the present invention for evoking and sensing ophthalmic physiological signals in an eye; [0039] FIG. 13 is a schematic view showing an alternative form of the apparatus shown in FIGS. 6-12 ; [0040] FIG. 14 is a schematic view showing another alternative form of the apparatus shown in FIGS. 6-12 ; and [0041] FIGS. 15-17 are schematic views showing exemplary novel apparatus formed in accordance with the present invention for evoking and sensing ophthalmic physiological signals in an eye. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0042] The present invention provides a new and improved approach for quickly and easily performing ophthalmic electrophysiology on mice. [0043] More particularly, and looking now at FIGS. 6-11 , there is shown a combined stimulator and bipolar electrode assembly 5 formed in accordance with the present invention. Combined stimulator and bipolar electrode assembly 5 generally comprises a housing 10 , a light pipe subassembly 15 and a light source subassembly 20 . [0044] Housing 10 preferably comprises a main body 22 having a cavity 25 formed therein, and a side arm 30 extending at an angle (e.g., 125 degrees) to the longitudinal axis of main body 22 . Side arm 30 includes a cavity 35 formed therein, and a magnetic mount 40 (preferably in the form of a steel ball) secured to side arm 30 . [0045] Light pipe subassembly 15 is disposed partially within, and protrudes from, cavity 25 of main body 22 . Light pipe subassembly 15 generally comprises a light pipe 45 formed out of a light-transmissive material (e.g., Plexiglass) and having a distal end 50 and a proximal end 55 . Light pipe 45 has an elongated configuration, and may be cylindrical (e.g., substantially straight with a substantially circular cross-section), or non-linear pseudo-cylindrical (e.g., bent or curved with a substantially circular cross-section), or light pipe 45 may have another acceptable configuration. Distal end 50 of light pipe 45 has a spheroid recess 60 formed therein. The radius of curvature of spheroid recess 60 is preferably similar to the radius of curvature of the eye of a mouse, so that the distal end 50 of light pipe 45 can be seated against the outside surface of the eye of a mouse. Light pipe 45 also comprises a pair of slots 65 A, 65 B formed in the outer surface of light pipe 45 . In one preferred form of the invention, slots 65 A, 65 B are diametrically opposed to one another. The distal end of slot 65 A has a greater depth than the remainder of slot 65 A, so that the distal end of slot 65 A approaches (but preferably does not reach) the center of spheroid recess 60 . Preferably at least the distal portion of slot 65 A outboard of wire 70 A is filled with an appropriate material (e.g., a light-transmissive, non-conductive, waterproof material) so as to eliminate air gaps between light pipe 45 and the eye of the mouse. A platinum (or silver or gold, etc.) wire 70 A, which serves as the active electrode for combined stimulator and bipolar electrode assembly 5 , is disposed in slot 65 A. Note that the distal end of platinum wire 70 A follows the floor of slot 65 A so that the distal end of platinum wire 70 A approaches the center of spheroid recess 60 . The distal end of platinum wire 70 A communicates with spheroid recess 60 . A platinum (or silver or gold, etc.) wire 70 B, which serves as the reference electrode for combined stimulator and bipolar electrode assembly 5 , is disposed in slot 65 B. The distal end of platinum wire 70 B also communicates with spheroid recess 60 . Preferably at least the distal portion of slot 65 B outboard of wire 70 B is filled with an appropriate material (e.g., a light-transmissive, non-conductive, waterproof material) so as to eliminate air gaps between light pipe 45 and the eye of the mouse. Note that the distance between the distal end of platinum wire 70 A (which will act as the active electrode) and the distal end of platinum wire 70 B (which will act as the reference electrode) is substantially equal to the distance between a portion of the eye which exhibits an evoked physiological signal and a portion of the eye which exhibits a lesser evoked physiological signal (or, preferably, does not exhibit an evoked physiological signal), e.g., the distance between the cornea and the perimeter of the eye. The intermediate portions of platinum wires 70 A, 70 B may be held to the body of light pipe 45 with shrink bands 75 . The proximal end 55 of light pipe 45 is disposed in cavity 25 of main body 20 , and the proximal ends of platinum wires 70 A, 70 B are passed through cavity 35 of side arm 30 so that they can be brought out the proximal end 80 of side arm 30 for connection to appropriate amplification (e.g., by a differential amplifier) and processing electronics (not shown) for ERG signal processing. [0046] Light source subassembly 20 is disposed within cavity 25 of main body 20 . Light source subassembly 20 generally comprises LEDs 85 for generating light, and any appropriate optics (not shown) required to transmit the light generated by LEDs 85 into the proximal end 55 of light pipe 45 , whereupon the light will travel down the length of light pipe 45 to the distal end 50 of light pipe 45 . A power line 90 provides power to LEDs 85 . Preferably a wire mesh 95 (or similar element) is provided distal to LEDs 85 and proximal to platinum wires 70 A, 70 B so as to provide electromagnetic interference (EMI) shielding between LEDs 85 and platinum wires 70 A, 70 B. [0047] It will be appreciated that, on account of the foregoing construction, combined stimulator and bipolar electrode assembly 5 can be supported via its magnetic mount 40 for use with an ERG mouse platform, with the proximal ends of platinum wires 70 A, 70 B being connected to appropriate amplification and processing electronics for ERG signal processing, and with power line 90 being connected to an appropriate source of power. When a mouse is to be tested, the mouse is placed on the ERG mouse platform, a ground electrode (not shown) is attached to the mouse, and then housing 10 can be moved so as to bring the distal end 50 of light pipe 45 into contact with the eye of the mouse. This action will position the distal end of platinum wire 70 A (i.e., the active electrode) at the appropriate position on the eye of the mouse, and will simultaneously position the distal end of platinum wire 70 B (i.e., the reference electrode) at another appropriate position on the eye of the mouse. When LEDs 85 are thereafter energized, the light from LEDs 85 passes down light pipe 45 and into the eye of the mouse, whereby to stimulate the eye of the mouse. Platinum wires 70 A (i.e., the active electrode) and 70 B (i.e., the reference electrode) pick up the electrophysiological response of the eye of the mouse as electrical signals, and these electrical signals are passed along platinum wires 70 A, 70 B to appropriate amplification and processing electronics for ERG signal processing. [0048] Thus it will be seen that with the combined stimulator and bipolar electrode assembly 5 of the present invention, the assembly simultaneously provides (i) the stimulator needed for conducting ophthalmic electrophysiology on a mouse (i.e., LEDs 85 and light pipe 45 ), (ii) the bipolar electrode needed for conducting ophthalmic electrophysiology on a mouse (i.e., platinum wires 70 A, 70 B supported by light pipe 45 ), and (iii) the support structure (e.g., magnetic mount 40 ) for holding the bipolar electrode securely against the eye during testing. [0049] Significantly, mounting platinum wires 70 A, 70 B to the light pipe 45 provides a robust mechanical support for the platinum wires, making it possible to quickly, easily and precisely position the active electrode (i.e., platinum wire 70 A) and the reference electrode (i.e., platinum wire 70 B) on the eye of the mouse. At the same time, the small acceptance angle of light pipe 45 restricts the light reaching the eye of the mouse to that generated by LEDs 85 , which eliminates the normal need for a large Ganzfeld to conduct ophthalmic electrophysiology. Note that LEDs 85 may be a three-color RGB system, although UV could also be used and would be desirable in mice. In one preferred form of the invention, appropriate electronic drivers are provided to drive RGB LEDs 85 accurately enough to form precisely-defined metameric colors. If desired, and looking now at FIG. 12 , light pipe 45 may comprise a main body 45 A and an end diffuser 45 B. End diffuser 45 B can, advantageously, help provide full retinal illumination. More particularly, end diffuser 45 B acts to broaden the angle at which light exits main body 45 A of light pipe 45 and enters the eye of the mouse, and ensures that light exiting the light pipe is distributed equally to all parts of the retina of the mouse. The diffusing material of end diffuser 45 B is preferably of non-uniform thickness, i.e., it is made thinner at the edges to compensate for the lower flux density occurring at the perimeter of the light pipe. Furthermore, if desired, reference electrode 70 B may be “doubled over” so as to increase the surface area contact of reference electrode 70 B with the eye of the mouse. And, if desired, and looking now at FIG. 13 , a conductive foil (or conductive film) 100 may be provided at distal end 50 of light pipe 45 , with conductive foil (or conductive film) 100 electrically connected to reference electrode 70 B so as to increase the surface area contact of reference electrode 70 B with the eye of the mouse. [0050] In some cases, it can be helpful to provide the user with “red light” illumination to help the user set the combined stimulator and bipolar electrode assembly 5 against the eye of the mouse. To this end, if desired, and looking now at FIG. 14 , a light-transmissive sleeve 105 may be disposed coaxially about light pipe 45 , with light-transmissive sleeve 105 acting as an additional light pipe for delivering red light to the distal end of light pipe 45 . More particularly, in this form of the invention, when red light is introduced into the proximal end of light-transmissive sleeve 105 , a ring of red light will be provided at the distal end of light-transmissive sleeve 105 , whereby to provide a rim of red illuminating light about the distal perimeter of light pipe 45 . [0051] The combined stimulator and bipolar electrode assembly 5 of the present invention can be set up not only more accurately, but also much more quickly, than the present state-of-the-art, even by relatively unskilled personnel. After positioning the mouse on the heated table described above and inserting the ground electrode (e.g., in the haunch or tail of the animal), the combined stimulator and bipolar electrode assembly 5 is simply brought into contact with the eye of the mouse by moving housing 10 (which causes magnetic mount 40 , e.g., a steel ball, to roll within a magnetic cup, e.g., a magnetic ball holder (see FIG. 1 above, which shows a magnetic ball holder of the sort which may be used), and then the test is ready to run. A second device can be used simultaneously on the fellow eye (i.e., the other eye of the mouse) if desired. This eliminates several minutes fumbling in near darkness to carefully adjust the electrodes and position the Ganzfeld. Additionally, since light pipe subassembly 15 is held in position against the eye by an external mechanical mount (i.e., magnetic mount 40 ) and is not supported by the eye per se, it is not necessary to use particular care to position combined stimulator and bipolar electrode assembly 5 precisely against structurally robust eye tissue. Furthermore, since light pipe subassembly 15 has no accessible distal surface once it is seated against the eye, it is substantially impossible to obscure the light path from light pipe subassembly 15 into the eye by the use of excessive saline. [0052] Testing of the combined stimulator and bipolar electrode assembly 5 on mice has yielded excellent results. It produces expected waveforms with very little noise, although the overall amplitude of the waveforms is small. [0053] In addition to the foregoing, some investigators have used an active electrode in one eye, and a reference electrode in the other eye. This technique still involves accurate placement of two corneal wires (extremely challenging with prior art electrodes), but the fellow eye makes an excellent impedance-matched reference. However, with this approach, care must be taken to avoid light crosstalk between the eyes—the reference eye must not receive any stimulus light. [0054] Using the combined stimulator and bipolar electrode assembly 5 of the present invention solves both problems (i.e., accurate placement of electrode and avoiding light crosstalk between the eyes). More particularly, in one form of the invention, the corneal electrode 70 A of, for example, the right eye is plugged into the active side of the differential amplifier, and the corneal electrode 70 A of the left eye into the reference side of the differential amplifier. The electrodes in each eye are automatically correctly positioned. The eyes are then stimulated one at a time using the light source subassemblies 20 of the combined stimulator and bipolar electrode assemblies 5 , and there is no optical crosstalk because of the light pipe configuration (i.e., the positioning of a light pipe on an eye of the mouse limits the light reaching that eye of the mouse to only the light transmitted by that light pipe). When the right eye is being driven, the signal is normally polarized, and when the left eye is being driven, the signal is inverted. Alternatively, both eyes of the mouse could be simultaneously stimulated using light source subassemblies 20 of the combined stimulator and bipolar electrode assemblies 5 , and the differential between the two corneal electrodes 70 A may be measured so as to identify differences in eye function. [0055] Alternatively, the reference electrodes 70 B may be used in place of the corneal electrodes 70 A. In this form of the invention, the reference electrode 70 B of, for example, the right eye is plugged into the active side of the differential amplifier, and the reference electrode 70 B of the left eye is plugged into the reference side of the differential amplifier. The electrodes in each eye are automatically correctly positioned. The eyes are then stimulated one at a time using the light source subassemblies 20 of the combined stimulator and bipolar electrode assemblies 5 , and there is no optical crosstalk because of the light pipe configuration (i.e., the positioning of a light pipe on an eye of the mouse limits the light reaching that eye of the mouse to only the light transmitted by that light pipe). When the right eye is being driven, the signal is correctly polarized, and when the left eye is being driven, the signal is inverted. Alternatively, both eyes of the mouse may be simultaneously stimulated using light source subassemblies 20 of the combined stimulator and bipolar electrode assemblies 5 , and the differential between the two reference electrodes 70 B may be measured so as to identify differences in eye function. [0056] In one preferred form of the invention, and looking now at FIGS. 15-17 , platinum wire 70 A can be omitted and platinum wire 70 B can be provided with a conductive foil (or conductive film) 100 . When configured in this manner, the present invention essentially comprises a combined stimulator and monopolar electrode assembly. This form of the invention can be advantageous where combined stimulator and monopolar electrode assemblies are positioned against both eyes of the mouse (for stimulating one eye at a time or for simultaneously stimulating both eyes at the same time). [0057] The robustness of the electrical and optical connections that the new combined stimulator and bipolar electrode assembly 5 makes with the mouse has been dramatically demonstrated during testing. Toward the end of testing, the mice may wake up and begin to move. With conventional setups, the first movement of the awakening mouse breaks corneal contact and the testing is over. With the combined stimulator and bipolar electrode assembly 5 of the present invention, contact with the awakening mouse was successfully maintained even though the mouse was moving and testing continued with good results until the mouse literally walked away. [0058] In the foregoing disclosure, platinum wire 70 A (i.e., the active electrode) is disposed within slot 65 A which extends along an outer surface of light pipe 45 , and platinum wire 70 B (i.e., the reference electrode) is disposed within slot 65 B which extends along an outer surface of light pipe 45 . However, if desired, slot 65 A could be replaced with a bore extending longitudinally through light pipe 45 and platinum wire 70 A (i.e., the active electrode) may be disposed within this longitudinal bore, and/or slot 65 B could be replaced with another bore extending longitudinally through light pipe 45 and platinum wire 70 B (i.e., the reference electrode) may be disposed within this other longitudinal bore. In such a construction, the longitudinal bore receiving platinum wire 70 A (i.e., the active electrode) is disposed closer to the longitudinal axis of light pipe 45 than the longitudinal bore receiving platinum wire 70 B (i.e., the reference electrode). Modifications Of The Preferred Embodiments [0059] It should be understood that many additional changes in the details, materials, steps and arrangements of parts, which have been herein described and illustrated in order to explain the nature of the present invention, may be made by those skilled in the art while still remaining within the principles and scope of the invention.

Apparatus for evoking and sensing ophthalmic physiological signals in an eye, the apparatus comprising: an elongated tubular light pipe having a longitudinal axis, a distal end and a proximal end, the distal end terminating in a spheroid recess; an active electrode having a distal end and a proximal end, the active electrode being mounted to the elongated tubular light pipe and extending proximally along the elongated tubular light pipe so that the distal end of the active electrode terminates at the spheroid recess at the distal end of the elongated tubular light pipe; and a reference electrode having a distal end and a proximal end, the reference electrode being mounted to the elongated tubular light pipe and extending proximally along the elongated tubular light pipe so that the distal end of the reference electrode terminates at the spheroid recess at the distal end of the elongated tubular light pipe; wherein the distal end of the active electrode is located closer to the longitudinal axis of the elongated tubular light pipe than the distal end of the reference electrode.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an ophthalmic apparatus for photographing the anterior part of an examinee&#39;s eye, particularly to an ophthalmic photographing apparatus comprising a device capable of photographing sectional images of the anterior part of the eye with a reproducible photographing position. 2. Description of Related Art Conventionally, there are some kinds of ophthalmic photographing apparatuses which project a slit light to the examinee&#39;s eye, and photograph a sectional image of the anterior part of the eye on the basis of Scheimpflug&#39;s principle. Picture images of the eye obtained through the conventional apparatuses are analyzed to provide useful data including inclination and decentration of the IOL (Intra Ocular Lens). For analysis to find the inclination and decentration of the IOL and for another analysis, for instance Densitometry and Biometry, it is useful to reproduce the photographing position in order to detect the progressing variation in the data. To align a conventional photographing optical system to an examinee&#39;s eye, a reticle of the photographing optical system is adjusted to Purkinje images focused on the cornea of the examinee&#39;s eye, particularly the first Purkinje image on the anterior surface of the cornea, by the hand of an operator with experience. However, in the above conventional alignment operation, depending on the experience of the operator, the quality of photographed picture images will differ from operator to operator. Even same operator can not execute closely the alignment between the photographing optical system and the examinee&#39;s eye every time. Thus, photographed picture images would be in disagreement. And even if a photographing apparatus of a same type is used, photographed picture images would be in disagreement according to the respective adjustment condition of the apparatus. In order to solve the above disagreement between picture images, the adjustment of the photographing apparatus and the alignment operation would take a long time and, if a special alignment device is added to the conventional photographing apparatus, the price will increase greatly. In film photography, in particular, disagreement of picture image could be found out only after development of the photographed film. Thereby it is necessary to photograph the examinee&#39;s eye again for the analysis of image of the eye. SUMMARY OF THE INVENTION The present invention has been made in view of the above circumstances and has an object to overcome the above problems and to provide an ophthalmic photographing apparatus capable of reproducing picture images with a consistent photographing position. To achieve the objects and in accordance with the purpose of the invention, as embodied and broadly described herein, the ophthalmic photographing apparatus of this invention comprises an alignment optical system including a reflection image forming means for forming an image reflected on the cornea of the examinee&#39;s eye and an observation optical system for observing image of the anterior part of the examinee&#39;s eye, comprising an alignment reticle; a photographing optical system for photographing the anterior part of the examinee&#39;s eye; a picture image memory means for memorizing the picture image of the anterior part of the eye photographed with the photographing optical system; an alignment deviation detecting means for detecting alignment deviation by processing the memorized picture image signal to detect a designated part and by finding a dislocation distance of the designated part from a reference position; a correction means for correcting an analyzing position, at which the memorized picture image of the anterior eye is analyzed, on the basis of the alignment deviation detected through the detecting means; and an analysis means for analyzing the picture image of the anterior eye. According to the ophthalmic photographing apparatus of this invention, it is possible to obtain easily picture images of the anterior eye with high reproductivity of the photographing position. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of this specification illustrate an embodiment of the invention and, together with the description, serve to explain the objects, advantages and principles of the invention. In the drawings, FIG. 1 is a schematic view of the ophthalmic photographing apparatus of the present embodiment. FIG. 2 is a schematic view of showing an monitor image photographed through CCD camera 21. FIG. 3 is a block diagram of the image signal level control system. FIG. 4(a) and FIG. 4(b) are flow charts for calculating dislocation distance in X-Y direction. FIG. 5 is a schematic view of explaining the calculation for dislocation distance in X-Y direction. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A detailed description of one preferred embodiment of an ophthalmic photographing apparatus embodying the present invention will now be given referring to the accompanying drawings. FIG. 1 shows schematically an optical system of a photographing apparatus for photographing sectionally the anterior eye on the basis of the Scheimpflug&#39;s principle. The optical system comprises a slit projection optical system, a photographing optical system, an alignment/fixation index projection system, the alignment observing system, and alignment reticule projection system. First, the slit projection optical system comprises an illumination light source 1 for projecting a slit image onto an anterior eye 12 of the examinee&#39;s eye 11, an infrared irradiation transmitting filter 2, condenser lenses 3 and 4, a photographing flash light source 5, a slit 6 of which a slit width is variable as well as a conventional slit lamp, a polarizing filter 7 for preventing the slit light from being incident into an alignment CCD camera 21 mentioned later, a slit projection lens 8, a rectangular aperture diaphragm 9 for deepening the depth of focus of the slit projected image, and a polarized beam splitter 10. The light emitted from the flash light source 5 in the slit projection optical system is introduced into a brightness level detector 26 through a filter 25 for reducing quantity of light. On receiving the reduced light, the brightness level detector 26 monitors the quantity of light. A signal of quantity of light from the detector 26 is calculated in comparison with reference data of light quantity stored in advance, and corrected picture element (pixel) data is found out. In the photographing optical system, a focusing lens 13 and a CCD camera 14 are arranged so that an optical sectional plane of the projection image of the slit 6, each extended plane of a principal plane of the focusing lens 13 and a focused plane of the CCD camera 14 intersect each other by one intersection line. In this embodiment, the photographing optical axis is arranged at an angle of 45° to the slit projection optical axis. The alignment and fixation index projection optical system includes an alignment light source 15 consisted of a visible ray source such as an LED, a fixation and alignment index 16 of a pin hole form, an index projection lens 17, and a half mirror 18. The alignment observing optical system comprises a focusing lens 19, a half mirror 20 and an alignment CCD camera 21. The alignment reticule projection optical system consists of a light source for reticule projection 22 using an infrared light, an alignment reticule 23 of a ring form, and a reticule projection lens 24. In the above mentioned apparatus, the slit projection optical system of numerals 1-10, the photographing optical system of 13 and 14 and the alignment/fixation index projection system of 15-18 are able to revolve around a visual axis of the examinee&#39;s eye 11. Therefore the anterior eye can be sectionally photographed at two or more positions. In FIG. 2, a monitor image photographed by the CCD camera 21 is shown, wherein numeral 16a is a reflected image of the fixation/alignment index on the front surface of cornea, and numeral 23a is the alignment reticule image. FIG. 3 shows a block diagram of an image signal level control system for correcting changes of the quantity of light emitted from the photographing light source. Synchronizing with an emission of the flashing light source 5, an image signal of the anterior eye is detected by the CCD camera 14 through the photographing lens 13. And then, the image signal is converted into digital signal through an operational amplifier circuit 30 and an analog/digital(A/D) converter circuit 31, and is given to an frame memory 32. At the same time, the light monitor signal of the brightness level detector 26 is fetched out, and then is amplified at an amplifier 33, converted into digital signal through A/D converter circuit 34, and input into a microcomputer 35. The microcomputer 35 reads out the digital signal of the image signal from the frame memory 32, corrects and calculates it on the basis of reference data of the quantity of light memorized in a fixed memory 36 and a digital signal of the light monitor signal of the detector 26. The microcomputer 35 calculates also dislocation distance of the picture image signal in X-Y direction as described below. After the luminance and the dislocation distance of the image signal are corrected as mentioned above, the signal is converted into analog signal at a D/A converter 37 through the frame memory 32. And the analog signal is superposed with a graphic index showing letter or axis at a superimpose circuit 38, displayed on a CRT display 40 through the operational amplifier circuit 39. According to the above apparatus, the operation is explained as follows. Since an image of the fixation/alignment index 16 is first projected onto the examinee&#39;s eye 11, the examinee should fixedly stare at the image. The image of the index 16 reflected on the front surface of cornea of the eye 11 is monitored in the alignment CCD camera 21 through an focusing lens 19. To align the apparatus with the examinee&#39;s eye, the apparatus is moved in a horizontal or vertical direction so as to put the point image 16a of the index 16 into a small circle of an alignment reticule image 23a on the monitored image in the CCD camera 21. And to set the alignment in the optical axis direction, the apparatus is moved forward or backward along the optical axis until the point image 16a comes into focus. To bring the photographing system in focus, based on the CRT display 40 of photographing CCD camera 14, the focusing lens 13 is moved in the extending direction of its principal plane, or the CCD camera 14 is moved in the extending direction of the focus point. Usually, the depth of focus is deep because the F-number of the focusing lens 13 is large, so that the focusing operation is almost unnecessary if the alignment is finally fixed. Synchronizing with the emission of the flash light source 5, the image signal detected through the CCD camera 14 is input to the frame memory 32 through the operational amplifier 30 and the A/D converter circuit 31. The image signal read out from the frame memory 32 is corrected and calculated in the image signal level control system (microcomputer 35), based on the light monitor signal fetched out the detector 26, and then the corrected and calculated signal is displayed on the CRT display 40 through the frame memory 32. The microcomputer 35 calculates the dislocation distance of the picture image signal in X-Y direction in accordance with the following operation, referring to FIGS. 4(a) and 4(b). Each picture element signal of the picture image includes a position information in X-Y direction and density of 256 grades (0-255). In a slit sectional image, a high light scattering part, for example a cornea or a crystalline lens, is whitish (=high density), and a scarcely light scattering part, for example a front part to the cornea or an anterior chamber, is blackish (=low density). At first, an apex of cornea is detected on the basis of a center of picture image in X direction and each picture element signal at positions apart right and left from the center by a predetermined distance (called a detecting width, predetermined within ±1.5 mm in the present embodiment). A surface part within 3 mm in area where the apex of cornea centers is nearly homogeneous toric face, and the surface part can be regarded as a spherical surface. Thereby it is preferable that a detected point is in the area. The microcomputer 35 reads out each picture element signal on a parallel axis to the Y-axis, passing through each point from the frame memory 32, and investigates successively the picture element from a light source side to a fundus of eye side by utilizing a common picture image analytical technique (for instance, binary method, smoozing method or the like) and finds a pulse rising point at which a density is higher than a predetermined reference value respectively. When each picture element signal is successively investigated along the Y-axis direction from the light source side to the fundus side of the eye, as shown in FIG. 5, a first part showing a high density indicates the cornea. The pulse rising point in density variation means a front position of the cornea. After extraordinary data caused by noise and the like is cancelled, respective coordinates at three points on a front surface of cornea at three points are substituted into an equation of a circle to find a center of curvature &#34;O&#34; (a, b) of the front surface of cornea. In the present embodiment, the data at only three points are utilized as mentioned above, but if a plurality of data are calculated through the minimum multiplication method, a more precise value may be obtained. It is possible to assume the cornea is an approximation of a spherical surface in the neighborhood of the apex of cornea. Thereby, the sectional plane can be considered as circle and each coordinate at three points is substituted into an usual formula, (x-a) 2 +(y-b) 2 =c 2 , to find a center of curvature &#34;O&#34; (a, b). If the found center of curvature &#34;O&#34; is positioned at an abnormal position to the cornea or the crystalline lens, and a radius of curvature is not found within a reference value, the found value is judged to be error. If the found value is error, the center of curvature is detected again at different detecting conditions including a detecting center point and a detecting width. If a proper position of the apex of cornea can not be detected in a memorized condition in advance, an error index is displayed, and then a manual operation follows. In the manual operation, the operator (photographer) moves a cursor through an operation panel (not shown) to designate three points on a front surface of cornea. Scanning the neighborhood of each designated point to Y-axis direction, the front surface position of cornea is detected on the basis of signals obtained through the scanning, following which the center of curvature &#34;O&#34; is found. On the basis of the x coordinate of the center of curvature found at the first operation, a similar detecting operation is repeated to find a center of curvature &#34;O&#39;&#34;, putting a center of curvature &#34;O&#34; of the front surface of cornea as a center axis. It is possible to improve the precision of detecting the center of curvature &#34;O&#39;&#34; accordingly. The microcomputer 35 taking a parallel line to Y-axis through passing the center of curvature &#34;O&#39;&#34; for a center axis Y 1 of the sectional image of the anterior eye, reads out a picture element signal on the center axis Y 1 and calculates it to find a coordinate (a, c) of the apex of cornea &#34;U&#34; at which the center axis Y 1 intersects with the front surface of cornea, referring to FIG. 5. An operation between the coordinate of &#34;U&#34; and a coordinate of a predetermined position is carried out to find a dislocation distance in X-Y direction. In the present embodiment, the predetermined position means an apical position of cornea in the ideal alignment condition in which the apex of cornea is on an optical axis of a slit image projecting system and in focus. The dislocation distance of the picture image found as mentioned above is stored in a memory. When the operator selects a sort of picture image analysis, an analysis axis is displayed on the monitor. In the ideal alignment condition, the analytic axis is displayed at a position correspondent to position with a center axis of photographing image, but in a condition out in alignment, the analytic axis is shifted to and displayed at a position passing through the apex of cornea on the basis of the dislocation distance. When the sectional image of the anterior eye is off to the round direction, the detecting operation as expected can not be executed. Then, three points on a front face of cornea and three points on a front face of a crystalline lens are designated respectively, thereby each center of curvature is found, following which a line passing through the both center of curvature is displayed as an analysis axis. In such operation, it is possible to substitute a center of the pupil for the center of curvature of the front surface of crystalline lens, the center of the pupil which is found on the basis of each position of both ends of the iris. When the analysis axis is displayed at a proper position to the sectional image of the anterior eye, microcomputer 35 reads out the picture element signal on the analysis axis to analyze it, and then displays the analyzed result on the monitor. Although the analysis axis is shifted in the present embodiment, it is possible to fix the analysis axis and shift the displayed image itself by the dislocated distance. The corrected picture image signal can be stored by usual means, for instance in a disk, thereby a progressing change in the sectional image of the examinee&#39;s eye can be found out precisely by comparison with the stored former image. The present invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. For instance, in the above embodiment, the present invention is applied to the photographing apparatus for photographing sectional image of the anterior part of the examinee&#39;s eye, it may be of course applied to an ophthalmic photographing apparatus using ultrasound or laser-scanning. The dislocation distance is detected by specifying a front surface form of cornea in the above embodiment, it may be detected also by detecting a position of reflection luminescent spot of cornea when photographed. The foregoing description of the preferred embodiment of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, and modifications and variations are possible in light of the above teachings or may be acquired from practice of the invention. The embodiment has been chosen and described in order to explain the principles of the invention and its practical application to enable one skilled in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims appended hereto, and their equivalents.

Ophthalmic photographing apparatus for photographing an anterior part of examinee's eye provides an alignment optical system including a reflection image forming device for forming an image reflected on the cornea of the examinee's eye, an observation optical system for observing image of the anterior part of the examinee's eye, comprising an alignment reticle, and a photographing optical system for photographing the anterior part of the examinee's eye. The picture image data of the anterior part of the eye photographed with the photographing optical system is memorized by a picture image data memory, and an alignment deviation is detected by operating the memorized picture image signal to detect a designated part and by finding a dislocation distance of the designated part from a reference position, and an analyzing position of the image is corrected on the basis of the alignment deviation and the picture image of the anterior eye is analyzed.

This application claims priority to application Ser. No. 10/146,588 filed May 15, 2002, now U.S. Pat. No. 6,932,796 as a continuation application thereof, the contents of which are incorporated by reference herein in its entirety. This application claims subject matter disclosed in application Ser. No. 09/867,003 filed May 29, 2001, now U.S. Pat. No. 6,582,393, the contents of which are incorporated by reference herein in its entirety. BACKGROUND OF THE INVENTION A. Field of the Invention This invention relates to the measurement of properties of liquids moving in a conduit and specifically the measurement of the flow rate of a liquid moving at a relatively low flow rate of less than one liter per minute in a conduit. Most specifically, it relates to the measurement of the rate of infusion of therapeutic agents to patients to achieve highly accurate dosing of these patients according to a prescribed administration regimen. B. Related Art Many methods of measuring the flow rate of liquids, and in particular the rate of infusion of a pharmaceutical to a patient are known. Best known are positive displacement systems wherein a known volume of fluid is moved over time independent of other system parameters such as pressure and liquid viscosity. Today, the most commonly used positive displacement pump for accurate infusion of a pharmaceutical to a patient is the syringe pump. A motor moves a plunger down the barrel of a syringe with tightly controlled manufacturing tolerances on inside diameter. The rate of advance of the plunger times the time of advance times the cross-sectional area of the syringe determines the volume of fluid infused. This positive displacement method is used, for example, in the MiniMed Model 508 insulin pump, the current market share leader in insulin pumps. The suggested retail price for the MiniMed 508 pump is $5,995.00. A second example of a positive displacement system is the peristaltic pump, where rollers placed against a flexible conduit roll along the conduit to move the fluid down the conduit. In peristaltic pumps, enough force is applied to the liquid in the flexible conduit to eliminate any dependence on pressure and viscosity. However, the volume of liquid dispensed remains dependent on the volume of fluid in the tubing, which depends on the square of the inside diameter of the elastomeric tubing. Since the manufacturing tolerance on the inside diameter of economic elastomeric tubing is on the order of +/−10%, the delivery accuracy is limited to +/−20%. Peristaltic pumps are also expensive, but somewhat less expensive that syringe pumps. Today, peristaltic pumps are seldom used for accurate delivery of pharmaceuticals. Given the expense of these positive displacement pumps, and the need to find less expensive systems for accurate delivery of pharmaceuticals, many other devices and methods have been proposed to maintain the required level of accuracy while reducing the cost. It is clear that many of these proposed systems achieve the goal of reduced expense. However, the problem that these proposed schemes face is that they do not achieve the required accuracy of delivery of the pharmaceutical. For example, in a liquid dispensing system with a pressurized liquid container where the pressure on the liquid forces it along the conduit, the parameters dictating the flow include the pressure that is causing the liquid to flow, the inside diameter of the conduit along which the liquid is flowing, the length of the conduit, and the viscosity of the liquid, which is in turn dependent on the temperature of the liquid. This problem is further compounded by the fact that the dependence on the inside diameter of the conduit is a fourth power dependence. In many delivery systems of this type, the pressure on the liquid decreases as the amount of liquid in the container decreases, leading to a reduction in the flow rate. The solution to this pressure decrease is known. O&#39;Boyle in U.S. Pat. No. 4,874,386, teaches a liquid dispensing device that accurately controls the pressure in this type of dispensing system by incorporating a constant pressure spring. But the dimensions of the flow conduit, its cross section, and the temperature for viscosity control are left uncontrolled, with the result of inaccurate dispensing of the fluid. In order to overcome the situation of having to manufacture dispensing system components to higher tolerances than is economically feasible, many methods of measuring the liquid flow rate have been taught. If the actual flow rate is measurable, the flow rate may be adjusted to the desired flow rate. Or, if an accurate total volume rather than flow rate is required, the required time of flow may be calculated using the actual flow rate to achieve the desired volume. In general, the different types of liquid flow measuring systems can be divided into two classes—those that require contact with the liquid to measure the flow, and those that measure the flow without requiring contact with the liquid. Flow measuring systems in the first class include a) turbines, where the angular speed of the propeller in the stream is a measure of flow rate, b) pressure drop systems, where the pressure difference across a flow resistor is used to calculate the flow rate, and c) certain forms of “thermal time of flight” systems where elements that add heat to the stream and measure heat in the stream are used to measure flow rate. Examples of these “thermal time of flight” systems are taught by Miller, Jr. in U.S. Pat. No. 4,532,811 and by Jerman in U.S. Pat. No. 5,533,412. However, in many liquid delivery systems, the conduit along which the liquid flows requires frequent replacement and, in the case of pharmaceutical infusion systems, the total flow path must also be kept sterile. In this first class of types of flow meters, the added complexity of adding components, and their necessary leads and connectors to the replaceable conduits, causes the replacement conduits to be expensive. And if these additional components are added to a reusable portion of the dispensing system, the replacement of the liquid container, or addition of fresh liquid to an existing container opens the flow path to an unsterile environment. For these reasons, attention has been paid to the invention of the second class of flow meters—those that do not require contact with the liquid in the conduit and add complexity to the conduit. Kerlin, Jr, in U.S. Pat. No. 4,777,368, teaches a method and apparatus for non-contact measurement of the velocity of a moving mass. In a preferred embodiment, an infrared heat source raises the temperature of an element of the moving mass and an infrared detector, viewing this element of the moving mass at a later time, detects the heated element and records the time required for the moving mass to move from heater to detector. Given the physical separation of the heater and the detector, the speed of the moving mass may be calculated. Kerlin makes reference to the use of this concept for liquids as well as solids. Goldberg, in U.S. Pat. No. 4,938,079 teaches the same basic concept as Kerlin, Jr. with the modification that microwave energy is used to heat the liquid within a conduit and a microwave detector is used to sense the heated liquid downstream from the heater. Frank et al in U.S. Pat. No. 5,211,626 also teaches a thermal time of flight flow metering method, and while at least one infrared detector is used to detect the heated liquid, the liquid is heated by thermal contact with the liquid through the wall of the conduit. Taught by Goldberg and Frank is the need for accurate delivery of the liquid (although Frank admits that his teachings apply only to relatively non-accurate delivery of the liquid) the need for a closed flow path, and the need for an inexpensive replaceable conduit. However, each of these patents fails to recognize that the measured time of flight and the calculated stream velocity are insufficient to completely correct for variations in system components. Flow rate, as measured in volume per unit time, requires not only a measurement of the time, but also the volume of liquid dispensed in that time. Or, if the measurement of velocity is made, as described in all three of these teachings, then to obtain the flow rate, the cross-sectional area of the conduit must be known. These above three teachings teach the measurement of time only. The volume component is critically dependent on the inside diameter of the conduit. If time is the measured parameter, then flow rate depends on the cross-sectional area of the column of liquid and the length of the column of liquid. The cross-sectional area depends on the square of the inside diameter of the conduit. As described above, typical tolerances on the inside diameter of a conduit, especially for conduits of relatively small inside diameter, are +/−10%. Hence the variation in volumetric flow rate, even given a perfectly accurate measurement of the time of flight, is +/−20%. And if the liquid velocity is calculated from the time of flight, the flow rate depends on the cross-sectional area, which, as described above, leads to a flow rate uncertainty of +/−20%. And in situations where the conduit is to be replaced frequently, unless the inside diameter of the conduit is measured by the device or measured in the factory and communicated to the device, both expensive steps, the uncertainty due to the unknown inside diameter remains. A device and method that achieves accurate measurement of flow rate, and hence accurate liquid delivery by compensating for both variations in the inside diameter of the conduit and the velocity of the liquid flowing in the conduit is disclosed in pending U.S. application Ser. No. 09/867,003 filed May 29, 2001. This application is incorporated herein by reference. In the teachings of U.S. Pat. Nos. 4,777,368, 4,938,079, and 5,211,626 there are additional practical considerations that make these teachings difficult to reduce to practice in cost-effective commercial products. The first of these practical aspects is the heating of the portion of the liquid to be sensed. Due to the high heat capacity and the rapid thermal diffusivity of virtually all liquids of commercial importance, and especially water, which is the base of all pharmaceutical infusion fluids, heating the liquid fast enough and to a high enough temperature to realize an operation flow meter is very difficult. Kerlin, Jr. in U.S. Pat. No. 4,777,368 implicitly recognizes this by advocating a high power CO2 laser. Neither Frank in U.S. Pat. No. 5,211,626 nor Goldberg, in U.S. Pat. No. 4,938,368 recognize this problem. And the problem is especially acute for Frank since his teachings require the heat to pass through the wall of the conduit by conduction, which is especially time-consuming and lossy. A solution to this problem, which is not alluded to in any of these three teachings, is to stop the flow of the liquid and to heat the liquid while it is stationary. The flow rate is measured by restarting flow once the liquid is heated. The two advantages of stopping the flow to heat the liquid is that the total mass of liquid that must be heated is greatly reduced and the heat pulse is relatively confined in position along the conduit. This solution is taught in pending U.S. application Ser. No. 09/867,003. The second practical aspect which makes the prior art teaching, including the teaching in pending U.S. application Ser. No. 09/867,003, difficult to commercialize is the mode of detecting the heat pulse. Many pharmaceutical solutions, especially protein solutions such as insulin, degrade at temperatures above room temperature, and begin to denature at temperatures above 40 deg centigrade. A preferred temperature rise would be less than 5 centigrade degrees above ambient. For these systems to operate successfully the heated portion of liquid must be accurately detected and its location along the conduit accurately measured. Detection methods relying on detecting the infrared radiation from such a small change in temperature, such as proposed by Frank in U.S. Pat. No. 5,211,626, Kerlin, Jr. in U.S. Pat. No. 4,938,079, and Sage, Jr. in pending U.S. application Ser. No. 09/867,003, must operate in the far infrared where detectors are either too slow to respond to the heated liquid or must be cooled, making them large, energy consuming and expensive. Goldberg in U.S. Pat. No. 4,938,079 is sensitive to this issue, but offers no data to support a practical or operational device. Thus there continues to be a need for improved devices and methods for accurate and economical measurement of liquid flow in liquid dispensing systems, especially in the area of infusion of pharmaceutical solutions. This invention meets these needs. An object of the current invention is to provide an accurate, inexpensive, and practical system and method for measuring the volumetric flow of a liquid in a conduit. It is a further object of the current invention to use this system and method for measuring the volumetric flow of a liquid in a conduit to infuse pharmaceutical solutions. This flow rate may be used for either accurate delivery of the pharmaceutical solutions or, when zero flow rate is measured, to detect occlusions in a delivery system for pharmaceutical solutions. It is yet another object of the current invention to provide an accurate, inexpensive and practical system and method for detecting and measuring the temperature of a liquid in a conduit. SUMMARY OF THE INVENTION The present invention provides for a device and method for measuring the time of flight and/or the velocity of a liquid moving in a conduit. The apparatus includes an optically transmissive conduit through which the liquid flows. A light source illuminates a portion of the liquid through the optically transmissive conduit. A portion of the illumination proceeds by reflection at the liquid conduit interface to a detector in one embodiment. A portion of the illumination proceeds by transmission through the conduit and liquid to a detector in a second embodiment. In a second embodiment, the light source is a coherent light source, and a second reference pathway is provided to the detector. When a heated portion of the liquid, which has been heated upstream of the position of illumination of the liquid, flows through the illumination a property of the reflected or transmitted illumination changes due to the change of the index of refraction of the heated portion of the liquid. In the reflected illumination embodiment, the intensity of the reflected illumination changes. The detector detects this change. In the transmitted illumination embodiment, the phase of the transmitted illumination changes. The detector detects this change. The time required for the heated portion of the liquid to flow from the heating position to the detecting position is a measure of the time of flight of the liquid. When combined with the physical distance between the location of heating and the location of detection, this time of flight provides the velocity of the liquid. When combined with the cross sectional area of the conduit, provided the conduit is of uniform inside diameter, this liquid velocity provides the volumetric flow rate of the liquid. Other aspects and advantages of the invention will become apparent from the following detailed description and drawings of two embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a function block diagram of a liquid dispensing system with a flow meter designed according to the invention. FIG. 2 is an optical schematic of the portion of the liquid flow meter where the change in the index of refraction is detected by measuring the change in the intensity of light reflected from the inside surface of the conduit. FIG. 3 is a theoretical plot of the intensity of the light reflected from the inside surface of a glass conduit when water is flowing as a function of the angle of incidence of the light from a light source. FIG. 4 is an optical schematic of the portion of the liquid flow meter where the change in the index of refraction of the liquid is detected by measuring the difference in phase difference between coherent light transmitted through the conduit and a reference light path. DETAILED DESCRIPTION OF THE INVENTION The optical flow meter of this invention will be described in terms of a liquid dispensing system for use in infusion of pharmaceutical solutions. FIG. 1 shows a block diagram of such a system. The liquid to be dispensed is contained in pressurized reservoir 10 . When pinch tube member 14 is moved away from stop 12 , conduit 11 is opened and the liquid is free to flow down conduit 11 to the flow outlet. When pinch tube 14 presses conduit 11 against stop 12 , stopping flow, the liquid is not free to move down the conduit to the flow outlet. At a selected time, microprocessor 17 signals heating element 13 to heat the portion of the liquid at its location along the conduit. Once the portion of the liquid is heated, the pinch tube member is moved away from the conduit, and the liquid begins to flow. At some later time, the heated portion of the liquid passes heat sensor 16 where the heated portion is detected. The time required for the heated portion of the liquid to move from the location of the heater to the heat sensor is measured. Additionally, the velocity of the liquid may be calculated by dividing the distance between the heating element 13 and the heat sensor 16 by the measured elapsed time. A first preferred embodiment of heat sensor 16 is shown in FIG. 2 . Within heat sensor 16 is optical detector 30 . Conduit 11 of FIG. 1 is shown in section with conduit wall 33 and conduit lumen 32 . Conduit wall 33 is optically transparent, made of any material capable of achieving optically smooth surfaces but preferably made of glass. Also preferably, conduit wall 33 has at least one flat side. One trivial example of conduit 11 is square or rectangular in cross section, as shown in FIG. 4 . Prism 31 is in optical contact with conduit wall 33 . Prism 31 is preferably mounted on conduit wall 33 by optical cement but may be mounted on conduit wall 33 with an optical index matching medium or conduit 11 and prism 31 may be an integral structure. Optical prism 31 is also made of any optically transparent material capable of achieving optically smooth surfaces such as glass or polycarbonate. Preferable, the index of refraction of conduit 11 and prism 31 are matched at the wavelength of light from light source 36 . Light from light source 36 follows path 35 and is preferably normally incident on the left surface of prism 31 . Light from light source 36 continues through the interface between prism 31 and the outside surface of conduit 11 , through conduit wall 33 to the interface between the inside wall of conduit 11 and the liquid in lumen 32 at point 39 . At this interface at point 39 , light is both reflected (beam 37 ) and refracted (beam 34 ). The reflected light beam 37 proceeds out of prism 31 , preferably normal to the right surface of prism 31 and proceeds to light detector 38 . The fraction of the intensity of light 35 that is reflected at point 39 to form light beam 37 may be calculated using the standard Fresnel equations. A graph of this calculation for all angles of incidence from normal incidence (where beam 35 would be normal to conduit outside surface 33 ) to the critical angle (where total internal reflection occurs) is shown in FIG. 3 . The materials used for this calculation are BK-7 glass for prism 31 and conduit 11 and water for liquid 32 . Shown in this figure is the reflected energy for P polarization. The preferred embodiment utilizes P polarization for beam 35 because of the larger reflected signal. The light detector will typically be monitoring changes in reflectance, not absolute reflectance. As a consequence, it is more germane to calculate the change in the reflected light (beam 37 ) as a function of angle for a given change in temperature of the fluid. Solid curve 21 in FIG. 3 shows the percentage change in the reflected light (beam 37 ) as a function of reflected angle for a change in fluid temperature of 10 centigrade degrees. As can be seen from the solid curve 21 in FIG. 3 , there is a range of angles of incidence from about 45 degrees to nearly 60 degrees where the percent change in the reflected signal is relatively large (about one percent of the reflected intensity) and relatively independent of the angle of incidence. The intensity of the refracted light in light beam 34 is the difference between the incident intensity and the reflected intensity. This light is directed down the flow tube, away from light sensor 38 . When light source 36 of FIG. 2 emits steady illumination, and the temperature of liquid 32 remains constant, the intensity of light beam 37 is constant, and detector 38 detects no change in the intensity of light beam 37 . However, when the portion of liquid in lumen 32 that has been heated by heat source 13 in FIG. 1 passes point 39 , the intensity of light beam 37 will change as a consequence of the dependence of the index of refraction of fluid 32 on temperature. For example, in the preferred embodiment, heated water has a lower index of refraction than cooler water, thus more light will reflect when water of a higher temperature is present at location 39 . In one specific embodiment, the incident/reflected angle is 60 degrees, the water temperature is 20 centigrade degrees prior to heating and 25 centigrade degrees after heating. In this specific embodiment, 10% of the incident light is reflected for water prior to heating as shown by the dashed curve in FIG. 3 . Once heated water is present at location 39 , the signal will increase by 1%. Thus, one milliwatt illumination will present a constant signal of 100 microwatts to detector 38 via beam 37 . When heated water (25 centigrade degrees) is present at location 39 , the signal will increase to 101 microwatts. Given today&#39;s laser and detector components, generating and detecting these signals are routine. Note that with the appropriate conduit 11 , it is possible to detect the presence of the heat pulse in liquid in lumen 32 by detecting a change in intensity in refracted light beam 34 . While this is a much larger base signal (approximately 90% of the intensity incident at point 39 is in light beam 34 ), the magnitude of the change in the intensity of light beam 34 due to the passing heat pulse in liquid 32 is equal to that received by detector 38 shown in FIG. 2 . The output from detector 38 in FIG. 2 is an electronic signal that changes with the temperature of the heat pulse in liquid 32 . This electronic signal may be subjected to either analog or digital processing to measure the time of flight from the location of heat source 13 . By analog processing, the signal may be differentiated, and the axis crossing of the differentiated signal would be a measure of the location in time of the peak of the heat pulse in liquid 32 . The time of this axis crossing could be used to identify the time when the peak of the heat pulse passed location 39 in FIG. 2 . This and alternate methods of processing an analog electronic signal to locate the heat pulse in time are known to those skilled in the art of analog signal processing. Alternately, the electronic signal from detector 38 could be processed digitally to locate the heat pulse in time. The center of gravity of this electronic signal could be calculated, and the location in time of this center of gravity could be used to measure the time required for the heat pulse to move from the heat source 13 to location 39 in FIG. 2 . A second preferred embodiment for heat sensor 16 in FIG. 1 is an interferometric measurement of the index change induced by temperature in liquid 32 . A specific embodiment of this concept with a Michelson interferometer is shown schematically in FIG. 4 . However, with the appropriate illumination, detection, and construction, other interferometer configurations are applicable. Shown in FIG. 4 is a specific embodiment of conduit 11 : a rectangular conduit 50 containing liquid in lumen 32 . Conduit 50 is optically transparent and manufactured from any material capable of achieving optically smooth surfaces on both the inside and outside surfaces of the top and bottom of conduit 50 . Optical glass is preferred, but certain optical polymers such as polycarbonate would also be acceptable. Also shown in FIG. 4 is coherent light source 100 . Light source 100 is preferably a laser, but any light source with the appropriate coherence length would be appropriate. Elements 102 and 104 are beamsplitting elements, preferably 50% transmissive and 50% reflective. Elements 101 and 103 are reflective mirrors. Element 175 is a detector suitable for detecting the emission of light source 100 . In one embodiment, element 150 is an optical path delay element (e.g. glass, polycarbonate, fiber loop, et. al.). In this embodiment, it is preferred that the delay element provides a precise delay of one half of the wavelength of illumination. In another embodiment, element 150 is a separate section of conduit 50 where the liquid in lumen 32 has not been heated. Light beam 110 emanates from source 100 . This beam is split into two paths by beamsplitter 102 . One beam, 111 passes through conduit 50 and subsequently fluid the liquid in lumen 32 . Depending on the definition of element 150 , beam 112 may pass through air, an optical delay element, or a separate section of conduit 50 . Beam 111 is reflected by mirror 101 and redirected towards beamsplitter 104 . Beam 112 is reflected by mirror 103 and redirected towards beamsplitter 104 . Beam splitter 104 combines beams 111 and 112 into beam 113 . Beam 113 is now the coherent sum of the two beams, 111 and 112 . The phases of beams 111 and 112 add, creating an intensity pattern that is dependent upon the phase delay induced by the liquid in lumen 32 . This intensity pattern is detected by detector 175 . When fluid 32 is heated, the index of refraction changes. As a consequence, so does the phase of beam 111 . This in turn causes an intensity variation that is detected by detector 175 . In the specific embodiment where element 150 produces an optical delay of precisely one half of a wavelength in beam 112 prior to heating the liquid in lumen 32 , the intensity detected by detector 175 will be very small. Then, when fluid 32 is heated, the percentage change in intensity at detector 175 will be very large. The electrical signal may be processed in ways similar to the electrical signal described earlier for the first embodiment where the heat pulse is detected as a change in illumination reflected from point 39 in FIG. 2 . The descriptions of these two embodiments illustrate how a heated segment of a liquid in a conduit may be used to measure the flow of the liquid down the conduit, thereby providing information allowing the calculation of the velocity of the liquid in the conduit. In pharmaceutical applications, such measurements provide the basis for the more accurate delivery of the pharmaceutical solution. Also in pharmaceutical delivery applications, especially during intravenous administration when the conduit is part of an IV administration set and the motion of the liquid is caused by gravity or an infusion pump, there is also a need to verify that the liquid path stays open. Frequently, for example when a patient rolls over, the administration set may be crimped, stopping flow even though the infusion pump is operating or there is adequate head on the gravity flow system. The flow sensor of this invention is also capable of the rapid detection of this situation. Whenever such an occlusion of the conduit occurs, the heated segment of the liquid does not move when the pinch tube is opened. Hence the detector does not detect any change in an optical property of the illumination. The absence of a detected signal from the heated segment of the liquid is then a measure of lack of flow, which may be caused by an occlusion in the conduit or a number of other possibilities. Thus the flow sensor of this invention also provides for the detection of flow system failures, among which is an occluded conduit. The descriptions of the optical systems of FIGS. 2 and 4 are meant to be illustrative and not definitive. Persons skilled in the art may be able to provide variations on the basic design of these optical systems in the detecting and measuring a heat pulse in a liquid in a conduit and the subsequent measurement of the flow of the liquid in the conduit.

Systems and methods for measuring the flow of a liquid along a conduit are disclosed. A heat source applies thermal energy to a portion of a liquid flowing along a conduit thereby elevating its temperature. A light source generates a first beam that passes through the liquid in the conduit downstream from the position of application of the thermal energy and an optical detector receives this beam in combination with a second beam that is not passed through the liquid in the conduit and measures a change in intensity of a combined beam. The time required for the heated portion of the liquid to move from the point of application of thermal energy to the point at which the beam passes through the liquid is measured. This measured time, along with the distance of separation of the heat source and the optical sensing means permits calculation of the velocity of the liquid in the conduit.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] This invention is directed to a training device for indicating to golfers the correct stroke direction taking into account the slope of the putting green or other terrain in close proximity to the putting green. [0003] 2. Description of Prior Art [0004] In the game of golf, putting greens and fringe areas alongside the greens are frequently sloped in several directions in order to add additional skill requirements for golfers. Strokes referred to as chip or lob strokes will not often not travel in a straight line to the hole once they hit the ground. Also the path of the golf ball during a putting stroke will curve according to the slope of the green between the hole and the position of the ball on the green. This concept is sometimes difficult to explain to new golfers. Verbal instruction as to where to initially direct the golf ball such as inside the right edge of the cup or one cup to the left are not readily understood. [0005] Consequently, there is a need for a training device that will readily assist a new golfer in understanding the need to compensate for the slope of the terrain on or near the green when attempting a stroke. BRIEF SUMMARY OF SOME OF THE PREFERRED EMBODIMENTS [0006] These and other needs in the art are addressed by an apparatus that includes a plurality of colored balls on a support device. In one embodiment the balls are supported by a vertical shaft that is adapted to be placed within a regulation golf cup and supported in the same manner as a flagstick. In another embodiment, the training device is supported above the ground by a pair of spaced support legs. [0007] The foregoing has outlined rather broadly the features and technical advantages of the present invention in order that the detailed description of the invention that follows may be better understood. Additional features and advantages of the invention will be described hereinafter that form the subject of the claims of the invention. It should be appreciated by those skilled in the art that the conception and the specific embodiments disclosed may be readily utilized as a basis for modifying or designing other embodiments for carrying out the same purposes of the present invention. It should also be realized by those skilled in the art that such equivalent embodiments do not depart from the spirit and scope of the invention as set forth in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS [0008] For a detailed description of the preferred embodiments of the invention, reference will now be made to the accompanying drawings in which: [0009] FIG. 1 is a perspective view of an embodiment of the invention adapted to be supported within a conventional golf cup. [0010] FIG. 2 is a top view of the device placed in a golf cup and showing possible paths of the golf ball to the golf cup. [0011] FIG. 3 is a perspective view of a second embodiment of the invention adapted to rest upon a golfing surface such as the green or fringe area. [0012] FIG. 4 is a perspective view of an alternate embodiment of the support member shown in FIG. 1 . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0013] FIG. 1 illustrates a first embodiment of the training device 10 which is adapted to be positioned within a conventional golf cup located on the green surface 12 . The device includes a vertical shaft 13 which is adapted to be placed in a supporting hole 45 which normally supports a flagstick within the golf cup 11 . A horizontally extending shaft having arms 15 and 14 is secured at its mid-point to vertical shaft 13 [0014] A plurality of bodies shown as spherical balls 16 - 27 are supported by arms 13 and 14 . Balls 16 - 27 may be the approximate size of a golf ball and have a central bore through which arms 15 and 14 pass. The ball closest to vertical shaft 13 may be multicolored, one half 20 being of a different color. The same is true for half ball segments 22 and 23 . The remaining balls 16 - 19 and 24 - 27 are also of different colors from each other. Balls 22 - 27 may have the same color pattern of balls 16 - 21 as they are positioned away from shaft 13 . For example balls 19 and 24 may be off of the same color as well as half balls 21 and 22 . [0015] FIG. 2 illustrates the use of the training device. The head of a putter 31 a may be positioned to be perpendicular to a straight line 29 to the hole which would correspond to a straight put having no break to it. [0016] On the other hand, if the putt is expected to break to the right, the putter face 31 b would be positioned as shown at 31 b. [0017] A golfer must “read” the green to estimate how much the putt will break. Depending on the estimate the instructor would tell the student which ball to aim at. [0018] The anticipated path of the ball based on the estimate and aiming point is illustrated by the dotted lines 16 a - 27 a. Thus if by reading the green the golf ball would break two balls to the right, the student would be told to aim for ball 19 so that the ball would enter the cup in the middle. If the balls were one inch in diameter and the put was expected to break five inches to the right, then the student would be instructed to aim at ball number 17 . [0019] For putts that were expected to break to the left as illustrated by lines 22 a - 27 a, the same process of instruction would be used with the face of the putter being generally oriented as shown at 31 c. [0020] A second embodiment of the invention is illustrated in FIG. 3 . The device includes a pair of spaced apart supports 41 , 43 have ground engaging foot members 42 , 44 . Members 42 and 4 may have holes 62 such that a golf tee 61 may be used to anchor the supports to the ground. A shaft 45 is supported by supports 41 , 43 . Shaft 45 would have a length for example between one foot to 10 feet and supports 41 , 43 could be one inch to several feet in height. Balls 51 - 57 are supported on shaft 45 . Supports 41 and 43 may consist of two shafts that are vertically adjusted with respect to each other by any known mechanism. [0021] In this embodiment ball 51 could be a first color and indicate a straight shot. This embodiment is intended to be used for a chip shot in which the ball 32 is struck by a lofted club such that the ball becomes airborne as a result of the stroke. Area 41 may correspond to the fringe area around green surface 12 . [0022] Pair of balls 52 - 57 may be of the same color but a different color that the other pairs. [0023] In use, the instructor would again “read” the green or surface to estimate the path of the ball once it lands on the surface of the fringe or green. The student would be instructed to hit the golf ball over or under the pair of balls that would represent the estimated path of the golf ball once it hits that surface. For example, if the estimated path of the ball is 53 a, then the student would be instructed to hit the ball 32 either over or under the pair of balls 53 . [0024] FIGS. 4 illustrates an embodiment of the support mechanism of FIG. 1 . It includes a first shaft 13 adjustably positioned within support shaft 82 which is adapted to rest in aperture 45 of golf cup 11 . A compression fitting 81 may be provided for adjusting the position of shaft 13 within support shaft 82 . Any other known adjustment mechanism such as those discussed above may also be utilized. [0025] Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations may be made herein without departing from the spirit and scope of the invention as defined by the appended claims. [0026] Bodies 15 - 27 and 51 - 57 are shown spherical in shape, however they may be formed as other shapes such as rectangles or other bodies of revolution.

A golf stoke training aide includes a plurality of spaced spherical objects of different colors supported on or above a golf playing surface. The aide is placed between the golfer and golf hole cup. The spaced apart spheres represent the preferred direction to strike the ball based upon the anticipated path of the ball to the hole.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This is a continuation of U.S. application Ser. No. 10/700,863, filed 3 Nov. 2003, which claims priority to U.S. Application No. 60/469,441, filed 21 Aug. 2003, and is a continuation-in-part of U.S. application Ser. No. 10/369,550, filed 21 Feb. 2003, which claims priority to U.S. Application No. 60/359,287, filed 25 Feb. 2002 and to U.S. Application No. 60/389,346, filed 18 Jun. 2002, each of which is incorporated by reference herein in its entirety. FIELD OF THE INVENTION [0002] The invention is generally in the field of medical devices. More particularly, it relates to implantable pump-assisted drainage devices, e.g., for transvesicluar drainage, capable of draining fluid from a bodily cavity into another bodily cavity, such as a bladder. BACKGROUND OF THE INVENTION [0003] There are a variety of conditions which result in pathologic chronic collection of bodily fluids within the body of a person. Chronic pericardial effusions, normopressure hydrocephalus, hydrocephalus, chronic pulmonary effusion, pulmonary edema, and ascites are but a few of the conditions in which chronic fluid collections persist and result in increased morbidity and mortality. [0004] These types of conditions currently are treated typically by one of three methods: 1) external drainage with a high-risk of infection and long-term requirement for multiple punctures, 2) drainage to another body cavity, or 3) treatment with various drugs. For pericardial effusions and hydrocephalus of all types, the treatment of choice is typically drainage to another region of the body. For pericardial effusions this entails a pericardial window, a highly invasive procedure in which a large section of the external heart cavity is removed. For hydrocephalus, the treatment typically involves the use of a ventriculo-peritoneal shunt draining the cerebrospinal fluid into the peritoneal cavity. This device frequently becomes clogged due to the proteinaceous environment of the peritoneal cavity and requires removal or revision. [0005] One problem which may arise with the chronic collection of bodily fluids is ascites, which is a highly debilitating complication associated with many medical conditions including liver failure and congestive heart failure. Untreated ascites can result in respiratory compromise, compression of the inferior vena cava (a vital blood vessel) and spontaneous bacterial peritonitis (a life-threatening condition). In order to treat chronic ascites, medicine has turned to both drugs and surgery. [0006] The drugs required to treat ascites are typically long-term and frequently result in complications. The most common pharmaceutical treatment of ascites involves the use of diuretics to remove fluid from the patient&#39;s body through their urine. The difficulty with this treatment, though, is that fluid is removed from the entire body, including the circulating volume of blood, and can result in excessive loss of fluid required to perfuse the vital organs of the human body. Thus, even with frequent application, the medicines frequently fail. In such cases, surgical, or invasive, procedures are indicated. [0007] Currently the most common surgical treatment is paracentesis. In paracentesis, the peritoneal fluid is drained through the abdominal wall via the insertion of a needle through the abdominal wall into the peritoneal cavity. This procedure is only a temporary solution as the ascites quickly refills the peritoneal cavity in most chronic conditions. Furthermore, repeated paracenteses places the patient at increased risk for a life-threatening infection of their peritoneal cavity. Other surgical/invasive procedures typically involve treatment of the cause of the ascites (for example, the Transjugular Intrahepatic Portosystemic Shunt) but these measures also frequently result in complications, which are often serious and are thus performed infrequently. [0008] Many of the existing commercially available devices provide little improvement over the intermittent punctures of paracentesis and result in increased rates of infection or other complications if left in place for any length of time. Therefore, there is a need for a device which effectively reduces the need for repeated punctures or abdominal incisions and thereby reduces the risk of serious infection. SUMMARY OF THE INVENTION [0009] An implantable fluid management system, as described herein, may typically comprise a first tube member having a first end, a second end, and a length which defines a lumen therethrough and having at least one opening at the first end or along the length, a second tube member having a first end, a second end, and a length which defines a lumen therethrough, a pump fluidly coupled to the first tube member and the second tube member for urging fluid through each tube member, and a shunt connected to the second end of the second tube member, wherein the shunt is adapted to anchor the second end of the second tube member to a wall of a hollow body organ in a fluid-tight seal. [0010] This system may avoid difficulties typically associated with the current therapies. For instance, in the treatment of chronic ascites, the devices of the system may allow for the removal of peritoneal fluid without 1 ) serious complications generally associated with use of pharmaceuticals, 2) inconvenience, for example, the substantial costs and the increased risk of infection associated with frequent paracenteses, or 3) multiple severe complications associated with more invasive and risky surgical operations to treat the cause of ascites. The implantable fluid management system may be utilized for chronic excess fluid drainage from one bodily cavity to a second bodily cavity, e.g., a urinary bladder. An implantable electromechanically powered and/or magnetically coupled vesicular pump may be utilized to permit assisted flow of the excess fluid collections into the bladder. This flow may be directed to be uni-directional through the system. [0011] One particular variation of the system may be used as an ascites drainage device. For instance, the device of the system may be used for peritoneovesicular drainage of the peritoneal fluid from the peritoneal cavity into, e.g., the bladder. The drainage of the fluid may be uni-directional through the system. To urge the fluid through the fluid management system, a pump which is fully implantable may be utilized with the system to transfer excess fluid from a variety of locations in the human body, for instance, the peritoneal cavity, to another region within the body, for instance, the urinary bladder, for the treatment of chronic fluid collections. [0012] The system, including the pump and/or tubular members, may be configured to enable fluid flow in only one direction into, e.g., the bladder, to prevent the reflux of urine or other fluids into the area being drained while still allowing the drainage of the fluid into the bladder. This uni-directional configuration may be achieved through incorporation of a uni-directional valve in the lumen of the tubing or through the use of a uni-directional pump which may also be prevented from being driven in reverse. [0013] The device may include at least two distinct flexible tubular members each defining at least one lumen therethrough. One tubular member may be used for drawing fluid from the region to be drained into or through the pump while the other tube may be used for channeling the fluid from the pump into the hollow body organ such as the bladder. The tube for drawing the excess fluid from the the body cavity may contain or define at least one opening, and may preferably define multiple perforations, and/or anti-clogging mechanisms in the region of the fluid intake. This tubular member may also optionally incorporate chemical- or pressure-sensing elements to trigger and/or prevent activation of the pump under specific circumstances. The tubular member carrying the pumped fluid to the bladder may feature an anchoring mechanism such as a shunt mentioned above (e.g., a flange, pigtail coil, etc.) and may optionally be coated with a hydrophilic material to prevent encrustation. The tip of this tubing may also optionally incorporate chemical- or pressure-sensing elements to trigger and/or prevent activation of the pump under specific circumstances ensuring that the pump does not generate excessive bladder pressures. These sensors can be placed anywhere along the length of either tube, including the extremes of a position at the site of pump attachment and a position at the tip of the tubing. Optionally, the two tubes can be integrated together into a single tubular member having two distinct lumens for ease of insertion. [0014] The shunt for anchoring to the bladder wall may, in one variation, comprise a hollow, cylindrical column with flanges at either or both ends to provide secure anchorage in the bladder wall. The shunt may have an integrated mechanism to ensure unidirectional flow of fluid while preventing reflux of urine and other fluids back through the shunt. One variation of the shunt may provide a passive ball-valve mechanism which allows for drainage of fluid into the bladder whenever a certain minimum threshold pressure is achieved at the collection site. Another variation may provide an active valve mechanism which allows for controlled drainage of fluid into the bladder whenever the valve is actuated. [0015] The system can be made available in multiple configurations and designs for varying types and severity of fluid collections. For drainage of excess cerebrospinal fluid, for example, the tubing connecting the pump to the ventricle of the brain may be fabricated to be significantly longer than the tubing for chronic ascites which need only reach an adjacent peritoneal cavity. [0016] The methods of insertion of the fluid management system may be based, in part, on the location of the fluid collection. On the other hand, the tubular member spanning to the bladder wall may be placed, e.g., cystoscopically or transabdominally, using minimally invasive procedures. The pump may be placed subcutaneously using interventional radiology techniques including radiographic imaging such as ultrasound. The inflow tubing connected to the pump, in one variation, may be tunneled subcutaneously to the site of drainage and the outflow tubing can be subcutaneously channeled to the bladder. Alternatively, the pump can be placed in the peritoneal cavity, or other bodily cavity, and activated remotely or set to operate independently based on pressure signals sensed from the fluid. In this variation, the pump may be tethered to an inductive charging coil for recharging or, if a battery with sufficient life is used, may carry its own independent power supply. [0017] The system may also optionally include controls to limit the operation of the pump and provide feedback to ensure that the pump is operating correctly. Thus the total fluid flow can be monitored and tightly controlled. BRIEF DESCRIPTION OF THE DRAWINGS [0018] FIG. 1 shows a cross-sectional view of a variation of a shunt device. [0019] FIG. 2 shows a cross-sectional view of an implanted shunt. [0020] FIG. 3 shows a cross-sectional view of the implanted shunt when the peritoneal fluid pressure is insufficient to open the valve. [0021] FIG. 4 shows a cross-sectional view in an illustration of an example of an insertion device within which the shunt can be implanted in the bladder wall. [0022] FIGS. 5A to 5 C show alternative variations of the fluid management system with differing valve types, differing valve positioning and differing number of valves. [0023] FIGS. 6A and 6B show cross-sectional illustrations of an alternative variation of the system and a detail view of the shunt, respectively, in which an active, externally, or internally controlled valve is utilized. [0024] FIG. 7 shows a cross-sectional illustration of an alternative variation of the drainage system in which a pump may be included along the length of the tubing. [0025] FIGS. 8A to 8 C show illustrations of a few of the alternative variations of the drainage system in which the peritoneal cavity, the pulmonary space, and the ventricular space are able to be drained. [0026] FIG. 9 shows an illustrative magnetically-coupled variation of the drainage system with an illustration of an externally located drive. [0027] FIGS. 10A to 10 C show a variation of the drainage system in which the tubes and pump may be removably attachable allowing for increased ease of insertion. [0028] FIG. 11A shows an implantable pump variation having removably attachable tubing in the attached position. [0029] FIG. 11B shows a variation on an implantable pump which may have its moment forces generated by the pump balanced. [0030] FIG. 12A shows a variation of the drainage system having a single dual-lumen tube. [0031] FIGS. 12B to 12 G show additional variations of the single dual-lumen tube. [0032] FIG. 13 shows a magnetically-coupled variation of the pump and external drive in which the magnetic interaction is circumferential. [0033] FIG. 14 shows an illustration of an electromechanical variation of the system in which the implanted pump may be rechargeable. [0034] FIG. 15 shows an illustration of an electromechanical variation of the device in which the implanted pump may be placed in a non-subcutaneous position. [0035] FIGS. 16A to 16 C show illustration of a few of the possible uses of the drainage system in the drainage of chronic fluid collections in various regions of the body. [0036] FIG. 17 shows a variation of the drainage system which may be fluidly coupled to the vascular system. [0037] FIG. 18 shows another variation of the drainage system which may be coupled to a stomach or another portion of the gastro-intestinal system. DETAILED DESCRIPTION OF THE INVENTION [0038] The implantable fluid management system may comprise devices for facilitating the removal of fluid from a body region where drainage is desired. For instance, the devices disclosed herein may be utilized for chronic excess fluid drainage from one bodily cavity to a second bodily cavity, e.g., a urinary bladder. An implantable electromechanically powered and/or magnetically coupled vesicular pump may be utilized to permit assisted flow of the excess fluid collections into the bladder. This flow may be directed to be uni-directional through the system. [0039] As can be seen in FIG. 1 , a vesicular shunt or drain 1 may be utilized with the fluid management system for anchoring a tubing member to the wall of a urinary bladder. A further detailed description of the shunt and its applications may be seen in U.S. application Ser. No. 10/369,550 filed on Feb. 21, 2003, which has been incorporated herein by reference above. Shunt or drain 1 may be implanted in the bladder wall 9 , as shown in FIG. 2 , and can be configured to provide for uni-directional drainage of fluid into the bladder. In one variation, the shunt or drain 1 may comprise a flange or projection 2 , 3 at each end of the shunt 1 to facilitate firmly anchoring the shunt 1 across the bladder wall 9 . Alternative variations of the shunt 1 may utilize other anchoring mechanisms, including, but not limited to, screw threading on the outside of shunt 1 , staples, sutures, adhesive compounds, one or more barbs, etc., and combinations thereof. [0040] In one variation, the shunt 1 may be configured to define a lumen through the shaft of the device with a valving mechanism positioned within this lumen. For instance, a ball-valve 4 may be positioned to obstruct an inflow opening of the lumen. A biasing element such as a spring 5 may be configured to provide a closing pressure against the ball-valve 4 such that the lumen remains shut until a minimum threshold pressure is developed by the fluid which may force the ball-valve 4 open or until a pump is actuated to open the valve 4 . The inflow port of the shunt 1 may optionally include a porous mesh or filter 6 to allow for the free flow of fluid through shunt 1 while preventing the incarceration of tissues at the drainage site. Moreover, the mesh or filter 6 may be configured to filter the fluid through a polymer to sequester components which may be present within the fluid, such as albumin and other proteins, while allowing the flow of fluids and ions across the semi-permeable membrane. [0041] As can be seen in the variation of FIG. 2 , once a pressure of the collected peritoneal fluid 19 has built up, in this case within the peritoneal cavity 7 , and exceeds the combined threshold force of the spring 5 and a pressure of the fluid-filled bladder cavity 8 , the peritoneal fluid 19 may urge the ball-valve 4 open to then allow fluid flow into the bladder 8 . Once the peritoneal fluid 19 has entered the bladder, the peritoneal fluid 19 may mix with the urine 20 and any other fluids which may be present. Once a sufficient amount of fluid 19 has passed through shunt 1 and the fluid pressure within the peritoneal cavity 7 falls below the threshold pressure of the spring 5 , the ball-valve 4 may be urged shut to prevent further fluid flow through the shunt 1 . The spring force exerted by the biasing element to shut the valve 4 within the shunt 1 may be varied depending upon the amount of fluid flow desired. [0042] If the combined pressure from the fluid pressure within the bladder 8 and the closing force of the spring 5 is greater than the pressure exerted by the collected fluid within the peritoneal cavity 7 , then the valve 4 will remain closed preventing reflux of urine and other fluids back into the peritoneal cavity 7 , as depicted in FIG. 3 . [0043] The shunt 1 may be designed to be deployed transurethrally or transabdominally via an insertion device 10 , such as that depicted in the variation of FIG. 4 . Various devices such as endoscopes, catheters, introducers, etc., may also be utilized as an insertion device 10 depending upon the patient anatomy and the location where the shunt 1 is to be placed. A specially configured insertion device 10 may define a cavity or channel within which the shunt 1 may be positioned for deployment within a patient. The variation shown in the figure may incorporate flexible flanges 2 , 3 on one or both ends of the shunt 1 . During delivery, one or both flanges 2 , 3 may be configured in a low profile configuration and after delivery, one or both flanges 2 , 3 may be configured to self-expand or reconfigure into a larger configuration. Accordingly, flanges 2 , 3 may optionally be fabricated from spring steels, shape memory alloys and superelastic alloys such as nitinol, etc. Once the distal end of insertion device 10 has been brought into proximity or adjacent to the region of tissue where shunt 1 is to be inserted, the shunt 1 may be urged out of insertion device 10 via a pusher or plunger, as shown in the figure. Alternatively, shunt 1 may be positioned upon the distal end of an insertion device and released into the tissue wall via a release mechanism. [0044] A tubing member 11 may be attached to the inflow port of shunt 1 . This tubing member 11 may be made such that it is sufficiently long enough to reach the region within the body where excess fluid collects. As shown in the illustrative drawings in FIGS. 5A to 5 C, tubing member 11 may have a perforated receptacle 12 , as described in further detail below, through which the collected fluid may drain into the tubing 11 . Other methods for fluid transport may include, but are not limited to, conduits, catheters, saphenous arteries or vessels, artificial tubular grafts, etc. [0045] In addition to the shunt 1 having a ball valve 4 in combination with the tubing member 11 , other variations may utilize one or more valves of a variety of different types. For instance, passively-actuated valves, i.e., valves which are configured to automatically open and close without being actively actuated, such as the ball-valve 4 shown in FIG. 5A and flapper valve 13 as shown in FIG. 5B . The flapper type valve 13 may be positioned within shunt 1 near the outflow port, as shown in FIG. 5B , or it may also be positioned closer to the inflow port, as shown in FIG. 5C . An additional optional valve 14 may be incorporated into the tubing member 11 anywhere along the length of tubing 11 . The types of valves disclosed are intended to be illustrative and is not intended to be limiting. Other variations of the valves are intended to be within the scope of this disclosure. [0046] Alternatively, active valves, i.e., valves which may be configured to open and close via an actuation or sensing element, may also be utilized with the fluid management system. The use of active valves may be utilized for maintaining a tighter control of fluid drainage. For instance, FIG. 6A shows one variation of an active valve 15 positioned within the lumen of shunt 1 in combination with the tubular member 11 . FIG. 6B shows a cross-sectional side view of the shunt 1 along having the active valve 15 positioned within. Active valve 15 may be actuatable via a remotely located controller to open and shut upon receiving a signal. Alternatively, sensors positioned within the shunt 1 or within the tubing 11 may provide a signal to the active valve 15 to open or shut according to the signal. [0047] In another variation, an electronic valve may be configured to become triggered via communication across the tissues of the human body through electromagnetic signals such as radio frequency, microwave, or other electromagnetic frequencies. Alternatively, pressure (patient-applied or otherwise) mechanical, magnetic, or other methods of communication may be utilized to signal allowing for drainage only at selected times. The valve of the device can take many shapes and the device can be manufactured from any of a variety of materials provided that they are biocompatible. [0048] The fluid management system may also be configured to incorporate a pump 16 , as shown in FIG. 7 . Pump 16 , when placed subcutaneously, can be actuated to provide an active pumping mechanism with or without the use of passive or active valves, as described in further detail below. Pump 16 may be configured as a uni-directional pump to facilitate fluid transfer in a single direction. This uni-directional pump feature may be utilized in place of the valve or in combination with the valves. [0049] The patient may optionally perform maneuvers to help increase the pressure of any fluid which may be contained within the body cavity. For instance, the patient may bear down to increase intra-abdominal pressure to facilitate drainage of the peritoneal cavity. Alternatively, the patient may also wear or apply a girdle designed to increase abdominal pressure or apply a urethral catheter to decrease bladder pressure. [0050] The fluid management system may be configured to drain fluid collections from a variety of different regions within the body. For example, while the shunt 1 may be anchored within the bladder wall, the receptacle 12 may be placed, as described above, within the peritoneal cavity as shown in FIG. 8A . Another example is shown in FIG. 8B where the receptacle 17 may be positioned within the pulmonary space for draining pulmonary effusions and FIG. 8C shows an example where the receptacle 18 may be positioned within the cerebrospinal region for draining excess cerbrospinal fluid. In another variation, a receptacle may be positioned within the pericardial region for draining pericardial effusions. [0051] In yet another variation, the shunt, pump, or tubular devices may incorporate one or several anti-infective agents to inhibit the spread of infection between body cavities. Examples of anti-infective agents which may be utilized may include, e.g., bacteriostatic materials, bacteriocidal materials, one or more antibiotic dispensers, antibiotic eluting materials, entrained radioisotopes, heating elements, bioactive plastics, surfaces which encourage epithelialization, and coatings which prevent bacterial adhesion, and combinations thereof. [0052] Additionally, the devices may also incorporate anti-clogging agents. Examples of anti-clogging agents may include, e.g., active ultrasonic components, an inner and outer sleeve which, when actively agitated through coupling to the pump drive or through a flow driven mechanism, disrupts the inner lumen, surfaces which encourage epithelialization, enzyme eluting materials, enzyme eluting materials which specifically target the proteinaceous components of ascites, enzyme eluting materials which specifically target the proteinaceous and encrustation promoting components of urine, chemical eluting surfaces, an intermittent plunger mechanism, coatings which prevent adhesion of proteinaceous compounds, and combinations thereof. The anti-infective and/or anti-clogging agents may be infused through the devices via a reservoir contained, for instance, in the pump or in a separate reservoir. Alternatively, the agents may be integrated within or coated upon the surfaces of the various components of the system. [0053] FIG. 9 shows an illustrative detail view of another variation of the system of FIG. 7 above. As shown, fluid may be drawn up and carried away by the uptake tube 107 , which in this case, has been perforated to prevent blockage. Alternate variations may include an uptake screen at the terminus of the uptake tubing member 107 . Although multiple perforations or openings are shown in tubing member 107 , a single opening may also be defined at the terminal end of the tubing 107 or along the length of the tubing 107 . As mentioned above, the uptake tubing 107 may also include, but is not limited to, conduits, catheters, saphenous arteries or vessels, artificial tubular grafts, etc. The tubing 107 may be positioned where the excess fluid typically collects within the cavity. Tubing 107 may simply be left within the cavity or it may be anchored to a tissue wall via any number of methods for fastening the tubing 107 , e.g., sutures, staples, clamps, adhesives, etc. [0054] The uptake tubing 107 leads to the pump 101 , which may be used to actively pump or urge the fluid from the uptake tubing 107 and through the outflow tube 108 and into the bladder 110 . In this variation, an optional bladder anchor or shunt 109 may be utilized to secure the distal end or portion of outflow tube 108 and prevent detachment of tubing 108 during bladder contraction. The bladder anchor or shunt 109 may be configured in any one of the variations as described above for the shunt 1 . [0055] The pump 101 , can be powered and operated by electromechanical forces or magnetic coupling. The pump 101 may be placed under the skin 111 in either the subcutaneous space 112 or in the musculature of the abdominal wall 113 . The pump 101 may be configured as a peristaltic pump, but may also be a gear-pump, turbine-pump, impeller-pump, radial-flow-pump, centrifugal-pump, piston-pump, or any other suitable pump type. Ideally, the pump 101 design ensures uni-directional operation. Moreover, the pump 101 may be configured to incorporate a pulsatile or oscillating mechanism within the pump 101 to aid in jarring free any materials from collecting or becoming encrusted to thereby prevent the pump 101 or tubing from clogging. However, valves may be configured to ensure uni-directional operation. The pump 101 is preferably enclosed in a housing, shroud or casing 125 made of any suitable biocompatible material. [0056] Also enclosed in the pump housing 125 , in this particular variation, is the magnetically-coupled drive. One, two, or more magnets 103 may be provided to operate the pump 101 . A separate control module 116 which is remotely located from the implanted pump 101 may be used to drive external magnets 105 located within the drive unit 102 or magnets 105 may be used to provide an oscillating or alternating electromagnetic field to correspondingly couple through the skin 111 with a magnetic field of the implanted magnets 103 located within the pump 101 . By rotating or oscillating the magnets 105 in the drive unit 102 , the implanted magnets 103 are stimulated or urged to move, thereby transferring their kinetic force to operate the pump 101 . While FIG. 9 shows a drive unit 102 with a motor and a linkage, any magnetic field capable of causing or urging the pump magnets 103 to rotate could be used to operate the pump. Furthermore, in order to reduce the torque seen by tissues adjacent to the implanted pump, the pump may utilize a gear mechanism whereby the external drive rotates or oscillates two elements in opposite direction thereby canceling any torques generated. Alternatively, the pump 101 could be electromechanically powered through an implanted battery with external activating and/or monitoring without the requirement for magnetic coupling in which case drive unit 102 may be configured to function as a remote switch for activating the pump 101 . One or more sensors may be integrated into the implanted pump 103 for detecting a variety of fluid and/or pump parameters. For instance, FIG. 9 shows at least one sensor 104 integrated within implanted pump 101 . A corresponding sensor 106 may be built into the interface of the external drive 102 . Both sensors 104 and 106 may be positioned within their respective units such that when the drive 102 is optimally aligned with implanted pump 101 , the sensors 104 , 106 may indicate to the physician or patient that the pump 101 and drive 102 are optimally engaged and able to efficiently transfer power and/or information. The drive 102 or some other indicator may be used to convey the presence of an optimal engagement to the physician or patient through a variety of methods, for instance, a visual message or indicator signal such as a light or audible signal may be initiated once the sensors 104 , 106 have been aligned. These sensors 104 , 106 may also transfer information from the pump 101 to the drive 102 , and/or from the drive 102 to the pump 101 , during operation to monitor fluid pressures and/or fluid flows. Alternatively, additional magnets could also be utilized to anchor the pump 101 to the drive 102 against rotational forces generated during the power transfer operation. [0057] The individual implantable components of the system are shown in detail in FIGS. 10A to 10 C. In FIG. 10A , the outflow tubing 108 is shown in one variation in its insertion trocar 117 . Also illustrated are the bladder anchor 109 and an optional removably attachable port 118 which may be designed to couple with an insertion port 120 on the pump 101 . FIG. 10B illustrates one variation of the inflow drainage tubing 107 in an insertion trocar 117 with an optional removably attachable port 119 . Although these variations show the tubing 107 , 108 positioned within insertion trocars 117 for deployment within a patient, the tubing 107 , 108 may be implanted through various other methods as may be contemplated by one of ordinary skill in the art. [0058] FIG. 10C illustrates one variation of the implantable pump 101 with tubing detached. The pump 101 is illustrated with anchors 121 to resist rotational forces generated with pump use. The pump housing 125 may be anchored by barbed insertion pins 121 and/or materials designed to promote fibrotic ingrowth for anchoring the pump 101 within the muscle 113 or subcutaneous space 112 . Alternative variations of the pump device 101 may use other anchoring mechanisms, e.g., screw threading defined on outside surfaces of pump 101 , staples, sutures, adhesive compounds, a porous solid promoting interstitial cell growth, one or more pins designed to be inserted into the abdominal wall, etc., and combinations thereof. In the variation shown, the tubing 107 , 108 and pump 101 are separate components and may placed individually. For instance, the two tubes 107 , 108 may be first inserted through a single incision in the skin and placed in their approximate positions within the patient. The pump 101 may then be inserted through the incision and attached to both tubes 107 , 108 and secured at the implantation site. Alternatively, the tubing 107 , 108 may be attached to the pump 101 prior to implantation or during manufacture and the entire system may be implanted as a single system. [0059] FIG. 11A illustrates the pump 101 and tubing 107 , 108 of FIGS. 10A to 10 C in which the tubing 107 , 108 has been attached to the corresponding outflow and inflow ports of pump 101 at the junctures of tubing port 118 to pump 120 and tubing port 119 to pump 120 . Also shown are optional sensors 122 , 124 on the ends of the inflow tubing 107 and outflow tubing 108 , respectively. One or both of these sensors 122 , 124 may be configured to sense any one of a number of fluid parameters. For instance, one or both sensors 122 , 124 may detect fluid pressures and/or various chemical parameters such as pH of the fluid, or the presence of certain chemicals, etc. One or both sensors 122 , 124 may also be configured to provide positive and/or negative feedback to the control mechanism, such as the externally located drive unit 102 or an integrated controller located within the pump 101 , in the control of fluid flows. Although both sensors 122 , 124 are shown located at the terminal ends of tubing 107 , 108 , respectively, they may optionally be located anywhere along the lengths of their respective tubes 107 , 108 , if desired or necessary. [0060] FIG. 11B shows a cross-sectional view of another variation of pump 101 which may be utilized to effectively eliminate any excessive movement which may be imparted by torquing forces generated by the pump 101 . After pump 101 has been implanted within a patient, it is generally desirable to inhibit movement of the pump 101 within the body. This may be accomplished through a variety of methods, such as securely anchoring the pump 101 to the surrounding tissue. This pump variation may also be configured to reduce any torque which may be seen by tissues adjacent to the implanted pump 101 . This may be accomplished, in part, by utilizing at least two counter-rotating or counter-oscillating elements within the pump 101 which may rotate or oscillate during pumping such that oppositely generated moments or rotational moments effectively cancel out or balance each other. As seen in this variation, if a driver unit, such as that described above, were activated to rotate element 138 in a first direction, a first rotational moment 141 is generated. This moment 141 , if unbalanced, may impart forces from the pump 101 to the surrounding tissue potentially resulting in damage to the tissue. Element 138 may be rotationally coupled to a gear box 140 which may be configured to reverse the imparted direction of rotation such that element 139 , which is also rotationally coupled to gear box 140 , is compelled to rotate in an opposite direction from element 138 thus creating a rotational moment 142 . The opposite rotational moments 141 , 142 may effectively balance or cancel one another such that the net force imparted by the pump 101 to the surrounding tissue is minimized, potentially to a zero load. The counter-rotating or counter-oscillating (depending upon the type of pump utilized) elements within a pump may be balanced in mass and in configuration in any number of ways to optimize the resulting effect on the pump, depending upon the desired effects. [0061] FIG. 12A illustrates one variation of the fluid management system in which both inflow 107 and outflow 108 tubing share a common wall. This arrangement may be utilized ideally for the peritoneal fluid draining design because the bladder 110 and peritoneal cavity 115 share a common wall which facilitates the insertion of a single dual-lumen tube. Also shown is flange 123 which can be utilized to prevent insertion of the inflow tubing 107 into the bladder 110 in the case of the single-puncture placement. Moreover, any one of the shunt 1 variations described above may be utilized with this variation. [0062] FIGS. 12B and 12C show cross-sectional side and end views, respectively, of the tubing variation of FIG. 12A . As shown, inflow tubing 107 and outflow tubing 108 may share common wall 133 , which may be reinforced to maintain the structural integrity of the tubing. The inflow tubing 107 may define one or a plurality of openings 134 for drawing the fluid within tubing 107 . Openings 134 may be defined along just a portion of tubing 107 or it may be defined along a majority of the length of tubing 107 depending upon the desired application. In operation, the fluid within the body cavity may be drawn into tubing 107 through openings 134 and drawn into pump 103 . The fluid may then be passed through outflow tubing 108 in the opposite direction as the fluid flowing through inflow tubing 107 and subsequently into the bladder 110 . FIGS. 12D and 12E show another variation of tubing 107 ′ and 108 ′ in which both tubes are formed from a single extrusion 135 . In this variation, tubing 107 ′ may define one or a plurality of openings 134 . FIGS. 12F and 12G show cross-sectional side and end views of yet another variation of a single-tube dual-lumen variation in which outflow tubing 108 ″ may be coaxially positioned within inflow tubing 107 ″. In this variation, openings 134 may be defined along a length of inflow tubing 107 ″ while outflow tubing 108 ″ may remain intact. [0063] Both inflow and outflow tubing, or just one of the tubes, may be reinforced along a portion of its length of along its entire length. Reinforcement of the tubing may be accomplished via ribbon or wire braiding or lengths of wire or ribbon embedded or integrated within or along the tubing. The braiding or wire may be fabricated from metals such as stainless steels, superelastic metals such as nitinol, or from a variety of suitable polymers. [0064] FIG. 13 illustrates one variation of the pump device in which the magnetic coupling mechanism employed allows for circumferential interaction. As shown, the pump 101 may be implanted under the skin 111 yet close to the surface such that the pump magnets 103 may be positioned within the inner diameter of, and/or in the same plane as, the external drive magnets 105 . The arms 127 of the drive unit may protrude to define a circumferential cavity for receiving the implanted pump 101 and the overlying skin 111 within this channel. The design of the holding arms 127 may be blunted to prevent excessive pressure from being exerted upon the skin 111 over the site of insertion. In this variation, the driveshaft 126 is shown which transfers power to the magnet holding arm 127 of the drive. This design can also employ one or several pump anchors 121 , sensors 104 , 106 and/or other features and combinations of the pump and tubing. [0065] FIGS. 14 and 15 illustrate non-magnetically powered pumps in which the implanted pump may be powered by a battery or other implantable power source. In this instance the pump 101 may communicate with the external interface 116 using radiowave or electromagnetic signal generators and receivers 128 , 129 to transfer information and/or activation signals. This pump 101 can be placed subcutaneously (as shown in FIG. 14 ) or in any other region suitable for implantation (for instance, the pump 101 of FIG. 15 may be implanted directly within the peritoneal cavity) so long as it can communicate with the external component 116 . The pump can also be internally controlled using the sensors 122 , 124 to determine when to activate the pump. These variations may be configured so that the physician or patient may be able to intervene using the external control mechanism 116 in order to prevent the operation of the pump 101 in undesirable circumstances. For example, if the sensors detect negative feedback, the physician and/or patient may activate the pump 101 using the external controls 116 at their discretion. The controls, though, may be easily programmed to incorporate various parameters such as a maximum drainage per day and simple drainage controls such as no drainage when the bladder exceeds a certain pressure. The pump 101 can also be programmed to be activated under certain circumstances, e.g., once the peritoneal pressure sensor 122 experiences a pressure above a certain threshold. [0066] The device may be designed to drain a variety of different fluid collections including, but not limited to, the excess fluid within the peritoneal cavity, as shown in FIG. 16A , pulmonary effusions, as shown in FIG. 16B , and excessive cerebrospinal fluid, as shown in FIG. 16C . These figures show the bladder anchor 109 , the outflow tube 108 , the pump 101 , the inflow tube 107 , and the drainage ports for the peritoneal 130 , pleural 131 and cerebrospinal 132 drainage sites, although other variations utilizing different features, such as the single tube, dual-lumen tubing described above may be substituted in further variations. Moreover, drainage from other regions of the body using the system and variations thereof are contemplated, such as application for drainage of pericardial effusions. It is important to note that any feature of the present invention can be incorporated into any these designs. [0067] The housing, shroud or casing 125 of the pump can take many shapes and the pump housing 125 can be manufactured from any of a variety of biocompatible materials. Alternatively, the pump housing 125 may incorporate anti-infective components or agents in order to prevent the spread of infection between the body cavities. Such anti-infective components or agents may include, e.g., bacteriostatic materials, bacteriocidal materials, one or more antibiotic dispensers, antibiotic eluting materials, entrained radioisotopes, heating elements, bioactive plastics, surfaces which encourage epithelialization, coatings which prevent bacterial adhesion, etc., and combinations thereof. Alternatively, the device may also incorporate anti-clogging components, e.g., active ultrasonic components, surfaces which encourage epithelialization, enzyme eluting materials, chemical eluting surfaces, coatings which prevent adhesion of proteinaceous compounds, etc., and combinations thereof. [0068] The device has been designed to allow for minimally invasive placement, ideally through the use of non-invasive radiographic imaging tools such as abdominal ultrasound. Placement of the fluid management system may be facilitated by filling the bladder 110 and using ultrasound to locate this space; the outflow tubing 108 can then be placed through a small incision and a simple puncture. The inflow tubing 107 can also be placed in a similar manner using subcutaneous tunneling of the tubing and ultrasound guidance. Once the tubing has been placed, the outflow tubing 107 and the inflow tubing 108 may then be attached to the pump 101 at the insertion sites. The pump 101 may then be set into its site of implantation (for instance, in the subcutaneous space) after which the wound is closed and allowed to heal. [0069] Another application for the fluid management system may be seen in FIG. 17 , which shows ouflow tubing 108 fluidly coupled in a fluid-tight seal to the vasculature 136 of the patient. The fluid collected through inflow tubing 107 may be urged via pump 101 through outflow tubing 108 and passed into the vasculature 136 via an anastomotic connection at one of any number of suitable locations along the vasculature. In such a variation, the outflow tubing 108 may be a saphenous vein or artery. The anastomotic connection between tubing 108 and the vasculature is preferably a fluid-tight seal and may be accomplished through any variety of methods as known to one of skill in the art. [0070] Yet another variation is shown in FIG. 18 , which shows outflow tubing 108 fluidly connected to a stomach 137 of the patient. The collected fluid may be passed into the stomach 137 through use of the shunt described above or through another anastomotic connection to allow for the absorption of any additional nutrients which may be present in the excess fluid. The fluid urged into the stomach may then be passed through the gastro-intestinal system of the patient and eventually voided from the body. Although this example shows fluid connection to the stomach 137 , outflow tubing 108 may alternatively be coupled to other suitable regions of the gastro-intestinal tract, such as regions of the small and large intestinal tracts. [0071] While the device is primarily contemplated for use in human patients, the invention will also have veterinary uses or product development purposes in equine, bovine, canine, feline, and other mammalian species. [0072] The applications of the devices and systems discussed above are not limited to certain treatments, but may include any number of other maladies. Modification of the above-described methods for carrying out the invention, and variations of the mechanical aspects of the invention that are obvious to those of skill in the arts are intended to be within the scope of the claims. Moreover, various combinations of aspects between examples is also contemplated and is considered to be within the scope of this disclosure.

An implantable fluid management device, designed to drain excess fluid from a variety of locations in a living host into a second location within the host, such as the bladder of that host. The device may be used to treat ascites, chronic pericardial effusions, normopressure hydrocephalus, hydrocephalus, pulmonary edema, or any fluid collection within the body of a human, or a non-human mammal.

Botanical classification: Tiarella cordifolia. Varietal denomination: ‘Susquehanna’. SUMMARY OF THE INVENTION The new Tiarella cordifolia as selected during 2007 as a seedling from the garden at the Nursery of Sinclair A. Adam Jr. at Coatesville, Pa., U.S.A. The exact parentage of the new variety is unknown. It resulted from seedlings grown from open-pollinated plants of Tiarella cordifolia , and Tiarella cordifolia var. collina . Several hundred plants are grown for seed production, and some or all of these plants are likely included in the parentage of the new variety of the present invention. The new variety has been carefully preserved and studied since the time of its discovery. Had such new variety not been discovered and preserved, it would have been lost to mankind. It was found that the new Tiarella cordifolia , variety of the present invention exhibits the following combination of characteristics: (a) exhibits a compact mounding clump growth habit with substantial runners, (b) forms attractive white flowers on branched flower stalks, (c) forms lobed ovate green leaves having a matte finish during the summer that bear maroon markings primarily along the leaf veins maroon and this pigment expands in the late summer outward from along the veins. In fall the leaves turn darker red of variable intensity during the fall, but retain a green margin. and (d) is particularly well suited for growing as a distinctive ornamental ground cover, creating a dense stand in a season. The new variety of the present invention can be readily distinguished from other previously known varieties of the species in view of the distinctive combination of characteristics discussed herein. The red, and green spring, summer, and fall color is considered to be particularly noteworthy. The new variety well meets the needs of the horticultural industry and expands the choices of ornamental ground covers which fills in as a stand well. It performs well wherever a ground cover is desired, and is particularly well suited for use as a border planting, use in shaded areas, and for ecology and restoration casting open pollinated seedlings, and asexual runners. The runners (stolons) and flower stems of clumps have been used to asexually propagate the new variety at Delhi, N.Y. (laboratory), and Coatesville, (breeder and nursery) Pa., U.S.A. It has been found that the distinctive combination of characteristics of the new variety is firmly fixed and is reliably transmitted to succeeding generations. During observations to date, the new variety has been found to be readily amenable to such propagation. The new variety ‘Susquehanna’ can be compared to ‘Elizabeth Oliver’ (not patented), which differs from ‘Susquehanna’ in having foliage that turns purple rather than red with green margins in fall. ‘Susquehanna’ can also be compared to cultivars from the same breeding program, ‘Delaware’ (U.S. patent application Ser. No. 12/589,997), ‘Octoraro’ (U.S. patent application Ser. No. 12/589,995), and ‘Lehigh’ (U.S. patent application Ser. No. 12/589,998). ‘Delaware’ differs from ‘Susquehanna’ in having foliage that is less lobed. ‘Octoraro’ differs from ‘Susquehanna’ in having more pubescent foliage that is yellow in color in fall and in having flowers that are tinted pink in color. ‘Lehigh’ differs from ‘Susquehanna’ in having foliage that is less pubescent with more pointed lobes and in having more maroon markings between the veins. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 depicts a two year-old plant of ‘Susquehanna’ as grown in a garden in Baltimore, Md. in May. The plant parts depicted in FIG. 2 , FIG. 3 , and FIG. 4 were taken from a two year-old plant of ‘Susquehanna’ as grown in a garden in Coatsville, Pa. in May. FIG. 1 : Shows a typical plant in bloom. FIG. 2 : Shows the maturation of inflorescences with the least mature on the left and the most mature on the right. FIG. 3 : Shows leaves in various stages of development. FIG. 4 : Shows a stolon. DETAILED DESCRIPTION The following is a detailed description of the new variety that was obtained while observing plants being grown outdoors, and in the greenhouse during 2007-2008 at Coatesville, Pa., U.S.A. The plants were approximately two years of age and were being grown on their own roots. The chart used in the identification of color is The R.H.S. Colour Chart of The Royal Horticultural Society, London, England. More common color terms are to be accorded their ordinary dictionary significance. Botanical classification: Tiarella cordifolia ‘Susquehanna’. Plant: Habit.— Compact mounding clump, several runners. Type.— Evergreen. Height.— Approximately 15 to 20 cm without blooms, and approximately 25 to 30 cm with blooms. Width.— Approximately 30 cm. Stolons.— Greyed-Green Group 195A in color, surface is pubescent with hairs 0.5 to 2 mm in length, internode length 1.25 to 2 cm. Foliage: Type.— Simple. Shape.— Ovate to broadly ovate, palmately five-lobed (seven-lobed as the leaf expands) with an elongated central lobe, and irregularly crenate margins on all lobes having mucronate teeth. Each tooth has a small point, which is relatively firm with a leaf vein extending to the end of the tip. Length.— Approximately 9.5 to 12.1 cm. Width.— Approximately 8-11 cm. Margins.— Incised with dentation. Apex.— The lobes are broadly obtuse to rounded and cuspidate. Base.— Cordate. Texture.— Upper surface; Slightly rugose with a velvet matte finish with hairs about 2 mm in length and 2 to 3 mm apart with greater density on margins, lower surface; glabrous with hairs along the veins. Arrangement.— Basal clump, with branched runners 4-8 in number, usually 20 to 38 cm in length. Venation.— Palmately reticulate. Young foliage: On the upper surface Yellow-Green Group 144A to 144B, and Greyed-Purple Group 187A at the center and along the main vein, and on the lower surface Yellow-Green Group 146B to 146C. Adult foliage: On the upper surface Green Group 137B to 137D, and Brown Group 200B at the center and along the main vein, and on the lower surface Yellow-Green Group 146B to Greyed-Green Group 191A. Fall foliage: Both the ventral leaf surface (upper) and the dorsal leaf surface (lower) are characterized by areas of light red and darker reddish-purple that are near and through the following colors: Red Group 49D and Red-Purple Group 62D in the lighter areas to Red Group 53D and Greyed-Purple Group 186B in the mid-tones to Greyed-Purple Group 187A and 187B in the darker areas. The dorsal leaf surface exhibits a slightly glossier appearance when compared to the more matte appearance of the ventral leaf surface that commonly is increased in expression in the autumn foliage. Petiole.— The length commonly varies from approximately 9 to 15 cm, and the diameter commonly is approximately 2 to 3 mm, Yellow-Green Group N144D in color, surface is pubescent with hairs 0.5 mm to 2 mm in length. Inflorescence: Type.— Raceme and perfect (bisexual). Number.— Approximately 30 to 50 blooms per raceme. Bearing.— On a branched stalk commonly having a height of approximately 25 to 30 cm, with up to 2-3 short side branches. Side branches are 2-10 cm in length, bearing 5-10 blooms. Lastingness of inflorescence.— About 3 weeks. Flower buds.— Ellipsoid in shape, perigynous, 2 to 3 mm in depth and 2 mm in diameter, White Group 155B in color. Calyx.— Five-lobed, White Group 155B in color, 6 to 8 mm in diameter. Petals.— Five. Petal shape.— Triangular. Stamens.— Ten, 3 to 4 mm in length. Anthers Orange Group 27 D. Pistil.— One, 4 mm in length. Flower size.— Approximately 6 to 9 mm on average per floret. Color.— On the dorsal surface White Group 155B and on the ventral surface White Group 155A. Fragrance.— Slight and sweet. Pedicel.— Approximately 6 to 7 mm in length on average, Yellow-Green Group 146D in color. Development: Vegetation.— Clump-forming, with runners (stolons). Blooming.— Abundantly when initially blooms during May/June and sporadically thereafter during the summer and fall. Resistance to disease.— No susceptibility to diseases has been noted during observations to date. Hardiness.— Has proven to grow well in U.S.D.A. Hardiness Zones No. 4 to 7. Propensity to form fruit/seeds.— Approx 0.16 grams per (1 year old) plant (about 500 seeds). Plants of the new ‘Susquehanna’ variety have not been observed under all possible environmental conditions to date. Accordingly, it is possible that the phenotype expression may vary somewhat with changes in light intensity and duration, cultural practices, and other environmental conditions.

A new and distinct Tiarella cordifolia plant characterized by its deep green foliage with deep purple markings and white blooms.

BACKGROUND [0001] 1. Field of the Invention [0002] This invention relates generally to accessories for domestic animals, and more particularly to a head covering that protects against the intrusion of such things as insects, foreign matter, and weed seeds (also known as “foxtails”), from entering the animal&#39;s ears, eyes, or nose. [0003] 2. Background [0004] Weed seeds, and particularly the grass seeds that are often referred to as “foxtails”, have barbs that cause the seeds to attach themselves on passing animals. Foxtails imbed painfully in ear canals, nostrils, and eyes. As the animal shakes its head, sneezes, and paws its face, trying to expel the seed, the seed only goes deeper because of the one-way barbs. Within minutes, the seed has gone so deep that the seed must be removed by a veterinarian, under anesthetic, at great cost to the owner and pain to the animal. [0005] Several products currently exist that attempt to solve this problem, but they are either ineffective or have significant flaws. Blessing&#39;s protective bonnet for animals (U.S. Pat. No. 3,753,334 to Blessing, Aug. 21, 1973) is designed to protect eyes and ears from insects, but not the nose or mouth. The present invention protects the nose and mouth in addition to the eyes and ears because it encloses the entire head. [0006] Waltz and Davidson (U.S. Pat. No. 1,004,507 to Waltz, Sep. 26, 1911 and U.S. Pat. No. 5,367,706 to Davidson, Nov. 29, 1994) both designed head enclosures for people to keep the insects away from the face. Both have stiffening ribs to hold the net away from the face. The stiffening ribs cause a visual distraction, which can be especially annoying to an animal and can cause it to be less tolerant of the enclosure. By contrast, the present invention can be made from a fabric stiff enough to stand away from the face without the added stiffening ribs, and therefore there can be no visual distraction for the animal. When made of stiff mesh fabric, the protective hood can stand away from the face, therefore not irritating the animal by touching its face. Because of the lack of visual distraction and facial irritation, the animal could be more willing to wear the device. Finally, construction of the present invention can be simpler and more economical to manufacture without the added stiffening ribs of Waltz and Davidson. [0007] Vaughn&#39;s Inhalation Net (U.S. Pat. No. 6,832,581B1 to Vaughn, Dec. 21, 2009) protects only the nose and its construction is very complex. The present invention protects the eyes, ears, nose, nostrils and mouth from the intrusion of insects, foreign matter, and weed seeds. Also, because the construction can be very simple, it can be economical to manufacture. In some embodiments, the present invention uses one piece of mesh fabric, to form a hood that can be gathered with a piece of adjustable elastic at a rearward opening end. Vaughn&#39;s Inhalation Net could cause discomfort and distraction to the animal because it is secured to the animal&#39;s muzzle with a piece of elastic that wraps around the lower jaw. The present invention can be designed with as much comfort as possible and therefore little distraction for the animal wearing it. It can be sized larger, longer and wider than the head, so that it doesn&#39;t touch the face, and can be shaped so that it has enough room for the animal to pant and drink (through the mesh), and can be secured gently with elastic around the neck in a fashion that is similar to the animal&#39;s own collar. There could be no visual distractions because any seams are generally out of the animal&#39;s line of sight and the mesh can be easy to see through. Though the present invention can be made in any color mesh, in some embodiments it can be black, which generally doesn&#39;t reflect light and thereby reduces distracting glare. [0008] Finley and Harris&#39; Protective Ear Canal Covering for dogs and other animals (U.S. Pat. No. 5,163,272 to Finley and Harris, Nov. 17, 1992) protects only the ear canals. The present invention protects eyes, nose and mouth, in addition, to the ear canals, from the intrusion of weed seeds (including foxtails), insects and other foreign matter, lodging therein. [0009] The Lecys&#39; Pet Hood (U.S. Pat. No. 7,523,720 to Lynda and Duane Lecy, Apr. 28, 2009) is made of an inflexible metal mesh that is die cut and is used to prevent animal from biting. The present invention can be primarily used to protect the animal from the weed seeds, insects, and other foreign matter getting into its eyes, ears, nose, and mouth. The present invention is made of a flexible material and can therefore be much more easily manufactured because it does not need an expensive die created for its manufacture and is easily assembled with a simple sewing machine. Because the present invention is made of a more flexible material it is more comfortable for the animal to wear. It is conceivable that the Lecys&#39; Pet Hood could be used to protect animals from weed seeds, insects and other foreign matter, but it would not be comfortable for the animal or as economical as the present invention. [0010] What is needed is an apparatus to protect animals against the intrusion of such things as insects, foreign matter, and weed seeds, from entering the animal&#39;s ears, eyes, or nose that can be easily manufactured and is comfortable for the animal to wear than current products. [0011] In some embodiments, the apparatus should be flexible and free of distracting or uncomfortable stiffening ribs and/or seams. SUMMARY OF THE INVENTION [0012] Accordingly, several objects and advantages of my invention are: [0013] It protects an animal&#39;s entire head, including the ear canal, nose/nostrils and eyes, from intrusion of weed seeds, insects and other foreign matter, therefore avoiding pain and suffering of the animal and costly visits to the veterinarian. [0014] It is easily worn by an animal and comfortable so therefore is more acceptable to the animal who will be more willing to wear it &amp; much less likely to try to take it off. The protective mesh hood is shaped and sized so that the fabric generally doesn&#39;t touch face and the elastic does not need to be tight to secure the hood in place around the neck. Pets are accustomed to collars around their necks so securing the hood around the neck will be the least irritating way of securing the hood and the elastic length is adjustable if an animal changes in size. Also, the animal can see, pant, drink, and bark while wearing the protective mesh hood and it is not visually distracting since the seams are out of the animal&#39;s line of sight and the mesh is easy to see through. [0015] The invention is easy for a pet owner to use because the elastic fastening and adjustment is easily accessed on the back of the animal&#39;s head. Once the elastic is drawn up, adjusted for the particular animal and secured with the cord lock, the protective mesh hood can easily be slid on and off without having to release and re-adjust the cord-lock each time. Optional hook/loop fastener straps to prevent animal from removing the protective mesh hood are made to quickly and easily wrap and secure around the animal&#39;s own collar. [0016] The simple design is easy to manufacture and made of common, inexpensive materials. Further objects and advantages of my invention will become apparent from a consideration of the drawings and ensuing description of it. BRIEF DESCRIPTION OF THE DRAWINGS [0017] FIG. 1 An elevation that shows the head of the animal with the protective mesh hood in place. [0018] FIG. 2 A front view that shows the head of the animal with the protective mesh hood in place. [0019] FIG. 3 A perspective view that shows the head of the animal with the protective mesh hood in place. [0020] FIG. 4 A back view that shows the head of the animal with the protective mesh hood in place, illustrating the back of the hood with the hook/loop fastener straps that secure it to the animal&#39;s own collar. [0021] FIG. 5 A construction detail of hood opening casing, showing the reinforced opening, the elastic with the cord-lock adjuster and hook/loop fastener straps. [0022] FIG. 6 A flat side view of the hood only, without opening end gathered. [0023] FIG. 7 A side view of the hood only, with opening end gathered to fit neck. [0024] FIGS. 8 through 19 show alternate embodiments, but are not limited to only these embodiments of the protective mesh hood: [0025] FIG. 8 A perspective view of a modification, illustrating an additional piece of mesh at front end of the apparatus that creates a rounded shape at top, front end of apparatus. [0026] FIG. 9 A back view of a modification that shows the head of the animal with the protective mesh hood in place, illustrating the back of the hood without straps that secure it to the animal&#39;s own collar. [0027] FIG. 10 An elevation of an alternate embodiment of the apparatus showing wide elastic sewn directly to the screen mesh, rather than elastic being fed through a casing. [0028] FIG. 11 An elevation of an alternate embodiment of the apparatus that shows a separate casing made of a non-mesh fabric that can be sewn onto the opening end of apparatus. [0029] FIG. 12 An elevation of an alternate embodiment of the apparatus that shows the back of hood made out of a non-mesh fabric. [0030] FIG. 13 An elevation of an alternate embodiment of the apparatus that shows possible placement of extra seams throughout the protective mesh hood. All seams are placed out of animal&#39;s line of sight. [0031] FIG. 14 An elevation of an alternate embodiment of the apparatus that shows it without the reinforced opening or the cord lock. [0032] FIG. 15 An elevation of an alternate embodiment of the apparatus that shows it without elastic and without the cord lock. [0033] FIG. 16 Side ( FIG. 16 a ) and back ( FIG. 16 b ) views of an embodiment that shows an opening at the top of the protective mesh hood for the erect types of ears, in which a separate gathered piece of can be inserted and stitched to enclose the ears. [0034] FIG. 17 Side ( FIG. 17 a ) and back ( FIG. 17 b ) views of an embodiment that shows the addition of extra fabric to the protective mesh hood that creates extra room at the top of the mesh hood for the erect types of ears that can be shaped with darts at the back of the hood. [0035] FIG. 18 An elevation of an alternate embodiment of the apparatus that shows it with a narrow type of material threaded through several, evenly spaced holes, and reinforced at the opening end of the protective mesh hood. [0036] FIG. 19 An elevation of an alternate embodiment of the apparatus that illustrates how the protective mesh hood could be made of one single piece of mesh, suitably shaped to animal&#39;s head using folded darts, pleats or gathers and then secured with stitching to a buckled collar. DETAILED DESCRIPTION [0037] Referring to FIG. 1 , a protective hood 2 can be configured and designed to protect an animal from insects and foreign matter by enclosing the entire head in mesh material. Mesh material can be comprised of vinyl coated polyester threads but may be comprised of any material that has the correct size openings between the threads. The threads can be woven together to create openings between threads that can block foreign matter and insects from entering a hood 2 , while allowing visibility and air circulation through openings to animal. In some embodiments, mesh material can have anti-bacterial and/or ultraviolet protective coating and/or inherent properties. In yet other embodiments, a hood 2 can be coated or sprayed with insect repellant. [0038] A hood 2 can reflect the shape of an animal&#39;s head and can be larger than the circumference of the animal&#39;s head. The size of a hood 2 can be designed larger than an animal&#39;s head so that there can be space between the material and all around the animal&#39;s head. This is for the animal&#39;s comfort and to allow the animal room to open its mouth and pant. In some embodiments, the material that comprises the hood can be shaped by having at least one seam 4 . FIG. 1 depicts an embodiment in which only one seam 4 is used, but see FIGS. 6-8 , 12 and 13 for embodiments utilizing multiple seams 4 . FIGS. 6-8 depict embodiments comprising a gusset 20 that can add additional room for an animal&#39;s head and/or can provide added structural support to a hood 2 . A gusset 20 can be coupled with the rest of a hood 2 via a seam 4 . A seam 4 can be stitched, as depicted in FIG. 1 , or can be bonded using adhesive or any other known and/or convenient bonding process. In alternate embodiments, a hood 2 can be molded using other methods such as heat formation (such as placing a piece of mesh over a mold of preferred shape and heating it to conform to shape). [0039] Referring to FIGS. 1 , 3 and 4 , an opening end 6 of a hood 2 can be greater than largest circumference of an animal&#39;s head so as to facilitate easy placement of a hood 2 over the animal&#39;s head. An opening end 6 can then be gathered to the size of the animal&#39;s neck. Gathering can be accomplished through utilization of an elongated member 12 , drawn up within a casing 8 , drawn through a reinforced opening 10 in the casing 8 , and secured by a cord lock device 14 . In some embodiments, an elongated member 12 can be elastomeric. In alternate embodiments, an elongated member 12 can be any other type of material shaped in a long thin strip, such as cording or strapping that can be drawn up within the casing 8 and secured by a cord lock device or tied. [0040] A casing 8 at the opening end 6 of a hood 2 can be formed by folding the mesh material of a hood 2 and then stitching the material back onto itself to secure the edge to a hood 2 . In other embodiments, a casing 8 can be a separate component that can be formed separated and subsequently coupled with a hood 2 (see FIG. 11 ). In such an embodiment, the material of a casing 8 can be different from that of a hood 2 . In yet other embodiments, a casing 8 and a hood 2 can be made of substantially the same material. [0041] Referring to FIG. 5 , a casing 8 can be any width that is large enough for an elongated member 12 to move through easily. A casing 8 can enclose an elongated member 12 that can be any width that can be accommodated by a cord lock device 14 . A casing 8 comprise a small reinforced opening 10 to allow exit of an elongated member 12 , which then can be threaded through a cord lock device 14 to secure the length of an elongated member 12 to a size that fits the animal&#39;s neck, just behind the ears. The loose ends of an elongated member 12 can hang freely, as shown in FIGS. 1 and 4 , and/or each end can be knotted and/or folded or stitched onto itself to prevent passage through a cord lock device 14 . In other embodiments, the loose ends of an elongated member 12 can be coupled together via tying, gluing, stitching, rivets, or any other known and/or convenient method of coupling. [0042] An opening 10 can be reinforced by any known and/or convenient method, including stitching similar to how a buttonhole is typically reinforced, or with a small piece of closely woven fabric glued or otherwise bonded around the opening 10 . In other embodiments, an opening 10 can be reinforced with grommets or any other known and/or convenient reinforcement mechanism or method. [0043] Referring to FIGS. 1 and 5 , to prevent an animal from taking a hood 2 off, straps 16 can be coupled with an opening end 6 and can be adapted to temporarily couple with an animal&#39;s own collar 18 . Straps 16 can be made of hook and loop fastener material or any known and/or convenient flexible material. In the embodiment depicted, straps 16 have a long, narrow shape, but in other embodiments, straps 16 can have any other known and/or convenient geometry. Straps 16 can be positioned substantially perpendicular to an animal&#39;s collar 18 , and can be long enough to wrap and secure around the collar 18 . Straps 16 can be coupled with a collar 18 via stitching, adhesive, rivets, snaps or any other known and/or convenient method of permanent or temporary attachment. Similarly, the ends of a strap 16 can be adapted to couple with each other temporarily and selectively via adhesive, snaps, hook and loop mechanism, buckle, or any other known and/or convenient fastening mechanism. [0044] An alternate embodiment of a hood 2 is shown in FIG. 9 . Since many animals may not have the ability to, or can be trained not to, take off a hood 2 , in some embodiments straps 16 can be eliminated. [0045] An alternate embodiment of a hood 2 is shown in FIG. 14 . In the embodiment shown, a casing 8 does not have an opening 10 or cord lock device 14 . Instead, an elongated member 12 can form a loop and can made of elastomeric material substantially the circumference of an animal&#39;s neck such that, in use, a hood 2 can fit closely around the animal&#39;s neck without applying too much pressure and/or causing strangulation or discomfort. [0046] In some embodiments, a hood 2 may not have a casing 8 . Instead, as shown in FIG. 10 , a piece of elastomeric material 22 can be secured directly to the opening end 6 edge of a hood 2 via stitching, adhesive, snaps, or any other known and/or convenient mechanism. In other embodiments, as shown in FIG. 18 , an elongated member 12 can be threaded through several holes 32 located proximate to the opening end 6 of a hood 2 , such that when an elongated member 12 is drawn up, an opening end 6 is gathered and tightened around an animal&#39;s neck. An elongated member 12 can be secured in a drawn position via a cord lock device 14 , by tying the ends, or by any other known and/or convenient method. FIG. 15 depicts an embodiment in which an elongated member 12 is secured without the aid of a cord lock device 14 . [0047] In some embodiments, a hood 2 can be secured around an animal&#39;s head and neck without the use of an existing collar 18 . FIG. 19 depicts an embodiment in which a hood 2 is coupled with a built-in collar 34 . In this embodiment, a collar 34 can be tightened and secured around an animal&#39;s neck via a buckle mechanism or any other known and/or convenient tightening and fastening mechanism. A collar 34 can be made of nylon, leather, or any other known and/or convenient material. In some embodiments, a collar 34 can at least partially comprise reflective coating and/or material and/or battery or solar-powered lights so as to provide increased visibility of the animal in the dark. [0048] Although FIGS. 1-4 , 6 - 7 , 9 - 11 depict a hood 2 substantially made of one piece of material and one seam 4 , in some embodiments, a hood 2 can comprise a plurality of sections and seams 4 . As depicted in FIGS. 12-13 , parts of a hood 2 that are out of the line of sight of an animal can be made out of different material. In the embodiments depicted, sections 24 are comprised of more closely woven material that can provide further protection, reinforcement, and/or sun blockage. Sections 24 can be coupled with a hood 2 via stitching, adhesive, or any other known and/or convenient method of bonding at a seam 4 . [0049] FIGS. 16-17 depict embodiments in which a hood 2 is designed to fit animals with erect ears. In FIGS. 16A-16B , an ear section 28 can be coupled with a hood 2 and can be adapted to accommodate the height of an animal&#39;s erect ears. In FIGS. 17A-17B , a hood 2 can comprise darts 30 to create extra room at the top of the hood 2 for erect ears. [0050] Referring to FIG. 1 , in use, a pet owner can hold a hood 2 with a seam 4 facing the ground, and an opening end 6 substantially perpendicular to the ground and facing away from the owner and toward an animal. The owner can then guide an opening end 6 over the animal&#39;s head beginning at the animal&#39;s nose, and then progressing over the ears, to finally lay behind the ears on the animal&#39;s neck. The opening end 6 can then be secured around the neck by drawing up an elongated member 12 and securing it with a cord lock device 14 . Straps 16 can then be wrapped around the animal&#39;s own collar and secured at a length that is comfortable for the animal. In other embodiments, other methods of application and use can be employed, depending on user preference, hood 2 structure and design, and type and size of animal. [0051] Although a hood 2 has been described for use as a protective enclosure to keep pests or other harmful objects away from an animal&#39;s head, in some embodiments a hood 2 can be used to protect other people or animal&#39;s from the animal wearing the hood 2 by preventing biting, spread of disease, or other harmful activity by the animal. In yet other embodiments, a hood 2 can be used as a barrier to deter an animal from licking itself, irritating a wound, or interfering with a bandage or sutures after surgery or other medical procedures. A hood 2 can also prevent an animal from eating things it shouldn&#39;t, such as feces, plants, or other potentially harmful substances. [0052] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, the invention as described and hereinafter claimed is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

A head covering that protects a dog or other animal against the intrusion of harmful things or elements such as insects, foreign matter, and weed seeds, which can enter the animal's ears, eyes, or nose and cause discomfort or damage.

BACKGROUND OF THE INVENTION This invention relates generally to turf care equipment and more particularly concerns an improved blade for a turf spiker for aerating turf and reducing surface filming effects. By way of background, a turf spiker is a device which creates small cross-sectional area, relatively deep holes in a turf ground surface to allow air, moisture and other elements to penetrate the ground surface. The spike holes reduce surface filming effects and stimulate the growth of desirable grasses in the turf. One of the primary uses for a turf spiker is for spiking of golf course greens. Because of heavy demand for continuous play on golf courses, it is highly desirable to have turf care equipment which conditions the turf without substantially interfering with play. This has been a drawback of prior turf spikers. Prior art turf spikers have had what might be referred to as a star-shaped blade. The individual teeth of the blade have generally been substantially symmetrical about a line from the tooth tip to the axis of rotation of the blade. In general the leading and trailing edges of each tooth in prior art spiker blades have been straight line segments so that the portion of the blade penetrating the ground surface has been V-shaped. This type of prior art blade may be referred to for simplicity as a &#34;straight&#34; star-wheel blade. In turf spiking apparatus using the straight star-wheel blade at a setting at which the blade penetrates any substantial percentage of its radius, say greater than ten percent, a great deal of dirt, turf and other materials are lifted out of the spiker hole by the spiker blade and deposited forward of the spiker hole above the existing ground surface. This leaves a ruffled, unsightly appearance on the turf, especially on golf course greens. It also renders a green spiked with such a blade annoying and almost impossible to use for its intended purpose by golfers for a substantial time period after spiking of the green with such a blade occurs. The present invention is a spiker blade which accomplishes the important function of aerating and penetrating the ground surface but is capable of doing so without undesirable &#34;ruffling&#34; that is, deposit of substantial amounts of turf and dirt above the ground surface resulting from the spiking process. Thus after use of the turf spiker of the present invention for aeration of the green, the green surface has a relatively smooth, unruffled appearance which allows use of the green for putting immediately after the spiking operation has occurred. Furthermore, prior art turf spikers using traditional spiker blade configurations may be fitted with the present invention to enable them to eliminate the substantial shortcomings of prior art devices. SUMMARY OF THE INVENTION In accordance with the invention, a spiker blade adapted for mounting on the rotatable shaft of a turf spiker is provided. The spiker blade is configured with a plurality of teeth spaced about its periphery. Each of the teeth has a profile defined by its leading and trailing edges. The leading and trailing edges of the profile meet to form a tooth tip. The trailing edge of each tooth has a piercing segment leading upward from the tooth tip. Together with the entrance edge opposite the piercing segment these segments form a narrow tapered profile proximate the tip. Above the piercing segment on the trailing edge is a counterdepression segment directed at a substantially larger angle to said leading edge than said piercing segment. In opeation, the spiker blade will be mounted to penetrate to depth so that the counterdepression segment comes into contact with the ground surface during spiking thereof. The counterdepression segment forms a counterdepression in the turf slightly in front of the normal area swept out by the piercing segment of the blade. This allows material lifted upward by the piercing segment to be deposited in the counterdepression below ground level, leaving virtually no ruffling above ground level. In certain embodiments of the invention, the blade teeth will include an undercut segment separating the piercing and counterdepression segments of the trailing edges, the undercut segment sweeping out a lesser volume during spiking, therefore drawing less dirt, turf, and other material forward and upward during the spiking operation than would be lifted by a tooth without an undercut. BRIEF DESCRIPTION OF THE DRAWING Additional desirable features and advantages of the invention will become apparent upon particular reference to the drawings and detailed description which follow, in which: FIG. 1 is a sectioned side elevational view of a turf spiker assembly showing one embodiment of a spiker blade constructed according to the present invention; FIG. 2 is a greatly enlarged fragmentary view of a portion of the spiker blade of FIG. 1 with emphasis on the tooth profile to illustrate the important features of the profile characterizing the present invention; and FIGS. 3 and 4 respectively are sectional, partially subterranean representations showing successive positions of a spiker blade tooth constructed according to the present invention and a conventional spiker blade tooth during turf spiker operation, and illustrating the effect of each on the ground surface as well as resultant migration of material. While the invention will now be described in connection with preferred embodiments thereof, it will be understood that the invention is not limited in scope to those embodiments. On the contrary, all alternatives, modifications and equivalents included within the spirit and scope of the invention as defined by the appended claims are covered. DETAILED DESCRIPTION OF THE INVENTION Turning first to FIG. 1, there is shown in section a turf spiker assembly generally designated 10. Although a specific embodiment of a turf spiker assembly is shown and described in connection with the present invention in the sectional view of FIG. 1, it should be clearly understood that the spiker blade construction of the present invention is not limited to use with such an assembly. In fact, any spiker in which the spiking blades rotate into contact with the turf surface for the purpose of spiking could be adapted for use with the present invention. Turf spiker assembly 10 is illustrated with a section taken vertically through the turf spiker near one of the frame members thereof. Turf spiker assembly 10 rides on front and rear supporting rollers 12 and 14 respectively. Supporting rollers 12 and 14 provide rolling contact between turf spiker assembly 10 and a ground surface 16 defined by turf to be spiked. Assembly 10 includes two generally vertical frame members 18, only one of which is shown in the sectional view of FIG. 1. Extending horizontally and generally parallel between the two frame members are a tubular member 20, a spring tube 22 and front and rear supporting rollers 12 and 14. Tubular member 20, spring tube 22, rotatable shaft 24, and front and rear supporting rollers 12 and 14 are all shown in section in FIG. 1. Mounted generally parallel to member 20, spring tube 22 and rollers 12 and 14 is a rotatable shaft 24. One end of rotatable shaft 24 is received in a one way slip clutch gear box 26. Gear box 26 is fastened to frame or housing 18 by means of a number of ears 28 extending outward from gear box 26 through which bolts 30 fasten into frame 18. The opposite end of rotatable shaft 24 may extend through bearing means in the frame member opposite frame member 18. Considerable drawbar force, that is, force exerted in a direction parallel to ground surface 16, is required to move turf spiker assembly 10 forward and rotate the spiker blades of assembly 10 when the blades are in a penetrating position. Due to this significant drawbar force requirement, the traction unit used to move the assembly may not be able to develop enough traction to smoothly move the assembly depending upon the turf condition, moisture content, soil type and other factors. Therefore it may be desirable to apply power to rotatable shaft 24 from gear box 26 through conventional power transfer means not shown in the figure. In this way, the drawbar force exerted on the turf spiker assembly by the traction unit with which it is used may be supplemented by additional drawbar force supplied by powering rotatable shaft 24. Since the purpose of the turf spiker is to penetrate the ground surface rather than till it, it is vital that rotatable shaft 24 be powered to drive the spiker blades at a rate less than or equal to the forward motion of the tractor or prime mover with which the spiker assembly is used. In the turf spiker assembly shown in FIG. 1, this is accomplished by use of a gear box 26 with one way slip clutch which allows the rotatable shaft 10 to &#34;free wheel&#34; with no appreciable drag when the turf spiker assembly is pulled at a speed faster than it would normally travel under its own power. Also, to assure that the traction unit is not driven by the power provided to the rotatable shaft, the gear box and associated power train may be designed to drive the spiker blades at a speed less than the resultant speed of the traction unit. For example, in one embodiment, the resultant speed of the spiker blades was designed to be 93% of or, 7% less than, the speed of the traction unit. Keyed or otherwise fixed to rotatable shaft 24 by means of keys 32 is a spiker blade 34 constructed according to a preferred embodiment of the present invention. Although only one spiker blade 34 is shown in the sectional view of FIG. 1, it should be understood that a number of such spiker blades, say 8 or 10, would in the assembly be spaced along rotatable shaft 24 in different orientations to distribute the forces required for penetration and movement as evenly as possible over each revolution of shaft 24. Spiker blade 34 may be cut from a sheet of high carbon steel in a shape generally as shown in FIG. 1 or may be made from any other suitable material with strength and hardness appropriate to maintain its cutting edges. In one embodiment the spiker blades 34 were made from soft annealed, cold rolled steel 0.109 inch thick, then heat treated to give sufficient hardness. Each spiker blade has a number of spiking teeth located about the periphery thereof. The teeth extend generally radially from the center of a hole provided for mounting of the blade on rotatable shaft 24. The normal direction of rotation of spiker blade 34 and rotatable shaft 24 is shown by an arrow on the blade 34. In the particular embodiment shown, each tooth has a profile defined by a leading edge which is essentially a straight line segment and a trailing edge which includes a number of segments. One of the teeth on blade 34 has the leading edge thereof designated by reference numeral 36, and its trailing edge designated by reference numeral 38. These two edges meet to define a tooth tip 40. The details of spiker tooth construction and functions performed by various tooth segments are discussed in more detail in connection with FIG. 2. Attached to tubular member 20 is a U-shaped lift bail 42. In FIG. 1, the U of the bail is in a plane substantially perpendicular to the plane of the figure. The lift bail receives a lift arm or lifting linkage (not shown) attached to the traction unit for lifting the turf spiker assembly from contact with the ground during turns or other times when spiking of turf is not desired. Because turf spiker assembly 10 must exert a substantial downward force in order for the spiker blades to penetrate the ground surface, either the turf spiker must be heavily weighted or some downward force must be transferred to the assembly. In the embodiment shown in section in FIG. 1, this is accomplished by means of a torsion spring arrangement which transfers forces from the traction unit to the spiker assembly. One end of a torsion spring 44 on turf spiker assembly 10 is fastened to spring tube 22 by means of a spring anchor bolt 46. Torsion spring 44 is helically wound about spring tube 22. The end of torsion spring 44 opposite the end anchored by bolt 46 extends generally tangentially outward from spring tube 22 and ends in a hooked portion 48. Hooked portion 48 extends through a U-shaped bracket 50 attached to tubular member 20 to a position proximate lift bail 42. When the lift arm on the traction unit (not shown) raises assembly 10 by lift bail 42 to discontinue spiking, hooked portion 48 bears against bracket 50. However, when the lift arm lowers the turf spiker assembly to the ground surface the lift arm may engage hooked portion 48, effectively providing a point against which torsion spring 44 can flex and transfer its stored force through assembly 10 to the spiker blade teeth to aid in effective penetration of the ground surface. FIG. 2 is a greatly enlarged fragmentary view of a portion of spiker blade 34 constructed in accordance with the present invention. Spiker blade 34 has a center of rotation 56. Extending from center of rotation 56 to tooth tip 40 is a radial line which will, for purposes of this specification, be defined as a tooth axis 58. To the right of tooth axis 58 is entrance edge 36 which, together with trailing edge 38, defines the tooth profile. Entrance edge 36 is in the specific embodiment shown essentially a straight cutting edge. Trailing edge 38, on the other hand, is constructed from a number of individual segments. Beginning from tooth tip 40 these segments include a piercing segment 60, which in the figure is a straight line segment making a sharp acute angle with tooth axis 58, a curved undercut segment 62 extending slightly back toward tooth axis 58 from a point of greatest width of piercing segment 60, and a counterdepression segment 64, which is a generally straight line segment in the figure. Counterdepression segment 64 is directed more tangentially to the rotation center 56 than is piercing segment 60. Therefore, the portion of the tooth profile bounded by counterdepression segment 64 increases in thickness at a faster rate than the portion bounded by piercing segment 60. Stated another way, counterdepressionn segment 64 makes a substantially greater angle with tooth axis 58 than does piercing segment 60. Those of skill in the art will understand that the &#34;ruffling&#34; effect or migration of material caused by spiking will be minimized by minimizing the angle through which the tooth rotates while in contact with the turf and by minimizing the ratio d/r where d is the intended depth of tooth penetration, and r is the distance between the center of rotation of the spiker blade and the tooth tip. In order that counterdepression segment 64 may provide a place for the ruffled material to be deposited below the ground surface, the position of the counterdepression segment with respect to the remainder of the tooth profile is preferably maintained within predetermined limits. It has been found that the spiker blades constructed according to the present invention function more desirably if the position of the beginning of the counter-depression segment described as the limits of the distance P between the beginning of the segment and the center of rotation of the blade (identified by dotted line 66 in FIG. 2), is as follows: (r- 0.90d) ≦ P ≦ (R- 0.55d) (1) Where r is the distance from the center of rotation to the tooth tip and d is the intended depth of spike penetration. From industry standards, d will normally be between 0.75 inches and 2.50 inches. The constants 0.90 and 0.55 in the expressions above are the percentages of depth of spiker penetration that will not be disturbed by intrusion of the counterdepression edge. Stating the limits of P in words, the counterdepression segment functions most effectively to provide a counterdepression for deposit of ruffled material if it penetrates at least 10% of the total depth of spiked penetration, but it should not penetrate such a substantial portion of the total depth of penetration that in effect becomes a broad piercing segment. The relative angle of the counterdepression edge is also extremely important. Turf and dirt displaced from the counterdepression area must be displaced in a downward direction to prevent ruffling ahead of the counterdepression area from occurring. The relative angle A of the counterdepression edge controls the direction of displacement. The angle A may be defined as the angle between counterdepression segment 64 and a straight line between the blade center of rotation and the beginning of the counterdepression segment (dotted line 66 in FIG. 2). The preferred range for the relative angle A is as follows: ##EQU1## It should be noted that the constant 0.15 inches appears in this equation. This represents the maximum possible necessary ground clearance of the counterdepression segment. Expression (2) defines the limits within which the relative angle A can fall and still not significantly affect the direction that the material from the counterdepression segment is displaced, consistent with the limits placed on P by Expression (1). Expression (2) means that the relative angle of the counterdepression segment must be small enough so that the counterdepression segment is not below the ground surface when the segment is horizontal, yet large enough so that the counterdepression dirt does not itself cause &#34;ruffling.&#34; To provide the most clearance for the spiker tooth as it rotates through the angle during which it is in contact with the ground surface, the value of the angle B between the tooth axis and the line from tooth tip 40 to the beginning of counterdepression segment 64 is important. The smaller this angle is, the more clearance is allowed. However, one can see that if this angle were selected too small the strength of the spiking tooth tip would be unacceptable. It has been determined that it is preferable to maintain this angle B less than or equal to 15 degrees, consistent with sufficient strength in the tooth tip to perform the spiking task. In order to assure that the counterdepression segment results in an effective counterdepression area, it is desirable to maintain the length &#34;L&#34; of the counterdepression segment with preferred limits. These limits are set forth in the following expressions: ##EQU2## If &#34;L&#34; were longer than the upper limit shown in expression (4), the counterdepression segment would tend to roll back down into the turf as the tooth completed its intended rotation. On the other hand if &#34;L&#34; were shorter than the lower limit which appears in expression (3), the counterdepression segment would not continue to and rise above the turf surface smoothly. It should be clearly understood that the limits specified above are only preferred ranges for specific embodiments of the present invention. It is not necessary to the present invention that the spiker blade be constructed within all of the above limits. What is necessary is that the blade teeth be followed by some sort of counterdepression segment which creates a depression area by predominately compression force on the turf surface so that ruffled material lifted by the lower part of the tooth as it rotates through the earth may be deposited in the counterdepression area. FIGS. 3 and 4 illustrate the operation of the present invention by contrasting sequential positions of a portion of a blade constructed according to the present invention with those of a prior art blade as turf spikers with the blades move from left to right across a ground surface 70. FIG. 4 illustrates a prior art star-wheel spiker blade and its effect on the turf and ground surface. The sequence of tooth positions in FIGS. 3 and 4 are alphabetically labeled. Referring to FIG. 4, in position A the spiker blade tooth is beginning to pierce and penetrate surface 70 and is cutting into and downward through the ground surface. Positions B, C, and D show successive stages of greater penetration as the tooth moves downward and rotates toward a vertical position in the soil. At point E the blade is centered in the depression with the blade center of rotation directly over the tooth tip. Through the sequence of positions A, B, C, D, and E the turf and surrounding soil are put in compression by the movement of the tooth tip downward and forward into the turf. Continuing from position E in a cycloidal path, the tooth tip moves backward then forward and upward eventually clearing the ground surface. In so doing, the tooth sweeps out an area marked by crosshatching and identified with reference numeral 72. In positions occurring subsequent to position E, the trailing edge of the tooth is moving forward and upward. Friction between the trailing edge and the turf and soil draws the material previously in crosshatched area 72 forward of the hole above the ground surface to create a ruffle 74. This is the undesirable ruffle which the spiker blade construction in accordance with the present invention eliminates. Referring now to FIG. 3, sequential positions of a portion of a spiker blade with teeth constructed according to the present invention are shown. In positions A, B, C, and D the entrance edge and the piercing segment of the trailing edge of a tooth pierce, penetrate and compress the turf and surrounding soil creating the basic depression. At positions D and E the counterdepression segment begins to contact and create a downward compression force on the ground surface slightly forward of the basic depression. As in FIG. 4, position E is the position at which the tooth tip is directly under the center of rotation of the spiker blade. After position E, the blade tooth tip rotates in cycloidal fashion backward then upward and forward and is lifted out of the hole by rotation of the spiker blade. As this occurs however, the counterdepression segment continues to move downward compressing an area shown by a crosshatched area 76. This provides a counterdepression immediately forward of the basic hole for deposit of material lifted by the spiker tooth as it is removed from the hole. From FIG. 3, it will be seen that the undercut segment of the trailing edge of the tooth allows the tooth to sweep out a significantly smaller area as it is being withdrawn from the hole. A crosshatched area identified with reference numeral 78 represents the area from which material will be displaced by the tooth upward and into the counterdepression area. Unlike the action of the spiker tooth of FIG. 4, the action of the spiker tooth of FIG. 3 creates no above-ground surface ruffle. The material previously present in area 78 is redeposited in counterdepression 76 below the ground surface. It is apparent that the improved spiker blade accomplishes spiking without creating ruffling at the turf surface. From the foregoing description, it should be understood that it is not essential that the piercing or counterdepression segments of the trailing edge be straight line segments. It is sufficient that the piercing segment be configured to give as narrow as possible a tooth tip to minimize the amount of area swept out by the tooth tip, at the same time minimizing the size of the required counterdepression; and that the counterdepression segment exert a predominantly downward compression force so that it does not in itself cause above-ground ruffling of the turf. While the improved spiker blade has been described in conjunction with specific embodiments and ranges of parameters it is evident that a number of alternatives, modifications, and variations will be apparent to those of skill art in light of this description. Accordingly, it is intended to embrace all alternatives, modifications and variations falling within the spirit and broad scope of the appended claims.

