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BEEspoke Data 44

CONTINUATION INFORMATION [0001] This application is a utility patent application which claims priority from, and is a continuation of, a U.S. provisional application, Ser. No. 60/532,815, filed Dec. 29, 2003, and titled “TRD Fit Junior Golf Club Shaft.” BACKGROUND OF THE INVENTION [0002] The present invention relates to golf clubs and, more specifically, to golf clubs whose shaft lengths may be adjusted. [0003] There is a need for a competitively playable golf club with a shaft whose length maybe easily adjusted. For example, children have an obvious need for such clubs as they grow. [0004] Collapsible and/or telescoping golf clubs are known. See, e.g., U.S. Pat. No. 5,792,006 to Hesser; U.S. Pat. No. 5,029,860 to Ehrich; U.S. Pat. No. 5,282,619 to Napolitano; U.S. Pat. No. 6,623,372 to Beebe; U.S. Pat. No. 5,788,608 to Wilkinson; and U.S. Pat. No. 6,723,000 to Dombrowski. While such clubs may function suitably as putters, non-putter, swingable golf clubs exert a relatively large amount of centrifugal and torsional force on the shaft of a club, which may result in the fracture or other failure of collapsible and/or telescoping golf club shafts during play. [0005] Even relatively skilled golfers may be conscious of swing weight and swing speed. Relatively small changes in the location of weight along the club shaft can affect these factors, and may be detected by golfers and possibly negatively influence play. Obstructions on the outer periphery of the golf club shaft, while not aesthetically appealing, may also disturb laminar flow and swingability of the club, as well as the golfer's concentration. The above-referenced patents, such as Napolitano (note collar 41) and Beebe (note thumbscrew 32), as well as other prior patents (e.g., U.S. Pat. No. 4,664,382 to Palmer (note threaded cap 41) and U.S. Pat. No. 5,569,096 to Lee (note threaded locking sleeve 22) suffer from such deficiencies. [0006] Still other prior patents disclose golf clubs with relatively complex mechanisms (U.S. Pat. No. 6,413,168 to McKendry, disclosing movable tooth and tooth rack assembly), or which are not intended for providing adjustable-length shafts for non-putters (U.S. Pat. No. 6,317,866 to Rivera, disclosing one shaft length for putters, and another for non-putters; U.S. Pat. No. 4,712,798 to Preato, directed to a putter). [0007] One recent patent, U.S. Pat. No. 6,749,521, discloses a golf club with an extendable shaft similar to the present invention, but not one whose shaft may be shortened. [0008] The shaft material used can be important, as well. Many modern golf clubs are made with graphite shafts. However, it was discovered that when used with the present invention, graphite shaft extensions more than a few inches in length form hairline fractures at the length-adjustment points in the shaft which, over time, can result in catastrophic failures. [0009] Accordingly, it would be advantageous to provide a golfclub with a shaft that maybe quickly and easily lengthened or shortened while overcoming these problems. DEFINITION OF CLAIM TERMS [0010] The following terms are used in the claims of the patent as filed and are intended to have their broadest meaning consistent with the requirements of law. Where alternative meanings are possible, the broadest meaning is intended. All words used in the claims are intended to be used in the normal, customary usage of grammar and the English language. [0011] “High speed” means a speed substantially faster than the conventional speed at which the club head of a putter impacts a golf ball and, for purposes of this application, is intended to reference golf club head speeds at ball impact in excess of 50 miles/hr or about 73 ft/sec. [0012] “Relatively quick and easy manner” means adjusting the golfclub shaft length within minutes or less, using the dexterity of a normal lay adult, and not requiring special skills or tools only possessed by golf experts, golf designers or golf mechanics. [0013] “Reverse-thread connection” means a threaded connection in which tightening occurs through a rotation opposite to the normal direction, i.e., for a right-hand club, tightening is accomplished by a counterclockwise turn, while for a left-hand club, a standard threaded connection may be used such that tightening is accomplished by a clockwise turn. [0014] “Secure” means a golf club having a shaft which will not substantially loosen during play in a manner that might substantially affect play or lead to fracture or breakage of the golf club. [0015] “Swingable” refers to a golf club whose club head is swung above the shoulder, i.e., an “iron” or “wood” type golf club, as opposed to a putter. [0016] “Substantial instances” refers to fracture or breakage of golf clubs in the shaft at the connection locations which occurs, statistically, substantially more often than occurs generally within the golf club industry. SUMMARY OF THE INVENTION [0017] The objects mentioned above, as well as other objects, are solved by the present invention, which overcomes disadvantages of prior golfclubs capable of adjusting shaft length, while providing new advantages not believed currently available with such golf clubs. [0018] In a preferred embodiment, a swingable, secure “wood”-type or iron-type golf club is provided whose shaft may be lengthened or shortened in a relatively quick and easy manner. The golf club of this embodiment includes a club head intended for high-speed impact of a golf ball, and a shaft. The shaft includes a first shaft portion having a predetermined shaft length. The first shaft portion is permanently attached to the club head. The shaft may include at least a first shaft extension section removably attached by reverse-thread connections at a first connection location to the first shaft portion, and removably attached at a second connection location to a shaft section carrying a grip. Different shaft extensions may be substituted having different lengths, as desired. Additional shaft extensions, having predetermined lengths for example, may also be added or removed, as desired, to change the length of the golf club. When made according to the present invention using a suitably strong material, the shaft extensions may be in the range of about 2-14 inches, for example, such as 4 inches, 6 inches, 8 inches, etc. [0019] One or more locking mechanisms may be provided for preventing relative axial movement at the connection locations along the shaft. One preferred locking mechanism includes a tubular sleeve or annular clip surrounding a portion of the shaft at a connection location; the clip may include a tab for engaging adjacent grooves at the connection location. Alternatively, the locking mechanism may consist of a set screw (preferably accessible by a non-standard fastening device such as an Allen wrench, for example), a spring roll pin, a mechanical spring locking device, or a detent or other mechanism. [0020] The shaft so constructed preferably forms a substantially continuous and substantially smooth outer periphery, substantially void of gaps or steps at the connection locations that create stress points within the shaft leading to substantial instances of fracture or breakage of the golf club during play. [0021] Preferably, the shaft and any extension(s) are made of a relatively high-strength material such as a low-carbon steel. [0022] Each shaft section may terminate in a threaded end, with adjacent threaded ends being, alternatively, internally and externally threaded ends configured for mating connection. These threaded ends are preferably quickly and easily threadably connected and disconnected, preferably using a reverse thread connection. BRIEF DESCRIPTION OF THE DRAWINGS [0023] The novel features which are characteristic of the invention are set forth in the appended claims. The invention itself, however, together with further objects and attendant advantages thereof, will be best understood by reference to the following description taken in connection with the accompanying drawings. The drawings illustrate currently preferred embodiments of the present invention. As further explained below, it will be understood that other embodiments, not shown in the drawings, also fall within the spirit and scope of the invention. [0024] FIGS. 1-4 are perspective views of golf clubs showing various embodiments of the present invention; [0025] FIG. 1A is a partial, enlarged perspective view of a preferred locking mechanism of the present invention, for preventing relative axial movement in the connection location between adjacent shaft sections; [0026] FIG. 5 is an enlarged, exploded view of the golf club shown in FIG. 1 ; [0027] FIG. 6 is an exploded view of various components of the shaft connection and locking mechanisms according to a preferred embodiment of the present invention; [0028] FIG. 7 is an enlarged, perspective view of the currently preferred locking mechanism of the present invention; [0029] FIG. 8 is an enlarged, perspective view of a wood-type golf club head which may be used with the present invention; [0030] FIG. 9 is an enlarged, exploded view of a preferred embodiment in which one shaft extension section is interconnected between grip and club head shaft sections to form a golf club with an adjustable-length shaft according to the present invention; [0031] FIG. 10 is an enlarged, perspective view of a shaft extension connection mechanism and an alternative locking mechanism according to the present invention; [0032] FIG. 11 is a cross-sectional view of the components shown in FIG. 10 ; [0033] FIGS. 12-14 are top, side and rear perspective views of a locking mechanism component shown in FIG. 10 ; and [0034] FIGS. 15-18 are elevation and perspective views of an alternative connecting and locking mechanism of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0035] Set forth below is a description of what are currently believed to be the preferred embodiments and/or best examples of the invention claimed. Future and present alternatives and modifications to these preferred embodiments are contemplated. Any alternatives or modifications which make insubstantial changes in function, in purpose, in structure or in result are intended to be covered by the claims of this patent. [0036] Referring first to FIG. 1 , reference numeral 20 generally designates a golf club with length-adjustment capabilities according to the present invention. In FIG. 1 , golf club 20 includes a shaft, generally designated as 25 , having a shaft section 25 a connected to a second shaft section 35 a largely covered by tubular grip 35 . Shaft section 25 a may be permanently attached to hosel or neck portion 30 a of club head 30 in any suitable manner as is well known in the art. [0037] As shown in FIGS. 2-4 , additional, separate shaft extension sections may be employed to form the overall shaft length 25 , thereby allowing selective adjustment of the shaft length of the golf club. For example, FIGS. 2 and 3 show golf clubs 20 with identical shaft portions 25 a but differently-sized shaft extension sections 25 b. FIG. 4 shows a golf club similar to FIG. 3 but with an additional shaft extension section 25 c. While shaft extensions of predetermined length are preferred for manufacturing convenience, any of these shaft extension sections may be provided in varying sizes. [0038] In a particularly preferred embodiment, for ease of manufacture and simplicity, only one shaft extension section, available in predetermined, varying sizes, may be used. However, in other embodiment, two or more separate shaft extension sections may be employed, depending upon the shaft materials used, the desired shaft length ranges, player ability and corresponding swing speed ranges, and other parameters identified below. [0039] Referring now to FIGS. 5-8 , in a preferred embodiment of the invention, the upper shaft section 35 a largely covered by grip 35 may terminate in an outer threaded male end 42 . Male threaded end 42 may be permanently attached to shaft section 35 a, as further explained below. Likewise, the end of shaft section 25 a opposing hosel 30 a of club head 30 may terminate in a female threaded end 46 . Ends 42 and 46 may be threadably attached to removably attach shaft sections 25 a and 35 a. [0040] The shaft and shaft extension sections are preferably made of a suitable material which will withstand the torque of a swing sweep for a conventional golf swing, as well as the torque of ball impact at a normal swing speed. One such suitable material is low carbon steel, such as an alloy-type 4140, though other materials, such as aluminum, graphite or other composites, may be used. [0041] Referring now to FIG. 9 , in a preferred embodiment golf club 20 may be designed so that its shaft length is adjustable for any age junior golfer, from ages 4-14, for example. Preferably, it is unnecessary to change or adjust the grip end or the head end to effectuate a shaft length adjustment. To accomplish this, an appropriately-sized shaft extension section 25 b may be used. The extension sections may be made of the same steel material that shaft 25 is made of. As shown in FIG. 9 , each opposing end of extension section 25 b may include threaded fastener ends 42 , 46 . These threaded fastener ends may be made as one piece with the shaft extension sections, or may be permanently attached to the sections by adhesives such as epoxy. [0042] Preferably, the young junior golfer starts playing with a golf club with no shaft extension section that is properly sized for him or her, as shown in FIG. 1 . As the junior player grows and the golf club becomes too short for proper use, an appropriately-sized shaft extension section may then be added to the golf club, as shown in FIG. 2 . Continuing player growth may require substitution of a longer shaft extension section, as shown in FIG. 3 or, if preferred, stacking of shaft extension sections as shown in FIG. 4 . Additionally, with the present invention, because these shaft extension section interconnections are not permanent, shaft extension sections may be removed and/or substituted for shorter shaft extension sections, quickly and easily, allowing the same golf club set to be used by children of different ages and sizes, for example. [0043] The shaft 25 thus constructed is a substantially continuous piece with a relatively smooth outer periphery, substantially void of gaps or steps at the connection locations that may create stress points within the shaft length that may lead to shaft fracture or breakage. (The overall shaft may and preferably does have gradual increments or steps of increased width along its length, to allow for a gradual change from the grip diameter to the hosel portion that is inserted into the golf club head. However, such increments are gradual, not localized at the connection locations, so that they do not cause undue stresses during play.) [0044] Accordingly, it will now be understood that the present invention allows adjacent shaft and shaft extensions to be quickly and easily interconnected, without introducing substantial stress points within or along the shaft length. The shaft extension sections may also be easily assembled or disassembled to allow lengthening or shortening of the golf club, as desired. Also, once an adjustment is made, the golf club may be immediately used. [0045] The shaft extension sections are also preferably self-tightening and will not loosen during play, as now explained below, to restrict relative axial movement of the various shaft sections during play. It was found that playing with golf clubs having conventionally threaded shaft extensions causes the shaft extensions to loosen during ball impact, due to rotational forces exerted on the lower shaft as a result of ball impact forces on the club head. To counter this, reverse threads are preferably used, so that these rotational forces will actually cause adjacent shaft sections to tighten during play. [0046] However, it was also discovered that during the portions of the golf swing both prior to and after ball impact, a reverse rotational force counter to that experienced at ball impact can be exerted on the shaft which may cause adjacent shaft sections connected by reverse threads to loosen during play. To prevent this, two alternative locking mechanism were devised, as now described, which are designed to prevent relative rotational movement between adjacent shaft sections and/or shaft extension sections and, thus, prevent relative axial movement along the entire shaft length. [0047] Referring now to FIGS. 6-7 , a first, preferred mechanism for locking adjacent, connected shaft sections is shown. In this embodiment, threaded ends 42 , 46 may again be permanently attached to the shaft sections as explained above. To prevent relative rotational movement, and thus relative axial movement, between adjacent shaft sections, a locking mechanism 40 , in the preferred embodiment taking the form of a generally C-shaped clip, maybe used. Annular clip 40 , which may be made of steel or another suitable material, includes a sleeve 40 a with edges 40 b and a tab 41 . Clip 40 is designed to surround and hug shaft 25 in the area of interconnection or connection location between adjacent shaft sections. Threaded ends 42 , 46 may include flanges or stops 38 , 47 , respectively, having longitudinal spaces or grooves 43 , 49 , respectively. When threaded ends 42 , 46 are connected, tab 41 is designed to fit within the open area formed by adjacent grooves 43 , 49 between stops 38 , 47 , as shown in FIG. 1A . In this manner, adjacent shaft extensions may be securely interconnected and retained by locking clip 40 such that relative rotation between adjacent shaft sections and, thus, their relative axial movement, will be prevented. The space in C-shaped clip 40 allows a finger or instrument to enter this area; by pushing on the edge of the groove and applying a rotational force, the clip will expand and can be removed from the shaft. [0048] If desired, adjacent shaft sections in the connection location may be designed with a slightly smaller outer diameter such that, when fitted with clip 40 , the exterior surface 40 a of clip 40 will smoothly merge, without any bumps or protuberances, into the outer shaft periphery. However, because clip 40 may be designed with a thickness of only about {fraction (1/64)} of an inch, this may not be necessary. [0049] Referring now to FIGS. 10-14 , an alternative locking mechanism is shown. In a preferred embodiment of this locking mechanism, after adjacent shaft sections are connected by a reverse thread connection as explained above, a set screw 60 may be threadably inserted into internally threaded end 46 . For this purpose, threaded end 46 may include a threaded passage 63 ( FIG. 11 ) designed to accommodate set screw 60 . Frictional impact of the end of set screw 60 on threads 45 of externally threaded end 42 will now prevent relative rotation between threads 45 of end 42 and threads 37 of end 46 , and thus prevent relative axial movement between adjacent shaft sections such as 35 a and 25 a. [0050] In a preferred embodiment, and still referring to FIGS. 10-14 , set screws 60 , for example, may include a head 61 ( FIG. 12 ) only accessible using an Allen-type wrench, for example. A set screw head turnable using a conventional screw driver may not be preferred, to prevent non-owners from disassembling the golf club. Threaded passage 63 may include an enlarged opening (not shown) to accommodate head 61 of set screw 60 , allowing the set screw to be sunk within the outer periphery of end 50 or 51 , to further streamline the outer periphery of the club, for functional and/or aesthetic reasons. [0051] Referring now to FIGS. 15-18 , yet another alternative connecting and locking mechanism is shown. In this embodiment, externally threaded insert 42 again connects to internally threaded insert 46 (threads not shown). Here, apertures 70 , 75 on the inserts accept a spring roll pin 73 that may be inserted by tapping it into these apertures. As with the slot/groove, described above, the holes may be drilled into the inserts after the externally and internally threaded inserts are threaded together, to insure proper alignment for the roll pin. Instead of a spring roll pin, a mechanical spring locking device may be used, as may be envisioned by those of ordinary skill in the art. [0052] Other types of locking mechanisms positioned at the connection locations between adjacent shaft sections may be employed to prevent relative axial movement, while still allowing the shaft sections to be quickly and easily connected and disconnected. [0053] Regarding manufacturing of the threaded ends or inserts 42 , 46 , in a preferred embodiment these internally and externally inserts may be machined without slots. One set of male and female inserts may then be threaded fully onto each other and slotted as an assembly. These first slotted inserts may then be used as “masters” for slot alignment of all subsequent inserts for a complete set of clubs. The male threaded insert may be fixtured solidly and all female inserts may be threaded fully onto the fixtured male insert and slotted. The female insert may then be fixtured solidly and the male insert may then be threaded fully onto it and slotted. These steps ensure that the indexing of the slot is similar regardless of the start point of the threads on both the male and female inserts. (Inserts 42 , 46 may be fabricated having grooves or spaces 43 , 49 which, alternatively, only run the width of the stops 38 , 47 , or which run the length of the inserts as shown in FIG. 8 ; the latter may be easier to manufacture.) The inserts may then be plated bright zinc to better match a steel shaft and to avoid rusting. [0054] Regarding manufacturing of the club/shaft assembly, each of the separate grip end shaft section, head end shaft section, and shaft extension sections may first be cut to length. The inserts may then be fixed permanently into the shaft sections. The ends of the inserts that will be fixed into the shaft should have the plating removed (light sanding is adequate). The preferred method for assembly is to use the same epoxy that affixes the golf club head to the shaft in the hosel region. After all inserts are affixed to the shaft sections, the grip end shaft section and the head end shaft sections may be assembled and locked with suitable locking mechanisms such as locking clips or set screws. The club head may then be affixed permanently to the shaft (hosel portion) and allowed to set. Finally, the grip may be attached to the shaft using the standard method of affixing a golf grip (e.g., the use of a two-sided grip tape). [0055] Using a low carbon steel alloy-type 4140, the designs and manufacturing methods described here, extensions of relatively widely varying lengths may be provided, while still providing a sturdy golf club substantially free of shaft fracture or breakage concerns during normal play. For example, a conventional adult golf club may have a length of between about 40-45 inches, with the grip end having a length of 10.5 inches, the shaft end including the club head having a length of about 18 inches, and the hosel portion having a length of about 1.5 inches. A single shaft extension section made according to the present invention may be provided in the useable range of about 1-14 inches, and more preferably 4-10 inches, while still providing a sufficiently sturdy club with removably attached shaft section(s). [0056] It will be understood that various modifications to the preferred embodiment disclosed above may be made. The above description is not intended to limit the meaning of the words used in the following claims that define the invention. Rather, it is contemplated that future modifications in structure, function or result will exist that are not substantial changes and that all such insubstantial changes are intended to be covered by the following claims.

A secure golf club, of the "wood" or "iron" variety intended for high-speed impact of a golf ball, whose shaft may be lengthened or shortened in a relatively quick and easy manner. In a preferred embodiment, the shaft includes one or more shaft extension sections rigidly attached to the shaft or to each other by reverse-thread connections, to reduce the tendency of the shaft sections to loosen during play. Shaft locking mechanisms are also preferably employed for preventing relative axial movement along the shaft and between the shaft sections. Preferably, the shaft has a substantially continuous and substantially smooth outer periphery, substantially void of gaps or steps creating stress points within the shaft that might lead to fracture or breakage of the golf club during play.

CROSS REFERENCE TO RELATED APPLICATION This application claims priority from U.S. Provisional Application No. 60/181,867 filed Feb. 11, 2000. BACKGROUND OF THE INVENTION Oral dosage forms are known which provide a zero order or first order release in which the drug is released at a substantially steady rate of release per unit of time. These dosage forms are satisfactory for the administration of pharmaceutical dosage forms of many drugs. However, there are instances where maintaining a constant blood level of a drug is not desirable. In such cases (e.g., optimization of chemotherapy, reducing nocturnal or early morning systems of chronic diseases such as ischemic heart disease, asthma, arthritis, avoiding developing a tolerance to nitrates, antibiotics and steroidal contraceptives, or where absorption windows exist), a ‘time-controlled’ pulsatile drug delivery system may be more advantageous. There are also instances in which a ‘position-controlled’ drug delivery system (e.g. treatment of colon disease or use of colon as an absorption site for peptide and protein based products) may prove to be more efficacious. A pulsatile delivery system is capable of providing one or more immediate release pulses at predetermined time points after a controlled lag time or at specific sites. However, there are only a few such orally applicable pulsatile release systems due to the potential limitation of the size or materials used for dosage forms. Ishino et al. disclose a dry-coated tablet form in Chemical Pharm. Bull. Vol. 40 (11), p3036-3041 (1992). U.S. Pat. No. 4,851,229 issued Jul. 25, 1989 to P. R. Magruder et al., U.S. Pat. No. 5,011,692 issued Apr. 30, 1991 to K. Fujioka et al., U.S. Pat. No. 5,017,381 issued May 21, 1991 to Maruyama and R. Cortese, U.S. Pat. No. 5,229,135 issued Jul. 20, 1993 to F. Philippon et al., and U.S. Pat. No. 5,840,329 issued Nov. 24, 1998 to J. P. -F. Bai disclose preparation of pulsatile release systems. Some other devices are disclosed in U.S. Pat. No. 4,871,549 issued Oct. 3, 1989 to Y. Ueda et al., U.S. Pat. Nos. 5,260,068 and 5,260,069 both issued Nov. 9, 1993 to C. M. Chen and U.S. Pat. No. 5,508,040 issued Apr. 16, 1996 to C. M. Chen. U.S. Pat. No 5,229,135 issued Jul. 20, 1993 and U.S. Pat. No. 5,567,441 issued Oct. 22, 1996 both to C. M. Chen disclose a pulsatile release system consisting of pellets coated with delayed release or water insoluble polymeric membranes incorporating hydrophobic water insoluble agents or enteric polymers to alter membrane permeability. U.S. Pat. No. 5,837,284 issued Nov. 17, 1998 to A. M. Mehta et al. discloses a dosage form which provides an immediate release dose of methylphenidate upon oral administration, followed by one or more additional doses spread over several hours. Thus there is a need for a pulsatile drug delivery system which is intended to provide for the simultaneous delivery of a single or a combination of drug substances as well as time-controlled series of pulses for efficacious treatment of diseases with maximum patient compliance and minimum side effects. Provision of a single targeted pulse several hours after oral administration, with or without an immediate release pulse upon oral administration, is a desired manifestation of the timed pulsatile release drug delivery systems of the present invention. SUMMARY OF THE INVENTION The present invention provides a method for manufacturing a pharmaceutically elegant multi-particulate dosage form having timed pulsatile release characteristics, i.e., a well time-controlled series of pulses occurring several hours after oral administration, with or without an immediate release pulse upon oral administration. The present invention also provides a novel multicoated particulate dosage form having an active core and a first membrane of an enteric polymer and a second membrane of a mixture of water insoluble and enteric polymers. An organic acid containing membrane may be provided between the first and second membrane layers referred to above to provide for time-separated pulses. While the membranes can be applied in any order, the enteric polymer membrane is usually applied as the innermost membrane. DETAILED DESCRIPTION OF THE INVENTION The active core of the novel dosage form of the present invention may be comprised of an inert particle such as a commercially available non-pareil sugar sphere. The amount of drug in the core will depend on the drug and the dose that is desired. Generally, the core will contain about 5 to 60% by weight of the drug based on the total weight of the core. Those skilled in the art will be able to select an appropriate amount of drug for coating or incorporation into the core to achieve the desired dosage form. An aqueous or a pharmaceutically acceptable solvent medium may be used for preparing core particles. The type of inert binder that is used to bind the water soluble drug to the inert particle is not critical but usually water soluble or alcohol soluble binders are used. Binders such as polyvinylpyrrolidone (PVP), carboxyalkylcelluloses, polyethylene oxide, polysaccharides such as dextran, corn starch, hydroxypropyl methylcellulose (HPMC), hydroxypropylcellulose, may be used by dispersing them in water at a concentration of from about 0.5 to 5 weight %. The drug substance may be present in this coating formulation in the solution form or may be suspended. The drug concentration may vary from about 10 to 30 weight % depending on the viscosity of the coating formulation. In one embodiment, the active core may be prepared by granulation or by extrusion and spheronization. The drug substance, a binder such as PVP, an optional dissolution rate controlling polymer such as high viscosity HPMC, and optionally other pharmaceutically acceptable excipients are blended together in a high shear granulator, such as Fielder granulator, or a fluid bed granulator, such as Glatt GPCG granulator, and granulated to form agglomerates by adding/spraying a granulating fluid such as water or alcohol and dried. The wet mass can be extruded and spheronized to produce spherical particles (beads) using an extruder/marumerizer. In these embodiments, the drug load could be as high as 90% by weight based on the total weight of the extruded or granulated core. One of the layers of membrane coating on the water soluble/dispersible drug containing particle may comprise a plasticized enteric polymer while the other layer may comprise a mixture of a water insoluble polymer and a plasticized water dispersible/enteric polymer wherein said water insoluble polymer and said water dispersible polymer may be present at a weight ratio of 10:1 to 1:1 and typically about 4:1 to 1:1 and the total weight of the coatings is about 15 to 80 weight % and more typically about 20 to 60 weight % based on the total weight of the multiparticulate dosage form. The intermediate acid containing membrane, if present, may be comprised of an organic acid such as fumaric acid, citric acid, succinic acid, tartaric acid, malic acid, and maleic acid; and a binder such as PVP. The nature of the binder is not critical, but water or alcohol soluble polymers are usually used. The weight of this acid coating is about 5 to 20% based on the total weight of the coated beads. The acid in this membrane delays dissolution of the enteric polymer in the inner layer thereby increasing the lag time as well as decreasing the rate of release of the active ingredient from the coated bead. The composition of the outer layer of the polymeric membrane, as well as the individual weights of the inner, intermediate and outer membrane layers are optimized to achieve pulsatile release profiles for a given therapeutic agent or agents, which are predicted based on in vitro/in vivo correlations. Representative examples of enteric polymers useful in the invention include esters of cellulose and its derivatives (cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate), polyvinyl acetate phthalate, pH-sensitive methacrylic acid-methamethacrylate copolymers and shellac. These polymers may be used as a dry powder or an aqueous dispersion. Some commercially available materials that may be used are methacrylic acid copolymers sold under the trademark Eudragit(L100, S100, L30D) manufactured by Rhom Pharma, Cellacefate (cellulose acetate phthalate) from Eastman Chemical Co., Aquateric (cellulose acetate phthalate aqueous dispersion) from FMC Corp. and Aqoat (hydroxypropyl methylcellulose acetate succinate aqueous dispersion) from Shin Etsu K.K. Representative examples of water insoluble polymers useful in the invention include cellulose derivatives (e.g. ethylcellulose), polyvinyl acetate (Kollicoat SR30D from BASF), neutral copolymers based on ethyl acrylate and methylmethacrylate, copolymers of acrylic and methacrylic acid esters with quaternary ammonium groups, such as Eudragit NE, RS or RS30D, RL or RL30D and the like. Both enteric and water insoluble polymers used in forming the membranes are usually plasticized. Representative examples of plasticizers that may be used to plasticize the membranes include triacetin, tributyl citrate, triethyl citrate, acetyl tri-n-butyl citrate diethyl phthalate, castor oil, dibutyl sebacate, acetylated monoglycerides and the like or mixtures thereof. The plasticizer may comprise about 3 to 30 wt. % and more typically about 10 to 25 wt. % based on the polymer. The type of plasticizer and its content depends on the polymer or polymers, nature of the coating system (e.g., aqueous or solvent based, solution or dispersion based and the total solids). In general, it is desirable to prime the surface of the particle before applying the pulsatile release membrane coatings or to separate the different membrane layers by applying a thin hydroxypropyl methylcellulose (HPMC) (Opadry Clear) film. While HPMC is typically used, other primers such as hydroxypropylcellulose (HPC) can also be used. The membrane coatings can be applied to the core using any of the coating techniques commonly used in the pharmaceutical industry, but fluid bed coating is particularly useful. The present invention also provides a method of manufacturing a timed pulsatile release dosage form which comprises: coating an inert particle such as a non-pareil seed (sugar sphere), with a drug and polymeric binder or preparing a drug containing particle by granulation or/and extrusion/spheronization to form an active drug particle; coating said active drug particle with a plasticized enteric coating which forms a plasticized enteric coated drug particle; and coating said plasticized enteric coated drug particle with a mixture of a water insoluble polymer and an enteric polymer. The second and third operations can be interchanged and this feature affords an added flexibility in modulating the release profile from said drug particle. Another added flexibility of the present invention is the optional application of an organic acid (such as fumaric or succinic acid) containing membrane between the second and third coating operations to further modulate the lag time and release profile from the drug particle. Dosage forms incorporating the multicoated drug containing particles in accordance with the invention may take a variety of forms. In one embodiment the formulation may employ a single form of the particulate to provide a time-controlled pulsatile release of the drug several hours after oral administration or to target to specific absorption sites, such as at or near the duodenum/jejunum or colon. In another embodiment, the formulation may contain two or more drug particles with different release characteristics, viz., combination of one or more modified release beads with distinctly different lag times and release rates with or without an immediate release bead to form said timed pulsatile release drug delivery system. The multicoated particulates of two or more drugs can also be combined to obtain synergistic efficacy and patient compliance. The therapeutic agents suitable for incorporation into these time-controlled or position-controlled pulsatile release systems include acidic, basic, zwitterionic, or neutral organic/inorganic bioactive molecules or their salts. The drug substance can be selected from the group of pharmaceutically acceptable organic or inorganic chemicals with proven pharmacological activity in humans. Representative active compounds include analgesics, anticonvulsants, anesthetics, antidiabetic agents, anti-infective agents, antineoplastics, antiParkinsonian agents, antirheumatic agents, cardiovascular agents, central nervous system (CNS) stimulants, dopamine receptor agonists, gastrointestinal agents, psychotherapeutic agents, or urinary tract agents. Representative examples of specific therapeutic agents or drugs suitable for use in the invention include, but are not limited to, albuterol sulfate, amoxicillin, bupropion hydrochloride, carbidopa, cefaclor, diclosfenac sodium, erythromycin, felodipine, loratidine, lithium carbonate, methyl phenidate, metaprolol tartrate, nifedipine, omeprazole, sotalol hydrochloride, verapamil hydrochloride or a therapeutically relevant combination thereof. The above list of drugs is not intended to be exhaustive. Many other drugs are suitable for use in the present invention either singly or in combination with other drugs. The aqueous solubility of the drug can vary from about 0.01 to about 1,000 mg/mL. The following non-limiting examples illustrate the dosage formulations in accordance with the invention: EXAMPLE 1 Sotalol HCl (194.7 g) is slowly added to an aqueous solution of polyvinylpyrrolidone (9.8 g Povidone K-30) and mixed well. Sugar spheres (750 g. 20-25 mesh) are coated with the drug solution in a Versa Glatt fluid bed granulator. The drug containing particles are dried and a sealcoat of Opadry Clear (2% w/w) is applied thereto. The first coating is applied to the active particles by spraying on a suspension of Eudragit L30D (480.8 g); acetyl tri-n-butyl citrate (14.4 g); micronized talc (28.8 g) and purified water (462.8 g). The second or outer coating is prepared by mixing two separate aqueous dispersions. The first dispersion is prepared by adding acetyl tri-n-butyl citrate (26.7 g) and Eudragit L30D (891.5 g) to purified water (995.9 g). A second dispersion is prepared by adding dibutyl sebacate (59.5 g) to Aquacoat, a 30 wt. % ethylcellulose dispersion from FMC. The two dispersions are blended together (1:1 ratio) with continuous agitation. The combined coating formulation is then slowly sprayed onto the active particles coated with the first coating. The multicoated particles are cured at 45 to 70° C. until the polymers are coalesced. The final compositions of the multicoated particles of Example 1 are presented in Table 1. Two lots of finished particles with identical drug contents and inner coating but having the outer coating at 45 and 55% w/w were tested for in vitro dissolution properties in a USP Dissolution Apparatus 2 at 37° C. at a paddle speed of 50 rpm in 0.1N HCl for 2 hours and then at pH 6.8 for an additional 4 hours. The results obtained are presented in Table 2. The dissolution results show that there is a lag time of three to four hours depending on the level of second/outer coating applied and almost complete drug release occurring within 90 min. Similar results have been achieved for methylphenidate hydrochloride using the composition and procedure of Example 1. TABLE 1 Formulation of Example 1 2 nd Coating 2 nd Coating Ingredient (45% w/w) (55% w/w) Core Sotalol HCl, USP 8.80 7.20 #25 mesh Sugar spheres, NF 33.91 27.72 Povidone, USP 0.43 0.36 Seal Coating Opadry Clear YS-1-7006 0.88 0.72 Inner Coating Methacrylic acid copolymer, 8.46 6.92 Type C, NF Talc, USP 1.69 1.39 Acetyl tri-n-butyl citrate 0.85 0.69 Outer Coating Methacrylic acid copolymer 20.47 25.04 Acetyl tri-n-butyl citrate 2.02 2.47 Ethylcellulose Aqueous 18.14 22.16 Dispersion, NF Dibutyl Sebacate, NF 4.36 5.33 Purified Water, USP Trace Trace TABLE 2 Dissolution Data for Example 1 Time (hours) 2 nd Coating (45% w/w) 2 nd Coating (55% w/w) 1 0 0 2 0 0 3 0 0 4 81.2 0.2 4.33 95.0 — 5 — 70 5.67 — 92.5 Although the inventors do not wish to be bound by any theory of operation, the mechanism of release is believed to be as follows: The second coating, which is a matrix coating, is held in place by the ethylcellulose polymer. During the first two hours of dissolution testing in 0.1N hydrochloric acid, drug is not released because the enteric polymer in both the inner and outer membranes is impermeable to 0.1N HCl. When the dissolution medium is changed to pH 6.8, the enteric polymer starts dissolving from the outer membrane, and pores and channels are formed. It takes a while for the dissolution medium to enter the core to dissolve the active and trigger its release, and hence results in additional lag time. EXAMPLE 2 This Example is based on the use of solutions of the enteric polymer and the ethylcellulose in organic solvents. The sotalol hydrochloride containing particles are produced following the procedure of Example 1. These particles are coated to a 20% weight gain by spraying an enteric polymer (hydroxypropylmethyl cellulose phthalate) solution comprising of 98 parts of acetone and 2 parts of water. The second coating is applied using a solution of ethylcellulose 10 cps and hydroxypropyl methylcellulose phthalate in equal amounts in a solvent comprising 98 parts of acetone and 2 parts of water. The final compositions of the multicoated particles of Example 2 are presented in Table 3. The finished coated particles are tested for in vitro dissolution as described in Example 1 and the results obtained are presented in Table 4. TABLE 3 Formulations of Examples 2 2 nd Coating 2 nd Coating Ingredient (35% w/w) (40% w/w) Core Sotalol HCl 10.40 9.60 #25 mesh Sugar spheres 40.05 36.97 Povidone 0.51 0.47 Seal Coating Opadry Clear YS-1-7006 1.04 0.96 Inner Coating HPMC phthalate, NF 10.40 9.6 Diethyl phthalate 2.60 2.4 Outer Coating HPMC phthalate 14.00 16.00 Ethylcellulose 10 cps, NF 15.93 18.20 Diethyl phthalate 5.07 5.80 TABLE 4 Dissolution Data for Example 2 Time 2 nd Coating 2 nd Coating (hours) (35% w/w) (40% w/w) 1 0 0 2 0 0 3 0 0 4 2.74 1.6 4.33 7.1 2.1 4.67 21.5 4.1 5 45.3 10 5.33 70.5 22.9 5.67 89.7 42.8 6.0 101.9 65.1 6.33 84.8 6.67 99.3 It is obvious from Table 4 that the use of the solvent applied coating results in lag times similar to those achieved at higher levels of the aqueous coating. For example, a 35 wt. % solvent coating has a lag time similar to that of the 55 wt. % aqueous coating. EXAMPLE 3 The multicoated beads with the formula of 2 nd Coating (at equal amounts for a weight gain of 45% w/w) of Example 1 are produced except that the inner and outer coatings are switched. The dissolution data obtained presented in Table 5 indicate that the invention has the flexibility of interchanging the inner and outer coatings. TABLE 5 Dissolution Data for Example 3 Time Inner Coating (hours) (45% w/w) 1 0 2 0 2.5 0 3 71.3 3.5 95.1 4 101.7 EXAMPLE 4 The drug layered non-pareil seeds are coated with an Eudragit L30D dispersion for 20% weight gain following the procedure of Example 1. A fumaric acid/PVP composition is applied on these coated beads for a weight gain of 24% w/w. The outer membrane applied is composed of the enteric polymer and ethylcellulose at 1:1 ratio. The final compositions of the multicoated particles of Example 4 are presented in Table 6. The finished coated particles are tested for in vitro dissolution as described in Example 1 and the results obtained are presented in Table 7. It is evident from Tables 2 and 7 that a longer lag time of four hours is achieved at the outer level of 45% w/w. Furthermore, the drug is released not as a pulse but is spread over 6 to 7 hours. TABLE 6 Formulations of Example 4 Outer Coating Outer Coating Ingredient (30% w/w) (45% w/w) Core Sotalol HCl 8.51 6.42 Sugar spheres (20-25 mesh) 32.78 26.03 Povidone 0.42 0.33 Seal Coating Opadry Clear YS-1-7006 0.85 0.67 Inner Coating Methacrylic acid Copolymer 8.18 6.43 Acetyl tri-n-butyl citrate 0.82 0.64 Talc 1.64 1.29 Intermediate Coating Fumaric acid 15.12 11.88 Povidone 1.68 1.32 Outer Coating Methacrylic acid Copolymer 13.65 20.46 Acetyl tri-n-butyl citrate 1.35 2.03 Ethylcellulose Dispersion 12.09 18.14 Dibutyl sebacate 2.91 4.36 TABLE 7 Dissolution Data for Example 4 Time Outer Coating Outer Coating (hours) (30% w/w) (45% w/w) 1 0 0 2 0.3 0 3 9.6 0.1 4 27.3 7.7 5 56.2 18.7 6 77.2 37.4 7 89.5 54.8 8 97.1 67.0 9 76.4 10  83.5 11  89.8 12  94.3 While the invention has been described in detail and with respect to specific embodiments thereof, it will be apparent that numerous modifications and variations are possible without departing from the scope of the invention as defined by the following claims.

A pharmaceutical dosage form such as a capsule capable of delivering therapeutic agents into the body in a time-controlled or position-controlled pulsatile release fashion, is composed of a multitude of multicoated particulates (beads, pellets, granules, etc.) made of one or more populations of beads. Each of these beads except an immediate release bead has at least two coated membrane barriers. One of the membrane barriers is composed of an enteric polymer while the second membrane barrier is composed of a mixture of water insoluble polymer and an enteric polymer. The composition and the thickness of the polymeric membrane barriers determine the lag time and duration of drug release from each of the bead populations. Optionally, an organic acid containing intermediate membrane may be applied for further modifying the lag time and/or the duration of drug release. The pulsatile delivery may comprise one or more pulses to provide a plasma concentration-time profile for a therapeutic agent, predicted based on both its pharmaco-kinetic and pharmaco-dynamic considerations and in vitro/in vivo correlations.

FIELD OF INVENTION [0001] The instant application relates to a device, and a method for extending a distal end of an anatomic tube. BACKGROUND OF THE INVENTION [0002] Congenital abnormalities may cause serious threats to the well-being of individuals with such abnormalities. Congenital abnormalities, i.e. birth defects, include a wide range of malformations that occur during the fetal development. For example, esophageal atersia is a congenital abnormality where the esophagus fails to connect to the stomach. As a result, the esophagus ends in a pouch, and nothing the baby swallows gets into the stomach. [0003] In the case of a baby with esophageal atersia, a surgery is generally required to connect the esophagus to the stomach. In general, a residual esophagus is expanded via a bladder thereby facilitating the connection between the esophagus and the stomach via surgery. Residual esophagus, as used herein, may be a tubular extension of the stomach; or in the alternative, it may be an incomplete esophagus that fails to connect to the stomach. However, the expansion of the residual esophagus via the current methods causes expansion of the residual esophagus both circumferentially and longitudinally. Although the longitudinal expansion of the residual esophagus facilitates the connection to the stomach and the esophagus; thus a desired outcome, the circumferential expansion of the residual esophagus is an undesired by-product, which must be corrected via surgery. [0004] Accordingly, there is a need for a device to facilitate the extension of the distal end of an anatomic tube, e.g. a residual esophagus, along its longitudinal axis while minimizing any circumferential expansion. SUMMARY OF THE INVENTION [0005] The instant application relates to a device, and a method for extending a distal end of an anatomic tube. This device includes an accordion pleated bladder, which includes a proximal end and a distal end. The method includes the steps of (1) providing a device for extending a distal end of an anatomic tube including an accordion pleated bladder, wherein said bladder has a proximal end and a distal end; (2) placing the device for extending a distal end of an anatomic tube in the anatomic tube; (3) connecting the device to a pressure generator; (4) increasing the internal pressure of the device thereby extending the bladder along its longitudinal axis; and (5) thereby extending the anatomic tube along its longitudinal axis. BRIEF DESCRIPTION OF THE DRAWINGS [0006] For the purpose of illustrating the invention, there is shown in the drawings a form that is presently preferred; it being understood, however, that this invention is not limited to the precise arrangements and instrumentalities shown. [0007] FIG. 1 is a first embodiment of the instant invention in a compressed state; and [0008] FIG. 2 is the first embodiment of the instant invention in an extended state. DETAILED DESCRIPTION OF THE INVENTION [0009] Referring to the drawings wherein like numerals indicate like elements, there is shown, in FIGS. 1-2 , a first embodiment of device 10 for extending a distal end of an anatomic tube such as a residual esophagus. Device 10 includes an accordion pleated bladder 12 . The bladder 12 has a proximal end 14 and a distal end 16 . [0010] The instant invention, for convenience, has been described in terms of a device for extending the distal end of a residual esophagus; however, the instant invention is not so limited, and it may be employed to extend the distal end of any anatomic tube, e.g. the distal end of an intestine in the case of bowl removal. Residual esophagus, as used herein, may be a tubular extension of the stomach; or in the alternative, it may be an incomplete esophagus that fails to connect to the stomach. [0011] Bladder 12 may be made of any biocompatible elastomeric material. For example, bladder 12 may be made of a biocompatible elastomeric material selected from the group consisting of silicone rubber, natural rubber, styrene-butadiene copolymer, polychloroprene, nitrile rubber, butyl rubber, polysulfide rubbercis-i,4-polyisoprene, ethylene-propylene terpolymers (EPDM rubber), certain metallocene grades of elasticated polyolefins such as elasticated polypropylene or elasticated polyethylene, and polyurethane rubber. Bladder 12 may have any shape adapted to facilitate the longitudinal extension of any anatomic tube such as a residual esophagus. Bladder 12 may, for example, have a tubular shape. Bladder 12 may further include different physical configurations; for example, bladder 12 may have a compressed state or an extended state, as shown in FIGS. 1 and 2 respectively. [0012] Bladder 12 is pleated. Bladder 12 may have any number of pleats 18 . For example, bladder 12 may have a single pleat 18 ; or it may have a plurality of pleats 18 . Pleats 18 may be any type of pleats; for example, pleats 18 may be annular pleats. Pleats 18 may have any shape; for example, pleats 18 may have a discoid shape. [0013] Bladder 12 may further include a small diameter rib 24 or a large diameter rib 26 . Bladder 12 may include any number of small diameter ribs 24 or any number of large diameter ribs 26 . Bladder 12 may, for example, include one or a plurality of either of small diameter ribs 24 or large diameter ribs 26 . [0014] Small diameter rib 24 may have any shape adapted to minimize the uncontrolled circumferential expansion of bladder 18 ; for example, small diameter rib 24 may have an annular shape. Small diameter rib 24 may be made of any biocompatible elastomeric material. Small diameter rib 24 , for example, may be a biocompatible elastomeric material selected from the group consisting of silicone rubber, natural rubber, styrene-butadiene copolymer, polychloroprene, nitrile rubber, butyl rubber, polysulfide rubbercis-i,4-polyisoprene, ethylene-propylene terpolymers (EPDM rubber), certain metallocene grades of elasticated polyolefins such as elasticated polypropylene or elasticated polyethylene, and polyurethane rubber. Small diameter rib 24 may be an integrated component of bladder 12 , or in the alternative, it may be a separate component secured thereto bladder 12 . [0015] Large diameter rib 26 may have any adapted to minimize the uncontrolled circumferential expansion of bladder 12 ; for example, large diameter rib 26 may have an annular shape. Large diameter rib 26 may be made of any biocompatible elastomeric material. Large diameter rib 26 may, for example, may be a biocompatible elastomeric material selected from the group consisting of silicone rubber, natural rubber, styrene-butadiene copolymer, polychloroprene, nitrile rubber, butyl rubber, polysulfide rubbercis-i,4-polyisoprene, ethylene-propylene terpolymers (EPDM rubber), certain metallocene grades of elasticated polyolefins such as elasticated polypropylene or elasticated polyethylene, and polyurethane rubber. Large diameter rib 26 may be an integrated component of bladder 12 , or in the alternative, it may be a separate component secured thereto bladder 12 . [0016] Proximal end 14 is a non-pleated proximal portion of bladder 12 , and it may have a sealable opening 32 . Proximal end 14 may include alternative means for securing bladder 12 to the proximal end of an anatomic tube such as a residual esophagus. Proximal end 14 may have any shape adapted to facilitate the extension of the distal end of an anatomic tube such a residual esophagus. For example, proximal end 14 may have a cylindrical shape adapted for securing bladder 12 to the proximal end of an anatomic tube such as a residual esophagus. Proximal end 14 may be adapted to expand circumferentially in a range of about 1% to about 30% thereby securing bladder 12 to the proximal end of an anatomic tube such as a residual esophagus. Proximal end 14 may further include first anchors (not shown) to secure the bladder 12 to the proximal end of an anatomic tube such as a residual esophagus. Proximal end 14 may further include the means for connecting bladder 12 to a pressure generator (not shown). Means for connecting bladder 12 to a pressure generator includes, but is not limited to, quick-connect fittings, threads, or other detachable coupling means such as clamps or fasteners. [0017] Distal end 16 is a non-pleated distal portion of bladder 12 , and it is sealed. Distal end 16 may include alternative means for securing bladder 12 to the distal end of an anatomic tube such as a residual esophagus. Distal end 16 may have any shape adapted to facilitate the extension of the distal end of an anatomic tube such a residual esophagus. For example, distal end 16 may have a cylindrical shape adapted for securing bladder 12 to the distal end of an anatomic tube such as a residual esophagus. Distal end 16 may be adapted to expand circumferentially in a range of about 1% to about 30% thereby securing bladder 12 to the distal end of an anatomic tube such as a residual esophagus. Distal end 16 may further include second anchors (not shown) to secure the bladder 12 to the distal end of an anatomic tube such as a residual esophagus. [0018] In operation, device 10 is disposed in a residual esophagus, employing conventional methods known in the medical field. Device 10 is connected to a pressure generator (not shown) via a pressure pipe coupled with the proximal end 14 . Pressure generator, for example, may generate pressure by pumping a fluid into device 10 thereby facilitating the expansion of bladder 12 . Fluid, as used herein, refers to any liquid, e.g. saline solution, or any gas, e.g. CO 2 . As the fluid is pumped into device 10 , the internal pressure of device 10 increases thereby inducing bladder 12 to expand both circumferentially and longitudinally. However, the small diameter ribs 24 and the large diameter ribs 26 prevent the uncontrolled circumferential expansion of bladder 12 thereby facilitating the extension of the bladder 12 along its longitudinal axis. The controlled circumferential expansion of bladder 12 facilitates securing the proximal end 14 of the bladder 12 to the proximal end of the residual esophagus; and, it further facilitates securing the distal end 16 of bladder 18 to the distal end of the residual esophagus. The longitudinal extension of bladder 12 facilitates the extension of the distal end of the residual esophagus along its longitudinal axis. The extended residual esophagus may be maintained in an extended state until its extension along its longitudinal axis becomes permanent. For example, the extended residual esophagus may be maintained in an extended state for a period of about 1 month to about 6 months. During this period of extended state, as the residual esophagus gradually extends further, the internal pressure of device 10 declines; therefore, supplemental fluid is pumped into device 10 in order to increase the internal pressure of device 10 thereby inducing bladder 12 to further extend along its longitudinal axis. The longitudinal extension of bladder 12 facilitates further extension of the distal end of the previously extended residual esophagus. The addition of the supplemental fluid to facilitate further extension of the distal end of residual esophagus may be repeated as many times as necessary until an optimum extension of the distal end of the residual esophagus is achieved. In the alternative, the residual esophagus may be extended along its longitudinal axis as many times as necessary to induce a permanent extension along its longitudinal axis. For example the internal pressure of device 10 may, repeatedly, be reduced, and then, increased in order to induce a permanent extension along the longitudinal axis of the residual esophagus. [0019] In an alternative operation, device 10 is disposed in residual esophagus, employing conventional methods known in the medical field. Device 10 is connected to a pressure generator (not Shown) via a pressure pipe coupled with the proximal end 14 . Pressure generator, for example, may generate pressure by pumping a fluid into device 10 thereby facilitating the expansion of bladder 12 . Fluid, as used herein, refers to any liquid, e.g. saline solution, or any gas, e.g. CO 2 . The proximal end 14 of the bladder 12 is secured to the proximal end of the residual esophagus via first anchors, and the distal end 16 of the bladder 12 is secured to the distal end of the residual esophagus via second anchors. As the fluid is pumped into device 10 , the internal pressure of device 10 increases, and the bladder 12 begins to expand both circumferentially and longitudinally. However, the small diameter ribs 24 and the large diameter ribs 26 prevent the uncontrolled circumferential expansion of bladder 12 thereby facilitating the extension of the bladder 12 along its longitudinal axis. The longitudinal extension of bladder 12 facilitates the extension of the distal end of the residual esophagus along its longitudinal axis. The extended residual esophagus may be maintained in an extended state until its extension along its longitudinal axis becomes permanent. For example, the extended residual esophagus may be maintained in an extended state for a period of about 1 month to about 6 months. During this period of extended state, as the residual esophagus gradually extends further, the internal pressure of device 10 declines; therefore, supplemental fluid is pumped into device 10 in order to increase the internal pressure of device 10 thereby inducing bladder 12 to further extend along its longitudinal axis. The longitudinal extension of bladder 12 facilitates further extension of the distal end of the previously extended residual esophagus. The addition of the supplemental fluid to facilitate further extension of the distal end of residual esophagus may be repeated as many times as necessary until an optimum extension of the distal end of the residual esophagus is achieved. In the alternative, the residual esophagus may be extended along its longitudinal axis as many times as necessary to induce a permanent extension along its longitudinal axis. For example the internal pressure of device 10 may, repeatedly, be reduced, and then, increased in order to induce a permanent extension along the longitudinal axis of the residual esophagus. [0020] The present invention may be embodied in other forms without departing from the spirit and the essential attributes thereof, and, accordingly, reference should be made to the appended claims, rather than to the foregoing specification, as indicated the scope of the invention.