A spiker blade for use on a turf spiker assembly to break and ventilate a ground surface thereby facilitating penetration of air, water and nutrient through the surface. The spiker blade has a tooth profile with a trailing edge having a counterdepression segment. The counterdepression segment functions to create a ground surface depression into which ruffled material kicked up by the tooth during spiking may be deposited. As a result, the ground surface after spiking has taken place is maintained relatively smooth with an unruffled appearance.

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation in part of U.S. patent application Ser. No. 12/383,207, entitled “Utensil Storage Stand”, filed on 20 Mar. 2009 now abandoned. The benefit under 35 USC §119(e) of the United States provisional application is hereby claimed, and the aforementioned application is hereby incorporated herein by reference. This application is related to U.S. patent application Ser. No. 29/108,107, entitled “Utensil Storage Stand”, filed on 8 Feb. 2008, now U.S. Pat. No. D595,996. This application is related to U.S. patent application Ser. No. 11/805,111, entitled “Utensil Storage Stand”, filed on 22 May 2007, now abandoned. FEDERALLY SPONSORED RESEARCH Not Applicable SEQUENCE LISTING OR PROGRAM Not Applicable TECHNICAL FIELD OF THE INVENTION The present invention relates generally to utensil storage. More specifically, the present invention relates to a utensil storage stand. BACKGROUND OF THE INVENTION Preparation of food in the kitchen sometimes is a quite complex affair requiring many pots, pans and kitchen utensils. Pots and pans are usually stored out of sight in the kitchen area and a majority of utensils may be stored in a drawer that is convenient to the food preparation area. Utensils may also be stored on a countertop that is near and convenient to the food preparation area. In preparing food or following a recipe the sequential use of many cooking utensils, and even the repeated use of the same utensil may be required, in which case it would be desirable to have a nearby and convenient place to store multiple utensils. Typically some form of open topped canister may be used to store numerous utensils on a countertop with no organization to the assembly of utensils that are accumulated in the canister. The open topped canister has the drawback of trapping and collecting dust and debris through its open top while also having the further disadvantage that the utensils may become tangled with one another and not easily withdrawn from the canister. In addition if utensils are placed in the canister just after being washed they may drip some moisture into the bottom of the canister where it can accumulate and create unhealthy conditions. Limited space on a countertop also limits the use of canisters because the utensils in the back of the canister are not easily accessible with the utensils in the front of the canister blocking an easy reach to the rear of the canister. The canister or area that is usually available for the storage of utensils may be typically below the kitchen cabinets thereby limiting the space above the canister that is available to reach the utensils in the rear of the canister. Utensil stands are known from which one may hang a utensil but either do not provide for rotation of the utensils or the compact storage of the utensils that are stored on the unit. Many utensils used in the kitchen have perforations in their handles that are there for the purpose of hanging the utensils when not in use. Putting these utensils in drawers or upside down in canisters does not utilize the perforations as originally intended by the manufacturer. Hanging the utensils on known non-rotatable and non-compact stands takes up too much counter space and is not convenient to the user. SUMMARY OF THE INVENTION This invention has to do with a utensil storage stand, which comprises a base, a column extending away from the base, a distal end on the column, and utensil engagement means rotatably mounted on the column. The utensil engagement means is mounted on the column a spaced distance from the base, usually the distal end of the column, by a ball bearing arrangement comprising plastic or ceramic races, co-operating with plastic or ceramic bearings interposed between the races. The utensil engagement means comprises a first set of radially extending spokes with enlarged perforations through the spokes and a second set of radially extending spokes with utensil support hooks extending from the spokes. The utensil engagement means is rotatably mounted with respect to the column having an axis substantially perpendicular to the plane of the base. The first set of radial support spokes preferably have enlarged perforations and hooks so that utensils may be stored and efficiently positioned on the storage stand. The utensil engagement means comprises a co-operating element for connecting to the column a cylinder having a bearing housing area, a bearing in said bearing housing area comprised of plastic inner and outer races with plastic or ceramic bearing interposed between the races. Radially extending spokes from the disk have enlarged perforations formed therein. Radially extending spokes from the cylinder have outwardly extending hooks with upwardly facing ends located thereon. The perforations will be spaced along the spokes extending from the disc and sized so as to allow utensil handles to pass therethrough for storage on the utensil storage stand. The upwardly facing hooks are preferably formed as pegs on the periphery of the radially extending spokes from the cylinder with the hooks having upwardly turned ends on the pegs. Preferably there will also be hooks or pegs with upturned ends located between the column and the radially extending spokes from the cylinder and the hooks or will form an acute angle of acute angle of 53 degrees plus or minus 5 degrees with the central longitudinal axis of the spokes. The utility engagement means located at a spaced distance from the support base may also be comprised of a polygonally sided disc with the spokes radially extending from the outer periphery of the polygonally sided disc. The perforations for holding the utensil handles are then formed in the polygonally sided disc. The open body of the cylinder creates a canister when combined with the disc. The disc spokes engage the cylinder slots which locks the cylinder and disc in a stationary position relative to each other as they are rotated around the central post via the connector creating a canister for the purpose of containing small kitchen items with the disc top acting as the floor or bottom of the canister. It is an object of the present invention to provide convenient storage facility for kitchen utensils. It is an object of the present invention to organize kitchen utensils on a convenient countertop location. It is an object of the present invention to provide a kitchen utensil stand that allows kitchen utensils to be easily stored and removed. It is an object of the present invention to provide a kitchen utensil organizer that is compact and easily accessible. It is an object of the present invention to provide a lazy-susan type of kitchen utensil organizer. It is an object of the present invention to provide a kitchen utensil stand with rotating storage hooks for hanging kitchen utensils thereon. It is a further object of the present invention to provide a utensil storage stand that will compactly store at least fifteen utensils at one time. It is a further object of the present invention to provide a storage stand having open perforations and hooks for easy compact and convenient access and storage. It is an object of the present invention to provide an easy assembled and/or disassembled utensil storage stand, where the stand is comprised four individual pieces: a base, a column, and a disc and cylinder which forms a utensil engagement top. It is an object of the present invention to provide a lightweight, compact utensil storage stand that may be disassembled into three pieces for shipping and cleaning purposes. TABLE OF NUMERICAL REFERENCES 100. Utility Storage Stand 101. Support Base 102. Central Post 103. Connector 104. Cylinder 105. Utensil Means 106. Disc 107. Slots 108. Perforations 109. Hooks 110. Upward Extending Section 111. Hooks 112. Cylinder Utensil Retaining Means 113. Disc Utensil Retaining Means 114. Cylinder Spokes 115. Disc Spokes 116. Co-operating Element of Releasable Attachment 117. Co-operating Element of Releasable Attachment 118. Co-operating Element of Releasable Attachment 119. Co-operating Element of Releasable Attachment 120. Ribs 121. Struts 122. Base 123. Bearing 124. Bearing Race 125. Bearing Race 126. Diameter Portion 127. Bearings 128. Upper Rib 129. Base Portion 130. Other Portion 131. Base 132. Top 133. Lower Rib 134 Canister 135 Disc Top BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate the present invention and, together with the description, further serve to explain the principles of the invention and to enable a person skilled in the pertinent art to make and use the invention. FIG. 1 is a top view of the utensil storage stand according to the present invention; FIG. 2 is a top view of the utensil storage stand according to the present invention; FIG. 3 is a partially expanded side view of the utensil storage stand according to the present invention; FIG. 4 is a side view of the utensil storage stand according to the present invention; FIG. 5 is a sectional view through FIG. 4 of the utensil storage stand according to the present invention; FIG. 6 is a top perspective view of the disc according to the present invention; FIG. 7 is a bottom perspective view of the disc according to the present invention; FIG. 8 is a top perspective view of the cylinder according to the present invention; FIG. 9 is an end planar view of the cylinder according to the present invention; FIG. 10 is a perspective view of the connector according to the present invention; and FIG. 11 is a side planar view of the connector according to the present invention. DETAILED DESCRIPTION OF THE INVENTION In the following are detailed descriptions of the invention of exemplary embodiments. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, but other embodiments may be utilized and logical, mechanical, electrical, and other changes may be made without departing from the scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined only by the appended claims. In the following description, numerous specific details are set forth to provide a thorough understanding of the invention. However, it is understood that the invention may be practiced without these specific details. In other instances, well-known structures and techniques known to one of ordinary skill in the art have not been shown in detail in order not to obscure the invention. Referring now to the invention in more detail, in FIGS. 1 and 4 there is shown a utensil storage stand 100 . The utensil storage stand 100 is comprised of a support base 102 . The support base 102 joins a central post 101 that arises and extends away from the support base 102 until it comes to a connector 103 . The connector 103 is rotatable with respect to the central post 101 and base 102 . The connector 103 has means on the central post 101 for allowing rotation of the utensil means 105 . The utensil means 105 is comprised of a cylinder 104 and a disc 106 , each having utensil retaining means 112 and 113 . The utensil means 105 may be formed out of one piece making the cylinder 104 and a disc 106 integral. As shown in FIGS. 8 and 9 , the utensil retaining means 112 of the cylinder 104 has a plurality of cylinder spokes 114 immediately extending from the cylinder 104 . On the distal end of the cylinder spokes 114 are upwardly facing hooks 109 shown on the periphery of the distal end of the cylinder spokes 114 with upwardly extending sections 110 , thereon forming an upwardly facing hook on the utensil connector 103 . Inwardly of the distal end of the cylinder spokes 114 , on the spokes 114 are two upwardly facing hooks 111 which preferably form an acute included angle with the longitudinal axis of the spokes 114 of approximately 53 degrees plus/minus five degrees. Hooks 111 , differ from the other hooks only in the fact that 111 designates the hooks having the specific relationship of the acute angle. The acute angle of 53 degrees allows utensils to be hung so as to have easy access on the stand and provide more space for storage. When the hooks are arranged at such angles the utensils, when hung on the hooks, will usually have their widest part facing each other with their narrowest dimension extending in a radial direction from the central column of the stand. The preferable arrangement is that there will be five spokes 114 on the disc means 106 and each spoke 114 will have at least one, most preferably two, upwardly facing hooks 109 on said arrangement. The open body of the cylinder 104 creates a canister 134 when combined with the disc 106 . The disc spokes 115 engage the cylinder slots 107 which locks the cylinder 104 and disc 106 in a stationary position relative to each other as they are rotated around the central post 101 via the connector 103 creating a canister 134 for the purpose of containing small kitchen items with the disc top 135 acting as the floor or bottom of the canister 134 . As shown in FIGS. 6 and 7 , the utensil retaining means 112 of the disc 106 has disc spokes 115 immediately extending from the disc 106 and having enlarged perforations 108 on the disc spokes 115 with each perforation 108 so that the handle of a utensil may extend through the perforation 108 and towards the support base 102 . The disc spokes 115 engage the cylinder slots 107 which locks the cylinder 104 and disc 106 in a stationary position relative to each other as they are rotated around the central post 101 via the connector 103 creating a canister 134 for the purpose of containing small kitchen items with the disc top 135 acting as the floor or bottom of the canister 134 . What is shown in FIG. 4 is a side view of the utensil storage stand 100 according to the present invention. The utensil storage stand 100 has a base 102 with a post 101 extending up from the base 102 to an upper utensil connector 103 . The utensil connector 103 has co-operating elements of releasable attachment shown at 116 and 117 . The post 101 extends into telescopic engagement with the upper utensil connector 103 through the cooperating elements 116 and 117 . Shown on the utensil means 105 are the perforations 108 with the spokes 107 extending out from the disc 106 and the cylinder spokes 114 immediately extending from the cylinder 104 and the upwardly facing hooks 109 shown on the periphery of the distal end of the cylinder spokes 114 with upwardly extending sections 110 , thereon forming an upwardly facing hook on the utensil connector 103 . Shown at the lower part of FIG. 4 are cooperating elements of releasable attachment shown 118 and 119 , in that 118 being at one end of the post 101 and 119 being a hole or perforation formed in the base 102 to accept the end 118 of the post 101 . In 118 of the post 101 will be telescopically engaged in hole 119 formed in the base 102 . Base 102 has struts 121 that are tapered ribs 120 that form a strengthening effect on the bottom of the base 102 . What is shown in FIG. 2 is the top perspective view of the base 102 with the perforation 119 shown therein having the post 101 shown with its end 118 in the perforation 119 , as can be seen therein. There will be a friction pressed fit between the end 118 of the column 101 and perforational hole 119 formed in the base 102 . Tapered ribs 120 on the sides of said perforation hole 119 engage the column end 118 so as to provide an increasing tight fit as the column end 118 is telescopically engaged in hole 119 . What is shown in FIG. 5 is a cross sectional view 5 - 5 through FIG. 4 of the utensil storage means 100 according to the present invention. The utensil storage means 100 has the post 101 that extends from the base 102 with the perforation 119 shown formed in the base 102 . The perforation 119 has sidewalls 121 and a base 122 as such that the end 118 of post 101 can be telescopically pressed and engaged into the hole 119 . On the top of the post 101 is shown the end 117 of the post 101 as it engages with the cooperating element of attachment 116 . The disc spokes 115 engage the cylinder slots 107 which locks the cylinder 104 and disc 106 in a stationary position relative to each other as they are rotated around the central post 101 via the connector 103 creating a canister 134 for the purpose of containing small kitchen items with the disc top 135 acting as the floor or bottom of the canister 134 . In an alternative embodiment, a lid can be provided which is removably attached to the cylinder at the opposing side of the cylinder that is mounted to the disc. As shown in FIGS. 10 and 11 , the cooperating element of attachment 116 is a circular rube like portion extending down from the utensil connector 103 and is telescopically engaged within 117 or the post 101 . The end 117 again forms a friction fit with the element 116 such that the parts may be easily assembled or disassembled, and when pressed together will tend to stay in an assembled configuration. The cooperating element of attachment 116 has struts that are tapered ribs 120 that form a strengthening effect on the top of the central post 101 . The disc 106 houses the plastic bearing race shown at 123 and 124 . As shown in FIG. 5 , the bearing race 123 and 124 is tightly fitted within the disc housing wall shown at 125 and an inner-race 124 is press fit over the up standing tubular or diameter portion 126 shown on the utensil connector 103 . A bearing 127 is interposed between the inter-race 124 and the other race 125 as such that the bearing means 127 holds the inter-race 124 in position with regard to outer race 125 . The inter-race 124 is rotatable in relation to 125 because of the bearings 127 , but is not linearly displaceable along the axis of the central post 101 . Preferably, the bearing races 124 and 125 are made of a plastic material and the bearing 127 is made of a ceramic material. It is however possible that all or both of the races and the bearings could be made of a ceramic material and/or a plastic material. It is preferable that the bearing, however, be comprised of plastic and ceramic with the plastic forming the bearing races and the ceramic material forming the bearing material between the bearing races. What also is shown in FIG. 4 is the upper end 116 of the central post 101 that is a pressed fit into the utility engagement means. The upper rib 128 is shown having a base portion 129 that tapers lower to the other portion 130 of the ribs as such that the end 116 of the post 101 will have cooperation elements that press fit between the two parts. Shown also in the lower portion of FIG. 4 is the base portion of the lower rib 131 having a top thinner section 132 of the lower rib 133 . The lower rib 133 is tapered also so that the rib is thinner at the top 132 than at the base 131 . In this manner the end 118 of the post 101 may then be pressed fit into the base and held together in that fashion. Thus, it is appreciated that the optimum dimensional relationships for the parts of the invention, to include variation in size, materials, shape, form, function, and manner of operation, assembly and use, are deemed readily apparent and obvious to one of ordinary skill in the art, and all equivalent relationships to those illustrated in the drawings and described in the above description are intended to be encompassed by the present invention. Furthermore, other areas of art may benefit from this method and adjustments to the design are anticipated. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents, rather than by the examples given.

A utensil storage stand, which comprises a base, a column extending away from the base, a distal end on the column, and utensil engaging means rotatably mounted on the column. The utensil engaging means is rotatably mounted on the distal end of the column by a ball bearing arrangement comprising plastic races cooperating with plastic or ceramic bearings interposed between the races. The utensil engagement means comprises a first set of radially extending spokes with enlarged perforations through the spokes and a second set of radially extending spokes providing utensil support hooks extending from the spokes. The utensil engagement means is rotatably mounted with respect to column having an axis substantially perpendicular to the plane of the base. The open body of the utensil engagement means creates a canister for the purpose of containing small kitchen items with the disc top acting as the floor or bottom of the canister.

FIELD OF THE INVENTION This invention relates generally to air cleansing devices. More particularly, this invention relates to ultraviolet irradiation and filtration devices. BACKGROUND OF THE INVENTION Ultraviolet (UV) light in the form of germicidal lamps has been used since the early 1900&#39;s to kill the same types of microorganisms that typically cause the same types of problems today. Since then, UV radiation in the short wave or C band range (UVC) has been used in a wide range of germicidal applications to destroy bacteria, mold, yeast and viruses. After World War II, the use of UVC rapidly increased. UVC is generally understood to exist in the 180 nm to 280 nm wave length area. Typical examples included hospitals, beverage production, meat storage and processing plants, bakeries, breweries, pharmaceutical production and animal laboratories; virtually anywhere microbial contamination was of concern. Early UVC strategies primarily consisted of an upper air approach. This method directed a beam across the ceiling of a room. During the 1950&#39;s when tuberculoses infections were on the rise, the use of UVC became a major component in the control and irradiation of TB. It was discovered that by placing UVC lamps in the air handling equipment, they could initially be more effective. However, certain conditions found within the air handling systems drastically reduced UVC performance. Moving air, especially below 77° F., over the tubes decreased the output and service life of conventional UVC products and thus their ability to destroy viable organisms. The use of UVC and HVAC systems virtually disappeared over the next decade due to the introduction of new drugs, sterilizing cleaners and control procedures combined with the performance problems of UVC lamps and air handling systems (reduced output, short tube life, and high maintenance). In order for UVC to be effective in the “hostile” environment of indoor central air circulating systems (or HVAC systems), a new method of producing effective UV had to be developed. The ability of ultraviolet light to decompose organic molecules has been known for a long time, but it is only recently that UV cleaning of surfaces has been explored. In 1972, it was discovered that ultraviolet light could clean contaminated surfaces. Plus, it was learned that there exists a predictable nanometer location of absorption of ozone and organic molecules. It was then learned that the combination of ozone and UV could clean surfaces up to two thousand times quicker than one or the other alone. However, from testing it can be seen that the destructive potential of a combination of UVC and ozone for system components is detrimental. The negative side effects of ozone are now known. In 1972, tests were conducted using a quartz tube filled with oxygen. A medium pressure mercury (Hg) UV source which generated ozone was placed within centimeters of the tube. A several thousand angstrom thick polymer was exposed to this and was depolymerized in less than one hour. The major products of this reaction were water (H 2 O) and carbon dioxide (CO 2 ). It was discovered that UV (300 nm and below) and oxygen played a major role in depolymerization. In 1974, research concluded that during such cleaning, the partial pressure of O 2 decreased and that of CO 2 and H 2 O increased, suggesting breakdown. It was also discovered that the absorption coefficient of O 2 increases rapidly below 200 nm with decreasing wave lengths. A 184.9 nm wave length (optimal spectral line for ozone generation) is readily absorbed by oxygen, thus leading to the generation of ozone (O 3 ). Ozone may be generated at undetectable levels at other wave lengths below 200 nm. Therefore, radiation emission below 200 nm was found undesirable. Similarly, most organic molecules have a strong absorption band between 200 nm and 300 nm. A wave length of 253.7 nm is useful for exciting and disassociating contaminant molecules. 265 nm was thought to be the optimal spectral line for germicidal effectiveness. The 253.7 nm wave length is not absorbed by O 2 , therefore, it does not contribute to ozone generation, but it is absorbed by most organic molecules and by ozone (O 3 ). Thus, when both wave lengths are present, ozone is continually being formed and destroyed. Unfortunately, previously existing lamps operated between 250 nm and 258 nm, peaking at 254 nm, missing out on the optimal 265 nm goal. With regard to HVAC systems, biological contaminants are difficult to control because they grow in our moist, indoor environment. The most common strategy is to try to use an effective air system filter to rid indoor air of biological contaminants. While this is an important element of cleaning air, this has its problems. Most filters are inadequate because of the many organisms that pass right on through the filter. Also, any organisms that collect on the filter can form germ colonies that may soon contaminate passing air. Further, if the filter should be too efficient, it blocks the passage of air and creates back pressure, causing the blower to struggle to move air through the system. Furthermore, when the system is turned off, natural temperature differences between the system and indoor air spaces cause convection or back draft flow into the supply ducts (bypassing the filter). This causes contaminants to be pulled back into the duct work, implanting microbes in the air flow duct cavity. These new cultures become added sources of contaminant. In the past, to try to eliminate the biological contaminants in ducts, a common strategy was to clean the ducts followed by a biocide treatment. But this has its draw backs also. Most biological contaminants return and are active in the treated area within three months. Further, if the system is being treated for severe contamination such as legionela, an acid wash of the coil is common. This is not only expensive, but can shorten the life of the equipment. Furthermore, all biocide used in the ducts are chemical based, leaving potential toxic vapors and chemical pollutants circulating in the system as well. For obvious health reasons, the preferred way to control biological contaminants is through natural, non-polluting strategies. As indicated above, the effective killing power of UV seemed to be greatest at 265 nm. However, conventional UV has its maximum intensity at 254 nm. Furthermore, the intensity degrades as a function of temperature and distance. This was due to the conventional tubes being designed as long, straight lamps. The following prior art reflects the state of the art of which applicant is aware and is included herewith to discharge applicant&#39;s acknowledged duty to disclose relevant prior art. It is stipulated, however, that none of these references teach singly nor render obvious when considered in any conceivable combination the nexus of the instant invention as disclosed in greater detail hereinafter and as particularly claimed. SUMMARY OF THE INVENTION An air cleaning apparatus is disclosed including UV lamps, aluminum filters, and a polished aluminum housing. The UV lamps include a U-bend crystal of quartz, ruby, or sapphire contained within a quartz sleeve. Useful substances for containment within the U-bend bulb are mercury, argon, gallium, iron, xenon or krypton. Between the sleeve and lamp, certain gases (nitrogen or atmospheric gases) are contained therein or the area is possibly evacuated. There are advantages and disadvantages to each. By using a mixture of above gases and/or by varying the electrical charge, one can increase the bandwidth to about 240 nm to about 280 nm, including the 265 nm optimum wave length. Further, increased electrical charge can increase bandwidth and spectral line output from 240 nm to 360 nm for more germicidal effect (UVC/UVB). Polished aluminum filters and chamber walls are also included in this invention. The treated, polished aluminum alloy provides enhanced reflectivity for the UV rays to enhance the irradiation of particulate flowing through the filters and by the lamps. The aluminum filters have an additional special feature in that one side of the filter is of a coarse mesh whereas the other side of the filter is of a fine mesh. Air flow is from the coarse side to the fine side of one filter, past the UV bulbs, through the fine side, and out the coarse side of another aluminum filter and then back into the duct work of an HVAC system. By providing treated, polished aluminum surfaces surrounding the UV lamps, irradiation is enhanced significantly. An alternate embodiment in the form of a portable air cleaning device is also described herein. The purpose of the portable device is to clean a single room with a similar system as described hereinabove, but also including a fan built into the portable unit to move through the system. Another embodiment is described wherein a UV lamp array is mounted exterior to a compressor coil of an HVAC system thereby allowing for cleansing of contaminants contained on the coil and fin structure of the compressor. It has been known that this is a breeding ground for microorganisms and cleansing of this breeding ground will enhance cleansing of the entire HVAC system. OBJECTS OF THE INVENTION Accordingly, it is a primary object of the present invention to provide an ultraviolet ray actinism chamber for destroying contaminants thereby. Another object of the present invention is to avoid the production of ozone in such a system. Another object of the present invention is to provide increased UV bandwidth to so increase the “killing” power of the UV system. Another object of the present invention is to maintain a substantially constant temperature around the UV bulb. Another object of the present invention is to increase UV reflectivity in and around the UV bulbs to enhance the UV irradiation. Another object of the present invention is to provide self cleaning filters for a UV system. Another object of the present invention is to provide better, yet shorter lamp lengths to fit in conventional HVAC systems. Yet another object of the present invention is to enhance the bulb life of a UV bulb for such a system. Viewed from a first vantage point, it is an object of the present invention to provide an apparatus for purging impurities from ambient conditions, comprising, in combination, a source of radiation in operative communication with the ambient conditions, and means for maintaining the source in a preferred temperature range to promulgate radiation emissivity. Viewed from a second vantage point, it is an object of the present invention to provide a method for sterilizing air, the steps including, passing the air adjacent a source of ultraviolet light, and resisting temperature drop of the ultraviolet light caused by the passage of the air. Viewed from a third vantage point, it is an object of the present invention to provide a chamber for cleansing ambient air, comprising, in combination, an air inlet, an air outlet, the chamber interposed and communicating between the inlet and outlet, a source of radiation in the chamber, the chamber imperforate to the radiation, and the chamber having an interior surface with means for reflecting substantially all the radiation. These and other objects will be made manifest when considering the following detailed specification when taken in conjunction with the appended drawing figures. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of the UV lamp of the present invention. FIG. 2 is a top view of the invention. FIG. 3 is a cross-sectional front view taken along lines 3 — 3 of FIG. 2 . FIG. 4 is a cross-sectional side view taken along lines 4 — 4 of FIG. 2 . FIG. 5 is an exploded parts perspective view of the invention. FIG. 6 is a perspective view of a portable alternate embodiment of the invention with a side panel and curved reflective plate projected. FIG. 7 is a perspective view of an external alternate embodiment of the invention. FIG. 8 is a perspective view of the electrode connection of the invention. FIG. 9 is a cutaway view of the chamber of the invention showing rays bouncing within the chamber of the invention. FIG. 10 is a top cutaway view of the coarse filter weave. FIG. 11 is a top cutaway view of the fine filter weave. DESCRIPTION OF PREFERRED EMBODIMENTS Considering the drawings, wherein like reference numerals denote like parts throughout the various drawing figures, reference numeral 10 is directed to the air actinism chamber according to the present invention. The invention consists of three main components: UV lamp 50 , photon chamber 34 and filters 20 . Each component will be described more particularly below. As seen in FIGS. 1 and 8, UV lamp 50 consists of a U-shaped UV quartz, ruby, or sapphire crystal 12 (with quartz being preferred), a quartz sheath 14 , lamp coupling overlay 16 , lamp base 32 , U-shaped bulb gases 41 , and lamp gas 44 . U-shaped bulb 12 is preferably a quartz glass tube up to fifty inches long that is bent at the center to form a U-shaped bulb filled with one or more of the following: mercury, argon, iron, gallium, xenon or krypton. Aluminum metal or ceramic material is machined for the base 32 of the lamp for holding both the lamp tube 12 and electrode igniters 18 . That, preferably aluminum coupling 16 allows for good heat transference resulting from the heating of electrodes 18 inside the aluminum coupling 16 . That convection heat will be used to maintain its own stabilizing environment around the U-shaped bulb 12 and within the quartz sleeve 14 regardless of ambient temperatures. Once the U-shaped bulb 12 is mounted onto the aluminum coupling 16 at the point where electrodes 18 extend from within the coupling 16 , a gas or gas mixture is sealed within quartz safety shield sleeve 14 . That gas or gas mixture is preferably comprised of nitrogen, ordinary air, or evacuated space. By using just air, an approximately 3% loss of intensity of UV is suffered, but certain other costs are lessened. The 3% loss could be eliminated by evacuating the space, however, heat convection does not work as well without gases. Nitrogen gas hermetically sealed under the shell 14 seems to be best, but manufacturing is more complicated. By sealing the U-shaped quartz bulb 12 within shield 14 a constant temperature around bulb 12 is maintained at approximately 80° F. to 90° F. This has been found to be the case even when ambient air temperatures are as low as 45° F. The entire lamp 50 coupled to a proper power supply, as seen in FIGS. 1 and 5, then, for all normal intents and purposes, has the ability to maintain the highest level of intensity regardless of surrounding air temperature or air speed. UV lamp 50 provides a broader bandwidth compared to conventional UV lamps. As described above, conventional UV lamps emit a bandwidth of about 250 nm to 258 nm. UV lamp 50 provides a bandwidth of about 240 nm to 280 nm, including the optimal 265 nm wavelength and provides approximately six times the UV intensity of conventional lamps at colder temperatures. Furthermore, this is achieved while ambient air temperature around UV lamp 50 is 45° F. to 90° F. Although more power may be required, it has also been discovered that operation at “medium-pressure” will achieve a bandwidth of 230 nm to 380 nm, with an excellent spike at 264 nm. Another optimum point has also been discovered between 310 nm and 340 nm. So, although greater power, and therefore cost, may be required, greater particulate destruction is possible. The chamber is shown in FIGS. 2 through 5. Lamps 50 are then mounted into housing 28 that includes the electronics and power supply to drive the lamps 50 . The power supply is preferably either a matched 110 or 220 volt AC input power supply having a power cord 64 . To start the lamp, the power supply sparks the UV gas core 44 and ignites it from a cold start with a temporary voltage spike of about 3,000 volts passing through electrodes 18 and wires 19 to the substances contained within bulb 12 . Once the substances are ignited by this starting voltage, the power supply output voltage adjusts down to an operating voltage of about 200 volts to 240 volts AC. By inserting lamps 50 into a chamber of an HVAC unit, UV irradiation of air flowing over and by the lamps 50 is achieved. However, the actinism in the chamber can be enhanced by using special aluminum filters 20 and reflective surfaces within chamber 34 . UV ray reflection can be accomplished by several surface types. Magnesium Oxide, for instance, has been found to achieve the greatest reflectivity (75% to 90%), but is not suited for normal use due to its negative properties. Polished aluminum alloy (treated with Alzak), on the other hand, can achieve up to 95% reflectivity and is well suited to production and manufacture. Typical duct liner reflects 0% to 1% of UV rays which is a draw back of the prior art. Even stainless steel only achieves 25% to 30% reflectivity. Therefore, treated aluminum alloy is preferred. First, with regard to the filters, a two layered filter constructed of buffed aluminum is preferred. A first coarse layer 22 on an outside of the filter 20 and a second fine mesh layer 24 on the inside of the filter is preferred, wherein the mesh is a wavy aluminum strand weave 21 (FIGS. 10 and 11 ). That weave may also consist of ribbons of aluminum strands 21 A, 21 B, 21 C interwoven with other such ribbons 21 D, 21 E, 21 F, as shown in FIG. 10 . As air flows through the coarse mesh 22 large particulate can be captured and irradiated within the filter before exiting through fine mesh 24 . Additionally, because the mesh is polished aluminum and of a reflective nature, reflection of the UV rays is thereby enhanced. Particles trapped within the filter will be bombarded with UV until destroyed, thereby causing the filters to be self-cleaning within the effective irradiation range. Furthermore, by providing curved side panels 26 running parallel to the lamp that are also made of treated aluminum and polished, reflection is additionally enhanced. The curvature tends to reflect UV rays back toward the central portion of the chamber 34 . By also providing wall 42 and bottom wall 40 of a polished aluminum material, maximum reflective irradiation is achieved. The UV rays will either strike particulate directly or be reflected about the chamber enhancing the irradiation bombardment. Certainly, by sizing the chamber 34 appropriately, it could be retrofitted within existing certain HVAC filter housings without modification to the existing housings. However, where an HVAC unit is of an unusual size, minor modifications may be rendered so to fit chamber 34 . In use and operation, air A traveling through the duct work of a HVAC system will travel through a first aluminum filter 20 by way of its coarse mesh 22 and then its fine mesh 24 . Thereafter, the air enters chamber 34 and flows by UV lamps 50 , the whole time being irradiated. The air then exits the actinism chamber 34 through the mesh 24 of another aluminum filter 20 and out through coarse mesh 22 . Thereafter, having been irradiated and filtered, the air is returned to the HVAC ducts. Any particulate remaining in filter 20 mesh will continue to be irradiated until destroyed by UV lamps 50 as seen in FIG. 9 . The above-described configuration is ideal for insertion into the return of an HVAC system. FIG. 6 depicts a similar, but alternative embodiment for portable use within a room. Fan 46 provides for the air flow A of this portable device through similar but smaller aluminum filters 20 . Between the filters 20 , again are maintained one or more UV lamps 50 . To transport this item, handle 48 is also provided. Reflective enhancement of the radiation is likewise caused by a plurality of polished aluminum surfaces throughout the inside of the chamber. This is an ideal apparatus for cleaning the air in a single room. FIG. 7 depicts another alternate embodiment for use with an external HVAC device. An evaporative coil 54 coupled to a typical compressor 52 having fins 56 thereby is depicted in FIG. 7 . To prevent contamination build-up and to destroy contamination build-up on or about coil 54 , UV lamp or lamps 50 are mounted near coil 54 . By continuing the lamps 50 in an “on” setting, and additionally using the reflective properties of the aluminum fins, any contamination on or near the coils is eliminated. By maintaining this area in a clean manner, air flow over the area and into the duct work of an HVAC system will be less likely to carry such contamination. Moreover, having thus described the invention, it should be apparent that numerous structural modifications and adaptations may be resorted to without departing from the scope and fair meaning of the instant invention as set forth hereinabove and as described hereinbelow by the claims.

An apparatus and method for ultraviolet irradiation of air for the purpose of removing contaminants from that air is disclosed. A U-shaped ultraviolet bulb enshrouded within a quartz tube provides enhanced contaminant destruction characteristics. By combining a plurality of those bulbs in a chamber that is of polished aluminum, and further combining aluminum filters therewith, added irradiation enhancement is achieved.

[0001] The present invention claims the benefit of US provisional application Ser. No. 61/040,891 filed on Mar. 31, 2008, which is incorporated herein by reference. [0002] In skin ageing, disequilibrium occurs in the balance between synthesis of the extracellular matrix (ECM) and its degradation by matrix metalloproteases (MMPs). This disequilibrium leads to an excessive degradation of the extracellular matrix, a characteristic of skin ageing (Cauchard &amp; Hornebeck (2004) Vivant 5). Skin ageing is associated to an increase in the number and the deepness of wrinkles, a direct consequence of the degradation of macromolecules of the dermis, such as collagens and elastin. [0003] In dermis, MMP overproduction which occurs in chronological and photo-induced ageing is stimulated by oxygenated free radicals. Besides, in skin areas exposed to sun, such as facial skin, other deleterious effects of UV rays occur, in particular incomplete collagen synthesis, skin pigmentation, and solar elastosis (which presents as a degradation of the cutaneous elastic lattice). Furthermore, in vitro studies have shown that MMP are overproduced by skin fibroblasts submitted to UV-ray treatment (Brennan et al. (2003) Photochem. Photobiol. 78:43-48) [0004] Collagenases 1 and 3 (MMP-1 et MMP-13) and MT1-MMP (MMP-14) degrade collagens, while gelatinases A and B (MMP-2 and MMP-9) degrade elastin. Other metalloproteinases such as stromelysin 1 (MMP-3) are involved both in collagen and elastin degradation. [0005] Dermal fibroblasts have been used in the frame of the treatment of skin ageing (Weiss et al. (2007) Dermatol Surg. 33:263-8). An increase of the collagen lattice could be observed in 215 subjects injected autologous dermal fibroblasts (20 millions/ml) in deep wrinkles. The improvement in wrinkles was still clearly visible on 80% of the subjects, one year after injection. [0006] Gingival fibroblasts are mesenchymal cells which are capable of migrating, adhering and proliferating within the soft connective tissues of the gum, thereby maintaining the integrity of the gingival tissue which is exposed to numerous aggressions, such as mechanical stresses, bacterial infections, or pH and temperature variations. Gingival fibroblasts are in particular described in Gogly et al., (1997) Clin. Oral Invest. 1:147-152; Gogly et al. (1998) Biochem. Pharmacol. 56:1447-1454; and Ejeil et al. (2003) J. Periodontol. 74:188-195. [0007] Depending on environmental conditions, gingival fibroblasts are capable to modulate their phenotype, and to respond by proliferating, migrating, synthesising matrix components or matrix-related enzymes. [0008] Gingival fibroblasts synthesise collagens (e.g. types I, III, V, VI, VII, XII), elastic fibers (oxytalan, elaunin and elastin), proteoglycans and glycosaminoglycans (e.g. decorin, biglycan), and glycoproteins (e.g. fibronectin, tenascin). Simultaneously, gingival fibroblasts synthesise enzymes that are able to degrade the macromolecular compounds (matrix metalloproteinases; MMPs), but also enzymes inhibiting active forms of MMPs (Inhibitors of metalloproteinases; TIMPs). Gingival fibroblasts are thus important actors of extracellular matrix remodelling. SUMMARY OF THE INVENTION [0009] The present invention arises from the unexpected finding, by the inventors, that gingival fibroblasts are more suited than dermal fibroblasts for inhibiting MMP activity originating from UV-treated dermal fibroblasts. [0010] Thus, the present invention relates to a method for the cosmetic prevention or treatment of skin ageing in an individual, comprising administering to said individual a cosmetically active quantity of a gingival fibroblast-derived product. [0011] The present invention also relates to a gingival fibroblast-derived product for use in the prevention or treatment, in particular the cosmetic prevention or treatment, of a skin ageing in an individual. DESCRIPTION OF THE FIGURES [0012] FIG. 1 represents the quantity of MMP-9 (vertical axis, pg/100,000 cells) in the culture medium of: untreated human dermal fibroblasts (hDF); 7.5 Joules/cm 2 UV-A-treated human dermal fibroblasts (hDFi1); hDFi1 in the presence of human gingival fibroblast conditioned medium (cmhGF); hDFi1 in the presence of human dermal fibroblast conditioned medium (cmhDF); 15 Joules/cm 2 UV-A-treated human dermal fibroblasts (hDFi2); hDFi2 in the presence of human gingival fibroblast conditioned medium (cmhGF); and hDFi2 in the presence of human dermal fibroblast conditioned medium (cmhDF). [0013] FIG. 2 represents the concentration of TIMP-1 (vertical axis, pg/ml/100,000 cells) in human dermal fibroblast conditioned medium (cmhDF), in the culture medium of UV-A-treated human dermal fibroblast at 7.5 Joules/cm 2 (hDFi1) or 15 Joules/cm 2 (hDFi2), or in human gingival fibroblast conditioned medium (cmhGF). [0014] FIG. 3 represents the concentration of MMP-9/TIMP-1 complexes (vertical axis, pg/ml/100,000 cells) in the culture medium of: untreated human dermal fibroblasts (hDF); 7.5 Joules/cm 2 UV-A-treated human dermal fibroblasts (hDFi1); hDFi1 in the presence of human gingival fibroblast conditioned medium (cmhGF); hDFi1 in the presence of human dermal fibroblast conditioned medium (cmhDF); 15 Joules/cm 2 UV-A-treated human dermal fibroblasts (hDFi2); hDFi2 in the presence of human gingival fibroblast conditioned medium (cmhGF); and hDFi2 in the presence of human dermal fibroblast conditioned medium (cmhDF). DETAILED DESCRIPTION OF THE INVENTION [0015] As intended herein “skin ageing” relates to skin defects which occur as a consequence of a degradation of skin constituents due to chronic factors, such as mechanical, oxidative and/or photo stresses. [0016] In particular, skin aging can be a consequence of chronological ageing and/or photo-ageing. “Chronological ageing” relates to skin defects which occur as a consequence oldness. “Photo-ageing” relates to skin defects which occur as a consequence of skin exposition to light, and in particular to UV rays, more particularly UV-A rays. [0017] The skin defects can notably be wrinkles or loss of skin elasticity. The degraded skin constituents can be elastin and/or collagens, which the method according to the invention is useful for increasing synthesis thereof within dermis. [0018] Preferably, the method of the invention is for the prevention or treatment of facial skin ageing. [0019] Preferably the individual is a mammal and more preferably a human. [0020] Procedures for taking, culturing and preserving gingival fibroblasts are well known to the man skilled in the art and are particularly described in Naveau et al. (2006) J. Periodontol. 77:238-47 and in Gogly et al. (2007) Arterioscler. Thromb. Vasc. Biol. 27:1984-90. [0021] Advantageously, gingival fibroblasts are easily sampled and cultured. Besides, gingival fibroblasts possess a high expansion rate. [0022] Preferably, the gingival fibroblasts used in the method according to the invention are autologous, that is they are taken from the individual, to whom the gingival fibroblast-derived product is intended to be administered. [0023] Advantageously, gingival fibroblasts provide for an almost limitless source of autologous fibroblasts. Furthermore, in case of aged skin, culture-competent autologous gingival fibroblasts are usually still available, whereas, in contrast, sources of culture-competent autologous dermal fibroblasts are scarce. [0024] However, the gingival fibroblasts can also be allogenic, that is taken from another individual of the same species or heterologous, that is taken from another individual of another species. [0025] As intended herein “gingival fibroblast-derived product” relates to any product which can be obtained from gingival fibroblasts in themselves or which contains gingival fibroblasts secretions. For example, it is preferred that the gingival fibroblast derived product is selected from the group consisting of gingival fibroblast whole cells, a gingival fibroblast culture, a gingival fibroblast extract, and a gingival fibroblast conditioned medium. [0026] Gingival fibroblast extracts can be obtained by any cell fragmentation method known in the art. [0027] Gingival fibroblast conditioned medium relates to any medium, such as a liquid cell culture medium, which has been contacted by gingival fibroblasts, in particular for a time sufficient for the gingival fibroblasts to have secreted in the medium. [0028] Administration of the gingival fibroblast-derived product, preferably at a site near the skin area to be treated, can proceed by any method known in the art. However, it is preferred that the gingival fibroblast-derived product is administered topically or by intradermal injection. Such administration routes are well known to anyone of skill in the art and are notably described by Weiss et al. (2007) Dermatol Surg. 33:263-8. [0029] Preferably, the method according to the invention comprises the following steps: taking gingival fibroblasts from the individual; culturing the gingival fibroblasts; obtaining a gingival fibroblast-derived product from the cultured gingival fibroblasts; administering the gingival fibroblast-derived product to the individual. [0034] All cited references are incorporated herein by reference. EXAMPLE Methods 1. Cell Culture [0035] Five human gingival fibroblast (hGF) and three dermal fibroblast (hDF) cultures were obtained from gingival and dermal explants of healthy patients (20-30 years old). Primary explant cultures were established and used from passage 3 to 5. Preparation of hGF or hDF Conditioned Medium [0036] The culture medium (DMEM/FCS) from 75 cm 2 flasks of confluent hGF and hDF cultures, was discarded. 24 ml of DMEM was then added and retrieved 24 hours later. Conditioned medium was then freezed until use. Preparation of Cells [0037] Three 12-wells plates were seeded with hDF from two 25 cm2 flasks at confluence. When confluence was reached (150,000 cells per well), 2 plates were UVA-irradiated respectively at 7.5 and 15 joules/cm 2 , the third plate was used as a control, to check for the absence of MMP-9 in absence of irradiation. [0038] The culture media were changed after irradiation. For each flask, the following media were added: DMEM only for 4 wells (1 ml per well) hGF conditioned medium for 4 wells (1 ml per well) hDF conditioned medium for 4 wells (1 ml per well) [0042] Culture media were then collected 24 h later, aliquoted and stored at −80° C. for further protein secretion analysis. Cells were fixed in the wells and GIEMSA stained. 2. MMP-9 and TIMP-1 Secretion Analysis Gelatin Zymography (MMP-9) [0043] Gelatin zymographies were performed on 20 μl of culture medium. 10 μl of pro-MMP-9 (92 kDa) and 10 μl of pro-MMP-2 (72 kDa) (10 ng) (BC058 and BC057; ABCys) were ran on the same gel in order to facilitate the identification of the MMP types. Furthermore, 10 μl of pro-MMP-9 incubated with APMA (2 mM) at 37° C. for 1 hour was ran in parallel to visualize MMP-9 position. Dot Blotting (MMP-9 and TIMP-1) [0044] 10 μl of culture media were applied onto nitrocellulose membrane. Membranes were then treated with primary anti-MMP-9 (free form) and anti-TIMP-1 (IM37 and IM32, respectively; Calbiochem) monoclonal mouse antibodies at a 1/500 dilution. Following washing in TBS/Tween (50 mM Tris, 150 mM NaCl, 0.1% Tween 20, pH 7.5), membranes were incubated with a peroxydase-labelled goat anti-mouse secondary antibody ( 1/1000, DC08L; Calbiochem) for 1 hour. Immunoreactive proteins visualized on Kodak Biomax MR films. The size of the blot (surface area) and grey intensities were analysed using Image J software (Image J; http:/rsb.info.nih.gov/ij/index.html). Concentration was determined by comparison with 10 pg MMP-9 or TIMP-1 standards (PF140 and PF019, respectively; Calbiochem). [0045] Complementary quantitative analysis of free MMP-9 and TIMP-1 were made by ELISA (DMP900 and DTM100; R&amp;D Systems). [0046] Statistical analysis between the different experiments was performed using Paired Student&#39;s t-test. 3. MMP-9/TIMP-1 Complexes Determination [0047] Total human MMP-9/TIMP-1 complexes were quantified, using an enzyme-linked immunosorbent assay kit (ELISA) (DY1449; R&amp;D Systems). Results [0048] 1. Conditioned Medium from Human Gingival Fibroblasts Inhibits MMP-9 from UV-Irradiated Human Dermal Fibroblasts [0049] FIG. 1 shows that human dermal fibroblasts (hDF) do not produce MMP-9 except after irradiation by UV-A at 7.5 joules/cm2 (hDFi1) or 15 joules/cm2 (hDFi2). A human gingival fibroblast conditioned medium (cmhGF) reduces MMP-9 production by UV treated-dermal fibroblasts by 50%, while a human dermal fibroblast conditioned medium (cmhDF) reduces MMP-9 production by only 15%. [0000] 2. Human Gingival Fibroblasts Produce More TIMP-1 (MMP-9 Tissular Inhibitor) than Human Dermal Fibroblasts [0050] FIG. 2 shows that hGF conditioned medium of contains at least 3 times more TIMP-1 than that of hDF, irradiated or not. 3. Increase in the Quantity of MMP-9/TIMP-1 Complexes in the Presence of Human Gingival Fibroblasts [0051] FIG. 3 shows that the quantity TIMP-1/MMP-9 complexes is twice as important in the presence of cmhGF as in the presence of cmhDF.

The present invention relates to a method for the cosmetic prevention or treatment of skin ageing in an individual, comprising administering to said individual a cosmetically active quantity of a gingival fibroblast-derived product.

This application claims the benefit of copending U.S. Provisional Application No. 60/087,391, filed May 30, 1998. FIELD OF THE INVENTION The invention relates to a method of controlling the fiber, digestible nutrients and crude protein in alfalfa. Specifically, it relates to the application of a acylcyclohexanedione Plant Growth Regulator to alfalfa sufficient to improve overall alfalfa quality. BACKGROUND OF THE INVENTION Alfalfa (Medicago sativa) is a forage crop grown primarily for its nutritive properties. Crude protein is the measure of the total nitrogen in a forage. It includes true plant proteins and non-protein nitrogen compounds, both of which are useable by ruminant animals. High protein content is the primary reason that legumes such as alfalfa are grown for forage. Another important measure of nutritive value for forage crops is how digestible the crop is. Acid detergent fiber (ADF) is that portion of the forage remaining after treatment with detergent under acidic conditions. ADF measures cellulose, lignin, and silica. As the value of ADF increases, the forage becomes less digestible. Lastly, nutritive value of the forage measured by percent total digestible nutrients (TDN) which is equal to the sum of percent digestible protein, percent digestible crude fiber, percent digestible starch and sugar and percent digestible fat. Plant growth regulators (PGR&#39;s) are used in a wide variety of crops. There are a number of different types of PGR&#39;s, including anti-gibberellin, auxin-like, anti-auxins, and ethylenegenerators which have a wide ranging and unpredictable effect. Prohexadione belongs to a new family of plant growth regulators (acylcyclohexanedione type plant growth regulators). These growth regulators block the biosynthesis of gibberellin (GA). Gibberellin is mainly responsible for controlling cell elongation. When gibberellin biosynthesis is blocked, plant cells will divide normally but the cells will be shorter. This results in shorter plants (reduced stature). Inhibitors of gibberillin biosynthesis are used in many crops to reduce stature, prevent lodging and the like. U.S. Pat. No. 4,560,403 describes prohexadione (3-hydroxy4-propionyl-5-oxo-3-cyclohexene carboxylic acid) and a number of other compounds of a class of cyclohexene plant growth regulators. No information to date has been available on the actual effect of this new group of growth retardants, the acylcyclohexanediones, on alfalfa. Plant growth regulators have been tested for further effects on the nutritive value and yield of alfalfa (Can. J. Plant Sci. 68:95-101). PGR&#39;s were tested from various classes of PGR&#39;s including anti-gibberellins; however, no acylcyclohexanedione types were tested. The results varied with all groups and appear to be total unpredictable, with both positive and negative neutral results both overall and for individual parameters. Within the anti-gibberellin group, both positive and negative effect were shown on ADF. In some cases, the results showed a complete reversal of effects in successive years. However, to date, none of the anti-gibberellin PGR&#39;s have shown a positive effect on total protein. So, while they have improved certain aspects of the nutritive value of alfalfa, none have improved all the parameters which comprise the nutritive value of alfalfa. It appears that due to the lack of consistent results, both positive and negative, with plant growth regulators; the large number of compounds disclosed in the prior art; the lack of any test data in the art which would show the effects of prohexadione; the unpredictability of anti-gibberellin compounds on the art; the lack of any effect in total protein in the art that any reference is merely an invitation to experiment with these compounds in alfalfa. It would be highly desirable that a PGR decrease ADF, increase TDN and increase Total Protein in alfalfa to improve the overall nutrient value of the alfalfa. It would be useful, in general, to accomplish this without significant crop injury that can occur with PGR applications; and to have the possibility of normal stature of the plant at some point after treatment. SUMMARY OF THE INVENTION It has been surprisingly found that acylcyclohexanedione type PGR&#39;s, preferably cyclohexene PGR&#39;s, most preferably those that block the biosynthesis of gibberellin, can be used to improve the nutritive quality of alfalfa in three areas, namely ADF, TDN and Total Protein. They solve the above problems as well as others that will become clear from the disclosure. Accordingly, provided herein is a method for improving the overall nutritive value of alfalfa comprising applying an effective amount of an acylcyclohexanedione plant growth regulator to a growing pre-harvest alfalfa plant sufficient to improve the overall nutritive value of alfalfa at harvest. DETAILED DESCRIPTION OF THE INVENTION Compounds that may be used to practice particular embodiments of the invention include those described in U.S. Pat. No. 4,560,403, incorporated herein by reference, as represented by the formula: ##STR1## wherein R represents a hydrogen atom or an alkyl group, an alkylthioalkyl group or an unsubstituted or substituted phenyl group; and R 1 represents an alkyl group, an unsubstituted or substituted benzyl group, a phenethyl group, a phenoxymethyl group, a 2-thienylmethyl group, an alkoxymethyl group or an alkylthiomethyl group, or a salt of said cyclohexane compound. A preferred compound for use in practicing embodiments of the present invention is prohexadione represented by the formula: ##STR2## As used herein, prohexadione includes the compound (IUPAC name) 3,5-dioxo4-propionylcyclohexanecarboxylic acid (or 3,5-dioxo4-(1-oxopropyl)cyclohexanecarboxylic acid (C.A. name)) and also 3-hydroxy4-prionyl-5-oxo-3-cyclohexene carboxylic acid and its pharmacological effective salts for example a chloride, sulfate, metrab, acetate, carbonate, hydride, hydroxide, sodium, potassium, calcium, magnesium, barium, aluminum, nickel, copper, manganese, cobalt zinc, iron or silver. The preferred compound for use in preferred embodiments of the invention is prohexadione calcium and is represented by the formula: ##STR3## In another aspect of the invention, the method may also be practiced with compounds described in U.S. Pat. No. 4,693,745, incorporated herein by reference, represented by the formula: ##STR4## wherein A is an --OR 2 or --NR 3 R 4 radical, R is C 3 -C 6 cycloalkyl, R 2 R 3 and R 4 are each independently hydrogen, C 1 -C 6 alkyl, C 1 -C 6 haloalkyl, C 2 -C 10 alkoxyalkyl, C 2 -C 10 alkylthioalkyl, C 3 -C 6 alkenyl, which is unsubstituted or substituted by halogen, C 1 -C 4 alkoxy or C 1 -C 4 alkylthio; C 3 -C 6 alkynyl; phenyl or C 1 -C 6 aralkyl, wherein the phenyl nucleus is unsubstituted or substituted by halogen, C 1 -C 4 alkyl, C 1 -C 4 alkoxy, C 1 -C 4 haloalkyl, nitro or cyano; one of R 3 and R 4 is methoxy; or R 3 and R 4 , together with the nitrogen atom to which they are attached, form a 5-or 6-membered heterocyclic ring system which may contain an additional oxygen or sulfur atom in the ring; and the metal or ammonium salts thereof. Specific compounds of the immediately above noted formula, for use in practicing embodiments of the invention include trinexapac (IUPAC name 4-cyclopropyl(hydroxy)methylene-3,5-dioxyocyclohexanecarboxylic acid) and preferably its ethyl ester, trinexapac-ethyl (IUPAC name, ethyl 4-cyclopropyl(hydroxy)methylene-3,5-dioxocyclohexanecarboxylate; CA name, ethyl 4-(cyclopropylhydroxymethylene)-3,5-dioxyocyclohexanecarbocylate) represented by the formula: ##STR5## By overall nutritive value of alfalfa is meant a combination of a decrease in the ADF, an increase in the TDN and an increase in the Total Crude Protein. It may also include the ability to rebound or continue with increased growth after treatments and do this without significant injury to the alfalfa crop. Preferably the appropriate compounds of the present invention are applied while the plant is still growing. The compound should be applied before the plant is cut for harvest in order to obtain the maximum benefit of the invention. The compounds of this invention may be used directly in alfalfa, but are more conveniently formulated into compositions for such usage. The compounds and salts can be applied in a number of ways, for example, they can be applied, formulated or unformulated, directly to the foliage of alfalfa or they can be sprayed on, dusted on or applied as a cream or paste formulation or they can be applied as slow release granules. The compositions may be in the form of dusting powders or granules comprising the active ingredient and a solid diluent or carrier, for example fillers such as kaolin, bentonite, dolomite, calcium carbonate, talc, powdered magnesia, Fuller&#39;s earth, gypsum, diatomaceous earth and China clay. The compositions may also be in the form of dispersible powders, granules or grains comprising a wetting agent to facilitate the dispersion in liquids of the powder or grains which may contain also fillers and suspending agents. The aqueous dispersions or emulsions may be prepared by dissolving the active ingredient in an organic solvent optionally containing wetting, dispersing or emulsifying agent(s) and then adding the mixture to water which may also contain wetting, dispersing or emulsifying agents(s). Suitable organic solvents are kerosene, cyclohexanone, methylethyl ketone, acetone, methanol, acetonitrile, and the like. The compositions may also be in the form of liquid preparations for use as dips or sprays which are generally aqueous dispersions or emulsions containing the active ingredient in the presence of one or more of wetting agent(s), dispersing agent(s), emulsifying agent(s) or suspending agent(s). The agents can be anionic or nonionic agents. The compositions for use as aqueous dispersions or emulsions are generally supplied in the form of a concentrate containing a high proportion of the active ingredient. The composition of this invention may usually be formulated into a wettable powder comprising 5 to 95%, preferably 10 to 50% by weight of the new compounds of this invention as active ingredient; 1 to 20%, preferably 5 to 10% by weight of surfactant; and 4 to 44%, preferably 40 to 85% by weight of solid carrier, the solid carrier being preferably ammonium sulfate. The composition of this invention may be formulated into an emulsifiable concentrate (EC) comprising 5 to 95%, preferably 20 to 70% by weight of the new compound of this invention as active ingredient; 1 to 40%, preferably 5 to 20% by weight of surfactant; and 4 to 94%, preferably 10 to 75% by weight of liquid carrier. The composition of this invention may be made up as granules comprising 0.5 to 40%, preferably 2 to 10% by weight of the new compound of this invention as active ingredient; 1 to 20%, preferably 2 to 10% by weight of the surfactant; and 40 to 98.5%, preferably 20 to 96% by weight of solid carrier. And, the composition of this invention may be formulated into dust comprising 0.5 to 10%, preferably 1 to 5% by weight of the active ingredient; and 99.5 to 90%, preferably 99 to 95% by weight of finely divided solid carrier. The composition of this invention may also be formulated into a paste comprising 0.1 to 20%, preferably 1 to 10% by weight of the active ingredient, 1 to 20%, preferably 2 to 10% by weight of surfactant; and 60 to 98.9%, preferably 80 to 97% by weight of paste base. The rate of application will vary based on the particular plant size and spacing at the time of application. More exact amounts can be determined at the time of use by one skilled in the art. The rate of application of the compound of this invention may be in the range of 5 g to 1000 g per hectare and preferably 25 g to 300 g per hectare as the active ingredient. The applications are preferably made when the plants are from 10 cm to 40 cm upright growth. The following examples are representative of the invention only and are not intended to be limiting; one skilled in the art will be able to fully practice the invention based on the disclosure and claims, and the examples. EXAMPLE 1 A formulation containing 10% prohexadione calcium with 60% ammonium sulfate (used as a carrier) and other inert ingredients was prepared. Experiments were conducted in a similar manner at several different sites across the United States. Applications of the formulation were made with hand held sprayer booms delivering between 10 and 40 gallons of spray volume per acre. The rates of application of the formulation are expressed in terms of active ingredient per hectare and were performed at 0, 0.0347, 0.0701 and 0.140 kg active ingredient (ai) per hectare (kg ai/ha). These rates were applied at two timings, A and B. Timing A was when the alfalfa was at about 12 to 18 cm of upright growth. Timing B was one week following A. After treatment the alfalfa was harvested at three different dates called harvest X, Y, and Z. Harvest X was made when the alfalfa was at the growth stage called first flower. Harvest Y and Z were collected at 4-5 days and 8-10 days respectively after harvest X. The alfalfa samples were harvested and analyzed. Relative Feed Value (RFV) was measured and the results are displayed in Table 1. RFV is an index used to rank cool season perennial forage crops by their potential intake of digestible dry matter. RFV is obtained by multiplying the digestible dry matter times the dry matter intake and dividing by 1.29. TABLE 1______________________________________RELATIVE FEED VALUE INDEX OF PROHEXADIONE TREATEDALFALFAProhexadione HarvestCa X Y Ztmt #s kg ai/ha Application Relative Feed Value Index______________________________________1.8.15 0 172.8 161.1 156.22.9.16 0.0347 A 175.6 166.4 163.23.10.17 0.0701 A 177.9 166.2 160.14.11.18 0.140 A 184.2 173.7 163.45.12.19 0.0347 B 172.1 166.8 166.06.13.20 0.0701 B 179.1 173.7 159.37.14.21 0.140 B 184.4 176.1 171.2______________________________________ N = 8 locations Application A = 5-7 inches of upright growth Application B = one week later Harvest X = first flower Harvest Y = 4-5 days after X Harvest Z = 8-19 days after X RFV is known to decrease as harvest is delayed. As expected, the RFV of the untreated plots decreased as harvest was delayed. Prohexadione calcium applied at timing A increased the RFV by 3 to 12 points. A dramatic increase in RFV occurred with the highest rate of prohexadione calcium. The RFV increase with prohexadione calcium was noted at each of the three harvest dates (X, Y and Z), but the most consistent increases occurred at the earlier harvest dates (X and Y). Application of prohexadione calcium at timing B also resulted in increased RFV, especially at the 0.140 kg ai/ha rate. The increases in RFV at the lower rates were not as consistent at timing B as compared to timing A. However, individual treatments at timing B at the lower rates still proved dramatic increases of over 9 points. Crude protein was measured and the results are displayed in Table 2. Crude protein is a measure of the total nitrogen in the forage. It includes true plant proteins and non-protein nitrogen compounds, both of which are usable by ruminant animals. TABLE 2______________________________________PERCENT CRUDE PROTEIN OF PROHEXADIONE TREATEDALFALFAProhexadione HarvestCa X Y Ztmt #s kg ai/ha Application Percent Crude Protein______________________________________1.8.15 0 22.2 20.4 19.32.9.16 0.0347 A 22.1 21.1 20.53.10.17 0.0701 A 22.9 21.0 20.34.11.18 0.140 A 23.4 21.6 20.85.12.19 0.0347 B 22.3 21.1 21.16.13.20 0.0701 B 22.8 21.5 20.47.14.21 0.140 B 23.2 21.4 21.1______________________________________ N = 8 locations Application A = 5-7 inches of upright growth Application B = one week later Harvest X = first flower Harvest Y = 4-5 days after X Harvest Z = 8-19 days after X Percent crude protein was increased by the prohexadione calcium treatments applied at rates of 0.0701 and 0.140 kg ai/ha. This increase was observed at both application dates (A and B). Even the lowest prohexadione calcium tended to increase crude protein in the alfalfa forage. Percent total digestible nutrients (TDN) was measured and the results are displayed in Table 3. TDN is equal to the sum of percent digestible crude protein, percent digestible crude fiber, percent digestible starch and sugars, and percent digestible fats time 2.25. The fats are multiplied by 2.25 because they contain that much more energy per unit weight. TABLE 3______________________________________TOTAL DIGESTIBLE NUTRIENTS OF PROHEXADIONE TREATEDALFALFAProhexadione HarvestCa X Y Ztmt #s kg ai/ha Application Total Digestible Nutrients______________________________________1.8.15 0 40.5 39.9 39.12.9.16 0.0347 A 40.9 40.4 39.83.10.17 0.0701 A 41.1 40.2 39.34.11.18 0.140 A 41.9 40.9 39.45.12.19 0.0347 B 40.9 40.0 41.36.13.20 0.0701 B 40.9 40.5 38.97.14.21 0.140 B 41.8 41.3 40.1______________________________________ N = 8 locations Application A = 5-7 inches of upright growth Application B = one week later Harvest X = first flower Harvest Y = 4-5 days after X Harvest Z = 8-19 days after X The data of Table 3 shows that the TDN of the untreated plots decreased as harvest was delayed. This is the same trend as noted with Relative Feed Value, i.e. that alfalfa quality decreases as harvest is delayed . Prohexadione calcium applied at timing A increased the RFV by as much as 1.8 points. The most dramatic increase in TDN occurred with the highest rate of prohexadione calcium (0.140 kg ai/ha). The RFV increase with prohexadione calcium was noted at each of the three harvest dates (X, Y and Z) Application of prohexadione calcium at timing B also resulted in increased TDN. Indeed, the most dramatic increase in TDN (1.9 points) occurred with the highest rate of prohexadione calcium at timing B. The invention has been described with reference to various specific embodiments. However, many variations and modifications may be made while remaining within the scope and spirit of the invention.

Applying an effective amount of an acylcyclohexanedione plant growth regulator to a growing pre-harvest alfalfa plant improves the overall stature and overall nutritive value of alfalfa at harvest.

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application Ser. No. 60/635,557, filed Dec. 13, 2004. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a device and method for rapidly and efficiently acquiring a sample of a fluid. Specifically, the device and method provides a sample container in which a vacuum is created. The sample is then rapidly sucked into the container by the vacuum thereby avoiding loss of volatiles in the solution and alteration of its chemical composition. 2. Background In many fields it is necessary to routinely take samples of various fluids to determine their chemical composition. It is often necessary to determine the precise chemical make up of a fluid including the gases and volatile components of the sample. This is especially true in the petroleum industry in which mud and other fluid samples are routinely taken to measure various data. Various methods have been developed for obtaining samples to be tested. One common method is to simply use a syringe to suck fluid into it and subsequently deposit it into a sample vial. The physical action of this often results in the removal of especially volatile compounds from the fluid. This alters the chemical composition of the sample and provides for less accurate readings. It is therefore desirable to provide a device and method for collecting a fluid sample without substantially removing volatiles therefrom. SUMMARY OF THE INVENTION A new simple sampling device collects and seals volatile fluid samples without volatile loss in a single simultaneous operation. Fluid samples that can benefit from sampling using this sampling device include, but are not limited to, environmental water and air samples and drilling mud from oil and gas exploration and production wells. The sampling device consists of a hermetically sealed sample bottle, or other suitable hermetically sealed container such as a can, sampling bag, or any other appropriate container. The hermetically sealed sample bottle or other suitable hermetically sealed container must have a septum, or other appropriate device, that allows a needle to be introduced and removed from the container. Prior to collecting the fluid sample, the hermetically sealed sample bottle, or other suitable hermetically sealed container, can simply contain air, or can be filled with any other type of gas, or can be evacuated. Any desired agent that can be of benefit to maintaining sample quality, or have any other desired purpose, can be added to the sample bottle prior to sealing. The sampling device also consists of a syringe with a side port, or opening, and a needle. The volume of fluid sampled is determined by the size of the syringe, the placement of the side port on the syringe, and the pressure inside the sample bottle. A fluid sample is collected using the following steps. First, the plunger on the syringe is inserted and pushed into the body of the syringe as far as possible. Second, the needle on the syringe is inserted into the sample bottle through the septum. Third, the syringe is partly or completely submerged into the fluid to be sampled so that the side port on the syringe is completely submerged in the said fluid. Fourth, the plunger on the syringe is retracted until the sealing mechanism at the end of the syringe passes part of the side port, it is not necessary for the seal to pass by the entire side port. The fourth step of retracting the plunger results in the sample bottle or other suitable container to be filled with the desired volume of fluid. A vacuum is generated in the sample bottle by the initial retracting of the plunger. The vacuum in the sample bottle is generated before the seal at the end of the plunger reaches the side port on the syringe. The sample bottle is filled with the desired volume of fluid when the plunger is retracted to the point that the seal at the end of the plunger passes the lowest terminus of the side port. The vacuum generated by the initial retraction of the plunger causes the fluid to enter the bottle through the side port, into the body of the syringe, and through the needle into the sampling bottle. The process of filling the sealed bottle with fluid is extremely fast, taking only a fraction of a second. The very short time required to capture a sealed sample aids in the capture of a representative fluid sample having the same composition as the body of fluid being sampled. Sampling is completed by removing the bottle from the needle on the syringe. Other means, not described here, of sampling fluids with syringes, or other devices that generate a vacuum, can be problematic. The vacuum used to suction the sample into these other means can cause the removal of volatiles from the fluid. Such volatiles can include benzene, MTBE, and other volatiles from environmental water samples, or light hydrocarbon and non-hydrocarbon gases such as methane, ethane, and carbon dioxide from oil and gas well drilling mud. These other sampling means usually require transferring the sample from a syringe or other sampling device to another container, providing additional time and opportunity for compositional change to the fluid sample. The sampling means described herein is designed to obtain a sample that has the same composition as the body of fluid sampled. The fluid sampling means described herein preserves the volatiles in the sample as the vacuum is generated in the sample container itself. There is no transfer of the fluid sample after sampling, as the fluid is collected directly into the sampling bottle. Sampling time is very short, reducing the possibility of compositional change of the fluid sample. The fluid sample can be analyzed directly from the sampling bottle eliminating the possibility of compositional changes incurred by handling the sample in the laboratory. The bottle can be completely filled with fluid, if the bottle is pre-evacuated before sampling. The bottle can also be partly filled with fluid, and partly left unfilled. The amount of filling is reproducible and can be pre-determined by the initial pressure in the bottle, the size of the bottle and the syringe, and the placement of the side port on the syringe. The ability to partially fill sample bottles, as described herein, is a distinct advantage over simply opening a bottle under the surface of a fluid and resealing, as that process results in only completely filled bottles. Partly filled bottles are useful to analyses of volatiles in the fluid. The volatiles can be analyzed using vacuum extraction of head space gas, and vacuum extraction of volatiles in the liquid that enter the gas phase under vacuum. This gas can then be analyzed by known techniques such as mass spectrometry or gas chromatography. Filling the sampling bottle submerged below the surface of the fluid can be a distinct advantage over collecting a surface fluid sample. Collecting submerged fluid samples in pre-sealed bottles, as described herein, allows chemical profiling of fluids as a function of depth in the body of fluid. Volatiles in fluids can degas at the surface of a liquid, but may be present in a fluid sample that is collected submerged. Also, the composition of fluids may vary with depth and latitude and longitude in bodies of fluid, such as in oceans, lakes, environmental monitoring wells, mud pits on oil and gas wells, septic tanks, and other bodies of fluids. In many cases it can be useful to study the compositional variations within such bodies of fluids. Volatiles in the fluids can be analyzed directly from the partly filled sampling bottles, thus eliminating any volatile loss or other sample degradation caused by re-sampling. Liquids in completely filled bottles can also be directly analyzed using techniques such as liquid chromatography. Filled or partly filled sample bottles can also be sub-sampled for multiple analyses, if desired or necessary. Sub-sampling can be performed using a syringe and passing its needle through the septum of the hermetically sealed sample bottle. Use of pre-sealed sample bottles allows enhanced quality control over sealing in the field, providing greater insurance of volatile retention. It can also be difficult to hermetically seal bottles in the field if submerged in a fluid rich in solids, such as oil and gas well drilling mud. Pre-sealing of crimp-sealed bottles eliminates the need to provide expensive and complicated crimping apparatus to multiple field locations. Affecting a good crimp-seal can be difficult by an inexperienced technician, or in difficult or dirty field conditions, such as on oil and gas wells. Extensions can be added to the syringe body and plunger to allow samples to be taken in hard to reach locations, such as environmental monitoring wells at gasoline filling stations, or sampling water at various depths in a lake. Triggering mechanisms can be added to the sampling device to permit sampling without an operator present under predetermined conditions. These conditions could include such factors as time, date, depth, temperature, amount of precipitation, traffic flow through a gasoline filling station, or any other desired criteria. The process can be automated. Those skilled in the art will appreciate that there are many devices for automating the actuation of a syringe. Most consist of a piston device attached to the plunger and a motor. The motor may be actuated by a simple switch mechanism or may be operated by a computer that may be timed. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a side view of a preferred embodiment of the invention. FIG. 2 shows a side view of a preferred embodiment of the invention after a fluid sample has been taken. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The embodiments discussed herein are merely illustrative of specific manners in which to make and use the invention and are not to be interpreted as limiting the scope of the instant invention. While the invention has been described with a certain degree of particularity, it is to be noted that many modifications may be made in the details of the invention&#39;s construction and the arrangement of its components without departing from the spirit and scope of this disclosure. It is understood that the invention is not limited to the embodiments set forth herein for purposes of exemplification. FIG. 1 shows fluid sample collecting device 10 just prior to collection of a sample. Device 10 consists of a syringe 12 having a needle 26 . Plunger 14 fits inside syringe 12 and has rubber seal 18 at the end of it. Those skilled in the art will realize that the seal at the end of the plunger may be comprised of rubber, an elastomer or other material so long as it forms an air tight seal with the inside wall of the plunger. Syringe 12 can be any of various sizes and is a typical syringe known in the art. One distinguishing feature of device 10 is side port 16 . Side port 16 is an opening in the side of syringe 12 . In this particular embodiment, side port 16 is rectangular. However, those skilled in the art will appreciate that side port 16 may be comprised of any geometry, but should not be so small that a vacuum is applied to liquid entering it. Vacuum should only be applied to the sample by the sample bottle. Needle 26 is inserted through septum 24 into empty bottle 22 . Bottle 22 and syringe 12 are placed partially below the surface of a fluid 20 from which a sample is to be taken. The syringe need only be placed far enough into the fluid such that side port 16 is completely submerged. To collect a sample, the plunger 14 is pulled upward. This causes a vacuum to form inside the fluid sample bottle. When the rubber seal at the end of the plunger is pulled past side port 16 , the vacuum inside the sample bottle 22 is exposed to the fluid that the sampling device has been placed in. This causes a fluid sample to rush through the side port and into the collection bottle 22 . FIG. 2 shows the sampling device 10 after a sample has been taken. Plunger 14 has been lifted in the direction of arrow 30 while the syringe 12 is remained stationary. Plunger seal 18 has been lifted past side port 16 . Because only a partial vacuum was formed in bottle 22 , the bottle is only partially filled with sample fluid 28 . It is often desirable to not fill bottle 22 all the way with sample. The amount of fluid collected in sample collection bottle 22 is dependent on how high up on syringe 12 side port 16 is located. The higher side port 16 , the greater vacuum formed in bottle 22 and therefore the larger the amount of sample 32 collected. The device as shown rapidly and efficiently collects a fluid sample with a minimum of mechanical or other interference of the sample. This prevents volatiles, gases and other chemicals from being removed from the sample. The sample therefore is more accurate and more representative of the contents of the fluid being sampled. In the illustrated embodiment, a syringe is used in conjunction with a rubber seal to hermetically seal the sample bottle to the syringe. Those skilled in the art will appreciate that there are other methods to hermetically seal the syringe to the sample bottle. A bottle top that may be screwed or snapped on to the top of the bottle having a tube that connects to the syringe could also be used. Any means that allows the syringe to be hermetically sealed to the sample bottle will work with the present invention. Whereas, the present invention has been described in relation to the drawings attached hereto, it should be understood that other and further modifications, apart from those shown or suggested herein, may be made within the spirit and scope of this invention.

A modified syringe collects samples of a fluid without removing volatile compounds by forming a vacuum within a sample collection vial. A fluid sample is drawn into the collection vial by means of the applied vacuum.

FIELD OF THE INVENTION [0001] This invention in general relates to furniture and, in particular, to apparatus and methods for securing personal belongings in an office and other environments. BACKGROUND OF THE INVENTION [0002] A long-standing problem for employees is how and where to secure their personal belongings at the office. Such belongings might include purses, lunches, books and magazines, walking shoes and personal supplies. Of particular concern is the secure storage of purses containing valuables, which are often placed under the worker&#39;s desk or in a drawer of the desk. [0003] When stored under the desk, a purse often interferes with the worker&#39;s leg room, may be damaged by accidental kicking, and is inconvenient to retrieve. Further, the purse is not secure from theft when the worker leaves the desk area. When stored in a desk drawer, the purse takes up valuable space which would normally be used for files or supplies, and unless the desk is locked every time the worker leaves the area, theft remains a problem. [0004] Some employers provide workers with lockable metal storage lockers, much like those used in schools for storing student&#39;s belongings. However, these lockers are expensive and take up significant office space. [0005] A similar problem arises in public places such as restaurants and automobiles, where it is desired to have a secure storage area in the interior of the car which is large enough to accommodate a purse, and yet is easily reachable by a seated passenger or driver. SUMMARY OF THE INVENTION [0006] This invention broadly resides in systems and associated methods for securing personal belongings to a seat or chair. In contract to existing systems, the invention provides two locking mechanisms, one associated with a container having a locking door, and the second associated with a tether with a second lock for locking the container to the seat or chair. The preferred embodiments further provide a bracket for mounting the container on the seat or chair for more convenient access. The system may further include a slide assembly between the container and the bracket allowing the container to be positioned for more convenient access while remaining tethered to the seat or chair. [0007] The invention is applicable to virtually any type of seat or chair with appropriate modification. For example, where the seat or chair has a back rest with an upper edge, the bracket may includes a bent lip configured to hang over the top edge. Where the seat or chair includes a seat portion with opposing side edges, the bracket may have two ends, each terminating in a bent lip to engage with a respective one of the opposing side edges. In embodiments of this kind, the bracket may feature an adjustable length to accommodate seat portions of varying width. [0008] Where the seat or chair includes a seat portion with opposing side edges and a central post under the seat portion, the bracket may have two ends, each terminating in a bent lip to engage with a respective one of the opposing side edges, with a central aperture through which the central post extends. [0009] Where the seat or chair includes a plurality of legs, the tether may be adapted to attach to one or more of the legs. Where the seat or chair includes a seat portion with opposing side edges and a central post under the seat portion, the tether may be adapted to attach to the central post. In situations where the seat or chair includes a seat portion with opposing side edges and a central post under the seat portion attached to a plurality of radial caster supports, the bracket may mount the container to one or more of the radial caster supports. In cases where the seat or chair includes a seat portion with opposing side edges and a central post under the seat portion attached to a plurality of radial caster supports, the tether may be adapted to attach to one or more of the radial caster supports. [0010] Wherein the seat or chair includes a back rest with opposing side edges, the bracket may have two ends, each terminating in a bent lip to engage with a respective one of the opposing side edges of the back rest. If the seat or chair includes a back rest with opposing side edges, a back surface and a region between the back rest and a seat portion, the tether may be adapted to attach to the region between the back rest and the seat portion. The tether may be provided on a spring-loaded reel attached to the bracket, and the container may assume the form of a purse or handbag. [0011] Thus, the invention provides an article storage container that is secured to either a swivel, or straight-legged chair, or vehicle seat. The container may located in a stowed position that occupies space not normally utilized by the person sitting in the chair and is moveable to an accessible position that permits article to be stored and retrieved from the container. BRIEF DESCRIPTION OF THE DRAWINGS [0012] FIG. 1 is a perspective view of a conventional swivel or task chair used in an office environment; [0013] FIG. 2 is a perspective view of a conventional, straight-legged chair; [0014] FIG. 3 is a front view of the chair of FIG. 1 , showing a first embodiment of the invention where a storage container is attached underneath the chair in a stowed position, and also showing how the container is secured to the chair by a locking cable; [0015] FIG. 4 is a front view of the chair of FIG. 3 , showing the storage container in an accessible position; [0016] FIG. 5 is a front elevation view of the bracket for mounting the storage container of FIG. 3 to the chair; [0017] FIG. 6 is a top plan view of the bracket of FIG. 5 ; [0018] FIG. 7 is a side elevation view of the bracket of FIG. 5 ; [0019] FIG. 8 is a side elevation view of the storage container of FIG. 3 ; [0020] FIG. 9 is a top plan view of the storage container of FIG. 3 ; [0021] FIG. 10 is a side elevation view of the chair of FIG. 3 showing in detail how the storage container engages the bracket; [0022] FIG. 11 is a side elevation view of the chair of FIG. 1 showing a second embodiment of the invention where a storage container is mounted to the back of the chair, and also showing how the container is secured to the chair by a locking cable; [0023] FIG. 12 is a top view of the chair and storage container of FIG. 11 ; [0024] FIG. 13 is a side elevation view of the chair of FIG. 2 with the second embodiment showing a storage container mounted on the back of the chair, and also showing how the container is secured to the chair by a locking cable; [0025] FIG. 14 is a front elevation view of the chair of FIG. 13 ; [0026] FIG. 15 is a side elevation view of the chair of FIG. 2 with the first embodiment showing the storage container attached underneath the chair, and also showing how the container is secured to the chair by a locking cable; [0027] FIG. 16 is a front elevation view of the chair of FIG. 1 showing a third embodiment of the invention where the container is located on the legs of the chair, and also showing how the container is secured to the chair by a locking cable; [0028] FIG. 17 is a front elevation view of the chair of FIG. 1 showing a fourth embodiment of the invention, and also showing how the container is secured to the chair by a locking cable. [0029] FIG. 18 is a front view in elevation of automobile driver and passenger seats, showing the attachment of secured storage containers in another embodiment of the invention; [0030] FIG. 19 is a side elevation view of the automobile driver&#39;s seat of FIG. 18 , taken along the line 19 - 19 , showing a storage container mounted on the back of the seat, and also showing how the container is secured to the seat by a locking cable; [0031] FIG. 20 is a top view of the chair and storage container of FIG. 19 ; [0032] FIG. 21 shows an embodiment of the invention which includes a hook to hook over a chair back; [0033] FIG. 22 shows the embodiment of the invention depicted in FIG. 21 in conjunction with a chair and a user&#39;s purse; [0034] FIG. 23 shows the embodiment of the invention depicted in FIG. 21 with the cord in the retracted position; and [0035] FIG. 24 shows yet another embodiment of the invention, wherein a retractable tether is built into a specially designed locking purse. DETAILED DESCRIPTION OF THE INVENTION [0036] FIG. 1 shows a “task chair” 8 of the type commonly used in an office environment. The chair 8 has a center post 10 , a seat 12 , a back 14 and four caster supports 16 . [0037] With reference to FIGS. 3-10 a personal belongings storage system according to the invention is installed on the chair of FIG. 1 . An adjustable bracket 18 ( FIGS. 5, 6 and 7 ) has mutually slidable parts 20 and 22 with a series of mounting holes 24 , 26 , respectively. Bracket 18 has a slotted opening 28 through which center post 10 can pass ( FIG. 6 ). The underside of part 20 has guide tracks 30 ( FIG. 7 ) that engage guide rails 32 ( FIGS. 8 and 9 ) mounted on a slidable storage container 34 . [0038] To install bracket 18 it is positioned under seat 12 , and parts 20 , 22 are pushed together until they firmly embrace seat 12 . Then fasteners represented at 36 are installed in overlapping pairs of holes 24 and 26 to hold parts 20 and 22 in place. The top of container 34 has a hinged door 38 in which a lock 40 is installed ( FIG. 9 ). Thus to gain access to the inside of container 34 , one must have a key to lock 40 . [0039] Container 34 has an eyelet 42 either attached in a non-removable fashion or is formed in a one-piece construction with the body of container 34 . A tether 46 , which is preferably made of steel, is attached to loop 42 at one end and to center post 10 at the other end in a manner so tether 46 cannot be removed from container 34 or center post 10 . One way to accomplish this uses a two-wire connector that will not permit removal of the wires after they have entered the connector. [0040] Loops are formed in the ends of tether 46 by use of the connectors. The size of the loop formed around the post 10 is made sufficiently small so that the cable cannot be slipped over the seat 18 or over the legs 16 , effectively locking the tether 46 and the container 34 to the chair 8 . Alternatively, the connectors can be replaced by a key or combination lock 47 in a manner similar to that use to secure a bicycle to a bike rack, whereby the user can remove the container 34 from the chair 8 using a key or combination. [0041] To place personal belongings or other articles in container 34 , container 34 is pulled out from under seat 12 to an accessible position as shown in FIG. 4 and door 38 is unlocked. Then door 38 is relocked and container 34 is slid back under seat 12 as shown in FIG. 3 . In summary, container 34 is permanently secured to chair 8 so that it cannot be removed under normal circumstances and only one in possession of a key to lock 40 can open container 34 . [0042] In a second embodiment of the invention shown in FIGS. 11 and 12 , a container 47 is mounted on the rear of seat back 14 of chair 8 by a bracket 48 which fits over the top of the back 14 . A tether 49 secures container 56 to center post 10 using a lock 51 in a similar manner to that described in the previous embodiment, whereby the container 47 cannot be removed from the chair 8 without a key. By making the tether 49 sufficiently short, it is possible to tightly secure the container 47 and the bracket 48 to the back 14 so that the container cannot be lifted off the back 14 . [0043] Alternatively, by making the tether longer, it is possible to allow the container 47 to be lifted off the back 14 , whereby the seated user can reach behind, remove the container, and swing it around to the front for access without getting up from the seat. The container can then be swung to the rear and replaced on the seat back. In either instance, the container 47 remains attached to the chair by the tether 49 . Container 47 has a hinged door with a lock and an eyelet formed in a one piece construction with container 47 . [0044] FIG. 2 shows a conventional straight four-legged chair 53 having a seat 50 , a back 52 and four legs 54 . In FIGS. 13 and 14 , a container 56 is mounted on the chair 53 of FIG. 2 , specifically on the rear of back 52 by one or more brackets 58 which fit over the top of the back 52 . An eyelet 60 is either attached in a non-removable fashion or is formed in a one-piece construction with container 56 . A tether 64 is placed around two of rear legs 54 and extends tightly across the junction of seat 50 and back 52 and is secured by a lock 65 . The tether 64 is made sufficiently tight so that it cannot be slipped over the back 52 or over the legs 54 without removing the lock 65 . A second tether 62 extends between eye 60 and tether 64 in an endless loop that is linked around the tether 64 before it is locked to the chair 53 . [0045] The ends of tethers to 62 and 64 may be configured in endless loops via one-way connectors, as described above. As a result, container 56 is secured to the chair and can only be removed from the chair by severing tether 62 or 64 or unlocking the lock 65 . As in the previous embodiment, the length of the tether 60 may be adjusted to either tightly secure the container 56 and the bracket 58 to the back 52 so that the container cannot be lifted off, or by making the tether longer, to allow the container 56 to be lifted off the back 52 , whereby the seated user can reach behind, remove the container from the back 52 , and swing it around to the front for access without getting up from the seat. In either instance, the container 56 remains attached to the chair by the tethers 62 and 64 . [0046] In FIG. 15 , the slidable container of the embodiment of FIGS. 3 and 4 is mounted on the chair 53 of FIG. 2 by a tether arrangement as shown in FIGS. 13 and 14 . The same reference numerals used in the previously described figures are used to identify the same components. [0047] In FIG. 16 , a lockable container 70 is mounted on one of legs 16 of the task chair of FIG. 1 . Container 70 is secured by a tether 72 to center post 10 and/or by a tether 74 to leg 16 , and locked in place by one or more suitable locks 75 , 77 . The tethers are made sufficiently tight to prevent them being slipped off the chair without removal of the respective locks 75 , 77 . [0048] In FIG. 17 an arcuate lockable container 76 is mounted on two of legs 16 , secured to center post 10 by a tether 78 and locked in place by a suitable lock 80 . [0049] FIG. 18 is a front view of typical automobile driver and front passenger seats 90 and 92 , respectively. Each seat comprises a back 94 , 96 , a seat 98 , 100 , rails 102 , 104 for securing the seats to the car floor, and headrests 106 , 108 . The seat backs 94 , 96 are connected to the seats 98 , 100 by steel connectors 110 , 112 at either end of the respective seat. Typically, the connectors are hinged to permit reclining. As shown in FIGS. 19 and 20 , which are side and top views of the driver seat 90 , a container 114 is mounted on the rear of back 94 by brackets 116 which fit over the top of the back 94 on either side of the headrest 106 . An eyelet 118 is either attached in a non-removable fashion or is formed in a one-piece construction with container 114 . A tether 120 extends between eyelet 118 and a connector 110 in a loop that is secured using a lock 122 . As a result, container 114 is secured to the seat connector 110 and can only be removed by unlocking the lock 122 . A lockable door 124 is provided on the side of the container, for example, at 114 facing the passenger seat to permit storing and removing belongings. [0050] In like manner to that described above, the passenger seat 92 may be similarly equipped with a container (not shown) mounted on the back 96 using brackets 126 and having a lockable door facing the driver seat. In use, the seated driver can reach behind the passenger seat with the right hand, and unlock and open the container door to store and retrieve belongings while seated. Similarly, the seated passenger can reach behind the driver&#39;s seat with the left hand, and unlock and open the container door 124 to also store and retrieve belongings while seated. [0051] FIG. 21 shows an embodiment of the invention 200 , which includes a hook 210 to hook over a chair back. The hook, which may be made of a rigid material such as plastic or metal, is attached to a spring-loaded reel 212 from which extends a retractable cord or band 214 of a strong flexible material, such as metal or a strong plastic, which is not easily cut by a would-be thief. The end of the cord 214 is formed into a loop 216 suitable for looping around the end of chair leg. The reel 212 includes a locking control button or lever 218 for releasing and retracting the cord. [0052] The operation of the embodiment 200 is shown in FIG. 22 in conjunction with a chair 220 and a user&#39;s purse 222 . The hook 210 is hooked over the back of the chair 220 , and the cord is pulled out from the reel 212 using the release button 218 , and looped around the purse 222 and can also be looped through the purse strap 224 , if there is one. The chair is then tilted by the user so that the loop 216 can be slipped over one of the legs, preferably a rear leg 226 . Using the lockable button 218 , the cord 216 is then retracted so that the loop 216 moves up snugly against the bottom surface of the chair seat. The tension of the cord 216 thus established between the hook 210 and the loop 216 pulls the cord 214 tight, which holds the purse 222 snugly against the back of the chair, while also preventing a thief from easily opening the purse to remove its contents. The reel 212 may be locked in this tight position with a suitable key, which may be in the form of a combination lock. [0053] It may be seen from the above description that the embodiment 200 serves to secure conventional purses to a chair back using a portable device, and is thus useful for temporary venues such as restaurants and meeting rooms. A view of the embodiment 200 with the cord in the retracted position is shown in FIG. 23 . [0054] The embodiment 200 is suitable for use with conventional purses, which in general do not have locking mechanisms for their contents. FIG. 24 shows yet another embodiment 300 of the invention, where the apparatus of embodiment 200 is built into a specially designed locking purse 310 . In this instance, the hook 210 may be connected to the purse 310 with a flexible cord or chain 312 , so that when not in use, the hook 210 can be stored in a compartment 314 in the purse 310 . The spring loaded reel 212 is placed inside the purse 310 , and the cord 214 and loop 216 extend from a second compartment 316 . The operation of this embodiment is substantially the same as that described above for the embodiment 200 , except that there is no need to wrap the cord 214 around the purse 310 , and when the purse is securely in place against the chair back, it can be locked by a lock 318 provided, which secures the contents as well as the reel 212 . [0055] In each of the described embodiments of the invention, the tethers are secured by one means or another to both the chair and to the storage container so the container cannot be removed by an unauthorized person. The container is locked so it can only be opened by a key. As a result, the security of the contents of the container is ensured. [0056] The described embodiments of the invention are only considered to be preferred and illustrative of the inventive concept, the scope of the invention is not to be restricted to such embodiments. Various and numerous other arrangements may be devised by one skilled in the art without departing from the spirit and scope of this invention. It is therefore intended by the appended claims to cover any and all such applications, modifications and embodiment within the scope of the present invention.

Systems and associated methods are disclosed for securing personal belongings to a seat or chair. The invention provides two locking mechanisms, one associated with a container having a locking door, and the second associated with a tether with a second lock for locking the container to the seat or chair. The preferred embodiments further provide a bracket for mounting the container on the seat or chair for more convenient access. The system may further include a slide assembly between the container and the bracket allowing the container to be positioned for more convenient access while remaining tethered to the seat or chair. The invention is applicable to virtually any type of seat or chair with appropriate modification. That is, the invention provides an article storage container that is secured to either a swivel, or straight-legged chair, or vehicle seat. The container may located in a stowed position that occupies space not normally utilized by the person sitting in the chair and is moveable to an accessible position that permits article to be stored and retrieved from the container.

REFERENCE TO RELATED APPLICATION This is a continuation-in-part of U.S. patent application Ser. No. 788,823 filed Oct. 18, 1985, now U.S. Pat. No. 4,734,283. FIELD OF INVENTION The present invention relates to a method of making an improved foodcomposition containing at least 5 mg inositoltriphosphate (IP 3 ) per 100 g composition and such composition having such content of IP 3 . There is an increasing need for counteracting any bad influence of civilization, of instance environmental dangers caused by input of dangerous materials like heavy metals and radiation. There is also a need for counteracting the hazards of smoking and other bad habits by development of healthy diet and nutrition agents. Even as early as the year 1900, different researchers had reported the finding of the organic phosphate compound phytic acid, i.e., 1,2,3,4,5,6-hexakis(dihydrogenphosphate)myo-inositol (also sometimes called inositol-hexaphosphoric acid) in plants. The content of phytic acid in different plants varies considerably. The content in grain is usually approximately 0.5-2%, with certain exceptions. Polished rice has a level of only 0.1% while wild rice contains as much 2.2% phytic acid. Beans contain about 0.4-2%, oil plants approximately 2-5% and pollen 0.3-2%. The content of phytic acid in the plant varies during the growth period. The content is also influenced by, among other things, the climate. In the literature there are reports on the presence of inositol pentaphosphate (IP 5 ) and inositol tetraphosphate (IP 4 ) in a few plants. It is further known that phosphate derivates lower than IP 6 are formed at germination of grain. For instance the final products at the germination are inositol and phosphate. The use of IP 6 has been described in several scientific publications. The majority of the authors of these articles have observed several negative effects on humans and animals when consuming IP 6 or substances containing IP 6 . Feeding dogs with too high an amount of IP 6 gives rise for example to rachitis. In humans lack of zinc and as a consequence thereof slower growth of children has been observed. Anemia has been observed mainly in women. Because of the above mentioned negative effects on the mineral balance in humans and animals, attempts have so far been made to reduce the intake of IP 6 and its derivatives to a minimum. Cadmium also has been found to be detrimental to human health. While this metal in general is present in a low level in our environment, the amount of cadmium we are exposed to depends on several factors. Cadmium occurence as well as its availability in the ground varies among different areas, with a relatively high uptake in plants growing in areas with relatively low pH value. By industrial activity, mainly handling of metals, cadmium can be released into the air, ground and water. Cadmium in soil is absorbed by plants and thus can come into the diet of human beings and animals. The most important routes of exposure to cadmium are via smoking, food and, to a certain extent, drinking water. Cadmium is mainly absorbed in the intestine and through the lungs, although only a small part of the cadmium in the diet is absorbed. The average cadmium intake via food is estimated to be approximately 50 μg per day in most countries, but the variation is large among different geographic areas and among individuals. Data from smokers show that as much as 50% of the inhaled cadmium can be absorbed. Several investigations show twice as high blood- and organ-levels of cadmium in smokers compared to non-smokers. The excretion of cadmium from the human body is slow and a half-life of 10-30 years has been reported. This means that cadmium is accumulated in the body. The main part, 80-90% of the accumulated cadmium, is bound to a protein, metallothionein, mainly in the liver and kidneys. The formation of metallothionein is induced by metals, mainly zinc and cadmium. The binding of cadmium to metallothionein is very strong and results in a detoxification of cadmium. The remaining cadmium is in the body, i.e. that not bound to metallothioneins, is distributed among the other organs of the body with relatively high levels in the intestine, lungs (especially of smokers), the circulatory system (heart, artery walls, spleen) and glands like the pancreas and prostate. Among the negative effects, it is known that cadmium can affect the elastin/elastase system of the body. It is also known that cadmium can affect several different enzymes in the body, examples of which are Na + , K + (Mg 2+ )-ATP-ase and Ca 2+ , Mg 2+ -ATP-ase, which are important in ion transport systems. Further examples are cytochrome-P450-enzymes which hydrolyze steroids, fatty acids, aromatic compounds and toxic compounds. Other important enzymes, which are inhibited by cadmium, are glutathion-peroxidase, and superoxiddismutase, which protect against occurence of peroxidation. Zinc dependent enzymes, such as leucine-aminopeptidase, are also inhibited by cadmium. Results from a large number of animal experiments obtained over many years show negative effects even at very low levels of cadmium. This would mean that a large proportion of the population is negatively affected, and this is above all valid for smokers. Epidemiological research shows a connection between the presence of high blood pressure and cardiovascular diseases (for instance, arteriosclerosis, heart infarction, sudden heart death) and the occurence of cadmium in the environment. Exposure to cadmium also seems to be a factor in increasing the risk of age diabetes. There are also investigations showing that cadmium can have negative effects on the kidneys, lungs (fibrosis, emphysema), blood vessel walls (fat deposition, arteriosclerosis, vessel wall contraction, elasticity, damage to endothelium), prostacycline production, prostate, heart (conduction system, force of contraction), placenta, testicles and central nerve system. Cadmium can also induce the formation of free radicals and thereby cause lipid peroxidation, which can be important in the origin of other diseases like rheumatism. Allergies and bronchitis can also be connected with cadmium exposure. The knowledge of the negative influence of cadmium on humans and animals has increased considerably over the last decades. A very intensive research effort has been made for many years seeking to counteract the above mentioned negative effects of heavy metals, such as cadmium and the negative effects of free radicals which are formed in different ways, for instance by metals such as iron, aluminium and cadmium and by radiation. Of course, also the hazards of smoking have been studied for a long time. SUMMARY OF THE INVENTION According to the present invention it has been possible to avoid or at least alleviate the above negative effects observed on humans and animals, by consumption of the special inositolphosphate IP 3 . Thus, the invention provides a method of making a food composition and the said compositioin containing at least 5 mg of IP 3 per 100 g of composition. Generally, it is preferred to use the IP 3 in salt form. However, it can also be used in acid form, if desired. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS According to the present invention a food composition having a content of IP 3 of at least 5 mg per 100 g composition has been brought about. Very often the IP 3 content is at least 20 mg per 100 g composition. Adventageously, the content of IP 3 should be within the range of 5-500, preferably in the range of 20-500, more preferably 50-500, 100-500 or 150-500 mg IP 3 per 100 g food composition. The composition can be used as an additive or an intermediate concentrate to increase the IP 3 content of other foodstuff products. Then the content of IP 3 in said intermediate concentrate should be at least 20 mg per 100 g of the concentrate. Usually, however, the content of IP 3 in the concentrate is much higher, advantageously 50 mg-100 g and with preference 75 mg-80 g, 100 mg-80 g, 150 mg-60 g, 200 mg-60 g, 250 mg-50 g or 300 mg-50 g respectively per 100 g concentrate. Preferably, the content of IP 3 of the concentrate should be as high as possible. The intermediate concentrate can be used in many different forms, such as powder, tablets, capsules and granules. However, it is also possible to use it in the form of a liquid, such as an aqueous solution. The IP 3 is preferably selected from the group consisting of D-myo-inositol-1.2.6-triphosphate, D-myo-inositol-1.2.5-triphosphate, myo-inositol-1.2.3-triphosphate, L-myo-inositol-1.3.4-triphosphate and D-myo-inositol-1.4.5-triphosphate and mixtures thereof. Of these isomers D-myo-inositol-1.2.6-triphosphate is preferred. Often 20-100, preferably 40-100% by weight of the IP 3 content consists of D-myo-inositol-1.2.6-triphosphate. According to one suitable method for the production of IP 3 a material containing IP 6 is broken down enzymatically with phytase enzyme. The IP 6 can be provided either as pure material or in the form of an IP 6 containing source, such as wheat bran. Phytase enzyme can be found for instance in plants, seeds and microorganisms. By the enzymatic treatment of the IP 6 a hydrolysis takes place resulting in a mixture of different lower inositolphosphates, i.e. inositolpentaphosphate (IP 5 ), inositoltetraphosphate (IP 4 ), inositoltriphosphate (IP 3 ), inositoldiphosphate (IP 2 ) and inositolmonophosphate (IP 1 ). Usually, the hydrolysis is carried out at a temperature of 20°-70° C. and a pH of 4 to 8. The hydrolysis is suitable stopped when the liberation of about 30-60% of the total ester phosphorus has been achieved. At said stage a high proportion of the desired IP 3 isomer of isomers has been formed by hydrolysis of the IP 6 containing material. The mixture of inositolphosphates obtained may hereafter be separated by chromatography to isolate the IP 3 -containing fraction. Preferably, this is made in a column. If the IP 3 fraction contains more than one isomer, these isomers are separated in another subsequent chromatographic separation step. The IP 3 can be obtained as a salt or as an acid thereof. The salt form is preferred, since it is easier to produce in pure and concentrated form than the acid. The salt form of the IP 3 isomer is readily obtainable from the acid form using standard procedures. Thus, there can be prepared salts, such as alkali metal and alkaline earth metal salts, e.g. lithium, sodium, potassium, calcium or magnesium. However, also the zinc salts are very useful as well as the NH 4 + and organic amine salts. Exemplary amines are triethanolamine, diethanolamine, triisopropanolamine, N,N-dimethyl-2-amino-2-methyl-1-propanol, N,N-dimethylethanolamine, tetrabutylamine and cyclohexylamine. Also other salts might be used. Especially preferred salts are those which are physiologically acceptable. Advantageously, the distribution curve showing the content of the different inositolphosphates has a maximum and preferably the sole maximum for IP 3 which means that the content of IP 3 is larger than IP 2 and/or IP 4 . Usually the proportion of IP 3 is at least 10% of the total amount of inositolphosphates. Sometimes the composition in addition to IP 3 has a content of IP 4 and/or inositoldiphosphate (IP 2 ). Then, preferably more than 40% by weight of the total amount of inositolphosphates in the composition consists of IP 3 , while 30-85% by weight of the remaining inositolposphates consists of IP 2 plus IP 4 . In such a composition the IP 3 can consist essentially of D-myo-inositol-1.2.6-triphosphate. However, also other IP 3 isomers, especially those mentioned above, can be used in such a foodstuff product. Depending for instance on the form of the composition the IP 3 can be present in salt form or in acid form. The acid form is usually used as a liquid, preferably an aqueous solution. In salt form the IP 3 can be used as a dry product or alternatively as a liquid, preferably an aqueous solution. When IP 3 is present as a salt, said salt is generally selected from the group mentioned above. The invention provides a method of making a food composition, said food being initially substantially free of IP 3 . The method comprises adding a source of IP 3 to the composition in an amount sufficient to provide a final concentration of at least 5 mg IP 3 per 100 g of composition. The source of IP 3 can be IP 3 as such produced separately or, alternatively, be IP 6 , IP 5 and/or IP 4 in the presence of phytase for enzymatic production of IP 3 . The term &#34;initially substantially free of IP 3 &#34; is intended to mean that the food composition produced in the conventional way does not contain a substantial amount of IP 3 . Thus, the content of IP 3 will be less than 3 mg, normally less than 2 mg and most often below 1 mg per 100 g of the composition. The invention also comprises a method of making a food composition wherein in the materials composing the composition, a content of phytase and of an inositolphosphate selected from the group consisting of inositoltetraphosphate (IP 4 ), inositolpentaphosphate (IP 5 ) and inositolhexaphosphate (IP 6 ), is established, and at at least one stage of the production process, the time and the temperature of the processing as well as the pH-value are controlled to allow an incubation in such a way that a content of inositoltriphosphate (IP 3 ) of at least 20 mg per 100 g composition is obtained. At said incubation step, at least a portion of the inositolphosphate selected from IP 6 , IP 5 and IP 4 is enzymatically broken down to IP 3 with phytase enzyme. The proportion of the original inositolphosphate content transformed to IP 3 can be regulated within wide limits by varying the production parameters, such as incubation time, temperature and pH as mentioned. Phytase enzyme may be present in plants or seeds provided they have a content of inositolhexaphosphate. Because of this it may according to the invention, not be necessary in all cases to add the enzyme if a plant or seed product is used as starting material. In the cases where said natural product has too low and enzymatic activity or when IP 6 , IP 5 or IP 4 or--a mixture of these is used as starting material, a phytase enzyme, for example, from bran can be added. Yeast can be used advantageously as a source of phytase. Preferably baker&#39;s yeast is used. Swedish baker&#39;s yeast produced by Jastbolaget, Sweden, as well as baker&#39;s yeast produced by Rajamaki, Finland and Hefefabriken AG, Switzerland have for instance been used according to the present invention. When using yeast according to the present invention it has been established very surprisingly that essentially only one isomer is obtained, namely D-myo-inositol-1.2.6-triphosphate. Of course, the use of yeast is a very valuable procedure if said isomer only is desirable. During the incubation a hydrolysis takes place at a suitable temperature, usually 20°-70° C., preferably 30°-60° C., and at a pH of 4-8. In order to stop the hydrolysis at the intended level the enzyme may be destroyed or inactivated, for instance by a rapid heating of the hydrolyzed starting material. The method according to the invention can be modified in different ways, for instance depending on the starting material chosen. The starting material can for instance: 1. have a certain content of IP 6 , IP 5 and/or IP 4 . 2. have no content of IP 6 , IP 5 or IP 4 . At the first alternative above, there are different possibilities to achieve a desired amount of IP 3 in the final foodstuff product. For instance the above method of hydrolyzing the inositolophosphates to IP 3 by means of phytase can be used. If the content of IP 6 , IP 5 and/or IP 4 is not high enough in the starting material, an addition thereof can be made. In this way the IP 3 content of the final product can be increased. The above method can be used also for the production of an intermediate product with a desired content of IP 3 , which product can be added to the starting material for the food composition. The intermediate product can also be introduced at a later stage of the production of the foodstuff product. Methods of producing IP 3 and its isomers as such are disclosed in applicant&#39;s copending U.S. patent application Ser. No. 788,829 filed Oct. 18, 1985 having the title &#34;Inositoltriphosphate&#34;. At the second alternative above, where the starting material has no content of IP 6 , IP 5 or IP 4 , such an inositolphosphate can be added together with phytase, if phytase is lacking. Then the above hydrolysis method can be used again to give the desired content of IP 3 in the final product. Alternatively, the intermediate product mentioned above can be added to the starting material or at a later stage of the production of the food composition. At both aforementioned methods, IP 3 in concentrated form can be added at a later or final stage of the production of the composition. In another embodiment of this invention a method of making a food composition is provided in which the composition is initially containing less than about 10 mg of IP 3 per 100 g of composition, wherein the content of IP 3 is increased to at least 20 mg per 100 g of composition by addition of IP 3 or a source thereof or conversion of initially contained inositolphosphate selected from the group consisting of IP 6 , IP 5 and IP 4 by enzymatic process. In such method of making a composition according to the present invention, said composition can advantageously be an cereal based material, such as breakfast cereals, cakes, biscuits and bread. The composition can also be selected from the group consisting of sweets, chocolates and chewing gums. Often, quite preferably, the composition is also a vegetable, fruit, beverage, soup or a product based on milk, e.g. yoghurt. In another embodiment of the invention where the composition initially is containing less than about 20 mg of IP 3 per 100 g composition. The content of IP 3 is increased to at least 50 mg per 100 g composition in the same way. In a further embodiment of the invention where the composition initially is containing less than about 50 mg of IP 3 per 100 g composition. The content of IP 3 is increased to at least 100 mg per 100 g composition in the same way. The content of IP 3 in the composition can be varied within wide limits. It is preferred to have a content of IP 3 of 20-500, such as 50-500, 100-500 or 150-500 mg IP 3 respectively based on 100 g composition. For bakery food the interval is advantageously 20-500, preferably 100-500, and most preferably 150-500 or 200-500 mg IP 3 respectively per 100 g dry bakery food. The daily intake of IP 3 is at least 10 mg, perferably at least 50 mg. At the production of a liquid composition according to the present invention, the content of IP 3 can also be varied to a large extent. Generally, the content of IP 3 is 5-500, such as 10-500, 20-500 or 5-300 mg IP 3 per 100 g of the liquid composition. The liquid composition can for instance be a beverage or soup. According to the invention a food composition can be provided where in the concentration of IP 3 is at least 20 mg per 100 g of dry composition. The IP 3 has been added to the composition and/or formed by adding phytase and an inositol phosphate selected from the group consisting of IP 4 , IP 5 and IP 6 . In the frame of the invention, bakery products are especially preferred. Thus, a bakery food composition is provided wherein the concentration of IP 3 is at least 20 mg per 100 g of dry composition and the degree of hydrolysis of naturally contained IP 6 and/or of added IP 6 is 20-90% preferably between 40 and 70%. Thus, the ration of inorganic phosphorus to the total amount of phosphorus is at least 20%, preferably at least 40%. At a special bakery food composition the initial content of IP 3 is less than 150 mg per 100 g composition and the initial content of IP 6 is less than 200 mg per 100 g composition. The content of IP 3 in the final composition is then increased by breaking down IP 6 . The IP 3 -isomers mentioned above have the following formulas: D-myo-inositol-1.2.6-triphosphate of the formula. ##STR1## where X is hydrogen, at least one univalent, divalent or multivalent cation, or a mixture thereof, n is the number of ions, and z is the charge of the respectively ion; D-myo-inositol-1.2.5-triphosphate of the formula ##STR2## where X, n and z have the above mentioned meaning; myo-inositol-1.2.3-triphosphate of the formula ##STR3## where X, n and z have the above mentioned meaning; L-myo-inositol-1.3.4-triphosphate of the formula ##STR4## where X, n and z have the above mentioned meaning; and D-myo-inositol-1.4.5-triphosphate of the formula ##STR5## where X, n and z have the above mentioned meaning. In each of the above formulas n ranges between 6 to 1 inclusively and z ranges from 1 to 6 inclusively. Preferably, n is between 3 to 6 inclusive and z is 3, 2 or 1. The composition according to the present invention has a good influence on the organism in many ways. However, it is mainly intended to prevent or alleviate conditions created, induced or furthered by heavy metals, especially cadmium or diseases related to such heavy metals. Also the composition is intended to give a good effect on smokers. As examples of conditions which the present composition is intended to prevent or alleviate the following can be mentioned; high blood pressure, a cardiovascular disease, emphysema and increased platelet aggregation. However, the composition has a good effect on many other conditions too. For purposes of further understanding the invention, formulas are given below of some of the IP 3 -isomers of the invention. Formulas are also given for IP 6 , IP 5 , IP 4 and IP 2 . The lower phosphate-esters of myoinositol are named depending on where the phosphoric acid groups are situated on the inositol ring, with the numbering giving as low position numbers as possible. L and D stand for clockwise and counterclock-wise counting respectively, and are used depending on which result gives the lowest position number. The carbon atom which has an axial phosphoric acid group always has the position number 2. The structural formulae below are simplified to the acid form. ______________________________________ ##STR6## myo-inositol; C.sub.6 H.sub.6 (OH).sub.6 ##STR7## ##STR8## 1.2.3.4.5.6-hexakis-(dihydrogen- phosphate)-myo-inositol al- ternatively myo-inositol hexakis (phosphate) or IP.sub.6 ##STR9## D-myo-inositol-1.2.6-triphos- phate alternatively D-1.2.6-IP.sub.3 ##STR10## D-myo-inositol-1.2.5-tri- phosphate alternatively D-1.2.5-IP.sub.3 ##STR11## myo-inositol-1,2,3-tri- phosphate alternatively 1.2.3-IP.sub.3 ##STR12## L-myo-inositol-1.3.4-tri- phosphate alternatively L-1.3.4-IP.sub.3 ##STR13## L-myo-inositol-1.2-diphos- phate alternatively L-1.2-IP.sub.2 ##STR14## D-myo-inositol-1.2.5.6- tetra-phosphate or D-1.2.5. 6-IP.sub.4 ##STR15## L-myo-inositol-1.2.3.4.5- penta phosphate or L-1.2.3.4.5-IP.sub.5______________________________________ Other isomers of inositol triphosphate within the contemplation of the present invention include compounds having the structural formula ##STR16## One group of inositol triphosphate compounds are defined by structural formula (I) where three of R 1 , R 3 , R 5 , R 7 , R 10 and R 11 are hydroxyl and the remaining three are phosphate and R 2 , R 4 , R 6 , R 8 , R 9 and R 12 are hydrogen. Another group of inositol triphosphates are defined by structural formula (I) where three of R 1 , R 3 , R 6 , R 7 , R 9 and R 12 are hydroxyl and the remaining three are phosphate and R 2 , R 4 , R 5 , R 8 , R 10 and R 11 are hydrogen. Still another group of inositol triphosphates are defined by structural formula (I) where three of R 1 , R 3 , R 5 , R 8 , R 10 and R 12 are hydroxyl and the remaining three are phosphate and R 2 , R 4 , R 6 , R 7 , R 9 and R 11 are hydrogen. Yet another group of inositol triphosphates are defined by structural formula (I) where three of R 1 , R 4 , R 5 , R 8 , R 9 and R 12 are hydroxyl and the remaining three are phosphate and R 2 , R 3 , R 6 , R 7 , R 10 and R 11 are hydrogen. Still yet another group of inositol triphosphates are defined by structural formula (I) where three of R 1 , R 3 , R 6 , R 8 , R 9 and R 12 are hydroxyl and the remaining three are phosphate and R 2 , R 4 , R 5 , R 7 , R 10 and R 11 are hydrogen. Even still another group of inositol triphosphates are defined by structural formula (I) where three of R 1 , R 3 , R 6 , R 7 , R 10 and R 12 are hydroxyl and the remaining three are phosphate and R 2 , R 4 , R 5 , R 8 , R 9 and R 11 are hydrogen. Even yet group of inositol triphosphates are defined by structural formula (I) where three of R 1 , R 3 , R 5 , R 8 , R 10 and R 11 are hydroxyl and the remaining three are phosphate and R 2 , R 4 , R 6 , R 7 , R 9 and R 12 are hydrogen. Finally, another group of inositol triphosphates are defined by structural formula (I) where three of R 1 , R 3 , R 5 , R 7 , R 9 and R 11 are hydroxyl and the remaining three are phosphate and R 2 , R 4 , R 6 , R 8 , R 10 and R 12 are hydrogen. Particular inositol triphosphate compounds within the contemplation of the above groups include compounds having the structural formula (I) where R 5 , R 7 and R 10 are phosphate, R 1 , R 3 and R 11 are hydroxyl and R 2 , R 4 , R 6 , R 8 , R 9 and R 12 are hydrogen; R 1 , R 10 and R 11 are phosphate, R 3 , R 5 and R 7 are hydroxyl and R 2 , R 4 , R 6 , R 8 , R 9 and R 12 are hydrogen; R 1 , R 3 and R 11 are phosphate, R 5 , R 7 and R 10 are hydroxyl and R 2 , R 4 , R 6 , R 8 , R 9 and R 12 are hydrogen; R 3 , R 5 and R 7 are phosphate, R 1 , R 10 and R 11 are hydroxyl and R 2 , R 4 , R 6 , R 8 , R 9 and R 12 are hydrogen; R 3 , R 7 and R 10 are phosphate, R 1 , R 5 and R 11 are hydroxyl and R 2 , R 4 , R 6 , R 8 , R 9 and R 12 are hydrogen; R 3 , R 10 and R 11 are phosphate, R 1 , R 5 and R 7 are hydroxyl and R 2 , R 4 , R 6 , R 8 , R 9 and R 12 are hydrogen; R 1 , R 3 and R 6 are phosphate, R 7 , R 9 and R 12 are hydroxyl and R 2 , R 4 , R 5 , R 8 , R 10 and R 11 are hydrogen; R 6 , R 7 and R 9 are phosphate, R 1 , R 3 and R 12 are hydroxyl and R 2 , R 4 , R 5 , R 8 , R 10 and R 11 are hydrogen; R 3 , R 5 and R 8 are phosphate, R 1 , R 10 and R 12 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 9 and R 11 are hydrogen; R 1 , R 3 and R 12 are phosphate, R 5 , R 8 and R 10 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 9 and R 11 are hydrogen; R 1 , R 3 and R 5 are phosphate, R 8 , R 10 and R 12 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 9 and R 11 are hydrogen; R 1 , R 5 and R 8 are phosphate, R 3 , R 10 and R 12 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 9 and R 11 are hydrogen; R 1 , R 5 and R 12 are phosphate, R 3 , R 8 and R 10 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 9 an R 11 are hydrogen; R 1 , R 3 and R 12 are phosphate, R 6 , R 8 and R 9 are hydroxyl and R 2 , R 4 , R 5 , R 7 , R 10 and R 11 are hydrogen; R 1 , R 3 and R 6 are phosphate, R 7 , R 10 and R 12 are hydroxyl and R 2 , R 4 , R 5 , R 8 , R 9 and R 11 are hydrogen; R 4 , R 5 and R 8 are phosphate, R 1 , R 9 and R 12 are hydroxyl and R 2 , R 3 , R 6 , R 7 , R 10 and R 11 are hydrogen; R 3 , R 5 and R 8 are phosphate, R 1 , R 10 and R 11 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 9 and R 12 are hydrogen; R 1 , R 3 and R 5 are phosphate, R 8 , R 10 and R 11 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 9 and R 12 are hydrogen; R 1 , R 3 and R 5 are phosphate, R 7 , R 9 and R 11 are hydroxyl and R 2 , R 4 , R 6 , R 8 , R 10 and R 12 are hydrogen; R 1 , R 3 and R 12 are phosphate, R 5 , R 8 and R 9 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 10 and R 11 are hydrogen; R 1 , R 3 and R 8 are phosphate, R 5 , R 9 , R 12 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 10 and R 11 are hydrogen; R 3 , R 5 and R 12 are phosphate, R 1 , R 8 and R 9 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 10 and R 11 are hydrogen; R 1 , R 5 and R 9 are phosphate, R 3 , R 8 and R 12 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 10 and R 11 are hydrogen; R 1 , R 5 and R 12 are phosphate, R 3 , R 8 and R 9 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 10 and R 11 are hydrogen; R 1 , R 3 and R 9 are phosphate, R 5 , R 8 and R 12 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 10 and R 11 are hydrogen; R 1 , R 8 and R 9 are phosphate, R 3 , R 5 and R 12 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 10 and R 11 are hydrogen; R 1 , R 8 and R 12 are phosphate, R 3 , R 5 and R 9 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 10 and R 11 are hydrogen; R 5 , R 8 and R 12 are phosphate, R 1 , R 3 and R 9 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 10 and R 11 are hydrogen; R 1 , R 9 and R 12 are phosphate, R 3 , R 5 and R 8 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 10 and R 11 are hydrogen; R 5 , R 8 and R 9 are phosphate, R 1 , R 3 and R 12 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 10 and R 11 are hydrogen; R 3 , R 8 and R 9 are phosphate, R 1 , R 5 and R 12 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 10 and R 11 are hydrogen; R 3 , R 9 and R 12 are phosphate, R 1 , R 5 and R 8 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 10 and R 11 are hydrogen; R 3 , R 8 and R 12 are phosphate, R 1 , R 5 and R 9 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 10 and R 11 are hydrogen; and R 8 , R 9 and R 12 are phosphate, R 1 , R 3 and R 5 are hydroxyl and R 2 , R 4 , R 6 , R 7 , R 10 and R 11 are hydrogen. The above discussed compounds having structural formula (I) are made by the same procedure set forth in Examples 32 to 35. The invention is further explained below in connection with embodiment examples, of which examples 1 and 2 relate to a comparison test where an analysis of inositolphosphates in some commercially available breads and breakfast cereals respectively is made. Examples 3-7 illustrate a method of making bread according to the invention. Example 8 relates to the production of a cake baked on wheat flour with the addition of a calciumsalt of inositolphosphates. Example 9 shows the production of breakfast cereals after addition of a sodiumsalt of inositolphosphates. Example 10 illustrates the production of table-salt by addition of the sodiumsalt of D-myo-inositol-1.2.6-triphosphate. Example 11 illustrates the production of beverages by addition of a sodiumsalt of inositoltriphosphates. Example 12 relates to the production of honey by addition of a sodiumsalt of D-myo-inositol-1.2.6-triphosphate. Example 13 illustrates the production of chocolate by addition of a sodiumsalt of inositolphosphates. Example 14 shows that in blood of rabbits, platelet aggregation caused by an injection of cadmium can be prevented by administration of a diet containing IP 3 . Example 15 shows the effect of IP 3 on the cadmium content in different organs of mice which had got an injection of cadmium. Example 16 shows that IP 3 prevents an increase of platelet aggregation caused by smoking. Examples 17 and 18 show that IP 3 prevents or reduces the formation of free radicals. Examples 19-24 illustrate hydrolysis of phytic acid in different foodstuff sources. Examples 25-31 show production of IP 3 and the separation thereof into different isomers. EXAMPLE 1 Analysis of inositolphosphates in some commercially available breads. Three commercially available breads, one white bread and two crisp breads, were analyzed for the contents of inositolphosphates with HPLC. The white breads were baked on whole rye flour and whole wheat flour respectively. A 20 gram quantity of the breads were ground and extracted with 1% hydrochloric acid for two hours at shaking. The suspension was centrifuged and the supernatant was collected. The supernatant was analyzed with well-defined inositolphosphates and the results were quantified as mg inositolphosphates per 100 g (solid contents). ______________________________________ (mg/100 g solidType of bread IP.sub.2 IP.sub.3 IP.sub.4 IP.sub.5 IP.sub.6 content)______________________________________White bread 33 2 3 2 2Crisp bread/whole 37 6 14 71 515wheat f1ourCrisp bread/whole 27 10 13 25 64rye flour.______________________________________ The results show that the amount of inositoltriphosphates in the commercially available breads are low. EXAMPLE 2 Analysis of inositolphosphates in breakfast cereals. Commercially available Corn Flakes®, Kellog&#39;s was analyzed for the content of inositolphosphates with HPLC. The extraction procedure and analysis were the same as described in Example 1. 19 mg IP 2 and 2 mg IP 3 per 100 g solid content was found. No IP 4 , IP 5 or IP 6 could be detected. The IP 6 contained in the raw material had almost completely been broken down and the amount of IP 3 was very low. EXAMPLE 3 Variation of the fermentation period for crispbread baked on rye flour. Biologically acidfied crisp bread was baked on rye flour (1% IP 6 content). The dough formulation was: 54.6 g flour, 41.8 g water, 1.3 g salt (NaCl) and 2.4 g of a dough from a preceding doughformulation. A sour dough consisting of the above 2.4 g of dough from a preciding doughformulation and 40% of the flour and 85% of the water amount was fermented in a first step for 6 hrs before mixing with the other ingredients (flour, water and salt). After mixing, the dough was fermented in a second step before bread forming and baking. The oven temperature was 250° C. Three breads with three different times for the second fermentation period were produced. The breads were ground, extracted and analyzed as described in Example 1. The content of IP 3 versus fermentation time was determined as follows: ______________________________________Second fermen- Amount of IP.sub.3tation time (mg/100 g solid content)______________________________________30 min 10490 min 89225 min 78______________________________________ The result shows that an increased second fermentation period resulted in a decrease of IP 3 content. EXAMPLE 4 IP 3 -content in a bread baked on wheat and oat flour. Chemically acidfied bread was baked on a combination of wheat and oat flour (0.9% IP 6 content). The dough formulation was: 37.7% wheat flour, 17.7% oat flour, 39.5% water, 1.3% salt (50% NaCl and 50% kalciumacetate). 1% sucrose and 2.8% baker&#39;s yeast. After mixing the ingredients the dough was fermented before bread forming and baking. The fermentation period was 90 minutes and the temperature was 37° C. The breads obtained were ground, extracted and analyzed as described in Example 1. The content of IP 3 was determined to be 120 mg per 100 g dry bread. EXAMPLE 5 IP 3 -content in a bread baked on whole wheat flour. A white bread was baked on whole wheat flour (0.9% IP 6 content). The dough formulation was: 55.9% flour, 38.4% water, 3.5% yeast, 0.6% salt (NaCl) and 1.7% sucrose. After mixing the ingredients, the dough was fermented before the bread was formed. After an additional fermentation period the bread was baked. The total fermentation period was 60 minutes and the baking temperature was 175° C. The bread was ground, extracted and analyzed as described in Example 1. The content of IP 3 was 70 mg per 100 g dry bread. EXAMPLE 6 IP 3 -content in a bread baked on rye flour with addition of sodiumphytate. Biologically acidified crisp bread was baked on rye flour (1% IP 6 -content) as described in Example 3 but with the difference that 0.8 g sodiumphytate was added to 100 g dough. The fermentation period was 225 minutes. The bread was ground, extracted and analyzed as described in Example 1. The amount of IP 3 in the bread was 180 mg per 100 g dry bread. EXAMPLE 7 IP 3 -content in a bread baked on rye flour with addition of calciummagnesiumphytate. Biologically acidified crisp bread was baked on rye flour (1% IP 6 -content) as described in Example 3 but with the difference that 1.5 g calciummagnesiumphytate was added to 100 g dough. The fermentation period was 225 minutes. The bread was ground, extracted and analyzed as described in Example 1. The amount of IP 3 in the bread was 250 mg per 100 g dry bread. EXAMPLE 8 IP 3 -content in a cake baked on wheat flour with the addition of a calciumsalt of inositolphosphates. A cake was baked on wheat flour (0.2% IP 6 -content). The dough formulation was 60.1% wheat flour, 35.7% water, 0.6% salt (NaCl) and 3.6% yeast. After mixing the ingredients the dough was fermented. 0.2 g of a calciumsalt of inositolphosphates containing 30% by weight of IP 3 was added in 10 ml water per 100 g dough before the cake was formed. After an additional fermentation period the cake was baked in the oven. The total fermentation time was 75 minutes and the baking temperature was 225° C. The cake was ground, extracted and analyzed as described in Example 1. The amount of IP 3 was 60 mg per 100 g dry cake. EXAMPLE 9 IP 3 -content in breakfast cereals after addition of a sodiumsalt of inositolphosphates. 1000 g commercially available Corn Flakes®, Kellogg&#39;s was sprayed with 10 ml warm (80° C.) aqueous solution containing 50% sucrose and 10% of a sodiumsalt of inositolphosphates (containing 30% IP 3 ). After drying, the breakfast cereals were granned, extracted and analyzed as described in Example 1. The content of IP 3 was 30 mg per 100 g dry material. EXAMPLE 10 Table-salt with addition of sodiuminositoltriphosphate. The sodiumsalt of D-myo-inositol-1.2.6-triphosphate was mixed with table-salt in such a way that a final concentration of 200 ppm IP 3 was obtained. EXAMPLE 11 Beverages with addition of a sodiumsalt of inositolphosphates. 20 ml of a 15% aqueous solution of a sodiumsalt of inositolphosphates (containing 40% of IP 3 ) was added to 5 l commercially available Coca-cola®, Seven-Up® and orange juice respectively. The final concentration of IP 3 in the beverages was found by HPLC to be 190 mg/l. EXAMPLE 12 Honey with addition of a sodiumsalt of inositoltriphosphates. 5 ml of a 20% aqueous solution of the sodiumsalt of D-myo-inositol-1.2.6-triphosphate was added to 50 kg commercially available honey. The final concentration of inositoltriphosphate was determined by HPLC to be 20 mg/kg. EXAMPLE 13 Chocolate with added IP 3 . To 1500 g melted chocolate, 6 ml of a 10% aqueous solution of a sodiumsalt of inositolphosphates (containing 30% IP 3 ) was added before lowering the temperature and forming the final chocolate product. The content of IP 3 in the chocolate was 110 mg per kg chocolate as determined by HPLC. EXAMPLE 14 Rabbits (New Zealand white, males) weighing 2-2.5 kg were used. They were fed with a diet free from inositol phosphates, for 10 days before the experiment. 2 hours before the start of the experiment, 50 mg of a sodiumsalt of myo-inositol-1.2.6-triphosphate was mixed into 5 g of the diet for a group of 18 animals. Another group with 12 animals got no addition of inositoltriphosphate. Time: Treatment 0 minute: Blood sample 1 (9 ml+1 ml 3.8% sodium citrate) taken. 1 minute: Intravenous injection of 4 microgram Cd as CdCl 2 in 0.5 ml physiological saline, or 0.5 ml physiological saline respectively. 4 minutes: Blood sample 2 (9 ml+1 ml 3.8% sodium citrate) taken. TREATMENT OF SAMPLES The two blood samples from each animal were centrifuged at 1200 revolutions per minute, for 10 minutes, and the plasma with platelets was obtained. The plasma with platelets from the two samples was analyzed concerning the response to addition of ADP (adenosin diphosphate) in an aggregometer (Chronopar Corp Mod, 440) according to Born (J. Physiol: 67, 1968). The two samples were analyzed simultaneously at the same concentration (1-20 micromolar) of ADP, in the two channels of the instrument. The principle of this test is that the plasma with platelets is turbid, and has a low transmittance for light. As ADP is added, the platelets aggregate, and form clumps. This results in an increase fo transmittance which is quantified by the instrument. The response to ADP was measured in scale units, with 80 scale units representing maximal aggregation. In order to have a maximal sensitivity of the method to pick up changes in platelet reactivity, the ADP dose should cause a response of 5-30 scale units. This was normally achieved with 5 uM ADP, but in some animals a lower or higher dose (1-20 uM) was necessary. The result of the test is expressed as maximal aggregation in sample 2 (scale unite) minus maximal aggregation in sample 1. The following results were obtained: ______________________________________ Change in aggre-Oral gation from sampleadministration Injection No 1 to sample 2 (scale unit)______________________________________No addition to Cd 12 +2.3the dietIP.sub.3 added to Cd 18 -0.2the diet______________________________________ At the dose used in this experiment, the IP 3 prevented the effect of Cd on platelet aggregation. An increase in platelet aggregation is regarded as one of the most important factors causing cardiovascular diseases e.g. arteriosclerosis, and the ability of IP 3 to prevent the aggregation induced by cadmium shows that IP 3 is very useful in preventing or allievating such disease. EXAMPLE 15 Mice weighing 18-20 gram at the start of the experiment were used. During the experiment and for at least seven days before the experiment the mice were fed a semisynthetic diet free of inositol phosphates. The mice were divided in two groups. They received daily intraperitoneal injections of physiological saline and inositoltriphosphate (IP 3 ) respectively for 9 days. The dose fo IP 3 was 5.0 mg/day. The injected volume was 0.2 ml. On day two of the experiment, 5-10 minutes after the second intraperitoneal injection, all mice received an intravenous injection of 2.5 microcurie of 109 Cd as cadmium chloride in 50 ul of saline. After the last intraperitonial injection the mice were killed and several organs were dissected out and weighed. Radioactivity in the different organs were measured by counting with a gamma-counter. Radioactivity in the organs of the IP 3 -treated animals was compared with that of control animals which had been treated with saline for the same period of time. In the results radioactivity in the organs of the animals treated with IP 3 is expressed as % of the radioactivity found in controls. The results were as follows: Organ levels of mice treated with cadmium and IP 3 as percent of control levels (controls=100). 15 mice in each group. Said control group had been treated with saline and Cd as mentioned. ______________________________________ Organ IP.sub.3______________________________________ Lung 80 Heart 77 Aorta 89 Spleen 81 Salivary gland 82 Liver 100 Kidney 102______________________________________ The results show that IP 3 caused a reduction in cadmium levels in all studied organs except liver and kidney at which letter sites the Cd is believed to be relatively safe. EXAMPLE 16 The effect of IP 3 on platelet aggregation after smoking in humans was studied. Four young healthy male non-smokers received, on two occasions, a capsule containing 50 mg of IP 3 or 50 mg of a placebo. The IP 3 used was the Ca-salt of D-myo-inositol-1.2.6-triphosphate. Neither subject nor investigator knew whether the subject had received IP 3 or placebo. Two hours after ingestion of the capsule, a blood sample was obtained. The subject then smoked two cigarets in rapid succession. A second blood sample was obtained after smoking. The aggregation responses of the platelets to ADP and collagen in the two samples were determined, using essentially the same procedure as in Example 14. The results are expressed as change in aggregation from the pre-smoking to the post-smoking sample. A positive sigh indicates that aggregation was stronger after smoking. ______________________________________ Concentration DifferenceAggregation of aggregating between IP.sub.3agent agent IP.sub.3 Placebo and placebo______________________________________ADP 0.5 mmol +1.5 +7.25 5.85&#34; 1 mmol -1.5 +0.25 1.75&#34; 2.5 mmol -1.5 0 1.5&#34; 5 mmol -2.5 -0.75 1.75Collagen 0.5 mg +5.75 +12.25 6.5&#34; 1 mg -8.25 +1.75 10.0&#34; 2.5 mg -3.75 0 3.75&#34; 5 mg -1.5 -0.25 1.25______________________________________ In the placebo group, smoking caused an increase in aggregation, which was most marked at low concentrations of aggregation agents. In all cases this effect was counteracted by IP 3 . Thus IP 3 prevents increase of platelet aggregation caused by smoking. EXAMPLE 17 A reaction mixture consisting of 48 mmol KH 2 PO 4 , 2 mmol Na-ascorbate, 0.1 mmol H 2 O 2 , 0.5 mmol Fe and 1.7 mmol deoxyribose was incubated at 37° C. for 1 hour. Similar reactions mixtures including EDTA 1 mmol or inositoltri-phosphate (IP 3 ) 1 mmol were similarly incubated. After incubation 1.65 ml thiobarbituric acid in 50 mmol NaOH and 1.65 ml 2.8% trichloroacetic acid was added to 2 ml of the reaction mixture. The mixture was heated to 100° C. for 20 minutes and the absorbance at 532 nm was measured with water as a blank. The experiments were performed with iron in the form of Fe 2+ (Fe(NH 4 )SO 4 ) and Fe 3+ (Fe Cl 3 ). The results were as follows: ______________________________________Production of free radicals catalyzed by Fe.sup.2 + and Fe.sup.3+in the presence of IP.sub.3 or EDTA, expressed as absorbanceat 532 nm.Group Fe.sup.2+ Fe.sup.3+______________________________________Control 0.76 0.79EDTA 2.2 1.86IP.sub.3 0.46 0.43______________________________________ These results show that the formation of free radicals in the reaction mixture was diminished by 40% after addition of IP 3 . The addition of EDTA had an opposite effect. It strongly increased production of free radicals. Thus IP 3 was shown to reduce iron-dependent formation of free radicals. EXAMPLE 18 Lipid peroxidation was studied in lipid micelles. The following reaction mixture was incubated for 2 hours at 37° C.: 0.4 ml Clark-Lubs buffer pH 5.5 0.2 ml phospholipid liposomes 0.1 ml IP 3 0.5-5 mM or 0.1 ml H 2 O 0.1 ml Fe 2+ 1 mM or 0.1 ml H 2 O 0.1 ml Al 3+ 4 mM or 0.1 ml H 2 O 0.1 ml H 2 O The IP 3 was D-myo-inositol-1.2.6-triphosphate. After incubation, 0.5 ml of thiobarbituric acid +0.5 ml 25% HCl was added and the mixture was heated at 100° C. for 15 minutes. 1 ml Lubrol PX 1% (Sigma) was added and lipid peroxidation was measured by measuring the absorbance at 532 nm. The results were as follows: ______________________________________Concentration, mM AbsorbanceExperiment Fe.sup.2+ Al.sup.3+ IP.sub.3 532 nm______________________________________1 0.1 0 0 0.3672 0 0.4 0 0.1283 0.1 0.4 0 0.8964 0.1 0.4 0.5 0.3675 0.1 0 0.5 0.3036 0.1 0 0.4 0.2607 0.1 0 0.2 0.2978 0.1 0 0.1 0.2839 0.1 0 0.05 0.27110 0 0 0 0.133______________________________________ Fe 2+ caused lipid peroxidation (group 1 vs 10). Al 3+ itself caused no peroxidation (2 vs 10) whereas the combination of Fe 2+ +Al 3+ caused much stronger peroxidation than Fe 2+ alone (1 vs 3). Addition of IP 3 completely prevented the interaction between Fe 2+ and Al 3+ (3 vs 4). In systems with only Fe 2+ , IP 3 caused marked reduction in radical formation (1 vs 5-9). EXAMPLE 19 Hydrolysis of phytic acid in wheat, extraction and analysis of IP 3 . Ground wheat seeds, 100 g containing 1% myo-inositolhexaphosphate IP 6 was incubated in 1000 ml sodiumacetate buffer at pH 5.2 at 35° C. After an incubation period of 30 minutes, the slurry was frozen to -10° C. in order to stop the hydrolysis. 10 g of the frozen material was extracted with 100 ml 0.4M HCl. The suspension was shaken for 1 hr and subsequently centrifuged. The supernatant was collected and neutralized to pH 7 with an aqueous solution of NaOH. A sample of the supernatant was analyzed with HPLC. The analysis method was calibrated with welldefined inositolphosphates. The IP 3 content of the extract was 10 mg inositoltriphosphate. EXAMPLE 20 Hydrolysis of phytic acid in white beans, extraction and analysis of IP 3 . The same method was used as described in Example 19 except for the difference that 100 g white beans containing 1% myo-inositol hexaphosphate was incubated at 55° C. for 10 hrs. 10 g of the frozen material was extracted with 100 ml 0.4M HCl. The suspension was shaken for 1 hour and subsequently centrifuged. The supernatant was collected and neutrilized to pH 7 with an aqueous solution of NaOH. A sample of the supernatant was analyzed with HPLC. The IP 3 content of the extract was 5 mg inositoltriphosphate. EXAMPLE 21 Hydrolysis of phytic acid in soybeans after addition of a phytase source from microorganisms, extraction and analysis of IP 3 . 300 g soy beans were soaked over night (1.4% IP 6 content), peeled and then boiled for 30 minutes. 3 ml water containing about 1 g Rhizopus oligosporus, NRRL 2710 was added and the mixture was incubated at 40° C. for 20 hours. 10 g of the mixture was extracted and analyzed by HPLC as described in Example 19. The IP 3 content of the extract was 160 mg. EXAMPLE 22 Hydrolysis of phytic acid in white beans with crude wheat phytase, extraction and analysis of IP 3 . Ground beans, 100 g, containing 1% myo-inositol-hexaphosphate were suspended in 1000 ml sodiumacetate buffer at pH 5.2. 500 mg crude wheat phytase (from Sigma Chemical Co) was added. The mixture was incubated at 55° C. at shaking. After an incubation period of 12 hrs the slurry was frozen to -10° C. in order to stop the hydrolysis. 10 g of the frozen material was extracted with 100 ml 0.4M HCl. The suspension was shaken for 1 hour and subsequently centrifuged. The supernatant was collected and neutralized to pH 7 with an aqueous solution of NaOH. A sample of the supernatant was analyzed with HPLC. The IP 3 content of the extract was 40 mg IP 3 . EXAMPLE 23 Content of IP 3 in white beans after addition of sodiumphytate and hydrolysis. 0.3 grams of sodiumphytate was added to 100 g ground white beans (1% IP 6 ). The mixture was incubated in 1000 ml sodiumacetate buffer at pH 5.2 at 55° C. After an incubation period of 4 hours the slurry was frozen to -10° C. in order to stop the hydrolysis. 10 g of the frozen material was extracted and analyzed by HPLC as described in Example 19. The IP 3 content of the extract was 15 mg IP 3 . EXAMPLE 24 1.0 kg of rice bran, containing ca 1% inositolhexaphosphate (IP 6 ) was suspended in 10 l sodiumacetate buffer at pH 5 at 25° C. After 4 hours when 50% inorganic phosphorus had been released the slurry was extracted with an addition of 1 l 2M HCl. The suspension was shaken for 1 hour and subsequently centrifuged. The supernatant was neutralized to pH 7 with an aqueous solution of Ca(OH) 2 . A precipitate was obtained when 5 l ethanol was added. The calciumsalt consisting of a composition of different inositolphosphates was centrifuged, dried and recrystalized. 20 mg of the recrystallized calciumsalt was converted to the acid form by addition of diluted hydrochloric acid and was analyzed by HPLC. The composition consisted of 20% inositoltriphosphate. The rest consisted of other inositolphosphates. EXAMPLE 25 Hydrolysis of sodium phytate with wheat phytase and fractionation of a mixture of inositolphosphates. A 1.6 gram quantity of sodium phytate (from corn, Sigma Chemical Co) was dissolved in 650 ml sodium acetate buffer, pH 5.2. 2.7 gram wheat phytase (EC 3.1.3.26, 0.015 U/mg, from Sigma Chemical Co) was added and the mixture was incubated at 38° C. The dephosphorylation was followed by determining the inorganic phosphorus released. After 3 hours when 50% inorganic phosphorus was liberated the hydrolysis was stopped by adding 30 ml ammonia to pH 12. A liquid mixture containing inositolphosphates was obtained. 350 ml of the mixture was passed through an ion-exchange column (Dowex 1, chloride form, 25 mm×250 mm) and eluted with a linear gradient of hydrochloric acid (0-0.7N HCl). Aliquots of eluted fractions were completely hydrolyzed in order to determine the contents of phosphorus and inositol. The peaks correspond to different inositolphosphates i.e. a peak with the ratio of phosphorus to inositol of three to one consists of inositoltriphosphate etc. Two fractions with the ratio of phosphorus to inositol of three to one were obtained. EXAMPLE 26 Fractionation of inositoltriphosphates. 100 ml of the first fraction obtained in Example 25 with a phosphorus/inositol ratio of three to one was neutralized and precipitated as a bariumsalt after addition of 10% excess of 0.1M bariumacetate solution. 600 mg of the precipitated salt was dissolved in 50 ml of 0.18N hydrochloric acid. The solution was separated on an ion-exchange column (Dowex 1, chloride form, 25 mm×2500 mm) with diluted hydrochloric acid as eluent. Aliquots of eluted fractions were analyzed for phosphorus. Three peaks consisting of isomers of inositoltriphosphates can be seen. EXAMPLE 27 Structural determination of isomers of inositol-triphosphates with NMR. The three peaks obtained in Example 26 was analyzed by H-NMR. Data show that the peaks consist of myo-inositol-1.2.6-triphosphate, myo-inositol-1.2.3-triphosphate and myo-inositol-1.3.4-triphosphate respectively. The second fraction obtained in Example 25 with a phosphorus/inositol ratio of three to one was analyzed by H-NMR. Data show that the fraction consists of myo-inositol-1.2.5-triphosphate. EXAMPLE 28 Determination of optical isomers of inositol-triphosphates. 20 mg of the compounds determined with NMR according to Example 27 to be myo-inositol-1.2.6-triphosphate and myo-inositol-1.3.4-triphosphate were further chromatographed on a chiral column based on acetylated cellulose (20 mm×300 mm from Merck) with a mixture of ethanol and water as eluent. The fractions were analyzed with a polarimeter. As can be seen each compound consists of one optical isomer, D-myo-inositol-1.2.6-triphosphate and L-myo-inositol-1.3.4-triphosphate respectively. EXAMPLE 29 Hydrolysis of sodium phytate with baker&#39;s yeast and fractionation of a mixture of inositolphosphates. A 0.7 gram quantity of sodium phytate (from corn, Sigma Chemical Co) was dissolved in 600 ml sodium acetate buffer pH 4.6. 50 gram of baker&#39;s yeast from Jastbolaget, Sweden (dry substance: 28%, nitrogen content: 2%; phosphorus content: 0.4%) was added with stirring and incubation was continued at 45° C. The dephosphorylation was followed by determining the inorganic phosphorus released. After 7 hours when 50% inorganic phosphorus was liberated the hydrolysis was stopped by adding 30 ml of ammonia to pH 12. The suspension was centrifuged and the supernatant was collected. 400 ml of the supernatant was passed through an ion-exchange column (Dowex 1, chloride form, 25 mm×250 mm) and eluted with a linear gradient of hydrochloric acid (0-0.7N HCl). Aliquots of eluted fractions were completely hydrolyzed in order to determine the contents of phosphorus and inositol. The peaks correspond to different inositolphosphates i.e. a peak with the ratio of phosphorus to inositol of three to one consists of inositoltriphosphates etc. EXAMPLE 30 Structural determination of isomers of inositoltriphosphate. The fraction obtained in Example 29 with a phosphorus/inositol ratio of three to one was neutralized and evaporated before analysis with H-NMR. Data show that the peak consists of myo-inositol-1.2.6-triphosphate. EXAMPLE 31 Determination of optical isomers of myo-inositol-triphosphate. The same method was used as described in Example 28 with the difference that 10 mg of the compound determined with NMR according to Example 30 was analyzed. As can be seen the compound consists of one optical isomer, D-myo-inositol-1.2.6-triphosphate. EXAMPLE 32 A 0.5 gram quantity of D-chiro-inositol was dissolved in 1 ml phosphoric acid at 60° C. 20 g polyphosphoric acid was added and the mixture was heated to 150° C. under vacuum for 6 hours. The mixture was diluted with water to a volume of 200 ml and passed through an ion-exchange column (Dowex 1, chloride form, 25 mm×250 mm) and eluted with a linear gradient of hydrochloric acid (0-2.0N HCl). The content of the peak with the ratio of phosphorus to inositol of six to one was precipitated by addition of calciumhydroxide. The precipitate was filtered, washed and mixed with 10 ml of a cation-exchange resin to give the acid form of the inositolhexaphosphate. After neutralization with sodium hydroxide and freeze-drying the sodiumsalt of D-chiro-inositolhexaphosphate was obtained. EXAMPLE 33 A 0.8 gram quantity of the sodium salt of D-chiro-inositolhexaphosphate produced according to Example 32 was dissolved in 300 ml sodium acetate buffer, pH 5.2. 1.3 gram wheat phytase (EC 3.1.3.26 0.015 U/mg from Sigma Chemical Co.) was added and the mixture was incubated at 38° C. After the liberation of 50% inorganic phosphorus the hydrolysis was stopped by adding ammonia to pH 12. The mixture containing D-chiro-inositolphosphates was passed through an ion-exchange column (Dowex 1 chloride form, 25 mm×250 mm) and eluted with a linear gradient of hydrochloric acid (0-0.7N HCl). The peak with the ratio of phosphorus to inositol of three to one was neutralized with 1.0M sodium hydroxide and freeze-dried. Structural determination with NMR and IR showed the product to be D-chiro-inositoltriphosphate. EXAMPLE 34 A 0.8 gram quantity of epi-inositol was dissolved in 1.5 ml or phosphoric acid at 60° C. 32 g polyphosphoric acid was added and the mixture was heated to 150° C. under vacuum for 6 hours. The mixture was diluted with water to a volume of 200 ml and passed through an ion-exchange column (Dowex 1, chloride form, 25 mm×250 mm) and eluted with a linear gradient of hydrochloric acid (0-2.0N HCl). The content of the peak with the ratio of phosphorus to inositol of six to one was precipitated by addition of calcium hydroxide. The precipitate was filtered, washed and mixed with 10 ml of a cation-exchange resin to give the acid form of the inositol hexaphosphate. After neutralization with sodium hydroxide and freeze-drying the sodium salt of epi-inositolhexaphosphate was obtained. EXAMPLE 35 A 1.2 gram quantity of the sodium salt of epi-inositolhexaphosphate produced according to Example 34 was dissolved in 500 ml sodium acetate buffer, pH 5.2. 2.0 gram wheat phytase (EC 3.1.3.26, 0.015 U/mg from Sigma Chemical Co.) was incubated at 38° C. After the liberation of 50% inorganic phosphorus the hydrolysis was stopped by adding ammonia to pH 12. The mixture containing epi-inositolphosphates was passed through an ion-exchange column (Dowex 1, chloride form, 25 mm×250 mm) and eluted with a linear gradient of hydrochloric acid (0-0.7N HCl). The peak with the ratio of phosphorus to inositol of three to one was neutralized with 1.0M sodium hydroxide and freeze-dried. Structural determination with NMR and IR showed the product to be epi-inositoltriphosphate.

A food composition was prepared containing at least 5 mg of inositol triphosphate per 100 g of food. This composition was found to have utility in counteracting deliterious effects of heavy metals, radiation and smoking.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Patent Application No. 61/791,289 filed Mar. 15, 2013, which is hereby incorporated by reference in its entirety. FIELD OF THE INVENTION [0002] This invention is in the field of intravenous catheters, methods of using the catheters and a kit comprising the catheters. BACKGROUND [0003] Intravenous catheters are used for administration of intravenous medications, fluids and blood products routinely in emergency departments, hospitals and other patient care areas. Placing a peripheral venous catheter (PIV), is relatively easy in adults, but can be tedious, difficult (even for an experienced provider) and time consuming in infants and younger children as they have smaller and more fragile veins than adults and the veins are difficult to locate and stabilize while inserting and securing the catheter. [0004] Once placed, it is harder to maintain the catheter in place, due to its short length, constant movement of the extremity and non-cooperation from younger children. Under the age of 5 years, the mean duration of patency of catheters is less than two days and it is shorter for infants and neonates. Maintenance of patency of these catheters is important for reducing patient discomfort and need for restarting of the PIV. Fewer IV restarts can reduce pain and anxiety to the patient and its family members; conserve supplies and professional time for any busy hospital. [0005] When IV therapy is needed for a longer duration, peripherally inserted central venous catheters (PICC) are used. These catheters require provider expertise on the part of the provider, ultrasound guidance and special catheter kits and may also require fluoroscopy. PICC line placement, especially in children, is time consuming and can be associated with similar complications as central venous catheters including thrombosis, infection and bleeding. Accordingly there is an ongoing need for a catheter that can be placed by clinical providers without the need special training and will last longer than traditional IV catheters. SUMMARY [0006] The invention is an extendable intravenous catheter. The catheter is configured as a conventional catheter for purposes of insertion and placement. However, the catheter may be lengthened after placement to extend farther into the vessel. [0007] The catheter includes a hub and an intravenous portion having fluid communication therethrough. The intravenous portion has a tip portion, an extendable portion and a proximal portion attached to the hub. The extendable portion has a retracted position and an extended position. An extender tool is insertable and removable from the catheter. The extender tool is dimensioned for passing through said hub, proximal portion and extendable portion but not through said opening in said tip portion such that said extenable portion may be extended to its extended position by inserting and applying sufficient pressure to said extender tool. [0008] In another embodiment, a wire is incorporated in the intravenous portion. The wire includes a coiled portion that supports maintenance of said intravenous portion of said catheter in said extended position [0009] In another embodiment, the wire has a receiver disposed in the tip portion. [0010] In another embodiment, this invention is a method of inserting a catheter into a patient comprising inserting into the patient an extendable catheter of the invention wherein the extendable portion is in its retracted position, inserting the extender tool into said catheter and exerting sufficient pressure on said extender tool to extend the catheter to its full length. [0011] In another embodiment, this invention is a kit comprising an extendable catheter of the invention and an extender tool. [0012] Further areas of applicability of the present invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0013] Embodiments of the present invention will become more fully understood from the detailed description and the accompanying drawings, wherein: [0014] FIG. 1 shows a prior art intravenous catheter. [0015] FIG. 2 shows an extendable intravenous catheter of the present invention. [0016] FIG. 3 shows a coiled and unwound spring. [0017] FIG. 4 depicts an embodiment of the extender tool. [0018] FIG. 5 is a cut away side view of an embodiment of the extendable intravenous catheter. [0019] FIG. 6 is a cut away side view of an embodiment of the extendable intravenous catheter with the extender tool inserted. DETAILED DESCRIPTION [0020] The following description of the preferred embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. [0021] FIG. 1 shows a prior art intravenous catheter without a needle. FIG. 2 shows an extendable intravenous catheter of the present invention 10 without a needle. The extendable intravenous catheter of the present invention 10 includes an intravenous portion 12 , which is further comprised of a tip portion 14 , an extendable portion 16 and a proximal portion 18 . The proximal portion 18 is attached to or integrally formed with a hub 20 . An entrance opening 22 in the hub 20 is in fluid communication with an outlet tip, outlet 24 because all of these portions are assembled together or integrally formed to create a continuous lumen from the hub entry to the tip outlet. This patent lumen will accommodate a needle for placement of the IV, followed by an extender to dispose the catheter in the vessel and finally throughput of fluid solutions containing therapeutic agents. [0022] The extendable portion 16 has a first position which is retracted and short relative to a second position, which is extended and long. [0023] In an embodiment, the intravenous portion 12 of the catheter 10 includes a wire 30 . Wire 30 has a retracted configuration 32 which is compacted in an axial direction and wound relatively tightly. The wire 30 has no memory for retaining this configuration 32 . The wire 30 may be extended to an extended position 34 , which is relatively less compacted axially, unwound and long. The metal or other material of which spring 30 is fabricated is selected for retaining the extended configuration 30 after having been placed in the extended configuration 34 . [0024] As is seen in cutaway side view 5 , in an embodiment of the invention, the entrance opening 22 and tip outlet 24 are in fluid communication through a patent lumen throughout the catheter 10 . The side wall 40 of the catheter 10 includes wire 30 . Wire 30 may be embedded in the side wall 40 , attached to an outer wall or an inner wall of said side wall 40 or sandwiched between laminated layers of said wall 40 as at layer 42 for example. In a preferred embodiment, the interior lumen of the catheter maintains a smooth wall. In an alternate embodiment (not shown), the wire 30 could be completely omitted, as long as the receiver 54 is sturdy enough to withstand axial force generated by the extender tool, and to maintain a lengthened position after being extended in situ. [0025] As can be seen in FIG. 4 , an extender tool 50 is provided. In the depicted embodiment, the extender tool 50 comprises a relatively stiff wire that includes a ball end 52 . Referring now to FIG. 5 , the wire 30 includes a receiver 54 . In the depicted embodiment, the receiver 54 is a loop in the end of the wire disposed proximate to the tip outlet 24 . The receiver loop 54 is dimensioned to have a diameter smaller than ball 52 at the end of extender 50 . [0026] The catheter of the invention can be constructed of any material that is biocompatible and hemocompatible. Suitable biomaterials include polytetrafluorethylene (PTFE), polyvinyl chloride (PVC), and polyurethane (PU). In an embodiment, the catheter will be constructed using PTFE because it has a greater rate of hemocompatibility than PVC or PU, as well as a longer duration period. [0027] In operation, the catheter with the extendable portion 16 in its retracted position has a needle placed therein, with the point of the needle extending through the tip outlet 24 . The IV is placed in the conventional manner. Once free flow of blood is obtained indicating the presence of the needle in the lumen of the vein, the needle is withdrawn and through the outlet opening 22 , the extender 50 is placed within the catheter 10 . Appropriate pressure is placed by the operator on the extender 50 in order to place its ball end 52 against receiver 54 of wire 30 and thereafter extend wire 30 and the intravenous catheter extendable portion 16 to move it from the retracted short position to the extended long position. Thereafter, the extender 50 is withdrawn. The wire 30 maintains its extended configuration 34 and supports the catheter in retaining its long, extended configuration for its in-dwelling duration. [0028] In the depicted embodiment, the wall 40 of the intravenous portion 12 of the catheter includes an accordion shape or corrugated configuration having its outer pleats substantially corresponding to the coiled portion of said wire 30 . Thus, the material of side wall 40 can contribute to the provision in the overall catheter of a first short retracted position and then an extended long position during its indwelling use. In the embodiment depicted, the wire 30 has a proximal end anchored substantially within or near said hub 20 . [0029] The catheter may be manufactured in various lengths and gauges depending on its intended use. The catheter gauge will be essentially identical to that of conventional, non-extendable catheters used for a given application. Selection and placement of the extendable catheter for a given application is well within the skill of the clinical provider. Typically the catheter will be extendable to about 3 to about 5 times its unextended length. For example, in certain embodiments, the catheter may have an unextended length of up to about 1.5 inches and an extended length of up to about 4.5 to about 7.5 inches within the patient. In other embodiments, the catheter will have a fully extended length between the lengths of a peripheral IV and that of a PICC. [0030] Just after birth, the average upper arm length is 4.1 inches, while at 5 years old the length is 7.5 inches. This particular invention is applicable for all ages but is particularly applicable to the younger age groups. The gauge and length of the catheter will depend on the age and size of the patient as determined by the provider. The catheter material will be biocompatible, and smooth on the outside when extended. Like a PICC, our catheter will be inserted peripherally, but it will require less training for nurses and a shorter insertion time. [0031] As various modifications could be made to the exemplary embodiments, as described above with reference to the corresponding illustrations, without departing from the scope of the invention, it is intended that all matter contained in the foregoing description and shown in the accompanying drawings shall be interpreted as illustrative rather than limiting. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims appended hereto and their equivalents.

An intravenous catheter has a tip portion, an extendable portion and a proximal portion attached to a hub. The extendable portion has a refracted position and an extended position. A wire may be incorporated in the intravenous portion. The wire may have a receiver disposed in the tip portion. An extender tool is insertable and removable from the catheter. The extender is dimensioned to engage the receiver upon insertion into said catheter and lengthen the extendable portion of said catheter to said extended position when inserted.

TECHNICAL FIELD [0001] The present invention relates to a method for the treatment of erectile dysfunction by administering levosimendan, or (−)-[[4-(1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl]hydrazono]propanedinitrile (I), or pharmaceutically acceptable salts thereof, to a patient in need of such treatment. BACKGROUND OF THE INVENTION [0002] Levosimendan, which is the (−)-enantiomer of [[4-(1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl]hydrazono]propanedinitrile, and the method for its preparation is described in EP 565546 B1. Levosimendan is potent in the treatment of heart failure and has significant calcium dependent binding to troponin. Levosimendan is represented by the formula: [0003] The hemodynamic effects of levosimendan in man are described in Sundberg, S. et al., Am. J. Cardiol., 1995; 75: 1061-1066 and in Lilleberg, J. et al., J. Cardiovasc. Pharmacol., 26(Suppl.1), S63-S69, 1995. Pharmacokinetics of levosimendan in man after i.v. and oral dosing is described in Sandell, E.-P. et al., J. Cardiovasc. Pharmacol., 26(Suppl.1), S57-S62, 1995. The use of levosimendan in the treatment of myocardial ischemia is described in WO 93/21921. The use of levosimendan in the treatment of pulmonary hypertension is described in WO 99/66912. Transdermal delivery of levosimendan is described in WO 98/01111. Transmucosal delivery of levosimendan is described in WO 99/32081. Clinical studies have confirmed the beneficial effects of levosimendan in heart failure patients. [0004] Erectile dysfunction is the inability to obtain and sustain sufficient penile erection and is referred to as impotence. It can result from a variety of underlying causes ranging from purely psychogenic to completely physical dysfunctioning. Both surgical and pharmacological therapies have been used in the treatment of impotence. SUMMARY OF THE INVENTION [0005] It has now been found that levosimendan is capable of restoring or improving the erectile function in patients suffering from erectile dysfunction. [0006] Therefore, the present invention provides the use of levosimendan or a pharmaceutically acceptable salt thereof in the manufacture of a medicament for the treatment of erectile dysfunction. [0007] The present invention also provides a method for the treatment of erectile dysfunction in a patient, said method comprising administering to a patient in need thereof an effective amount of levosimendan or a pharmaceutically acceptable salt thereof. DETAILED DESCRIPTION [0008] The method of the invention comprises a step of administering to a subject an amount of levosimendan effective to restore the erectile function of the patient. The drug is preferably administered perorally, transmucosally including transurethrally, intravenously, intramuscularly including intracavernosal injection or transdermally. The administration may be systemic or local. [0009] The effective amount of levosimendan to be administered to a subject depends upon the route of administration. Levosimendan is administered orally to man in daily dose from about 0.1 to 15 mg, preferably from about 0.5 to 10 mg, given once a day or divided into several doses a day. For transmucosal, intravenous, intramuscular or transdermal delivery the daily dose range is from about 0.005 to 0.7 mg/kg, preferably from about 0.01 to 0.5 mg/kg. [0010] Levosimendan is formulated into dosage forms suitable for the treatment of erectile dysfunction using the principles known in the art. It is given to a patient as such or preferably in combination with suitable pharmaceutical excipients in the form of tablets, dragees, capsules, suppositories, emulsions, suspensions or solutions whereby the contents of the active compound in the formulation is from about 0.5 to 100% per weight. Choosing suitable ingredients for the composition is a routine for those of ordinary skill in the art. It is evident that suitable carriers, solvents, gel forming ingredients, dispersion forming ingredients, antioxidants, colours, sweeteners, wetting compounds, release controlling components and other ingredients normally used in this field of technology may be also used. [0011] For oral administration in tablet form, suitable carriers and excipients include e.g. lactose, corn starch, magnesium stearate, calcium phosphate and talc. For oral administration in capsule form, useful carriers and excipients include e.g. lactose, corn starch, magnesium stearate and talc. Disintegrants, such as croscarmellose sodium, may be used to accelerate the dissolution of the formulation. [0012] Tablets can be prepared by mixing the active ingredient with the carriers and excipients and compressing the powdery mixture into tablets. Capsules can be prepared by mixing the active ingredient with the carriers and excipients and placing the powdery mixture in capsules, e.g. hard gelatin capsules. Typically a tablet or a capsule comprises from about 0.1 to 10 mg, more typically 0.2 to 5 mg, of levosimendan. In general, rapidly dissolving peroral tablets or capsules, e.g. having a dissintegration time of 1 to 20 minutes, are preferred. [0013] Formulations suitable for intravenous administration such as injection formulation, comprise sterile isotonic solutions of levosimendan and vehicle, preferably aqueous solutions. Typically an intravenous infusion solution comprises from about 0.01 to 0.1 mg/ml of levosimendan. [0014] Formulations of levosimendan suitable for transmucosal or transdermal administration are disclosed in WO 99/32081 and WO 98/01111, respectively. [0015] Salts of levosimendan may be prepared by known methods. Pharmaceutically acceptable salts are useful as active medicaments, however, preferred salts are the salts with alkali or alkaline earth metals. EXAMPLES [0016] [0016] Pharmaceutical example. Hard gelatin capsule size 3 Levosimendan 2.0 mg  Lactose 198 mg  [0017] The pharmaceutical preparation in the form of a capsule was prepared by mixing levosimendan with lactose and placing the powdery mixture in hard gelatin capsule. [0018] Clinical Data [0019] Two NYHA III heart failure patients, who had not had erections for several years were treated with levosimendan. Patient I was exposed to 0.05 μg/kg/min continuous infusion of levosimendan for 7 days. The patient reported erections 1 day after starting the infusion and he had erections in the mornings during the whole study. Patient II reported erections after 0.1 μg/kg/min continuous infusion of levosimendan for 2 days.

Levosimendan, or (-)-[[4-(1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl]hydrazono]propanedinitrile, which has been previously suggested for the treatment of congestive heart failure is useful in the treatment of erectile dysfunction.

FIELD OF THE INVENTION [0001] The present invention relates to methods and compositions for the treatment of neural disorders. In particular, but not exclusively, the invention relates to methods and compositions for restoring or improving neural transmission in damaged nerve cells. Certain aspects of the invention relate to methods and compositions for treatment of non-demyelinating neural disorders. Other aspects of the invention relate to methods of treatment of autoimmune diseases selected from the group consisting of lupus, psoriasis, eczema, thyroiditis, and polymyositis; and certain aspects of the invention relate to a medicament for treatment of such diseases. BACKGROUND OF THE INVENTION [0002] PCT publications WO03/004049 and WO03/064472 describe therapeutic agents and treatments which are based on a serum composition with many surprising beneficial effects. The respective content of each of these two texts is incorporated in full by specific reference. In particular, the reader is referred to them for an understanding of how the therapeutic agent can be prepared, and for the indications which can be treated. [0003] Typically a goat is immunised with HIV-3B viral lysate raised in H9 cells. The resulting serum is believed to be active against HIV, and multiple sclerosis. The reader is further referred in particular to the section on pages 3 and 4 of WO03/004049 headed ‘Example of Production of Goat Serum’ for further details of the production of serum. This section is incorporated herein by reference. The use of HIV-3B viral lysate as an immunogen is not believed to be essential for the production of active serum; it is believed that a medium which has been used for growth of a viral culture, or which is suitable for such growth, may also produce a suitable response when used as an immunogen. The supernate of a cell culture growth medium such as PBMC or the cancer immortal cell line as used to grow HIV-3B are given as an example. The HIV or other virus does not need to be present to produce an effective immunogen to create the composition. Other suitable immunogens are recited on pages 12 and 13 of WO03/064472. [0004] The serum is believed to be effective against HIV and against multiple sclerosis. An important component of the activity of the serum is suggested in WO03/064472 as being anti-HLA or anti-FAS activity. Such antibody components would be expected to be relatively slow acting. [0005] The same publication also suggests that the serum may be used to treat traumatic axonal or nerve damage, and that the serum may also include some neural growth factor (NGF) activity, and may function in remyelinating demyelinated traumatically damaged nerves. Again, such activity would be expected to be relatively slow acting. [0006] The present applicants have now surprisingly determined that the serum composition has an additional rapid effect on deteriorated nerves, with preliminary observations suggesting that a relatively rapid restoration of transmission of nerve impulses may occur. It is thought that this rapid effect may apply to both demyelinated and non-demyelinated deteriorated nerves. [0007] The detection of this rapid effect on nerve transmission suggests that the serum must contain some active component other than NGF activity, which is relatively fast acting. This realisation leads to important new insights regarding the nature of neural disorders which may be treated with the serum. In particular, the inventors have now realised that the serum may be effectively used for the treatment of neural disorders which are non-demyelinating, and for the treatment of non-traumatic demyelinating disorders. These insights have been based on the newly-identified rapid effect on nerve transmission, and would not have been expected based on the previously-identified slow NGF-like activity imputed to the serum. [0008] Further, the inventors believe that the serum composition may be useful in the treatment of certain autoimmune diseases. There are a number of autoimmune or immune-mediated diseases found in humans. Current therapies for such diseases generally involve either the administration of immune suppressants, or the administration of steroids. [0009] Some of the main autoimmune diseases are as follows. [0010] Systemic lupus erythematosus is a chronic autoimmune disease in which the patient&#39;s antibodies attack healthy tissues and organs. The severity may range from mild to life threatening. Lupus may also affect the skin, causing a rash and lesions, usually across the face and upper part of the body. [0011] Psoriasis is a common, chronic skin disorder which is believed to be autoimmune in nature. [0012] Eczema is another common skin disorder, which is believed to have an autoimmune component. [0013] Thyroiditis mainly has an autoimmune cause, in which the patient&#39;s antibodies attack the thyroid. [0014] Polymyositis is an autoimmune neuromuscular diseases, leading to limb and neck weakness, sometimes associated with muscle pain. [0015] There is a need for an alternative treatment for these disorders. SUMMARY OF THE INVENTION [0016] According to a first aspect of the present invention, there is provided a method of treatment of a non-demyelinating neural disorder, the method comprising administering a serum composition obtained from a goat after challenge with an immunogen. [0017] The serum composition may be as previously described in WO03/004049 and WO03/064472. The immunogen may comprise HIV, in intact host cells, cell-free extracts, viral lysate, or a mixture thereof. Alternatively, the immunogen may be a medium suitable for growth of a viral culture. Other suitable immunogens are described in WO03/004049 and WO03/064472. An example of preparation of goat serum is given below. [0018] Examples of non-demyelinating disorders which may be treated in accordance with the present invention include cerebrovascular ischaemic disease; Alzheimer&#39;s disease; Huntingdon&#39;s chorea; mixed connective tissue diseases; scleroderma; anaphylaxis; septic shock; carditis and endocarditis; wound healing; contact dermatitis; occupational lung diseases; glomerulnephritis; transplant rejection; temporal arteritis; vasculitic diseases; hepatitis; and burns. All of these disorders may have an inflammatory component, but are believed to be additionally treatable based on the non-demyelinating neural aspect of the disorder. Further non-demyelinating disorders which may be treated, and which are considered to have a degenerative component include multiple system atrophy; epilepsy; muscular dystrophy; schizophrenia; bipolar disorder; and depression. Other non-demyelinating disorders which may be treated Include channelopathies; myaesthenia gravis; pain due to malignant neoplasia; chronic fatigue syndrome; fibromyositis; irritable bowel syndrome; work related upper limb disorder; cluster headache; migraine; and chronic daily headache. [0019] The serum composition is preferably administered in a dosage of between 0.01 and 10 mg/kg to the subject; more preferably between 0.01 and 5 mg/kg, between 0.05 and 2 mg/kg, and most preferably between 0.1 and 1 mg/kg. The precise dosage to be administered may be varied depending on such factors as the age, sex and weight of the patient, the method and formulation of administration, as well as the nature and severity of the disorder to be treated. Other factors such as diet, time of administration, condition of the patient, drug combinations, and reaction sensitivity may be taken into account. An effective treatment regimen may be determined by the clinician responsible for the treatment. One or more administrations may be given, and typically the benefits are observed after a series of at least three, five, or more administrations. [0020] The serum composition may be administered by any effective route, preferably by subcutaneous injection, although alternative routes which may be used include intramuscular or intralesional injection, oral, aerosol, parenteral, or topical. [0021] The serum is preferably administered as a liquid formulation, although other formulations may be used. For example, the serum may be mixed with suitable pharmaceutically acceptable carriers, and may be formulated as solids (tablets, pills, capsules, granules, etc) in a suitable composition for oral, topical or parenteral administration. [0022] The invention also provides a pharmaceutical composition comprising serum obtained from a goat after challenge with an immunogen, for use in treatment of a non-demyelinating neural disorder. [0023] The serum according to the invention may also be used in the preparation of a medicament for treatment of a non-demyelinating neural disorder. [0024] A further aspect of the invention provides a method of improving neural transmissions in non-demyelinated damaged nerves, the method comprising administering a serum composition obtained from a goat after challenge with an immunogen. [0025] The invention also provides a method of restoring neural transmission in degenerated nerves, the method comprising administering a serum composition obtained from a goat after challenge with an immunogen. The nerves may be demyelinated or non-demyelinated. Surprisingly, it has been identified that the action of the serum on damaged nerves may be effective on both demyelinated and non-demyelinated nerves. [0026] Accordingly, we have also identified a number of specific demyelinating disorders which may be treated using the serum. The invention thus further provides a method of treatment of a demyelinating neural disorder, comprising administering a serum composition obtainable from or obtained from a goat after challenge with an immunogen, the neural disorder being selected from the group comprising infections of the nervous system; nerve entrapment and focal injury; traumatic spinal cord injury; brachial plexopathy (idiopathic and traumatic, brachial neuritis, parsonage turner syndrome, neuralgic amyotrophy); radiculopathy; channelopathies; and tic douloureux. [0027] Also treatable are multifocal motorneuropathy with persistent block; and chronic inflammatory demyelinating polyneuropathy (CIDP). [0028] According to a further aspect of the present invention, there is provided a method of treatment of an autoimmune disorder selected from the group comprising lupus, psoriasis, eczema, thyroiditis, and polymyositis in a human, the method comprising administering a serum composition obtained from a goat after challenge with an immunogen. [0029] In one embodiment, the disorder is lupus. In one embodiment, the disorder is psoriasis. In one embodiment, the disorder is eczema. In one embodiment, the disorder is thyroiditis. In one embodiment, the disorder is polymyositis. [0030] The serum composition may, but need not, comprise anti-HLA antibody. It is believed that this may play a role in the activity of the serum. [0031] A further aspect of the invention provides a method of treatment of an autoimmune disorder selected from the group comprising lupus, psoriasis, eczema, thyroiditis, and polymyositis in a human, the method comprising administering a serum composition obtainable from a goat after challenge with an immunogen. [0032] The present invention also provides the use of a serum composition obtained from a goat after challenge with an immunogen in the manufacture of a medicament for the treatment of an autoimmune disorder selected from the group comprising lupus, psoriasis, eczema, thyroiditis, and polymyositis in a human. The use of a serum composition obtainable from a goat after challenge with an immunogen in the manufacture of a medicament for the treatment of an autoimmune disorder selected from the group comprising lupus, psoriasis, eczema, thyroiditis, and polymyositis in a human is also provided. [0033] Also provided is a pharmaceutical composition for the treatment of an autoimmune disorder selected from the group comprising lupus, psoriasis, eczema, thyroiditis, and polymyositis in a human, the composition comprising a serum composition obtained from a goat after challenge with an immunogen, suitable for administration to a patient. [0034] Examples of pharmaceutical compositions include any solid (tablets, pills capsules, granules, ointments, etc) with suitable composition for oral, topical, or parenteral administration; fluids suitable for injection; or aerosols suitable for administration to a patient. The compositions may include a carrier. [0035] According to a further aspect of the present invention, there is provided a method of treatment of an autoimmune disorder selected from the group comprising lupus, psoriasis, eczema, thyroiditis, and polymyositis in a patient, the method comprising administering a serum composition comprising anti-HLA antibody. It is believed that at least a component of the serum activity is linked with anti-HLA activity; the activity may reside in the antibody itself or in some other factor associated with the antibody. Preferably the anti-HLA antibody is goat anti-HLA antibody. The antibody may be polyclonal. BRIEF DESCRIPTION OF THE DRAWINGS [0036] FIG. 1 . “Visual Evoked Potentials pre-treatment”. [0037] Pre-treatment. Visual evoked potentials, recorded from the occipital cortex in response to standard checkerboard stimuli (OZ-FZ). a) 3 individual runs. b) The same runs, superimposed. c) Mean response. [0038] FIG. 2 . “Visual Evoked Potentials post-treatment”. [0039] Post-treatment. Using the same recording paradigm as for FIG. 1 , 30 minutes after sub-cutaneous injection of Aimspro. a) 2 individual runs. b) The same runs, superimposed. c) Mean response. A reproducible P100 response is now evidence, with a markedly delayed latency of 165 ms. DETAILED DESCRIPTION OF THE INVENTION Example of Production of Goat Serum [0040] A goat was inoculated by intramuscular injection with lysed HIV viral cocktail and formulated with Freund&#39;s adjuvant. The virus was previously heat killed at 60° C. for 30 minutes. Blood samples were drawn after an appropriate interval, such as two weeks, for initial assessment. In the optimised procedure, the goat is injected every week for four weeks, then at six weeks the animal is bled to obtain the reagent. [0041] Approximately 400 cc of blood is drawn from the goat under sterile technique. The area for needle extraction is shaved and prepared with betadine. An 18-gage needle is used to draw approximately 400 cc of blood from the animal. Of note is that the animal can tolerate approximately 400 cc of blood drawn without the animal suffering any untoward effects. The animal does not have to be sacrificed. The animal can then be re-bled in approximately 10 to 14 days after it replenishes its blood volume. [0042] The presence of potentially useful antibodies was confirmed, having regard to the desired antibody activity. Once the presence of such reagents was confirmed, blood was then taken from the goat at between 4-6 weeks. [0043] The base blood product in order to create the reagent is then centrifuged to create the serum. 300 ml of serum was then filtered to remove large clots and particulate matter. The serum was then treated with supersaturated ammonium sulphate (45% solution to room temperature), to precipitate antibodies and other material. The resulting solution was centrifuged at 5000 rpm for five minutes, after which the supernatant fluid was removed. The precipitated immunoglobulin was resuspended in phosphate-buffered saline (PBS buffer, see Sambrook et al, ‘Molecular Cloning: A Laboratory Manual’, 1989) sufficient to redissolve the precipitate. [0044] The solution was then dialysed through a membrane with a molecular weight cut off of 10,000 Daltons. Dialysis was carried out in PBS buffer, changed every four hours over a period of 24 hours. Dialysis was carried out at 4° C. [0045] After 24 hours of dialysis the contents of the dialysis bag were emptied into a sterile beaker. The solution was adjusted such that the mass per unit volume 10 mg per ml. The dilution was carried out using PBS. The resulting solution was then filtered through a 0.2 micron filter into a sterile container. After filtration, the solution was aliquoted into single dosages of 1 ml and stored at 22° C. prior to use. The composition is referred to herein as AIMSPRO serum. [0046] Neural Disorders [0047] Acute optic neuritis is a common manifestation of multiple sclerosis. It presents as an episode of monocular blurring of central vision, with a pronounced effect on colour discrimination. While spontaneous resolution usually follows, successive attacks may result in irreversible and often slowly progressive, visual loss 1 . No medication has been available to improve visual function in these chronically affected patients. Here we present evidence of a promising approach to therapy along with electrophysiological indications of a remarkable rapidity of onset. [0048] Six multiple sclerosis patients with stable visual dysfunction due to chronic optic neuropathy (2 males, 4 females, aged from 32 to 42 years, disease duration 8 to 16 years) were treated with a product referred to as Aimspro, which is obtained from purified goat serum as described above and in WO03/004049 and WO03/064472. Administration of the drug was 1 ml by sub-cutaneous injection, generally self-administered after the first or second dose. The frequency of administration, adjusted according to response, varied from once, to three times weekly. No patient had received the product previously, but one (Case 2) had been taking interferon beta-1a (Rebif) for nearly a year: this treatment was ceased the day prior to treatment with Aimspro. Recordings were carried out immediately prior to the first injection, and at approximately one hour, one week and 4 to 7 weeks thereafter. Prior to treatment, all subjects described that their vision had slowly and progressively deteriorated over periods of from 3 to 14 years, and none could recall intervening periods of what may have represented acute optic neuritis. [0049] Corrected distance acuity (Snellen chart) and colour vision (square root of total error score from the Farnsworth-Munsell 100-Hue test 2 ) data, acquired under standardized lighting conditions, are presented (Table). Monocular visual evoked potential (VEP) studies were carried out on each occasion. Perimetry was not performed. Sub-lingual temperature was monitored and showed no significant variability, within subjects, over time. Data from left and right eyes were considered to be independent for analysis and colour vision scores were treated as non-parametric for statistical purposes. [0050] Comparison of pre-treatment and follow-up distance acuities showed no significant change and in only two eyes (Case 2 left eye and Case 5 right eye) was there an improvement of one line or more on the Snellen chart. A repeated measures analysis of variance (ANOVA) test on the colour vision scores, however, yielded F=(2.16, 23.73)=8.52, p=0.001. Within approximately one hour of injection, there was significant improvement in colour vision (p=0.008, Z=−2.667, Wilcoxon signed ranks test). Comparison of pre-treatment and “one week” values showed no significant difference (p=0.055, Z=−1.923) but comparison of pre-treatment and follow up data (at 4 to 7 weeks) showed significant benefit (p=0.003, Z=−2.981). No significant side effects other than local pain and swelling at injection sites over the first two to three weeks, in three patients, were encountered. [0051] For cases 5 and 6, VEP response latencies lay towards the upper limits of normal. Pre-treatment VEP studies from all but one of the remaining eyes showed delay in the P100 response, consistent with demyelination within visual pathways. In only one instance (Case 4 right eye) was no response obtainable prior to treatment and this was the only eye from the entire series to show a significant change in averaged cortical responses at any time during the observation period. This 42 year old female with secondary progressive multiple sclerosis of spinal onset in 1992, had complained of gradually deteriorating vision since 1998. There had been four periods of 3 to 7 days&#39; duration of resolving blurring of vision between 1993 and 1997, but there had been no more recent episodic visual features in the history. Examination showed bilateral optic atrophy and marked impairment of distance and colour vision. Pre-treatment full field pattern reversal VEP studies at 15:02 hrs yielded no reproducible tracings from the right eye (see FIG. 1 ). A test dose of Aimspro (0.1 ml) was administered subcutaneously at 15:13 hrs, followed by an additional 0.9 ml at 15:25 hrs. A markedly delayed but reproducible P100 response could now be obtained at 15:43 hrs, at 171 ms (see FIG. 2 ). The scalp leads had remained attached throughout the study and test conditions, including body temperature, were monitored. While this neurophysiological finding was consistent with reversal of conduction block in severely demyelinated fibres 3 , it was not accompanied by a clinically significant Improvement in acuity data. The fact that no improvement in P100 latency could be detected from any eye over the study period argues against there having been significant remyelination during this time, further but observations at perhaps 6 months would be needed to assess this adequately. [0052] In summary, non-blinded, uncontrolled observations in 6 patients with slowly progressive visual dysfunction due to optic neuritis, show a significant improvement in colour vision over the course of between 4 and 7 weeks of treatment with a novel medication, Aimspro. Neurophysiological data from one affected eye in a patient with a five year history of marked visual deficit are consistent with an interpretation that the drug administration caused a reversal of axonal conduction block. Moreover, while this phenomenon was shown to have occurred within 30 minutes of treatment, a clinical observation by the author (unpublished observation) on a 38 year old female patient with a “spinal” relapse of relapsing remitting multiple sclerosis, suggests that “unblocking” may be seen within as little as ten minutes. A further clinical observation (unpublished observation) on a patient with 18 years of stable motor deficit following severe Guillain-Barré syndrome suggests that the effect may pertain to the peripheral nervous system as well. [0053] Visual deficit in acute optic neuritis (as gauged by clinical and neurophysiological examination) is thought to reflect axonal conduction block related to local inflammatory demyelinating activity 4,5,6 , but inflammation seems unlikely to be a persisting factor in chronically affected cases such as the six patients described above. A direct effect of a component of the medication on nerve transmission is, therefore, suspected. Basic neurophysiological techniques are now being harnessed with a view to clarifying the mechanism of action. [0054] Aimspro is a serum product initially intended to provide high titer neutralizing antibodies for use in HIV patients. Characterization of the serum has revealed a high titer of anti-HLA class 2 antibodies which are able to inhibit a variety of mixed lymphocyte reactions (unpublished observations). As increased HLA class 2 expression on brain cells and lymphocytes is recognized to be a major factor in the inflammatory process in multiple sclerosis, it was postulated that the polyclonal serum may be beneficial in multiple sclerosis and similar conditions (for review see Reference 1). Indeed, monoclonal antibodies against HLA class 2 are under development by several companies. However, the rapidity of the clinical responses seen here suggests that other mechanisms may be operating in vivo. A delay in the inactivation of sodium channels, and the blockade of potassium channels have both been shown to improve conduction in experimentally demyelinated axons 7 . Alternatively, a removal of blockade of axonal sodium channels by endogenous substances such as nitric oxide may explain the rapidity of the drug effect. It is therefore possible that in addition to any effects that the serum may have in influencing immunological events, it may also affect the security of axonal conduction directly. [0055] Autoimmune Disorders [0056] The Aimspro product may also be used for treatment of autoimmune disorders as follows. A 1 ml aliquot of serum, prepared as described, is adjusted to provide a dose of 0.1 mg/kg, and injected subcutaneously to a patient suffering from an autoimmune disease selected from the group comprising lupus, psoriasis, eczema, thyroiditis, and polymyositis. [0057] The product was given to a patient as follows. The male patient experienced psoriasis de nova with a first presentation which started on the hands but spread over most of lower legs and arms. The treating physician prescribed Timodine, then Mometasone. By the end of the month, the condition was widespread. Prescribed Polytar emollient and referred to consultant dermatologist who confirmed acute psoriasis, and prescribed Mometasone, Polytar and Exorex. The treatment had little effect, with psoriasis worst on arms and legs. Commenced AIMSPRO product an day 1, 1 ml weekly. Day 5, psoriasis started improving. Day 23, exfoliating much improved. Increase in dose to 2 amps weekly. After 2 months, patient much improved, and by 3 months and 18 days, psoriasis now considered resolved, and the patient wished to stop treatment. Thus given 1 amp weekly for 4/52, 2 amps weekly for 12/52; in total 28 amps over 16 weeks. There were no side effects reported. REFERENCES [0000] 1. Compston A, Coles A. Multiple Sclerosis. Lancet 2002; 359:1221-31 2. Farnsworth D. The Farnsworth-Munsell 100-Hue and Dichotomous Tests for Color Vision, J Opt Soc Am, 33, 568 (1943). 3. McDonald W I, Sears T A. The effect of experimental demyelination on conduction in the central nervous system. Brain 1970; 93, 583-598. 4. Hawkins C P, et al. Duration and selectivity of blood-brain barrier breakdown in chronic relapsing experimental allergic encephalomyelitis studied by gadolinlum-DTPA and protein markers. Brain 1990; 113, 365-378. 5. Katz D, Taubenberger J, Raine C, McFarlin D, McFarland H. Gadolinium-enhancing lesions on magnetic resonance imaging, Ann Neurol 1990; 28, 243. 6. Youl B D, et al The pathophysiology of acute optic neuritis: an association of gadolinium leakage with clinical and electrophysiological deficits. Brain 1991; 114; 2437-2450. 7. Smith K J, McDonald W I. The pathophysiology of MS: the mechanisms underlying the production of symptoms and the natural history of disease. Philos Trans R Soc Lond B Biol Sci 1999; 354: 1649-1673. 8, Redford E J, Kapoor R and Smith K J. Nitric oxide donors reversibly block axonal conduction: demyelinated axons are especially susceptible. Brain Part 12 (December 1997) 2149-57. [0000] Demographic, Psychophysical Neurophysiological Data. Dx VsDtn P100 VA VA VA CV CV CV CV MSTYPE yrs yrs EYE ms pre 1 hour 7 days VAFU pre post 7 days FU SP 16 14 R 146 6 6 − 3 6 6 − 2 6 6 6 6 11.83 10.77 10.77 10.2 L 158 6 9 − 2 6 9 − 2 6 6 − 1 6 6 − 2 15.23 11.66 9.8 9.8 SP 9 3 R 152 6 6 − 1 6 6 − 1 6 6 − 1 6 6 7.75 8.72 6.93 6.32 L 161 3 24 − 1 3 12 − 1 3 12 − 1 3 12 − 1 21.82 19.8 19.08 12.33 SP 8 6 R 173 6 18 6 12 6 18 + 1 6 18 21.26 17.2 16.37 13.42 L 207 6 18 − 1 6 18 + 1 6 18 6 18 19.6 18.97 19.18 12.96 SP 12 5 R NR 1 18 − 1 1 9 − 1 1 18 1 18 + 1 30.59 27.86 33.29 29.33 L 161 3 18 − 1 3 18 3 18 3 18 + 1 27.42 25.69 28.21 27.78 SP 16 14 R 112 3 36 3 24 3 36 + 2 3 18 − 1 14.97 13.56 11.66 12.96 L 115 6 18 6 18 6 18 6 18 + 1 14.28 13.11 11.83 10.95 RR 14 4 R 114 6 6 6 6 6 6 6 6 7.21 6.63 7.75 5.29 L 114 6 6 6 6 6 6 6 6 7.75 7.75 7.21 6.02 TABLE LEGEND: MS TYPE SP (Secondary Progressive) RR (Relapsing Remitting) Dx yrs Years since probable onset of multiple sclerosis VsDtn yrs Years of progressive visual loss EYE Right and left eyes are treated independently P100 ms The P100 VEP positivity latency in milliseconds VA pre Snellen chart derived visual acuity pre-treatment VA 1 hour As above, at about 1 hour post treatment VA 7 days As above, at 7 days VA FU As above, at follow-up (4-7 weeks) CV pre Square root of the Farnsworth-Munsell 100-Hue Test CV 1 hour As above, at about 1 hour post treatment CV 7 days As above, at 7 days CV FU As above, at follow-up NR No response

Methods of treatment of various non-demyelinating and demyelinating neural disorders are provided, comprising administering a serum composition obtained from a goat after challenge with an immunogen. Also provided are methods of treatment of certain autoimmune disorders using such a composition.

RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 10/004,017 filed Oct. 18, 2001 which is a continuation of U.S. patent application Ser. No. 09/843,326 filed Apr. 26, 2001, now U.S. Pat. No. 6,645,071 issued Nov. 11, 2003 which is a continuation of U.S. patent application Ser. No. 09/218,500 filed Dec. 22, 1998, now U.S. Pat. No. 6,398,644 issued Jun. 4, 2002, and which claims benefit of U.S. Provisional Patent Application Ser. No. 60/083,658 filed Apr. 30, 1998 and Ser. No. 60/068,624 filed Dec. 23, 1997. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention pertains to games suitable for play in a casino and, more particularly, to a modified form of keno. 2. Statement of the Problem Casino keno, and its close relative, the lottery, generally have the player select, a plurality of numbers (lottery) or numbered positions (keno), followed by the house randomly selecting a plurality of numbered balls. Wagers are settled based on the number of matching numbers (or numbered positions). For example, the New York State LOTTO game allows players to select six different numbers in the range 1 to 54, inclusive. Thereafter, the state randomly, and without replacement, draws six numbered balls from a pool of 54 balls (numbered from 1 to 54). Other states, and often other games within a state, employ slightly different schemes. For example, in Massachusetts, the MASS MILLIONS game chooses six balls from a field of 49. MASS CASH, on the other hand, chooses 5 balls from a field of 35, and so forth. Players are generally rewarded for obtaining 3 or more matches. Casino and state-run keno, however, are typically games of chance. Some keno games allow players to choose patterns of numbers on their tickets. Higher payoffs are made when such patterns are hit. However, players do not develop strategies because the pattern is chosen by the house at random after the player has made a selection. A need exists to provide new games with the familiar keno matrix format incorporating a new type of game contained therein, such as that found in popular home games. One popular home game involving a matrix of numbered positions is the game of BATTLESHIP trademarked by Hasbro, Inc. In the BATTLESHIP game, each player has a target grid and an ocean grid. To play the game each player secretly places a fleet of five ships on their respective ocean grid. Once the ships are placed, they cannot be changed. Players take shots by calling out a letter and a number to identify a location on the target grid. As a shot is made, the other player informs the shooter whether a boat on his ocean grid has been hit or not. When a hit occurs, the shooter places a red peg in the identified location of the target grid for a hit and a white peg for a miss. The first player to sink all five of the opponent&#39;s ships becomes the winner. In the play of this game, each ship occupies a certain number of locations of the grid. For example, a battleship occupies four locations whereas as a submarine has three locations, etc. Essentially, the players use their skill to identify the ship and the location of the ship on the target grid to sink the other&#39;s fleet. A continuing need also exists for new casino wagering games and for variations and modifications thereto, and in particular to games that will keep the player&#39;s attention by allowing the player to develop a strategy. SUMMARY OF THE INVENTION 1. Solution to the Problem The present invention is different from conventional keno or lotto games in that the player of the present invention may employ a unique strategy to solve an underlying puzzle thereby meeting the aforesaid needs. Even an incorrect guess by the player eliminates possible choices. Thus the player is able to continue developing a strategy for uncovering a hidden pattern or patterns in a modified Keno game. When utilized as a bonus game, a player tends to play underlying games longer, because with each play the player draws closer to solving the puzzle in the bonus game. Another advantage of the present invention, whether utilized as a stand-alone game or as a bonus game, is the potential for larger jackpots for a player who uncovers the pattern in a minimal number of guesses or who uncovers larger, more complex, or even multiple patterns. 2. Summary The present invention sets forth a method for playing a keno-type casino game. A virtual matrix comprised of a plurality of grid elements is provided, on which a pattern hidden from the player is randomly placed. The hidden pattern is comprised of a plurality of matrix entries. The player is unable to view or have knowledge of the virtual matrix. However, the player is able to view a gaming matrix which has a plurality of grid elements. Each visible position corresponds to one of the grid elements on the virtual matrix. In response to either the player submitting a wager, or winning a play as part of a bonus condition occurring in an underlying game, the player chooses at least one of the plurality of visible positions on the gaming matrix. The game of the present invention then displays, on the gaming matrix, the contents of the corresponding grid element of the virtual matrix. The game can either accept another choice from the player, or allow the player to guess the remaining visible positions where the player believes the hidden pattern is positioned. If the player guesses correctly and uncovers the hidden pattern, the player is awarded and a media presentation signals the player&#39;s success. If the player guesses incorrectly, a second media presentation signals the incorrect guess. In some embodiments of the method of the present invention, the player receives payoff multiples that are higher when the pattern is identified with a minimal number of misses. In some embodiments of the method of the present invention, a number of hidden patterns are provided and the player receives a payoff for solving each separate hidden pattern. Finally, a number of other embodiments, variations, and versions of the method of the present invention are set forth. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a block diagram illustrating the components of the present invention. FIG. 2 shows a virtual matrix of a first embodiment of the method of the present invention. FIG. 3 shows a virtual matrix of a second embodiment of the method of the present invention. FIG. 4 shows a video gaming matrix corresponding to the virtual matrix of FIG. 3 . FIG. 5 shows the video gaming matrix of FIG. 4 illustrating the player&#39;s guesses. FIG. 6 is a process diagram, depicting the steps of one preferred mode of operation for method of the present invention. FIGS. 7 ( a ), 7 ( b ), 7 ( c ), and 7 ( d ) represent a variation of the method of the present invention based upon a prior art Keno game. FIGS. 8 ( a ), 8 ( b ), 8 ( c ), and 8 ( d ) represent a variation of the method of the present invention used as a bonusing game to an underlying game. DETAILED DESCRIPTION OF THE INVENTION 1. Overview The present invention provides a method for reversing and expanding the traditional play of keno by introducing novel hidden patterns into the game. FIG. 1 generally outlines one preferred embodiment for the system 10 of the present invention. The system 10 includes central processing unit (CPU) 20 , media display 50 , an activation signal received over line 25 , a payout signal received over line 40 , random number generator (RNG) 60 , video screen 100 , a memory 200 and, optionally, a solve indicator 30 . The CPU 20 of the present invention receives an activation signal over line 25 indicating that either a wager has been placed, or a bonus game condition has occurred in an underlying game, or any other condition signaling play to commence. Media display 50 may be used to entice players to play the game 10 , or to let the player know the game 10 is about to start. The media display may be audio, digital, graphic, and/or a combination thereof and may have different presentations stored in memory 200 for different stages of game play. The media display 50 could also be incorporated into display 100 . The media display 50 could also be a separate computer-based media system. The CPU 20 next generates or uses a virtual matrix 210 , which is stored in memory 200 (or the internal memory of the CPU 20 ). The preferred embodiment uses a two-dimensional virtual matrix 210 having X and Y-axises as shown and, therefore, the following will be described with respect to a two-dimensional matrix. However, the game of the present invention is not limited to a two-dimensional matrix and a one-dimensional or multi-dimensional matrix could also be used. The virtual matrix 210 is comprised of a plurality of grid elements 220 , and is kept hidden from the player of the present invention (i.e., in computer memory 200 ). The player is able, however, to view the gaming matrix 110 on video screen 100 . The gaming matrix 110 is comprised of a plurality of visible positions 120 , each visible position 120 corresponding to one of the grid elements 220 of the virtual matrix 210 in the X and Y-axis. A representation of the hidden pattern 70 is displayed on the screen 100 in area 130 so that the player knows the shape of the pattern 70 and the number of matrix elements 75 of the pattern 70 . In some methods of the present invention, this display 130 may be a display separate from screen 100 or simply a printed diagram. The present invention uses a random number generator 60 (or suitable software) to randomly place the hidden pattern 70 , comprised of one or more matrix entries 75 , onto the virtual matrix 210 . This occurs in response to the first signal on line 25 indicating start of the game 10 . In FIG. 1 , the hidden pattern 70 is a rectangular bar composed of three matrix elements 75 . In practice, the hidden pattern 70 can be quite robust, and it thus provides for considerable variety in play. Each matrix entry 75 can also be a shape (i.e., the clover shown in FIG. 1 ) or letters of the alphabet, which when combined to create the hidden pattern 70 , form a compound image or a word. Alternatively, each hidden pattern 70 or matrix entry 75 together can represent an establishment logo or other icon. Or, the pattern 70 may be a geometric shape (e.g., a cross composed of shaded areas 75 ). The matrix entries 75 and the pattern 70 can be any of innumerable colors, shapes, designs, etc., and the method of the present invention is not limited by a particular pattern 70 or matrix entry 75 . Furthermore, more than one pattern 70 can be used and each different pattern 70 can have different matrix entries 75 . After the hidden pattern 70 has been randomly placed by the CPU 20 in the virtual matrix 210 , the player is given a number of “guesses” or “shots” (e.g., six guesses or 10 misses, etc.) with which to uncover the hidden pattern 70 by selecting visible positions 120 (such as by touching) on the video screen 100 . This player input is received over line 80 by the CPU 20 . CPU 20 then retrieves the content of corresponding grid element 220 of the virtual matrix 210 and displays it in the selected and corresponding visible position 120 on the gaming matrix 110 at the same x, y location. If the corresponding grid element 220 contains a matrix entry 75 of the hidden pattern 70 , that matrix entry 75 is displayed in the selected visible position on the gaming matrix 110 (i.e., a “hit” is indicated). Likewise, when the corresponding grid element 220 does not contain a matrix entry 75 of the hidden pattern 70 , an empty indicator 225 (e.g., the words “empty,” an “O,” other indication) may be displayed in the selected visible position 120 of the gaming matrix 110 (i.e., a “miss” is indicated). In some embodiments of the method of the present invention, a “miss” may not be indicated, thereby leaving it to the player to remember not to touch that visible element again. A message or other indication may also be displayed with media display 50 , corresponding to whether a matrix entry 75 of the hidden pattern 70 was uncovered, or whether the entire hidden pattern 70 has been uncovered. This process continues with each guess until the player runs out of a given number of guesses (or misses) or the hidden pattern 70 is uncovered. The media display 50 may also be used to indicate the player has run out of guesses and must start over. In one embodiment of the method of the present invention, the player may choose to solve the puzzle (e.g., to touch the remaining locations of the hidden pattern 70 on video screen 100 ) at any time during play of the game, or by activating the optional solve device 30 . If the optional solve device 30 is included, after receiving a signal from solve device 30 over line 85 , the CPU 20 accepts signals over line 80 from the gaming matrix for each visible position 120 indicated by the player until either an indicated visible position 120 does not match a matrix entry 75 of the hidden pattern 70 (i.e., a miss), or the player correctly identifies each remaining visible position 120 corresponding to each matrix entry 75 of hidden pattern 70 , at which time the game is ended. A separate solve feature need not be included in the present invention, however, and the player could simply choose the grid elements (i.e., the visible portions 120 ) corresponding to the known location of the hidden pattern 70 . In such an embodiment, the paytable would simply be adjusted according to the total number of guesses. In one embodiment of the method of the present invention, a single match to an element of the hidden pattern 70 is sufficient to reveal the entire pattern 70 . In this fashion, the game can be faster, but the element of strategy still remains. Also in this embodiment, multiple hidden patterns 70 may be employed to create a compound pattern. In this case, a single hit to any one matrix element 75 in each hidden pattern may be required, or simply one hit to any one matrix element 75 in any one pattern may reveal the entire compound pattern. For example, if two patterns each consisting of 3 matrix elements are hidden, then the game may be played in one of three ways: 6 hits may be required to completely uncover the two hidden patterns (each hit uncovers only one matrix element), 2 hits may be required to completely uncover the two hidden patterns (each hit uncovers the corresponding hidden pattern), or 1 hit may be required to completely uncover two hidden patterns (the I hit on any one of the two patterns uncovers both hidden patterns). The term hidden pattern used herein includes not only one hidden pattern, but a number of hidden patterns sometimes referred to as a compound hidden pattern. The hidden pattern can be formed of non-adjacent matrix entries, adjacent matrix entries, groups of adjacent matrix entries, etc. Payoffs are established based either on the number of successful hits (identifications) when the solve area 30 is touched, or the number of matches (i.e., hits) to hidden pattern 70 in light of the total number of guesses. Payoffs can be based on, for example, the number of individual matrix entries 75 , individual hidden patterns 70 , or to multiple hidden patterns 70 that are matched by the player during play of the game. The solve feature will be described in greater detail below. However, if a solve area 30 is not included, the number of incorrect guesses (i.e., misses) may be factored into the payoff table as a design choice so that, for example, a player uncovering hidden pattern 70 immediately with only a few misses would receive a higher award than a player who uncovers hidden pattern 70 only after a large number of misses. How the award is modified based upon misses, hits, guesses, and/or a combination thereof is left to design choice under the teachings contained herein. Payoffs may also be given for each correct hit (regardless of misses), for each successful complete identification of a hidden pattern, and/or for identifying the entire compound hidden pattern. The player may receive any suitable award such as a payoff corresponding to the units of the wager (or wagers), objects such as vehicles, tickets, comps such as free dinners, credits, free games, multiples of awards, or any other benefit for the player. It is to be expressly understood that the system 10 shown in FIG. 1 represents one block diagram approach of the teachings of the present invention. It is functionally described and any of a number of different components, designs, arrangements, or electronic memory, processors, graphic displays, video displays, and/or random number generators, could be utilized to incorporate the teachings and methods of the present invention contained herein. Many of the details of operating conventional gaming devices such as reel-based slot machines, video-based poker games, coin acceptors, card readers(credit, debit, smart, etc.) are well known and are not important to the teachings of the present invention other than in a functional approach. It is well known how to place bets, recognize the amount bet, and award the winning player based upon a pay table stored in memory 200 . Therefore, the method and teachings of the present invention can be incorporated into a stand-alone casino game such as commonly seen with stand-alone keno, slot, and poker games. Or, the game can be incorporated as a choice of games so that a player coming to the gaming machine can select a game from a menu of games and the present game could be one of the choices. Or, the present invention can be incorporated over a network so that players can play in hotel rooms, at casinos, or over a communication network at their home by playing the game on their home personal computer. In the latter situation, the home or room computer would communicate over the communications network with a centrally located computer which would have memory 200 random number generator 60 , etc. How the method of the present invention is incorporated, whether as a stand-alone game or as a bonus game, can be one of many equivalent designs. 2. Details of Pattern Placement FIG. 2 illustrates one embodiment for randomly placing a hidden pattern 70 a on a virtual matrix 210 a in memory 200 by CPU 20 . Grid elements 220 a are designated along the X-axis from 1 to 10 and along the Y-axis from 1 to 10. The grid elements 220 a in FIG. 2 are numbered 1 to 100 . The following discussion will refer to specific grid elements 220 a by their column-row designation (i.e., (x,y)). In FIG. 2 , a 10×10 virtual matrix 210 a is shown onto which a rectangular pattern 70 a (comprised of 1×5 matrix entries 75 a ) is randomly placed. It is to be expressly understood that while a 10×10 matrix is shown, that the virtual matrix 210 a may be any size or dimension. In addition, while hidden pattern 70 a is shown as a rectangle placed horizontally on virtual matrix 210 a , hidden pattern 70 a may take any form or orientation on the virtual matrix 210 a . For example, the hidden pattern 70 a may have uneven dimensions, be separated by grid positions 220 a that do not contain matrix entries 75 a , or contain a plurality of individual discontiguous hidden patterns 70 a . Likewise, as discussed above, the hidden pattern 70 a may be comprised of any suitable matrix entries 75 a such as a series of letters or icons. In FIG. 2 , the icon is an “X.” In addition, the CPU 20 may randomly generate different hidden patterns 70 a , or the player may be allowed to select the hidden pattern 70 a from a plurality of hidden patterns, before the hidden pattern 70 a is positioned on the virtual matrix 210 a for each game. In this latter embodiment, more difficult patterns would have higher payoffs. Of course, in the preferred embodiment of the present invention the player must know in advance of the play what the hidden pattern is. In an alternative version, the player plays to uncover a random pattern with knowledge of a set of possible random patterns from which the hidden pattern 70 was chosen. For example, the hidden pattern 70 itself may be indicated simply as a letter of the alphabet; in this case the player would have to determine which letter was hidden as an additional stratagem. In another alternative version, the player has no knowledge of the hidden pattern 70 . Hence, the hidden pattern 70 can be displayed as shown in FIG. 1 , at location 130 on the monitor 100 , or it can be permanently affixed to the game (when the fixed pattern is always the same). Or, CPU 20 can allow the player to select the hidden pattern 70 from a menu containing a number of hidden patterns, then display the hidden pattern 70 in an area 130 of the screen so that the player can easily refer to it as the player is seeking to uncover the hidden pattern 70 in the gaming matrix 110 . One technique used by CPU 20 to randomly position hidden pattern 70 a on virtual matrix 210 a is to first randomly choose an orientation (horizontal or vertical), and then to randomly choose a grid element 220 a for the left—(if horizontal) or lower—(if vertical) most matrix entry 75 a of the pattern 70 a . In FIG. 2 , the hidden pattern 70 a starts at grid position ( 2 , 6 ) and extends horizontally to grid position ( 6 , 6 ). Using this technique, the lower- or left-most matrix entry 75 a of hidden pattern 70 a may be situated anywhere starting in the first six grid positions 220 a along the X-axis (e.g., (1,1), (1,2), . . . (1,10), (2,1), (2,2), . . . (6,10)) if horizontal, or anywhere starting in the lower six grid positions along the Y-axis (e.g., (1,10), (1,9), . . . (1,6), (2,10), (2,9), . . . (10,6)) if vertical, so as to fit hidden pattern 70 a completely within virtual matrix 210 a . Thus, if each of the possible placements for the lower- or left-most matrix entry 75 a are weighted equally (6×10×2=120), the present invention has an algorithm for randomly placing the pattern 70 a in 120 possible positions of the 10×10 virtual matrix 210 a based upon the random number generator 60 . Multiple hidden patterns 70 a may also be randomly placed using this procedure in a sequential fashion, with the additional step of checking that the pattern to be placed does not overlap any prior placed hidden patterns 70 a on the virtual matrix 210 a. Although an explicit method for placing a hidden pattern 70 a on a virtual matrix 210 a has been set forth, this method is only intended as an example to illustrate one of many possible algorithms. It is not meant to limit the possible hidden patterns 70 a or the means by which random placement is achieved. Indeed, the random placement of the pattern(s) may be constructed so as to bias the placement toward a certain region of the virtual matrix, if desired. 3. Details of the Method of Play FIGS. 3 , 4 , and 5 illustrate one method for playing the game of the present invention. FIG. 3 shows a hidden pattern 70 b (T-shaped in this illustration) randomly placed on a 5×5 virtual matrix 210 b by CPU 20 that is used in conjunction with video screen 100 a , shown in FIGS. 4 and 5 . FIG. 4 shows video screen 100 a before play begins (i.e., no visible positions 120 a have been selected by the player) and the shape of the hidden pattern 70 b shown in area 130 . FIG. 5 shows the video screen 100 a of FIG. 4 after two visible positions 120 a have been selected by a player first at (1, 2) which is a “O” and second at (4,3) which is an “X.” The numbering 1 through 25 may or may not be displayed. The X and Y number may or may not be displayed. Although FIGS. 4 and 5 show a video screen 100 a , gaming matrix 110 a may be displayed in any convenient manner, such as mechanically displayed, and need not have visible positions at each coordinate of gaming matrix 110 a . It is only important that each visible position 120 a correspond to a grid element 220 b of virtual matrix 210 b. In FIG. 3 , the hidden pattern 70 b before, at, or after (i.e., contemporaneously with) the start of the game is randomly placed on virtual matrix 210 b by CPU 20 , such that each grid element 220 b is comprised of an “O” (indicating there are no matrix entries 75 b of the hidden pattern 70 b at that grid element 220 b ) or a matrix entry 75 b (e.g., an “X” to indicate a portion of the hidden pattern 70 b is evident at that grid element 220 b ). An executable computer software program contained in CPU 20 brokers the game according to the following description. In FIG. 4 , the video screen 100 a displays a two-dimensional gaming matrix 110 a in which each of the visible positions 120 a are enumerated (i.e., with keno-style numbering, individual labels, matrix locations, borders or patterns). Touch screen areas form the visible positions 120 a and provide players with the ability to indicate their selection. Or, a separate keyboard or any other suitable input device such as a mouse-activated pointer, not shown, could be used. The player initiates the game by wagering a prescribed number of units. In a preferred method of play, money, gaming chips, credit, or their equivalent may be wagered. Alternatively, the game is initiated as a bonus game to an underlying game (i.e., a slot machine game or a table game). If initiated as a bonus game, it may be initiated once and played to completion, or it may be “visited” as many times as required to complete the pattern. In this case, each “visit” may comprise one guess, one miss (hence, possibly several guesses provided the player is selecting well), and so forth. Once the game is initiated such as by a signal (i.e., wager for a stand-alone or bonus condition for a bonus game) on line 25 , the player is given a predetermined number of guesses with which to completely identify all grid elements 220 b corresponding to the matrix entries 75 b of the hidden pattern 70 b , indicating in the preferred embodiment, their selection by touching visible positions 120 a on gaming matrix 110 a . With each guess, the corresponding grid element 220 b in virtual matrix 210 b is displayed on gaming matrix 110 a . For example, if the player chooses the visible position 120 a at coordinates (1,2) on gaming matrix 110 a (FIG. 4 ), the empty indicator 225 b of grid element 220 b at coordinates (1,2) on the virtual matrix 210 b ( FIG. 3 ) is displayed on gaming matrix 110 a , shown as an “O” in FIG. 5 . If the player next selects visible position 120 a at coordinates (4,3) on gaming matrix 110 a (FIG. 4 ), the content of grid element 220 b at coordinates (4,3) on the virtual matrix 210 b ( FIG. 3 ) is displayed on gaming matrix 110 a (in this example, matrix entry 75 b ), shown as an “X” in FIG. 5 . In one embodiment including solve area 30 a , at anytime during guessing, the player can touch the solve area 30 a and attempt to identify the remaining portions of the hidden puzzle, the earlier the player solves the puzzle during the guesses, The higher the payoff. In a second embodiment not including solve area 30 a , the player who discovers the location of hidden pattern 70 b would simply uncover the remainder of hidden pattern 70 b without any further incorrect guesses, and thus be rewarded with a higher payoff than the player who does not discover the location of hidden pattern 70 b and instead makes both correct and incorrect guesses before uncovering hidden pattern 70 b . In either case, should the player be successful in identifying the coordinates of the entire hidden pattern 70 b , the game is over and the player is paid a predetermined number of units. Should the player run out of guesses and only be partially successful, the game is over and the player is paid a prescribed number of units according to the number of chosen visible positions 120 a matching grid elements 220 b containing a matrix entry 75 b . Should the player run out of guesses and be unsuccessful in identifying any of the hidden pattern 70 b , the wager is lost. The present invention is not to be limited by the method of awarding the player. For instance, the player may be paid immediately for each correctly chosen visible position 120 (i.e, hit), or the award may be based on the number of incorrectly chosen visible positions 120 (i.e., misses), the complexity of the hidden pattern 70 , the number of guesses taken, or the number of guesses allowed but not used. In addition, the player may be able to continue play of the game by wagering additional units. Indeed, a wide-area-progressive network may be tied to the method of the present invention. Every time the game of the present invention is played, a fraction of the wager is separated and added to the progressive meter (or, a separate progressive wager may be played). At such time as the predetermined sequence of events occurs (i.e., the pattern is uncovered with no misses) the winning player is awarded the progressive amount or a fraction thereof, based on the number of winning players. The game of the present invention is robust in that it can accommodate varying methods of play. The player can be given a fixed number of guesses, with which to uncover as much of the underlying pattern 220 as possible. Alternatively, the player may be afforded a fixed number of misses, whereby after said number of misses the game is over. Or the player may be given an initial number of guesses, which increment by a predetermined amount based on successful hits. In addition, the player may be given the option to guess the position of hidden pattern 70 at any time during play of the game (i.e., by activating solve device 30 shown in FIG. 1 ). Other embodiments may include giving the player a predetermined number of guesses, which may be increased by correctly guessing the position of a matrix entry 75 , or the player may only be permitted a predetermined number of incorrect guesses. Additionally, the player may be able to take multiple guesses before learning the results of those guesses, or the guess may encompass, for example, a 2×2 array. A successful guess may also be rewarded with another “free” guess. It is to be expressly understood that more complex and/or compound patterns 70 will lead to more variety in game play. For example, rectangles of dimension 1×5, 1×4, 1×3, 1×3, and 1×2 (i.e., based upon the conventional BATTLESHIP game patterns) could all be situated on the matrix at once. In addition, a multimedia presentation 50 may accompany each successful or unsuccessful match. The game may also be utilized as a bonus in conjunction with an underlying game(s) (i.e., a slot machine(s)). In the case where the underlying game is a slot machine, the player is rewarded with a guess on the game of the present invention when a predetermined symbol, or combination of symbols appear on the payline of the slot or any bonus condition signal is received from the underlying game. A large number of different bonus condition such as signals, events, triggers, etc. are known in the gaming industry to effectuate bonus play in a bonus game from an underlying game such as a table game, gaming machine, etc. Hence, whenever the symbol to play the bonus game occurs (which is random in the play of the slot machine), the player is able to make one more guess. This continues until the player completes the puzzle. The use of the solve area (or button) 30 is optional. It is an advantage of this invention that the bonus game may run “in parallel” with the underlying game. Generally, several guesses will be required to uncover the hidden pattern 70 . Hence, a player who has partially uncovered the hidden pattern will be more inclined to continue play on the underlying machine in order to revisit the bonus game and finish the pattern. Too, even incorrect guesses are informational strategically, and so a player who is “unlucky” in uncovering the hidden pattern 70 is also encouraged to continue play by virtue of eliminating possible matrix positions 220 where the hidden pattern 70 may be hidden. 4. Details of the Strategy Generally, the player will want to uncover the entire hidden pattern 70 a ( FIG. 2 ) with a minimum number of guesses to gain the highest payoff. An advantage of the present invention is that players may develop a strategy for playing the game of the present invention because the player plays a key part in determining the proper grid elements 220 a to choose. In particular, consider the 10×10 virtual matrix 210 a and the randomly placed hidden pattern 70 a shown in FIG. 2 and whose random placement is described earlier. A strategy in which a player chooses a visible position 220 a located at a corner (e.g., coordinates (1,1)), and thereafter, with each miss, chooses an adjacent element (e.g., at coordinates (1,2), (1,3) and so on), is inferior, as generally in excess of 50 guesses will be required to discover the hidden pattern 70 a. A player of the present invention may do substantially better by utilizing the following algorithm, given only as an example using FIG. 2 . At each point in the game, the player calculates for each grid element 220 a , the number of possible positions that a portion of the hidden pattern 70 a may have at that location. For example, at each corner (1,1), (1,10), (10,1), and (10,10), there are only two possibilities that the hidden pattern 75 a is positioned there. On the other hand, in each of the center locations of (5, 5); (5, 6); (6, 5); and (6, 6) of virtual matrix 210 a , there are ten possible positions of the bar 75 a . This strategy thus comprises, for each guess: performing the above calculation, finding the set of grid elements 220 a with the greatest number of possible positions, and randomly choosing from among this set. The process continues until the entire hidden pattern 70 a is revealed. An identical process can be employed for a compound hidden pattern (comprising more than one hidden pattern), by cycling through all hidden patterns in the compound pattern that correspond to a each matrix position. 5. Details of the Bonus Game The mechanism of utilizing a bonus game is well known. Typically, the pay table on the underlying game is modified somewhat, to allow the bonus game to be played. For example, if an underlying slot machine typically paid 5 coins on 20% of the plays, the pay table may be modified to dispense only 4 coins in these situations, so as to “gain” 0.2 coins per play. Thereafter, if a bonus game occurs every, 100 plays, for example, it literally “costs” twenty coins to participate (0.2×100=20). The connection between stand-alone and bonus versions of the present invention is thus self-evident. As a bonus game in the aforesaid example, the underlying game can dispense an average of twenty coins, maintaining an identical house advantage on the underlying game in addition to the bonus game combination. The bonus game may dispense on average less than twenty coins to increase the house edge. Alternatively, new underlying games may be designed with the bonus game in mind. Clearly, this same type of bonus game “kick-off mechanism” can be used with the teachings of the present invention. Assuming a player develops the strategy discussed above, the player will uncover the entire hidden pattern 70 a ( FIG. 2 ) within thirty guesses on almost every instance of the bonus game. Therefore, the house may award the player with thirty guesses in the bonus game in an effort to uncover the entire hidden pattern 70 a , awarding twenty coins if the hidden pattern 70 a is indeed uncovered. Alternately, based on the probabilities of finding the hidden pattern 70 a as a function of the number of guesses, the paytable may be structured with an average payoff of only fifteen coins. An advantage of this approach is that inferior play (play not utilizing a strategy such as the strategy set forth above), whether as a bonus or stand-alone game, adds to the house advantage. In an alternative embodiment, the underlying game periodically provides means for a guess at the bonus game of the present invention. This is a distinct advantage as typically in bonus games, the entire bonus game is completed in each instance. By tying the underlying game and bonus games together, the player will periodically (randomly in the preferred embodiment) visit the bonus game, thus ensuring suspense and positive feedback through progress within the bonus game. The player is thus encouraged to play the underlying game longer, so as to see the resolution of the bonus game. In such a game, thirty guesses may be too many and so the bonus game may use less guesses. The following sets forth an example. EXAMPLE As a preferred embodiment of the method of the present invention and as shown in FIG. 8 , consider an underlying slot machine with the present invention utilized as a bonus game. The exact nature of the underlying game is not material, but for purposes of this example, the underlying gaming machine is a conventional slot machine that allows players to wager on five individual paylines. Each payline has an equal chance, 1 in 50, of generating a bonus condition (i.e., on line 25 of FIG. 1 ) as a result of a symbol combination (or a symbol) which results in a visit to the bonus game of the present invention. Each visit gives the player one guess at the 7×7 game matrix 800 . The virtual matrix is also 7×7, and has the following five hidden patterns (shown by dotted lines in FIG. 8 ) randomly placed thereon: 1×2 ( 810 ), 1×3 ( 812 ), 1×3 ( 814 ), 1×4 ( 816 ), 1×5 ( 818 ) (which corresponds to patterns, for example ships, in the BATTLESHIP game). The random method of placement comprises randomly placing the largest hidden pattern (according to the placement algorithm specified above), followed by the next largest, and so forth until all hidden patterns are randomly placed in the virtual matrix. The method of playing the bonus game in this example follows. Assuming a wager of 1 credit per payline, upon visiting the bonus game, the player is awarded a prize of 5 credits (5×the line wager on the payline that provided the bonus combination) just as a conventional payoff in the underlying game causes a credit meter to increment. Thereafter, the player is allowed to guess at one of the 49 matrix elements in the game matrix 800 . Should the “guess” result in a “hit” the player is awarded an additional prize of 10 credits (10×line wager) which would also cause the underlying game credit meter to increment by this amount (e.g., signals over line 40 of FIG. 1 ). Finally, an amount equal to 20 credits (20×line wager) is added to an “escrow award,” and the hidden pattern which was “hit” is fully exposed (i.e., a single correct guess exposes the associated hidden pattern). Should the “guess” result in a “miss” the player is not awarded an additional prize. The underlying gaming machine then resumes play. Upon correctly uncovering the entire compound hidden pattern (consisting of five individual hidden patterns), the player is awarded the cumulative “escrow award” multiplied by a bonus factor, as appears below: TABLE I Number of Misses Multiple 0 misses 50×  1 miss 10×  2 misses 5× 3 misses 4× 4 misses 3× 5 misses 2× 6+ misses 1× By employing the “smart” strategy given earlier, the average number of guesses required to uncover the entire pattern is 13.9. Hence, on average 13.9×50=695 line plays are necessary to complete the bonus game. In addition, the chance of finishing the game with 0, 1, 2, 3, 4, and 5 misses is approximately 1 in 437, 112, 47, 25, 17, and 12, respectively. Hence, the average accrued escrow is approximately 161 credits (for a constant one-credit line wager each visit to the bonus game). When the escrow is combined with the 13.9×5=70 credits associated with visiting the bonus and the 5×10=50 credits associated with immediate award for uncovering a hidden pattern, the total value for the bonus game over time is approximately 161+70+50=281 credits. The 281 credits in 695 line plays result in the bonus being an expected return of 281/695=40%. When coupled with a base game otherwise returning 50%, the entire base game+bonus game total return is 90%, leading to a 10% house advantage for the product. FIG. 8 illustrates the method of this embodiment in more detail. Assume a player in playing the underlying machine receives a bonus condition providing the player with an opportunity to play the bonus game for the first time. The screen 800 showing the matrix elements 1 through 49 is displayed. The matrix elements 1 through 49 can each bear a number as shown in FIG. 8 ( a ) or, as in the game of BATTLESHIP, have the columns numbered and the rows labeled with a letter of the alphabet. Any suitable identification design could be used under the teachings of the present invention. Indeed, no identification could appear in some embodiments of the present invention. Assume in this illustration that the matrix 800 is a touch screen and that it is presented to the player entering the bonus game for the first time, completely blank, as the hidden patterns 810 , 812 , 814 , 816 , and 818 (shown in dotted lines) are unknown to the player except to the extent that the player knows this set of hidden patterns have been randomly placed in the virtual matrix. The shape of the hidden patterns as well as the number of matrix entries for each hidden pattern may also be shown at area 130 so that the player understands what is to be uncovered. As illustrate in FIG. 8 , the hidden patterns are generically shown as elongated ovals, but it is to be expressly understood that the actual hidden patterns can be any graphic, design, etc. as previously discussed. In adapting the conventional BATTLESHIP game to the game of the present invention, the shapes can be pictures of ships. However, any suitable graphics could be used such as animals (e.g., uncovering animals hidden in a jungle, celebrities, etc. The player touches matrix element “10” and scores a “hit”. As shown in FIG. 8 ( b ) elements 9 , 10 , 11 , 12 , and 13 become activated 822 to show pattern 818 . Also displayed to the player is a suitable display 820 which escrows the payoff value 20 for scoring a “hit” (which as shown in FIG. 8 ( a ) is set to 20). Also a display 830 is provided which displays the current status of the player&#39;s misses and the multiple value presently in place. At the start of the bonus game in FIG. 8 ( a ) the player has zero misses and the multiple is 50× which shown in display 830 . It is to be understood that displays 820 and 830 could be located in any suitable location or orientation on a gaming machine and that the method is not limited thereby. Furthermore, these displays are conventionally connected to a controller or CPU 20 such as that shown in FIG. 1 . At this point, the player has received five credits in the underlying game for entering the bonus game, ten credits entered into the meter of the underlying gaming machine for correctly hitting a hidden pattern, and twenty credits in escrow as shown in display 820 . Under the method of the present invention, variations on this could occur. For example, an initial payoff for entering the bonus game need not be made or could become a part of the escrow value shown in display 820 . Likewise, a payoff credit for hitting a pattern need not be paid in the underlying gaming machine credit meter, and a wide variety of combinations of payoffs back to the player can be designed under the teachings of the present method. For example, in one version the player simply receives credits for hitting and causing the pattern to be fully exposed. With the first “guess” in this example over, play now returns to the underlying game. Subsequently, the player receives the proper bonus condition from the underlying game to once again play the bonus game and this time the player touches matrix element 41 which is activated 824 , but is a “miss” ( FIG. 8 c ). The payoff display 820 still shows 20 credits. The display 830 now displays “misses” equal to one and a drop in the multiple according to Table I to 10×. The bonus game continues in this fashion until, as shown in FIG. 8 ( d ), the bonus game is over. The bonus game has been played in parallel with the play of the underlying game as discussed above. As shown in FIG. 8 ( d ), the player encountered a total of five “misses” at matrix elements 15, 17, 27, 41, and 44 causing the multiple to be displayed as 2× in display 830 according to Table I. In order to complete the hidden patterns, the player entered the bonus game ten times (five “hits” plus five “misses”). In this example, twenty credits for each uncovered pattern was added to payoff display or meter 820 so that at the end of the bonus game, 100 credits are shown. At the end of the game, the player receives the multiple times the payoff so the player actually receives 200 credits (i.e., 100×2). The purpose of providing the multiple in display 830 is to encourage players to more skillfully play the game which adds to excitement in the play thereof and provides greater payoffs. It is to be expressly understood that this example is only one embodiment of the method of the present invention and that in other variations, the use of a multiple based upon “misses” may not be present. Indeed, the method of the present invention can be played simply providing payoff values displayed in display 820 . As mentioned before, a desirable feature of this embodiment is that inferior play will lead to a larger house advantage because more guesses, hence more spins on the base game, will be generally needed before receiving the bonus. The preceding example is merely illustrative and is not meant to limit the teachings of this invention. Alternately, the player may be awarded varying amounts of rewards, and the rules for guessing may be modified to allow multiple guesses, guess until you miss, accumulation of guesses from the underlying game, accumulation of misses from the underlying game, etc. Too, free guesses may be given upon a correct guess, etc. Generally, the bonus game may be invoked each time a predetermined event occurs, or may be played in parallel with the underlying game in a continuous-type manner. The underlying game may or may not provide a means to establish the number of guesses or misses in the bonus game. The underlying game may only provide the bonus condition to visit the bonus game (i.e., the occurrence of a predetermined event during the underlying game, a function of the wager on the underlying game, or fixed to occur within a known period of play on the underlying game such as every ten games played or every five games lost). Alternatively, the mechanism to participate in or visit the bonus may be random. In addition, the underlying game may provide means to collect guesses for the bonus game (e.g., a combination of symbols on an underlying slot machine) and may allow for more than one guess to be accumulated or taken at once. 6. Operation. FIG. 6 shows the steps of one embodiment for playing the present invention implemented into the system of FIG. 1 . The game is started in step 600 upon receiving a signal such as a wager or signal over line 25 from an underlying game that a bonus round is to be played. An i×j virtual matrix 210 in memory 200 is cleared by CPU 20 in step 610 . For example, referring to FIG. 4 , each grid element may be represented by its row (i) and column (j) or an associated number (k). For purposes of this representation, k=f(i,j)=5×(i−1)+j. Next, a hidden pattern 70 , made up of a plurality of matrix entries 75 , is chosen by CPU 20 in step 620 from memory. The hidden pattern(s) 70 can always be the same shape(s) from game-to-game or memory 200 may contain a number of patterns that could be randomly selected by the CPU 20 (and random number generator 60 ), or which could be selected by the player from a menu. In this later case, and not shown in FIG. 6 , the CPU 20 in stage 600 would first display patterns in display 100 for selection by the player. Once a pattern 70 is selected (whether the same for each game, randomly selected or player selected), the computer randomly places the pattern 200 in the virtual matrix 210 in stage 620 . The player then selects a visible position 120 from the displayed gaming matrix 110 (e.g., at coordinates ( 2 , 3 )) in step 630 . This is received as an input over lines 80 by the CPU 20 . The CPU 20 retrieves the contents for the corresponding position 220 in the virtual memory 200 and displays it in the gaming matrix 110 at the touched visible position as either a “hit” or a “miss.” Stage 650 represents an optional step. In stage 650 , the player is given the opportunity to press solve button 30 when a hit occurs in order to solve the pattern by pressing the remaining physical positions 120 of the pattern. Hence, if the player presses solve area 30 (or activate any suitable activation device), in stage 650 the CPU 20 detects the signal over line 85 and causes the operation to enter stage 630 a to receive the player additional inputs. In the absence of a solve area 30 , the present invention would simply continue to step 660 and steps 630 a and 640 a would be eliminated. If the player successfully completes a pattern in stages 630 a and 640 b by touching the remaining positions, then a match has occurred in stage 670 . Stage 680 is entered and the player is awarded a suitable award from the pay table which is stored in memory 200 by the CPU 20 . If the player is wrong and no match occurs in stage 670 , the game is over in stage 690 . The player continues in the normal play of the game (i.e., without pressing solve area 30 ) in stage 660 . This continues for a requisite number of guesses. Hence, if the player has six guesses, the loop through steps 630 to 660 continues until a counter (not shown) equals six and in stage 660 exits to stage 670 . Any suitable number of guesses (in addition to six) may be used to generate a play over signal for a condition to end the game. What has been described is measuring the play over based upon the number of (guesses). It is to be expressly understood that a set certain number of “misses” could be utilized to generate this signal or any other suitable parameter in the play of the game. In addition, a player may activate a solve area 30 , described in more detail below. If the player is successful in completing the hidden pattern, the player is awarded in stage 680 . Because the player knows the shape of hidden pattern 70 (since it is displayed 130 ) or alternatively knows the set of possible shapes from which the hidden pattern was chosen, the present invention is unlike traditional keno, in which the knowledge of one selected number yields no additional information with regard to remaining hidden numbers. The game continues through steps 630 to 660 until the player either completely uncovers hidden pattern 70 or is afforded no more guesses, in which case the game moves to step 670 . In step 670 , the initial wager and/or the uncovered number of matrix entries 75 are evaluated in order to determine an appropriate payoff in step 680 , and then the game ends in step 690 . If there are not sufficient matches, the game proceeds to end with step 690 . While the operation shown in FIG. 6 and discussed above is a preferred embodiment, it is to be expressly understood that it represents only one approach to implementing the game of the present invention. This speeds up play of the game. Other equivalent changes to the operation of the present invention can be made. In summary the method of the present invention allows a player to play a casino game having the following steps: providing a virtual matrix having a plurality of grid elements; randomly associating a hidden pattern on the virtual matrix, the hidden pattern having a plurality of matrix entries, each of the plurality of matrix entries assigned to one of the grid elements; providing a gaming matrix having a plurality of visible portions, each of the plurality of visible portions corresponding to one of the plurality of grid elements; receiving an input signal from the player, the input signal identifying one of the plurality of visible portions on the gaming matrix; determining the input signal to be a hit when the identified visible portion corresponds to a grid element having a matrix entry and to be a miss otherwise; playing on the gaming matrix the matrix entry when the matrix entry is assigned to the corresponding grid element of the virtual matrix in response to receiving the input signal from the player and awarding the player based on the hits and misses. Under this general method, a number of variations can occur. For example, in the step of awarding the player, the step of awarding, in one version, may be based only upon the occurrence of a hit by the player. In other variations, the award to the player may be based solely on misses or a combination of hits and misses. Indeed, an award may only be made when the complete hidden pattern is fully identified based upon the input signals from the player. In addition, the award value awarded to the player can be modified, under the teachings of the present invention, based upon the determination of the input signal from the player to be a miss. In which case, the award value for a given number of misses is greater than or equal to an award value for the given number plus one number of misses. In a typical embodiment under this version, the award value would decrease with each new miss. This would provide incentive to the player to avoid misses in the play of the game. To do so would result in a greater award value. Furthermore, wagering may occur at the beginning of the casino game and/or wagering may occur at various stages within the casino game of the present invention. Of course a hidden pattern can be a permanent hidden pattern for the game, the selection of the hidden pattern to be solved from a plurality of hidden patterns (the choice being made by the player), or the hidden pattern being chosen by the game from a plurality of hidden patterns. 7. Optional Solve Feature. Optionally, a solve feature may be included in step 650 . If the player does not wish to solve the puzzle for the hidden pattern, the player continues play of the game by not pressing the solve area 30 and simply continues to guess (e.g., steps 630 through 660 ) as described above. However, if the solve area 30 is included in the present invention, the player at any point after an inputted result is displayed in stage 640 has the option of solving the puzzle by pressing area 30 on display 100 and then pressing the visible positions 120 under which the remaining entry 75 of the hidden pattern 70 exists. The results are displayed in stage 640 a . When the requisite number of additional matrix entries of the pattern 70 have been uncovered in stage 630 a and displayed in stage 640 b , the player is done and stage 670 is entered to determine whether a match has occurred. It is to be expressly understood that, under this embodiment, when a player is given a number of guesses and when the player presses the solve area 30 early in the guessing game, the player receives a higher payoff. For example, assume a player has six guesses to solve the pattern 70 . If, after the first guess, the result is displayed in stage 640 , the player activates the solve button 30 and successfully completes the hidden pattern 70 , the player receives the highest payoff. However, should the player wait and push the solve area 30 after five prior guesses, then the player receives a much lower payoff if the player is successful in uncovering the entire hidden pattern 70 . Alternatively, rather than waiting for the player to enter all remaining entries after pushing the solve area 30 to make the match in stage 670 , the matching could occur with each entry by the player so that when the player misses, the game is immediately over. 8. Keno Modification Alternate Embodiment. In FIG. 7 , the conventional game of keno is modified according to the hidden pattern teachings of the present invention as a bonus game. Assume a keno matrix shown in FIG. 7 ( a ) is used. This matrix 110 c has forty-nine visible positions 120 c which are labeled 1-49. In a conventional fashion, the player may play this game such as at a stand-alone keno video game by touching visible positions 120 c in which to play the keno underlying game. For example, and as shown in FIG. 7 ( a ), the encircled numbers 9, 19, 23, 32, 35, and 43 are the six numbers selected by the player to play the conventional game of keno. It is to be expressly understood that the matrix 110 c can be of any size with any set of numbers in corresponding visible positions 120 c . Furthermore, any number of visible positions 120 c ) can be selected by the player to play the keno game. Hence, the player places a wager in the machine and then selects, in this example, the six numbers encircled in FIG. 7 ( a ). The CPU 20 in a conventional fashion and in conjunction with a random number generator 60 (or random number generating software) selects six numbers, and those six numbers are then displayed as shown in FIG. 7 ( b ) with the numbers within a rectangle. In FIG. 7 ( b ) and in our example, 3, 6, 23, 32, 35, and 46 were randomly selected as the outcome of the conventional keno game. The player in the underlying keno game has three matches. The numbers 23, 32, and 35 are each encircled (player selected) and placed within a square (computer randomly selected). Hence, the player receives a payoff for three correct matches from a Keno pay table which may exist in memory 200 . This is conventional play of the underlying Keno game. It is to be understood that the encircling and the placing of numbers and rectangles is simply used as an illustration and that other display devices can easily convey this information to players. At this point, the pattern feature of the game can be played as a bonus game according to the method of the present invention. This can be automatic so that at the end of every keno game, the player is given the opportunity to complete the pattern as a bonus game. Or, the player may be required to wager the winnings of the keno game, to place a separate wager, or push a separate button, or otherwise activate the bonus game over lines 25 . When this occurs, at least four alternate embodiments exist. The first embodiment in FIG. 7 ( c ) simply turns over the player selected (i.e., encircled) positions of 9, 19, 23, 32, 35, and 43. This uncovers, as shown in FIG. 7 ( c ), behind player selected positions 32 and 35 two matrix entries 75 c of the hidden pattern 70 c . Nothing is displayed at locations 9, 19, 23, and 43. The player knows that the hidden pattern is a bar having four spaces from area 130 and, hence, easily solves the bonus game by pressing areas 33 and 34 to complete the hidden pattern. This is an easy bonus win for this player. The four matrix bar 70 c , of course, is randomly oriented anywhere within the overall matrix of 1 through 49 positions. In this case, the player playing the underlying keno game had three keno matches, received a suitable payoff and then went on to the opportunity to solve the bonus game of the present invention to receive a bonus payoff. In a second embodiment only the keno randomly selected numbers are uncovered. In the third embodiment illustrated in FIG. 7 ( d ), the player selected numbers (i.e., encircled) and the randomly selected numbers (i.e., placed in squares) are each uncovered, as shown in FIG. 7 ( d ). This results in the same information to the player who then proceeds to press locations 33 and 34 to complete the pattern and win the bonus game. This embodiment provides more spaces that are uncovered and, therefore, a greater chance of solving the bonus game. In the fourth embodiment, only the visible positions that correspond to both the player selected and the keno game randomly selected numbers would be uncovered (i.e., 23, 32, and 35 in FIG. 7 b ). This provides a more difficult game. Of course, other equivalent embodiments are possible. It is to be expressly understood that under either embodiment, the player is given either automatically, upon the basis of a separate wager, or any other suitable activation approach, a chance to participate in a pattern recognition game in conjunction with the underlying standard keno game. In the preferred embodiment, the pattern (such as the four matrix entry bar 70 c , as shown in FIGS. 7 ( c ) and 7 ( d ), is preferably displayed such as being printed on or near the screen 100 . However, it is to be expressly understood that with each keno game a new pattern can be randomly selected and first displayed to the player to recognize the pattern before playing the keno game. Or, that the player can select which pattern to play from a database. Many alternatives can be incorporated under the teachings of the present invention. The above disclosure sets forth a number of embodiments of the present invention. Those skilled in this art will however appreciate that other arrangements or embodiments, not precisely set forth, could be practiced under the teachings of the present invention. For example, while a virtual memory has been disclosed into which the hidden pattern is randomly placed, any suitable software, hardware, and/or combination thereof design can be used to functionally associate the hidden pattern to the gaming matrix. For example, a wide variety of designs could be utilized to provide the gaming matrix with visible portions such as a back lit panel, a matrix of liquid crystal displays, etc. Therefore, the scope of this invention should only be limited by the scope of the following claims and not by the title, the abstract, the background of the invention, and/or the summary of the present invention.

A casino game wherein the player has a fixed number of play positions. During play of the casino game at least one of the visible play positions has a hidden element changing the fixed number to control the length of the casino game when the displayed hidden element changes the fixed number by adjusting (or incrementing) the number of remaining selections. This results in a player selection in a player being awarded additional selections.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This is a U.S. national application of International Application PCT/JP2010/063049, filed Aug. 3, 2010, which claims priority to Japanese Application No. 2009-183696, filed Aug. 6, 2009, the contents of each of which are incorporated by reference in their entireties for all purposes. FIELD OF THE INVENTION [0002] The present invention relates to an immune balance regulating agent comprising a preparation obtained by superheated steam treatment of garland chrysanthemum (crown daisy). BACKGROUND OF THE INVENTION [0003] Superheated vapor is a vapor which is heated at or above a temperature at which vapor and liquid can co-exist keeping equilibrium under a constant pressure, and for example, steam which is heated at or above 100° C. at 1 atm is called superheated steam. Technology utilizing superheated steam has extended to the fields of sterilization, drying, food processing and the like; technical developments have been carried out, which utilize the advantage of superheated steam treatment of not changing the quality such as color, flavor, taste, texture of food materials in the field of food processing among others [0004] Superheated steam treatment does not change the quality of food materials (Patent Literatures 3 and 4) and has effects of reducing undesirable excessive oils and fats and odor components as well. Furthermore, its utilization has also been advanced as a technology to enhance desired components, and for example, a quercetin-containing composition obtained by superheated steam treatment of quercetin glucoside-containing materials such as onion skin is disclosed in Patent Literature 5, and it is disclosed in Patent Literature 6 that superheated steam treatment of coffee beans provides roasted coffee beans with a decreased content of acrylamide and an increased contents of chlorogenic acids. [0005] Although it is thus expected to obtain a new material in which some physiological functions are provided or enhanced, a material with satisfactory physiological functions has not yet been obtained. SUMMARY OF THE INVENTION [0006] An object of the present invention is to provide a new application of a preparation obtained by superheated steam treatment. [0007] The present inventors have found that a preparation obtained by superheated steam treatment of garland chrysanthemum (crown daisy) exhibits an effect of alleviating allergic diseases caused by excessive type 2 immune response by regulating the immune balance, in addition to infection preventive and anti-tumor activities due to the effect of stimulating type 1 immunity, and completed each of the following inventions. [0008] (1) An immune balance regulating agent containing a preparation obtained by superheated steam treatment of garland chrysanthemum. [0009] (2) The immune balance regulating agent according to (1), which is used for anti-infectious disease. [0010] (3) The immune balance regulating agent according to (1), which is used for anti-tumor. [0011] (4) The immune balance regulating agent according to (1), which is used for enhancing type 1 immune system function. [0012] (5) The immune balance regulating agent according to (4), which is used for dendritic cell activation. [0013] (6) The immune balance regulating agent according to (4), which is used for promoting IFN-γ and/or interleukin (IL)-12 production. [0014] The immune balance regulating agent of the present invention is an extremely highly safe composition having an effect of regulating and normalizing the immune balance of a living body, comprising a preparation obtained by superheated steam treatment of garland chrysanthemum , which has been utilized as food from a long time ago, as an active component. BRIEF DESCRIPTION OF THE DRAWINGS [0015] FIG. 1 is a diagram showing the upper and lower graphs show an effect of IFN-γ inducing production (promoting production) of the preparations obtained by superheated steam treatment of Example and Comparative Example 1, respectively. The longitudinal axis indicates IFN-γ production level and the abscissa axis indicates the preparations obtained by superheated steam treatment added. FIG. 2 is a diagram showing the influence of IL-12 on the induction of IFN-γ production from spleen cells by the preparation obtained by superheated steam treatment of Example. The longitudinal axis indicates the IFN-γ production level, and the abscissa axis indicates groups without and with the preparation obtained by superheated steam treatment of Example added (a group without addition and a group with garland chrysanthemum added), respectively. [0016] FIG. 3 is a graph depicting flow cytometric results demonstrating the dendritic cell activation effect of the preparation obtained by superheated steam treatment of Example. The abscissa axis indicates the expression level of the measurement target molecule on the cell surface; a group without addition denotes a group without the preparation obtained by superheated steam treatment of Example added and a group with garland chrysanthemum added denotes a group with the preparation obtained by superheated steam treatment of Example added, respectively. [0017] FIG. 4 is a diagram showing an IL-12 production induction ability, which demonstrates the dendritic cell activation effect of the preparation obtained by superheated steam treatment of Example. The longitudinal axis indicates the IL-12 production level and the abscissa axis indicates groups without and with the preparation obtained by superheated steam treatment of Example added (a group without addition and a group with garland chrysanthemum added), respectively. [0018] FIG. 5 is a diagram showing that the preparation obtained by superheated steam treatment of Example demonstrates, TLR (Toll Like Receptor)—dependently, an IFN-γ production inducing (production promoting) effect. The longitudinal axis indicates the IFN-γ production level and the abscissa axis indicates spleen immune cells of a 7-week-old C57BL/6 female mouse (wild type), spleen immune cells of a TLR2-deficient mouse, spleen immune cells of a TLR4-deficient mouse, and spleen immune cells of a TLR9-deficient mouse in the groups without and with the preparation obtained by superheated steam treatment of Example added (a group without addition and a group with garland chrysanthemum added), respectively. [0019] FIG. 6 is a graph depicting the results of the measurement of IFN-γ production in NK1.1-positive and TCR β-negative cells, NK1.1-positive and TCR β-positive cells, CD4-positive cells and CD8-positive cells, without and with the preparation obtained by superheated steam treatment of Example added (a group without addition and a group with garland chrysanthemum added), respectively, by flow cytometry using an intracellular staining method. The longitudinal axis of each graph indicates the expression level of the target molecule of measurement on each cell surface, respectively and the abscissa axis indicates the IFN-γ production level. [0020] FIG. 7 is diagram showing IFN-γ production levels in spleen immune cells of a 7-week-old C57BL/6 female mouse (control) and spleen immune cells of a 7-week-old C57BL/6 female mouse having no NK1.1-positive cells when preparation obtained by superheated steam treatment of Example is not added (a group without addition) and added (a group with garland chrysanthemum added). The longitudinal axis indicates the IFN-γ production level and the abscissa axis indicates respective cells in the groups without and with the preparation obtained by superheated steam treatment of Example added (a group without addition and a group with garland chrysanthemum added). [0021] FIG. 8 is a diagram showing IFN-γ production inducing (production promoting) effect of the preparation obtained by superheated steam treatment of Example (garland chrysanthemum nepurée) and the preparation obtained by ordinary heat treatment of Comparative Example 2 (garland chrysanthemum purée). The longitudinal axis indicates the IFN-γ production level and the abscissa axis indicates groups without and with the preparation obtained by superheated steam treatment of Example added (a group without addition and a group with garland chrysanthemum added), respectively. DETAILED DESCRIPTION OF THE INVENTION [0022] The present invention is an immune balance regulating agent containing a preparation obtained by superheated steam treatment belonging to Chrysanthemum Asteraceae , leaves and stems of which are generally considered to be edible and widely distributed domestically in Japan as a commonly ingested vegetable. [0023] In carrying out the present invention, any edible garland chrysanthemum can be used, and for example, the species termed as Chrysanthemum coronarium in nomenclature can be used. [0024] It should be noted that garland chrysanthemum is known to contain a plenty of vitamin C and carotene as nutrients but nothing is known with regard to its immunoregulating effect. [0025] The superheated steam treatment is carried out using garland chrysanthemum as it is or after ground in to an adequate size. The garland chrysanthemum may be raw or dried. [0026] The temperature of steam used for the superheated steam treatment ranges preferably from approximately 120° C. to 500° C., more preferably from 230° C. to 280 20 C. The time for the superheated steam treatment will be set appropriately depending upon the size and quantity of a material, and the time ranging approximately from 30 seconds to 240 seconds is preferable in order for the function of immune balance regulating agent of the present invention to be satisfactory. [0027] In addition, the superheated steam treatment may be carried out twice or more with the condition kept the same or changed with regard to the temperature or time condition; furthermore, a grinding process may be incorporated between two or more superheated steam treatments as described in the above-described Patent Literature 1. [0028] A material after superheated steam treatment can be utilized not only as it is for the immune balance regulating agent of the present invention, but also can be used after further treatment such as solid/liquid separation by centrifugation or filtration, extraction using a solvent such as water, alcohols such as ethanol and a mixture thereof, and drying such as spray drying and freeze drying; all of them are called herein “preparation obtained by superheated steam treatment”. [0029] Immune balance regulation, that is, the immune balance regulating effect in the present invention, means an effect which resolves the state in which either one of a type 1 immune system function or a type 2 immune system function, especially the type 2 immune system function is enhanced, and leads to the state where the both immune system functions are regulated. Regulation of immune balance meant in the present invention is used interchangeably with modulation or adjustment of immune balance. [0030] Generally, the type 1 immune system is understood as an immune system involving Th1 cells (type 1 helper T cells) induced by the presentation of an antigenic peptide from dendritic cells and/or macrophages which are antigen-presenting cells and by the effects of IL-12 and/or IFN-γ. Th1 cells produce IL-2, TNF-α, etc., in addition to cytokines such as IFN-γ which suppress the production of IgE antibody through the inhibition of differentiation of Th2 cells (type 2 helper T cells) and the inhibition of maturation of B cells to activate cell-mediated immunity such as killer T cells and enhance the activity of antigen-presenting cells such as dendritic cells and macrophages. On the other hand, the type 2 immune system is understood to be an immune system involving Th2 cells induced by the presentation of an antigenic peptide from macrophages that are antigen-presenting cells and by the effect of IL-4. Th2 cells produce IL-5, IL-6 and IL-10 in addition to cytokines such as IL-4 and IL-13 which enhance the production of antibodies such as IgE through the maturation of B cells and activate humoral immunity. [0031] It is known that IL-4 and IL-10 produced from Th2 cells control the effect of each other to suppress the production of IFN-γ from Th1 cells. It is believed that if the type 2 immune system function is predominant, cell-mediated immunity is suppressed and an infectious disease tends to be serious, and further, IgE antibody production through the maturation of B cells increases, likely leading to allergic predisposition. Therefore, breaking of the balance of the type 1 immune system function and the type 2 immune system function, particularly, excessive enhancement or dominance of the type 2 immune system function is not always preferable for a living body. [0032] The preparation obtained by superheated steam treatment used in the present invention exhibits effects of activating dendritic cells and natural killer cells (NK cells), natural killer T cells (NKT cells), and inducing or promoting the production of IFN-γ and IL-12. The effects of activating NK cells and NKT cells may include, for example, an effect of inducing the production of IFN-γ in NK cells and NKT cells. Thus, by administering the immune balance regulating agent of the present invention to an individual having an enhanced type 2 immune system function among others, the type 1 immune system function can be enhanced, resulting in regulation of the immune balance. In this way, the preparation obtained by superheated steam treatment used in the present invention can be utilized as a type 1 immune system function enhancer to enhance the type 1 immune system function, as well as a dendritic cell activator, an NK cell activator, an NKT cell activator, an IFN-γ production promoter, and an IL-12 production promoter. [0033] In addition, a physiological activity presented by the above mentioned preparation obtained by superheated steam treatment used in the present invention has been confirmed, quite unexpectedly, to be very strong compared to a case where ordinary heat treatment is carried out using the same material. [0034] Furthermore, the preparation obtained by superheated steam treatment used in the present invention can alleviate a condition in which the type 2 immune system function is dominant, for example, allergy, by enhancing the type 1 immune system function, or it is effective in the treatment of diseases such as infectious diseases and malignant tumors in which enhancement of cell-mediated immunity is required, in addition to the treatment of allergic diseases, because it can induce the production of IFN-γ in NK cells and NKT cells to yield an infectious disease suppressing effect and an anti-tumor effect. In other words, a preparation obtained by superheated steam treatment used in the present invention can be utilized as an allergy, an inhibitor, an infectious disease inhibitor, and an anti-tumor agent. [0035] In addition, it can be expected that the preparation obtained by superheated steam treatment used in the present invention has effects of balancing the type 1 immune system function and the type 2 immune system function usually by its oral application, enhancing resistance against the invasion of foreign matters such as infectious diseases, and further, alleviating allergy and autoimmune diseases that are excessive immune response. [0036] Specifically, the prevention, treatment or effect of improving symptoms of infectious diseases with viruses or bacteria, tumors, inflammation, allergic diseases such as atopic dermatitis, skin roughness, sensitive skin, pollinosis, asthma, bronchial asthma, rhinitis, urticaria, and the like can be expected for the immune balance regulating agent of the present invention. [0037] The preparation obtained by superheated steam treatment of the present invention can be used as an immune balance regulating agent as it is, as well as for a pharmaceutical composition such as a prophylactic, suppressive or therapeutic agent for infectious diseases, an anti-tumor agent, and a prophylactic, suppressive or therapeutic agent for allergic diseases. In addition, it can be combined with common excipients to prepare a composition and the composition can be further formulated into common dosage forms of external use for skin, oral formulations, injections, and others. [0038] The above-mentioned compositions or various dosage forms may be provided in a form of drug or quasi drug, by incorporating pharmaceuticals such as vitamins, galenicals, anti-inflammation agents, antihistamic agents, etc., as an active component, if necessary, in addition to the preparation obtained by superheated steam treatment. [0039] As the excipients used in formulation, for example, ingredients widely known and used by those skilled in the art for each dosage form of a solid oral formulation such as a tablet or a capsule, a liquid internal formulation such as aqueous liquid or suspension, ointment, patch, lotion, cream, spray, suppository, etc., can be used in a proper combination with each other. [0040] The amount of the preparation obtained by superheated steam treatment incorporated in the above mentioned composition or dosage form is not specified, somewhat different depending upon the type of dosage form, quality and the degree of expected effect, may be from 1 to 99% by weight, preferably from 10 to 99% by weight, more preferably from 50 to 99% by weight as a dry solid in the total amount of the composition or formulation. [0041] The immune balance regulating agent of the present invention may be formed into a beverage such as a juice or a milk beverage, a dairy product such as yogurt or ice cream, and foods such as soup, jelly, jam, confectionery or breads as it is or in combination with a proper component for beverages or foods; further, it may be formed into a health food or supplement. When the immune balance regulating agent is ingested or administered in the combination with a food, it can be mixed with an excipient, a filler, a binder, a thickener, a emulsifier, a coloring agent, a flavor, a food additive, a condiment or the like, as appropriate, and formed into powder, granules, and tablets depending upon the intended use. Furthermore, it can be ingested by being mixed in a raw material of food to prepare a food, and commercialized as a functional food. [0042] Since the raw material of the preparation obtained by superheated steam treatment used in the present invention is food, the amount of ingestion in a form as the above-mentioned beverage or food is not particularly restricted. An ingestion amount within the range of being ordinarily used as food is desirable, and specifically the amount is from 0.5 to 250 g, preferably from 1 to 200 g per ingestion, and the total amount of ingestion per day is from 0.5 to 500 g, preferably from 1 to 400 g. [0043] In the following, the present invention will be described in more details with reference to Example, but it should not be construed that the present invention be restricted by such an Example. EXAMPLE Example [0044] Three kg of garland chrysanthemum ( Chrysanthemum coronarium ) cut to a length of 4 cm was superheat-treated with a high temperature steam under atmospheric pressure for 10 minutes. Garland chrysanthemum after the treatment was treated with “high speed planetary mixer NewTon UM-N13” made by NAGATA SEIKI CO., LTD. at 1100 rpm, for 100 seconds. The garland chrysanthemum treated with the mixer was treated with an ultracentrifuge (SCR2OBA: Hitachi, Ltd.) at 2000 revolution (25,000×g) for 10 minutes to obtain a precipitated fraction and a supernatant fraction, which supernatant fraction was dried using a freeze dryer to prepare a water soluble fraction. Then, the precipitated fraction was suspended in 10 times volume of a 30% by volume ethanol aqueous solution and after stirred for 30 minutes, separated using a filter paper (Whatman Ltd.) into a solid component from the 30% by volume ethanol aqueous solution and a filtrate from the 30% by volume ethanol aqueous solution. After the filtrate from the 30% by volume ethanol aqueous solution was treated with a concentration centrifuge (EYELA) and evaporated, an extracted fraction from the 30% by volume ethanol aqueous solution was prepared by cooling with liquid nitrogen and complete removal of the solvent with a freeze dryer. Subsequently, after the solid component from the 30% by volume ethanol aqueous solution was suspended in 10 times volume of a 60% by volume ethanol aqueous solution and stirred for 30 minutes, it was separated into solid component from the 60% by volume ethanol aqueous solution and filtrate from the 60% by volume ethanol aqueous solution using filter paper (Whatman Ltd.). An extracted fraction from the 60% by volume ethanol aqueous solution was prepared by treating the filtrate from 60% by volume ethanol aqueous solution in a similar manner to the filtrate from the 30% by volume ethanol aqueous solution. Comparative Example 1 [0045] An extracted fraction from the each 30% by volume ethanol aqueous solution was obtained in the same way as Example except that garland chrysanthemum of Example was replaced with carrot ( Daucus carota ), tomato ( Solanum lycopersicum ), spinach ( Spinacia oleracea ), or onion ( Allium cepa ). Comparative Example 2 [0046] After 2 L of water was placed in a relatively large pot and completely boiled, 100 g of garland chrysanthemum was added and heated for 3 minutes. Garland chrysanthemum after heated was thoroughly ground with ACE HOMOGENIZER (AM-3/KN3325012; NIHONSEIKI KAISHA LTD.). After that, ultracentrifugation and ethanol extraction were carried out in a similar manner to Example to obtain an extracted fraction from the 30% by volume ethanol aqueous solution. Test Example (1) IFN-γ Production Inducing (Production Promoting) Effect [0047] A spleen was taken from a 7-week-old C57BL/6 female mouse purchased from Charles River Inc. The spleen was loosened using tweezers in an RPMI-1640 medium (Wako Pure Chemical Industries, Ltd.) comprising 10% FCS, 2.38 mg/mL Hepes, 0.11 mg/mL sodium pyruvate, 200 U/mL penicillin G, and 0.1 mg/mL streptomycin. Cells were passed through nylon mesh (Wako Pure Chemical Industries, Ltd.) together with the culture and recovered with the tissue part being removed. After the centrifugation treatment using a small cooling centrifuge (himac CF7D2, Hitachi, Ltd.) at 1500 rpm for 5 minutes, the supernatant was discarded, and the sediment was incubated with 2 mL of 0.155 M ammonium chloride at 37° C. for 1 minute and 30 seconds to eliminate erythrocytes and to prepare spleen immune cells/the RPMI-1640 medium. Each of extracted sample obtained in Example and Comparative Example 1 was co-cultured from the concentration of 200 μg/mL, the culture being carried out using a carbon dioxide gas incubator at 37 ° C. under 5% CO 2 atmosphere. After 48 hours, the supernatant of the culture was recovered and the IFN-γ amount in the culture supernatant was determined using ELISA Mouse IFN-γ BD Opt EIA set (BD Biosciences). [0048] The results are shown in FIG. 1 . Only the extract from garland chrysanthemum with 30% by volume ethanol of Example demonstrated a strong activity of inducing IFN-γ production. [0000] (2) Effect of IL-12 on the Induction of IFN-γ Production from Spleen Cells. [0049] A similar experiment to (1) was carried out using the extract from garland chrysanthemum with 30% by volume ethanol of Example, except that the function of IL-12 was inhibited by adding a monoclonal anti-IL-12 antibody in the culture of spleen cells. [0050] The results are shown in FIG. 2 . It was confirmed that IFN-γ production induction by garland chrysanthemum was strongly suppressed by the addition of anti-IL-12 antibody, and thus it was shown that IFN-γ production was induced by IL-12. (3) Dendritic Cell Activation Effect [0051] Bone marrow cells were collected from the femora of a 7-week-old C57BL/6 female mouse purchased from Charles River Inc., seeded in a 6-well flat bottom plate (Nunc) to be 1×10 6 cells/well, and cultured in the presence of 10 ng/mL of GM-CSF (PeproTech Inc.) for 6 days to induce dendritic cells that are antigen-presenting cells. These cells and the extract from garland chrysanthemum with the 30% ethanol of Example were co-cultured an in RPMI-1640 medium containing 10% FCS, 2.38 mg/mL Hepes, 0.11 mg/mL sodium pyruvate, 200 U/mL penicillin G, and 0.1 mg/mL streptomycin. Expression levels after 24 hours of MHC class I molecules, MHC class II molecules, CD40 molecules and CD86 molecules on the cell surface were detected by flow cytometry (FACS Calibur; BD Biosciences) using an anti-MHC class I molecule antibody (AF6-88.5), an anti-MHC class II molecule antibody (AF6-88.5), an anti-CD40 antibody (3/23) and an anti-CD86 antibody (GL1). [0052] The results are shown in FIG. 3 . In the groups in which the extract from garland chrysanthemum with 30% by volume ethanol was added, a significant increase in expression of MHC class I molecules, MHC class II molecules, CD40 molecules and CD86 molecules was observed, compared to the control without addition. From this, the extract from garland chrysanthemum with 30% by volume ethanol was found to activate dendritic cells. [0000] (4) Ability of Inducing IL-12 Production from Dendritic Cells [0053] IL-12 production using the extract from garland chrysanthemum with 30% by volume ethanol of Example was studied in the same condition as (3). The amount of IL-12 p70 contained in the culture supernatant in recovering cells was determined using ELISA Mouse IL-12 p70 BD Opt EIA set (BD Biosciences). [0054] The results are shown in FIG. 4. It was confirmed that the extract from garland chrysanthemum with 30% by volume ethanol induced IL-12 production from dendritic cells. (5) Study of TLR Dependency in the Induction of IFN-γ Production [0055] A spleen was collected from a 7-week-old C57BL/6 female mouse purchased from Charles River Inc., or a TLR2 (Toll Like Receptor 2)-deficient mouse, a TLR4 (Toll Like Receptor 4)-deficient mouse and a TLR9 (Toll Like Receptor 9)-deficient mouse obtained from Oriental BioService, Inc., and an experiment was carried out using the extract from garland chrysanthemum with 30% by volume ethanol of Example in the same condition as (1). [0056] The results are shown in FIG. 5 . From the fact that induction of IFN-γ production from spleen cells by garland chrysanthemum was hardly observed when TLR4 was deficient, and attenuated when TLR9 was deficient, it has been revealed that the immune balance regulating effect by garland chrysanthemum is dependent strongly upon TLR4 and partly upon TLR9. (6) Identification of IFN-γ Production Inducing Cell [0057] Spleen immune cells/RPMI-1640 medium were prepared in the same way as (1). To this, 25 μg/mL of the extract from garland chrysanthemum with 30% by volume ethanol of Example was added, and cultured using a carbon dioxide gas incubator at 37° C. under 5% CO 2 atmosphere for 12 hours. After Brefeldin A (BFA) was added and an additional 12 hours elapsed, cells were recovered and reacted with an anti-TCR β antibody, an anti-CD4 antibody (GK1.5), an anti-CD8 antibody (53-6.7), an anti-NK1.1 antibody (PK136) and an anti-IFN-γ antibody (XMG1.2), and examined to detect IFN-γ production in NK1.1-positive and TCR β-negative cells, NK1.1-positive and TCR β-positive cells, CD4-positive cells and CD8-positive cells, by flow cytometry (FACS Calibur; BD Biosciences) using an intracellular staining method. [0058] The results are shown in FIG. 6 . NK1.1-positive and TCR β-negative cells are found to be NK cells due to expressing the marker of NK cells but not T cell specific marker, while NK1.1-positive and TCR β-positive cells are found to be NKT cells due to expressing the marker of NK cells as well as T cells specific marker. Further, it is revealed that NK1.1-positive and TCR β-negative cells and NK1.1-positive and TCR β-positive cells are activated by the addition of the extract from garland chrysanthemum with 30% by volume ethanol to induce IFN-γ production. From these facts, it has been shown that cells from which IFN-γ production is induced by the addition of the extract from garland chrysanthemum with 30% by volume ethanol are NK cells and NKT cells. (7) Confirmation of IFN-γ Production Induction in NK Cells and NKT Cells [0059] From the result of (6), an experiment for confirming IFN-γ production induction in NK cells and NKT cells by the addition of the extract from garland chrysanthemum with 30% by volume ethanol was further carried out. [0000] [7-1] [0060] 200 μg of an anti-NK1.1 antibody (PK136) was administered into the peritoneal cavity of a 7-week-old C57BL/6 female mouse purchased from Charles River Inc., and after 24 hours elapsed, the spleen was taken. After that, spleen immune cells/RPMI-1640 medium were prepared in the same way as (1), and after confirmed that NK1.1-positive cells, namely NK cells and NKT cells were not contained, 25 μg/mL of the extract from garland chrysanthemum with 30% by volume ethanol of Example was added and cultured using a carbon dioxide gas incubator at 37° C. under 5% CO 2 atmosphere for 48 hours. Subsequently, the culture supernatant was recovered, and the amount of IFN-γ in the culture supernatant was determined using ELISA Mouse IFN-γ BD Opt EIA set (BD Biosciences). [0000] [7-2] [0061] Spleen immune cells/RPMI-1640 medium were prepared in the same way as [7-1] except that an anti-NK1.1 antibody (PK136) was not administered, and to this added was 25 μg/mL of the extract from garland chrysanthemum with 30% by volume ethanol of Example, and cultured using a carbon dioxide gas incubator at 37° C. under 5% CO 2 atmosphere for 48 hours. Subsequently, the culture supernatant was recovered, and the amount of IFN-γ in the culture supernatant was determined using ELISA Mouse IFN-γ BD Opt EIA set (BD Biosciences), this being taken as a control. [0062] The results are shown in FIG. 7 . By comparison to the control, from the fact that the amount of IFN-γ in the spleen cells not containing NK cells and NKT cells was very low, it has been shown that the extract from garland chrysanthemum with 30% by volume ethanol activates NK cells and NKT cells to induce IFN-γ production, and IFN-γ, production of which is induced by the addition of the extract from garland chrysanthemum with 30% by volume ethanol, is mainly derived from NK cells and NKT cells. (8) Difference in IFN-γ Induction Activity by Extracting Methods [0063] In order to compare IFN-γ induction abilities in the superheated steam-treated sample of Example (garland chrysanthemum nepurée; “nepurée” is a registered trade mark) and in the ordinarily heat-treated sample in Comparative Example 2 (garland chrysanthemum purée), experiments were carried out using each extract with 30% by volume ethanol in the same way as (1). [0064] As the result, a stronger activity was demonstrated in nepurée (registered trade mark) as shown in FIG. 8 . From this result, it has been shown that a substance which induces the production of IFN-γ is contained naturally in garland chrysanthemum , and the activity is further enhanced by superheated steam treatment.