The instant application relates to a device, and a method for extending a distal end of an anatomic tube. This device includes an accordion pleated bladder, which includes a proximal end and a distal end. The method includes the steps of (1) providing a device for extending a distal end of an anatomic tube including an accordion pleated bladder, wherein said bladder has a proximal end and a distal end; (2) placing the device for extending a distal end of an anatomic tube in the anatomic tube; (3) connecting the device to a pressure generator; (4) increasing the internal pressure of the device thereby extending the bladder along its longitudinal axis; and (5) thereby extending the anatomic tube along its longitudinal axis.

This application is a divisional of application Ser. No. 11/756,965, filed Jun. 1, 2007 now U.S. Pat. No. 7,682,320, which is hereby incorporated by reference. BACKGROUND Pain management has become a significant struggle in the lives of many people today. Often pain is attempted to be controlled through medication, both through prescription and over the counter forms, with varying degrees of success. Other pain management techniques are also employed, including homeopathic remedies, chiropractic treatments, and acupuncture, to name a few. The efficacy of any type of pain management technique is determined by the skill of the practitioner, whether it be a medical doctor or acupuncturist, for example, and by the receptiveness of the patient to the treatment. Additionally, most types of pain management or control techniques work by treating the symptoms, or apparent source, of the pain. Massage therapy, for example, is directed to relieving soreness or tightness of particular muscles, and often causes increased discomfort or pain before improvement is felt. What is needed is a process, technique, or device that relieves pain without forcing a patient to feel worse before they feel better. The present disclosure is directed to just such techniques and associated devices. SUMMARY The present disclosure is directed to a therapeutic method for normalizing a spine of an individual including identifying a first point on the spine that exhibits the greatest degree of spinal misalignment and the hemisphere of the misalignment. A second point on the back of the individual is found using a measuring device to measure along the spine a calculated distance specific to the individual. The second point on the back is then translated to a third point on the front of the individual opposite the second point. Application of therapeutic treatment near the third point normalizes the spine. In one embodiment, the distance is calculated by dividing the height of the individual by eight. Further objects, embodiments, forms, benefits, aspects, features and advantages of the present disclosure may be obtained from the description, drawings, and claims provided herein. DESCRIPTION OF THE DRAWING FIG. 1 is a front diagrammatic view of a portion of the human anatomy, illustrating a correlation in accordance with the present disclosure. FIG. 2 illustrates a front diagrammatic view of a human form, showing the location of relationship zones in accordance with the present disclosure. FIGS. 3A , 3 B, 3 C, and 3 D show the location and arrangement of relationship zones in the arm in accordance with the present disclosure, as the arm is held in different positions. FIG. 4 is a front diagrammatic view of the head, showing the location of relationship zones in accordance with the present disclosure. FIG. 5 is a side diagrammatic view of the head, showing the location of relationship zones in accordance with the present disclosure. FIG. 6 is a front diagrammatic view of a portion of the human anatomy similar to that shown in FIG. 1 , illustrating additional correlations in accordance with the present disclosure. FIG. 7 is a side diagrammatic view illustrating relationship zones in the arm and the leg, and also showing a correlation in accordance with the present disclosure. FIG. 8 is a side diagrammatic view of another portion of the human anatomy, illustrating another correlation in accordance with the present disclosure. FIG. 9A is a back diagrammatic view illustrating a portion of the typical human anatomy including the spine, illustrating a correlation in accordance with the present disclosure. FIG. 9B is a front diagrammatic view illustrating a view of a human torso, illustrating a correlation in accordance with FIG. 9A . FIG. 10 is a front diagrammatic view of the height measurement of a person between the top of the head and the sole of the feet. DETAILED DESCRIPTION The present disclosure describes unique pain management or treatment methods, techniques, and devices that operate under the theory that when muscles are relaxed and in balance, the skeletal system of the body will have a tendency to be aligned, and will thus be structurally strengthened. Skeletal alignment improves circulation of the vascular and the nervous systems, increasing energy flow throughout the body, which enhances and allows the body to better heal itself. Specifically, the present disclosure describes a process that from any specific pain location on the body, a series of specific related points can be found. When these related points are treated, either individually or in some combination, the pain felt at the original complaint point is alleviated or reduced. In order to describe this process, reference is made to FIG. 1 , which shows a drawing 10 illustrating a portion of the typical human anatomy. Drawing 10 shows the head 12 , torso 14 , arms 16 , hands 18 , and the upper part of legs 20 . Also shown in FIG. 1 is an overlay 22 of a pair of feet. Overlay 22 is scaled to provide a precise correlation between the dimensions of the feet and a particular part of the human anatomy, namely the torso. As can be seen in FIG. 1 , overlay 22 extends so as to completely overlay torso 14 thereby providing visible correlations as will be described below. Drawing 10 may be a photograph or outline drawing of an individual patient, and overlay 22 may be a scaled photograph or outline drawing of the actual feet of such patient. Drawing 10 may also be merely a representation of a typical or generic human form, with overlay 22 also being merely a representation of generic human feet. For purposes of explaining the pain treatment method of the present disclosure, the representations are equivalent. In practice, the skill of the therapist or practitioner may determine whether actual or generic patient representations are needed and used. Highly skilled practitioners may not require the creation of a drawing 10 and overlay 22 at all, as they may be able to visualize the feet to torso correlation for a particular patient. Less experienced practitioners or therapists, or those being trained or still learning the methods and techniques of the present disclosure, may find it helpful to create or refer to an actual drawing and overlay in order to understand the principles of the disclosure. As previously described, overlay 22 is scaled to match the vertical dimensions of torso 14 such that there is a correlation between the torso and the top 24 (toes) and bottom 26 (heel) of the feet, as well as correlations between the feet and the top of the shoulders 28 , the fifth metatarsal bone in the foot to the lower rib, the heel 26 to the top of the hip 30 , the waistline to the feet, the groin to the heel 26 , and the feet to the chest and abdomen. These correlations are formed as part of a locator system that is integral with the present disclosure. The locator system involves, in one component, a series of measurements that are developed for an individual patient to determine the location of the various points on the patient's body that are to be treated. The use of the locator system will be explained in the following paragraphs. In accordance with one embodiment of the disclosure, an individual (e.g., patient or client) presents themselves to a practitioner of the method of the disclosure with a problem or condition that is causing pain. In some cases the patient may be able to describe the initial event that originally caused the problem, but in other cases the patient may just know that some area of the body hurts or is sore. The practitioner then identifies, through sight or by touch, the spots or areas of tenderness or soreness on the patient's feet. There may be multiple points, spots, or areas of tenderness on the patient's feet. These points or areas of tenderness or soreness, referred to as congested areas, may or may not be related to each other, but typically the most tender spot will relate to that particular pain of which the patient is primarily complaining. The spot or area on the feet that is determined to be the most tender or sore is designated as the primary reference point. In FIG. 1 , this is designated as point 32 . As described above, overlay 22 correlates the feet of the patient to torso 14 . By this correlation, point 32 on the feet of the patient physically corresponds to a spot or point on torso 14 ; in FIG. 1 , this is illustratively shown as point 32 ′. This corresponding point 32 ′ is designated as the primary referral point. The patient will typically experience some degree of pain or soreness when the primary referral point is touched. Treating or working the primary referral point 32 ′, e.g., through massage, will relieve at least some, and occasionally all, of the original pain complained of by the patient. The locator system is used to identify additional points or areas of the patient's body which, when treated, will further relieve or alleviate the patient's original pain. These points or spots are designated as related referral points and helper referral points and are located as follows. With the patient lying down, the therapist or practitioner measures the height or length of the patient from the top of the head to the sole of the feet, i.e., the feet are held perpendicular to the body. This measurement is then divided by four to determine the distance between related referral points, i.e., the distance from the primary referral point to a related referral point and the distance from one related referral point to the next referral point. The distance between related referral points is also divided by two to determine helper referral measurement 67 , the distance from a related referral point to a helper referral point. One method of locating referral points is to measure whole number multiples of helper referral measurement 67 away from primary reference point 66 . Even whole number multiples, e.g., 2, 4, etc., locate related referral points while odd whole number multiples, e.g., 1, 3, etc., locate helper referral points. The body height or length measurement is recommended to be made with a metric (i.e., base 10 ) ruler or measuring tape for ease in calculating the related referral point and helper referral point distances. Treating or working each referral point, whether it be a primary referral point, a related referral point, or a helper referral point, will act to reduce or alleviate the pain experienced by the patient. However, merely knowing the distances between referral points is not enough to accurately locate those points on the patient. The additional information that is needed is described as follows. related . referral . measurement = height 4 ( 1 ) helper . referral . measurement = related . referral . measurement 2 = height 8 ( 2 ) Referring now to formulas (1) and (2), the calculations for the related referral measurement and the helper referral measurement are expressed as mathematical equations. Referring to formula (2), the helper referral measurement can be calculated by either dividing the related referral measurement by two or by dividing the height of the patient from the top of the head to the sole of the feet by eight. Referring to FIG. 10 , the measurements and calculations discussed above are illustrated. FIG. 10 depicts a front view of person 60 including top of the head 61 and sole of the feet 63 . Height H is the distance between top of the head 61 and sole of the feet 63 . Related referral measurement 69 is determined by dividing height H into four equal lengths, as shown in FIG. 10 . Once the distances between the various referral points are calculated, placement of the actual referral points is made by using the calculated distances and measuring within the particular body zone in which the primary referral point is located. Referring now to FIG. 2 , there is shown a human form diagram 34 with body zones identified in accordance with the present disclosure. Diagram 34 comprises a plurality of longitudinal body zones that progress laterally from the median plane. Central zone 36 begins at the top of the head and follows a path through the torso and includes an inner region of each leg and each foot. Symmetrical zones 38 L and 38 R are located on either side of central zone 36 , followed by symmetrical zones 40 L and 40 R, symmetrical zones 42 L and 42 R, and symmetrical zones 44 L and 44 R. The arms 46 of the human form in diagram 34 comprise zones flowing from the head and neck. These zones run diagonally across the vertical zones in the torso and also directly correlate to the respective zones in the rest of the body described above. These zones are identified as zones 48 L and 48 R, 50 L and 50 R, 52 L and 52 R, 54 L and 54 R, and 56 L and 56 R. The zones of arms 46 can be seen more clearly in FIGS. 3A and 3B . Each zone defines a particular shape or contour along diagram 34 . In accordance with the present disclosure, each related or helper referral point will be located within the same zone as is their primary referral point. With reference to FIGS. 1 and 2 , it is apparent that primary referral point 32 ′ is located within zone 40 L. Each of the related referral points and helper referral points identified by use of the locator system previously described will therefore also be located within zone 40 L. The various zones as illustrated in FIGS. 1-3 are illustratively shown as being well defined with sharp or precise delineations. In practice, however, the crossover between one zone and another may be less sharp, but an experienced practitioner will be able to accurately separate one zone from another through treatment and patient feedback. FIGS. 4 and 5 illustrate the zones of the head. Although the head zones are continuations of the body zones illustrated in FIG. 2 and consequently are correlated to the body zones, the head zones have particular shapes and define much more specific regions than do the zones that comprise the body, as is particularly apparent in FIG. 5 . For that reason, treatment of the head for purposes of pain management requires precision in the locating and defining of the particular zone in which the relevant referral points are to be found. FIG. 6 illustrates one example of how various referral points can be located on an individual or person 60 . The representation of person 60 in FIG. 6 illustrates the previously described zones of the body, head and arms, as well as a scaled overlay 62 of the feet of person 60 . As described above, a point of soreness or tenderness in the feet of person 60 defines a primary reference point 64 on overlay 62 . This correlates to a primary referral point 66 on the torso of person 60 . As can be seen, primary referral point 66 is located within zone 42 R. Therefore, all related referral points will also be located within zone 42 R. There may, of course, be other areas or points of soreness that define other primary reference points or primary referral points that are located in other zones, but the referral points associated with primary referral point 66 will all be located within zone 42 R. Related referral point 65 is identified and its location determined by measuring one related referral measurement 69 below primary referral point 66 within zone 42 R using measuring device 71 . (Note that other related referral points can also be located above primary referral point 66 , if space permits.) Helper referral points 68 and 70 can be identified and their location determined by measuring one helper referral measurement 67 above and below primary referral point 66 or related referral point 65 within zone 42 R using measuring device 71 . The locator system can also be used to find additional helper referral points from helper referral points 68 and 70 . Treating the various related referral points through massage, manipulation, heat, or other therapeutic means, singly or in combination, will relieve or lessen the soreness associated with primary referral point 66 . By treating the helper referral points as well as the primary referral point, pain relief can be realized while avoiding repeated painful treatment or manipulation of only the “sore spot.” The pain management method of the present disclosure therefore can be used to relieve pain without subjecting the patient or client to the added pain of the treatment itself. For this reason, the disclosed pain management method can be used on babies and individuals having low pain tolerance or acute localized pain without aggravating the source of the pain. Related referral points can be directly correlated from the feet to the torso, from the head or the legs to the torso, or from the torso to the head or legs. Due to a difference in scaling factor, the locator system does not permit direct correlation to and from the arms. However, as shown in FIG. 7 , the arm 72 of a patient or client can be physically correlated or scaled to the patient's or client's leg 74 , such as along illustrative transfer or correlation lines 76 , for example, such that referral points located in the leg can be transferred to the arm, within the corresponding zone (e.g., zones 78 and 78 ′), for treatment, or points of soreness in the arm can be transferred to the leg where the locator system will then allow direct correlation to the primary referral point 66 on the torso, and subsequently, other body parts to locate the related referral points such that treatment of such referral points will act to alleviate the pain or soreness in the arm. The previous description has explained the correlation between tenderness or soreness along the bottom of a patient's feet with a source of pain or discomfort in other regions of the body. Human form diagram 34 , depicted in FIG. 2 , illustrates that the spine and the inside of the feet are all in zone 36 and that the left foot is in the left hemisphere and the right foot is in the right hemisphere. FIG. 8 illustrate a correlation of the spine to the feet. An area of discomfort, or “sore spot,” along the inside of the feet can be correlated to skeletal pain in the spine or back. FIG. 8 depict an overlay of foot 88 superimposed on spine 84 . From the depicted overlay, it is possible to translate pain in the inside of foot 88 to a specific area or location along spine 84 that is causing the associated body or skeletal pain. For example, as depicted in FIG. 8 , sore spot 86 along the inside of foot 88 correlates to a primary referral point 86 ′ on spine 84 . Using the locator system described above with respect to primary referral point 86 ′ on spine 84 will lead to the identification of related and helper referral points that, when treated, will aid in the overall reduction of pain and discomfort felt by the patient. Another embodiment of the disclosure is depicted in FIGS. 9A and 9B which show drawing 90 illustrating a portion of the typical human anatomy including spine 91 illustrated in FIG. 9A . This embodiment deals with normalizing the spine using the same overall techniques described above. With the patient lying on their stomach, the therapist or practitioner observes the spine to find the point at which the spine is exhibiting the greatest degree of misalignment, which is illustrated as point 92 in FIG. 9A . The therapist or practitioner also notes whether the spine at point 92 is being pulled to the right or left hemisphere of the torso. The therapist or practitioner then measures up (or down) one helper referral measurement 67 from point 92 to point 94 in zone 36 and either physically or mentally marks point 94 on the back. The actual treatment area 94 ′ is on the front of the torso, directly opposite point 94 , as illustrated in FIG. 9B . The therapist or practitioner then works treatment area 94 ′ on the front of the torso. The therapist or practitioner interacts with the patient to verify the exact location by degree of tenderness or soreness and then works that area until the tenderness/soreness subsides. Zone 36 (the zone the spine is in) extends to both the left and right hemispheres of the body. The therapist or practitioner works in the same hemisphere of the body that the spine is pulled towards at point 92 . By relaxing the tight muscles that are pulling the spine to either the right or left hemispheres of the torso, the spine is allowed to normalize by reverting to its normal, straight, position. The therapist or practitioner then rechecks the alignment of the spine with the patient lying on their stomach. For some patients, the spine will normalize itself very easily. In other patients, it may take several iterations of the process described above to fully normalize the spine. After each iteration, the therapist or practitioner rechecks the spine for the point of greatest misalignment. If a new point of misalignment is discovered, this creates a new treatment point 92 and thus, a different treatment area 94 ′ as detailed above. Spine normalization, as described herein, when used in conjunction with the other embodiments described herein, may provide an overall reduction of pain related to other treatments and for some patients, spine normalization increases how long the benefits of other treatments last. Thus, it is preferable to use spine normalization as the first treatment applied to a patient. While the disclosure has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiments have been shown and described and that all changes, modifications and equivalents that come within the spirit of the disclosure provided herein are desired to be protected. The articles “a”, “an”, “said” and “the” are not limited to a singular element, and may include one or more such elements.

Disclosed is a method of normalizing a spine of an individual including identifying a first point on the spine that exhibits the greatest degree of spinal misalignment and the hemisphere of the misalignment. A second point on the back of the individual is identified using a measuring device to measure along the spine a calculated distance specific to the individual. The second point on the back is then translated to the front of the individual opposite the second point to identity a third point. Application of therapeutic treatment near the third point normalizes the spine. In one embodiment, the distance is calculated by dividing the height of the individual by eight.

FIELD OF THE INVENTION This invention relates to a web wrap apparatus with a brake device acted upon by a web pulled by an article being wrapped, and having a feeder to transport the web. BACKGROUND OF THE INVENTION EP 2 044 830 A1 discloses a wrapping means tensioning device having a control arm and a brake arm, both being pivotally connected to one another and pivoting as a unit about an axis. The brake arm presses on a net roll to achieve a certain tension in the net during the wrapping process. The free end of the control arm is applied by the net and is deflected by it even more as the tension in the net increases. As a result, the pressing force onto the web roll will disappear, once the net is cut. The problem this invention is based on is seen in the fact, that the net roll continues with its rotation even after the net is cut, which results in net being wound off the roll and being apt to create a net curl. SUMMARY OF THE INVENTION According to the invention the brake arm rests against the roll of web, even when the latter is cut and the brake device is no longer activated by the web. The force applied by the brake device does not necessarily need to remain at the highest level, but be at least sufficient to hinder the web roll from further rolling. The retainer may be a mechanical lock as well as a powered device like a motor, a solenoid activated clutch, lock, etc. The feeder may be of any type, like a duckbill, feed roller(s), feeder comb, etc. The movement of the feeder to start the feeding process will be used to unlock the brake device and release the brake. In case the feeder has a built-in reservoir for the web, the brake may open later; the brake may open earlier as well, provided the web roll has stopped rolling. If the retainer is in the form of a multi-position ratchet, one part of it being located on the brake device and one part on the feeder, the brake device may be locked not just in one position, but at the position of maximum brake force, which has been achieved by the brake device. The ratchet may be a toothed rod, arc, etc. and a small driver entering the teeth. In order to release the brake device, a lever, linkage, Bowden cable or the like may be used, which is activated by a movement of the feeder. A spring—mechanical or pneumatic—may force the lever into the locked position. BRIEF DESCRIPTION OF THE DRAWINGS The preferred embodiments of the invention will be described in detail below with reference to the accompanying drawings wherein: FIG. 1 is a round baler in schematic side view provided with a web wrap apparatus; FIG. 2 is the web wrap apparatus of FIG. 1 depicted in a waiting position; FIG. 3 is the web wrap apparatus of FIG. 1 depicted in a waiting position; FIG. 4 is the web wrap apparatus of FIG. 1 depicted in a feeding operation on the way back to the waiting position; and FIG. 5 is the web wrap apparatus of FIG. 1 depicted in a partly retracted position acting on a lever. DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 shows around baler 10 , which has a chassis 12 , a pick-up 14 , a bale chamber 16 , a web wrap apparatus 18 , an axle with wheels 20 , a tongue 22 and baling elements 24 . The round baler 10 shown is of an ordinary fixed chamber design, but could also be a variable chamber design. The chassis 12 rests on the axle with the wheels 20 , carries the pick-up 14 and can be connected to a tractor or the like by way of the tongue 22 . The chassis 12 has one or multiple part side walls 26 , which are spaced apart from one another to receive between them the bale chamber 16 , all or part of the web wrap apparatus 18 and the baling elements 24 . The pick-up 14 picks up crop from the ground and delivers it to the bale chamber 16 through a crop inlet 28 between the baling elements 24 . The bale chamber 16 is covered substantially by the baling elements 24 on the circumference and by the side walls 26 on the face sides. Beside the crop inlet 28 a gap 30 is provided between the baling elements 24 , through which web 32 may be fed into the bale chamber 16 . The bale chamber 16 serves to form a cylindrical bale of hay, straw or the like, which will be covered by the web 32 of plastic, net paper or the like. The baling elements 24 in this embodiment are in the form of steel rolls rotatably received in the sidewalls 26 and extending perpendicular to them. These baling elements 24 are arranged substantially on a circle. The web wrap apparatus 18 is visible in more detail in FIG. 2 and contains among other things a housing 34 , a motion element 36 , a brake device 38 , a feeder 40 and a separator and an actuating mechanism (not shown). The latter are described in more detail in European Patent Appl. No. 09155481.6 filed on 18 Mar. 2009. The housing 34 is located in the front upper part of the round baler 10 between or substantially between the side walls 26 and has a rear wall 46 and a left and a right wall 48 connected to one another and suitable to be connected to the side walls 26 . Depending on the width of the web 32 , the housing 34 and the entire web wrap apparatus 18 may extend beyond the side walls 26 . The rear wall 46 may be of a material, or may have a layer, which creates a certain friction, which will have an influence on the rolling resistance of a roll 50 of the web 32 . The housing 34 may be used to attach all components and parts of the web wrap apparatus 18 to it to form an autonomous unit. The right and left walls 48 extend to the rear towards the bale chamber 16 as needed to take up some of the parts described later. The motion element 36 is formed by a roll 52 , preferably rubber coated, which is journalled rotatably about a horizontal axis in the side walls 48 and which is located such that the roll 50 of the web 32 can rest on it. As is known in the art, but not shown here, the roll 52 is connected via a chain drive and a free-wheel to the baling elements 24 such that it must rotate slower than the baling elements 24 . The brake device 38 substantially has a control arm 58 and a brake arm 60 connected together on a shaft 62 to pivot about a horizontal axis of the latter. A gas spring (not shown) may be connected to the shaft 62 via an arm (not shown) to assist or resist the rotational movement of the shaft 62 . It is the purpose of the brake device 38 to exert a certain pressure onto the roll 50 of the web 32 to assure a sufficient tension in it, when it is wrapped onto a bale (not shown). The shaft 62 is located at about the same height as the roll 52 and at a certain distance to it forwardly. The control arm 58 extends underneath the roll 52 and from a location rearward of the roll 52 to the shaft 62 and ends at about the center of the roll 52 . The control arm 58 has an idler bar 68 or an angle extending parallel to the axis of the roll 52 between the side walls 48 of the web wrap apparatus 18 . The brake arm 60 extends from the shaft 62 to a location above a completely wrapped roll 50 of the web 32 and has a cross element 70 designed to push onto the circumferential surface of the roll 50 , thereby pressing the roll 50 against the rear wall 46 and creating the desired rolling resistance. As is apparent from the drawing, a downward, counter-clockwise movement of the control arm 58 will provoke a counter-clockwise movement of the brake arm 60 upon the roll 50 of the web 32 . The feeder 40 in this embodiment is formed as a so-called duckbill, which however is not mandatory; it could be any other moving part pulling the web 32 from the roll 50 and feeding it into the bale chamber 16 through the gap 30 . The feeder 40 is composed of struts 72 on each side holding between them a carrier 74 in the form of a mouthpiece at a lower end thereof, two vertically distant bearings 76 . The carrier 74 as such is known and has two opposite plates biased onto one another to clamp a piece of the web 32 and move it rearward. An upper link 82 and a lower link 84 forming part of a parallelogram linkage are connected with one end area to the bearings 76 and with their other end areas to the bearings 86 on the side walls 48 of the web wrap apparatus 18 being offset horizontally as well as vertically; lines through the bearings 76 at one end and the bearings 86 at the other end do not run parallel but divergently. The upper link 82 has an eye 88 on its upper side or a bore or the like useful to provide a connection to an actuator 110 such as an electric or hydraulic motor. An idler element 116 is connected to and connects the struts 72 on both sides. The idler element 116 assists in feeding the web 32 in a proper way into the carrier 74 . The idler element 116 may consist of a simple bar or shaft. The motor 110 , which may be actuated electrically, hydraulically or pneumatically is connected with one side to the side walls 48 of the web wrap apparatus 18 or any other stationary feature of the chassis 12 and with the other side to the eye 88 on the upper link 82 . As is best seen in FIG. 3 a lever 118 is provided, with which an upper end area is journalled in a bearing 120 (see FIG. 2 ) in the wall 48 and which in its lower end area has a longitudinal slot 122 extending substantially on a circle about the bearing 120 . Furthermore the lever 118 has a contact area 124 on the rear side and an aperture 126 . The contact area 124 may be an angle or flat steel welded to the lever 118 and extending perpendicular to it. The lever 118 extends substantially vertically. At the wall 48 a guide 128 is provided, which in a simple manner consists of a bolt, a bushing, a rod or the like, protruding through the slot 122 to limit the pivot movement of the lever 118 about the bearing 120 . A retainer 130 in the form of a ratchet is provided in an area, where the control 58 and the lever 118 make contact with one another. The retainer 130 has a first part 132 in the form of a toothed bar, cam or the like, wherein the teeth face towards the lever 118 . The teeth are oriented and slanted downwardly to provide a good grip. A second part 134 of the retainer 130 is provided at the end of the lever 118 and has the form of a tooth, which may enter the space between two teeth on the first part 132 . This second part 134 is oriented upwardly to engage securely in the first part 132 . Finally a spring 136 is installed between the aperture 126 and a location at the wall 48 . The spring 136 , which in this case is a coil tension spring, can be of any kind but needs to bias the lever 118 in a mating position of the first and the second part 132 , 134 , respectively. While on either side one lever 118 , one retainer 130 and one spring 136 would be sufficient it would be beneficial to have such a set on both sides of the round baler 10 . Based on this structural description the function is described as follows starting from a state shown in FIG. 2 , in which the web wrap apparatus 18 waits to be operated. In a state as shown in FIG. 2 , the roll 50 with the web 32 is placed on the roll 52 and is secured in its position between the cross element 70 and the rear wall 46 . The feeder 40 is in a position remote from the gap 30 . The web 32 extends from the roll 50 , underneath the roll 52 over the idler bar 68 , through the carrier 74 , where it is clamped. As soon as a manual or electrical signal is given to the actuating motor 110 to initiate wrapping the web 32 around a bale, the motor 110 is extended, thereby moving the feeder 40 downward and towards the gap 30 . Once the carrier 74 protrudes the gap 30 , the web portion hanging down from the carrier 74 is caught by the rotating bale and pulled from the roll 50 . Tension is created in the web 32 , since the roll 50 experiences friction on the wall 46 and since the roll 52 is hindered from free movement. FIG. 5 shows a situation, in which the motor 110 is retracted and thereby the feeder 40 is on its way back to a resting or home position. FIG. 3 shows a situation, in which both parts 132 , 134 are in a positive locking condition, whereas the control arm 58 is in a low position, which corresponds to the lowest position reached in the preceding wrapping cycle. The struts 72 are distant from the contact area 124 of the lever 118 . Due to the connection between the control arm 58 and the brake arm 60 , pivoting about the shaft 62 , this location of the control arm 58 will exert considerable pressure on the web roll 50 through the contact with the cross member 70 . FIG. 2 shows the feeder 40 on its way to the gap 30 by pivoting about the bearings 86 . During this downward movement the upper end of the struts 72 will hit the lever 118 in the contact area 124 and will push the lever 118 forward. The clockwise movement will disconnect the two parts 132 , 134 of the retainer 130 and the assembly of the control arm 58 and the brake arm 60 is free to pivot upwardly either by the inherent bending forces in the brake device 38 and/or by the gas spring acting between the shaft 62 and the brake arm 60 . The result is the position shown in FIG. 2 . FIG. 4 shows a situation, in which the web 32 is pulled by the bale in the bale chamber 16 and due to the tension in the web 32 the idler bar 68 is pushed down. Since at the same time the feeder 40 returns to its home position, the retainer 130 is disconnected, which at that time is no problem, since the tension in the web 32 still endures. In FIG. 5 the feeder 40 has almost passed the lever 118 , which then will again connect the two parts 132 , 134 of the retainer 130 by virtue of the spring 136 . When the web 32 is separated by a separator (not shown), the retainer 130 is locked and remains locked, until the wrapping cycle starts from the beginning. Having described the preferred embodiment, it will become apparent that various modifications can be made without departing from the scope of the invention as defined in the accompanying claims.