Disclosed is a novel use of superheated stream-treated material. Disclosed is an immune balance-regulating agent comprising a superheated steam-treated product of crown daisy ( Chrysanthemum coronarium). This immune balance-regulating agent, which comprises, as the active ingredient, a superheated stream-treated product of crown daisy that has been used as a food for a long time, is a composition having a very high safety and exerting an effect of controlling and normalizing the immune balance of a living organism. The present invention has been completed based on the finding that the superheated steam-treated product of crown daisy has anti-infective and antitumor activities based on type-1 immune stimulating effect and, moreover, shows an effect of ameliorating allergic diseases, which are caused by excessive type 2 immune responses, by controlling immune balance.

CROSS REFERENCE TO RELATED APPLICATIONS The present application is a continuation-in-part of application Ser. No. 07/943,353, filed Sep. 10, 1992, now abandoned. BACKGROUND OF THE INVENTION Diabetes mellitus is a systemic disease characterized by disorders in the metabolism of insulin, carbohydrates, fats and proteins, and in the structure and function of blood vessels. The primary symptom of acute diabetes is hyperglycemia, often accompanied by glucosuria, the presence in urine of large amounts of glucose, and polyuria, the excretion of large volumes of urine. Additional symptoms arise in chronic or long standing diabetes. These symptoms include degeneration of the walls of blood vessels. Although many different organs are affected by these vascular changes, the eyes and kidneys appear to be the most susceptible. As such, long-standing diabetes mellitus, even when treated with insulin, is a leading cause of blindness. There are two recognized types of diabetes. Type I diabetes is of juvenile onset, ketosis-prone, develops early in life with much more severe symptoms and has a near-certain prospect of later vascular involvement. Control of this type of diabetes is difficult and requires exogenous insulin administration. Type II diabetes mellitus is of adult onset, ketosis-resistant, develops later in life, is milder and has a more gradual onset. One of the most significant advancements in the history of medical science came in 1922 when Banting and Best demonstrated the therapeutic effects of insulin in diabetic humans. However, even today, a clear picture of the basic biochemical defects of the disease is not known, and diabetes is still a serious health problem. It is believed that two percent of the United States&#39; population is afflicted with some form of diabetes. The introduction of orally effective hypoglycemic agents was an important development in the treatment of hyperglycemia by lowering blood glucose levels. Oral hypoglycemic agents are normally used in the treatment of adult onset diabetes. A variety of biguanide and sulfonylurea derivatives have been used clinically as hypoglycemic agents. However, the biguanides tend to cause lactic acidosis and the sulfonylureas, though having good hypoglycemic activity, require great care during use because they frequently cause serious hypoglycemia and are most effective over a period of ten years. In Chemical &amp; Pharmaceutical Bulletin, 30, 3563 (1982), Chemical &amp; Pharmaceutical Bulletin, 30, 3580 (1982) and Chemical &amp; Pharmaceutical Bulletin, 32, 2267 (1984), reference is made to a variety of thiazolidinediones which have blood glucose and lipid lowering activities. Antidiabetic activity of ciglitazone was also reported in Diabetes, 32, 804 (1983). However, these compounds have proven difficult to use because of insufficient activities and/or serious toxicity problems. Furthermore, Alzheimer&#39;s disease, a degenerative disorder of the human brain, continues to afflict more and more persons throughout the world. Such disease results in progressive mental deterioration manifested by memory loss, confusion, disorientation and the concomitant loss of enjoyment of life associated therewith. At the present time there is no scientifically recognized treatment for Alzheimer&#39;s disease. Because of this, and because of the debilitating effects of the disease, there continues to exist an urgent need for effective treatments. The present invention relates to a series of hypoglycemic agents which are capable of lowering blood glucose levels in mammals. Accordingly, one object of the present invention is to provide compounds having excellent hypoglycemic activity. The hypoglycemic agents of the present invention are believed to have minimal toxicological effects. It is, therefore, believed that the compounds of the present invention may be very useful for treating diabetes. The present invention also relates to a series of compounds having cathepsin inhibitory activity. As will be discussed more fully below, compounds capable of inhibiting cathepsin (and, in particular, cathepsin D) may be useful for treating Alzheimer&#39;s disease. Accordingly, a further object of the present invention is to provide compounds which can be used to treat Alzheimer&#39;s disease. Other objects, features and advantages of the present invention will become apparent from the subsequent description and the appended claims. SUMMARY OF THE INVENTION The present invention provides a method of reducing blood glucose concentrations in mammals comprising administering a therapeutically effective amount of a compound of formula (I) ##STR1## wherein: Ar is (i) phenyl, (ii) phenyl substituted with from one to three substituents independently selected from C 1 -C 8 alkyl, C 1 -C 8 alkoxy, C 1 -C 8 alkylthio, trifluoromethyl, C 1 -C 4 alkylphenyl, phenyl, NO 2 , F, Cl, hydroxy, phenoxy, C 1 -C 4 alkyloxyphenyl, thiophenyl, C 1 -C 4 alkylthiophenyl, --COOR 7 , --N(R 7 )SO 2 R 7 or --N(R 7 ) 2 , where each R 7 is independently hydrogen or C 1 -C 6 alkyl, (iii) 1- or 2-naphthyl, (iv) 2- or 3-benzofuranyl, (v) 2- or 3-benzothiophenyl, (vi) 2-, or 3-thienyl, (vii) 2-, 3- or 4-pyridyl, (viii) 2- or 3- furanyl, (ix) 1,3-benzodioxanyl, (x) substituted 1,3-benzodioxanyl, (xi) quinolinyl, (xii) 2- or 3-indolyl or (xiii) N-substituted 2- or 3- indolyl; R 1 is C 1 -C 6 alkyl, C 1 -C 4 alkylphenyl, hydrogen, phenyl or phenyl substituted with one or two substituents independently selected from Cl, Br, F, I, C 1 -C 4 alkyl, C 1 -C 4 alkoxy, hydroxy, trifluoromethyl, --NH 2 , --NH(C 1 -C 4 alkyl), --N(C 1 -C 4 alkyl) 2 or C 1 -C 4 alkylthio; R 2 and R 3 are each hydrogen or when taken together form a bond; R 4 and R 5 are each hydrogen or when taken together are ═S, or when one of R 4 and R 5 is hydrogen, the other is --SCH 3 ; R 6 is hydrogen, C 1 -C 6 alkyl, C 3 -C 8 cycloalkyl, C 2 -C 6 alkenyl, --SO 2 CH 3 , or --(CH 2 ) p --Y where p is 0, 1, 2, or 3 and Y is cyano, --OR 8 , ##STR2## tetrazolyl, --NR 10 R 11 , --SH, C 1 -C 4 alkylthio, or ##STR3## where R 8 is hydrogen, C 1 -C 4 alkyl or ##STR4## alkyl, R 9 is hydrogen, C 1 -C 4 alkyl, C 1 -C 4 alkoxy, hydroxy or NH 2 , and R 10 and R 11 are each independently hydrogen, C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, phenyl, C 1 -C 4 alkylphenyl, --(CH 2 ) q OH, --(CH 2 ) q N(C 1 -C 4 alkyl) 2 , or --(CH 2 ) q S(C 1 -C 4 alkyl), where q is an integer from 1 to 6, both inclusive, or R 10 and R 11 , taken together with the nitrogen atom to which they are attached, form a morpholinyl, piperidinyl, piperizinyl, or N-methylpiperazinyl ring; and m is 0, 1, or 2; with the provisos that Ar cannot be phenyl substituted solely with one chloro substituent at the 4-position of the phenyl ring; Ar cannot be phenyl substituted with a COOH moiety at the 2-position of the phenyl ring; when Ar is phenyl substituted with two ethoxy moieties at the 3- and 4-positions of the phenyl ring, R 1 must be hydrogen; Ar cannot be phenyl substituted solely with two hydroxy substituents; and when R 4 and R 5 are each hydrogen, R 6 cannot be C 1 -C 6 alkyl, or a pharmaceutically acceptable salt thereof, to a mammal in need of having its blood glucose concentration reduced. The present invention also provides a method of treating Alzheimer&#39;s disease in a mammal suffering from or susceptible to such disease comprising administering a therapeutically effective amount of a compound of formula (Ia) ##STR5## wherein: Ar is (i) phenyl, (ii) phenyl substituted with from one to three substituents independently selected from C 1 -C 8 alkyl, C 1 -C 8 alkoxy, C 1 -C 8 alkylthio, trifluoromethyl, C 1 -C 4 alkylphenyl, phenyl, NO 2 , F, Cl, hydroxy, phenoxy, C 1 -C 4 alkyloxyphenyl, thiophenyl, C 1 -C 4 alkylthiophenyl, --COOR 7 , --N(R 7 )SO 2 R 7 or --N(R 7 ) 2 , where each R 7 is independently hydrogen or C 1 -C 6 alkyl or (iii) 1- or 2-naphthyl; R 1 is C 1 -C 6 alkyl, C 1 -C 4 alkylphenyl, hydrogen, phenyl or phenyl substituted with one or two substituents independently selected from Cl, Br, F, I, C 1 -C 4 alkyl, C 1 -C 4 alkoxy, hydroxy, trifluoromethyl, --NH 2 , --NH(C 1 -C 4 alkyl), --N(C 1 -C 4 alkyl) 2 or C 1 -C 4 alkylthio; R 2 and R 3 are each hydrogen or when taken together form a bond; R 4 and R 5 are each hydrogen or when taken together are ═S, or when one of R 4 and R 5 is hydrogen, the other is --SCH 3 ; R 6 is hydrogen, C 1 -C 6 alkyl, C 3 -C 8 cycloalkyl, C 2 -C 6 alkenyl, --SO 2 CH 3 , or --(CH 2 ) p --Y where p is 0, 1, 2, or 3 and Y is cyano, --OR 8 , ##STR6## tetrazolyl, --NR 10 R 11 , --SH, C 1 -C 4 alkylthio, or ##STR7## where R 8 is hydrogen, C 1 -C 4 alkyl or ##STR8## alkyl, R 9 is hydrogen C 1 -C 4 alkyl C 1 -C 4 alkoxy hydroxy or NH 2 , and R 10 and R 11 are each independently hydrogen, C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, phenyl, C 1 -C 4 alkylphenyl, --(CH 2 ) q OH, --(CH 2 ) q N(C 1 -C 4 alkyl) 2 , or --(CH 2 ) q S(C 1 -C 4 alkyl), where q is an integer from 1 to 6, both inclusive, or R 10 and R 11 , taken together with the nitrogen atom to which they are attached, form a morpholinyl, piperidinyl, piperizinyl, or N-methylpiperazinyl ring; and m is 0, 1, or 2; or a pharmaceutically acceptable salt thereof, to a mammal in need of such treatment. Certain of the compounds which can be employed in the methods of the present invention are novel. As such, the present invention also provides novel compounds of the formula (II) ##STR9## wherein: Ar is (i) phenyl, (ii) phenyl substituted with from one to three substituents independently selected from C 1 -C 8 alkyl, C 1 -C 8 alkoxy, C 1 -C 8 alkylthio, trifluoromethyl, C 2 -C 4 alkylphenyl, NO 2 , F, Cl, phenoxy, C 1 -C 4 alkyloxyphenyl, thiophenyl, C 1 -C 4 alkylthiophenyl, --COOR 7 , --N(R 7 )SO 2 R 7 or --N(R 7 ) 2 , where each R 7 is independently hydrogen or C 1 -C 6 alkyl, (iii) 1- or 2-naphthyl, (iv) 2- or 3-benzofuranyl, (v) 2- or 3-benzothiophenyl, (vi) 2- or 3-thienyl, (vii) 2-, 3- or 4-pyridyl, (viii) 2- or 3-furanyl, (ix) 1,3-benzodioxanyl, (x) substituted 1,3-benzodioxanyl, (xi) quinolinyl, (xii) 2- or 3-indolyl or (xiii) N-substituted 2- or 3-indolyl; R 1 is C 1 -C 6 alkyl, C 1 -C 4 alkylphenyl, hydrogen, phenyl or phenyl substituted with one or two substituents independently selected from Cl, Br, F, I, C 1 -C 4 alkyl, C 1 -C 4 alkoxy, hydroxy, trifluoromethyl, --NH 2 , --NH(C 1 -C 4 alkyl), --N(C 1 -C 4 alkyl) 2 or C 1 -C 4 alkylthio; R 2 and R 3 are each hydrogen or when taken together form a bond; R 4 and R 5 are each hydrogen or when taken together are ═S, or when one of R 4 and R 5 is hydrogen, the other is --SCH 3 ; R 6 is hydrogen, C 1 -C 6 alkyl, C 3 -C 8 cycloalkyl, C 2 -C 6 alkenyl, --SO 2 CH 3 or --(CH 2 ) p --Y where p is 0, 1, 2, or 3 and Y is cyano, OR 8 , ##STR10## tetrazolyl --NR 10 R 11 , --SH C 1 -C 4 alkylthio or ##STR11## where R 8 is hydrogen, C 1 -C 4 alkyl, or ##STR12## alkyl; R 9 is hydrogen, C 1 -C 4 alkyl or NH 2 ; and R 10 and R 11 are each independently hydrogen, C 1 -C 6 alkyl, C 2 -C 6 alkenyl, --(CH 2 ) q OH, --(CH 2 ) q N(C 1 -C 4 alkyl) 2 , --(CH 2 ) q S(C 1 -C 4 alkyl), C 2 -C 6 alkynyl, phenyl, or C 1 -C 4 alkylphenyl, where q is 1 to 6, both inclusive, or R 10 and R 11 , taken together with the nitrogen atom to which they are attached, form a morpholinyl, piperidinyl, piperazinyl or N-methylpiperazinyl ring; and m is 0, 1, or 2; with the provisos that when Ar is (i) phenyl, (ii) phenyl substituted with from one to three substituents selected from C 1 -C 8 alkyl, C 1 -C 8 alkoxy, F, Cl, trifluoromethyl, phenoxy, C 1 -C 4 alkyloxyphenyl, C 1 -C 8 alkylthio, NO 2 , --N(R 7 ) 2 or --COOR 7 , where each R 7 is independently hydrogen or C 1 -C 6 alkyl, (iii) 1- or 2-naphthyl, (iv) 2- or 3-benzofuranyl, (v) 2- or 3-benzothiophenyl, (vi) 2- or 3-thienyl, (vii) 2- or 3-indolyl, (viii) 2- or 3- furanyl, (ix) quinolinyl or (x) 2-, 3- or 4-pyridyl; R 1 is hydrogen or C 1 -C 6 alkyl; R 2 and R 3 taken together form a bond; m is 0; and R 4 and R 5 taken together are ═S, R 6 must be other than hydrogen or C 1 -C 6 alkyl; when Ar is phenyl; R 1 is hydrogen, methyl or ethyl; R 2 and R 3 taken together form a bond; m is 0; R 4 and R 5 taken together are ═S; R 6 must be other than phenyl or C 1 -C 4 alkylphenyl; Ar cannot be phenyl substituted solely with one chloro substituent at the 4-position of the phenyl ring; when Ar is phenyl substituted with two ethoxy moieties at the 3- and 4-positions of the phenyl ring, R 1 must be hydrogen; Ar cannot be phenyl substituted with a COOH moiety at the 2-position of the phenyl ring; and when R 4 and R 5 are each hydrogen R 6 cannot be C 1 -C 6 alkyl, and the pharmaceutically acceptable salts thereof. In addition to the genus of novel compounds described by formula II, above, certain other of the compounds which can be employed in the methods of the present invention also appear to be novel. These compounds, while structurally similar to compounds specifically known in the art (see, for example, European Patent Application Nos. 343643, 391644 and 39817 as well as U.S. Pat. No. 4,552,891), are not actually described in any of those patents or applications. As such, the present invention also encompasses the following novel compounds and their pharmaceutically acceptable salts: 5-[(2-nitrophenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(4-fluorophenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(2-thienyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(2-furanyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3,4,5-trimethoxyphenyl)methylmethylene]-2-thioxo-4-thiazolidinone; 4-[(2-thioxo-4-thiazolidinone) methylene]benzoic acid; 5-[(3-hydroxy-4-nitrophenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3-hydroxyphenyl)methylmethylene]-2-thioxo-4-thiazolidinone; 5-[(3-methoxy-4-pentoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3-hydroxy-4-ethoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(4-pentoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3-ethoxy-4-propoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3-propoxy-4-ethoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3,4-dipropoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[[3-(methyloxyphenyl)phenyl]methylene]-2-thioxo-4-thiazolidinone; 5-[[3,5-bis(1,1-dimethylethyl)-4-methoxyphenyl]methylene]-2-thioxo-4-thiazolidinone; 5-[(3-ethoxy-4-hydroxy)phenyl]methylene]-2-thioxo-3-methyl-4-thiazolidinone; 5-[(3-ethoxy-4-hydroxyphenyl)methylene]-2-thioxo-3-dimethylamino-4-thiazolidinone 5-[(3,4-dipentoxyphenyl)methylene]-4-oxo-2-thioxo-3-thiazolidine acetic acid; 5-[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methylene]-4-oxo-2-thioxo-3-thiazolidine acetic acid; 5-[(3,5-dichloro-4-hydroxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3-ethoxy-4-butoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3-ethoxy-4-methoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[[3,5-bis(1-methylpropyl)-4-hydroxyphenyl]methylene]-4-oxo-2-thioxo-3-thiazolidine acetic acid; 5-[(4-butoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3-methoxy-4-pentoxyphenyl)methylene]-2-thioxo-3-methyl-4-thiazolidinone; 5-[(3-methoxy-4-octoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3,5-dimethoxy-4-pentoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[[3-(1,1-dimethylethyl)-4-hydroxy-5-(methyl-thiophenyl)phenyl]methylene]-2-thioxo-4-thiazolidinone; 5-[[3-ethoxy-4-hydroxy-5-(methylthiophenyl)phenyl]methylene]-2-thioxo-4-thiazolidinone; 5-[[3-ethoxy-4-hydroxy-5-(methylthiophenyl)phenyl]methylene]-2-thioxo-3-methyl-4-thiazolidinone; 5-[[3-ethoxy-4-hydroxy-5-(methylthiophenyl)phenyl]methylene]-4-oxo-2-thioxo-3-thiazolidine acetic acid; 5-[(3-(1,1-dimethylethyl)-4-hydroxyphenyl]methylene]-2-thioxo-3-methyl-4-thiazolidinone. Certain of the above compounds and, in particular, 5-[(4-pentoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3-propoxy-4-ethoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3-ethoxy-4-butoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(4-butoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3-methoxy-4-pentoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methylene]-4-oxo-2-thioxo-3-thiazolidine acetic acid; and 5-[[3,5-bis(1-methylpropyl)-4-hydroxy-phenyl]methylene]-4-oxo-2-thioxo-3-thiazolidine acetic acid (especially the latter three compounds), appear to possess a surprising ability to lower blood glucose levels in mammals compared to structurally similar compounds known in the art. Because of such surprising activity, these compounds are particularly preferred compounds of the present invention. In addition, 5-[[3-(1,1-dimethylethyl)-4-hydroxy-5-(methylthiophenyl)phenyl]methylene]-2-thioxo-4-thiazolidinone, 5-[(3,5-dichloro-4-hydroxyphenyl)methylene]-2-thioxo-4-thiazolidinone, 5-[(3-ethoxy-4-butoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, 5-[[3-ethoxy-4-hydroxy-5-(methylthiophenyl)phenyl]methylene]-2-thioxo-4-thiazolidinone, 5-[[3-ethoxy-4-hydroxy-5-(methylthiophenyl)phenyl]methylene]-4-oxo-2-thioxo-3-thiazolidine acetic acid, 5-[(3-ethoxy-4-hydroxyphenyl)methylene]-2-thioxo-3-methyl-4-thiazolidinone, 5-[(3-ethoxy-4-hydroxyphenyl) methylene]-2-thioxo-3-dimethylamino-4-thiazolidinone, 5-[(3,4-dipentoxyphenyl)-methylene]-4-oxo-2-thioxo-3-thiazolidine acetic acid and 5-[[3-(1,1-dimethylethyl)-4-hydroxyphenyl]methylene-2-thioxo-3-methyl-4-thiazolidinone appear to possess a surprising ability to inhibit cathepsin D levels compared to structurally similar compounds known in the art. Because of such surprising activity, such compounds are also particularly preferred compounds of the present invention. Finally, the present invention also provides pharmaceutical formulations comprising a compound of the present invention, or a pharmaceutically acceptable salt thereof, in combination with one or more pharmaceutically acceptable carriers, diluents or excipients therefor. DETAILED DESCRIPTION OF THE INVENTION As used herein, the term &#34;C 1 -C 8 alkyl&#34; represents a straight or branched alkyl chain having from one to eight carbon atoms. Typical C 1 -C 8 alkyl groups include methyl, ethyl, n-propyl, isopropyl, n-butyl, sec-butyl, isobutyl, t-butyl, n-pentyl, and the like. The term &#34;C 1 -C 8 alkyl&#34; includes within its definition the terms &#34;C 1 -C 4 alkyl&#34; and &#34;C 1 -C 6 alkyl&#34;. &#34;C 1 -C 4 alkylphenyl&#34; represents a straight or branched chain alkyl group having from one to four carbon atoms attached to a phenyl ring. Typical C 1 -C 4 alkylphenyl groups include methylphenyl, ethylphenyl, n-propylphenyl, isopropylphenyl, n-butylphenyl, isobutylphenyl, and tert-butylphenyl. The term &#34;C 1 -C 4 alkylthiophenyl&#34; represents a straight or branched chain alkyl group having from one to four carbon atoms attached to a thiophenyl moiety. Typical C 1 -C 4 alkylthiophenyl groups include methylthiophenyl, ethylthiophenyl, isobutylthiophenyl and the like. In a similar fashion, the term &#34;C 1 -C 4 alkyloxyphenyl&#34; represents a straight or branched chain alkyl group having from one to four carbon atoms attached to phenoxy moiety. Typical C 1 -C 4 alkyloxyphenyl groups include methyloxyphenyl, ethyloxyphenyl, propyloxyphenyl and the like. &#34;C 1 -C 8 alkoxy&#34; represents a straight or branched alkyl chain having one to eight carbon atoms, which chain is attached to the remainder of the molecule by an oxygen atom. Typical C 1 -C 8 alkoxy groups include methoxy, ethoxy, propoxy, isopropoxy, butoxy, isobutoxy, sec-butoxy, tert-butoxy, pentoxy, hexoxy, heptoxy, and the like. The term &#34;C 1 -C 8 alkoxy&#34; includes within its definition the term &#34;C 1 -C 4 alkoxy&#34;. &#34;C 1 -C 8 alkylthio&#34; represents a straight or branched alkyl chain having one to eight carbon atoms, which chain is attached to the remainder of the molecule by a sulfur atom. Typical C 1 -C 8 alkylthio groups include methylthio, ethylthio, propylthio, butylthio, tert-butylthio, octylthio and the like. The term &#34;C 1 -C 8 alkylthio&#34; includes within its definition the term &#34;C 1 -C 4 alkylthio&#34;. The term &#34;C 2 -C 6 alkenyl&#34; refers to straight and branched chain radicals of two to six carbon atoms, both inclusive, having a double bond. As such, the term includes ethylene, propylene, 1-butene, 2-butene, 2-methyl-1-propene, 1-pentene, 2-methyl-2-butene and the like. The term &#34;C 2 -C 6 alkynyl&#34; refers to straight and branched chain radicals of two to six carbon atoms, both inclusive, having a triple bond. As such, the term includes acetylene, propyne, 1-butyne, 2-hexyne, 1-pentyne, 3-ethyl-1-butyne and the like. The term &#34;C 3 -C 8 cycloalkyl&#34; refers to saturated alicyclic rings of three to eight carbon atoms, both inclusive, such as cyclopropyl, methylcyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl, cyclooctyl and the like. The terms &#34;1,3-benzodioxanyl&#34; and &#34;substituted 1,3-benzodioxanyl&#34; refer to structures of the formulae ##STR13## where each R is independently hydrogen or C 1 -C 4 alkyl. &#34;Quinolinyl&#34; refers to a quinoline ring system which is attached to the rest of the molecule at the 4, 5, 6, 7 or 8 position of such ring system. &#34;N-substituted 2- or 3- indolyl&#34; refers to a 2- or 3- indolyl ring system substituted on the nitrogen atom of that ring system with a C 1 -C 6 alkyl, C 1 -C 4 alkylphenyl, or C 3 -C 8 cycloalkyl group. The term &#34;pharmaceutically acceptable salts&#34; refers to salts of the compounds of the above formulae which are substantially non-toxic to living organisms. Typical pharmaceutically acceptable salts include those salts prepared by reaction of the compounds of the above formulae with a pharmaceutically acceptable mineral or organic acid, or a pharmaceutically acceptable alkali metal or organic base, depending on the types of substituents present on the compounds of the formulae. Examples of pharmaceutically acceptable mineral acids which may be used to prepare pharmaceutically acceptable salts include hydrochloric acid, phosphoric acid, sulfuric acid, hydrobromic acid, hydroiodic acid, phosphorous acid and the like. Examples of pharmaceutically acceptable organic acids which may be used to prepare pharmaceutically acceptable salts include aliphatic mono and dicarboxylic acids, oxalic acid, carbonic acid, citric acid, succinic acid, phenyl-substituted alkanoic acids, aliphatic and aromatic sulfonic acids and the like. Such pharmaceutically acceptable salts prepared from mineral or organic acids thus include hydrochloride, hydrobromide, nitrate, sulfate, pyrosulfate, bisulfate, sulfite, bisulfite, phosphate, monohydrogenphosphate, dihydrogenphosphate, metaphosphate, pyrophosphate, hydroiodide, hydrofluoride, acetate, propionate, formate, oxalate, citrate, lactate, p-toluenesulfonate, methanesulfonate, maleate, and the like. Many compounds of formulae I, Ia or II which contain a carboxy, carbonyl, hydroxy or sulfoxide group may be converted to a pharmaceutically acceptable salt by reaction with a pharmaceutically acceptable alkali metal or organic base. Examples of pharmaceutically acceptable organic bases which may be used to prepare pharmaceutically acceptable salts include ammonia, amines such as triethanolamine, triethylamine, ethylamine, and the like. Examples of pharmaceutically acceptable alkali metal bases included compounds of the general formula MOR 13 , where M represents an alkali metal atom, e.g. sodium, potassium, or lithium, and R 13 represents hydrogen or C 1 -C 4 alkyl. It should be recognized that the particular anion or cation forming a part of any salt of this invention is not critical, so long as the salt, as a whole, is pharmacologically acceptable and as long as the anion or cationic moiety does not contribute undesired qualities. A preferred genus of compounds useful in the instantly claimed method of reducing blood glucose concentrations includes those compounds wherein Ar, R 1 , R 2 , R 3 , m, R 4 , and R 5 are as set forth for formula I, and R 6 is hydrogen, C 1 -C 6 alkyl, C 3 -C 8 cycloalkyl, C 2 -C 6 alkenyl, --SO 2 CH 3 or --(CH 2 ) p --Y where p is 0, 1, 2, or 3 and Y is cyano, --OR 8 , ##STR14## tetrazolyl, NR 10 R 11 --SH, --S(C 1 -C 4 alkyl), or ##STR15## where R 8 is hydrogen, C 1 -C 4 alkyl, or ##STR16## alkyl, R 9 is hydrogen, C 1 -C 4 alkyl, or NH 2 ; and R 10 and R 11 are each independently hydrogen, C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, phenyl, C 1 -C 4 alkylphenyl, --(CH 2 ) q OH, --(CH 2 ) q N(C 1 -C 4 alkyl) 2 , or --(CH 2 ) q S(C 1 -C 4 alkyl) where q is 1 to 6, both inclusive, or R 10 and R 11 , taken together with the nitrogen atom to which they are attached, form a morpholinyl, piperidinyl, piperazinyl, or N-methylpiperazinyl ring. Of this preferred genus, those compounds in which m is 0 are more preferred. Of this more preferred genus, those compounds in which R 4 and R 5 taken together are ═S are even more preferred. Of this even more preferred genus, those compounds in which R 1 is hydrogen are especially preferred. Of this especially preferred genus, those compounds in which R 6 is hydrogen, C 1 -C 6 alkyl, C 2 -C 6 alkenyl, or --(CH 2 ) p --Y where p is 0, 1, 2, or 3 and Y is --OR 8 , ##STR17## --NR 10 R 11 , or C 1 -C 4 alkylthio, where R 8 is hydrogen, C 1 -C 4 alkyl or ##STR18## alkyl, R 9 is hydrogen, C 1 -C 4 alkyl or NH 2 ; and R 10 and R 11 are each independently hydrogen, C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, phenyl, or C 1 -C 4 alkylphenyl are particularly preferred. Of this particularly preferred genus, those compounds in which R 6 is hydrogen, C 1 -C 6 alkyl, or C 2 -C 6 alkenyl are more particularly preferred. Of this more particularly preferred genus, those compounds in which Ar is (i) phenyl, (ii) phenyl substituted with from one to three substituents independently selected from C 1 -C 8 alkyl, C 1 -C 8 alkoxy, C 1 -C 8 alkylthio, trifluoromethyl, C 1 -C 4 alkylphenyl, phenyl, NO 2 , F, Cl, hydroxy, phenoxy, C 1 -C 4 alkyloxyphenyl, thiophenyl, C 1 -C 4 alkylthiophenyl, --COOR 7 , --N(R 7 )SO 2 R 7 or --N(R 7 ) 2 , where each R 7 is independently hydrogen or C 1 -C 6 alkyl, (iii) 2-, 3- or 4-pyridyl, or (iv) 2- or 3- furanyl are substantially preferred. Of this substantially preferred genus, those compounds wherein Ar is phenyl substituted with from one to three substituents independently selected from C 1 -C 8 alkyl, C 1 -C 8 alkoxy, C 1 -C 4 alkylphenyl, phenyl, NO 2 , F, Cl, hydroxy, phenoxy, C 1 -C 4 alkylthiophenyl, --COOR 7 or --N(R 7 )SO 2 R 7 , where each R 7 is independently hydrogen or C 1 -C 6 alkyl, are more substantially preferred. Of this more substantially preferred genus, those compounds wherein Ar is phenyl substituted with from one to three substituents independently selected from C 1 -C 8 alkyl (especially C 1 -C 4 alkyl), C 1 -C 8 alkoxy (especially C 1 -C 6 alkoxy), or hydroxy are even more substantially preferred. The most preferred compounds which may be employed in the method of reducing blood glucose concentrations of the present invention include 5-[(3,4-diethoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3-methoxy-4-butoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3-methoxy-4-pentoxy-phenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3-methoxy-4-pentoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, sodium salt; 5-[(3-methoxy-4-pentoxyphenyl)methyl]-2-thioxo-4-thiazolidinone; 5[[(3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methylene]-2-thioxo-4-thiazolidinone; 5[(3,5-dimethyl-4-hydroxyphenyl)methylene]-2-thioxo-4-thiazolidinone and 5-[(3,5-dimethoxy-4-hydroxyphenyl)methylene]-2-thioxo-4-thiazolidinone. A preferred genus of compounds useful in the instantly claimed-method of treating Alzheimer&#39;s disease includes those compounds wherein Ar, R 1 , R 2 , R 3 , m, R 4 and R 5 are as set forth for formula Ia, and R 6 is hydrogen, C 1 -C 6 alkyl or --(CH 2 ) p Y where p is 0, 1, 2 or 3 and Y is ##STR19## where R 9 is hydrogen, C 1 -C 4 alkoxy or hydroxy, or --NR 10 R 11 where R 10 and R 11 are each independently hydrogen, C 1 -C 6 alkyl, phenyl or C 1 -C 4 alkylphenyl. Of this preferred genus, those compounds in which m is 0 are more preferred. Of this more preferred genus, those compounds in which R 4 and R 5 taken together are ═S are even more preferred. Of this even more preferred genus, those compounds in which R 2 and R 3 taken together form a bond are especially preferred. Of this especially preferred genus, those compounds in which Ar is phenyl substituted with from one to three substituents independently selected from C 1 -C 8 alkyl, C 1 -C 8 alkoxy, C 1 -C 8 alkylthio, trifluoromethyl, C 1 -C 4 alkylphenyl, phenyl, NO 2 , F, Cl, hydroxy, phenoxy, C 1 -C 4 alkyloxyphenyl, thiophenyl, C 1 -C 4 alkylthiophenyl, --COOR 7 , --N(R 7 )SO 2 R 7 or --N(R 7 ) 2 , where each R 7 is independently hydrogen or C 1 -C 4 alkyl, are particularly preferred. Of this particularly preferred genus, those compounds in which R 1 is hydrogen are more particularly preferred. Of this more particularly preferred genus, those compounds in which Ar is phenyl substituted with from one to three substituents independently selected from phenoxy, phenyl, C 1 -C 8 alkoxy, C 1 -C 8 alkyl (especially C 1 -C 4 alkyl), hydroxy, Cl, F, C 1 -C 4 alkylthiophenyl, C 1 -C 4 alkyloxyphenyl, --N(R 7 )SO 2 R 7 and --N(R 7 ) 2 , where each R 7 is independently hydrogen or C 1 -C 4 alkyl, are substantially preferred. The most preferred compounds which may be employed in the method of treating Alzheimer&#39;s disease of the present invention include 5-[(4-phenoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3-phenoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[[(1,1&#39;-biphenyl)-4-yl]methylene]-2-thioxo-4-thiazolidinone; 5-[(3-methoxy-4-hexoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3-methoxy-4-heptoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3-methoxy-4-octoxyphenyl]methylene]-2-thioxo-4-thiazolidinone; 5-[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methylene]-2-thioxo-4-thiazolidinone; 5-[(3,5-dichloro-4-hydroxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[[3-(1,1-dimethylethyl)-4-hydroxy-5-(methylthiophenyl)phenyl]methylene]-2-thioxo-4-thiazolidinone; 5-[(3-methoxy-4-heptoxyphenyl)methylene]-2-thioxo-3-dimethylamino-4-thiazolidinone; 5-[(3-ethoxy-4-hydroxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3-ethoxy-4-butoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[[3-ethoxy-4-hydroxy- 5-(methylthiophenyl)phenyl]methylene]-2-thioxo-4-thiazolidinone; 5-[[3-ethoxy-4-hydroxy-5-(methylthiophenyl)phenyl]methylene]-4-oxo-2-thioxo-3-thiazolidine acetic acid; 5-[[3-(methyloxy-phenyl)phenyl]methylene]-2-thioxo-4-thiazolidinone; 5-[(3-ethoxy-4-hydroxyphenyl)methylene]-2-thioxo-3-methyl-4-thiazolidinone; 5-[(3-ethoxy-4-hydroxyphenyl)methylene]-2-thioxo-3-dimethylamino-4-thiazolidinone; 5-[(3,4-dipentoxyphenyl)methylene]-4-oxo-2-thioxo-3-thiazolidine acetic acid; 5-[[3-(1,1-dimethylethyl)-4-hydroxyphenyl]methylene]-2-thioxo-3-methyl-4-thiazolidinone; and 5-[[4-(dimethylamino) phenyl]methylene]-2-thioxo-4-thiazolidinone. A preferred genus of compounds of the present invention includes those compounds wherein Ar, R 1 , R 2 , R 3 , R 4 , R 5 and R 6 are as set forth for Formula II, and m is 0. Of this preferred genus, those compounds in which R 4 and R 5 taken together are ═S are more preferred. Of this more preferred genus, those compounds in which R 2 and R 3 taken together form a bond are especially preferred. Of this especially preferred genus, those compounds in which R 6 is hydrogen, C 1 -C 6 alkyl, C 2 -C 6 alkenyl, or --(CH 2 ) p --Y where p is 0, 1, 2, or 3 and Y is --OR 8 , ##STR20## --NR 10 R 11 , or C 1 -C 4 alkylthio, where R 8 is hydrogen, C 1 -C 4 alkyl or ##STR21## alkyl, R 9 is hydrogen, C 1 -C 4 alkyl or NH 2 ; and R 10 and R 11 are each independently hydrogen, C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, phenyl, or C 1 -C 4 alkylphenyl are particularly preferred. Of this particularly preferred genus, those compounds in which R 6 is hydrogen, C 1 -C 6 alkyl, C 2 -C 6 alkenyl or --NR 10 R 11 where R 10 and R 11 are independently C 1 -C 6 alkyl are more particularly preferred. Of this more particularly preferred genus, those compounds in which R 1 is hydrogen or phenyl are even more particularly preferred. Of this even more particularly preferred genus, those compounds in which Ar is (i) phenyl, (ii) phenyl substituted with from one to three substituents independently selected from C 1 -C 8 alkyl, C 1 -C 8 alkoxy, C 1 -C 8 alkylthio, trifluoromethyl, C 2 -C 4 alkylphenyl, NO 2 , F, Cl, phenoxy, C 1 -C 4 alkoxyphenyl, thiophenyl, C 1 -C 4 alkylthiophenyl, --COOR 7 , --N(R 7 )SO 2 R 7 or --N(R 7 ) 2 , where each R 7 is independently hydrogen or C 1 -C 6 alkyl, (iii) 1,3-benzodioxanyl,(iv) substituted 1,3-benzodioxanyl or (v) quinolinyl are substantially preferred compounds. Of this substantially preferred genus, those compounds wherein Ar is (i) phenyl substituted with from one to three of phenoxy, C 1 -C 8 alkoxy, C 1 -C 4 alkyloxyphenyl or --N(R 7 )SO 2 R 7 , where each R 7 is hydrogen or C 1 -C 6 alkyl or (ii) 1,3-benzodioxanyl are more substantially preferred. Certain preferred compounds of the present invention include 5-(diphenylmethylene)-2-thioxo-4-thiazolidinone; 5-[(1,3-benzodioxol-5-yl)methylene)-2-thioxo-4-thiazolidinone; 5-[(4-phenoxyphenyl)methylene]-2-thioxo-4-thiazolidinone; 5-[(3-methoxy-4heptoxyphenyl)methylene]-3-amino-2-thioxo-4-thiazolidinone; 5-[(3-methoxy-4-heptoxyphenyl)methylene]-3-dimethylamino-2-thioxo-4-thiazolidinone; 5-[(3,4-diheptoxyphenyl)methylene]-2-thioxo-3-dimethylamino-4-thiazolidinone; 5-[(3,4-dibutoxyphenyl)methylene]-2-thioxo-3-dimethylamino-4-thiazolidinone; 5-[(3-methoxy-4-heptoxyphenyl)methylene]-2-thioxo-3-(2-propenyl)-4-thiazolidinone; 5-[(3-methanesulfonamidophenyl)methylene]-4-oxo-2-thioxo-3-thiazolidine acetic acid; 5-[[3-(methyloxyphenyl)phenyl]methylene]-2-thioxo-4-thiazolidinone; 5-[(3-methoxy-4-heptoxyphenyl)methylene]-2-thioxo-3-dimethylamino-4-thiazolidinone; and 5-[(3-methanesulfonamidophenyl)methylene]-2-thioxo-4-thiazolidinone. An alternative preferred genus of compounds of the present invention includes those compounds wherein Ar, R 1 , R 2 , R 3 , R 4 , R 5 , and m are as defined for formula II, and R 6 is C 3 -C 8 cycloalkyl, C 2 -C 6 alkenyl, --SO 2 CH 3 or --(CH 2 ) p --Y where p is 0, 1, 2, or 3 and Y is cyano, --OR 8 , ##STR22## tetrazolyl, --NR 10 R 11 , --SH, C 1 -C 4 alkylthio, or ##STR23## where R 8 is hydrogen, C 1 -C 4 alkyl, or ##STR24## alkyl; R 9 is hydrogen, C 1 -C 4 alkyl, or NH 2 ; and R 10 and R 11 are each independently hydrogen, C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, phenyl, C 1 -C 4 alkylphenyl, --(CH 2 ) q OH, --(CH 2 ) q N(C 1 -C 4 alkyl) 2 , or --(CH 2 ) q S(C 1 -C 4 alkyl) where q is 1 to 6, both inclusive, or R 10 and R 11 , taken together with the nitrogen atom to which they are attached, form a morpholinyl, piperidinyl, piperazinyl, or N-methylpiperazinyl ring. Of this preferred genus, those compounds in which m is 0 are more preferred. Of this more preferred genus, those compounds in which R 4 and R 5 taken together are ═S are even more preferred. Of this even more preferred genus, those compounds in which R 2 and R 3 taken together form a bond are especially preferred. Of this especially preferred genus, those compounds in which R 6 is C 2 -C 6 alkenyl, or --(CH 2 ) p --Y where p is 0, 1, 2, or 3 and Y is --OR 8 , ##STR25## --NR 10 R 11 , or C 1 -C 4 alkylthio, where R 8 is hydrogen, C 1 -C 4 alkyl or ##STR26## alkyl, R 9 is hydrogen, C 1 -C 4 alkyl or NH 2 ; and R 10 and R 11 are each independently hydrogen, C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, phenyl, or C 1 -C 4 alkylphenyl are particularly preferred. Of this particularly preferred genus, those compounds wherein R 1 is hydrogen or phenyl are more particularly preferred. Of this more particularly preferred genus, those compounds in which Ar is (i) phenyl, (ii) phenyl substituted with from one to three substituents independently selected from C 1 -C 8 alkyl, C 1 -C 8 alkoxy, C 1 -C 8 alkylthio, trifluoromethyl, C 2 -C 4 alkylphenyl, NO 2 , F, Cl, phenoxy, C 1 -C 4 alkoxyphenyl, thiophenyl, C 1 -C 4 alkylthiophenyl, --COOR 7 , --N(R 7 )SO 2 R 7 or --N(R 7 ) 2 , where each R 7 is independently hydrogen or C 1 -C 6 alkyl (iii) 2-, 3- or 4-pyridyl, or (iv) 2- or 3- furanyl are even more particularly preferred. Of this even more particularly preferred genus, those compounds wherein Ar is phenyl substituted with from one to three substituents independently selected from C 1 -C 8 alkyl, C 1 -C 8 alkoxy, C 1 -C 8 alkylthio, trifluoromethyl, C 2 -C 4 alkylphenyl, NO 2 , F, Cl, phenoxy, C 1 -C 4 alkoxyphenyl, thiophenyl, C 1 -C 4 alkylthiophenyl, --COOR 7 , --N(R 7 )SO 2 R 7 or --N(R 7 ) 2 , where each R 7 is independently hydrogen or C 1 -C 6 alkyl, are substantially preferred. Of this substantially preferred genus, those compounds wherein Ar is phenyl substituted with from one to three substituents independently selected from C 1 -C 8 alkyl or C 1 -C 8 alkoxy are most preferred. The present invention also encompasses formulations comprising a compound of the present invention in combination with a pharmaceutically acceptable carrier, diluent, or excipient therefor. Preferred formulations of the present invention are those formulations which contain a preferred compound or genus of compounds of the present invention, as described above. The compounds of the present invention, as well as the compounds employed in the methods of the present invention, can, typically, be prepared by methods well known to one skilled in the art of organic chemistry. For example, such compounds may be prepared by condensation of rhodanine, or an appropriately substituted rhodanine derivative, with an appropriately substituted aromatic aldehyde or aldehyde derivative such as a mono or disubstituted imine of the formula ##STR27## Such reaction is illustrated utilizing an appropriately substituted aromatic aldehyde as follows ##STR28## where Ar and R 6 are as defined in formulae I, Ia and II. Compounds of the present invention (as well as those compounds employed in the methods of the present invention) wherein R 2 and R 3 are hydrogen, or when taken together form a bond, and R 4 and R 5 are each hydrogen can be prepared by subjecting the compound wherein R 4 and R 5 taken together form ═S to catalytic hydrogenation. The relative proportions of compound obtained (R 2 , R 3 , R 4 and R 5 all hydrogen vs. R 2 and R 3 taken together form a bond and R 4 and R 5 are hydrogen) depends upon the temperature, pressure, and duration of hydrogenation, the solvent employed and the particular catalyst used. Alternatively, the above transformations may be accomplished by heating the compounds wherein R 4 and R 5 taken together are ═S and R 2 and R 3 taken together are a double bond in a mixture of hydrochloric acid and an alcohol, such as ethanol, in the presence of zinc. Reduction of the thione without affecting the benzylic double bond may be accomplished by heating the thione with a reducing agent such as tri-n-butyl tin hydride in a non-reactive solvent, such as toluene, and preferably in the presence of a free radical initiator, such as azobisisobutyronitrile. However, for such reduction to work, an N-substituted rhodanine substrate must be employed. The transformation of compounds wherein R 2 and R 3 taken together form a bond and R 4 and R 5 taken together are ═S to those compounds wherein R 2 and R 3 are both hydrogen while R 4 and R 5 remain unchanged may be accomplished by treating the unsaturated compound with a dihydropyridine, such as diethyl 2,6-dimethyl-1,4-dihydro-3,5-pyridine dicarboxylate in the presence of silica gel. The reaction is best carried out in the presence of a nonreactive solvent such as benzene or toluene, preferably under an inert atmosphere. The reaction may be accomplished at temperatures from about 25° C. up to the reflux temperature of the mixture. At the preferred temperature of approximately 80° C., the reaction is essentially complete after about 12-18 hours. Compounds of formulae I, Ia or II wherein R 1 is C 1 -C 6 alkyl, phenyl, a substituted phenyl of the type described above, or C 1 -C 4 alkylphenyl may be prepared by conventional Friedel-Crafts acylation of an appropriately substituted aromatic compound with an acyl halide of the formula R 1 --C(O)--X, wherein R 1 is as defined in formulae I or II and X is chloro, fluoro, bromo or iodo. The resulting aromatic ketone is then condensed with rhodanine, or an appropriately substituted rhodanine derivative. The compounds of the present invention (as well as the compounds employed in the methods of the present invention) allow various R 6 substituents. These R 6 substituents can be prepared as follows. Compounds of formulae I, Ia and II wherein R 6 is hydrogen, C 1 -C 6 alkyl, C 3 -C 8 cycloalkyl or --(CH 2 ) p --Y where p is as defined for formulae I, Ia and II and Y is cyano, or NR 10 R 11 where R 10 and R 11 are each independently hydrogen or C 1 -C 6 alkyl may be prepared using the method set forth in the above reaction scheme. Alternatively, rhodanine may be used for condensation with an aldehyde or aldehyde derivative forming those species wherein R 6 is hydrogen, followed by alkylation or acylation with the appropriate R 6 -containing halide. The alkylation or acylation is usually accomplished in an inert solvent such as tetrahydrofuran or dimethylformamide and in the presence of a strong base such as sodium hydride. Alternatively, compounds of formulae I, Ia and II wherein R 6 is --(CH 2 ) p --Y where Y is cyano may be prepared by treating the non-cyanated analog with a halo-substituted aliphatic nitrile. From this cyano derivative the tetrazolyl is prepared as by treatment with tri-N-butyl tin azide in, for example, ethylene glycol dimethyl ether. Compounds of formulae I, Ia and II wherein R 6 is --(CH 2 ) p --Y (p=0) and Y is NR 10 R 11 , where R 10 and R 11 are as defined in formulae I, Ia and II, may also be prepared by employing an appropriately substituted hydrazine. In this reaction sequence, benzaldehyde is reacted with an appropriately substitued hydrazine, in an alcoholic solvent, yielding III. An appropriately substituted alkyl halide is then reacted with III, in the presence of triethylamine and acetonitrile, to provide IV, which is then further reacted with hydrazine to yield the R 10 , R 11 hydrazine V. Compound V may alternatively be prepared by the reduction of a nitroso-R 10 R 11 amine using zinc dust and acetic acid or aluminum and a strong base. The R 10 , R 11 hydrazine is then treated with carbon disulfide, chloroacetic acid and triethylamine to provide intermediate VI. Condensation of VI with an appropriately substituted aromatic aldehyde or aldehyde derivative yields the desired product, as represented by the following reaction scheme. ##STR29## Furthermore, the thione portion of the compound produced above may be reduced by treatment with a reducing agent such as tri-n-butyltin hydride in an inert solvent such as toluene, preferably in the presence of a free radical initiator such as azobisisobutyronitrile. Preparation of compounds wherein one of R 10 and R 11 is hydrogen may be effected before or after reduction of the thione, as desired, by heating the disubstituted compound in a mixture of ethanol/water in the presence of a catalyst such as a rhodium catalyst. Compounds of formulae I, Ia and II wherein R 6 is --(CH 2 ) p --Y and Y is OR 8 or NR 10 R 11 (where R 8 is hydrogen, acetyl or tosyl and R 10 and R 11 are each independently hydrogen or C 1 -C 6 alkyl) may also be prepared according to the following reaction scheme: ##STR30## A hydroxyalkyl rhodanine is prepared by condensing carbon disulfide, chloroacetic acid, and the appropriate hydroxyalkylamine by standard techniques. When condensed with the appropriately substituted aromatic aldehyde (or aldehyde derivative), as described above, the resulting product is the condensed 2-thioxo-4-thiazolidinone VIII which has been transformed into the acetyl derivative. The thioxo compound VIII may optionally be converted to the methylene compound of formulae I or II as described above. The acetyl group of intermediate IX may be removed upon treatment with aqueous ammonia in a solvent such as acetonitrile to provide compound X. The hydroxy compound X is then converted to the tosyl derivative upon treatment with p-toluenesulfonyl chloride in pyridine, preferably at temperatures of around 0° C. The versatile tosyl intermediate XI may then be transformed into the compounds of formulae I or II upon treatment with an appropriate HNR 10 R 11 amine. This latter transformation is best accomplished by allowing XI to react in the presence of a molar excess of the amine. Once again, a solvent such as acetonitrile is useful for accomplishing this transformation. Those compounds where m is 1 or 2 are readily prepared from the sulfide (m=0) by treatment with an oxidizing agent, such as m-chloroperbenzoic acid, in a suitable solvent for a time sufficient to generate the desired oxidative state. Depending upon the definitions of R 1 , R 2 , and R 3 , the compounds of formulae I, Ia and II may exist in various isomeric forms. The compounds, formulations and methods of the present invention are not related to any particular isomer but include all possible isomers and racemates. It will be readily appreciated by one skilled in the art that the aromatic portion of the compounds of the invention (or the compounds employed in the methods of the present invention) can be provided by compounds which are either commercially available or may be readily prepared by known techniques from commercially available starting materials. Similarly, the rhodanine or N-substituted rhodanine starting material is either commercially available or may be prepared by well known methods from commercially available substrates. The following Examples illustrate the preparation of the compounds of the present invention, as well as compounds which may be employed in the methods of the present invention. The Examples are illustrative only and are not intended to limit the scope of the instant invention in any way. EXAMPLE 1 5-[(3-methanesulfonamidophenyl)methylene]-2-thioxo-4-thiazolidinone Thirty seven grams (185.9 mmol) of 3-methanesulfonamidbenzaldehyde, 25.0 g (187.9 mmol) of rhodanine, 48.0 g (585.3 mmol) of anhydrous sodium acetate and 950 ml of acetic acid were stirred while heating at reflux for 20 hours. The reaction was then stirred at room temperature for approximately another 60 hours. The resulting slurry was poured into 3000 ml of a 1:1 ethanol/water mixture. Solids precipitated and were recovered by filtration, washed with water and then vacuum dried to provide 54 g of title compound. m.p. 260°-265° C. Analysis for C 11 H 10 N 2 O 3 S 3 : Calculated: C, 42.02; H, 3.20; N 8.91; Found: C, 42.15; H, 3.57; N 8.71. EXAMPLE 2 5-[(1,3-benzodioxol-5-yl)methylene]-2-thioxo-4-thiazolidinone Twenty grams (133.2 mmol) of piperonal were reacted with 17.74 g (133.2 mmol)of rhodanine in 38.24 g (466.2 mmol) of glacial acetic acid at reflux for about 3 hours. The mixture was then poured into water and stirred overnight. A precipitate formed which was recovered by filtration and then air dried overnight to provide 27.8 g of title product. m.p. 194°-195° C. Analysis for C 11 H 7 N 1 O 3 S 2 : Calculated: C, 49.80; H, 2.66; N 5.28; S, 24.17; Found: C, 50.04; H, 2.38; N 5.27; S, 23.98. EXAMPLE 3 5-[(4-quinolinyl)methylene]-2-thioxo-4-thiazolidinone Rhodanine (2.2 g; 16.5 mmol), 1.3 ml of concentrated ammonium hydroxide and 1 g of ammonium chloride in 20 ml of ethanol were heated on a steam bath for 15 minutes. 4-Quinoline carboxaldehyde (2.6 g; 16.5 mmol) was added and the resulting mixture was heated on the steam bath for another hour. Upon cooling to 5° C. a precipitate formed. This precipitate was recovered by filtration and then washed with water to provide 4 g of title compound, m.p. 325°-328° C. Analysis for C 13 H 8 N 2 OS 2 : Calculated: C, 57.33; H, 2.96; N 10.29; Found: C, 57.11; H, 3.11; N 10.21. EXAMPLE 4 5-(diphenylmethylene)-2-thioxo-4-thiazolidinone One hundred and ninety grams (1.05 mol) of diphenyl ketimine, 140 grams (1.05 mol) of rhodanine, 5 ml of acetic acid and 1500 ml of toluene were heated at reflux for 3 hours. Crystals formed upon cooling. The solvent was decanted, fresh toluene was added to the residue and the resulting suspension was filtered. The recovered crystals were recrystallized from methanol to provide 172.0 g of title product, m.p. 192°-194° C. Analysis for C 16 H 11 NOS 2 : Calculated: C, 64.62; H, 3.73; 0, 5.38; N 4.71; S, 21.56; Found: C, 64.13; H, 3.84; 0, 5.57; N 4.59; S, 22.38. EXAMPLE 5 5-[(4-phenoxyphenyl)methylene]-2-thioxo-4-thiazolidinone A mixture of 9.9 g (50.0 mmol) of 4-phenoxybenzaldehyde, 6.8 g (51.1 mmol) of rhodanine, 15.5 g of sodium acetate and 60 ml of acetic acid was heated on a steam bath for two hours. The reaction solution was then poured into water causing crude product to precipitate. The precipitate was filtered and then washed successively with water followed by diethyl ether to provide 8.6 g of title product, m.p. 195°-200° C. Analysis for C 16 H 11 NO 2 S 2 : Calculated: C, 61.32; H, 3.54; N 4.47; Found: C, 61.07; H, 3.63; N 4.47. The following compounds were synthesized using methods substantially equivalent to those described in Examples 1-5 above or as described elsewhere herein. EXAMPLE 6 5-(phenylmethylene)-2-thioxo-4-thiazolidinone, m.p. 202°-203.5° C. EXAMPLE 7 5-[(2-hydroxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 220°-222° C. EXAMPLE 8 5-[(4-hydroxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 287°-290° C. EXAMPLE 9 5-[(2-nitrophenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 197.5°-199° C. EXAMPLE 10 5-[(3-nitrophenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 277°-280° C. EXAMPLE 11 5-[(3-hydroxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 242°-244° C. EXAMPLE 12 5-[(2,4-dimethoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 253°-255° C. EXAMPLE 13 5-[(4-fluorophenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 225°-227° C. EXAMPLE 14 5-[(2-thienyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 231°-233° C. EXAMPLE 15 5-[(2-furanyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 217°-219° C. EXAMPLE 16 5-[(4-pyridyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 297°-298° C. EXAMPLE 17 5-[(3,4,5-trimethoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 203°-205° C. EXAMPLE 18 5-[(4-methoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 252°-254° C. EXAMPLE 19 5-[(3,4,5-trimethoxyphenyl)methylmethylene]-2-thioxo-4-thiazolidinone, m.p. 210°-213° C. EXAMPLE 20 5-[(3-methoxy-4-hydroxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 229°-231° C. EXAMPLE 21 5-[(4-methoxyphenyl)phenylmethylene]-2-thioxo-4-thiazolidinone, m.p. 169°-171° C. EXAMPLE 22 5-[(3-pyridyl)methylene]-2-thioxo-4-thiazolidinone, m.p. ˜286° C. EXAMPLE 23 5-[(3-chlorophenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 233°-235° C. EXAMPLE 24 5-[(2,3-dimethoxyphenyl)methylene]-2-thioxo-4-thiazolidinone EXAMPLE 25 5-[(3-methoxyphenyl)methylene]-2-thioxo-4-thiazolidinone EXAMPLE 26 5-[(2-methoxyphenyl)methylene]-2-thioxo-4-thiazolidinone EXAMPLE 27 5-[(3-methyl-4-methoxyphenyl)methylene]-2-thioxo-4-thiazolidinone EXAMPLE 28 5-[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methylene]-2-thioxo-4-thiazolidinone, ˜260° C. EXAMPLE 29 5-[[(1,1&#39;-biphenyl)-2-yl]methylene]-2-thioxo-4-thiazolidinone EXAMPLE 30 5-[(3-methoxy-4-hydroxyphenyl)methylene]-3-(2-propenyl)-2-thioxo-4-thiazolidinone, m.p. 146°-148° C. EXAMPLE 31 5-[(3-methoxy-4-heptoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 130°-132° C. EXAMPLE 32 5-[(3-ethoxy-4-hydroxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 217°-217.5° C. EXAMPLE 33 5-[(3-methylphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 197°-202° C. EXAMPLE 34 5-[(4-methylphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 229°-234° C. EXAMPLE 35 5-[(2-naphthalenyl)methylene)-2-thioxo-4-thiazolidinone, m.p. 224°-225° C. EXAMPLE 36 5-[(3,4-dichlorophenyl)methylene]-2-thioxo-4-thiazolidinone EXAMPLE 37 4-[(2-thioxo-4-thiazolidinone)methylene]benzoic acid, m.p. ˜320° C. EXAMPLE 38 5-[(3,4-diethoxyphenyl)methylene]-2-thioxo-4-thiazolidinone EXAMPLE 39 5-[(1H-indol-3-yl)methylene]-2-thioxo-4-thiazolidinone EXAMPLE 40 5-[(3-hydroxy-4-methoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 218°-220° C. EXAMPLE 41 5-[(3-methoxy-4-butoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 175°-176° C. EXAMPLE 42 5-[[(1,1&#39;-biphenyl)-4-yl]methylene]-2-thioxo-4-thiazolidinone, m.p. 245°-250° C. EXAMPLE 43 5-[(3-hydroxy-4-nitrophenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. ˜224° C. EXAMPLE 44 5-[(3-hydroxyphenyl)methylmethylene]-2-thioxo-4-thiazolidinone EXAMPLE 45 5-[(3-methoxy-4-pentoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 170°-171° C. EXAMPLE 46 5-[(3-hydroxy-4-ethoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. &gt;225° C. EXAMPLE 47 5-[(4-pentoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 158.5°-160° C. EXAMPLE 48 5-[(3-methoxy-4-ethoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 207°-207.5° C. EXAMPLE 49 5-[(3-ethoxy-4-propoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 156°-157° C. EXAMPLE 50 5-[(3-propoxy-4-ethoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 186.5°-188° C. EXAMPLE 51 5-[(3,4-dipropoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 167.5°-168.5° C. EXAMPLE 52 5-[(3-methoxy-4-butoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, sodium salt m.p. &gt;225° C. EXAMPLE 53 5-[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methylene]-4-oxo-2-thioxo-3-thiazolidine acetic acid, m.p. ˜265° C. EXAMPLE 54 5-[(3-methoxy-4-butoxyphenyl)methyl]-2-thioxo-4-thiazolidinone, m.p. 152°-153.5° C. EXAMPLE 55 5-[(3,5-dichloro-4-hydroxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. &gt;260° C. EXAMPLE 56 5-[(3-ethoxy-4-butoxyphenyl)methylene]-2-thioxo-4-thiazolidinone EXAMPLE 57 5-[(3-methoxy-4-pentoxyphenyl)methylene]-2-thioxo-4-thiazolidinone sodium salt, m.p. ˜254° C. EXAMPLE 58 5-[(3-ethoxy-4-methoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. &gt;225° C. EXAMPLE 59 5-[[3,5-bis(1-methylpropyl)-4-hydroxyphenyl]methylene]-4-oxo-2-thioxo-3-thiazolidine acetic acid, m.p. 191°-193° C. EXAMPLE 60 5-[(3,4-dimethoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 231.5°-233° C. EXAMPLE 61 5-[(4-propoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 180° C. EXAMPLE 62 5-[(3,5-dimethyl-4-hydroxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 260° C. EXAMPLE 63 5-[(3,5-dimethoxy-4-hydroxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 230° C. EXAMPLE 64 5-[(3-methoxy-4-pentoxyphenyl)methyl]-2-thioxo-4-thiazolidinone, m.p. 163°-164° C. EXAMPLE 65 5-[(3-methoxy-4-pentoxyphenyl)methylene]-2-thioxo-3-methyl-4-thiazolidinone, m.p. 117°-118° C. EXAMPLE 66 5-[(3-methoxy-4-pentoxyphenyl)methylene]-4-thiazolidinone, m.p. 174°-175° C. EXAMPLE 67 5-[(3-methoxy-4-pentoxyphenyl)methyl]-4-thiazolidinone, m.p. 108°-109° C. EXAMPLE 68 5-[(3-methoxy-4-hexoxyphenyl)methylene]-2-thioxo-4-thiazolidinone EXAMPLE 69 5-[(3-methoxy-4-octoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 125°-127° C. EXAMPLE 70 5-[(3,5-dimethoxy-4-pentoxyphenyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 166°-167° C. EXAMPLE 71 5-[[3-(1,1-dimethylethyl)-4-hydroxy-5-(methylthiophenyl)phenyl]methylene]-2-thioxo-4-thiazolidinone, m.p. 181°-184° C. EXAMPLE 72 5-[[3-ethoxy-4-hydroxy-5-(methylthiophenyl)phenyl]methylene]-2-thioxo-4-thiazolidinone, m.p. 190°-192° C. EXAMPLE 73 5-[[3-ethoxy-4-hydroxy-5-(methylthiophenyl)phenyl]methylene]-2-thioxo-3-methyl-4-thiazolidinone, m.p. 137° C. EXAMPLE 74 5-[[3-ethoxy-4-hydroxy-5-(methylthiophenyl)phenyl]methylene]-4-oxo-2-thioxo-3-thiazolidine acetic acid m.p. 202°-206° C. EXAMPLE 75 5-[(1-naphthyl)methylene]-2-thioxo-4-thiazolidinone, m.p. 224°-225° C. EXAMPLE 76 5-[(2-naphthyl)methylmethylene]-2-thioxo-4-thiazolidinone EXAMPLE 77 5-[(3-phenoxyphenyl)methylene]-2-thioxo-4-thiazolidinone EXAMPLE 78 5-[(3-phenoxyphenyl)methylmethylene]-2-thioxo-4-thiazolidinone EXAMPLE 79 5-[[3-(methyloxyphenyl)phenyl]methylene]-2-thioxo-4-thiazolidinone, m.p. 177°-180° C. EXAMPLE 80 5-[(3-methoxy-4-heptoxyphenyl)methylene]-2-thioxo-3-amino-4-thiazolidinone, m.p. 118°-121° C. (dec). EXAMPLE 81 5-[(3-methoxy-4-heptoxyphenyl)methylene]-2-thioxo-3-dimethylamino -4-thiazolidinone Two hundred and fifty milligrams (1 mmol) of 3-methoxy-4-heptoxy benzaldehyde, 233 mg (1.2 mmol) of 2-(N-dimethylamino-dithiocarboxamido)acetic acid (a compound of formula VI, above), 330 mg (4 mmol) of anhydrous sodium acetate and 5 ml of acetic acid were stirred while heating at reflux for 15 hours. The reaction was then quenched by pouring the reaction solution into 10 ml of an ice/water mixture. The resulting solids were recovered by filtration, washed with ethyl acetate and then water to provide 450 mg of impure title compound. The impure compound was purified via recrystallization from hexane/methylene chloride to provide 180 mg of pure title compound. m.p. 105°-108° C. EXAMPLE 82 5-[[4-(dimethylamino)phenyl]methylene]-2-thioxo-4-thiazolidinone EXAMPLE 83 5-[(4-heptoxyphenyl)methylene]-2-thioxo-3-dimethylamino-4-thiazolidinone, m.p. 80° C. EXAMPLE 84 5-[(3-ethoxy-4-hydroxyphenyl)methylene]-2-thioxo-3-cyclohexyl-4-thiazolidinone, m.p. 122°-123° C. EXAMPLE 85 5-[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methylene]-2-thioxo-3-methyl-4-thiazolidinone, m.p. &gt;200° C. EXAMPLE 86 5-[(3-methanesulfonamidophenyl)methylene]-4-oxo-2-thioxo-3-thiazolidine acetic acid, m.p. &gt;230° C. EXAMPLE 87 5-[[3,5-bis(1,1-dimethylethyl)-4-methoxyphenyl]methylene]-2-thioxo-4-thiazolidinone, m.p. 234°-236° C. EXAMPLE 88 5-[(3-ethoxy-4-hydroxyphenyl)methylene]-2-thioxo-3-methyl-4-thiazolidinone, m.p. 157° C. EXAMPLE 89 5-[[3-ethoxy-4-hydroxy-5-(methylthiophenyl)phenyl]methylene]-2-thioxo-3-dimethylamino -4-thiazolidinone, m.p. 137°-141° C. EXAMPLE 90 5-[(3-ethoxy-4-hydroxyphenyl)methylene]-2-thioxo-3-dimethylamino-4-thiazolidinone, m.p. 194°-198° C. EXAMPLE 91 5-[(3,4-dipentoxyphenyl)methylene]-4-oxo-2-thioxo-3-thiazolidine acetic acid, m.p. 179°-182° C. EXAMPLE 92 5-[[3-(1,1-dimethylethyl)-4-hydroxyphenyl]methylene]-2-thioxo-3-methyl-4-thiazolidinone, m.p. &gt;230° C. EXAMPLE 93 5-[(3,4-diheptoxyphenyl)methylene]-2-thioxo-3-dimethylamino-4-thiazolidinone, m.p. 67° C. EXAMPLE 94 5-[(3,4-dibutoxyphenyl)methylene]-2-thioxo-3-dimethylamino-4-thiazolidinone, m.p. 92° C. EXAMPLE 95 5-[(3-methoxy-4-heptoxyphenyl)methylene]-2-thioxo-3-(2-propenyl)-4-thiazolidinone, m.p. 75°-78° C. The present invention provides a method for lowering blood glucose levels in mammals comprising administering a therapeutically effective amount of a compound of formula I. The term &#34;therapeutically effective amount&#34;, as defined herein, means the amount of compound necessary to provide a hypoglycemic effect following administration, preferably to a human susceptible to adult onset diabetes. The hypoglycemic activity of the compounds of the present invention was determined by testing the efficacy of the compounds in vivo in male viable yellow obese-diabetic mice. The test procedure is described in detail below. Test formulations were prepared by dissolving the test compound in a saline solution containing 2% Emulphor (a polyoxyethylated vegetable oil surfactant from GAP Corp.) to provide the dose level desired. Each test formulation was administered to six viable yellow obese-diabetic mice intraperitoneally at the beginning of the experiment. Blood glucose levels were determined immediately before the first dose and at 2 and 4 hours thereafter using glucose oxidase. A mean was taken of the 6 values obtained before the first dose and at the 2 and 4 hour intervals. The 2 and 4 hour mean values, calculated as a percentage of the first dose mean value, are reported in Table 1, below. In Table 1, Column 1 provides the example number of the test compound, Column 2 provides the dose level of compound tested, and Columns 3 and 4 provide a measurement of the test animal&#39;s blood glucose level 2 and 4 hours after test compound administration, respectively, as a percentage of the test animal&#39; s pre-administration blood glucose level. TABLE 1______________________________________HYPOGLYCEMIC ACTIVITY OF TEST COMPOUNDSIN OBESE DIABETIC MICEExample # of Percent of InitialCompound Dose Blood Glucose LevelTested (mg/kg) After 2 hrs. After 4 hrs.______________________________________ 1 50 82 ± 5 75 ± 2 2 50 96 ± 1 82 ± 3 3 50 90 ± 10 73 ± 3 4 50 91 ± 4 72 ± 7 5 50 79 ± 4 71 ± 3 6 50 85 ± 6 72 ± 4 6 50 92 ± 4 79 ± 4 7 50 80 ± 4 91 ± 7 8 50 94 ± 4 84 ± 6 9 50 91 ± 8 83 ± 610 50 89 ± 4 80 ± 411 50 84 ± 3 85 ± 612 50 90 ± 7 69 ± 613 50 94 ± 4 88 ± 514 50 84 ± 7 71 ± 815 50 73 ± 5 62 ± 416 50 94 ± 8 96 ± 917 50 88 ± 8 89 ± 1018 50 89 ± 4 88 ± 519 50 85 ± 14 75 ± 420 50 76 ± 3 70 ± 521 50 99 ± 4 81 ± 622 50 77 ± 5 67 ± 222 50 77 ± 6 69 ± 623 50 74 ± 6 90 ± 624 50 78 ± 4 80 ± 525 50 78 ± 4 74 ± 425 25 84 ± 5 87 ± 626 50 80 ± 4 75 ± 227 50 93 ± 3 84 ± 628 50 83 ± 9 79 ± 729 50 84 ± 5 77 ± 630 50 78 ± 7 81 ± 531 50 76 ± 7 76 ± 532 50 75 ± 4 80 ± 832 50 80 ± 18 66 ± 1133 50 91 ± 6 86 ± 734 50 85 ± 8 79 ± 935 50 83 ± 5 85 ± 636 50 81 ± 7 90 ± 837 50 89 ± 4 80 ± 438 50 60 ± 5 59 ± 438 50 96 ± 6 80 ± 338 50 86 ± 4 81 ± 538 25 69 ± 9 65 ± 738 10 72 ± 4 71 ± 638 10 73 ± 8 59 ± 739 50 83 ± 4 76 ± 440 50 78 ± 5 72 ± 441 50 61 ± 3 51 ± 441 50 64 ± 6 54 ± 541 50 77 ± 5 62 ± 541 50 77 ± 5 72 ± 841 25 58 ± 6 45 ± 541 25 72 ± 7 64 ± 441 25 74 ± 7 70 ± 841 25 87 ± 5 85 ± 641 10 80 ± 7 59 ± 441 10 97 ± 7 75 ± 541 10 92 ± 7 92 ± 741 5 93 ± 10 71 ± 441 5 95 ± 4 97 ± 542 50 87 ± 8 70 ± 843 50 92 ± 7 88 ± 444 50 98 ± 4 88 ± 545 50 76 ± 7 57 ± 345 50 68 ± 2 66 ± 445 25 93 ± 4 87 ± 545 25 83 ± 10 78 ± 1246 50 79 ± 4 77 ± 547 50 99 ± 14 76 ± 848 50 70 ± 3 65 ± 348 25 87 ± 4 81 ± 549 50 83 ± 5 77 ± 750 50 75 ± 5 69 ± 551 50 89 ± 7 85 ± 852 50 73 ± 3 61 ± 453 100 83 ± 9 80 ± 1453 50 73 ± 4 55 ± 554 50 76 ± 7 74 ± 655 50 81 ± 3 75 ± 356 50 78 ± 4 72 ± 356 25 81 ± 8 75 ± 356 10 94 ± 4 97 ± 457 50 63 ± 6 58 ± 757 50 69 ± 5 63 ± 757 25 67 ± 7 66 ± 757 25 79 ± 10 70 ± 457 10 95 ± 3 87 ± 657 5 82 ± 6 68 ± 558 50 67 ± 2 75 ± 559 50 62 ± 5 59 ± 960 50 85 ± 4 78 ± 360 50 102 ± 6 81 ± 560 25 87 ± 7 89 ± 661 50 76 ± 5 61 ± 561 50 98 ± 8 79 ± 4______________________________________ The hypoglycemic activity of the compounds of the present invention was confirmed in a second in vivo test system; namely, the normal fed rat system. The procedure used in this test system is described below. Male Sprague Dawley rats (Charles River Laboratories) weighing 175-200 g were used in this test system. Test formulations were prepared by suspending the test compound in 5% acacia (concentration of the drug was adjusted such that 0.25 ml/100 g body weight administered orally gave the desired dose on a body weight basis). The desired dose level of each test formulation was administered to four rats by oral garage at the beginning of the experiment. Blood glucose levels were determined immediately before the first dose and at 3 and 5 hours thereafter by an enzymatic procedure employing glucose oxidase and peroxidase coupled with a chromogenic oxygen acceptor. A mean was taken of the 4 values obtained before the first dose and at the 3 and 5 hour intervals. The 3 and 5 hour mean values, calculated as a percentage of the first dose mean value, are reported in Table 2, below. In Table 2, Column 1 provides the example number of the test compound, Column 2 provides the dose level of compound tested, and Columns 3 and 4 provide a measurement of the test animal&#39;s blood glucose level 3 and 5 hours after test compound administration, respectively, as a percentage of the test animal&#39;s pre-administration blood glucose level. TABLE 2______________________________________HYPOGLYCEMIC ACTIVITY OF TEST COMPOUNDSIN NORMAL FED RATSExample # of Percent of InitialCompound Dose Blood Glucose LevelTested (mg/kg) After 3 hrs. After 5 hrs.______________________________________15 167 84 8716 200 92 7917 200 78 6822 200 84 6824 200 100 10025 200 100 10026 200 100 10031 200 95 9232 200 100 9638 200 90 7441 160 76 6745 167 61 6347 200 82 7348 167 87 8149 200 100 9856 150 79 6557 200 84 7358 200 100 10061 200 89 8262 200 78 5363 200 69 5264 200 91 8965 200 100 9166 200 100 8667 200 92 8868 200 88 8969 200 93 88______________________________________ The hypoglycemic activity of the compounds of the present invention was confirmed in yet a third in vivo test system; namely, the obese diabetic Zucker rat (Zucker Diabetic Fatty Rat) test system. The rats used in this test system were 6 to 8 months old, weighed between 550 to 625 grams and had a pre-drug blood glucose level between 250 to 350 mg/dl. The procedure used in this test system is the same as that described for the normal fed rat test system, above. The results of such tests are set forth in Table 3, below. The format of Table 3 is the same as that used in Table 2. TABLE 3______________________________________HYPOGLYCEMIC ACTIVITY OF TEST COMPOUNDSIN OBESE DIABETIC ZUCKER RATSExample # of Percent of InitialCompound Dose Blood Glucose LevelTested (mg/kg) After 3 hrs. After 5 hrs.______________________________________22 50 53 5645 167 30 2047 167 74 6656 50 79 66______________________________________ Finally, the long-term hypoglycemic activity of the compounds of the present invention was tested in yet another in vivo test system. This long-term test system entailed incorporating test compound into the test animal&#39;s diet at various concentrations (control animal&#39;s diet contained no test compound). Such diet was then fed to the test or control animals for either 14 or 21 days. Each test or control animal was then bled from the tail (200-400 μl sample of blood) at 0 (before diet started), 7, 14 and, if appropriate, 21 and 28 days after diet administration was started. Plasma samples were then obtained from each blood sample collected and the glucose concentration of such plasma samples was determined enzymatically. The results of the long-term hypoglycemic test system described above are set forth in Table 4, below. In Table 4, Column 1 describes the type of rodent used in the test system, Column 2 provides the example number of the test compound or indicates that the numbers reported are for a control animal, Column 3 provides the concentration, in percent, of test compound in the test or control animal&#39;s diet. Columns 4-8 provide the plasma glucose concentration at days 0, 7, 14 and, if appropriate, 21 and 28, respectively, for the animals tested. Glucose lowering was not associated with depressed diet consumption. TABLE 4______________________________________LONG-TERM HYPOGLYCEMIC ACTIVITY OFTEST COMPOUNDS Concen- Example tration No. of of Test Plasma Glucose ConcentrationType of Cmpd. Cmpd. in (mg/dl)Rodent* Tested Diet (%) 0 7 14 21 28______________________________________ZDF 45 0.1 388 140 155 -- --ZDF control -- 416 364 445 -- --ZDF 45 0.1 464 215 238 285 --ZDF 45 0.025 467 451 452 517 --ZDF control -- 478 499 571 565 --ZDF 45 0.1 357 171 166 -- --ZDF 64 0.1 339 187 182 -- --ZDF control -- 343 423 454 -- --ZDF 45 0.1 309 137 142 -- --ZDF 71 0.1 311 237 232 -- --ZDF 70 0.1 300 190 195 -- --ZDF control -- 317 286 255 -- --Male A.sup.vy /a 45 0.1 438 338 315 287 295(Harlan)Male A.sup.vy /a 38 0.1 340 351 328 303 331(Harlan)Male A.sup.vy /a control -- 429 414 410 390 359(Harlan)______________________________________ *ZDF = 8 week old male Zucker Diabetic Fatty rat; A.sup.vy /.sup.a = viable yellow mouse The present invention also provides a method for treating Alzheimer&#39;s disease in mammals comprising administering a therapeutically effective amount of a compound of formula Ia. The term &#34;therapeutically effective amount&#34;, as defined for this method, means the amount of compound necessary to reduce, eliminate or prevent the physiological effects or causes of Alzheimer&#39;s disease following administration, preferably to a human suffering from or susceptible to Alzheimer&#39;s disease. Alzheimer&#39;s disease is a degenerative disorder of the human brain. Clinically, it appears as a progressive dementia. Its histopathology is characterized by degeneration of neurons, gliosis, and the abnormal deposition of proteins in the brain. Proteinaceous deposits (called &#34;amyloid&#34;) appear as neurofibrillary tangles, amyloid plaque cores, and amyloid of the congophilic angiopathy. [For reviews, see, Alzheimer&#39;s Disease, (B. Reisberg, ed., The Free Press 1983).] While there is no general agreement as to the chemical nature of neurofibrillary tangles, the major constituent of both the amyloid plaque cores and the amyloid of the congophilic angiopathy has been shown to be a 4500 Dalton protein originally termed β-protein or amyloid A4. Throughout this document this protein is referred to as β-amyloid peptide or protein. β-amyloid peptide is proteolytically derived from a transmembrane protein, the amyloid precursor protein (APP). Different splice forms of the amyloid precursor protein are encoded by a widely expressed gene. see, e.g., K. Beyreuther and B. Muller-Hill, Annual Reviews in Biochemistry, 58:287-307 (1989). βamyloid peptide consists, in its longest forms, of 42 or 43 amino acid residues. J. Kang, et al., Nature (London), 325:733-736 (1987). These peptides, however, vary as to their amino-termini. C. Hilbich, et al., Journal of Molecular Biology, 218:149-163 (1991). Because senile plaques are invariably surrounded by dystrophic neurites, it was proposed early that β-amyloid peptide is involved in the loss of neuronal cells that occurs in Alzheimer&#39;s disease. B. Yankner and co-workers were the first to demonstrate that synthetic β-amyloid peptide could be neurotoxic in vitro and in vivo. B. A. Yankner, et al., Science, 245:417 (1989); see also, N. W. Kowall, et al., Proceedings of the National Academy of Sciences, U.S.A., 88:7247 (1991). Other research groups, however, were unable to consistently demonstrate direct toxicity with β-amyloid peptide. see, e.g., Neurobiology of Aging, 13:535 (K. Kosik and P. Coleman, eds. 1992). Even groups receiving β-amyloid peptide from a common source demonstrate conflicting results. D. Price, et al., Neurobiology of Aging, 13:623-625 (1991) (and the references cited therein). As mentioned supra, cells have alternative mechanisms for processing APP which can result in the formation of the β-amyloid protein and subsequently, the senile plaques. It is likely that this alternative processing route occurs in the lysosomes. It has been found that compounds that inhibit lysosomal enzymes inhibit the fragment formation. see, e.g., Science, 155:689 (1992). A lysosome is a membranous reservoir of hydrolytic enzymes responsible for the intracellular digestion of macromolecules. Lysosomes are known to contain approximately forty hydrolytic enzymes, including proteases, nucleases, glycosidases, lipases, phospholipases, phosphatases and sulfatases. These enzymese are all acid hydrolases which are optimally active at about pH 5. Therefore, it is necessary to determine which enzyme or enzymes are responsible for this alternative processing of the APP and the consequent formation of the β-amyloid protein. Abnormally high concentrations of the proteases cathepsins D and B have been observed in the brains of patients with early-onset Alzheimer&#39;s disease. Yu Nakamura, et al., Neuroscience Letters, 139, 195-198 (1991). Furthermore, elevated activity for cathepsin D has been observed in the brains of Alzheimer&#39;s patients. M. Takeda, et al., Neurochemistry Research, (abstract), 11:117 (1986). Cathepsin D is a lysosomal endoprotease that is present in all mammalian cells. see, e.g., &#34;Proteinases in Mammalian Cells and Tissues,&#34; ed. (A. J. Barret, ed. 1977) pp. 209-248. It is the only aspartyl protease that is known to be a lysosomal enzyme. The cathepsins are a family of hydrolase enzymes that are usually located in the lysosomes. These enzymes are endopeptidases with an acidic optimum pH. Cathepsin A is a serine carboxypeptidase, cathepsin C [EC 3.4.14.1] is a dipeptidyl peptidase, cathepsin D [EC 3.4.23.5] is an aspartyl protease, and cathepsin B 2 [EC 3.4.16.1] is a serine carboxypeptidase. Cathepsin B [EC 3.4.22.1] (also known as cathepsin B 1 ) and cathepsin L [EC 3.4.22.15] are thiol proteases having activity within the lysosomes. It has been found that inhibition of cathepsin D using an aspartyl protease inhibitor reduces the formation of β-amyloid protein and the resultant senile plaque. As such, compounds which inhibit cathepsins (and, in particular, cathepsin D) or reduce the formation of β-amyloid protein would be expected to be useful in treating Alzheimer&#39;s disease. Such activities were demonstrated in the following test systems. CATHEPSIN D PERCENT INHIBITION ACTIVITY A fluorometric assay was adapted from the method disclosed by Murakami et al., Anal. Biochem. 110:232-239 (1981) for measuring renin activity. Human liver cathepsin D (Athens Research and Technology, Athens, Ga.) was diluted in assay buffer, 200 mM NaOAc, pH 4.5, 150 mM NaCl to 500 ng/mL and then 100 μL of this cathepsin D solution was added to each well of a 96 well plate with the exception of control wells which received just 100 μL of assay buffer. Compound stocks were prepared by dissolving a sufficient quantity of the particular compound to be tested in DMSO such that various concentrations (either 10 μg/ml, 8.3 μg/ml or 4.15 μg/ml) of test compound in DMSO were obtained and then 5 μL of the compound stock was added to each of the wells prepared above. Blank and enzyme control wells each received 5 μL of the DMSO vehicle. Following a ten minute incubation at 25° C. to allow enzyme/compound interaction, 5 μL of a 500 μM solution of a derivative of a known porcine renin tetradecapeptide fluorometric substrate (Bachem Biosciences, Inc. 1993 Catalog ID No. I-1340; Bachem Biosciences, Philadelphia, Pa.) in DMSO was added per well to initiate the reaction. After incubation at 37° C. for 30 minutes, cathepsin D activity was terminated by the addition of 100 μL per well of 400 mU/mL microsomal leucine aminopeptidase (EC 3.4.11.2, Sigma, St. Louis, Mo.) in 1M Tris-HCl, pH 8.0. The plates were then analyzed in a fluorometer (CytoFluor 2350, Millipore, Bedford, Mass.) with an excitation wavelength of 360 nm and an emission wavelength of 460 nm, in order to check for background fluorescence due to test compounds. Following a two hour incubation at 37° C., to allow the aminopeptidase to release the fluorophore, 7-amido-4-methylcoumarin (AMC) from the products of cathepsin D cleavage, the plates were again analyzed in the fluorometer. In order to check for potential false positives, i.e., inhibitors of microsomal leucine aminopeptidase, residual aminopeptidase activity was monitored directly in each well by the addition of 20 μL/well of 2.5 mM Leu-pNA (Bachem Biosciences, Philadelphia, Pa.) in 10% DMSO. Aminopeptidase activity was measured as an increase in the absorbance of 405 nm in a UV max microplate reader (Molecular Devices, Menlo Park, Calif.). Cathepsin D activity was linear under these conditions and the results are expressed as a percentage of the controls in Table 5, below. All results presented are the mean and standard deviation of at least four replicate assays. TABLE 5______________________________________CATHEPSIN D INHIBITION ACTIVITY Compound Stock Concentration % InhibitionExample No. (μg/ml) of Cathepsin D______________________________________ 1 10.0 36 4 10.0 50 5 10.0 76 5 8.3 100 6 10.0 29 8 10.0 6418 10.0 3821 4.15 4031 10.0 88.531 4.15 69.532 4.15 7535 4.15 5742 10.0 87.542 4.15 7845 8.3 9545 4.15 49.547 4.15 60.550 4.15 4055 4.15 9056 4.15 7360 8.3 3860 4.15 45.563 4.15 5368 4.15 53.769 4.15 5170 4.15 6671 10.0 7671 8.3 9472 8.3 9672 4.15 8873 8.3 7673 4.15 6974 8.3 9575 10.0 4376 10.0 3277 10.0 8777 4.15 6478 4.15 4179 4.15 8780 8.3 3381 8.3 2182 10.0 73.583 4.15 4784 4.15 5186 8.3 4288 8.3 8288 4.15 6789 8.3 7190 8.3 9290 4.15 7991 4.15 7292 4.15 7494 4.15 4895 8.3 36______________________________________ CATHEPSIN D INHIBITION IC 50 ACTIVITY The above assay was repeated with the exception that the compound stocks were prepared in concentrations such that IC 50 values (concentration of test compound at which 50% inhibition of cathepsin D was obtained) for the test compounds could be determined. The results obtained from such assay system are set forth in Table 6 below. TABLE 6______________________________________Example No. IC.sub.50 (μM)______________________________________ 5 3.628 3.131 1.935 8.942 1.747 5.256 12.360 14.7568 10.269 2.170 5.471 2.172 1.773 9.974 5.877 3.778 22.179 3.780 47.081 319.485 14.387 2.288 11.289 9.290 7.791 9.792 3.993 7.5______________________________________ β-AMYLOID PROTEIN PRODUCTION INHIBITION Two cell lines (human kidney cell line 293 and Chinese hamster ovary cell line CHO) were stably transfected with the gene for APP751 containing the double mutation Lys-651-Met-652 to Asn-651-Leu-652 (APP-751 numbering) commonly called the Swedish mutation using the method described in Citron et al., Nature 360:672-674 (1992). The transfected cell lines were designated as 293 751 SWE and CHO 751 SWE, and were plated in Corning 96 well plates at 2.5×10 4 or 1×10 4 cells per well respectively in Dulbecco&#39;s minimal essential media (DMEM) plus 10% fetal bovine serum. Following overnight incubation at 37° C. in an incubator equilibrated with 10% carbon dioxide (CO 2 ), the media were removed and replaced with 200 μL per well of conditioned media (media containing compound stocks; compound stocks diluted with media such that the concentration of DMSO in the media/compound stock solution did not exceed 0.5%) for a two hour pretreatment period during which the cells were incubated as described above. These compound stocks were prepared by dissolving a sufficient quantity of the particular compound to be tested in DMSO such that various concentrations were obtained. After this pretreatment period, the conditioned media was removed and replaced with fresh conditioned media and the cells were incubated for an additional two hours. After treatment, plates were centrifuged in a Beckman GPR at 1200 rpm for five minutes at room temperature to pellet cellular debris from the conditioned media. From each well, 100 μL of conditioned media were transferred into an ELISA plate precoated with antibody 266 [Seubert et al., Nature, 359:325-327 (1992)] and stored at 4° C. overnight prior to the completion of the ELISA assay the next day. Cytotoxic effects of the compounds were measured by a modification of the method of Hansen et al., J. Immun. Meth. 119:203-210 (1989). To the cells remaining in the tissue culture plate, was added 25 μL of a 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) stock solution (5 mg/mL) to a final concentration of 1 mg/mL. Cells were incubated at 37° C. for one hour, and cellular activity was stopped by the addition of an equal volume of MTT lysis buffer (20% w/v sodium dodecylsulfate in 50% DMF, pH 4.7). Complete extraction was achieved by overnight shaking at room temperature. The difference in the OD 562nm and the OD 650nm was measured in a Molecular Devices UV max microplate reader as an indicator of the cellular viability. The results of the β-amyloid protein ELISA were fit to a standard curve and expressed as ng/mL β-amyloid protein peptide. In order to normalize for cytotoxicity, these β-amyloid protein results were divided by the cytotoxicity results and expressed as a percentage of the results from a drug-free control. TABLE 7______________________________________β-AMYLOID PROTEIN INHIBITION Compound Stock Concentration % Inhibition ofExample No. (μg/ml) β-Amyloid Protein______________________________________ 5 10.0 4731 10.0 5731 5.0 3731 2.5 2831 1.25 1531 0.62 731 0.31 042 10.0 5142 5.0 3542 2.5 1642 1.25 1442 0.62 1142 0.31 870 10.0 3871 10.0 6577 10.0 2581 10.0 100______________________________________ As can be seen from the data in Tables 5, 6 and 7, the compounds of formula Ia can be administered for prophylactic and/or therapeutic treatment of diseases related to the deposition of β-amyloid protein such as Alzheimer&#39;s disease, Down&#39;s syndrome, and advanced aging of the brain. In therapeutic applications, the compounds are administered to a host already suffering from the disease. The compounds will be administered in an amount sufficient to inhibit further deposition of β-amyloid protein plaque. For prophylactic applications, the compounds of formula Ia are administered to a host susceptible to Alzheimer&#39;s disease or a β-amyloid protein related disease, but not already suffering from such disease. Such hosts may be identified by genetic screening and clinical analysis, as described in the medical literature. see e.g., Goate, Nature 349:704-706 (1991). The compounds will be able to inhibit or prevent the formation of the β-amyloid protein plaque at a symptomatically early stage, preferably preventing even the initial stages of the β-amyloid protein disease. The compounds of the present invention and the compounds utilized in the methods of the present invention are effective over a wide dosage range. For example, dosages per day will normally fall within the range of about 0.5 to about 500 mg/kg of body weight. In the treatment of adult humans, the range of about 1.0 to about 100 mg/kg, in single or divided doses, is preferred. However, it will be understood that the amount of the compound actually administered will be determined by a physician in light of the relevant circumstances including the condition to be treated, the choice of compound to be administered, the age, weight, and response of the individual patient, the severity of the patient&#39;s symptoms and the chosen route of administration. Therefore, the above dosage ranges are not intended to limit the scope of the invention in any way. While the present compounds are preferably administered orally, the compounds may also be administered by a variety of other routes such as the transdermal, subcutaneous, intranasal, intramuscular and intravenous routes. While it is possible to administer a compound of the invention, or a compound used in the methods of this invention, directly, the compounds are preferably employed in the form of a pharmaceutical formulation comprising a pharmaceutically acceptable carrier, diluent or excipient and a compound of the invention. Such formulations will contain from about 0.01 percent to about 90 percent of a compound of the invention. In making the formulations of the present invention, the active ingredient will usually be mixed with at least one carrier, or diluted by at least one carrier, or enclosed within a carrier which may be in the form of a capsule, sachet, paper or other container. When the carrier serves as a diluent, it may be a solid, semi-solid or liquid material which acts as a vehicle, excipient or medium for the active ingredient. Thus, the formulations can be in the form of tablets, granules, pills, powders, lozenges, sachets, cachets, elixirs, emulsions, solutions, syrups, suspensions, aerosols (as a solid or in a liquid medium) and soft and hard gelatin capsules. Examples of suitable carriers, diluents and excipients include lactose, dextrose, sucrose, sorbitol, mannitol, starches, gum acacia, calcium phosphate, alginates, liquid paraffin, calcium silicate, microcrystalline cellulose, polyvinyl pyrrolidone, cellulose, tragacanth, gelatin, syrup, methyl cellulose, methyl- and propyl-hydroxybenzoates, vegetable oils, such as olive oil, injectable organic esters such as ethyl oleate, talc, magnesium stearate, water and mineral oil. The formulations may also include wetting agents, lubricating, emulsifying and suspending agents, preserving agents, sweetening agents, perfuming agents, stabilizing agents or flavoring agents. The formulations of the invention may be formulated so as to provide quick, sustained or delayed release of the active ingredient after administration to the patient by employing procedures well-known in the art. For oral administration, a compound of this invention, or a compound used in the methods of this invention, ideally can be admixed with carriers and diluents and molded into tablets or enclosed in gelatin capsules. The compositions are preferably formulated in a unit dosage form, each dosage containing from about 1 to about 500 mg, more usually about 5 to about 300 mg, of the active ingredient. The term &#34;unit dosage form&#34; refers to physically discrete units suitable as unitary dosages for human subjects and other mammals, each unit containing a predetermined quantity of active material calculated to produce the desired therapeutic effect, in association with a suitable pharmaceutical carrier, diluent or excipient therefor. In order to more fully illustrate the operation of this invention, the following examples of formulations are provided. The examples are illustrative only and are not intended to limit the scope of the invention. The formulations may employ as active compounds any of the compounds of the present invention. FORMULATION 1 Hard gelatin capsules suitable for use in treating Alzheimer&#39;s disease or reducing glucose concentration are prepared using the following ingredients: ______________________________________ Amt. per Concentration by Capsule Weight (percent)______________________________________Compound of Example No. 5 250 mg 55.0Starch dried 220 mg 43.0Magnesium stearate 10 mg 2.0 460 mg 100.0______________________________________ The above ingredients are mixed and filled into hard gelatin capsules in 460 mg quantities. FORMULATION 2 Capsules each containing 20 mg of medicament are made as follows: ______________________________________ Amt. per Concentration by Capsule Weight (percent)______________________________________Compound of Example No. 1 20 mg 10.0Starch 89 mg 44.5Microcrystalline 89 mg 44.5celluloseMagnesium stearate 2 mg 1.0 200 mg 100.0______________________________________ The active ingredient, cellulose, starch and magnesium stearate are blended, passed through a No. 45 mesh U.S. sieve and filled into a hard gelatin capsule. FORMULATION 3 Capsules each containing 100 mg of active ingredient are made as follows: ______________________________________ Amt. per Concentration by Capsule Weight (percent)______________________________________Compound of Example No. 45 100 mg 29.0Polyoxyethylenesorbitan 50 mcg 0.02monooleateStarch powder 250 mg 71.0 250.05 mg 100.02______________________________________ The above ingredients are thoroughly mixed and placed in an empty gelatin capsule. FORMULATION 4 Tablets each containing 10 mg of active ingredient are made up as follows: ______________________________________ Amt. per Concentration by Capsule Weight (percent)______________________________________Compound of Example No. 71 10 mg 10.0Starch 45 mg 45.0Microcrystalline 35 mg 35.0cellulosePolyvinyl 4 mg 4.0pyrrolidone (as 10%solution in water)Sodium carboxyethyl 4.5 mg 4.5starchMagnesium stearate 0.5 mg 0.5Talc 1 mg 1.0 100 mg 100.0______________________________________ The active ingredient, starch and cellulose are passed through a No. 45 mesh U.S. sieve and mixed thoroughly. The solution of polyvinylpyrrolidone is mixed with the resultant powders which are then passed through a No. 14 mesh U.S. sieve. The granule so produced is dried at 50°-60° C. and passed through a No. 18 mesh U.S. sieve. The sodium carboxymethyl starch, magnesium stearate and talc, previously passed through a No. 60 mesh U.S. sieve, are then added to the granule which, after mixing, is compressed on a tablet machine to yield a tablet weighing 100 mg. FORMULATION 5 A tablet formula may be prepared using the ingredients below: ______________________________________ Amt. per Concentration by Capsule Weight (percent)______________________________________Compound of Example No. 2 250 mg 38.0Cellulose 400 mg 60.0microcrystallineSilicon dioxide 10 mg 1.5fumedStearic acid 5 mg 0.5 665 mg 100.0______________________________________ The components are blended and compressed to form tablets each weighing 665 mg. FORMULATION 6 Suspensions each containing 5 mg of medicament per 40 ml dose are made as follows: ______________________________________ Per 5 ml of suspension______________________________________Compound of Example No. 59 5 mgSodium carboxymethyl 50 mgcelluloseSyrup 1.25 mlBenzoic acid solution 0.10 mlFlavor q.v.Color q.v.Water q.s. to 5 ml______________________________________ The medicament is passed through a No. 45 mesh U.S. sieve and mixed with the sodium carboxymethylcellulose and syrup to form a smooth paste. The benzoic acid solution, flavor and color is diluted with some of the water and added, with stirring. Sufficient water is then added to produce the required volume. FORMULATION 7 An aerosol solution is prepared containing the following components: ______________________________________ Concentration by Weight (%)______________________________________Compound of Example No. 53 0.25Ethanol 29.75Propellant 22 70.00(Chlorodifluoromethane) 100.00______________________________________ The active compound is mixed with ethanol and the mixture added to a portion of the propellant 22, cooled to -30° C. and transferred to a filling device. The required amount is then fed to a stainless steel container and diluted further with the remaining amount of propellant. The valve units are then fitted to the container.

Provided are methods for treating hyperglycemia and Alzheimer's disease utilizing certain rhodanine derivatives. Certain of the rhodanine derivatives utilized in the instant methods are novel and, accordingly, such compounds and pharmaceutical formulations thereof are also provided.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Application No. 61/755,114, filed Jan. 22, 2013, the content of which is incorporated by reference herein in its entirety. FIELD OF THE INVENTION [0002] The present invention relates to orthopedic braces and more particularly to orthopedic braces with micro-adjustable telescoping arms. BACKGROUND OF THE INVENTION [0003] There are many forms of orthoses, or devices used externally to modify the structure and/or function of the skeletal and/or neuromuscular systems of the body. For example, there are orthoses that are applied to the neck, to the spine, to the upper limbs, and to the lower limbs. Additionally, there are many different purposes for using orthoses ranging from rehabilitative, to prophylactic. Rehabilitation braces are typically used to limit the movement of the portion of the body following an injury or a surgery. [0004] Certain rehabilitation braces, for example orthopedic knee braces, typically immobilize the leg and/or limit the motion in both the lateral and medial directions. These braces provide a mechanism to reduce the range of motion for a healing limb. The ability to limit flexion and extension are important features for an effective orthopedic knee brace. To maximize the benefits of an orthopedic brace it must be properly fitted and adjusted to the patient. Adjustment variables include fitting patients of various sizes and body proportions, and accommodating a variety of possible surgical sites. The adjustment of the brace will also be continual as the patient heals and can tolerate larger ranges of motion, as swelling is reduced, and the like. At times there may also be readjustment of the braces paddles to adapt accessories and product upgrades. [0005] To accomplish adjustability in existing orthotic braces, some brace designs utilize a system of holes in the strut. For example, in U.S. Pat. No. 6,821,261 a series of holes incorporated into the brace&#39;s strut is disclosed. This system of holes allows support members to be adjusted into a small number of positions on the patient. The holes disclosed in the aforementioned patent slide over a button and a biasing spring forces the button into the respective hole at a particular position. The operator, or physician, must depress the button in order to advance to the next available hole. This is done repeatedly until the closest available length is achieved. One problem with this method is that the notched holes where the locking feature, or button, can engage are grossly separated along the strut, and thus, only provide for gross adjustment of the lengths of the orthopedic brace. In the case of a knee brace, there would be a need to adjust both the upper and lower lengths of the brace (as described in reference to the hinge element). Other orthopedic braces may have additional areas where the length needs to be adjusted, further compounding the gross adjustment issue. [0006] Similarly, in U.S. Pat. No. 7,384,406 B2, a series of notches incorporated into the brace&#39;s strut is disclosed. This system of notches, just as in the previous system, allows support members to be adjusted into a small number of positions ort the patient. The notches disclosed in this system are engaged by a screw with a biasing spring and a retaining bushing. The biasing spring pushes a button in an upward position. By depressing the same button, the spring pushes the retaining bushing out of a particular notch. With pressure still applied, the length of the portion of the brace is adjusted to the next available notch and the retaining bushing re-engages to lock the length. As previously described, this method only allows for gross adjustment with constant user input and thus accurate size and fit are sacrificed to the detriment of the patient. [0007] Another existing adjustment method utilizes a cam lever and a friction lock to adjust the length of the struts. When the cam lever is unlocked the support members freely move along the struts. This system allows for a range of adjustments and sizing. However, there is no way to index the components into position and as such, accurate adjusting, or re-adjusting, of the length of the portion of the brace is difficult to accomplish. [0008] One aspect of the present invention is an adjustable orthopedic strut system that combines a locking system with an incremental or “micro” adjustment method that is size adaptable and easy to use. One embodiment of the present invention comprises a locking system, adjustable support members, struts, and an indented molded track. The present invention improves user fitting and sizing creating better support and comfort. The present invention provides “micro” incremental adjustments on support members to allow strategic positioning of the support members near surgical incisions without the need for constant user input. Furthermore, the present invention locks and telescopes on a non-interrupted strut surface with. minimal “snag” points thus reducing the difficulty in achieving fine adjustments. The system of the present invention easily indicates and indexes in a molded track and can be reduced in scale to fit many orthopedic devices to provide accurate micro-adjustments to a variety of applications and patients. SUMMARY OF THE INVENTION [0009] The present invention is a system comprising an orthotic brace with at least one hinge; a plurality of deformable struts comprising an indexable, micro-adjustable track, wherein the struts have a first end and a second end, and the first end of the strut is attached to the hinge; a plurality of innermost support members slidably attached to the struts wherein each innermost support member comprises a button, wherein the button is configured to engage the track, such that the support members may be incrementally indexed along the strut and locked when the support member is in the desired position along the track; and a plurality of outermost support members slidably attached to the second end of the struts wherein each outermost support member comprises a button, wherein the button is configured to engage the track, such that the support members may be incrementally indexed along the strut and locked when the support member is in the desired position along the track, thereby locking the outermost support member in position along the track and extend the apparent length of the strut. [0010] In one embodiment of the present invention, the micro-adjustable track comprises a plurality of grooves wherein the plurality of grooves represent increments of adjustment. The increments may be the same along the length of the micro-adjustable track or vary along the length of the micro-adjustable track. [0011] In one embodiment of the present invention, the increments are less than ⅓ of an inch apart. In another embodiment, the increments range from one quarter of an inch increments to one eighth of an inch increments on the same track. [0012] In one embodiment of the present invention, the indexable, micro-adjustable track is flexible. In another embodiment, the indexable, micro-adjustable track is integral to the strut. [0013] In one embodiment of the present invention, the struts are configured to be bent to properly fit a patient. [0014] These aspects of the invention are not meant to be exclusive and other features, aspects, and advantages of the present invention will be readily apparent to those of ordinary skill in the art when read in conjunction with the following description, appended claims, and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0015] The foregoing and other objects, features, and advantages of the invention will be apparent from the following description of particular embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. [0016] FIG. 1A shows a side view of an entire orthotic knee brace with micro-adjustable telescoping arms of one embodiment of the present invention. [0017] FIG. 1B shows a side view of an orthotic knee brace with micro-adjustable telescoping arms of one embodiment of the present invention. [0018] FIG. 2 shows an enlarged view of the micro-adjustable telescoping arm of one embodiment of the present invention. [0019] FIG. 3 shows a cross sectional view of the micro-adjustable telescoping arm of one embodiment of the present invention. [0020] FIG. 4 shows a series of images ( 4 . 1 - 4 . 6 ) deconstructing the micro-adjustable telescoping arm of one embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION [0021] In one embodiment of the present invention, the orthotic brace is a knee brace. In certain embodiments, the orthotic knee brace comprises a “micro-adjustable” telescoping system comprising two bendable, lightweight struts or arms extending off an adjustable hinge located axially near the knee. In certain embodiments, one strut extends and telescopes up along the thigh and the other strut extends down the leg along the calf In one embodiment of the present invention, a series of tubular “telescoping” support members are located along these struts. These support members, when unlocked, are adjustable incrementally along a molded track. In certain embodiments, each of the support members has a strap running radially through it and adjustably connects around the body. The telescoping support members allow the brace to be fit to a variety of patients in specific locations along the leg. [0022] In the current invention the strut or arms are connected to a rotatable hinge mechanism. This hinge mechanism is adjustable in both directions of flexion and extension, allowing the user incrementally to control the user&#39;s range of motion. However, it is not outside of the scope of this invention to use other hinge variations. Even attaching the upper and lower struts together in a simple rotatable fashion could suffice in certain applications. In relationship to the struts, the telescoping support members are connected to contoured paddles and allow the brace to be affixed to the user&#39;s body. The support member and paddle travel together along the bendable struts and are adjustable along, the length of the limb. These support members are mechanically locked in place once they have been fitted and adjusted to the correct orientation. The current invention&#39;s locking mechanism uses a slidable bezel and button configuration. This is not a permanent locking mechanism because support members may have to be readjusted based on the patient&#39;s healing patterns (and/or therapy). Once in place they are affixed to the user&#39;s body and secured with adjustable straps and closures. [0023] Referring to FIG. 1A , one embodiment of a brace of the present invention is shown. More specifically, an orthotic knee brace of the present invention comprises a brace 100 with innermost 80 and outermost 60 telescoping support members located on a strut 70 . The innermost 80 and outermost 60 telescoping support members have padded straps 10 that reversibly connect the brace to the patient. In one embodiment of the present invention, the strut 70 has a molded micro-adjustable track 40 embedded in the strut 70 . The flexible, indexable micro-adjustable track is configured to remain integral to the strut when the strut is bent to fit a user so that the adjustment mechanism functions smoothly. An adjustable, locking hinge 20 separates the upper and lower portions of the orthotic knee brace of one embodiment of the preset invention. Easy to use, locking buttons 30 engage the track and hold the support members in place. The outermost support members 60 move along the strut, but also effectively lengthen the brace 100 . The innermost support members 80 allow for greater accuracy and flexibly in fitting the brace 100 to a particular patient. The buttons 30 are configured to be unlocked and have the support members slidably indexed along the length of the strut. Once the desired length has been achieved, the button can be locked into position. [0024] Referring to FIG. 1B , a side view of one embodiment of an orthotic knee brace of the present invention with micro-adjustable telescoping arms is shown. More specifically, a brace 100 is shown with four moveable support members. The inner most support members 80 travel along a track 40 in the strut 70 . An indexed portion 50 provides for accurately reproducible adjustments for the support members. The outermost support members 60 also travel along a track 40 in the strut 70 . An indexed portion 50 provides for accurately reproducible adjustments for the support members. The support members contain paddles 90 that support and direct flexible, adjustable straps (not shown) which reversibly attach the brace to a patient. The hinge provides an adjustable, locking mechanism to control the range of motion for both flexion and extension. Locking buttons 30 are located on the tubular support members and engage the track to provide easy to use, micro-adjustability for each support member. Each support member has the ability to be readjusted repetitively to fit the brace to the patient as needed. [0025] Referring to FIG. 2 , an enlarged view of the micro-adjustable telescoping arm of one embodiment of the present invention is shown. More specifically, FIG. 2 shows one embodiment of the telescoping support member 80 , which rides over and along the strut 70 . The support member indexes the micro-adjustment using the gradations along the arm 50 . The support member comprises an easy to use, easy to lock/unlock button 30 , which engages the micro-adjustable track 40 . Semi-flexible paddles 90 are carried on the support members and position and hold flexible straps (not shown), which reversibly attach the brace to a patient. [0026] Referring to FIG. 3 , a cross sectional view of the micro-adjustable telescoping arm of one embodiment of the present invention is shown. More specifically, FIG. 3 shows one embodiment of the locking button 30 of the present invention. In certain embodiments, the locking button is recessed into a bezel and comprises a locking tooth for engaging the track 40 . In another variation, it is possible for the locking feature to be part of the telescope and the locking button can vary in motion, such as a rotation or lever instead of a slide. Conversely, a containing pin can be used instead of a locking arm and pressed down into the track by a slide, rotation or lever. [0027] As seen in FIG. 4 , one embodiment of the present invention is an orthotic brace with a cut out in the elongated support that incorporates a modular approach to building the brace. This modular approach offers a series of benefits including 1) the molded track can be embedded inside the metal support to create an internal low profile design, 2) the molded track bends more easily with the support than if it were mounted or applied, 3) the molded track can be specifically designed to have the proper locking geometry, 4) the molded track can be changed and incorporated into an existing metal stamping, 5) the separate molded track allows for significant control in material choice, and 6) the separate molded track provides the advantage of being able to change materials without interrupting the design. [0028] Referring to FIG. 4 , a series of images ( 4 . 1 - 4 . 6 ) deconstructing the micro-adjustable telescoping arm of one embodiment of the present invention is shown. More specifically, in FIG. 4.1 the full assembly of the slidable and lockable plastic button is shown. Plastic material options for all of the following related components include ABS, polypropylene, polyethylene, nylon, polycarbonate and even compounded resins. In FIG. 4.2 , the mechanical, snap-fit slidable button is removed to expose the fixed bezel portion with an integrated locking button, which comprises a locking tooth to engage the track. In this assembly, the bezel is snap-fit into position. However, in other configurations it can easily be adhesively bonded or mechanically fastened. In FIG. 4.3 , the bezel is removed to expose the portion of the support member, which surrounds the strut. Its tubular design allows it to travel closely along the strut. In FIG. 4.4 , the tube portion of the support member is removed to expose the track in the arm. The tubular support member may be mechanically joined to the paddle by means of adhesive, fasteners, snap-fit, sonic welding or even the heat stake process. In FIG. 4.5 , the adjustment track is removed to expose the paddle 90 as is interacts with the arm. in FIG. 4.6 , the paddle is finally removed to expose the arm. [0029] In one embodiment of the present invention, the struts for the orthotic brace utilize laser or die cut metal. In certain embodiments, the struts utilize 6061 T6 aluminum. This material choice is strong, lightweight, non-corrosive and bendable. However, other sufficient strut material replacements include aluminum alloys 7075 and 5052 for their specific metallurgical properties. [0030] In one embodiment, the adjustable track is molded from an ABS blend and slides into place through a series of snaps and slides. Considering there are many choices of plastics with this approach the material can be reconfigured to create a different result. The product can be made more flexible or rigid depending on the plastics blend and composition. Other viable materials for the track include polypropylene, nylon, polyester, polycarbonate and even compounded resins. Furthermore, since the part is molded, the track can be configured to a variety of shapes and geometries. Results from this include a range of different increments of adjustment. [0031] For example, in certain embodiments, the track is molded to be more adjustable in a specific area allowing the engagement tooth from the locking mechanism to change from eighth of an inch increments to one quarter of an inch increments on the same track. This creates the advantage of fully controlling the micro adjustment of the brace if desired. The flexibility of the micro-adjustable telescoping arms of the present invention allow for orthoses that are easy to adjust and to re-adjust as needed by each particular patient at each particular stage of treatment. The fine adjustments provide a more accurate and secure lit for a large variety of patients who are dealing with a range of different injuries and/or surgeries. [0032] In one embodiment, the adjustable track is adjustable in a range of ⅛ ″ increments. However other possible increments include 3/16″ and ¼″ if desired and Metric equivalents. [0033] Within the scope of a modular design in one embodiment of the present invention, the ability separately to mold the adjustable track allows for many functional advantages. One benefit of the modular design of one embodiment of the present invention includes having incremental control of the support members around a patient&#39;s surgical site or sites. Another benefit of one embodiment of the present invention is the ability to change the increment engagement along the track if fine increments are not needed. Another benefit of one embodiment of the present invention is having certain smooth areas along the track and/or non-locking areas along the track for certain applications. [0034] One embodiment of the brace of the present invention attaches to the patient&#39;s leg through a series of straps woven through the support members. To make the brace adjustable (telescoping) the support members must travel up and down the strut assembly. It is, however, essential that the support members move easily along the strut assembly and still maintain the ability to be locked into position. This is in contrast to other patents like U.S. Pat. No. 7,385,406 and U.S. Pat. No. 6,821,261 that require downward pressure to be constantly applied to the button in order to extend the length of the brace. This makes adjustment, albeit coarse adjustment, tedious and awkward as you travel from one point to the next. It is desirable to have fine adjustments, but also to have smooth adjustments when dealing with an injured patient. [0035] In certain embodiments of the present invention, the support member and locking mechanism are made up of the following: a support member molded as a tubular channel (Lustran or other ABS equivalent) that excepts the bezel and button mechanism; a molded bezel (Lustran or other ABS equivalent) with integrated locking tooth that snaps into the support member; a molded button (Lustran or other ABS equivalent) that snap tits into the bezel located in the support member. The bezel and button assembly is permanently mounted into the support member through a series of interference fits. In certain embodiments, the completed assembly has the ability to be repeatedly locked/unlocked into position. As the brace is being fit in the unlocked position, the locking tooth floats along the incremental track in and out of molded valleys. This allows the person applying the brace not to have to keep his finger on the button until it is ready for final engagement. Once the brace is fully adjusted the support members are then locked into position. If any more “micro-adjustment” is desired, the person simply unlocks the button and continues to fit the brace. This helps in fitting around surgical sites and tender areas by repositioning the supports delicately and with fine degrees of adjustment. [0036] The micro-adjustment system of the present invention is very distinct from prior art in a number of ways. First, U.S. Pat. No. 7,383,406 and U.S. Pat. No. 6,821,261 telescope by indexing a tensioned button into stamped metal holes. As the holes get too small and incremental, the button/lock becomes more difficult to locate into position. Because of this, the holders of these patents have manufactured their product with one half inch increments. Second, U.S. Pat. No. 3,805,773 uses punched holes in metal and a releasable pin to index the telescoping struts providing only similarly gross adjustments. The micro-adjustable telescoping arms of the present invention offer a novel solution to both problems by having a track with incremental “micro-adjustment” spacing and a hands five corresponding lock/unlock button. These embodiments present the benefits of telescoping “micro-adjusting” support members with an easy to use luck/unlock button. [0037] In another embodiment of the present invention, the orthotic brace may be integrally molded, machined or stamped such that the track and strut is one unit. In certain embodiments, braces can incorporate a single material strut. In certain embodiments, the single material strut can be a knee brace. in certain embodiments, the single material strut can he an elbow brace or T.L.S.O. back brace component. Additionally, the strut can be applied to a brace where the strut is used as a “stay” and does not require a bend. In certain embodiments of the present invention, the strut is comprised of lightweight composites, molded plastics, extruded plastics, and the like. [0038] While the principles of the invention have been described herein, it is to be understood by those skilled in the art that this description is made only by way of example and not as a limitation as to the scope of the invention. Other embodiments are contemplated within the scope of the present invention in addition to the exemplary embodiments shown and described herein. Modifications and substitutions by one of ordinary skill in the art are considered to be within the scope of the present invention.