A web wrap apparatus is provided and has a brake device that exerts pressure on a roll of a web material. In order to exert pressure even after the web material is cut, the brake device is locked by a retainer once the web is separated and is released by a feeder, when moving from a home position to a web feed position.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a National Phase of International Application PCT/EP2009/059494, filed on Jul. 23, 2009, which claims priority to European Patent Application 08161000.8 filed on Jul. 23, 2008, U.S. patent application Ser. No. 12/269,241 filed on Nov. 12, 2008, and European Patent Application 09305237.1 filed on Mar. 13, 2009, all of which are hereby incorporated by reference in their entireties. TECHNICAL FIELD [0002] The disclosure relates to quinoline derivatives, in particular endowed with inhibitory properties of Human Immuno-deficiency Virus (HIV) integrase. [0003] It also relates to a synthetic process for these derivatives and their biological uses. BACKGROUND [0004] The replication cycle of HIV and other retroviruses involves three major viral enzymes: reverse transcriptase, protease and integrase. Integrase catalyzes the integration of the viral DNA into chromosomal DNA of the host infected cell, it is an essential step for the replication of HIV and other retroviruses. Consequently, an integrase inhibitor constitutes ipso facto an accurate candidate for blocking infection by HIV, and possibly an effective therapeutic agent. [0005] Poly therapy targeting reverse transcriptase and/or protease and/or integrase is today the only method to effectively combat the rapid development of the virus. Currently, HIV reverse transcriptase and protease are each targeted by about 10 therapeutic agents. However, integrase is targeted by only one commercialized medication: the Merck's Isentress (raltegravir or MK-0518), approved by the U.S. Food and Drug Administration (FDA) in October 2007. A second integrase inhibitor, Gilead's elvitegravir (GS-9137), is in advanced clinical trials. [0006] The integration of the viral DNA into the chromosomal DNA of the infected cells occurs through a two-steps process: (i) in the “3′ processing step”, integrase in the cytoplasm of the host cell removes a dinucleotide from 3′ end of the viral 25 DNA, while (ii) in the “strand transfer step”, integrase in the nucleus catalyzes the insertion of the processed 3′ end viral DNA into the host cell DNA. [0007] Integrase inhibitors can be divided into two groups: (i) inhibitors of the 3′ processing (referred to as INBIs) and (ii) selective strand transfer inhibitors (referred to as INSTIs) (Pommier Y, and al. Nat Rev Drug Discov 2005, 4:236-248). INBIs act as docking at the HIV DNA-binding site, preventing 3′ processing and strand transfer and INSTIs act as occupying the infected cells DNA-binding site, thus only preventing strand transfer (Johnson A A et al. Mol Pharmacol. 2007 71 (3):893-901). Raltegravir and elvitegravir belong to the INSTIs group. However, a limit of these inhibitors is the high rate of virus mutations in treated patients leading to INSTIs resistance. [0008] It is thus a substantial advantage to identify a potent inhibitor of the 3′ processing step of integrase with a specific mechanism of action leading to the inhibition of the both steps of integration. Moreover this kind of inhibitor could remain still active on virus bearing mutations which lead to INSTIs resistance. SUMMARY [0009] The disclosed quinoline derivatives have demonstrated anti-integrase properties in vitro as well as in vivo, these properties being accompanied by significant innocuity. WO 98/45269 discloses phenyl substituted quinolines, in particular styryl quinolines, where the various positions of the quinoleine and phenyl moieties may be optionally substituted. [0010] The presence of a substituent on the 5-position of the quinoline moiety, combined with a 8-OH on the quinoline core, surprisingly leads to substantially increased properties, such as their antiviral efficacy, their stability, and/or their biodisponibility. [0011] Noteworthy, the stability of the compounds disclosed herein is particularly advantageous. Indeed, styryl quinolines disclosed in WO 98/45269 showed poor stability, thus constituting a major drawback for further drug development. [0012] Moreover, it is particularly desirable to provide drug candidates with satisfying solubility, in particular in aqueous medium at the pH of the intestinal tractus, to allow administration by oral route. Although, quinoline derivatives may have a low solubility, the disclosure identifies exemplary formulations of the compounds to increase solubility. [0013] Further, the disclosed quinoline derivatives are moreover efficient against INSTIs resistant integrase. Noteworthy, the disclosed quinoline derivatives are particularly useful for inhibiting Raltegravir and/or Elvitegravir resistant integrase. [0014] A combination of said quinoline derivatives with other anti viral agent(s) is also disclosed herein. Indeed, said combinations, in particular those of quinoline derivatives with INSTIs or reverse transcriptase inhibitors, show synergistic effects. [0015] The disclosed derivatives are characterized in that they correspond to the general formula (I): [0000] [0016] wherein: [0017] R1, R2, R4, R5, R6, R7, R8 identical or different, independently represent a hydrogen atom or a group chosen from —(CH 2 ) n —Y or —CH═CH—Y, where Y represents a halogen atom, —OH, —OR, —COH, —COR, —COOH, —COOR, —CONH 2 , —CON(Rx,Ry), —CH═NOH, —CO—CH═NOH, —NH 2 , —N(Rx,Ry), —NO 2 , —PO(OR) 2 , —PO(OH) 2 , —C(═O)—NH—OH, —SH 2 , —SR, —SO 2 R, —SO 2 NHR, CN, [0018] X represents a group chosen from —(CH 2 ) n —Y or —CH═CH—Y, where Y represents —OH, —OR, —COH, —COR, —CONH 2 , —CON(Rx,Ry), —CH═NOH, —CO—CH═NOH, —NH 2 , —N(Rx,Ry), —PO(OR) 2 , —PO(OH) 2 , —C(═O)—NH—OH, —SH 2 , —SR, —SO 2 R, —SO 2 NHR, CN, [0019] where R represents an alkyl, or an aryl or heterocycle, Rx and Ry, identical or different represent an alkyl, and n is an integer chosen from 0, 1 to 5; as well [0020] as well as their pharmaceutically acceptable salts, their diastereoisomers and enantiomers. [0021] The disclosure also encompasses the following preferred exemplary embodiments and any of their combinations: [0022] X represents a group chosen from a halogen atom, —OH, —OR, —COH, —COR, —COOH, —COOR, —NO 2 , CN; more preferably —COH, —COR, —OH or —NO 2 ; and/or [0023] R1 and R2 are H; and/or [0024] R1, R2, R3, R4, R5, R6, R7, R8 identical or different, independently represent a hydrogen atom or a halogen atom or a group chosen from —OH, —OR, —COH, —COR, —COOH, —COOR, —NO 2 , —PO(OR) 2 , —PO(OH) 2 , —C(═O)—NH—OH, CN; more preferably chosen from a hydrogen atom, halogen atom or a group chosen from —OH, —OR, —COH, —COR, —COOH, [0025] —COOR, —NO 2 ; still more preferably chosen from a hydrogen atom, or a group chosen from —OH, —COR, —COOH, —NO 2 , and/or [0026] two or three of R4, R5, R6, R7, R8 are distinct of H; and/or [0027] at least one of R4, R5, R6, R7, R8 is OH; and/or [0028] R6 is OH; and/or [0029] X represents a group chosen from —(CH 2 ) n —Y or —CH═CH—Y, where Y represents —OH, —OR, —COH, —COR, —COOR, —CONH 2 , —CON(Rx 1 Ry), [0030] CH═NOH, [0031] CO—CH═NOH, —NH 2 , —N(Rx 1 Ry), —PO(OR) 2 , —PO(OH) 2 , —C(═O)—NH—OH, [0032] SH 2 , —SR, —SO 2 R, —SO 2 NHR, CN, more preferably, Y is —COR; and/or [0033] R1=R2=H; and/or R4=R8=H, and/or [0034] At least one of R5, R7 is chosen from a halogen atom or a group chosen from —COH, —COR, —COON, —COOR, —NO 2 , —PO(OR) 2 , —PO(OH) 2 , [0035] —C(═O)—NH—OH, CN; more preferably chosen from a halogen atom or a —NO 2 . [0036] Preferably, the compounds are chosen from: 1-{2-[2(E)-(3-chloro, 4,5-dihydroxyphenyl)-vinyl]-8-hydroxy-quinolin-5-yl}-ethanone; 5-[2(E)-(5-Acetyl-8-hydroxy-quinolin-2-yl)-vinyl]-2-hydroxy-benzoic acid; 1-{2-[2(E)-(2,3-Dihydroxy-4-methoxy-phenyl)-vinyl]-8-hydroxy-quinolin-5-yl}-ethanone; 1-{2-[2(E)-(2,4,5-thhydroxyphenyl)-vinyl]-8-hydroxy-quinolin-5-yl}-ethanone; 1-{2-[2(E)-(3,4,5-thhydroxyphenyl)-vinyl]-8-hydroxy-quinolin-5-yl}-ethanone; 1-{2-[2(E)-(3,4-dihydroxy, 5-nitrophenyl)-vinyl]-8-hydroxy-quinolin-5-yl}-ethanone; 1-{2-[2(E)-(4-hydroxy, 5-methoxy, 3-nitrophenyl)-vinyl]-8-hydroxy-quinolin-5-yl}-ethanone; 4-[2(E)-(5-Acetyl-8-hydroxy-quinolin-2-yl)-vinyl]-5-nitro-benzoic acid; 4-[(E)-2-(5-Acetyl-8-hydroxy-quinolin-2-yl)-vinyl]-3-nitro-benzoic acid methyl ester; 3-[(E)-2-(5-Acetyl-8-hydroxy-quinolin-2-yl)-vinyl]-4-nitro-benzoic acid methyl ester; 5-[2(E)-(5-Acetyl-8-hydroxy-quinolin-2-yl)-vinyl]-2-hydroxy-4-nitro-benzoic acid; 1-{2-[2(E)-(3-nitro, 4-hydroxy, 5-methoxyphenyl)-vinyl]-8-hydroxy-quinolin-5-yl}-ethanone; 1-{2-[2(E)-(3,4-dihydroxy, 5-methoxyphenyl)-vinyl]-7-chloro, 8-hydroxy-quinolin-5-yl}-ethanone; [0050] as well as their pharmaceutically acceptable salts, their diastereoisomers and enantiomers. [0051] Unless specified otherwise, the terms used hereabove or hereafter have the meaning ascribed to them below: [0052] “Halo” or “halogen” refers to fluorine, chlorine, bromine or iodine atom. [0053] “Alkyl” represents an aliphatic-hydrocarbon group which may be straight or branched, having 1 to 20 carbon atoms in the chain unless specified otherwise. Preferred alkyl groups have 1 to 12 carbon atoms, more preferably have 1 to 6 carbon atoms in the chain. Branched means that one or more lower alkyl groups such as methyl, ethyl or propyl are attached to a linear alkyl chain. Exemplary alkyl groups include methyl, ethyl, n-propyl, i-propyl, n-butyl, t-butyl, n-pentyl, 3-pentyl, octyl, nonyl, decyl. [0054] “Aryl” refers to an aromatic monocyclic or multicyclic hydrocarbon ring system of 6 to 14 carbon atoms, preferably of 6 to 10 carbon atoms. Exemplary aryl groups include phenyl, naphthyl, indenyl, phenanthryl, biphenyl. [0055] The terms “heterocycle” or “heterocyclic” refer to a saturated or partially unsaturated non aromatic stable 3 to 14, preferably 5 to 10-membered mono, bi or multicyclic rings, wherein at least one member of the ring is a hetero atom. Typically, heteroatoms include, but are not limited to, oxygen, nitrogen, sulfur, selenium, and phosphorus atoms. Preferable heteroatoms are oxygen, nitrogen and sulfur. Suitable heterocycles are also disclosed in the Handbook of Chemistry and Physics, 76th Edition, CRC Press, Inc., 1995-1996, pages 2-25 to 2-26, the disclosure of which is hereby incorporated by reference. [0056] Preferred non aromatic heterocyclic include, but are not limited to oxetanyl, tetraydrofuranyl, dioxolanyl, tetrahydropyranyl, dioxanyl, pyrrolidinyl, piperidyl, morpholinyl, imidazolidinyl, pyranyl. Preferred aromatic heterocyclic, herein called heteroaryl groups include, but are not limited to, pyridyl, pyridyl-N-oxide, pyrimidinyl, pyrrolyl, imidazolinyl, pyrrolinyl, pyrazolinyl, furanyl, thienyl, imidazolyl, triazolyl, tetrazolyl, quinolyl, isoquinolyl, benzoimidazolyl, thiazolyl, pyrazolyl, and benzothiazolyl groups. [0057] “Alkyl”, “aryl”, “heterocycle” also refers to the corresponding “alkylene”, “arylene”, “heterocyclene” which are formed by the removal of two hydrogen atoms. [0058] The compounds herein described may have asymmetric centers. Compounds containing an asymmetrically substituted atom may be isolated in optically active or racemic forms. It is well-known in the art how to prepare optically active forms, such as by resolution of racemic forms or by synthesis from optically active starting materials. Geometric isomers of double bonds such as olefins and C═N can also be present in the compounds described here, all the stable isomers are contemplated here. All chiral, diastereomeric, racemic forms and all geometric isomeric forms of a compound are intended, unless the stereochemistry or the isomeric form is specifically indicated. All processes used to synthesize the disclosed compounds are considered as part of the present disclosure. [0059] The term “substituted” as used herein means that any one or more hydrogens on the designated atom is replaced with a selection from the indicated group, provided that the designated atom's normal valency is not exceeded and that the substitution results in a stable compound. [0060] As used herein, the term “patient” refers to a warm-blooded animal such as a mammal, preferably a human or a human child, which is afflicted with, or has the potential to be afflicted with one or more diseases and conditions described herein. [0061] As used herein, a “therapeutically effective amount” refers to an amount of a compound of the present disclosure which is effective in reducing, eliminating, treating or controlling the symptoms of the herein-described diseases and conditions. The term “controlling” is intended to refer to all processes wherein there may be a slowing, interrupting, arresting, or stopping of the progression of the diseases and conditions described herein, but does not necessarily indicate a total elimination of all disease and condition symptoms, and is intended to include prophylactic treatment and chronic use. [0062] As used herein, the expression “pharmaceutically acceptable” refers to those compounds, materials, compositions, or dosage forms which are, within the scope of sound medical judgment, suitable for contact with the tissues of human beings and animals without excessive toxicity, irritation, allergic response, or other problem complications commensurate with a reasonable benefit/risk ratio. [0063] As used herein, the expression “pharmaceutically acceptable salts” refers to derivatives of the disclosed compounds wherein the parent compound is modified by making acid or base salts thereof. The pharmaceutically acceptable salts include the conventional non-toxic salts or the quaternary ammonium salts of the parent compound formed, for example, from non-toxic inorganic or organic acids. For example, such conventional non-toxic salts include those derived from inorganic acids such as hydrochloric, hydrobromic, sulfuric, sulfamic, phosphoric, nitric and the like; and the salts prepared from organic acids such as acetic, propionic, succinic, tartaric, citric, methanesulfonic, benzenesulfonic, glucoronic, glutamic, benzoic, salicylic, toluenesulfonic, oxalic, fumaric, maleic, and the like. Further addition salts include ammonium salts such as tromethamine, meglumine, epolamine, etc., metal salts such as sodium, potassium, calcium, zinc or magnesium. [0064] The pharmaceutically acceptable salts of the compounds of the present disclosure can be synthesized from the parent compound which contains a basic or acidic moiety by conventional chemical methods. Generally, such salts can be prepared by reacting the free acid or base forms of these compounds with a stoichiometric amount of the appropriate base or acid in water or in an organic solvent, or in a mixture of the two. Generally, non-aqueous media like ether, ethyl acetate, ethanol, isopropanol, or acetonitrile are preferred. Lists of suitable salts are found in Remington's Pharmaceutical Sciences, 17th ed., Mack Publishing Company, Easton, Pa., 1985, p. 1418 and P. H. Stahl, C G. Wermuth, Handbook of Pharmaceutical salts—Properties, Selection and Use , Wiley-VCH, 2002, the disclosures of which are hereby incorporated by reference. [0065] The compounds of the general formula (I) having geometrical and stereoisomers are also a part of the disclosure. [0066] The disclosure also relates to a synthetic process for the derivatives defined above. The compounds of formula (I) may be prepared in a number of ways well-known to those skilled in the art. In particular, they may be synthesized by application or adaptation of the process of preparation disclosed in WO 98/45269, or variations thereon as appreciated by the skilled artisan. The appropriate modifications and substitutions will be readily apparent and well-known or readily obtainable from the scientific literature to those skilled in the art. [0067] In particular, such methods can be found in R. C. Larock, Comprehensive Organic Transformations , VCH publishers, 1989 [0068] It will be appreciated that the compounds of the present disclosure may contain one or more asymmetrically substituted carbon atoms, and may be isolated in optically active or racemic forms. Thus, all chiral, diastereomeric, racemic forms and all geometric isomeric forms of a structure are intended, unless the specific stereochemistry or isomeric form is specifically indicated. It is well-known in the art how to prepare and isolate such optically active forms. For example, mixtures of stereoisomers may be separated by standard techniques including, but not limited to, resolution of racemic forms, normal, reverse-phase, and chiral chromatography, preferential salt formation, recrystallization, and the like, or by chiral synthesis either from chiral starting materials or by deliberate synthesis of target chiral centers. [0069] Compounds of the present disclosure may be prepared by a variety of synthetic routes. The reagents and starting materials are commercially available, or readily synthesized by well-known techniques by one of ordinary skill in the arts. All substituents, unless otherwise indicated, are as previously defined. [0070] In the reactions described hereinafter, it may be necessary to protect reactive functional groups, for example hydroxy, amino, imino, thio or carboxy groups, where these are desired in the final product, to avoid their unwanted participation in the reactions. Conventional protecting groups may be used in accordance with standard practice, for examples see T. W. Greene and P. G. M. Wuts in Protective Groups in Organic Synthesis , John Wiley and Sons, 1991; J. F. W. McOmie in Protective Groups in Organic Chemistry , Plenum Press, 1973. [0071] Some reactions may be carried out in the presence of a base. There is no particular restriction on the nature of the base to be used in this reaction, and any base conventionally used in reactions of this type may equally be used here, provided that it has no adverse effect on other parts of the molecule. Examples of suitable bases include: sodium hydroxide, potassium carbonate, thethylamine, alkali metal hydrides, such as sodium hydride and potassium hydride; alkyllithium compounds, such as methyllithium and butyllithium; and alkali metal alkoxides, such as sodium methoxide and sodium ethoxide. [0072] Usually, reactions are carried out in a suitable solvent. A variety of solvents may be used, provided that it has no adverse effect on the reaction or on the reagents involved. Examples of suitable solvents include: hydrocarbons, which may be aromatic, aliphatic or cycloaliphatic hydrocarbons, such as hexane, cyclohexane, benzene, toluene and xylene; amides, such as dimethyl-formamide; alcohols such as ethanol and methanol and ethers, such as diethyl ether and tetrahydrofuran. [0073] The reactions can take place over a wide range of temperatures. In general, it is convenient to carry out the reaction at a temperature of from 0° C. to 150° C. (more preferably from about room temperature to 100° C.). The time required for the reaction may also vary widely, depending on many factors, notably the reaction temperature and the nature of the reagents. However, provided that the reaction is effected under the preferred conditions outlined above, a period of from 3 hours to 20 hours will usually suffice. [0074] The process of the disclosure is characterized in that it comprises the reaction of a quinaldine of formula (II): [0000] [0075] with a compound of formula (III): [0000] [0076] where R1′, R2′, R4′, R5′, R6′, R7′, R8′, X′ are defined as R1, R2, R4, R5, R6, R7, R8, X above, provided any reactive function present in R1, R2, R4, R5, R6, R7, R8, X may be protected by an appropriate protective group in R1′, R2′, R4′, R5′, R6′, R7′, R8′, X′ respectively, and where Pg denotes either H or a protective group of the OH function if required, followed by the deprotection of any protective group present as appropriate. [0077] The coupling may be advantageously conducted in an organic solvent, such as acetic anhydride and/or a mixture of pyhdine/water. The reaction may be carried out at a temperature comprised between the room temperature and the boiling temperature of the reacting mixture. [0078] Generally, OH groups may be protected in the form of acetoxy groups. The deprotection may be conducted by hydrolysis. [0079] The derivatives used as starting products in these syntheses are commercially available or easily accessible by synthesis for a person skilled in the art. [0080] Thus, for example, the derivatives of formula (II) may be synthesized in accordance with Meek et al., J. Chem. Engineering data, 1969, 14, 388-391 or Przystal et al, J. Heterocycl. Chem., 1967, 4, 131-2. As a representative example, the compound of formula (II) where R1=R2=H and X is —COR may be obtained by reacting the corresponding compound of formula (II) where R1=R2=X═H, with a compound of formula X-Hal, where Hal represents a halogen atom. [0081] The compounds of formula (III) are generally commercially available. [0082] If desired, the salts of the compounds of formula (I) may be obtained by adding the appropriate base or acid. For instance, where compounds of formula (I) comprise an acid function the sodium salt may be obtained by adding sodium hydroxide. [0083] The process of the disclosure may also include the additional step of isolating the obtained product of formula (I). The compound thus prepared may be recovered from the reaction mixture by conventional means. For example, the compounds may be recovered by distilling off the solvent from the reaction mixture or, if necessary after distilling off the solvent from the reaction mixture, pouring the residue into water followed by extraction with a water-immiscible organic solvent and distilling off the solvent from the extract. Additionally, the product can, if desired, be further purified by various well known techniques, such as recrystallization, reprecipitation or the various chromatography techniques, notably column chromatography or preparative thin layer chromatography. [0084] Study of the biological properties of the derivatives of the disclosure showed an inhibitory activity vis-á-vis HIV integrase in vitro. Further experiments have also shown their inhibitory effect on the replication of HIV and the absence of effect on the late phases of the replication of HIV. These results are thus extremely interesting for the treatment of an infection by this virus, especially as the toxicity studies have shown the significant innocuity of these derivatives. [0085] The disclosure thus relates to pharmaceutical compositions characterized in that they contain an effective quantity of at least one derivative as defined above, in combination with pharmaceutically acceptable vehicles. [0086] In particular, the present disclosure concerns formulations of a compound of formula (I) suitable for oral administration. Said formulation may comprise one or more excipient(s) chosen from surfactant, emulsifier, solubility enhancers, etc. . . . [0087] The compounds of the disclosure are advantageously used in combination with other anti-viral agents, such as HIV medicaments, in particular medicaments endowed with an inhibitory effect vis-á-vis the integrase, reverse transcriptase and/or protease. [0088] Such combinations are particularly advantageous in that the compounds of the disclosure are active on resistant viruses, in particular viruses resistant to reverse transcriptase inhibitors and/or to INSTI integrase inhibitors. [0089] Further, such combinations are particularly advantageous in that they exhibit synergism. [0090] The present disclosure thus also concerns such combinations of a compound of the disclosure with one or more integrase, reverse transcriptase and/or protease inhibitor(s), in particular, combinations of a compound of the disclosure with one or more INSTI inhibitor, such as raltegravir or elvitegravir. [0091] The doses and administration methods are adapted as a function of the single-drug, two-drug or three-drug combination therapy treatment used. [0092] The disclosure also relates to the use of the derivatives defined above as biological reagents usable in particular for mechanism studies concerning the viral infection. [0093] The identification of those subjects who are in need of treatment of herein-described diseases and conditions is well within the ability and knowledge of one skilled in the art. A clinician skilled in the art can readily identify, by the use of clinical tests, physical examination and medical/family history, those subjects who are in need of such treatment. [0094] The compounds of the disclosure may be advantageously used for inhibiting INSTIs resistant integrase. [0095] A therapeutically effective amount can be readily determined by the attending diagnostician, as one skilled in the art, by the use of conventional techniques and by observing results obtained under analogous circumstances. In determining the therapeutically effective amount, a number of factors are considered by the attending diagnostician, including, but not limited to: the species of subject; its size, age, and general health; the specific disease involved; the degree of involvement or the severity of the disease; the response of the individual subject; the particular compound administered; the mode of administration; the bioavailability characteristic of the preparation administered; the dose regimen selected; the use of concomitant medication; and other relevant circumstances. [0096] The amount of a compound of formula (I), which is required to achieve the desired biological effect, will vary depending upon a number of factors, including the dosage of the drug to be administered, the chemical characteristics (e.g. hydrophobicity) of the compounds employed, the potency of the compounds, the type of disease, the diseased state of the patient, and the route of administration. [0097] In general terms, the compounds of this disclosure may be provided in an aqueous physiological buffer solution containing 0.1 to 10% w/v compound for parenteral and/or oral administration. Typical dose ranges are from 1 μg/kg to 0.1 g/kg of body weight per day; a preferred dose range is from 0.01 mg/kg to 10 mg/kg of body weight per day. A preferred daily dose for adult humans includes 1, 5, 50, 100 and 200 mg, and an equivalent dose in a human child. The preferred dosage of drug to be administered is likely to depend on such variables as the type and extent of progression of the disease or disorder, the overall health status of the particular patient, the relative biological efficacy of the compound selected, and formulation of the compound excipient, and its route of administration. [0098] The compounds of the present disclosure are capable of being administered in unit dose forms, wherein the term “unit dose” means a single dose which is capable of being administered to a patient, and which can be readily handled and packaged, remaining as a physically and chemically stable unit dose comprising either the active compound itself, or as a pharmaceutically acceptable composition, as described hereinafter. As such, typical daily dose ranges are from 0.01 to 10 mg/kg of body weight. By way of general guidance, unit doses for humans range from 0.1 mg to 1000 mg per day. Preferably, the unit dose range is from 1 to 500 mg administered one to four times a day, and even more preferably from 1 mg to 300 mg, once a day. Compounds provided herein can be formulated into pharmaceutical compositions by admixture with one or more pharmaceutically acceptable excipients. Such compositions may be prepared for use in oral administration, particularly in the form of tablets or capsules; or parenteral administration, particularly in the form of liquid solutions, suspensions or emulsions; or intranasally, particularly in the form of powders, nasal drops, or aerosols; or dermally, for example, topically or via trans-dermal patches or ocular administration, or intravaginal or intra-uterine administration, particularly in the form of pessaries or by rectal administration. [0099] The compositions may conveniently be administered in unit dosage form and may be prepared by any of the methods well known in the pharmaceutical art, for example, as described in Remington: The Science and Practice of Pharmacy, 20 th ed.; Gennaro, A. R., Ed.; Lippincott Williams & Wilkins: Philadelphia, Pa., 2000. Pharmaceutically compatible binding agents and/or adjuvant materials can be included as part of the composition. Oral compositions will generally include an inert diluent carrier or an edible carrier. [0100] The tablets, pills, powders, capsules, troches and the like can contain one or more of any of the following ingredients, or compounds of a similar nature: a binder such as microcrystalline cellulose, or gum tragacanth; a diluent such as starch or lactose; a disintegrant such as starch and cellulose derivatives; a lubricant such as magnesium stearate; a glidant such as colloidal silicon dioxide; a sweetening agent such as sucrose or saccharin; or a flavoring agent such as peppermint, or methyl salicylate. Capsules can be in the form of a hard capsule or soft capsule, which are generally made from gelatin blends optionally blended with plasticizers, as well as a starch capsule. In addition, dosage unit forms can contain various other materials that modify the physical form of the dosage unit, for example, coatings of sugar, shellac, or enteric agents. Other oral dosage forms syrup or elixir may contain sweetening agents, preservatives, dyes, colorings, and flavorings. In addition, the active compounds may be incorporated into fast dissolve, modified-release or sustained-release preparations and formulations, and wherein such sustained-release formulations are preferably bi-modal. [0101] Preferred formulations include pharmaceutical compositions in which a compound of the present disclosure is formulated for oral or parenteral administration, or more preferably those in which a compound of the present disclosure is formulated as a tablet. Preferred tablets contain lactose, cornstarch, magnesium silicate, croscarmellose sodium, povidone, magnesium stearate, or talc in any combination. It is also an aspect of the present disclosure that a compound of the present disclosure may be incorporated into a food product or a liquid. [0102] Liquid preparations for administration include sterile aqueous or non-aqueous solutions, suspensions, and emulsions. The liquid compositions may also include binders, buffers, preservatives, chelating agents, sweetening, flavoring and coloring agents, and the like. Non-aqueous solvents include alcohols, propylene glycol, polyethylene glycol, acrylate copolymers, vegetable oils such as olive oil, and organic esters such as ethyl oleate. Aqueous carriers include mixtures of alcohols and water, hydrogels, buffered media, and saline. In particular, biocompatible, biodegradable lactide polymer, lactide/glycolide copolymer, or polyoxyethylene-polyoxypropylene copolymers may be useful excipients to control the release of the active compounds. Intravenous vehicles can include fluid and nutrient replenishers, electrolyte replenishers, such as those based on Ringer's dextrose, and the like. Other potentially useful parenteral delivery systems for these active compounds include ethylene-vinyl acetate copolymer particles, osmotic pumps, implantable infusion systems, and liposomes. [0103] Alternative modes of administration include formulations for inhalation, which include such means as dry powder, aerosol, or drops. They may be aqueous solutions containing, for example, polyoxyethylene-9-lauryl ether, glycocholate and deoxycholate, or oily solutions for administration in the form of nasal drops, or as a gel to be applied intranasally. Formulations for buccal administration include, for example, lozenges or pastilles and may also include a flavored base, such as sucrose or acacia, and other excipients such as glycocholate. Formulations suitable for rectal administration are preferably presented as unit-dose suppositories, with a solid based carrier, such as cocoa butter, and may include a salicylate. Formulations for topical application to the skin preferably take the form of an ointment, cream, lotion, paste, gel, spray, aerosol, or oil. Carriers which can be used include petroleum jelly, lanolin, polyethylene glycols, alcohols, or their combinations. Formulations suitable for transdermal administration can be presented as discrete patches and can be lipophilic emulsions or buffered, aqueous solutions, dissolved and/or dispersed in a polymer or an adhesive. [0104] Alternative administrations include also solutions, ointments or other formulations acceptable for ocular administration. [0105] According to a particular aspect, the compound of the disclosure may be administered by the cutaneous, ocular or inhalation route as disclosed above. These formulations are particularly advantageous as they ensure a local treatment, without associated lymphopenia which may occur with systemic administration routes. BRIEF DESCRIPTION OF THE DRAWINGS [0106] FIG. 1 illustrates the cross-resistance assay results obtained with a compound of the disclosure on INSTIs mutants. [0107] FIG. 2 illustrates the cross-resistance assay results obtained with a compound of the disclosure on RTIs mutants. [0108] Other features of the disclosure will become apparent in the course of the following description of exemplary embodiments that are given for illustration of the claimed invention and not intended to be limiting thereof. DETAILED DESCRIPTION Examples Example 1 Synthesis of (E)-1-(2-(3-chloro-4,5-dihydroxystyryl)-8-hydroxyquinolin-5-yl)ethanone, also denoted 1-2-{2-[2(E)-(3-chloro, 4,5-dihydroxyphenyl)-vinyl]-8-hydroxy-quinolin-5-yl}-ethanone herein (SQE86) [0109] First step: Preparation of: 1-(8-hydroxy-2-methylquinolin-5-yl)ethanone [0110] [0111] To a solution of commercial 2-methylquinolin-8-ol (4.00 g, 25.13 mmol) in nitrobenzene (10 mL) were added acetyl chloride (1.96 mL, 27.64 mmol) and aluminium chloride (8.38 g, 62.82 mmol). The reaction mixture was heated at 70° C. overnight. After the mixture cooled, water and HCl 10% (10 mL) were added with stirring, and reaction mixture was heated at 160° C., collecting nitrobenzene with a Dean-stark trap. After cooling and ethyl acetate washing, mixture was neutralized to pH 6-7 with NaOH. Aqueous phase was extracted with ethyl acetate, then organic layer was washed with brine, dried over MgSO 4 and concentrated under vacuo. Crude product was purified by silica gel chromatography (cyclohexane/ethyl acetate 100:0 to 60/40) to give 1-(8-hydroxy-2-methylquinolin-5-yl)ethanone as a pale yellow powder (3.51 g, 70%). Second step: Preparation of (E)-1-(2-(3-chloro-4,5-dihydroxystyryl)-8-hydroxyquinolin-5-yl)ethanone [0112] To a solution of quinoline (0.300 g, 1.49 mmol) in acetic anhydride (10 mL) was added commercial aromatic aldehyde (0.772 g, 4.47 mmol). Mixture was heated in a sealed tube at 160° C. for 16 h and concentrated under vacuo. Residue was redissolved in a pyridine (10 mL)/water (5 mL) mixture and heated at 130° C. for 3 h. Solvents were evaporated and residue was purified by silica gel chromatography (ethyl acetate/cyclohexane 0:1 to 1:0) to yield (E)-1-(2-(3-chloro-4,5-dihydroxystyryl)-8-hydroxyquinolin-5-yl)ethanone as a yellow solid (0.010 g, 2%). [0113] Fp: 256°-258′C [0114] ESI Mass: m/z 355.92 ([M+H] + ) Example 2 Synthesis of (E)-5-(2-(5-acetyl-8-hydroxyquinolin-2-yl)vinyl)-2-hydroxybenzoic acid, also denoted 5-[2(E)-(5-Acetyl-8-hydroxy-quinolin-2-yl)-vinyl]-2-hydroxy-benzoic acid (SQE 89) [0115] First step: Preparation of: 1-(8-hydroxy-2-methylquinolin-5-yl)ethanone [0116] To a solution of commercial 2-methylquinolin-8-ol (4.00 g, 25.13 mmol) in nitrobenzene (10 mL) were added acetyl chloride (1.96 mL, 27.64 mmol) and aluminum chloride (8.38 g, 62.82 mmol). The reaction mixture was heated at 70° C. overnight. After the mixture cooled, water and HCl 10% (10 mL) were added with stirring, and reaction mixture was heated at 160° C., collecting nitrobenzene with a Dean-stark trap. After cooling and ethyl acetate washing, mixture was neutralized to pH 6-7 with NaOH. Aqueous phase was extracted with ethyl acetate, then organic layer was washed with brine, dried over MgSO 4 and concentrated under vacuo. Crude product was purified by silica gel chromatography (ethyl propionate/ethyl acetate 100:0 to 60/40) to give 1-(8-hydroxy-2-methylquinolin-5-yl)ethanone as a pale yellow powder (3.51 g, 70%). Second step: Preparation of (E)-5-(2-(5-acetyl-8-hydroxyquinolin-2-yl)vinyl)-2-hydroxybenzoic acid [0117] To a solution of quinoline (0.300 g, 1.49 mmol) in acetic anhydride (15 mL) was added commercial aromatic aldehyde (0.743 g, 4.47 mmol). Mixture was heated in a sealed tube at 160° C. for 12 h and concentrated under vacuo. Residue was redissolved in a pyridine (10 mL)/water (10 mL) mixture and heated at 110° C. for 2 h. Solvent were evaporated and residue was triturated with methanol, to give (E)-5-(2-(5-acetyl-8-hydroxyquinolin-2-yl)vinyl)-2-hydroxybenzoic acid (0.217 g, 41.79%) as a dark brown solid. [0118] Fp: 266° C.-268° C. ESI [0119] Mass: m/z 348.40 ([M+H] + ) [0120] The following compounds were also synthesized by application or adaptation of the procedures above, from the corresponding starting materials: 1-{2-[2(E)-(2,3-Dihydroxy-4-methoxy-phenyl)-vinyl]-8-hydroxy-quinolin-5-yl}-ethanone: [0000] 1-{2-[2(E)-(2,4,5-thhydroxyphenyl)-vinyl]-8-hydroxy-quinolin-5-yl}-ethanone: [0000] 1-{2-[2(E)-(3,4,5-thhydroxyphenyl)-vinyl]-8-hydroxy-quinolin-5-yl}-ethanone: [0000] 1-{2-[2(E)-(3,4-dihydroxy, 5-nitrophenyl)-vinyl]-8-hydroxy-quinolin-5-yl}-ethanone: [0000] 1-{2-[2(E)-(4-hydroxy, 5-methoxy, 3-nitrophenyl)-vinyl]-8-hydroxy-quinolin-5-yl}-ethanone: [0000] 4-[2(E)-(5-Acetyl-8-hydroxy-quinolin-2-yl)-vinyl]-5-nitro-benzoic acid: [0000] 4-[(E)-2-(5-Acetyl-8-hydroxy-quinolin-2-yl)-vinyl]-3-nitro-benzoic acid methyl ester [0000] 3-[(E)-2-(5-Acetyl-8-hydroxy-quinolin-2-yl)-vinyl]-4-nitro-benzoic acid methyl ester: [0000] 5-[2(E)-(5-Acetyl-8-hydroxy-quinolin-2-yl)-vinyl]-2-hydroxy-4-nitro-benzoic acid: [0000] 1-{2-[2(E)-(3-nitro, 4-hydroxy, 5-methoxyphenyl)-vinyl]-8-hydroxy-quinolin-5-yl}-ethanone: [0000] 1-{2-[2(E)-(3,4-dihydroxy, 5-methoxyphenyl)-vinyl]-7-chloro, 8-hydroxy-quinolin-5-yl}-ethanone: [0000] Example 4 Material & Methods and Results [0132] 1—Biochemical Activity Assay [0133] Integrase Preparation and Purification [0134] The pET-15b-IN plasmid contains the cDNA encoding the HBX2 HIV integrase. His-tagged integrase protein was overexpressed in Escherichia coli BL21 (DE3) and purified under native conditions. Briefly, at an OD of 0.8, fusion protein expression was induced in bacterial cultures by the addition of IPTG (1 mM). Cultures were incubated for 3 h at 37° C., of ter which cells were centrifuged. The cell pellet was resuspended in ice-cold buffer A [20 mM Ths-HCl (pH 8), 1 M NaCl, 4 mM β-mercaptoethanol, and 5 mM imidazole], treated with lysozyme for 1 h on ice, and sonicated. After centrifugation (30 min at 10 000 rpm), the supernatant was filtered (0.45 μm) and incubated for at least 2 h with Ni-NTA agarose beads (Pharmacia). The beads were washed twice with 10 volumes of buffer A, 10 volumes of buffer A with 50 mM imidazole, and 10 volumes of buffer A with 100 mM imidazole. His-tagged integrase was then eluted with buffer A supplemented with 50 μM ZnSO4 and 1 M imidazole. The integrase concentration was adjusted to 0.1 mg/mL in buffer A. The fusion protein was cleaved using thrombin and dialyzed overnight against 20 mM Ths-HCl (pH 8), 1 M NaCl, and 4 mM (3-mercaptoethanol. After removal of biotinylated thrombin by incubation with streptavidin-agarose magnetic beads (Novagen, Madison, Wis.), a second dialysis was performed for 2 h against 20 mM Ths-HCl (pH 8), 1 M NaCl, 4 mM mercaptoethanol, and 20% (v/v) ethylene glycol. Fractions were aliquoted and rapidly frozen at −80° C. [0135] Nucleic Acid Substrates [0136] Oligonucleotides U5B (5′-GTGTGGAAAATCTCTAGCAGT-3′), U5B-2 (5′-GTGTGGAAAATCTCTAGCA-3′), U5A (5′-ACTGCTAGAGATTTTCCACAC-3′) were purchased from Eurogentec (Liege, Belgium) and further purified on an 18% denaturing acrylamide/urea gel. For processing, strand transfer, 100 pmol of U5B, U5B-2, respectively, were radiolabeled using T4 polynucleotide kinase and 50 μCi of [γ-32P]ATP (3000 Ci/mmol). The T4 kinase was heat inactivated, and unincorporated nucleotides were removed using a Sephadex G-10 column (GE Healthcare). NaCl was added to a final concentration of 0.1 M, and complementary unlabeled strand USA was added to either U5B or U5B-2. The mixture was heated to 90° C. for 3 min, and the DNA was annealed by slow cooling. [0137] 3′ LTR Processing Assays [0138] Processing reaction was performed using U5A-U5B, in buffer containing 20 mM Tris (pH 7.2), 50 mM NaCl, 10 mM DTT, and 10 mM MgCl 2 . The reaction was initiated by addition of substrate DNA (12.5 nM), IN 200 nM and the mixture was incubated for up to 2 h at 37° C. The reactions were stopped by phenol/chloroform extraction, and DNA products were precipitated with ethanol. The products were separated in TE containing 7 M urea and electrophoresed on an 18% denaturing acrylamide/urea gel. Gels were analyzed using a STORM Molecular Dynamics phosphorimager and quantified with Image Quant™ 4.1 software. [0139] Strand Transfer Assays [0140] Processing, strand transfer reactions were performed using U5A-U5B-2, in buffer containing 20 mM Tris (pH 7.2), 50 mM NaCl, 10 mM DTT, 1 OmM MgCl 2 . The reaction was initiated by addition of substrate DNA (12.5 nM), IN 200 nM and the mixture was incubated for up to 2 h at 37° C. The reaction was stopped by phenol/chloroform extraction, and DNA products were precipitated with ethanol. The products were separated in TE containing 7 M urea and electrophoresed on an 18% denaturing acrylamide/urea gel. Gels were analyzed using a STORM Molecular Dynamics phosphorimager and quantified with Image Quant™ 4.1 software. [0141] 2—Stability Assays [0142] Two protocols were carried out: [0143] 2.1. Hepes Buffer 0.5M, pH 7.5. 16 μl of drug at 25 mM, in 8 ml of Hepes Buffer. Different time points were done, Oh, 2 h, 4 h, 24 h, and 48 h. [0144] Stability of the compounds was performed in HEPES Buffer 0.5 M (pH 7.5) at 37 O, at a concentration of 50 μM. Compounds SQE94 and 79 were tested at a concentration of 25 μM to avoid parasite precipitation phenomena. Typically, stock solutions of compounds in DMSO (25 mM) were diluted in HEPES Buffer. Dilutions were stored at 37° C., protected from light. Sampling was done at different time points. Samples were analyzed on an UV-spectrophotometer using a wavelength scan between 200 and 700 nm. Superposition of UV-spectra gives the qualitative aspect of the stability of the drug. Based on the Beer-Lambert law, percentage of degradation of the drug over time was calculated, when placed at the maximum absorption wavelength. Results are summarized below: [0000] % of degradation Compound λ max (nm) 0 2 hrs 4 hrs 24 hrs SQE74 307 n/a 17.2 26.1 24.1 SQE75 322 n/a 15.7 17.5 18.7 SQE79 360 n/a 19.2 26.9 42.9 SQE86 356 n/a 12.1 12.5 22.4 SQE89 321 n/a <5 <5 <5 SQE94 369 n/a <5 8.2 30.8 SQE96 299 n/a <5 <5 <5 FZ41 332 n/a 31.1 59.6 64.6 [0145] These results show that the compounds of the disclosure show an improved compared to compound FZ41 of the prior art (WO 98/45269) which shows a poor stability. [0146] 2.2. The second stability assay consists in the assessment according to standard HPLC analysis protocols over 24 hrs in PEG400 and Vitamine E-TPGS/PEG 400 mixtures, by focusing on the evolution of the concentration and peak purity of the compound. [0147] Compounds were dissolved in appropriate amounts of solvent and let under stirring protected from light for 24 hrs. Aliquots were transferred into eppendorfs and centrifuged at 10 000 g for 10 min. Supernatants were collected and appropriately diluted in DMSO/mobile phase mixtures before HPLC analysis. The Waters HPLC analysis system equipped with an ultraviolet detector and a Waters Symmetry Shield C18 column of 2.1 mm×50 mm (3.5 μM) was used. A mobile phase of water/acetic acid 0.1% (Solvant A): Acetonitrile/acetic acid 0.1% (solvent B) mixture or a water/trifluoroacetic acid 0.1% (Solvant A): Acetonitrile/trifluoroacetic acid 0.1% (solvent B) mixture in the case of compound FZ41 was pumped according to a binary gradient described below, at a flow rate of 0.4 ml/min. [0148] Results are summarized below: [0149] Compound SQE94: [0000] Acetonitrile/acetic acid Time (min) Water/acetic acid 0.1% 0.1% 0 80% 20% 10 20% 80% 15 20% 80% Wavelength 312 nm [0150] Compound FZ41 (WO98/45269): [0000] Water/trifluoroacetic acid Acetonitrile/trifluoroacetic Time (min) 0.1% acid 0.1% 0 95% 5% 15 40% 60% 15.1 10% 90% 20 10% 90% Wavelength 290 nm [0151] The compounds of the disclosure, and more particularly compound SQE94, demonstrated high stability over 24 hrs at room temperature in several mixtures of excipients with less than 10% degradation, whereas FZ41 exhibited at least 10% degradation within only 3 hrs, as stated by the apparition of impurity peaks. [0152] Moreover, the compounds and more particularly compound SQE94, exhibited very stable chemical profiles over 24 hrs at pH comprised between 1 and 7, whereas FZ41 degradated at rates reaching 50-60% within less than 24 hrs. [0153] 3—Antiviral & Viability Assays [0154] Viability Assay [0155] The cytotoxicity of compounds was evaluated using un-infected and infected Hel_a-P4 cell and CEM leukemia cells. CEM cell were obtained from the American Type Tissue Collection (Rockville, Md.). [0156] A serial dilution of drugs is done to evaluate the cytotoxicity concentration and is identified by CC50 (concentration of drug which induces 50% of cytotoxicity) [0157] The HeLa-P4 was cultured in the presence or absence of compounds for 2 days. After this time period, cells were cultivated with MTT for 3 hours, further the medium is removed. And the lysis buffer is incubated for 1 hour, followed by plate reading at 540 nm in a microplate reader. [0158] Antiviral Activity Assay on Hela P4 Cells [0159] The antiviral activity is determined by infecting HelaP4 cells with a wild type HIV-1 virus (NL 4.3 strains at 3 ng) on cells in presence or absence of drugs. [0160] A serial dilution of drugs is done to evaluate the EC50. The effective concentration is the concentration of product at which virus replication is inhibited by 50 percent. [0161] After 48 hours incubation, the quantification is done by the evaluation of β-Galactosidase produced by the infected Hela P4 cells. The viral activity is evaluated by colorimethc assay, CPRG, followed by plate reading at 570 nm with a reference of 690 nm. The CPRG test is a colorimetric assay which allows to quantity the β-galactosidase produced by HIV-1 infected indicator cells (the β-Gal gene being under the control of the HIV-1 LTR). [0162] Antiviral Activity Assay CEM Cells [0163] The activity is determined by infecting CEM cells with a wild type HIV-1 virus (NL 4.3 strains at 3 ng) on cells in presence or absence of drugs. [0164] A serial dilution of drugs is done to evaluate the EC50. [0165] The effective concentration is the concentration of product at which virus replication is inhibited by 50 percent. [0166] After 48 hours incubation, the quantification is done by the evaluation of the viral protein p24 with a commercial Elisa Kit. P24 is a protein essential to the replication virus cycle. The quantification of this enzyme is proportional to the amount of virus produced by the infected cells. [0167] A summary of results obtained in Biochemical activity, and Antiviral & viability assays is showed below: [0000] [0000] P4 Cytotoxicity Processing Transfert IC50 CEM IC50 Name R1 R2 X R4 R5 R6 R7 R8 IC50 (μM) IC50 (μM) (μM) (μM) SQE74 H H COMe OH H OH OH H 0.225 0.225 11.8 0.35 11.7 SQE75 H H COMe H OH OH OH H 0.51 0.51 9.6 24.7 >100 SQE79 H H COMe H OH OH NO 2 H 0.225 0.225 4.6 0.4 4.2 SQE86 H H COMe H Cl OH OH H 0.53 0.53 1 0.5 15 SQE89 H H COMe H COOH OH H H 0.56 0.56 1 No data 12.6 SQE94 H H COMe H NO2 OH OMe H 0.724 0.724 1.6 No data 56 SQE96 H H COMe H H COOH H NO 2 2.3 2.3 40.0 No data >100 [0168] As a comparative example, the following FZ41 compound representative for compounds disclosed in WO98/45269 was also tested, as shown below: [0000] P4 Processing Transfert IC50 CEM Cytotoxicity Name R1 R2 X R4 R5 R6 R7 R8 IC50 (μM) IC50 (μM) (μM) IC50 (μM) FZ41 COOH H H H OH OH OMe H 0.7 1.7 5 25 >100 [0169] It is apparent from the results above that the compounds of the disclosure are more active than those of the prior art, in particular during the first step (3′ processing), and the second step (strand transfer step). [0170] 4—Cross-Resistance Assay [0171] Antiviral products targeting the same protein (typically products of the same drug class) may develop mutations that lead to reduced susceptibility to one antiviral product and can result in decreased or loss of susceptibility to other antiviral products in the same drug class. This observation is referred to as cross-resistance. Cross-resistance is not necessarily reciprocal, so it is important to evaluate the activity of our new compounds on viruses containing mutations observed with other drugs of the anti-integrase class or reverse transcriptase inhibitors (RTI) class. Mutant viruses which are Raltegravir & Elvitegravir resistant were constructed on the NL43 backbone. [0172] Mutants viruses were as followed, where the first letter corresponds to the wild type amino acid, the number corresponds to the position of the amino acid in the integrase sequence and the second letter corresponds to the mutated amino acid. [0173] NL4.3 E92Q, [0174] NL4.3 G140S, [0175] NL4.3 Q148H, [0176] NL4.3 N155H, [0177] NL4.3 E92Q+N155H, [0178] NL4.3 G140S/Q148H. [0179] Resistant mutant viruses of RTI are known and include K103N, Y178L, Y181C, G190A, V108I/Q151M, K103N/G190A, K103N/Y188C, K103N/Y181C, M41L/T215Y/K103N, M41L/T215Y/Y181C, M41 L/T215Y/M184V. [0180] The assay to evaluate the activity against resistant viral strains is the same that antiviral assay. Instead of using a Wild-type virus, the virus studied contains mutations. The results are presented as a fold change corresponding to the ratio between the IC50 obtained for the mutant virus and the IC50 obtained for the wild type virus. More the virus is resistant to the compound more the fold change is elevated. If the mutation has no impact on the activity of the drug, the fold change is around 1. [0181] The results obtained with the SQE94 compound of the disclosure on INSTIs mutants are illustrated on FIG. 1 . [0182] The results obtained with the SQE94 compound of the disclosure on RTIs mutants, compared to common RTIs are illustrated on FIG. 2 . [0183] 5—Synergism with Other Anti-Viral Compounds [0184] A combination manifests therapeutic synergy if it is therapeutically superior to the addition of the therapeutic effects of the independent constituents. The efficacy of a combination may be demonstrated by comparing the IC50 values of the combination with the IC50 values of each of the separate constituents in the study in question. This efficacy may be readily determined by the one skilled in the art. From the IC50 values, a combination index (Cl) may be calculated, for instance using the computer program CalcuSyn software from Biosoft, for inhibition efficiencies of 50%, 75% or 90%. The program CalcuSyn performs multiple drug dose-effect calculations using the Median Effect methods described by Chou et al Trends Pharmacol. Sci. 4:450-454, 1983 and Chou et al Enzyme Regul. 22, 27-55, 198″, which are incorporated herein by reference. [0185] The combination index (CI) equation is based on the multiple dose effect equation of Chou et al derived from enzyme kinetics model. The synergism is defined as a more than expected additive effect and antagonism as a less than expected additive effect. Chou et al proposed the designation of CI=1 as the additive effect. Thus from the multiple drugs effect equation of two drugs, for mutually non exclusive drugs that have totally independent modes of action, CI is calculated as follows: [0000] CI=[( D 1)/( Dx 1)]+[( D 2)/( Dx 2)]+[( D 1 D 2)/( Dx 1 Dx 2)] [0186] In the equation, (D1) and (D2) are the concentrations of drug 1 and 2, respectively, for which x % of inhibition is obeyed in the drug combination. (Dx1) and (Dx2) are the concentrations of drug 1 and 2 respectively for which x % of inhibition is obeyed for drugs alone. [0187] CI<1, =1 and >1 respectively indicates synergism, additive effect and antagonism. [0188] Compounds of the Disclosure (SQE94) Show Synergism with INSTI: [0189] Synergistic interactions between compounds of the disclosure (SQE94) and INSTI (Raltegravir or RGV) were investigated using a NL43 HIV-1 laboratory strain replication assay. Virus infectivity in the presence of inhibitors was monitored with HelaCD4+β-Gal indicator cells (P4 cells). Inhibition by combination of SQE94 and INSTI was evaluated at two fixed molar SQE94/INSTI ratios: (i) 100:1 when the combination is tested on wild type virus and (ii) 6:1 when the combination is tested on INSTI resistant virus. [0190] Interactions were calculated by the multiple drug effect equation of Chou et al 1983 and 1984 (supra) based on the median effect principle, using CalcuSyn® software (Biosoft, UK). Efficacy of drug combination was given by the combination index for the inhibition efficiencies of 50%, 75% and 90%. At a given effective dose, drugs were classically considered synergistic when the combination index was <1 and antagonistic when combination index was >1. [0191] Material and Methods [0192] Step 1: Preparation of HeLa P4 Cells in a 96 Flat Bottom Well Plate [0193] Two days before the test, 4000 HeLa P4 cells per well are seeded in 100 μl of 10% FBS DMEM supplemented with 100 UI/ml penicillin, 100 μg/ml streptomycin and 0.5 mg/ml geneticin (G418). [0194] One plate is used for the 2 drugs alone. Half a plate is used for the combination between the two drugs. The cytotoxicity of the drugs alone and the combination is tested by MTT assay. [0195] Step 2: Drug Dilution [0196] The dilutions tested for the “Wild type” virus are as follows: [0000] 16IC 50 →8IC 50 →4IC 50 →2IC 50 →1IC 50 →IC 50 /2→IC 50 /4→IC 50 /8→IC 50 /16→IC 50 /32 [0197] Drugs Alone: [0000] INBI (SQE94) ALONE Blank Virus IC 50 /32 IC 50 /16 IC 50 /8 IC 50 /4 IC 50 /2 1IC 50 2IC 50 4IC 50 8IC 50 16IC 50 alone IC 50 /32 IC 50 /16 IC 50 /8 IC 50 /4 IC 50 /2 1IC 50 2IC 50 4IC 50 8IC 50 16IC 50 IC 50 /32 IC 50 /16 IC 50 /8 IC 50 /4 IC 50 /2 1IC 50 2IC 50 4IC 50 8IC 50 16IC 50 INSTI (RGV) ALONE Blank Virus IC 50 /32 IC 50 /16 IC 50 /8 IC 50 /4 IC 50 /2 1IC 50 2IC 50 4IC 50 8IC 50 16IC 50 alone IC 50 /32 IC 50 /16 IC 50 /8 IC 50 /4 IC 50 /2 1IC 50 2IC 50 4IC 50 8IC 50 16IC 50 IC 50 /32 IC 50 /16 IC 50 /8 IC 50 /4 IC 50 /2 1IC 50 2IC 50 4IC 50 8IC 50 16IC 50 [0198] Combination SQE94+RGV: [0000] INBI (SQE94)/INSTI (RGV) Combination Blank Virus IC 50 /32 IC 50 /16 IC 50 /8 IC 50 /4 IC 50 /2 IC 50 /4 2IC 50 4IC 50 8IC 50 16IC 50 alone Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + IC 50 /32 IC 50 /16 IC 50 /8 IC 50 /4 IC 50 /2 IC 50 /4 2IC 50 4IC 50 8IC 50 16IC 50 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 IC 50 /32 IC 50 /16 IC 50 /8 IC 50 /4 IC 50 /2 IC 50 2IC 50 4IC 50 8IC 50 16IC 50 Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + IC 50 /32 IC 50 /16 IC 50 /8 IC 50 /4 IC 50 /2 IC 50 2IC 50 /4 4IC 50 8IC 50 16IC 50 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 IC 50 /32 IC 50 /16 IC 50 /8 IC 50 /4 IC 50 /2 IC 50 /4 2IC 50 4IC 50 8IC 50 16IC 50 Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + IC 50 /32 IC 50 /16 IC 50 /8 IC 50 /4 IC 50 /2 IC 50 /4 2IC 50 4IC 50 8IC 50 16IC 50 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 [0199] The dilutions tested for the “INSTI's Mutants” virus are as follows: [0000] 60IC 50 →20IC 50 →6.7IC 50 →2.2IC 50 →0.74IC 50 →0.25IC 50 →0.08IC 50 →0.03IC 50 →0.009IC 50 →0.03IC 50 [0200] Drugs Alone: [0000] INBI (SQE94) ALONE Blank Virus 0.003IC 50 0.009IC 50 0.03IC 50 0.08IC 50 0.25IC 50 0.74IC 50 2.2IC 50 6.7IC 50 20IC 50 60IC 50 alone 0.003IC 50 0.009IC 50 0.03IC 50 0.08IC 50 0.25IC 50 0.74IC 50 2.2IC 50 6.7IC 50 20IC 50 60IC 50 0.003IC 50 0.009IC 50 0.03IC 50 0.08IC 50 0.25IC 50 0.74IC 50 2.2IC 50 6.7IC 50 20IC 50 60IC 50 INSTI (RGV) ALONE Blank Virus 0.003IC 50 0.009IC 50 0.03IC 50 0.08IC 50 0.25IC 50 0.74IC 50 2.2IC 50 6.7IC 50 20IC 50 60IC 50 alone 0.003IC 50 0.009IC 50 0.03IC 50 0.08IC 50 0.25IC 50 0.74IC 50 2.2IC 50 6.7IC 50 20IC 50 60IC 50 0.003IC 50 0.009IC 50 0.03IC 50 0.08IC 50 0.25IC 50 0.74IC 50 2.2IC 50 6.7IC 50 20IC 50 60IC 50 [0201] Combination SQE94+RGV: [0000] INBI (SQE94)/INSTI (RGV) Mix Blank Virus 0.003IC 50 0.009IC 50 0.03IC 50 0.081IC 50 0.25IC 50 0.741IC 50 2.2IC 50 6.71IC 50 20IC 50 60IC 50 alone Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + 0.003IC 50 0.009IC 50 0.03IC 50 0.081IC 50 0.25IC 50 0.741IC 50 2.2IC 50 6.71IC 50 20IC 50 60IC 50 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 0.003IC 50 0.009IC 50 0.03IC 50 0.081IC 50 0.25IC 50 0.741IC 50 2.2IC 50 6.71IC 50 20IC 50 60IC 50 Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + 0.003IC 50 0.009IC 50 0.03IC 50 0.081IC 50 0.25IC 50 0.741IC 50 2.2IC 50 6.71IC 50 20IC 50 60IC 50 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 0.003IC 50 0.009IC 50 0.03IC 50 0.081IC 50 0.25IC 50 0.741IC 50 2.2IC 50 6.71IC 50 20IC 50 60IC 50 Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + Drug1 + 0.003IC 50 0.009IC 50 0.03IC 50 0.081IC 50 0.25IC 50 0.741IC 50 2.2IC 50 6.71IC 50 20IC 50 60IC 50 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 Drug2 [0202] Combination Index for the Combination SQE94+RGV: [0000] Combination index for % inhibition efficiency Wild type and INSTI Inhibition efficiency resistant Viruses 50% 75% 90% Wild Type Mean 0.51 ± 0.12 0.18 ± 0.03 0.11 ± 0.02 E92Q Mean  0.18 ± 0.017 0.13 ± 0.02 0.168 ± 0.03  G140S Mean 0.3052 ± 0.17  0.09 ± 0.03 0.18 ± 0.08 Q148H Mean 0.59 ± 0.2  0.59 ± 0.19 0.65 ± 0.19 N155H Mean 0.47 ± 0.16 0.21 ± 0.04  0.16 ± 0.005 E92Q/N155H Mean 1.09 ± 0.49 0.88 ± 0.37 1.043 ± 0.65  G140S/Q148H Mean 1.37 ± 0.19 0.93 ± 0.12 0.65 ± 0.08 [0203] The combinations of the compounds of the disclosure with an INSTI show synergism on wild type viruses and INSTI resistant viruses. [0204] 6-Formulations of the compounds of the disclosure [0205] Quinoline derivatives may present a low solubility in aqueous buffers at pH 5, 6 and 7. Two formulations were identified to solve this drawback: [0206] Formulation A: Tween 80/Labrafac® Lipophile/DMSO:65/25/10 [0207] Formulation B: Tween 80/Labrafil® M1944 CS/DMSO:65/25/10 [0208] Labrafil® and Labrafac® are solubility enhancers; Labrafil® M1944 CS comprises Oleoyl Macrogolglycerides (Polyoxylglycehdes) and Labrafac® Lipophile is a mixture of Medium Chain Triglycerides. [0209] Tween 80, Labrafac™ Lipophile WL 1349 and Labrafil M1944 CS are purchased from Gattefosse (France). [0210] Solubility of Compound SQE94 in pH-Buffers and Formulations [0211] Solubility of compound SQE94 was determined in pH-buffers at pH values of 5, 6 and 7. 10 mg of SQE94 are added to 10 ml of each pH-buffer. Each solution is stirred at room temperature, away from light, for 24 h, then centrifugated. The amount of dissolved compound is determined by HPLC analysis. [0212] Solubility of compound SQE94 was determined in formulation A and B. 50 mg of product is dissolved in 5 mL of formulation and stirred at 370 for 24 h, then centrifugated. The amount of dissolved compound is determined by HPLC analysis. [0213] Dilution of Formulated Compound in pH-Buffers at pH 5, 6 and 7. [0214] Formulated compound SQE94 (in formulation A or B) is diluted 1/10e with 370 pH-buffers (pH 5, 6 and 7). Samples are immediately collected and centrifuged. The amount of dissolved compound is determined by HPLC analysis. [0215] Material: [0216] Formulation A and B enable to increase the solubility of compound SQE94 at pH 5, 6 and 7 by at least a 80-fold. These pHs mimic the pH within the intestinal tractus, where the maximum of absorption of a drug takes place. Results are summarized in following table: [0000] Dissolved compound SQE94 (μg/ml) pH5 pH6 pH7 Compound alone 1.4 1.4 5.5 Formulation A 470 540 450 Formulation B 410 560 450 [0217] Formulations A and B show good solubility, suitable to oral formulation of quinoline derivatives of the disclosure. [0218] Further tests were conducted on the compounds of the disclosure, including Log D determination, and Absorption, Distribution, Metabolism and Excretion (ADME). These tests confirmed the drug candidate profile of quinoline derivatives of the disclosure.

The present disclosure concerns new substituted styrylquinolines, the process of their preparation and their therapeutic uses as integrase inhibitors and/or for the treatment and/or prevention of HIV.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates to therapeutic treatment of abnormal conditions in the vagina caused by microbial organisms and, more particularly, to such treatment utilizing a vaginal therapeutic device having an exterior surface made of copper metal. [0003] 2. Brief Discussion of the Related Art [0004] In the area of female personal hygiene and gynecological health, many efforts have been made to reduce microbial organisms in the vagina which create abnormal conditions such as vaginal odor, bacterial and viral infections, yeast infections and the like. Most of the attempts have involved medication and/or douching. Particularly effective douching systems utilizing a stainless steel douche appliance and methods using metal oxides are described in U.S. Pat. Nos. 6,190,365, No. 6,589,216, No. 7,276,056 and No. 7,270,653 to Abbott et al. Abnormal vaginal conditions are caused by various microbial organisms including bacterial, viral and fungal organisms. No device or associated method has been found to provide an anti-microbial treatment to kill such microbial organisms. [0005] It is known that many bacteria known to be human pathogens cannot survive on surfaces of copper metal. As used herein, “copper metal” means pure copper and copper alloys such as brasses, bronzes, copper-nickels and copper-nickel-zincs as described in “Abstract from Copper Alloys for Human Infection Disease Control” by H. T. Michaels, S. A. Wilks, J. O. Noyce and C. W. Keivel. The number of live bacteria drops from several orders of magnitude to almost zero on copper metal in a few hours. Copper metals which have been tested include high (pure) coppers, brasses, bronzes, copper-nickels, and copper-nickel-zincs. The bacteria tested include Methicillin-resistant staphylococcus aureus (MRSA), the cause of serious hospital-acquired infections, pseudomonas aeruginosa enterbacter aerogens and Acinetobartor baumonaii , as well as E. coli 0157:H7 and listeria monocytogenes , foodborne pathogens associated with several large-scale food recalls. Copper metal as a “static” agent inhibits microbial growth by means other than killing such that it limits the growth of microorganisms and may inactivate them. Copper metal as an “antimicrobial” substance (chemical or physical) can prevent microbial growth either by some ‘-static’ action or by the outright killing of microbial organisms. Copper metal as a “-cidal” agent either damages a microbial organism at low concentration and/or reduced contact time or interacts permanently so that it ceases to function normally. Such “-cidal” agent damages a microorganism sub-lethally. Total inactivation is functionally equivalent to killing the organism (0% survival). SUMMARY OF THE INVENTION [0006] In accordance with the present invention, a copper metal surface is provided in the vagina for a sufficient period of time such that microbial organisms in the vagina are killed. In this manner, various bacterial conditions, fungal conditions and viral conditions are treated. [0007] In one aspect, the present invention utilizes a vaginal therapeutic device formed of a body having an exterior surface made of copper metal, the body having a shape to fit in the vagina such that the copper metal exterior surface contacts the inner walls of the vagina to act as an anti-microbial agent. [0008] In another aspect, the present invention treats abnormal biological conditions in the vagina by inserting a therapeutic device having an exterior surface made of anti-microbial copper metal in the vagina, retaining the therapeutic device in the vagina for a time sufficient to kill microbial organisms and thereafter removing the therapeutic device from the vagina. [0009] Other aspects and advantages of the present invention will become apparent from the following description of the preferred embodiments taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0010] FIG. 1 is a perspective view of a vaginal therapeutic device according to the present invention. [0011] FIG. 2 is an exploded perspective view of the vaginal therapeutic device of FIG. 1 . [0012] FIG. 3 is a sectional view of a vaginal therapeutic device according to the present invention positioned within the vagina. [0013] FIG. 4 is an exploded sectional view of a modification of a vaginal therapeutic device according to the present invention. [0014] FIG. 5 is a perspective view of another modification of a therapeutic vaginal device according to the present invention in a contracted state. [0015] FIG. 6 is a perspective view of the vaginal therapeutic device of FIG. 5 in an expanded state. [0016] FIG. 7 is an elevation of a further modification of a vaginal therapeutic device according to the present invention in a contracted state. [0017] FIG. 8 is an elevation of the vaginal therapeutic device of FIG. 7 in an expanded state. DETAILED DESCRIPTION OF THE INVENTION [0018] A vaginal therapeutic device 10 according to the present invention is shown in FIG. 1 and is formed of a rigid body 12 having a rounded shape, cylindrical in cross-section, with a rounded exterior surface made of copper metal. As noted above, “copper metal” as used herein means pure copper (99.5% or greater copper) and copper alloys such as brasses, bronzes, copper-nickels and copper-nickel-zincs. The body 12 has a distal end 14 with a semispherical shape and a proximal end 16 that is rounded and has a longitudinally extending neck 18 with an opening 20 therein. A retraction structure 22 is inserted in the opening to be carried at the proximal end 16 . The body 12 can be hollow or solid, and the retraction structure 22 is designed such that it can be inserted in the opening 20 to facilitate insertion of the device in the vagina and removal of the device from the vagina. The retraction structure can be made of a light weight (as compared to copper metal) material which can also be flexible, such as plastic. The retraction structure 22 includes a pivotally movable ring 24 passing through a bore in a spherical end 26 at the proximal end of a stem 28 which has a spherical distal end 30 to be “snapped” into opening 20 . [0019] Due to the weight of copper metal, it is preferred that the body 12 is hollow; however, the body 12 can be solid if desired. Additionally, it is preferred that the copper metal be pure copper, i.e. 99.95% copper after processing; however, while pure copper has the greatest anti-microbial effect, various copper alloys as described above, can be utilized. [0020] In use, the vaginal therapeutic device 10 inserted in the vagina V (vaginal canal) through the vaginal opening VO as shown in FIG. 3 with the retraction structure protruding therefrom, it being appreciated that the elastic nature of the walls W of the vagina will permit the inner walls of the vagina to contact the external surface 12 of the vaginal therapeutic device thereby causing microbial organisms to contact the copper metal. The time required to kill the microbial organisms depends upon the purity of the copper metal; however, if the device 10 is inserted in the vagina overnight, essentially all microbial organisms will be killed by the time the vaginal therapeutic device 10 is removed in the morning. The rounded shape of the body 12 facilitates insertion and removal of the vaginal therapeutic device in the rigid form shown in FIGS. 1 and 2 . [0021] When the body 12 is hollow, the walls of the body can be solely copper metal. A lighter weight, less expensive modification of a vaginal therapeutic device 10 ? is shown in FIG. 4 , wherein a body 12 ? is formed of an inner part 32 made of a less expensive, lighter weight material, such as plastic, with the inner part 32 carrying an outer layer 34 formed of copper metal. [0022] Another modification of a vaginal therapeutic device 40 according to the present invention is shown in a contracted state in FIG. 5 and has a body 42 including an expandable absorbent, sponge- or cotton-like material 44 having a rounded tampon-like shape with an expandable coiled wire 46 wrapped around the absorbent material, the coiled wire 46 being made of copper metal to form the exterior surface of the body for contacting microbial organisms in the vagina. Once the vaginal therapeutic device 40 is inserted in the vagina, the absorbent material 44 will expand from absorbing fluids within the vagina, and the coiled wire 46 will similarly expand, such that the vaginal therapeutic device 40 will have the expanded size shown in FIG. 6 to improve contact with the walls of the vagina. Of course, the vaginal therapeutic device 40 need not be expandable since the elasticity of the vaginal walls will provide good contact. A string 48 is attached to the proximal end of the body 42 , in particular to the end of the absorbent material 44 , to form a retraction structure for vaginal therapeutic device 40 . [0023] FIG. 7 shows another modification of a vaginal therapeutic device 50 according to the present invention having a body 52 formed of an expandable absorbent material 54 with a shape similar to the absorbent material of vaginal therapeutic device 40 but with an expandable mesh arrangement of wires 56 surrounding the absorbent material to form the exterior surface of the vaginal therapeutic device for contacting microbial organisms within the vagina, the wires of the mesh arrangement being made of copper metal to form the copper metal exterior surface of the vaginal therapeutic device. Once inserted, the absorbent material and the mesh arrangement of wires will expand as shown in FIG. 8 to facilitate contact of the external surface of the device with the walls of the vagina. Of course, the vaginal therapeutic device 50 need not be expandable since the elasticity of the vaginal walls will provide good contact. A string 58 is attached to the proximal end of the body 52 to form a retraction structure for vaginal therapeutic device 50 . [0024] To fabricate the vaginal therapeutic devices, it is noted that copper metal can be readily electro-formed, plated, hot rolled, extruded, cast or forged and can be cold rolled to a desired thickness to form sheets or thin layers or wire-like structures. The vaginal therapeutic device shown in FIG. 1 can, for example, be made of one piece or two or more welded pieces with a wall thickness of 0.06 mm with a length of 3.25 inches and a diameter of 0.75 inches. The ring of the retraction structure can, for example, have an outer diameter of 0.75 inches and an inner diameter of 0.625 inches. [0025] When a vaginal therapeutic device according to the present invention is inserted or positioned in the vagina, the antimicrobial effect of the copper metal will kill or inactivate and inhibit growth of microbial organisms in the vagina which cause abnormal conditions, including viruses, bacterium, fungi and the like. Thusly, undesirable conditions such as odor, vaginitis, yeast infections, bacterial infections, viral infections, sexually transmitted diseases and the like are treated, cured or prevented, it being noted that HIV (human immunodeficiency virus), which causes AIDS, can be treated in accordance with the subject invention in that a vaginal eco-system imbalance caused by microbial organisms causes the vagina to be receptive to HIV. [0026] Inasmuch as the present invention is subject to many variations, modifications and changes in detail, it is intended that all subject matter discussed above or shown in the accompanying drawings be interpreted as illustrative only and now be taken in a limiting sense.

A vaginal therapeutic device made of copper metal has a shape to fit in the vagina and utilizes the copper metal as an antimicrobial agent to therapeutically treat abnormal biological conditions in the vagina.

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a milk-extraction device with a drive motor and a vacuum generation unit having a vacuum-generating device, a change-over unit attached thereto, which determines the extraction cycles by a rotatingly driven change-over member, and at least one extraction attachment which is or can be brought into a flow connection with it and has a suction funnel, which can be applied to a breast, and a milk receptacle. 2. Discussion of Related Art A milk-extraction device for human breast milk is disclosed in German Patent Reference DE 102 28 455 B4. In this known milk-extraction device a vacuum generation unit, having a vacuum source or vacuum unit driven by a motor, is connected via a change-over unit, which has a rotating valve and determines the suction cycle to an extraction attachment which has a suction funnel for placement against the breast. For receiving the extracted milk, is a milk receptacle, wherein the milk reaches the latter, secure against flow-back, via a valve arranged at the receptacle opening. For a connection with the vacuum-generation unit on the one hand, and the extraction attachment on the other, openings are in the change-over unit which, for the cyclic generation of the vacuum by rotating channels, can be brought into a flow connection with each other in a rotating change-over member. Also, openings are in the change-over unit which, during the rotation of the change-over unit and the connecting channels contained therein, make a cyclic connection between the extraction attachment and the pressure side of the vacuum unit between the suction phases, so that the extraction effect at the breast is aided, and the actuation of the receptacle valve operates dependably. A cyclical connection with the exterior atmosphere, also provided via the rotating channels, is at a further opening of the change-over unit by an outlet line with a ventilation section and a muffler arranged thereon. Reference is made to the mentioned publication regarding further details of this milk-extraction device, in which regulating possibilities regarding the cycle and/or the strength of the vacuum are also listed. The change-over unit with the rotating valve has proven itself in actual use. However, possibilities still exist for further optimization regarding operation, control and construction. German Patent Reference DE 10 2004 030 692 B3 discloses a milk-extraction device with two suction attachments, which can be connected to a pump unit 10, wherein a vacuum-generation unit and a change-over unit in accordance with the previously mentioned publication can be contained in the pump unit. Further milk-extraction devices are shown in German Patent Reference DE 37 38 282 C2, in which a pulsing device is provided for affecting the suction cycle, and U.S. Pat. No. 6,090,065, in which a vacuum-generation device with diaphragm elements arranged in a special way and channel arrangements are provided. A further milk-extraction device is shown in German Patent Reference DE 38 20 211 C2, in which a fluid-collecting vessel is connected via a valve arrangement with a vacuum source or with the atmosphere, and a cyclical change between suction and airing phases is controlled by a timed switching arrangement. A valve arrangement is actuated by a magnetic coil. SUMMARY OF THE INVENTION One object of this invention is to provide a milk-extraction device of the type mentioned above but in which dependable functioning is achieved, along with a compact structure. This object is attained by a milk extraction device having characteristics taught in the claims and this specification. For being rotatorily driven, the change-over member is coupled via a gear train with the drive motor of the vacuum generation unit. With these steps the drive of the vacuum generation device is also used for the change-over unit, with which a compact construction is achieved, along with a compact construction, and advantageous uses also result with respect to operation and handling. In one embodiment, with respect to function and construction, the gear train is designed as an adjusting unit for the mechanical, continuous setting of the number of revolutions, or at least a stepped two-stage setting of a differing number of revolutions, of the change-over member. The gear train has a drive worm gear seated in the extension of, or parallel to, a motor shaft of the drive motor, which drives a first toothed disk. The first toothed disk which is orthogonally seated in relation to the motor shaft, can be brought into engagement by an axial displacement with at least two further toothed disks with a number of teeth different from each other and which determine the stepping of the number of revolutions of the change-over member. The steps, wherein the further toothed disks are concentrically seated on a common shaft, can be axially shifted in relation to the shaft and can be brought relatively to it into fixed engagement in the circumferential direction, in which the change-over member is also seated in fixed engagement in the circumferential direction relative to the shaft, to provide a compact construction and dependable functioning. The cyclic flow conditions, along with dependable functioning, are aided because the change-over member is provided with at least one bridging channel, by which an alternating connection between the extraction attachment on the one side and a vacuum pump device on the other side can be established. Also, advantages regarding the construction and mode of functioning result if the rotatingly driven change-over member is designed flat on at least one side, and with this side sufficiently covers openings arranged on a facing, also flat designed stationary section on the opening side of the change-over unit for assuring a sufficient vacuum effect and overpressure effect. For producing the alternating connection of the extraction attachment with the vacuum side and the overpressure side of the vacuum generation unit, connecting openings of the at least one bridging channel are arranged, which can be cyclically brought into flow connection with openings of the stationary section, which are to be respectively assigned to them. Advantageous setting possibilities are obtained if the change-over unit has an actuating lever, which can be manually operated, with which the relative displacement of the at least two further toothed disks with respect to the first toothed disk can be performed. Here, functioning and handling are eased because the actuating lever is seated on the shaft so it can be rotated relatively to it and has an at least partially circumferential tilted adjustment section, by which the axial displacement of the two further toothed disks can be provided via at least one possibly provided intermediate piece. Advantages regarding construction and functioning are further obtained if, for operating the vacuum pump device, a crankshaft is arranged in the drive train, to which a vacuum pump unit is coupled by at least one intermediate member connected to it. The steps, wherein at least two vacuum pump units are placed, axially offset, opposite each other at identical angular distances around the crankshaft, also contribute to a dependable mode of operation, because their suction and pressure forces are distributed during rotation. In this case further advantages, for example regarding a freedom from vibration, result if the vacuum pump units are coupled to the crankshaft so that they simultaneously generate suction on the one hand, and simultaneously pressure with respect to each other. The use of the milk-extraction device is improved if more than one extraction attachment is connected to the change-over unit. BRIEF DESCRIPTION OF THE DRAWINGS This invention is explained in greater detail in view of exemplary embodiments, making reference to the drawings, wherein: FIG. 1 is a unit having the vacuum generation device and the change-over unit, in a perspective view; FIG. 2 is a schematic representation of a milk-extraction device with a vacuum generation device and change-over unit, as well as an extraction arrangement; FIG. 3 shows the unit represented in FIG. 1 in an exploded perspective representation; FIG. 4 shows the unit represented in FIG. 1 but in an opened state in an expanded perspective representation; FIG. 5 shows a further perspective representation of the unit in accordance with FIG. 1 in the opened state; FIGS. 6A and 6B each shows a view from above on the unit in accordance with FIG. 1 in a partially opened state, as well as in longitudinal section along a section plane A-A; FIGS. 7A and 7B each shows a lateral view on the unit in accordance with FIG. 1 in a partially opened state and a cross section along a section line D-D; and FIGS. 8A and 8B each shows a further lateral representation of the unit in accordance with FIG. 1 in a partially opened state, with a supplementary motor, and a sectional representation along a section plane C-C. DETAILED DESCRIPTION OF THE INVENTION A portion of the milk-extraction device is represented in FIG. 1 , in which a vacuum generation unit 1 with a drive motor 1 . 1 and two oppositely arranged vacuum pump units 1 . 2 , 1 . 2 ′ are combined, together with a change-over unit 2 , in a common housing 70 having a housing base 71 and a housing top 72 . Respectively, two pump unit connectors 1 . 4 , 1 . 5 or 1 . 6 , 1 . 7 are provided at the vacuum pump units 1 . 2 , 1 . 2 ′, one side of which is in a flow connection with the vacuum side and the other side with the pressure side of the vacuum pump units 1 . 2 , 1 . 2 ′. The change-over unit 2 is partially received in a cylinder-shaped housing section 2 . 7 , which is covered on its top by a cover element 2 . 8 which is maintained on the cylinder-shaped housing section 2 . 7 by snap-in fingers 2 . 71 . First, second, third and fourth openings 2 . 3 , 2 . 4 , 2 . 5 , 2 . 7 with respective connecting sleeves are arranged in the cover element 2 . 8 , of which the first and third openings 2 . 3 or 2 . 5 are connected by an underpressure line 9 . 1 or by an overpressure line 9 . 3 with the vacuum side or with the pressure side of vacuum pump unit 1 . 1 , 1 . 2 ′, wherein the two pressure sides of the vacuum pump units 1 . 2 , 1 . 2 ′ are connected by a Y-piece with the underpressure line 9 . 1 or the overpressure line 9 . 3 . FIG. 1 shows a supplementary motor housing element 61 , in which a supplementary motor 60 , as shown in FIG. 5 , can be housed as an alternative drive mechanism for the change-over unit 2 . FIG. 2 shows the connection of the unit including the vacuum generation unit 1 and the change-over unit 2 represented in FIG. 1 with an extraction attachment 10 via a connecting line 9 . 2 , and with a further extraction attachment 10 ′ via a further connecting line 9 . 4 . Each of the extraction attachments 10 or 10 ′ has a suction funnel 6 for placement against the breast and a receptacle 7 for storing the extracted milk, connected with it via a conduit, wherein an inlet valve 8 is provided in the inlet area of the receptacle 7 , which prevents a return flow of milk and also contributes to the creation of a defined vacuum in the extraction attachment 10 , 10 ′ at the breast. The vacuum in the suction funnel 6 can be regulated, preferably manually, by an auxiliary air regulating device 5 . With the aid of a manually operable actuating lever 4 . 1 the suction cycle can be varied by an adjusting unit 4 represented in FIG. 1 so that the number of revolutions of a change-over member 2 . 10 , which is rotatorily driven in the change-over unit 2 , is placed between different settings a), b) into at least two stages, or alternatively is set to continuous operation. For rotatory driving, the change-over member 2 . 10 is connected via a gear train 20 with the drive motor 1 . 1 of the vacuum generation unit 1 , with which the vacuum pump units 1 . 2 , 1 . 2 ′ are also driven. A further regulating device 5 ′ can be provided in the underpressure line 9 . 1 , for example, for the further regulation of the vacuum generation. Reference is made to the German Patent Reference DE 102 28 455 B4 mentioned with respect to more detailed information regarding the functioning of the change-over unit 2 with the rotating change-over member 2 . 10 and the alternating connection of the vacuum source or vacuum side on the one hand and the pressure source or pressure side on the other, of the vacuum generation unit 1 with the extraction arrangement 10 . The alternating charging with vacuum and compressed air of the further extraction arrangement 10 ′ takes place correspondingly via the further connecting line 9 . 4 . The exploded representation in accordance with FIG. 3 shows the interior components of the unit including the vacuum generation unit 1 and change-over unit 2 . With a drive coupling element 21 , the drive motor 1 . 1 is connected via a motor shaft to a crankshaft 22 , at whose crank sections coupling elements in the shape of connecting rods 22 . 1 are seated, by which the vacuum pump units 1 . 2 , 1 . 2 ′ are driven by the respective back and forth movement of pump pistons or diaphragms for generating the vacuum on the one side and the pressure on the other side. This drive mechanism of the vacuum pump units 1 . 2 , 1 . 2 ′ operates in accordance with the principle of a boxer motor. Other coupling elements, which are put eccentrically into motion, can also be provided in place of the connecting rods 22 . 1 . As shown in connection with FIGS. 4 , as well as FIGS. 6A , 6 B, in the extension of the crankshaft 22 a worm drive 23 which is schematically represented is arranged on the drive train 20 at the end section of the crankshaft 22 , which works together with a first toothed disk 24 , also schematically represented, for putting the latter into rotation. The axis of rotation of the first toothed disk 24 is arranged orthogonally with respect to the axis of the crankshaft, or motor shaft, is offset parallel, if required, and has, as FIGS. 6B and 7B show, two further gear rims of different diameter, which can be brought into engagement with a second toothed disk 25 , or third toothed disk 26 , and are in engagement with one of these two toothed disks as a function of the switched position. The second and the third toothed disks 25 or 26 are also seated, axially displaceable, on a shaft 2 . 11 of the change-over unit 2 arranged orthogonally with respect to the axis of the crankshaft 22 , or motor shaft, wherein as a result of the axial displacement either the second toothed disk or the third toothed disk comes into engagement with a toothed member 28 , which is seated, fixed against relative rotation, on the shaft 2 . 11 , namely the one which has also been put into engagement with the first toothed disk 24 . In order to come into engagement with the toothed member 28 , particuarly with its upper tooth arrangement or its lower tooth arrangement, the second and third toothed wheels 25 , 26 have appropriately matched tooth arrangements in the interior area, such as FIG. 3 shows for the third toothed disk 26 . The respective second or third toothed disks 25 , 24 not in engagement with the first toothed disk 24 are also not in engagement with the toothed member 28 . Thus the shaft 2 . 11 is rotatingly driven at the respective number of revolutions either via the second toothed disk 25 or the third toothed disk 26 . The gear for driving the change-over member 2 . 10 thus corresponds in principle to a Hirth gear, or also a planetary gear. The change-over member 2 . 10 is seated on the upper section shaft 2 . 11 , fixed against relative rotation with respect to it, and has bow-shaped bridging paths 2 . 1 , 2 . 2 , such as shown in FIG. 2 , in order to bring the two extraction attachments 10 , 10 ′ alternatingly into contact with the vacuum and the pressure side of the vacuum pump unit 1 . 2 , 1 . 2 ′ via the pump unit connectors 1 . 4 , 1 . 5 , 1 . 6 , 1 . 7 , as well as the first, second, third and fourth openings 2 . 3 , 2 . 4 . 2 . 5 , 2 . 6 and the respective lines 9 . 1 , 9 . 2 , 9 . 3 , 9 . 4 . A circumferential inclined adjustment device, by which the second and third toothed disks 25 , 26 are displaced by several intermediate pieces 4 . 2 , 4 . 3 , 4 . 4 and an inclined counter-adjustment device, are arranged on the actuating lever 4 . 1 , which is rotatably seated in the lower area of the shaft 2 . 11 and is axially immovably maintained in the housing base 71 , for the axial displacement of the second and third toothed disk 25 , 26 on the shaft 2 . 11 . A counter-force is exerted from above on the toothed disks 25 , 26 by an actuating spring 27 , by which the toothed disks 25 , 26 are displaced in the opposite direction after returning the actuating lever 4 . 1 . In place of driving by the drive motor 1 . 1 by the gear train 20 , in an alternative embodiment the drive of the change-over member 2 . 1 takes place via the supplementary motor 60 , as shown in FIGS. 5 and 8A , 8 B. In this case, the motor shaft of the supplementary motor 60 drives the first toothed disk 24 via a further worm gear 62 , and also causes the driving of the shaft 2 . 11 via the second and third toothed disk 25 , 26 , and thus of the change-over member 2 . 10 , as described above.

A device for expressing milk, with a vacuum-generating unit, which includes a drive motor and a vacuum-generating device, with a switching unit, which is linked to the vacuum-generating unit and determines the suction cycles via a rotatably driven switching member, and with at least one milk expression attachment, which is or can be brought into flow communication therewith and which includes a suction funnel that can be placed on the breast, and a milk collection receptacle. A compact design with reliable function is achieved by the switching member being coupled to the drive motor of the vacuum-generating unit via a transmission for the rotary drive.

CROSS-REFERENCE TO RELATED APPLICATIONS The present application claims priority under 35 USC 119 to Japanese Patent Application No. 2004-278543 filed on Sep. 24, 2004 the entire contents of which are hereby incorporated by reference. FIELD OF THE INVENTION The present invention relates to a polygonal rib structure having ribs directed orthogonal to one plane and intersecting each other to form polygonal shapes, and particularly a shock absorbing polygonal rib structure. DESCRIPTION OF BACKGROUND ART A honeycomb structure having a hexagonal cross-sectional shape is disclosed in Japanese Patent Laid-Open No. Hei 9-105013. The honeycomb structure disclosed in Japanese Patent Laid-Open No. Hei 9-105013 has a structure in which a surface formed by connecting end edges of ribs arranged in a honeycomb shape is a curved surface, and it has been attempted to apply the honeycomb structure to a shock absorbing member for helmets. In manufacturing this honeycomb structure, as shown in FIGS. 20 and 21 of the drawings, a band-like blank material 01 that is directed rectilinearly in one direction and has a rectangular cross-sectional shape is fed between a pair of truncated conical rolls 02 , and is rolled to have an elongate trapezoidal cross-sectional shape as shown in FIG. 21 . Thus, a band-like blank material 01 A is obtained in which the band-like blank material 01 directed rectilinearly in one direction is spirally wound. The band-like blank material 01 A that is spirally wound is divided into a plurality of portions, for example, three portions evenly over the winding direction, as shown in FIG. 23 . The surface of the arcuate band-like blank material 01 B is divided at regular angular intervals from the spiral center O into sections (X 1 , X 2 , X 3 , X 2 ) (X 1 , X 2 , X 3 , X 2 ) . . . , as shown in FIG. 22 . In the surface of one of the adjacent arcuate band-like blank materials 01 B, an adhesive is applied to the sections X 1 intermediated by the three sections X 2 , X 3 , X 2 . In the surface of the other of the adjacent arcuate band-like blank materials 01 A, an adhesive is applied to the central section X 3 located at an intermediate position between the adhesive-coated sections X 1 . After curing of the adhesives, both upper and lower end portions of the band-like blank materials 01 B that are divided into arcuate forms are broadened from each other as shown in FIG. 24 , whereby a honeycomb structure as shown in FIG. 14 can be manufactured. In order to manufacture the honeycomb structure disclosed in Japanese Patent Laid-Open No. Hei 9-105013, a process is used in which the rectangular band-like blank material 01 having a cross-sectional shape with a fixed thickness over the longitudinal direction is formed into the band-like blank material 01 A having an elongate trapezoidal cross-sectional shape. It is necessary to prepare a band-like blank material 01 which is free of dispersions in the width direction and in the thickness over the longitudinal direction thereof. At the same time, it is necessary that the accuracy of the outer peripheral surfaces of the pair of truncated conical rolls 02 and the accuracy of the parallelism and size between the roll axes should be high. Moreover, a large number of working steps is required. As a result, productivity is low, and it is impossible to obviate a high cost. In addition, it has been difficult to apply the structure disclosed in Japanese Patent Laid-Open No. Hei 9-105013 to polygonal rib structures other than the honeycomb structure. SUMMARY AND OBJECTS OF THE INVENTION The present invention pertains to an improvement in a polygonal rib structure which overcomes the above-mentioned difficulties. In one embodiment of the present invention a polygonal rib structure is provided which is rich in mass-producibility and is low in cost. An embodiment of the present invention resides in an opened polygonal rib structure having ribs directed orthogonal to one plane and intersecting each other to form polygonal shapes. A thickened central portion located at a substantially central portion in the longitudinal direction of each side of the polygonal rib is bisected, and the opposed parting surfaces formed upon the bisection are spaced from each other to form an opening portion. Each side of the polygonal rib is shaped so that the cross-sectional area of each opening portion is reduced along the direction from the opening end toward the depth. An embodiment of the present invention resides in an opened polygonal rib structure, wherein the shape and size of the rhombic opening portions of the polygonal rib are varied as one goes in one direction or a plurality of directions in the one plane. An embodiment of the present invention resides in an opened polygonal rib structure wherein the opening portion is closed, and the outer peripheral surface of the opening portion is in contact with a rib edge on the side where the opening area is wider and is formed as a projectingly curved surface. An embodiment of the present invention resides in a polygonal rib structure wherein the cross-sectional shape of the polygonal rib is a set of connected regular hexagons or rectangles. An embodiment of the present invention resides in a polygonal rib structure wherein the polygonal rib structure is a shock absorbing member. An embodiment of the present invention resides in a polygonal rib structure wherein the polygonal rib structure is a shock absorbing member for a helmet. An embodiment of the present invention resides in a mold for molding an opened polygonal rib structure, comprised of an upper-lower pair of molds, wherein one of the molds has a structure in which a tapered tetragonal pyramidal male mold being rhombic in cross-sectional shape and tapered toward the tip end thereof is located at the center of each outer peripheral surface of a virtual regular polygonal columnar surface, and the longitudinal section of the tapered tetragonal pyramidal male mold is disposed along the virtual regular polygonal columnar surface. The other of the molds has a structure in which a regular polygonal groove with a fixed width is formed, with the virtual regular polygonal columnar surface as a center. A V-shaped recessed portion that is gradually reduced toward the groove depth is formed at the center in the longitudinal direction of the regular polygonal groove. An embodiment of the present invention resides in a method of molding a polygonal rib structure, including the steps of charging the space between the pair of molds with a molding material and thereafter bringing the opposed wall surfaces of the tetragonal pyramidal opening portion formed by the tapered tetragonal pyramidal male mold into contact with each other to constitute a polygonal rib structure. According to an embodiment of the present invention, an opened polygonal rib structure is provided having ribs directed orthogonal to one plane and intersecting each other to form polygonal shapes wherein a tapered tetragonal pyramidal opening portion having a rhombic sectional shape is formed in a thickened central portion located at substantially a central portion in the longitudinal direction of each side of the polygonal rib that can be mass-produced at low cost. According to an embodiment of the present invention, the outer peripheral surface in contact with the rib edges of the polygonal rib can be so varied that the radius of curvature varies from location to location. According to an embodiment of the present invention, by closing the rhombic tapered tetragonal pyramidal opening portions a polygonal rib structure is formed wherein the outer peripheral surface of the opening portion is in contact with the rib edge on the side where the opening area is broader that is formed as a projectingly curved surface that can be easily produced. According to an embodiment of the present invention, a polygonal rib structure wherein the cross-sectional shape of the polygonal rib is a set of connected regular hexagons or rectangles can be easily produced. According to an embodiment of the present invention, a polygonal rib structure that is light in weight and high in shock absorbing property can be obtained. According to an embodiment of the present invention, by adding the polygonal rib structure to the inner peripheral surface of a helmet, a helmet is obtained that is light in weight and high in shock absorbing property and inexpensively to manufacture. By using the mold according to the present invention, the polygonal rib structure can be easily obtained inexpensively. By applying the method of molding according to the present invention, the polygonal rib structure can be easily mass-produced at a low cost. Further scope of applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description. BRIEF DESCRIPTION OF THE DRAWINGS The present invention will become more fully understood from the detailed description given hereinbelow and the accompanying drawings which are given by way of illustration only, and thus are not limitative of the present invention, and wherein: FIG. 1 is a plan view of an opened hexagonal rib structure according to one embodiment of the present invention; FIG. 2 is an enlarged view of a major part of FIG. 1 ; FIG. 3 is a vertical sectional view taken along line III-III of FIG. 2 ; FIG. 4 is a vertical sectional view taken along line IV-IV of FIG. 2 ; FIG. 5 is an exploded perspective view of a mold; FIG. 6 is a bottom view, as viewed upwards from the lower side, of an upper mold; FIG. 7 is a plan view of a lower mold; FIG. 8 is an enlarged plan view of a major part of FIG. 7 ; FIG. 9 is a sectional view taken along line IX-IX of FIG. 5 ; FIG. 10 is a sectional view taken along line X-X of FIG. 5 ; FIG. 11 is a plan view of a hexagonal rib structure; FIG. 12 is a sectional view taken along line XII-XII of FIG. 11 ; FIG. 13 is a sectional view taken along line XIII-XIII of FIG. 11 ; FIG. 14 is an overall perspective view of the hexagonal rib structure; FIG. 15 is an enlarged plan view of a major part of an opened rib structure in which the shapes of rhombuses of opening portions are different; FIG. 16 is a sectional view taken along line XVI-XVI of FIG. 15 ; FIG. 17 is a plan view of a square rib structure according to another embodiment of the present invention; FIG. 18 is a plan view of a regular triangular rib structure according to a further embodiment of the present invention; FIG. 19 is a plan view of a combined square-octagonal rib structure according to yet another embodiment of the present invention; FIG. 20 is a perspective view showing a part of the process of manufacturing a hexagonal rib structure in the related art; FIG. 21 is a horizontal sectional view along line XXI-XXI of FIG. 20 ; FIG. 22 is an illustration of the condition where an adhesive is applied to a band-like blank material obtained in FIG. 20 ; FIG. 23 is a perspective view of an arcuate blank material obtained by dividing the band-like blank material obtained in FIG. 20 ; and FIG. 24 is an illustration of the last step, after the adhesive shown in FIG. 22 is applied and cured. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Now, one embodiment of the present invention shown in FIGS. 1 to 14 will be described. An opened hexagonal rib structure 2 according to one embodiment of the invention is shown in FIG. 1 . FIG. 2 is an enlarged plan view of a major part of this embodiment of the present invention. In the opened hexagonal rib structure 2 , end portions of ribs 3 are integrally joined to each other at angular intervals of 120°, a thickened central portion is located at a substantially central portion in the longitudinal direction of each of the ribs 3 that is bisected to form a rhombic opening portion 4 . The rhombic opening portion 4 is rhombic in cross-sectional shape, and is so shaped that the cross-sectional area thereof is reduced as one goes downwardly from the upper opening end. The outside surfaces of the ribs 3 adjacent, respectively, to a longitudinal valley line 6 directed in the longitudinal direction of the rib 3 in the opening inside surface 5 and a widthwise valley line 7 directed in the width direction of the rib 3 are provided, respectively, with a notch 8 and a notch 9 which are V-shaped in section. In order to manufacture the opened hexagonal rib structure 2 shown in FIGS. 1 and 2 , a mold 20 consisting of an upper mold 21 and a lower mold 30 is used which constitute an upper-lower pair shown in FIG. 5 . As shown in FIGS. 5 and 6 , the upper mold 21 has a structure in which truncated tetragonal pyramidal male molds 23 project downwardly from the lower surface of an upper base 22 of the upper mold 21 so that the longitudinal edge lines 26 of the truncated tetragonal pyramidal male molds 23 coincide with the sides of a virtual regular hexagon 24 indicated by dot-dash line. In addition, the truncated tetragonal pyramidal male molds 23 are located at the centers of the sides of the virtual regular hexagon 24 . In addition, the lower mold 30 has a structure in which a mold thick plate (not shown) is provided with regular hexagonal grooves 34 having a width equal to the thickness of the opened hexagonal rib structure 2 shown in FIG. 2 , along virtual regular hexagons 33 indicated by dot-dash line having the same shape as the virtual regular hexagons 24 of the upper mold 21 . A truncated tetragonal pyramidal recessed portion 35 having the same shape as the outside surface 25 of the truncated tetragonal pyramidal male mold 23 of the upper mold 21 is formed at a central portion of each side of the regular hexagonal grooves 34 . A projected beam 36 that is triangular in section is directed in the vertical direction and is formed at the groove bottom of the truncated tetragonal pyramidal recessed portion 35 . End edges of the truncated tetragonal pyramidal recessed portion 35 are provided with projecting beams 37 along the end edges, whereby the lower mold 30 has a structure in which deformed hexagonal columnar male molds 32 are integrally joined to a lower base 31 . In the condition where the truncated tetragonal pyramidal male molds 23 of the upper mold 21 are loosely fitted in the truncated tetragonal pyramidal recessed portions 35 of the lower mold 30 so that the center line of the truncated tetragonal pyramidal male mold 23 of the upper mold 21 is set coinciding with the center line of the truncated tetragonal pyramidal recessed portion 35 located at the central portion of each side of the regular hexagonal groove 34 of the lower mold 30 , a thermoplastic resin is injected into the cavities between the upper mold 21 and the lower mold 30 . Thus, the opened hexagonal rib structure 2 shown in FIGS. 1 to 4 can be injection molded. When an adhesive is applied to the opening inside surfaces 5 of the injection-molded opened hexagonal rib structure 2 shown in FIGS. 1 to 4 , and then both side surfaces of each of the rhombic opening portions 4 are pressed so as to bring the opposed widthwise valley lines 7 into contact with each other, the rhombic opening portions 4 are closed and the hexagonal rib structure 1 shown in FIG. 11 is formed. In the rib top face 10 of the opened hexagonal rib structure 2 , as shown at a right lower portion of FIG. 2 , the distance S 1 between the rib top face intersection center point 11 where three ribs 3 intersect and the adjacent rib top face intersection center point 11 is the sum of the interval 2 A 1 of the longitudinal valley line top points 12 of both longitudinal valley lines 6 and the double 2 C of the distance C between the rib top face intersection center point 11 and the longitudinal valley line top point 12 , that is: S 1 =2( A 1 +C ). In the rib bottom face 14 of the opened hexagonal rib structure 2 , as shown at a left lower portion of FIG. 2 , the distance T 1 between the rib bottom face intersection center point 15 where three ribs 3 intersect and the adjacent rib bottom face intersection center point 15 is the sum of the distance 2 B 1 between both longitudinal valley line bottom points 16 and the double 2 D of the distance D between the rib bottom face intersection center point 15 and the longitudinal valley line bottom point 16 , that is: T 1 =2( B 1 +D )= S 1 . When the rhombic opening portions 4 of the opened hexagonal rib structure 2 are closed, the widthwise valley line top points 13 of the widthwise valley lines 7 in the hexagonal rib structure 1 come into contact with each other. Therefore, as shown in FIG. 12 , the distance S 2 between the longitudinal valley line top point 12 in the rib top face 10 and the adjacent longitudinal valley line top point 12 is the sum of the double 2 A 2 of the distance A 2 between the longitudinal valley line top point 12 and the widthwise valley line top point 13 and the double 2 C of the distance C between the rib bottom face intersection center point 15 and the longitudinal valley line bottom point 16 , that is: S 2 =2( A 2 +C ). In the rib bottom face 14 of the hexagonal rib structure 1 in the condition where the rhombic opening portions 4 of the opened hexagonal rib structure 2 are closed, the distance T 2 between the rib bottom face intersection center point 15 and the adjacent rib bottom face intersection center point 15 is the sum of the double 2 B 2 of the distance B 2 between the longitudinal valley line bottom point 16 and the widthwise valley line bottom point 17 and the double 2 D of the distance D between the rib bottom face intersection center point 15 and the longitudinal valley line bottom point 16 , that is: T 2 =2( B 2 +D ). In the rib top face 10 , when the rhombic opening portions 4 are closed, the distance S 1 between the adjacent rib top face intersection center points 11 of the opened hexagonal rib structure 2 becomes the distance S 2 between the adjacent rib top face intersection center points 11 of the hexagonal rib structure 1 , and the difference between the two kinds of distances is: S 2 −S 1 =2( A 2 −A 1 ). Here, as is clear from FIG. 2 , A 2 is the length of the oblique line 12 - 13 of the right-angled triangle having the longitudinal valley line top point 12 , the widthwise valley line top point 13 and the opening center point 18 as apexes, and is longer than the base 12 - 18 of the triangle. Therefore, when the rhombic opening portions 4 are closed, the distance between both rib top face intersection center points 11 is increased by 2(A 2 −A 1 ). Similarly, in the rib bottom face 14 also, the distance T 2 between both rib bottom intersection center points 15 in the condition where the rhombic opening portions 4 are closed and the distance T 1 between both rib bottom face intersection center points 15 in the condition where the rhombic opening portions 4 are formed are in the relationship of: T 2 −T 1 =2( B 2 −B 1 ). Thus, when the rhombic opening portions 4 are closed, the distance between both rib bottom face intersection center points 15 is increased by 2(B 2 −B 1 ). However, this elongation amount is small, since B 1 and B 2 are shorter as compared with A 1 and A 2 . Therefore, the surface formed by joining the rib top faces 10 is an upwardly projecting curved surface as shown in FIG. 14 , which makes it possible to apply the hexagonal rib structure 1 to a helmet shock absorbing member (not shown). According to the embodiment shown in FIGS. 1 to 14 , the opened hexagonal rib structure 2 can be efficiently injection molded in a short time, by only using the mold 20 composed of the upper mold 21 and the lower mold 30 constituting an upper-lower pair and injecting a thermoplastic resin or thermosetting resin into the cavities formed between the upper mold 21 and the lower mold 30 . Therefore, productivity can be enhanced, and the opened hexagonal rib structure 2 can be mass-produced at a low cost. In addition, by integrally joining the opposed opening inside surfaces 5 in the molded opened hexagonal rib structure 2 by use of an adhesive, the rhombic opening portions 4 can be closed, and the hexagonal rib structure 1 curved to the upper side as shown in FIG. 14 can be produced. Further, when a material comparatively low in shock breakage strength is used as the material for constituting the opened hexagonal rib structure 2 , a structure can be obtained that is light in weight and favorable in shock absorbing property. With the size and shape of the rhombic opening portions 4 in the opened hexagonal rib structure 2 appropriately varied depending on the location in the opened hexagonal rib structure 2 , the curved surface shape of the hexagonal rib structure 1 can be conformed to the shape of a helmet, and the hexagonal rib structure can be easily applied to a shock absorbing member for helmets. While the opposed opening inside surfaces 5 in the opened hexagonal rib structure 2 have been integrally joined by use of an adhesive, the opposed opening inside surfaces 5 in the opened hexagonal rib structure 2 may be integrally joined by fusing (welding) in the case where a thermoplastic resin is used as the material for constituting the hexagonal rib structure 1 . While the rhombus of the upper opening of the rhombic opening portion 4 and the rhombus of the lower opening of the rhombic opening portion 4 have been different in size and substantially analogous in shape in the embodiment shown in FIGS. 1 to 14 , there may be adopted a configuration in which, as shown in FIGS. 15 and 16 , the size in the longitudinal direction of the upper opening 4 a of the rhombic opening portion 4 X is equal to the size in the longitudinal direction of the lower opening 4 b of the rhombic opening portion 4 X. However, the size in the width direction of the upper opening 4 a is larger than the size in the width direction of the lower opening 4 b , and the shape of the upper opening 4 a is conspicuously different from the shape of the lower opening 4 b. While the polygon has been a regular hexagon in the embodiment shown in FIGS. 1 to 14 , the present invention naturally is applicable also to a square rib structure 40 as shown in FIG. 17 and to a regular triangular rib structure 41 as shown in FIG. 18 . The invention being thus described, it will be obvious that the same may be varied in many ways. Such variations are not to be regarded as a departure from the spirit and scope of the invention, and all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims.