The adjustable orthopedic strut system comprises a locking system with an incremental or "micro" adjustment method that is size adaptable and easy to use. The adjustable orthopedic strut system comprises a locking system, adjustable support members, struts, and an indented molded track. The adjustable orthopedic strut system improves user fitting and sizing creating better support and comfort. The adjustable orthopedic strut system provides "micro" incremental adjustments on support members to allow strategic positioning of the support members near surgical incisions. Furthermore, the adjustable orthopedic strut system locks and telescopes on a non-interrupted strut surface with minimal "snag" points, thus reducing the difficulty in achieving fine adjustments. The system of the present invention easily indicates and indexes in a molded track and can be reduced in scale to fit many orthopedic devices to provide accurate micro-adjustments to a variety of applications and patients.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] The present invention is a continuation application of U.S. application Ser. No. 13/547,757, filed on Jul. 12, 2012, which will issue on Nov. 17, 2015 as U.S. Pat. No. 9,186,350, which claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application 61/506,732, entitled “COMPOSITION, AND METHOD OF USING THE COMPOSITION, EFFECTIVE FOR MINIMIZING THE HARMFUL EFFECTS ASSOCIATED WITH INDIVIDUALS SUFFERING FROM ALCOHOL INTOXICATION” filed on Jul. 12, 2011, the contents of which are herein incorporated in their entirety. FIELD OF THE INVENTION [0002] The present invention relates to a composition which reduces the levels of alcohol in an individual&#39;s system; and more particularly to a composition specifically formulated to increase one or more metabolic pathways resulting in the breakdown of alcohols to sugars in the body, thereby clearing the alcohol from the body at a rate that is faster than normal physiological time periods. BACKGROUND OF THE INVENTION [0003] Metabolism is a vital aspect of all living organisms. It is the set of chemical reactions which occur within all living organisms in order to maintain life. In humans, metabolism involves complex networks of hormones and enzymes which convert foods into fuel. In general humans receive the energy needed for daily functioning and driving of cellular mechanisms from food sources through metabolism. Specific proteins in the body control the chemical reactions of metabolism, and each chemical reaction is coordinated with other body functions. The process of metabolism involves a continuous balancing of catabolism, the set of processes that break down molecules into smaller units and release energy, and anabolism, the set of processes which build molecules from smaller units. [0004] Alcohol, while prohibited by certain users such as individuals under the age of 21, is commonly used within a variety of beverage types. As a result of its status and ease of manufacture, it is one of the most widely used drugs in the world, acting as a central nervous system depressant. The central nervous system, therefore, is the body system that is most severely affected by alcohol. The drug quickly enters the bloodstream where, depending on the user, it can have numerous effects. Blood alcohol levels are used to legally define if an individual suffers from alcohol intoxication, or is considered “drunk.” In most states, the blood alcohol legal limit usually falls between 0.08 and 0.10. The degree to which the central nervous system function is impaired is directly proportional to the concentration of alcohol in the blood. [0005] When ingested, alcohol passes from the stomach into the small intestine, where it is rapidly absorbed into the blood and distributed throughout the body. Because it is distributed so quickly and thoroughly, alcohol can affect the central nervous system even in small concentrations. The American Medical Association has defined the blood alcohol concentration (BAC) level of impairment for all people to be 0.04 grams/100 milliliters of blood (equivalent to 0.04 grains/210 liters of breath). Numerous studies have been undertaken in order to better understand the affects alcohol has on individuals, and how they are commonly expressed, For example, at BAC levels of 0.03 to 0.12, it is not uncommon for individuals to feel euphoria and have one or more symptoms: mild euphoria, become more social and talkative, increased self-confidence, decreased inhibitions, diminution of attention, judgment and control, sensory-motor impairment, and loss of efficiency in finer performance tests. At levels of 0.09-0.25. individuals begin to suffer from emotional instability, loss of critical judgments, impairment of perception, memory and comprehension, deceased sensatory response, increased reaction times, reduced visual acuity, impaired balance, lack of sensory-motor coordination, and drowsiness. At BAC of 0.18-0.3, individuals often become confused, disorientated, have mental confusion, dizziness and exaggerated emotional states, suffer from disturbances in vision and perception, have increased pain thresholds, suffer from apathy, and have slurred speech. At levels of 0.25-0.4, individuals may suffer from near complete loss of motor functions, decreased responses to stimuli, lack of muscular coordination; and impaired consciousness. At levels greater than 0.45, complete unconsciousness and death from respiratory arrest could result. [0006] Once alcohol is consumed, the body handles the drug through the processes of absorption, distribution, and elimination. All three processes generally occur simultaneously. Alcohol is absorbed from the stomach and small intestine by diffusion. Most absorption occurs from the small intestine due to its large surface area and rich blood supply. The rate of absorption varies with the emptying time of the stomach. Generally, the higher the alcohol concentration of the beverage, the faster the rate of absorption. However, above a certain concentration, the rate of absorption may decrease due to the delayed passage of alcohol from the stomach into the small intestine. The maximum absorption rate is obtained with the consumption of an alcoholic beverage containing approximately 20-25% (by volume or v/v) alcohol solution on an empty stomach. The absorption rate may be less when alcohol is consumed with food or when a 40% (v/v) alcohol solution is consumed on an empty stomach. The rate may also slow down when high fluid volume/low alcohol content beverages, such as beer, are consumed. For normal social-type drinking, the highest BAC is usually achieved within 30 minutes after completion of consumption, though it could take as long as 60 minutes. When large amounts of alcohol are consumed over a short time interval, or when a large quantity of food is eaten with the alcohol, the absorption phase may not be complete for up to two (2) hours after last consumption. In other situations, a subject may develop a plateau, where the blood alcohol level does not change for up to two hours. When this occurs, the rate of absorption is equal to the rate of elimination and hence the blood alcohol concentration does not change. After two hours, the rate of elimination will exceed the rate of absorption and the blood alcohol level will begin to decrease. Once in the blood, alcohol is carried throughout the body. The alcohol diffuses into tissues and fluids according to their water content. During the absorption phase, the BAC of arterial blood is greater than the BAC of venous blood. Arteries carry blood to a tissue, and veins remove blood from the tissue. At equilibrium, where the tissue has absorbed a proportionate quantity of alcohol, the BAC of arterial blood is equal to the BAC of venous blood. [0007] Alcohol is eliminated from the body by excretion and metabolism, typically through elimination by the kidney (urine), lung (exhale), or liver where it is chemically broken down to acetic acid. An average person can eliminate 0.5 oz (15 ml) of alcohol per hour. So, it would take approximately one hour to eliminate the alcohol from a 12 oz (355 ml) can of beer. Most alcohol is metabolized, or burned, in a manner similar to food, yielding carbon dioxide and water. A small portion of alcohol is excreted, such as through the breath, leaving the body as alcohol, unchanged. Elimination occurs at a constant rate for a given individual. The median rate of decrease in BAC is considered to be 15 milligrams percent (mg %) per hour. The range of decrease in BAC is 10-20 mg % per hour. This range represents the extreme ends of the rate encountered in a normal population. Most people eliminate at a rate of between 13 and 18 mg % per hour. [0008] Given its effects on individuals, alcohol consumption is commonly undertaken in social situations. Drank responsibly, the body can process the drug accordingly. For the average individual, it is estimated that it takes approximately 4 hours for the body to process and filter 4 ounces of alcohol. The problem associated with alcohol consumption rests in the fact that too much too fast prevents proper possessing and failure to eliminate quickly enough. As increasing levels of alcohol are placed in the body, at some point the body cannot process it fast enough, and high levels circulate within the blood. These high levels affect the brain, resulting in people becoming “drunk.” Under the right circumstances, being drunk may not be a problem. However, many individuals who are drunk engage in behavior that often results in unintended consequences. For example, drunken individuals sometimes become very aggressive. This behavior can result in the individual engaging in fights with others, which if sober, would not typically occur. These fights sometimes result in broken bones or bloody lips. However, such actions can result in individuals suffering more severe injuries, such as blunt traumas to the head and/or face, lacerations, or gun shot wounds which may be fatal. [0009] Intoxicated individuals may engage in other risky behaviors, such as driving while intoxicated. As described earlier, drunk individuals often suffer from confusion, decreased motor skills, and inability to properly operate vehicles, resulting in death or serious drunk-driving related injuries. For those individuals who continue to drink extremely large amounts or play various known drinking games which have the affect of consuming large amounts of alcohol, in short times, alcohol poisoning may result. If individuals are not treated properly and/or immediately, death may result. [0010] While there are many home remedies for becoming sober, the most reliable method of reducing inebriation is the passage of time. This allows the body the time to process and clear any alcohol in the individual&#39;s system. One of the most difficult parts of treating a person suffering from alcohol poisoning is making the decision to seek medical help. Typically, treatment includes letting the individuals sleep it off This provides passage of time in order to allow the body to clear the drug from its system. However, in the case where someone is suffering from alcohol poisoning, delay in treatment can be fatal. Treatment for alcohol poisoning typically requires gastric lavage, or stomach pumping, as well as careful monitoring of the individual&#39;s respiratory system. Drawbacks to this treatment include the need to get the person to the hospital, the need for invasive medical procedures, and time to allow such actions to counteract the effects of the alcohol. [0011] What is needed in the art, therefore, is a composition, which when taken by individuals suffering from alcohol intoxication, results in the clearance of alcohol from the body at a faster rate than clearance associated under normal physiology. Such a composition, therefore, would have the advantage of reducing negative consequences of intoxicated individuals, such as drunk driving or aggressive behavior, and offer quick relief for those who suffer from the often fatal alcohol poisoning. DESCRIPTION OF THE PRIOR ART [0012] The instant invention is a unique composition comprising a plurality of ingredients, which have been found to provide unexpected results of reducing the time it takes for an individual suffering from alcohol intoxication to return to a normal, non-inebriated state, The composition includes individually known substances used for other purposes. However, none of the cited references describe a single composition including all of the ingredients for the intended purposes. U.S. Pat. No. 6,245,360 and U.S. Patent Application Publication Number 2007/0202215 describe nutritional supplements which are administered to individuals who are treated for nutritional deficiencies related to alcohol use. Both references describe supplements that comprise mostly a combination of several Vitamin B types as well as other ingredients. [0013] U.S. Pat. No. 6,340,482 discloses materials derived from Citrus plants which can be administered orally to humans for the purpose of producing or maintaining weight loss. In addition, the reference describes using the materials to improve a person&#39;s physical performance and increase the person&#39;s lean muscle mass. The materials contain at least one of the alkaloids from the group consisting of synephrine, hordenine, octopamine, tyramine and N-methylamine. Two species, Citrus aurantium and Citrus reticulata , were described as particularly useful. The materials can be administered in their natural form or as extracts, and can be administered in various ways including capsules and tablets. For weight loss and weight control, the materials were described as being administered concurrently with caloric restriction or in the absence of caloric restriction. The description also provides for the materials to be administered for the purpose of increasing muscle mass concurrently with a high protein diet, as well as with an exercise program. [0014] U.S. Publication No. 2006/0153899 and 2009/0181922 describe a dietary supplement comprising palatinose or a derivative thereof. The dietary supplement is described as a nutritional product, a sports performance product, a weight loss product or a meal replacement product. A method of increasing the absorption of a compound into the bloodstream, cells and tissue comprising administering palatinose, or a derivative thereof, in combination with the compound is also described. [0015] United States Patent Application Publication No. 2004/0077556 describes a composition and a method for promoting weight loss in mammals. In addition to promoting weight loss, the composition is described as useful for promoting thermogenesis in mammals, for increasing metabolism and boosting energy levels in mammals, promoting appetite suppression in mammals, for promoting lean muscle mass in mammals and for a diet supplement. The primary mechanism of action is described as increasing norepinephrine levels, which promotes a rise in metabolism, thus leading to more calories being burned and more energy expended primarily through the burning or metabolism of adipose tissue through lipolysis, without the destruction or metabolism of muscle tissue. The nutritional supplement composition comprises of an effective amount of epigallocatechin gallate (EGCG) and other substances which inhibit cyclic adenosine monophosphate (cAMP) phosphodiesterase, stimulate lipolysis, stimulate thermogenesis (i.e., increase metabolism) and/or increase norepinephrine levels, or any combination thereof. [0016] U.S. Publication No. 2010/0081626 discloses an invention which provides formulations and methods for weight loss. The composition described includes a stable aqueous composition with at least one active fat loss agent, particularly, one agent that stimulates a receptor of the beta-adrenergic receptor family and at least one agent that inhibits the alpha-adrenergic family receptor. [0017] U.S. Publication No. 2010/0239667 discloses a layered pharmaceutical composition suitable for oral use in the treatment of diseases where absorption takes place over a large part of the gastrointestinal tract. The composition is described as comprising A, a solid inner layer comprising: i) an active substance, and ii) one or more disintegrants/exploding agents, one or more effervescent agents or a mixture thereof. The solid inner layer is sandwiched between two outer layers B1 and B2, each outer layer comprising iii) a substantially water soluble and/or crystalline polymer or a mixture of substantially water soluble and/or crystalline polymers, the polymer being a polyglycol in the form of one of a) a homopolymer having a molecular weight of at least about 100,000 daltons, and b) a copolymer having a molecular weight of at least about 2,000 daltons, or a mixture thereof, and iv) an active substance, which is the same as in the solid inner layer A, and layer A being different from layer B. The layered composition is further described as being coated with a coating C that has at least one opening exposing at least one surface of said outer layer, the coating being substantially insoluble in and impermeable to fluids and comprising a polymer, and the composition having a cylindrical form optionally with one or more tapered ends, wherein the ratio between the surface area of one end surface of the cylinder and the length of the cylinder is in a range of from 0.02 to 45 mm. [0018] U.S. Publication No. 2005/0181041 describes a method of preparing mixed phase co-crystals of active agents with one or more materials that allows the modification of the active agent to a new physical/crystal form with unique properties useful for the delivery of the active agent. [0019] U.S. Publication No. 2011/0059882 describes a method for cleaning dentures by contacting the dentures with a solid, multi-layered composition having at least two parts in water. The first part of the composition comprises calcium hypochlorite, magnesium hypochlorite and mixtures thereof, a builder, a water-soluble polymer, and an acid. The first part does not contain sodium hypochlorite, lithium hypochlorite, potassium hypochlorite and mixtures thereof. The second part comprises a functional ingredient and a builder or filler. The second part does not contain any oxidants. [0020] International Publication No. WO2008/070368 describes compositions and methods for diminishing signs of photodamage and/or aging. Certain of the methods are described as comprising contacting skin with an effective amount of one or more elastase enzymes. Certain of the compositions reduce the evidence of elastotic material when contacted with skin. The compositions and methods provide for topical application as well as administration by injection. [0021] U.S. Publication No. 2009/0068255 discloses a system for treating or caring for skin using matrix metalloproteinase (MMP) inhibitors. The system is described as including the use of cosmetic pharmaceuticals which are capable of inhibiting the degradation of proteins found in the skin including collagen, elastin, and other basement membrane and extracellular matrix protein. The MMP inhibitors may be used in both cosmetic compositions and pharmaceutical compositions for application to skin. MMP inhibitors are further described as being formulated with a cosmetically suitable vehicle or pharmaceutically acceptable excipient for application to the skin as creams, lotions, ointments, solutions, or face masks. As for cosmetics, the MMP inhibitor compositions are also described as being capable of preventing or reducing the appearance of wrinkles, pigmentation changes, loss of elasticity, or other effects associated with aging or sun damage. With respect to pharmaceuticals, the MMP inhibitor compositions were also described as applicable to the skin to treat or prevent a skin disease (e.g., proliferative disease, inflammatory disease). [0022] U.S. Publication No. 2009/0214628 discloses compositions and their use for the treatment of human skin, particularly facial skin, to alleviate the symptoms of cosmetic or determatologic skin conditions. The invention describes a composition comprising: one or more metasilicate, one or more carbonate, one or more glyconate, and one or more sulfate. The composition may also contain salts, such as sea slats and other additives or active agents. SUMMARY OF THE INVENTION [0023] The present invention relates to a composition, and methods of using the composition, for minimizing the harmful effects associated with alcohol consumption. The composition includes a plurality of components, including cognitive enhancers, neurostimulants, metabolic stimulants, mental clarifiers, or mental focusing agents, amino acids, vitamins, electrolytes, minerals, stabilizers, detoxifying agents, metal, toxin, fat absorbing agents, fibers, including dietary fibers, anti-oxidants, and other agents, which when combined, have the unexpected effect of increasing one or more metabolic pathways in the individual. As the metabolic rate is increased, alcohol is burned off, or utilized as an energy source, at a considerably much faster rate than under normal physiological means. It is believed that the composition may have an effect on the brain, causing it to increase metabolic rates. As the brain undergoes such a super-fast metabolic process or directs other metabolic processes to rapidly increase, it utilizes alcohol, which in an inebriated person is plentiful. The alcohol is converted to sugar in order to provide an energy source for the increased metabolism. As a result, alcohol levels in the individual are burned off and removed at a much faster rate than under&#39; normal physiological time frames. As the alcohol is burned off, the individual returns to a pre-inebriated state and can function as a normal “non-drunk” individual. [0024] The present invention includes a plurality of components in an effective amount to provide an alcohol based treatment. As used herein, the term “effective amount” generally refers to the amount of a compound that is sufficient to effect treatment as defined herein when administered to an individual, such as a mammal, preferably a human, in need of such treatment. As used herein, the term “treat”, “treating” or “treatment” refers to the administration of therapy to a subject, particularly a mammal, more particularly a human, who already manifests or is suspected of manifesting at least one symptom of alcohol inebriation, impairment or poisoning to obtain a desired pharmacological and physiological effect. The term may also include 1) preventing the alcohol intoxication, inebriation, impairment or poisoning, i.e. causing the clinical symptoms and/or characteristics not to develop in a human that may be exposed to or predisposed to the effects of alcohol but does not yet experience or display symptoms of alcohol inebriation, severe or moderate impairment, or poisoning, 2) inhibiting the alcohol intoxication, inebriation, severe or moderate impairment, or poisoning, i.e. arresting or reducing the development of its characteristics or symptoms, including but not limited to sobering up, reducing blood alcohol concentrations, improving cognitive behavior to a level which corresponds to the same level of the individual when not suffering alcohol intoxication, inebriation, severe or moderate impairment, or poisoning, burning off and removing alcohol levels in the blood at a much faster rate than under normal physiological time frames, thus returning the individual to a pre-inebriated state, allowing that individual to function as a normal “non-drunk,” or providing for the brain to undergo increased metabolic processes or directing other metabolic processes to rapidly increase and it utilize alcohol in the individual&#39;s system as an energy source, or 3) relieving the alcohol intoxication, inebriation, severe or moderate impairment, or poisoning i.e., sobering up, causing regression of characteristics or symptoms including but not limited to reducing blood alcohol concentrations, improving cognitive behavior to a level which corresponds to the same level of the individual when not suffering alcohol intoxication, inebriation, severe or moderate impairment, or poisoning, burning off and removing alcohol levels at a much faster rate than under normal physiological time frames, thus returning the individual to a pre-intoxication or inebriated state, allowing the individual to function as a normal “non-drunk”, or providing for the brain to undergo increased metabolic processes or directing other metabolic processes to rapidly increase and it utilize alcohol in the individual&#39;s system as an energy source. [0025] Accordingly, it is an objective of the instant invention to provide a composition which, when administered to an individual suffering from alcohol intoxication or alcohol poisoning, results in clearance of any alcohol within the body at a much faster rate than under normal physiological time frames. [0026] It is also an objective of the instant invention to provide a composition which, when administered to an individual suffering from alcohol intoxication or alcohol poisoning, results in increasing one or more metabolic pathways that converts the alcohol to sugars as a source of energy. [0027] It is a further objective of the instant invention to provide a composition which acts as a neurostimulant acting on the brain to increase metabolic pathways, converting alcohol to sugar. [0028] It is a further objective of the instant invention to provide a composition which reduces the time it takes for an alcohol intoxicated individual to become sober. [0029] It is yet another objective of the instant invention to provide a composition which reduces the time it takes to remove alcohol from an individual who suffers from alcohol poisoning. [0030] It is a still further objective of the invention to provide a composition which reduces the time it takes the body of an individual who suffers from alcohol intoxication to remove the alcohol from a period measured in hours to a period measured in minutes. [0031] It is a further objective of the instant invention to provide a composition which reduces the time it takes the body of an individual person who suffers from alcohol intoxication to reduce levels alcohol to less than the legal limit within less than 30 minutes. [0032] It is a further objective of the instant invention to provide a composition which reduces the time it takes the body of an individual person who suffers from alcohol intoxication to reduce the amount of alcohol levels in a time period of around 15 minutes. [0033] Other objectives and advantages of this invention will become apparent from the following description. DETAILED DESCRIPTION OF THE INVENTION [0034] In certain embodiments of the present invention, a plurality of ingredients is combined to form a unique composition. Administering the composition to an individual who is intoxicated or otherwise contains high levels of alcohol in their blood results in increasing the rate of one or more metabolic pathways, thereby decreasing the amount of alcohol in the blood as the metabolic processes use the alcohol as a source of energy. Administration of the composition, therefore, results in breakdown of the alcohol, as well as a removal or reduction of the feeling of inebriation, at a much faster rate than accomplished under normal physiological time frames. [0035] In certain embodiments, the composition comprises bitter orange. Bitter orange refers to a citrus tree, Citrus aurantium , and its fruit. Although native to east Africa and tropical parts of Asia, Citrus aurantium is now grown in the Mediterranean regions and parts of the United States. It is also known as Seville orange, sour orange, Zhi shi, and marmalade orange. Bitter orange is used in a variety of applications including foods, cosmetics, essential oils for perfumes, and aromatherapy products. Bitter orange has been used in traditional Chinese medicine and by indigenous people of the Amazon rainforest for nausea, indigestion, and constipation. The extract of bitter orange peel has been used in dietary supplements as an aid to fat loss and as an appetite suppressant. Bitter orange contains the tyramine metabolites N-methyltyramine, octopamine and synephfine, substances similar to epinephrine, which acts on the α 1 -adrenergic receptor to constrict blood vessels and increase blood pressure and heart rate. Other uses include as a remedy to treat heart burn, nasal congestion, treat fungal infections, as a fat burner, and for increasing mental focus and providing energy. The bitter orange peel is used as an appetite stimulant and for dyspepsia. Bitter orange fruit and peel are also used orally for weight loss, increasing lean body mass, body building, improving athletic performance, nasal congestion, allergic rhinitis, and chronic fatigue syndrome (CFS). The bitter orange flower and its oil are used orally for gastrointestinal (GI) disturbances, duodenal ulcers, constipation, regulating blood lipid levels, lowering blood sugar in diabetes, hyperlipidemia, blood purification, functional disorders of liver and gallbladder, stimulation of the heart and circulation, frostbite, as a sedative for sleep disorders, for kidney and bladder diseases, general feebleness, anemia, imbalances of mineral metabolism, impurities of the skin, hair loss, as a tonic, anti-flatulent, and for cancer. Other uses include administration to relieve prolapsed uterus, prolapsed anus or rectum, diarrhea, and blood in the stools. Topically, bitter orange peel is used for inflammation of the eyelid, conjunctiva, and retina. It is also used for retinal hemorrhage and to relieve exhaustion accompanying colds. [0036] In certain embodiments, the composition comprises 1, 3 dimethylethylalanine. Alanine is an alpha-amino acid having a chemical formula of CH 3 Ch(NH) 2 COOH. It is a non-essential amino acid found in foods, and acts as one of the building blocks for proteins. [0037] In certain embodiments, the composition comprises Hordenine. Hordenine is an ingredient of some plants which are used as feed for animals, i.e. in sprouting barley. Hordenine (N,N-dimethyl-4-hydroxyphenylethylamine) is a phenethylamine alkaloid with antibacterial and antibiotic properties. It stimulates the release of norepinephrine in mammals, working as a stimulant. It is produced in nature by several varieties of plants in the family Cactaceae and by some in Acacia. Hordenine has been promoted as a weight loss agent with the claim that it stimulates the central nervous system. It has also been used as a beta agonist and as a metabolic stimulant. Although little research has been done on hordenine, results of some experiments in pharmacological models show that hordenine is an indirectly acting adrenergic drug. In isolated organs and those structures with reduced epinephrine contents, the hordenine-has been shown to have minimal effect. Experiments in intact animals (rats, dogs) show that hordenine has a positive inotropic effect upon the heart, increases systolic and diastolic blood pressure, peripheral blood flow volume, and inhibits gut Movements. [0038] In some embodiments, the composition comprises green apple pectin, or fibersol, or other fiber source. Pectin in the plant starting material is part of a very complex structure, which gives shape to the soft non-woody parts of the plant. It is a structural heteropolysaccharide contained in the primary cell walls of terrestrial plants. Pectin is a natural part of human diet, but does not contribute significantly to nutrition as it is a soluble dietary fiber. Green apple pectin has been used to absorb metals, toxins, fats, and to reduce heaviness in the blood. Fibersol is a resistant maltodextrin, or alternatively, a digestion resistant maltodextrin. It is 90% resistant to digestion by the human digestive system. Fibersol is sold as digestion resistant maltodextrin to clearly define that is it resistant to digestion and that it is not a digestible carbohydrate. It is typically supplied in capsules containing natural, bulk producing, soluble dietary fiber derived from fruit and plants. Each capsule provides the benefits of hemicelluloses (gum and pectin) and polysaccharides which are important for maintaining the proper pace and bulk required for healthy digestive function. [0039] In some embodiments, the composition comprises N-acetyl L-cysteine (NAC). It is a pharmaceutical drug and nutritional supplement which has been used primarily as a mucolytic agent (expectorant), and in the management of paracetamol (acetaminophen) overdose. Other uses include sulfate repletion in conditions, such as autism, where cysteine and related sulfur amino acids may be depleted. NAC is a derivative of cysteine in which an acetyl group is attached to the nitrogen atom. It is sold as a dietary supplement commonly claiming antioxidant and liver protecting effects (detoxifying). It is used as a cough medicine because it breaks disulfide bonds in mucus and liquefies it, making it easier to cough up. It is also this action of breaking disulfide bonds that makes it useful in thinning the abnormally thick mucus in Cystic Fibrosis patients. [0040] In some embodiments, the composition comprises vinpocetine. Vinpocetine is a semi-synthetic derivative alkaloid of vincamine, an extract from the periwinkle plant. Vinpocetine has been shown to be a cerebral metabolic enhancer and a selective cerebral vasodilator. Vinpocetine is reported to have cerebral blood flow enhancing and neuroprotective effects, and has been used for the treatment of cerebrovascular disorders and age-related memory impairment. Vinpocetine is marketed as a supplement for vasodilation and as a nootropic for the improvement of memory. Vinpocetine may help support brain functions such as concentration and memory by activating cerebral metabolism. Vinpocetine has also been identified as a potent anti-inflammatory agent that might have a potential role in the treatment of Parkinson&#39;s disease and Alzheimer&#39;s disease. [0041] In some embodiments, the composition comprises tyrosine. Tyrosine (4-hydroxyphenylalanine) is a nonessential amino acid the body makes from another amino acid called phenylalanine. Tyrosine is found in soy products, chicken, turkey, fish, peanuts, almonds, avocados, bananas, milk, cheese, yogurt, cottage cheese, lima beans, pumpkin seeds, and sesame seeds. It is a building block for several important neurotransmitters, including epinephrine, norepinephrine, and dopamine. Tyrosine also helps produce melanin (the pigment responsible for hair and skin color) and helps in the function of organs responsible for making and regulating hormones, including the adrenal, thyroid, and pituitary glands. It is involved in the structure of almost every protein, in the body and in the production of the stress hormones epinephrine and norepinephrine. A number of studies have found tyrosine to be useful during conditions of stress, cold, fatigue, loss of a loved one such as in death or divorce, prolonged work and sleep deprivation, with reductions in stress hormone levels, reductions in stress-induced weight loss seen in animal trials, and improvements in cognitive and physical performance seen in human trials. [0042] In some embodiments, the composition comprises quercetin. Quercetin is a type of plant-based chemical, or phytochemical, known as a flavonoid found in apples, onions, teas, red wines, and many other foods. Flavonoids such as quercetin are antioxidants which scavenge free radicals, the substances which damage cell membranes, tamper with DNA, and even cause cell death. Antioxidants can neutralize free radicals and may reduce or even help prevent some of the damage they cause. They also help keep LDL cholesterol from being damaged, Quercetin may have anti-inflammatory properties. It has been promoted as being effective against a wide variety of diseases, including cancer. [0043] In some embodiments, the composition comprises piracetam. Piracetam chemical name 2-oxo-1-pyrrolidine acetamide, is a nootropic drug. Nootropics are known commonly as cognitive enhancers, improving cognitive functions of the brain such as memory, attention and intelligence. Piracetam improves brain function and stimulates the central nervous system without any toxicity or addictive properties. [0044] In some embodiments, the composition comprises B-vitamin mix. B-vitamins are a group of water-soluble vitamins that play important roles in cell metabolism. While originally thought to be a single vitamin, referred to as vitamin B, there exists eight chemically distinct B vitamins, including Vitamin B 1 (thiamine), Vitamin B 2 (riboflavin), Vitamin B 3 (niacin or niacinamide), Vitamin B 5 (pantothenic acid), Vitamin B 6 (pyridoxine, pyridoxal, pyridoxamine, or pyridoxine hydrochloride), Vitamin B 7 (biotin), Vitamin B 9 (folic acid), Vitamin B 12 (various cobalamins, commonly cyanocobalamin in vitamin supplements). B vitamins are essential for growth, development, and a variety of other bodily functions. They play a major role in the activities of enzymes, proteins that regulate chemical reactions in the body, which are important in turning food into energy and other needed substances. The B vitamins are thought to be necessary to support and increase the rate of metabolism, maintain healthy skin and muscle tone, enhance immune and nervous system function, promote cell growth and division, including that of the red blood cells that help prevent anemia, and reduce the risk of pancreatic cancer when consumed in food, but not when ingested in vitamin tablet form. [0045] In some embodiments, the composition comprises an electrolyte mix. Electrolyte refers to salts, specifically ions, which are used by the body&#39;s cells (especially nerve, heart, muscle) to maintain voltages across their cell membranes and to carry electrical impulses (nerve impulses, muscle contractions) across themselves and to other cells. One or more of the major electrolytes found in the body may be included in the mix, such as: sodium (Na + ), potassium (K + ), chloride (Cl − ), calcium (Ca 2+ ), magnesium (Mg 2+ ), bicarbonate (HCO 3 − ), phosphate (PO 4 2− ), and sulfate (SO 4 2− ). The electrolyte mix may include, for example, calcium glycerol phosphate, magnesium glycerol phosphate, potassium glycerol phosphate, or combinations thereof. Other electrolytes known to one of skill in the art may be used as well. [0046] In some embodiments, the composition comprises dimethylethanolamine (DMAE). DMAE, also known as N,N-dimethyl-2-aminoethanol, beta-dimethylaminoethyl alcohol, beta-hydroxyethyldimethylamine and deanol, is an organic compound. It is a choline molecule that has been used to improve memory and concentration. Some studies have shown that an increase in vigilance and alertness resulted following administration of DMAE, vitamins, and minerals. While long term studies have not been undertaken, nutritional uses for the molecule include boosting immunity, energy, anti-aging effects, weight loss, and aggression. [0047] In some embodiments, the composition comprises xylitol. Xylitol is an organic compound with the formula (CHOH) 3 (CH 2 OH) 2 . Xylitol is a naturally occurring sugar substitute. It is a sugar alcohol sweetener found in the fibers of many fruits and vegetables, including various berries, corn husks, oats, and mushrooms. Xylitol differs from other sweeteners such as sorbitol, fructose and glucose in that the Xylitol molecule contains five carbons instead of six. [0048] In some embodiments, the composition comprises potassium bicarbonate. Also known as potassium hydrogen carbonate or potassium acid carbonate, potassium bicarbonate, KHCO 3 , has been used as a dietary supplement as a source of potassium and as an antacid. Accordingly, the potassium bicarbonate may provide a source of minerals. In some embodiments, the composition may therefore include one or more dietary minerals, i.e. an inorganic element that is essential for human nutrition or promote certain physiological functions, including but not limited to calcium, phosphorous, selenium, magnesium, potassium, sodium, zinc, and iodine. The dietary mineral may be provided individually or in combination such as a salt containing the mineral element and another ion. [0049] In some embodiments, the composition comprises, in combination, one or more ingredients at for example, concentrations of 100 mg to 1500 mg which act as cognitive enhancers (i.e. substances that improve mental functions such as but not limited to cognition, memory, intelligence, motivation, attention, or concentration), neurostimulants, or combinations thereof. Such ingredients include, but are not limited to, one or more of betaphenyethylamine, sida cordifolia, Ma Huang, ephedra, alkaloids ephedrine, C-AMP-adenosine cyclic 3,5-monophosephate, adrafinil, olmifon, synephrine HCl, methyl synephrine, theobromide, theobromine, evodiamine, octopamine, 1,3 dimethylamylamine, (geranamine, or 1,3 dimethylpentylamine), schisandra chemensis, citrus sinensis, paulinia cupana, adhatoda vasica, visnea mocanera, vitis vinfera, cocoa bean extract, 99% methylxanitines, evodia rutaecarpa 99% evodiamine, Rauwolscine canescens, raspberry ketones, tyramine, sulbutiamine, methyl B-12, proactive B-vitamins, Phenyl ethyl amine (PEA), amino acid precursors, dendrobium nobile (DEN, herb and member of the family Orchidaceae), dihydromyricetin (DHM). [0050] In some embodiments, the composition comprises one or more ingredients at concentrations of 100 mg to 1000 mg that act as mental focusing agents. Such ingredients include, but are not limited to, one or more of oxytropis falcate, caffeine based or derived stimulants such as yerba mate, chocoamine, theobromine, bromide, guranna, green or black teas, kola nut. [0051] In some embodiments, the composition comprises one or more amino acids other than described above, particularly those that act as cognitive enhances, improve mental focus, and act as balance enhancers. Such amino acids include, but are not limited to, one or more of L-carnitine in any form, serine in any form, choline in any form, alpha glycerol phosphocholine, and glutamine in any form. [0052] In some embodiments, the composition comprises herbal substances or compositions such as Milk thistle. Milk thistle, a thistle of the genus Silybum , contains active an flavanoid-lignan constituent called silymarin. Such constituent is known to act as an anti-oxidant, and has shown to have liver protective and regenerative properties. [0053] In some embodiments, the composition comprises stabilizers, which may include preservatives such as but not limited to benzaldehydes, PEG (poly ethyl glycohol), or carboxylic acid. [0054] The composition can be formulated in any conventional manner. The actual composition may, therefore, be formulated based on the route of administration chosen. Illustrative administration routes include, but are not limited to, oral (such as but not limited to liquid), parenteral (for example, intravenous, intraarterial, subcutaneous, rectal, intramuscular, intraorbital, intracapsular, intraspinal, intraperitoneal, intrasternal), topical (for example nasal, transdermal, intraocular), intravesical, intrathecal, enteral, pulmonary, intralymphatic, intracavital, vaginal, transurethral, intradermal, aural, intramammary, buccal, orthotopic, intrathecal, intralesional, percutaneous, endoscopical, transmucosal, sublingual, and intestinal administration. Accordingly, illustrative examples of the composition form may include but are not limited to tablets, capsules, caplets, pills, gel caps, troches, dispersions, suspensions, liquids, solutions, syrups, or dissolvable strips for placement in the mouth, granules, beads, transdermal patches, gels, powders, pellets, magmas, lozenges, creams, pastes, plasters, lotions, discs, suppositories, liquid sprays for nasal or oral administration, dry powders, dry powder or aerosolized formulations for inhalation, compositions and formulations for intravesical administration. Example 1 [0055] Composition for improving cognitive ability and/or reducing blood alcohol levels in an individual impaired or suspected of being impaired by an alcoholic substance. [0000] Percentage of Overall Composition Compound (by weight or volume) At least one Neurostimulants/Metabolic 40% Stimulants At least one Cognitive enhancers 20% At least one Amino acids 20% At least one Vitamins and minerals 10% At least one Antioxidants 5% At least one Stabilizers/Preservatives/other 5% [0056] In an alternative embodiment, the composition for reducing blood alcohol levels, in an individual impaired by an alcoholic substance in accordance with the present invention may comprise about 8 parts by weight of at least one neurostimulant, about 4 parts by weight of at least one cognitive enhancer, about 4 parts by weight of at least one amino acid, about 2 parts by weight of at least one vitamin and/or mineral, about 1 part by weight of at least one antioxidant, and about 1 part by weight of at least one stabilizer. Example 2 [0057] Composition for improving cognitive ability and/or reducing blood alcohol levels in an individual impaired or suspected of being impaired by an alcoholic substance. [0000] Compound Amount Cognitive Enhancers 1.0 mg-1500 mg Neurostimulants and/or Metabolic stimulants 1.0 mg-1500 mg Amino acids 1.0 mg-1000 mg Vitamins 1.0 mg-500 mg  Electrolytes 1.0 mg-500 mg  Minerals 1.0 mg-500 mg  Dietary fiber 1.0 mg-2000 mg Preservatives 1.0 mg-1000 mg Anti-oxidants 1.00 mg-1000 mg  Example 3: Oral (Liquid) Composition [0058] [0000] Compound Amount Bitter orange  15-1000 mg 1,3 dimethylethylalanine  15-1000 mg Hordenine  15-1000 mg green apple pectin, or fibersol, or other fiber source 500-2000 mg N-acetyl cysteine (NAC) 250-1000 mg Vinpocetine  10-100 mg Tyrosine 250-1000 mg Quercetin 250-1000 mg Piracetam 250-1000 mg B-vitamin mix: mixture of one or more of Vitamin B 1  100-500 mg (thiamine), Vitamin B 2 (riboflavin), Vitamin B 3 (niacin or niacinamide), Vitamin B 5 (pantothenic acid), Vitamin B 6 (pyridoxine, pyridoxal, or pyridoxamine, or pyridoxine hydrochloride), Vitamin B 7 (biotin), Vitamin B 9 (folic acid), Vitamin B 12 (various cobalamins). Electrolyte mix: mixture of one or more of sodium (Na + ),  50-500 mg potassium (K + ), chloride (Cl − ), calcium (Ca 2+ ), magnesium (Mg 2+ ), bicarbonate (HCO 3 − ), phosphate (PO 4 2− ), and sulfate (SO 4 2− ). Dimethylethanolarnine (DMAE)  50-500 mg Xylitol As needed Potassium bicarbonate As needed Flavoring As needed Example 4: Oral (Liquid) Composition [0059] [0000] Compound Amount Bitter orange 50 mg 1,3 dimethylethylalanine 30 mg Hordenine 25 mg green apple pectin or fibersol, or other fiber source 1 g N-acetyl cysteine (NAC) 250 g Vinpocetine 10-20 mg Tyrosine 250 mg Quercetin 500 mg Piracetam 500 mg B-vitamin mix: mixture of one or more of Vitamin B 1 250 mg Vitamin B 2 , Vitamin B 5 , Vitamin B 6 , Vitamin B 12 . Electrolyte mix 250 mg Dimethylethanolamine (DMAE) 100 mg Xylitol As needed Potassium bicarbonate As needed Lemon-lime or tropical punch As needed Example 5: Oral (Liquid) Composition [0060] [0000] Compound Amount Bitter orange 50 mg 1,3 dimethylethylalanine 30 mg Hordenine 25 mg green apple pectin 1 g N-acetyl cysteine (NAC) 250 g Vinpocetine 20 mg N-acetyl-tyrosine 300 mg Quercetin 500 mg Piracetam 500 mg Vitamin B 1 50 mg Vitamin B 2 50 mg Vitamin B 3 200 mg Vitamin B 5 50 mg Vitamin B 6 200 mg Vitamin B 12 1000 mg N-acetyl cysteine 250 mg Milk Thistle 300 mg Calcium glycerol phosphate 200 mg Magnesium glycerol phosphate 100 mg Potassium glycerol phosphate 50 mg Dimethylethanolamine (DMAE) 100 mg Xylitol As needed Potassium bicarbonate As needed Flavoring agent As needed [0061] Methods for Testing of Intoxicated Individuals and Administration of Composition: [0062] The Example 3 composition was tested in order to observe and record the effects the liquid composition has in relation to individuals who are intoxicated from drinking beverages containing alcohol. Five individuals, four men and one woman, were used in the test population. Each of the individuals was allowed to consume beverages containing alcohol, such as beer or liquor, over a specific time such that their blood alcohol levels were over the legal driving limits of 0.08. Since a person found driving with a blood-alcohol concentration (BAC) level exceeding the legal limit can be arrested and charged with the offense of driving under the influence (DUI), this was the value chosen as a comparison point. However, the compositions in accordance with the instant invention can be effective in individuals who have lower BAC levels as well. A standard breathalyzer machine, such as the Intoxilyzer 8000 (CMI, Inc. Owensboro, Ky.) or portable breathalyzer machines, such as AlcoHawk (Q3 Asset Acquisition, LLC, Independence, Iowa) which measures the blood-alcohol concentration was used to determine the levels of alcohol in each of the individual&#39;s system. In addition to measuring the blood alcohol level, each of the individuals was tested to examine their facultative and physical capabilities in order to determine effects and improvement to the individual&#39;s cognitive capabilities or behaviors. Such testing is similar to field sobriety tests performed by police offers in the field when the officers encounter drivers they believe exhibit characteristics of drunk driving, and/or asked to comment about their state of drunkenness. Table 1 below summarizes the results for all individuals that participated in the experiment. [0000] TABLE 1 Summary: Experimental Results: Post- Post- Time Period of Pre- Administration Administration BAC Drink of of Determination Post BAC Post Drink Composition: Composition: Administration of Subject Level Behavior BAC Levels Behavior Composition 1. Male 0.18 Feeling of 0.03 Appeared to 16 minutes being drunk exhibit normal (second post drink or “buzzed”; behavior; test of 0.03 at 45 most likely increased minutes) would have cognitive failed a field capabilities sobriety test compared to- impaired state 2. Male 0.21 Feeling of 0.05 Appeared to 16 minutes being drunk; exhibit normal (second post drink most likely behavior; test result of 0.05 at would have increased 34 minutes) failed a field cognitive sobriety test capabilities compared to- impaired state 3. Male 0.10 Most likely 0.04 Appeared to 16 minutes would have exhibit normal failed a field behavior; sobriety test increased cognitive capabilities compared to- impaired state 4. Female 0.17 Most likely 0.05 Appeared to 15 minutes would have exhibit normal (second post drink failed a field behavior; test result of 0.05 at sobriety test increased 34 minutes) cognitive capabilities compared to- impaired state 5. Male 0.14 Most likely 0.01 Appeared to 15 minutes would have exhibit normal failed a field behavior; sobriety test increased cognitive capabilities compared to- impaired state Example 1: Subject 1 [0063] Subject Number 1 was allowed to drink beverages containing alcohol. An initial alcohol drunkenness assessment was carried out, consisting of both subjective and objective testing means. A standard portable breathalyzer machine was used to determine the levels of alcohol in his system. In addition to the breathalyzer test, Subject Number 1 was visually examined, asked to perform a variety of tests in order to subjectively determine the level of alcohol impairment or intoxication by evaluating his/her coordination, cognitive abilities, and capacity to follow instructions, and/or asked to describe state of drunkenness. After drinking the alcoholic beverages, the initial breathalyzer test indicated a BAC of 0.18. The subject described himself as feeling drunk. After an initial assessment was determined, Subject Number 1 was given an oral dosage of the composition in accordance with Example Number 3. After a period of 16 minutes post administration of the composition, Subject Number 1 was given a second evaluation to determine the level of alcohol impairment. As before, the assessment consisted of a determination of the amount of alcohol in the blood through the use of a standard breathalyzer machine, and a subjective test. Subject Number 1 had a post-drink breathalyzer test BAC of 0.03 and exhibited normal behavior. A third measurement of BAC levels was determined for Subject Number 1. After a period of 45 minutes after drinking the composition, BAC was measured at 0.03. Example 2: Subject 2 [0064] Subject Number 2 was allowed to drink beverages containing alcohol. An initial alcohol drunkenness assessment was carried out, consisting of both subjective and objective testing means. A standard portable breathalyzer machine was used to determine the levels of alcohol in his system. In addition to the breathalyzer test, Subject Number 2 was visually examined, asked to perform a variety of tests in order to subjectively determine the level of alcohol impairment or intoxication by evaluating his coordination, cognitive abilities, and capacity to follow instructions, and/or asked to describe state of drunkenness. After drinking the alcoholic beverages, the initial breathalyzer test indicated a BAC of 0.21. The subject described himself as feeling drunk. After an initial assessment was determined, Subject Number 2 was given an oral dosage of the composition in accordance with Example Number 3. After a period of 16 minutes post administration of the composition, Subject Number 2 was given a second evaluation to determine the level of alcohol impairment. As before, the assessment consisted of a determination of the amount of alcohol in the blood through the use of a standard breathalyzer machine, and a subjective test. Subject Number 2 had a post-drink breathalyzer test BAC of 0.05 and exhibited normal behavior. A third measurement of BAC levels was determined for Subject Number 2. After a period of 34 minutes after drinking the composition, BAC was measured at 0.05. Example 3: Subject 3 [0065] Subject Number 3 was allowed to drink beverages containing alcohol. An initial alcohol drunkenness assessment was carried out, consisting of both subjective and objective testing means. A standard portable breathalyzer machine was used to determine the levels of alcohol in his system. In addition to the breathalyzer test, Subject Number 3 was visually examined, asked to perform a variety of tests in order to subjectively determine the level of alcohol impairment or intoxication by evaluating his coordination, cognitive abilities, and capacity to follow instructions, and/or asked to describe state of drunkenness. After drinking the alcoholic beverages, the initial breathalyzer test indicated a BAC of 0.10. The subject described himself as feeling drunk. After an initial assessment was determined, Subject Number 3 was given an oral dosage of the composition in accordance with Example Number 3. After a period of 15 minutes post administration of the composition, Subject Number 3 was given a second evaluation to determine the level of alcohol impairment. As before, the assessment consisted of a determination of the amount of alcohol in the blood through the use of a standard breathalyzer machine, and a subjective test. Subject Number 3 had a post-drink breathalyzer test BAC of 0.04 and exhibited normal behavior. A third measurement of BAC levels was not determined for Subject Number 3. Example 4: Subject 4 [0066] Subject Number 4 was allowed to drink beverages containing alcohol. An initial alcohol drunkenness assessment was carried out, consisting of both subjective and objective testing means. A standard portable breathalyzer machine was used to determine the levels of alcohol in her system. In addition to the breathalyzer test, Subject Number 4 was visually examined, asked to perform a variety of tests in order to subjectively determine the level of alcohol impairment or intoxication by evaluating her coordination, cognitive abilities, and capacity to follow instructions, and/or asked to describe state of drunkenness. After drinking the alcoholic beverages, the initial breathalyzer test indicated a BAC of 0.17. The subject described herself as feeling drunk. After an initial assessment was determined, Subject Number 4 was given an oral dosage of the composition in accordance with Example Number 3. After a period of 15 minutes post administration of the composition, Subject Number 4 was given a second evaluation to determine the level of alcohol impairment. As before, the assessment consisted of a determination of the amount of alcohol in the blood through the use of a standard breathalyzer machine, and a subjective test. Subject Number 4 had a post-drink breathalyzer test BAC of 0.05 and exhibited normal behavior. A third measurement of BAC levels was determined for Subject Number 4. After a period of 34 minutes after drinking the composition, BAC was measured at 0.05. Example 5: Subject 5 [0067] Subject Number 5 was allowed to drink beverages containing alcohol. An initial alcohol drunkenness assessment was carried out, consisting of both subjective and objective testing means. A standard portable breathalyzer machine was used to determine the levels of alcohol in his system. In addition to the breathalyzer test, Subject Number 5 was visually examined, asked to perform a variety of tests in order to subjectively determine the level of alcohol impairment or intoxication by evaluating his coordination, cognitive abilities, and capacity to follow instructions, and/or asked to describe state of drunkenness. After drinking the alcoholic beverages, the initial breathalyzer test indicated a BAC of 0.14. The subject described himself as feeling drunk. After an initial assessment was determined, Subject Number 5 was given an oral dosage of the composition in accordance with Example Number 3. After a period of 15 minutes post administration of the composition, Subject Number 5 was given a second evaluation to determine the level of alcohol impairment. As before, the assessment consisted of a determination of the amount of alcohol in the blood through the use of a standard breathalyzer machine, and a subjective test. Subject Number 5 had a post-drink breathalyzer test BAC of 0.01 and exhibited normal behavior. A third measurement of BAC levels was not determined for Subject Number 5. [0068] While the present invention is susceptible of embodiment in various forms, there is shown and will hereinafter be described a presently preferred, albeit not limiting, embodiment with the understanding that the present disclosure is to be considered an exemplification of the present invention and is not intended to limit the invention to the specific embodiments illustrated. [0069] All patents and publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication, was specifically and individually indicated to be incorporated by reference. [0070] It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and any drawings/figures included herein. [0071] One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.

The present invention relates to a composition, and methods of using the composition, for minimizing the harmful effects associated with alcohol consumption. The composition includes a plurality of ingredients, which when combined, have the unexpected effect of increasing one or more metabolic pathways in the individual. As the metabolic rate is increased, alcohol is burned off, or utilized as energy source, and occurs at a considerably much faster rate than under normal physiological means. It is believed that the composition may have an effect on the brain causing it to increase metabolic rates. By administering the composition to an inebriated individual, the rate at which a person sobers up, occurs at a faster rate than would occur under normal physiological time frames.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS [0001] The present patent application is a continuation of U.S. non-provisional patent application Ser. No. 12/580,078, filed Oct. 15, 2009, entitled “Microneedle Transdermal Delivery Device” (Attorney docket no. C7706/40623) which is a continuation of PCT/GB2008/000998 filed Mar. 25, 2008, designating the United States, which claims the benefit of Great Britain Application No. 0707282.0 filed Apr. 16, 2007, the entire teachings and disclosures of which are incorporated herein, in their entireties, by reference thereto. FIELD OF THE INVENTION [0002] The invention relates generally to drug delivery, and specifically relates to devices that deliver pharmacologically active substances transdermally using microneedles. The invention also relates to transdermal retrieval of body fluid for analysis. BACKGROUND OF THE INVENTION [0003] Microneedles are a recent invention arising from the application of etching and lithographic techniques from the semiconductor fabrication processes, to produce sharp, high aspect ratio, solid or hollow features on materials such as plastics or metals, which are termed “microneedles” because they have dimensions on the micrometre scale. [0004] Microneedles have strong potential for the transdermal delivery of a very wide range of drugs, pharmacologically active agents and therapeutic agents, for both immediate effect and possibly for sustained action through appropriate formulation enhancements, and indeed have found potential applications as a mechanism for the delivery of drugs and various therapeutic molecules. The range of molecules in terms of size, chemistry or the dosage formulation in which the agent is contained that may be administered into humans and animals using microneedles is virtually unlimited. [0005] There are a number of advantages associated with the use of microneedles for the delivery of drugs through the skin, i.e. transdermally. The first of these relates to the advantages relating to the mechanism of drug absorption and distribution when administered through the skin, such as avoidance of the first pass metabolism by the liver, and a reduction of side effects, together with the rapid onset of action. Additionally in this case there are a number of further advantages ranging from the ability to deliver drugs of almost any physicochemical nature, any type of formulation, e.g., liquid, gel, emulsion, or even as a solid whereby the drug could form part of the needle or be used to coat the needle. [0006] Microneedles are generally fabricated in arrays, synthesised using etching techniques, such as chemical or physical etching and standard lithographic procedures. The materials used range from silicon to polymers such as PDMS. They generally measure tens of microns to hundreds of microns in length and have varying tip diameters, usually less than 10 microns. [0007] Some examples of microneedles are shown in FIG. 16 . [0008] It has been demonstrated (“Microfabricated microneedles: a novel approach to transdermal drug delivery” J Pharm Sci. 1998 August; 87(8):922-5”) that application of microneedles on the human skin for 10 seconds resulted in a 1000-fold increase in permeability of the skin to calcein. However upon removal of the microneedle array there was a 10,000-fold increase in permeation. i.e., drug was able to permeate much more readily through the holes/microchannels created by the microneedles. [0009] It has also been demonstrated (“Transdermal delivery of desmopressin using a coated microneedle array patch system”. J Control Release. 2004 Jul. 7; 97(3):503-11) that an array of solid microneedles coated with the drug desmopressin was able to deliver more than 90% of the drug transdermally, with metabolites comparable to those produced when desmopressin is delivered intravenously. [0010] The delivery of vaccines requires a strong immune response to optimise the effect of the drug, and such response is generally achieved through the use of adjuvants designed to boost the immune response. The skin is a major immunological organ with antigen-presenting Langerhans cells in rich supply, covering almost 15% of the surface area of the skin. Vaccines delivered by the transdermal route are taken up by these Langerhans cells and migrate to the lymph nodes where antigen-specific immunity is activated. This provides a highly efficient means therefore for administering vaccines. Skin Penetration [0011] The mechanics of microneedle insertion into the skin arc critical to its practical application. Needles with the correct geometry and physical properties, such as strength, are able to penetrate the skin provided the penetration force is less than the breaking force of the needle/tip. The optimum needle types are those with a small tip radius and high wall thickness. [0012] Another factor for drug delivery is ensuring that microneedles penetrate to the correct depth. Penetration depth is partly dictated by needle shape, and partly by needle diameter, inter-needle spacing, length and applied force. [0013] In addition to the design and geometry of the needles due consideration must be given to the method by which the microneedles arc applied to the skin, to ensure the requisite depth of penetration occurs, and such that drug permeation is predictable and not erratic. [0014] There are a number of organizations developing microneedle based systems for the drug delivery applications, and each is developing and optimising the needles for its particular application. Generally speaking these systems are split between using solid microneedles to simply create cavities through which drug will then permeate, and using hollow microneedles, the bore of which acts as a conduit for the transport of drug from a reservoir upon compression of the drug reservoir, usually by hand. [0015] The mechanism by which microneedles are adhered or applied to the skin is therefore very important and a number of different techniques are illustrated in the literature. The most common method is depression of an array of microneedles on the skin and holding for a defined period of time. For example, it is known from International Patent Application WO 2006/055771 to propel a microneedle array to the skin surface from a predetermined distance, whereas International Patent Application WO 2006/055795 teaches that a flexible sheet can be used to move a microneedle array in the direction of the skin surface. [0016] An alternative propulsion means is known from International Patent Application WO 2006/055802, which uses an elastic band to propel a microneedle array towards the skin. Finally, International Patent Application WO 2007/002521 teaches an impactor which accelerates a microneedle array towards the surface of the skin, moving along an arcuate path. [0017] Another known device is the ‘Dermaroller™’, which is used for both cosmetic and drug delivery applications. This uses a cylinder with surface projections of solid stainless steel microneedles of varying geometries. Cavities are created in the skin using the solid array of microneedles. Drug delivery is achieved by using the roller to ‘press’ drug or cosmetic material stored on a needle-free area of the roller in to the cavities created. An example of the roller is shown in FIG. 17 . [0018] A number of mechanisms have been developed to address the need for a reproducible means of applying the microneedles to the skin, which is crucial to their clinical exploitation. The majority of methods rely on the impact of an array of needles with the skin, either through mechanical means or manually by depressing with the thumbs for example. [0019] The Dermaroller is one example whereby the force is applied using a cylinder to simultaneously bring the needles into contact with the skin and apply pressure over the region where the needles are in contact with the skin, followed by a region where the outer surface of the cylinder is absent of needles and is coated with drug which are claimed to be manually compressed and forced into the cavities created by the microneedles. There are two problems with the Dermaroller. First, the surface area of the skin through which drug permeation will occur cannot be easily determined as there is no mechanism for limiting the area over which the Dermaroller is applied. Secondly, the technique is inherently unreliable in accurately delivering a defined quantity because it depends entirely upon drug entering the skin through a combination of diffusion and forced entry by compression through the cavities created by the needles. In a clinical setting it is very important to be able to accurately define how much drug is administered. [0020] The other known microneedle devices do not provide a satisfactory means of supplying accurate quantities of drugs transdermally in a controllable fashion, nor any means for staged delivery. [0021] Embodiments of the invention overcome the problems with the Dermaroller and improve on the known devices. BRIEF SUMMARY OF THE INVENTION [0022] Embodiments of the invention generally provide a microneedle time-controlled patch and applicator device which can pump a defined amount of a substance through the bore of a hollow microneedle or microneedles into the skin at a predetermined depth. [0023] The device ensures that the microneedles penetrate the skin in the desired manner and to the desired depth in a reproducible manner. It may have an integral pumping means for forcing the substance through the bore of the microneedle into the depth of the skin from where it will diffuse into the systemic circulation. [0024] The substance could be any of various substances including drugs, pharmacologically active agents or therapeutic agents. Where any of these words is used, it will be understood to include the others. [0025] The microneedle device is suitable for use with drugs of almost any type of formulation, which could range from liquid to solid. When the device is used in a timed controlled delivery mode or version, it is particularly well suited to delivering drugs with a short half life such as sumatriptan succinate. [0026] The microneedle time-controlled patch and applicator will preferably provide a means of inserting the needles into the skin without using high impact forces, and furthermore it may simultaneously or nearly simultaneously pump defined quantities of drug through the bores of the microneedles to defined depths within the skin. Furthermore the device will ensure there is good contact between the needles and the skin at the point of administration to prevent backflow of drug by actively forcing the drug through the bores of the microneedles into the skin. The device will preferably force the drug into the skin without allowing any liquid to travel back up the bores into the drug reservoir, without the use of external pistons or pumps. [0027] The mechanism may be incorporated into a patch for the time-controlled delivery of drugs from the microneedles, with appropriate microelectronic circuitry, or may be operated manually for a bolus dose or for vaccine delivery. [0028] The invention has one or more suitable microneedles with a bore therethrough. The bore may be a bore running centrally through the microneedle with an exit at or near the tip. The microneedles extend away from a substrate, and may be arranged thereon in regular arrays such as single rows. The orientation and geometry of the microneedles relative to the substrate will be such that their penetration through the skin will be enhanced during travel over an arcuate pathway. As shown in the drawings, the rows may extend substantially perpendicularly to the direction of movement of the microneedles. As shown in FIGS. 3, 6 and 7 , the microneedles may have a generally triangular profile and be arranged so that a sharp leading edge is directed towards the skin for entry into it. The bore may exit through the leading edge near the tip. The microneedles may be made from any suitable materials, ranging from silicon and stainless steel to plastics. [0029] Each microneedle substrate may be mounted about a single roller. In a preferred alternative embodiment, each substrate is provided on a belt or track that runs around one or more rollers to form a conveyor mechanism. Preferably the belt forms a closed loop about the rollers but it could alternatively be unwound from a first roller and wound onto a last roller. It will be understood that the terms “belt”, “track” and “loop” are used generally interchangeably in this description. [0030] The rollers may be slidably and rotatably mounted about their axes on a guide on a frame, so that the loop can rotate around the rollers, and the rollers and loop can simultaneously move linearly along the guide as one body. The conveyor mechanism forms part of an applicator of the device. [0031] Preferably the belt is sufficiently rigid to provide a supporting surface for the microneedle substrate, yet sufficiently flexible to closely follow the curvature of the rollers. Support may also be provided by providing additional rollers in the interstices between the principal rollers. Alternatively, the track may be made in rigid sections joined by a flexible linkage. [0032] The belt may be arranged to move a fixed distance corresponding to a single delivery of drug, or it may move in small increments to deliver pre-defined quantities of drug over time, either pre-programmed, or self regulated. The conveyor mechanism may be manually operated, for example by a sliding means. Alternatively, the conveyor mechanism may be automated using a micro-mechanism to drive the conveyor along defined distances over a defined period of time to provide sustained drug release over a period of time. The mechanism for moving the conveyor along the fixed track may be a simple micro-motor, or a linear actuator such as one produced from shape memory alloy. In either case it is preferred that the pressure distribution is even over the entire body of the patch in contact with the skin. [0033] Where the mechanism is manually operated, e.g. by hand, the device may lack the electronics for driving the microneedles over the skin, or they could be selectively switched off The device would be housed in a suitably designed casing and driving means would be provided. A manually operated device could be used for single dose administration, e.g., the administration of vaccines. It is unlikely that the applicator would simply be rolled over the skin, and most likely will be secured to a limb using a belt/strap to ensure that when the needle is in contact with the skin the pressure is firm and even, and sustained over a period of time to ensure the drug has had time to penetrate the skin completely. [0034] Each roller may be substantially or wholly cylindrical. Each roller, or the leading roller, may be polyhedral or have a protruding bulbous section as shown in FIG. 14 . The rollers both support the belt and exert a substantially uniform pressure on the belt. [0035] Each roller may be substantially the same size and shape to remain in contact with the belt such that the lower surface of the belt is parallel to the guide, i.e. parallel to the skin. Alternatively the rollers may be of differing sizes so that the lower side of the belt has a non planar topology for example. [0036] The bore of each microneedle is in fluid communication with a flexible reservoir containing the drug formulation, either directly or through a solid capillary network. Each microneedle or each array of microneedles may be linked to its own reservoir, which may be isolated from other reservoirs. Each microneedle array and reservoir forms a patch. [0037] The reservoir is preferably provided on the substrate. Preferably the reservoir is provided on the same outwardly facing surface of the substrate as the microneedles, but spaced from the microneedles parallel to the length of the belt. The reservoir is located after the microneedles on the belt relative to the direction of rotation of the belt in use. The reservoir may be a bulbous dome that projects above the microneedles when uncompressed. The reservoir may be made of a polymeric material such as methacrylates or silicone polymers for example. [0038] The conduit connecting the reservoir to the microneedle is preferably substantially compression-resistant, and may be formed of a suitable flexible material, e.g., plastic or metal. [0039] The conveyor frame and rollers may be composed of a dense solid material which will act to restrain the microneedles in the pierced position and depth in the skin, preventing them from detaching from the skin at the point where the drug is forced through the bore of the needle into the skin, delivering a pre-defined dose of drug. [0040] A suitable housing may be used to cover the patch and the body of the device, which may be made of a polymeric material. [0041] The periphery of the conveyor mechanism and patch may be adhered to the skin using a suitable adhesive, such as pharmaceutical pressure sensitive adhesives. [0042] A belt or strap may be used to secure the device to a patient, e.g. on a limb. [0043] The applicator may be separate from the reservoir and microneedle array or patch such that the device is re-usable, and thin films of microneedle with reservoir on a thin polymer film with adhesive backing may be supplied separately and adhered to the applicator at point of use. [0044] The device may also be used to withdraw fluid from the skin for analysis. An example of this would be analysis of blood sugar for self-regulating insulin delivery. The device, and in particular each patch, may therefore have analytical instrumentation or microelectronics built in. To achieve the required negative pressure in the reservoir after the associated needle(s) have penetrated the skin, the reservoir may have resilient compressible channels such that when channels are compressed air is forced out through a one way valve leading to negative pressure in the chamber directly below the microneedle(s) leading to fluid withdrawal from the skin. Alternatively suction means may be applied to the patch via a port. Microneedles associated with this section of the patch may be designed to maximise fluid uptake, e.g., by making these needles slightly longer for example. [0045] The microneedles and reservoirs may be fabricated as two separate components and then assembled into a patch, or they may be fabricated in one piece in a single process. [0046] The microneedle component may also be made by micromoulding or embossing. BRIEF DESCRIPTION OF THE DRAWINGS [0047] The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention and, together with the description, serve to explain the principles of the invention. In the drawings: [0048] FIG. 1 is a top view of the reservoir/microneedle component; [0049] FIG. 2 is a top view of the reservoir/microneedle component with multiple channels; [0050] FIG. 3 is a view of the reservoir/microneedle compartment of FIG. 1 from Side A; [0051] FIG. 4 is a view of the reservoir/microneedle compartment of FIG. 1 from Side B; [0052] FIG. 5 is a top view of two alternative reservoir/microneedle arrays on a polymer patch; [0053] FIG. 6 is a schematic of a microneedle in top view and perspective view; [0054] FIG. 7 is a perspective view of a reservoir/microneedle component similar to that of FIG. 1 ; [0055] FIG. 8 is a schematic of a reservoir docking port on the microneedle chamber of FIG. 7 ; [0056] FIG. 9 is a schematic of a conveyor mechanism; [0057] FIG. 10 is a cross section of the conveyor mechanism of FIG. 9 ; [0058] FIG. 11 is a schematic of a conveyor, support frame and glide track; [0059] FIG. 12 is a schematic of a conveyor, support frame and glide track with manual support housing; [0060] FIG. 13 is a perspective view of a roller; [0061] FIG. 14 is a cross section of two alternative rollers; [0062] FIG. 15 is a top view of an arrangement of resilient compressible passages for sample withdrawal; [0063] FIG. 16 is a set of photographs of known microneedles; and [0064] FIG. 17 is an illustration of a known Dermaroller™ device. [0065] While the invention will be described in connection with certain preferred embodiments, there is no intent to limit it to those embodiments. On the contrary, the intent is to cover all alternatives, modifications and equivalents as included within the spirit and scope of the invention as defined by the appended claims. DETAILED DESCRIPTION OF THE INVENTION [0066] Each array of microneedles 6 , as shown in FIG. 1 , is mounted on a hollow, rigid chamber 8 which acts as a distribution reservoir. This is connected to a flexible polymer reservoir 2 containing a drug. When drug is forced out of the flexible reservoir 2 , it will enter this chamber 8 and then be distributed to each of the needles 6 , and enter the skin 24 ( FIG. 10 ) through the bore 10 of each needle ( FIG. 6 ). This hollow chamber 8 may be produced as an integral part at the time of fabrication of the needles 6 , using a single polymer or metal substrate for both the needles 6 and chamber 8 . [0067] Design of the needle 6 will ensure the edge 12 which slices into the skin 24 is sharp and of the optimum geometry to ensure smooth penetration into the skin. [0068] A connection port 14 ( FIG. 8 ) provided on this chamber 8 allows the flexible reservoir 2 to be interfaced directly to this chamber 8 though a docking and locking mechanism. The docking port 14 on the flexible reservoir component may be used for the purpose of filling the reservoirs 2 with the appropriate drug formulation. [0069] There may be a porous membrane or septum (not shown) between the reservoir 2 and the microneedle 6 and chamber 8 section, which will prevent drug from escaping the flexible reservoir 2 during storage but allow drug to pass through when the reservoir 2 is compressed. As can be seen in FIG. 2 , there may be more than one channel 4 leading from the reservoir 2 to the microneedle chamber 8 . [0070] The microneedle 6 and reservoir 2 arrays can be arranged on a thin polymer film with small, discrete reservoirs 2 or alternatively long, linear reservoirs 2 , as schematically shown in FIG. 5 . [0071] The rollers 16 are mounted in a frame (not illustrated) that holds them at a fixed spacing from one another with their axes parallel, while leaving the rollers 16 free to rotate. As shown in FIGS. 9-12 , the rollers 16 will be stabilised by a rigid track 22 along which they will glide, maintaining firm and even pressure across the surface of the reservoir/needle combination. The track 22 is housed in a frame 26 also composed of a rigid material. The rollers 16 are immediately interfaced to a belt 18 which may be rubber, plastic or metallic in composition. The underside of the belt 18 has teeth (not shown) which slot onto teeth (not shown) on the rollers 16 to facilitate their movement. [0072] As shown in FIG. 14 , the rollers 16 may not be completely cylindrical and have one or more parts of the surface 32 proud of the main body 16 of the roller to enhance the force exerted at the point at which the proud portion 32 of the roller is directly above the reservoir 2 and/or needle 6 . Alternatively, they may be mounted eccentrically about their axis of rotation. The rollers 16 may be driven either by some form of linear actuator such as shape memory wire, or a micro-mechanical system (not shown), or by hand with a suitable casing 28 to allow firm grip to be established on the device with even distribution of pressure as shown in FIG. 12 . [0073] The belt 18 has an area designated for the needle/reservoir patch 40 to be adhered. Adhesive is standard, pressure-sensitive adhesive, and one which may be easily removed when the patch 40 is removed from the applicator. [0074] The overall dimensions of the motorised patch will be variable depending on the application. However the patch/applicator and combined electronics and actuation mechanism may be as small as a few mm in thickness. [0075] In use, the device is attached to a suitable area of skin, for example by tightly strapping the device to a limb. Attachment for a belt or strap shall exist which may be used to secure the applicator/patch on a limb of a patient, and may be fastened using hook-and-loop fastener or an adjustable strap mechanism. [0076] The conveyor mechanism is activated so that the conveyor moves forward along the track in the direction indicated by arrow 20 and the belt 18 rotates, so that the needles 6 are successively eased under the belt 18 and brought into contact with the skin surface 24 at which point the needles 6 gently pierce and penetrate the skin 24 as they rotate about the arc of the leading roller 16 . As the conveyor continues to move forwards, the belt 18 unwraps from the first roller 16 to lie against the skin 24 . The longitudinal position of the needles 6 relative to the skin 24 remains fixed, thereby avoiding tearing. As the last roller 17 in the set passes the needles 6 , the belt 18 is taken up onto the last roller 16 , thereby withdrawing the needles 6 from the skin 24 . [0077] The rollers 16 , 17 supporting the belt act to compress the reservoir 2 containing the drug against the skin 24 at a point after the microneedles 6 have penetrated the skin 24 , forcing the contents of the reservoir 2 into the skin 24 via the bore 10 of the needles 6 . The rollers 16 , 17 may also exert pressure on a reservoir 2 and microneedle 6 simultaneously depending on the relative location of the reservoir 2 and needles 6 . Alternatively the rollers 16 , 17 can be smaller in diameter such that a single roller is responsible for maintaining pressure on the reservoir 2 whilst another is responsible for exerting pressure on the needles 6 . [0078] Subsequent pressing of each reservoir 2 by each roller 16 , 17 ensures all drug is delivered. [0079] FIG. 15 illustrates a patch for withdrawing fluid samples from a patient for analysis, instead of delivering an agent into the patient. The patch comprises a reservoir 2 formed from flexible channels 4 , which have sufficient resilience to remain normally inflated and are directly interfaced to the microneedle array 6 . After the hollow needles 6 of the array have been inserted into the skin 24 , the passage of the rollers 16 squeezes the channels 4 against the skin 24 , thereby expelling air from the reservoir 2 through non-return valves 34 at the end of the reservoir 2 that is remote from the needles 6 . As the rollers 16 move off the reservoir 2 the resilient channels 4 attempt to spring open again but air cannot enter them via the non-return valves 34 . This causes a drop in pressure in the reservoir channels 4 and hence within the bores 10 of the needles 6 with which the channels 4 are interfaced, with the result that interstitial fluid or blood is withdrawn from the patient via the needles 6 . A suitable sensor system 36 can be incorporated in the patch or interfaced with it to allow for in situ and real time diagnostics/measurements to be undertaken using appropriate microprocessor controls and off-the-shelf sensor components. [0080] All references, including publications, patent applications, and patents cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein. [0081] The use of the terms “a” and “an” and “the” and similar referents in the context of describing the invention (especially in the context of the following claims) is to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms “comprising” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention. [0082] Preferred embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Variations of those preferred embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.

A drug delivery device that delivers pharmacologically active substances transdermally using microneedles arranged on a belt mounted rotatably about a plurality of rollers, the microneedles having an associated drug reservoir mounted on the belt which is compressed when the needles and belt arc brought into contact with the skin.

BACKGROUND OF THE INVENTION The invention set forth in this specification pertains to new and improved container and toy block sets. These sets are considered to be more desirable for play purposes than prior related container and toy block sets. The term &#34;container&#34; is used in this specification to designate either a receptacle and a closure for the receptacle or so as to designate such a receptacle without any separate closure for use with it. Thus, this term &#34;container&#34; is used hereinto designate an item such as a wide variety of different boxes, pails and the like as well as such items including lids or covers for such receptacles. Such receptacles are often used to hold parts or blocks which are shaped or otherwise constructed so as to include interlocking elements enabling such blocks to be assembled together into what may be referred to as an &#34;assembly&#34;. Such an assembly is most commonly some sort of a fanciful shape which appeals to a child who has created it. There are many types of such blocks; many different types of interlocking elements are used with or on them so that they can be assembled into structures or assemblies which are relatively resistant to being knocked down. Because of this the term &#34;blocks&#34; is used in this specification in a rather broad, generic sense. It is intended to include toy building elements as generally rectangular hollow blocks having cylinders arranged in a pattern on one of their surfaces in such a manner that the cylinders on one block can be frictionally fitted within the interior of an adjacent block. It is also intended to include comparatively long, notched, rod-like or log elements capable of being assembled in the manner in which log cabins were once constructed. The term &#34;blocks&#34; as used herein is also intended to cover a wide variety of other reasonably related construction toy elements having different types of shapes and using differet interlocking structures. Such blocks are commonly sold in containers as indicated in the preceding so that in effect the container used and the blocks sold within it constitute what may be referred to as a &#34;set&#34;. Normally the container in such a set is constructed so that it can serve as a place for a child to store the blocks originally sold in it during the times when such blocks are not being employed for play purposes. During the use of the blocks of such a set a child will frequently desire to make as large an assembly of blocks as reasonably possible. Frequently a child will also desire to protect and store a partially completed or a fully completed assembly of the blocks. Because of the fact that the containers used with such sets have been constructed so as to serve only as containers it has not been possible to effectively use such a container as a part of an assembly created with such blocks so as to increase the dimensions of such an assembly by in effect supplementing the blocks in the set by using the container as a part of the set. Further, the containers of known sets have not been especially constructed for use in protecting and storing an assembly of blocks as, for example, when it may be desired to complete such an assembly at a subsequent time. BRIEF SUMMARY OF THE INVENTION Broadly, the invention is intended to supply new and improved container and toy blocks sets. More specifically an object of the invention is to provide such sets which are of such a nature that either all or a part of the containers used in the set can be incorporated into as assembly of the blocks originally packaged in the container so as to make it possible to construct an assembly which is significantly larger than one constructed using only the blocks in the set. Another objective is to provide sets as noted which can be used in storing an assembly made form the blocks in the set. Further, the invention is intended to provide sets as noted which are not significantly more expensive than prior related sets not having the capability of the sets of the invention. In accordance with this invention these various objectives are achieved by providing in the combination of a container, said container comprising a receptacle and a lid for said receptacle, and a series of blocks, each of said blocks including interlocking means, said interlocking means on said blocks being of such a character as to enable said blocks to be assembled into an interlocked assembly of said blocks the improvement which comprises: an external surface on a part of said container including other interlocking means which are capable of interlocking with said interlocking means on said blocks so as to be assembled into an interlocked assembly incluing both said part and said blocks. BRIEF DESCRIPTION OF THE DRAWINGS Because of the nature of this invention it is best more fully described with reference to the accompanying drawings in which: FIG. 1 is a top plan view of a presently preferred container including a crate-like receptacle and an assembled lid which is intended to be used in a container and block set in accordance with the invention; FIG. 2 is a side elevational view of one type of block which is capable of being used with the container shown in the preceding figure; FIG. 3 is a side elevational view of the container shown in FIG. 1, the other side elevational view of the container being the mirror image of this view; FIG. 4 is an end elevational view of the container shown in FIG. 1, the other end elevational view of the container being a mirror image of this view; FIG. 5 is a bottom plan view of the container shown in FIG. 1; FIG. 6 is a partial cross-sectional view taken at line 6--6 of FIG. 3; FIG. 7 is a partial cross-sectional view taken at line 7--7 of FIG. 4; FIGS. 8, 9, and 10 are diagrammatic views showing the various uses of a container as shown in FIG. 1; FIG. 11 is a side elevational view of another presently preferred embodiment of a container including a pail and an assembled lid which is intended to be used in a container and toy block set in accordance with this invention; FIG. 12 is a side elevational view at an enlarged scale of a toy block for use with a container as shown in FIG. 8, this view being partially broken away so as to indicated the nature of the block illustrated; FIG. 13 is a partial cross sectional view taken at line 12--12 of FIG. 10; FIG. 14, 15, and 16 are diagrammatic views of a container as shown in FIG. 10; The two different presently preferred container shown in the drawings are constructed so as to employ the operative concepts or principles of the invention as are set forth and defined in the appended claims. Those skilled in the toy block will field will realize that a wise variety of differently appearing and differently constructed container and block sets can be constructed using these concepts or principles on the basis of the disclosure of this specification. For this reason the invention is not to be considered to be limited to precise structures as shown. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS In FIG. 1 of the drawing there is shown a container 10 in accordance with the present invention which includes a generally rectangular receptacle 12 having a normally open top 14. This top 14 is adapted to be closed off through the use of a cover or lid 16. The receptacle 12 and the lid 16 can conveniently be formed of the same or different comparatively rigid or self supporting polymers by known, conventional techniques. If the container 12 is a comparatively large container it may be preferable to form the receptacle 12 and the lid 16 out of wood. The receptacle 12 has a base or bottom 18 which carries a series of four upstanding corner posts 20, a series of slats 22 and end panels 24. These panels 24 are located between two of the slats 22 as shown. Small flanges 26 capable of being used as handles are located at the tops of the panels 24 so as to extend parallel to the bottom 18. If desired a reinforcing band 28 as shown in phanton can be located parallel to the bottom 18 in order to reinforce the corner posts 20 and the slats 22. Normally such a band 28 will not be needed in those cases where the container 10 is of a comparatively small size. The lid 16 preferably includes corner angles 30 which frictionally engage the corner posts 20 so as to hold the lid 16 in place on the receptacle 12 in such a manner that it can be easily removed. If desired, conventional detents or latches can be employed to hold the lid 16 in place. Notches 32 may be provided in the bottom 18 to facilitate molding of the receptacle 18. Except for the presence of these notches 32 the bottom 18 and the lid 16 are identical. It is presently preferred to construct 10 so that both the lid 16 and the bottom 18 are provided with identical square holes 34 as shown. These holes 34 are located in rows (not separately numbered) in a two dimensional rectangular pattern in which the distances between the holes 34 is slightly less than the side dimension of any of the holes 34. As a consequence of such spacing the holes 34 will interfit with or accommodate notches 36 in elongated, log-like toy blocks 38 such as the block 38 shown in FIG. 2. As a result of such accommodation various assemblies 40 of such blocks 38 as indicated in FIGS. 8 and 9 can be constructed directly on the lid 16 or the bottom 18 either when the container 10 is assembled with the lid 16 in place as shown or when the lid 16 has been removed from the receptacle 12. When the lid 16 has been removed from the receptacle 12 it is considered preferable to support the lid 16 on several of the blocks 38 as indicated in FIG. 9 so as to achieve a &#34;good&#34; interlock between the blocks 38 and the lid 16. Further in this case the receptacle 12 can be inverted on the lid 16 to protect an assembly 40. If desired, an assembly 40 of the blades 38 can be conveniently interfitted with both the lid 16 and the receptacle 12 as shown in FIG. 10. The receptacle 12 is also preferably formed so that the corner posts 20 and slats 22 are spaced in such a manner as to accommodate or receive these same notches 36. If for any reason the complete container 10 or the receptacle 12 is used or is intended to be used on its side or end. To facilitate such use it would be possible to form the container 10 so that all of its surfaces were provided with holes 34 in a pattern as indicated. This is not considered necessary. It is also considered that this would unnecessarily complicate the manufacture of the receptacle 12. The particular blocks 38 shown are of a square cross-sectional configuration and are provided with the notches 36 as shown so that they can be interlocked together in a conventional or known manner to form various assemblies. It is a matter of choice as to whether or not the blocks 38 are solid or are hollow and as to whether or not the notches 36 are shaped so as frictionally fit or closely fit together. It is possible to use blocks 38 with the invention which only have a single notch 36 or which only have a pair of notches 36 (not separately illustrated) with a notch 36 of each pair adjacent to each end 42 of a block 38. Preferably the blocks 38 are used as a set (not separately numbered) which will fill the receptacle 12 when the blocks 38 of the set are neatly stacked together so as to extend in the same direction within the receptacle 12. These blocks 38 can be of the same or various different lengths. If desired somewhat related blocks 38 of different types can, of course, be employed together. The important thing is for the blocks 38 to be able to be used so that they interlock together and with the container 10 as a result of the spacing of the holes 34 and preferably also of the posts 20 and the slats 22. In FIGS. 11 and 13 of the drawings there is shown another container 50 in accordance with this invention. This container 50 includes a receptacle or pair 52 having a peripherial sloping, conically shaped wall 54 which extends upwardly from a bottom 56 and which terminates in a an offset top 58 joined to the wall 54 by a radially extending flange or shoulder 60. Normally it is preferred to mount a handle 62 upon the offset top 58 in a conventional manner. The pail 52 is used with a lid 64 forming a part of the container 50; this lid 64 is shaped so as to include a peripheral flange 66 fitting within the top 58 against the shoulder 60. It is preferred to form the lid 64 so that it includes a pair of adjacent depressions 68 capable of being used as a handle. Preferably these depressions 68 are separated by a flat area 70 capable of receiving a label or the like. In the container the lid 64 is preferably formed so as to include areas 72 which are provided with a pattern (not numbered) of upwardly extending, regularly spaced cylinders 74 located in rows (not numbered) extending in two different directions at right angles to one another. These cylinders 74 are capable of being interfitted within cavities or interiors 76 of known, hollow, generally rectangular blocks 78 so as to be held in place by friction. The blocks 78 are constructed so as to include other cylinders 80 corresponding to the cylinders. 74. It is also preferred--but not necessary--to form the bottom 56 so that it includes a pattern (not numbered) of cavities 82 which are capable of frictionally receiving the cylinders 80 or the cylinders 74. Normally the container will be supplied to a user with the pail 52 filled with a set (not shown) of the blocks 78 so that upon removal from the container the blocks 78 can be assembled together into what may be referred to as an assembly 84 in a known or conventional manner. With the present invention such an assembly 84 can be constructed directly upon the lid 64 as shown in FIG. 14. When this is done the pail 52 can be inverted and located on the lid 64 to protect such an assembly 84 as indicated in this FIG. 14 if the assembly 84 is of a reasonably confined dimension such that it will fit within the pail 52. As an alternate to this when the lid 64 is in position on the pail 52 an assembly 84 can be created directly on the lid 64 so that the container 50 in effect enters into the assembly 84 as indicated in FIG. 15. This is considered to be desirable since such an assembly 84 tends to be a convenient height for common play purposes when the container 50 is approximately 20-30 cm. tall. If the bottom 56 is provided with cavities 82 one or more assemblies 84 of the blocks 78 can be used to support the bottom 56 so that the entire container 50 in effect is a part of an entire &#34;creation&#34; based upon the blocks 78. As an alternate when the bottoms 56 of two or more of the containers 50 are provided with such cavities 82 the containers 50 can be assembled together as indicated in FIG. 16. This can be desirable for storage as well as for play purposes. When several of such container 50 are assembled together as indicated in FIG. 16 an assembly 84 can be formed on the lid 64 of the upper most container 50 as shown. It is also possible to separate several &#34;stacked&#34; containers 50 by various blocks 78 or an assembly (not shown) of such blocks 78.

A construction set including a set of interlocking blocks and a container for the set which can be constructed so that at least a part of the container interlocks with the blocks. As a consequence, a structure may be erected using both the blocks and the container. Such a structure is desirable because it is significantly larger than a structure which could be created from the set of blocks alone.

BACKGROUND OF THE INVENTION [0001] The present invention relates to devices used for cleaning shaving razors, and more particularly to a portable device that produces a flow of cleaning fluid, which can be directed at hair particles and shaving cream trapped in a razor, thereby dislodging and washing such debris away from the razor. [0002] Trapped hair particles in a razor reduce its cutting effectiveness, and are a source of skin irritation during shaving. Therefore, constant cleaning of the razor during shaving is required to maintain an acceptable performance. The most common method of cleaning is by placing the razor under running water and, often, imparting mechanical shock by “tapping” the razor against the sink surface. This method is very ineffective and time-consuming, especially with the double- and triple-blade razors, and the newer, thicker shaving creams. These creams, mixed with the hair particles, are extremely difficult to remove from the crevices between the blades. “Tapping” also creates mechanical stresses that are damaging to the razor. [0003] Clearly, a need exists for a fast, effective and low-mechanical-stress method to clean razors. There is a number of patents describing devices that attempt to address the issue. U.S Pat. No. 4,027,387 (Kellis), U.S Pat. No. 4,480,387 (d&#39;Alayer de Costemore d&#39;Arc), U.S Pat. No. 4,838,949 (Dugrot) and U.S Pat. No. 4,941,492 (Morgan) all describe devices that have a chamber which receives the razor head and means that attach to a water faucet, which provides water under pressure for cleaning the razor. The usefulness of such devices is limited, as they cannot be used with all available faucet designs. Furthermore, as the water flow needs to be aimed accurately at the areas of hair particle and soap accumulation, positioning the razor head within the cavity that receives it, is critical. “Blindly” placing the razor head within the cavity will not result in an effective cleaning. Additionally, with the proliferation of razor head shapes and sizes in the market, proper fit between the chamber and the razor head is not always possible. [0004] U.S Pat. No. 5,365,958 (Stuhlmacher) describes a device which allows the razor to be moved relative to the water jets, therefore addressing one of the disadvantages of the earlier inventions. However, this device requires permanent attachment to the water supply for operation, hampering its portability. [0005] All the patents discussed so far need to be attached to the water supply during operation, which limits their flexibility and requires them to use water as the only cleaning fluid. [0006] U.S Pat. No. 6,009,622 (Liedblad) describes a device having a recess for the razor, which is submerged in water together with the razor and water pressure is generated by squeezing the device. This system requires the application of manual power in real time for its operation, so results will vary from person to person. While this device eliminates the need for connection to the faucet, and is capable of using cleaning fluids other than water, it still has the disadvantage of most of the previously discussed devices in that the placement of the razor head relative to the water flow is fixed resulting, as explained earlier, in diminished cleaning effectiveness. This device will also be slippery, and therefore difficult to operate, when covered with shaving cream and water. [0007] A simple approach to cleaning razors would be to use a syringe with a nozzle attached to one end and a piston-plunger combination that is able to move freely within it. After initially filling the syringe with water, pushing the plunger would force water to be expelled through the nozzle. The water jet thus created could be used to clean a razor. A disadvantage of this approach is that it is difficult to accurately aim the nozzle while concurrently pushing the plunger on the opposite end of the syringe. [0008] The advantages of a moveable and aimable nozzle are clear in mouth irrigation systems. There exist in the market several such systems capable of producing a high pressure, aimable water jet that could be used to clean razors. The disadvantage of such devices is that they all require AC power, and they are fairly large in size, both of which reduce their portability and their usefulness as razor cleaning systems. [0009] The need, therefore, exists for a portable, self-contained razor cleaning system, capable of using water and/or a variety of other cleaning fluids, that allows the user to direct a stream of said cleaning fluids to areas of shaving residue accumulation in the razor for high cleaning effectiveness. BRIEF SUMMARY OF THE INVENTION [0010] The present invention addresses the above and other needs, by providing a method of generating pressure independent of the user&#39;s physical ability and independent of faucet design, using relatively small amounts of water or other cleaning fluids. Furthermore, this invention describes a razor cleaning device able to produce at least one maneuverable stream of cleaning fluid that can advantageously be directed at areas of shaving residue accumulation in a razor, for cleaning the razor. [0011] One important advantage of this invention is that it allows manipulation of the stream of cleaning fluid, in moving this stream across the razor and altering its angle of incidence, which further enhance the ability of this invention to clean the razor, as these actions create pressure waves that dislodge all shaving residue. Another advantage of this invention is the use of turbulent flow to enhance its cleaning ability. [0012] A further advantage of this invention is that it is capable of cleaning any razor, cartridge or blade of any size, of the single- or multi-blade configuration, and whether the razor cartridge or blade is attached to the body of the razor or has been removed therefrom. The usefulness of the device is not limited to cleaning razor blades only, but this invention is also capable of cleaning the entire body of the razor, or other items, from accumulated debris over a period of use. [0013] In the following, we shall refer to water and the cleaning fluid interchangeably, with the understanding that this invention is capable of using a variety of cleaning fluids, even including compressed gases, instead of, or in addition to, water. [0014] In a preferred embodiment of this invention a set of batteries supply power to an electric motor driving a pump. Water is stored in a compartment within the device, and is forced by the pump through an opening in the wall of the device. This opening, by manipulation of the device, can easily and advantageously be directed at the specific locations of hair and lather accumulation in the razor. The battery-motor combination allows the device to be extremely small in size and self-sufficient in regards to energy needs. The water holding compartment and the small size of the device increase its portability. The pressure that the motor generates can advantageously and controllably produce a high velocity stream of water, with high cleaning effectiveness, such that smaller amounts of water and shorter times are necessary to thoroughly clean a razor. [0015] In a second embodiment of this invention a set of batteries supply current to an electric motor driving a pump, which is immersed in water. The pump is forcing water through flexible tubing having one open end. This open end can easily and advantageously be directed at the specific locations of hair and lather accumulation in the razor. The battery-motor combination allows the device to be extremely small in size, and self-sufficient in regards to energy needs. The small size of the device permits its placement in an open container as small as a drinking cup. The pressure that the motor generates can advantageously and controllably produce a high velocity stream of water, with high cleaning effectiveness, such that smaller amounts of water and shorter times are necessary to thoroughly clean a razor. [0016] In a third embodiment of the invention a spring located within the proximal end of a water chamber is driving a piston that moves within said water chamber. On the distal end of the water chamber a nozzle, or flexible tubing terminating in a nozzle, is attached. In operation the user preloads the spring by pulling onto a plunger connected to the piston. This action also may be used to fill the water chamber with water through the nozzle. Once the spring is preloaded, it can be controllably released via a mechanical trigger that acts directly onto the plunger, or via a valve advantageously located near the nozzle or at the distal end of the water chamber. This design combines the operation of preloading and filling the device with water in one step. Operating costs of this embodiment are minimal. [0017] A variety of other embodiments are within the scope of the present invention. By way of example such an embodiment may comprise a miniature compressed gas cylinder which is attached to the main body of the device via a quick disconnect valve, and forces water contained in a chamber within the device, through a nozzle. The nozzle may be attached to the main body of the invention either directly or through flexible tubing. Means for controlling the pressure and flow of the water may advantageously be located near the nozzle and, optionally, between the compressed gas cylinder and the water chamber. [0018] In yet another embodiment of the invention a manual pump and pressure chamber may replace the compressed gas cylinder. The user at first uses the pump to drive and pressurize air into the pressure chamber. Then operation continues as in the previous embodiment. This design eliminates the dependency on the availability of a compressed gas cylinder, and has lower operating costs. [0019] These embodiments of the invention describe a miniature, flexible, self-contained, and very portable system, with improved cleaning and water usage efficiency over systems described in the prior art. All these embodiments can operate independently of faucet design and employ a maneuverable nozzle, which advantageously permits directing the water jet to the specific locations of the razor with hair and lather accumulation. The designs describe a single nozzle, but a multiple-nozzle design is also within the scope of this invention. [0020] Although the invention has been presented herein in terms of specific embodiments, a person skilled in the art will realize that several other variations are possible and are within the scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS [0021] The above and other features and advantages of the present invention will be more apparent from the following more particular description thereof, presented in conjunction with the following drawings, wherein: [0022] [0022]FIG. 1 is a cross-sectional view of a self-contained, motor-driven razor cleaner; [0023] [0023]FIG. 2 is a cross-sectional view of an immersion-type, motor-driven razor cleaner having a flexible output tube; [0024] [0024]FIG. 3 is an isometric view of an immersion-type, motor-driven razor cleaner; [0025] [0025]FIG. 4 is a cross-sectional view of a tabletop, AC motor-driven razor cleaner, having flexible intake and output tubes; [0026] [0026]FIG. 4A is a cross-sectional view of a motor-driven razor cleaner, wherein the free end of the intake tube has a weight attached; [0027] [0027]FIG. 4B depicts a clip and ring system for attaching an intake tube to a cleaning fluid container. [0028] [0028]FIG. 5 is a cross-sectional view of a manually-operated razor cleaner; [0029] [0029]FIG. 6 is a detail cross-sectional view of a nozzle; [0030] [0030]FIG. 6A is a detail cross-sectional view of a nozzle, having turbulence-generating internal wall features; [0031] [0031]FIG. 6B is a detail cross-sectional view of a nozzle, having splash guards; [0032] [0032]FIG. 7 is an isometric view of an AC operated, tabletop, motor-driven razor cleaner, having conditioning electronics, a collapsible chamber for holding cleaning fluid, and a multi-output nozzle design; [0033] [0033]FIG. 8 is an isometric view of a charging station, and a motor-driven razor cleaner having rechargeable batteries; [0034] [0034]FIG. 9 is a cross-sectional view of a manually-operated razor cleaner, having a brake for controlling the flow of cleaning fluid; [0035] [0035]FIG. 10 is a cross-sectional view of a nozzle having a flow control valve. [0036] For the convenience of the reader, below is a list of reference numbers associated with the figures. Ref. Number Component 10 Housing 15 Clearance Bump 20 Motor 25 Motor Shaft 30 Holding Chamber 35 Cleaning Fluid Container 36 Cleaning Fluid 40 Battery 45 Pump Cavity 50 Impeller 60 Pump Intake Port 70 Pump Output Port 75 Nozzle 76 Nozzle Input Aperture 77 Nozzle Output Aperture 78 Roughened Interior Wall of Output Aperture 79 Splash Guard 80 Pump Seal 90 Intake Channel 100 Switch 110 Switch Cover 120 Negative Wire 121 Neutral Wire 125 Positive Wire 126 Hot Wire 130 Battery Chamber Cover 140 Negative Contact 150 Vent 160 Holding Chamber Cover 170 Vent Valve 180 Battery Chamber 190 Positive Contact 200 Flexible Output Tube 210 Free End of Flexible Output Tube 220 Attached End of Flexible Output Tube 230 Flexible Intake Tube 240 Free End of Flexible Intake Tube 245 Weight 247 Clip 248 Ring 250 Attached End of Flexible Intake Tube 260 Plunger 270 Piston 280 Spring 290 Electric Cable 300 Electric Plug 310 Charging Base 320 Conditioning Electronics 350 Valve Actuator 360 Actuator Port 370 Actuator Spring 380 Valve Input Aperture 390 Valve Output Aperture 400 Brake Mechanism 410 Brake Handle 420 Brake Plate 430 Brake Spring 440 Pivot Pin 450 Brake Support Structure 460 Brake Plate Opening DETAILED DESCRIPTION OF THE INVENTION [0037] The following description is of the best modes presently contemplated for carrying out the invention. This description is not to be taken in a limiting sense, but is made merely for the purpose of describing the general principles of the invention. The scope of the invention should be determined with reference to the claims. [0038] [0038]FIG. 1 depicts a cross section of a preferred embodiment of this invention, comprising a Housing 10, having a Holding Chamber 30, for holding cleaning fluid. The Holding Chamber 30, has a Holding Chamber Cover 160, having a Vent 150, and a Vent Valve 170, and is fluidly communicating with a Pump Intake Port 60, via an Intake Channel 90. The Pump Intake Port 60, leads to a Pump Cavity 45, which houses an Impeller 50. The Pump Cavity 45, also has a Pump Output Port 70, which forms the output of the system. [0039] The Impeller 50, is mechanically connected to a Motor 20, via a Motor Shaft 25. A Pump Seal 80, around said Motor Shaft 25, separates the Pump Cavity 45, from said Motor 20, and prevents cleaning fluid from flowing towards the Motor 20. [0040] Said Motor 20, is electrically connected to Batteries 40, residing in a Battery Chamber 180, within said Housing 10, via a Positive Contact 190, a Switch 100, a Positive Wire 125, a Negative Wire 120, and a Negative Contact 140, such that the Switch 100, controls the flow of electrical current through the Motor 20. Said Negative Contact 140, is attached to a Battery Chamber Cover 130, said Battery Chamber Cover 130, forcing the Batteries 40, against themselves and the Negative Contact 140, and the Positive Contact 190, thereby maintaining good electrical connection between said components. [0041] A flexible Switch Cover 110, preferably made by an elastomeric material, is attached to the Housing 10, and environmentally protects the Switch 100. [0042] The Switch 100, is preferably a push-on momentary switch, but other types of switches, including toggle types may be used. [0043] Wherein, in operation, a user first fills the Holding Chamber 30, with cleaning fluid, and then closes the Holding Chamber 30, using the Holding Chamber Cover 160. Then the user operates the Switch 100, by depressing the Switch Cover 110, thus activating the Motor 20. The Motor 20, pumps cleaning fluid from the Holding Chamber 30, and expels it through the Pump Output Port 70. The user, by manipulating the entire device, may then direct the stream of cleaning fluid thus generated, at locations of shaving residue accumulation in the razor, cleaning said razor. The Holding Chamber Cover 160, prevents cleaning fluid from flowing outside the Holding Chamber 30, while the device is manipulated by the user. The Vent Valve 170, is preferably a thin elastomeric leaf, such as one made of silicone rubber, of generally rectangular shape, having three free sides and having a fourth side attached to the inside surface of the Holding Chamber Cover 160, extending over the opening of the Vent 150. The Vent Valve 170, is thus able to maintain atmospheric pressure within the Holding Chamber 30, by allowing air to enter, while keeping cleaning fluid from flowing out of the Holding Chamber 30. Other valve designs, commonly known as check valves, essentially accomplishing the same task, may be used in lieu of the aforementioned valve design. [0044] [0044]FIG. 2 depicts a different embodiment of the invention, of the immersion type, wherein the invention comprises a Housing 10, having a Motor 20, mechanically connected to an Impeller 50, residing in a Pump Cavity 45, via a Motor Shaft 25. A Pump Seal 80, around the Motor Shaft 25, keeps fluids from entering the Motor 20. [0045] The Pump Cavity 45, has a Pump Intake Port 60, connected to the outside via an Intake Channel 90, and a Pump Output Port 70, fluidly communicating with a Flexible Output Tube 200, having an Attached End 220, attached to the Housing 10, and a Free End 210, open to the outside. [0046] The motor is electrically connected to Batteries 40, residing in a Battery Chamber 180, via a Positive Wire 125, a Switch 100, a Positive Contact 190, a Negative Contact 140, and a Negative Wire 120, such that the Switch 100, controls the flow of electrical current through the Motor 20. Said Negative Contact 140, is attached to a Battery Chamber Cover 130, said Battery Chamber Cover 130, forcing the Batteries 40, against themselves and the Negative Contact 140, and the Positive Contact 190, thereby maintaining good electrical connection between said components. [0047] The Switch 100, is advantageously located in the bottom of the Housing 10, and operated by the weight of said Housing 10. The Switch 100, is preferably a push-on momentary switch, but other types of switches, including toggle types may be used. [0048] Said Battery Chamber Cover 130, environmentally protects the Battery Chamber 180, preventing liquids from entering the Battery Chamber 180, whereas a flexible Switch Cover 110, attached to the Housing 10, environmentally protects the Switch 100. [0049] [0049]FIG. 3 depicts an isometric view of the immersion-type device, having Clearance Bumps 15, at the bottom of the Housing 10, which Clearance Bumps 15, facilitate the flow of cleaning fluid into Intake Channel 90. Furthermore, in this variation the Switch Cover 110, protecting the Switch 100, is at the top of said Housing 10. Finally, the Flexible Output Tube 200, terminates in a Nozzle 75, attached at the Free End 210, of said Flexible Output Tube 200. [0050] Wherein, in operation, a user fills a Cleaning Fluid Container 35, such as a small drinking cup, with Cleaning Fluid 36, and immerses the device within said Cleaning Fluid Container 35. Whereas the Switch 100, is at the bottom of the Housing 10, the device will automatically operate, else the user will depress the Switch Cover 110, activating the device. Upon such activation, the Motor 20, rotates the Impeller 50, forcing the Cleaning Fluid 36, into the device through the Intake Channel 90, and expelling it through the Free End 210, of the Flexible Output Tube 200, or through the Nozzle 75, in the form of a powerful jet. The user, by manipulating the Free End 210, of the Flexible Output Tube 200, may then direct the stream of cleaning fluid thus generated, at locations of shaving residue accumulation in the razor, cleaning said razor. [0051] Other variations of the invention exist, such as depicted in FIG. 4. This variation is a countertop device, comprising a Housing 10, having a Motor 20, mechanically connected to an Impeller 50, residing in a Pump Cavity 45, via a Motor Shaft 25. A Pump Seal 80, around the Motor Shaft 25, keeps fluids from entering the Motor 20. [0052] The Pump Cavity 45, has a Pump Intake Port 60, fluidly communicating with an Attached End 250, of a Flexible Intake Tube 230, via an Intake Channel 90, said Flexible Intake Tube 230, also having a Free End 240 open to the outside. Said Pump Cavity 45 furthermore has a Pump Output Port 70, fluidly communicating with a Flexible Output Tube 200, having an Attached End 220, attached to the Housing 10, and a Free End 210, open to the outside. [0053] Said Motor 20, is electrically connected to an Electric Plug 300, via an Electric Cable 290, a Hot Wire 126, a Switch 100, and a Neutral Wire 121, whereby, when the Electric Plug 300 is plugged into a wall outlet, and the Switch 100, operated, electric current flows through the Motor 20. [0054] A flexible Switch Cover 110, protects the Switch 100, from splashes of liquid and other debris. [0055] In operation, a user fills a small container such as a drinking cup with cleaning fluid, and immerses the Free End 240, of said Flexible Intake Tube 230, within such cleaning fluid. Then the user plugs in the device and runs the Motor 20, by activating the Switch 100. The Motor 20, rotates the Impeller 50, which forms a self-priming pump within said Pump Cavity 45, and forces cleaning fluid into the Free End 240, of said Flexible Intake Tube 230, expelling it through the Free End 210, of said Flexible Output Tube 200, forming a powerful jet of cleaning fluid. The user, by manipulating the Free End 210, of said Flexible Output Tube 200, may then direct the stream of cleaning fluid thus generated, at locations of shaving residue accumulation in the razor, cleaning said razor. [0056] [0056]FIG. 4A shows a variation of the device depicted in FIG. 4, wherein the Free End 240, of said Flexible Intake Tube 230, has a Weight 245, attached, wherein said Weight 245, ensures proper immersion of the Free End 240, of said Flexible Intake Tube 230, within the cleaning fluid. [0057] [0057]FIG. 4B shows another example of securing the Flexible Intake Tube 230, to a Cleaning Fluid Container 35, and ensuring that the Free End 240, of said Flexible Intake Tube is immersed within the Cleaning Fluid 36. A Clip 247, having an attached Ring 248, is placed on the lip of said Cleaning Fluid Container 35, such that the Ring 248, hangs on the inside of said Cleaning Fluid Container 35. The Flexible Intake Tube 230, is threaded through said Ring 248, and the Free End 240, of the Flexible Intake Tube 230, is immersed in said Cleaning Fluid 36. Said Clip 247, with said attached Ring 248, could be an integral part of said Flexible Intake Tube 230, with the Clip 247, and its attached Ring 248, being slidably adjustable along said Flexible Intake Tube 230. Other methods of attachment, such as magnetic attachment of the Flexible Intake Tube 230, to the Cleaning Fluid Container 35, are also within the scope of the present specification. [0058] [0058]FIG. 5 depicts a manually operated embodiment of the invention, wherein a Housing 10, has a Holding Chamber 30, of generally cylindrical shape, wherein a Piston 270, attached to a Plunger 260, is moving freely. A Spring 280, is biasing the Piston 270, toward the front end of said Holding Chamber 30, said front end forming a Nozzle 75, having a Nozzle Input Aperture 76, and a Nozzle Output Aperture 77, open to the outside. In operation, a user immerses the nozzle in cleaning fluid and withdraws the Piston 270, by pulling back the Plunger 260. This action compresses the Spring 280, and fills the Holding Chamber 30, with cleaning fluid. The user subsequently releases the Plunger 260, and the Spring 280, forces the Piston 270, forward, expelling fluid in a powerful stream through the Nozzle Output Aperture 77. The user, by manipulating the entire device, may then direct the stream of cleaning fluid thus generated, at locations of shaving residue accumulation in the razor, cleaning said razor. [0059] The nozzle design and/or use is not limited to the specific embodiments described thus far. By way of example, a Nozzle 75, could be attached to the Pump Output Port 70, of the self-contained device described in conjunction with FIG. 1. FIG. 6A depicts such an embodiment. FIG. 6B depicts a similar embodiment, wherein the Nozzle 75, has Roughened Interior Walls 78, advantageously inducing a turbulent flow, which more effectively cleans razors with the inherent sudden velocity variations within the turbulent stream of cleaning fluid. FIG. 6C depicts a Nozzle 75, having a Splash Guard 79, preferably of sufficient size to contain the entire razor head. Said Splash Guard 79, controls splashes of cleaning fluid as it is deflected by the razor, and may be rigid or flexible, permanently attached to the Nozzle 75, or removable, or having features to attach directly to Housing 10. [0060] [0060]FIG. 7 is an isometric view of a countertop embodiment of the invention, wherein the Flexible Output Tube 200, terminates in a Nozzle 75, having multiple Nozzle Output Apertures 77. Furthermore, the Flexible Intake Tube 230, is connected to the Holding Chamber Cover 160, of a Holding Chamber 30, said Holding Chamber 30, advantageously having collapsible walls. Additionally, an Electric Cable 290, has Conditioning Electronics 320, attached to its end, wherein, in operation a user fills the Holding Chamber 30, with cleaning fluid, and attaches the Flexible Intake Tube 230, to said Holding Chamber 30, by means of the Holding Chamber Cover 160. Then the user depresses the Switch Cover 110, operating the device. The Conditioning Electronics 320, reduce the electric outlet voltage to a safe level, and may also perform an AC/DC conversion. Although the Conditioning Electronics 320, are depicted attached at the free end of the Electric Cable 290, they alternatively may reside within the Housing 10. [0061] The collapsible walls of Holding Chamber 30, collapse as the cleaning fluid is removed from the Holding Chamber 30, thus eliminating the need for a vent valve for venting said Holding Chamber 30. [0062] Yet another embodiment of the invention comprises rechargeable batteries enclosed within the Housing 10. For example, the device depicted in FIG. 8, may contain a rechargeable battery permanently installed within the Housing 10, or removable, a power coil, and conditioning electronics for charging the battery. A user would recharge the battery by placing the device within a Charging Base 310, having a matching power coil, and an Electric Cable 290, connected to an Electric Plug 300, and plugging the Electric Plug 300, into a wall outlet. The use of such methods for charging rechargeable batteries is well known in the art. [0063] [0063]FIG. 9 is a cross-sectional view of a variation of the manually-operated embodiment shown in FIG. 5, wherein this variation has means for controllably releasing a stream of cleaning fluid. Said means comprise a Brake Mechanism 400, having a Brake Handle 410, rigidly attached to a Brake Plate 420, said Brake Plate 420, having an Opening 460. Said Brake Mechanism 400, pivots about a Pivot Pin 440, attached to a Brake Support Structure 450. Said Brake Support Structure 450, is rigidly attached to the Housing 10. A Brake Spring 430, is biasing the Brake Handle 410, in a clockwise direction with reference to FIG. 9, and away from the Housing 10. This action of the spring rotates the Brake Plate 420, thereby rotating the Opening 460, such that the internal walls of the Opening 460, interfere with the Plunger 260. When the user withdraws the Plunger 260, compressing the spring, the shape of the Opening 460, and its position relative to the Pivot Pin 440, force the Brake Mechanism 400, to rotate slightly counterclockwise and allow movement of the Plunger 260. Upon release of the Plunger 260, the frictional forces generated by the interference between the Plunger 260, and the internal walls of the Opening 460, further tend to rotate the Brake Mechanism 400, clockwise, increasing the interference, effectively locking the Plunger 260, and preventing its motion. To release the Plunger 260, and expel cleaning liquid from the Nozzle 75, the user slightly depresses the Brake Handle 410, removing the interference. Upon release of the Brake Handle 410, the Brake Spring 430, biases the Brake Mechanism 400, clockwise again, thereby stopping the plunger once more, stopping the ejection of cleaning fluid. [0064] Whereas a specific brake mechanism is described herein, several other brake mechanisms and other methods of controlling the flow of cleaning fluid may be implemented and are within the scope of the present invention. By way of example, FIG. 10 depicts a cross-sectional view of a flow control valve located in the Nozzle 75, separating the Nozzle Input Aperture 76 from the Nozzle Output Aperture 77. The valve comprises walls having a Valve Input Aperture 380, and a Valve Output Aperture 390. Within the valve a Valve Actuator 350, having an Actuator Port 360, is allowed to move. An Actuator Spring 370, biases the Valve Actuator 350, such that the Actuator Port 360, the Valve Input Aperture 380, and the Valve Output Aperture 390, are misaligned, thereby preventing the flow of cleaning fluid through the valve. When the pressurizing means of the razor cleaning device is activated, a user depresses the Valve Actuator 350, thereby aligning the Actuator Port 360, the Valve Input Aperture 380 and the Valve Output Aperture 390, permitting the flow of cleaning fluid from the Nozzle Input Aperture 76 to the Nozzle Output Aperture 77. Upon release of the Valve Actuator 350, the Actuator Spring 370, biases the Valve Actuator 350, in a position of misalignment, thereby stopping the flow of cleaning fluid. [0065] The valve described herein is commonly known in the art as a gate valve. Other types of valves may be used instead, such as a ball valve, a needle valve, a valve wherein a flexible tube gets pinched thereby controlling the flow of fluid, etc. [0066] Whereas the invention has been described herein in terms of specific embodiments, persons skilled in the art will readily recognize that many more embodiments are possible and fall within the scope of this invention. For example, all combinations of all features of each embodiment with each other embodiment will result in a multitude of new embodiments which all fall within the scope of this invention. Furthermore, a variety of other features, may be added or substitute existing features in each embodiment. By way of example, pressurizing means may include a pressurized gas cylinder able to attach to the Housing 10, by means of quick disconnect valves, or a manual pump and a pressure chamber, in fluid communication with the Holding Chamber 30. In such embodiments means for controlling the gas pressure may be included. The flow valve may be placed within the Housing 10, instead of in the Nozzle 75. The electrical switch may be substituted by an optoelectronic switch, or Hall effect switch, or a Reed switch. The switch may be placed near the Free End 210, of the Flexible Output Tube 200. Alternatively, such embodiments may have no switch at all, operating the moment that are plugged into the wall, or the batteries installed, for example. Also, the rechargeable batteries may be recharged by photoelectric cells, attached to the Housing 10, or in a separate module that the device is plugged in after each use. Therefore, the scope of this invention should be determined in reference to the claims, herein.

A device for cleaning razors uses a variety of pressurizing means to force water or other cleaning fluid contained in an external container or in a chamber within the device, through a maneuverable nozzle. The maneuverability of the nozzle allows the user to direct the jet of water or other cleaning fluid to areas of the razor that are filled with lather and hair particles, and quickly and efficiently clean the razor. Means for controlling the water flow may be included and preferably located near the nozzle.

RELATED APPLICATION [0001] This application claims the benefit under 35 U.S.C. § 119(e) of U.S. provisional application 60/932,437, filed May 31, 2007, the entire disclosure of which is incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention relates to a novel reference plant, a method for producing a novel reference plant, extracts free of a medicinally active compound or group of compounds obtained therefrom and their use. More particularly, the novel reference plant is a plant derived from a comparator plant. In an exemplifying embodiment the medicinal compounds, which are “knocked out”, are one or more cannabinoids and the plant is cannabis, Cannabis sativa, plant. BACKGROUND OF THE INVENTION [0003] Many pharmaceuticals are derived from plants and indeed many plants or extracts obtained therefrom are taken as medicines. There are over 120 distinct chemical substances derived from plants that are considered as important drugs that are currently in use. The table below lists some of these substances. [0004] There are many examples of plant-based substances that are known for their medicinal properties. For example a tropical plant, Cephaelis ipecacuanha , is known to produce the chemical emetine. A drug was developed from this substance called Ipecac; this was used for many years to induce vomiting. Another example of plant-based substances used as medicines is the plant chemical named taxol found in the Pacific Yew tree. The taxol molecule was produced synthetically to produce the drug PACLITAXEL™, which is used in the treatment of various types of tumours. [0005] The plant substance, cynarin, is a plant chemical found in the common artichoke ( Cynara scolymus ). A cynarin drug is sold for the treatment of liver problems and hypertension. The drug is simply an extract from the artichoke plant that has been standardized to contain a specific amount of cyanarin. Similarly the substance silymarin is a chemical found in the milk thistle plant and natural milk thistle extracts that have been standardized to contain specific amounts of silymarin are also used for the treatment of liver problems. [0006] Some of the drugs/chemicals shown in the table below are sold as plant based drugs produced from processing the plant material. Many plant chemicals cannot be completely synthesised in the laboratory due to the complex nature of the plant extract. For example the tree Cinchona ledgeriana produces the substance quinine, which is used in to treat and prevent malaria. Quinine is now chemically synthesised; however, another chemical in the tree called quinidine, which was found to be useful for the treatment of heart conditions, couldn&#39;t be completely copied in the laboratory. The tree bark is used to produce a quinidine extract. [0007] The table below details some of the plant-based medicines that are in use today. [0000] Drug/Chemical Action/Clinical Use Plant Source Acetyldigoxin Cardiotonic Digitalis lanata Adoniside Cardiotonic Adonis vernalis Aescin Anti-inflammatory Aesculus hippocastanum Aesculetin Anti-dysentery Frazinus rhychophylla Agrimophol Anthelmintic Agrimonia supatoria Ajmalicine Circulatory Disorders Rauvolfia sepentina Allantoin Wound healing Several plants Allyl isothiocyanate Rubefacient Brassica nigra Anabesine Skeletal muscle relaxant Anabasis sphylla Andrographolide Baccillary dysentery Andrographis paniculata Anisodamine Anticholinergic Anisodus tanguticus Anisodine Anticholinergic Anisodus tanguticus Arecoline Anthelmintic Areca catechu Asiaticoside Wound healing Centella asiatica Atropine Anticholinergic Atropa belladonna Benzyl benzoate Scabicide Several plants Berberine Bacillary dysentery Berberis vulgaris Bergenin Antitussive Ardisia japonica Betulinic acid Anticancerous Betula alba Borneol Antipyretic, analgesic, Several plants anti-inflammatory Bromelain Anti-inflammatory, Ananas comosus proteolytic Caffeine CNS stimulant Camellia sinensis Camphor Rubefacient Cinnamomum camphora Camptothecin Anticancerous Camptotheca acuminata (+)-Catechin Haemostatic Potentilla fragarioides Chymopapain Proteolytic, mucolytic Carica papaya Cissampeline Skeletal muscle relaxant Cissampelos pareira Cocaine Local anaesthetic Erythroxylum coca Codeine Analgesic, antitussive Papaver somniferum Colchiceine amide Anti-tumour agent Colchicum autumnale Colchicine Anti-tumour agent, Colchicum autumnale anti-gout Convallatoxin Cardiotonic Convallaria majalis Curcumin Choleretic Curcuma longa Cynarin Choleretic Cynara scolymus Danthron Laxative Cassia species Demecolcine Anti-tumour agent Colchicum autumnale Deserpidine Antihypertensive, Rauvolfia canescens tranquillizer Deslanoside Cardiotonic Digitalis lanata L-Dopa Anti-parkinsonism Mucuna species Digitalin Cardiotonic Digitalis purpurea Digitoxin Cardiotonic Digitalis purpurea Digoxin Cardiotonic Digitalis purpurea Emetine Amoebicide, emetic Cephaelis ipecacuanha Ephedrine Sympathomimetic, Ephedra sinica antihistamine Etoposide Anti-tumour agent Podophyllum peltatum Galanthamine Cholinesterase inhibitor Lycoris squamigera Gitalin Cardiotonic Digitalis purpurea Glaucarubin Amoebicide Simarouba glauca Glaucine Antitussive Glaucium flavum Glasiovine Antidepressant Octea glaziovii Glycyrrhizin Sweetener, Addison&#39;s Glycyrrhiza glabra disease Gossypol Male contraceptive Gossypium species Hemsleyadin Bacillary dysentery Hemsleya amabilis Hesperidin Capillary fragility Citrus species Hydrastine Hemostatic, astringent Hydrastis canadensis Hyoscyamine Anticholinergic Hyoscyamus niger Irinotecan Anticancer, anti-tumour Camptotheca acuminata agent Kaibic acud Ascaricide Digenea simplex Kawain Tranquillizer Piper methysticum Kheltin Bronchodilator Ammi visaga Lanatosides A, B, C Cardiotonic Digitalis lanata Lapachol Anticancer, anti-tumour Tabebuia species a-Lobeline Smoking deterrant, Lobelia inflata respiratory stimulant Menthol Rubefacient Mentha species Methyl salicylate Rubefacient Gaultheria procumbens Monocrotaline Anti-tumour agent Crotalaria sessiliflora (topical) Morphine Analgesic Papaver somniferum Neoandrographolide Dysentery Andrographis paniculata Nicotine Insecticide Nicotiana tabacum Nordihydro- Antioxidant Larrea divaricata guaiaretic acid Noscapine Antitussive Papaver somniferum Ouabain Cardiotonic Strophanthus gratus Pachycarpine Oxytocic Sophora pschycarpa Palmatine Antipyretic, detoxicant Coptis japonica Papain Proteolytic, mucolytic Carica papaya Papavarine Smooth muscle relaxant Papaver somniferum Phyllodulcin Sweetner Hydrangea macrophylla Physostigmine Cholinesterase Inhibitor Physostigma venenosum Picrotoxin Analeptic Anamirta cocculus Pilocarpine Parasympathomimetic Pilocarpus jaborandi Pinitol Expectorant Several plants Podophyllotoxin Anti-tumour, anticancer Podophyllum peltatum agent Protoveratrines A, B Antihypertensive Veratrum album Pseudoephredrine* Sympathomimetic Ephedra sinica Pseudoephedrine, Sympathomimetic Ephedra sinica nor- Quinidine Antiarrhythmic Cinchona ledgeriana Quinine Antimalarial, antipyretic Cinchona ledgeriana Quisqualic acid Anthelmintic Quisqualis indica Rescinnamine Antihypertensive, Rauvolfia serpentina tranquillizer Reserpine Antihypertensive, Rauvolfia serpentina tranquillizer Rhomitoxin Antihypertensive, Rhododendron molle tranquillizer Rorifone Antitussive Rorippa indica Rotenone Piscicide, Insecticide Lonchocarpus nicou Rotundine Analgesic, sedative, Stephania sinica tranquilizer Rutin Capillary fragility Citrus species Salicin Analgesic Salix alba Sanguinarine Dental plaque inhibitor Sanguinaria canadensis Santonin Ascaricide Artemisia maritma Scillarin A Cardiotonic Urginea maritima Scopolamine Sedative Datura species Sennosides A, B Laxative Cassia species Silymarin Antihepatotoxic Silybum marianum Sparteine Oxytocic Cytisus scoparius Stevioside Sweetener Stevia rebaudiana Strychnine CNS stimulant Strychnos nux - vomica TAXOL ® Anti-tumour agent Taxus brevifolia Teniposide Anti-tumour agent Podophyllum peltatum Tetra- Antiemetic, decrease Cannabis sativa hydrocannabinol ocular tension Tetrahydropalmatine Analgesic, sedative, Corydalis ambigua tranquilizer Tetrandrine Antihypertensive Stephania tetrandra Theobromine Diuretic, vasodilator Theobroma cacao Theophylline Diuretic, bronchodilator Theobroma cacao and others Thymol Antifungal (topical) Thymus vulgaris Topotecan Anti-tumour, anticancer Camptotheca acuminata agent Trichosanthin Abortifacient Trichosanthes kirilowii Tubocurarine Skeletal muscle relaxant Chondodendron tomentosum Valapotriates Sedative Valeriana officinalis Vasicine Cerebral stimulant Vinca minor Vinblastine Anti-tumour, Catharanthus roseus Antileukemic agent Vincristine Anti-tumour, Catharanthus roseus Antileukemic agent Yohimbine Aphrodisiac Pausinystalia yohimbe Yuanhuacine Abortifacient Daphne genkwa Yuanhuadine Abortifacient Daphne genkwa [0008] There are many examples of extracts that are characterized by reference to a supposed active or marker. The principle described herein with reference to cannabis plants would thus be applicable to other plant types as are shown in the table above. [0009] As an example of a botanical drug, Cannabis sativa has been used as a drug for centuries, although the precise basis for the plants activity is not known. Both THC and CBD, two of the plants cannabinoids, are known to have distinct pharmacological activities and Marinol® (THC) and Sativex® (an extract containing defined amounts of both THC and CBD) are approved products for various medical indications. [0010] In the case of extracts it is of course unclear whether the efficacy of a botanical drug extract is attributable to the identified “active(s)” or “markers” and/or other components present in an extract which may provide an unidentified additive or synergistic effect or in fact be directly responsible for the activity. [0011] In the case of cannabis the supposed actives, the cannabinoids, are produced through a series of enzymatic synthesis which are outlined below: [0012] The first specific step in the pentyl cannabinoid biosynthesis is the condensation of a terpenoid moiety, geranylpyrophosphate (GPP), with the phenolic moiety, olivetolic acid (OA; 5-pentyl resorcinolic acid), to form cannabigerol (CBG). This reaction is catalysed by the enzyme geranylpyrophosphate:olivetolate geranyltransferase (GOT); [1]. Precursors for GPP are the C 5 isomers isopentenyl pyrophosphate (IPP) and dimethylallyl pyrophosphate (DMAPP). These compounds can originate from two different pathways: the mevalonate pathway (MVA) that is located in the cytoplasm; and the deoxyxylulose pathway (DOX) that operates in the plastid compartments. [0015] According to Fellermeier et al. [2], the GPP incorporated into cannabinoids is derived predominantly, and probably entirely, via the DOX pathway of the glandular trichome plastids. The phenolic moiety OA is generated by a polyketide-type mechanism. Rahaijo et al. [3] suggest that n-hexanoyl-CoA and three molecules of malonyl-CoA condense to a C 12 polyketide, which is subsequently converted into OA by a polyketide synthase. [0016] CBG is the direct precursor for each of the compounds THC [4], CBD [5] and CBC [6], [7] and [8]. The different conversions of CBG are enzymatically catalysed, and for each reaction an enzyme has been identified: THC acid synthase [4] CBD acid synthase [5] and CBC acid synthase [7] and [8]. [0017] Cannabinoids with propyl side chains, as identified by Vree et al. [9] and de Zeeuw et al. [10], result if GPP condenses with divarinic acid (DA; 5-propyl resorcinolic acid) instead of OA, into cannabigerovarin (CBGV). The condensation of n-hexanoyl-CoA and two, instead of three, molecules of malonyl-CoA, results in a C 10 polyketide, which is subsequently cyclisised into DA by a polyketide [11]. The three cannabinoid synthase enzymes are not selective for the length of the alkyl side chain and convert CBGV into the propyl homologues of CBD, THC and CBC, which are indicated as cannabidivarin (CBDV), delta 9-tetrahydrocannabivarin (THCV) and cannabichromevarin (CBCV), respectively [12]. SUMMARY OF THE INVENTION [0018] The above pathway information is provided, as it will assist in an understanding of the probable mechanism—giving rise to the zero cannabinoid plants exemplifying the broader aspects of the invention. [0019] Indeed it would be particularly useful to develop “knock out” plants in which the one or more “actives” or “markers” believed to be characteristic of a plants pharmaceutical activity are not expressed. Such plants would be useful in formulating “true” placebo extracts or comparator extracts for clinical trials and for producing extracts which could be used in pharmacological tests and experiments in order that a better understanding of an extract, and its perceived actives/markers activity. [0020] In the case of cannabis, the plant produces a vast array of cannabinoids (including THC and CBD—the main perceived cannabinoid actives) as well as a number of ‘entourage’ compounds. Entourage compounds are compounds which are related to cannabinoids but have little or no activity at the cannabinoid receptors. Such entourage compounds are thought to behave as modifiers of cannabinoid activity and therefore could enhance pharmacological efficacy. It would be useful to have a plant which did not produce the cannabinoids BUT which produced the entourage compounds and other significant compounds in combinations/amounts which at least substantially qualitatively and preferably also substantially quantitatively resembled that of a comparator plant, i.e. one which chemotypically bears a recognizable resemblance to the medicinal plants used to generate a pharmaceutical or medicine or a nutraceutical or functional food. [0021] According to a first aspect of the present invention there is provided a reference plant which has been selected to: a. not express a medicinally active compound or group of compounds; yet express, at least substantially qualitatively, most other non medicinally active compounds present in a therapeutically active comparator plant such that the reference plant can be used to generate a reference extract with a reference chemical profile which resembles that of the comparator plant less the active compound or group of compounds and may thus be used as a placebo or to otherwise test the hypothesis that the active compound or compounds are responsible for an extracts perceived medicinal activity. [0024] The term “most other” is taken herein to refer to an amount of non medicinally active compounds expressed by the reference plant which is at least greater than 50% (w/w) of the total compounds in the plant. In specific embodiments the amount is greater than 60% (w/w) non medicinally active compounds, or the amount is greater than 70% (w/w) non medicinally active compounds, or the amount is greater than 80% (w/w) non medicinally active compounds, or the amount is greater than 90% (w/w) non medicinally active compounds, or the amount is greater than 95% (w/w) non medicinally active compounds. [0025] Preferably the reference plant is a cannabis plant and the active compound or group of compounds are the cannabinoids. [0026] The cannabis plant is preferably a Cannabis sativa plant containing a monogenic mutation that blocks the cannabinoid biosynthesis. Preferably the plant comprises a cannabinoid knock out factor governing a reaction in the pathways towards the phenolic moieties olivetolic and divarinic acid. [0027] Significantly, the reference plant is characterised in that a homogenised bulk extract exhibits a profile of entourage compounds, which is quantitatively substantially similar to that of a reference plant; as for example is shown in FIG. 3 . [0028] In one embodiment the homogenised bulk extract has a % v/w oil yield of greater than 0.14%, more preferably greater than 0.2%, through 0.3% to 0.4% or more. [0029] A homogenised bulk steam distilled extract comprises both monoterpenes and sesquiterpines. The monoterpenes comprise detectable amounts of at least myrcene, alpha pinene and beta pinene. Preferably the combined myrcene, alpha pinene and beta pinenes comprise at least 50%, through 60% to at least 70% of the monoterpenes detected. Preferably it will also comprise one or more of limonine and optionally linalool and cis- and/or trans-verbenol. [0030] The sesquiterpenes preferably comprise at least carophyllene and humulene and may further comprise carophyllene oxide. [0031] Preferably humelene epoxide II is not detected in the reference plant. [0032] The reference plants of the invention preferably comprise stalked glandular trichomes. These are present at a density comparable to those present in comparator drug type cannabinoid producing plants. The reference plants typically have small, grey, dull trichomes of various shapes ( FIG. 2 a ). Some trichomes comprise headless; pinhead and/or shrivelled trichomes, which may be, flat, convex or concave. They are also free of white trichome heads. [0033] The reference plant may be further characterized in that it expresses monoterpenes, diterpenes, carotenoids, phytol and tetraterpenes. It additionally expresses sesquiterpenes, sterols and triterpenes. [0034] The reference plant is further characterized in that it exhibits branching characteristic of a drug producing phenotype as opposed to a fibre producing phenotype and vigour, characterized in that the total above ground dry weight is comparable to drug producing phenotypes. [0035] According to a further aspect of the present invention there is provided a method of producing a reference plant which does not express a medicinally active compound or group of compounds yet express, at least substantially qualitatively, most other non medicinally active compounds present in a therapeutically active comparator plant comprising: a) Selecting a plant which does not express a medicinally active compound or group of compounds; b) Selecting a therapeutically active comparator plant; and c) Crossing the plant which does not express a medicinally active compound or group of compounds with the therapeutically active comparator plant to obtain an F1 progeny and self-crossing the F1 progeny to obtain an F2 progeny which is selected for the characteristics sought. [0039] According to yet a further aspect of the present invention there is provided an extract obtainable from a reference plant of the invention. [0040] According to yet a further aspect of the present invention there is provided an extract obtainable from a reference plant of the invention. Such extracts may be prepared by any method generally known in the art, for example by maceration, percolation, vaporisation, chromatography, distillation, recrystallisation and extraction with solvents such as C1 to C5 alcohols (ethanol), Norflurane (HFA134a), HFA227 and supercritical or subcritical liquid carbon dioxide. In particular embodiments the extracts may, for example, be obtained by the methods and processes described in International patent application numbers WO02/089945 and WO 2004/016277, the contents of which are incorporated herein in their entirety by reference. [0041] In one embodiment the extract is used or formulated as a placebo. In particular embodiments such formulations and/or placebos may, for example, be formulated as described International patent application numbers WO01/66089, WO02/064109, WO03/037306 and WO04/016246, the contents of which are incorporated herein in their entirety by reference. [0042] According to a further aspect of the present invention there is provided a method of testing a hypothesis that one or more compounds present in a plant extract are responsible or are solely responsible for the extracts pharmacological activity comprising: i) selecting a plant according to the first aspect of the invention; ii) obtaining an extract therefrom; and iii) running comparative tests against the extract obtained from a comparator plant. [0046] According to a further aspect of the present invention there is provided a method of producing a designer plant extract comprising the steps of: i) selecting an extract obtainable from a reference plant according to the first aspect of the invention and ii) combining the extract of (i) with one or more medicinally active components. [0049] By “designer plant extract” is meant a plant extract which includes one or more medicinally active components which do not naturally occur in the reference plant of part i). [0050] In specific embodiments, the medicinally active components may be purified naturally occurring compounds, synthetic compounds or a combination thereof. In a specific embodiment the medicinally active components may be present in a plant extract. This plant extract may be an extract from a “drug producing” plant of the same species as the reference plant of part i). Typically this drug producing plant will not be the comparator plant to the reference plant of part i). [0051] The invention is further described, by way of example only, with reference to novel Cannabis sativa plants (and not specific varieties), which do not express cannabinoids but which otherwise, resemble, chemotypically, medicinal cannabis plants. BRIEF DESCRIPTION OF THE DRAWINGS [0052] The invention will be further described, by way of example only to the following figures in which: [0053] FIGS. 1 a - d are GC chromatograms from different chemotype segregants from a 2005.45.13 F 2. progeny (Table 2) a: is from cannabinoid-free plants; b: is from low content and THC predominant plants; c: is from high content and THC predominant plants; and d: is from high content and CBG predominant plants. The peaks at 8.2, 16.0 and 16.7 min. represent the internal standard, THC and CBG, respectively; [0058] FIG. 2 a - d are microscopic images of the bracteole surfaces from different chemotype segregants from the 2005.45.13 F 2 progeny. a: is from cannabinoid-free plants; b: is from low content and THC predominant plants; c: is from high content and THC predominant plants; and d: is from high content and CBG predominant plants. (The bar represents 500 μm) and [0063] FIG. 3 shows graphically, the chemical profile (both qualitatively and quantitatively) of respectively: Top—a high cannabinoid bulk segregant; Middle—a cannabinoid free bulk segregant of the invention; and Bottom—a pharmaceutical production comparator (M3). DETAILED DESCRIPTION OF THE INVENTION [0067] By way of introduction it should be noted that there are many different Cannabis sativa varieties and chemotypes. These include both wild type plants and cultivated varieties. The cultivated varieties include plants which have been cultivated as fibre producers (low THC varieties); those that have been bred (illegally) for recreational use (high THC) and more recently medicinal plants which have been selectively bred for their cannabinoid content (one or more cannabinoids predominate) and optionally the profile of e.g. entourage compounds. [0068] In order to produce plants with the desired characteristics it was necessary to “knock out” the expression of cannabinoids in a manner, which did not detrimentally effect the production of e.g. entourage compounds in the medicinal plants. How this was achieved is set out below: Identification of a Cannabinoid-Free Chemotype Plant. [0069] Because in many countries cannabis cultivation is restricted to fibre hemp cultivars having specified “low” levels (typically below either 0.1 or 0.3% w/w of the dry floral tissue) of THC, several breeding programmes have been devoted to meeting these legal limits. [0070] According to a survey of the European commercial fibre cultivars [13], the cultivars bred at the Ukrainian Institute of Fibre Crops (Glukhov, formerly, Federal Research Institute of Bast Crops) have the lowest THC contents and the lowest total cannabinoid contents. The cannabinoid breeding programme at this institute started in 1973. Their usual selective breeding methodology consists of family selection within existing cultivars with a high agronomic value and the elimination, before flowering, of plants with relatively high contents [14] and [15]. This effort has resulted in a gradual decrease of both THC content and total cannabinoid content. [0071] Gorshkova et al. [16] evaluated the densities of sessile and stalked glandular trichomes on the bracteoles of various plants. They found that plants with stalked trichomes had relatively high cannabinoid contents and that their contents were positively correlated with the density of the stalked trichomes. Plants that had solely sessile trichomes always had low contents that were uncorrelated with the densities of the sessile trichomes. Gorshkova et al. [16] also mention plants without glandular trichomes that were found to be cannabinoid-free. [0072] Since then, Ukrainian plant breeders have reported several times on the existence of cannabinoid-free breeding materials [15], [17] and [18] [0073] Pacifico et al. [1,9] analysed individual plants from the Ukrainian cultivar USO 31 and found that one third of the individuals contained no cannabinoids. He also found that a minority of the plants (&lt;10%) in a French fibre cultivar, Epsilon 68, were cannabinoid-free. [0074] The Ukrainian cultivar USO 31 is amongst several varieties of hemp that have been approved for commercial cultivation under subsection 39(1) of the Industrial Hemp Regulations in Canada for the year 2007. [0075] These cannabinoid free plants are phenotypically and chemotypically different to those developed by the applicant through artificial manipulation and differ from those cannabinoid free plants that have been isolated in nature. [0076] Theoretically, two different physiological conditions could make a plant cannabinoid-free: (1) a disrupted morphogenesis of glandular trichomes that, according to Sirikantaramas et al. [20], appear to be essential structures for cannabinoid synthesis, and (2) a blockage of one or more biochemical pathways that are crucial for the formation of precursors upstream of CBG. [0079] The first condition would also seriously affect the synthesis of other secondary metabolites that are produced largely or uniquely in the glandular trichomes. [0080] In 1991, field grown cannabinoid-free plants, resulting from Gorshkova et al. [16] programme were viewed and the bracts and bracteoles of these plants were apparently lacking glandular trichomes. Also, the plants did not exude the characteristic cannabis fragrance. This suggests that the volatile mono- and sesquiterpenes were not produced in these plants. Such cannabinoid free plants might therefore have been considered unsuitable for the purpose of breeding a cannabinoid free plant with typical entourage compounds. [0081] The second condition could also affect metabolites other than cannabinoids, as in the case of an obstruction of the basic pathways of common precursors for different classes of end products. [0082] The IPP incorporated, via GPP, into cannabinoids is derived from the DOX pathway in the plastids [2]. Monoterpenes, diterpenes, carotenoids, phytol and tetraterpenes are also uniquely synthesised in the plastids and one could therefore conclude that the IPP incorporated in these compounds, as with cannabinoids, is derived from the DOX pathway [21]. [0083] Sesquiterpenes, sterols and triterpenes are uniquely synthesised in the cytoplasm. Presumably they are synthesised from MVA derived IPP [21] and so do not share a fundamental pathway with the terpenoid moiety of cannabinoids. [0084] Even so, according to Evans [22], there is also evidence for a cooperative involvement of the DOX- and the MVA pathway in the synthesis of certain compounds, through the migration of IPP from the plastids into the cytoplasm and vice versa. [0085] The potentially wider chemical effect of engineering plants with the cannabinoid knockout factor yet which express selected entourage compounds has implications for pharmaceutical cannabis breeding. Cannabinoids, and THC in particular, are generally considered as the major pharmaceutically active components of Cannabis . Nevertheless, according to McPartland and Russo [23], the terpenoid fraction may modify or enhance the physiological effects of the cannabinoids, providing greater medicinal benefits than the pure cannabinoid compounds alone. As summarized by Williamson and Whalley [24], there are indications that the non-cannabinoid ‘entourage’ of constituents, such as: monoterpenes; sesquiterpenes; and flavonoids modulate the cannabinoid effects and also have medicinal effects by themselves. Speroni et al. [25] reported an anti-inflammatory effect from an extract that was obtained from a cannabinoid-free chemotype. Selection [0089] Whilst USO-31 was selected as the source of a “knockout” gene to be introduced into pharmaceutical plants the challenge remained of achieving plants which were devoid of cannabinoids but which retained a good profile of selected entourage compounds (i.e. were broadly speaking comparable to plants grown to produce extracts for pharmaceutical use). In this regard USO-31 had a chemical profile, which was not similar to medicinal varieties in that it was lacking both in cannabinoids, and monoterpenes. Furthermore, the sesquiterpene profile also differed both quantitatively and qualitatively from that of plants used to produce pharmaceutical extracts. EXAMPLES Example 1 Breeding Programme [0090] To overcome the problem of creating a reference plant which is, in the case of Cannabis sativa , free of cannabinoids BUT which had a chemical profile of entourage compounds resembling pharmaceutical cannabis , selective breeding programmes were undertaken. [0091] A first cross was made between the selected cannabinoid free plant USO-31 and a plant having a high cannabinoid content of a given cannabinoid, in this case M35, a high THCV containing plant (83.4% by weight of cannabinoids THCV), and M84, a high CBD containing plant (92.4% by weight of cannabinoids CBD). The high cannabinoid plants were selected both for their high and specific cannabinoid contents and their vigour. [0092] Alternatively, a direct cross with a selected pharmaceutical plant could have been made. [0093] Table 1, bottom 2 rows, provides details of the cannabinoid composition of these parental clones: [0000] TABLE 1 Characteristics of parental clones used in breeding experiments with cannabinoid-free materials. Cannabinoid Cannabinoid composition b Code Generation/type Source population content a CBDV CBCV THCV CBD CBC CBGM c THC CBG M3 Non-inbred clone Skunk, marijuana strain 18 0.5 1.5 97.2 0.8 M16 Non-inbred clone Turkish fibre landrace 12 91.5 2.6 1.3 3.8 0.8 M35 S 1 inbred clone (California Orange × 14 1.0 83.4 15.6 Thai), marijuana strains M84 F 1 hybrid clone (Afghan × Skunk) × 15 1.0 92.4 1.0 3.7 1.9 (Afghan × Haze), hashish and marijuana strains a The total cannabinoid content (% w/w) of the floral dry matter assessed at maturity. b The proportions (% w/w) of the individual cannabinoids in the total cannabinoid fraction assessed at maturity. c Cannabigerol-monomethylether. [0094] Of course other strains containing a high percentage of another cannabinoids e.g. THC, CBDV, CBG, CBGV, CBC, CBCV, CBN and CBNV could be used. By “high” is meant that the specific cannabinoid predominates and would typically comprise greater than 50% by weight of the total cannabinoids present, more particularly greater than 60%, through 70% and 80% to most preferably greater than 90% by weight. [0095] The initial cross generated an F1 progeny (Table 2 rows 1 and 2) which were then self crossed to generate an F2 progeny from which plants having the desired characteristics (zero cannabinoid/good entourage compound chemotype profile) were selected for back crossing to pharmaceutical varieties. [0096] The selected zero-cannabinoid plant, USO-31, was monoecious. i.e. it has unisexual reproductive units (flowers, conifer cones, or functionally equivalent structures) of both sexes appearing on the same plant. In order to self-fertilise USO-31 and mutually cross female plants, a partial masculinisation was chemically induced. Self-fertilisations were performed by isolating plants in paper bags throughout the generative stage. The USO-31 source plants were evaluated for their drug type habit. Inbred seeds from the best individual apparently devoid of cannabinoids and another with only cannabinoid traces were pooled. [0000] i) Crosses of Low/Zero Cannabinoid USO-31 Offspring with M35 and M84 [0097] Twenty-four plants of the 2003.8 F 1 (table 2, row 2) were evaluated. [0000] TABLE 2 Pedigrees and codes of the progenies studied for chemotype segregation. Seed parent a Pollen parent b F 1 code F 2 code c M35 (THCV) USO-31 (low/zero) 2003.17 2003.17. 19 M84 (CBD) USO-31 (low/zero) 2003.8 2003.8. 21 M3 (THC) 2003.8.21.76 F 3 (zero) 2005.45 2005.45. 13 M16 (CBD) 2003.8.21.76 F 3 (zero) 2005.46 2005.46. 27 M3 (THC) 2003.17.19.67 F 3 (zero) 2005.47 2005.47. 9 M16 (CBD) 2003.17.19.67 F 3 (zero) 2005.48 2005.48. 7 a Of the parents with cannabinoids present, the major one is indicated in brackets. b The USO-31 pollinators were two plants with very low cannabinoid content and/or true cannabinoid absence. The other pollinators were F 3 lines confirmed to be devoid of cannabinoids. c The underlined ciphers in the F 2 codes indicate the single F 1 individual that was self-fertilised to produce the F 2 generation. The majority of the plants had ‘normal’ cannabinoid contents, falling within a Gaussian distribution range from 1.13 to 4.56%. Three plants had only trace amounts of cannabinoids, ranging from approximately 0.02 up to 0.15%. [0098] Similarly, the 19 plants of the 2003.17 F 1 comprised a majority of individuals with a cannabinoid content in the range of from 1.69 to 13.76%, and two plants with cannabinoid traces of only ca. 0.02%. [0099] From both F 1 s, an individual with only trace cannabinoid amounts was self-fertilised to produce an inbred F 2 2003.8.21 and 2003.17.19. Both F 2 s comprised plants that were confirmed to be devoid of cannabinoids. [0100] The remaining plants, those with cannabinoids present, could be assigned to two categories on the basis of a discontinuity in the cannabinoid content range: a group with low contents ranging from trace amounts up to roughly 0.6%; and a group with higher contents. [0103] The newly obtained cannabinoid-free plants designated 2003.8.21 and 2003.17.19 F 2 had more branching (typical of a drug type phenotype and in contrast to that of a fibre type phenotype), a stronger fragrance (due to the presence/increase in the terpenes and sesquiterpenes) and higher trichome density (determinable on examination) than the original USO-31 plants. [0104] The cannabinoid-free F 2 individuals with the best drug type plant habit, 2003.8.21.76 and 2003.17.19.67, were self-fertilised to produce fixed cannabinoid-free F 3 inbred lines (Table 2, rows 3-6, col 2) for use in a backcrossing programme with pharmaceutical production clones M3 (High THC 97.2%) and M16 (High CBD 91.5%) (Table 1, top 2 rows). [0105] Backcrosses were performed in order to obtain cannabinoid-free material, more closely resembling (both qualitatively and quantitatively) the pharmaceutical production clones by way of their non-cannabinoid profile, particularly those of the entourage compounds. [0106] All the Clones Listed in Table 1 were True Breeding for their Chemotype. ii) Backcrossing of Cannabinoid-Free Lines to Pharmaceutical Production Clones M3 and M16 [0107] The cannabinoid-free lines 2003.8.21.76 and 2003.17.19.67, (Table 2, column 2, last 4 rows) were then back crossed with pharmaceutical production clones M3 and M16 and the resulting F1&#39;s crossed to generate an F2 progeny. [0108] The resulting progeny had their cannabinoid content evaluated as shown in Table 3 below. [0000] TABLE 3 Total cannabinoid contents of F 1 progenies resulting from crosses between two cannabinoid-free inbred lines (P1) and two high content clones (P2). Total cannabinoid content (% w/w) F 1 F 1 No. of F 1 individual individual F 1 plants self- F 1 range self- progeny evaluated fertilised P1 P2 Min-avg-max fertilised 2005.45 57 2005.45.13 0 18 0.22-0.58-1.09 0.89 2005.46 57 2005.46.27 0 12 0.16-0.46-1.00 0.47 2005.47 57 2005.47.9 0 18 0.24-0.45-0.75 0.36 2005.48 57 2005.48.7 0 12 0.10-0.42-1.25 0.83 [0109] Within the F 1 s the cannabinoid contents showed a single Gaussian distribution. The F 1 contents were much lower than the parental means and therefore much closer to the cannabinoid-free parent than to the production parent. The F 1 s were well covered with trichomes and were quite fragrant. [0110] In respect of the cannabinoid composition, the 2005.45 F 1 segregated into two chemotypes: THC predominant plants and mixed CBD/THC plants, in a 1:1 ratio. [0111] The 2005.46 F 1 had a uniform CBD chemotype. [0112] The 2005.47 F 1 was uniform and consisted of THC plants, all with a minor proportion of THCV. [0113] The 2005.48 F 1 was uniform and consisted of CBD/THC plants that also had minor proportions of CBDV and THCV. [0114] Per F 1 , one individual was selected on the basis of criteria such as ‘drug type morphology’ (e.g. branching) and minimal monoeciousness to produce back cross generations. These individuals were used for a repeated pollination of M3 or M16, which is not discussed here. [0115] To examine chemotype segregation, the selected F 1 individuals were also self-fertilised to produce large inbred F 2 s. [0116] FIG. 1 shows chromatograms of different chemotype segregants from the 2005.45.13 F 2 . FIG. 1 a is the chromatogram for a zero cannabinoid plant. [0117] The different chemotype segregants were microscopically compared. The cannabinoid-free plants of each progeny all had small, grey, dull trichomes of various shapes ( FIG. 2 a ). Some were headless; some were pinhead and shrivelled, either flat, convex or concave. [0118] By way of contrast: [0119] The high content CBD- and/or THC-predominant individuals of each group all had big, round clear heads that sparkled under the lamp ( FIG. 2 b ); [0120] The low content plants from each progeny were almost indistinguishable from the cannabinoid-free plants except that there was an occasional small but bright trichome in some ( FIG. 2 c ); and [0121] The high content CBG predominant plants from the 2005.45.13 F 2 had big, round, opaque white heads ( FIG. 2 d ), clearly distinct from the transparent ones occurring on the THC predominant plants of the same progeny. [0122] The low content CBG predominant 2005.45.13 plants did not show opaque white trichome heads and were indistinguishable from the low content THC predominant plants. Neither were white trichome heads observed in any of the cannabinoid-free plants of this progeny. [0123] As an indication of their vigour, the total above ground dry weights of all the cannabinoid-free- and the high content segregants were assessed. Per progeny, per segregant group the weights showed a Gaussian distribution. [0124] For the 2005.45.13, 2005.46.27 and the 2005.47.9 progenies the cannabinoid-free individuals on average had a ca. 10% higher dry weight than the high content individuals. [0125] In the 2005.48.7 progeny however, the average weight of the high content group exceeded that of the cannabinoid-free group by about 10%. [0126] In order to characterize the plants a chemical analysis of both the cannabinoid content, and selected other chemicals, was undertaken as set out below: Example 2 i) Analysis of Cannabinoid Content and Other Chemicals [0127] Mature floral clusters were sampled from every individual plant considered in the breeding experiments. Sample extraction and GC analysis took place as described by de Meijer et al. [26]. [0128] The identities of the detected compounds were confirmed by GC-MS. Cannabinoid peak areas were converted into dry weight concentrations using a linear calibration equation obtained with a CBD standard range. The contents of the individual cannabinoids were expressed as weight percentages of the dry sample tissue. The total cannabinoid content was calculated and the weight proportions of the individual cannabinoids in the cannabinoid fraction were used to characterize the cannabinoid composition. ii) Chemical Comparison of Bulk Segregants [0129] Each of the six F 2 s listed in Table 2 segregated into: cannabinoid-free plants; plants with cannabinoid traces; and plants with high cannabinoid contents. [0133] In each case, per F 2 , the floral leaves, bracts and bracteoles of all the cannabinoid-free plants were pooled and homogenised, as was the floral fraction of all the plants belonging to the group with high cannabinoid contents. The different bulks from the: 2005.45.13 (from M3-THC), 2005.46.27 (from M16-CBD), 2005.47.9 (from M3-THC) and 2005.48.7 (from M16-CBD) F 2 were steam-distilled and the essential oil yields were assessed. [0138] The monoterpene and sesquiterpene composition of these essential oils was analysed by Gas Chromatography with Flame Ionisation Detection (GC-FID). [0139] The relative amounts of a wide range of entourage compounds in the bulk homogenates of: 2003.8.21 (from M84-CBD) and 2003.17.19 (from M35 THCV) F 2 s were also compared by using the following analytical techniques: a) Gas Chromatography—Mass Spectrometry (GC-MS) [0142] To obtain comparative fingerprints, GC-MS analyses were performed on a HP5890 gas chromatograph, coupled to a VG Trio mass spectrometer. The GC was fitted with a Zebron fused silica capillary column (30 m×0.32 mm inner diameter) coated with ZB-5 at a film thickness of 0.25 μm (Phenomenex). The oven temperature was programmed from 70° C. to 305° C. at a rate of 5° C./min. Helium was used as the carrier gas at a pressure of 55 kPa. The injection split ratio was 5:1. [0000] b) Gas Chromatography with Flame Ionisation Detection (GC-FID) [0143] GC profiles of terpenoids were generated in the splitless mode with a HP5890 gas chromatograph. The GC was fitted with a Zebron fused silica capillary column (30 m×0.32 mm inner diameter) coated with ZB-624 at a film thickness of 0.25 μm (Phenomenex). The oven temperature was held at 40° C. for 5 minutes, programmed to 250° C. at a rate of 10° C./min then held at 250° C. for 40 minutes. Helium was used as the carrier gas at a pressure of 9.2 psi. The injection split ratio was 10:1. [0000] c) High-Performance Liquid Chromatography (HPLC) with Ultra-Violet (UV) Detection [0144] HPLC profiles were obtained using methods specific to a variety of compound classes. All samples were analysed using Agilent 1100 series HPLC systems [0000] (i) Cannabinoid profiles were generated using a C 18 (150×4.6 mm, 5 μm) analytical column. The mobile phase consisted of acetonitrile, 0.25% w/v acetic acid and methanol at a flow rate of 1.0 ml/min and UV profiles were recorded at 220 nm. (ii) Carotenoid profiles were generated using a Varian Polaris C 18 (250×4.6 mm, 5 μm) analytical column. The mobile phase consisted of acetonitrile:methanol:dichloromethane: water at a flow rate of 1.2 ml/min and UV profiles were recorded at 453 nm. (iii) Chlorophyll profiles were generated using the same column, mobile phase and flow rate described for carotenoids. UV profiles were recorded at 660 nm. (iv) Non-polar compound profiles (triglycerides, sterols etc) were generated by a gradient LC method using a Phenomenex Luna C 18 (2) (150×2.0 mm, 5 μm) analytical column. The mobile phase consisted of solvent A (acetonitrile:Methyl-tert-butyl-ether (9:1)) and solvent B (water) with the proportion of B decreased linearly from 13% to 0% over 30 minutes then held constant for 20 minutes at a flow rate of 1.0 ml/min. The flow rate was then increased linearly to 1.5 ml/min over 40 minutes and UV profiles were recorded at 215 nm. [0145] (v) Polar compound profiles (phenolics) were generated by a gradient LC method using an Ace C 18 (150×4.6 mm, 5 μm) analytical column. The mobile phase consisted of solvent A (acetonitrile:methanol, 95:5) and solvent B (0.25% w/v acetic acid:methanol, 95:5). The proportion of B was decreased linearly from 75% to 15% over 30 minutes then held constant for 10 minutes at a flow rate of 1.0 ml/min and UV profiles were recorded at 285 nm. Results Chemical Comparison of Cannabinoid-Free- and High Content Bulks [0146] The yields and compositions of steam-distilled essential oils from bulked cannabinoid-free- and bulked high content segregants of the four F 2 progenies are presented in Table 4 below. [0000] C H I Parent D F G Back cross Back cross USO-31 Parent E Intermediate Intermediate parent parent Zero M35 Parent USO-31 × USO-31 × M16 M3 97.2% A cannabinoid 83.4% M84 M35 F2 M84 F2 91.5% CBD THC R/T B Control 1 THCV 92.4% CBD Table 5 Table 5 Control 2 Control 3 Weight of material (g) 73.8 g 117.7 g 120.5 g Volume of oil (ml) 0.10 ml 0.3 0.95 % OIL (% v/w) 0.14% 0.25 0.79 MONOTERPENES 10.3 alpha-pinene UDL 7.3 4.95 11.8 beta-pinene UDL 2.65 3.58 12.2 myrcene UDL 42.55 39.02 13.7 limonene UDL 5.27 6.66 14.2 beta-ocimene UDL 2.5 UDL 16 Linalol UDL 3.68 4.65 17.8 cis-verbenol UDL UDL UDL 18 trans-verbenol UDL UDL TOTAL 0 63.95 58.86 SESQUITERPENES 28.8 caryophyllene 33.02 25.11 16.44 trans alpha 28.9 bergamotene 5.75 UDL 2.45 29.2 (z)-beta farnesene 9.34 UDL 4.25 29.8 humulene 11.96 8.71 7.65 30.7 Unidentified 5.95 30.8 (e)-beta farnesene 1.59 2.23 UDL 31.1 gamma gurjunene 4.01 UDL UDL 31.3 delta guaiene UDL UDL 31.6 Unidentified 1.03 32.3 (e)-nerolidol 0.98 UDL 5.31 32.7 unknown UDL 5.03 33.6 Unidentified 1.91 33.8 caryophyllene oxide 6.42 UDL UDL 34.5 humulene epoxide II 3.17 UDL UDL 36.4 alpha bisabolol UDL UDL 47.5 Unidentified 7.48 TOTAL 92.61 36.05 41.13 J L N P Final zero Final zero Final zero Final zero 2005.45.13 K 2005.46.27 M 2005.47.9 O 2005.48.7 Q A M3 backcross 2005.45.13 M16 backcross 2005.46.27 M3 backcross 2005.47.9 M16 backcross 2005.48.7 R/T B zero high zero high zero high zero high Weight of material 104.5 g 88.1 g 95.1 92.2 87.1 86.4 85.2 123.6 (g) Volume of oil (ml) 0.68 0.5 0.64 0.8 0.24 0.74 0.35 0.78 % OIL (% v/w) 0.65 0.57 0.67 0.87 0.28 0.87 0.41 0.63 MONOTERPENES 10.3 alpha-pinene 16.64 11.83 28.53 26.8 10.27 2.86 33.52 22.53 11.8 beta-pinene 7.65 6.58 12.6 9.37 5.57 2.22 15.51 8.98 12.2 myrcene 51.1 42.11 34.16 42.86 19.84 41.45 24.82 36.47 13.7 limonene 4.76 4.53 6.41 7.41 7.27 5.54 5.17 4.58 14.2 beta-ocimene UDL UDL UDL UDL UDL 9.58 UDL 8.6 16 Linalol 1.62 2.78 UDL UDL 10.48 2.95 2.91 UDL 17.8 cis-verbenol UDL UDL UDL UDL UDL UDL 1.73 UDL 18 trans-verbenol UDL UDL UDL UDL 3.31 UDL 2.61 UDL TOTAL 81.77 67.83 81.7 86.44 56.74 64.6 86.27 81.16 SESQUITERPENES 28.8 caryophyllene 3.9 12.25 7.28 8.35 7.97 15.93 4.73 9.84 trans alpha 28.9 bergamotene 3.86 3.71 1.71 UDL UDL UDL UDL UDL 29.2 (z)-beta farnesene 4.83 6.05 2.78 1.95 UDL 3.48 UDL 1.86 29.8 humulene 3.04 6.83 3.27 3.26 7.88 7.68 2.12 3.69 30.8 (e)-beta farnesene UDL 1.69 UDL UDL UDL UDL UDL UDL 31.1 gamma gurjunene UDL UDL UDL UDL UDL 1.78 UDL UDL 31.3 delta guaiene UDL UDL UDL UDL 3.64 4.67 1.67 3.44 32.3 (e)-nerolidol UDL 1.65 UDL UDL UDL UDL UDL UDL 32.7 unknown UDL UDL UDL UDL UDL 1.86 UDL UDL 33.8 caryophyllene oxide 2.62 UDL 3.25 UDL 13.43 UDL 5.19 UDL 34.5 humulene epoxide II UDL UDL UDL UDL 6.06 UDL UDL UDL 36.4 alpha bisabolol UDL UDL UDL UDL 4.27 UDL UDL UDL TOTAL 18.25 32.18 18.29 13.56 43.25 35.4 13.71 18.83 [0147] In three (2005.46.27, 2005.47.9, and 2005.48.7), the cannabinoid-free bulks contained less essential oil than the high content ones. [0148] In 2005.45.13 however, the cannabinoid-free bulk was slightly richer. [0149] No significant qualitative differences in the essential oil composition were found, only minor quantitative ones, which generally did not show a systematic pattern. [0150] The only consistent quantitative difference between the low and high content progeny was difference was found for caryophyllene oxide that in all four progenies, reached a higher proportion in the cannabinoid-free bulks than in the high content bulks. [0151] When the zero cannabinoid backcross plants of the invention were compared to control 1 (the original zero cannabinoid plant which was also devoid of monoterpenes) and controls 2 and 3 (the pharmaceutical plants with a high cannabinoid content and a range of entourage compounds) the following differences were observed: 1. The volume of oil (%) obtained by steam distillation in the zero cannabinoid plants of the invention was on average 0.50%. By way of comparison control 1 is 0.14%, and the mean of control 2 and 3 was 0.52%. In other words the % oil is representative of the pharmaceutical clones. 2. The total measured monoterpene fraction in the zero cannabinoid plants of the invention was on average about 76. By way of comparison control 1 is 0, and the mean of control 2 and 3 was about 61. In other words the monoterpene fraction is representative of the pharmaceutical clones. 3. Within the monoterpence fraction in the zero cannabinoid plants of the invention the predominant terpene was myrcene, followed by alpha pinine and beta pinine with smaller amounts of limonine and linalol. Whilst quantitatively there were differences compared to the pharmaceutical controls there was, broadly speaking, a qualitative relationship. 4. The total measured sesquiterpene fraction in the zero cannabinoid plants of the invention was on average about 23. By way of comparison, control 1 is about 93, and the mean of controls 2 and 3 was about 39. In other words the sesquiterpene fraction is much more representative of the pharmaceutical clones than control 1. 5. Within the sesquiterpene fraction in the zero cannabinoid plants of the invention the predominant sesquiterpene were carophyllene, humulene and carophyllene oxide (accounting for more than 50% of the sesquiterpence fraction). Whilst there were differences compared to the pharmaceutical controls (where quantitatively carophyllene and humulene were again the most significant sesquiterpenes but carophyllene oxide was absent) there was, broadly speaking a qualitative, if not quantitative relationship between the plants of the invention and the pharmaceutical plants as compared to the starting zero cannabinoid plants which had much higher levels of sesquiterpenes and a wider detectable range of sesquiterpenes. [0157] By way of comparison Table 5 gives some analytical data on the intermediate plants generated. It is a comparison of the different segregant bulks from 2003.8.21 and 2003.17.19 for a variety of compound classes. [0000] TABLE 5 The composition of bulked cannabinoid-free-(Zero) and bulked high content segregants of two intermediate F 2 progenies. F 2 progenies 2003.8.21 2003.17.19 Segregant bulks Zero High Zero High (i) Cannabinoids c CBDV — 0.00566 — — THCV — — — 0.08814 CBGV — — — 0.01157 CBD — 0.47868 — — CBC — 0.04855 — 0.02771 CBGM — 0.00671 — — THC — 0.01605 — 0.32459 CBG — 0.20785 — 0.05573 CBN — — — 0.01179 Triterpenes b Squalene 4.1 × 10 7 7.9 × 10 7 2.1 × 10 7 1.9 × 10 7 Unidentified hydrocarbon 5.2 × 10 8 5.4 × 10 8 1.1 × 10 8 1.6 × 10 8 Unidentified alcohol 1 3.8 × 10 8 5.1 × 10 8 1.1 × 10 8 3.3 × 10 8 Unidentified alcohol 2 1.3 × 10 8 1.3 × 10 8 5.5 × 10 7 1.4 × 10 8 Diterpenes c Phytol 0.0587 0.0591 0.0511 0.0487 Sesquiterpenes c Beta-caryophyllene 0.0043 0.0105 0.0022 0.0102 Alpha-caryophyllene 0.0022 0.0037 0.0027 0.0035 Caryophyllene oxide 0.0049 0.0041 0.0020 0.0041 Nerolidol 0.0030 0.0024 0.0043 0.0027 Monoterpenes c Alpha-pinene 0.0010 0.0015 0.0015 0.0085 Myrcene 0.0017 0.0057 0.0024 0.0180 Limonene — 0.0011 — 0.0015 Linalol 0.0030 0.0053 0.0035 0.0053 Long-chain alkanes b Nonacosane 1.1 × 10 9 9.5 × 10 8 2.0 × 10 8 4.7 × 10 8 Heptacosane 1.5 × 10 8 1.8 × 10 8 5.5 × 10 7 4.7 × 10 7 Pentacosane 2.5 × 10 7 2.0 × 10 7 1.3 × 10 7 7.4 × 10 6 Hentriacontane 2.7 × 10 8 1.6 × 10 8 4.2 × 10 7 7.3 × 10 7 Sterols b Sitosterol 2.3 × 10 8 1.5 × 10 8 7.6 × 10 7 2.9 × 10 8 Campesterol 6.6 × 10 7 4.0 × 10 7 1.3 × 10 7 5.9 × 10 7 Stigmasterol 5.1 × 10 7 3.3 × 10 7 8.1 × 10 6 4.6 × 10 7 Fatty acids a Palmitic acid ✓ ✓ ✓ ✓ Linoleic acid ✓ ✓ ✓ ✓ Oleic acid ✓ ✓ ✓ ✓ Stearic acid ✓ ✓ ✓ ✓ Linolenic acid ✓ ✓ ✓ ✓ Aldehydes b Octadecanal 2.4 × 10 7 5.5 × 10 7 8.1 × 10 7 6.9 × 10 7 Vitamins b Vitamin E 1.6 × 10 7 2.1 × 10 7 1.2 × 10 7 1.3 × 10 7 (ii) Carotenoids a Beta-carotene ✓ ✓ ✓ ✓ (iii) Chlorophylls a Chlorophyll a ✓ ✓ ✓ ✓ Triglycerides d GGL 49.13 22.67 39.07 32.81 GLL 19.40 7.00 9.71 7.03 OLLn 39.37 22.87 48.23 39.36 OLL 20.14 6.21 15.53 10.80 a compounds scored as present (✓) or absent (—). b quantities expressed as GC-MS peak areas. c quantities expressed as w/w contents. d quantities expressed as HPLC-UV peak areas. [0158] In general the differences between the entourages of the cannabinoid-free and the high content bulks were only quantitative. Limonene was an exception, as it was not detected in the cannabinoid-free bulks whereas a minor presence was found in both of the high content bulks. [0159] However, the essential oil data in Table 4 does not confirm this finding for the other F 2 s. Likewise, Table 5 does not show the difference in caryophyllene oxide as it appears in Table 4. [0160] Both progenies in Table 5 had consistently higher levels of four different triglycerides in the cannabinoid-free bulks than the high content bulks. The occurrence of none of the entourage compounds listed in the Tables 4 and 5 appears to be critically associated with the presence or absence of cannabinoids. [0161] With the reported exception of the triglycerides, the quantitative differences in the entourage compounds does not show a consistent trend between cannabinoid-free- and high content bulks. [0162] This is most clearly seen in FIG. 3 , which compares high cannabinoid bulks with cannabinoid free bulks. It also shows an M3 pharmaceutical bulk. What is apparent from a comparison of these extracts is that the profiles between the high content bulk and the cannabinoid free bulk of the segregating plants are very similar and that further more there is substantial similarity to the pharmaceutical extract M3, particularly at the earlier retention times (less than 30 minutes). Discussion [0163] The cannabinoid-free segregants resulting from backcrosses with high content drug clones had glandular trichomes in normal densities but the trichome heads were dull and much smaller than those of high cannabinoid content sister plants. Nevertheless the trichomes of cannabinoid-free segregants appear to be functional metabolic organs, as the chemical comparison of contrasting segregant bulks did not reveal big differences in the content and composition of volatile terpenes, which are also produced in the trichomes. The absence of cannabinoids probably causes the small trichome heads, rather than being a result of them. [0164] The abundant presence of apparently functional trichomes on the cannabinoid-free plants rules out that the absence of cannabinoids is due to a disrupted morphogenesis of the glandular trichomes. It thus appears that the cannabinoid knockout factor is not derived from the gland free plants selected by Gorshkova et al [16]. [0165] It is more plausible that the absence of cannabinoids is attributable to the blockage of one or more biochemical pathways that are crucial for the formation of precursors upstream of CBG. As the chemical entourage of cannabinoid-free plants is intact, the obstacle is probably not in the MVA and DOX pathways towards IPP. [0166] A blocked MVA pathway would not affect cannabinoid synthesis [2], but it should reduce levels of sesquiterpenes, sterols and triterpenes [21]. [0167] A blockage of the DOX pathway would obstruct the synthesis of the terpenoid moiety of cannabinoids [2] but it should also negatively affect the synthesis of monoterpenes, diterpenes, carotenoids, phytol and tetraterpenes [21]. [0168] An alternative is that the knockout allele encodes a defective form of the enzyme GOT [1] that catalyses the condensation of resorcinolic acids (OA and DA) with GPP into CBG. However, with such a mechanism one would expect an accumulation of the phenolic moieties OA and/or DA in the cannabinoid-free segregants. Our GC method for cannabinoid analysis detects the decarboxylated forms of both acids but they were observed in none of the cannabinoid-free plants&#39; chromatograms. [0169] The most plausible hypothesis for the absence of cannabinoids appears to be a blockage in the polyketide pathway towards the phenolic moieties OA and DA. Whatever the working mechanism of the cannabinoid knockout factor is, one would expect that a functional synthase dominates a non-functional version, and so it remains obscure as to why the heterozygous genotypes (O/o) have such a strongly suppressed cannabinoid synthesis. [0170] The essential oil comparison and the chromatographic fingerprinting of contrasting segregant bulks demonstrated that except the cannabinoids, all the monitored compound classes were present in both segregant groups. The relative levels of the compound classes did vary between the contrasting segregant groups but not usually in a systematic way. [0171] The quantitative differences between contrasting bulks could be attributable to the fact that in cannabinoid-free plants the trichome heads, as the metabolic centres for a range of end products, are not inflated with cannabinoids. This may change the physical environment in which the reactions occur so that it quantitatively affects the synthesis of entourage compounds. The fact that large amounts of basic cannabinoid precursors are not incorporated may also affect equilibriums of other biosynthetic reactions. [0172] A further benefit of the plants of the present invention is that they can be used to create plant extracts containing cannabinoids in quantities/purities, which could not be achieved naturally. Such plant extracts providing the benefits arising from the presence of one or more selected entourage compounds. The cannabinoids, which could be introduced to the cannabinoid free extracts, could include one or more natural cannabinoids, synthetic cannabinoids or biosynthetic cannabinoids (modified natural cannabinoids). This would produce a “designer” plant extract that could be used in clinical trials or as medicines. [0173] The benefits of natural or biosynthetic cannabinoids over synthetic cannabinoids lies in the fact that all of the cannabinoids are in the active form as opposed to a racemic mixture. [0174] Other aspects of the invention will be clear to the skilled artisan and need not be repeated here. Each reference cited herein is incorporated by reference in its entirety for the relevant teaching contained therein. [0175] The terms and expressions that have been employed are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, it being recognized that various modifications are possible within the scope of the invention. REFERENCES [0000] [1] Fellermeier M, Zenk M H (1998) Prenylation of olivetolate by a hemp transferase yields cannabigerolic acid, the precursor of tetrahydrocannabinol. FEBS Letters 427:283-285 [2] Fellermeier M, Eisenreich W. Bacher A, Zenk M H (2001) Biosynthesis of cannabinoids, incorporation experiments with 13 C-labeled glucoses. Eur. J. Biochem. 268:1596-1604 [3] Rahaijo T J, Chang W T, Verberne M C, Peltenburg-Looman A M G, Linthorst H J M, Verpoorte R (2004a) Cloning and over-expression of a cDNA encoding a polyketide synthase from Cannabis sativa . Plant Physiology and Biochemistry 42:291-297 [4] Taura F, Morimoto S, Shoyama Y, Mechoulam R (1995) First direct evidence for the mechanism of delta-1-tetrahydrocannabinolic acid biosynthesis. J Am Chem Soc 38: 9766-9767 [5] Taura F, Morimoto S, Shoyama Y (1996) Purification and characterization of cannabidiolic-acid synthase from Cannabis sativa L. J of Biol Chem 271:17411-17416 [6] Gaoni Y, Mechoulam R (1966) Cannabichromene, a new active principle in hashish. Chemical Communications 1:20-21 [7] Morimoto S, Komatsu K, Taura F, Shoyama Y (1997) Enzymological evidence for cannabichromenic acid biosynthesis. J Nat Prod 60:854-857 [8] Morimoto S, Komatsu K, Taura F, Shoyama Y (1998) Purification and characterization of cannabichromenic acid synthase from Cannabis sativa . Phytochemistry 49:1525-1529 [9] Vree T B, Breimer D D, Ginneken C A M van, Rossum J M van (1971) Identification of the methyl and propyl homologues of CBD, THC and CBN in hashish by a new method of combined gas chromatography-mass spectrometry. Acta Pharm Suedica 8:683-684 [10] Zeeuw R A de, Wijsbek J, Breimer D D, Vree T B, Ginneken C A van, Rossum J M van (1972) Cannabinoids with a propyl side chain in Cannabis . Occurrence and chromatographic behaviour. Science 175:778-779 [11] Raharjo T J, Chang W T, Choi Y H, Peltenburg-Looman A M G, Verpoorte R (2004b) Olivetol as a product of a polyketide synthase in Cannabis sativa L. Plant Science 166:381-385 [12] Samuelsson G (1999) Drugs of natural origin, 4 th edition. Swedisch Pharmaceutical Press, Stockholm 551 pp [13] Meijer E P M de (1995) Fibre hemp cultivars:a survey of origin, ancestry, availability and brief agronomic characteristics. J Int Hemp Association 2:66-73 [14] Virovets V G (1996) Selection for non-psychoactive hemp varieties ( Cannabis sativa L.) in the CIS (former USSR). J Int Hemp Association 3:13-15 [15] Virovets V G, Scherban I, Orlov N (1997) Selektion auf niedrige Gehalt der Cannabinoid und hohe Produktivität im Schaffingsprogramm von Hanfsorten ( Cannabis sativa L.), die keine narkotische Ativität besitzen. Proceedings of the symposium Bioresource Hemp 97, Frankfurt am Main, Germany. P 135-153 [16] Gorshkova L M, Senchenko G I, Virovets V G (1988) Method of evaluating hemp plants for content of cannabinoid compounds [Russian]. Referativnyi Zhurnal 12.65.322. [17] Virovets V G (1998) Interview. J Int Hemp Association 5:32-34 [18] Virovets V G, Senchenko G I, Gorshkova L M, Sashko M M (1991) Narcotic activity of Cannabis sativa L. and prospects of its selection for decreased content of cannabinoids [Russian]. Agricultural Biology 1:35-49 [19] Pacifico D, Miselli F, Micheler M, Carboni A, Ranalli P, Mandolino G (2006) Genetics and marker-assisted selection of the chemotype in Cannabis sativa L. Molecular Breeding 17:257-268 [20] Sirikantaramas S, Taura F, Tanaka Y, Ishikawa Y, Morimoto S, Shoyama Y (2005) Tetrahydrocannabinolic acid synthase, the enzyme controlling marijuana psychoactivity, is secreted into the storage cavity of the glandular trichomes. Plant Cell Physiol 46:1578-1582 [21] Samuelsson G (1999) Drugs of natural origin, 4 th edition. Swedisch Pharmaceutical Press, Stockholm 551 pp. [22] Evans W C (2002) Pharmacognosy 15 th edition. Saunders, Edinburgh, 585 pp. [23] McPartland J M, Russo E B (2001) Cannabis and Cannabis extracts:greater than the sum of their parts? J. Cannabis Therapeutics 1:103-132. [24] Williamson E M, Whalley B J (2002) Cannabis as a medicine:evidence for synergy. In: Medicinal uses of Cannabis, 26 th LOF Symposium, Leiden. [25] Speroni E, Govoni P, Grassi G, Utan A (2003) Antiinflammatory effects of Cannabis sativa L. extracts containing nonpsychoactive cannabinoids. In:Borrelli F, Capasso F, Milic N, Russo A (eds) Proceedings 3rd International Symposium on Natural Drugs, Indena, Naples, pp 107-114. [26] Meijer E P M de, Hammond K M (2005) The inheritance of chemical phenotype in Cannabis sativa L. (II):cannabigerol predominant plants. Euphytica 145:189-198.

The invention relates to a reference plant which has been selected to: a) not express a medicinally active compound or group of compounds; yet b) express, at least substantially qualitatively, most other non medicinally active compounds present in a therapeutically active comparator plant. The reference plant can be used to generate a reference extract with a reference chemical profile which resembles that of the comparator plant less the active compound or group of compounds and may thus be used as a placebo or to otherwise test the hypothesis that the active compound or compounds are responsible for an extracts perceived medicinal activity.

Botanical/commercial classification: Rosa hybrida /Hybrid Tea Rose Plant. Varietal denomination: cv. Meimarkize. SUMMARY OF THE INVENTION The new variety of Rosa hybrida Hybrid Tea rose plant was created by artificial pollination wherein two parents were crossed which previously had been studied in the hope that they would contribute the desired characteristics. The female parent (i.e., the seed parent) was the ‘Meisatex’ variety (non patented in the United States). The male parent (i.e., the pollen parent) was the product of the cross of the ‘Meikola’ variety (U.S. Plant Pat. No. 5,607) and the ‘Keidargo’ variety (non-patented in the United States). ‘Meisatex’×(‘Meikola’בKeidargo’). The seeds resulting from the above pollination were sown and small plants were obtained which were physically and biologically different from each other. Selective study resulted in the identification of a single plant of the new variety. It was found that the new Hybrid Tea rose plant of the present invention: (a) forms strong vegetation, (b) forms substantially globular-shaped buds, (c) forms at mid-season abundantly and substantially continuously attractive yellow-green blossoms suffused with pink possessing a light fragrance wherein the numerous petals are positioned in a quartered manner, (d) displays attractive green foliage, (e) forces well under greenhouse growing conditions, and (f) is particularly well suited for cut flower production under greenhouse growing conditions. The new variety well meets the needs of the horticultural industry and performs well under greenhouse growing conditions. No disease problem has been observed during observations to date when the new variety was being grown in greenhouses. The new variety can be readily distinguished from its ancestors. For instance, the blossom coloration is considerably different from that of the ‘Meisatex’, ‘Meikola’, and ‘Keidargo’ varieties. More specifically, the ‘Meisatex’ variety forms orange-red blossoms, the ‘Meikola’ variety forms Venetian pink blossoms, and the ‘Keidargo’ variety forms dark red blossoms. The new variety has been found to undergo asexual propagation in France by a number of routes, including budding, grafting, and the use of cuttings. Asexual propagation by the above-mentioned techniques in France has shown that the characteristics of the new variety are stable and are strictly transmissible by such asexual propagation from one generation to another. The new variety has been named ‘Meimarkize’. BRIEF DESCRIPTION OF THE PHOTOGRAPH The accompanying photograph shows that as nearly true as it is reasonably possible to make the same, in a color illustration of this character, typical specimens of the plant parts of the new variety. The rose plants of the new variety were approximately one year of age and were observed during May while growing on Rosa indicia Major understock and growing in greenhouses at Le Cannet des Maures, Var, France. Dimensions in centimeters are indicated at the bottom of the photograph, as is a standard color comparison. FIG. 1 illustrates a specimen of a young shoot; FIG. 2 illustrates a specimen of a floral bud before the opening of the sepals; FIG. 3 illustrates a specimen of a floral bud at the opening of the sepals; FIG. 4 illsutrates a specimen of a floral bud at the opening of the petals; FIG. 5 illustrates a specimen of a flower in the course of opening; FIG. 6 illustrates a specimen of an open flower— plan view— obverse; FIG. 7 illustrates a specimen of an open flower— plan view— reverse; FIG. 8 illustrates a specimen of a fully open flower— plan view— obverse; FIG. 9 illustrates a specimen of a fully open flower— plan view— reverse; FIG. 10 illustrates a specimen of a floral receptacle showing the arrangement of the stamens and pistils; FIG. 11 illustrates a specimen of a floral receptacle showing the arrangement of the pistils (stamens removed); FIG. 12 illustrates a specimen of a flowering stem; FIG. 13 illustrates a specimen of a main branch; FIG. 14 illustrates a specimen of a leaf with three leaflets— plan view— upper surface; FIG. 15 illustrates a specimen of a leaf with five leaflets— plan view— under surface; and FIG. 16 illustrates a specimen of a leaf with seven leaflets— plan view— upper surface. DETAILED DESCRIPTION The chart used in the identification of the colors in that of The Royal Horticultural Society (R.H.S. Colour Chart). The description is based on the observation of one-year-old plants during May which were budded on Rosa indicia Major understock and growing in greenhouses at Le Cannet des Maures, Var, France. Class: Hybrid Tea. Plant: Height. —When pruned to a height of 0.85 cm, floral stems having lengths of approximately 60 to 70 cm on average are produced. Width. —Approximately 80 cm on average. Branches: Color. —Young stems: near Yellow-Green Group 144A. Adult wood: near Green Group 143A. Thorns. —On young stems: Small Prickles: Quantity: none. Long prickles: Quantity: none. On adult stem: Small prickles: Quantity: Approximately 10 on average on a stem length of 10 cm. Length: approximately 0.2 cm. average. Color: near Greyed-Yellow Group 160D with some Greyed-Orange Group 166A. Base: Obovate. Long prickles: Configuration: rather slightly, very longish pointed and curved downwards on the upper surface, and concave on the under surface. Quantity: approximately 1 on average on a stem length of 10 cm. Length: approximately 0.4 cm on average. Color: near Yellow-Green Group 160D with Greyed-orange Group 166A. Base: obovate. Leaves: Stipules. —Adnate, pectinate and narrow, smooth, approximately 1.8 cm in length on average, approximately 0.2 cm in width on average, near Green Group 138A no the upper side, and near Green Group 138B on the under surface. Petioles. —Upper surface: near Green Group 143A in coloration. Under surface: near Green Group. 143B in coloration. Length: approximately 2.8 cm for the terminal leaflet. Rachis. —Upper surface: Near Green Group 143A in coloration. Under surface: near Green Group 143B in coloration. Leaflets. —Number: 3, 5 and 7 (most often). Shape: generally elliptical with a pointed tip and an obtuse base. Size: the terminal leaflet commonly are approximately 9.6 cm in length on average and approximately 5 cm in width on average. Serration: small and single (as illustrated). Texture: physically firm and thick. Color (young foliage): Upper surface: near Green Group 138A. Under surface: near Green Group 136B. Color (adult foliage): Upper surface: near Green Group 139A. Under surface: near Green Group 138B. Inflorescence: Number of flowers. —Commonly approximately 5 to 7 blossoms per stem. Peduncle. —Smooth, approximately 2.5 cm in length on average, approximately 0.6 cm in diameter on average, and near Yellow-Green Group 144A in coloration. Sepals. —Upper surface: smooth and near Yellow-Green Group 146B in coloration. Under surface: glandular and near Yellow-Green Group 144A in coloration. Size. —Approximately 3.6 cm in length on average, and approximately 1.2 cm in width at the widest point on average. Shape: longish-pointed and new at the top and somewhat straight at the base. Extensions: two sepals commonly possess no extensions and three sepals commonly possess very weak extensions. Buds. —Shape: substantially globular. Size: medium. Length: approximately 3 cm on average. Width: approximately 2.3 cm on average. Color as calyx breaks: Upper surface: near Red Group 56C, and amply suffused with near Red group 49A, and with a spot at the base of the near Green-Yellow Group 1C. Under surface: near Red Group 56C, and amply suffused with Red Group 49A and margined with Red Group 54A, and with a spot at the base of near Green-Yellow Group 1C more or less suffused with Yellow-Green Group 149A. Flower. —Shape: cup-shaped. Diameter: approximately 8 cm on average. Color (in the course of opening): Upper surface: near Red Group 56C suffused with near Red Group 49A. Under surface: near Red Group 56C suffused with near Red Group 49A and more or less margined with Red Group 54A. Spot at base: near Green-Yellow Group 1C on both surfaces. Upper side: possesses external whorls of near Red Group 56C and 56D, and internal whorls of near Red Group 56C and 56D, more or less suffused with Red Group 49A. Under surface: near Yellow-Green 150D with suffused with Yellow-Green Group 144B and 144D on the external petals. External whorls are near Green-Yellow Group 1C margined with near Red Group 56C, and internal whorls are near Green-Yellow Group 1C and one more or less suffused with near Red Group 56C and near Red Group 49A. Spot at base: bear Green-Yellow Group 1A. Color stability: slight change with age. Fragrance: light. Lasting quality: the blossoms commonly last approximately 14 to 16 days on the plant on average, and approximately 9 or 10 days on average when cut and placed in a vase. Petal number: approximately 97 on average under normal growing conditions. Petal shape: with a substantially rounded tip and base. Petal texture: consistent and somewhat firm. Petal length: approximately 5.4 cm on average. Petal width: approximately 5.7 cm on average. Petal arrangement: imbricated, without petaloids, and commonly quartered. Petal drop: good with the petals commonly detaching cleanly before drying. Stamen number: approximately 57 on average. Anthers: regularly arranged around the styles, approximately 0.3 cm in size on average, and near Orange Group 26B in coloration. Pollen: present. Filaments: approximately 0.5 cm in length on average and near Group 1A in coloration. Pistils: approximately 172 on average. Stigmas: approximately 0.8 cm in size on average and near Green-Yellow Group 1D in coloration. Styles: approximately 0.1 cm in length on average, and near Red-Purple Group 58A in coloration. Receptacle: smooth, funnel-shaped in longitudinal section, approximately 1.5 cm in length on average, approximately 1.7 cm in width on average at the widest point, and near Yellow-Green Group 144A in coloration. Hips: none observed to date when grown under greenhouse growing conditions. Development: Vegetation. —Strong. Blooming. —Mid-season, abundant and substantially continuous. Tolerance to diseases. —No diseases have been observed during observations to date when grown in greenhouses. Aptitude to bear fruit. —None observed during observations to date. Aptitude to to forcing. —Good.

A new and distinct variety of Hybrid Tea rose plant is provided that forms at mid-season abundantly and substantially continuously attractive yellow-green blossoms suffused with pink processing a light fragrance wherein the numerous petals are positioned in a quartered manner. The buds are substantially globular-shaped. The vegetation is strong and attractive green foliage is formed. The plant forces well and is particularly well suited for cut flower production under greenhouse growing conditions.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to United Kingdom Patent Application No. 0805052.8 filed Mar. 19, 2008. FIELD OF THE INVENTION [0002] The invention relates to a method for making a dental blank of a ceramic material, as typically used for making dental restorations. The invention also relates to a press and a system for making dental blanks. BACKGROUND OF THE INVENTION [0003] Dental restorations are often made of ceramic materials because ceramic materials generally provide relatively good physical, aesthetic and biological properties as commonly desired in the field of dentistry. Examples of such dental restorations are crowns, bridges, inlays, onlays, veneers, implants. One way to make dental restorations of ceramic materials includes the use of an automated process, in which a dental restoration precursor is machined from a ceramic blank. A type of blank as it is typically used in such process is made of pressed and pre-sintered ceramic particles. Relative to the use of a solid ceramic material, a so formed dental blank is porous and relatively soft so that it can be machined relatively easily. On the other hand such blank is sufficiently stable so that it can be handled in a machine. [0004] Dental blanks for making dental restorations may be formed by pressing ceramic particles, like a ceramic powder, at relatively high pressure so that the ceramic particles block with each other and form a generally cohesive body of material. A subsequent pre-sintering step typically adds further mechanical stability to the body and thereby forms the dental blank which can then be used for producing a dental restoration precursor. [0005] A dental restoration precursor obtained from such pressed and pre-sintered blank is typically further sintered, and subsequently polished or furnished with a veneer. Typically the precursor shrinks, generally proportionally, during sintering because the initially porous material reduces in porosity and increases in density. For this reason the restoration precursor may be initially larger, for example about 20% to 30% in each dimension, than the desired final shape after sintering, to account for shrinkage during the sintering step. It has been found desirable that the material structure of the blank is of a generally uniform density. This is because a non-uniform density or inhomogeneity of the blank material may cause the dental restoration precursor obtained from that blank to shrink non-uniformly in one or more dimensions during sintering. Thus, the precision of the final dental restoration may be adversely affected, resulting in wasted time and expense for a dentist. [0006] To achieve a relatively uniform density of the blanks the ceramic particles are often pressed by isostatic pressing techniques. Isostatic pressing typically is based on the use of a hydraulic fluid, for example oil, water or an emulsion of both, to apply pressure to the ceramic particles generally uniformly from all sides, or isotropically. Typically isostatic pressing is used with cylindrical blanks because the cylindrical shape provides for relatively isotropic compaction, and therefore provides for a relatively homogeneous inner structure of such blanks However, there have been efforts to find alternative pressing techniques that are less expensive, and/or which can be reliably used for different blank shapes. [0007] SE-7807661 describes a tool for isostatic pressing. The tool has an upper and a lower tool component which can be combined to form a mold. Each of the tool components have a membrane which join to form a closed space within the mold when the tool components are combined. A material to be pressed may be accommodated in the space between the membranes. Each of the tool components provide for a pressure medium to be supplied between the mould walls and the outside of the membranes, so that the pressure medium can be used to pressurize the membranes for pressing of the material accommodated in between. [0008] It is still desired to manufacture blanks having any desired shape with a consistently high degree of homogeneity of the inner material. Also, it is a general desire to provide a relatively inexpensive manufacturing process. Especially for dental purposes there is also demand for a manufacturing process that provides for maintaining a high hygiene level during production. SUMMARY OF THE INVENTION [0009] The invention provides a method, a press and a system for making a dental blank. Preferably the dental blank is comprised of ceramic particles of a ceramic material based on zirconium or aluminum oxide. The dental blank is preferably usable in the preparation of dental restorations. [0010] According a first aspect, the invention provides a method of making a dental blank. The method comprises the steps of: [0011] (a) pressing ceramic particles to form a dental blank precursor; and [0012] (b) pressing the dental blank precursor to form the dental blank, [0013] wherein one of the steps (a) and (b) includes uniaxial pressing and the other one of the steps (a) and (b) includes isostatic pressing. Preferably the step (b) includes isostatic pressing. Step (a) accordingly preferably includes uniaxial pressing. [0014] The method preferably provides at least to some extent for independent controlling of the general shape, and the material homogeneity of the dental blank. For example, one pressing step may be adapted and/or controlled to achieve a relatively precise general shape of the blank. In a subsequent pressing step may be adapted and/or controlled to increase the material homogeneity of the blank, preferably without substantially changing the shape of the blank. This may be advantageous because relative to a single continuous process the invention preferably allows splitting of the blank manufacturing process into separate steps, each allowing the application of appropriate parameters (for example pressures, pressing speeds etc.), and the use of appropriate tooling. The invention, for example, may provide for pre-shaping blanks in a relatively easy, robust and inexpensive process. The so formed blank precursors may be subsequently increased in their material homogeneity rather effectively in a process that would probably be less effective in shaping. The invention may therefore provide for minimizing the overall process time required for making dental blanks. Further the invention may provide for a relatively homogeneous inner material structure of the dental blanks independently from their shape. The invention may also provide a cost effective method of making blanks, and further may provide for dental blanks to be manufactured at relatively high quality. [0015] Preferably uniaxial and isostatic pressing are only used separate from each other. For example, isostatic pressing may only be performed when uniaxial pressing is inactive. Further uniaxial pressing may only be performed when isostatic pressing is inactive. In particular the step (a) may comprise a step of releasing the dental precursor from pressure. Therefore the material of the dental blank precursor may relax between steps (a) and (b). For example, the material density of the dental blank precursor may decrease during relaxation. This may provide for a better material homogeneity of the dental blank in the step (b). [0016] Preferably uniaxial pressing comprises pressing of the ceramic particles or the dental blank precursor from generally mainly opposite sides, for example two opposite sides, preferably by moving at least two pressing dies towards one another. Preferably such two pressing dies during pressing also move relative to a die plate which laterally restrains the ceramic particles or the dental blank precursor. [0017] During step (b) “pressing the dental blank precursor to form the dental blank” the dental blank precursor is preferably in touch with a pressing member. The pressing member is preferably arranged between the dental blank precursor and a hydraulic fluid. Further the pressing member preferably transmits pressure received from the hydraulic fluid to the dental blank precursor. The pressing member is preferably adapted to generally conform to the shape of at least a portion of the dental blank precursor. This also includes that the pressing member is adapted to generally conform to a shape change of the portion of the dental blank precursor. Such change of the shape may, for example, result from a compression of the dental blank precursor during the step (b). Therefore the pressing member is preferably also adapted to generally conform to the shape of a portion of the dental blank. The pressing member is preferably flexible or deformable. In particular the pressing member may be a membrane, preferably a flexible membrane. [0018] Preferably the general shape of the dental blank is mainly provided by the step (a) “pressing ceramic particles to form a dental blank precursor”. In contrast, the dental blank preferably does not obtain its general shape as a result of an initial shape of the pressing member used in step (b). In one embodiment step (a) provides the dental blank precursor with a shape that substantially corresponds to a proportionally enlarged shape of the dental blank. Further, step (b) may substantially proportionally (in three dimensions) reduce the dental blank precursor provided in step (a) in shape. For example, the dental blank precursor may be shaped generally cuboid in step (a). Then the cuboid shape may generally be maintained in step (b), but the length, width and height of the cuboid may be reduced proportionally. Other shapes, however, are possible like cylindrical shapes, or shapes having an elliptical or other suitable profile. Generally any such profile (including a rectangular and circular profile) may extend generally straight or curved to form the overall shape of the dental blank precursor and/or blank. [0019] In one embodiment step (a) increases the material density of the bulk of ceramic particles used to form the dental blank precursor. Preferably step (a) increases the material density of a bulk of ceramic particles by a factor of between about 1.7 and 3, preferably by a factor of between about 2.2 and 2.3. The material density of the dental blank precursor of the ceramic particles is preferably between about 2.5 g/cm 3 and 3.0 g/cm 3 , preferably about 2.9 g/cm 3 . In another embodiment step (a) increases the material density of a bulk of glass ceramic particles by a factor of between about 1.5 and 6.7, preferably by a factor of between about 2.9 and 3.1. The material density of the dental blank precursor of the glass ceramic particles is preferably between about 1.2 g/cm 3 and 2.0 g/cm 3 , preferably about 1.5 g/cm 3 . [0020] In another embodiment step (b) increases the material density of the dental blank relative to the dental blank precursor. Preferably step (b) increases the material density of the dental blank precursor of a ceramic material by a factor of between about 1.02 and 1.4, preferably by a factor of between about 1.08 and 1.1. The material density of the dental blank of a ceramic material is preferably between about 2.9 g/cm 3 and 3.4 g/cm 3 , preferably about 3.15 g/cm 3 . In another embodiment step (b) increases the material density of the dental blank precursor of a glass-ceramic material by a factor of between about 1.02 and 1.9, preferably by a factor of between about 1.1 and 1.3. The material density of the dental blank of a glass-ceramic material is preferably between about 1.6 g/cm 3 and 2.2 g/cm 3 , preferably about 1.7 g/cm 3 . [0021] Other factors and densities are possible as appropriate for other materials used with the invention. [0022] In another embodiment step (b) may be performed with a plurality of dental blank precursors generally simultaneously or in parallel. The step (b) may be performed generally simultaneously in the same press and/or in two or more presses. This may allow minimizing the cycle time required for pressing, for example. In one embodiment of the invention the method may comprise a step (c) of placing a plurality of dental blank precursors in different predetermined positions in a press. Dental blank precursors may, for example, be placed arranged in a generally two-dimensional pattern, for example side by side along two rows, on the pressing member. [0023] In another embodiment of the invention at least two steps of the method of the invention are performed automated in a sequence. A preferred sequence of steps is step (a), and step (b), in the order as listed. Another sequence of steps may be step (a), step (c), and step (b), in the order as listed. The sequence of steps may also be repeated. A method of the invention may thus comprise: repeatedly pressing ceramic particles to form blank precursors, and thereby forming a plurality of dental blank precursors in a sequential manner; and pressing of the plurality of dental blank precursors in-parallel to form a plurality of dental blanks. [0026] Such a method may be advantageous for concatenating a method step comprising uniaxial pressing with an a method step comprising isostatic pressing. For example, this may allow for concatenating an uniaxial press inline with an isostatic press in case one of the isostatic or uniaxial presses has a longer cycle time relative to the other. [0027] In another embodiment the ceramic material has a relatively low content of binders, or is generally free of binders. Preferably the amount of binders is below 5% by weight, for example between about 2% to 4%. A ceramic material as it may be used with the invention may comprise between 90 and 99% by weight zirconium oxide, and preferably 91 to 97.25% by weight zirconium oxide. The ceramic material may further comprise 0-1% by weight aluminium oxide. The ceramic material may also be based on aluminium oxide, meaning the ceramic material may comprise 90 to 99% by weight aluminium oxide and 0 to 1% by weight zirconium oxide. Further, the ceramic material may comprise 0-10% by weight of at least one of hafnium oxide, yttrium oxide and oxides from gallium, germanium, and indium, as well as 0.0005 to 1.5% by weight of colouring additives, selected from the group consisting of the oxides Fe2O3, Er2O3 and/or MnO2. The ceramic material is preferably selected to be compatible for use in human bodies. [0028] In another aspect the invention relates to an isostatic press for making a dental blank. The isostatic press comprises: a first and a second pressing member that are shaped to form in cooperation a closed chamber for encasing a dental blank precursor; and the pressing members being separable to provide the chamber to be opened. [0031] Preferably the pressing members in the area in which they encase the dental blank are generally not supported by solid parts of the mold, in particular in a stage in which the pressing members are separated. [0032] In one embodiment of the invention the first and second pressing members are flexible. Preferably one or both of the first and second pressing members have a thickness of between about 0.05 mm and 5 mm, preferably between about 0.05 mm and 0.10 mm. [0033] In another embodiment the size and shape of the chamber generally corresponds to a cuboid having dimensions of between about between 10 mm×10 mm×10 mm and 30 mm×200 mm×200 mm, preferably between about 25 mm×25 mm×40 mm and 40 mm×25 mm×70 mm. The general size of the chamber may be provided mainly by a correspondingly sized receptacle in one of the first and the second pressing members, or by a correspondingly sized receptacle formed between both pressing members. [0034] For example, the first pressing member may have a receptacle which is covered by the second pressing member when the first and second pressing members are combined. In this case, the first pressing member may have a receptacle of a generally cuboid shape, and the receptacle in size and shape may generally correspond to the size and shape of the chamber. Further, the corresponding second pressing member may be generally flat in at least an area covering the receptacle. Therefore a dental blank or blank precursor placed in the receptacle may be typically generally flush with the opening of the receptacle. [0035] In another embodiment the first or the second pressing member may have a plurality of receptacles and the corresponding other pressing member may be generally flat in at least the areas covering the receptacles. [0036] Further, the first and the second pressing members may have a first and second plurality of receptacles, respectively, with the first and second receptacles in combination forming chambers for encasing dental blank precursors. Therefore dental blanks or blank precursors received in the receptacles may project over the openings of the receptacles. This may provide the advantage of facilitating gripping of the blanks or blank precursors for insertion in or removal from the pressing members. This may be particularly advantageous if the press is used in an automated process. [0037] In another embodiment the first and second pressing members encase a dental blank precursor. In this case preferably all sides of a dental blank precursor are surrounded by and in contact with the at least one of the first and second pressing members. [0038] In another embodiment of the invention the press may be adapted to perform at least step (b) of the method of the invention. [0039] Another aspect of the invention is related to a system for making dental blanks. The system comprises: an isostatic press; and an uniaxial press. [0042] The system may further comprise a pick and place system for moving dental blank precursors between the isostatic press and the uniaxial press. Preferably, the pick and place system is adapted for moving dental blank precursors from the uniaxial press towards the isostatic press. The pick and place system thereby may also be indirectly coupled with one or both of the uniaxial and isostatic press. For example, the dental blank precursors may be stored in an output buffer associated or connected with the uniaxial press, and fed from the output buffer to the pick and place system. The pick and place system may then load the dental blank precursors into an input buffer associated or connected with the isostatic press. A system combining a uniaxial and a isostatic press may provide for an automated manufacturing of dental blanks. As an advantage the throughput of the manufacturing process may be maximized. Further, the automatic handling may provide for maximizing the hygiene during manufacturing of dental blanks because manual handling steps may be minimized. Such system may also allow for optimizing the cooperation of the two different pressing techniques according to the invention. [0043] Still another aspect of the invention is related to a kit, comprising at least a part of an isostatic press, and instructions for connecting the isostatic press and an uniaxial press. This may provide for easy adaptation of an isostatic press with an uniaxial press, for example, to facilitate implementation of the method of the invention in a manufacturing plant for making dental blanks BRIEF DESCRIPTION OF THE DRAWINGS [0044] The invention is described in the following by way of example only with reference to the accompanying figures, in which: [0045] FIG. 1 is a perspective view of an uniaxial pressing tool which is filled with ceramic particles according to an embodiment of the invention; [0046] FIG. 2 is a perspective view of an uniaxial pressing tool in which the ceramic particles are pressed according to an embodiment of the invention; [0047] FIG. 3 is a perspective view of a dental blank precursor according to an embodiment of the invention; [0048] FIG. 4 is a perspective view of a portion of an isostatic press with a pressing member holding a dental blank precursor according to an embodiment of the invention; [0049] FIG. 5 is a perspective view of a portion of a pressing member holding a dental blank precursor according to an embodiment of the invention; [0050] FIG. 6 is a perspective view of portions of two pressing members encasing a dental blank precursor according to an embodiment of the invention; [0051] FIG. 7 is a perspective view of portions of two pressing members encasing a dental blank precursor according to an alternative embodiment of the invention; [0052] FIG. 8 is a schematic cross-sectional view of an isostatic press according to an embodiment of the invention, when it is opened; [0053] FIG. 9 is a schematic cross-sectional view of the press of FIG. 8 in when it is closed; [0054] FIG. 10 is a schematic top view on the bottom part of the press of FIG. 8 ; and [0055] FIG. 11 is a schematic view of an isostatic press having input and output stations according to an embodiment of the invention. DETAILED DESCRIPTION OF THE INVENTION [0056] FIG. 1 shows a pressing tool 10 for uniaxial pressing of ceramic particles by way of example only. The pressing tool 10 has a lower pressing die 12 which is placed partially in a through-hole 14 of a die-plate 13 . The die-plate 13 with its through-hole 14 thereby forms together with the lower pressing die 12 a receptacle. An upper pressing die 11 is positioned above the receptacle and leaves a space to the opening of the receptacle so that the receptacle is accessible for filling. The Figure shows the receptacle already filled with ceramic particles 15 , for example with a ceramic powder. The example of FIG. 1 shows a tool as it is particularly used for preparing dental blank precursors of a generally cuboid shape, and has therefore a through-hole of a generally rectangular cross-section. Further, the opposing surfaces of the pressing dies 11 , 12 are generally parallel to one another. [0057] The terms “upper”, “lower”, “top” and “bottom” as they may be used to designate locations or parts in this specification are used for ease of explanation only. The so designated parts or locations may in other examples be arranged differently, for example at any angle or orientation, as appropriate. [0058] FIG. 2 shows the same pressing tool 10 as shown in FIG. 1 , but with the upper pressing die 11 moved into the through-hole 14 (depicted in FIG. 1 ), and the lower pressing die 12 moved further in a direction towards the upper pressing die 11 . The ceramic particles 15 (depicted in FIG. 1 ) are thus pressed between the upper and lower pressing dies 11 , 12 . Preferably, such pressing is performed at forces causing the ceramic particles to block with each other to a degree that provides the particles to form a generally solid body of material. The so formed body is shown in FIG. 3 , and may be used as dental blank precursor 16 for further processing. Uniaxial pressing may comprises applying a pressure to a part or material to be pressed (for example the ceramic particles) of between about 10 MPa and 1000 MPa, in more particular between about 30 MPa and 150 MPa by a pressing die. Uniaxial pressing may be advantageous to manufacture dental blank precursors at relatively high automation level, and at relatively short cycle times. [0059] In contrast to FIGS. 1 and 2 , FIG. 4 shows a portion of an isostatic press 20 . Generally isostatic presses use hydraulic fluids instead of pressing dies as used in uniaxial presses. Blanks pressed by isostatic processes are typically exposed to relatively isotropic pressing forces relative to generally parallel forces typically occurring in uniaxial processes. Therefore, depending on the type of process used for pressing, different inner material structures of the blank may be achieved. The isostatic press 20 of the example has an upper part 23 with an upper fluid chamber 27 a , and a lower part 24 with a lower fluid chamber 27 b . The fluid chambers 27 a , 27 b may be filled with a hydraulic fluid, such as hydraulic oil or an emulsion. In the example shown the fluid chambers 27 a , 27 b are closed by pressing members 21 , 22 , respectively. The press is openable between the pressing members 21 , 22 for insertion of blanks or blank precursors in the press and removal from blanks or blank precursors from the press. Thereby the hydraulic fluid is kept encapsulated in the press. The pressing members 21 , 22 further keep the blank separate from the hydraulic fluid. The press 20 in FIG. 4 is shown when it is closed, and a dental blank precursor 16 is encased between the pressing members 21 , 22 . The pressing members 21 , 22 are preferably flexible. Therefore for pressing the dental blank precursor 16 the hydraulic fluid in the upper and lower chambers 27 a , 27 b may be pressurized, and the pressing members 21 , 22 may transmit that pressure to the dental blank precursor 16 . [0060] For pressing the dental blank precursor 16 the fluid may preferably be pressurized to pressures of between about 10 MPa and 1000 MPa, in more particular between about 50 MPa and 700 MPa, preferably between about 100 MPa and 400 MPa. [0061] As shown, the dental blank precursor 16 is almost entirely surrounded by the hydraulic fluid with only the relatively thin and flexible pressing members arranged between. Therefore the pressing forces arriving at the dental blank precursor are relatively isotropic. This may result in a relatively homogeneous inner material structure of the blank. In one embodiment of the invention the pressing members are considerably thinner than 30 mm, preferably between about 0.05 mm and 5 mm, and in particular preferably between about 0.05 mm and 0.10 mm. Preferably the flexibility of the pressing members is mainly provided by a relatively low thickness of the pressing members in relevant areas rather than by a soft material. Materials as they may be used for a pressing member are, for example polyurethane, polyethylene, polypropylene, but also rubbers, silicones, latex, thermoplastic elastomers, for example. Different materials may also be combined, for example layered. The pressing member may also comprise a coating providing for relatively low surface energy, for example a polytetrafluoroethylene coating. This may help to separate the blank form the pressing member. [0062] The pressing members may comprise a reinforcement layer, for example a wire mesh. Such reinforcement layer is preferably provided in areas of the pressing member that are adapted to encase the blanks or blank precursors. [0063] The pressing members 21 , 22 in the example of FIG. 4 in combination form a structure resembling a bag which is part of the press. Such bag may be used multiple times in a continuous process. However, an alternative embodiment of the press (not shown) may have only one continuous larger fluid chamber in which a loose bag encasing a blank may be disposed freely movable. The bag in this case may be formed by sealing two pressing members to each other that are not parts of the press. This may for example be advantageous in case the pressing members are only made for single use, for example due to hygiene requirements applying for products obtained from the blanks. [0064] FIGS. 5 and 6 show the dental blank precursor 16 placed in a lower pressing member 22 . FIG. 6 shows the embodiment of FIG. 5 with the dental blank precursor 16 covered by an upper pressing member 21 . The upper and lower pressing members 21 , 22 are preferably shaped so that they in cooperation form a closed chamber that generally corresponds in size and shape to the size and shape of the dental blank precursor 16 . Therefore the pressing members 21 , 22 are adapted to tightly encase the dental blank precursor 16 between each other. In the example shown in FIGS. 5 and 6 one part of the chamber is formed by a receptacle in the lower pressing member 22 that generally corresponds in size and shape to the size and shape of the dental blank precursor 16 . Therefore dental blank precursor 16 may fit entirely in the receptacle of the lower pressing member 22 , so that the upper surfaces of the blanks are flush with the opening of the receptacle of the pressing member 22 (shown in FIG. 5 ). On the other hand the upper pressing member 21 is generally flat and closes the receptacle to form the closed chamber. [0065] An alternative configuration of the pressing members is shown in FIG. 7 . The pressing members 21 ′ and 22 ′ of FIG. 7 both have receptacles that together can form a closed chamber which generally corresponds in size and shape to the size and shape of the dental blank precursor 16 . The depth of the receptacle in pressing member 22 ′ may be selected to provide the dental blank precursor or the dental blank to stick out sufficiently so that it can be grasped manually or automatically for handling. Such configuration may be advantageous for example to facilitate an automation of the dental blank making method. An appropriate configuration may be, for example, one in which the pressing members 21 ′, 22 ′ have receptacles of substantially equal depths. This may allow relatively easy insertion of the dental blank precursor in the lower pressing member 22 ′, and may provide for generally trouble free insertion in the upper pressing member 21 ′ when the pressing members are combined. [0066] FIGS. 8 and 9 illustrate schematically an embodiment of a press 30 of the invention. The press 30 comprises an upper part 33 , and a lower part 34 . In FIG. 8 , the press 30 is shown in its open state, whereas FIG. 9 shows the press 30 in its closed state. [0067] The lower part 34 comprises a flexible pressing member 32 having a plurality of receptacles 35 . Some of the receptacles 35 are illustrated as containing a dental blank precursor 36 . The upper part 33 of the press 30 also comprises a flexible pressing member 31 which in this case is generally flat. The upper and lower pressing members 31 , 32 when combined, as shown in FIG. 9 , form several closed chambers each for encasing a dental blank precursor 36 . However, as described for the embodiment shown in FIG. 7 , both pressing members may have receptacles of smaller depths (not shown) that together form larger closed chambers as appropriate to encase dental blank precursors. The upper and lower parts 33 , 34 have upper and lower fluid chambers 37 a , 37 b which in the example are closed by the upper and lower pressing members 31 , 32 . [0068] As shown in FIG. 10 , several dental blank precursors, and the corresponding receptacles in the pressing members, may be arranged not only side by side, but also two-dimensionally spread over an area of the pressing member 32 . This allows a relatively compact design of the press, and provides for a relatively high throughput of the process. [0069] The dental blank precursors 36 may be loaded in the lower pressing member 32 automatically, for example by a pick and place system. The dental blank precursors 36 may be delivered from a previous manufacturing step to a pick up location from which they are picked up and placed in empty receptacles of the pressing member 32 . After pressing of the dental blank precursors, the so formed dental blanks may be removed by the same or another pick and place system, and the receptacles may be filled again. [0070] FIG. 11 shows a manufacturing line 40 having a press 41 , an input station 42 and an output station 43 . The press is configured to process a plurality of blanks in parallel. Therefore the press 41 may have a pressing member 47 in which several receptacles for receiving dental blank precursors 46 b are arranged in a generally two-dimensional pattern. The press further has an input station 42 which can receive a plurality of dental blank precursors 46 a in an arrangement that generally corresponds to the two-dimensional pattern provided in the pressing member 47 . The press can process the plurality of dental blank precursors 46 b , while in parallel the input station 42 may already be loaded with new dental blank precursors 46 a . Because the pressing method on dental blank precursors 46 b may require some time the input station may in the meantime be loaded, for example sequentially by a pick and place system. When the pressing process is finished the dental blank precursors 46 a may all at once be charged in the press 41 , for example by a multiple picker system. At the same time the press may be unloaded all at once, and the output transferred to the output station 43 . The example shows dental blanks 46 c which can be unloaded sequentially or in parallel from the output station 43 . Unloading of the output station 43 may also happen in parallel to the pressing process and the loading of the input station 42 . A cycle in which dental blanks are pressed, the input station is loaded, and the output station is unloaded may be repeated continuously. As an advantage such system may provide for a relatively high throughput because loading, unloading and pressing may be performed in a single cycle.

The invention relates to a method of making a dental blank which combines uniaxial pressing isostatic pressing techniques. The invention also includes a press for performing the method and a system comprising a uniaxial and a isostatic press. The invention may help in efficient manufacturing of dental blanks at minimized costs and maximized quality.

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a U.S. National Stage Application under 35 U.S.C. §371 of International Patent Application No. PCT/IB2014/064399, filed Sep. 10, 2014 which claims priority to Portugal Patent Application No. 107150, filed Sep. 10, 2013, which are hereby incorporated by reference as if set forth in their respective entireties herein. TECHNICAL FIELD The present subject matters relates to light-activatable polymeric nanoparticles (NPs) for the transportation and release of an active substance, methods for obtain said particles and their uses. BACKGROUND ART The development of triggerable systems that allow precise control of the timing, duration and magnitude of drug release is important for therapeutic medicine. Micellar aggregates (core-shell micelles, vesicles, etc.) formed by amphiphilic block copolymers or small molecule surfactants have been reported as possible light-activatable drug delivery systems (Jiang, J., Tong, X., Morris, D. &amp; Zhao, Y. Toward photocontrolled release using light-dissociable block copolymer micelles. Macromolecules 39 (2006); Jiang, J., Tong, X. &amp; Zhao, Y. A new design for light-breakable polymer micelles. Journal of the American Chemical Society 127 (2005)). In this sense, polymer micelles could release the drugs at a required time and tumor location. In some cases the dissociation of the micelles occurs due to structural arrangements of the photo-sensitive molecule attached to the block copolymer or surfactant. In other cases, the interaction of the photo-sensitive molecule with light results in a structural change that alters the hydrophilic/hydrophobic balance toward the disassembly of the micelle (Babin, J. et al. A new two-photon-sensitive block copolymer nanocarrier. Angew Chem Int Ed Engl 48, 3329-3332 (2009)). Recently, these studies have been extended to NPs that disassemble in reaction to light (Fomina, N., McFearin, C., Sermsakdi, M., Edigin, O. &amp; Almutairi, A. UV and near-IR triggered release from polymeric nanoparticles. J Am Chem Soc 132, 9540-9542 (2010); Timko, B. P., Dvir, T. &amp; Kohane, D. S. Remotely triggerable drug delivery systems. Adv Mater 22, 4925-4943 (2010)). However, the demonstration that these systems can be used to release efficiently biomolecules within cells either in vitro or in vivo with precise temporal and dosage control remains elusive. These systems should be formed by (i) components that can be eliminated by the human body while being able to (ii) efficiently cross the cell membrane and (iii) disassemble by light releasing consequently the cargo. Additionally, retinoic acid (RA) as a differentiation agent is used in the clinic for the treatment of human chronic myelogenous leukemia (CML), human acute promyelocytic leukemia (APL) and acute myeloid leukemia (AML) (Warrell, R. P., Jr. et al. Differentiation therapy of acute promyelocytic leukemia with tretinoin (all-trans-retinoic acid). N Engl J Med 324, 1385-1393 (1991); Russo, D. et al. All-trans retinoic acid (ATRA) in patients with chronic myeloid leukemia in the chronic phase. Leukemia 12, 449-454 (1998)). RA activates nuclear RA receptors (RARs) that forms heterodimers with retinoid X receptors (RXRs) which in turn binds to the RA response element (RARE) resulting in the activation of target genes causing cell growth arrest, apoptosis and differentiation (Si, J., Mueller, L. &amp; Collins, S. J. CaMKII regulates retinoic acid receptor transcriptional activity and the differentiation of myeloid leukemia cells. J Clin Invest 117, 1412-1421 (2007). However, in some cases, the intracellular concentration of RA available is relatively low to induce significantly the differentiation of leukemia cells, due to the low solubility of RA in physiologic milieu and low capacity to accumulate in cell cytoplasm. So, in order to overcome the problems of the state of the art, the present invention and different embodiments established an opto-nanomedicine approach for the treatment and study of leukemic (stem) cells either in vitro or in vivo. This new technology allows remote control in the release of biomolecules with spatio-temporal resolution. The light-activatable NPs disclosed are suitable for general therapeutic and regenerative medicine applications. The NP formulation described here is irreversible disassembled by a photochemical process (UV or blue laser). Several light-activatable polymeric NPs have been reported 12 , however the internalization and intracellular trafficking of these NPs containing bioactive agents and their effect in the modulation/differentiation of cells both in vitro and in vivo has not been studied. Here, we demonstrate the precise spatial and temporal control in the release of RA. We show for the first time that cells transfected with light-activatable NPs can be activated after 2 days while maintaining the same inductive properties. This gives an opportunity to use cells as “Trojan horses” for activation at specific sites of human body. Although several NP formulations have been reported for the release of RA, including from our group, no formulation can release high doses of RA (120 μg of RA per mg of NP) in minutes-range. This is very important to enhance the differentiation of leukemic cells, in particular in APL caused by PLZF/RARα, which exhibits impaired sensitivity to RA. In this case, the light-activated RA + NPs enhanced 2-4 fold the differentiation of the leukemic cells as compared to cells treated with non-activated RA + NPs. These facts are disclosed in order to illustrate the technical problem addressed by the present disclosure. SUMMARY OF THE DISCLOSURE The disclosure subject matter relates to a light-activatable nanoparticle for the transportation and release of an active substance, comprising a polycation, namely a polimer polycation, a polyanion and a light-sensitive photochrome attached to the polycation or the polyanion, wherein said photochrome is hydrophobic and suitable to photo-cleave when activated by an irradiation source, generating a negative charge and releasing the active substance. In an embodiment of the light-activatable nanoparticle disclosed the said polycationic polymer is at least one of the followings: poly(ethyleneimine), polylysine, poly(amino esters, poly(disulfide amines), chytosan, or others that one skilled in the art will recognize. In other preferred embodiment the said light-sensitive photochrome is at least one of the followings: an o-nitrobenzyl (o-NB) alcohol derivative, coumarin, 4,5-dimethoxy-2-nitrobenzyl chloroformate or others that someone skilled in the art will recognize. In other embodiment of the light-activatable nanoparticle disclosed the polyanion is at least one of the followings: dextran sulphate, polyaspartic acid, hyaluronic acid, among others. In other embodiment the light-activatable nanoparticle comprises: poly(ethyleneimine) (PEI) as polycation; 4,5-dimethoxy-2-nitrobenzyl chloroformate (DMNC) as a light-sensitive photochrome and dextran sulphate as polyanion. In another embodiment of the light-activatable nanoparticle disclosed the said active substance may beat least one of the followings: a cellular modulation agent, including a differentiating agent, a metabolic regulator, a cell cycle regulator, an epigenetic regulator, a reprogramming agent, a transcription factor, among others; in particular retinoic acid. In another embodiment of the light-activatable nanoparticle disclosed the molar ratio of DMNC to PEI could be between 1% and 100%. In another embodiment of the light-activatable nanoparticle disclosed the final degree of substitutions PEI-DMNC can be between 20-100%, preferably 25-50%. In another embodiment of the light-activatable nanoparticle disclosed the average diameter of the nanoparticle may be between 1-1000 nm, preferably 100-300 nm, more preferably 160 nm. In another embodiment of the light-activatable nanoparticle disclosed said irradiation source may be UV light or a blue laser, among others. In another embodiment the light-activatable nanoparticle disclosed can be for use in medicine, namely in regenerative medicine preferably for use in the treatment of neoplasias or cancer diseases, more preferably, for use in the treatment of leukemia. The light-activatable nanoparticle disclosed are able to transfer stem cells, allowing their homing into the in vivo niche (for example bone marrow) and then activating the said nanoparticles remotely by a laser. Another aspect of the present subject matter also discloses a composition comprising the light-activatable nanoparticle disclosed. Preferably, a pharmaceutical, a medical or a cosmetic composition. In another embodiment the light-activatable nanoparticle formulation may comprise a concentration of said nanoparticles up to 100 μg/mL. In another embodiment of the said composition light-activatable nanoparticle disclosed may be a topic formulation or an injectable formulation. In another embodiment of the light-activatable, to improve the stabilization of NP formulation zinc sulfate may be added. Another aspect of the present subject matter also discloses a method for obtaining light-activatable polymeric nanoparticles comprising the following steps: derivatizing the polycation with the photochrome in DMSO; precipitation of polycation-photochrome solution into an aqueous solution of a polyanion, separation of the nanoparticles from the remaining polymers, preferably by centrifugation or dialysis. In another embodiment the method for obtaining light-activatable polymeric nanoparticles comprises the following steps: Derivatizing the poly(ethyleneimine) with 4,5-dimethoxy-2-nitrobenzyl chloroformate in DMSO, in presence of triethylamine; precipitation of PEI-DMNC solution into an aqueous solution of dextran sulphate, the polyanion. In another embodiment zinc sulfate may be added as stabilizer to obtain a more stablelight-activatable polymeric nanoparticles. The present disclosure shows that light-activatable polymeric NPs may enhance the efficiency of transportation and release of an active substance to the target cells, in particular RA delivery to leukemic cells either in vitro or in vivo. The light-activatable polymeric NPs disclosed in the present subject matter surprisingly allow that the timing of drug release following delivery by NPs can be tightly controlled, in particular the efficiency of differentiation of leukemic cells induced by RA can be increased. The efficiency is due to a combination of several factors including (i) high internalization in terms of kinetics (in the first 4-6 h) and in magnitude (60 and 75 pg of NPs per cell following exposure for 4 h to cell culture medium containing 100 μg/mL of NPs), (ii) high endolysomal escape (80% of the NPs escape the endolysomal compartment in the first 2 h; this is approximately 18 pg of NPs per cell), (iii) durable intracellular accumulation of the NPs (no exocytosis mediated by Pgp; accumulation for more than 5 days in CD34 + cells) and (iv) fast disassembly of the NPs once activated by UV or blue light (minutes range). The present disclosure also shows that is possible to activate light-activatable NPs that have been accumulated in the cell cytoplasm for a few days (at least 48 h) and trigger the release of their payload. BRIEF DESCRIPTION OF THE DRAWINGS The following figures provide preferred embodiments for illustrating the description and should not be seen as limiting the scope of invention. The figures that do not fall under the scope of the claims represent reference examples. FIG. 1 : Preparation of PEI derivatized with DMNC. Photo-disassembly of PEI-DMNC 25 : DS NPs: (A) Schematic representation for the conjugation of PEI with DMNC and subsequent scission of the conjugate by UV light. (B) A suspension of NPs (n=3) (2 mL, 50 μg/mL in water) was exposed to UV light (365 nm, 100 Watts) for up to 10 min. At each time, the size, zeta potential and number of NPs (kcps) in the suspension was evaluated by dynamic light scattering. (C) A suspension of NPs containing NR (n=3) (2 mL, 50 μg/mL in water) was exposed to UV light (365 nm, 100 Watts) for up to 10 min. At each time, the size, zeta potential and number of NPs (kcps) in the suspension was evaluated by dynamic light scattering. (D) Confocal images showing light-disassembly of Qdot525-labeled NPs. A section of a NP aggregate (area delimited in the figure) was bleached continuously by a laser at 405 nm as confocal images were collected every 20 s. The images show the disassembly of the bleached area of the NP aggregate. Fluorescence intensity of the area bleached by the laser and reference area (i.e., not activated by the laser) overtime. (E) Normalized fluorescence vs. time for the same NR-loaded NP formulation when exposed or not to UV light (365 nm, 100 Watts), showing the increase in the release rate with UV exposure. Nile Red in aqueous solution exposed to UV light is presented to demonstrate its photostability. FIG. 2(A) Amount of NPs internalized by leukemia cell lines K562, NB4 and U937 as determined by ICP-MS (Zn quantification). Cells were incubated with NPs for 4 h, washed, lysed and Zn content of the NPs was quantified by ICP-MS. Results are expressed as Mean±SEM (n=3). (B) Cytotoxicity of NPs against K562, NB4 and U937 cells. Cells were cultured in medium supplemented with light-sensitive RA + NPs for 4 h, washed, exposed or not to a UV light for 10 min, and then cultured for 20 h. Cell cytotoxicity was evaluated by an ATP kit. Results are expressed as Mean±SEM (n=3). (C) Internalization mechanisms of NPs. (C.1) Uptake of TRITC-NPs by U937 cells in the presence of several endocytosis inhibitors. Results are expressed as Mean±SEM (n=3). (C.2) Uptake of TRITC-NPs in U937 cells after silencing key regulators of CME (CLTC and LDLR), caveolin-mediated endocytosis (CAV1), GEEC-CCLIC pathways (CDC42) and macropinocytosis (RAC1 and CTBP1) with siRNAs. The results are expressed as Mean±SEM (n=3). P value indicate significance relative to control. (D) Cellular trafficking of FITC-labeled NPs. HUVEC cells were incubated with FITC-labeled NPs (1 μg/mL) for 1 or 4 h, washed extensively, exposed or not to UV light (365 nm, 100 Watts), cultured in normal conditions for 1 or 2/8 additional hour/s, respectively, and stained with LysoTracker DND-99 before cell fixation. Results are expressed as Mean±SEM (n=3). (E) Intracellular trafficking of FITC-labelled NPs through endocytosis. Early endosome were stained with EEA1 antibody, early/late endosomes were stained with Rab-5 antibody and late endosome/lysosomes were stained with Rab7 antibody. Representative images of the intracellular distribution of FITC-labelled NPs in relation to early/late endosomes stained with Rab-5 antibodies (left image), and late endosome/lysosome stained with Rab7 antibody (right image). HUVEC cells were incubated with FITC-labelled NPs (1 μg/mL) for 4 h, washed extensively and cultured in normal conditions for 1 additional hour before cell fixation. Quantification of FITC-labelled NPs co-localized with EEA1, Rab-5 and Rab7 (right graph). HUVEC cells were incubated with 1 μg/mL for 4 hours, washed extensively and cultured in normal conditions for ⅛ additional hour&#39;s before cell fixation. Results are expressed as Mean±SEM (n=3). (F) TRITC-labelled PEI-DMNC:DS NPs (10 μg/mL) or TRITC-labelled USPIO NPs (100 μg/mL) intracellular accumulation in Zn-induced U937 cells in the presence of the Pgp antagonist verapamil and of the endosome disruption agent chloroquine. Cells were exposed to culture medium with chemical agents, FITC-labelled NPs for 4 h, cultured for additional 8 h and finally characterized by FACS. Results are expressed as Mean±SEM (n=3). FIG. 3 —(A) Confocal imaging of HUVEC cells after exposure for 4 h to QDot525-labelled NPs. A small section of the cell (region 1, created by a mask) was then exposed to blue light laser cycles (405 nm) in a Zeiss confocal microscope and the intensity of fluorescence at 525 nm monitored. In parallel, the fluorescence of another section of the cell (region 2) not excited with the laser was monitored as a control. Our results show that the fluorescence intensity in region 2 maintains overtime while in region 1 the intensity increases. Blue dots and line presents the blue light laser-exposed area of Qdot525-labelled NPs; orange dots and line presents the control unexposed area of Qdot525-labelled NPs. Dashed areas show cell membrane and nucleus. (B) Intracellular release of RA as evaluated by a RARE luciferase assay. NB4-RARE cells were cultured with soluble RA (10 μM; 3 μg of RA per mL) in culture medium for the entire duration of the experiment, or light-activatable RA + NPs (5 μg/mL; 0.6 μg of RA per mL). Cells were exposed to NPs for 1 h, washed with PBS, and resuspended in cell medium. Some samples were exposed to UV light (365 nm, 100 Watts) for 5 min. The cells were then cultured for 12/24 h before luciferase luminescence reading. Results are expressed as Mean±SEM (n=3). (C) [ 3 H]-RA uptake by NB4 cells. NB4 cells were cultured with soluble 3 H-RA (1 and 10 μM) in culture medium for the entire duration of the experiment, or light-activatable 3 H-RA + NPs (1 and 10 μg/mL). Cells were exposed to NPs for 4 h, cells washed with PBS and then resuspended in cell medium for additional 20/68 h before scintillation counting. Results are expressed as Mean±SEM (n=3). *P&lt;0.05, **P&lt;0.01, ***P&lt;0.001. FIG. 4 : Effect of time in the activation of RA + NPs within the cells. (A) Schematic representation of the methodology. Zn-induced U937-B412 (A.1), NB4 (A.2) or NB4-RARE-luciferase reporter (A.3) cells were cultured with RA + NPs (1 μg/mL) for variable period of times (1 up to 24 h), washed with PBS, resuspended in cell culture media, exposed to UV light (365 nm, 100 Watts) for 5 min, and cultured for 12 h (luciferase measurements) or 72 h (flow cytometry analyses). Results are expressed as Mean±SEM (n=3). (B) Schematic representation of the methodology. Zn-induced U937-B412 (B.1), NB4 (B.2) or NB4-RARE-luciferase reporter (B.3) cells were cultured with RA + NPs (1 μg/mL) for 4 h, washed with PBS, resuspended in cell culture media, exposed to UV light (365 nm, 100 Watts) for 5 min at variable periods of time (0 up to 44 h), and cultured for 12 h (luciferase measurements) or 72 h (flow cytometry analyses). Results are expressed as Mean±SEM (n=3). In A.3 and B.3, the activation of RA-dependent signaling pathway was measured by luminescence while cell differentiation was evaluated by the expression of CD11b. (C) Effect of multiple light activation in CD11b expression in Zn-induced U937-B412 cells. Cells were cultured with RA + NPs (10 μg/mL) for 4 h, washed with PBS, resuspended in cell culture media, exposed to multiple 5 min-cycles of UV light (365 nm, 100 Watts) during the 72 h of culture. Myelocytic differentiation (CD11b + cells) of human leukemia Zn-induced U923-B412 cells was determined by FACS. Results are expressed as Mean±SEM (n=3). FIG. 5 —In the case of cells treated with NPs, cells were treated with RA + NPs for 4 h, washed, activated or not with UV light (365 nm, 100 Watts) for 5 min, and then cultured for a certain period of time. In case of cells treated with soluble RA, cells were cultured in media containing soluble RA for the entire period of culture. (A.1) Erythroid differentiation of human leukemia K562 cells cultured with light-activated NPs or soluble RA. K562 cells were cultured for 6 days. (A.2) Percentage of benzidine + cells in K562 cells after 6 days of culture. (B.1) Myelocytic differentiation (CD11b + cells) of human leukemia NB4 cells cultured with light-activated NPs or soluble RA. NB4 cells were cultured for 3 days. (B.2) Percentage of CD11b + cells in NB4 cell cultures after 1 and 3 days of culture. (C.1) Myelocytic differentiation (CD11b + cells) of human Zn-induced U937-B412 cells cultured with light-activated NPs or soluble RA. Zn-induced U937-B412 cells were cultured for 3 days. (C.2 and C.3) Percentage of CD11b + cells in Zn-induced U937-B412 cell cultures after 1 day (C.2) or 3 days (C.3) of culture. Cells cultured with 10 −7 M of vitamin D3 for 1 or 3 days were used as positive controls. (D.1 and D.2) Differentiation of AML stem cells cultured with light-activated NPs or soluble RA. Cell differentiation was evaluated by a colony forming unit assay at day 14. (D.2) AML stem cells were cultured for 14 days with RA in medium (10 2 -10 5 nM) or RA + NPs (0.01-10 μg/mL) or blank NPs (10 μg/mL), exposed or not to UV light. Cell differentiation was evaluated by a colony forming unit assay at day 14. (D.3) Long-term culture-initiating cell assay results. AML stem cells were cultured on feeder layers for 5 weeks and then on methylcellulose medium for 14 days with blank NPs (10 μg/mL) or RA + NPs (10 μg/mL) exposed or not to UV light. Results are expressed as a mean percentage of control plates containing only AML cells. Results are expressed as Mean±SEM (n=3). *P&lt;0.05, **P&lt;0.01, ***P&lt;0.001. FIG. 6 —In vivo differentiation of NB4 cells exposed to light-activatable RA + NPs. (A) Schematic representation of the in vivo experimental set up. Cells were treated with blank or RA + NPs (10 μg/mL) for 4 h, washed, and then activated or not with a blue optical fiber (405 nm, 80 mW) for 5 min. Cells were then resuspended in a 1:1 (v/v) Matrigel solution and subcutaneously injected in a PDMS cylinder construct implanted in the dorsal region of mice. After 5 days, cells were removed from the construct and characterized by FACS, for CD11b expression. (B) Representative flow cytometry plots. Representative flow cytometry plots showing mice recipient cells (B.1), human leukemia NB4 cells (B.2) and a mixture of mice recipient cells with human leukemia NB4 cells (B.3). (C) Percentage of CD11b + cells in human leukemia NB4 cells collected 5 days after subcutaneously injection. Results are expressed as Mean±SEM (n=4). *P&lt;0.05, **P&lt;0.01, ***P&lt;0.001. (D) Schematic representation of the in vivo set up. Cells were treated with RA + NPs (10 μg/mL) for 4 h, washed and then encapsulated in a 1:1 (v/v) Matrigel solution and subcutaneously injected in a PDMS cylinder construct implanted in the dorsal region of mice. After 24 h, some experimental groups were activated in vivo with a blue optical fiber for 5 min. (E) Percentage of CD11b + cells in human leukemia NB4 cells collected 3 days after the in vivo activation. Results are expressed as Mean±SEM (n=3). ***P&lt;0.001, ****P&lt;0.0001. FIG. 7 : Characterization of PEI derivatized with DMNC. (A) Degree of substitution (DSn) of PEI with DMNC. The DStheoretical was calculated as molar ratio of DMNC to tertiary amines in PEI. The DSexperimental was determined by spectrophotometry. (B) Effect of 10 min-UV exposure (365 nm, 100 Watts) in the absorbance of DMNC (250 μg/mL, in DMSO), PEI (1 mg/mL, in DMSO), and PEI-DMNC25 (1 mg/mL, in DMSO) conjugate. For DMNC, the absorption maximum at 355 nm reverted to baseline levels after 10 min of UV exposure, indicating the photo-cleavage of DMNC, and a new absorption peak was observed at 320 nm, due to the formation of 4,5-dimethoxy-2-nitrobenzyl alcohol (DMNA). For PEI-DMNC, there was a decrease in the intensity of the peak at 355 nm and a concomitant increase in the peak at 320 nm; however our results suggest that not all the attached DMNC molecules were photo-cleaved. (C) 1H NMR spectra of PEI, DMNC and PEI-DMNC. 1H NMR spectra of (a) PEI-DMNC conjugate in DMSO-d6, (b) DMNC in DMSO-d6 and (c) PEI in DMSO-d6, showing effective conjugation between PEI and DMNC. FIG. 8 : Light-activation of NPs. (A) SEM of PEI-DMNC25:DS NPs. (B,C,D) Blue laser (405 nm, 80 mW) activation of PEI:DS NPs (B), PEI-DMNC100:DS (C) and PEIDMNC25: DS NPs (D). A suspension of NPs (n=3) (100 μL, 100 μg, in water) was exposed to a blue laser up to 20 min. Then, the NP suspension was diluted up to 50 μg/mL in water and the size, zeta potential and number of NPs (Kcps) in the suspension was evaluated by dynamic light scattering. FIG. 9 : Stability of NPs suspended in basal culture medium. (A) Zeta potential of NPs suspended in H2O, basal RPMI medium or EBM medium. (B) Diameter (nm) and counts (Kcps) of NPs suspended in H2O, basal RPMI medium or EBM medium. A suspension of NPs (2 mL, 25 μg/mL) was prepared and diameter, counts and zeta potential determined by dynamic light scattering method (DLS) using a Zeta Plus Analyzer (Brookhaven). Results are expressed as Mean±SEM (n=3). FIG. 10 : Cellular uptake of NPs. (A) Quantification of NP internalization in leukemia cell lines NB4 and U937 as determined by ICP-MS analysis (Zn quantification). Cells were incubated with 10 μg/mL NPs up to 24 h. After each incubation period, the cells were extensively washed with PBS followed by the addition of an aqueous solution of nitric acid (1 mL, 69% (v/v)). The concentration of intracellular levels of Zn was quantified by ICP-MS. The concentration was normalised per cell. The estimation of NPs was done based on standard solutions. The results are expressed as Mean±SEM (n=3). (B.1) Uptake of TRITC-labeled NPs in leukemia cells as determined by FACS. Cells were cultured in medium supplemented with NPs for the time specified in the graph, washed and characterised by FACS. The results are expressed as Mean±SEM (n=3). (B.2) AML stem cells (CD34+CD38−) were labeled with TRITC-labeled NPs for 4 h and then cultured for 5 days. The histogram plot shows the percentage of cells labelled after 5 days. (C) Expression of Pgp in U937 cells as evaluated by FACS. A PE-conjugated mouse anti-human P-glycoprotein has been used (Abcamab93590—Clone UIC2). FIG. 11 : Effect of UV light and Blue Light in DNA damage in HUVEC cells. Immunofluorescent staining of normal HUVEC cells mock treated or exposed to 10 min or 60 min of UV light (365 nm, 100 W) (A) or blue light (405 nm, 80 mW) (B) and allowed to recover for 6 h. Cells were then fixed and stained to readily identify γH2AX-containing foci, as biomarker for nuclear sites of DNA damage in affected cells. (C) Time-dependent increase of γH2AX after UV light (365 nm, 100 W) or blue light (405 nm, 80 mW) irradiation. Quantitative analysis of foci intensity were quantified using image) software and normalised to the control condition. FIG. 12 : (A) Cytotoxicity of chemical inhibitors against U937 cells. Cells were cultures in medium supplemented with growing concentrations of chemical inhibitors for 24 h. Cell cytotoxicity was evaluated by an ATP kit. Results are expressed as Mean±SEM (n=3). (B) Transport of FITC-labeled transferrin (1 μg/mL) known to selectively enter cells via clathrin-mediated endocytosis. Dynasor at concentration of 80 μM inhibits the internalisation of transferrin in U937 cells. Cells were exposed to culture medium with and without dynasor for 30 min, exposed to FITC-labeled transferrin for 3 min, at 4° C., and finally characterized by FACS. Results are expressed as Mean±SEM (n=3). **** Denotes statistical significance (P&lt;0.0001). FIG. 13 : Expression of RAR-α, RAR-β and RAR-γ genes (normalized to GAPDH) in human leukemia cell lines as assessed by qRT-PCR analysis. Results are expressed as Mean±SEM (n=3). FIG. 14 : Tritium-labeled retinoic acid uptake assay in K562 (A) and U937 (B) cells. K562 and U937 cells were cultured with soluble 3 H-RA (1 and 10 μM) in culture medium for the entire duration of the experiment, or light-activatable 3 H-RA + NPs (1 and 10 μg/mL). NPs were added to cell culture for 4 hours. Then, the cells were washed with PBS, and fresh cell medium added and the cells remained in culture for 24/72 hours before scintillation counting. FIG. 15 : Myelocytic differentiation of human leukemia U937-B412 cells without zinc-induction. (A.1) Percentage of CD11b + cells in U937-B412 cells cultures without zinc-induction after being exposed for 1 day to various concentrations of light sensitive RA + NPs, exposed or not to UV light (365 nm, 100 Watts, 5 min) after a 4 h-period of internalization and 1300 rpm centrifugation washing step, or cultured with 10-7 M of vitamin D3 (Sigma) in culture medium during 1 day. (A.2) Percentage of CD11b + cells in U937-B412 cells cultures without zinc-induction after being exposed for 3 day to various concentrations of light sensitive RA + NPs, exposed or not to UV light (365 nm, 100 Watts, 10 min) after a 4 h-period of internalization and 1300 rpm centrifugation washing step, or cultured with 10-7 M of vitamin D3 (Sigma) in culture medium during 3 day. DETAILED DESCRIPTION The development of a nanoparticle system possessing a trigger to allow precise control of the timing, duration and magnitude of drug release is important for therapeutic and regenerative medicine, namely in cancer chemotherapy. A light-activatable polymeric nanoparticles (NPs) that rapidly release an active substance namely, retinoic acid (RA), when exposed to a blue laser/UV light is disclosed. These NPs reduce the clonogenicity of bone marrow tumor cells from patients with acute myeloid leukemia (AML) and induce the differentiation of RA-low sensitive leukemia cells expressing the chimeric promyelocytic leukemia zinc finger/RARα (PLZF/RARα) fusion protein. In another embodiment, RA released from light-activated NPs was superior at inducing leukemia cell differentiation compared to RA released by passive diffusion. Further, we demonstrate the importance of temporal activation of the nanoformulation during the intracellular trafficking to maximize RA effect and show in vivo that leukemic cells loaded with NPs can be light-activated to release RA, thereby allowing greater spatio-temporal control of drug delivery. NPs can enhance the efficiency an active substance, namely RA delivery to leukemic cells either in vitro or in vivo. We further show that the timing of drug release following delivery by NPs can be tightly controlled, and that the efficiency of differentiation of leukemic cells induced by RA can be increased. To prepare an embodiment of the present invention light-dissociable polymeric NPs, poly(ethyleneimine) (PEI, Mw of 25 kDa) was initially derivatized with 4,5-dimethoxy-2-nitrobenzyl chloroformate (DMNC) in DMSO, a light-sensitive photochrome ( FIG. 1A ). PEI was selected as initial NP block because it facilitates the cellular internalization of NPs and subsequent escape from endosomes (Boussif, O. et al. A versatile vector for gene and oligonucleotide transfer into cells in culture and in vivo: polyethylenimine. Proc Natl Acad Sci USA 92, 7297-7301 (1995); Maia, J. et al. Controlling the neuronal differentiation of stem cells by the intracellular delivery of retinoic acid-loaded nanoparticles). ACS Nano 5, 97-106 (2011)), while DMNC was selected because responds rapidly to light and the degradation products are relatively non-cytotoxic (Dvir, T., Banghart, M. R., Timko, B. P., Langer, R. &amp; Kohane, D. S. Photo-targeted nanoparticles. Nano Lett 10, 250-254 (2010)). Synthesis of PEI-DMNC conjugates with different degree of substitution (PEI-DMNC100; PEI-DMNC50 and PEI-DMNC25 with a theoretical degree of substitution of 100%, 50% and 25% of the tertiary amines of PEI) were performed in the presence of triethylamine for 24 h, at 25° C. The conjugation of DMNC to PEI was confirmed by spectrophotometry ( FIG. 7A ) and 1 H-NMR ( FIG. 7C ). Approximately 20% of the initial DMNC added to the reaction vial reacted with PEI. Moreover, the final degree of substitution in PEI-DMNC was controlled by varying the molar ratio of DMNC to PEI ( FIG. 7A ). To prepare NPs, a solution of PEI-DMNC in DMSO was precipitated into an aqueous solution of dextran sulfate. NPs were formed because of the hydrophobicity of PEI-DMNC conjugate and the electrostatic interaction of PEI-DMNC (polycation) with dextran sulfate (DS, polyanion). To stabilize the NP formulation, zinc sulfate was added. NPs with a diameter between 150 (PEI-DMNC 100 :DS NP) and 110 nm (PEI-DMNC 25 :DS NP) and a zeta potential between 20 (PEI-DMNC 100 :DS NP) and 25 mV (PEI-DMNC 25 :DS NP) were prepared. To verify that DMNC could be photo-degraded, solutions of DMNC or PEI-DMNC in DMSO were exposed to UV-light (365 nm, 100 Watts) for 10 min and then analyzed by spectrophotometry. For DMNC, the absorption maximum at 355 nm reverted to baseline levels after 10 min of UV exposure, indicating the photo-cleavage of DMNC, and a new absorption peak was observed at 320 nm, due to the formation of 4,5-dimethoxy-2-nitrobenzyl alcohol (DMNA) ( FIG. 7B ). For PEI-DMNC, there was a decrease in the intensity of the peak at 355 nm and a concomitant increase in the peak at 320 nm; however the results suggest that not all the attached DMNC molecules were photo-cleaved ( FIG. 7B ). NMR results suggest that PEI is retarding the photo-cleavage of the attached DMNC ( FIG. 7C ). In an embodiment of the present invention to prepare NPs, a solution of PEI-DMNC (50 mg/mL, in DMSO) was precipitated into an aqueous solution of dextran sulfate (2 mg/mL). NPs were formed because of the hydrophobicity of PEI-DMNC conjugate and the electrostatic interaction of PEI-DMNC (polycation) with dextran sulfate (DS, polyanion). To improve the stabilization the NP formulation, zinc sulfate may be added (Maia, J. et al. Controlling the neuronal differentiation of stem cells by the intracellular delivery of retinoic acid-loaded nanoparticles. ACS Nano 5, 97-106 (2011); Tiyaboonchai, W., Woiszwillo, J. &amp; Middaugh, C. R. Formulation and characterization of amphotericin B-polyethylenimine-dextran sulfate nanoparticles. J Pharm Sci 90, 902-914 (2001)). In another embodiment the NPs with a diameter between 150 (PEI-DMNC 100 :DS NP) and 110 nm (PEI-DMNC 25 :DS NP) and a zeta potential between 20 (PEI-DMNC 100 :DS NP) and 25 mV (PEI-DMNC 25 :DS NP) were formed. To demonstrate that PEI-DMNC:DS NP formulation could be photo-disassembled, a suspension of NPs (50 μg/mL) was exposed to UV light for up to 10 min and both the diameter, counts per second (i.e., number of NPs per volume unit) and zeta potential were assessed. The number of NPs decreased below half of the initial number after 1 min of UV exposure indicating NP disassembly ( FIG. 1B ). Under UV irradiation, the photolysis of DMNC disrupts the NPs because of the changing of hydrophilic-hydrophobic balance in the NP. In addition, the NPs that remained in suspension had a significant decrease in diameter from 110 to 5 nm after 10 min of UV exposure, while zeta potential was kept constant (25 mV). Importantly, UV light can be replaced by a blue laser (404 nm, 80 mW), which has minimal impact in cell biology, to induce the photo-disassembly of PEI-DMNC:DS NPs. As observed for UV-exposed NPs, blue light-exposed NPs have a decrease in number and in diameter overtime ( FIG. 8D ). The response of the NPs to UV light was mediated by DMNC coupled to one of the components of the NP, since NPs without DMNC did not respond to light ( FIGS. 8A and 9A ). In addition, the concentration of DMNC conjugated to PEI is important for the light-responsiveness of the NP. NPs formed by PEI with high degree of substitution with DMNC are less susceptible to photo-disassembly than NPs with PEI with low degree of substitution ( FIG. 8C ). Therefore, for subsequent studies the NP formulation having PEI with low degree of substitution was selected (PEI-DMNC 25 :DS NP). To further confirm light-disassembly of the NPs, the NPs were conjugated with quantum dots (Qdots525) and their fluorescence monitored overtime after exposure of small regions of the NP to a blue confocal laser (405 nm). The results show that fluorescence intensity increases after light exposure due to the disassembly of the NP and the decrease in the quenching of Qdot fluorescence after NP disassembly ( FIG. 1D ). To evaluate the characteristics of light-activatable polymeric NPs as a controlled release system, NPs were encapsulated with Niles Red (NR), a small hydrophobic dye with excellent photostability. NR fluorescence at about 530 nm shows good quantum yields in apolar solvents. When exposed to water its fluorescence emission shows a shift to approximately 640 nm and the quantum yield is significantly reduced (Jose, J. &amp; Burgess, K. Syntheses and properties of water-soluble Nile Red derivatives. J Org Chem 71, 7835-7839 (2006)). The NP suspension was then exposed to UV light for up to 10 min and NP properties (diameter, counts, zeta potential) as well as release of NR were evaluated. As obtained for blank NPs, the number of NR containing NPs decreased overtime, indicating the encapsulated NR did not affect the photo-cleavage of the NPs ( FIG. 1C ). Then, the release of NR upon UV exposure was monitored by fluorescence spectroscopy ( FIG. 1E ). The fluorescence intensity (in percentage) of the NP suspension decreased to 20% of the initial value after 10 min of UV exposure, due to the controlled triggered burst release of NR in aqueous solution. In contrast, no significant release of NR was observed for NPs not exposed to UV light. Induction of leukemic cell differentiation by RA is a therapeutic strategy that has been used with great success in the treatment of acute promyelocytic leukaemia (APL). APL is a subtype of acute myeloid leukaemia (AML) characterized by a unique translocation between chromosomes 15 and 17, which leads to the formation of the fusion oncogene PML-RARα involving the transcription factor RA receptor alpha (RARα). RA activates nuclear RA receptors (RARs) that forms heterodimers with retinoid X receptors (RXRs) which in turn binds to the RA response element (RARE) resulting in the activation of target genes causing cell growth arrest, apoptosis and differentiation. Despite its clear therapeutic efficacy, approximately 25% of patients receiving RA will develop serious complications including the “differentiation syndrome”. Clinical trials of RA in other types of AML have been less successful, possibly because of the relatively higher concentrations of RA that are required to induce differentiation in non-APL AML. For both of these reasons, the design of a delivery system with precise temporal and dosage control will be important for leukemia treatment. The present disclosure surprisingly show that light-activatable polymeric NPs can enhance the efficiency of RA delivery to leukemic cells either in vitro or in vivo. We further show that the timing of drug release following delivery by NPs can be tightly controlled, and that the efficiency of differentiation of leukemic cells induced by RA can be increased. NPs have no substantial effect in cell metabolism of human leukemic cells such as chronic myelogenous leukemia (CML) K562 cells, human bone marrow acute promyelocytic leukemia (APL) NB4 cells and human myelomonoblastic cell line U937, as evaluated by an ATP assay, for concentrations up to 100 μg/mL. Cells were exposed to NPs for 4 h, washed to remove NPs not taken up by the cells, either exposed or not to UV light for 10 min, and finally cultured for additional 20 h ( FIG. 2B ). To identify the pathways of NP internalization, U937 cells were incubated in the presence of endocytosis chemical inhibitors at concentrations that were not cytotoxic for the cells ( FIG. 12A ), after which, fluorescently labelled NPs were added and the internalization monitored by flow cytometry. Filipin III inhibits cholesterol dependent internalization mechanisms, ethylisopropylamiloride (EIPA) inhibits macropinocytosis, nocodazole inhibits microtubule dependent pathways, cytochalasin D inhibits all pathways dependent on actin (including macropinocytosis), dansylcadaverine and dynasore inhibits clathrin-mediated endocytosis and polyinosinic acid inhibits scavenger receptors. Whenever possible molecules that enter by a specific internalization pathway were used as positive controls to show the efficacy of our inhibitors ( FIG. 12B ). Dynasore treatment (clathrin-mediated endocytosis (CME) inhibitor) reduced the uptake of NPs by 90%, compared to control cells ( FIG. 2C . 1 ). To confirm the endocytosis mechanisms involved in NP internalization, U937 cells were transfected with siRNAs to down-regulate key components of different endocytic mechanisms ( FIG. 2C . 2 ). We observed a ˜ 60% and ˜ 70% reduction on NPs uptake upon downregulation of clathrin heavy chain (CLTC), and low-density lipoprotein receptor (LDLR), respectively, confirming a role for CME. The knockdown of macropinocytosis regulators (Rac1 and CTBP1), led to a ˜ 40% and ˜ 50% decrease in NPs uptake, suggesting that macropinocytosis was also involved in NPs internalization. Downregulation of Caveolin 1 (CAV1), involved in caveolin-mediated endocytosis, and GPI-anchored protein-enriched early endocytic compartment/clathrin-independent carriers (GEEC-CLIC) pathways (CDC42) had no significant impact in NPs uptake. To further elucidate the intracellular trafficking of the NPs, we used adherent cells (HUVECs) to facilitate the characterization by confocal microscopy. The intracellular trafficking of the NPs was assessed first by performing a LysoTracker staining to see the general distribution of the FITC-labeled NPs in the endolysosomal system ( FIG. 2D ). During the first few hours of incubation with FITC-labeled NPs there was a clear drop in the intensity of LysoTracker in the cell suggesting a decrease in the pH of the endosomal vesicles by the presence of PEI (a strong base) in the cell and also possible vesicle disruption as the FITC-labeled NPs signal was increased in the cytoplasm. At later time points (12 hours) of incubation with FITC-labeled NPs the intensity of LysoTracker reached control levels suggesting that the endolysosomal system regained its normal characteristics ( FIG. 2D ). To fully characterize the route of FITC-labeled NPs inside the endolysosomal system a time-dependent colocalization study of FITC-labeled NPs with the specific markers: EEA1 for early endosomes, Rab-5 for early/late endosomes and Rab-7 for late endosome/lysosomes was done. For short incubation times (1-2 h) not many vesicles are seen with FITC-labeled NPs; instead there is a diffuse distribution of green allover the cytoplasm (ca. 80-90% of the fluorescence). This is consistent with a rapid escape of the NPs from endosomes after entering the cell likely due to their buffering capacity, leading to osmotic swelling and rupture of endosomes 14 . For later time points (over 5 hours) of incubation with FITC-labeled NPs there is a clear accumulation of FITC-labeled NPs inside vesicles that are mostly Rab-5 and/or Rab-7 positive with very low EEA-1 colocalization. The high colocalization with Rab-5 and the size of the vesicles containing NPs suggests that macropinocytosis is also an entrance route for these NPs ( FIG. 2E ). Taken together, our results indicate that the major endocytic mechanism for the internalization of the NPs is clathrin-mediated endocytosis. Our siRNA results indicate that macropinocytosis might be also involved but at minor extent. It is likely that both endocytic pathways are interconnected as demonstrated recently for lipid nanoparticles. Our results further show that the internalization of the NPs is rapid and in the first 2 h a significant percentage of NPs tend to escape the endolysomal compartment, while the ones that did not escape accumulate in early/late endosomes. Next, we asked whether NPs would be effluxed by leukemic cells overtime. It is known that tumor cells high express P-glycoprotein (Pgp), a membrane transporter that is responsible for the efflux of drugs21 and nanoparticles22. Therefore, we studied by flow cytometry the effects of the Pgp antagonist verapamil22 and the endosome disruption agent chloroquine23 in the intracellular accumulation of NPs on RA-resistant Zn-induced U937-B412 cells. Our results showed that the intracellular accumulation of the NPs in U937 was similar with or without inhibition of Pgp or promoting endosomal escape by chloroquine ( FIG. 2F . 2 ). In contrast, the intracellular accumulation of control ultra small paramagnetic iron nanoparticles (USPIO) required the inhibition of Pgp ( FIG. 2F . 1 ). Overall, our results show the unique properties of our NP formulation to accumulate in leukemic cells. To evaluate the feasibility of remotely trigger the disassembly of a specific population of NPs during their intracellular trafficking, we transfected HUVECs with Qdot525-labelled NPs (10 μg/mL) for 4 h. When a small region of the cell having NPs is excited by blue light laser (405 nm) under a confocal microscope, NP fluorescence increases as compared to a reference region not excited with UV light ( FIG. 3A ). This increase is due to the disassembly of the NPs and a decrease in the quenching of the quantum dots immobilized in the NPs. The potential of the light-activatable NPs described was assessed in the control of the differentiation of leukemia cells. The differentiation of leukemia cells is a therapeutic platform very often used in the clinic to eradicate blood cancers, being the concentration of the inductive agent and the time of its application very important variables for the success of the therapy. RA was used as differentiation agent. To assess the efficiency of the RA + NPs in delivering RA inside leukemic cells and induce an RA-dependent signaling pathway a RARE reporter cell line was generated using NB4 cells. The RA-dependent induction of a RARE element driving the transcription of the firefly luciferase gene was used to evaluate the kinetics of RA-induction using RA + NPs or RA in solution. These luciferase assays showed that RA + NPs are able to induce high levels of luciferase activity shortly after light activation ( FIG. 3 b ). RA + NPs are more efficient than RA in solution at inducing transcription from the RARE-Luciferase locus and are also quicker. In order to assess if this higher efficiency is related with a higher amount of RA being delivered inside the cells using the NPs, radioactive RA was used. Cells were incubated in the presence of [ 3 H]RA (1 uM and 10 uM) and [ 3 H]RA-NPs (1 ug/mL and 10 ug/mL) at 3° C. for 4 hours. After 24 and 72 hours, cells were washed and the amounts of [ 3 H]RA internalized were measured. Comparable results were obtained for NB4 ( FIG. 3C ), K562 and U937 cell lines ( FIG. 14 ). The uptake of [ 3 H]RA was higher using the NPs when comparing with [ 3 H]RA available in solution. Considering that there was a smaller amount of RA in the NP formulation than the one available when cells were incubated with RA in solution the rational for NP utilization as a carrier for RA is well justified both from an efficiency point of view as from an uptake yield perspective (values below 2% were obtained for [ 3 H]RA in solution comparing with values above 20% obtained when nanoparticles are employed). RA uptake reached its peak at 24 h; after which there is a small decrease in the total amount of RA present in culture for longer times. Considering individual cells there is a higher decrease in the amount of RA with the time, which is probably due to proliferation of the cells along the time. Furthermore, RA + NPs can reduce the dose of RA that very often (up to 20-30% of the patients) lead to hyperleukocytosis as well as the syndrome of respiratory distress. Complexes of RA with PEI were formed by the electrostatic interactions of the carboxyl groups of RA with the amine groups of PEI. The NP formulation contained approximately 120 μg of RA per mg of NP, had an average diameter of 160 nm and a zeta potential of 22 mV. To further explore the therapeutic potential of light-activatable RA + NPs, human CML K562 cells were incubated for 4 h with NPs, washed, and further cultured for 1 to 3 days. K562 cells differentiate into the erythroid lineage when treated with soluble RA, although the efficiency is relatively low. The treatment of K562 with light-activated RA + NPs improved largely (from 100 up to 1000 fold) the differentiation of K562 cells, as compared to soluble RA ( FIG. 5A . 1 ). Importantly, the disassembly of RA + NPs triggered by light enhanced the differentiation process of the cells as compared to cells treated with non-activated RA + NPs ( FIG. 5A . 2 ). Next, the therapeutic effect of the light-activatable RA + NPs was evaluated in human acute promyelocytic leukemia (APL) cells. APL is a subtype of myeloid leukemia that comprises 10 to 15% of patients with acute myeloid leukemia (AML) and it is characterized by a unique translocation between chromosomes 15 and 17. The translocation causes the fusion of 2 genes, PML and RARα, leading to the aberrant fusion protein PML-RARα which disrupts the function of both normal PML and RARα. It has been shown that RA can induce the degradation of the PML-RARα and induce cell differentiation. The effect of soluble RA and light-sensitive RA + NPs was examined in the induction of APL-derived NB4 cells differentiation by assessing CD11b expression, a marker of myeloid differentiation. RA + NPs were much more effective (from 100 up to 1000 fold) in the differentiation of leukemia cells than soluble RA (FIG. 5 B 1 ). Furthermore, cells treated with RA + NPs activated by light showed higher (from 1.5 to 2 fold) differentiation into the myeloid lineage than cells treated with non-activated RA + NPs (FIG. 5 B 2 ). Importantly, the differentiation effect exerted by the NPs is mediated by the intracellular delivery of RA since the supernatant of NPs suspended in media for 6 days at 37° C. had no significant effect in the differentiation of NB4 cells. The differentiation capacity of light-activatable RA + NPs was evaluated in APL cells having chimeric PLZF/RARα fusion protein resulting from a translocation between chromosomes 11 and 17. APL caused by PLZF/RARα is morphologically indistinguishable from APL caused by PML/RARα and exhibits impaired sensitivity to RA. The differentiation of a U937 promonocytic leukemia clone transduced with a zinc-inducible U937 cell system expressing the PLZF/RARA fusion protein (U937-B412) was analyzed. The results show that the induction of PLZF/RARα expression by zinc in U937-B412 cells decreases their ability to differentiate into myeloid cells (CD11b + cells) as compared to cells without PLZF/RARα expression ( FIG. 5C and FIG. 15 ). However, U937-B412 cells treated with RA + NPs were more prone to differentiate into myeloid cells (approximately 1000 fold) than cells treated soluble RA (FIG. 5 C 1 ). Moreover, cells treated with light-activated RA + NPs show higher (from 2 to 4 fold depending in the differentiation time and NP concentration) capacity for myelocytic differentiation than cells treated with non-activated RA + NPs (FIGS. 5 C 2 and 5 C 3 ). The results seem to indicate that the intracellular concentration of released RA saturates the RAR and RXR available on the cell overcoming the transcription repression induced by PLZF/RARα protein. To further validate the potential of the opto-nanomedicine approach bone marrow aspirates from human patients with AML were treated and their clonogenic potential was evaluated by the colony-forming cell (CFC) and long-term culture-initiating cell (LTC-IC) assays. AML encompasses functionally diverse cells originating from a leukemic stem cell (LSC). LSCs initiate and sustain the AML clonal hierarchy and possess biological properties rendering them resistant to conventional chemotherapy. Initially, CD34 + cells were isolated from bone marrow by FACS and sorted cells treated with RA + NPs or soluble RA. Our results indicate that light-activatable RA + NPs were higher effective than soluble RA in decreasing the number of CFCs (from 100 to 1000 fold) (FIG. 5 D 1 ). Cell treatment with blank nanoparticles (RA − NPs) activated or not with light had no significant effect in the CFC number relatively to control (FIG. 5 D 2 ). Results further indicate that RA + NPs activated by light are more effective in decreasing the number of CFCs as well as LTC-ICs (FIG. 5 D 3 ) as non-activated RA + NPs. Next, we evaluated if RA + NPs can function in vivo. NB4 cells were cultured with RA + NPs for 4 h, washed and activated ex-vivo by exposure to a 405 nm blue laser (80 mW) for 5 min, embedded in Matrigel and then injected into a cylindrical poly(dimethylsiloxane) (PDMS) construct that has been previously implanted subcutaneously in NOD/SCID recipients ( FIG. 6A ). The PDMS cylinder was used to restrict cell position inside the animal. After 5 days, human cells were isolated from the implants and CD11b expression measured by flow cytometry ( FIGS. 6B . 1 - 6 B. 3 ). Consistent with the in vitro data, CD11b expression was statistical higher in NB4 cells treated with ex vivo light-activated RA + NPs than in cells treated with RA + NPs without light activation ( FIG. 6C ). The experiment was then repeated but this time with in vivo activation. One day after implantation the recipients were exposed to a 405 nm blue optical fibre for 5 min at the sites of the implants that contained the cells ( FIG. 6D ). After 3 days the recipients were sacrificed, human cells isolated and CD11b expression was assessed. CD11b expression was higher in NB4 cells from mice that had been exposed to the blue laser demonstrating that internalised RA + NPs can be activated to release RA in vivo in a highly controlled manner ( FIG. 6E ). METHODS Preparation and Characterization of Poly(Ethyleneimine) (PEI) Conjugated with 4,5-dimethoxy-2-nitrobenzyl chloroformate (DMNC) DMNC (DS100: 194.1 mg; DS25: 48.5 mg, Sigma) was slowly added to a solution of PEI in DMSO (2 mL containing 50 mg/mL PEI, Sigma) containing triethylamine (DS100: 98.2 μL; D25: 24.5 μL, Sigma), and the reaction flask cooled to 0° C. by immersion on ice. Then, the reaction was allowed to proceed for 24 h at 25° C. with stirring. At the end, the PEI-DMNC conjugate was purified by dialysis (Spectra/Por® 1 Regenerated Cellulose dialysis membrane, MWCO 6000-8000 Da, Spectrum) against DMSO overnight at room temperature. Reaction yields above 54% were obtained using a dialysis purification methodology. For NMR characterization, PEI-DMNC (in DMSO) was precipitated in water, washed, freeze-dried, and then dissolved (10 mg/mL) in DMSO-d6 and 1 H NMR spectra were acquired using a Bruker Avance III 400 MHz spectrometer. Preparation of NPs Non-activatable NPs were prepared by the electrostatic interaction of PEI (polycation) with dextran sulfate (DS, polyanion) in water, at room temperature, as previously described by us (Maia, J. et al. Controlling the neuronal differentiation of stem cells by the intracellular delivery of retinoic acid-loaded nanoparticles. ACS Nano 5, 97-106 (2011)). Briefly, an aqueous DS solution (1 mL, 10 mg/mL) was added drop-by-drop to an aqueous solution of PEI (5 mL, 10 mg/mL) and stirred for 5 min. Then, an aqueous solution of ZnSO 4 (0.6 mL; 1 M) was added and stirred for 30 min. The NP suspension was then dialyzed (Spectra/Por® 1 regenerated cellulose dialysis membrane, MWCO 6000-8000 Da, Spectrum) for 24 h, in the dark, against an aqueous solution of mannitol (5%, w/v), lyophilized for 1 day and stored at 4° C. before use. Light-activatable NPs were prepared by adding a PEI-DMNC solution (66.7 μL, 150 mg/mL, in DMSO) to an aqueous solution of DS (5 mL, 0.4 mg/mL) and stirred for 5 min. Then, an aqueous solution of ZnSO 4 (120 μL, 1 M) was added and stirred for 30 min. The NP suspension was then dialyzed (Spectra/Por® 1 Regenerated Cellulose dialysis membrane, MWCO 6000-8000 Da, Spectrum) for 24 h, in the dark, against an aqueous solution of mannitol (5%, w/v), lyophilized for 1 day and stored at 4° C. before use. In some cases, PEI-DMNC was labeled with Qdot525. For that purpose, an aqueous solution of 1-ethyl-3-(3-dimethyllaminopropyl)carbodiimide hydrochloride (EDC; 500 μL of EDC (10 mg/mL, aqueous solution at pH 6.0)) was added to a suspension of Qdots525 (0.16 mmoles, in 310 μL of PBS). After 5 min, PEI-DMNC solution (200 μL, 25 mg/mL in DMSO) was added to the previous solution and allowed to react for 1 h, in the absence of light, at room temperature. For the preparation of NR-containing NPs, initially a NR solution (60 μL, 2% w/v, in DMSO) was added to a solution of PEI-DMNC (66.7 μL, 150 mg/mL in DMSO) and maintained at room temperature for 30 min, under stirring. The solution was then carefully added to an aqueous solution of DS (5 mL, 0.4 mg/mL) and stirred for 5 min. The NPs in suspension were treated with an aqueous solution of ZnSO 4 (120 μL; 1 M) for 30 min. NR that was not encapsulated in the NPs was removed by centrifugation (2,000 g for 3 min). The NP suspension was then dialyzed (Spectra/Por® 1 Regenerated Cellulose dialysis membrane, MWCO 6000-8000 Da, Spectrum) for 24 h, in the dark, against an aqueous solution of mannitol (5%, w/v), lyophilized for 1 day and stored at 4° C. before use. For the preparation of RA-containing NPs, a RA solution (24 μL, 50 mg/mL, in DMSO) was added to a solution of PEI-DMNC (66.7 μL, 150 mg/mL in DMSO). The subsequent steps were similar to the ones described above for NR-containing NPs. For the preparation of fluorescently labelled NPs, NPs (2 mg) were resuspended in 0.1 M carbonate/bicarbonate buffer (1 mL, pH 8.3) followed by the addition of FITC or TRITC (5 μL in DMSO, 3-fold molar excess). The NP suspension was stirred for 1 h in the absence of light and then dialyzed (Spectra/Por® 1 regenerated cellulose dialysis membrane, MWCO 6000-8000 Da, Spectrum) for 24 h against an aqueous solution of mannitol (5%, w/v), lyophilized, and stored at 4° C. before use. Characterization of the NPs In an endodiment, the diameter of the NPs was measured by photon correlation spectroscopy (PCS) using quasi-elastic light scattering equipment (Zeta-Pals™ Zeta Potential Analyzer, Brookhaven Instruments Corp., Holtsville, N.Y.) and ZetaPlus™ Particle Sizing Software (version 4.03). To measure NP diameter, the NP suspension (2 mL, 50 μg/mL in water for molecular biology) was added to a cuvette and allowed to stabilize for 10 min. The sample was then vortexed for 5 s and subjected to NP size analysis in the ZetaPlus™ for 3 min (3 times; all data were recorded at 90°). After each reading the cuvette was again vortexed for 5 s and exposed to UV light (365 nm) or blue light (405 nm) for a certain period of time (see above). The values of NP diameter and NP counts were recorded. The average diameters described in this work are number-weighted average diameters. The zeta potential of NPs was determined in a 1 mM KCl pH 6 solution, at 25° C. (2 mL, 50 μg/mL). All data were recorded with at least 5 runs (in triplicate) with a relative residual value (measure of data fit quality) of 0.03 mm. In an embodiment, the diameter of NPs was also confirmed by ultra-high-resolution analytical FE-SEM SU-70 with a dedicated detector of STEM. Diluted NP suspensions (in H 2 O) were placed on a 400-mesh 3 mm copper grid coated with a carbon support film (Taab Labs Ltd.) and dried overnight. Cell Culture Human umbilical vascular endothelial cells (HUVECs) were obtained from Lonza and cultured in EGM-2 medium (Lonza) in a CO 2 incubator at 3° C., 5% CO 2 in a humidified atmosphere, with media changes performed every other day. Cells were passaged every 2-5 days and used for experiments between passage 4 and 6. Human chronic myelogenous leukemia K562 cells, kindly provided by Dr. Veronica Buckle (Weatherall Institute of Molecular Medicine) were cultured in RPMI-1640 (Gibco) in a CO 2 incubator at 3° C., 5% CO 2 in a humidified atmosphere, supplemented with 10% fetal bovine serum (Gibco) and 100 U/mL PenStrep (Lonza). Human bone marrow acute promyelocytic leukemia NB4 cells, kindly provided by Dr. Arthur Zelent (Institute of Cancer Research, Royal Cancer Hospital) were cultured in RPMI-1640 (Gibco) in a CO 2 incubator at 3° C., 5% CO 2 in a humidified atmosphere, supplemented with 10% fetal bovine serum (Gibco) and 100 U/mL PenStrep (Lonza). Human myelomonoblastic cell lines U937-MT and U937-B412 (Ruthardt, M., et al. Opposite effects of the acute promyelocytic leukemia PML-retinoic acid recpetor alpha (RAR alpha) and PLZF-RAR alpha fusion proteins on retinoic acid signalling. Mol Cell Biol 17 (8), 4859-4869 (1997)), kindly provided by Dr. Estelle Duprez (Centre de Recherche en Cancérologie de Marseille, France), were maintained at exponential growth in RPMI-1640 medium supplemented with 10% fetal bovine serum and 100 U/mL of PenStrep. U937-MT is the empty vector control and U937-B412 contains PLZF/RARA cDNA under the control of the zinc inducible human-metallothionein promoter (Ruthardt, M., et al. Opposite effects of the acute promyelocytic leukemia PML-retinoic acid recpetor alpha (RAR alpha) and PLZF-RAR alpha fusion proteins on retinoic acid signalling. Mol Cell Biol 17 (8), 4859-4869 (1997)). For PLZF/RARA induction cells were stimulated with 0.1 mM ZnSO 4 for at least 24 h. DNA Damage Induced by Light. NPs Cytotoxicity, Internalization, Uptake, Intracellular Trafficking and Accumulation Studies Assessment of histone γH2AX phosporylation (DNA damage) induced by UV light or blue light irradiation. To assess histone γH2AX phosporylation (DNA damage) induced by UV light or blue light irradiation, HUVEC cells (passage 4) were cultured on 1% gelatin-coated slides until subconfluency in EGM-2, followed by exposure to UV light (365 nm, 100 Watts) or blue light (405 nm, 80 mW) for 1, 3, 5, 10, 15, 30 or 60 min, in triplicates. Control conditions did not receive any light radiation. Following treatment, the medium was replaced by fresh medium and the cells were incubated for additional 6 h on normal culture conditions. The cells were then fixed with 4% paraformaldehyde (Electron Microscopy Sciences) for 10 min at room temperature and then washed with PBS. The cells were then permeabilized with 1% (v/v) Triton-X, blocked with PBS+2% BSA and stained for 1 h with anti-human primary γH2AX antibody (clone: N1-431, BD Biosciences). Detection was done with secondary antibody anti-mouse Cy3 conjugate (Jackson ImmunoResearch). Cell nuclei were stained with 4′,6-diamidino-2-phenylindole (DAPI) (Sigma), and the slides were mounted with mounting medium (Dako) and examined with a Zeiss inverted fluorescence microscope. NP cytotoxicity analysis. To evaluate NP cytoxicity, NPs were suspended in a solution of milli-Q water with PenStrep (5 μL/mL of 10000 U/mL stock solution, Lonza) and Fungizone (2.5 μg/mL, Sigma-Aldrich) for 30 min, centrifuged (14,000 g for 10 min), and finally resuspended in serum free cell culture medium. K562, NB4 and U937 cells (0.1×10 6 cells/condition) were incubated in serum free RPMI-1640 for 4 h in a 96-well plate containing variable amounts of PEI-DMNC:DS NPs. Once the incubations were terminated the cells were washed gently with medium to remove NP excess, and half of the samples were exposed to UV light (365 nm, 100 Watts) for 10 min. The cells were then cultured for 20 h in 100 μL of complete medium (RPMI-1640 medium supplemented with 10% fetal bovine serum and 100 U/mL PenStrep). A CellTiter-Glo® luminescent cell viability assay (ATP, Promega, Wis., USA) was performed according to the recommendations of the vendor. NP internalization analysis. NP internalization studies were performed in K562 and AML cells derived from bone marrow aspirates. K562 or AML cells (0.1×10 6 cells/condition) were incubated for 4 h in serum free RPMI-1640 or serum free Ex-Vivo medium (Lonza) containing NPs (10 μg/mL), respectively, in a 6 well plate. Once the incubations were terminated, the cells were centrifuged at 1300 rpm, 2° C. for 5 min, washed one time with cold trypan blue solution (200 μL; 600 μg/mL), re-washed 3 times with cold PBS and then resuspended in PBS containing 2.5% FBS (500 μL), ready for FACS analysis. A total of 10,000 events were recorded per measurement. In some conditions, AML cells were cultured in StemSpan SFEM (Stemcell Technologies) supplemented with a human cytokine cocktail containing SCF (50 ng/mL, Stemcell Technologies), TPO (15 ng/mL) and Flt-3L (50 ng/mL, PeproTech) plus PenStrep (10,000 U/mL, Lonza) and Fungizone (25 μg/mL, Sigma) for 5 days after NPs internalization for 4 h. NP internalization was also monitored by inductive coupled plasma mass spectrometry (ICP-MS). In this case, the intracellular levels of Zn were measured before and after cell exposure to NPs. K562, NB4 and U937 cells (0.1×10 6 cells/well) were plated in 24 well plates and incubated in serum free RPMI-1640 from 1 to 24 h with variable amounts of PEI-DMNC:DS NPs. After incubations, NPs that have were not internalized by the cells were washed three times with PBS an the cells centrifuged followed by the addition of an aqueous solution of nitric acid (1 mL, 69% (v/v)). The samples (n=3) were analyzed by ICP-MS for the concentration of intracellular levels of Zn. The concentration of Zn was normalized per cell. The estimation of NPs was done based on controlled standard solutions. Uptake mechanisms analysis. For determining the uptake mechanism(s), we first perform NP uptake assays in the presence of endocytosis inhibitors. U937 cells were cultured on 24 well plates (1×10 5 cells/well) and inhibited by one of the following chemicals during 30 min before adding a suspension of TRITC-labelled NPs (5 μg/mL): dynasor (80 μM), cytochalasin D (10 μM), nocodazole (50 uM), filipin III (100 μM) and polyinosinic acid (100 μg/mL). The inhibitor concentrations were based in values reported in literature and further validated by us to have no cytotoxic effect over the period of the assay (6 h), as confirmed by ATP assay. The incubation of the cells with NPs for different times was performed in the presence of the inhibitor. As controls, we used cells without NPs and cells incubated with NPs without inhibitor. At the end of each time point, cells were centrifuged at 1300 rpm, 2° C. for 5 min with PBS, washed one time with cold trypan blue solution (200 μL; 600 μg/mL), re-washed 3 times with cold PBS and then resuspended in PBS containing 2.5% FBS (500 μL) for FACS analysis. A total of 10,000 events were obtained per measurement. To validate the inhibitory activity of dynasor we performed uptake studies of FITC-labeled transferrin, known to selectively enter cells via clatherin-mediated endocytosis. Briefly, U937 cells were cultured on 24 well plates (1×10 5 cells/well) and treated or not with dynasor (80 μM, 30 min pre-incubation), followed by addition of 1 μg/mL FITC-labeled transferrin (Life Technologies). The transferrin was allowed to bind for 3 min at 4° C. Cells were then evaluated as before. The NP uptake mechanism was also studied on U937 cells by silencing specific proteins of clathrin-mediated endocytosis (CLTC and LDLR), caveolin-mediated endocytosis (CAV1), GEEC-CCLIC pathways (CDC42) and macropinocytosis (RAC1 and CTBP1) by siRNA (Thermo Fisher). Transfection was performed in a 24 well plate with 0.5×10 5 cells in antibiotic-free complete medium with 100 nM siRNA and 1.5 μL of Lipofectamine RNAiMAX (Life Technologies) transfection reagent for 24 h. After this initial period, the transfection medium was replaced by complete medium and the cells incubated for another 48 h. Then, cells were cultured with TRITC-labelled NPs (5 μg/mL) for 6 h. Once the incubations were terminated, the cells were centrifuged at 1300 rpm, 20° C. for 5 min, with PBS, washed one time with cold trypan blue solution (200 μL; 600 μg/mL), re-washed 3 times with cold PBS and then resuspended in PBS containing 2.5% FBS (500 μL) for FACS analysis. Non-transfected cells or cells transfected with lipofectamine but without siRNAs (MOCK) were used as controls. In all FACS analysis, a total of 10,000 events were recorded per run. All conditions were performed in triplicate. Intracellular trafficking analysis. HUVEC cells (passage 4) were cultured on 1% gelatin-coated slides until subconfluency in EGM-2. The cells were then incubated with 1 μg/mL FITC-labeled NPs for 1 or 4 hours, washed extensively, exposed or not to UV light (365 nm, 100 Watts), cultured in normal conditions for 1 or 2/8 additional hour/s, respectively. For LysoTracker staining, at time points 2, 6 and 12 hours, the cells were incubated with 50 nM LysoTracker Red DND-99 (Invitrogen). After 30 min of incubation, the coverslips were washed extensively with PBS, followed by cell fixation with 4% paraformaldehyde (Electron Microscopy Sciences) for 10 min at room temperature and then washed with PBS. Cell nuclei were stained with 4′,6-diamidino-2-phenylindole (DAPI) (Sigma), and the slides were mounted with mounting medium (Dako) and examined with a Zeiss LSM 50 confocal microscope. Co-localization analysis was performed by culturing HUVEC cells (passage 4) on 1% gelatin-coated slides until subconfluency in EGM-2. Cells were treated with 1 μg/mL FITC-labeled NPs for 1 or 4 hours, washed extensively and cultured in normal conditions for 1 or 1/8 additional hour/s, respectively. Then the cells were fixed with 4% paraformaldehyde (Electron Microscopy Sciences) for 10 min at room temperature, blocked with 2% (w/v) BSA, and when necessary, permeabilized with 0.5% (v/v) Triton-X. Cells were then stained for 1 h with anti-human primary antibodies (EEA1, clone: C45B10, Cell Signaling), Rabankyrin-5 (ANKFY1 (D-15), Santa Cruz Biotechnology), or Rab 7 (clone: D95F2, Cell Signaling). In each immunofluorescence experiment, an isotype-matched IgG control was used. Binding of primary antibodies to specific cells was detected with anti-rabbit or anti-goat IgG Cy3 conjugate (Jackson ImmunoResearch). Cell nuclei were stained with 4′,6-diamidino-2-phenylindole (DAPI) (Sigma), and the slides were mounted with mounting medium (Dako) and examined with a Zeiss LSM 50 confocal microscope. Co-localization analysis was done in ImageJ through assessment of the percentage of overlapping objects. Two objects are considered to be co-localizing when their intensity profile is overlapping more than 40%. For this analysis the number (percentage of FITC-labeled NPs foci that are positive for EEA-1/Rab-5/Rab-7) and the intensity volume (percentage of FITC-labeled NPs in the EEA-1/Rab-5/Rab-7-positive compartments) were used. This approach was found to be more adequate than classical co-localization tools in ImajeJ or other softwares that measure pixel co-occurrence and correlation analyses, because it allowed us to (i) discriminate between background and vesicle/NP-foci fluorescence and (ii) interpret the results in terms of percentage of NP-foci that are localized to vesicles in another channel of interest. Intracellular NPs accumulation analysis. To determine exocytose of NPs, NP uptake assays were performed in the presence of Pgp antagonist verapamil or the endosome disruption agent chloroquine. U937 cells were cultured on 24 well plates (1×10 5 cells/well) and chloroquine (100 μM, no pre-incubation) and verapamil (100 μM, 60 min pre-incubation) conditions were tested. The chemical agents concentrations were based on values reported in the literature and further validated by us to have no cytotoxic effect over the period of the assay (12 h). After the pre-incubation with the chemical agents, TRITC-labelled PEI-DMNC:DS NPs (10 μg/mL) or TRITC-labelled poly-L-lysine USPIO NPs (100 μg/mL) were added to the cells, maintaining the chemical agents concentration. As controls we used cells incubated without NPs and cells incubated with NPs without chemical agents. At the end of each experiment, the cells were centrifuged at 1300 rpm, 2° C. for 5 min with PBS, washed one time with cold trypan blue solution (200 μL; 600 μg/mL), re-washed 3 times with cold PBS and then resuspended in PBS containing 2.5% FBS (500 μL) for FACS analysis. A total of 10,000 events were recorded per measurement, and all conditions were performed in triplicate. RARE Cell Line Generation The cignal lenti RARE reporter kit (CLS-016L SABiosciences) was used for the establishment of a RA reporter NB4 cell line. For that purpose, rectronectin solution (15 μg/cm 2 , 30 μg, 500 μL on PBS, Takara) was plated in a 24-well plate 2 hours prior to cell seeding. The plate was kept at room temperature and was washed one time, immediately before seeding, with PBS. NB4 cells (1×10 5 ) were plated in 175 μL of RPMI-1640 medium (Gibco) supplemented with 0.5% FBS and 100 U/mL PenStrep and to this condition 125 μL of cignal lentiviral particles were added to a total experimental volume of 300 μL. After a gentle swirl of the plate the cells were incubated 20 hours at 3° C. in a humidified incubator with 5% CO 2 atmosphere. In the following day, cells were washed and allowed to recover in the incubator for 24 hours cultured in 500 μL of fresh RPMI-1640 medium supplemented with 10% FBS and 100 U/mL PenStrep. After that, 2 μg/mL of puromycin (Invitrogen) was added to the culture medium for selection of transduced cells. Evaluation of selection efficiency in puromycin-containing medium was performed every 3 days for a period of 5 weeks. Luciferase Assay To assess the biological effect of RA in RAR-regulated signalling pathway activity, luciferase reporter assay was performed. NB4-RARE cells (2.5×10 4 cells/condition) were plated in v-shaped 96-well plates and cultured with soluble RA (10 μM) or light-activatable RA + NPs (5 μg/mL). The NPs were suspended in serum free medium and added to cells for 1 h. The cells were then washed by centrifugation (1300 rpm, 5 min) to remove non-internalized NPs, and half of the samples were exposed to blue light (405 nm, 80 mW, 5 min). The cells were then cultured for 12/24 hours in RPMI-1640 medium supplemented with 10% fetal bovine serum and 100 U/mL PenStrep. After these incubation times, the conditions were centrifuged (1500 rpm, 3 min), excess medium carefully aspirated and the cells washed with 100 uL of PBS. After a new centrifugation and removal of PBS, 60 uL of cell lysis buffer (8 mM of magnesium chloride; 1 mM DL-Dithiothreitol; 1 mM Ethylenediaminetetraacetic acid; 25 mM of 1 M Trizma Base with 1 M Sodium phosphate monobasic; 15% Glycerol; and 1% Triton X-100), was added to each condition. The plate was kept on ice, under agitation for 15 min to allow complete lysis and then the plate was placed on −8° C. for the amount of time necessary for the samples to freeze. After these steps, the plate was removed from the −8° C., put on ice and allowed to defrost at slow rate. For the preparation of the luminescence reading, 40 μL of ATP (100 μM, Sigma) was added to 1960 μL of reading buffer solution (8 mM of magnesium chloride; 1 mM DL-Dithiothreitol; 1 mM Ethylenediaminetetraacetic acid; 25 mM of 1 M Trizma Base with 1 M Sodium phosphate monobasic; and 15% Glycerol) to a final concentration of 2 μM ATP. On a second tube, 2 mL of D-Luciferin working solution (167 μM, Sigma) was prepared protected from light. The injection system of the luminometer was primed until ready. Following that step, the luminometer software was programmed to set the temperature to 3° C., and under stirring for the duration of the experiment accept 50 μL of sample per condition in a 96-white plate, inject 100 μL of ATP working solution 3 seconds after reading cycle begins; inject 100 μL of D-Luciferin working solution 4 seconds after reading cycle begins and read the luminescence 5 seconds after reading cycle begins. The luciferase luminescence was quantified in a microplate luminometer reader LumiStar Galaxy (BMG Labtech). All conditions were performed in triplicate. Retinoic Acid Uptake Assay Experiments were initiated by the addition of medium containing [ 3 H]RA (1 μM and 10 μM) and [ 3 H]RA-NPs (1 μg/mL and 10 μg/mL) to cultures (60,000 cells/condition, 24-well plate, 1 mL) of K562, NB4 and U937 cells. After experimental incubations with medium containing [ 3 H]RA and [ 3 H]RA-NPs for 4, 24 and 72 hours, cells were collected to eppendorfs, washed with PBS by centrifugation (1500 rpm, 5 min, 2 times) to remove non-internalized [ 3 H]RA and then resuspend in 100 μL of lysis buffer (see above) and kept on ice until scintillation counting procedure. The titrium content of the samples was assayed by adding 100 μL aliquot of the samples to 1 mL liquid scintillation fluid (Packard Ultima Gold) and counted in a TriCarb 2900 TR Scintillation analyzer (Perkin Elmer). All conditions were performed in triplicate. Time-activation of NPs within cells. NB4 and Zn-induced U937-B412 cells (6.0×10 4 cells/condition) were plated in 24-well plates and transfected with RA + NPs (1 μg/mL) for different time periods (1, 2, 4, 6, 8, 12 and 24 h). The cells were then washed by centrifugation (1300 rpm, 5 min) to remove non-internalized NPs, and immediately exposed to UV light (365 nm, 100 Watts, 5 min). In a second experimental setup, NB4 and Zn-induced U937-B412 cells (6.0×10 4 cells/condition) were plated in 24-well plates and transfected with RA + NPs (1 μg/mL) for 4 h. The cells were then washed by centrifugation (1300 rpm, 5 min) to remove non-internalized NPs, cultured in normal conditions and exposed to UV light (365 nm, 100 Watts, 5 min) at different time points (0, 4, 8, 20 and 44 h). The effect of the intracellular release of RA was evaluated in terms of differentiation of the cells into the myeloid lineage (as assessed by the expression of CD11b) at day 3, as assessed by flow cytometry. All conditions were performed in triplicate. NB4-RARE cells (2.5×10 4 cells/condition) were plated in v-shaped 96-well plates and transfected with RA + NPs (1 μg/mL) for different time points (1, 2, 4, 6, 8, 12 and 24 h). The cells were then washed by centrifugation (1300 rpm, 5 min) to remove non-internalized NPs, and immediately exposed to UV light (365 nm, 100 Watts, 5 min). For the second experimental setup, NB4-RARE cells (2.5×10 4 cells/condition) were plated in v-shaped 96-well plates and transfected with RA + NPs (1 μg/mL) for 4 h. The cells were then washed by centrifugation (1300 rpm, 5 min) to remove non-internalized NPs, cultured in normal conditions and exposed to UV light (365 nm, 100 Watts, 5 min) at different time points (0, 4, 8, 20 and 44 h). The cells were then cultured for 12 hours after each condition light activation in RPMI-1640 medium supplemented with 10% fetal bovine serum and 100 U/mL PenStrep. After these procedures luciferase luminescence was quantified as described above for the luciferase assays. All conditions were performed in triplicate. Multiple activation of NPs within cells. Myelocytic differentiation of Zn-induced U937 cells was assessed by the quantification of CD11b expression by flow cytometry. U937-B412 cells (6.0×10 4 cells/condition) were cultured with ZnSO 4 (0.1 mM) in culture medium up to 24 h prior to experiment to induce the expression of promyelocytic leukemia zinc finger/RARα (PLZF/RARα). Then cells were transfected with RA + NPs (1 μg/mL) for 4 h, washed, placed in normal culture medium and then different activated by UV light (365 nm, 100 Watts, 5 min). Cells without light activation were used as control. The following conditions were tested: i) single light activation at 4 h; ii) light activations at 4 h and 6 h; iii) light activations at 4 h, 6 h and 8 h and iv) light activations at 4 h, 6 h, 8 h and 10 h. After 3 days, expression of CD11b on U937 cell surface was measured by staining with a fluorescent (PE)-conjugated anti-CD11b mAb (BD Biosciences) using FACS. All conditions were performed in triplicate. Relative Gene Expression of RAR-α, RAR-β and RAR-γ (Normalized to GAPDH) in Leukemia Cell Lines RNA was extracted using TRIzol® (Ambion) and RNAeasy mini kit (Qiagen) and cDNA was obtained from 1 μg RNA using TaqMan® Reverse Transcription Reagents (Invitrogen), according to supplier&#39;s instructions. Gene expression levels of RAR-α, RAR-β and RAR-γ (normalized to GAPDH) in NB4 and U937-B412 Zn-induced or not were quantified with Power SYBR® Green PCR Master Mix using a 7500 Fast Real-Time PCR System (Applied Biosystems, Foster City, USA). Specific primer pairs were SEQ. ID NO:1-CCATCCTCAGAACTCACAA and SEQ. ID NO:2—ACCAGCGAGAATTAATACCT for RAR-α, SEQ. ID NO:3—CACCTAGAGGATAAGCACTT and SEQ. ID NO:4—GGACTCACTGACAGAACA for RAR-β, SEQ. ID NO:5—CCACCTTCTTGCTCCTAC and SEQ. ID NO:6—CTTTCACCCTCTGTTCCT for RAR-γ, SEQ. ID NO:7—AGCCACATCGCTCAGACACC and SEQ. ID NO:8—GTACTCAGCGCCAGCATCG for GAPDH, forward and reverse, respectively. Thermal cycling conditions were 30 s at 94° C., 30 s at 60° C. and 33 s at 72° C., for 40 cycles, followed by a melting curve. K562 Differentiation Assay Erythroid differentiation of K562 cells was assessed by cytochemical staining with benzidine solution. K562 cells (6.0×104 cells/condition) were exposed to a wide range of free-RA concentrations for 6 days. Since RA display a very low solubility, DMSO was used to dissolve RA to the culture medium before cell culture experiments (final concentration of DMSO was below 0.01% in culture medium). To investigate the effect of RA + NPs on K562 differentiation, K562 cells (6.0×104 cells/condition) were transfected with RA + NPs (from 0.01 up to 10 μg/mL; in serum-free medium) for 4 h, washed by centrifugation (1300 rpm, 5 min) to remove NP excess, and part of the samples exposed to UV light (365 nm, 100 W, 5 min). The cells were then cultured for 6 days in complete medium (RPMI-1640 medium supplemented with 10% FBS (Gibco) and 100 U/mL PenStrep), after which they were stained by a benzidine solution (to stain the heme groups of erythrocytes). The benzidine stock solution was prepared by dissolving benzidine dihydrochloride (20 mg, Sigma) in glacial acetic acid (292 μL) and water (9.7 mL) solution. The working solution was prepared by mixing part of the benzidine stock solution (1 mL) with 30% H 2 O 2 (20 μL, Panreac). The staining was performed by mixing 50 μL of K562 cells (in the evaluated condition medium) with benzidine working solution at a 1:1 (v/v) ratio, at room temperature for 3 minutes. Following the staining the number of positive cells was determined using a hemocytometer. The staining was performed in three individual experiences for all conditions. NB4 Differentiation Assay Myelocytic differentiation of NB4 cells was assessed by quantifying the CD11b expressing population, using flow cytometry. NB4 cells (6.0×10 4 cells/condition) were plated in 24-well plates and cultured with soluble RA or light-activatable RA + NPs. The NPs were suspended in serum free medium and added to cells for 4 h. The cells were then washed by centrifugation (1300 rpm, 5 min) to remove non-internalized NPs, and half of the samples were exposed to UV light (365 nm, 100 W, 5 min). The cells were then cultured for 6 days in RPMI-1640 medium supplemented with 10% FBS (Gibco) and 100 U/mL PenStrep with half medium changes every 3 days. Conditioned medium (CM) was obtained from the centrifugation of RA + NPs (10 μg/mL) in culture medium for 6 days. After 1, 3 and 6 days, expression of CD11b on NB4 cell surface was measured by FACS using a fluorescent (PE)-conjugated anti-CD11b antibody (BD Biosciences, ICRF44 clone). All conditions were performed in triplicate. U937 Differentiation Assay Myelocytic differentiation of U937 cells was assessed by the quantification of CD11b expression by flow cytometry. U937-B412 cells (6.0×10 4 cells/condition) were cultured either with or without ZnSO 4 (0.1 mM). To induce the expression of PLZF/RARα in U937-B412 cells they were treated for 24 h with ZnSO 4 (0.1 mM). Then cells were treated with soluble RA or light-activatable RA + NPs (transfection for 4 h followed by light activation for 5 min) for 3 days. After 1 and 3 days, expression of CD11b on U937 cell surface was measured by staining with a fluorescent (PE)-conjugated anti-CD11b mAb (BD Biosciences) using FACS. All conditions were performed in triplicate. AML Differentiation Assay AML bone marrow mononuclear cells isolated by Ficoll-Histopaque (GE Healthcare) gradient centrifugation, enriched using the MACS CD34 isolation kit (Miltenyi Biotec) and cryopreserved were kindly provided by Dr. Rajeev Gupta (Department of Haematology, UCL Cancer Institute). The isolated CD34 + AML cells were maintained in StemSpan SFEM (Stemcell Technologies) supplemented with a human cytokine cocktail containing SCF (50 ng/mL, Stemcell Technologies), TPO (15 ng/mL) and Flt-3L (50 ng/mL, PeproTech) plus PenStrep (10,000 U/mL, Lonza) and Fungizone (25 μg/mL, Sigma) up to 3 days. Prior to the colony-forming cell (CFC) and long-term culture-initiating cell (LTC-IC) assays, AML cells were incubated for 4 h in Ex-Vivo (Lonza) serum free medium, with and without blank NPs or RA + NPs in a 24 well plate. After that time, the cells were washed to remove loosely bound NPs. For the CFC assays (2.0×10 5 cells/condition) AML cells were plated in triplicate in MethoCult H4230 (3 mL, StemCell Technologies) supplemented with SCF [50 ng/mL], IL-3 [10 ng/mL], and Flt-3L [50 ng/mL], all human, plus PenStrep (10,000 U/mL, Lonza) and Fungizone (25 μg/mL, Sigma) in 6-well plate. For some conditions UV light (365 nm, 100 W, 5 min) was used to activate RA + NPs. Cultures were scored after 14 days for the presence of clusters and colonies containing &gt;20 cells using an inverted microscope. LTC-IC assays were performed in triplicate in a 6-well plate gelatinized for 2 hours prior to adding the feeders. The feeder layer was composed of a 1:1 mixture of irradiated (80 Gy) SL/SL (1.5×10 4 cells/condition) and M210B4 mouse fibroblasts (1.5×10 4 cells/condition), kindly provided by Dr. Rajeev Gupta (Department of Haematology, UCL Cancer Institute). AML cells (1×10 6 cells/condition) were plated in Myelocult H5100 medium (StemCell Technologies), supplemented with Flt-3L [50 ng/mL], hydrocortisone [10 −6 M] (StemCell Technologies) and PenStrep (10,000 U/mL, Lonza) and fungizone (25 μg/mL, Sigma). For some conditions UV light (365 nm, 100 Watts, 5 min) was used to trigger RA release. After the cells were inoculated, weekly half medium changes were performed (with Flt-3L [100 ng/mL]) for the duration of the culture. After 5 weeks, all cells were harvested and placed into methylcellulose based assay for the detection of AML-CFC as described above. In vivo study—All animal work has been conducted according to relevant national and international guidelines and approved by the Bioethics Committee of University of Salamanca. On the day before injecting the cells, PDMS cylindrical constructs (Øinternal=1.0 cm; Øexternal=1.5 cm) were implanted subcutaneously on NOD/SCID mice (Jackson Laboratory) maintained in pathogen-free conditions with irradiated chow. For the ex-vivo activation studies in the day of the experiment, NB4 cells were suspended in serum free medium with (i) no NPs, (ii) with empty NPs (10 μg/mL) or RA + NPs (10 μg/mL) for 4 h. At the end, cells were washed by centrifugation (1300 rpm, 5 min), and the ones treated with RA + NPs were either activated or not with a blue laser (405 nm, 80 mW) for 5 min. NB4 cells (5×10 6 cells per PDMS construct) were injected subcutaneously in the center of the PDMS construct embedded in Matrigel (200 μL, BD Biosciences). Five days after injection of the cells, animals were sacrificed by cervical dislocation and cells within the cylindrical construct were collected and characterized by flow cytometry. For the in vivo activation studies in the day of the experiment, NB4 cells were suspended in serum free medium with (i) no NPs, (ii) with RA + NPs (10 μg/mL) for 4 h. At the end, cells were washed by centrifugation (1300 rpm, 5 min), and 5×10 6 NB4 cells per PDMS construct were injected subcutaneously in the center of the PDMS construct embedded in Matrigel (200 μL, BD Biosciences). One day after injection, some of both conditions under study were either activated or not with a blue optical fiber (405 nm, 80 mW) for 5 min. Three days after injection of the cells, animals were sacrificed by cervical dislocation and cells within the cylindrical construct were collected and characterized by flow cytometry. The disclosure is of course not in any way restricted to the embodiments described and a person with ordinary skill in the art will foresee many possibilities to modifications thereof. The above described embodiments are obviously combinable. The following claims further set out particular embodiments of the disclosure.