The present invention relates to a polygonal rib structure having ribs directed orthogonal to one plane and intersecting each other to form polygonal shapes. More particularly, to a shock absorbing polygonal rib structure. In a polygonal rib structure having ribs directed orthogonal to one plane and intersecting each other to form polygonal shapes, a thickened central portion located at a substantially central portion in the longitudinal direction of each side of the polygonal rib is bisected. The opposed parting surfaces formed upon the bisection are spaced from each other to form an opening portion, and each side of the polygonal rib is so shaped that the cross-sectional area of the opening portion is reduced as one goes from the opening end toward the depth. Thus, an opened polygonal rib structure is formed.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a non-provisional application related to U.S. Ser. No. 60/186,944, “Knee and Ankle Alignment Pillow” filed Mar. 4, 2000. The present application claims priority to and benefit of U.S. Ser. No. 60/186,944, which is incorporated herein by reference for all purposes. FIELD OF THE INVENTION [0002] The present invention relates to pillows, particularly pillows which are designed to accommodate the legs of a person during rest. BACKGROUND OF THE INVENTION [0003] Recently there has been renewed interest in the design of specialized pillows for improved comfort and to provide medical benefits. For example, U.S. Pat. No. 6,006,380 “Adjustable cervical pillow with depressions for a user's ear;” U.S. Pat. No. D416,742 “Adjustable pillow;” U.S. Pat. No. 5,926,880 “Adjustable cervical pillow with depressions for a user's ears;” and U.S. Pat. No. 5,781,947 “Adjustable cervical pillow with depressions for a user's ears;” all by Sramek, provide fundamental advances in head and neck pillow designs, providing pillows that improve comfort, reduce snoring and which can reduce incidence of sleep apnea. [0004] In addition to pillows which serve to cushion the head of a user, pillows are often used to cushion other parts of a user's anatomy during rest or sleep. For example, standard bed pillows are often used under the knees or between the legs of a user to provide general comfort while sleeping. This can lead to improper spinal alignment, undue pressure on the knees and ankles or other unwanted effects. [0005] Specialized pillows for aligning the lower back which are designed to fit under and between a user's legs have been proposed (e.g., Stokes, U.S. Pat. No. 5,878,453), but these pillows are relatively complicated, involving several pieces and, in some cases, extending well above the body of a user, e.g., while lying supine. This makes it awkward to use the pillow when bedcovers are in place. [0006] Similarly, several pillows which are designed to fit between or under a user's legs are commercially available, including: the “knee pillow” from Burbank Valley Products (www.burbankvalley.com/knee.htlm); the “Angel Foam™ knee pillow” (www.janlee.com/kneepillow.htm); the “Contour Cloud™” (www.feelgoodfast.com); the Ortho Support Buddy™ pillow, the Ortho Support Ortho Adjustable Knee Cushion™ pillow, and the Bed Wedge Leg Support™ Cushion, all now or formerly available from Self Care (www.selfcare.com or www.gaiam.com); and the Contour Leg Pillow (www.comfort-trac.com). However, these pillows generally lack multipurpose functionality, i.e., the pillows are not generally well-suited to alternate uses for different sleeping positions (e.g., between the legs of a person when side-sleeping and under the legs of a user when sleeping prone or supine). Moreover, certain of these pillows can actually pull the spine out of proper alignment during use. [0007] Finally, specialized pillows which address post-surgical recovery uses in the cases of back, hip, knee, ankle or foot surgery are generally lacking. [0008] The present invention provides simple and effective knee/ankle alignment pillows which remedy the above noted deficiencies in the prior art, providing comfort for the general user during rest such as nightly sleep. The pillows of the invention can also help speed recovery following back, knee, hip, ankle or foot surgery and may provide pain relief to arthritis sufferers. Further details regarding the structure function and manufacture of the pillows of the invention will be apparent upon review of the following. SUMMARY OF THE INVENTION [0009] The present invention provides pillows which fit and/or elevate the legs of a user during use of the pillow, in supine, side sleeping and prone positions. The pillow comprises a resilient body structure comprising a first groove extending longitudinally through an inward or central region of a first side of the body and a second groove opposed to the first groove on a second side of the body. The first and second grooves are each contoured to receive a leg of a person, e.g., when the pillow is fitted between the legs of the user. [0010] Typically, the resilient body structure has an upper face, which includes a first sloping region and a second sloping region. The first and second sloping regions are at least partly separated on the upper face by an upper face groove extending longitudinally along an at least partly inward region of the upper face, e.g., where the first and second sloping regions are each at least partially outwardly sloped from an outer region of the upper face towards the inward region of the upper face. [0011] The resilient body also typically includes a bottom face opposite the upper face. Most typically, the top and bottom faces of the body are symmetrical. Thus, the bottom face typically has a third sloping region and a fourth sloping region, which are separated on the bottom face by a bottom face groove extending longitudinally along an at least partly inward region of the bottom face. The bottom face grove is typically opposed to the upper face groove on opposite sides of the resilient body structure, where the third and fourth sloping regions are each at least partly outwardly sloped from an outer region of the bottom face towards the inward region of the bottom face. The upper face and bottom face grooves are each contoured to receive a leg of a user, e.g., when side sleeping. [0012] A typical configuration of the pillow body is a double-lobed or double-wedged structure with the lobes or wedges (which can include flat or curved surfaces) being joined at edges of the grooves. Thus, in one embodiment, the body has a first resilient lobe or wedge structure that extends from a first edge of the upper face groove to a first edge of the bottom face groove. In this embodiment, the lobe or wedge includes the first and third sloping regions. Similarly, a second resilient lobe or wedge structure that extends from a second edge of the upper face groove to a second edge of the bottom face groove can be included, e.g., in which the lobe or wedge includes the second and fourth sloping regions. The lobes or wedges can be adjustable. [0013] Thus, in one embodiment, the first and third sloping regions form a first wedge or lobe while the second and fourth sloping regions form a second wedge or lobe. The first and second wedges or lobes are formed in opposite orientations, with opposing grooves connecting the opposing wedges/lobes. Advantageously, the slopes and dimensions of the first, second, third and fourth sloping regions are selected to provide support to the legs of a user when sleeping in a supine or prone position. [0014] A variety of basic configurations of the sloping regions can be adopted. For example, the slope of the first and second sloping regions are most typically equal, but can also be different. Similarly, the slope of the third and fourth sloping regions are typically equal, but can differ. In one typical embodiment, the pillow is symmetrical, and, thus, the slope of the first, second, third and fourth sloping regions are equal. However, one or more portions of the pillow body is/are optionally non-symmetrical. [0015] While the pillow body is typically formed from a single piece of resilient material, it can also be formed from multiple pieces of one or more resilient materials. The body can also incorporate features for customizing the pillow to an individual user, or which modify the function of the basic pillow design. For example, the body optionally includes a tear away portion, an inflatable portion, a re-attachment portion, or an adjustable portion. For example, to properly size the pillow for a user, the pillow can be formed of abutting tear away sections that provide for easy overall size (e.g., length) adjustment of the pillow. Similarly, inflatable portions can be used to modify the dimensions of the pillow to fit a particular user. Other adjustable portions (e.g., adhesive (e.g., hook and loop (e.g., Velcro™) fasteners can be used to provide for the addition to or removal from components of the basic pillow design. [0016] Methods of manufacturing the pillows, e.g., by providing the elements of the pillows in operable combination, are provided. Typically, the body structure is fabricated by injection molding, e.g., of a urethane foam, or by die (or “contour”) cutting a urethane blank. The pillow can also be provided in customizable form, providing for use of tear-away sections or inflatable portions to provide the final pillow body configuration. [0017] The body can be made from any material typically used in pillow construction, including, e.g., plastic foam, urethane foam, feathers, natural fibers, etc. Most typically, the pillows of the invention are made from one or more urethane foam(s), although other resilient man made and natural materials are also appropriate. Commonly, the urethane or other foam is shaped into pillow components using a cavity molding or free-rise molding process, or by cutting (e.g., die cutting) a foam blank to a desired size and shape. Most commonly, foams used for the pillow components of the invention will be standard polyurethane foams, though more advanced “memory” foams such as TEMPER FOAM®, MEMORY FOAM®, MEMORY FLEX® and VISCO ELASTIC® can also be used for all or a portion of the pillow body. [0018] Uses of the pillows and of the manufacturing methods herein are provided. Kits comprising the elements of the pillows in conjunction with, e.g., packaging materials and assembly instructions are provided. BRIEF DESCRIPTION OF THE DRAWING [0019] [0019]FIG. 1, panels A-G are schematic drawings of a pillow of the invention, along with a user showing use of the pillow in supine, side sleeping and prone positions. DESCRIPTION OF THE PREFERRED EMBODIMENT [0020] The knee-ankle pillows of the invention are designed to fit the legs of a user, particularly between and including the knees and ankles of the user. The pillows provide enhanced knee, ankle and leg comfort, as well as improved spinal alignment, when compared to placing a standard pillow between the legs of the user. The pillows are designed to provide support between the legs (e.g., when side sleeping), or under the legs (e.g., when the user is in a prone or supine position). [0021] While the majority of users are accommodated with a single unit pillow body, or simply by varying the sizes of such a body (e.g., providing small, medium, large and extra large pillows), the pillows are optionally individually customizable and can include multiple components. For example, the pillows can be individually configured for optimal comfort, optionally including features such as tear-away portions, inflatable portions, adhesive portions, attachable portions (e.g., hook and loop (VELCRO™) systems), or the like. [0022] Typically, the materials used in the pillow bodies are of a suitable density and compressibility to support one or both of a person's legs. The pillows of the invention are optionally made from one or more of a variety of resilient materials, such as man-made plastic foams (e.g., polyurethanes), feathers (e.g., goose or duck down) or natural fibers (e.g., cotton, kapok, or the like). Preferably, the pillows of the invention are made from any of a variety of resilient urethane foams, e.g., by molding polyurethane in a cast, or, even more commonly, by contour (die)-cutting the polyurethane from a larger resilient polyurethane foam blank. [0023] “Resilient” pillow component materials are those which compress or flex with the application of pressure (e.g., the weight of a person's leg or body applied to the component during use). Resilient components tend to return to approximately the same shape when the pressure is removed from the component. [0024] Materials with shape memory, i.e., which retain the shape of a pressure imprint for a time, slowly returning to approximately the shape of the component prior to the application of pressure, are considered “resilient” materials for purposes of this disclosure. Examples of such materials include polyurethane isocyanate foam components which conform to a person's legs at body temperature and/or under body weight pressure, but which gradually return to an original shape after the person's legs are removed from the component and/or the component cools to room temperature (certain forms of such foams soften with temperature, while others do not). Similarly, down or natural fiber pillow components which are quilted or packed to retain a given shape are “resilient” materials for purposes of this disclosure. [0025] It is expected that one of skill is fully aware of manufacturing methods for making and shaping resilient polyurethane foams. A general introduction to the manufacture of plastics in general, and urethane foams in particular is found in Kirk - Othmer Encyclopedia of Chemical Technology third and fourth editions, esp. volumes 18 and volume 23, Martin Grayson, Executive Editor, Wiley-Interscience, John Wiley and Sons, NY, and in the references cited therein (“Kirk-Othmer”). [0026] Resilient flexible urethane foams are typically processed into pillow components, or blanks from which these components are cut using known techniques such as “die” or “contour” cutting. These techniques can include, e.g., free rise processing, extrusion, cavity molding, injection molding, structural foam molding, rotational molding, thermoforming, calendaring, thermosetting, reaction injection molding, and the like. See, Kirk-Othmer, supra. [0027] The physical properties of urethane foams such as indentation force deflection (° F.)), modulus (i.e., Young's modulus; stress=force/area; the resulting relative change in size is termed strain and the modulus of elasticity=stress/strain) and rebound depend on, e.g., the density of the foam, the catalyst used to set the foam, the presence of surfactant in the foam, the presence of polyols and isocyanates and the type of mixing. A variety of manufacturing techniques are known for both thermoplastic and thermosetting urethanes, and polyurethanes and associated solvents, reagents, catalysts and the like are commercially available from J. P. Stevens (East Hampton, Mass.) as well as many other commercial sources such as Akzo, BASF, Dow, Mobay, Olin, Rubicon, Upjohn, Bayer, Takeda, Veba, Eastman, Sun Oil, and other manufacturers known to persons of skill. See also, Kirk Othmer, id. [0028] For example, in the free rise process, the chemical components of the urethane foam are mixed, e.g., in a vat or in a slip-form mold where they foam and rise. Bales of the foam are cut into blanks and milling is performed using a cutting tool such as a “contour” or “die” cutter (or, even, optionally, by hand cutting the blank). The die or contour cutter performs a set cutting operation, by a combination of the shape of the cutting heads and the movement instructions provided to the cutting heads, to produce a pillow body having a given shape. [0029] In the cavity molding process, a shaped cavity is made, e.g., from fiberglass or aluminum. The chemical components of the urethane foam are sprayed into the shaped cavity, where they expand to fit the shaped cavity. The cavity is then opened, and the shaped foam is released. [0030] While the pillows of the invention are typically made from low-cost foams to reduce manufacturing costs, the foams used in the pillow can be made from a higher grade of foam such as a “memory” foam. One of skill can make such foams using known techniques, and several suitable classes of foams are commercially available, such as TEMPER FOAM® (available, e.g., from Kees Goebel Medical, Hamilton, Ohio), MEMORY FOAM®, MEMORY FLEX®, and VISCO ELASTIC® (all available, e.g., from North Carolina Foam, Inc., Mount Airy, N.C., as well as a variety of other commercial sources). [0031] Optional inflatable portions of the pillows of the invention can include air or fluid bladders, e.g., comprising reinforcing regions for controlling expansion and the shapes of the bladders resulting from expansion. For example, nylon mesh or other synthetic materials can be incorporated into the bladders. The main portion of an air (or hydraulic) bladder is made from rubber, plastic, or any other air (or water or other fluid)-tight inflatable material. [0032] In one embodiment, the pillows of the invention have an absorptive pillow covering encasing the pillow body. This absorptive covering can be made from a bacteriocidal fabric such as STAPH-CHECK®. The pillow, with or without an absorptive covering is often used in conjunction with a loose-fitting pillow case. In one embodiment, the pillow case is made from a silk, cotton, synthetic or blended fabric. [0033] The invention is illustrated with reference to FIG. 1, panels A-G. As depicted, FIG. 1A provides a top perspective view of one embodiment of the pillow body. FIG. 1B provides a cross-sectional end view of the pillow body. FIG. 1C provides a top view of the pillow body. FIG. 1D provides a side view of the pillow body. [0034] [0034]FIG. 1E provides a view of the pillow in use by a user who is resting on the user's side, e.g., in a side-sleeping position. This fixes the knees and ankles of the user in an aligned position, resulting in proper pelvic and spinal alignment. FIG. 1F provides a view of the pillow in use by a user sleeping or resting supine (face up), with the pillow supporting the upper legs of the user. This eliminates knee hyperextension and preserves correct lordosis (curvature) in the lower spine. FIG. 1G provides a view of the pillow in use by a user sleeping in a prone (face down) position, with the pillow supporting the lower legs of the user to reduce stress on the feet and ankles of the user when sleeping prone. This lifts the lower legs of the user preventing hyperextension of the knees and preserving correct lordosis of the lower spine. [0035] As shown, pillow body 1 comprises upper face (central) groove 20 on upper pillow face 25 . Groove 20 is formed along an inward portion of pillow face 25 , i.e., a portion that extends between outer face regions 22 and 24 . That is, while groove 20 extends to end edge 33 and end edge 34 , the groove is inward from outer face regions 22 and 24 . Thus, a pillow face or body region is “inward” if it is located between at least two outer regions (e.g., opposing regions) of the pillow face or body. [0036] As depicted, pillow body 1 is symmetrical, comprising central groove 30 on bottom face 35 , with the bottom face having the same features as the upper face. This symmetry is further illustrated in FIG. 1B. [0037] It will be understood that the use of the terms “upper” and “bottom” with respect to the faces of the pillow are intended to facilitate discussion, rather than to limit the positioning of the pillow, or to necessarily indicate a particular orientation of the components. That is, the upper face may actually be the bottom of the pillow during use and vice-versa, depending on the position of the pillow during use. Of course the upper and bottom faces may actually be vertical faces as well, e.g., if the pillow is held in a vertical orientation. [0038] Resilient curved wedge portions 40 and 50 are depicted, e.g., in FIG. 1B. As shown, the portions are formed in partly curved wedge shapes that include sloped regions 60 , 70 , 80 , and 90 . As shown, the sloped regions slope outward, that is, the thickest point of the wedges is towards the center of the pillow, with the outer edges being less thick. The wedges are partly curved in that outer regions 22 and 24 form a curve from the top to the bottom of the pillow body, rather than coming to a point. In other embodiments, the regions are still more curved, making the shapes more lobe-like than wedge like. The precise angle of the wedges or lobes (and, thus, the slopes of the sloped regions) varies depending on the application. For example, if greater lifting of the legs during supine or prone sleeping is desired, the angle (and/or thickness of the wedges) can be increased. The slopes of the sloped regions typically range from between about 5° and about 45° above horizontal. Resilient wedges 40 and 50 can have essentially flat sloped regions as depicted, or the sloped regions can be more rounded, resulting in a more lobed or bulbous appearance. [0039] [0039]FIG. 1E shows the pillow in use by a user sleeping in a side-sleeping position. As shown, user's right leg 100 fits into groove 20 , including the joints of user knee 110 and ankle 120 . Right leg 100 is partly separated from left leg 130 (which fits into groove 30 on the bottom face of the pillow) by lobe/wedge 40 . Thus, as shown, when lying in a side-sleeping position, grooves 20 and 30 receive the legs of the user, e.g., in the region from the knee (or slightly above the knee) to the ankle. As depicted, the pillow is about 20-30 (e.g., about 24) inches long; however, this length can easily be customized to a length of the leg of the user. The knee of the user can fit into grooves 20 and 30 , or a widened portion of the groove at one end of the pillow body can be provided to permit partial rotation of the knee. Of course, a slightly widened region can also be provided at the other end of the pillow to provide for partial rotation of the ankle. [0040] [0040]FIG. 1F depicts a user resting supine with the weight of the user's legs partly compressing the pillow (e.g., lobe 40 ). As depicted, the user's legs are held in a more comfortable position that avoids knee hyper-extension and which preserves correct lordosis in the lower spine. As shown, when lying supine, lobe portion 40 is compressed relative to lobe 50 , thereby preserving lordosis in the lower spine and providing comfortable support to the legs of the user. Compression of the pillow by the user's legs is slightly exaggerated for purposes of illustration. [0041] Similarly, FIG. 1G further shows compression of wedge 40 when the user is lying prone, again preventing stress on the feet and hyperextension of the knees while preserving correct lordosis of the spine. Again, compression of the pillow by the user's legs is slightly exaggerated for purposes of illustration. [0042] As depicted, the wedge portions are typically about 3-5 inches thick at the thickest point, but this thickness can be customized to the size of the user, either by providing different molds or different cutting instructions to produce pillows with different heights, or, e.g., by providing tear-away foam pieces (e.g., which optionally include perforations) which can be removed or attached (e.g., using VELCRO™) to the main pillow body to adjust the overall size or shape of the pillow body. Similarly, the lobe/ wedge regions (or the grooves) can include inflatable bladders to customize any portion of the pillow to the user. [0043] The foregoing description of the device of the invention is illustrative and not limiting. All publications, patents, patent applications and other documents cited herein are incorporated by reference for all purposes to the extent as if each were specifically and individually indicated to be incorporated by reference for all purposes.

Pillows which are designed to fit the legs of a user during sleep or recovery from surgery are provided.