The present subject matter relates to light-activatable polymeric nanoparticles (NPs) for the transportation and release of an active substance, methods for obtain said particles and their uses. A light-activatable nanoparticle for the transportation and release of an active substance, comprising a polycation preferably a polimer polycation, a polyanion and a light-sensitive photochrome attached to the polycation or the polyanion, wherein said photochrome is hydrophobic and suitable to photo-cleave when activated by an irradiation source, generating a negative charge and releasing the active substance. Light-activatable. The disclosure subject matter shows that NPs are a highly efficient drug delivery system to primary leukemic cells based on opto-nanomedicine system. Therefore, the present disclosure is useful for remote control in the release of biomolecules with spatio-temporal resolution with applications in the areas of general therapeutic and regenerative medicine applications.

FIELD OF THE INVENTION This invention relates to the field of bathtubs, especially bath tubs which are adaptable to the changing demands of those who have decreasing abilities to care for themselves. BACKGROUND OF THE INVENTION Innumerable studies and publications report &#34;The Graying of America&#34;, i.e., the percentage of the population which is &#34;aged&#34; or &#34;chronologically gifted&#34; is constantly increasing. What is certain about this phenomenon, but much less frequently mentioned, is the declining capacity of the aged to care for themselves. It has been concluded, sadly, that when such necessary activities as food preparation, hygenic functions, grooming, and the like, consume the entire day, the quality of life is zero. In other words, there no longer is time for elective and pleasurable pursuits. The logical solution to the reduction of abilities through ageing is the application of resources, human and mechanical, to ease the performance of these tasks by bringing the aid to the person and by bringing the person to the aid. Although ageing persons generally realize that disabilities of one sort or another have made life more arduous, nearly all desire to remain among famililar and friendly surroundings and companions. For the large number who resist relocation, help is sought in the form of mechanical devices. But what is highly important in the minds of the ageing is that any mechanical help must not appear to be too different from their usual environment. Especially, it must not be suggestive of a hospital or nursing home. The strong tendency is to avoid as long as possible anything that labels them as &#34;frail&#34; or &#34;old&#34; or &#34;infirm&#34;. Bath tubs and wall enclosures already known are shown in U.S. Pat. Nos. 3,588,925 and 4,080,710. The invention of U.S. Pat. No. 4,592,099 provides ample assistance to many disabled, but some find little immediate need for all the benefits that this bathing system makes available, recognizing, of course, that it will be desirable in the future. BRIEF SUMMARY OF THE INVENTION The instant invention resides in tub surround panels useful with a conventional bath tub or with a tub configured to the special needs of the disabled. Unobtrusively reinforced side panels are recessed to accept a full length chair height reclining shower seat and a tilting bath tube to contain the bathing water for use when these bathing aids are necessary or desireable. When they are no longer needed, the seat and tube are easily removed and the side panels and back wall are restored to their original appearance. The invention will be more fully understood from the following drawings and description. THE DRAWINGS FIG. 1 is a view of a tub surround including the recessed side panels atop a conventional style bath tub. FIG. 2 is a view of reclining bath and shower seat and its supporting accessory. FIG. 3 is a view of a tiltable bath tube. FIG. 4 is a view showing an assembly of the parts of FIGS. 1, 2 and 3. DETAILED DESCRIPTION Referring to FIG. 1, there is shown a bath tub 10 having a rim 11. The tub may or may not have been modified in detail to accomodate the special needs of the mobility impaired. A surround to protect the bathing enclosure from splashed water includes an upstanding first side panel 12 having a front edge 13 and a rear margin 14. An opposed upstanding second side panel 15 has a front edge 16 and a rear margin 17. A back wall 8 connects the side panels at their rear margins. The panels 12 and 15 and the back 8 surmount the tub and are joined to the rim 11 with a water tight seal. Constructing the surround and tub as separate elements overcomes the bulkiness of a one piece unit which may be difficult or impossible to transport through narrow passages to the bathroom location. This is especially true in remodeling work. The side panels have opposed matching recesses which open to the respective front edges of said side panels. In a preferred embodiment, side wall 12 has an upper recess 18 and a lower recess 19; side wall 15 has an upper recess 20 and a lower recess 21. The recesses have lower surfaces 22, 23, 24, and 25 respectively which open to the front edges of the walls. In a preferred embodiment the surfaces 22, 23, 24 and 25 are substantially horizontal. The upper surface of each recess diverges slightly from the lower surface so that the vertical dimension of each recess is greatest where it meets the edge of the side wall. The surround, bath and shower seat and tiltable tube are constructed of fiberglass reinforced polyester laminate with a sanitary gel coat but other suitable materials may be used. The areas 26 and 27 behind the recesses are reinforced during manufacture by molding in a strengthening material of suitable characteristics and dimensions. Marine plywood is one such material. Also shown in FIG. 1. are molded-in hselves 28, 29, 30, 31, 32 and 33 which are of sufficient strength and of appropriate configuration to serve as supplemental body support surfaces to conveniently aid the bather when entering or leaving the tub or also to hold bath materials such as soap, shampoo and the like. The water control 34 is located above a cascade water discharge 35 and also controls the shower spray head 36 which rides on a positioning bar 37. Grab bars 38 and 39 are provided for additional support to a bather. Referring to FIG. 2 there is shown a reclining bathing and shower seat 40 having a rest 41 at the top of the back 42. The foot end 43 is secured with a hinge 44 or other suitable movable mount. A counter balancing apparatus (not shown) is located within console 45. Optional water controls may also be mounted on the console. Referring to FIG. 3, there is shown a bath tube 50 which is tiltable about pivots 51 and 52. Drain apparatus 53 is operated remotely by knob 54. When a bather or the bather&#39;s caregiver elects to transform the bath apparatus of FIG. 1 to that of FIG. 4, plate 55 is removed to expose a latch on the back wall 8. The pivots 51 and 52 on tube 50 are placed on surfaces 23 and 25 of the lower recesses 19 and 21 and moved toward the back wall 8 until they reach the limit of the recess. The pivots are secured in this location with blocks 60 and 61 which are attached with bolts inserted in predrilled holes. When not needed the holes are concealed with removable caps. Handle 62 is inserted to operate the latch which engages a detent on the tube to maintain it in either an open inclined position shown in FIG. 4 or horizontal closed position. The counterbalance mechanism inside the console 45 is located on the surface 24 in the recess 20 and fastened to the wall at that location with bolts inserted in predrilled holes. The top 41 of the seat 40 then engages and rests on the surface 22 of the matching opposed recess 18. To take a bath, a bather sits on the seat as one might sit on the edge of a bed, and once seated, swings the feet onto the foot 43 of the seat 40. Water spray may be started over the bather at this time, or the tube 50 may be first tilted to the horizontal position by releasing the latch with handle 62 and moving the tube to the horizontal or soaking position. In this position, overflow 63 directs any excess water to the drain. While there is water in the tube, a float interlock prevents accidental tilting from the horizontal. Upon completion of the bath, the water is released by rotation of knob 54 and when the water level is low enough to release the interlock, the handle 62 is moved to release the latch and permit returning the tube to its original inclined position so the bather may exit. It is a considerable advantage that while entering or leaving the tube the bather need never support his weight on his feet while they are on a wet and/or slippery surface. To wipe the interior of the tube, the reclining seat 40 is lifted to provide improved access, an operation which is greatly aided by the counterbalance concealed in the console 45. Should a bather recover from an infirmity and desire to return to use of the apparatus of FIG. 1, the seat 40 and tube 50 are readily removed by reversing the installation steps described above and replacing the concealing caps in the now empty bolt holes. The embodiments described above and illustrated in the drawings are, of course, to be regarded as non-limiting examples and as to their details may be modified in several ways within the scope of the following claims.

A bathing device including tub surround panels useful with a conventional bath tub or with a tub configured to the special needs of the disabled. The panels have unobtrusively reinforced side panels recessed to accept a full length chair height reclining shower seat and a tilting bath tube to contain the bathing water for use when these bathing aids are necessary or desirable. When they are no longer needed, the seat and tube are easily removed and the surround panels are restored to their original appearance.

CROSS-REFERENCE TO RELATED DOCUMENTS [0001] The present application claims priority as a continuation-in-part (CIP) to application Ser. No. 10/447,014 filed May 27, 2003, which is a CIP of application Ser. No. 09/533,614, filed Mar. 22, 2000 (now U.S. Pat. No. 6,569,064 issued on May 27, 2003. The present application is also related in part, but does not claim priority to U.S. Pat. No. 5,147,257 issued on Sep. 15, 1992 and filed on Sep. 4, 1990, which is a divisional of U.S. Pat. No. 4,953,853 issued on Sep. 4, 1990 and filed on Apr. 6, 1988, which is a continuation-in-part of U.S. Pat. No. 4,743,014 issued on May 10, 1988 and filed on Jul. 30, 1987. The present application is also related to, but does not claim priority to U.S. Pat. No. 5,020,793 issued on Jun. 4, 1991 filed on Oct. 24, 1989, which is also a continuation-in-part of U.S. Pat. No. 4,743,014. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not Applicable INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC [0003] Not Applicable BACKGROUND OF THE INVENTION [0004] 1. Field of the Invention [0005] The present invention relates to exercising apparatus for a user to simulate the motions, exertions and techniques involved in skiing, and for rehabilitation that simulates the range of motion and balance required in many sports, while providing modality for dynamic balance and functional rehabilitation, thereby increasing the user&#39;s strength and skill, and more particularly to improvements in such apparatus. [0006] 2. Discussion of the State of the Art [0007] Apparatus for use by skiers on which they may simulate the motions, exertions and techniques required in skiing has been built and sold for several years, in particular U.S. Pat. No. 3,524,641 was issued to Robert J. Ossenkop on Aug. 18, 1970, for a device comprising a movable carriage on a set of rails. The carriage of that device is constrained in its movement on the rails by flexible members attached to both the carriage and to transverse members between the rails near each end of the set of rails, and a user can move the carriage from side to side on the rails to simulate the Wedeln or “parallel” technique of skiing. [0008] U.S. Pat. No. 3,547,434 was issued to the same inventor on Dec. 15, 1970. This later patent is for a device similar to the first device, but comprising a number of improvements, such as movable footrests on the carriage whereby a user may simulate turning and edging techniques in addition to parallel skiing; and, in some embodiments may also move the feet relative to one another. [0009] The inventions referenced above each include a safety strap attached to a transverse member between the parallel rails and to the carriage on the rails in addition to the flexible member by which the carriage is constrained to travel on the rails. The purpose of the safety strap is to provide for a situation in which the aforementioned flexible member might rupture on one side of the carriage, providing a sudden force urging the carriage to the side where the flexible member remains unruptured, which sudden force could dislodge a user and perhaps cause serious injury. The safety strap in such instance provides a restoring force toward the center tending to lessen the amplitude of carriage displacement that might otherwise occur. [0010] In U.S. Pat. No. 4,743,014, to which this case is related, and by the same inventor, an exerciser is disclosed having a pair of spaced-apart rails, a platform for riding on the rails, a first resilient element providing a first restoring force on the platform, and a second resilient element providing a second restoring force on the platform. The second resilient element has an adjustment element contacting the second resilient element in at least three points. [0011] In the latter exerciser, the rails are held in a spaced-apart relationship by a brace element in the center, which is fastened to the rails by screw-type fasteners, and by transverse elements fastened at the ends of the rails. The transverse elements at the ends are tubular in form, and the rails pass through openings in the tubular transverse elements, fastening to a bracket internal to each tubular transverse element. This joining arrangement is illustrated by FIG. 1A and FIG. 1B of the referenced patent. As shown in these figures rails 301 and 303 pass through holes 305 and 307 respectively into tubular transverse element 309 . Inside, the rails are fastened to a bracket 311 by screw fasteners 313 and 315 . Rubber-like end caps 317 and 319 close the ends of the tubular transverse element after assembly and act as non-skid pads in contact with the floor in operation. The end caps are of molded rubber-like material, and disk-like pieces carrying designs and lettering are added for identification and aesthetic effect. This particular method of joining and spacing the rails has not proved entirely satisfactory in terms of cost and ease of assembly, and in terms of strength and rigidity of assembly, and the multiple-piece construction of the end caps has also proved to be relatively expensive. [0012] In U.S. patent application Ser. No. 09/533,614, (hereinafter &#39;614), to which the present application is related, a ski-exercising machine is provided comprising a set of at least two parallel rails joined to cross members at the ends, the cross members providing support on a horizontal support surface, and joined to a central frame structure extending from the horizontal surface near the center to the rails, the rails extending from each cross member at each end upward at an acute angle with the horizontal rising to a maximum height in the center; a wheeled carriage riding on the rails; at least one articulated footpad mounted to the wheeled carriage; and a set of three power bands each anchored at both ends by a clamp to a bottom surface of the frame structure beneath the wheeled carriage, passing over separate roller sets, with one or more of the power bands anchored to the wheeled carriage and one or more passing over a roller anchored to the wheeled carriage. [0013] Although related U.S. patents issued to the inventor address the above problem and other problems related to construction and function of various components of the parent ski exerciser, there are still non-obvious improvements desired in several areas related to construction or assembly techniques, profile, materials, operation and longevity of the apparatus. For example, in U.S. Pat. No. 5,147,257 (hereinafter &#39;257), in FIGS. 5A and 5B , a ski exerciser is illustrated both in an elevation view ( FIG. 5A ), and in a plan view (overhead FIG. 5B ). Arcuate rails 15 comprise tubing structures having a continuous arc or bow over their entire length. [0014] Additionally, further non-obvious improvements are desired in several areas related to tension adjustability of the power bands, band roller operation, positioning of individual footpads on the wheeled carriage, simulation of actual skiing movements and dynamics, as well as rehabilitation and versatility of the skiing apparatus to simulate range of motion and balance required in many sports other than downhill skiing. Still further improvements are desired in areas relating to safety aspects of apparatus to minimize the possibility of injury to the user. [0015] It has been discovered partly through empirical methods that an even better action may be simulated with rails shaped somewhat differently than in the prior art. Firstly, the arcuate portions of the parallel rails can be shortened, and the straight portions lengthened to provide more intensity in the simulation of the skiing action. Secondly, the inventor has discovered that further adjustability of the power bands, in addition to footpad positioning, pivoting and sliding action, provide more accurate skiing motion simulation than the apparatus in the referenced prior art. [0016] FIG. 5A in &#39;257 illustrates roller assemblies housing rollers such as rollers 25 and 27 which are identical in size and construction with other illustrated rollers which make rolling contact with resilient members 23 and 59 . The diameter of the aforementioned rollers is disclosed as approximately 1 inch, and the rollers are generally cylindrical. It has been discovered that larger rollers, also crowned have a beneficial effect in smoother power band operation. The crowned rollers keep the belts better centered on the rollers. [0017] The present inventor has also determined that improvements may be made in the positioning of wheels for the wheeled carriage, and in the form of the rails and how the wheels interface to the rails. [0018] FIG. 16 in &#39;614 illustrates a ski exercising apparatus 301 according to an embodiment of the present invention having an optional third power band assembled between the first, or outer power band, and the second, or inner, power band, and a pair of tensioning structures ( 303 and 304 ), each having a single roller assembly rotatably mounted to the tensioning structure such that consistent tension is provided to the wheeled carriage assembly given a specific range of motion of the carriage assembly. [0019] What is clearly needed is a modularly enhanced ski-excising device that provides further distinct advantages for the expanding field of users. Such an improved device could provide further adjustability of power band tension, and additional pivoting action for suspended footpad assemblies to provide a more realistic simulation of skiing movements and dynamics in varying skiing terrain. What is also clearly needed is an improved method and apparatus enabling the user to quickly interchange footpad assemblies of a wheeled carriage assembly having additional attachments for rehabilitation and selective body strengthening, which simulates the range of motion and balance required in many sports other than downhill skiing, accurately reproducing lateral movements required in most sports, thereby optimizing rehabilitation and helping to prevent injury to the user. Such an improved apparatus incorporates additional safety features, which further protect the user from injury during operation of the exercise apparatus. [0020] In addition to the above problems and unmet needs, the present inventor has also identified a serious need in exercise apparatus that limits the use of such apparatus due to a reluctance of users to initiate exercise activity. Enhancement in tracking and control in such apparatus can overcome this defect, and an invention to accomplish the same is described below in enabling detail, and claimed. SUMMARY OF THE INVENTION [0021] In an embodiment of the present invention a control system for an exercise apparatus is provided, comprising an input mechanism for setting a goal for exercise in measurable units, a display for displaying the goal in the measurable units, and an initiation mechanism. Upon setting the goal, the goal in measurable units is displayed in the display, upon activating the initiation mechanism the display begins to decrement in the measurable units, and upon reaching zero, the original goal is displayed and then increments in the measurable units. [0022] In some embodiments the measurable units are one of time units, calories burned, or number of repetitions. Also in some embodiments, at the point the display reaches zero, an alert is provided in one or both of a visual or an audio mode. In some embodiments the initiation mechanism is a Start button. There may also be a Stop button, wherein the system stops and clears to zero if the stop button is pressed. [0023] In another aspect of the invention a control method for an exercise apparatus is provided, comprising the steps of (a) setting a goal for exercise in measurable units by manipulating an input mechanism in a control system for the exercise apparatus; (b) displaying the goal in the measurable units on a display device; (c) starting the control mechanism to decrement from the displayed goal; and (d) upon reaching zero, resetting the display to the originally set goal in measurable units, and incrementing the display. [0024] In some embodiments of this method the measurable units are one of time units, calories burned, or number of repetitions. Also in some embodiments, at the point the display reaches zero, an alert is provided in one or both of a visual or an audio mode. Also in some embodiments the initiation mechanism is a Start button. In some the system stops and clears to zero if the stop button is pressed. BRIEF DESCRIPTION OF THE DRAWING FIGURES [0025] FIG. 1A is an elevation view of a frame structure of a ski-exercising device according to an embodiment of the present invention. [0026] FIG. 1B is a cross section taken along line IB-IB of FIG. 1A . [0027] FIG. 2 is a plan view of the frame structure of FIG. 1 with added components illustrated according to an embodiment of the present invention. [0028] FIG. 3 is a perspective view of a center portion of the structure of FIG. 1 with covering components removed. [0029] FIG. 4 is a perspective view of a wheeled carriage-assembly shown without an upper carriage according to an embodiment of the present invention. [0030] FIG. 5 is a perspective view of an upper carriage-assembly supporting a suspended footpad mounted according to an embodiment of the present invention. [0031] FIG. 6 is an elevation view of a wheeled carriage-assembly and mounted foot platforms according to an embodiment of the present invention. [0032] FIG. 7A is perspective broken-view of a portion of a rail, transverse end member, and end-cap according to an embodiment of the present invention. [0033] FIG. 7B is an elevation view of an end-side of the end cap of FIG. 7A . [0034] FIG. 7C is an elevation view of a bottom-side of the end cap of FIG. 7B . [0035] FIG. 8 is a perspective view illustrating various components of a quick-release roller assembly according to an embodiment of the present invention. [0036] FIG. 9A is a plan view of an elongated footpad and carriage-assembly according to an embodiment of the present invention. [0037] FIG. 9B is an elevation view of the footpad and carriage assembly FIG. 9A . [0038] FIG. 10 is an elevation view of the frame structure of FIG. 1 illustrating roller-band tensioning hardware according to an embodiment of the present invention. [0039] FIG. 11A is a broken view of a potion of toothed rails and a toothed gear of FIG. 10 according to an embodiment of the present invention. [0040] FIG. 11B is an elevation view of the handle assembly of FIG. 10 . [0041] FIG. 11C is an elevation view of the rail-guide bracket of FIG. 10 . [0042] FIG. 11D is a right-side view of the bracket of FIG. 11C . [0043] FIG. 11E is a broken view of a portion of the bottom toothed-rail, roller, and bracketed roller-mount of FIG. 10 . [0044] FIG. 11F is a broken view of the bottom toothed-rail, roller, and bracketed roller-mount of FIG. 10 as seen from an overhead vantage. [0045] FIG. 12 is a perspective view of an adjustable double footpad module according to an embodiment of the preset invention. [0046] FIG. 13A is a plan view and FIG. 13B is a side view of a slotted base-plate according to an embodiment of the present invention. [0047] FIG. 13C is an end-view of the slotted cam-rod of FIG. 12 . [0048] FIG. 14 is a cross-sectional view of a main wheel, a keeper wheel, and a semi-arcuate rail according to an alternate embodiment of the present invention. [0049] FIG. 15 is a cross section of an integral captive rail and wheel arrangement in an embodiment of the present invention. [0050] FIG. 16 is an elevation view of a ski-exercising device illustrating an optional third power band according to another embodiment of the present invention. [0051] FIG. 17 is an elevation view of a ski-exercise device illustrating adjustable tensioning structures for an optional third power band according to an embodiment of the present invention. [0052] FIG. 18A is an elevation view of an adjustable tensioning structure of FIG. 17 , and a roller axle. [0053] FIG. 18B is an elevation end view of the adjustable tensioning structure and roller axle of FIG. 18A and a roller axle nut. [0054] FIG. 19 is an elevation view of a frame structure of the ski-exercising device of FIG. 17 . [0055] FIG. 20A is a top view of an adjustable mounting plate according to an embodiment of the present invention. [0056] FIG. 20B is a section view of the mounting plate of FIG. 20A taken along section line 20 B- 20 B. [0057] FIG. 21A is a top view of a sliding attachment plate according to an embodiment of the present invention. [0058] FIG. 21B is a section view of the sliding attachment plate of FIG. 21A taken along section line 21 B- 21 B. [0059] FIG. 22 is a top view of the mounting plate of FIG. 20A and a pair of sliding attachment plates of FIG. 21A according to an embodiment of the present invention. [0060] FIG. 23 is an elevation view of a suspended footpad assembly and the sliding attachment plate of FIG. 21A . [0061] FIG. 24 is an elevation view of the footpad assembly and attachment plate of FIG. 23 and the mounting plate of FIG. 20A attached to a carriage assembly according to an embodiment of the present invention. [0062] FIG. 25A is a top view of the mounting plate and attachment plates of FIG. 22 , a pair of suspended footpad assemblies of FIG. 24 and a carriage assembly according to an embodiment of the present invention. [0063] FIG. 25B is an elevation view of the mounting plate, attachment plates, suspended footpad assemblies and carriage assembly of FIG. 25A . [0064] FIG. 26A is an elevation view of an upper body conditioner (UBC) elevated grip according to an embodiment of the present invention. [0065] FIG. 26B is a top view of the UBC elevated grip of FIG. 26A . [0066] FIG. 27A is a top view of a UBC lower grip according to an embodiment of the present invention. [0067] FIG. 27B is a side elevation view of the lower grip shown in FIG. 27A . [0068] FIG. 28A is a top view of the mounting plate, attachment plates and carriage of FIG. 25A , and a pair of UBC elevated grips and a pair of UBC lower grips affixed to the attachment plates according to an embodiment of the present invention. [0069] FIG. 28B is an elevation side view of the mounting plate, attachment plates, carriage, UBC elevated grips and UBC lower grips of FIG. 28A . [0070] FIG. 29A is a top view of a footpad pivot base according to an embodiment of the present invention. [0071] FIG. 29B is an elevation side view of the footpad pivot base of FIG. 29A . [0072] FIG. 29C is an elevation end view of the footpad pivot base of FIG. 29A . [0073] FIG. 30A is an elevation end view of a footpad pivot support structure according to an embodiment of the present invention. [0074] FIG. 30B is an elevation side view of the footpad pivot support structure of FIG. 30A . [0075] FIG. 30C is a top view of the footpad pivot support structure of FIG. 30A . [0076] FIG. 31A is a top view of a pivot roller base assembly according to an embodiment of the present invention. [0077] FIG. 31B is an elevation end view of the pivot roller base assembly of FIG. 31A . [0078] FIG. 31C is an elevation side view of the pivot roller base assembly of FIG. 31A . [0079] FIG. 32A is an elevation view of the footpad pivot base of FIG. 29B , footpad pivot support structure of FIG. 30B and the pivot roller base assembly of FIG. 31B according to an embodiment of the present invention. [0080] FIG. 32B is an elevation end view of the footpad pivot base, footpad pivot support structure, and pivot roller base assembly of FIG. 32A . [0081] FIG. 33A is an elevation view of a roller axle assembly according to an embodiment of the present invention. [0082] FIG. 33B is an elevation end view of the roller axle assembly of FIG. 33A . [0083] FIG. 34 is an elevation side view of a cable-securing axle according to an embodiment of the present invention. [0084] FIG. 35 is an elevation side view of an optical sensor assembly according to an embodiment of the present invention. [0085] FIG. 36 is an elevation view of the frame structure of FIG. 17 , the carriage assembly, mounting plate, attachment plate, and suspended footpad assemblies of FIG. 25A , and sensor system according to an embodiment of the present invention. [0086] FIG. 37 is a top view of the carriage assembly, mounting plate, attachment plate, suspended footpad assemblies, and sensor system of FIG. 37 . [0087] FIG. 38 is a perspective view of an adjustable flag assembly according to an embodiment of the present invention. [0088] FIG. 39 is an elevation view of the carriage assembly, mounting plate, attachment plate, suspended footpad assemblies, and sensor system of FIG. 38 incorporating a pair of flag assemblies of FIG. 36 according to an embodiment of the present invention. [0089] FIG. 40 is an elevation view of the carriage assembly, mounting plate, attachment plate, suspended footpad assemblies, sensor system and flag assemblies of FIG. 39 , incorporating a progressive resistance cord system according to an embodiment of the present invention. [0090] FIG. 41 is a plan view of a panel for a entry and display in an embodiment of the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0091] It is the object of the present invention to provide a ski exercising apparatus similar to that apparatus covered in cross-related documents above that is modularly enhanced such that, among other improvements, changing applications on the apparatus may be performed with minimal effort. It is also an object of the present invention that the above apparatus be generally and innovatively improved to accomplish a goal of maintaining a light weight while increasing strength and durability of the apparatus. A further object of the present invention is to provide such an apparatus as described above having a lower profile, improved safety features, and having fewer assembly parts with which to contend. It is also an object of the present invention to more accurately simulate the motions and dynamics of skiing in terrain, which varies in steepness, bumpiness and other aspects of the terrain, as well as skiing in such terrain at varying speeds and aggressiveness. Yet another object of the present invention is to provide a ski apparatus having a monitoring system integrated therein which provides the user with information pertaining to the workout in order to enable the user to best utilize the apparatus and maximize effectiveness of the workout or training. Such information may include elapsed time from start to finish of the workout, goal determination and accomplishment, energy or calories expended by the user, speed of turns, side travel distance of the wheeled carriage, and so on. It is still further an object of the present invention to provide such a ski exercising apparatus which, when used with special attachments and other new and novel apparatus, becomes a versatile rehabilitation and training tool that simulates the range of motion and balance required in many sports other than downhill skiing. Such an apparatus is enabled for selectively stretching, strengthening or rehabilitating specific areas of the body, core stabilization, balance training and many other aspects of selected training and exercise. Such an apparatus and system accurately reproduces the lateral movements required in most sports, thereby optimizing rehabilitation and helping to prevent injury to the user. Such a ski-exercising apparatus is described in enabling detail below. [0092] FIG. 1 is an elevation view of a frame structure 11 of a ski-exercising apparatus 9 according to an embodiment of the present invention. Apparatus 9 is provided having a generally similar frame-architecture to previously described exercisers disclosed in related U.S. patents issued to the inventor except for novel improvements that are described below. For the purpose of clarification, only a frame structure 11 of apparatus 9 is described in this embodiment. Additional components not seen here are described later in this specification. [0093] In a preferred embodiment of the present invention, frame structure 11 comprises a pair of semi-arcuate rails 22 that are held parallel to each other and are affixed at either end of each rail to a pair of transverse end-members 27 . As this is an elevation view, only one of the pair of rails is seen. The spacing and parallelism is seen in plan view FIG. 2 . This arrangement of rails 22 affixed to members 27 forms the basic frame-structure 11 of apparatus 9 . One notable difference between semi-arcuate rails 22 and the fully arcuate rails disclosed in related patents such as rails 15 of U.S. Pat. No. 5,147,257, is as the respective descriptors imply. That is, as in FIG. 1A , rails 22 are arced only in their center portions 23 and illustrated by a dimensional notation E. The dimension lines associated with portion 23 mark the locations where the arced portion of each rail 22 ends at positions sharing an equal distance from a theoretical vertical center of rails 22 . [0094] The total distance E in a preferred embodiment is approximately 26 inches, defined as that portion of each rail 22 that is arced. The stated arc of arcuate portion 23 has a radius of approximately 76 inches although a somewhat higher or lower radius may be used in other embodiments. Non-arcuate portions of rails 22 are witnessed by element numbers 19 and 21 on the left and right side of apparatus 9 as seen in this view. The lengths (taken horizontally) for rail portions 19 and 21 are approximately 15 inches respectively. Rail portions 19 and 21 are substantially straight from their junctures with arcuate portion 23 . The dimensions cited above are intended to be approximate only. When including an approximate 2.36-inch (6 cm) diameter for each transverse member 27 , the approximate overall length of frame structure 11 is about 61 inches. Semi-arcuate rails 22 may be manufactured from heavy-gauge steel tubing as described in U.S. Pat. No. 5,147,257. In one embodiment, rails 22 may be made of extruded steel or aluminum bars rather than steel tubing, and rails may be solid or hollow in different embodiments. Such rails may often also be formed in a forming die to manufacture tracks. [0095] Solid aluminum bars may in some circumstances offer more strength than steel tubing in terms of flexing or bending while retaining a lightweight characteristic. Moreover, such bars may be extruded to comply with varied shapes as may be desired, and may also be produced in hollow configurations. In this particular embodiment, rails 22 are solid and round in cross-section (rods). The semi-arcuate design and solid structure of rails 22 adds considerable strength and durability causing less flex when rails are in use. It is not specifically required that rails 22 be of round cross-section in order to practice the present invention. The inventor intends merely that keeping a round cross-section consistent with previously used steel tubing is consistent with conventional wheels used on wheeled-carriage assemblies such as carriage 11 described in U.S. Pat. No. 5,147,257. [0096] In another embodiment, rails 22 may be extruded and then die-formed to a shape that may conform to an alternate wheel design. Such an embodiment is described later in this specification. The size of rails 22 is approximately 2.5 cm. (1-inch) in diameter as is consistent with previous related embodiments. However, this should not be construed as a limitation in diameter but only a preference in balancing durability with lightweight characteristics. Other diameters for rails 22 are plausible. Transverse members used in an embodiment where rails are aluminum will also be made of aluminum tubing to facilitate welding. However, where rails are steel tubing or rods, transverse members will typically be manufactured from steel tubing. A durable polymer coating is applied to all visible parts and surfaces of apparatus 9 in order to provide a resistance to corrosion and for appearance purposes. [0097] The straight portions of rails 22 to each side of arcuate portion 23 provide a carriage movement in operation that more nearly simulates an actual skiing experience, as has been testified to by users of the apparatus. [0098] In a preferred embodiment of the present invention, rails 22 are welded to transverse members 27 to form a one-piece truss-frame insuring long life and durability along with ease of assembly of associated elements. However, many fastening methods are known and practiced in the art and could also be used to affix rails 22 to transverse members 27 . The frame structure 11 of apparatus 9 also comprises belt guides 24 located in a substantially centered and parallel position in-between rails 22 and welded, at opposite ends, to transverse members 27 and to a support frame member 31 supporting the rails in the centered arcuate portion. Belt guides 24 allow a power band such as element 23 of FIG. 5A of &#39;257 to be separated from the floor or carpet during operation, thus contributing to longer life and sparing wear and discoloration of the floor or carpet. A belt guide of the type disclosed herein has not been previously taught. A pair of raised ribs 26 running the length of belt guides 24 on each side of member 31 are provided and adapted to allow a power band to avoid contact with the bottom of belt guide 24 further reducing wear and noise. [0099] Support member 31 is provided for the purpose of lending additional support to the frame structure 11 of apparatus 9 , and for housing mechanisms associated with operation of the exerciser. A structure of the same name is illustrated in FIG. 5A (element 55 ) of &#39;257 and member 31 is analogous to that member, but improved in function. For example, support member 31 as illustrated herein, is longer in length than the aforementioned member 55 thereby supporting more area of rails 22 . Support member 31 may be provided as one piece or as a plurality of components welded together such that one single piece is formed. Support member 31 is made wider than previously disclosed support members such that it may be welded in some embodiments to the outside edges of rails 22 instead of having rail-inserted tabs as described with member 55 of FIG. 5A in &#39;257. Welding support member 31 to the outside edges of rails 22 increases the strength and durability of frame structure 11 , and allows further improvements described more fully below. [0100] Support member 31 is further welded to belt guides 24 as previously described, effectively adding these components to frame structure 11 so as to form a single contiguous and integral frame, thereby lending strength, durability, and eliminating assembly requirements. Also welded to support member 31 is a tension-adjustment structure 25 . Structure 25 in this embodiment is a u-shaped structure welded to the bottom of member 31 such that two vertical planes are presented, one on each side of the power band path, with holes for positioning rollers for adjustment of power band tension. The length of structure 25 is such that it extends beyond each side of member 31 , as shown, and guides 24 weld to structure 25 . In this manner structure 25 becomes a part of the overall welded structure 11 adding durable strength to the structure as a whole. Additionally, two roller brackets 34 are illustrated, housing rollers 35 in this embodiment, and these are also welded to transverse members 27 and to belt guide 24 , and are part of frame structure 11 of apparatus 9 . Much assembly is avoided and much durability and strength is added by providing a multi-component but single piece welded frame architecture for apparatus 9 as will readily be appreciated by one with skill in the art. [0101] A protective resilient, non-skid pad 29 is provided and mounted in a position beneath support member 31 . Pad 29 may be affixed to support member 31 by gluing, fastening such as by recessed screws, or other known methods. The purpose of pad 29 is to protect floor coverings from contact with support member 31 so as to avoid scratching and the like, as well as to keep apparatus 9 from skidding when in use. This pad also provides service in reducing vibration and noise. Four resilient end-caps 17 are provided to cover the ends of transverse members 27 . End-caps 17 provide non-skid contacts between apparatus 9 and a floor or other support surface. [0102] Another component illustrated in this embodiment is an optional support frame 14 for a novice user to hold on to for stabilization while using apparatus 9 . Support frame 14 , termed an Assistant Coach by the inventor, comprises a tubing structure 16 , a cross member 13 , and padded gripping areas 15 . Tubing structure 16 may be a one-piece tube bent to form structure 16 , or a combination of straight and curved pieces, which are provided and assembled to form structure 16 . Steel or another form of durable tubing of an approximate 1-inch diameter may be used. Other sizes are also useful. [0103] Gripping areas 15 (one on each side) may be formed of a durable synthetic material such as a dense polyurethane foam, vinyl, or other materials known for providing a gripping surface to tube handles and the like that are common in the field of exercise equipment. In one embodiment, gripping areas 15 may be removed such as by conventional methods known in the art. In another embodiment, gripping areas 15 are permanent such as sprayed on or glued. Cross member 13 may be manufactured from a durable plastic or other material such as sheet steel or aluminum. Cross member 13 may in some embodiments be welded to tube structure 16 . In other embodiments, other known fastening techniques such as nut and bolt, or metal screws may be used. There are many possibilities. [0104] Support frame 14 is welded or fastened to two transverse members similar to members 27 but not seen here because of the direction of view (see FIG. 2 element 49 ). Such members act as an optional extension to transverse members 27 at the rear of apparatus 9 . By removing resilient end-caps 17 from the rear or front of apparatus 9 , support structure 14 may be connected to the transverse members 27 of frame structure 11 . In some embodiments an additional interface and support element is added between elements 11 and 27 . [0105] FIG. 2 is a plan view of the frame structure 11 of apparatus 9 of FIG. 1 with added components illustrated according to an embodiment of the present invention. As previously described, support frame 14 is an optional extension to frame structure 11 of apparatus 9 . A user wishing to install support frame 14 simply removes two end caps 17 from the rear of frame structure 11 and connects the support frame. The point of connection for the two structures is illustrated as line 51 at either end of device 9 . [0106] Transverse members 49 each have a fitting end 52 that is of a smaller diameter over a suitable length than the inside diameter of transverse members 27 . The diameter is small enough so that transverse members 49 may be easily fit into transverse members 27 such that when fully inserted lines 51 are formed representing the joining of each structure. Circular shims (not shown) that are once split through along a longitudinal edge of each shim are used to obtain a snug fit between transverse members 27 and 49 . Such shimming methods are well known in the art. Setscrews (not shown) or other known types of fasteners may be used to secure the installation. [0107] As seen in this overhead view, power band guides 24 extend from each end of the structure (members 27 ) toward the center and are welded at opposite ends to structure 25 , which in turn welds to member 31 ( FIG. 1A ). Roller brackets 34 are welded to transverse members 27 and to belt guide 24 as previously described above. Two rollers 47 and 45 are illustrated as mounted to tensioning structure 25 . Rollers 47 and 48 are provided and adapted to support a central power band 46 . Likewise, a power band 43 is supported by rollers 35 and 37 . An additional roller (not shown) is provided for further support of power band 46 and is centered in-line and in-between rollers 47 and 45 at a raised position such that a triangular configuration of the three rollers is formed. Power bands 43 and 46 are manufactured of a proprietary rubber compound or similar material as described in U.S. Pat. No. 5,147,257. Aforementioned rollers such as rollers 35 and 37 are manufactured of polypropylene or similar material in a preferred embodiment. [0108] Tension-adjustment structure 25 acts as a rigid mounting location for rollers 47 and 45 . A plurality of openings provided in collinear arrangement through opposite-facing sides of structure 25 are used to mount rollers 47 and 45 via a quick-release pin-and-shaft mounting technique that is described in detail later in this specification. By removing and re-mounting rollers in different positions on structure 25 , tension adjustments to power band 46 may be affected. [0109] A wheeled lower carriage assembly indicated as element 33 in FIG. 2 , but best seen in FIG. 4 , rides on rails 22 . This carriage is described in further detail below with reference to FIG. 4 . Foot platforms 39 and 41 are mounted to an upper platform unit 89 , which in turn mounts to the lower wheeled carriage assembly by fasteners 53 . The arrangement of an upper platform for footpads mounting as a unit to a lower wheeled carriage allows different footpad arrangements to be quickly and easily traded on a standard wheeled carriage. [0110] Center fastener 54 is not used when installing and removing upper foot platforms, because it is a mounting fastener for a power-band roller beneath carriage 33 . A clearance hole is provided in the upper platform for this fastener. [0111] Foot platforms 39 and 41 , in the arrangement shown, provide a parallel skiing simulation that is one option for mode of operation with apparatus 9 . By swapping upper platforms with different foot interface arrangements the overall apparatus can be quickly adapted to other applications, as will be clearer with following description. [0112] In the embodiment shown, foot platforms 39 and 41 each have a footpad surface thereon. Footpad surface 38 is affixed to platform 39 , and footpad surface 42 is affixed to platform 41 . Footpad surfaces 38 and 42 are preferably made of a non-skid durable rubber material. Surfaces 38 and 42 may be installed using an adhesive, or other known methods such as screw fasteners or the like. Similarly, other materials may be used instead of rubber as long as a non-skid effect is maintained. [0113] Rollers 35 , 37 , 47 , 45 , and the previously described roller (not shown) that completes a triangular configuration with rollers 47 and 45 are now significantly larger in diameter than rollers previously disclosed in related applications. Whereas previously disclosed rollers were described as having about a 1-inch (2.5 cm) diameter, the rollers of the present invention have substantially a 2-inch (5 cm) diameter and are crowned. That is, the rollers are somewhat curved on the outer surface that meets the power band, so there is a marginally larger diameter at the center plane of the roller than at the roller edges. This improvement in design ensures that the power bands always remain centered on the rollers, which obviates contact with roller brackets and the like, reducing frictional wear to the power bands, and leads to smoother and quieter operation of apparatus 9 . [0114] FIG. 3 is a perspective view of the center portion of frame structure 11 of FIG. 1 with covering components removed to show the elements beneath. As previously described, support member 31 is welded to rails 22 . In this example, a plurality of individual welds 55 is placed symmetrically along the length of support member 31 . There are three welds 55 shown in this example, however, there may be more or fewer such welds without departing from the spirit and scope of the present invention. In one embodiment, a continuous weld may run the entire length of support member 31 . Also in this example, welds 55 are illustrated as being placed from the outside edges (rear-edge welds not visible) of support member 31 to the outside of rails 22 . There are many possibilities regarding number of and location of welds 55 . [0115] Tensioning structures 25 , as described with reference to FIGS. 1 and 2 , are welded to belt guides 24 and to support member 31 . Brackets 25 are shown with rollers 47 and 45 mounted thereon. A suitable thickness for the material used to manufacture support member 31 and belt guide 24 is about 3 mm. or ⅛ of an inch. In one embodiment of the present invention, aircraft quality aluminum may replace sheet steel for such components where possible. Using high quality aluminum instead of materials such as steel cited in related applications helps to strengthen frame structure 11 as well as to reduce weight. [0116] Yet another marked improvement over the prior art is in the method of clamping the ends of power bands. In related documents it is described that the central resilient element has it&#39;s ends clamped at one location while a second resilient element has its ends clamped at locations on either side of the central clamp. Therefore three clamping locations exist for securing the free ends of power bands. In this example, only one clamping location 57 is required. Clamp 57 secures both the ends of power band 43 and those of power band 46 of FIG. 2 . This method reduces work-steps required to install power bands. A single clamping location also ads considerable safety in that only one clamp must be checked for integrity therefore lessening the possibility of error in set-up. In this particular example, clamp 57 is a bar clamp utilizing two standard hex-head nuts and bolts to effect tightening. [0117] FIG. 3 also illustrates the positioning of rollers 45 and 47 in structures 25 . The position of the rollers in this embodiment can be changed into any other of the holes in the sides of structures 25 to adjust the tension on the inner power band. [0118] FIG. 4 is a perspective view of wheeled carriage-assembly 33 shown without an upper foot-platform 89 according to an embodiment of the present invention. As disclosed in related applications such as U.S. Pat. No. 5,147,257, for example, there are four main weight-bearing wheels that are mounted to the carriage body and adapted to make contact on the upper surfaces of rails 22 such that the carriage assembly may ride side-to-side on the rails as urged by a user. The wheels are approximately 2 cm wide and are machined using an ultra high molecular weight (UHMW) long-chain polymer material as described in U.S. Pat. No. 5,147,257. A standard button-head shoulder-bolt (not shown) forms the shaft of each wheel. Ball bearings, washers, a lock washer, and a castle nut complete the assembly components for mounting wheels to the carriage body as described in U.S. Pat. No. 5,147,257. [0119] As in &#39;257, there are four main wheels that ride on upper surfaces of rails 22 . Two are visible in this embodiment and are represented by element numbers 67 and 68 . The remaining two main wheels are located toward the rear portion of carriage assembly 33 and are therefore hidden from view by carriage body 70 , and are not represented in FIG. 4 to avoid unnecessary detail. These main wheels are mounted rotationally to carriage body 70 . [0120] Wheels 67 and 68 in a preferred embodiment are mounted at an approximate 12 degree angle from vertical with the angle toward the space in-between rails 22 such that they make contact with a more inwardly surface of each rail. The rolling surface of each wheel is concave such that the radius across the width of each wheel substantially matches the cross-sectional radius of rails 22 . Wheels 67 and 68 as well as two main wheels that are not visible here are mounted through provided openings strategically located on carriage body 70 . [0121] In this embodiment, an additional set of four keeper wheels is provided of which two wheels 71 and 69 are visible in this view. Two other keeper wheels are located toward the rear of carriage assembly 33 and are hidden in this view by carriage body 70 . Components forming the shaft and mounting hardware for keeper-wheels 71 and 69 are the same as those already described for wheels 67 and 68 . [0122] Keeper wheel 71 and 69 are strategically located beneath rails 22 at angled positions that are inverted from the angled positions of main wheels 67 and 68 , and directly below weight-bearing wheels. Two angled mounting brackets 75 and 73 are provided and adapted to secure keeper wheels 71 and 69 by being also mounted to upper wheels 67 and 68 . Wheels at the rear of carriage assembly 33 (not shown) are similarly secured as brackets 75 and 73 run the entire length of carriage assembly 33 . [0123] In this embodiment brackets 73 and 75 are secured to the upper wheels and the lower wheels, so the lower keeper wheels are positioned by the upper wheels, which are mounted to the carriage body. In other embodiments brackets 73 and 75 may extend further upward and be fastened to the underside of the carriage, such as by rivets or welding. The brackets may, for example, be fastened by any convention joining means. Angled mounting-brackets 75 and 73 assume an inclusive angle of approximately 140 degrees such that each wing is substantially parallel to desired wheel positions when mounted. Ideally, carriage assembly 33 will remain resident on rails 22 when changing applications. This will allow for interchangeability of pre-assembled modules that are complete with selected foot platforms mounted. Upper platforms such as platform 89 of FIG. 2 may vary in physical appearance depending on the application; however, identical fastening locations allow interchangeability with carriage assemblies such as carriage assembly 33 . [0124] There are yet additional improvements made to assembly 33 over the prior art. One such improvement is the provision of two clamping locations 63 a and 65 a located on the under-surface of carriage body 70 for the outer power band. A clamp bar 63 is illustrated as one of two such clamp bars that are used to secure resilient element 43 . A second clamp bar for clamping location 65 a is not shown, but may be assumed to be present. Previous embodiments disclosed in related documents describe only one clamping location located directly beneath the center of the carriage assembly. An advantage of having power band 43 clamped in two locations is that noise caused by a resilient element flapping against the underside of the carriage body is eliminated, and the carriage is stabilized even further. [0125] Roller 59 is a third roller previously described to form a triangular configuration of rollers to support power band 46 of FIG. 2 . Like all rollers described in this specification, roller 59 is crowned for the purpose of guiding resilient member 46 such that it remains centered on the rollers. [0126] In this embodiment, roller 59 assumes a position much nearer in proximity to the underside of carriage body 70 than in the cross-referenced patents. This is due in part to the larger diameter (2 inch) attributed to rollers of the present invention as opposed to previously disclosed 1 inch diameter rollers in related documents. In addition, roller 59 is simply mounted in a position that is nearer the underside of carriage body 70 by means of a roller bracket 61 . This is done to reduce wear caused by resilient members rubbing and slapping against each other, and also, to reduce associated noise. The clearance is carefully designed as well so that, as the roller carriage moves to each side and back on the rails, the slack portion of the outer power band is carried to the side in the direction of carriage motion, which also reduces noise and sudden engagement. [0127] It will be apparent to one with skill in the art that there are other possible wheel arrangements that may be used with carriage assembly 33 than the one illustrated herein without departing from the spirit and scope of the present invention. For example, the tilt angle of main and keeper wheels may be more or less than 20 degrees as mentioned in this embodiment. There may also be more or fewer main and or keeper wheels than is illustrated here. [0128] In one embodiment, independent wheel pairs comprising one main wheel and an associated keeper wheel may be bracketed independently such that there are four independently movable wheel sets. [0129] FIG. 5 is a perspective view of an upper platform assembly 90 supporting a suspended footpad 79 mounted to a carriage assembly 33 (wheels and brackets not shown) according to an embodiment of the present invention. [0130] In this example, a single suspended footpad 79 is provided and adapted to be pivotally suspended over upper platform assembly 90 , termed a cradle in related U.S. Pat. No. 5,020,793, by means of two pivot points 85 and 87 . Each pivot point 85 and 87 , in a preferred embodiment, comprises a journal bearing, a spacer bushing, and a threaded stud with suitable lock washers and a nut fastener. There are equivalent ways known in the art to accomplish such a pivot. A suitable rubber cover is provided and adapted to fit over pivot points 85 and 87 to protect components from corrosion and general exposure. Pivot points 85 and 87 are arraigned in collinear fashion on opposite facing support wings represented by element number 81 . The 15 pivots are fixedly mounted in vertical structures 83 , which are a part of the platform that mounts to carriage 33 . As described in U.S. Pat. No. 5,020,793, footpad 79 may swing freely about pivot points 85 and 87 as illustrated by double arcs that represent direction of swing. [0131] The general application illustrated in this example is as stated in the aforementioned related document whereas a user places only one foot in footpad 79 after it is installed on apparatus 9 of FIG. 1 . By traversing back and forth over rails 22 of FIG. 1 , he or she experiences a benefit of simulated edging. As the length of traversing approaches maximum length of rails 22 , footpad 79 pivots maximally about pivot ends 85 and 87 . [0132] Also noted herein is a no-skid surface 93 provided in the same fashion as previously disclosed in FIG. 2 (elements 38 and 42 ). The fasteners for mounting the upper platform to carriage 33 are not seen in this view, but are the same as previously described for upper platforms in this disclosure. [0133] According to a preferred embodiment of the present invention, footpad 79 with upper platform assembly 90 may be removed as one unit from and installed as one unit onto any wheeled carriage assembly having suitable mounting locations. In this way, a carriage assembly such as assembly 33 of FIG. 2 may be kept resident on apparatus 9 of FIG. 2 with the loosening, removing, and re-tightening of only two hex-head nuts being required to change applications. This method reflects the modular nature of accessories such as footpad 79 mounted to upper platforms according to a preferred embodiment. Loosening and tightening bolts may be performed with the aid of a convenient T-handle socket tool (not shown) adapted to fit hex-head nuts 53 . In a preferred embodiment, all hex-head nuts subject to requirements of being removed and replaced due to the change of applications are the same size fitting the T-handle socket tool. [0134] Carriage assembly 33 is shown in this example to illustrate orientation of footpad 79 . Carriage assembly 33 may be of a different overall length than assembly 33 of FIG. 2 . For example, a single footpad such as footpad 79 does not require a longer carriage assembly whereas a dual footpad installation would require a longer carriage assembly. In a preferred embodiment, carriage assembly 33 of FIG. 2 has a maximum length such that all modular accessories are supported. That is not to say, however, that a modular accessory cannot have it&#39;s own carriage of a different overall length. [0135] Carriage assembly 33 of FIG. 2 would preferably remain resident on rails 22 of apparatus 9 ( FIG. 2 ), especially if keeper wheels are used as previously described. However, in an alternate embodiment where keeper wheels are not used, the carriage assembly illustrated in this example may have main wheels installed and may be thought of as one module comprising assembly 33 , upper platform 90 , and footpad 79 . In this embodiment, a roller such as roller 59 of FIG. 4 may be shared between different applications. A quick release of roller 59 and removal of bar clamps such as clamp 63 a of FIG. 4 will also allow removal and replacement of different modules. However, removing bar clamps entails much more effort on the part of a user. The added effort may be offset by the fact that different applications may require different tensioning adjustment with respect to a resilient member such as member 46 of FIG. 2 . [0136] In addition to providing a single footpad in modular fashion as illustrated herein, in a further embodiment an upper platform is provided having two such single suspended footpads may be mounted in spaced-apart fashion. In yet another embodiment an upper platform assembly is provided wherein the spacing between suspended footpads is adjustable, and the adjustment apparatus is described further below with reference to FIG. 12 . Also, because of added keeper wheels such as wheels 69 and 71 of FIG. 4 , retaining a wheeled carriage on rails 22 , footpad(s) 79 may be significantly extended in length without the risk of tipping carriage 33 off of rails when in use. [0137] FIG. 6 is an elevation view of wheeled carriage-assembly 33 , upper platform 89 , and mounted foot platforms 39 and 41 of FIG. 2 according to an embodiment of the present invention. Part of the upper carriage walls are broken out in this figure for the purpose of enabling a view of inner components, and the bottom plate of upper platform 89 is therefore shown partially in cross-section. [0138] As with previously disclosed embodiments described in related documents, footpads 39 and 41 are pivotally mounted to pivot supports 103 and 105 respectively. Supports 103 and 105 are part of the upper-platform assembly not removed in this example. There are four pivot supports such as supports 103 and 105 with the remaining two identical supports positioned directly behind and to the backside of assembly 33 and therefore not seen in this view. Pivot pins 102 and 111 form a pivotal connection between depended ears 109 and 110 and an identical set of depended ears (not shown) located at the backside of footpads 39 and 41 respectively. A section-view of this relationship is detailed and described in &#39;257 FIG. 6 . Footpads 39 and 41 are die-cast in one embodiment to include the described depended ears. [0139] A link-rod 115 is provided and attached to pivot points 104 and 113 . The above-described configuration including components is duplicated at the backside of the assembly. [0140] The connected link-rod assembly enables footpads 39 and 41 to pivot in unison during operation of apparatus 9 of FIG. 2 . Resilient blocks 97 and 95 are provided as shock absorbers and are made of rubber or other suitable resilient materials. [0141] Link-rod 115 is of a length such that when attached to pivot points 104 and 113 with footpads 39 and 41 brought to their center-most position about pivot rods 102 and 111 , that each footpad is canted, in some embodiments, somewhat toward the center (canted positions not specifically shown). However, in other embodiments it is desired that footpads 39 and 41 may be adjusted to assume a more level profile to facilitate use by more experienced users. [0142] There are two ways to accomplish this task. In one embodiment, a second set of link-rods (not shown) is provided of a shorter overall length than the set represented by link-rod 115 . By replacing link-rods 115 with the shorter rods, footpads 39 and 41 may be canted to a more level position. This, of course assumes that footpads 39 and 41 as used, in this embodiment, with link-rod 115 are canted in as described above. This method requires that four link-rods be provided with the modular footpad-assembly, two for the canted-in configuration, and two for the more level configuration. [0143] In another embodiment link rods are provided that are themselves adjustable, so the effective length of the rods, and therefore the degree of cant of the footpads may be adjusted within certain limits. [0144] FIG. 7A is perspective broken-view of a portion of a rail 22 , transverse end-member 27 , and end-cap 17 according to an embodiment of the present invention. In a preferred embodiment, rails 22 are welded to a location (W) above the longitudinal centerline of transverse end-members 27 . The higher location allows keeper wheels such as wheels 71 and 69 of FIG. 4 from coming in contact with the floor at maximally traversed locations on rails 22 . End-cap 17 now has a corrugated bottom for shock absorption as well as additional no-skid protection. [0145] FIG. 7B is an elevation view of an end-side of end cap 17 of FIG. 7A . End-cap 17 is molded of rubber-like material as described in previous embodiments. In order to improve over previous designs, a series of alternating raised portions 119 and grooves 117 are provided to form a corrugation feature extending across the bottom surface of cap 17 . As described above, this adds a no-skid enhancement and a shock absorption enhancement. [0146] FIG. 7C is a plan view of a bottom-side of end cap 17 of FIG. 7B . In addition to a corrugation formed by hills 119 and valleys 117 , a pattern containing a plurality of through openings is provided generally through the bottom surface of end cap 17 and extending into the inner space reserved for housing the circular end of transverse member 27 of FIG. 7A . These openings are also illustrated in FIG. 7B as vertical dotted lines but are not described or witnessed. Openings 121 provide additional shock absorption capability. There are nine such openings in this example, however, it will be apparent to one with skill in the art that more or fewer openings 121 may be provided. Moreover, differing patterns may be used as well. [0147] FIG. 8 is a perspective view illustrating components of a quick-release roller-assembly according to an embodiment of the present invention. As previously described in FIGS. 2 and 4 above, rollers supporting power bands such as roller 47 illustrated here, are crowned. Such a crowned area is labeled and illustrated by an accompanying witness arrow. A dimension C represents the diameter of roller 47 at the crowned area. It has been described above that a preferred diameter is 2-inches for rollers, which is assumed to be taken at the crowned area leaving the end diameters of each roller less than two inches in diameter. However, in some embodiments, the crowned area of a roller such as roller 47 may be larger than 2-inches. [0148] A roller shaft or pin 123 is provided and adapted to be an axle for roller 47 between elements of structure 25 of which broken portions are represented here. Pin 123 has a spring-loaded detent 125 in one end and a pull ring 124 through a hole in the other end. Through-openings in elements 25 , each having a polymer bushing 127 , are provided to receive pin 123 . By placing a roller in position between brackets 25 , pin 123 may be placed through selected collinear bracket-holes with bushings 127 and roller 47 . Pin 123 is of sufficient length such that it protrudes past the outer surfaces of structure 25 on both sides, and when in place detent 125 prevents accidental withdrawal. The quick-release pins for rollers provide a means of quickly re-positioning rollers in structure 25 for tensioning adjustment. In an alternative embodiment later described, the rollers may be adjustably spaced even more simply using a dialed adjustment mechanism. [0149] FIG. 9A is a plan view of an elongated footpad 133 and carriage-assembly 33 according to an embodiment of the present invention. A single footpad 133 is provided and adapted as a snowboard simulator presented as an option for apparatus 9 of FIG. 2 . Footpad 133 is pivotally mounted to an upper platform assembly 89 in much the same fashion as footpads 39 and 41 of FIG. 6 except that footpad 133 is centrally mounted and there is no link-rod assembly required. Carriage assembly 33 is also illustrated in this example to show orientation only. A non-slip surface 135 , preferably made of rubber-like material, is provided as in other embodiments previously described. Raised edges 131 are provided around the outer edges of footpad 133 for added protection from slipping. [0150] A dimension L (length) is provided to be sufficient for allowing a user to place both feet on footpad 133 in positions similar to those used in snowboarding. A standard example would be standing sideways one foot spaced apart from the other about shoulder width. The exact dimension may vary according to application, however 25 inches should be sufficient for most users. A dimension W (width) is provided to be sufficient for covering the length of a users shoe or boot, about 15 inches. [0151] In some embodiments not shown, there may be molded or otherwise formed positions to engage a user&#39;s feet, and fastening arrangements are also possible. [0152] In another preferred embodiment of the invention the mounting of the single footpad for simulating operation of a snowboard is as shown for the footpads of FIG. 5 , with the footpad suspended from pivots higher than the foot position. [0153] The application presented here is only possible in an embodiment wherein keeper wheels are used such as wheel 71 and 69 of FIG. 4 . Footpad 133 and upper platform 89 is a modular accessory and may be easily mounted to carriage assembly 33 of FIG. 2 by removing two hex-head nuts 132 , placing the unit over carriage assembly 33 of FIG. 2 and then replacing and re-tightening the nuts. Clearance holes 134 are provided through footpad 133 to allow access for a T-handle socket-tool such as the one previously described in FIG. 5 . [0154] FIG. 9B is an elevation view of mounted footpad 133 of FIG. 9A . As described in previous embodiments, footpad 133 is die-cast. However, other suitable materials and forming methods may also be used. Depended ears 137 are provided at either end on the underside of footpad 133 for the purpose of accepting a pivot rod 141 through collinear and opposite facing openings. Pivot rod 141 also extends through collinear openings provided in support wings 142 arranged in similar opposite facing fashion as depended ears 137 . When mounted, pivot rod 141 extends through all four collinear openings in depended ears 137 and support wings 142 . Pivot rod 141 also extends through both walls of the upper platform assembly 89 of FIG. 9A (not shown). Pivot rod 141 may be secured to the above mentioned carriage walls by castle nuts or other types of fastening nuts (not shown) as described in U.S. Pat. No. 5,147,257. [0155] In this example, there are no link-rods or other required hardware to direct rotation of footpad 141 . Rather, a resilient stop is provided and adapted to stabilize the rotation of footpad 133 while in use. Stop 139 is analogous to resilient blocks 97 and 95 of FIG. 6 in that it acts to impede and direct rotation. However, resilient stop 139 is provided as one piece rather than two pieces in this example. Stop 139 also extends the length of carriage assembly 89 such that maximum support is afforded. When not in use, footpad 133 rests against stop 139 in a centered and level position. [0156] In one embodiment, stop 139 has two areas within its molded architecture that are hollow or perhaps filled with a less dense material than rubber. These areas are shown here by dotted polygonal shapes. The respective areas lie, one beneath the left side of footpad 133 , and one beneath the right of footpad 133 . When footpad 133 is in use such as on apparatus 9 of FIG. 2 , the areas within stop 139 are caused to collapse under pressure of a respective side of footpad 133 during normal rotation. For example, each time a user traverses to one side of apparatus 9 , the opposite-side area is caused to collapse. Several factors dictate the amount of collapse. These factors include a user&#39;s weight, speed of traverse, and any hard motions urged on footpad 133 by the user. Preferably, resilient stop 139 is manufactured to withstand sudden shock, and be strong enough to support a considerable stress without complete collapse. Advanced users may simulate back and forth movements experienced in snowboarding. [0157] FIG. 10 is an elevation view of frame structure 11 of FIG. 1 illustrating an optional roller/band tensioning hardware 143 according to an embodiment of the present invention. According to this embodiment of the present invention, an optional apparatus and method is provided for tensioning a central power band such as band 46 of FIG. 2 . Instead of a quick-release method for rollers as described in FIG. 5 , whereby rollers are removed and then re-mounted in different positions, structure 25 on each side now has an elongated slot 153 for enabling a mounted roller such as roller 45 to be loosened and slidably positioned. Each structure 25 has opposite slots 153 on either side of belt-guide 24 such that a pair of slots 153 may accept a roller assembly such as for rollers 45 and 47 . [0158] Rollers 47 and 45 are, in this embodiment, held by an upper toothed-rail 145 for roller 45 , and a lower toothed-rail 147 for roller 47 , further illustrated in following FIG. 11A . Bracketed roller mounts (not detailed) on the roller side of each toothed rail form a rigid connection between the roller shafts of respective rollers to respective toothed rails. Toothed rail 145 is rectangular in cross-section and has a plurality of gear-teeth (not shown) arraigned along its length in the manner of a gear rack. In some embodiments a standard gear rack may be used. [0159] When positioned properly, toothed rail 145 presents its gear teeth in a downward direction or along its bottom surface. Toothed rail 147 is identical to toothed rail 145 and they are, in fact, interchangeable. An inverse positional relationship exists with toothed rails 145 (top rail) and 147 (bottom rail) such that respective gear tracks will face each other. Toothed rails 145 and 147 are held parallel and in position by a rail guide 150 , as shown in FIG. 10 and 11 C and D. Rail guide 150 has two rail-keepers installed thereon and adapted to hold toothed rails 145 and 147 in a parallel relationship and at the required distance apart. These are a rail keeper 149 positioned left of center, and a rail keeper 151 positioned right of center. The above-mentioned components of hardware 143 are manufactured of a durable material to provide wear resistance, for example, and there are several suitable materials for such applications. [0160] A gear (pinion) 159 , as shown in FIG. 11A and B, is provided and adapted to mesh with opposite-facing gear tracks as presented on toothed rails 145 and 147 . In this example, the gear is positioned directly behind of and forms a part of a gear-handle assembly 155 . Hardware 143 may be conveniently mounted to the inside front surface of U-shaped support member 31 with conventional fasteners as known in the art. A cutout opening 157 is provided through the front wall of U-shaped support structure 31 to enable user access to a gear-handle assembly 155 for the purpose of adjusting tension. In some embodiments there is an access door. [0161] In operation, a user adjusts power band tension to a greater or lesser amount by turning gear-handle assembly 155 clockwise (more tension) or counterclockwise (less tension). When the desired tension is achieved, he or she then releases a spring-loaded handle, and the positions are maintained. It may be assumed, of course, that a power band such as band 46 of FIG. 2 is in place during this operation. An incremental scale is preferably provided as a stamped or otherwise marked convention on the front face of support member 31 , or along surfaces of the guides for the adjustment assembly. This will allow a user to return to known tension amounts without experimentation. [0162] It will be apparent to one with skill in the art that a method for mounting hardware 143 to frame structure 11 may differ from the specific apparatus illustrated here without departing from the spirit and scope of the present invention. For example, U-shaped support member 31 may have a suitable slot running along its length for hardware 143 to fit into. There are other possibilities. [0163] FIG. 11A is a broken view of a portion of toothed rails (racks) 145 and 147 and a toothed gear (pinion) 159 of FIG. 10 according to an embodiment of the present invention. Gear 159 , as previously described in FIG. 10 , is positioned between and meshes with toothed rails 145 and 147 . [0164] FIG. 11B is an elevation view of the handle assembly 155 of FIG. 10 , and its integration with gear 159 and its mounting and operation. In this embodiment gear 159 is fixedly mounted to a shaft 173 that extends through opposite frame members 167 and 175 carried by bearings 177 . A serrated wheel 165 is slidably mounted to shaft 173 outside the area of gear 159 by a spline on the shaft and the wheel. Shaft 173 has an end 161 and a compression spring which urges wheel 165 toward frame member 167 . Pins 169 fit into matching holes in frame member 167 , urged by spring 165 . A user may grasp wheel 165 , pull it toward end 161 against spring 165 , whereby pins 169 are withdrawn from the matching holes in frame member 167 , and the wheel is free to turn the gear. By turning the gear in either direction the user can then move rollers 47 and 45 either closer together or further apart, thus adjusting the tension on the power band. When the user releases the wheel, the spring causes the pins to re-engage, and the rollers are then retained in the new positions. [0165] It will be apparent to one with skill in the art that there are many other mechanisms that may be employed to create a spring-loaded engagement handle for gear 159 without departing from the spirit and scope of the present invention. Other handle functions and assembly requirements may differ from the example shown here. The inventor intends the above-described handle assembly to be only one example. [0166] The skilled artisan will understand that supporting guide 150 , as shown in FIG. 11C and FIG. 11D , and other supporting elements for the rack-and-pinion mechanism described above may be accomplished in a number of different ways, and is within the skill of engineering practitioners. Detailed description of this portion of the mechanism is therefore not undertaken here. [0167] FIG. 11E is a broken view of a portion of lower rack 147 , roller 47 , and a bracketed roller-mount 187 of FIG. 10 . As previously described, a roller such as roller 47 is mounted to a rack such as rack 147 by means of a bracketed roller mount shown here as element 187 . Roller mount 187 is adapted to fit over the ends of a roller axle by virtue of a forked construction, similar in some respects to a mount for a paint roller, for example. [0168] FIG. 11F is a plan view of the assembly of FIG. 11E . As can be seen in this view, roller mount 187 is a simple forked bracket structure fastened to the end of rack 147 . Guide ends 188 are provided for guiding in slots of the rail guides 150 to constrain the translation direction in operation. In a preferred embodiment these guides are of a UHMW material for low-friction and for noise and vibration reduction. [0169] FIG. 12 is a perspective view of an adjustable double-footpad upper module 195 according to a further embodiment of the present invention. This model is termed the Double Black Diamond model by the inventor. As previously noted in FIG. 5 , a suspended footpad assembly such as footpad 79 may be double mounted in an adjustable manner. Two suspended footpads 79 are illustrated in this embodiment mounted in a locked position on an adjustable plate assembly 189 . Footpads 79 are similar in construction to footpad 79 of FIG. 5 ; hence they retain the same element number here. [0170] Plate assembly 189 is an intermediary base that bolts on to a wheeled carriage such as carriage 33 of FIG. 4 . Plate 189 has two opposite facing edges that provide guide channels 193 and 194 for movable suspended footpad assemblies. Channel 193 on one side is best illustrated in FIG. 12 . Channel 193 is adapted to house a slotted cam-rod 191 , which is adapted to lock the movable footpad assemblies in place. [0171] Cam-rod 191 has a plurality of slots 192 arranged in equally spaced and collinear fashion, and presented over the entire length of channel 193 along one side of the plate assembly. The purpose of slots 192 is to engage a plurality of equally spaced teeth provided on one edge each of two toothed base-plates (not shown here but illustrated below), one each affixed to the bottoms of footpad assemblies 79 . [0172] A spring-loaded lever 197 is provided on one end of cam-rod 191 and is adapted to cause rotation of cam-rod 191 within channel 193 enabling slots 192 to be presented inward as shown or rotated back into channel 193 as directed by a user. Spring lever 197 in this embodiment fastens to channel 193 such that a wound spring engages a fixed location in the channel while the opposite end of the spring is retained by lever 197 creating a spring tension. There are several ways known in the art for a spring lever to be mounted such that a shaft or other part is put under spring tension. The spring-loaded arrangement provides for the cam rod to be always urged into the locked position for the footpad assemblies, so these assemblies may only be moved to adjust center distance under positive direction of the user. [0173] By manually rotating spring lever 197 a user can unlock the footpad assemblies and manually move each to a new position as desired. In this way, footpads may be slidably inserted from either end of adjuster-plate 189 , as indicated by directional arrows, and adjusted to any desired spacing related to center distance. When desired positions are attained, letting go of spring lever 197 locks the footpads in place on plate assembly 189 . In one embodiment, a safety lock is provided to give added assurance that the footpad assemblies will stay in position during operation. Channel 194 on the opposite side is adapted to house non-toothed edges of the aforementioned toothed base-plates. [0174] FIG. 13A is a plan view of a toothed base-plate 199 according to an embodiment of the present invention, and FIG. 13B is a side view of the base plate of FIG. 13A . As previously described, footpads 79 of FIG. 12 each have a toothed base-plate 199 installed on the bottom surfaces of associated footpad assemblies 79 ( FIG. 12 ). Each base-plate 199 has a row of equally spaced teeth 205 presented along one edge for the purpose of engaging slots 192 of FIG. 12 in cam 191 . In this embodiment, base-plate 199 has two spacer bars 201 and 203 adapted to space it from the underside of the outer frame member of a footpad assembly when mounted. [0175] Bars 201 and 203 are, in this example, formed of one piece with base-plate 199 , however, in other embodiments, they may be separate mounted structures. There are four threaded holes 207 (two for each spacer bar) provided through base-plate 199 and spacer bars 201 , and 203 for mounting purposes. Machine screws or the like may be used for mounting plate 199 to the outer frame member of each footpad assembly. As seen in FIG. 13B , bolt holes 207 are chamfered on the side making contact with carriage assembly 33 such that they lay flat and may slide without scratching or marring the surface. [0176] FIG. 13C is an end-view of the slotted cam-rod 191 of FIG. 12 in this embodiment. Cam-rod 191 has a slotted portion 192 as previously described, a radiused back-grind 209 , and a flat portion 207 . As slots 192 are rotated in the direction of the arrow, engaging teeth 205 on base-plate 199 of FIG. 13A are released at the beginning point of back-grind 209 . As flat 207 rotates so as to face teeth 205 , a small amount of space is created between the top land portions of teeth 205 and the surface of flat 207 enabling footpad assemblies such as footpads 79 to be moved to a different position or removed altogether. [0177] It will be apparent to one with skill in the art that there may be more than one general configuration of slots and teeth than is illustrated here without departing from the spirit and scope of the present invention. For example, a base-plate such as plate 199 may be slotted while a cam-rod such as rod 191 is toothed. There may be more or fewer slots and teeth presented, and so on. In an alternate embodiment, footpad assemblies may be lowered in from the top with teeth and slots remaining in a rigid configuration on both sides of a base-plate and on opposite facing structures mounted to an adjuster-plate wide enough to support this type of fitting. Clamps could be used to secure the footpad assemblies after lowering them into place. [0178] In another embodiment of the present invention an alternative adjustment mechanism for footpads may be used comprising one or more spring-loaded pop-up detents. A first footpad assembly may be mounted to the plate assembly separately, allowing for individual adjustment, or with a second footpad as an assembly. A pop-up detent can be mounted on an edge of a footpad assembly in a position so that when a user manually pulls back and then releases a spring-loaded pin within the detent assembly, the pin slides in and out of a slot or hole on the face or edge of the plate assembly, the pin and slot or hole being in-line when the desired footpad position is attained. The plate assembly can have a plurality of such slots or holes arranged in equally spaced and collinear fashion. A spring-loaded detent assembly could comprise a cylindrically shaped casing open on the end facing the hole or slot and containing a pin that slides in and out in both directions. A protrusion or attachment to the pin serves as a handle enabling a user to manually pull the pin back within the casing. Within the casing and located behind the pin a spring of roughly the same diameter of the pin provides outward tension to the pin when a user manually pulls it back using the handle. When a user manually releases the pin in the mounted detent assembly the spring tension behind the pin pushes the pin into the aligned slot or hole and locks the footpad assembly into the desired position. Once locked into the desired position by the pin assembly, the footpad assembly may be otherwise mainly secured to the plate assembly by utilizing many different methods. By again pulling back the pin a user can unlock the footpad assembly and adjust to another position as desired. This manner of spring-loaded pin arrangement within the detent assembly provides for the locking pin to be always urged into the outer or locked position. In addition to the footpad adjustment functionality of the pop-up detent assembly, in various alternative embodiments the detent assembly may have more or less of an integral role of securing the footpad assembly to the plate assembly. [0179] It will be apparent to the skilled artisan that there are alternative arrangements and mechanisms that might be used to allow the footpads to be spaced and secured with the new spacing. The mechanisms described above are but a few of the possibilities. There are many others. For example, an intermediate plate assembly could be provided wherein there are two plates with one telescoping into the other, and having a locking apparatus to fix the relative positions when the desired separation is achieved. In this embodiment one footpad would be mounted to one of the telescoping plates and the other footpad to the other. [0180] FIG. 14 is a cross-sectional view of a semi-arcuate rail 217 with a main wheel 213 , and a keeper wheel 215 in position according to an alternate embodiment of the present invention. As previously described in FIG. 1 above, semi-arcuate rails, shown round in FIG. 1 and other FIGS. in embodiments described above, may also be extruded to provide opposite channels for wheels, and then die-formed to obtain a desired semi-arcuate shape. This embodiment is especially useful for applications having footpads or platforms of exceptionally large dimensional features (length and width) than standard assemblies. Keeper-wheels such as wheels 215 and wheels 71 and 69 of FIG. 4 provided added restraint in order to prevent an assembly from tipping or otherwise being lifted from rails during operation. [0181] Rail 217 is shown welded in this illustration to frame member 31 , and in embodiments of the overall apparatus using such extruded rails, the rails would also be welded to end rails 27 as described previously for rails 22 . Wheels 213 and 215 are not shown as assembled to a wheeled carriage in this illustration, but would in practice be mounted to such carriages in much the same manner as already described for wheels used with round rails. [0182] FIG. 15 is a cross-section view through a rail 219 in yet another embodiment of the invention, showing a wheel assembly 221 having a shaft 223 , with the wheel engaged in rail 219 . In this embodiment rails 219 replace rails 22 or 217 shown in other embodiments, and are formed in an arc or an arc with straight-leg portions as taught elsewhere in this disclosure. Rails 219 may be extruded from suitable material, or may be formed by bending a plate and then forming the necessary arc using a die or other suitable tool. In preferred embodiments rails 219 are welded to structure 31 as shown, and also to end rails 27 (not shown). [0183] In this embodiment Wheels 221 are mounted to a wheeled carriage by shafts 223 in various positions to support the carriage in its to-and-fro movements on (in) rails 219 . Some wheels are mounted to contact the upper portion of rails 219 as shown in FIG. 15 , and others are mounted to contact the lower portion of rails 219 , thus accomplishing the functions of the wheeled carriage taught with reference to FIG. 4 having keeper wheels. It will be apparent to the skilled artisan that there are a variety of positions wheels may be mounted to accomplish the purpose. [0184] FIG. 16 is an elevation view of a ski-exercising apparatus 301 according to an embodiment of the invention illustrating an optional third power band. Apparatus 301 is provided having elements similar to those of exercisers previously described herein except for novel improvements described below. For this reason only the improvements are described. To better illustrate elements within, additional roller-mount openings similar to those of tensioning structure 25 of FIG. 1A are not shown but may be assumed to be present, and cut-away views are shown of the wheeled carriage and support member. [0185] Apparatus 301 provides a third power band 302 assembled between the first, or outer, power band and the second, or inner, power band. In this embodiment the free ends of third power band 302 are illustrated as fastened at clamp 306 , having one end clamped between the free ends of the outer band and the other end in between the ends of the outer and inner bands. It will be apparent that the clamping locations of power bands and positions of clamped free ends may vary. A tensioning structure 303 is provided, illustrated as a modification to a tensioning structure such as that of FIG. 1A , having a longer length and properties to support a third power band and hardware. Tensioning structure 303 is welded in this embodiment to the bottom surface of the central frame structure similarly to embodiments previously described. Rollers 304 and 305 are rotatably mounted to the outer positions of tensioning structure 303 providing support to third power band 302 , third power band 302 extending from clamp 306 passing under the inner rollers mounted between rollers 304 and 305 and passing under and over rollers 304 and 305 back toward center, over a third roller rotatably mounted under the wheeled carriage and fastened with the outer power band to the underside of the wheeled carriage by clamps 307 and 308 . [0000] Improvements [0186] FIG. 17 is an elevation view of a ski-exercise apparatus 401 illustrating adjustable tensioning structures for an optional third power band according to an embodiment of the present invention. Apparatus 401 in this embodiment provides many of the features and elements of apparatus previously described herein except for new and novel improvements described in detail below, therefore, only the improvements are described. [0187] Apparatus 401 provides a third power band 302 assembled between the first, or outer power band, and the second, or inner power band, as described previously for apparatus 301 of FIG. 16 . However, apparatus 401 provides a pair of improved tensioning structures for the optional third power band. [0188] Tensioning structure 405 is illustrated as a modification to a tensioning structure such as structure 303 of FIG. 16 , and is provided as a separate structure which, in the embodiment illustrated is affixed at each end to the bottom surface of the central frame structure 404 in similar locations to embodiments described in previous embodiments, utilizing a common fastener such as a bolt and nut. In alternative embodiments, tensioning structures 405 may be welded directly to central frame structure 404 . Tensioning structure 405 is somewhat longer in length and has a lower profile than that of structure 303 of FIG. 16 . Tensioning structure 405 , in a preferred embodiment, is manufactured of strong, lightweight aluminum material, and may be die cast, machined, or otherwise formed utilizing similar strong, lightweight material in alternative embodiments. [0189] Tensioning structure 405 differs significantly, however, from that of FIG. 16 in that a second tension roller 409 is provided to increase smoothness of operation of the ski apparatus under extreme tensioning as the wheeled carriage travels from side to side on the parallel rails during operation. As shown in the illustration, the optional third power band 302 is assembled between the first, or outer power band, and the second, or inner power band, the ends clamped at the bottom of the central frame structure 404 , and the upper portion of the power band clamped at two locations under the wheeled carriage, similarly to apparatus 301 of FIG. 16 . [0190] The routing of power band 302 differs, however, from that of apparatus 301 of FIG. 16 in that it passes under the second tension roller 409 , and then over and under the main roller 407 and then back towards the center of the central frame structure where it is clamped along with the ends of the first, outer power band and second, inner power band. [0191] A plurality of through openings 411 are provided for tensioning structure 405 enabling the resistance point to be altered, thereby enabling the user to adjust the amount of tension encountered by the wheeled carriage when it travels to the outermost lateral positions. A total of three through openings 411 are provided in the embodiment illustrated, located near the upper edge of the body of structure 405 starting near the center and linearly arranged towards the outer edge of the structure. However, in alternative embodiments number and exact location of through openings 411 may differ to provide a varying range of tension adjustment positions. [0192] FIG. 18A is an elevation view of adjustable tensioning structure 405 of FIG. 17 , and a roller axle. The support structure of tensioning structure 405 is provided by bracket 425 which is u-shaped, comprising a base 426 and a pair of walls 427 extending upward from base 426 on either side. Through openings 420 extend through base 426 for the purpose of fastening tensioning structure 405 to the bottom of the central frame structure of the ski apparatus. [0193] Structure 405 utilizes an improved roller axle 413 for rotatably securing roller 407 to the structure through one of the sets of through openings 411 . Through openings 412 are provided at the opposite end of bracket 425 for rotatably securing tension roller 409 utilizing a standard clevis pin fastener 421 . [0194] A plate 417 is provided for adding stability and preventing flexing of walls 427 of tensioning structure 405 . Another function is to prevent the third band from interfering with the second band. Plate 417 is rectangular in shape and substantially flat, and has a plurality of through openings located near each of the corners for accommodating screw fasteners (not shown), securing plate 417 is adapted to fasten down to the upper surface of each wall 427 , utilizing holes 419 which extend down into walls 427 for accommodating the screw fasteners, and once fastened, bridges the gap between the inner surfaces of each wall 427 . [0195] Tensioning structure 405 is adapted to mount to the bottom of the central base structure of ski apparatus previously described in the present application and in related patents and applications referenced herein, using standard fasteners inserted through openings 420 , which extend through the thickness of base 426 , and a slight modification to the existing bottom central base structure of existing ski apparatus by adding mounting holes for such fasteners, or in other embodiments, tensioning structure may be fixedly attached by welding structure 405 to the central base structure of existing ski apparatus, for example. [0196] FIG. 18B is an elevation end view of tensioning structure 405 and roller axle 413 of FIG. 18A and a roller axle nut. In this view, walls 427 are shown extending up from either end of base 426 forming the U-shape of the overall structure of the bracket, and conical roller 407 is located in its mounting position between the inner surfaces of each wall 427 . Roller 407 is rotatably secured to walls 427 by inserting roller axle 413 through a first opening 411 of wall 427 , completely through passage 423 extending through the center of roller 407 , and is then secured with roller axle nut 414 . Roller axle 413 and roller axle nut 414 each have a collar, collar 416 and 423 respectively, each of which has a diameter somewhat less than that of through openings 411 of walls 427 , such that a snug fit is achieved when roller axle 413 and roller axle nut 414 are inserted into walls 427 . [0197] Roller axle 413 has an internally-threaded end portion 422 on the opposite end of roller axle 413 from collar 416 , matching and externally-threaded end portion 424 of roller axle nut 414 , for enabling roller axle nut 414 to be securely affixed to the threaded end of roller axle 413 . Roller axle 413 is of such a length that when fully inserted through the first opening 411 in wall 427 , the far edge of threaded portion 422 extends only to the edge of roller 407 , stopping just short of the inner surface of the opposing wall 427 through which roller axle nut 414 is inserted, such that roller axle 413 and roller axle nut 414 may be securely tightened together when attaching roller 407 to walls 427 , and still allow for free rotation of roller 407 around shaft portion 418 of roller axle 413 . In some embodiments a clevis pin with an R-clip is used instead. [0198] When securely tightened together through openings 411 of walls 427 and through roller 407 as described above, the roller axle assembly additionally becomes a stabilizing cross member adding strength to the overall structure at one end of structure 405 , and adds significantly to the overall structural integrity also enhanced by cross member plate 417 at the opposite end of the structure. [0199] A pair of slots 428 extend up into the bottom of each wall 427 of tensioning structure 405 at each edge of base 426 and extend along the entire length of structure 405 , and are adapted to fit snugly over the upwardly extending portions of power band guide 24 of ski apparatus 9 , for example, of FIG. 1B and FIG. 2 . Power band guides 24 , as is more clearly seen in FIG. 1B , has sides on either end that extend upward from the base of the frame structure. Slots 428 of tensioning structure 405 extend up into walls 427 to a distance somewhat greater than the height of the overly extending sides of power band guide 24 , thereby allowing the bottom surface of base 426 to securely rest upon the upper surface of the bottom of power band guide 24 , and enabling for a more secure attachment of tensioning structure 405 to the bottom central frame structure of the ski apparatus. In alternative embodiments of the present invention, slots 428 of tensioning structure 405 may also enable the user to slide structure 405 in its aligned position along band guides 24 , for example, and relocate structure 405 towards the center of the frame structure of the ski apparatus, or outward, in various predetermined attachment locations, thereby enabling still further adjustability of the location of the additional tension point provided by tensioning structure 405 in embodiments herein described. [0200] FIG. 19 is an elevation view of the frame structure of ski-exercising apparatus 401 of FIG. 17 . Frame structure 404 is provided in this embodiment having generally similar frame architecture to frame structure of ski apparatus described in the present application and in related U.S. patents and applications referenced herein except for novel differences relating to the parallel rails described below. For clarity, only the frame structure is described in this embodiment, as additional elements, such as power bands, and wheeled carriage assembly and related hardware have been adequately described herein in the preceding specification, and are removed in the present illustration. [0201] Frame structure 404 comprises a set of semi-arcuate rails 415 , only one of which is visible as this is an elevation view, which are held parallel to each other and affixed to transverse members at either end of frame structure 404 , generally similar to previous embodiments, along which a wheeled carriage assembly, such as carriage assembly 33 of FIG. 4 , travels during normal operation of the ski exercising apparatus, as described herein for other embodiments. Rails 415 , however, have several notable differences when compared to rail sets utilized in ski apparatus of previous embodiments described thus far. [0202] Rails 415 extend at an angle upward beginning at either end of frame structure 404 , towards the center, and are held parallel to each other and affixed at either end of each rail to a pair of transverse end-members, the center portion supported by support members 440 , similarly to that for previous ski apparatus embodiments. As this is an elevation view, only one of the pair of rails is seen. One notable difference between semi-arcuate rails 415 and those disclosed in the present and related patents is that rails 415 are arced in their center portions 447 , as illustrated by a dimensional notation F, and the arcuate portion of rails 415 is substantially shorter than that of previous embodiments. The dimension lines associated with arcuate portion 447 mark the locations where the arced portion of each rail 415 ends at positions sharing an equal distance from a theoretical vertical center of rails 415 . [0203] The total dimension F in a preferred embodiment is substantially less than the approximately 26 inches defined by dimension (E) of frame structure 11 of FIG. 1A of the present application, for example. [0204] Non-arcuate portions of rails 415 are witnessed by element numbers 443 and 445 on the left and right side of frame structure 404 as seen in this view. Non-arcuate rail portions 443 and 445 are substantially straight from their junctures with arcuate portion 447 . The lengths (taken horizontally) for rail portions 443 and 445 are substantially longer than the approximately 15 inches respectively, of rails portions in previous embodiments, such as non-arcuate portions 19 and 21 of frame structure 11 of FIG. 1A , for example. It must be noted that the dimensions cited above are intended to be approximate only, and may vary somewhat in alternative embodiments. The approximate overall length of frame structure 404 is about 61 inches, similar in length to frame structure 11 of FIG. 1A . [0205] Another notable difference between rails 415 and those of previous embodiments, such as those of frame structure 11 of FIG. 1A , is that non-arcuate portions 443 and 445 of rails 415 each extend upward from the transverse members at the outward ends of frame structure 404 , at a steeper angle towards the center compared to previously described embodiments, and the arcuate portion, which is substantially shorter than those of previous embodiments, has a maximum height at the center which is measured substantially higher, approximately three inches in this example, than the maximum arcuate portion height of rails 19 of FIG. 1A , for instance. [0206] The steeper angle and longer length of non-arcuate portions 443 and 445 of rails 415 , and the shorter length and increased height of arcuate portion 447 provides for a faster descent of a wheeled carriage assembly traveling from side-to-side along rails 415 , thereby enabling a stronger more abrupt stop at the end of each lateral stroke, particularly when an optional third power band, as shown for ski exercise apparatus 401 of FIG. 17 , is utilized. The inventor has discovered that operating a ski exercise machine utilizing rails having such an increased angle and height more closely simulates the increased lateral dynamic forces actually encountered during extreme downhill skiing, and other sports requiring explosive power in lateral movements, and therefore provides exercise for a participant in such activity, having maximum benefit to the user of such an exercise machine. [0207] Such specific high-intensity training for the enhancement of explosive power is often termed plyometric training in the art, and it is to exercise apparatus improvements in this field of exercising that many of the embodiments described presently and subsequently in the specification are related. The plyometric training method utilizing exercise apparatus elements in embodiments of the present invention is to be used in conjunction with other power development methods in a complete training program to improve the relationship between maximum strength and explosive power. Emphasis in such a training method is placed on generating the highest possible force in the shortest period of time, and reducing or stopping this force at the end of the action. Plyometric training has a primary role in training as well as rehabilitation programs, and, as will be further detail below, apparatus and methods of the present invention provide improvements to the current art relating to exercise apparatus and other hardware providing such training capability. [0208] It is known in the art that plyometric training may be applied in various exercises which specifically target certain areas of the body for muscle strengthening or rehabilitation. The specific areas of the body often include those other than areas of the legs or hips, for example. In these cases it is desirable to be able to quickly and easily interchange exercise attachments utilizing a single exercise apparatus, and be able to utilize a single exercise apparatus, such as that described herein having a tensioned lateral movement primarily designed for ski exercising, for providing such varied exercises targeting different specific areas of the body. [0209] FIG. 20A is a plan view of an adjustable slide plate according to an embodiment of the present invention. Slide plate 451 is provided for enabling the user to quickly and easily interchange exercise attachments utilizing a ski exercise apparatus and wheeled carriage assembly of the present invention. Slide plate 451 is adapted for mounting to a wheeled carriage assembly, such as carriage assembly 33 of FIG. 4 , and allowing exercise attachments to be adjustably mounted to plate 451 , easily repositioned at different locations along slide plate 451 , and quickly remove for interchanging with other additional exercise attachments, and further is provided with additional safety features not disclosed in previous embodiments, such as plate assembly 189 of FIG. 12 . [0210] Slide plate 451 is preferably manufactured of strong, lightweight aluminum material, or other suitable material having similar properties providing the best combination of strength, rigidity, and light weight, and has an elongated, rectangular shape having a length substantially greater than the width, the length being such that a pair of footpad assemblies may be mounted at s the desired width stance in accordance with that used typically for downhill skiing, for example or for other sports and exercise motions, as will be further detail below in other embodiments of the present invention. [0211] Slide plate 451 is adapted for mounting to the upper surface of a wheeled carriage assembly, such as carriage assembly 33 of FIG. 4 , in a location centered on the carriage assembly. A pair of through openings 457 are provided in the center of plate 451 for slide plate 451 to the upper platform of the wheeled carriage, and are spaced apart from each other at a distance equal to the spacing between the pair of mounting holes for carriage 33 of FIG. 2 , fastened by the pair of nuts 53 . [0212] Slide plate 451 in the present embodiment described, however, improves significantly over upper mounting platform 89 of carriage 33 of FIG. 2 , for example, in that slide plate 451 allows a pair of footpad assemblies, or other exercise attachments, to be independently and adjustably mounted to the carriage assembly such that various width stance positions can be utilized, and each independently mounted attachment assembly may be quickly repositioned along plate 451 and then re-secured in the new position. [0213] Slide plate 451 has a center through opening 458 for allowing access to the center fastener used as previously described for mounting the power band roller bracket 61 to the underside of carriage 33 of FIG. as shown for FIG. 4 . A plurality of holes 455 extending partially down into the upper surface of plate 451 , are arranged linearly along the length and on either side of the center of plate 451 , and each hole 455 is equally spaced from an adjacent hole 455 on either the left or right side of through holes 457 . Holes 455 represent the locations for a wide choice of width stance positions for mounting a pair of footpad assemblies, as will be described further below in enabling detail. [0214] Slide plate 451 , has on each side extending along the length, a rounded edge 453 , the rounded portion extending somewhat upward from the upper flat surface of slide plate 451 . The rounded shape of edges 453 is better illustrated in FIG. 20B . Edges 453 provide a guide rail on each longest side of plate 451 , and have the purpose of locating and guiding an attachment plate for mounting a footpad assembly, or other exercise attachment assembly, as will be shown in further embodiments presented below. [0215] Plate 451 also has a push-pin safety button 452 located near each end, provided as an additional safety feature in the embodiment presented. Safety buttons 452 , are standard spring-tensioned push-pins which, in their normal relaxed position, extend upwardly from the surface of plate 451 by the spring tension. Safety buttons 452 may be manually depressed into a cavity which extends down into the surface, such that the upper surface of the pin portion of safety pin 452 is at least flush with the surface of plate 451 . The safety function of these pins is to retain any carriage unit engaged to the slide plate from moving off the ends of the plate after assembly, unless the pin is intentionally depressed. This function is described and illustrated additionally in description below. [0216] Plate 451 has a groove channel 459 extending along the entire length of plate 451 in a center location. Channel 459 comprises a slot opening 461 which opens into an internal passage 466 (hidden view) beneath the surface of plate 451 . The internal space formed by passage 466 is substantially wider than slot opening 461 , and has the purpose of allowing a special nut fastener, fastened to a standard bolt fastener, to slide freely within passage 466 along the entire length of plate 451 , enabling adjustability in mounting positions for attaching a sliding attachment plate. [0217] FIG. 20B is a section view of plate 451 of FIG. 20A taken along section line 20 B- 20 B. The inventor provides FIG. 20B to better illustrate several of the elements described above for FIG. 20A , as well as additional elements not shown in FIG. 20A . Plate 451 has a rectangular central structure 464 , which protrudes down from the bottom surface of plate 451 , and extends along the entire length of plate 451 . Structure 464 encompasses internal passage 466 , and additionally provides added strength and rigidity to the overall structure of plate 451 . Plate 451 also has a pair of L-shaped side structures 462 extending down from the bottom of plate 451 to a distance equal to that of structure 464 , and located approximately midway between edges 453 and central structure 464 , on either side of structure 464 . Structures 462 also extend the entire length of plate 451 , adding still further to the overall structural rigidity of plate 451 , and accommodate push-pin safety buttons 452 . [0218] Structures 462 each have a substantially flat and level bottom surface 454 , and central structure 464 has a bottom flat surface 456 , which is flush with bottom surfaces 454 of structures 462 . Bottom surfaces 456 and 454 form the base surface which contacts the upper surface of a wheeled carriage assembly to which plate 451 is mounted according to an embodiment of the present invention, detailed further below. Through openings 457 are shown extending completely through side structures 462 and width stance adjustment holes 455 are shown extending partially down into plate 451 from the surface. Through opening 458 is shown extending down from the bottom of passage 466 , providing an opening through flat bottom surface 456 of structure 464 . [0219] The rounded shape of guide rail edges 453 on each side of plate 451 , and the substantially flat upper surface are readily apparent in this view. Safety buttons 452 are shown in their relaxed positions, extending upwardly from the surface of plate 451 . As described above, safety buttons 452 may be manually depressed down into cavities (not shown) within structures 462 adapted for the purpose. [0220] Slot opening 461 is shown extending down into the surface of plate 451 , opening into internal passage 466 , the internal rectangular space formed by passage 466 having a width substantially greater than that of slot opening 461 . [0221] FIG. 21A is a top view of a sliding attachment plate according to an embodiment of the present invention. Attachment plate 460 is provided in a preferred embodiment of the present invention as an interface for adjustably mounting various independent exercise attachments, such as a suspended footpad assembly as described above, to the wheeled carriage assembly of a ski exercise apparatus. Attachment plate 460 is provided to enable the user to quickly and easily attach, reposition or remove such exercise attachments to plate 451 , which attaches to a wheeled carriage assembly. [0222] Plate 460 is manufactured similarly to slide plate 451 , utilizing strong, lightweight material such as aluminum, or some other material having similar properties. Plate 460 is substantially rectangular in shape, substantially flat, and has a pair of edge channels 469 , one on each side of plate 460 , extending along the entire length of plate 460 . Edge channels 469 are rounded on the outside surface, extending somewhat down from the bottom surface of plate 460 , and are adapted to closely fit over the rounded edges 453 of slide plate 451 . Each edge channel 469 has a rounded inner surface, whose dimensions closely equal the outer dimensions of edges 453 of plate 451 . [0223] Attachment plate 460 is adapted for sliding over an end of slide plate 451 , and, guided by rounded edge channels 469 encompassing rounded edges 453 of plate 451 , is enabled to freely slide back and forth along the length of plate 451 . Plate 460 has a plurality of mounting holes 465 , arranged on either side from the center of plate 460 , which are provided for attaching such as an independent suspended footpad assembly, or some other attachment, to upper surface of plate 460 utilizing standard bolt or screw fasteners. Mounting holes 465 are spaced apart on either side of the center of plate 460 , at a distance defined by dimension (S). [0224] Plate 467 is also provided with through opening 467 located in the center, and passing completely through the thickness of plate 460 . Through opening 467 has the purpose of enabling insertion of a bolt fastener through plate 460 , for attaching plate 462 slide plate 451 , utilizing a special nut, as will be detailed further below. [0225] A pair of pull-pins 463 are provided for the embodiment shown, one pull-pin 463 located on either side of the center of plate 460 , near one end. Pull-pins 463 are standard, spring-tensioned devices which are provided for locating attachment plate 460 in the exact desired position on slide plate 451 , according to the various positions of width stance adjustment holes 455 of plate 451 . Pull-pins 463 , each have a pin portion (not shown) which extends below the bottom surface of plate 460 , adapted to fit securely into locator holes 455 of plate 451 . Spring tensioning of each pull-pin 463 urges the pin portion into the extended position, and by manually raising pull-pins 463 from above, the pin portions may be retracted up into the body of attachment plate 460 . [0226] FIG. 21B is a section view of attachment plate 460 of FIG. 21A taken along section line 21 B- 21 B. In this view, the rounded out and inner surfaces of edge channels 469 are clearly visible, the inner rounded surface of each edge substantially equaling the dimensions of the outer rounded surface of edges 453 of plate 451 . Through opening 467 is shown passing completely through the thickness of plate 460 , and mounting holes 465 are shown extending through plate 460 . Mounting holes 465 in this embodiment are threaded holes for which standard bolt fasteners may be threaded for attaching such as an independent footpad assembly. In alternative embodiments however, mounting holes 465 may or may not be threaded, depending on whether or not only a threaded bolt, or bolt and nut combination is utilized for mounting the attachment to attachment plate 460 . [0227] Pull-pins 463 , located on either side of the center through opening 467 , are clearly shown in this view mounted to the upper surface of plate 460 , each pull-pin 463 having a pin portion 468 which, in the relaxed position, are urged downward by spring tensioning, extending to a distance somewhat below the bottom surface of plate 460 . Pull-pins 463 are provided with handle grasps 464 enabling the user to easily grasp the pull-pins and raise the mechanism such that the bottom of each pin portion 468 may be elevated above the bottom surface of plate 460 . [0228] A clearance channel is designed into plate 460 , located directly below each row of width stance adjustment holes 465 , providing clearance for the lower end of a bolt fastener, and possibly a nut fastener if so incorporated, when an attachment such as a footpad assembly is secured to the upper surface of plate 460 . In such a manner, plate 460 , with pull-pins 463 raised, may freely slide along the length of slide plate 451 of FIGS. 20 A,B while the footpad assembly is secured to plate 460 . [0229] FIG. 22 is a top view of slide plate 451 of FIG. 20A and a pair of sliding attachment plates 460 A and B of FIG. 21A according to an embodiment of the present invention. The manner in which attachment plates 460 A and B are adjustably mounted to slide plate 451 is illustrated in this view. For the purpose of clarity, attachment plates 460 A and B are shown not to have an exercise attachment, such as a suspended footpad assembly affixed thereto. [0230] As mentioned above, plates 460 A and B are adapted to slide over the ends of slide plate 451 , guided by rounded edges 453 of plate 451 which are encompassed by the rounded edge channels of each plate 460 . In attaching attachment plate 460 A to slide plate 451 , first the user manually raises both pull-pins 463 at the same time, allowing plate 460 A to slide over the end of plate 451 . Next, the user releases pull-pins 463 into the relaxed, extended position, and then depresses push-pin safety button 452 , such that clearance is provided for sliding attachment plate 460 A further onto plate 451 towards the center. Although pull-pins 463 of attachment plate 460 A are naturally extended due to the spring tensioning, plate 460 A still freely slides along plate 451 until the lower pin portions of pull-pins 463 encounter one set of width stance adjustment holes 455 . [0231] Attachment plate 460 B is shown in this view after sliding it over the left end of plate 451 , located in a desired stance position, in this case, the sixth position to the left of center. Once attachment plate 460 B slides over the end of plate 451 towards the center, the user may hold pull-pins 463 in the raised position while sliding plate 460 B, until pull-pins 463 align directly above the desired set of adjustment holes 455 , at which time the user releases pull-pins 463 , which urges the lower pin portion of the pull-pins down into adjustment holes 455 . Repositioning attachment plate 460 simply involves manually raising pull-pins 463 , sliding plate 462 new desired position, aligning pull-pins 463 with the new set of adjustment holes 455 at the new location, and then releasing pull-pins 463 , thereby locking plate 460 into the new position. [0232] FIG. 23 is an elevation view of a suspended footpad assembly 470 and a sliding attachment plate 460 of FIG. 21A . Suspended footpad assembly 470 is similar to suspended footpad assemblies previously described herein, such as footpad 79 of FIG. 12 , and in related U.S. patents and applications, comprising a footpad support structure 473 , a pivoting footpad 476 which has support wings 475 extending upward from footpad 476 on either side, suspended within support structure 473 by a pair of pivot points 474 a set of four through holes 471 (only two of which are shown in this elevation view) pass through the base of support structure 473 , and are aligned with a set of four mounting holes 465 of attachment plate 460 . Footpad assembly 470 is lowered down onto the upper surface of attachment plate 460 , holes 471 of support structure 473 aligned with holes 465 of plate 460 , and footpad assembly 470 is then affixed to plate 460 utilizing standard screw fasteners 479 . [0233] Although a suspended footpad assembly is shown in the illustration for attaching to attachment plate 460 , a variety of attachments other than a suspended footpad assembly as shown, such as are described further in detail, may be attached to attachment plate 460 , according to alternative embodiments of the present invention, thereby providing the user the ability to perform exercises on a ski apparatus such as has been described, in training for sports other than downhill skiing, and for strengthening and rehabilitation exercises as well, without departing from the scope and spirit of the present invention. [0234] FIG. 24 is an elevation view of footpad assembly 470 and attachment plate 460 of FIG. 23 and slide plate 451 of FIG. 20A attached to a wheeled carriage assembly according to an embodiment of the present invention. For simplicity, not all of the elements previously described are shown in this view, only those elements pertinent to the present description. [0235] As shown in the illustration, slide plate 451 is attached to carriage assembly 484 utilizing bolt fasteners 486 , which are inserted up through openings in the upper surface of carriage assembly 484 , and are then secured by nut fasteners 487 . The manner in which slide plate 451 attaches to carriage 484 is not limiting, however, in describing embodiments of the present invention. For example, bolt fasteners 486 may be inserted down through the provided openings of slide plate 451 , and secured with a nut fastener from below the upper surface of carriage assembly 484 , or alternatively a type of fastener other than bolt fasteners 486 and nut fasteners 487 may be utilized in various embodiments. What is important, however, is that whichever type of fastener is used, the nut fastener or head of a bolt fastener must not project substantially above the upper surface of slide plate 451 , so as not to interfere with the sliding of attachment plate 460 . [0236] Suspended footpad assembly 470 is affixed to attachment plate 460 utilizing screw fasteners 479 , thereby forming a footpad/plate assembly 472 . Assembly 472 is adjustably mounted to plate 451 according to an embodiment of the present invention, with edge channels 469 of attachment plate 460 neatly encompassing the rounded outer edges 453 of plate 451 , guiding attachment plate 460 as it slides along the length of plate 451 . Once assembly 472 is positioned on slide plate 451 at the desired width stance location according to location adjustment holes 455 of plate 451 , pull-pins 463 (not shown) are released, urging the lower pin portions into the adjustment holes 455 of plate 451 , thereby locking assembly 472 into the desired position on plate 451 . [0237] Assembly 472 is fixedly attached to slide plate 451 utilizing bolt fastener 480 , which is inserted down through center hole 467 of attachment plate 460 , before assembly 472 is mounted to plate 451 . In practice of mounting footpad/plate assembly 472 to plate 451 , suspended footpad assembly 470 is pre-attached to attachment plate 460 utilizing screw fasteners 479 , as described above. Bolt fastener 480 is then inserted down through center opening 477 of the base of footpad support structure 473 , through center opening 467 of attachment plate 460 , and a special nut fastener 482 is then partially threaded onto the threaded portion of bolt fastener 480 . Footpad/plate assembly 472 , with bolt fastener 480 extending below the bottom surface of attachment plate 460 , then slides onto the end of slide plate 45 1 , as described above, such that the threaded portion of bolt fastener 480 passes along in between slot opening 461 of plate 451 , and the attached nut fastener 482 slides along the rectangular passage 466 within the center structure 464 of plate 451 . Once assembly 472 has been positioned as desired, and pull-pins 463 have released down into the proper set of adjustment holes 455 of plate 451 , locking assembly 472 into position on plate 451 , bolt fastener 480 may then be tightened from above the base of support structure 473 of suspended footpad assembly 470 , thereby securing assembly 472 to plate 451 . Nut fastener 482 , in the embodiment shown, is square in shape and substantially flat, and is prevented from rotating within passage 466 while bolt fastener 480 is tightened, due to the width dimensions of nut fastener 482 being just somewhat less than the width of passage 466 . [0238] FIG. 25A is a top view of slide plate 451 and attachment plate 460 to of FIG. 22 , a pair of suspended footpad assemblies of FIG. 24 attached to a wheeled carriage assembly according to an embodiment of the present invention. In this view a pair of independent footpad/plate assemblies 472 , each comprising a suspended footpad assembly 470 attached to attachment plate 460 , are mounted to plate 451 , each assembly 472 located at the desired width stance position by aligning pull-pins 463 over the desired set of adjustment holes 455 of plate 451 . In the example shown, each assembly 472 is first slid over each end of plate 451 after manually depressing each push-pin safety button 452 , and is then slid towards a center of plate 451 and located at the third position outward from the center of slide plate 451 . Once pull-pins 463 are centered over the desired set of adjustment holes 455 , pull-pins 463 are released, thereby urging the lower pin portions down into their respective adjustment holes 455 , securing each footpad assembly in its location. Each assembly 472 is then secured to plate 451 using the bolt fastener 480 and nut fastener 482 , combination (not shown) as described above for FIG. 24 . [0239] Slide plate 451 is shown in this view mounted to the upper surface of wheeled carriage assembly 484 as described for FIG. 24 , utilizing bolt fasteners 486 and nut fasteners 482 (not shown). In a preferred embodiment of the present invention, width stance adjustment holes 455 of plate 451 , which correspond to the various different width stance locations, are sequentially numbered, or otherwise similarly marked, outward from the center on the upper surface of plate 451 , such that the width stance position of the pair of footpad/plate assemblies may always be centered on plate 451 , regardless of the width stance chosen. For example, in the illustration given, footpad/plate assembly 472 A his located at the third width stance position to the left from the center position of plate 451 , and assembly 472 B is located at the third position to the right of the center position of plate 451 . For proper centering and balance each assembly 472 is located at the same numbered or marked position outward from the center. For instance, for a wider width stance position, assembly 472 A may be positioned at the sixth set of adjustment holes 455 to the left of the center of plate 451 , as shown in FIG. 22 , and assembly 472 B would then be located at the six set of adjustment holes 455 to the right of the center of plate 451 . The distance from the first footpad assembly from the center of plate 451 should always be equal to the distance between the second footpad assembly from the center of plate 451 , for proper centering and balance. [0240] If, for any reason, attachment bolt fastener 480 securing assemblies 472 to plate 451 loosens inadvertently, or the pull-pins somehow dislodge, during operation, push-pin safety buttons 452 , always protruding upward from the upper surface of plate 451 in their normally relaxed position, will stop assemblies 472 from sliding of the end of plate 451 , thereby providing an additional safety feature for the user if such an instance occurs. [0241] FIG. 25B is an elevation view of slide plate 451 , attachment plates 460 , suspended footpad assemblies 470 and wheeled carriage assembly 484 of FIG. 25A . Again, for simplicity, many elements previously described herein are not shown in this view, such as fasteners, elements of carriage assembly 484 , and so on. Only elements pertinent to the present description are illustrated and described here. Both footpad/plate assemblies 472 , each comprising a suspended footpad assembly 470 attach to an attachment plate 460 per shown mounted to plate 451 according to an embodiment of the present invention, each assembly 472 located at the third position outward from the center of plate 451 . Pull-pins 463 of plates 460 are shown in the relaxed extended position, the lower pin portions of each extending down into the respective adjustment holes 455 of plate 451 . Assemblies 472 may be easily and quickly repositioned inward or outward along the length of plate 451 simply by loosening bolt fastener 480 (not shown) which fixedly attaches each assembly 472 to plate 451 , raising pull-pins 463 such that the lower pin portions are elevated above adjustment holes 455 of plate 451 , and sliding assemblies 472 along plate 451 to the new positions, with pull-pins 463 and the desired set of adjustment holes 455 aligned with each other at the new positions, at which time pull-pins 463 will naturally extend down into the new adjustment holes 455 as described above. [0242] Push-pin safety buttons 452 are shown at each far end of plate 451 , in their relaxed extended positions, which prevent assemblies 472 from sliding of the ends of 451 . Safety buttons 452 may be depressed to allow assemblies 472 to slide of the end allowing the user to quickly and easily interchange various sliding attachment assemblies formed by attachment plate 460 and a suspended footpad assembly, such as assembly 470 , or other attachments for different exercises, as described previously. [0243] As described above for previous embodiments illustrated, attachment plate 460 is adapted for mounting footpad assemblies for ski exercises, as shown in previous illustrations, and may also be used for fixing other exercising attachment elements for providing a variety of different exercises possibilities to the user utilizing a ski apparatus as described herein and in related U.S. patent and applications referenced herein. [0000] Upper Body Conditioning [0244] The inventor of the present invention has discovered that the ski apparatus embodied in the present application and related patents and applications, may be effectively used for allowing advanced upper body conditioning (UBC) and core muscle and body strengthening exercises. The ski apparatus of the present invention, when used with special exercise attachments as are subsequently described, provides what is known in the art as neuromuscular training. It is for this area of exercising that the following new and novel attachments, used with the ski apparatus of the present invention as described herein, are provided. Such attachments, as will be described below in enabling detail, allow the exercise therapist or trainer to accomplish a number of exercises including shoulder strengthening and stabilization, as well as alternate core muscle conditioning, while allowing the therapist/trainer to spot control upper body movements. [0245] FIG. 26A is an elevation view of an upper body conditioner (UBC) elevated grip according to an embodiment of the present invention. UBC elevated grip 490 is provided as one part of a dual-handle attachment system allowing such exercises and strengthening/rehabilitation as described above, which can be adjusted quickly into several different width settings for providing different exercises specific to different areas of the body. [0246] UBC grip 490 in aid for embodiment comprises a hollow, lightweight tubular metal structure formed by tubing 493 , having a grip covering 498 formed of rubberized foam material or similar material providing a comfortable but secure grip to the user. UBC grip 490 as a straight portion on the upper end defined by dimension (G), which forms an upper grip portion which allows the user to grasp the attachment directly from above. Angled portions, defined by dimensions (H), extend downward from the ends of the upper grip portion G, which provide the user with an elevated gripping portion accessed from the side. Each angled portion H then curves downward and inward towards the center, and then angles perpendicular to the straight upper grip portion G, forming mounting extensions 495 , which are clearly illustrated in FIG. 26B . [0247] Mounting extensions 495 provide the mounting interface with which to mount UBC grip 490 to an attachment plate 460 , such as described previously. Each mounting extension 495 has a set of through openings 496 , each opening 496 passing completely through tubing 493 , for accommodating standard bolt fasteners. [0248] FIG. 26B is a top view of UBC elevated grip 490 of FIG. 26A . From this vantage point, mounting extensions 495 can now clearly be seen extending perpendicular to the direction of upper grip portions of dimensions (G) and (H). A pair of through openings 496 are shown extending through each mounting extension 495 . The distance between the center of each set of through openings 496 , defined by dimension (K), is equal to the distance between the center of each opposing set of mounting holes 465 of attachment plate 460 , defined by dimension (S), of FIG. 21B , such that the mounting holes 496 of mounting extensions 495 aligned with a set of mounting holes 465 of attachment plate 460 . [0249] FIG. 27A is a top view of a UBC lower grip according to an embodiment of the present invention. UBC lower grip 510 is formed of lightweight metal tubing 513 of similar composition and diameter of that of UBC elevated grip 490 of FIG. 26A , B., and also comprises a grip covering 517 covering a substantial portion of the length of grip 510 in two sections. A pair of through openings 515 are provided for mounting grip 510 to an attachment plate assembly for ultimately mounting to a wheeled carriage assembly of a ski apparatus as will be further described herein. Through openings 515 extend completely through both sides of tubing 513 , and have a center-to-center distance, defined by dimension (L), equal to that of dimension (K) of elevated grip 490 of FIG. 26B . A grip portion 519 , opposite of the mounting end, having a length substantially greater than the portion defined by dimension (K), provides a large gripping area enabling the user to fully grasp grip 510 by hand. [0250] FIG. 27B is an elevation view of UBC lower grip 510 of FIG. 27A . Lower grip 490 is provided as a second part of a dual-handle attachment system allowing such exercises and strengthening/rehabilitation as described above, the system being quickly and easily adjustable into several different width settings for providing different exercises specific to different areas of the body. In this view the lower grip portion 519 is shown having an angled portion extending downward from one end of the mounting portion, the angled grip portion defined by dimension (J). Lower grip portion 519 is angled such that the user is enabled for gripping from the side, at a lower level than back at which grip 510 is mounted, providing the user with varying grip positions for strengthening and rehabilitation of different parts of the body. [0251] Upper grip 490 and a lower grip 510 , when used with the ski apparatus and wheeled carriage and attachment mounting apparatus described herein, provide a new and unique dual-handle gripping system mountable to the wheeled carriage of the ski apparatus of the present invention, having the benefits of being quickly adjustable into many different width positions and quickly and easily interchangeable with, such as, ski footpad assemblies as described herein. The user is thereby enabled for achieving a number of advanced lateral-motion strengthening, stretching, stabilization and rehabilitation exercises not previously available for any lateral-motion ski apparatus of the prior art, as well as for minimizing the time and effort involved in changing the exercise function of the ski apparatus. [0252] FIG. 28A is a top view of UBC elevated grips 490 of FIG. 26A and UBC lower grips 510 of FIG. 27A , attachment plates 460 , slide plate 451 and wheeled carriage 484 of FIG. 25A , assembled according to an embodiment of the present invention. Slide plate 451 is affixed in the center position to the upper surface of roller carriage 484 utilizing standard bolt fasteners passed through openings 457 in the center, as described previously for FIGS. 25A , B. Also described in FIGS. 25A , B, suspended footpad assemblies are attached to the slide plates 460 forming a footpad/plate assembly 472 , and the assembly then slides over the ends of plate 451 towards the center for mounting on slide plate 451 at the desired position according to width stance adjustment holes 455 . [0253] However, in the embodiment presently illustrated the suspended footpad assemblies have been replaced with two upper body conditioning (UBC) grip assemblies each comprising one elevated grip 490 and one lower grip 510 , each set of grips mounted to a sliding attachment plate 460 , thereby forming UBC attachment assemblies 491 . UBC attachment assemblies 491 , as seen from the perspective given in this view, are formed by first placing elevated grip 490 atop an attachment plate 460 , aligning the four through openings of the mounting portions of grip 490 with four mounting openings of attachment plate 460 , the length of the upper grip portion of grip 490 perpendicular to the longer length of attachment plate 460 . A set of standard bolt fasteners 514 secure the portion of grip 490 towards the grip portion, securely to the upper surface of attachment plate 460 . [0254] Before securing the other end of the mounting portion of grip 490 , a lower UBC grip 510 is placed atop each end of the mounting portion of UBC grip 490 , the length of each lower grip 510 parallel to that of upper grips 491 , and its pair of mounting through openings 515 aligned with the end pair of through openings 496 of upper grip 490 , which align with mounting holes 465 of plate 460 . A pair of standard bolt fasteners 516 , significantly longer than bolt fasteners 514 , having sufficient length to pass completely through the thickness of both lower grip 510 and upper grip 490 , are then used to secure grips 510 over grips 490 and then to plate 460 . In a preferred embodiment, as is true for suspended footpad assemblies 472 of FIG. 25A , each attachment assembly 491 comprising an elevated grip 490 , lower grip 510 and sliding attachment plate 460 is pre-assembled, and therefore quickly and easily interchangeable on slide plate 451 with those of suspended footpad assemblies 472 of FIG. 25A , for example, or other attachment assemblies in alternative embodiments, and may also be quickly relocated to different positions on slide plate 451 as desired. [0255] FIG. 28B is an elevation view of slide plate 451 , attachment plates 460 , wheeled carriage 484 , UBC elevated grips 490 and UBC lower grips 510 of FIG. 28A . The inventor provides the elevation view to clearly illustrate the multiple gripping locations provided by the UBC system described herein, and the mounting configuration when attached to attachment plate 460 . Slide plate 451 is attached to carriage assembly 484 in a similar manner to that described herein for FIG. 24 above, and attachment plate 460 is shown as it fits over slide plate 451 , also similar to that previously described for FIG. 4 . [0256] Lower grip 510 is shown secured atop the mounting extensions of upper grip 490 secured with standard bolt fasteners 516 which are tightened into the mounting holes of attachment plate 460 . As can be seen in this view, a void is formed by the rectangular indention into the under surface of plate 460 , allowing bolt fasteners 516 to be tightly secured UBC assembly 491 is free to slide back and four along the length of slide plate 451 . [0257] The lower angled portion of lower UBC grip 510 provides the user with a gripping position from the side which positions the grip lower than the level of the upper surface of wheeled carriage 484 , for enabling such exercises which require the body of the user to be at a low angle to the floor. UBC upper grips 490 provide several additional gripping angles including at least two gripping positions at different angles on either angled side, and a straight upper portion spanning the angled ends providing a lengthy gripping portion from directly above. The variety of such upper and lower gripping areas provided by UBC assembly 491 enable many different additional lateral stretching and stabilization exercise movements using the ski apparatus of the present invention, as will be apparent to the skilled artisan. [0258] In embodiments of the present invention described herein, or part of or related to U.S. patents and applications referenced herein, independent-action suspended footpad assemblies for mounting on a wheeled carriage of the ski apparatus have been described previously utilizing embodiments of the present invention. Referring out to FIGS. 25A , B, the independent footpad assemblies, such as assemblies 472 of FIG. 25A may be adjusted to different width stances on the slide plate which attaches to the wheeled carriage assembly, by means of the sliding attachment plate coupled to the suspended footpad assemblies, which forms the interchangeable footpad assembly unit. Footpad assemblies 472 slide along the length of slide plate 451 until locked into their position according to the width stance adjustment holes of the sliding plate, and are then locked into the desired location by pull-pins 463 , and a securing bolt fastener as described previously, thereby preventing forward, backward or lateral of the footpad assembly 472 on plate 451 . [0259] Referring again to FIG. 25A , the suspended footpad assemblies 472 comprise a suspended footpad which pivots from side to side within the structure of the frame of the footpad assembly, to more closely simulate, during operation of the ski apparatus, at least the lateral motions, forces and dynamics exerted on the lower extremities of the user during actual downhill skiing. However, it is known that there are many other forces other than lateral forces, which exert on the lower extremities of the user during downhill skiing, particularly over steep and sharply variable terrain. During such conditions, the users feet are not held parallel for any significant period of time, and particularly when skiing over steep, bumpy terrain, the tips of the skis are constantly moving up and down, thereby pivoting each ski independently at the skiers ankles. [0260] A significant need thereby exists in the field of ski training apparatus for such extreme conditions, and in many other conditions as well, for the capability in a ski exercise machine to accurately reproduce such forces and movements other than lateral pivoting of the footpad assembly, as described thus far. Applicant&#39;s invention, in embodiments presented below in enabling detail, provides a new and novel interface for mounting a footpad assembly to the wheeled carriage of the ski apparatus of the present invention, providing the tensioned lateral movement and footpad pivoting action of embodiments disclosed herein, and also incorporating the ability for each footpad to slide forward and backward independently from one another, and still further incorporating independent front to back pivoting of each footpad assembly. The user of such an improved apparatus is enabled to better simulate the actual movements, forces and dynamics of the sport, to a significant degree, and further achieve a level of balance controls, due to the front to back sliding and pivoting action of each independent footpad assembly, that is not achievable in prior art ski exercise apparatus. [0261] FIG. 29A is a top view of a footpad pivot base according to an embodiment of the present invention. Pivot base 520 is preferably manufactured of strong, lightweight metal such as aluminum or some other material of similar strength and rigidity, and provides the supporting base structure portion for a sliding/pivoting footpad attachment interface system, as well as enabling a front to back sliding action for the footpad assembly, as will be shown in the embodiments detailed below. [0262] Pivot base 520 is rectangular in shape, having outside dimensions approximately equal to that of sliding attachment plate 460 of FIGS. 21 (A, B). The Pivot base 520 comprises a support base portion 533 , which is substantially flat and has a material thickness of approximately ½-¾ in., sufficient for substantial overall strength and rigidity of the structure. A set of through openings 529 extend completely through the thickness of base portion 533 located near each of the corners of base 533 , located to correspond with the mounting holes of the upper surface of the sliding attachment plate 460 disclosed herein, enabling mounting of pivot base 520 to attachment plate 460 using standard bolt fasteners. Pivot base 520 is also provided with a center through opening 531 enabling access to the center sliding securing bolt and nut fastener for securing attachment plate 460 to slide plate 451 , as described above. [0263] Pivot base 520 comprises a pair of elongated support structures 523 protruding upward from base 533 to a height substantially greater than the thickness of base 533 , and extending parallel to the length of base 533 . Structures 523 are preferably attached permanently to the upper surface of base 533 , or in alternative embodiments may be otherwise securely affixed to the upper surface of base 533 using standard fasteners, and so on. Each support structure 523 resembles a rectangular bar having a thickness approximately equal to the thickness of base 533 , and a height approximately twice that distance. [0264] Located near the outward opposite ends of each structure 523 , a pair of elongated slots 525 are formed completely through the thickness of structures 523 , the set of elongated slots of one structure 523 aligned with those of the opposite structure 523 . Each elongated slot 525 is adapted to accommodate the wheels of a roller assembly supporting a rolling footpad pivot support structure, as will be further detailed below. [0265] FIG. 29B is an elevation side view of footpad pivot base 520 of FIG. 29A , which illustrates the height and shape of structure 523 and location of elongated roller slots 525 . In the example shown, a pair of elongated slots 525 are shown, each slot 525 identical in size to the other within each support structure 523 , the left ends of each slot 525 distanced from each other as defined by dimension (M). Dimension (M) is equal to the distance between the rollers of a pair of roller assemblies on one side of a rolling footpad pivot support structure, as will be shown below, such that the outer ends of each elongated slot 525 provide a stop point for the rolling footpad pivot support structure, providing the range limit for the rollers traveling within slots 525 . The inner surfaces of each slot 525 form a roller surface 527 providing a smooth surface onto which a roller may travel. [0266] In alternative embodiments, however, the size and number of elongated roller slots 525 may vary depending on the size of the roller assemblies adapted to travel within, and their distance apart from each other, as well as the distance of travel desired. In some alternative embodiments support structures 523 may be secured to base 533 utilizing such as standard bolt fasteners, for example, allowing the user to interchange existing structures with other structures which may have elongated slots of different length, size, location and so on, to accommodate different rolling pivot support structures, for example. The preferred embodiment illustrated utilizes a pair of elongated slots 525 which are located within structure 523 so as to form a large supporting bridge of material between each elongated slot within a structure 523 . The inventor has determined that two such slots are the preferable configuration for the preferred embodiment, combining sufficient roller travel distance defined by the length and location of slots 525 , with substantial structural integrity. [0267] Through openings 529 are shown (hidden view) extending completely through the thickness of base 533 for accommodating bolt fasteners for securing structure 520 to an attachment plate 460 , in one embodiment, and through opening 531 is seen extending through the thickness of base 533 at the center, allowing access from above to the sliding securing bolt and nut fastener for attachment plate 460 . [0268] FIG. 29C is an elevation end view of footpad pivot base 520 of FIG. 29A . From this perspective the pair of elongated support structures 523 can be seen extending up from support base 533 near each edge, with the elongated slots 525 shown extending completely through each support structure 523 , forming the inner roller surfaces 527 . The center-to-center distance between each elongated slot 525 , as defined by dimension (L) is equal to the center-to-center distance between opposite rollers on a rolling support pivot plate adapted to travel within slots 525 , as will be shown further in detail. The width of dimension (L) may vary, however, in alternative embodiments depending on the width of the rolling support plate utilized. For example, as mentioned above, support structures 523 may be removably and adjustably attached to base 533 using bolt fasteners such that the support structures may be repositioned at different widths on support base 533 and re-secured utilizing different sets of mounting holes in support base 533 . [0269] FIG. 30A is an elevation end view of a footpad pivot support structure according to an embodiment of the present invention. Footpad pivot support structure 540 is a further key element in the new and innovative dual-action footpad assembly attachment system which enables an attached footpad assembly to slide forward and backward as well as pivot forward to backward, to a predetermined degree. Pivot support structure 540 is manufactured using similar materials and process as for support base 520 , having the best combination of light weight and overall structural rigidity. [0270] Pivot support structure 540 comprises a base portion 541 having a thickness approximately equal to that of base 533 of support structure 520 , approximately 3 / 4 inches in the embodiment presented, and having a rectangular shape also having similar in dimensions to that of rectangular shape of support structure 520 . A center through opening 554 is provided in base 541 for allowing the user access from above to the center sliding securing fastener, such as fastener 480 describe for FIG. 24 . [0271] A pair of vertical support members 547 forms walls extending upward from the upper surface of base 541 along each opposite edge, forming a distinct U-shaped structure, support member 547 extending to a height approximately equal to half the width of base 541 in the embodiment shown, and extending along the entire length of base 541 . Support member 547 has a thickness somewhat greater than that of base 541 , and are preferably permanently attached to base 541 by welding, or casting, or the like, or in alternative embodiments may be removably attached to base 541 using standard bolt fasteners, for example, and the width distance between support member 547 may also be adjustable by utilizing different sets of mounting openings (not shown) through base 541 , for instance, similarly to structures 523 of support structure 520 , so as to accommodate additional elements of different sizes, and so on. [0272] Each vertical support member has a large, arcuate slot 543 , curving somewhat upward at each end from the center, extending completely through the thickness of walls 547 . The inner surface 544 of each arcuate slot 543 is modified to provide a smooth roller surface, similarly to that of elongated roller slots 525 of FIG. 29B , except for the outer opening of arcuate slot 543 is somewhat greater than the opening to the inside of support members 547 , adapted as such for accommodating a roller assembly while minimizing lateral movement of the rolling assembly, as will be shown in greater detail in embodiments presented below. Dimension (Q), as shown in the illustration, defines the distance between the beginnings of the larger outward-facing opening of arcuate slots 543 of opposing vertical support structures 547 . [0273] A plurality of through openings 545 extend completely through the thickness of one wall 547 , shown on the left in FIG. 30A , and a corresponding number of threaded openings 546 , having the same number and pattern of through openings 545 , extend into the opposite support member 547 . Arcuate slot 543 and openings 545 and 546 are better illustrated, however, in the following figures. [0274] Pivot support structure 540 is provided with a pair of roller support structures 549 which are similar in size and rectangular bar-shape to structures 523 of support structure 520 of FIG. 29C , and are also, in a preferred embodiment, permanently attached by welding or formed by other permanent means on the bottom surface of base 541 , and extend along the entire length of base 541 . Roller support structures 549 extend down from the bottom surface of base 541 , and are provided with a plurality of mounting holes 555 , in this case a total of four, for the purpose of rotatably attaching four roller assemblies 552 , one pair of roller assemblies 552 attached to each roller support structure 549 , facing outward. Roller assemblies 552 comprise a roller 551 rotatably secured to support structures 549 utilizing roller axles 553 secured within mounting holes 555 of structures 549 . In the embodiment presented roller assemblies 552 heavy-duty, high-performance rollers designed to withstand substantial downward force while still rotating freely. Roller assemblies 552 are designed to at least support the weight of any exercise user adding that additional lateral forces related to the tensioned side-to-side action operation of a wheeled carriage assembly during operation of a ski apparatus as previously described. [0275] In the embodiment presented footpad pivot support structure 540 is adapted to roll freely back and forth within the set of elongated roller slots 525 of support structure 520 of FIG. 29 , supported by roller assemblies 552 . Roller assemblies 552 are located beneath base 541 on structures 549 such that the center-to-center distance between each opposing roller 551 , defined by dimension (N) in the example presented, is equal to dimension (L) between structures 523 of support structure 520 of FIG. 29C . In alternative embodiments however, dimensions (N) and (L) may vary somewhat, as long as they are equal in dimension to each other. [0276] FIG. 30B is an elevation side view of footpad pivot support structure 540 of FIG. 30A . The size and shape of arcuate slot 543 is clearly seen in this view, as are the locations of through openings 545 . As mentioned previously, although only one vertical support member 547 is visible in this elevation view, threaded openings 546 extending into the opposite (hidden) support member 547 are located and spaced identically to through openings 545 . The grooved roller surface formed by the inner walls of arcuate slot 543 is also clearly visible in this view. [0277] Two of the four roller assemblies 552 are visible in this view attached to facing side of one of structures 549 , near the forward and rearward ends of structure 549 , approximately halfway between the top and bottom of structure 549 . As mentioned previously relative to support structure 520 of FIG. 29B , elongated slots 525 each provide a forward or rearward stopping point for roller assemblies traveling back and forth within. Dimension (M) defines the distance between the left edge of a first elongated slot 525 , and that of the second slot 525 . In the embodiment presently illustrated, the center-to-center distance between the forward and rearward roller assemblies 552 , defined by dimension (P) in the illustration, is exactly equal to that of dimension (M) of FIG. 29B . As with the center-to-center width dimensions of opposing roller assemblies, as shown in FIG. 30A , the center-to-center length dimension (P) of FIG. 30B may vary in alternative embodiments as long as it equals dimension (M) of FIG. 29B , as it is preferable that when footpad pivot support structure 540 is rolling back and forth within elongated slots 525 of support structure 520 , the stopping points provided by the ends of elongated slots 525 should stop both rollers at exactly the same time when the rolling travel distance of support structure 540 has reached the limit. [0278] FIG. 30C is a top view of footpad pivot support structure 540 of FIG. 30A . In this view, the rectangular shape of base 541 is now clearly seen, and with vertical support members 547 located at each opposite edge of base 541 . All four roller assemblies 552 are seen in the hidden view, rotatably to roller support structures 549 attached near each end, structures 549 each having a thickness approximately equal to vertical support members 547 , and extending along the entire length of base 541 approximately halfway between the center and either edge of base 541 . Through opening 554 is shown extending completely through the center of base 541 for accessing the sliding attachment plate securing fastener as described above. [0279] FIG. 31 A is a top view of a pivot roller base assembly according to an embodiment of the present invention. Pivot roller base assembly 560 is provided as a further key element in the new and novel dual-action pivoting footpad attachment assembly of the present invention. Base assembly 560 is provided as essentially a rolling base adapted for attaching an exercise attachment such as suspended footpad assembly 470 , shown in FIG. 24 . Base assembly 560 comprises a base portion 563 , which is rectangular in shape, substantially flat and manufactured of strong, lightweight aluminum or similar material similarly to other footpad pivot system elements described above. Base 563 has a width dimension, which is somewhat less than the distance between the internal walls of vertical support members 547 of pivot support structure 540 of FIG. 30A , enabling roller base assembly 560 to freely move forward and backward between vertical support members 547 , while minimizing side play. A distance (S) defines the distance between the inner edges the rollers of each set of forward or rearward roller assemblies 565 on opposing sides of base 563 , a distance defined as dimension (R) in the illustration, is equal to dimension (Q) of FIG. 30A defining the distance between the beginning of the larger outward-facing openings of arcuate slots 543 of vertical support members 547 . Rollers 565 of roller base assembly 560 travel along roller surface 544 , as shown for support structure 540 of FIG. 30B , within the larger outward-facing openings formed in arcuate slots 543 . [0280] A plurality of threaded mounting holes 566 , one located near each corner of base 563 , extend somewhat down into the surface of base 563 , and are positioned on base 563 in accordance with the location of the mounting through openings 471 of footpad support structure 473 of FIG. 23 , such that suspended footpad assembly 470 , for example, may be mounted in a center position to the upper surface of base 563 , aligning four through openings 471 of footpad assembly 470 with the four corresponding mounting holes 566 , and securing with standard screw or bolt fasteners, as described for FIG. 23 . As with previous elements illustrated above, a center through opening 564 is also provided extending completely through the thickness of base 563 allowing the user to access the sliding securing faster for the sliding attachment plate 460 described previously [0281] Pivot roller base 560 also comprises a set of four roller assemblies 565 rotatably mounted to the sides of base 563 near each of the forward and rearward corners, utilizing roller axles 567 and threaded openings, (not shown), extending into the sides of base 563 . Roller base 560 is provided in this embodiment as essentially a sturdy, rolling platform adapted to travel forward and backward within arcuate slots 543 of vertical support members 547 of footpad pivot support structure 540 of FIG. 30 , while an independent footpad assembly is mounted thereupon as described above. [0282] As described for footpad pivot support structure 540 of FIG. 30 , roller assemblies 565 are heavy-duty, high-performance roller assemblies known in the art, capable of supporting at least the weight of exercising user as well as the additional forces placed thereupon by operation of the ski apparatus machine. [0283] FIG. 31B is an elevation end view of pivot roller base assembly 560 of FIG. 31 A , clearly showing the thickness of base portion 563 and two of the four threaded mounting holes 566 (hidden view) extending somewhat down into the upper surface of base 563 , and center through opening 564 can be seen extending completely through the thickness of base portion 563 . [0284] Two of the four roller assemblies 565 are shown in this elevation view, rotatably attached to the sides of base 563 , each roller assembly 565 positioned approximately level with base portion 563 . [0285] FIG. 31C is an elevation side view of pivot roller base assembly 560 of FIG. 31A . From this perspective only two of the four roller assemblies 565 are shown rotatably mounted on one side of base 563 , secured with roller axles 567 . Mounting holes 566 can be seen at their locations near the front and rear ends of base 563 , with through opening 564 extending through the thickness of base 563 at its center. [0286] FIG. 32A is an elevation view of footpad pivot base 520 of FIG. 29B , footpad pivot support structure 540 of FIG. 30B , and pivot roller base assembly 560 of FIG. 31 C , assembled according to an embodiment of the present invention. Footpad pivot roller assembly 580 is provided as a new and novel dual-action pivoting mounting interface for attaching such as a suspended footpad assembly 470 to a sliding attachment plate 460 , and ultimately to a wheeled carriage of a ski exercise apparatus such as described herein. [0287] As shown in this view, and described previously, footpad pivot support structure 540 rolls back and forth freely within elongated roller slots 525 of roller base 520 , suspended by roller assemblies 552 rotatably attached to the sides of roller support structures 549 of pivot support structure 540 . The distance range of travel for pivot support structure 540 within roller base 520 is limited by the length of each elongated roller slot 525 . [0288] Although it is not shown in this view for reasons of simplicity, roller base 520 , in practice of the invention, may be preassembled to a sliding attachment plate 460 for adjustably mounting onto a slide plate 451 mounted to a wheeled carriage 484 , as described for previous figures, or alternately, may also be mounted directly to the upper surface of the wheeled carriage of the ski apparatus exercise machine. In either application, pivot support structure 540 travels freely within elongated slots 525 , providing the free range of motion forward and backward for pivot support structure 540 . [0289] Pivot base assembly 560 is shown in this view positioned between vertical support members 547 , only one of which is seen in this elevated view, supported by roller assemblies 565 rotatably attached to each side of base assembly 560 , which travel freely within arcuate slots 543 along roller surface 544 adapted for the purpose. As can be seen in this view, base assembly 560 is enabled to travel within arcuate slots 543 , a distance range defined by the outer ends of arcuate slots 543 , and in doing so, enables a tilting action forward or backward for base assembly 560 . In practice of the invention, a suspended footpad assembly, such as footpad assembly 484 of FIG. 24 is secured to the upper surface of base assembly 560 , and therefore, when attached, tilts forward and backward in accordance with base assembly 560 within arcuate slots 543 . [0290] The purpose and function of the plurality of through openings 545 of vertical support members 547 also now becomes apparent in this view. From this perspective, through opening 545 are shown arranged linearly, at a slight angle, near each end of arcuate slot 543 . As mentioned previously for FIG. 30B , a corresponding set of threaded openings 546 (not shown) extending into the opposing vertical support member 547 (also not shown), arranged according to the locations of through openings 545 . Through openings 545 accommodate insertion of a threaded pivot stop bolt 585 , which is of sufficient length such that when fully inserted through an opening 545 the threaded end of pivot stop bolt 585 extends to a corresponding threaded hole 546 in the opposite vertical support member 547 , such that pivot stop bolt 585 may be secured to the threaded hole 546 . An identical pivot stop bolt 585 may also be inserted and threaded as described above that the opposite end of arcuate slot 543 , such that a stop bolt 585 is secured at either end of arcuate slot 543 . The purpose of stop bolts 585 is to provide the user a means for limiting the amount of travel of base assembly 560 within arcuate slot 543 , thereby limiting the tilting action of base assembly 560 , and ultimately an attached suspended footpad assembly. The travel of base assembly 560 within arcuate slot 543 is limited by the bottom corner of base assembly 560 making contact with an inserted pivot stop bolt 585 , as shown in the example presented. The travel/tilting range of base assembly 560 within arcuate slots 543 is increased by inserting pivot stop bolts 585 through outward sets of through openings 545 and threaded holes 546 of vertical support members 547 , and is thereby decreased by inserting pivot stop bolts 585 through inward sets of openings 545 and threaded holes 546 . The number and location of through openings 545 and threaded holes 546 in vertical support members 547 may vary in alternative embodiments of the present invention, those shown in this view are only exemplary. [0291] FIG. 32B is an elevation end view of footpad pivot base assembly 520 , footpad pivot support structure 540 , and pivot roller base assembly 560 of FIG. 32A . In this view, roller assemblies 552 are shown rotatably attached to roller support structures 549 , and positioned within the elongated slots of structures 523 of support structure 520 . Roller assemblies 565 , rotatably attached to pivot base assembly 560 , are positioned within arcuate slots 543 of vertical support members 547 of pivot support structure 540 . One of stop bolts 585 is shown in this elevation view inserted through opening 545 of a first vertical support member 547 , and its threaded end secured into threaded hole 546 of the second vertical support member 547 . [0292] The assembly shown in FIGS. 32A and 32B is meant to be mounted in pairs in a preferred embodiment to a wheeled carriage in the exercise apparatus such that the direction of translation of support structure 540 and of pivot base 560 is at right angles to the direction of travel of the wheeled carriage side-to-side. This arrangement allows a foot pads engaged to elements 560 , thus to a user&#39;s two feet, to translate to a limited degree forward and backward independently and to also rock arcuately, adding these degrees of freedom to the action of the overall apparatus, simulating much more truly the actual experience of slalom skiing. [0000] Energy Monitoring [0293] As mentioned above in the background section of the present application, one object of the present invention is to provide a ski apparatus having a monitoring system integrated therein which provides the user with information pertaining to the workout in order to enable the user to best utilize the apparatus and maximize effectiveness of the workout or training. Such information may include elapsed time from start to finish of the workout, goal determination and accomplishment, energy or calories expended by the user, speed of turns, side travel distance of the wheeled carriage, and so on. It is preferable that such a monitoring system is electronic and capable of being retrofitted to all ski exercise apparatus described herein in the present application and in related U.S. patents and applications included herein by reference. Elements of such a new and novel electronic monitoring system and apparatus, termed LifeBeat (LB) by the inventor of the present application, are disclosed in the following figures in enabling detail. [0294] FIG. 33A is an elevation side view of a LifeBeat (LB) cable-securing axle according to an embodiment of the present invention. LifeBeat (LB) axle 610 is provided in this embodiment as a roller axle mechanism which enables the connection of an optical sensor actuating cable (not shown) to the underside of a wheeled carriage assembly of a ski exercise apparatus as described herein. LB axle 610 is designed to replace an existing roller axle mounted beneath the wheeled carriage assembly of a ski exercise apparatus which is being retrofitted with monitoring sensor elements as will be described further below in enabling detail. [0295] LB axle 610 comprises an axle shaft portion 611 onto which an existing carriage roller, such as roller 59 of FIG. 4 , is rotatably mounted. LB axle 610 also comprises an enlarged stop collar 615 adapted for preventing LB axle 610 from rotating within the carriage roller bracket beneath the wheeled carriage. LB axle 610 comprises an internal threaded portion 614 on one end for securing LB axle 610 to the roller bracket utilizing a standard threaded nut fastener, and an external threaded portion at the opposite end of axle shaft portion 611 , for securing the end of an actuating cable for the optical sensor system as will be described below. [0296] FIG. 33B is an elevation end view of cable-securing LB axle 610 of FIG. 33A . Stop collar 615 of LB axle 610 is clearly shown in this view having a flat portion 617 on either side for preventing LB axle 610 from rotating within the roller mounting bracket of the wheeled carriage assembly, once LB axle 610 is attached. [0297] FIG. 34 is an elevation side view of a LifeBeat (LB) carriage wheel roller axle assembly according to an embodiment of the present invention. LB roller axle 590 is adapted for retrofitting with roller axles securing existing end rollers of a ski exercise apparatus being retrofitted with the monitoring system of the invention, such as those securing rollers 35 and 37 of ski apparatus 9 of FIG. 2 . However, LB roller axle assemblies 590 provide a carriage wheel rotatably mounted to roller axle 595 at one end, secured by lock nut 597 and washers 591 and 596 . [0298] Roller axle 595 is shown in this embodiment as an existing roller axle securing the end power band rollers, such as rollers 35 and 37 of apparatus 9 of FIG. 2 . LB axle 610 of FIG. 33A is shown in this view threaded onto the threaded end of existing roller axle 595 , and a carriage wheel 593 is rotatably mounted over LB axle 610 , secured by lock nut 597 . Star washers 599 are provided for more securely attaching roller axle 595 to the end power band roller mounting brackets, as is illustrated further below. [0299] FIG. 35 is an elevation side view of an optical sensor unit according to an embodiment of the present invention. LB sensor assembly 600 comprises an optical sensor unit 601 , which senses rotational changes of an attached sensor carriage wheel 603 , secured to optical sensor unit 601 by roller axle bolt 605 . A monitor wire 607 carries the sensed signals from the optical sensor unit to a conventional electronic monitor display unit (not shown) which may be attached to the frame of the ski apparatus, or may otherwise be provided with its own stand, enabling viewing of the displayed monitoring results by the exercising user, and enabling the exercising user to enter information into the monitor display unit. Such a unit and display is common to, for example, commercially-available treadmills. [0300] FIG. 36 is an elevation view of frame structure 404 of FIG. 17 , wheeled carriage assembly 484 , slide plate 451 , attachment plate 460 , and suspended footpad assemblies 472 of FIG. 25A , incorporating an electronic monitoring sensor system according to an embodiment of the present invention. As previously mentioned, elements comprising the LB monitoring system herein described may be retrofitted to existing ski exercise apparatus described in and in related U.S. patents and applications. Ski apparatus 701 is one such machine, comprising a set of semi-arcuate rails 415 upon which wheeled carriage 484 travels back and forth as described herein. For simplicity, a broken view is given for wheeled carriage 484 to show hidden elements, and many other elements such as the three power bands have also been omitted from this view for enabling a detailed view of the key components of the LB monitoring system. [0301] Suspended footpad assemblies 470 are mounted to sliding attachment plates 460 , which in turn are mounted to slide plate 451 , which is mounted to the upper surface of wheeled carriage 484 , as previously described herein. Wheeled carriage 484 has a power band roller bracket extending down from the underside containing a mounted power band roller, but in the embodiment shown the existing power band roller axle has been retrofitted with LB axle 610 , as shown in FIG. 33A . [0302] At each end of apparatus 701 , the existing roller axles rotatably mounting the outer power band rollers at each end, have been replaced with LB roller axle assemblies 590 as shown in FIG. 34 . LB sensor assembly 600 is mounted to the lower frame structure, near the center, as shown in the illustration, and be attached monitor wire leads away from LB sensor assembly 600 to an external monitor display and input device, as described above. [0303] An actuating cable 620 is attached at one end of LB axle 610 under wheeled carriage 484 , and is then routed to a first LB roller axle assembly 590 as shown, around the carriage wheel of the first roller axle assembly 590 , and then towards the LB sensor assembly 600 . Cable 620 is then wrapped once around sensor carriage wheel 603 of LB sensor assembly 600 , and then routes on towards the second LB roller axle assembly 590 securing the opposite end roller, where it is routed up and over the carriage wheel of the second LB roller axle assembly 590 , and then back up to LB axle 610 under carriage 484 . The second end of cable 620 is then secured along with the first end to LB axle 610 utilizing standard lock nut fasteners. [0304] Spring 623 provides constant tension to LB cable 620 once it is properly routed as described around the carriage wheels of LB roller axle assemblies 590 at each end of apparatus 701 , around sensor carriage wheel 603 of LB sensor assembly 600 and attached at both ends at LB axle 610 under carriage 484 . During operation of ski apparatus 701 wheeled carriage travels laterally along rails 415 , as described previously, but sensor carriage wheel 603 of LB sensor assembly 600 is now rotated in one direction or the other in direct relation to physical movements of wheeled carriage 484 along rails 415 . LB sensor assembly 600 and its monitoring display device (not shown) are adapted to interpret the signals provided by the rotating carriage wheel of LB sensor assembly 600 and reproduce the signals on the display monitor in meaningful information readable by the user, such as elapsed time from start to finish of the workout, goal determination and accomplishment, energy or calories expended by the user, speed of turns, side travel distance of the wheeled carriage, and so on. [0305] FIG. 37 is a top view of the frame structure and sensor system of FIG. 36 . In this view, LB cable 620 is clearly shown as it routes over carriage wheels 593 of end LB roller axles 590 , and once around sensor carriage wheel 603 of LB sensor assembly 600 , each free end of LB cable 620 attached to LB axle 610 . For simplicity, wheeled carriage 484 is not shown in this view. As shown in the illustration, roller axle carriage wheels 593 , sensor carriage wheel 603 , and a cable attach point of LB axle 610 or all aligned with each other such that LB cable 620 routes over and around them in a straight line. [0306] FIG. 38 is a perspective view of an adjustable flag assembly according to an embodiment of the present invention. Flag assembly 702 is provided by the inventor as part of the LifeBeat monitoring system described thus far, and has the purpose of giving the exercising user a clear visual and audible indication when the wheeled carriage assembly reaches a certain lateral range limit. Flag assembly 702 comprises a mounting base 715 having an upper clamp 713 secured to mounting base 715 by four bolt fasteners 709 . Clamp 713 is adapted to fit snugly over the rounded shape of transverse end-members 27 of the frame structure of the ski apparatus, a shown in FIG. 7A , B. [0307] Flag assembly 702 is also provided with a plurality of flag locator holes 711 extending down into the upper surface of mounting base 715 , adapted for attaching a flag 705 by inserting flag stem 707 into one of locator holes 711 , providing a wide choice of flag stem mounting positions on mounting base 715 . [0308] FIG. 39 is an elevation view of the frame structure, wheeled carriage assembly, slide plate, attachment plate, suspended footpad assemblies, and sensor system of FIG. 36 15 incorporating a pair of flag assemblies 702 of FIG. 38 according to an embodiment of the present invention. The manner in which flag assemblies 702 are attached at each end of frame structure 701 in one embodiment is clearly seen in this view, utilizing clamp 713 and bolts 709 , which secure mounting base 715 to each rounded transverse member at either end of frame structure 701 . In this example flag 705 are inserted into locator holes near the outermost locator hole position. In other embodiments the method and apparatus for holding flags may be different. During operation of the ski exercise apparatus, carriage 484 travels laterally along rails 415 , and when the outermost travel distance range is achieved by the user, the end of plate 451 mounted on wheeled carriage 484 makes physical contact with flag 705 , giving the user an instant visual and audible indication that the desired outermost travel distance range has been achieved. [0000] Additional Exercise Equipment [0309] As previously mentioned, a still further object of the present invention to enable the ski exercising apparatus of the present invention to be used with additional special attachments and other new and novel apparatus, to become a versatile rehabilitation and training tool that simulates the range of motion and balance required in many sports other than downhill skiing, and for selectively stretching, strengthening or rehabilitating specific areas of the body, core stabilization, balance training and many other aspects of selected training and exercise, not possible with using only the ski apparatus as described thus far in the present application. Such a ski exercise apparatus used with such special attachments accurately reproduces the lateral movements required in most sports, thereby optimizing rehabilitation and helping to prevent injury to the user. [0310] The inventor of the present application has discovered that the ski apparatus of the present invention, in addition to providing the tensioned lateral movement and balance exercises described herein utilizing suspended footpad assemblies and dual-action pivoting independent footpad attachment mechanisms, may also be used for exercises which create progressive resistance to the knee, hip and pelvic core musculature, allowing the user and therapist/trainer the option of implementing isolated progressive resistance at different levels. [0311] FIG. 40 is an elevation view of the frame structure, wheeled carriage assembly, slide plate, attachment plate, suspended footpad assemblies, sensor system and flag assemblies of FIG. 39 , an optional support frame and an exercising user, incorporating a progressive-resistance cord system according to an embodiment of the present invention, for providing such isolated progressive resistance exercises, as described above. Ski exercise apparatus 801 comprises the frame structure 701 previously described, including improved semi-arcuate rails 415 , and wheeled carriage assembly 484 utilizing a set of suspended footpad assemblies adjustably attached to carriage 484 , as described above. [0312] The embodiment illustrated however, comprises an optional support frame 803 for a novice user to hold on to for stabilization while using ski apparatus 801 . Support frame 803 , termed Assistant Coach by the inventor, is equivalent to support frame 14 as described for FIG. 1A , comprising a set of arcuate rails 807 , each having a grip covering portion, and a transverse cross member 811 which provides stability to the overall frame structure. [0313] An exercising user 805 is shown operating ski exercise apparatus 801 according to embodiment of the present invention described herein thus far, except that additional resistance is incorporated into the lateral movements of the user, by using the new and unique attachment cord with pulley system, anchor straps and resistance cords designed to be used with support frame 803 . [0314] Core muscle strengthening may be accomplished utilizing the ski exercise apparatus of the present invention with the use of resistance during exercises on the machine. Resistance cords attached to the upper leg of the user, for example, provide resistance for internal and external rotation, abduction and adduction of the femur during the lateral movements. Resistance cords may also be alternatively attached to a waist strap worn by the exercising user giving resistance to the pelvis and lumbar spine through lateral movements on the exercise apparatus. [0315] In the embodiment shown, a strap 815 is attached around the upper thigh of the user, and attached to strap 815 is an attachment cord 821 . Attachment cord 821 is routed to and through pulley 817 , which is anchored to support frame 803 just below where it meets cross member 811 , utilizing anchor strap 819 . Cord 821 is routed around the wheel of pulley 817 and then down at an angle where it is attached to an adjusting strap 823 . An elastic resistance cord 825 is anchored at one end to the lower straight portion of support frame 803 opposite from pulley 817 , utilizing another anchor strap 819 , and is connected at the other end to adjusting strap 823 . [0316] As user 805 moves wheeled carriage assembly 804 laterally across rails 415 , added resistance is selectively applied to the upper thigh area of user 805 , by virtue of the resistance of cord 825 . Resistance cords 825 may be supplied with varying lengths and elasticity to allow the option of implementing isolated progressive resistance at different levels. The length of adjusting strap 823 may also be adjusted to further add to the choice of resistance options. The system comprising movable anchor straps 819 cord 821 , pulley 817 and adjusting strap 823 allow the option of implementing isolated progressive resistance from multiple heights and angles along support frame 803 . Further, a larger version of strap 815 may be used to secure cord 821 to the user&#39;s hip, waist, or chest area, depending on the selective training preference. [0317] It is noted that the example shown in FIG. 40 is exemplary only, as the possibilities for achieving different resistance and selectively applying the resistance to specific areas of the body while exercising are plentiful. For example, the user may attach strap 815 to the opposite leg, switch locations of anchor straps 819 and pulley 817 for adding resistance to the other leg while exercising, or in other instances, cord 821 , pulley 817 and adjusting strap 823 may not be used at all, and the user may wish to anchor a resistance cord by one end to each side of a waste belt, and anchor the other ends of the resistance cords directly to frame 803 to the side, giving resistance to the pelvis and lumbar spine through the lateral movements to both sides of the ski apparatus. It will be apparent to the skilled artisan that the possibilities for applying selective resistance to specific parts of the body utilizing the elements described herein is virtually unlimited. [0000] Goal Achiever Control and Tracking [0318] In the manufacture, development and use of exercising equipment it is rather well-known that people often buy and install such equipment, and then fail to use the equipment regularly, so personal fitness goals may never be met. The present inventor has discovered that a singular reason for this kind of under-use is just that people have a certain inertia when it comes to initiating an exercise session. For example, it is well-known and publicized that vigorous exercise for 30 minutes or more is typically regarded as a minimum for good results. In five minutes, for example, a person is not even settled in to the change in activity, and the body has not adjusted. Runners typically report that in the first few minutes of a run they experience fatigue and breathlessness, but after a few minutes the body adjusts and assumes a rhythm. [0319] The net result of this natural dynamism of the human body is that a person typically does not look forward (has a natural reluctance) to starting an exercise session, and setting a time of thirty minutes or more for such a session. Take for example a working woman who comes home from a herd day on the job, knows she needs to exercise, but is already somewhat fatigued and looking forward to just a relaxing evening at home. [0320] In an embodiment of the present invention the LifeBeat system described in some detail above has novel features that address exactly this natural reluctance to exercise. The LifeBeat system for ski-exercise equipment has a control panel for input and readout of such as timing functions much like panels found on other exercise equipment, such as treadmills, and this fact was discussed above, although not shown in the accompanying figures. [0321] FIG. 41 is a plan view of a control panel 4101 for a LifeBeat system in an embodiment of the present invention. The skilled artisan will recognize that the layout and elements for this panel are exemplary, and might be done in many different ways. [0322] In this example goals may be set and tracked in three different ways: by time, by calories burned (really a function of time), and by repetitions, which may be independent of time. A goal can be set for any one of the three characteristics by pressing one of buttons 4102 , 4103 or 4104 , then using one of buttons 4105 or 4106 to run the value for that characteristic up or down. Once a goal is set, when the start button is pressed the value set as a goal will begin to decrement until either the Stop button 4111 is pressed, or the set value reaches zero. There is a conventional 5 times in the system, and there is a microprocessor with firmware for accomplishing the purposes described herein. The timer is referenced for decrementing an incrementing time displays. Calories burned is determined as a function of time, taking into account the repetitions accomplished, sensed by sensors on the apparatus. [0323] Assume now that a user comes to the exercise apparatus, reluctant to exercise for a full thirty minutes or more, and sets a time goal of seven minutes, as shown in FIG. 41 , thinking that this is a short time, and easily accomplished. After the user presses the start button and begins manipulating the apparatus for exercise, the time display begins to decrement one second at a time, going first to 6 . 59 , and then progressively until 0.00 is reached after the full seven minutes. [0324] In the system of the invention in this embodiment, the system provides a visual and/or audio alert that the goal has been achieved (seven minutes of vigorous exercise), but does not stop there. Instead, after the seven minutes has elapsed, the display ( 4107 ) changes (after one second) to one second over the time that was originally set as a goal, that is 7.01, and continues to increment until the user presses the stop button ( 4111 ). [0325] The beneficial effect in this innovation is, that by the time seven minutes has elapsed, the user&#39;s endorphins have kicked in, he or she has gotten past the reluctance, and may well be ready for a full thirty minutes or more. If so, the user need only keep exercising, paying attention to the incrementing readout value, until any new goal mentally set is reached. There is no need to stop and reset. The inventor believes this unique goal achiever function is new and not obvious in the art. [0326] The goal achiever function is not limited to time. The user may set goals in one of calories burned or repetitions as well, and the incrementing function works as described above for time. If the user sets a goal of 100 repetitions, for example, and the display decrements from the entered 100 to zero, the display, with one more repetition, display 101 , and then continues to increment while the user continues to exercise. [0327] It will also be apparent to one with skill in the art that the many improvements to existing ski-exercising equipment described as separate embodiments herein add durability, safety, much-improved operating characteristics which more closely simulate the lateral movements required in many sports, adjustability of footpad or other exercise attachments, manufacturability, and convenience over apparatus of the prior art. Moreover, future applications may now be implemented by developing new upper platform assemblies, and still be integrated easily with the improved rail and carriage apparatus, and improved adjustable attachment mechanisms as taught herein. Therefore, the present invention should be afforded the broadest scope possible. The spirit and scope of the present invention is limited only be the claims that follow.