CROSS-REFERENCES TO RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 10/903,521, filed on Jul. 30, 2004, which was a divisional of co-pending patent application Ser. No. 10/198,718, filed on Jul. 17, 2002, which was a continuation-in-part of and claimed the benefit of U.S. Provisional Patent Application Ser. No. 60/306,315, filed Jul. 17, 2001. BACKGROUND OF THE INVENTION Field of the Invention The devices and related methods of the invention relate to the controlled introduction and removal of fluids in diagnostic, therapeutic and imaging applications within the body. Specifically, the invention relates to the advantageous use of a fluid exchange device in combination with a catheter to produce a system for controlled aspiration and irrigation and the selective and localized exchange of fluids within a body conduit, for example, in the diseased region of a blood vessel having a blockage or lesion. The devices of the invention, and the methods enabled by the use of the devices, have several different components that can be used individually or integrated into a system for use within an organ and within the vasculature of the body where controlled and localized irrigation and aspiration are performed together as a therapeutic procedure or in tandem with a separate therapeutic procedure. Irrigation and aspiration are clinically important in many surgical procedures when fluids are selectively introduced into and removed from a target site within the body, usually while a surgery or other therapeutic medical procedure is performed. When the site of the therapeutic treatment is inside a body cavity or in the vasculature of the body, such as in a blood vessel, the irrigation and aspiration functions require special apparatus and methods. Surgical and percutaneous systems that both irrigate and aspirate have been developed, and some of these systems are catheter-based such that the introduction and removal of fluids is performed within an organ or a vessel by using the catheter as the conduit to introduce and remove fluids from a target site. As will be readily appreciated, the catheter allows the control elements to be remotely located, e.g., outside the body while the actual irrigation and aspiration functions are selectively provided within the body by selectively orienting the distal end of the catheter to the target site. In such cases, as is the case in open surgeries, the irrigation and aspiration functions accompany a therapeutic procedure that is performed at the target site along with the irrigation and aspiration. Catheter-based irrigation and aspiration systems are unique in many respects due to their use in clinical situations where blockages or lesions exist inside a blood vessel, such as a coronary or carotid artery, and dangers arise from the creation and release of emboli within the vessel. In many intravessel therapeutic procedures, the danger from the creation of emboli is an unavoidable aspect of the therapeutic procedure. For example, lesions of atherosclerotic plaques inside a blood vessel are treated by several therapeutic procedures including endarterectomy, atherectomy, the placement of intravessel stents, balloon angioplasty, surgical ablation of the lesion, thrombectomy, OCT, dialysis shunt clearing and others. However, while each of these procedures has great therapeutic value in treating the lesion, each carries the risk of creating emboli during the procedure. As with any procedure conducted in the cardiovascular system, the risk is particularly great where plaque dislodged from inside a blood vessel can travel to the brain causing serious brain injury or death. For example, treating lesions of the carotids necessarily involve high risk. Currently, carotid treatments are attempted together with deployment of a filter to attempt to track emboli generated by or released from a carotid lesion. Unfortunately, crossing a carotid lesion with a filter or other structure can generate a cerebral ischemia or stroke. Schlueter et al. 2001, Circulation 104 (17) II-368. Moreover, studies have shown that merely crossing a carotid lesion with a guide wire can generate emboli. Al-Mubarak et al.: Circulation 2001 OCT 23:104 (17): 1999-2002. Also, some lesions carry such a high risk of generating emboli that therapeutic treatments are attempted only in the most severe cases. Where a chronic total occlusion exists, the diagnosis is particularly poor because it is impossible to place a structure distal of the occlusion such that emboli generated by the removal of the occlusion can be captured before circulating in the bloodstream. Such occlusions can only be treated by removing the occlusion from the proximal side, where emboli removal is uniquely difficult. Accordingly, if the capability existed to dramatically reduce the dangers of emboli creation during therapeutic procedures inside a vessel or organ of the body, the existing procedures would be safer and more widely practiced, and new procedures would be performed. A variety of systems to contain and remove emboli have been proposed wherein a portion of a vessel that contains a lesion is segregated by two occluding members, typically two balloons, which are inflated proximate and distal to the lesion to effectively seal the inside of a region of the vessel containing a lesion prior to treatment of the lesion. Once treatment is complete, embolic particles such as dislodged plaque are removed by applying suction between the balloons. However, the tissue affected by a lesion is notoriously delicate and the treatment of the lesion has the capability to generate or release emboli whenever any mechanical manipulation of the lesion occurs. The generation and/or release of emboli is a concern virtually anytime a structure is passed through a susceptible vessel. Such circumstances include the placement of a balloon or stent, the placement of a filter, or simply the use of a catheter or guide wire for imaging, diagnostic, or any other procedure. In many procedures, the internal portion of a vessel is occluded to provide a segregated region of a vessel through which fluid does not flow. Moreover, virtually anytime structures are inserted into the vessel, the generation of release of emboli is a concern. For example, in the common practice of placing a stent inside an artery, a filter may be placed distally of the stent to attempt to collect emboli generated when the stent is expanded to engage plaques or lesions inside the vessel. All devices placed distal involve the crossing of the lesion. All crossings of lesions create emboli of some quantity and significance. Such systems cannot protect the patient against the potential harm inherent in the placing the device. Additionally, once the stent is in place, the filter must be removed by pulling it through the portion of the vessel in which the stent has been inserted. This carries the risk that the filter will impact the vessel and cause the release of emboli and/or contact the stent and either displace the stent or similarly cause the release of embolic particles. The use of occluding members of any type has certain drawbacks. Anytime a structure is used as an occlusive member inside a vessel, the structure must deform the vessel from the inside to create a seal about the periphery thereof with the internal surface of the vessel. For example, to make the seal tight enough to prevent the passage of fluid and emboli past the balloon, the expansion of the balloon typically deforms the vessel outward and may disrupt plaque in and about the point of contact between the vessel and the balloon. Moreover, any plaque that becomes dislodged outside the barrier formed by the balloon is released into the blood stream because there is no mechanism distal of the balloon to remove the emboli. For this reason, irrigation and aspiration proximate to the lesion are particularly important. To create a segregated region of a vessel, a two-balloon system may be used. However, certain disadvantages of a two-balloon system also arise from the placement of balloons on both sides of a lesion and the nature of the blood flow that occurs in the region of the vessel containing the lesion once the balloon is removed. At the point of contact between the balloon and the vessel, plaque may be compressed underneath the balloon and may become dislodged upon reestablishment of flow through the vessel. Furthermore, many clinicians have observed that the region distal of a lesion is more likely to exhibit plaque formation than the region proximal of a lesion. Thus, the use of an occluding member distal of a lesion does not eliminate the risk of creating emboli that may enter the vessel. The risk is particularly great when a second balloon is used because the balloon is not advantageously placed for the removal of emboli created by the use of the balloon itself and because the balloon must be removed by passing it across the lesion upon completion of a procedure. This drawback is present in all circumstances when a balloon is advanced across a lesion because, when any occluding member is placed distally of the lesion, the occluding member must be drawn back across the lesion to remove the occluding member at the end of a procedure. Each passage of an occluding member across the lesion, even in a retracted or deflated state, carries a substantial risk that additional emboli will be produced. Also, the placement of two balloons requires additional time to inflate the second balloon and adds to the complexity of a device due to an additional lumen that must be incorporated into the catheter to inflate the balloon. In a finite number of cases, the occluding member that is distal of a lesion, and is required to retain emboli in a defined area within the vessel, has been observed to fail, thereby releasing the emboli into the bloodstream. Because the second balloon is relied upon to prevent the flow of emboli past the region of the vessel containing the lesion, the failure of the balloon is a critical event that threatens the health of a patient undergoing the procedure. Furthermore, due to geometric constraints, the second balloon often acts as the guide wire as well. When delivering tools to perform the therapeutic or diagnostic procedure within the vessel, the balloon may move and disrupt the vessel wall. Introduction of tools and other manipulations of a distally located balloon can also result in deflating the balloon or otherwise causing the balloon to lose patency on the interior of the vessel. Anytime that a balloon is placed distal to a lesion, the contact between the balloon and the lesion carries the risk of damaging the vessel. For these reasons, the use of balloons inside the vessel is preferred to be minimized and the length of time and extent of contact between a balloon and the inside of a vessel should be reduced. Ideally, the balloon or other occluding member could be placed proximal to a lesion so that the area containing the lesion would be isolated. To achieve this, the irrigation and aspiration functions would have to be provided by a structure that is positioned distal of the occluding element, such that the occluding element could be placed proximal of the lesion, and the aspiration and irrigation functions achieved distal of the occluding member. Even under existing technologies where aspiration and irrigation are applied in a catheter based system, the parameters of fluid flow, as well as the placement of the aspiration and irrigation ports relative to an occluding member, are important to the physiological outcome for any given procedure. For example, removal of fluid and/or embolic particles by simple suction from within a body conduit may only remove a portion of the fluid present in the vessel and may leave emboli in place even if all of the fluid is removed and replaced. Deposits of plaque and other debris that may exist inside a vessel have a tendency to adhere to one another and particulate emboli tend to adhere to the sidewalls of the vessel. Thus, a system that provides limited fluid exchange is particularly unlikely to achieve a complete removal of emboli. Also, given that the interior walls of a vessel may have been contacted from within during a therapeutic procedure, a high likelihood exists that additional particles may be dislodged upon the establishment of a robust fluid flow through the vessel. Ideally, a system for aspirating and irrigating the interior or a vessel or organ would provide both fluid exchange and fluid flow parameters that are at least similar to that experienced during ordinary physiological functions and preferably would create a turbulent fluid flow that would proactively assist in the removal of particles and other emboli. Such a system would require both a catheter element that achieved aspiration and irrigation as well as a fluid exchange apparatus that would be coupled with the catheter to produce the desired fluid flow rates and other fluid parameters. Because of the wide variation in intravessel procedures and the location of disease, an irrigation and aspiration system would also be particularly useful if the catheter element could be selectively positioned along a specified length of a vessel where emboli may be created together with operation of the fluid exchange apparatus to control the irrigation and aspiration flow. This capability in the catheter element is most readily created with only a single balloon system having a separate, movable, irrigation and aspiration catheter. In the prior art two-balloon system described above, where a region of a vessel is segregated by a pair of balloons located both proximally and distally of a lesion, the area of fluid flow is limited to the region defined by the placement of the two balloons. The problem is particularly acute when a vessel is treated with a procedure that installs a stent or manipulates the plaque in a vessel, such as with an angioplasty, where the lesion is physically manipulated as part of the therapeutic treatment. Assuming that the therapeutic treatment is successful, the vessel is treated by virtue of expanding the interior volume and promoting the flow of blood through the vessel. Under these circumstances, the portions of the vessel distal of the lesion have been contacted by a balloon and are then exposed to a higher volume of fluid flow than existed before the procedure. In the context of a typical patient, a vessel which had become slowly blocked due to the deposit of plaque over a large number of years has been expanded by the treatment of the lesion and this therapeutic treatment at an upstream point subjects the region in which the lesion is located and those downstream internal portions to a rate and volume of blood flow that has not been experienced in the many years since the vessel began to become occluded. Under these circumstances, an additional risk exists that plaques located downstream from the lesion will be dislodged and will enter the circulation causing serious injury. As with ordinary irrigation and aspiration in an open surgery, the irrigation and aspiration that are applied through existing catheter systems are typically regulated only by setting the positive or negative pressure that is applied to the aspiration or irrigation lumen of the catheter and is in turn communicated to the distal end of the catheter to insert or remove fluid respectively. However, to create the specific fluid flow parameters that maximize the removal of emboli and the fluid displacement within a vessel, thereby establishing fluid change in the vessel in the most physiologically relevant manner, a specialized fluid exchange device would have to be created to regulate the fluid flow parameters of both the irrigation and aspiration functions of the system. An ideal irrigation and aspiration system could be an additive component to several other apparatus that are used in therapeutic, diagnostic, or imaging applications in the body such that the capability of the system would not be exclusive of other technologies that have been applied to enhance the safety of an intravessel procedure. Several different approaches apart from irrigation and aspiration have been attempted to physically capture emboli downstream at a lesion, most notably through the use of filters. However, filters have inherent drawbacks that cannot be completely eliminated. For example, embolic particles smaller than the filter pore size, commonly on the order of 100 microns evade filters, which must not be so small that physiologically important elements such as red and white blood cells are captured by the filter. Also, particles larger than the pore size tend to become trapped in the filter such that the filter itself becomes an occlusive element and blood flow through the filter is impeded. Also, as described above for occluding structures, whenever a filter is introduced distally to the lesion in a vessel; a finite probability exists that the removal of the filter will generate emboli. Still further, where a stent is placed at a lesion, the movement of the filter past the stent and through the vessel has the capability to catch or displace the stent. Although certain portions of the discussion herein are directed towards a preferred embodiment of the apparatus of the invention used in an intravessel procedure, the devices and methodologies of the invention can readily be applied to non-vessel sites within the body such as within any body conduit such as an ear canal, colon, intestine, the trachea, lung passages, sinus cartilages, or any internal volume wherein a controlled and localized irrigation and aspiration function are desired. For example, in a diagnostic colonoscopy an endoscope may be introduced to aid in optical visualization of the site. However, the colon responds to fluid pressure changes and thus while trying to clear the field the tissue of note may move. To aid in this diagnostic situation, a controlled introduction of a clear fluid could be introduced in concert with an equivalent aspiration of dirty fluid. As such, the tissue may remain in the field of view while the process occurs. For imaging purposes the introduction of a contrast agent while simultaneously extracting an equivalent fluid will allow a vessel or organ to maintain its normal fluid level and pressure. As the imaging is completed, the same system could then return a more normal fluid to the site while extracting the foreign contrast agent. Imaging “pig-tail” catheters are presently used to introduce contrast agents to vascular system, even though radiopaque contrast agents are known to maintain a level of toxicity (Solomon, Kidney International, 1998, vol. 53, pp. 230-242). If the field of contrast was introduced and extracted as proposed by Courtney, et al., the patient's exposure would be substantially reduced. BRIEF SUMMARY OF THE INVENTION The present invention provides control of both irrigation and aspiration functions at a selected location within a body cavity or conduit, such as a target region of a blood vessel. The region of the vessel to which an irrigation and aspiration function are provided may include both a therapeutic treatment site, the site proximal to the placement of a balloon, or a length of a vessel both proximal to and distal of a lesion wherein a surgical treatment was performed, where a diagnostic or therapeutic procedure caused the insertion of a dye or other solution, such as a clot dissolver, or where a total chronic occlusion occurs. Because the irrigation and aspiration functions are performed simultaneously, the fluid exchange apparatus of the invention is able to simultaneously regulate both irrigation and aspiration in a manner that advantageously controls the fluid flow rates and fluid flow parameters. This capability can be achieved both by controlling the flow rates using an electronic control system, as well as providing a mechanical apparatus that controls irrigation and aspiration flows when actuated by a user. When the catheter and fluid exchange device are combined into the system of the invention, the combination provides unique capabilities for treating or diagnosing a lesion contained within a vessel. For example, the lesion may be pre-treated prior to the therapeutic treatment which typically comprises ablation of a lesion or placement of a stent or expansion of the diameter of the vessel, i.e., through an angioplasty procedure. In a diagnostic embodiment, dye or other diagnostic markers can be infused distally of the occluding member and proximate to the lesion while avoiding the potential hazards of passing a collapsed balloon across the lesion. This provides a diagnostic capability which has substantially reduced risk relative to a therapeutic treatment that requires expansion of an occluding member distal of the lesion. Because of the added safety margin, the diagnostic procedures can be more readily performed without the risk of producing emboli and thus are a more available complement to the therapeutic procedure. Preferably, the system of the invention includes a catheter element having specific features designed to facilitate the desirable fluid flow parameters when connected to the fluid exchange apparatus. Ideally, when coupled with an apparatus that inherently provides controlled and regulated fluid flows for both aspiration and irrigation, the catheter works in tandem with the apparatus to create both controlled and localized irrigation and aspiration through a catheter-based system. For example, the apparatus of the invention allow the user to control the irrigation and aspiration flow volumes, and by virtue of a specially designed catheter system, provide improved fluid flow parameters that facilitate quantitative volume exchange within a vessel or other cavity and produce defined fluid flow parameters in a region bordered by an occluding element. Accordingly, the aspiration and irrigation functions provided by the fluid exchange device can be added to several existing devices such as balloon occluding elements or filters, or can be used alone as a catheter-based fluid exchange system without any additional device. Thus, the fluid exchange capabilities can be added to an existing device such as a straight catheter or filter, or an existing device can be integrated into the remaining components of the present invention to provide the advantageous irrigation and aspiration functions as described herein. For example, to decrease time during a therapeutic or diagnostic procedure, the portion of the catheter element providing the irrigation function could be combined with a catheter used to perform an angioplasty procedure. When so integrated, the irrigation and aspiration functions of the invention are located distal to the angioplasty balloon and the enhanced removal of emboli is facilitated. Also, the location of the irrigation and aspiration lumens can occur such that the aspiration ports are on opposite sides of an occluding member or other structure such that a direct irrigant to aspirant volume exchange may or may not occur in the lesion of a vessel. In preferred embodiments of the system of the invention, the catheter element provides turbulent, rather than laminar, flow within the vessel. Turbulence is introduced locally at the region of fluid exchange within the body. In a turbulent flow, the velocity at a point fluctuates at random with high frequency and mixing of the fluid is much more intense than in a laminar flow. Turbulent flow is specifically preferred because it reaches the walls of a body structure and facilitates both fluid exchange and dislodging of particulate matter. To reach the walls, the irrigation ports exit the catheter element in the direction of the wall. To accomplish this, the catheter element preferably has ports that exit orthogonal to the wall of the distal end of the irrigation lumen of the catheter. The aspiration lumen may establish a local laminar flow profile. This results in laminar flow about the vessel. Also, in a turbulent flow, the velocity at a point fluctuates at random with high frequency and mixing of the fluid is much more intense than in a laminar flow. This is of particular value when attempting to clear any site of debris. Without turbulence, the flow along the sides of a vessel/lumen is approximately 0. When trying to remove/clear or exchange fluids thoroughly is it imperative to facilitate mixing. Mixing can only reach the vessel walls through the application of turbulence. This is appreciated by the vessels as well, since turbulence can be achieved with this invention without high-powered injection systems that carry physiological risks associated with their inherent power and abnormally high flow rates. In more scientific terms, when a laminar flow is made turbulent, then the velocity will become more uniform and higher, and as a result, fluid particles in the boundary layer can move farther downstream before separation takes place. This turbulence is generally local to the irrigation area and controlled by the dimensions and orientation of the ports of the irrigation lumen. The flow and velocity exchange rate through the entire system is not altered significantly since the turbulence is local area around the irrigation ports. But turbulence for an equivalent flow produces a much more uniform flow across the vessel. This results in higher velocities along the wall where emboli and thrombus are known to be in residence. From a physiological relevance standpoint, blood clots, or thrombi, are much more likely to be released into turbulent than in laminar flow. (Berne & Levy, 2001, Cardiovascular Physiology, p. 126). Because flow is proportional to viscosity, irrigation with any number of fluids can increase the flow over just aspiration of the site. For example, the viscosity of blood is 5 times that of water in a vessel larger than 0.3 mm in diameter, (from graph 5-14, in Berne and Levy, p. 129). The resulting combination of turbulence and the introduction of various fluids allows for substantially variable fluid flows which cannot be achieved without the combination herein disclosed. Those of skill in the art will appreciate that the fluid exchange capabilities and fluid flow parameters provided by the invention can be integrated into a number of systems to provide irrigation and aspiration and essentially any physiological context where near quantitative removal of fluid or particles from a site is desired. As noted above, the enhanced fluid flow parameters can be strategically oriented relative to the placement of an occluding member, such as a balloon, to effectively remove fluids or solid matter either proximal to or distal of the occluding device. The catheter element of the apparatus can also be positioned to facilitate the removal of dyes, or therapeutic or diagnostic compounds as part of the fluid exchange function of the apparatus of the invention. In a preferred embodiment, the invention provides both irrigation and aspiration in a selected region of a vessel proximate to a lesion, but without any occlusion distal of the lesion such that the occluding element may be both inserted and removed without passing across the lesion. Because of the design of the catheter-based system, a single catheter element may both aspirate and irrigate and may be moved within the vessel whether or not used in combination with other apparatus. When used in combination with an occluding element, the irrigation and aspiration factors may be fixed in place proximate to a lesion within a vessel or may be movable such that a single catheter element having both aspiration and irrigation functions can be advanced into an area proximate a lesion and actuated to perform the irrigation and aspiration function both proximate to the lesion and distal to the occlusion element. Similarly, if there exists a distal device (filter or occlusion balloon) this system can be activated to accomplish the following optimum clinical benefit. The irrigation ports being just proximal, but not exclusively proximal, to the aspiration port, then the vessel can be irrigated actively with the local flow moving prograde. This drives the emboli up against a more distal occluder/filter and there the aspiration port evacuates the emboli. Used in concert with existing filters or balloons this results in optimum retrieval of emboli from the active irrigation. This embodiment does not require a proximal occlusion for clinical benefit. In procedures where emboli may be present, this device may be used as part of a method to extract the emboli generated during either a therapeutic, surgical, imaging or diagnostic procedure. The volume exchange provided by the current invention is also adapted to facilitate removal of fluids within a measured portion of a vessel where vessel dimensions and fluid volumes are known. This device affords a simple mechanical means through which these may occur in concert. Primary applications have been identified that produce a 1:1 exchange of fluids, but further applications include pulsatile exchange rates and ratios other than 1:1. The control aspect of the invention is derived in part from measured volumes that may be inserted and removed through a catheter system comprising an irrigation lumen and an aspiration lumen in fluid communication with irrigation and aspiration port(s) that insert and remove a defined or predetermined volume of solution. The design of the catheter and the fluid flow parameters achieved at the target site produce specific fluid dynamics within a vessel or body conduit that promote the removal of emboli and/or the near quantitative removal of a fluid contained in the region of a body conduit. In a preferred embodiment, a catheter coupled to a fluid exchange apparatus is actuated to create turbulence within the vessel or organ and proximate to the ports or exit holes of the irrigation lumen. As described in detail below, the size and orientation of the ports and lumen changes the fluid flow parameters such that defined flow rates, volumes, vortices, turbulence and ratios of fluids exchanged within the body can be custom designed for any application, vessel, or organ, as well as for specific diagnostic, therapeutic or imaging applications. Because many of the embodiments of the invention are used within the cardiovascular system, the irrigation and aspiration function can be designed such that fluids move into the vasculature in a pulsatile manner as with the movement of blood within the vessel caused by the beating heart. This type of fluid movement and fluid exchange provided by the aspiration and irrigation functions of the invention is advantageous because the insertion and removal of fluid in this manner exposes the vessels or other structures to fluid flow that is physiologically relevant. In the sense that the vessel experiences fluid flow that is similar to that experienced after the therapeutic, diagnostic, or imaging procedure is performed and any emboli that would be released following the procedure are more likely to be released during the irrigation or aspiration process performed by the devices of the invention. As described in more detail below, the design also facilitates a defined fluid exchange rate, such as 1:1 volume exchange that avoids damage to the vessel while producing turbulence to facilitate the removal of emboli. Generally, turbulent flows provided by the device of the invention are localized and controlled in both volume and location and are typically higher than that provided by the existing devices in terms of both flow and velocity. Target flows of ice/sec are relevant to vessels such as the vein grafts, flows up to 2 cc/sec are relevant for vessels such as the carotids. (Louagie et al., 1994, Thorac Cardiovasc Surg 42(3):175-81; Ascher et al., 2002, J Vasc Surg 35(3):439-44). As noted above, an advantage of the invention is the generation of localized turbulence in the vicinity of the infusion catheter such that volume exchange within the vessel promotes the disruption of embolic particles that are only loosely attached to the interior walls of a vessel. This advantage is derived from both the design of the catheter, which affects the location in which fluids are inserted and removed into a vessel or an organ, as well as the specific design and function of the fluid exchange apparatus that, when coupled with the catheter of the invention, combine to produce improved fluid exchange and fluid flow parameters. For example, in an ordinary vessel that is roughly cylindrical within a defined axial distance along the length of a vessel, the removal of liquid generally produces a laminar flow through the center of the annular structure of the vessel and the fluid along the walls of the vessel are largely left in place. With a turbulent fluid flow profile, the fluid introduced into the vessel causes an exchange between the irrigant the existing fluid that is localized along the vessel walls and generally causes a more thorough mixing of the fluids within the vessel such that a more complete fluid volume exchange occurs and the removal of embolic particles is enhanced. Although the particular parameters vary according to the designs described below, the fluid exchange achieved by the fluid exchange apparatus and the irrigation/aspiration catheter results in an insertion and removal of a defined volume within a vessel. As described in further detail below, the overall system is comprised of a fluid exchange apparatus that may have a mechanical or electrical, or both, fluid exchange component that converts a defined volume of fluid exchange with a defined axial movement of the catheter such that the volume of fluid exchanged per measure of distance of axial movement of the catheter through a vessel is known. Preferred embodiments of the fluid exchange apparatus are a substantially closed system wherein a reservoir containing irrigating fluid is combined with a reservoir containing the aspirated fluid such that known volumes are exchanged through a system that is essentially “closed” except for the exchange site within the vessel. The terms “substantially closed” mean that the system is closed because the volume of fluid inserted as irrigant solution is removed as aspirant solution in a predetermined ratio and any deviance from the ratio is attributed to only a volume of solution that is retained within the body at the target exchange site. For example, when a system of the invention is applied to irrigate and aspirate fluid from within a vessel, the system is substantially closed because the only difference between the fluid inserted as irrigant and removed as aspirant is that which is purposefully left behind in the vessel. When the volume exchange ratio of the device is set at a 1:1 ratio, the volumetric exchange of fluids is very near to equivalent. The fluid exchange apparatus may also be actuated in such a manner that the flow produced by actuating the fluid exchange apparatus is a defined increment. Thus, a known volume of fluid is exchanged at the target site and the clinician knows with certainty the volume of irrigant fluid that is inserted as well as the volume of fluid that is aspirated out of the target site. In one embodiment, the device of the invention provides a 1:1 ratio of irrigation to aspiration fluid exchange such that the volume of fluid introduced to a vessel or organ is exactly matched by the volume removed. Through control of the location and movement of the device of the invention, the interior of a vessel or organ can undergo a complete fluid exchange by advancing the infusion catheter along the length of a vessel where removal of fluid is desired. By this process, several results are achieved that are beneficial therapeutically. First, the vessel experiences a turbulence and a fluid flow that is physiologically relevant in the sense that both the volume of fluid moving across a vessel as well as the turbulence are similar to the parameters that the vessel would experience under blood pressure. This similarity has several aspects. First, the turbulence that occurs in a vessel is similar to the turbulence caused by the motion of blood moved by a beating heart. Second, the pulsatile nature of the fluid exchange is also similar to the varying pressures and pressure profile caused by ventricular contraction and the ordinary movement of blood throughout the arterial system. Finally, these specific fluid flow characteristics are achieved without producing substantially increased pressures within a vessel and without distending the vessel through the application of increased fluid pressures. Thus, the combined irrigation and aspiration of controlled volumes of liquid treat the vessel with a physiologically relevant fluid profile. Because the device of the invention offers the ability to introduce and remove a defined volume of fluid, the clinician can have a high degree of certainty that the entire internal volume of a region of a vessel has been rinsed with an irrigation fluid by knowing the approximate internal volume of the vessel and the length of the vessel in which irrigation and aspiration are performed. For example, assuming that a specified region of a vessel has an internal volume of 20 ml over a defined axial length. The device of the invention can be used to insert predetermined volumes of solution greater than, less than, or equal to 20 mls over the defined length of the vessel. Depending on the clinical environment, the ratio may be altered to remove greater volume by establishing a smaller ratio of irrigation to aspiration. One could, for example, irrigate with one volume of solution while removing twice the volume through the aspiration portion of the system to yield a 1:2 irrigation to aspiration volume. In a preferred embodiment, the fluid exchange device has the ability to perform a controlled exchange of fluid with predetermined ratios including a 1:1 irrigation to aspiration ratio and varying ratios particularly values ranging between a 1:2 irrigation to aspiration ratio and a 2:1 irrigation to aspiration ratio. Preferably, this is achieved by having irrigant and aspirant reservoirs of defined volumes built into the fluid exchange device. However, the device can also feature a selectable control that alters the ratio of fluid exchange between a minimum and a maximum as a function of the operation of the device. In the mechanical embodiment of the fluid exchange device, each actuation of the device may cause a defined volume of fluid to be propelled through an outlet that is in fluid communication with the irrigant lumen of a catheter element. In combination, the device also features an aspirant reservoir which is expanded by a predetermined volume relative to the volume of the irrigant that is expelled. The control of these parameters, in some aspects, by the fluid exchange device is the result of designing the fluid exchange device to cooperate with both conventional catheters as well as those specially designed to produce turbulent flow at the target fluid exchange site. The fluid control functions of the exchange device can also cooperate with the catheter element by incorporating the capability for the fluid exchange device to control motion of the catheter, specifically axial movement within a body conduit such as a blood vessel. In this embodiment, the catheter element is coupled to the actuation of the fluid exchange device by a coupled translation mechanism wherein, as described in further detail below, each actuation of the device results in automatic advancement or retraction of the catheter. Thus, a defined exchange of fluid volume at the target site occurs in combination with advancement or retraction of the aspiration and/or irrigation element of the catheter by a defined distance. In this manner, repeated actuation of the device provides a step-wise motion of the irrigation and evacuation functions and can insure a near quantitative volume exchange over a defined distance. As will be apparent from the following description, this aspect of the invention provides the ability to insert and/or remove a defined volume of fluid distal of an occluding member given an approximate knowledge of the dimensions of the vessel. As with the other embodiments, the operation of the system may provide fluid exchange with a pulsatile fluid flow by virtue of the application and dissipation of pressure achieved through the catheter. Any number of designs for the fluid exchange apparatus can be used to provide controlled volumes of irrigation and aspiration fluids, through the catheter element of the invention to the target exchange site. The simplest embodiment of the invention provides a squeeze bulb wherein the irrigant and aspirant reservoirs are typically separated by a membrane and are in fluid communication with a irrigation and aspiration lumen that communicate fluids to and from the target site. In this embodiment, a one-way valve is provided preferably on both the irrigant and aspirant side of the fluid flow, to prevent aspirated fluid from flowing back to the target site. In another embodiment, a mechanical device causes pressure to be exerted on an irrigant reservoir that is in fluid communication with an irrigation lumen that provides fluid flow to at least one irrigation port at the distal end of a catheter. The catheter element also comprises an aspiration lumen, that may or may not be integral with the irrigation lumen, and which facilitates fluid communication of the aspirant fluid back to an aspirant reservoir. In this embodiment, the irrigant is expelled from a reservoir by the application of mechanical force to reduce the volume of the irrigation reservoir and the mechanical force is preferably coupled to an expansion of the volume of the aspirant reservoir to yield a defined fluid exchange between the irrigant reservoir and the aspirant reservoir. Those skilled in the art of medical devices will appreciate that all of the component parts of the invention are assembled from biocompatible materials, typically medical plastics or stainless steel. The syringes described below may be ordinary medical-use syringes or may be custom fitted to be replaceable and to fit engagingly with the fluid exchange apparatus. An irrigant reservoir that is integral with the device may be pre-filled or a pre-filled syringe may be used to supply the irrigant fluid. In either a stainless steel or plastic embodiment, the device is stabilized. Typically, stainless steel devices are exposed to heat and steam in an autoclave, while medical plastics may be exposed to gamma irradiation or microbicidal gases such as EtO. The methods of the invention specifically include the use of any component of the system of the invention followed by sterilization of the components, or the entire system, and re-packaging for subsequent use. Although plastic embodiments are designed for single use, sterilization may be performed to functionally reconstruct the utility of the device after use with a patient. In one preferred embodiment, a hand-held mechanical device is actuated by a trigger to insert and remove controlled volumes of fluid through the catheter element. The hand-held embodiment is comprised of an actuator such as a movable trigger that is mechanically operated by being grasped by the hand and pulled towards a stationary structural housing of a complementary portion of a housing to cause a reduction in the volume of an irrigant reservoir and, accordingly, fluid movement through an irrigation lumen and out one or more irrigation ports at the distal end of a catheter. Fluid provided to the target site in this manner is recovered through one or more aspiration ports and communicated through an aspiration lumen and returned to the aspirant reservoir of the fluid exchange device. The irrigant and/or aspirant fluids are preferably contained in a sealed reservoir system such as a cylindrical chamber having a piston and a rod wherein the piston is mechanically coupled to the actuating element. Motion of the actuating element transfers force to the piston and causes contraction of the irrigant reservoir and expulsion of liquid from the reservoir. Simultaneously, the motion of the actuator causes the expansion of the volume of the aspirant reservoir and causes withdrawal of fluid through the aspiration lumen and into an aspirant reservoir. In such an embodiment, the actuation of the trigger may translate into varying amounts of fluid flow depending on the mechanical expedients used. A single actuation of the trigger may translate into an incremental movement of a piston that exerts force on an irrigant and/or aspirant reservoir. By the use of several conventional mechanical apparatus, such as a ratchet and gear mechanism, a lever and pivot system, or others, the mechanical fluid exchange device exerts a direct control over the exchange of fluid communicated through the irrigation and aspiration lumens. The control of the fluid and the particular features can be provided in several designs that achieve the same function. For example, in addition to the hand-held apparatus described below, the force needed to create the fluid flow in both the aspiration and irrigation sides of the system could be provided by a mechanical foot pump, vacuum pump or virtually any component device that provides controllable fluid flow. Moreover, to provide total reproducibility in the operation of the system, a console controlled by a computer with appropriate commands or a software program is readily used to produce the same fluid flows, fluid exchange parameters, including exchange ratios, and essentially all of the functions of the purely mechanical embodiments described below. Therefore, those of ordinary skill in the art will appreciate that any number of mechanical or electrical variations give rise to the same fundamental principle wherein controlled volumes are applied to a target site through a segregated irrigation and aspiration system, preferably comprised of irrigation and aspiration lumens that pass through at least one catheter element and engage in fluid exchange at a target exchange site by virtue of specially designed irrigation and aspiration ports at the distal end of the catheter element. By altering the dimensions of the irrigation reservoir and the aspiration reservoir, the ratio of fluid exchange between the irrigant and aspirant reservoirs is altered and, accordingly, the fluid exchange in the target vessel is adjusted. For example, where the irrigant reservoir and aspirant reservoir are of identical sizes, an actuation of the fluid exchange device may yield a 1:1 fluid exchange within the target vessel. Where, as described above, a different fluid exchange ratio is desired, the difference in the ratio may be achieved by a corresponding difference in the dimensions of the irrigant and aspirant reservoirs that are emptied and filled through the operation of the fluid exchange device. Also, variations in ratio may be accomplished by corresponding changes in the dimensions of in-line chambers as described below. Likewise, with a 1:1 ratio, equal volumes of irrigant and aspirant are exchanged in a single cycle of the fluid exchange apparatus. In the 1:1 embodiment, the entire irrigation and aspiration volumes may be exchanged within a defined number of cycles of the apparatus. For example, one may provide that each cycle of the hand-held apparatus provides 1 ml of irrigant volume and removes 1 ml of aspirant volume. By providing an irrigation and aspiration reservoir with known volumes, a known number of cycles translates into a known volume of irrigation and aspiration. As noted above, in one specific embodiment, the actuation of the device also causes translation of the infusion catheter along a defined axial path such that a known volume of solution is provided in both the irrigation and aspiration aspects as a function of the distance that is traveled by the infusion catheter. Clearly, the irrigation reservoir may advantageously be divided into subparts and is not limited to ordinary aqueous solutions used in a surgical context. Given the utility of the present device for diagnostic and imaging applications, the irrigation reservoir could be filled with dyes, contrast agents, or other solutions that aid in the diagnosis or treatment of the vessel. Given that the fluid exchange device of the invention also provides unique fluid flow parameters, the irrigation reservoir could contain therapeutically valuable solutions such as heparinized ringers lactate, streptokinase, urokinase, tissue plasminogen activator, or other thrombus or emboli treatment fluids that are used to perform the therapeutic procedure on the internal portion of a vessel or organ. Given the ability to specifically tailor the fluid exchange parameters for a target vessel, the device offers the ability to use therapeutic compounds that might not otherwise be available because the clinician can be certain of the enhanced ability to remove solutions introduced via the irrigation reservoir. The fluid exchange apparatus can also be used to promote absorption of a therapeutic layer on a vessel wall. If a drug coated stent is produced that can reabsorb drugs after they have eluted, then with this device a high concentration of the drug can be introduced and pooled about the stent for a brief period. This high dose may then be absorbed or bonded back to the structure or one of its components and thereby recharging the drug coated stent. Finally, in a system where it may be advantageous to have ratios other than 1:1 in the system it is also directly applicable. For example, in another vascular situation a virtual shunt may be created where a proximal fluid can be circulating and a fluid is infused distally. This would involve a ratio of greater than 1:1 irrigation to aspiration. Furthermore such an arrangement could introduce a second fluid to be the primarily distally delivered fluid. The second fluid could be blood, blood substitute, plasma or oxygenated fluid to produce a virtual shunt. In the diagnostic use of optical coherence tomography, OCT, the fields of applications are presently limited by the need for a clear field. Similarly the use of intravascular ultrasound, IVUS, is somewhat limited by the attenuation associated with the blood in vivo. A substantial volume exchange of the vessel region in proximity of the distal end of the OCT or IVUS catheter would provide the opportunity to replace blood or other fluids with transparencies other than that found in blood, thus improving and/or modifying the imaging quality. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows the basic components of the device necessary for implementation with the optional inclusion of components that generate a minimum flow rate of exchange, components that incorporate an upper flow rate of exchange, and a configuration where a combination of flow threshold and ceiling provide a flow rate bandwidth. FIGS. 2A-2D are cross-sections of a vessel showing the catheter element of the invention with aspiration and irrigation lumens combined in the same catheter element and terminating at an aspiration and irrigation port, respectively. FIG. 2A is a section of the catheter showing the aspiration and irrigation lumens. FIG. 2B is insertion of the catheter element into an exchange region established at a terminal lumen characterized by a total occlusion such as a clot, lesion, abscess, a ball of wax or a body conduit or organ that is closed-ended such as an ear canal. FIG. 2C shows a cross-section of the system with an occlusion balloon to establish a defined region of fluid exchange between the irrigation lumen and the aspiration lumen. FIG. 2D shows one example of the placement of an aspiration port and an irrigation port that is in fluid communication with the aspiration lumen and irrigation lumen, respectively. FIGS. 3A-3F show the catheter element in various configurations and illustrate the difference between laminar and turbulent flow. FIG. 3A is a catheter element having an occlusion member and comprising an occluding guiding catheter having an aspiration lumen and with the irrigation provided by a separate catheter to aid in defining a field of exchange. FIG. 3B shows a catheter element providing an isolated, localized region for fluid exchange that is maintained by irrigation occurring both proximal and distal to a centrally disposed aspiration port. FIG. 3C shows a typical laminar flow that fluids will naturally assume when passing through a cylindrical tube. The flow velocities are highest at the center of the tube and approach zero velocity at the walls of the tube. The length of the arrows indicate the magnitude of the velocity. FIG. 3D shows the turbulent region of flow created by a catheter element of the invention adjacent to a region where the flow transitions to a laminar flow, but still has a comparatively higher velocity along the walls of the tube. At a distance from the irrigation ports, the flow achieves laminar flow. FIG. 3E shows a catheter element with 3 rows of perfusion holes. The figure illustrates how the turbulent flow is most pronounced in the immediate vicinity of the infusion ports and begins to assume laminar characteristics until the next row of infusion ports is encountered. In the region designated “A,” turbulent flow is provided by the irrigation port geometry. In region “B,” flow is tending toward laminar flow. In region “C,” laminar flow is established. In FIG. 3F , the various regions of flow show the relative distances necessary for each activity. The transition region has typically been shown to be about the same length as the perforated region of the catheter element. FIG. 4A is a schematic of an embodiment of the fluid exchange device that produces pulsatile flow through the application of leverage to a hand-held unit that is actuated to communicate force to the irrigant reservoir and which collects fluid in the aspirant reservoir. FIG. 4B is an embodiment that accepts interchangeable fluid cartridges, similar to syringes, for irrigation and aspiration and where the exchange rates can be altered to other than a 1:1 ratio. In this example there is a 2:1 ratio of irrigant to aspirant dictated by the relative sizes of the fluid cartridges. FIG. 5A is a fluid exchange device incorporating a segregate irrigant reservoir that uses different types of irrigants, while FIG. 5B segregates the irrigant fluid into a sample to be inserted both proximal to and distal at a point of the target site. FIG. 6 is a tabletop version of the fluid exchange device that is suitable for either a mechanically drive hand system or an electronically controlled, pump-driven system, including an optional in-line air trap for the irrigant and a filter for the aspirant. FIGS. 7A and 7B are a grip lever activated embodiment of the hand-held fluid exchange device of the invention wherein the actuation of a trigger relative to the body of the handle translates into the motion of a piston that propels fluid from the irrigant chamber and collects fluid in an aspiration chamber (not shown). FIG. 8 is a preferred embodiment of the hand-held fluid exchange apparatus of the invention having a spring tensioned trigger mechanism that is actuated by manual motion of the trigger relative to the body of a handle. Actuation causes linear or incremental motion of a dedicated irrigant and aspirant carriage that move in opposite directions to control the force supplied to the irrigant and aspirant reservoir, respectively. FIGS. 9A and 9B illustrate an embodiment at the hand-held fluid exchange device having an adjustable pivot point on a trigger to produce different flow rates and peak pressures. FIG. 10 is an embodiment wherein the control of the movement of pistons that propel fluid from a cylindrical irrigant reservoir and into an aspirant reservoir is provided by a ratchet mechanism. FIG. 11 is a fluid exchange device with two chambers, such that both an irrigation and aspiration chamber are arranged to operate in concert, with one filling and one expelling fluid in each direction and having separate input and output pathways for connecting to the reservoir and lumen elements. FIGS. 12A and 12B show the apparatus configured as a compressible ball squeezed by the hand with the internal volume divided into irrigant and aspirant chambers and designed to be connected in-line with irrigation and aspiration lumens and reservoirs. FIGS. 13A and 13B are an embodiment wherein the fluid exchange device is a hand ball pump configured with an internal reservoir of irrigant fluid and a flexible member to separate the irrigant from in-flowing aspirant fluid. This device is initially loaded with a volume of irrigant that encompasses most of the initial internal volume of the ball and which flows through the target site to the internal aspirant reservoir. FIG. 13C is an embodiment having a substantially rigid external housing and an internal balloon. The interior of the housing is filled with fluid and an internal balloon containing air or a non-volatile gas. A volumetric pump changes the internal configuration of the balloon to force fluid from an internal irrigant reservoir to an internal aspirant reservoir. FIG. 14 is a device with both irrigant and aspirant chambers combined into one housing separated by a movable piston into two distinct chambers to allow for the simultaneous rinsing and aspirating. FIG. 15 shows a slidable and threaded combination configuration where an irrigant can be driven out and an aspirant simultaneously drawn in by both a sliding and a screw-type mechanism. The sliding provides gross travel and the rotation of the member about the axis produces a fine-tuning mechanism. FIG. 16 is an embodiment of the fluid exchange device that can be comprised of as few as the structural elements that preferably attach to a cylinder body of one reservoir and piston of the other. FIGS. 17A and 17B are a mechanical fixture for providing a self-advancing or retractors catheter element in combination with the fluid exchange device. FIGS. 18A-18C are an embodiment of the invention with a staging capability such that the means for aspiration and irrigation are linked mechanically to travel in equivalent and opposite directions. DETAILED DESCRIPTION OF THE INVENTION The present invention may be used in a number of different environments and for a variety of purposes including, but not limited to all physiological uses of peristaltic or other pump for aspiration and irrigation including, IVUS, OCT, angioplasty, endortarectomy, cardiac stent placement, vessel treatment, diagnosis and repair, surgical placement of non-cardiac stents, insertion of pig-tail catheters, ear rinsers, etc. The following detailed description is exemplary of possible embodiments of the invention. Referring to FIG. 1 , a schematic representation of the invention shows the basic components of the device necessary for implementation: The core fluid exchange or activation system maintains a substantially closed loop system with the target site for fluid exchange, e.g. the site within the body where aspiration and irrigation are applied. The irrigation component of the invention is conveniently provided by a dedicated irrigation reservoir 1 , particularly when the fluid exchange system is the mechanical embodiment described in greater detail below. The exchange site is in fluid communication with the fluid exchange system via the irrigation lumen 2 and the aspiration lumen 3 which have exit or entry ports (not shown) at the distal end of each lumen. The aspiration component may also feature an aspiration reservoir 4 in fluid communication with the aspiration lumen 3 and aspiration ports (not shown) such that fluids removed from the exchange site are stored in the aspiration reservoir 4 . As is apparent to one of ordinary skill in the art, the irrigation 1 and aspiration 4 reservoirs may be controlled electronically by valves or pumps to provide the controlled fluid exchange ratios described herein. Thus, while the embodiments of the invention featuring fluid exchange apparatus that are mechanically controlled by the user are preferred in certain versions of any system, controlled rate of fluid exchange at a target site maybe used in a system of the invention. Alternatively, fluids in the aspiration reservoir 4 may be discarded. In one embodiment of the invention, fluids communicated from the target exchange site through the aspiration component of the invention are analyzed for chemical or particulate content to determine a level of removal of fluids or solid matter from the exchange site. Referring again to FIG. 1 , an optional configuration of the components includes a flow valve 6 that produces a minimum lower threshold for irrigation flow. This minimum delivery flow is beneficial to ensure a minimum amount of exchange flow when the clinical indication dictates maintaining a minimum flow through the irrigation catheter. The flow threshold insures that the fluid exchange does not fall below a predetermined ratio as described herein. For example, although 1:1 fluid exchange rates are provided in several embodiments described herein, the exchange ratio may be altered such that a larger volume of fluid is aspirated compared to that which is used for irrigation or vice versa. Under such circumstances, the fluid exchange ratio would vary to, for example, a 1:2 irrigation to aspiration ratio under circumstances where a larger volume of liquid is desired to be removed from the exchange site. The components of the invention could also incorporate an upper flow rate of exchange or flow ceiling 6 . When conditions dictate that there is motivation to limit the velocity or overall flow parameters during a usage, a configuration that provides an upper limit may be provided. Accordingly, this embodiment would apply where a larger volume of fluid was desired to be inserted by irrigation compared to that which is removed by aspiration and the corresponding irrigation to aspiration exchange ratio would be increased to, for example, 2:1. The combination of a flow threshold and flow ceiling capability provide a flow rate bandwidth yielding a range of values between two extremes. In this embodiment, the exchange site can be irrigated and aspirated at a consistent level that is either fixed or varies within a range. This may also allow the activation system to sustain a change in the pressure level at the exchange site while delivering irrigant fluid or removing aspirant fluid at a steady rate or within a range of rates. As will be appreciated by one of ordinary skill in the art, the irrigation side of the system of the invention requires active force provided by the fluid exchange apparatus such that irrigant fluid flow is established at the target site. However, while the aspiration side may also be controlled through application of force to withdraw fluid from the target site, the aspiration side may also be passive such that the inherent pressure at the target site propels the aspirant fluid. The inherent pressure is typically provided both by the fluid pressure inside the body, e.g. the blood pressure within a vessel, and the pressure of the irrigant fluid entering the target site. This characteristically passive flow may be described as an efflux flow, see U.S. Pat. No. 4,921,478 which is specifically incorporated by reference herein. The passive flow of aspirant fluid is one way through the aspiration lumen and the fluid pathway is comprised of one-way valve, such as conventional duck bill valves having a minimal cracking pressure to allow passive fluid flow while preventing retrograde flow through the aspiration side of the system. This capability provides for constant extraction of embolic particles throughout a clinical procedure while irrigant fluid flow is maintained and/or when fluid existing at the target site flows from endogenous body pressure. FIG. 2A is a cross-section of a catheter element 7 of the invention at the exchange site. The irrigation lumen 2 in this configuration terminates at or proximate to the distal end of the catheter element. While the aspiration lumen 3 terminates proximally and both lumens terminate with exit ports 8 , 9 . FIG. 2B depicts the insertion of fluid into an exchange region at a terminal lumen. The irrigation port 6 in this depiction is dislodging a terminal occluding clot. The terminal occlusion may include but is not limited to a clot, lesion, abscess, a ball of wax or an ear canal. In such situations, simple aspiration may not eliminate the lesion and a non-traumatic irrigation of the lesion with a therapeutic formulation, in concert with aspiration after an improved treatment methodology. For example, even if the irrigation fluid is able to produce a substantial breakdown of a terminal occlusion, the occlusion itself must still be cleared. Moreover, the combination of irrigation and aspiration to yield fluid exchange after the ability to introduce pharmaceutical agents proximate to the occlusion and the ability to remove the agents before they enter the bloodstream. A specific example of this is a thrombolytic agent used to remove the occlusion or potentially dangerous thrombus, wherein the thrombus or occlusion must be both treated and removed to treat the condition and wherein the necessary dosage of the agent exceeds that which could otherwise be introduced without drug-related toxicity. FIG. 2C is a cross-section of the catheter element of the system incorporated with a proximal occlusion balloon 11 to establish a defined region of fluid exchange. This configuration may be useful for, but is not limited to, occluding flow, limiting a diagnostic agents field of deployment or limiting the bodies exposure to a high intensity agent. A dedicated balloon lumen 12 is provided for inflation of the occluding device. FIG. 2D is the catheter element of the system of the invention having an occlusion member 11 to aid in establishing an exchange site and having irrigation and aspiration functions distal to the occluding member wherein the arrows depict the general direction of fluid flow, distal to proximal, relative to the occluding member 11 . FIG. 3A is the device incorporated with a combined aspiration lumen 3 and occluding element 11 integral in the same catheter element with the irrigation driven by a separate catheter 2 to aid in defining a target site or field of fluid exchange. The irrigation lumen's 2 independent travel affords a means of adjusting the location of the fluid exchange site while maintaining the occlusion at a predetermined location. Furthermore, a treatment, diagnostic or imaging tool (not shown) can also be affixed to the irrigation catheter 2 . This is productive where the resident fluids are desired to be replaced with a dye or contract agent and then removed in turn prior to re-establishing normal blood flow. In optical coherence tomography (OCT), for example, it is advantageous to introduce and remove a low attenuating fluid. FIG. 3B is a fluid isolated region that is maintained by irrigation occurring through ports 8 located both proximal and distal to the aspiration port 9 . This configuration presents a means of maintaining a controlled introduced field of fluid between the proximal and distal irrigation ports 8 . As in the embodiment of FIG. 3A , a treatment, diagnostic or imaging tool could be attached or moved along in concert between the irrigation ports. Referring to FIG. 3C , a catheter element (not shown) that merely inserts and removes fluid from a vessel achieves only laminar flow in the direction of the arrows and with velocity illustrated by the size of the arrows. Near the vessel wall the total fluid flow approaches zero such that fluid containing emboli at the walls is not disturbed and loosely affixed emboli remain in place. FIG. 3D is a preferred embodiment of the catheter element of the invention having orthogonally disposed aspiration ports 8 located at the distal end of the catheter element 7 . The region “A” experiences turbulent flow, while region “B” experiences a flow profile that is in transition from turbulence to laminar flow. FIG. 3E shows a series of irrigation ports 8 spaced at intervals along the length of the distal end of a catheter 7 such that either turbulent flows, designated as “A” or regions where turbulence is transitioning to laminar flows, designated as “B” are established along a length of the catheter 7 to substantially eliminate areas of laminar flow. FIG. 3F shows a configuration wherein the irrigation ports are provided as a perforated region 81 at the distal end of the catheter 7 . The arrows indicate the direction and magnitude of flow showing that the perforated region establishes turbulence in a defined region, and as the distance away from the perforated portion 81 increases, the flow reverts to a laminar flow at a certain distance along the length of the vessel. FIG. 4A is an embodiment of the device 10 that produces pulsatile flow through the application of a mechanical force to an apparatus that propels fluid through the catheter element of the invention. In use, the action of a trigger 20 pulled toward a handle 21 exerts a force on a dedicated irrigant piston 22 that compresses the irrigant reservoir 1 thereby reducing the volume of the irrigant reservoir 1 and forcing fluid through the irrigant lumen (not shown) and simultaneously withdraws the dedicated aspirant 23 piston of the aspirant reservoir 4 to accomplish the fluid exchange at the target site. Actuation of the trigger 20 may cause the relative motion of the pistons 22 , 23 by connection handle to a ratchet or other gear mechanism that provides the exertion of force in an incremental amount based on the actuation of the handle in a cyclical fashion. See e.g. FIG. 10 below and accompanying text. As shown in FIG. 4A , the irrigant and aspirant reservoirs may advantageously be provided by conventional syringes or similar devices that provide for fluid containment and the controlled application of fluid flow. The syringes of FIG. 4A are merely examples of the use of replaceable cartridges that may be readily inserted and removed from the device. Such cartridges are particularly useful when pharmaceutically active solutions are pre-filled and used in specific clinical procedures where medicaments are provided to a body conduit or vessel by the system of this invention. In this respect, the use of this invention allows the selective introduction of pharmaceutical compositions of any type during the performance of an ordinary irrigation and aspiration operation. In the embodiment of FIG. 4A , the syringes comprising the irrigant reservoir 1 and aspirant reservoir 3 may be removably inserted into the hand-held fluid exchange apparatus 10 and used to both provide and expel a predetermined volume of fluid through the target exchange site. In this manner, both the volume and content of the irrigant fluid can be controlled by exchanging syringes and the contents of the aspirant reservoir can be retained and analyzed for fluid or particular content. The operation of preferred embodiments of the hand-held embodiment of the invention is also described at FIGS. 7-10 below and the accompanying text. FIG. 4B is an example of interchangeable fluid cartridges 24 a 24 b , similar to the syringes described in other embodiments, for irrigation and aspiration. As described in greater detail herein, the irrigant 1 and/or aspirant 3 fluid reservoirs may be provided by cartridges or reservoirs of differing sizes to accomplish the predetermined volume exchange ratio desired for the particular clinical indication. In the embodiment of FIG. 4B , the irrigant fluid cartridge 24 a has double the volume of the aspirant cartridge 24 b thereby providing a 2:1 fluid exchange ratio of irrigant to aspirant at the target site. In this respect, the loop established by the fluid exchange system is not a completely closed loop, but is described as a substantially closed loop, in that a difference exists between the volume expelled through the irrigant reservoir 1 via the irrigant lumen 2 and into the exchange site versus the difference in the aspirant volume taken up through the aspirant lumen and into the aspirant reservoir 40 although the volumes are not identical, the volumes are predetermined and known with certainty as is the volume of fluid that remains at the target site, which is the difference between the volume of the irrigant fluid introduced to the site and the volume of the aspirant fluid removed therefrom. As in the embodiment of FIG. 4A , the irrigant fluid cartridge 24 a has a dedicated piston 22 for expelling fluid from the cartridge. The aspirant cartridge 24 b similarly has a dedicated piston 23 for collecting fluid introduced to the aspirant reservoir via the aspiration lumen 3 . In this specific embodiment, more irrigant fluid is introduced due to the larger cross-section of the irrigant cartridge 24 a while the overall length of the cartridge that fits into the fluid exchange apparatus remains constant. This technique for providing varying fluid cartridge volumes is advantageous when the irrigant and aspirant cartridges are replaceable in a fluid exchange device. FIG. 5A is a revolving cartridge 25 that can rapidly provide a series of irrigant solutions. This revolver-style orientation of irrigant solution is advantageous for delivery of a sequence of different fluids or for delivery of a pharmaceutical composition at an intermediate point during a procedure. In use, the revolving cartridge 25 is oriented such that the series of irrigant fluids 24 b , 24 c , 24 d are positioned in line with the dedicated irrigant reservoir piston 22 to expel the selected irrigant solution placed in line with the piston 22 . Under certain clinical circumstances, the application of the system of the invention may provide an ordinary rinsing solution such as saline at the beginning of a procedure to clear resident fluids and/or emboli from a site, followed by the introduction of a pharmaceutical solution, followed by the removal of the pharmaceutical solution and the subsequent introduction of a neutral solution. In such a use, the saline solution would be confined in the first irrigant reservoir 24 b , which would be infused by actuating the handle 20 as in the embodiment of FIG. 4A described above. Subsequently, the contents of the second irrigant reservoir 24 c , such as a thrombolytic agent, dye, contrast agent or other formulation, is inserted by rotating irrigant reservoir 24 c in line with the irrigant reservoir piston 22 , and similar actuation of trigger 20 . Once the desired effect provided by the solution of reservoir 24 c has been achieved, the solution may be rinsed from the vessel by rotating the dedicated irrigant reservoir 24 d into place and actuating the fluid exchange system as above. Similarly, a variety of aspirant chambers (not shown) can be used to facilitate collection and testing of the aspirant fluid by segregating discrete volumes into containers that can be processed for analysis. FIG. 5B is an embodiment where two different irrigant fluids can be delivered at equal time and measure in a pair of cartridges 243 , 24 f that are designed to be delivered through one or a pair of irrigant lumens 2 , 2 ′ such that one irrigant lumen 2 delivers fluid distal to a predetermined point at the target site and the other irrigant lumen 2 ′ delivers fluid proximal to a predetermined point at the target site. In such a case, each of the two irrigant lumens 2 , 2 ′ has a dedicated irrigant port or ports located at the distal end of the catheter element. The division of the irrigant reservoir 1 into two components 24 e , 24 f allows for the selective introduction of irrigant fluids, which may be the same solutions or different solutions at two or more points within the target site. The predetermined point in the target site that separates the proximal and distal delivery of irrigant fluid may be an aspirant port located therebetween (as in the embodiment of FIG. 2D ) or any other structure where separation of irrigant fluid is desired. For example, some irrigants may mix advantageously only at the exchange site and could not be combined outside the body based on their chemical reactivity. FIG. 6 is a tabletop version of the fluid exchange device of the invention. As is described elsewhere herein, the fluid exchange apparatus of the invention may be controlled by the simple mechanical operation of a device by a user or by an electronic system that controls a mechanical or electrical pump- or valve-driven system to control the irrigant 1 and aspirant 4 reservoirs. In the embodiment of FIG. 6 , a variable position lever 30 drives the stroke of a dedicated piston 22 , 23 that forces fluid from the irrigant reservoir and draws fluid into the aspirant reservoir. As with the embodiments described above, the cycle and the volume of the reservoirs or motion of the pistons can be altered to match the fluid exchange volume needed for any flow in the vessel or body conduit. Because the rotation of the individual levers is variable, the ratio of fluid exchange can be achieved by different positioning of the lever arms 31 , 32 rather than by altering the volume of the individual irrigant 1 and aspirant 4 reservoirs. Although this embodiment shows the mechanical application of force through levers, a tabletop version of the apparatus of the invention is advantageous when electronically controlled pumps are provided to control the fluid exchange and fluid exchange ratios. The embodiment of FIG. 6 also may include an in-line air trap 33 for the irrigant reservoir 1 and/or a filter 34 for the aspirant reservoir 4 . As it may be advantageous to eliminate debris upon extraction of irrigant fluid and/or prevent air upon entry of irrigant fluid, the inclusion of a filter or trap 33 , 34 for air and/or emboli is appropriate in some cases. FIGS. 7A and 7B show the internal structure and function of a fluid exchange device 40 where a pair of reservoirs control fluid flow via the force exerted by pistons or plungers following the action of a trigger 20 and handle 21 connected to or integral with a lever 36 that rotates about a pivot 35 . In this embodiment, the actuation of the trigger 20 rotates the level 36 about pivot 35 and forces the irrigant reservoir piston 22 into the irrigant reservoir 1 and simultaneously withdraws the aspirant reservoir piston 23 out of the aspirant reservoir. From the relaxed position ( FIG. 7A ), the trigger 20 can be activated to drive the pistons 22 , 23 through either a direct coupling or a mechanism for incremental cycles. If desired, the trigger 20 can return to the relaxed position after a cycle from spring action in the handle or pivot 35 other automatic return mechanism. The reservoirs may be integral to the device 10 or the volume of the reservoir 1 may be attached to a separate reservoir (not shown) together with the appropriate lumens, and preferably in-line one-way valves, to facilitate the exchange between the separate reservoir and the chamber of the device. In the former embodiment, the reservoirs are integral to the handle-operated device such that the piston exerts a direct force on the irrigant 1 and/or aspirant 4 reservoir to exert the force necessary for fluid exchange. In the above embodiment, the internal structure of the device acts as an in-line chamber that is intermediate between the separate reservoir and the lumen such that irrigant fluid residing in a separate reservoir is drawn into the chamber prior to being expelled from the chamber through the irrigation lumen. In this embodiment, a pair of lumens are required, a first intermediate lumen connecting the separate reservoir to the chamber, and a second lumen communicating the irrigant fluid from the chamber through the irrigant lumen and via the irrigant ports to the target exchange site. FIG. 8 is a preferred embodiment of the invention having a trigger 20 that is squeezed by the hand to operate a syringe that acts as the aspirant reservoir 54 and the irrigant reservoir (not shown). As the trigger 20 moves toward the body of the handle 21 , the force is transmitted both to the piston 55 dedicated to the aspirant reservoir 54 and a separate piston (not shown) dedicated to the irrigant reservoir. Although the internal configurations can be varied to incorporate other mechanical expedients, the orientation of the lever 56 and pivot 62 of the present embodiment provide an advantageous mechanism for a. 1:1 ratio fluid exchange. The action of trigger 20 is communicated to a lever 56 that is connected to the trigger 20 by a first terminal lever connector 58 a . When the trigger 20 moves toward the body of the handle 21 , the force exerted on the lever 56 rotates the lever 56 around pivot 57 to exert a force, via a second terminal lever connector 58 b that is attached to an irrigant carriage 52 . Simultaneously, the motion of the trigger 20 exerts force on a second lever (not shown) that is connected to the aspirant carriage 51 in a similar matter as for the irrigant carriage 52 . The motion of the trigger 20 provides a simultaneous but opposite force on the aspirant cartridge 51 compared to the irrigant cartridge 52 . The simultaneous forces that are applied to the pistons dedicated to the irrigant reservoir and aspirant reservoir 54 , respectively, occur in opposite directions to yield a substantially equivalent volume exchange into the aspirant reservoir 4 and out of the irrigant reservoir 1 via the aspirant and irrigant lumens 4 , 2 respectively. The motion of the irrigant carriage 52 is translated to the piston dedicated to the irrigant reservoir by virtue of a connector 53 that is noncompressible and that is aligned with the length of the irrigant reservoir 1 . As noted specifically with the embodiments described at FIG. 4A herein, the irrigant and aspirant reservoirs 1 , 4 may be interchangeable syringes or cartridges that can be inserted and removed to introduce specific solutions or fluid volumes. In a preferred embodiment, the irrigant and aspirant reservoir 1 , 4 may be molded into the body of the device such that the fluid volumes for the irrigant and aspirant reservoirs are separately filled via a fixture that acts as an input valve to the irrigant and/or aspirant reservoir. The irrigant and aspirant reservoirs 1 , 4 preferably have removable fixtures at the output 60 thereof for attachment of the respective lumens 2 , 3 . The motion of the trigger 20 is rendered linear and reproducible by slots 61 cut into a portion of the trigger 20 that are engaged by the first pivot 57 and the second pivot 61 such that the body of the handle 21 and/or the trigger 20 slidingly move about either of the pivot structures. A second lever 63 operates parallel to the lever 56 to enable the trigger 20 to travel smoothly along its path. This configuration provides for reproducible motion of the trigger 20 relative to the body of the housing 21 and also facilitates attachment of a spring 62 that biases the trigger in the forward position so that actuation of the trigger 20 relative to the handle 21 produces a complete cycle that translates into a defined movement of both the irrigant cartridge 52 and the aspirant cartridge 51 . The volume exchange ratio provided by the device of this invention may be altered by changing the relative lengths of the lever 56 relative to the pivot 57 or by altering a ratcheting mechanism disposed at the connection point between the lever 56 and the irrigant cartridge 52 such that a complete cycle of the trigger 20 from the forward most position when moved toward the body of the handle 21 constitutes a complete cycle that moves the irrigant 52 and/or aspirant cartridge by fixed distance. The spring tension automatically returns the trigger 20 to the forward most position to prepare for a second cycle. FIG. 9A is an embodiment where the travel of the lever in the fluid exchange device is adjustable so that the amount of fluid displaced in a single cycle can be controlled, and both the distance traveled and the force generated can be adjusted by relative positions of the trigger 20 and the handle body 21 . The embodiments of FIGS. 9A and 9B illustrate the ability to alter the fluid flow parameters of the fluid exchange device by changing the configuration of the mechanical components that exert force on the irrigant reservoir 1 and aspirant reservoir 4 , respectively. FIG. 9B illustrates the adjustment of the pivot point 57 a to produce different flow ratios and peak pressures based on the relative position of the pivot point 57 a about which the trigger 20 rotates. In such an embodiment, if more fluid flow is desired the apparatus can be easily adjusted to accomplish a variable number of flows for a given grip cycle. The travel distance provided by the motion of the trigger 20 as exerted at the point of attachment by the second terminal lever connector 58 c dictates the amount of fluid flow expelled from the irrigant and/or aspirant reservoir 1 , 4 based on the action by a syringe or aspirant reservoir piston or carriage as described above. Accordingly, an increase in the motion of a piston compressing fluid in an irrigant or aspirant reservoir or chamber, due to changing the pivot point, results in an increased exchange rate for a given activation of the trigger 20 . As is shown in FIGS. 9A and 9B , the adjustment to the degree of travel of the trigger 20 relative to the handle 21 , when combined with aspiration 51 and irrigant 52 carriages and reservoirs as described in, for example FIG. 8 above, produces the variable fluid flow of this embodiment. As with the embodiments described above, the mechanical movement of the trigger 20 relative to the handle 21 is translated into fluid flow from an irrigant reservoir 1 , via irrigation lumen 2 , aspiration lumen 3 , and aspirant reservoir 4 by the configurations described herein. FIG. 10 is a hand-held fluid exchange apparatus of the invention wherein a ratchet mechanism provides for incremental movement of a piston, in this embodiment, a general set of pistons 71 , 71 a for driving fluid out of the irrigant reservoir 1 and into the aspirant reservoir 4 , respectively. As in the embodiment of FIG. 8 , the motion of a trigger, 20 relative to a body handle 21 completes one cycle. This embodiment may also contain a mechanical or electrical counter that provides a readout indicating the number of cycles that have been performed, the volume of fluid introduced or removed, or the amount of fluid present, or remaining in either reservoir. In this embodiment, the motion of the dedicated, geared piston 71 in the irrigant reservoir 1 is controlled by the ratchet mechanism which is comprised of the trigger 20 , a pivot 70 , about which the trigger 20 rotates, and gear 70 b that engages a first ratchet wheel 77 . Preferably, the ratchet mechanism is one-way such that motion of the trigger 20 toward the body handle 21 rotates the first ratchet wheel 72 that rotates to advance or contract the piston 71 . In the example of FIG. 10 , actuation of the trigger 20 about pivot 70 a translates to rotation of the first ratchet wheel 72 via gear 70 b . The rotation of the first ratchet wheel 72 is translated to the geared piston 71 and this rotation is in turn translated to a second ratchet wheel 73 that rotates in the opposite direction to the first ratchet wheel 72 that is in turn connected to a geared piston 71 a in the other reservoir. In the embodiment of FIG. 10 , the device is designed to be hand-operated such that the manual actuation of the trigger 20 causes automatic motion of the two ratchet wheels 72 , 73 and the geared pistons 71 . The equivalent dimensions of the reservoirs 1 , 4 , pistons 71 , 71 a , and the two ratchet wheels 72 , 73 shown in FIG. 10 yields an approximate 1:1 fluid exchange ratio. In addition to altering the dimensions of the aspirant 4 or irrigant 1 reservoirs, the alteration of the fluid exchange ratio can be achieved by altering the dimensions of the ratchet wheels 72 , 73 . FIG. 11 shows the principles of a fluid exchange device with a segregated irrigant 75 and aspirant chambers 76 each having a dedicated inflow and outflow line. In this embodiment, the inflow line of the irrigation chamber 75 is an irrigation inflow line 2 ′ that communicates fluid held in the irrigation reservoir 1 to the irrigation chamber 75 . The fluid is drawn into irrigation chamber 75 by the dedicated piston 22 and is subsequently expelled through the irrigation lumen 2 into the target site for fluid exchange as described previously. Similarly, fluid is drawn from the target site through the aspiration lumen 3 and into the aspiration chamber 76 by operation of the dedicated piston 23 whose motion both pulls fluid through the aspiration lumen 3 and into the aspiration chamber 76 , but also expels fluid from the aspiration chamber 76 to the aspiration reservoir 3 , via the aspiration reservoir outflow line 3 ′. This embodiment of the invention operates much like a two-stroke engine wherein fluid is pulled into the irrigation 76 and aspiration 75 chambers and subsequently expelled through the appropriate lumen. To control the flow of fluids, each of the dedicated inflow and outflow lines for each chamber have valves 77 a, b, c, d that control the fluid flow. For example, when fluid is drawn into the irrigation chamber 75 , a valve 77 a on the chamber inflow line 2 ′ is opened while the piston 22 is pulled back. Subsequently, the inflow valve 77 a closes and an outflow valve 77 b that is in line with the irrigation lumen is opened while the irrigation chamber piston 22 is forced into the irrigation chamber 75 to expel fluids through the irrigation lumen 2 . Similarly, when the action of the aspiration chamber piston 23 is used to draw out fluid into the aspiration chamber 70 via aspiration lumen 3 , an inflow valve 77 d on the aspiration chamber inflow line 3 is opened and the in-line valve 77 b in the aspiration chamber outflow line 3 ′ is closed. To expel fluid from the aspiration chamber 76 through the outflow line 3 ′ and into the aspiration reservoir 4 , the in-line valve 77 d on the aspiration lumen 3 is closed and the in-line valve 77 c on the aspiration reservoir outflow line 3 ′ is opened. As for the embodiments described above, the action of the individual pistons 22 and 23 used to cause the fluid flow throughout the system can be controlled manually by mechanical expedients affixed to the pistons. Alternatively, electronic circuitry can control the speed motion and cycle parameters of both pistons such that the fluid flow is electronically controlled according to a user interface or a predetermined fluid exchange profile. As will be apparent to one of skill in the art, the cycling action of this embodiment produces a pulsatile flow with the relative motion of both pistons 22 , 23 . Moreover, the particular minimum and maximum pressures in each pulsatile flow can be controlled by the relative action of the pistons 22 , 23 . In another embodiment, the in-line valves 77 a′ , 77 b′ , 77 c′ 77 d′ are not actively controlled, but are provided as simple one-way valves that only allow fluid inflow from the irrigation reservoir 1 into the irrigation chamber 75 and, likewise only allow fluid outflow from the irrigation chamber 75 through the irrigation lumen 2 . On the aspiration side of the system, one-way valves 77 a′ , 77 b′ allow fluid flow only from the aspiration lumen 3 to the aspiration chamber 76 , and from the chamber 76 to the aspiration reservoir 4 . In use, when the device is activated, the piston plunger in either chamber will produce a positive flow through the lumen. When the lever begins to relax, the one-way valve will close and the irrigation reservoir 1 will fill the irrigation chamber 75 . On the aspiration side, one-way valves 77 c′ , 77 d′ on both the lumen 3 and the reservoir 4 ensures that the aspirant fluid is extracted from the exchange site via aspiration lumen 3 , and, during relaxation, the aspirant fluid is purged into the reservoir. Actuation of the pistons simultaneously causes simultaneous fluid flow to and from the target site while a ½ cycle out of phase yields a transient pressure increase within the system. FIGS. 12A and 12B show a hand-held fluid exchange apparatus configured as a compressible handball with the internal volume divided into irrigant and aspirant aspirant chambers 78 , 79 in series with dedicated inflow and outflow lines connecting irrigation 1 and aspiration 4 reservoirs, respectively. With a fluid impermeable wall disposed between the irrigant 78 and aspirant 79 chambers, the collapse of the ball under force will circulate the fluids appropriately. Referring to FIG. 12A , the apparatus is divided into an irrigation chamber 78 and an aspiration chamber 79 by a fluid impermeable barrier 80 that completely segregates the two chambers 78 , 79 within the device. The expansion and contraction of the irrigant chamber 78 causes fluid flow through a dedicated inflow line 2 ′ between the irrigation reservoir 1 and the irrigant chamber 78 and out to the target exchange site via the irrigation lumen 2 and terminates at the target site as in the other embodiments described herein. Similarly, aspirant fluid is drawn in through the aspiration lumen 3 into the aspiration chamber 79 and out through the dedicated aspiration chamber outflow line 3 ′ and into the aspiration reservoir 4 . As in the embodiment of FIG. 11 , one-way flow valves are advantageously disposed in each inflow and outflow line between the lumen and chamber, and chamber and reservoir. Thus, a one-way flow valve 81 a allows fluid flow only in the direction from the irrigation reservoir, via inflow line 2 ′, into the irrigation chamber 78 . The fluid inside the irrigation chamber 78 may only flow in the direction through one-way valve 81 b and out through the irrigation lumen 2 . Aspiration fluid entering aspiration chamber 79 via aspiration lumen 3 may enter only in the direction through one-way valve 81 c and aspiration fluid inside the aspiration chamber 79 may pass only in the direction of the aspiration reservoir 4 through one-way valve 81 d. Referring to FIG. 12B , pressure exerted on the compressible structure of the device, as indicated by the bold arrows in FIG. 12B , compresses both irrigant chamber 78 and aspirant chamber 79 such that fluid flows in the direction of the arrows i.e. irrigant fluid flows through one-way valve 81 b , through irrigation lumen 2 and to the target exchange site. Aspirant fluid flows from the aspiration chamber 79 through the one-way valve 81 d and into the aspiration reservoir 4 . Fluid flow is prevented by one-way valves 81 c and 81 a from entering either the aspiration lumen 3 or the irrigation reservoir 1 . Upon relaxation, the outer surface of the handball moves in a direction opposite to the bold arrows in FIG. 12B and the flow is reversed. Thus, fluid flows from the irrigation reservoir 1 through the one-way valve 81 a and into the irrigation chamber 78 . Likewise, fluid flows from the aspiration lumen 3 , through one-way valve 81 c , and into the aspiration chamber 79 . This configuration is similar to the embodiment of FIG. 11 because a chamber 78 or 79 is provided at an intermediate position between the exchange site and the reservoir such that a volume of fluid is held at an intermediate position between each reservoir 78 , 79 and the exchange site for purposes of exerting control over a discrete volume of fluid separate from the irrigation and aspiration reservoirs 1 , 4 . However, the compressible handball configuration can be constructed to allow direct manipulation of the irrigation reservoir 1 to expel fluid while simultaneously collecting aspirant fluid within the discrete structure of the handball itself. FIGS. 13A and 13B show a handball pump configured with an internal reservoir of irrigant and a flexible barrier 82 to separate the irrigant and aspirant reservoirs 1 , 4 , which are disposed inside the handball. Referring to the embodiment of FIG. 13A , prior to connection of this embodiment of the invention to a catheter element, the irrigant reservoir 1 is preferably filled with fluid to substantially encompass the entire internal volume of the handball. The flexible and fluid impermeable barrier 82 deforms towards the outer wall of the handball to accept irrigant solution and to simultaneously minimize the internal volume of the aspirant reservoir 4 . When used in a clinical setting, the irrigant reservoir 1 is filled with the pharmaceutically acceptable composition to be used as the irrigant and the apparatus is sealed and may be sterilized while intact. Before using, the device is connected to the irrigation lumen 2 and aspiration lumen 3 which may be filled with fluid to establish the substantially closed loop as described previously. As in the embodiment of FIGS. 12A and 12B , one-way valves 83 a , 83 b are positioned in-line between the irrigant reservoir 1 and the irrigation lumen 2 , and between the aspiration lumen 3 and the aspirant reservoir 4 . As the handball is compressed, fluid flow generally occurs in the area of the arrows to force fluid out of the irrigant reservoir 1 , through the irrigation lumen 2 and into the target site while any backflow is prevented by the one-way valve 83 a . Accordingly, aspiration fluid is drawn through the aspiration lumen 3 and collects in the aspirant reservoir 4 . FIG. 13B shows an embodiment of the invention wherein approximately half of the irrigant solution has been expelled through the irrigation lumen 2 , exchanged at the target site, and collected back in the aspirant reservoir 4 via aspiration lumen 3 . As above, fluid flow generally occurs in the direction of the arrows as the internal irrigant volume is exchanged between the irrigant reservoir 1 and the aspirant reservoir 4 . As noted above, the principal of the invention may be achieved by both user operated, generally mechanically controlled embodiments of the invention, or through electronically controlled apparatus that usually require electronically controlled pumps and/or valves. In the embodiment of FIG. 13C , a volume metric pump 86 with an internal balloon 85 is provided to achieve the fluid exchange function of the invention. Generally, the device is comprised of a housing 84 that is preferably substantially rigid and which contains an internal irrigant reservoir 1 and aspirant reservoir 4 connected to dedicated irrigation and aspiration lumens 2 , 3 , as described previously. Volumetric control is achieved by selectively expanding an internal balloon 85 within the housing 84 to be positioned in either the irrigant reservoir 1 or aspiration reservoir 4 . As with the embodiments of FIGS. 13A and 13B , at a preliminary point in the use of the device the irrigant reservoir 1 is generally full and the internal volume balloon 85 is confined in the aspirant reservoir such that the internal volume of the balloon 85 is maximized within the aspiration reservoir 4 and does not displace a substantial volume of the irrigant reservoir 1 . This allows the maximum amount of irrigation fluid to exist within the irrigant reservoir 1 prior to use of the device. As the fluid exchange process occurs, the volumetric pump 86 functions by forcing a portion of the internal volume of the balloon 85 into the irrigant reservoir 1 . The volumetric pump 86 may be controlled by the user or through an electrical circuitry that provides an output reading to dictate the volumes or relative percentage volumes between the reservoirs 1 , 4 . As the volume exchange process continues, the internal volume of the balloon 85 is transferred to a greater and greater degree from the aspirant reservoir 4 to the irrigant reservoir 1 to displace the internal volume of the irrigation fluid. At a half-way point, the internal volume of the balloon is equally disposed between the two reservoirs (assuming that the beginning volume of the two reservoirs is equal) and the volumes of the fluid contained in both the irrigant 1 and aspirant 4 reservoirs is equal. As described previously, a simple modification of the dimensions of the apparatus allow variation of the volume exchange ratio from a 1:1 value to any prescribed ratio dictated by the clinical circumstances. FIG. 14 shows a side view of the device where the irrigation 90 and aspiration 91 fluid impermeable chambers are contained in the same, preferably rigid housing 92 and are separated by a centrally disposed piston 93 that engages the interior of the housing 92 about the entire periphery thereof to segregate the irrigant fluid from the aspirant fluid and allows the piston 93 to slide within the housing 92 . By moving the piston 93 within the interior of the housing, typically from one extreme end to another, the irrigant is forced out of the irrigant chamber 90 and into the irrigation lumen 2 . Fluid exchanged at the target site is collected through the aspiration lumens and into the aspirant chamber 91 . Thus, in the example of FIG. 14 , when the piston 93 slides from one end to the other, the irrigant chamber 90 expels irrigant, while the aspirant chamber 91 simultaneously draws in aspirant fluid. Then, as the piston 93 is moved back in the other direction, the irrigant chamber 91 refills itself with fluid from the irrigant reservoir 1 while the aspirant chamber 91 expels its contents into the aspiration reservoir 4 . As in other embodiments described herein, this simple, compact arrangement allows for simultaneous irrigation and aspiration and yield a pulsatile flow. Although shown as a cylindrical housing 92 , the construction and arrangement of the input, output, reservoir and piston elements could be altered without departing from the spirit of the invention. In the embodiment of FIG. 14 , the piston is designed to move repeatedly and reproducibly within the housing to expel and collect a defined volume of fluid with each operation cycle. The volume of fluid exchanged at the target site with each cycle of the piston 93 is substantially equivalent to the internal volume of the housing 92 assuming that the piston 93 is moved from one extreme to another extreme inside the housing 92 during each cycle of the operation of the device. This embodiment also demonstrates, as in the foregoing embodiments, that the fluid exchange device of the invention is readily adapted to be controlled either manually, in this case through the application of force to a handle 94 attached to the piston 93 , or by electronic control, which in this embodiment would be provided by a simple pump or electrical or magnetic force to move the piston 91 within the housing 92 . The separation of the irrigant and aspirant reservoirs 1 , 4 from an irrigant and aspirant chamber 90 , 91 permits the device to be repeatedly cycled to draw a defined volume into each chamber 90 , 91 for propulsion through the irrigation lumen 2 and collection through the aspiration lumen 3 . In an alternate embodiment, the entirety of the irrigant fluid to be exchanged at the target site would begin contained within an aspirant reservoir that is entirely located within the housing such that movement of the piston 91 from one extreme of the housing 92 to the other would communicate the entire volume of the irrigant reservoir 1 through the irrigation lumen 2 , to the target exchange site, and back into the aspirant reservoir 4 via the aspiration lumen 3 . A further example of this embodiment is shown in FIG. 15 below, having an alternate mechanical expedient for propelling fluid from the irrigant reservoir 1 into an aspirant reservoir 4 . In the embodiment of FIG. 15 , the irrigant and aspirant reservoirs 1 , 4 are separated by a fluid impermeable barrier 95 that is movable about a threaded axis 97 or other structure that passes within a slidable member 96 that rotates and slides about the threaded axis 97 to move the barrier 95 along the axis 97 to propel the irrigant fluid. Ideally, the slidable member 96 provide for a high rate of translation, while the member 97 provides for fine travel about the threaded axis 97 . The sliding element can be selectively disengaged from the threads to allow it to slide rapidly along the threaded axis for gross adjustment. When engaged, the sliding element can be rotated for fine adjustment. Interior to the sliding element is a mechanism which permits this selective thread engagement by retracting the thread contact when activated. Referring to FIG. 15 , this embodiment of the fluid exchange device is comprised of two main elements to achieve a configuration that allows for the body or cylinder actuation of both syringes in the desired and opposite manner. Essentially, a unitary body 101 connects of one syringe element 102 a and is connected rigidly to the piston 103 b of the other syringe element. A slidable element 104 engages the unitary body 101 and slides reproducibly in engagement therewith. As shown in FIG. 16 , the slidable element 104 is also attached to the cylinder 103 a of one syringe and the piston 102 b of the other. Motion of the slidable element 104 exerts a force withdrawing one piston while advancing the other and braces the application of force by the attachment of the body 101 or element 104 to the cylinder or body of each syringe 102 a , 103 a . The design could incorporate existing syringes or have the syringe elements molded into the piece. There are several distinct advantages to this embodiment. One is that it ensures a 1:1 exchange ratio in terms of travel distance between the syringes. Another, is that the geometric arrangement allows for a balancing of the forces involved in the device. Finally, the realization of the complex mechanics through just two moving parts is a significant advantage for the manufacturing and efficiency of the device. As described above, the element of turbulence is important to the efficacy of the device. Since fluids tend to assimilate to laminar flow, proximity of the irrigant ports or perforations that facilitates turbulence is important for optimal rinsing of the interior of a body structure. For this reason, translation of the catheter element may accompany the irrigation or aspiration or both. All embodiments described herein can be manually translated by means of the operator's hand. Additionally, the catheter can be translated using an automated translation system similar to those used in NUS and similar applications. Alternatively, the catheter could be translated by an element incorporated into the fluid delivery device. Referring to FIG. 17A a simple mechanism that could be used to realize this self-advancing aspect. When the catheter 7 element is moved to the left in the direction of the arrows in FIG. 17A , the round engaging element 110 slides up in the slot 111 and engages the catheter 7 to move it to the left as well. FIG. 17B shows the same mechanism. Once the catheter element 7 is slid to the right the round engaging element 110 slides down in the slot 11 and allows the catheter element 7 to slide freely to the right in the direction of the arrow without interacting or affecting the catheter's position. This allows for the selective retraction or advancement of the catheter 7 by a predetermined amount with each squeeze of the device. There are many ways in which this element could be realized. The simplest would be an apparatus that selectively grasps the catheter when moving one direction and idles or does not grasp when moving in the opposite direction. A guiding track that biases the element could be used to apply pressure and grasp the catheter moving in one direction and then release and allow idle sliding to the reset position in the other direction. This element could be selectively engaged by the operator when needed, and could be developed to allow for selection between advancement and retraction of the catheter. In the present preferred embodiment of the fluid exchange device, it is necessary to have a reset force supplied by an element such as a spring inherent in the device. This reset force is added to the resistance in the system that must be overcome by the operator to utilize the device. In some cases, an embodiment where this force was minimized or eliminated would allow more of the force generated by the operator to be directed to the work the device is performing and not to overcoming the reset force element. Referring to FIGS. 18A-18C , this function could be achieved through the use of a staged device. FIG. 18A shows a simple mechanical way in which the two sides of the device could be linked mechanically. It is important in this embodiment that the two sides be linked mechanically so that they behave in an equal and opposite manner. This is necessary so that the trigger can be actuated repeatedly in the same manner but engage just one of the sides while still driving the entire system. This allows the benefit of having the operator not realize the changes occurring internally in the device. The squeezes would not feel substantially different. In this embodiment, the first squeeze would activate the two chambers and the second squeeze would reset the two chambers. A simple mechanical setup could achieve this result. Similar mechanisms are commonly used in objects such as retractable ball point pens. Essentially, an element attached to the trigger element would be slightly biased to selectively engage one side or the other of the device. FIG. 18B shows a top view of the track layout that would guide the selectively engaging element of the trigger. With the two sides linked mechanically to travel in equivalent and opposite manners as described elsewhere, the force of the trigger element could always be applied in the same manner with varying effect. With the aid of the minimal return force element, the trigger is brought back to its full and extended position and biased to one side so that it will slip into the opposite track for the next actuation of the trigger. After that actuation, as the trigger is returning to its default position, it will be biased to one side of the device and slip easily into the track of the opposite side. FIG. 18C is a diagram of how the system could be achieved such that each time the trigger is expanded, it engages the other side of the device and pulls it back when squeezed. Many features have been listed with particular configurations, options, and embodiments. Any one or more of the features described may be added to or combined with any of the other embodiments or other standard devices to create alternate combinations and embodiments. Although the examples given include many specificities, they are intended as illustrative of only a few possible embodiments of the invention. Other embodiments and modifications will, no doubt, occur to those skilled in the art. Thus, the examples given should only be interpreted as illustrations of some of the preferred embodiments of the invention.

The control of fluid introduction into and out of body conduits such as vessels, is of great concern in medicine. As the development of more particular treatments to vessels and organs continues it is apparent that controlled introduction and removal of fluids is necessary. Fluid delivery and removal from such sites, usually referred to as irrigation and aspiration, using fluid exchange devices that control also need to be considerate of potential volume and/or pressure in a vessel or organ are described together with catheter and lumen configurations to achieve the fluid exchange. The devices include several electrically or mechanically controlled embodiments and produce both controlled and localized flow with defined volume exchange ratios for fluid management. The applications in medicine include diagnostic, therapeutic, imaging, and uses for the introduction or removal of concentrations of emboli within body cavities.

BACKGROUND OF THE INVENTION Field of the invention The field of the invention is the field relating to apparatus for pumping blood of a living person, or of a living animal, to replace one or more pumping functions of the human or animal heart in case of disability thereof. The heart replacement may be partial or complete. While the pumps provided according to the invention are provided principally for pumping blood, it will be apparent that the pumps may be employed in other instances for pumping other materials. The pumping equipment provided by the invention has rotating fluid accelerators or rotators. The pumps are adapted for pumping of blood and other delicate fluid materials without any pronounced physical effect on the blood or other fluid being pumped. The pumps do not impose sudden pressure changes, impacts, rapid changes in direction of flow, in order to prevent injury to or destruction of the pumped material and its components. Description of the prior art In the prior art, artificial heart pumps heretofore employed have been of the positive displacement type. Because of the relatively delicate nature and structure of blood, it has been found that use of centrifugal pumps invariably results in physical disruption of the blood and at least some of its components. Although it has been shown that a pulsating movement of blood through the body is not necessary to sustain life, the prior art has not afforded a solution to the problems involved in utilization of centrifugal pumps for pumping blood, since at least partial destruction of the blood has always resulted when centrifugal pumps were used. This invention solves these problems, by providing rotative pumping means for pumping blood, without any significant destruction of the blood and its components resulting from the pumping. SUMMARY OF THE INVENTION The invention is of rotative pumps which are suitable for use in primary blood for circulation through the body passages, veins, arteries, etc., of a living person or animal. The pumps are adaptable for use disposed within a body cavity, as replacements for either or both of the pumping functions of the heart. The pumps herein provided may also be used for pumping blood externally of the body. The pumps are adapted to pump without producing severe pressure changes, physical impacts, and the like, so that none of the blood components is subjected to treatment which will destroy it for use. The pumps do not require the use of valves, such as those of the heart, but valves may be provided if desired. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a cross sectional view of one preferred form of pump according to the invention. FIG. 2 is a partial cross sectional view showing a modification of the pump of FIG. 1. FIG. 3 is a cross sectional view of a three-stage pump, according to the invention. FIG. 4 is a cross sectional view of a modified form of pump according to the invention. FIG. 5 is a partial cross sectional view taken at line 5--5 of FIG. 4. FIGS. 6-8, 8A, and 9-12 show different forms of fluid accelerators or rotators which may be employed in pumps according to the invention; FIG. 9, in addition, shows a built-in drive motor for the accelerator or rotator. DESCRIPTION OF THE PREFERRED EMBODIMENTS Blood is a complex and delicate fluid. It is essentially made up of plasma, a pale yellow liquid containing microscopic materials including the red corpuscles (erythrocytes), white corpuscles (leukocytes), and platelets (thrombocytes). These and the other constituents of blood, as well as the nature of suspension of these materials in blood, are fairly readily affected by the manner in which blood is physically handled or treated. Blood subjected to mechanical shear, to impact, to depressurization, or the like, may be seriously damaged. The balance between the blood constituents may be affected. Commencement of deterioration may result from physical mishandling of blood. Blood which has been damaged may be unfit for use. The heart pumps blood through the body in a circulating, cyclic, fashion. The blood passes repeatedly through the heart. A pump for replacing one or more pumping functions of the heart should therefore be capable of repeatedly pumping the same blood, time and time again, without damaging the blood, at least not more than to the extent where the body can function to repair or replace the blood components and eliminate damaged and waste materials therefrom. Blood also contains dissolved and chemically combined gases, which may be seriously affected by improper physical handling of the blood. It has, for example, been established that subjecting blood to negative or subatmospheric pressures of, say, minus 300 millimeters of mercury, is detrimental, even when the reduced pressures are only temporary. The blood pressure is the pressure of the blood on the walls of the arteries, and is dependent on the energy of the heart action, the elasticity of the walls of the arteries, the peripheral resistance in the capillaries, and the volume and viscosity of the blood. The maximum pressure occurs at the time of the systole of the left ventricle of the heart and is termed maximum or systolic pressure. The normal systolic pressure may be from about 80 millimeters of mercury (mm. Hg) to about 150 mm. Hg. the pressure ordinarily increasing with increasing age. Pressures somewhat outside this range are not uncommon. The minimum pressure is felt at the diastole of the ventricle and is termed minimum or diastrolic pressure. The diastolic pressure is usually about 30 to 50 mm. Hg lower than the systolic pressure. The preferred embodiments of the invention shown and described have in common that the blood or other delicate fluid is handled gently, without shear, shock, vibration, impact, severe pressure or temperature change, or any other condition or treatment which would unduly damage the blood or other fluid. Essentially non-turbulent flow is maintained through the pumps, and the pumped fluid is accelerated gradually and smoothly. The pumping action obtained may be described as radially increasing pressure gradient pumping, or in some cases more specifically as forced vortex radially increasing pressure gradient pumping. In centrifugal pumps, the fluid acted on by the vanes of the impeller is positively driven or thrown outwardly (radially) by the vane rotation. The fluid as it moves from the vanes to the ring-shaped volute space beyond the tips of the vanes is reduced in velocity, and as the velocity decreases the pressure increases according to Bernoulli's theorum. On the other hand, in the pumps provided according to this invention, the pumped fluid is not driven or thrust outwardly but instead is accelerated to circulate in the pumping chamber at increasing speeds as it moves farther and farther from the center. As the outer periphery of the accelerator or rotator, the speed of the fluid is maximum. The action of the fluid in the pumps may be clarified by analogy to a glass of water turning about its vertical axis without sideways motion or wobble. Because of its contact with the sides and the inherent potential shear force of the water in the glass, the water will rotate, in the form of a forced vortex, without much clip or shear between radially adjacent particles of water, and the water radialy away from the center of rotation will be moving faster than water nearer the center. If water is introduced through a tube at the axis of the glass and water is removed through one or more holes through the side of the glass, water will be pumped by the rotation of the glass. In the pumps afforded by this invention, while rotators are provided, in a number of different forms, the rotators are designed such that they act to increase the swirling speed of the liquid passing through the pump, but do not act to drive or throw the liquid toward the periphery or volute of the pump chamber, but instead only increase the rotational speed of the liquid. As the rotative speed of the liquid is increased, it achieves a higher "orbit" about the center of the accelerator and moves toward the periphery of the chamber. Referring first to the apparatus shown in FIG. 1 of the drawings, a housing 15 has parallel spaced circular walls 16, 17. At the center of wall 16, an offset chamber 19 is formed which terminates outwardly in an inlet passage 20. Wall 17 has at its periphery circular formations 22, 23 joined by peripheral wall 24 between which is formed a peripheral ring-shaped chamber 27. Formation 22 is internally shaped to provide a flow-direction flaring surface 28. Wall 16 is connected to formation 22 by a plurality of circularly spaced screws 29. A rotative circular vane 31, forming one side of the accelerator or rotator 30, has at one side a flared inlet formation 32 which extends into chamber 19 and is sealed to the wall of chamber 19 by O-ring 34 and which rotates in bearing 35 disposed within chamber 19. The interior wall of inlet 32 is flush with the wall inlet 20. An O-ring 36 around the periphery of flat vane or disc 31 seals with the inner side of formation 22. The inner side of vane 31 is flush with the beginning of curved surface 28 so that fluid flowing through the pump introduced through entrance 20 flows smoothly from entrance 20 to entrance passage 32, through the pump chamber, and smoothly past the intersection of the periphery of vane 31 and surface 28. Vane 31 is connected to a second rotating vane 38, forming the other side of accelerator or rotator 30, which is concentric and parallel to vane 31, by circularly spaced pins or rods 39. Vane 38 has O-ring 40 about its periphery to seal with the inner side of formation 23. An outlet passage 41 is provided at one side of wall member 17, it being possible to provide any number of such outlets circularly spaced about the pump as is desired. Wall 17 has at its center a central passage 43 containing bearing 44 which is in contact with rotating shaft 45 connected to, or forms a part of, vane 38. Vane 38 has at the center of its inner side the rounded projection 38a, which guides incoming fluid to flow smoothly along the vanes. The pump shown in FIG. 1 operates in the following manner: The fluid to be pumped flows inwardly through passage 20 into passage 32 to the space between rotating accelerator vanes 31, 38. Shaft 45 is driven rotatively by means not shown, and vanes 31, 38 rotate together (in either direction) because of their connection at pins or rods 39. The pump operates on a forced vortex principal, there being no impeller surfaces in the pump for impelling blood or other fluid material being pumped radially outwardly toward the periphery of the pump chamber. A forced vortex pump operates on the principal that a rotating chamber causes rotation of its contents, with creation of a vortex, so that a body of circulating fluid is maintained within the pump chamber by rotation of the vanes 31, 38 at opposite sides of the chamber, whereby the rotational speed of liquid in the pump is increased from the center to the periphery of the chamber of the pump. The liquid is withdrawn through the outlet 41, and as has been stated before, a plurality of outlets 41 may be provided if desired. It will be seen that the blood or other fluid passing through the pump is not submitted to any substantial agitation by the rotation of the vanes, or by any other portion of the pump apparatus. There are no sudden changes in direction of the flow through the pump, all joints between surfaces being smooth and all surfaces over which the fluid flows being smooth. Referring now to FIG. 2 of the drawings, there is shown a portion of a pump identical to that shown in FIG. 1 except that the flow outlet is of modified form. The outlet 41a from the pump chamber is shown to be disposed radially from the pump chamber instead of parallel to the pump axis as in FIG. 1. The wall elements 16a, 17a are like those shown in FIG. 1 except that the curved surface 28 is omitted at the interior of formation 22a and the peripheral chamber 27a is of rectangular cross section. The vanes 31, 38 are as shown in FIG. 1, as is also the remainder of the pump, only the peripheral portions of the pump elements being modified as shown. The operation of the pump in FIG. 2 is the same as that of the pump of FIG. 1, except that the pumped fluid exists from the pump radially instead of in line with the pump inlet. Plural outlets 41a may be provided if desired. Referring now to FIG. 3 of the drawings, there is shown a pump 50 having three serially disposed pumping stages, whereby the pressure of blood (or other fluid) pumped may be higher than the pressure obtained in a single stage of pumping, such as by the pumps shown in FIGS. 1 and 2. The pump housing is made up of housing elements 51, 52, 53 and 54. The housing elements are joined at peripheral bolt flanges 55-56, 57-58, 59-60, the bolts not being shown. The pump of FIG. 3 has three pumping chambers 61a, 61b, 61c, and two return chambers 62a, 62b through which the fluid pumped by the first two pumping stages is returned to the center of the pump for the next pumping stage. The rotator or accelerator 63 in pumping chamber 61a includes a flat circuit vane 64, having peripheral flange 65, and sealed to the housing for rotation therein by O-ring seals 66, 67, and a flat circular vane 68 spaced from vane 64 and supported by plural circularly spaced pins or rods 69, and mounted at its center on shaft 70. The return chamber 62a is formed between circular plate 71 and housing wall 52a, plate 71 being supported by wall 52a through plural circularly spaced pins 72, and sealed to the periphery of vane 68 by O-ring 73. Vane 68 and plate 71 are of the same diameter. Shaft 70 is disposed for rotation through plate 71 at O-ring seal 74. The rotator or accelerator 75 in pumping chamber 61b includes vanes 76, 77 which are identical with vanes 64, 68, respectively, except that shaft 70 extends completely through vane 77 as shown. The seals 66, 67 and rods 69 are provided as before. Rotator 75 differs from rotator 63, however, in that a plurality of relatively thin flat plates or sheets 78a-78c are spaced parallelly between the facing sides of vanes 76, 77 within the pumping chamber. Plates 78a-78c are circular and may be of the same or different diameters. They are supported at perforations therethrough by the pins 69 extending between vanes 76, 77. Any number of these plates may be provided, so long as the spacings therebetwen do not become small. The spacings between the adjacent vanes and plates should not be less than about 1/4 inch. If the vanes and plates are spaced more closely, the shear stresses imposed on the blood or other fluid become excessive, with resulting trauma of blood and harmful physical effects in the case of other fluids. In Transactions of the ASME, July 1963, page 205, it is stated in the second complete paragraph of column 2, that in pumps therein termed "shear-force pumps," that "Due to the necessity for very close spacing of the shear surfaces, the pump" (ed) "fluid must be essentially free of suspensions." It should be made clear at this point that the utilization of very close spacings is not contemplated by this invention, so that the invention is distinguished over the apparatus described in the aforementioned article, and also is distinguished over apparatus of the type or kind proposed in Patent No. 1,061,206 to Tesla. In such apparatus, the emphasis is on very high rotational velocities and very close spacings, which make them unfit for use insofar as the contemplation of this invention is concerned. According to this invention, the emphasis is on gentle, non-turbulent handling of the pumped fluid, as is illustrated by the aforementioned rotating glass of water with nothing to rotationally accelerate the water but the smooth side of the glass. Yet, the water after a time rotates with the glass and continues the rotation as long as the glass continues to rotate. Return chamber 62b is identical with return chamber 62a, and includes elements 71a, 53a, 72a, 73a, 74a, respectively identical with elements, 71, 52a, 72, 73, 74 heretofore described. The rotator or accelerator 80 is made up of vanes 81, 82 which are respectively identical in form with vanes 64, 76 and 68, 77. The rods 69 are omitted, and the vanes 81, 82 are connected by plural vanes 83, radially disposed and arcuately spaced. The vanes 83 may be flat as shown, or may be curved end-to-end and twisted like the vanes shown in FIG. 9. Any suitable number of vanes 83 may be provided. Each vane 83 extends from near the axis of the pumping chamber to terminate the line with the inner face of vane 82, as shown. Within housing element 54, there is a ring-shaped chamber 85 disposed between circular walls 86, 87, 88, walls 87, 88 being aligned with the sides of the annular opening between vanes 81, 82. Outflow opening 89 is provided through wall 88, and plural such openings may be provided if desired. Shaft 70 is rotated by means not shown to rotate the vanes of the three rotators. The flow inlet to the pump is provided through nipple 51a and circular opening 64a aligned flushly therewith. It will be realized that pumps may be supplied according to the invention with any number of pumping stages, and may include individual pumping stages of any of the types mentioned herein in any combination. Referring now to FIGS. 4 and 5 of the drawings, there is shown a pump 110 having a housing made up of members 112, 113 identical with the corresponding housing members of FIG. 2 except that bearings 135 is in a different disposition than bearing 35 (see FIG. 1). Elements of FIGS. 1-2 which are the same as indicated by the same reference numerals in FIGS. 4-5. The accelerator 119 includes a flat circular vane 120 and a second flat circular vane 121. The vanes 120, 121 are connected by the full-radius curved vanes 125, and the shorter curved vanes 126, 127, and 128. As best shown in FIG. 5 of the drawings, the vanes 125 extend from the center of the accelerator to its periphery, the vanes 126 extend from a point spaced from the center of the accelerator to its periphery, and the vanes 127, 128 extend from about the centers of vanes 126 to the periphery of the accelerator. Four of each type of vanes are shown in the drawing. The objective of this configuration of the vanes is that the impetus of the vanes in thrusting the pumped fluid outwardly is minimal, only four of the sixteen vanes acting on the blood, or other fluid, as it emerges from the entrance into the pump chamber, and, as the blood progresses through the blood chamber, from its center toward the periphery, additional vanes take action to move the blood in its spiral motion, with increasing velocity, toward the periphery of the pumping chamber. The rotator 119 has a flared entrance 130 which merges smoothly into the face of vane web 120. The interior of entrance 130 blends smoothly with the interior of entrance 20 which is formed in the offset space 19 at a side of the housing. At the opposite side of the housing, wall 113 has at one side a cylindrical formation 134 through which rotative shaft 135 is disposed within bearing 136, and O-ring seal 137 is disposed about the outer periphery of vane 121 to seal between the vane and housing. The housing has at one side the radially disposed outlet 138 having outflow passage 139 therethrough. Any number of similar outlets may be provided. A ring shaped screen 140 is disposed around the ring shaped space 27a of the apparatus of FIGS. 4-5, the screen dividing the space into inner and outer annular portions. The screen may be omitted. Any porous or perforate divider may be substituted for the screen, e.g. a plate having one or more openings, spaced bars, etc. The screen serves to create two distinct annular flow zones within space 27a, an inner zone in which the fluid moves circularly as accelerated by the rotator, and an outer zone reached by the fluid by outflow through the screen, over its complete circular length, the fluid flow through the screen reducing its circular velocity. Thus, the outer zone is a zone of slower velocity from which the fluid moves in the outlet 139, whereby eddy currents and turbulence at the outlet is reduced. Referring now to FIGS. 6-12, there are shown a number of forms of rotators or accelerators which may be used in the pumps, these being shown more or less schematically. The rotators 141, 142 shown in FIGS. 6 and 7 are similar, each having a pair of curved blades or vanes 150-151 and 153-154, respectively. The views shown are cross sections taken at right angles to the axis of rotation of each rotator, and the rotator shown in FIG. 6 has a flat side plate or vane 155 which is circular, and similarly the accelerator shown in FIG. 7 has a side vane or plate 156, also circular. In most cases there will be another plate 155 or 156 at the other, or near, side of the vanes. The rotators, therefore, are enclosed at their sides by these plates. The rotator of FIG. 6 has central openings 158 where the liquid to be pumped enters, and a pair of flow passageways between the vanes indicated by reference numerals 159, 160 which are of constant cross section from the center to the periphery of the rotator. Fluid passing through this rotator does not have opportunity for volume expansion, as the flow passages, through which it moves are of constant size from their beginning to their end. The rotator of FIG. 7, on the other hand, has the pair of flow passages 162, 163 extending from the center to the outside of the rotator which increase in cross section from their central entrance to their peripheral outlet ends. The rotator shown in FIG. 8 consists of a hollow, drum-like, body 165, having a cylindrical tube 166 between central openings at each of its sides, and having a curved peripheral wall 167. The tube 166 and wall 167 have plural openings 168, 169, respectively, any suitable numbers and spacings of these being provided, four of each being shown circularly equally spaced. Fluid enters through tube 166 and flows into the drum through openings 168. The drum is rotated and the fluid therein is caused to rotate, the rotator giving the fluid circular motion but no outward radial motion. Centrifugal force resulting from circular motion of the fluid, however, causes the motion of the fluid to be spiral instead of circular, so that the fluid after moving spirally through the space within the drum flows outwardly through the openings 169 into the pumping chamber space annularly around the rotator, from which the fluid exits through one or more outflow passages of any suitable form. A pair of O-ring seals 170, 171 disposed in suitable grooves around the opposite edges of the body 165 seal between the rotator and the pump housing in the manner shown in other drawing figures. In FIG. 8A, a rotator is shown which is a modification of that shown in FIG. 8, and to which the description of FIG. 8 applies to the elements indicated by the reference numerals of FIG. 8, the modification residing in the addition of the tubes 173, each of which extends between one of the inner holes 168 and one of the outer holes 169 at the same side of the rotator. The tubes 173 may be straight and radial as shown in the drawing, or may be curved or angular, by proper positions of the holes 168, 169 and shaping of the tubes. In this rotator, the fluid would pass from tube 166 through tubes 173 to exit at the periphery, upon rotation of the rotator. Referring now to FIG. 9 of the drawings, a rotator 175 is shown which has a plate or disc 176 at each of its sides which may be identical or of different form or size, only one being shown in the drawing, and between which there are provided the equally circularly spaced curved blades 177a-177h, each curved from its inner end to its outer end as shown and each having a twist throughout its length similar to the twist of a propeller. The blades or vanes, may extend beyond the outer edges of the discs 176. Each blade 177a-177h carries a winding 178, which is covered by an impervious layer or membrane 179. The blade windings are connected to contact elements of a commutator 180. The surrounding pump housing is provided with the circularly spaced magnets or coils 181, which are separated from the pumping chamber by an impervious layer or membrane 182. The commutator rotates with the rotator in the usual manner of an electric motor. The rotator windings and housing magnets or coils constitute an internal electric motor for driving the rotator to pump fluid. The electric motor thus provided may be of any of the known types, AC or DC, with or without commutation powered by electrical conductors leading thereto from any suitable AC power source or from a battery, located either internally or externally of the body. The conductors may be disposed through the outer body wall from the exterior of the body, installed surgically. The power source may include capacitance connections, across the body wall, with both of its plates beneath the skin, or with one plate interior of the skin and the other exterior of the skin. A battery power source may be disposed within the body, and replaced periodically by surgery, or recharged inductively from the exterior of the body. Batteries capable of operation for periods in excess of one year are available, so that surgery for their replacement would need to be done either annually or at longer intervals. While the self contained drive motor is herein shown and described in connection with the rotator of FIG. 9, it will be understood that it may be provided in conjunction with all of the other forms of rotators disclosed herein. The descriptions concerning power supplies to the motor of FIG. 9 will, of course, relate also to power sources for motors connected to pump shafts external of the pump housings. Referring now to FIG. 10 there is shown a rotator in the form of a plate 185, the peripheral edge 186 of which is of corrugated formation. The radial corrugations each extend narrowingly to the center opening 187 of the plate. The curved corrugation surfaces are adapted for acceleration of fluid circularly as the rotator is rotated, in either direction, about its center. This form of plate may be used alone as a rotator, or plurality as the flat plates of the second stage of the pump shown in FIG. 3. Similarly, the flat vane surfaces, such as in FIGS. 1 and 2, may be corrugated to enhance their accelerative purpose. Rotators of this form present only smooth surfaces to the blood or other fluid being pumped. In FIG. 11, there is shown an accelerator or rotator having spaced parallel circular plates 190, 191 at the inner side of each of which are provided circularly spaced radial vanes 192 and 193. The vanes 192, 193 are staggered as shown, the vanes of each plate 190-191 being alternately disposed and extending only partway toward the opposite plate 190 or 191. Referring now to FIG. 12 of the drawings, the rotator therein shown has a pair of opposite sides vanes or plates 197, only one being shown, between which are disposed a plurality of circularly spaced curved vanes 198. These vanes are of a shape, when rotated in the direction of arrow 202, serve to pick up blood from the entrance 203 to move it into the rotative path of the vanes, and then the concave curves of the vanes act to accelerate the fluid circularly while restraining somewhat outflow toward the periphery of the rotator, and at the same time lengthening the flow paths of the fluid from the center to the periphery of the rotator. In each of the pumps shown in FIGS. 1-5, and pumps wherein use is made of rotators (or accelerators) of the different forms shown in FIGS. 6-12, it will be noted that the rotators are designed to avoid turbulence and to avoid rapid pressuring and depressuring of the blood or other fluid being pumped, and also to avoid any physical grinding or abrasive action upon the fluid. As has been made clear, these rotator designs are made in this manner in order that blood or other delicate liquids or gases being pumped, some containing solids in suspension, will not suffer detriment and will not be destroyed by the pumping operation. In contrast to centrifugal pumps, the revolutions per minute of the rotators employed with the pumps herein shown and described are kept minimal. The several rotator designs presented are each of a form adapted to progressively increase the circular fluid velocities as the rotator turns and as the fluid advances toward the periphery of the rotator. In each pump presented, an annular fluid circulation space is provided, which is entirely unobstructed and regular so that fluid can circulate therein without turbulence or baffle effects. As hereinbefore indicated, pumps may be made according to the invention incorporating features from one or more of the preferred embodiments shown and described herein, any particular feature not being confined to use only with the other features in connection with which it is herein shown and described. The pumps and their parts may be constructed of any materials compatible with their intended use, including metals, mineral materials, plastics, rubbers, wood, or other suitable materials. When blood is to be pumped, consideration must be given to biological compatibility so that trauma to the blood will not result. Teflon has been successfully used in contact with blood, without traumatic effects, and may be used in construction of the pumps for blood pumping adaptations. Non-corrosive metals and alloys may be used in the pumps where required. In the embodiment of FIG. 9, Teflon may be used for the membranes 179, 182 covering the windings of the electric motor structures. The housings and rotators may be constructed of suitable material so that the housing may be rigid, semi-rigid, or elastic in whole or in part. The non-rigid constructions can be used for imparting pulse configurations to blood in heart simulation pumps. While the rotators shown herein may in some cases perform better when rotated in one direction, it should be understood that they may be rotated in either direction, i.e. reversed, without other modification of the pumps. Each of the rotators presents surfaces to the fluid being pumped, to cause accelerating circular fluid motion in the pumping chamber. In some cases, the surfaces are parallel to the fluid flow; in other cases parallel and non-parallel surfaces are provided. Each of these surfaces, of whatever form, will accelerate the fluid regardless of the direction of rotation of the rotator. Each rotator should be rotated at a speed such that essentially no fluid turbulence occurs, and differences in the rotator designs affects the maximum speed at which a particular rotator may be rotated. The physical and flow properties of the fluid pumped will, of course, also affect the maximum speeds of rotation at which the rotators may be operated without turbulence and other objectionable effects, such as cavitation, vapor binding, and the like. It is, therefore, not possible to set forth exact rotational speed ranges for the rotators. But, the speeds of rotation will always be lower and will usually be substantially lower than those of centrifugal pumps and blowers, wherein turbulence always occurs at the impellers thrust the fluid radially outwardly against the periphery of the pumping chamber, and those of the aforementioned multiple disc pumps and compressors. To the end of achieving reduced rotator speeds, pumps provided according to this invention may be of larger size than other pumps, for the same pumping capacity. As internally placed heart pumps, the pumps may be as large as five inches in diameter, and, with removal of a lung, even larger. According to the precepts of this invention, the forms of the rotators may vary considerably. For example, the rotators may be constructed entirely or partly of porous or perforate materials, i.e. the vanes of the rotator which accelerate the fluid circularly may be made of screen, of perforate plates or sheets, of spaced rods, or the like, and will still ably perform their fluid accelerating function. Rotators may be of axially extended form, so that the fluid is accelerated axially or axially and radially. Designs of this nature would extend the flowpath from inlet to outlet so that acceleration would be at a slower rate. In the rotator of FIG. 7, the vanes could be made to become closer together, instead of farther apart, toward the periphery of the rotator. In each of the pumps shown and/or described, one or more tangential outlets could be provided, disposed in the direction of fluid flow inside the peripheral wall of the pump. In multi-stage pumps, such as that shown in FIG. 3, the several rotators, which may be alike or unlike, may be driven at different rotational speeds. The axes of multi-stage rotators may be offset and in other positions out of alignment. While preferred embodiments of apparatus according to the invention have been shown and described, many modifications thereof may be made by a person skilled in the art without departing from the spirit of the invention, and it is intended to protect by Letters Patent all forms of the invention falling within the scope of the following claims:

The disclosure is of pumps which are capable of use as heart pumps, that is, for pumping blood in connection with the maintenance of the life function in a human or animal body to replace one or more pumping functions of the heart.