A control system for an exercise apparatus has an input mechanism for setting a goal for exercise in measurable units, a display for displaying the goal in the measurable units, and an initiation mechanism. Upon setting the goal, the goal in measurable units is displayed in the display, upon activating the initiation mechanism the display begins to decrement in the measurable units, and upon reaching zero, the original goal is displayed and then increments in the measurable units.

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application claims priority to and the benefit of, Provisional Patent Application Ser. No. 60/923,777, filed on Apr. 17, 2007, the entire disclosure of which is hereby incorporated by reference herein. TECHNICAL FIELD [0002] The present invention relates to a medical syringe for the withdrawal of medication from medication bottles and injection of medication into patients via medication tubing systems, and more particularly switching between a needle interface for withdrawal of medications from medication bottles and a needleless interface for injecting the medicine into a tubing system. BACKGROUND OF THE INVENTION [0003] Currently, certain medical treatments require caregivers to place themselves at risk of needle stick, because of the requirements of working with needles and patient bodily fluids. Recent technological improvements have been safety focused and have lessened this risk with the trend toward needleless tubing systems and procedures involving retractable needles in catheters. Existing systems, however, continue to require caregivers to use a needle to draw medication from medication bottles and then convert this needle/syringe system to a needleless system by removing the needle. In addition to the safety concerns, caregivers must locate and open two different packages, attach the needle to the syringe, draw up medication, remove the needle, then attach the syringe to the needleless tubing system and inject the medication, and occasionally repeat the process. [0004] One known system utilizes a plastic needle-like system that can both puncture a medication bottle and access tubing systems by a puncture of the tubing system hub. This system utilizes a sharp point, like standard needles, and must be pushed into the needleless port. Inherent in this action is the risk of missing the port and sticking yourself with the device. The avoidance of this risk is the primary driver for innovative products in safer needleless systems. Moreover, the puncture of needleless hubs with needles or pointed plastic pieces may result in the creation of a leak in the tubing system and allow backflow of fluid out of the punctured hub. [0005] Some of the newer syringe devices focus on minimizing needle sticks by having a blunt cannula attached to the syringe that is used to puncture the bottle. The cannula is removed after the medication is drawn up and a sharp needle is attached. This device does add a layer of additional protection, but is inefficient, because the cannula must be removed and a needle attached. [0006] A second problem with newer safety systems is their potential lack of intercompatibility. For example, a nurse may draw up the medication with one system for an intramuscular injection. If the physician changes her mind and orders the medication be given intravenously, the syringe holding the medicine may be incompatible with intravenous injection system. SUMMARY OF THE INVENTION [0007] The present invention speeds the process, adds a layer of safety, and allows rapid conversion between a needle/syringe system and a needleless/syringe system, thus allowing an operator to move seamlessly between both systems while minimizing needle stick risk. In particular, the current invention provides for the insertion of the syringe into the needleless system with no exposed sharp point that may inadvertently lead to a skin puncture. [0008] The system allows for a collar or sheath with an attached fluid port to slide over the fixed needle at the end of the syringe and reversibly lock in an advanced position creating a functionally needleless adaptor for interfacing with the needleless tubing systems. The system also allows for retraction of the collar to expose the fixed needle at the end of the syringe for puncturing medication bottles. [0009] In use, the operator starts with the collar in a retracted position such that the needle is exposed, which allows the operator to puncture a medication bottle with the needle of the syringe. The operator then pulls back on the syringe plunger drawing medication through the needle and into the barrel of the syringe. When the correct amount of fluid has been drawn into the syringe barrel, the needle is withdrawn from the medication bottle. The operator then slides the collar forward and locks it in an advanced position that simultaneously covers the end of the needle and presents a needleless fluid port (e.g., a luer lock fitting) for interfacing with a tubing system. The operator can then connect the syringe to the needleless tubing system (e.g., by screwing the luer lock fitting to a corresponding fitting on the tubing system) and administer the medication by advancing the syringe plunger. [0010] In one aspect, the invention relates to a syringe system including a syringe barrel defining an interior space, a syringe plunger slidably disposed within the syringe barrel, a needle coupled to a distal end of the syringe barrel and in fluid communication with the interior space, a collar slidably disposed about the syringe barrel, and a fluid port disposed at a distal end of the collar. The collar can be coupled to the syringe barrel to prevent inadvertent disengagement therefrom. The fluid port is configured to interface with a needleless tubing system. [0011] In another aspect, the invention relates to a syringe system including a syringe barrel defining an interior space, a syringe plunger slidably disposed within the syringe barrel, a needle coupled to a distal end of the syringe barrel and in fluid communication with the interior space, a collar threadedly engaged with the syringe barrel, and a fluid port disposed at a distal end of the collar, the fluid port configured to interface with a needleless tubing system. The collar can be moved along the length of the syringe barrel by rotational movement thereof. [0012] In various embodiments of the foregoing aspects, the collar is configured to slide longitudinally along at least a portion of the syringe barrel. The collar can be secured in a first, retracted position exposing the needle and a second, advanced position encapsulating the needle. In the advanced position, the fluid port is presented for interfacing with the needleless tubing system. The fluid port can include threads and be secured to the needleless tubing system by a screw action (i.e., rotation of the port, collar, and/or syringe). In one embodiment, the fluid port is a luer lock type fitting, either male or female to suit the particular application. In addition, the collar can be locked in at least one of the first position and the second position, either reversibly or irreversibly. The syringe system can include a locking mechanism disposed on at least one of the syringe barrel and the collar for locking the collar in the first, retracted position and/or the second, advanced position. In one embodiment, the collar only locks in the advanced position. Additionally or alternatively, the collar can be locked in place by, for example, frictional engagement or with the use of an O-ring. [0013] In additional embodiments of the syringe system, the syringe barrel can include at least one slotted rail disposed on an outer surface of the syringe barrel and oriented longitudinally along a length of the syringe barrel and the collar can include at least one protuberance disposed on an inner surface of the collar for engaging the slotted rail. The collar is configured to slide along the syringe barrel via engagement of the protuberance and the slotted rail. In one embodiment, two longitudinal rails can be disposed on the syringe barrel on opposite sides thereof, e.g., 180 degrees apart on a cylindrically shaped syringe barrel. Alternatively, more that two rails can be included depending, for example, on the size of the syringe. In one embodiment, the longitudinal rail includes a transverse portion extending from a distal end of the longitudinal rail. The transverse portion of the slotted rail allows guided, rotational movement of the collar when in the second position. Alternatively or additionally, the longitudinal rail can include a transverse portion extending from a proximal end of the longitudinal rail to provide guided, rotational movement of the collar when in the first position. [0014] Furthermore, the locking mechanism can be disposed on the transverse portion of the rail and the collar engages the locking mechanism when rotated in the second position. In one embodiment, at least one of the transverse portions of the slotted rail includes a locking mechanism for securing the collar in at least one of the first position and the second position when the collar is rotated, such that the protuberance engages the locking mechanism. In another embodiment, the syringe system includes a second locking mechanism disposed near the proximal end of the longitudinal rail. The second locking mechanism configured to secure the collar in the first position. The locking mechanism in one embodiment can reversibly lock the collar in its position by frictional engagement between the protuberance and the rail. In another embodiment, the locking mechanism includes a projection that prevents the return rotational movement of the collar by blocking the protuberance. For example, the locking mechanism can be an inclined block that allows the protuberance to slide over the inclined surface, but is blocked by a vertical wall of the block when the operator attempts to rotate the collar into an unlocked position. [0015] In still further embodiments of the syringe system, the collar is guided between the first position and the second position by a thread disposed on an external diameter of the syringe barrel, for example as opposed to sliding on the rails. The fluid port can be configured for attachment of a secondary needle, for example, by threaded engagement. The secondary needle can provide a different needle configuration and/or size for a particular application and can be attached to the syringe in its extended position. In addition, the collar can be biased in at least one of the first position and the second position to prevent the inadvertent movement of the collar when in use. In one embodiment, the collar includes a spring mechanism for biasing the collar in the second position. For example, the spring mechanism can be a spring or other resilient member disposed within the collar between a distal end of the syringe barrel and a distal interior end of the collar, thereby biasing the collar in the second, advanced position. The collar can be forced back against the spring to the first, retracted position and locked in place. Such an arrangement will fail safe with the collar in the advanced position, thereby covering the needle. [0016] Moreover, the fluid port may conform to at least one of ISO standard 594-1 and 594-2. The collar can be removable from the syringe barrel and interchangeable with a second collar with an alternative fluid port. This arrangement allows the syringe assembly to be customized for the particular needleless tubing system to which it will interface. In one embodiment, the collar can be snap fit onto the syringe barrel and can be removed by flexing the collar such that the protuberance(s) are moved out of the slotted rail(s). Once the protuberances clear the slotted rail, the collar can be rotated and slid off of the syringe barrel. In another embodiment, a distal portion of the collar can include an internal channel for receiving at least a distal portion of the needle. The channel can be formed in the distal end of the collar or can include an additional cylindrical body formed coextensively with the collar and defining the channel running therethrough. The needle can be moved through the channel when the collar is retracted into the first position. The collar can further include an O-ring disposed in an annular groove formed in an internal surface of the channel. The O-ring provides a seal between an outer diameter of the needle and an inner diameter of the channel for the passage of a fluid between the syringe barrel and the needleless tubing system, without leakage. The seal facilitates generating a suction at the distal end of the collar when the collar is in the extended position and the syringe plunger is drawn back to draw fluid into the syringe barrel. Generally, the syringe plunger can be extended and retracted to draw in and dispense fluid, respectively, through the distal end of the collar through the fluid port between the syringe and the needleless system. In one embodiment, the friction between the O-ring and the needle will prevent or at least impede movement of the collar. Additionally, in an embodiment where the needle expands at its base, the increased interference fit between the outside diameter of the needle and the inside diameter of the O-ring will further secure the collar in place. [0017] In yet another embodiment of the syringe system, the syringe barrel has a generally circular cross-sectional shape and the collar has a generally elliptical internal cross-sectional shape, which provides for a slight interference between the outside diameter of the syringe barrel and the inside surface of the collar. This arrangement can provide sufficient surface tension between the collar and syringe barrel to prevent sliding movement between the collar and the syringe barrel. A light pressure can be applied to the collar to deform the internal cross-sectional shape of the collar from generally elliptical to generally circular and of a larger diameter than the outside diameter of the syringe barrel to enable slidable movement therebetween. For example, the operator applies a squeezing force to the collar with one hand to deform the collar and initiates sliding of the collar with the other hand, thereby sliding the collar along the syringe barrel between the first and second positions. When the force is removed, the collar returns to the generally elliptically shaped internal cross sectional shape which provides a partial interference fit with the outside diameter of the syringe barrel, which provides sufficient surface tension to prevent movement of the collar. [0018] These and other objects, along with advantages and features of the present invention herein disclosed, will become apparent through reference to the following description, the accompanying drawings, and the claims. Furthermore, it is to be understood that the features of the various embodiments described herein are not mutually exclusive and can exist in various combinations and permutations. BRIEF DESCRIPTION OF THE DRAWINGS [0019] In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the present invention are described with reference to the following drawings, in which: [0020] FIG. 1A is a schematic plan view of a syringe system in a retracted or needled position in accordance with one embodiment of the invention, the syringe system including a syringe barrel, a plunger, a needle, and a sliding collar; [0021] FIG. 1B is a schematic plan view of the syringe system of FIG. 1A , with the collar and plunger removed; [0022] FIG. 2 is a schematic plan view of the syringe assembly of FIG. 1A in partial cross-section, with the collar in an advanced position such that the needle is covered and a fluid port on the collar may engage a needleless system; [0023] FIG. 3 is a schematic enlarged view of the fluid port portion of the collar of the syringe system of FIG. 2 ; [0024] FIG. 4A is an enlarged schematic cross-sectional view of the collar of FIGS. 1-3 ; [0025] FIG. 4B is an enlarged schematic view of the distal end of the barrel of FIGS. 1-3 rotated 90 degrees; [0026] FIGS. 5A and 5B are schematic perspective views of a syringe system in accordance with one embodiment of the invention; [0027] FIG. 6 is a schematic exploded view of a syringe system in accordance with one embodiment of the invention; [0028] FIGS. 7A and 7B are schematic cross-sectional views of a syringe system in accordance with one embodiment of the invention with a spring that biases the collar and fluid port into an advanced position; [0029] FIGS. 8A and 8B are schematic cross-sectional views of a syringe system in accordance with one embodiment of the invention with a collar that may be directed over the needle by a side-arm to secure the collar in the advanced position; [0030] FIGS. 9A and 9B are schematic cross-sectional views of a syringe system in accordance with one embodiment of the invention with a threaded luer lock collar in a retracted position and in an advanced position; [0031] FIGS. 10A and 10B are schematic cross-sectional views of a syringe system in accordance with one embodiment of the invention with a deformable elliptical collar in a locked and an unlocked position; and [0032] FIGS. 11A and 11B are schematic cross-sectional views of an alternative embodiment of the syringe system of FIGS. 9A and 9B . DETAILED DESCRIPTION OF THE INVENTION [0033] In the following, embodiments of a syringe system in accordance with the invention are further described with reference to a single application. It is, however, to be understood that the present invention can also be used for other types of syringe or needle systems. For example, in one embodiment, the syringe is a hypodermic syringe used with a hypodermic needle to inject liquid or gases into body tissues, or to remove liquid or gases from the body. [0034] It will, therefore, be understood that the present invention is directed to a syringe for administering different fluids, which overcomes the problems of the prior art. In particular, a syringe system in accordance with the present invention includes a unique collar with a fluid port that may reversibly lock in a position to expose a puncturing needle or advance to shield the needle and provide a connection for needleless attachment to tubing systems. Manufacture of the component parts of the syringe of the present invention does not involve complicated and expensive manufacturing techniques or precise control over the dimensions of the component parts of the device. [0035] Referring now to the drawings, in particular FIGS. 1A and 1B , a disposable medical syringe system 1 in accordance with the invention includes a syringe barrel 10 , in the form of a hollow cylinder defining an interior space 40 . The system 1 further includes a plunger 20 inserted into a proximal end 11 of the syringe barrel 10 . The plunger 20 can be advanced into the barrel 10 such that a distal rubber portion 22 of the plunger 20 contacts an internal distal end 12 of the barrel 10 . The plunger 20 has a proximal handle 21 that is used by an operator to slide the plunger 20 through the interior space 40 of the barrel 10 from the proximal end 11 to the distal end 12 of the barrel 10 . The plunger 20 includes one or more sealing surfaces 23 that provide a water tight seal between the distal rubber portion 22 of the plunger 20 and the internal wall of the barrel 10 . [0036] The barrel 10 includes a generally centrally located opening 13 formed in the distal end 12 of the barrel 10 through which fluid or medication may be pushed or pulled by actuating the plunger 20 and creating forces (e.g., pressure and vacuum) within the interior space 40 , due to the watertight seal of the plunger 20 within the barrel 10 . A hollow needle 30 is coupled to the distal endpoint 14 of the barrel 10 and is in fluid communication with the opening 13 and the interior space 40 . The needle 30 has a proximal end 31 coupled to the distal endpoint 14 of the barrel 10 and a tapered distal end 32 . The tapered distal end 32 of the needle 30 has two side ports 33 that allow fluid transfer and are disposed on the tapered distal end 32 of the needle 30 . [0037] The volume of the interior space 40 is variable and defined as the space within the barrel 10 and distal to the rubber portion 22 of the plunger 20 . The volume of the space 40 can be varied by movement of the plunger 20 , for example, moving the plunger proximally toward the proximal end 11 enlarges the volume. Movement of the plunger 20 toward the distal end 12 via operator action at the handle 21 causes medication or fluid to be moved by the distal end 22 of the plunger 20 toward the distal needle tip 32 . For example, the fluid is driven through opening 13 and an internal channel 34 of the needle 30 out the needle&#39;s distal side ports 33 . [0038] Referring to FIGS. 1-3 , the syringe system 1 includes at its distal end a collar 60 and a fluid port 50 disposed in the distal end of the collar 60 . In one embodiment, the fluid port 50 is a luer lock type fitting. The collar 60 is coupled to the syringe barrel 10 . In one embodiment, the luer lock 50 includes a longer internal cylinder 51 and a shorter wider surrounding cylinder 52 . The cylinders 51 , 52 extend from a distal end 53 of the collar 60 , with the internal cylinder 51 extending beyond the surrounding cylinder 52 to a distal point 54 . The internal cylinder 51 has an inner diameter (ID 1 ) and an outer diameter (OD 1 ). The surrounding cylinder 52 extends to a distal end 56 and has an inner diameter (ID 2 ) and an outer diameter (OD 2 ). The second inner diameter (ID 2 ) of fluid port 50 includes an internal thread 57 molded therein. In one embodiment, the disposable medical syringe system 1 interfaces with a needleless tubing system via the circumferential thread 57 . [0039] The collar 60 surrounds and is coupled to at least a portion of barrel 10 near its distal end 14 . The collar 60 may slide back and forth along a portion of the barrel 10 such that when it is in the fully extended position (see FIG. 2 ), the distal end 32 of the needle 30 is covered by the distal end 54 of the fluid port 50 . Alternatively or additionally, the collar 60 may be retracted over the barrel 10 as shown in FIG. 1A , resulting in full exposure of the needle 30 . [0040] Referring to FIG. 1B , two slotted rails 15 are longitudinally disposed on an exterior surface of the barrel 10 ; however, more rails could be provided. In the embodiment shown, the two rails 15 are equally spaced about the circumference of the barrel 10 . Referring to FIGS. 2 and 4A , the collar 60 includes two protuberances or fingers 62 extending from an interior surface (ID 3 ) of the collar 60 . The protuberances 62 engage the slots 75 ( FIG. 4B ) in the rails 15 , thereby controlling the sliding motion of the collar 60 relative to the barrel 10 between the first, retracted position ( FIG. 1A ) and the second, extended position ( FIG. 2 ). The barrel 10 may include a transversely extending side rail 16 that extends along at least a portion of the circumference of the barrel 10 . The side rail 16 extends from a distal end of the slotted rail 15 and also is slotted for accommodating the protuberance 62 . When the collar 60 is advanced to the extended position, the collar 60 can be rotated such that the protuberances 62 slide within the transverse side rails 16 . By rotating the collar 60 , it can be locked in place to prevent it from sliding back into its retracted position. In the embodiment shown in FIG. 4B , a locking mechanism 17 is disposed in the side rail 16 to prevent the protuberances 62 on the collar 60 from inadvertently rotating out of the side rails 16 . In one embodiment, the locking mechanism is a ramp or inclined block that permanently locks the collar 60 in its extended position. Alternatively, the locking mechanism can be thinned area of the slotted side rail 16 that provides for frictional resistance to the movement of the protuberance 62 . As shown in FIG. 4B , the rail 15 includes a locking mechanism 19 in the form of a bump or thinned area of the rail which provides enough frictional resistance to prevent inadvertent sliding of the collar 60 from the retracted position. [0041] In one embodiment, again referring to FIG. 4B , the collar may be reversibly locked in the retracted or extended position when the sliding collar thread pushes through an inclined angle 19 , 17 on the barrel located at the proximal and/or distal portion of the slotted rails 15 , 16 . [0042] Referring to FIGS. 1A and 4A , the collar 60 includes a sealing component 61 . The sealing component 61 can be a rubber o-ring disposed in an annular groove 63 formed in the inside diameter (ID 1 ) of the fluid port. The sealing component 61 maintains a constant watertight seal between the internal diameter (ID 1 ) of the fluid port 50 and the outer diameter (OD 10 ) of the needle 30 through any movement of the collar 60 either proximally to expose the distal end 32 of needle 30 or distally to cover the distal end 32 of the needle 30 (see FIG. 3 ). This results in the prevention of any fluid leakage between the needle 30 and the collar 60 . The system 1 may be attached to a needleless tubing system by the fluid port 50 and medication or other fluid may be injected from the interior space 40 through the needle 30 and out of the fluid port 50 and into the needleless tubing system. In one embodiment, the collar 60 includes an internal channel 79 passing through the distal end of the collar 60 and in which the groove 63 and O-ring 61 are disposed. [0043] FIGS. 5A and 5B are perspective views of one embodiment of the invention from a user&#39;s vantage point. In FIG. 5A , the collar is in the retracted position. In FIG. 5B , the collar 60 is in the extended position. As shown, the collar 60 can include structure 77 , such as knurling or protuberances that aid in the movement of the collar 60 . [0044] Additional embodiments include the use of a spring 70 ( FIG. 6 ) that favors the uncoiled position 72 (biasing the collar into the advanced position as shown in FIG. 7B ) over the coiled position 71 (i.e., the retracted position shown in FIG. 7A ). The spring 70 can be secured against the internal surface of the distal end 53 of the collar 60 and the external surface of the distal end 12 of the barrel 10 . These surfaces can also include grooves for holding the spring 70 in place. [0045] Another embodiment allows for a side action luer lock collar attachment as shown in FIGS. 8A and 8B . The side arm 80 is extended in position 81 and the collar 60 is held out to the side such that needle 30 can be used to draw up fluid. In FIG. 8B , the collar 60 is slid over the needle 30 and the side arm 80 is moved into a shortened position 82 , such that the collar 60 covers the needle 30 and the luer lock can engage needleless tubing systems. The arm 80 can be a linkage or other mechanical assembly that can move the collar 60 between the two positions and may include structure for securing the collar 60 in at least one of the two positions, for example the advanced position on the syringe barrel 10 . [0046] In one embodiment ( FIGS. 9A and 9B ), the rails are replaced by a thread 90 running around the barrel and the collar has a protuberance 91 which may be locked in a retracted position ( FIG. 9A ) or the advanced position ( FIG. 9B ) by rotation of the collar around the barrel. The collar 60 may be locked in place by frictional forces between the thread 90 and protuberance 91 . [0047] In another embodiment ( FIGS. 10A and 10B ), the collar 60 has an elliptical or circular circumference in the retracted position (elliptical and locked in FIG. 10A ) which is then deformed to the other shape (elliptical or circular) to move the collar into the advanced position (circular and slideable in FIG. 10B ) to aid in reversibly holding the collar in the retracted or advanced position by the frictional engagement of the collar with the barrel. [0048] In yet another embodiment ( FIGS. 11A and 11B ), which is a variation of FIGS. 9A and 9B , there is an additional external cylinder 110 that has an internal thread 111 , such that rotation of the cylinder 110 causes advancement of the collar 60 from the retracted position ( FIG. 11A ) to the advanced position ( FIG. 11B ) by the interface of the thread 111 with an external collar thread 112 and by the internal collar thread 90 interfacing with the protuberance 91 . [0049] The syringe system 1 may draw up medication from a medication bottle in a standard fashion with the collar 60 reversibly locked in its retracted position ( FIG. 1A ) and the operator pulling back on the proximal handle 21 of the plunger 20 . By this action, medication is drawn into the enlarging interior space 40 . Once this is complete, the collar 60 may be reversibly locked into its extended position as seen in FIG. 2 , simultaneously covering the distal end 32 of the needle 30 , and maintaining a seal between the sealing component 61 and the needle 30 . After converting the system 1 from needled to needleless, the syringe system 1 may be easily attached to the needleless tubing system via, for example, the threads 57 on the fluid port 50 . The plunger 20 may be advanced to move the medication distally through the sealed system and out through the needle openings 33 into the needleless tubing system. [0050] The size and shape of the syringe and associated components will vary to suit a particular application and patient (e.g., adult or pediatric). The specific dimensions, capacities, configurations will be selected to suit a particular application. For example, the syringe can have a volumetric capacity of about 0.05 cc to about 100.0 cc, the needle can be from about 33 gauge to about 10 gauge, and the needleless interface can be a luer type fitting. [0051] Generally, the components of the syringe system can be manufactured by injection molding or by modifying an extruded tube. For example, extrusion can be used to provide a uniform polymeric tube, to which other components are attached. Insert molding can be used to provide the desired geometry of the components and openings in a component can then be created in the desired locations as a subsequent mechanical operation. Additional manufacturing techniques include blow molding, compression molding, transfer molding, and any other molding techniques. For example, single-shot or multi-shot injection molding. The various components of the syringe system can be assembled by snap fitting, bonding, and/or tongue and groove connection. [0052] The syringe and related components can be manufactured from glass or plastic and may be made of a biocompatible material, such as, for example, polyurethane, silicones, polyethylenes, nylons, polyesters and polyester elastomers, either with or without reinforcement. Stainless steel and titanium can also be used, for example, for the needle. In addition, the needle can be formed from a polymeric material or a combination of metal and polymeric materials, for example, the needle can be stainless steel with a polymer over-molded on to the needle. The needle can have a sharp or blunt tip. Also, the polymeric materials may be used in combination with other materials, for example, natural or synthetic rubber. Other suitable materials will be apparent to those skilled in the art. In one embodiment, the barrel of the syringe is made of plastic, has graduated marks indicating the volume of fluid in the syringe, and is substantially transparent. The syringe plunger or piston may be made of rubber, which provides a good seal between the piston and the barrel. [0053] Various examples of syringe systems and their manufacturing, material, and arrangement details can be found in U.S. Pat. Nos. 7,182,734; 5,817,065; 5,681,295; and 5,273,543, the entire disclosures of which are incorporated herein by reference in their entireties. [0054] Having described certain embodiments of the invention, it will be apparent to those of ordinary skill in the art that other embodiments incorporating the concepts disclosed herein may be used without departing from the spirit and scope of the invention. The described embodiments are to be considered in all respects as only illustrative and not restrictive.

The present invention relates to a syringe system that allows rapid conversion between a needle/syringe system and a needleless/syringe system and in doing so allows an operator to move seamlessly between both systems, while minimizing needle stick risk. In this way, an operator may rapidly access medication bottles requiring a needle puncture and access needleless tubing systems requiring a needleless interface.

CROSS-REFERENCE TO RELATED APPLICATION [0001] This non-provisional application claims priority to the provisional application for patent Ser. No. 61/072,974 filed Apr. 4, 2008, which is commonly owned by the same assignee. BACKGROUND OF THE INVENTION [0002] This product for liquid delivery fragrance samples relates to the manufacture of a fragrance sampler page or piece and more specifically to liquid-delivery type fragrance samplers. These samplers are well known in the industry and are commonly found in magazines, used as retail handouts, or contained in advertising mailers. A unique aspect of the system is retention of a liquid fragrance sample upon the sampler using surface tension of the fragrance in cooperation with the texture of the sampler and without a perimeter weld or gluing of the sampler. DESCRIPTION OF THE PRIOR ART [0003] Typically, liquid-delivery type samplers comprise a liquid fragrance contained in a hermetically sealed film envelope which has a heat-sealed, or glued, perimeter so as to contain the liquid fragrance within these samplers without leaking. These samplers are generally manufactured in the form of a label comprising multiple film layers. Generally, the manufacturing process produces the samplers at slow speeds on small-format web or label presses that have been modified to suit the application. Machinery then mechanically or physically attaches the samplers to a carrier page for later incorporation into magazines or other mailings. Further, small stand-alone sampler pieces also provide handouts or flyers in retail establishments. [0004] The liquid fragrance material carried by the sampler is generally accessed by removing, or pealing away, a laminated cover portion of the sampler. These sample devices provide to fragrance manufactures methods and devices that present a rendition of their products for trial by prospective customers. In addition, the sample pages and pieces include graphics and advertising prose printed thereon, commonly seen in printed advertising media for another viable sales instrument. [0005] Prior art label-type pieces such as Bootman et al., U.S. Pat. No. 5,391,420, Muchin, U.S. Pat. No. 5,161,688, and, Bishopp, U.S. Pat. No. 5,439,172, teach methods of producing an effective liquid-fragrance advertising device. This type of devices rely upon a perimeter glue band, or heat seal, to prevent capillary action of the fragrance from occurring between the substrate layers of the sampler. Fragrance capillary action arises from the surface tension of the fragrance and the close proximity of the substrates and layers. Fragrance capillary action would cause leakage from within the sampler and onto the sample page, the carrier, or the magazine. Prospective customers avoid fragrances that leak from a sampler and damage a magazine. Leaky fragrance samples also lose their volatile components upon exposure to the atmosphere. The seal also aids in preventing leakage caused by compression loads, which occur with common frequency in sampler pieces that are contained in large stacks of magazines during assembly, mailing, transport, and display. [0006] The manufacturing operations, necessary to produce these perimeter seals, require continuous process monitoring because even slight process variation can cause the perimeter seals to fail. These products also require a minimum of three expensive, discontinuous auxiliary operations to produce a finished sampler page. [0007] More particularly, Bootman describes a pressure sensitive label comprising two plies of a film or plastic material: one bottom pressure sensitive ply, a deposit of fragrance material and an overlay of a second ply which traps the fragrance deposit. The sealing is by a perimeter heat seal. The draw back of this product is that the fragrance material is often forced into and through the seal areas under pressure from the stacking forces of many magazines, or inserts, in distribution. [0008] Then, Muchin builds upon Bootman by introducing a center ply material which has a die-cut window. This window ply is introduced onto the bottom pressure sensitive ply and thus creates a well for the fragrance material. The top, third ply is then added and the result is that stacking forces are distributed on to the widow ply and the fragrance material is exposed to less force that would have lead to seal failures and leakage: a major defect from Bootman. [0009] A more cost-effective method to produce liquid-delivery sample pages, or pieces, constructs the page from a commercially printable paper substrate and contains the liquid, volatile, fragrance material between layers of the substrates. By following this method, a single manufacturing platform completes the entire printing and assembling process in-line. The paper and other required materials are mounted and processed on the single line, and the finished product exits the end of the manufacturing line for packaging and then shipment. [0010] Other prior art includes some instances of liquid fragrance delivery devices that are also produced in-line during a single operation. The patent to Charbonneau, U.S. Pat. No. 5,419,958 discloses a paper-based sampler page designed to defeat fragrance pre-release by applying a volatile liquid treatment or coating to the sample application area so as to block the penetration of fragrance oils into the paper. [0011] This method requires sequential layers of barrier coating and involves the use of huge curing ovens to provide an adequate barrier. Most existing printing lines lack the floor space required for such additions. Therefore, the necessity exists to design and to construct a custom manufacturing line for implementation of this product. [0012] Further, Charbonneau does not disclose any method that would prevent the fragrance material from leaking out of the sampler. The types of coatings cited by Charbonneau have high susceptibility to surface inconsistencies, known as pin-holes. The pin holes appear from vapor off-gassing during the curing stage of the process. Then the thick coatings that resist the off-gassing cause the paper to curl badly. [0013] Then the patent to Whitaker et al., U.S. Pat. No. 5,645,161 discloses a multiplicity of construction methods. One embodiment comprises a heat-sealed perimeter that contains the liquid fragrance. Such heat sealing is a slow, cumbersome, and expensive manufacturing method. The maximum speed of the heat-seal unit falls short of the minimum operational speed of present day printing presses leading to a bottle neck of production at the heat seal unit while the presses operate at less an optimum rates. Another embodiment involves equipment that applies a patch of barrier-type film to the moving paper web of a printing press. This operation, too, would also fall behind the minimum operational speed of a modern printing press. [0014] The patent to Jones et al., U.S. Pat. No. 6,125,614 discloses a method of manufacturing a laminated page comprising a paper substrate carrier and a film substrate barrier layer. This continuous, film-type barrier layer glues to a paper substrate web to provide impermeability to the. film. Then to defeat fragrance material capillary action between the film layers and leakage during compression loads, an additional adhesive is applied to become a perimeter seal on the film layer. Ideally, this secondary glue band requires in-line curing to avoid off-odor detectable by the prospective customer which can occur from interaction between the adhesive and the fragrance material. The fragrance is then printed onto the film, and the area of the page containing the laminated film is then folded over onto itself, forming a pouch, or envelope, containing the fragrance material. The application of the perimeter glue band requires continuous monitoring through visual inspection by workers or automated sensors of the finished pieces as they come along the manufacturing line. [0015] Another challenge from the laminated, film and paper, construction of Jones, Whitaker, and Charbonneau, exists in the manufacturing scraps and wastes. The paper related recycle waste stream at bindery operations becomes contaminated by the film substrate during magazine edge-trimming operations. This contamination can be avoided by an expensive secondary die-cutting operation that removes the film substrate from the magazine trim-off area. This secondary operation though defeats the original economics of performing an all in-line construction. SUMMARY OF THE INVENTION [0016] This sampler contains liquid fragrance within the texture of one or more substrate layers. When a material, such as a liquid, attains a steady state upon a surface, the liquid has reached a state of repose, also called a state of rest or inactivity. In that state, the liquid or other loose, cohesion-less material, comes to rest in a pile of a known geometry defined by its angle of repose which is the maximum angle of slope measured from a horizontal plane. The angle of repose is related to the coefficient of friction of the material. [0017] The preferred embodiment of the liquid-delivery fragrance sample page or piece has a construction without a liquid tight and a vapor tight, perimeter glue band or heat seal. The liquid-delivery fragrance sampler page comes from easily produced, in-line manufacturing of a commercially printable material, preferably paper, which has an applied barrier coating to defeat permeation by the liquid fragrance material. The material of this invention, preferably paper, provides a substantially irregular, or textured, fragrance sample material mounting and application surface that self creates an occlusive, cohesive seal between the substrate layers when fragrance materials are applied between the layers. The material of the invention provides a self sealing device that retains a fragrance sample placed therein. Then at the place of usage of the sampler, the fragrance sample materials are easily accessed for trial by a prospective customer who opens a fold or removes a die-cut portion on the page of the sampler. [0018] More particularly in this invention, the opposing, textured substrates of the sampler plies are maintained in close proximity. There, the textured surfaces modify the behavior of the deposited fragrance material so as to defeat its capillary action and, thereby, act to occlude the migration of the fragrance material from its application area out from the sampler. Also, because the textured surface contains the liquid fragrance, the inability of the fragrance to flow in conjunction with its inherent surface tension makes the fragrance material substantially repose and maintain its position within the texture of the barrier coating. [0019] Numerous objects, features and advantages of the present invention will be readily apparent to those of ordinary skill in the art upon a reading of the following detailed description of the presently preferred, but nonetheless illustrative, embodiment of the present invention when taken in conjunction with the accompanying drawings. Before explaining the current embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. [0020] Therefore the object of the present invention is to provide a product for liquid delivery fragrance samples that requires no continuous perimeter heat seal or glue band in the fragrance or sample material&#39;s containment zone. [0021] Another object of the product for liquid delivery fragrance samples is to occlude capillary action of the fragrance material by separation of the substrates using the coated substrate&#39;s texture. [0022] Another object of the product for liquid delivery fragrance samples is to substantially fill the textured surface without affecting the position, or repose, or the fragrance sample within the textured surface by compressive loads. The reposed fragrance material remains within the application area&#39;s target zone. [0023] Another object of the product for liquid delivery fragrance samples is to provide the fragrance material&#39;s angle of contact in the finished sampler of at least ninety degrees. [0024] Another object of the product for liquid delivery fragrance samples is to create a cohesive seal between the substrate layers&#39; barrier coating because of the inherent surface tension of the fragrance material, thereby substantially reducing the fragrance material&#39;s contact with the atmosphere and thus greatly reducing its ability to evaporate. [0025] And lastly, another object of the product for liquid delivery fragrance samples is to determine the volume of the sample material contained in the sample application area by the total area of the textured surface and surface tension characteristics of the sample material. [0026] These together with other objects of the invention, along with the various features of novelty that characterize the invention, are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and the specific objects attained by its uses, reference should be had to the accompanying drawings and descriptive matter in which there is illustrated a preferred embodiment of the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0027] In referring to the drawings, [0028] FIG. 1 shows a sampler in plan view; [0029] FIG. 2 illustrates a detailed depiction of a tight grid, or cross hatch, texture pattern with an application of liquid fragrance material; [0030] FIG. 3 illustrates a detailed magnified depiction of a quad cell-type texture pattern with an application of liquid fragrance material; [0031] FIG. 4 illustrates a detailed depiction of a wide grid, or dot matrix-type, texture pattern with an application of liquid fragrance material; [0032] FIG. 5 illustrates a detailed depiction of a random dot pattern applied to the base coating layer through the use of an atomizer and an application of liquid fragrance material; [0033] FIG. 6 illustrates a top view of a pattern of concentric shaped ridges of coating material on the base barrier coating layer and an application of liquid fragrance material; and, [0034] FIG. 7 describes in a detailed view the interaction of liquid fragrance materials with adjoining surface texture. [0035] The same reference numerals refer to the same parts throughout the various figures. DESCRIPTION OF THE PREFERRED EMBODIMENT [0036] The present art overcomes the prior art limitations by assembling a product for liquid delivery fragrance samples where the liquid fragrance remains within the surface texture of a substrate because of a high angle of contact, thus limiting the adverse effects of capillary infiltration of the fragrance into the material of the invention. The high angle of contact of the fragrance sample in relation to the material of the present invention prevents wetting of the sample into the material. The present invention utilizes a highly hydrophobic systems that induces an angle of contact exceeding ninety degrees. The present invention 10 begins with the components of a fragrance formulation selected by a fragrance house or manufacturer. The fragrance formulation is then rendered into a liquid for placement upon a sampler, or piece, as in FIG. 1 where the preferred embodiment is shown opened. The printable paper page, sheet of material, or substrate 1 , has a generally rectangular shape where the longitudinal axis is longer than the lateral axis. In this figure, the longitudinal axis is oriented upright. The substrate has a fold line, as at 2 , slightly off center to allow for covering the fragrance sample and the application of adjacent printing. The fold line divides the substrate into a base 1 a to the left of the fold line and a cover 1 b to the right of the fold line. Alternatively, the cover may be a hinged portion of the base that folds upon a portion of the base. In a further alternate embodiment, the cover and the base may be of separate sheets of material that overlay at least a portion of one sheet. Mutually spaced apart from the fold line 2 and in mutual registration, the substrate has two ultraviolet light cured, cationic barrier-type coated surfaces, as at 3 on the left or base 1 a and as at 4 on the right or the cover 1 b, that come into registered contact when the cover is folded along the fold line 2 upon the base. The coated surface 3 , or section of barrier coating, has a substantially smooth surface. In contrast, the opposite coated surface 4 includes a textured surface of known geometry applied upon a barrier coating, as later shown in FIGS. 2-5 , and an application of liquid fragrance sample material 5 within the perimeter of the textured surface. Though a sample material is described broadly, the sample includes lipstick, liquid cosmetics, liquid fragrances, substantially gelled fragrances, and liquid fragrances with chemically altered viscosity and surface tension. The liquid fragrances include various additives that manipulate the viscosity and surface tension of the fragrance solution without affecting its scent. Then an enlarged depiction of the coated surface 4 , or textured coating section, appears in FIGS. 2-6 . [0037] The liquid fragrance sample may undergo modification of its viscosity in various ways. Such modifications utilize fragrance oils or other fluids to change the resulting viscosity of the modified fragrance solution. Typically, fragrance oil has a viscosity range of about 2 to about 12 centipoise. However, the type of applicator or dispensing equipment may require thickening of the liquid, that is a higher viscosity, for proper passage of the fragrance liquid through the equipment. Most equipment operates upon liquids having a viscosity between 40 centipoise and 2400 centipoise, however, liquid viscosity in the range of 200,000 centipoise are still accommodated. The liquid fragrance of modified viscosity includes a blend of materials, or the addition of rheology modifiers, emulsions, suspensions, reacted materials, and other forms of thickened liquids. The liquid fragrance of modified viscosity may or may not have adhesive qualities. [0038] The Applicants foresee modifying the liquid fragrance&#39;s viscosity using various components. Those components include blends of cellulose gums, cellulose derivatives, carboxymethylcellulose, sodium carboxymethylcellulose, hydroxypropylcellulose, hydroxyethylcellulose, methylcellulose, ethylcellulose or ethycell; vegetable gums, xanthan gum, acacia gum; alginates, carrageenan, alcogum; silicones, versagels, silicone fluid 200; clays, veegum, bentone gel, silicas, untreated fumed silica or Cabosil® M-5 from Eager Plastics of Chicago, Ill., specially treated fumed silica or Cabosil®TS-720, TS-630; surfactants, sodium lauryl sulfate, ammonium lauryl sulfate; fillers, calcium polycarbophil; emulsions, polyvinyl alcohol or Celvol® from Celanese Corp. of Dallas, Tex.; and suspensions, acrylic acid derivatives such as Carbopol® 940 and Ultrez® 10 from Lubrizol Corp. of Wickliffe, Ohio. One example of medication adjusts the viscosity of fragrance oil by adding ethycell at the rate of five percent by weight and mixing the solution at room temperature under high shear for five hours. This modification produces a fragrance oil with its viscosity increased to the range of 1700 to 1900 centipoise. [0039] In the operations of this invention, the textured coating has the cosmetic sample locating within its interstices. Then mutually parallel barrier coatings layer upon and confront the textured coating. The sample remains with the textured coating because of stilting and its repose while the textured coating becomes effectively sealed by the adjacent barrier coatings. This layered arrangement of textured coating and barrier coating does not require a perimeter seal by heat or other welding methods. [0040] Generally, the textured coating section has a pattern of spaced apart cells or a plurality of pockets. The sample page 1 also has a plurality of means to adhere the invention into a closed form including non-permanent adhesive applications, as at 6 , in a pattern upon the cover 1 b that maintain the barrier surfaces 3 and 4 in close proximity when the cover 1 b is closed upon the base 1 a as at the end of manufacturing, during shipment, and through the mail. The adhesive applications may include a pressure sensitive adhesive activated during manufacturing when the textured coating section is closed upon the barrier coating section and a repositionable glue that adheres the material of the device to itself temporarily but allows for ready separation of the parts of the device or the device from a mailpiece. The adhesive applications, 6 , keep the sampler 1 closed until the cover 1 b is opened from the base 1 a by the prospective consumer. Additionally, either coated surface, 3 , 4 , or the sheet of material may have a further application of pressure sensitive adhesive that activates upon insertion of the invention into a printed material. This usage of adhesive secures the invention, when closed, upon a page or a card or into a magazine or other material as part of a consumer mailing campaign. [0041] Alternatively, the textured coating section and the barrier coating section are located upon separate. sheets of material, such as select papers. Each sheet of material then has a barrier coating applied thereto and one sheet has the textured section applied upon its barrier coating. Though on separate sheets. the textured coating section registers with the barrier coating section of another sheet so that the individual pieces of texture retain the liquid fragrance sample within the spaces of the textured surface as later shown in FIG. 7 . [0042] The barrier coating, or base coat, of the invention begins with an existing low odor, ultraviolet curable, cationic type varnish. Such a varnish includes RAD-KOTE product number K261 from Actega Radcure of Wayne, N.J. This varnish has a viscosity of approximately 375 centipoise. The low odor attribute of this varnish makes it preferable over coatings from other manufacturers. The barrier coating is applied on to a printed web of material using a flexographic coater with a Cyrel type printing plate. The printing plate has a smooth finish and is sized to meet the dimension of the desired application. Generally, the barrier coating is applied to the web of material in a thickness of about 0.3 to about 0.6 mils, depending on the surface finish or porosity of the web of material, commonly paper or substrate. An about 0.3 to about 0.4 mil thick application of base coat is effective on a high quality, smooth finish paper which is used in commercial printing. The coating then undergoes curing at an ultraviolet light curing station mounted directly after the flexographic coater. The intensity of ultraviolet light used relates to the desired operation speed of the press. Generally, printers provide approximately 100 watts of ultraviolet light per every 100 feet per minute of press web speed. As an example, a press running at 1000 feet per minute calls for 1000 watts of ultraviolet light curing capability. [0043] The present invention also provides an embodiment where the prospective customer accesses the sample of fragrance through a die cut opening. The die cut opening can be in the textured coating section, the opposite barrier coating section, or both the textured coating section and the barrier coating section. In usage, the textured coating section has the sample of fragrance deposited upon it and then folded upon the barrier coating section with the die cut opening upwards. The prospective customer then removes the textured coating section within the die cut to test the fragrance. [0044] Then FIG. 2 depicts a detailed view of a tight grid, or cross hatch, texture pattern upon the coated surface 4 . This pattern has lines intersecting at right angles with the lines of thinner width than the squares of substrate between adjacent lines. This pattern provides a suitable application surface for liquid fragrance sample material, as at 5 , along the thin lines between the squares of substrate material. [0045] The texture coating is preferably a low odor, ultraviolet curable, cationic type adhesive. Such an adhesive includes RAD-KOTE product number K6004B from Actega Radcure of Wayne, N.J. This adhesive has a viscosity of approximately 825 centipoise. The Applicants prefer this adhesive for its ability to build height to the texture, as it possesses a greater viscosity and solids content than what is used for the base coat. Though described as an adhesive, the present invention has the adhesive cured immediately in a pattern as later shown that builds the texture of the invention. [0046] The texture coating is also applied to the material, paper, or substrate, using a flexographic coater with a Cyrel type printing plate followed by immediate curing at an ultraviolet station as previously described. This printing plate though has a raised, or negative image, of the desired texture pattern in the appropriate size for the desired product. Generally, the texture coating is applied in a thickness ranging from about 0.25 mils to about 2.5 mils depending on the amount of fragrance loaded into the present invention. The Applicants prefer a thickness in the range of about 0.5 miles to about 1.25 mils. As an example of single sided texture delivery device includes a one square inch fragrance fluid application upon a 30 line per inch grid texture where the grid has a 1.0 mil height. This example yields a payload of approximately 0.27 fluid drams or about 0.1 milliliter. The present invention also includes textured coating upon both surfaces which doubles the fragrance payload. [0047] Alternatively, the liquid fragrance material is applied by a flexographic coater as previously described. This printing plate though is made of a soft, closed cell foam material, such as Poron®. These plates, or pads, possess a smooth surface and a low memory attribute that enhances application repeatability, usually for adhesive application. [0048] FIG. 3 illustrates a detailed view of an alternate embodiment of the texture pattern as a quad cell-type pattern also upon the coated surface 4 . This pattern has individual cells, of substrate material, with rounded corners where the cells are oriented at a forty five degree angle to the edges of the product sampler. The application of liquid fragrance material, as at 5 , generally occupies the diamond like shapes between the cells in this figure. [0049] FIG. 4 shows a detailed view of a dot matrix-type texture pattern upon the coated surface 4 . Similar to FIG. 2 , this pattern also has lines at right angle intersections with the lines having similar width to the squares of substrate between adjacent lines. This pattern has a suitable application surface for liquid fragrance sample material, as at 5 , along the wider lines between the squares of substrate material. [0050] FIG. 5 provides another detailed view but of a random dot pattern of the base coating layer applied to the substrate as the coated surface 4 through the use of an atomizing device. Alternatively, the random dot pattern arises upon mixing a fine aggregate particle material, such as nylon spheres of a certain diameter, into the barrier coating material and applying the mixture upon the substrate to create texture that secures an application of liquid fragrance material, as at 5 . In a further alternate embodiment, a textured barrier film applied to the cover forms the coated surface 4 . In another alternate embodiment, mechanically altered, or distressed, coating film applied to the cover makes the textured coating section. The textured coating section may also have porosity that defines a pattern of texture for retaining liquid fragrance material. [0051] And then, FIG. 6 shows a detailed view of a pattern of concentric shaped ridges of coating material on the base barrier coating layer, or coated surface 4 . The ridges, or surfaces, generally follow the shape of the perimeter of the sampler product and each ridge is spaced at an interval inwardly from the previous ridge. The interval, or spacing, between adjacent ridges retains an application of liquid fragrance material, as at 5 , upon the sampler product. In alternate embodiment, the outermost ridge may also be a glue band that seals the two surfaces together thus preventing contamination of the fragrance sample therein. [0052] Following the description of the various patterns upon the coated surface 4 , FIG. 7 shows the interaction of a liquid fragrance sample with the surface texture in a pattern similar to that shown in FIG. 4 . This view is highly magnified, generally showing individual droplets of fragrance secured within the texture, particularly its surface features. The paper of this invention provides a textured mounting surface, as at 4 , to which is applied fragrance material, as at 5 , here shown between individual cells of texture, as at 4 . Opposite the mounting surface 4 , the invention has a smooth surface 3 onto which the mounting surface abuts. The individual textures of the mounting surface contact the smooth surface and seal the gaps between individual textures. The individual textures modify the behavior of the deposited fragrance material, such as at 5 between two adjacent textures 4 , so as to defeat its capillary action. The textured surface thus occludes the migration, or flow, of the fragrance material from its application location through the smooth and the textured surfaces as at 3 , 4 and then out of the product sampler. The present invention achieves stilting between the cover and the mounting surface. In an embodiment with two separate films as the cover and mounting surface, the separate films with the appropriate surface coatings and textures avoid or retard the capillary infiltration of a liquid cosmetic into the fibers of the sampler. Further, because the textured surface contains the liquid fragrance, the inability of the fragrance to flow along with its inherent surface tension causes the fragrance material to substantially repose and remain within its locations inside the texture of the barrier coating supplied upon the textured surface 4 . Thus, the mounting surface and the smooth surface create an occlusive, cohesive seal between the surfaces at each location where fragrance materials are applied thus removing the need for any perimeter seal of the product sampler. [0053] In an alternate embodiment, two opposed textured surfaces, such as 4 , can be used. The high points of each textured surface abut each other and form a liquid retaining seal. Preferably, the two opposed textured surfaces utilize raised cross hatch patterns that seal against each other. [0054] From the aforementioned description, a product for liquid delivery fragrance samples has been described. The sampler product is uniquely capable of retaining a liquid fragrance sample upon a substrate within a folded cover and without a perimeter adhesive or heat seal. The sampler product may be manufactured from many materials, including but not limited to, paper, cardstock, paperboard, polymers, ferrous and non-ferrous metal foils and their alloys, and composites.

The product for liquid delivery fragrance samples lacks a liquid tight and a vapor tight, perimeter glue band or heat seal. The product comes from easily produced, in-line manufacturing of a commercially printable paper which has an applied barrier coating to defeat permeation by the liquid fragrance material. The product has a substantially irregular, or textured, fragrance sample material mounting and application surface that creates an occlusive, cohesive seal between the substrate layers when fragrance materials are applied. The opposing, textured substrates of the product are in close proximity where the textured surfaces defeat the capillary action of the fragrance sample, and thereby occlude the migration of the fragrance sample out from the product. Also, the inability of the fragrance to flow in conjunction with its inherent surface tension makes the fragrance sample substantially repose within the texture of the barrier coating. Then for usage, the fragrance sample is accessed by a prospective customer who opens a fold or removes a die-cut portion.

TECHNICAL FIELD [0001] The present invention relates to an ion diffusing apparatus that includes an ion generator and a fan, more particularly, to an ion diffusing apparatus that facilitates replacement of the ion generator and is able to keep a stable ion supplying capability; and to an ion generating cartridge. BACKGROUND ART [0002] In recent years, a function is discovered, in which by means of positive ions and negative ions generated into the air, germs floating in the air are killed and viruses are inactivated; and products such as an air cleaner and the like to which this technology is applied are attracting attention from people. [0003] Besides, as an ion generating portion that generates the positive ions and the negative ions, a plasma discharge type is known, in which electric discharge is performed between a needle-shape positive discharge electrode and a plate-shape induction electrode, and between a needle-shape negative discharge electrode and the plate-shape induction electrode; thus, the positive ions are generated from the positive discharge electrode and the negative ions are generated from the negative discharge electrode. The plasma discharge is performed at the needle-shape positive and negative discharge electrodes, so that the air and vapors are ionized and the positive ions and negative ions are generated. As the positive ion, H + (H 2 O) m (m is a natural number), in which a plurality of water molecules are bonding to a circumference of a hydrogen ion, is chiefly generated; and as the negative ion, O 2 − (H 2 O) n (n is a natural number), in which a plurality of water molecules are bonding to a circumference of an oxygen ion, is chiefly generated. [0004] If the above H + (H 2 O) m and O 2 − (H 2 O) n bond to a surface of a floating germ, chemical reaction occurs, thereby generating hydrogen peroxide (H 2 O 2 ) or hydroxyl radical (.OH) that are active species. Because of this, the floating germ is destroyed by the decomposition action of the active species. It is said that in this way, it is possible to kill or inactivate the germ-relatives in the air such as bacteria, viruses and the like to remove them. [0005] As described above, by supplying H + (H 2 O) m and O 2 − (H 2 O) n into a room at the same time, it becomes possible to kill and inactivate the germ-relatives contained in the air of the room. However, in a case where impurities or dust collects on the needle-shape discharge electrode that is the ion generating portion, the ion generation effect deteriorates, so that it becomes impossible to supply a desired amount of generated ions. [0006] To kill and inactivate the germ-relatives in the air to remove them, because an amount of the positive ions and of the negative ions are needed, more than a predetermined amount of the positive ions and of the negative ions per unit volume becomes necessary, so that as for an ion generating portion whose ion generation effect deteriorates, it is preferable to eliminate the cause of the deterioration or repair the ion generating portion. [0007] Because of this, to facilitate demounting, cleaning and maintenance of an air processing unit and an ion diffusing apparatus, an air processing unit and an ion diffusing apparatus which are removably mounted on a base portion for mounting the air processing unit and the ion diffusing apparatus are already proposed (e.g., see patent document 1). CITATION LIST Patent Literature [0008] PLT1: Japanese patent No. 4114602B2 SUMMARY OF INVENTION Technical Problem [0009] By supplying the positive ions and negative ions into a room, it is possible to kill and inactivate germ-relatives floating in the air to clean the room; however, the germ-relatives are killed, inactivated and removed by using the positive ions and negative ions at the same time, it is preferable the amounts of positive ions and negative ions remaining in the air are equal to or more than a predetermined amount; and the amounts are approximately equal to each other. [0010] Moreover, according to a method in which when diffusing, by means of a fan and the like, the positive and negative ions that are generated from an ion generating portion of an ion generating apparatus, the ions are diffused by means of an air flow generated by simply sending a wind to the ion generating portion, the positive and negative ions collide with each other to be neutralized, so that it is hard to evenly disperse the ions into the air without the neutralization. Besides, according to a method in which the positive and negative ions are separately generated and carried by means of a sending wind, it is possible to carry the ions to a distant place by preventing the ions from colliding with each other; however, the amount of the dispersed positive and negative ions does not become even, so that it is impossible to achieve desired killing and inactivating effects. [0011] Because of this, an ion diffusion apparatus is desired, in which the positive and negative ions are evenly generated; the remaining amount per unit volume of the ions sent out into a room is increased, and the percentages of the respective positive- and negative-ion remaining amounts are substantially the same as each other. Moreover, a structure which facilitates the maintenance of the ion generating portion is desired. [0012] In light of the above problems, it is an object of the present invention to provide an ion diffusing apparatus and an ion generating cartridge which are so structured as to allow an ion generating apparatus to be freely mounted and demounted; able to generate evenly the positive ions and the negative ions while sending out them far into a room. Solution to Problem [0013] To achieve the above object, an ion diffusing apparatus according to the present invention that diffuses positive ions and negative ions generated by plasma discharge into a room, the ion diffusing apparatus comprises: [0014] a fan that generates an air flow for exhaling air, which is inhaled from an inlet, from an outlet into the room via a flow passage that is formed in the apparatus; [0015] an ion generating apparatus that includes a positive ion generating portion and a negative ion generating portion; and supplies positive ions generated from the positive ion generating portion and negative ions generated from the negative ion generating portion into the air flowing through the flow passage; and [0016] an ion generating apparatus housing portion that houses the ion generating apparatus in such a posture that an ion generating surface of the ion generating apparatus is exposed with the ion generating surface matched with a flow surface of one surface which forms a wall surface of the flow passage; wherein [0017] the ion generating apparatus is able to be inserted and pulled out from an insertion opening that is formed through a side of the outlet, and freely mountable and demountable into and from the ion generating apparatus housing portion. [0018] According to this structure, the ion generating apparatus, whose ion generating surface is exposed in such a posture that the ion generating surface matches with the flow surface of the flow passage, and which is freely mountable and demountable into and from the ion generating apparatus housing portion, is disposed, so that it is possible to obtain the ion diffusing apparatus, in which the maintenance is easy and it becomes possible to exhale the ions emitted from the ion generating surface by means of a streamline flow along the flow surface, and to send out the positive ions and the negative ions far into the room by curbing the collision between the positive ions and the negative ions and preventing them from being neutralized. [0019] Besides, in the ion diffusing apparatus having the above structure according to the present invention, the one surface is composed of a lower lateral wind-direction plate that forms a lower wall surface of the flow passage. According to this structure, it is possible to obtain the ion diffusing apparatus that sends out the positive and negative ions in a horizontal direction of the room along a flow surface of the lower lateral wind-direction plate; and it becomes possible to exhale the positive and negative ions into the room region where people are living. [0020] Besides, the ion diffusing apparatus having the above structure according to the present invention is formed as an ion generating cartridge that includes an ion generator that has the positive ion generating portion and the negative ion generating portion, the ion generating cartridge houses the ion generator and unitarily includes: [0021] an insertion guide portion; [0022] a position guide portion; and [0023] a lever member that engages with an engagement portion disposed in the ion generating apparatus housing portion of the apparatus main body to fix the position of the cartridge; wherein a structure is employed, in which the ion generating apparatus is inserted from the insertion opening into the ion generating apparatus housing portion via the insertion guide portion and the position guide portion; and fixes the ion generating apparatus in such a posture that the ion generating surface is matched with the flow passage via the position guide portion and the lever member. [0025] According to this structure, the ion generating apparatus is formed as the cartridge type that unitarily includes: the insertion guide portion; the position guide portion; and the lever member, so that the ion generating apparatus which facilitates the maintenance is obtained. Besides, it is possible to fix the ion generating surface while exposing the ion generating surface, which has the curved surface matching with the flow surface of the lower wind-direction plate, via a cut-away portion formed through the lower wind-direction plate. [0026] Besides, in the ion diffusing apparatus having the above structure according to the present invention, the ion generating apparatus includes the ion generator in which the positive ion generating portion and the negative ion generating portion are spaced apart in a direction that intersects an air flow direction; and a vertical wind-direction plate, which partitions the flow passage into flow passages for the respective positive ion generating portion and negative ion generating portion, is disposed in the flow passage. According to this structure, it becomes possible to separately carry the positive ions and the negative ions, so that it is possible to curb further effectively the collision between both ions of the positive and negative ions; and to obtain the ion diffusing apparatus that is able to send out the ions far into the room without neutralizing the ions. [0027] Besides, in the ion diffusing apparatus having the above structure according to the present invention, an intermediate lateral wind-direction plate, which partitions a flow passage between the lower lateral wind-direction plate and an upper lateral wind-direction plate that forms an upper wall surface of the flow passage, is disposed to partition the flow passage that extends from the fan to the outlet into multi-stage streamline flow passages; [0028] a plurality of the ion generating apparatuses are disposed in parallel with each other to form a continuous-length ion generating surface that has alternately the positive ion generating portion and the negative ion generating portion in a line at a predetermined pitch along the flow passage of the lower lateral wind-direction plate; and [0029] the vertical wind-direction plate, which partitions the flow passage into the flow passages for the respective positive ion generating portion and negative ion generating portion, is so disposed as to penetrate the multi-stage streamline flow passages. [0030] According to this structure, each ion generating apparatus, which includes the positive ion generating portion and the negative ion generating potion, becomes freely mountable and demountable, so that not only the maintenance becomes easy but also sophisticated maintenance becomes possible. Besides, the flow passage is disposed for every electrode, so that it becomes possible to send out the positive and negative ions far into the room by curbing the neutralization of the positive and negative ions. [0031] Besides, in the ion diffusing apparatus having the above structure according to the present invention, the vertical wind-direction plate is angled in such a way that the ions are exhaled at a wide angle with respect to a width direction in which the ion generating apparatuses are disposed in parallel with each other. According to this structure, the flow passage disposed for every ion generating portion is widened in a wide angle, so that it is possible to disperse the ions into a predetermined area of the room. [0032] Besides, in the ion diffusing apparatus having the above structure according to the present invention, the ion generating cartridge includes: [0033] an input-output connector portion that connects with an external electrode to perform input and output; [0034] a control board that controls driving of the positive ion generating portion and the negative ion generating portion by means of electric power obtained via the input-output connector portion; and [0035] an ion sensor that detects the ions generated by the ion generating portion. [0036] According to this structure, it is possible to obtain the ion generating apparatus formed as the ion generating cartridge which is able to be connected to an external power supply or an external terminal via the input-output connector portion and is easy to check for normal operation via the ion sensor that is disposed in advance. [0037] Besides, in the ion diffusing apparatus having the above structure according to the present invention, the ion sensor is a negative ion detection sensor that is disposed on a downwind side with respect to the negative ion generating portion of the ion generating cartridge. According to this structure, the amount of negative ions generated from the negative ion generating portion during an operation time of the ion diffusing apparatus is detected, so that it is possible to detect whether the ion generating cartridge is normally operating or not and how much the ion generating cartridge deteriorates. [0038] Besides, in the ion diffusing apparatus having the above structure according to the present invention, a positive ion generating electrode of the positive ion generating portion of the ion generator and a negative ion generating electrode of the negative ion generating portion of the ion generator are each of a double electrode type in which two generating electrodes are disposed close to each other. According to this structure, it is possible to increase the amount of generated ions. [0039] Besides, in the ion diffusing apparatus having the above structure according to the present invention, the ion generating cartridge is formed as a two-stage ion generating type in which the ion generators are disposed in two stages and in parallel with each other; and positive and negative polarities of the positive ion generating electrode and the negative ion generating electrode of the respective ion generators are disposed at reversed positions. According to this structure, it becomes possible to exhale the positive ions and the negative ions into the same flow passage by driving the two-stage ion generators at the same time; and to alternately exhale the positive ions and the negative ions into the same flow passage by alternately driving the two-stage ion generators. [0040] Besides, in the ion diffusing apparatus having the above structure according to the present invention, the ion generators in the respective stages of the ion generating cartridge of the two-stage ion generating type are alternately operated. According to this structure, it is possible to prolong double the life of the ion generating cartridge. [0041] Besides, in the ion diffusing apparatus having the above structure according to the present invention, an open-close cover for closing and opening the insertion opening is disposed; the ion generating cartridge is inserted until a predetermined position; when the lever member is rotated to a fix lock position where a hook portion of the lever member is engaged with the engagement portion of the main body, the closing of the open-close cover is possible; and in a state in which the lever member is not rotated to the fix lock position, the lever member hinders the open-close cover from being closed. According to this structure, in a case where the ion generating cartridge is not disposed at a correct position of the ion generating apparatus housing portion and not locked, it is impossible to close the open-close cover, so that it is possible to easily detect the faulty disposition of the ion generating cartridge. [0042] Besides, in the ion diffusing apparatus having the above structure according to the present invention, a drive start-stop operation portion is disposed on the apparatus main body; the operation portion is provided with: a drive mode set portion that sets a rotation speed of the fan; a cartridge disposition time set portion that sets disposition of a new ion generating cartridge; a timer set portion; a replacement recommendation indication portion that recommends cartridge replacement after elapse of a predetermined time after the new cartridge is disposed and the operation is started; and a level indication portion that indicates whether the amount of the ions generated by each ion generating cartridge is equal to, over or under a predetermined amount. According to this structure, as for an ion generating cartridge whose service life is decided in advance, it is possible to notify that a replacement time is coming by performing indication for recommending the replacement after elapse of a time from the disposition of the new cartridge. Besides, if the amount of generated ions is equal to or under the predetermined amount, the information is indicated, so that it is possible to know the maintenance is necessary. [0043] Moreover, the ion generating apparatus according to the present invention, which generates the positive ions and negative ions by means of the plasma discharge, is formed as an ion generating cartridge that includes: [0044] an input-output connector portion that connects with an external electrode and performs input and output of a signal; [0045] an ion generator in which a positive ion generating electrode and a negative ion generating electrode are disposed; [0046] an ion sensor that detects ions generated by the ion generator; and [0047] a control board that controls drive of the ion generator by means of electric power obtained via the input-output connector portion. [0048] According to this structure, the respective ion generating portions for the positive ions and the negative ions are disposed, so that it becomes easy to handle the ion generating apparatus of the cartridge type that generates the positive and negative ions at the same time. Besides, the ion sensor is disposed, so that it is possible to obtain the ion generating cartridge which is easy to check for normal operation. [0049] Besides, in the ion generating cartridge having the above structure according to the present invention, the ion sensor is a negative ion detection sensor that detects the negative ions generated from the negative ion generating electrode. According to this structure, when the ion generating electrode portion deteriorates, the amount of the negative ions generated from the negative ion generating electrode also decreases, so that by detecting the amount of the negative ions generated from the negative ion generating electrode during the operation, it is possible to detect whether the ion generating cartridge is normally operating or not and how much the ion generating cartridge deteriorates. [0050] Besides, the ion generating cartridge having the above structure according to the present invention includes: [0051] a lever member which has: a handle portion that is held at times of insertion and pulling-out of the cartridge; and a hook member that fixes the cartridge at a predetermined position after the insertion; wherein [0052] a side portion of a frame body of the cartridge is provided with: a guide protrusion portion, a butt surface and a guide surface that perform a guide function at the time of inserting the cartridge. According to this structure, it is possible to obtain the ion generating cartridge that becomes easily mountable and demountable at the predetermined position of the ion diffusing apparatus via the butt surface, the guide surface that perform the guide function and the lever member that includes the hook member. [0053] Besides, the ion generating cartridge having the above structure according to the present invention has a rectangular shape when viewing an ion generating surface, from top, on which the positive and negative ion generating portions are disposed; [0054] the ion generator is formed as a two-stage ion generating type in which positive and negative polarities of the ion generating electrode portions are disposed at reversed positions in two stages and in parallel with each other; and [0055] the ion generating surface is formed into a curved surface that matches with a flow surface where the ion generating cartridge is disposed. [0056] According to this structure, the flow surface where the ion generating cartridge is disposed is provided with the rectangular-shape cut-away portion, so that it is possible to obtain the ion generating cartridge which is able to be disposed with the ion generating surface matched with the flow surface. Besides, it becomes possible to send out the positive and negative ions into the partitioned flow passages at the same time and to alternately send out them. [0057] Besides, in the ion generating cartridge having the above structure according to the present invention, the ion generators in the respective stages of the ion generating cartridge of the two-stage ion generating type are alternately operated. According to this structure, it is possible to obtain the ion generating cartridge which alternately sends out the positive and negative ions into the partitioned flow passages and the life of which becomes double. Advantageous Effects of Invention [0058] According to the present invention, the ion generating apparatus is obtained, in which while the ion generating surface is matched with the flow surface of the flow passage that extends from the fan to the outlet, the ion generating apparatus supplies the positive ions and the negative ions into the air flowing through the flow passage, and is freely mountable and demountable into and from the ion generating apparatus housing portion, so that it is possible to obtain the ion diffusing apparatus whose maintenance is easy and which is able to send out the positive ions and the negative ions far into a room by curbing the collision between the positive ions and the negative ions and without neutralizing them. Besides, the ion generating apparatus is formed as the ion generating cartridge that includes: the input-output connector; the ion generators for respectively generating the positive ions and the negative ions; the ion sensor; and the control board, so that it becomes easy to handle the ion generating apparatus of the cartridge type which generates the positive and negative ions at the same time and evenly. Besides, the ion sensor is disposed, so that it is possible to obtain the ion generating cartridge which is easy to check for normal operation. BRIEF DESCRIPTION OF DRAWINGS [0059] [ FIG. 1 ] shows an example of an ion diffusing apparatus according to the present invention, of which FIG. 1 ( a ) is a side sectional view; and FIG. 1 ( b ) is a front view. [0060] [ FIG. 2 ] is a schematic descriptive view showing an insertion procedure of an ion generating cartridge according to the present invention, of which FIG. 2 ( a ) is a side sectional view showing a state in which an insertion is started; FIG. 2 ( b ) is a side sectional view showing a state in which the insertion is being performed; and FIG. 2 ( c ) is a side sectional view showing a state in which the insertion is completed. [0061] [ FIG. 3 ] is a schematic descriptive view of a lever member of an ion generating cartridge, of which FIG. 3 ( a ) is an enlarged descriptive view showing a fix lock portion; and FIG. 3 ( b ) is a plan view of an entire lever member. [0062] [ FIG. 4 ] shows an example of an ion generating cartridge according to the present invention, of which FIG. 4 ( a ) is a plan view; and FIG. 4 ( b ) is a side view. [0063] [ FIG. 5A ] is a schematic descriptive view of a flow passage. DESCRIPTION OF EMBODIMENTS [0064] Hereinafter, embodiments of the present invention are described with reference to the drawings. Besides, the same constituent members are indicated by the same reference numbers and detailed description of them is suitably skipped. [0065] An ion diffusing apparatus according to the present embodiment is an ion diffusing apparatus that includes an ion generating apparatus and a fan, and sends out ions generated by the ion generating apparatus into a room; as shown in FIG. 1 ( a ), an apparatus main body 2 is provided with a fan 3 and an ion generating apparatus 10 that includes an ion generator which has a positive ion generating portion and a negative ion generating portion. Besides, an outlet 4 for sending out the ions generated by the ion generating apparatus 10 to outside is disposed on a front side of the apparatus main body 2 ; and an inlet 5 is disposed on another side (e.g., bottom surface) of the apparatus main body 2 . [0066] It is also possible to dispose an air filter at the inlet 5 that inhales air; and a stricture is employed, in which the air inhaled from the inlet 5 is sent to the ion generating apparatus 10 that performs plasma discharge via the fan 3 ; and the air and vapors are ionized and sent out from the outlet 4 . [0067] The ion generating apparatus 10 includes the ion generator that includes a pair of electrodes each of which performs the plasma discharge; as described later, a positive ion generating portion that includes a positive ion generating electrode and a negative ion generating portion that includes a negative ion generating electrode are disposed away from each other by a predetermined distance. [0068] Besides, a lower lateral wind-direction plate 22 A that serves as a lower wall surface of a flow passage which extends from the fan 3 to the outlet 4 , and an upper lateral wind-direction plate 22 E that serves as an upper wall surface of the flow passage which extends from the fan 3 to the outlet 4 are disposed. And, an ion generating apparatus housing portion, in which the ion generating apparatus 10 is disposed while an ion generating surface where the ion generator is disposed is matched with a flow surface of the lower lateral wind-direction plate 22 A, is formed. Besides, an insertion opening 6 is formed on the outlet side to make it possible to freely mount and demount the ion generating apparatus 10 from the front side of the ion diffusing apparatus 1 . Here, if a structure is employed, in which the ion generating apparatus 10 is formed as a cartridge type and disposed in the ion generating apparatus housing portion that is formed in the apparatus main body, the ion generating apparatus becomes freely mountable and demountable and the replacement becomes easy, which is preferable. Because of this, in the present embodiment, the ion generating apparatus 10 is formed as the cartridge type that unitarily includes: an insertion guide portion; a position guide portion; and a lever member 14 that engages with an engagement portion disposed in the ion generating apparatus housing portion of the apparatus main body to fix the position of the cartridge, so that a structure is obtained, in which the cartridge is freely mountable and demountable in such a posture that the ion generating surface is exposed to the flow surface via the lever member 14 . [0069] The ion generating apparatus 10 is formed as the cartridge type and freely mountable and demountable in a state in which the ion generating surface is matched with the flow surface that forms the flow passage; accordingly, it is preferable that the ion generating surface, where the positive ion generating portion and the negative ion generating portion are disposed, has a shape that matches with the flow surface. Besides, it is preferable that the positive and negative ion generating portions are disposed away from each other in a direction which intersects a flow direction. According to this structure, it becomes possible to send out the ions emitted from the ion generating surface by means of a streamline flow along the flow surface. Moreover, the positive and negative ion generating portions are disposed in the direction that intersects the flow direction, so that it becomes possible to send out the positive ions and the negative ions far into the room by curbing the collision between the positive ions and the negative ions and by preventing them from being neutralized. [0070] Because of this, in a case where the flow passage that extends from the fan 3 to the outlet 4 has a bent shape, it is preferable that the ion generating surface of the ion generating apparatus 10 is formed into a curved surface which matches with the flow surface of the lower lateral wind-direction plate 22 A that is bent. [0071] Besides, the ion generating apparatus 10 of the cartridge type, which unitarily includes: the insertion guide portion; the position guide portion; and the lever member 14 that engages with the engagement portion disposed in the ion generating apparatus housing portion of the main body to fix the position of the cartridge, is inserted from the insertion opening 6 formed through the front surface of the apparatus and disposed, from outside of the flow passage, in such posture that the ion generating surface is exposed to the flow surface, so that the ion generating surface matches with the flow surface and it is possible to supply the ions into the air flowing through the flow passage without disturbing the air flow. [0072] Because of this, along the streamline flow on the flow surface of the flow passage, it becomes possible to send out the positive and negative ions generated by the positive and negative ion generating portions disposed on the ion generating surface without disturbing the ions. Besides, the ion generating apparatus housing portion is formed under the lower lateral wind-direction plate 22 A that forms the lower wall surface of the flow passage, so that it becomes possible to stably send out the positive and negative ions in a horizontal direction by means of the streamline flow formed on the lower wall surface. [0073] To partition the flow passage extending from the fan 3 to the outlet 6 into streamline flow passages in a vertical direction, in the present embodiment, as shown in FIG. 1 , between the lower lateral wind-direction plate 22 A and the upper lateral wind-direction plate 22 E, a second lateral wind-direction plate 22 B, a third lateral wind-direction plate 22 C and a fourth lateral wind-direction plate 22 D are disposed as intermediate wind-direction plates; and by disposing these lateral wind-direction plates 22 ( 22 A to 22 E), the flow passage is partitioned into multi-stage streamline flow passages from an inner circumferential surface close to the fan 3 to an outer circumferential surface. [0074] In the case of the above structure, the ion generating apparatus housing portion is formed in the apparatus main body and under the flow passage along the lower lateral wind-direction plate 22 A, so that it is possible to insert the ion generating apparatus 10 of the cartridge type from the insertion opening 6 formed under the outlet 4 , and freely mount and demount the ion generating apparatus 10 , via an outer side of the lower lateral wind-direction plate 22 A, in such posture that the ion generating surface is exposed to the flow surface. [0075] Besides, to dispose the ion generating apparatus 10 with the ion generating surface matched with the flow surface of the lateral wind-direction plate 22 , the ion generating surface may be used as part of the flow surface of the lateral wind-direction plate 22 , which is able to be achieved by disposing the ion generating apparatus 10 in parallel with the lateral wind-direction plate 22 ; or by cutting away part of the flow surface of the lateral wind-direction plate 22 and disposing the ion generating apparatus 10 . Accordingly, in the present embodiment, a structure is employed, in which the lower wind-direction plate 22 is provided with a cut-away portion 22 a (see FIG. 2 ( a )) for exposing the ion generating surface; and the ion generating surface of the ion generating apparatus 10 is exposed via the cut-away portion. [0076] The ion generating apparatus 10 is so structured as to include the pair of the positive ion generating electrode and the negative ion generating electrode each of which performs the plasma discharge; accordingly, to make it possible to evenly send out the positive ions and the negative ions far into the room, it is preferable to carry the generated positive ions and negative ions by means of separate flow passages to prevent the ions from colliding with each other and being neutralized. [0077] Besides, to mingle the positive ions and the negative ions in the room, the positive and negative ion generating portions may be so disposed as to be successively alternately disposed; by disposing the ion generators that have the pair of positive and negative electrodes in a line at a predetermined pitch, it is possible to alternately dispose the positive ion generating portions and the negative ion generating portions. Besides, the positive and negative ion generating portions are disposed away from each other by the predetermined distance, so that it is possible to curb the collision between the positive and negative ions at a time immediately after the generation of the ions. [0078] Because of this, as shown in FIG. 1 ( b ), the ion diffusing apparatus 1 is so structured as to have the apparatus main body 2 that is laterally long; and in the inside of the main body 2 , a plurality of the ion generating apparatuses 10 ( 10 A, 10 B, 10 C, 10 D) are disposed. Besides, to send out the ions generated from these ion generating apparatuses, the laterally long fan 3 is used to send out the ions from the laterally long outlet 4 . [0079] In disposing laterally the plurality of ion generating apparatuses 10 ( 10 A, 10 B, 10 C, 10 D) in parallel with each other, by disposing the ion generating apparatuses 10 that have the positive ion generating portion and the negative ion generating portion in a line and in parallel with each other, it is possible to alternately dispose the positive ion generating portion and the negative ion generating portion. Besides, the positive ion generating portion and the negative ion generating portion are alternately disposed; accordingly, vertical wind-direction plates 21 ( 21 a to 21 j ) for partitioning the flow passage into flow passages for the respective ion generating portions are disposed; and the ions are sent out by means of the respective flow passages. [0080] Besides, it is possible to angle each of the vertical wind-direction plates to exhale the ions into the room across a wide angle. For example, the angle of a central wind-direction plate 21 d is set at 0°, and the angle is so set as to gradually become wider toward the sides, and the angles of the vertical wind-direction plates 21 a, 21 j at both ends are set at large angles facing outside, so that it is possible to exhale and diffuse the ions into the room across the wide angle. [0081] For example, as shown in FIG. 5 , the vertical wind-direction plates 21 a to 21 j , which partition the flow passage into the flow passages for the respective positive and negative ions generating portions of the ion generating apparatuses 10 A, 10 B, 10 C and 10 D, are disposed in such a way that the vertical wind-direction plates at the sides are more widely opened, so that it is possible to form the flow passages that exhale the ions across the wide angle. [0082] According to the above structure, it becomes possible to send out the ions generated by the respective ion generating portions without the collision between the adjacent ions that have different polarities, so that it is possible to evenly send out the ions far into the room. However, by means of a method in which the positive and negative ions are continuously sent out via the same flow passage, it is hard to evenly mingle the positive and negative ions; and a disadvantage that the flow passage is charged with electricity is likely to happen. Because of this, in the present embodiment, ion generators, which are each of a double electrode type that disposes the two generating electrodes, that is, the positive ion generating electrode and the negative ion generating electrode close to each other, are disposed in two stages; and the ion generators are each formed as an ion generating cartridge of a two-stage ion generating type in which the polarities of the ion generating electrodes of the respective ion generators are reversed to each other. In other words, the ion generating apparatuses 10 A, 10 B, 10 C and 10 D are each formed as the ion generating cartridge type. [0083] For example, in a case where the ion diffusing apparatus 10 having the above ion generating cartridge is operated in a living space of ten tatami mats (about 18 m 2 ), when the two-stage ion generators are alternately driven, it is experimentally confirmed that the average number of ions in the living space is 7,000/cm 3 or more for both of the positive ions and the negative ions. Besides, when the two-stage ion generators are driven at the same time, it is experimentally confirmed that the average number of ions is 50,000/cm 3 or more for both of the positive ions and the negative ions. Because of this, if the ion diffusing apparatus according to the present invention is used, it becomes possible to kill the influenza viruses and the like residing in the room in a short time. [0084] Conventionally, it is known that the positive ions H + (H 2 O)m (m is an arbitrary integer) and the negative ions O 2 − (H 2 O)n (n is an arbitrary integer) are sent out into the air; and floating germs and the like are killed by the reaction of the ions. However, the ions recombine with each other to disappear, so that even if it is possible to achieve a high concentration in the vicinity of an ion generating element, the longer the distance for which the ions are sent out becomes, the more rapidly the concentration decreases. Accordingly, even if it is possible to achieve an ion concentration of tens of thousands of ions per cm 3 in small-volume spaces such as an experimental apparatus and the like, it is possible to achieve concentrations of 2,000 to 3,000/cm 3 only at best in large spaces such as an actual living space, a working space and the like. [0085] On the other hand, the inventors have discovered that at a laboratory level, when the ion concentration is 7,000/cm 3 , it is possible to remove 99% of the bird-flu viruses in 10 minutes; and when the ion concentration is 50,000/cm 3 , it is possible to remove 99.9% of the bird-flu viruses in 10 minutes. Both removal rates mean that if it is supposed viruses reside in the air in a concentration of 1,000/cm3, viruses remain in a concentration of 10/cm 3 at the 99% removal rate, and in 1/cm 3 at the 99.9% removal rate. In other words, by increasing the ion concentration from 7,000/cm 3 to 50,000/cm 3 , the remaining viruses become 1/10. From this, it is understood that in a living space where people and the like live and a working space, for prevention of an infectious disease and for environmental cleaning, it is very important not only to send out a high concentration of ions but also to keep the high concentration throughout the spaces. [0086] Next, the ion generating cartridge having the above structure is described by means on FIG. 4 . This ion generating cartridge is the ion generating apparatus 10 formed as the cartridge type and has the same constituent members, so that the same reference numbers are used to describe the ion generating cartridge 10 . The ion generating cartridge 10 shown in FIG. 4 is of the two-stage ion generating type in which an ion generator 12 A including a positive ion generating portion 13 A of the double electrode type and a negative ion generating portion 13 B of the double electrode type; and an ion generator 12 B including a negative ion generating portion 13 B of the double electrode type and a positive ion generating portion 13 A of the double electrode type are disposed in parallel with each other and in two stages. [0087] The positive and negative ion generating electrodes each have a needle-shape discharge electrode HD and perform the plasma discharge between a plate-shape induction electrode around them and themselves to generate ions. Besides, if each of the discharge electrodes HD is formed as the double electrode type, the positive ion generating portion 13 A includes two electrodes, that is, positive ion generating electrodes 13 Aa, 13 Ab; and the negative ion generating portion 13 B includes two electrodes, that is, negative ion generating electrodes 13 Ba, 13 Bb, so that each discharge amount becomes double and it is possible to stably generate more than a predetermined amount of ions. [0088] If a structure is employed to alternately operate the ion generators 12 A, 12 B of the two-stage ion generating type; and if a structure is employed to partition the flow passage by means of the vertical wind-direction plate 21 , a structure is obtained, in which as the ions sent out by an air flow F 1 , the positive ions are sent out during a time the ion generator 12 A operates; and the negative ions are sent out during a time the ion generator 12 B operates. [0089] Because of this, by setting the operation periods of the ion generator 12 A and the ion generator 12 B at a predetermined time interval, it is possible to intermittently exhale the positive and negative ions into the same air flow at the predetermined time intervals and to mingle both of the positive and negative ions in a predetermined concentration. [0090] Besides, a structure is obtained, in which as the ions sent out by an air flow F 2 , the ion generator 12 A operates to send out the negative ions; and the ion generator 12 B operates to send out the positive ions. As described above, in the air flow F 1 and the air flow F 2 , the ions having the reverse polarities are intermittently sent out; in time-dependent average, it is possible to evenly exhale the positive ions and the negative ions into the respective flow passages. [0091] Besides, one ion generating cartridge 10 alternately operates the two ion generators 12 A, 12 B, so that the life of the ion generating cartridge 10 becomes double and it becomes possible to use the ion generating cartridge 10 for a long time. [0092] The disposition position of the vertical wind-direction plate 21 that partitions the flow passage for the respective ion generating portions may be any position where it is possible to partition the flow passage for the air flow F 1 and the air flow F 2 ; if a fan that generates parallel air flows is used, it is also possible to dispose the vertical wind-direction plate 21 from the vicinity of the front end of the ion generating cartridge 10 . [0093] In the ion generating cartridge 10 , the shape of a frame body 11 has a rectangular shape when viewing, from top, the ion generating surface from which the positive ion generating portion 13 A and the negative ion generating portion 13 B are exposed; when viewing from side, as shown in FIG. 4 ( b ), the ion generating surface 11 a is formed into a curved surface to match with the flow surface. [0094] Besides, the frame body 11 includes: an input-output connector portion 19 that connects with an external power supply and performs input/output of a signal; a control board that includes a high-voltage generating circuit for generating a predetermined discharge voltage from electric power obtained via the input-output connector portion, and a drive control circuit, and controls the driving of the positive ion generating electrode and the negative ion generating electrode; the ion generators 12 A, 12 B of the double electrode type in which the two electrodes, that is, the positive ion generating electrode and the negative ion generating electrode are disposed close to each other; and the ion sensor 18 that detects the ions generated by the ion generators. [0095] Besides, the frame body includes: a lever member 14 that has a handle portion which is held at times of insertion and pulling-out of the cartridge and a hook portion which fixes the cartridge at a predetermined position after the insertion; on sides of the frame body 11 , guide protrusion portions 15 , a butt surface 17 , and guide surfaces 16 that perform a guide function at the time of the cartridge insertion are disposed. The lever member 14 is rotatably disposed on a frame 11 c of a rear surface 11 b of the frame body 11 via a pivotal support portion 14 d. [0096] The ion sensor 18 is a negative ion detection sensor that is disposed close to the negative ion generating portion 13 B of the ion generator 12 A and in a downstream side with respect to the negative ion generating portion 13 B; and detects the negative ions generated from the negative ion generating portion 13 B. For example, it is possible to convert an ion electric current, which is output in accordance with the concentration of negative ions captured by the electrode portion that captures ions, into a voltage to detect the ions; however, this type is not limiting, and it is possible to use an ion sensor which has a function to detect that more than a predetermined amount of ions are generated. [0097] In the ion generator 12 A, the positive ion generating portion 13 A always generates the positive ions, while the negative ion generating portion 13 B always generates the negative ions. Besides, the predetermined positive and negative discharge voltages are applied to the respective needle-shape discharge electrodes at the same time, so that the amounts of the positive and negative ions are substantially the same as each other; by measuring the amount of either of the positive ions and the negative ions during the operation of the ion diffusing apparatus, it is possible to check whether the ion generator 12 A is operating normally or not. Besides, it is possible to presume whether the ion generating cartridge 10 which unitarily includes the ion generator 12 A and the ion generator 12 B is normal or not. In other words, by detecting the negative ions generated from the negative ion generating portion 13 B, it is possible to presume the deterioration degree of the ion generating cartridge 10 and to perform the maintenance. [0098] The guide protrusion portions 15 disposed on the sides of the frame body 11 of the ion generating cartridge 10 are insertion guide portions that at the insertion time of the cartridge, butt against a guide frame 24 b (see FIG. 3 ( a )) which forms the ion generating apparatus housing portion; with the guide protrusion portions 15 on both sides of the frame body 11 butted against the guide frames on both sides, the ion generating cartridge 10 is pushed into. [0099] The butt surface 17 is a portion that serves as an end surface of the frame body 11 when disposing the ion generating cartridge 10 into the ion generating apparatus housing portion; and is a surface that butts against a housing portion frame 25 , which forms the ion generating apparatus housing portion, to be positioned. [0100] The guide surface 16 butts against a rear surface frame 23 of the lower lateral wind-direction plate 22 A to be positioned when fixing the cartridge 10 at a predetermined position by engaging the hook portion 14 c of the lever member 14 with an engagement portion 24 a (see FIG. 3 ( a )). As described above, the butt surface 17 for defining the insertion-end position and the guide surface 16 for defining the fix position serve as the position guide portion. [0101] As described above, the ion generating apparatus housing portion for housing the ion generating cartridge 10 is formed at an inner place from the insertion opening 6 ; and is so structured as to include: the housing portion frame 25 for defining the insertion end of the cartridge; the guide frame 24 b for defining the sides of the cartridge; the cut-away portion 22 a from which the ion generating surface of the cartridge is exposed; the rear surface frame 23 for defining the fix position of the cartridge; and the engagement portion 24 a; wherein a number of the ion generating apparatus housing portions, the number of which is equal to the number of ion generating cartridges 10 , are disposed. [0102] The lever member 14 , as shown in FIG. 3 ( a ), is rotatably disposed on the ion generating cartridge 10 via the pivotal support portion 14 d; is provided with: an arm 14 b; a handle portion 14 a that is held at the times of the insertion and pulling-out of the cartridge; and the hook portions 14 c that engage with the engagement portions formed on the apparatus main body to fix the cartridge after the insertion. Because of this, by holding and rotating the handle portion 14 a in an arrow direction D 1 in the figure, it is possible to engage the hook portion 14 c with the engagement portion formed on the apparatus main body. [0103] The handle portion 14 a is bent by a predetermined angle that facilitates the operation and extended from the arm 14 b on which the pivotal support portion 14 d is disposed. Besides, the hook portion 14 c may be disposed on any portion of the lever member 14 that rotates, that is, may be disposed on the arm 14 b or the handle portion 14 a. In the present embodiment, as shown in FIG. 3 ( b ), a structure is employed, in which the handle portion 14 a is extended from the arm 14 b into a protrusion shape; and the arc-shape hook portions 14 c that engage with the engagement portions 24 a formed on the frame 24 of the apparatus main body are disposed at tip end portions of the arm 14 b formed on both sides of the handle portion 14 a. [0104] Because of this, a structure is obtained, in which the hook portions 14 c are formed at intermediate portions of the lever member 14 : and by means of force smaller than the fit-in force between the hook portion 14 c and the engagement portion 24 a, it is possible to perform: the operation for holding the handle portion 14 a formed at the tip end of the lever member 14 , rotating the lever member 14 , and engaging the hook portions 14 c with the engagement portions 24 a to fix the lever member 14 ; and the operation for disengaging the hook portion 14 c from the engagement portion 24 a to release the lever member 14 , so that the operations become easy. [0105] As described above, the ion generating cartridge is so structured as to include: the lever member 14 which includes the handle portion 14 a that is held at the times of insertion and pulling-out of the cartridge and the hook portions 14 c that fix the cartridge at the predetermined position after the insertion; the guide portions 15 , the butt surface 17 and the guide surfaces 16 that are formed on the side of the frame body of the cartridge and perform the guide function at the time of the cartridge insertion, so that it is possible to obtain the ion generating apparatus of the cartridge type that is easy to insert and pull out. [0106] Next, a structure is described by means of FIG. 2 , in which the ion generating cartridge 10 which includes the lever member 14 having the above structure is disposed in the ion diffusing apparatus 1 . [0107] As shown in FIG. 2 ( a ), an open-close cover 7 is opened to open the insertion opening 6 ; and the ion generating cartridge 10 is inserted from the opened insertion opening 6 . Here, the cartridge is inserted by holding the lever member 14 as if being pushed into until the butt surface 17 butts against the housing portion frame 25 . Besides, a structure is employed, in which in the time of the insertion operation, the guide protrusion portion 15 slides on the guide frame 24 b. [0108] After the ion generating cartridge 10 is pushed into until the butt surface 17 butts against the housing portion frame 25 , as shown in FIG. 2 ( b ), the lever member 14 is pushed down to engage the hook portion 14 c of the lever member 14 with the engagement portion 24 a of the apparatus main body. [0109] By means of the operation for pushing down the lever member 14 to engage the hook portion 14 c with the engagement portion 24 a of the apparatus main body, it is possible to fit the ion generating cartridge 10 into the cut-away portion 22 a formed through the lower lateral wind-direction plate 22 A. Besides, the guide surfaces 16 formed on the sides of the frame body of the ion generating cartridge 10 butt against the rear surface frame 23 of the lower lateral wind-direction plate 22 A, so that the fit-in posture is defined. [0110] When the hook portion 14 c of the lever member 14 is engaged with the engagement portion 24 a of the apparatus main body, as shown in FIG. 2 ( c ), the ion generating cartridge 10 is fixed in such a posture that the ion generating surface of the ion generating cartridge 10 is exposed via the cut-away portion 22 a. This posture is a posture in which the ion generating surface is matched with the flow surface and exposed, so that it is possible to surely exhale the ions generated from the ion generating surface into the air flow. [0111] Besides, a structure is employed, in which the in the state where the hook portion 14 c of the lever member 14 is engaged with the engagement portion 24 a of the apparatus main body, the opened open-close cover 7 is closable; however, as shown in FIG. 2 ( a ) and FIG. 2 ( b ), in the state where the hook portion 14 c is not fixed, the open-close cover 7 interferes with the handle portion 14 a of the lever member 14 when the open-close cover 7 is being closed. According to this structure, by means of the lever member 14 that is not disposed at the right position, it is possible to hinder the open-close cover 7 from being closed. [0112] As described above, the structure is employed, in which the lever member 14 hinders the open-close cover 7 from being closed, so that it becomes possible to easily check whether the ion generating cartridge 10 is correctly disposed or not, which is preferable. [0113] Besides, after the ion generating cartridge 10 is fixed at the predetermined position, the input-output connector portion 19 is connected to a connection terminal disposed in the apparatus main body to complete the disposition working of the ion generating cartridge 10 . [0114] The ion diffusing apparatus 1 according to the present invention has the laterally long structure to include the plurality of ion generating cartridges 10 ( 10 A, 10 B, 10 C, 10 D); accordingly, it is preferable that the utilised fan 3 is a crossflow fan which has a fan length to send a wind to the line in which the plurality of ion generating cartridges are disposed. A crossflow fan has high quietness, is able to be operated from a breeze range, and is preferable as a fan that is used for the ion diffusing apparatus 1 which is installed in a living room where a quiet operation is required. [0115] Besides, as shown in FIG. 1 ( a ), the flow passage partitioned into the plurality of streamline flow passages is branched into: a first flow passage 4 A partitioned by the lower lateral wind-direction plate 22 A disposed on the inner circumference side close to the crossflow fan and the next second lateral wind-direction plate 22 B; a second flow passage 4 B partitioned by the second lateral wind-direction plate 22 B and the next third lateral wind-direction plate 22 C; a third flow passage 4 C partitioned by the third lateral wind-direction plate 22 C and the fourth lateral wind-direction plate 22 D; and a fourth flow passage 4 D partitioned by the fourth lateral wind-direction plate 22 D and the upper lateral wind-direction plate 22 E, so that it is possible to adjust the flow speeds in the respective flow passages and carry the ions to a distant place. [0116] For example, it is possible to set the wind speed K 1 in the first flow passage 4 A on the inner circumference side at the lowest wind speed, increase gradually the wind speed K 2 in the second flow passage and the wind speed K 3 in the third flow passage, and set the wind speed K 4 in the fourth flow passage on the outer circumference side at the fastest wind speed. According to this structure, the first flow passage 4 A having the slowest wind speed carries the ions generated by the ion generating apparatus (ion generating cartridge) 10 , so that the faster air flow that flows over the first flow passage 4 A serves as a wall, which is able to prevent upward diffusion of the ions. Besides, the ions are carried to a distant place by means of the Coanda effect of the air flows having the faster wind speeds, so that it becomes possible to form an ion flow region having a high concentration in a lower predetermined space. [0117] In other words, by sending out the ions into the flow passage that is one of the flow passages partitioned into the plurality of streamline flow passages and has the lowest wind speed, it becomes possible to keep the ion concentration at a high concentration in a predetermined region of the room into which the air is sent; and becomes possible to effectively remove and kill the germs in the living space where people live. Besides, it is possible to change the wind speeds in the respective flow passages by adjusting the gaps among the upper lateral wind-direction plate, the lower lateral wind-direction plate, an the intermediate wind-direction plates and by adjusting the rotation speed of the crossflow fan. [0118] An drive start-stop operation portion 8 (see FIG. 1 ( b )) for driving the ion diffusing apparatus 1 by operating the crossflow fan is disposed on the front side of the apparatus main body. In the drive start-stop operation portion 8 , besides an on-off switch, it is possible to dispose, for example: an operation mode setting portion that sets the rotation speed of the crossflow fan; a cartridge disposition time setting portion that sets disposition of a new ion generating cartridge; a timer setting portion; a replacement recommendation indication portion that recommends cartridge replacement after elapse of a predetermined time after the new ion generating cartridge is disposed and the operation is started; and a level indication portion that indicates whether the amounts of the ions generated by the respective ion generating cartridges are equal to, over, or ender the predetermined amounts. [0119] Accordingly, because the service life of the ion generating cartridge is decided in advance, by setting the disposition of a new ion generating cartridge at the time the new cartridge is disposed, it is possible to perform indication for recommending the cartridge replacement in accordance with the apparatus use time from the disposition and to notify that the replacement time is coming. Besides, if the amount of the ions generated during the apparatus use is equal to or under the predetermined amount, the information is indicated, so that it is possible to know that the maintenance of the ion generating portion is necessary. [0120] As described above, according to the present invention, the ion generating apparatus is formed as the cartridge type in which the ion generating surface has the curved surface that matches with the flow surface of the wind-direction plate; and which unitarily includes the insertion guide portion; the position guide portion; and the lever member that engages with the engagement portion of the apparatus main body to fix the ion generating cartridge, and it is made possible to insert and pull out the cartridge from the insertion opening that is formed on the outlet side which is formed through the apparatus front side, so that it is possible to obtain the ion generating cartridge that is easy to mount and demount form the apparatus front side. Besides, the ion diffusing apparatus has the structure in which the vertical wind-direction plates for partitioning the flow passage into the flow passages for the respective positive and negative ion generating portions are disposed, so that it is possible to obtain the ion diffusing apparatus that is able to evenly send out the ions far into the room while evenly generating the positive ions and the negative ions. [0121] Besides, the ion generating cartridge is used, which includes: the ion generator that has the positive ion generating portion and the negative ion generating portion which are of the double electrode type in which the two ion generating electrodes are disposed close to each; and the ion sensor, so that it becomes easy to handle the ion generating apparatus of the cartridge type that generates the positive and negative ions in a large amount and it is possible to easily check whether the ion generating apparatus is operating normally or not. Because of this, it is possible to obtain the ion generating cartridge that is easily replaceable. [0122] Moreover, the ion generating cartridge is formed as the two-stage ion generating type in which the ion generators including the ion generating portions of the double-electrode type are disposed in the two stages and in parallel with each other while the polarities of the ion generating electrodes of the ion generators are disposed at reversed positions, so that it is possible to exhale the positive ions and the negative ions into the same flow passage at the same time or alternately at the predetermined time intervals to mingle both ions of the positive ions and the negative ions at a predetermined concentration. [0123] Besides, the structure is employed, in which the flow passage that extends from the fan to the outlet is partitioned into the multi-stage streamline flow passages; the lowest flow passage having the slowest wind speed is used as the streamline flow passage into which the ions are sent out; and the streamline flow passages having the faster wind speeds are formed successively, so that it is possible to form the air wall that prevents the ion diffusion and to form the predetermined space that where the ion concentration is kept. Moreover, the crossflow fan is used as the fan, so that it is possible to obtain the ion diffusing apparatus that has high quietness, is operable from a breeze range, and preferable to a living space where a quite operation is required. [0124] Here, the target where the ion diffusing apparatus according to the present invention is not limited to a living room; and the ion diffusing apparatus may be used in rooms (e.g., waiting rooms of a station and a hospital, halls, classrooms and the like) where general people stay for some time. Besides, the ion diffusing apparatus may be used in a room which is ventilated by opening a window or by a ventilator if the ventilation rate is equal to or under a predetermined value. Besides, the ion diffusing apparatus may be used in a room which is air-conditioned by means of an air conditioner. Moreover, by disposing a plurality of the ion diffusing apparatuses according to the present embodiments away from each other, it is possible to secure a sufficient ion concentration in wide regions of spaces (e.g., lobbies of hotels, airports and the like) that are not partitioned. INDUSTRIAL APPLICABILITY [0125] The ion diffusing apparatus and the ion generating cartridge according to the present invention respectively become an ion diffusing apparatus that is able to keep the remaining amount of positive and negative ions in a living room at a high concentration and become an ion generating cartridge whose maintenance is easy, so that the ion generating cartridge becomes preferably applicable to an ion diffusing apparatus that secures a living room where people want to prevent disease infection. LIST OF REFERENCE SYMBOLS [0000] 1 ion diffusing apparatus 2 apparatus main body 3 fan 4 outlet 5 inlet 6 insertion opening 7 open-close cover 8 drive start-stop operation portion 10 ion generating apparatus (ion generating cartridge) 11 a ion generating surface 12 ion generator 13 A positive ion generating portion 13 Aa, 13 Ab positive ion generating electrodes 13 B negative ion generating portion 13 Ba, 13 Bb negative ion generating electrodes 14 lever member 14 a handle portion 14 c hook portion 15 guide protrusion portion 16 guide surface 17 butt surface 18 ion sensor 19 input-output connector portion 21 vertical wind-direction plate 22 lateral wind-direction plate 22 A lower lateral wind-direction plate 22 E upper lateral wind-direction plate

Disclosed is an ion diffusing apparatus that can realize easy replacement of an ion generator and can maintain a stable ion supplying capability. Also disclosed is an ion generating cartridge. In the ion diffusing apparatus, the ion generator is so configured that the generator is detachable for easy maintenance, and can deliver the positive ions and negative ions to a position remote from the apparatus in a room while uniformly generating positive ions and negative ions. An ion diffusing apparatus ( 1) includes an ion generator housing part. An ion generator ( 10) is housed in the ion generator housing part in such a posture that a positive ion generating part ( 13 A) and a negative ion generating part ( 13 B) are provided separately from each other in a direction crossing a flow direction of a stream from a fan ( 3), and an ion generating surface ( 11 a) is exposed so as to conform to a stream flow surface of a stream flow passage extended from the fan ( 3) to a supply opening ( 4). The ion generator ( 10) is made to be a cartridge such that the ion generating surface ( 11 a) thereof has a shape conforming to the stream flow surface of the stream flow passage, and the cartridge can be taken in and out from the ion generator housing part through an insertion port ( 6) provided on the supply opening ( 4) side at the front of the apparatus and is detachably housed in the ion generator housing part in such a posture that the ion generating surface is exposed to the stream flow surface.