This invention relates to a biological method for controlling field infestations of corn rootworm. More particularly this invention is directed to the use of viable populations of parasporal-inclusion-forming bacteria of the species Bacillus laterosporus to reduce crop damage caused by corn rootworm. BACKGROUND AND SUMMARY OF THE INVENTION Corn rootworms are the most serious pests of corn in the major corn growing regions of North America. Root feeding of the larvae has a pronounced effect on corn growth and corn yields. Corn rootworm infestations have been shown to decrease yields of corn by 13 to 16 bushels per acre. The present day toll paid by U.S. farmers in treatment costs and crop losses is estimated to be in the range of $1 billion per year. Since crop rotation is the only practical, non-chemical control for corn rootworms [e.g., Western Corn Rootworm, Diabrotica virgifera virgifera (LeConte), and Northern Corn Rootworm, D. barberi (Smith and Lawrence)], there has been heavy reliance placed on the use of chemical insecticides. However the present day control of corn rootworms with soil insecticides has been complicated by additional technological problems. Not only has low levels of resistance developed to some of the newer insecticides, but accelerated microbial degradation has been noted where the soil microorganisms have developed a capacity to use the soil insecticide. Such has resulted in degradative rates of carbofuran and other soil pesticides as much as 10-fold higher in problem soils than in non-problem soils. These adverse factors, together with legal restrictions on use of insecticides because of potential user toxicity and environmental contamination, resulted between 1950 and 1983, in the withdrawal of recommendations for use of the following soil insecticides for corn rootworm control: benzene hexachloride, aldrin, dieldrin, heptachlor, chlordane, parathion, diazinon, disulfoton, fensulfothion, isofenphos, carbaryl, metalkamate, landrin, and carbofuran. Only a few new insecticides have been introduced during the 1980's as replacements. Thus the prognosis for long-term continuation of successful soil insecticide control of rootworms does not look promising. There are a number of parasporal-body-forming Bacilli that produce toxins for insect larvae. A number of soil bacteria effective in the control of insects of several orders have been commercially available since the 1960's. Examples are Bacillus popilliae for the control of Japanese beetle (Scarabaridae), several serotypes of Bacillus thuringiensis for the control of Lepidoptera pests of food and fiber crops and B. thuringiensis subsp. israelensis effective on Diptera, i.e., mosquitoes and black flies. A more recent isolate, B. thuringiensis subsp. tenebrionis, seems to be toxic to certain Coleoptera, that is, the Colorado potato beetle. In all cases, perhaps with the exception of B. popilliae, the bacteria produce a proteinaceous parasporal inclusion during sporulation. Generally, it is this inclusion which contains the lethal agent; that is, it is composed of protoxin molecules which are cleaved in the larval gut to toxins. In a few cases, the bacterial spore may also participate in the killing, and in the case of B. popilliae (and a few less prevalent related organisms), it is probably the multiplication of the bacterium in the larval haemolymph that results in the death of the host. There has been no isolation/description of soil bacteria that are effective on the coleopteran species, Diabrotica (corn rootworm). In view of the above-mentioned technological limitations on chemical control of corn rootworm, including Pest resistance, non-biodegradability, and animal toxicity, a biological control agent for corn rootworm would be a most desirable alternative. Accordingly, this invention is directed to the use of parasporal-inclusion-forming Bacillus laterosporus, which when present in the soil of growing corn crops are effective for controlling corn rootworm infestations. Compositions comprising (1) viable parasporal-inclusion-producing bacteria of the species Bacillus laterosporus in the form of vegetative cells or spores, and (2) an agriculturally acceptable carrier therefor can be applied to the soil in conjunction with (either before, with or after) planting of a corn crop. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a graphical illustration of the protection afforded growing corn from Diabrotica virgifera virgifera (Western Corn Rootworm) by Bacillus laterosporus P5 (ATCC 53694). FIG. 2 is a graphical illustration similar to that in FIG. 1 except showing protection by treatment with B. laterosporus P5 spores and inclusions. DETAILED DESCRIPTION OF THE INVENTION Soil samples were screened for bacteria capable of controlling corn rootworms. Soil samples were obtained from cornfields which had not been treated with insecticides in recent years. They were taken from fields infected with corn rootworm and from fields apparently free of corn rootworm infestation. Portions of soil (100 mg) were suspended in buffer, heated and plated on enriched media. The plates were incubated for sufficient time to permit cells to sporulate and these were then screened in the phase microscope for unusual morphology and particularly the presence of parasporal inclusions. The screening procedure turned up several unique isolates, all with similar morphology but present only in soil samples from non-infested portions of one field located at the Throckmorton Purdue Agricultural Center in Randolph Township, Tippecanoe County, Ind. One particular isolate, designated as Bacillus laterosporus P5, was found in a low frequency in eight of nine samples from non-infested soil but was absent in all nine samples of soil from areas known to be infected with corn rootworms. This correlation prompted initial tests of the toxicity of the B. laterosporus P5 species (cells or spores thereof) on various Lepidoptera as well as on corn rootworm. No toxicity was observed on the larvae of three test Lepidoptera (Manduca sexta, Trichoplusia ni, Heliothis virescens) but experiments with the Western Corn Rootworm looked promising. The Bacillus isolate, designated Bacillus laterosporus, P5 was deposited on Nov. 23, 1987, at the American Type Culture Collection and was assigned ATCC Designation "53694". Other isolates of Bacillus laterosporus having either free or attached parasporal inclusions have been found in soil samples free of corn rootworm. Both vegetative cells and spore suspensions were tested on corn seedlings in flats supplemented with larvae of Western Corn Rootworm. The mean height of the plants was then measured for at least 35 days. Those plants growing in flats infested with corn rootworm grew slowly for about 14 days and then stopped while plants exposed to both rootworm and either cells or spores of one of the B. laterosporus isolates continued growing at the control rate for 18-20 days before tapering off. Other studies confirming the efficacy of parasporal-inclusion-forming Bacillus laterosporus species for control of corn rootworm have been conducted and are described below. The plant protection properties of the P5 strain of Bacillus laterosporus were evaluated in a greenhouse study using Ohio 43 inbred corn planted in 15 cm diameter plastic pots. Individual kernels were planted approximately 2.5 cm deep in Promix, a commercial planting medium, that had been water saturated prior to being placed in the pots. There were two groups of treatments, and initially 13-14 pots were planted for each treatment. The first group was designed to evaluate the effects of actively growing B. laterosporus cells and the second group to evaluate B. laterosporus spores. Cells were applied with NYSM growth medium while spores were applied with water. There were three treatments in each group. In the first group, the treatments were: 1) and 2), 15 ml of sterile medium per pot and 3) 15 ml of NYSM media containing approximately 3.0×10 8 cells/ml. In the second group, treatments were: 4) 15 ml H 2 O containing approximately 6.0×10 8 spores/ml, and 5) and 6), 15 ml sterile H 2 O. Treatments were to the surface and applied above the kernel at planting time. Eight days after Planting, germination was evident. The number of Pots with germinated corn was reduced to 10 per treatment, and treatments were repeated. The following day, each plant in treatments 2, 3, 4 and 5 was infested with Western Corn Rootworm, Diabrotica virgifera virgifera (LeConte), eggs by placing 0.5 by 2.0 cm filter paper strips bearing the eggs 2.5 cm deep at the base of each plant. Treatments 1 and 6 were not infested. To estimate hatch time and rate, 20 eggs were kept on moist filter paper in a petri dish. (Beginning five days after infestation, 85% of these hatched over a three day period.) Extended plant height was the criterion used to evaluate treatment effect. Heights 48 days after planting were determined for each treatment and treatment means were compared using the general linear model (GLM) procedure on the Statistical Analysis System (SAS). In the spore group, results indicate that plant protection occurred in response to treatment of the planting medium with B. laterosporus. Infested plants treated with spores were numerically taller than those without spores (74.4 vs. 63.3 cm) but the difference was not statistically significant at the 95% confidence level. Uninfested plants (98.6 cm) were significantly taller than either of the infested treatments. In the cell group, however, no protection was evident because plants treated with the B. laterosporus cells were the shortest among the three treatments. Uninfested plants were significantly (probability<0.05) taller than infested plants treated with cells (100.6 vs. 80.4 cm) but not significantly taller than infested plants treated with cell free medium (92.9 cm). There was no significant difference in mean height between the infested groups. FIELD APPLICATION Large scale preparation of vegetative cells or spores of B. laterosporus can be accomplished in any of a variety of art-recognized complex media containing Yeast extract and peptones. Two liter flasks containing up to 500 ml of media can be inoculated and incubated in a rotary shaker at 30°-37° C. for 12-14 hours to provide the inoculum. Fermentor flasks containing the same medium can then be used for the growth of 10-80 l. Growth times will vary depending upon the nutrient medium, temperature, aeration and growth stage desired. Under typical cell growth conditions vegetative cells can be harvested after 8-10 hours; spores (plus inclusions) are harvested after 24-36 hours. Harvesting may be done in a Sharples continuous flow centrifuge. The resulting cell paste can then be suspended to any desired final concentration (determine the cell numbers with a Petroff-Hauser counter) in either a nutrient-containing medium, distilled water or a buffer of choice. The spores will keep well, but vegetative cells should be prepared immediately before field application. Field application of B. laterosporus in accordance with this invention can thus be accomplished as a cell or spore suspension in an agriculturally acceptable liquid carrier or as a granular formulation in which viable cells or spores are sprayed or otherwise coated onto a granular substrate. The substrate can be formed, for example, from an inert clay or other agriculturally acceptable mineral or organic material. Granular materials typically range in size from 20 to 80 mesh, sized for easy handling, for example, in equipment designed for application of granular fertilizers. The granular substrate is sprayed with a solution of viable cells and/or spores, optionally containing cell nutrients and coating-excipients, and then dried. Alternatively, the Bacillus species (cells or spores) can be applied, for example, with a nutrient supplement or binder as a seed treatment so that a viable rootworm-confronting population of the microorganism is initiated in the soil environment of the planted seed. Currently, granular formulations of commercially available rootworm insecticides are applied in an 18 cm band or in furrow at planting time. This method has also been tested on other biological insecticides such as Beauveria bassiana. Granular formulations of B. laterosporus spores can be applied in a similar manner at planting time in equipment already present on corn planters. Spores could also be suspended in water and applied as a spray at planting time. Again, the required equipment is currently used by farmers in other applications. Results from small plot field studies can be evaluated to determine optimal rates and methods of applications. Since planting densities are preset, initial application rates in terms of active ingredient per acre can be determined by extrapolation of the greenhouse treatment levels. FIELD TESTS WITH B. LATEROSPORUS VARIANT P5 VERSUS WESTERN CORN ROOTWORM (DIABROTICA VERGIFERA VERGIFERA) In this test, 12 plots were laid out on part of a 1/3 acre field. Each plot contained 4 rows 463 cm long and 84 cm apart and were spaced 168 cm from neighboring plots. All plots were seeded with OHIO 43 corn on May 26. Diabrotica eggs taken from 2-4° C. storage in soil were spread on filter paper strips (20 eggs/strip) on May 22 and incubated at room temperature with high humidity in the dark for hatching (60-80%) some 14 days later at which time most corn shoots were showing. Controls consisted of one plot with corn only, two with corn and rootworms and one corn rootworm treated with Cyanamid's Counter® brand insecticide (15 gm/row). Other plots were treated (30-40 minutes) Prior to the addition of the about-to-hatch egg papers with both sporulated and vegetative cultures of the test strain and with control cultures of B. laterosporus not containing inclusions (NRS-590 in Table I). Concentration of cells or spores varied from 2×10 7 to 1×10 11 per meter of row. Cells or spores grown up in 15 liter batches of NYSM broth, harvested by a "Pellicon" apparatus (Millipore), pelleted by centrifugation and resuspended in water (spores) or NYSM (cells) to 150 mls. The test suspensions at the calculated concentrations were suspended to 1 liter (water for spores and NYSM media for vegetative cells) and sprayed down the rows using a Green-Cross "Superspray" hand pump bottle. A one liter water spray followed to "wash in" the culture. Egg Papers were placed 1-2 cm from the developing roots. Corn growth (plant height) was measured each week for 12 weeks and on October 20 the cobs were weighed for yield. TABLE I__________________________________________________________________________MEAN Plant Height (and Std. Error) in Cm(Cultures added with rootworms to soil)Doses given per row (463 cm)20 rootworms/plant4 row/plot, n = 36-40__________________________________________________________________________PLOT #9 1 2 3 4 5 6 CONTROLDay (No Rootwormof COUNTER Added A7 (10.sup.10) P5 veg Only (10.sup.10) P5 NRS - 590GrowthCONTROL Rootworms) Veg. (10.sup.10) Control Spores (10.sup.10)__________________________________________________________________________16 59.9 78 71.6 82.3 77.1 53.9 40.6(3.1) (4) (55) (5.2) (4.2) (3.4) (3.4)22 154.6 169 131.7 152.7 143 117.7 95.9(5.1) (7) (8.3) (8.1) (5.2) (5.8) (5.1) 281 309 252 273 234 182.5 178.5(17) (14) (15) (16) (13) (14) (9)36 508.7 533 443 467 414 335 318(24) (20) (21) (23.6) (19.7) (22) (16.2)43 756.6 749 638 701 618 479 515(17) (14) (18) (20.1) (20) (36) (17.2)50 900 902 781 875 827 716 715(30) (23) (24) (28.6) (23) (31) (19.3)57 1032 992 916 1038 983 856 850(19) (36) (29) (29.4) (23) (33) (29)64 1159 1074 1088 1183 1160 958 1042(25) (49) (32) (39) (25) (49) (21.5)72 1401 1287 1384 1460 1427 1225 1313(40) (52) (34) (27) (23) (44) (26.1)78 1508 1467 1512 1561 1560 1390 1490(37) (36) (29) (23) (17) (42) (20.9)85 1554 1495 1569 1573 1603 1535 1620(17) (32) (22) (35) (12) (31.1) (15)CORN 151 136 140 155 94 127 144YIELD__________________________________________________________________________ PLOT # 7 8 10 11 12 Day P5 Spores Rootworm Of + Inc Only (10.sup.8) P5 (10.sup.10) P5 (10.sup.10) A7 Growth (5 × 10.sup.10) Control Spores 2b Spores__________________________________________________________________________ 16 64 55.7 48.3 73.9 52.5 (3.8) (2.4) (5.3) (6.3) (5.5) 22 130 125.3 115.7 143.9 110 (6.3) (4.1) (8.7) (11.2) (7.8) 249 243 213 287.6 205 (11.7) (8.5) (18) (19.5) (12.1) 36 446 457 360 438 326 (16.8) (11.7) (37) (31.4) (19.6) 43 647 675 646 655 421.4 (17.4) (23) (20) (34) (33) 50 838 816 807 818 577 (18) (24) (25) (41) (28) 57 969 951 960 959 671 (21) (15) (26) (39) (29.3) 64 1137 1075 1114 1076 781 (29) (16.8) (30.5) (53) (27) 72 1419 1308 1369 1296 954 (29.5) (24.9) (36.3) (39) (36) 78 1549 1479 1484 1406 1125 (21) (19.3) (29) (33) (44) 85 1587 1524 1487` 1462 1326 (19) (13) (53) (29) (37) CORN 146 133 132 140 114 YEILD__________________________________________________________________________ Raw data for 11 weeks of this 12 plot test are reported in Table I. The best control growth performance was shown by both the corn without added rootworms and the "Counter" treated plots; the latter out-performing the former in later growth and corn yield. A group of plots (Plots 2, 4, 8 and 12) unprotected by Counter or by the test culture or treated with a culture of B. laterosporus not containing inclusions (NRS-590) were suppressed in growth an average of 14% over the 12 weeks and were 20-22% behind Counter control from day 22 to day 42. Corn yields of these unprotected, rootworm treated plants were suppressed by 20%. Addition of resting spores+inclusions of the P5 culture at a dose 2×10 7 /meter showed no improvement, at 10 10 only slight protection and at 10 11 possibly moderate protection. The vegetative culture of P5, however, added at 10 10 /per row (2×10 9 /m) showed full protection of growth and a 29% improvement of corn yield over the unprotected controls (FIG. 1 and Table II). Lower doses of vegetative cells were not tested. Because of a suspected endogenous infestation of Diabrotica virgifera in the test field, a second series of tests was set up later in the summer when such eggs were presumably hatched out. In this study because of the apparent early failure of P5 spores and inclusions to show Protection, it was decided to pretreat the soil with test cultures. These were sprayed down the rows as in the previous study on Jul. 9. TABLE II______________________________________MEAN CORN YIELDGrams/Plant______________________________________Control Plot (Plot #1) 136Counter ® Plot (Plot #9) 1512 Rootworm Only Plots (Plots #4 and 8) 1134 Unprotected Plots (Plots 2, 4, 1208 and 12)P5 Vegetative Cell Plot (Plot #3) 155______________________________________ On Jul. 16, the rows were seeded and on Jul. 21 a moist paper strip with 20-30 eggs was added. The positive control here was not treated with insecticide and given no worms. Plant height was measured as before but the study was terminated at 60 days. The data for these eight plots is reported in Table III. The week's pretreatment apparently made the P5 spores as effective as the vegetative cells. A graph of controls without rootworms (C) and with rootworms (W) are compared to the rootworm plus P5 spore-treated plot (W+P5) in FIG. 2. Together these field tests suggest that vegetative cells are the active form rendering protection of corn plants to Diabrotica virgifera damage. Given time to germinate, the spores also become effective. Separate laboratory tests indicated no immediate toxicity when larvae (1st, 2nd and 3rd instar) were exposed to spores plus inclusions or purified inclusions of P5. Late additions of culture to infested corn were not protective. The apparent protective effect of P5 in growth studies suggests the culture, in vegetative form, either invades the very young larvae for immediate or later damage or that it blocks the receipt or response of the rootworm to the corn root signal that directs it to the roots. TABLE III__________________________________________________________________________Mean Plant Height (and Std. Error) in CmCultures added 7 days before Planting(July 9, 1987)n = 26-28doses in #/row (1080 cm)20 rootworms/plant Plot 20 Plot 14 Plot 15 Plot 17 Plot 19 Mut. P5 21Day of Corn Plot 13 Rootworms P5 Spores P5 Spores Plot 18 Rootworms InclusionsGrowth (Since Control Only + Inc. Plot 16 + Inc. P5 Cells Only + Some Sp.Planting) Corn Only Control 10.sup.10 A7 Spores 10.sup.9 10.sup.10 Control 10.sup.10__________________________________________________________________________15 222 (8.5) 181 (8.7) 217 (6.1) 184 (10) 189 (8.4) 203 (9.6) 164 (8.9) 178 (9.9)23 465 (16) 399 (13) 447 (13) 408 (14) 380 (26) 417 (16) 332 (19) 345 (24)29 660 (20) 578 (17) 634 (17) 575 (17) 502 (42) 556 (29) 466 (27) 521 (23)36 959 (22) 861 (21) 952 (21) 879 (20) 853 (29) 854 (32) 756 (33) 755 (34)43 1134 (21) 1041 (28) 1127 (21) 1096 (41) 1023 (31) 1035 (31) 884 (52) 899 (37)63 1682 (20) 1611 (26) 1635 (24) 1589 (26) 1573 (30) 1616 (34) 1442 (48) 1415 (60)__________________________________________________________________________

Corn rootworm infestations can be controlled by inoculating the soil with parasporal-inclusion forming species of Bacillus laterosporus to produce viable populations of that bacteria effective to reduce crop damage. Viable populations of B. Laterosporus can be initiated by application to the soil, of effective amounts of vegetative cells or spores of the organism either in liquid suspensions, or as coatings on seeds or granular substrates.

BACKGROUND OF THE INVENTION The present invention relates to an appliance for affixing surgical or ligating clips and more particularly to an appliance for rapidly employing several clips at a surgical site. There are many different designs for surgical clip applicators for a variety of surgical procedures including laproscopy in which a clipping appliance fits through a trocar tube into a body cavity where the clips are applied. This invention provides a repeating multi-clip applier having a simplified mechanism for applying clips which mechanism is suitable for the full spectrum of clip appliers including laparoscopy. The applier mechanism is particularly adaptable to the disposable cartridge/fixed handle design. The simplified mechanism reduces tooling and assembly requirements, provides high operating reliability at lower product cost. SUMMARY OF THE INVENTION A surgical clip applicator according to the invention comprises an operating handle and clip applying mechanism having an operating cycle in which operating levers are squeezed together and released. In this cycle, a clip is applied in surgery and the clip applicator is reloaded from a clip supply channel for clip application in the next cycle. The applicator provides a moveable clip supply channel containing a line of clips that are released seriatim. The supply channel integrates a clip pusher and an escapement or clip stop spring in a single stamped unit. Clip crimping jaws apply a clip with a rearward movement of a camming member thereby allowing the functions of clip loading and jaw closure to be coordinated and operated by a single sliding bar moving reciprocally to load and fire clips. A preferred embodiment of the clip actuating mechanism includes a combined actuating rod and in-line clip supply channel together with clip indexing mechanisms arranged so that with a squeeze of the operating levers, the actuating rod moves rearward in the appliance to apply a clip in surgery, capture the next in-line clip, indexes a line of clips rearward away from the clip jaws, and that with release of the operating levers, the jaws open, the next in-line clip is loaded into the jaws, the second next in-line clip is separated from the line, and the clip indexing movement is reset for the next cycle. The clip applicator provides a novel mechanism with minimal complexity especially suited to disposable cartridge for fixed handle appliances. A clip applicator according to the invention employs low operating force without recoil, a clip counter, jaw lockout after the last clip and is adaptable for use as a quick snap-in disposable cartridge with a fixed non-disposable operating handle. An operating handle that provides linear reciprocating motion including scissors-type or pistol grip may be used in the invention. OBJECTS OF THE INVENTION An object of the invention is to provide a novel clip applicator with minimum complexity and with adaptability to a complete range of clip applicators including laproscopic use. Another object of the invention is to provide a clip applicator adaptable for use with a replaceable cartridge. Another object of the invention is to provide a clip applicator in which clip feed and applying mechanisms are driven by an actuator having a linear reciprocating motion generated by operating handles. Another object of the invention is to provide a surgical clip applier useful with a variety of operating handle designs. Other and further objects of the invention will become apparent with an understanding of the following detailed description of the invention or upon employment of the invention in practice. A preferred embodiment of the invention has been chosen for detailed description to enable those having ordinary skill in the art to which the invention appertains to readily understand how to construct and use the invention and is shown in the accompanying drawing in which: FIG. 1 is a plan view of a surgical clip applicator according to the invention. FIG. 2 is an exploded perspective view of the components of a preferred embodiment of surgical clip applicator. FIGS. 3 a - 3 c are sequential fragmentary perspective views of a surgical clip applicating mechanism according to the invention. FIGS. 4 a - 4 b are sequential plan views of a preferred embodiment clip applicator jaws in open and closed positions, respectively. FIGS. 5 a - 5 b are sequential plan views of a modified embodiment clip applicator jaws in open and closed positions, respectively. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to the drawing, a preferred embodiment of the repeating multi-clip applier 10 comprises handle 12 and clip applicator 14 . The handle 12 (FIG. 2) includes a central casing 16 formed of upper 16 a and lower 16 b shells each having aligned confronting journal pin guiding slots 16 c. The shells are joined to each other along edges 16 d to define an enclosure 16 e for receiving handle components 18 including actuating levers 18 a-b pivotally mounted on adjacent posts 18 c-d, links 18 e-f joined to each other by journal pin 18 g and connected by pivot pins 18 h-i to levers 18 a-b, and compression spring 20 . In assembly, the compression spring is mounted on actuating rod 30 with one spring end 20 a abutting rod shoulders 30 s and the other spring end 20 b abutting a rear face 20 c of a spring housing 20 d. The end 30 a of the actuating rod extends through the spring for connection to links 18 e-f by means of journal pin 18 g. The exposed ends of the journal pin fit into the guiding slots 16 c which define the axial excursion of the actuating rod. When assembled, the spring urges the actuating rod forward in a straight line and (by means of actuating rod connection at 30 a to the journal pin 18 g and links 18 e-f ) urges the actuating levers 18 a-b to pivot outward from the casing to normal position. In use, the levers with finger loops are moved together (inward) against the spring for the purpose of applying a clip and moved apart (outward) to reload the applicator jaws with a clip. It is to be understood that the links-actuating rod journal pin 18 g moves in a rearward then forward linear excursion within the guiding slots for each inward-to-outward cycle of the operating levers. This reciprocating linear motion serves to operate the clip applicator 14 by means of the actuating rod 30 . In practice the clip applicator 14 can be used with any suitable handle that provides linear reciprocating motion. The description of a scissors-type handle is illustrative. The clip applicator 14 comprises an applicator housing 22 including cover 24 and base 26 connected to the forward end 16 f of the handle casing with the applicator housing enclosing and forming part of a clip applicator mechanism 28 . In the following description, the applicator housing cover and base are regarded as stationary in relation to movement of the applicator mechanism components. The applicator housing base 26 is an elongate open ended channel secured at its rear end 26 a to the operating handle casing and having an anchor pin 26 b affixed to the channel base 26 c. The elongate actuating rod 30 is located in the applicator base channel 26 c with the rod connected at its rear end 30 a to the handle link journal 18 g for receiving linear reciprocating motion with respect to the stationary base channel 26 c for each cycle of the handle operating levers. The actuating rod at its front end includes upstanding cooperating cam members 30 c-d for closing and opening clip applicator jaws 32 . The actuating rod also includes an anchor pin slot 30 e to accommodate reciprocal movement of the rod in the base channel and a circular hole 30 f to receive a retaining pin 38 a fitted to the clip supply channel as described below. Clip applying jaws 32 comprising spring biased arms 32 a-b (FIGS. 2, 4 a-b ) are mounted at hole 32 c to anchor pin 26 b on the applicator base with the jaws 32 d-e projecting from the front end of the channel. The applicator jaws are affixed to the base channel so that as the actuator rod reciprocates, cam means 30 c-d (FIGS. 2, 4 a-b ) forming part of the actuating rod ride along cam surfaces 32 f-g of the applicator jaws for closing the jaws to apply a clip and for opening the jaws to receive another clip. The normal position for the actuating rod and jaws occurs with the actuating rod at the forward end of linear excursion, with the jaws open and with the actuating rod cam means in an inactive position with respect to applicator jaws. Preferred and modified applicator jaws are illustrated in FIGS. 4 a-b and 5 a-b. FIGS. 4 a-b illustrate spring biased applicator jaws 32 affixed at a rear point 32 c to the applicator housing anchor pin 26 b with spring biased arms able to move from open-to-closed-to-open positions in applying a clip. The inner surfaces 32 h-i of the jaws are recessed to form cooperating channels for movement of each clip into the jaws. The outer surfaces of the jaws have aligned recesses 32 f-g defining cam surfaces cooperating with aligned cam members 30 c-d affixed to the actuating rod 30 for the purpose of closing the jaws for each rearward excursion of the actuating rod (FIG. 4 b ). The jaws are released to spring open on the forward excursion of the actuating rod placing the cam members within the recesses (FIG. 4 a ). FIGS. 5 a-b illustrate pivoted applicator jaws 34 with pivot arms 34 a-b affixed at aligned central pivot points 34 c-d to the applicator housing base 26 c. The rearward inner surfaces of the jaws have aligned recesses defining cam surfaces 34 e-f cooperating with cam member 30 g affixed to the actuating rod 30 for the purpose of closing the jaws for each rearward excursion of the actuating rod (FIG. 5 b ). The jaw arms move from open-to-closed-to-open positions in applying a clip. The jaws are moved to normally open position by means of a spring (not shown) or by a positive displacement cam means. The forward inner surfaces 34 g-h of the jaws are recessed to form cooperating channels for holding each clip in the jaws as the jaws close. The jaws move open on the forward excursion of the actuating rod and cam member 30 g (FIG. 5 a ). A sinuous interface 34 i of the jaw arms ensures true rocking or pivoting movement of the jaw arms from open to closed positions. The applicator mechanism 28 also includes a clip supply channel 38 (FIGS. 2, 3 a-c ) which is affixed to and reciprocates with the actuating rod 30 by means of an anchor pin 38 a at the underside the channel which fits into hole 30 f in the actuating rod. The supply channel 38 includes an elongate base plate 38 b with upstanding sides 38 c to define a central channel 38 d and includes flanges 38 e defining inwardly directed side channels 38 f-g for receiving and retaining a line of clips C. The clip supply channel has an integral forwardly extending pusher plate 38 h preferably with notched front edge conforming to clip contour for the purpose of pushing each clip into the jaws as it leaves the supply channel. A clip stop spring 38 m with vertical tip 38 n is formed integral in the base plate 38 b for gripping the leading clip C L at midpoint. The clip stop spring has a “spring set” wherein the spring is normally positioned or biased below the surface of base plate 38 c with the spring being accommodated in a slotted cam plate 39 located underneath the channel. The cam plate 39 (FIG. 2) is fixed to the stationary housing by means of tabs 39 t or mounted at hole 39 a to anchor pin 26 b, so that the back edge of the slot 39 b acts as a cam to urge the clip stop spring and its tip 38 n upward into the path of clips C when the clip cartridge 38 moves rearward with the actuating rod 30 . A slot 39 c in the cam plate accommodates reciprocal movement of the clip cartridge/actuating rod connecting pin 38 a. The housing cover 24 has an elongate transparent slot 24 a (FIG. 1) through which a user can see the supply of clips. The cover may also have count marks 24 b indicating the number of clips remaining in the applicator. The cover (FIGS. 3 a-c ) also has on its inner surface a clip block 24 c, a clip capture spring 36 and a guide ramp 24 d for positioning clips for movement into clip applying jaws as more fully described below. The underside surface of the cover may also have a set of longitudinally extending ratchet teeth 24 e (FIG. 3 b ) forming a part of a clip advancing mechanism described below. A clip advancing mechanism 40 (FIG. 3 b ) is positioned and retained in the clip supply channel 38 d and side channels 38 f-g in engagement with the last clip C Z for advancing the line of clips along the supply channel. The clip advancing mechanism includes a clip follower 40 a with forwardly directed fingers 40 b-c for engaging clip shoulders for constantly maintaining a force on the line of clips, a sinuous compression spring 40 d, and a ratchet head 40 e. The ratchet head is provided with upper 40 f and lower 40 g tangs or spring biased ratchet pawls for engagement, respectively, with ratchet edges or teeth 24 e in the under side of the housing cover and ratchet openings 38 p in the supply channel base plate 38 b. The ratchet head, the clip follower and follower spring by their design and operation, and in cooperation with the movable clip stop spring 38 m, regulate step-by-step or indexing movement of a line of clips through the supply channel toward the applicator jaws. In normal (or forward) position of the actuating rod 30 and supply channel 38 (which are affixed to each other), the bias spring 40 d, clip follower 40 a and ratchet head 40 e maintain contact and force on the clip line urging the line toward the clip stop spring 38 m by means of upper pawl 40 f engagement with ratchet teeth 24 e in the housing cover and by means of lower pawl 40 g engagement with ratchet openings 38 p in the supply channel base plate while the clips are at rest in the supply channel. The clip advance mechanism, the bias spring and clip follower, the cover ratchet teeth, the base plate ratchet openings, and the clip stop spring act together for step-by-step or indexed movement of the clips down the supply channel as now described. With the actuating rod and supply channel in forward or normal position, the upper pawl and compression spring hold the clip line stationary against the clip stop spring 38 m. When the actuating rod 30 and supply channel 38 move rearward with squeeze of the operating levers, the ratchet head and upper pawl remain stationary while the compression spring accommodates rearward movement of the clip stop spring and the contiguous line of clips. The rearwardly moving supply channel slips over the lower pawl 40 g bringing the next forward ratchet opening 38 p into contact with the lower pawl thereby indexing forward by one step the relative position of the ratchet head and the supply channel. Next the actuating rod and supply channel and line of clips move forward as a unit into normal position. During this forward movement, the upper pawl 40 f slips one notch along the under side of the housing cover into engagement with the next ratchet tooth 24 e. In lieu of the clip advancing mechanism 40 , an elongate compression spring 41 (FIG. 2) may be employed for advancing clips in the clip supply channel. As shown, a compression spring attached to a channel back wall 38 r and to a spring head 41 a lies in the clip channel for engaging and moving a line of clips C in the channel by spring force. Referring to FIGS. 3 a-c , with forward movement of the supply channel and coherent line of clips, a first in line of clips C F comes to rest against the clip block 24 c. The capture spring 36 straddles the clip block and separates clip C F . The capture spring 36 is stationary in that it is affixed to the under side of the housing cover in position to capture and hold the lead clip at the end of the forward excursion of the actuating rod and supply channel. The capture spring takes and separates the lead clip from the clip line in preparation for movement of the lead clip into the applicator jaws on a subsequent applicator cycle. The capture spring in preferred form is generally U-shaped with front tabs 36 a-b affixed to the cover, with spaced shoulders 36 e-f, and with inclined rear end 36 g. The spring captures clip C F by reaction as the inclined end rides up on forwardly moving clip C F and snaps down as the clip passes the shoulders. Such clip capture occurs as the actuating rod and supply channel reciprocate during operation of the applicator, as detailed below. At the end of rearward excursion of the supply channel (FIG. 3 b ), the capture spring 36 pushes clip C F downward and out of engagement with the clip block 24 c and into the path of the pusher plate 38 h. The pusher plate then engages the rear of captured clip C F with its contoured edge to advance clip C F into the applicator jaws on forward movement of actuating rod and supply channel. The guide ramp 24 d on the cover guides clip C F into the jaws. The operation of the applicator is as follows. Referring to FIGS. 1, 3 a and 4 a, the housing cover and base are stationary with respect to movements of the component parts of the actuating mechanism. At the beginning of an operating cycle (or normal position), the handle actuating levers are positioned apart, the actuating rod and supply channel are in forward position, the jaws are open holding a clip in position for surgical application, jaw actuating cam means are in inactive position, the lead clip in the capture position, the pusher plate lies under the lead clip, the clip stop spring is inactive and lies in the cam plate recess below the surface of the pusher plate, and the clip follower engages the last in line clip, the spring biased line of clips is in contact with lead clip C F , the lower pawl engages a corresponding supply channel ratchet edge, and the upper pawl engages a cover ratchet tooth. By squeezing the handle levers together (FIGS. 3 b and 4 b ), the actuating rod and supply channel move rearward relative to the stationary cover and base to accomplish: a. retraction of the actuating rod cam means along the jaws cam surfaces to close the jaws and apply a clip; b. movement of the pusher plate relative to the cam plate whereby the stop spring is cammed up so its tip grips the next in line clip C L and by rearward movement the stop spring separates the clip stack from the lead clip C F ; c. the captured clip C F is held in place under the capture spring; d. movement of the pusher plate from underneath into position behind the captured clip C F ; e. the upper pawl of the ratchet head is in engagement with a ratchet tooth of the housing cover as the clip follower and follower spring maintain back pressure on the clip line in the supply channel thereby holding the ratchet head stationary with respect to the upper housing cover as the staple supply channel moves rearward with the actuating rod, f. indexing the lower pawl one step of relative movement between the ratchet head and the supply channel; and by releasing the handle levers to move apart, the actuating rod and supply channel move forward in relative movement to the stationary cover and base to accomplish: g. movement of the pusher plate to advance the captured clip C F into the jaws; h. movement of the actuating rod cam means along the jaws cam surfaces into inactive position opening the jaws; i. with the lower pawl in engagement with a ratchet edge of the supply channel advance the ratchet head and the clip line and the supply channel for moving the clip line and the lead clip C L toward capture position; j. indexing the upper pawl one step along the cover ratchet teeth; and k. the pusher plate and stop spring moving relative to the cam plate with the stop spring reentering is slot in the cam plate out of the path of the clip line so as to permit the next in line clip C L to advance along the surface of the pusher plate to deflect the capture spring and be captured as C F . The invention provides that the clip applicator of FIG. 2 of the drawing can be made as a disposable cartridge to be inserted into a non-disposable handle with the cartridge removed from the handle and discarded after its clips are consumed. In a cartridge arrangement both the cartridge housing and rear end of the actuating rod have plug-in connections to the handle housing and link journal respectively. Various changes may be made to the structure embodying the principles of the invention. The foregoing embodiments are set forth in an illustrative and not in a limiting sense. The scope of the invention is defined by the claims appended hereto.

A repeating multi-clip applier for surgery with scissor-type or pistol grip operating handles, and a clip feeding and applying mechanism actuated by linear reciprocating movement generated by the handles. A unitary linear actuating rod and clip supply channel together with clip feed mechanisms reciprocate rearward-to-forward as the handles move for applying a clip in surgery and for advancing clips into the applying jaws.

This is a continuation of copending application Ser. No. 07/230,783, filed on Aug. 10, 1988, pending. BACKGROUND OF THE INVENTION This invention relates to measurement of pressures in catheter balloons and is particularly suited for measurement of such pressures in connection with coronary angioplasty catheters. Coronary angioplasty is a rapidly growing medical procedure. In angioplasty a coronary artery which has become partially blocked by a stenosis (an abnormal narrowing of the artery due to injury or disease) is opened by inflating a balloon carried by a dilatation catheter to the site of the stenosis. For placement purposes the dilatation catheter carries a movable guidewire which is advanced from the mouth of the respective coronary artery to the area of stenosis in the coronary artery or in one of the branches off the coronary artery. The dilatation catheter is then pushed over the guidewire to the stenosis and is placed so that the balloon carried by the dilatation catheter is disposed in the stenotic area. The balloon at this time is collapsed so that it fits through the passage through the stenosis. The dilatation or balloon catheter typically has a pair of lumens: one through which contrast media or other suitable inflating fluid flows under pressure to inflate or deflate the balloon, and one through which the guidewire moves. When properly positioned in the stenosis, the cardiologist manually inflates the balloon by forcing contrast media through the inflation lumen into the interior of the balloon. This expansion of the balloon, assuming the size of the balloon has been chosen properly, expands the passage through the blood vessel to something approaching its normal dimensions. It is often necessary to pressurize the balloon to a pressure in the range of from seven to ten atmospheres and to sustain this pressure for up to thirty seconds or so. During this pressurization, it is desirable to know the pressure to which the balloon is being inflated to ensure that the proper force has been applied to open the passageway. At present this pressure is displayed by an analog pressure gauge disposed in the vicinity of the syringe which is used to inflate the balloon. Although analog pressure gauges are fairly accurate, they are not particularly easy to read, and are fairly easy to misread. These gauges are also not extremely well suited for integration into a system which can display to the cardiologist other information which would be of interest, such as elapsed time of inflation of the balloon, total desired inflation time, number of times that particular balloon has been inflated, and so on. During coronary angioplasty the walls of the vessel are stretched and it sometimes occurs that the walls of the vessel fail under the force exerted by the expanded balloon. This incipient failure is reflected in the pressure in the balloon, but analog gauges are not especially well suited to detect this rapid change or to provide some alarm or other indication thereof to the cardiologist so that pressure could be immediately relieved before further damage to the vessel could occur. In order to determine the actual force exerted by the balloon on the walls of the passageway, prior to the procedure cardiologists sometimes test inflate the balloon in a fixture which measures the applied force. The analog pressure gauge can be observed during this test to correlate the applied force with the pressure reading shown by the analog gauge. Analog gauges, however, are not particularly well suited to automating this test procedure. Even if the force exerted by the balloon is not tested, the balloon is typically inflated before the procedure to ensure the patency of the balloon and to check whether the balloon can withstand the desired pressure. An analog gauge is typically used during this test to ensure that the desired pressure is applied. Such a gauge, however, is not particularly well suited to automation of this test either. Although the problems described above arise in the connection with the coronary angioplasty procedure, it should be realized that other medical procedures involving balloon catheters have similar problems. Peripheral angioplasty, for example, is a very similar procedure with similar concerns. Other procedures in which the present invention can be used will no doubt come to mind to those of ordinary skill in the art. SUMMARY OF THE INVENTION Among the various objects and features of the present invention may be noted the provision of a pressure monitoring system for medical procedures which facilitates the display of balloon pressure to the user. Another object is the provision of such a system which easily accommodates the display of additional information concerning balloon inflation to the user. A further object is the provision of such a system which detects and warns of incipient failure of the vessel wall. A fourth object is the provision of such a system which is especially suited for automation of various test procedures on the balloon. Other objects and features will be in part apparent and in part pointed out hereinafter. A system of the present invention for measuring fluid pressure in a balloon of a catheter includes a pressure transducer in fluid communication with the interior of the balloon. The pressure transducer includes an element for providing an electrical signal which is a function of the pressure in the interior of the balloon. An electronic digital display is responsive to the electrical signal from the pressure transducer to display the balloon pressure measured by the pressure transducer. A coronary angioplasty system of the present invention includes a catheter adapted for insertion through blood vessels in the human body to the vicinity of a stenosis. The catheter carries an inflatable balloon to the vicinity of the stenosis and has an inflation lumen providing a fluid path between the interior of the balloon and an external port adapted to receive fluid for inflating the balloon. A pressure transducer is in fluid communication with the interior of the balloon, which pressure transducer includes an element for providing an electrical signal which is a function of the pressure in the interior of the balloon. An electronic digital display is responsive to the electrical signal from the pressure transducer to display the balloon pressure measured by the pressure transducer. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematical representation of the system of the present invention in use during a coronary angioplasty procedure; FIG. 2 is a sectional view on an enlarged scale, with parts broken away for clarity, of the opening of a stenosis by the expansion of a balloon carried by a dilatation catheter; FIG. 3 is a perspective view illustrating the position of the pressure transducer used in the present invention in the fluid path between the source of inflating fluid and the balloon of FIG. 2; FIG. 4 is a sectional view taken along line 4--4 of FIG. 3; FIG. 5 is a block diagram illustrating the electrical interconnections of the system of the present invention; FIG. 6 is a perspective view of an alternative embodiment of the system of the present invention; and FIG. 7 is a front elevational view of a dilatation catheter being tested in a force measuring fixture. Similar reference characters indicate similar parts throughout the several views of the drawings. DESCRIPTION OF THE PREFERRED EMBODIMENTS A coronary angioplasty procedure involves a dilatation catheter 11 (FIG. 1) carrying a balloon 13 which is moved through the vascular system to the site of a stenosis 15. In FIG. 1, catheter 11 is shown passing through the aortic arch into a branch of the right coronary artery. Stenosis 15 is typically composed of atherosclerotic plaque which has partially occluded the blood vessel as shown. In FIG. 2, the balloon is shown inflated, which pushes the plaque to the sides of the passageway and, to some extent, distends the wall 17 of the vessel itself. Catheter 11 has a pair of lumens. The first is connected to a port 19 for injection of contrast media through the catheter for purposes of positioning the catheter. That same lumen has a guidewire 21 disposed therein, guidewire 21 being inserted through a port 23 into the catheter. The second lumen is connected by an opening 25 (FIG. 2) to the interior of balloon 13 and provides a fluid path between the interior of the balloon and an external source of balloon inflating fluid, such as the inflation/deflation syringe 27 shown in FIG. 1. Typically, such syringes have a threaded plunger which cooperates with a disengageable nut on the barrel of the syringe to permit accurate displacement of fluid (such as contrast media or any other suitable fluid) from the barrel of the syringe through the second lumen to inflate balloon 13. When the nut is disengaged, the cardiologist can quickly withdraw the piston to rapidly deflate the balloon. Heretofore, an analog pressure gauge has been disposed in the fluid path immediately adjacent the outlet of the syringe. This gauge has provided a visual indication to the cardiologist of the actual pressure being applied to the interior of the balloon. As mentioned above, however, such analog pressure gauges have certain drawbacks associated therewith. In the present system, a pressure transducer 29 (FIG. 4) disposed in a housing 31 (FIGS. 1, 3 and 4) is used instead of the prior art analog pressure gauges to monitor balloon pressure. Housing 31 is disposed in the inflation fluid path, specifically adjacent the outlet of the syringe. The exact placement of the transducer is not critical, so long as it is exposed to the pressure of the inflation fluid. Pressure transducer 29 is connected by a suitable cable 33 to a housing 35 which is suitably mounted (such as on a pole, not shown) so as to be readily visible to the cardiologist. The housing carries a plurality of displays 37, 39, 41, and 43, a set of manually operable switches (two of which, labelled 45 and 47 are shown), and an alarm 49. A foot pedal 51 is electrically connected to housing 35 by a cable 53 so that the cardiologist can supply signals to the housing by that means as well. Housing 35 contains much of the electronics of the present system. Specifically it holds a microcomputer 55 (FIG. 5) along with any necessary interface circuitry for supplying input signals to the microcomputer and control signals from the microcomputer. Although a microcomputer is shown in FIG. 5, it should be realized that discrete components could be used to control the functioning of the system of the present invention instead. Displays 37, 39, 41, and 43 are electronic digital displays of conventional construction. Display 37 displays the balloon pressure in large, easily read characters. Although the pressure shown in FIG. 1 is in pounds per square inch, the units could as easily be atmospheres or any other suitable unit of pressure. Display 39 displays to the cardiologist the elapsed time or duration (in seconds) for this particular expansion of the balloon. To initiate the measurement of this time by microcomputer 55, the cardiologist need only press the proper one of the manually operable switches shown, in this instance start switch 45. The timing can be stopped by pressing another switch such as switch 47 or foot pedal 51. Display 41 displays to the cardiologist a time (previously set by means of other manually operable switches, see FIG. 5) which represents the desired duration of this particular expansion of the balloon. For a procedure in which the balloon is expanded a number of times, it should be realized that the preset desired duration could differ for different inflations. By comparing the output of display 39 (the actual expansion time) with the output of display 41 (the desired expansion time), the cardiologist can easily determine when to deflate the balloon. Display 43 displays to the cardiologist the number of expansions of this particular balloon. This information is available from microcomputer 55 because the microcomputer keeps track of the interior pressure of the balloon. A measured pressure below a predetermined threshold which follows a measured pressure above that threshold signifies to the microcomputer that the balloon has been inflated and deflated. It is necessary, of course, for the user to indicate to the microcomputer by means of a manually operable switch when a catheter is replaced so that the output of display 43 may be reset. With regard to FIG. 2, it should be noted that inflation of the balloon results in some distension of the wall 17 of the blood vessel. Should this wall start to rupture, the pressure measured by transducer 29 would rapidly change. Microcomputer 55 is fast enough to detect such a change and signal that fact to the cardiologist over alarm 49. The cardiologist upon hearing alarm 49 can then release the pressure on the balloon to prevent further rupture of the vessel wall. Other failures such as loss of balloon patency and the like are also reflected in the pressure measured by transducer 29. Microcomputer 55 signals the occurrence of these failures over alarm 49 as well. Turning to FIGS. 3 and 4, housing 31 is removably connected between syringe 27 and catheter 11 by standard leur lock fittings 31A and 31B. Electrical connection is made between transducer 29 and electronics housing 35 by means of a removable plug 59, such as a standard four-pin telephone plug, which is accepted in a corresponding socket 61 formed in housing 31. A cover 59A is provided for closing socket 61 during those times when the plug 59 is not inserted therein. Housing 31 has a passageway 63 extending therethrough for passage of the inflating fluid from syringe 27 to catheter 11 and balloon 13. A port 65 in housing 31 extends from passageway 63 to pressure transducer 29 so that the pressure of the inflating fluid flowing through the passageway is transmitted to the pressure transducer. Pressure transducer 29 itself is constructed in accordance with the teachings in co-assigned U.S. Pat. No. 4,610,256. The present transducer differs from the one taught in that patent only in being engineered to measure somewhat higher pressures (several atmospheres as opposed to approximately one-half atmosphere). Port 65, as taught in U.S. Pat. No. 4,610,256 is filled with a silicone gel or oil which transmits the pressure in passageway 63 to pressure transducer 29. The transducer itself is a piezoresistive diaphragm which includes four resistive elements ion-implanted thereon in a Wheatstone bridge configuration. As is explained in U.S. Pat. No. 4,610,256, as the piezoresistive diaphragm is deflected, the resistive elements that form the Wheatstone bridge become unbalanced, thus causing electrical signals. These signals, representative of the pressure of the fluid in passageway 63, are sent to microcomputer 55 via plug 59. This connection of the pressure transducer with microcomputer 55 is illustrated in FIG. 5. Of course, the signal received from the pressure transducer may be filtered, temperature compensated, etc. as is well known in the art. For the purposes of this invention, however, the important fact is that the microcomputer acquires inflating fluid pressure information from pressure transducer 29. Also shown in FIG. 5 are the other significant inputs to and outputs from microcomputer. The inputs include the manually operable switches such as switches 45, 47 and foot pedal 51, the pressure transducer (discussed above), and an input from an inflation force fixture 67 (described below in connection with FIG. 7). The outputs include control signals for the displays (which includes displays 37, 39, 41, and 43), for the alarm 49, and for a syringe/injector mechanism 69 described below in connection with FIG. 6. Microcomputer 55 is under programmed logic control to govern the system to operate as described above. In response to actuation of the proper manually operable switches, it begins timing and displaying (on display 39) the duration of a balloon inflation. It also, at short intervals, reads the signal from pressure transducer 29 and displays the sensed pressure on display 37. If a desired inflation duration has been set, it also displays this time on display 41, and increments the balloon inflation count on display 43. If a pressure change is detected during the procedure which would indicate some failure (either of the vessel wall or of the catheter itself), microcomputer 55 sounds alarm 49. If desired, the process of injecting the inflating fluid into the balloon and of deflating the balloon can also be controlled by the microcomputer. Such a system is shown in FIG. 6. In addition to having the inputs and outputs of the system of FIG. 1 (omitted in this FIG. for clarity), the system of FIG. 6 also includes outputs for controlling a stepper motor 71, a solenoid 73 and a syringe release arm 75. The microcomputer provides control signals to stepper motor 71 to cause the motor to operate. Motor 71 is connected by a fitting 77 to the plunger of syringe 27, so that operation of motor 71 causes the plunger to force inflating fluid out of the syringe and (via the inflation lumen of catheter 11) into balloon 13. The microcomputer monitors the pressure during this operation, so that once the desired pressure is reached operation of the stepper motor is stopped. The microcomputer maintains the balloon pressure at this preset amount until the preset duration for that balloon expansion expires. Upon the expiration of that time, microcomputer 55 operates stepper motor 71 in the reverse direction to deflate the balloon. In the event that more rapid deflation of the balloon is need, the microcomputer activates arm 75 to move from its position shown in FIG. 6 to an operating position (not shown) in which is releases the threaded nut or cap 27A of the syringe so that the plunger may be rapidly withdrawn with respect to the barrel of the syringe. Actual rapid withdrawal of the plunger is accomplished by solenoid 73. The solenoid is secured to motor 71 by a shaft 79. Operation of the solenoid draws the shaft, along with the stepper motor and the plunger of syringe 27 upwardly to rapidly withdraw the inflating fluid from balloon 13. One condition in which the microcomputer rapidly withdraws the plunger, for example, is when the microcomputer detects a pressure change indicative of some failure condition during the inflation phase of the procedure. It should be realized that the microcomputer is capable of responding to such a failure situation much more rapidly and reliably that could a human operator of the syringe. Although the invention has been described heretofore with reference to the actual coronary angioplasty procedure, it has equal applicability to the preliminary testing of the balloon before actual insertion into the patient. It can readily be seen how the apparatus of FIG. 1 or the apparatus of FIG. 6 is usable to preliminarily inflate the balloon before insertion into the patient to test the patency of the balloon. That apparatus, or more specialized apparatus shown in FIG. 7, may also be used to correlate the balloon pressure with the force applied by the balloon. Such a force/pressure correlating apparatus includes a backing plate 81 upon which the balloon of the catheter under test is disposed. A force sensing arm 83 is lifted by the pressure in the balloon, and the corresponding force exerted by the balloon is measured by a transducer (not shown). Microcomputer 55 then displays on display 37 and on an additional display 85 the pressure in the balloon (obtained from pressure transducer 29) and the resulting force on force sensing arm 83. With this apparatus the pressure and force are easily correlated, and the force information may be recorded by microcomputer 55 for future reference, if desired. In view of the above it will be seen that the various objects and features of the present invention are achieved and other advantageous results attained. The described embodiments are illustrative only and the present invention is defined instead by the claims which are appended hereto.

A fluid pressure monitoring system for a balloon catheter includes a pressure transducer in fluid communication with the interior of the balloon. The pressure transducer includes elements for providing an electrical signal which is a function of the pressure in the interior of the balloon. An electronic digital display is responsive to the electrical signal from the pressure transducer to display the balloon pressure measured by the pressure transducer. The system is especially suited for coronary angioplasty in which a catheter is inserted through blood vessels in the human body to the vicinity of a stenosis. The catheter carries an inflatable balloon to the vicinity of the stenoisis, where it is inflated, and the fluid pressure monitoring system of the present invention detects and digitally displays to the cardiologist the pressure inside the inflated balloon.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates, in general, to sewn gloves and a manufacturing method thereof and, more particularly, to sewn gloves in which a sewing line is removed from the palm part and an edge of the palm part to thereby improve wearing sensation and workability, and a manufacturing method thereof. [0003] 2. Description of the Related Art [0004] Generally, gloves are classified into sewn and knit types according to the manufacturing method. Sewn gloves are manufactured by sewing the palm-side plate and the back-side plate together along their edge lines, whereas the knit gloves are integrally manufactured without forming a separate sewing line. [0005] Here, while the knit gloves have reduced merchantability because of limitations in the use, material, and design thereof, the sewn gloves put emphasis on the wearing sensation, protective capabilities, mobile functioning or the like and can be used widely using various kinds of material as compared to the knit gloves. [0006] Here, since the sewn gloves are manufactured by the process of cutting a material into patterns and sewing the patterns, sewing lines across the palm part and along edges of the palm part essentially exist. [0007] Such sewing lines formed on the palm part and the edges thereof of the sewn gloves make a sewing margin protrude from an inner side of the gloves, causing various inconveniences to a user wearing the gloves. [0008] The gloves may include gloves used for, e.g. playing golf, bicycling, working, motorcycle riding, playing baseball, training, driving, playing football, skiing and snowboarding, hunting, etc. When a user wears the gloves and holds or grips an object, because of the sewing margin provided on the palm part and the edges thereof as a result of the presence of the sewing line in the gloves, the user feels in the finger a sensation of being separated from the object and stress is placed on his palm and fingers, so that the wearing experience of the gloves deteriorates, continuously making the user feel fatigue in his hands, thereby reducing the functionality of the gloves. [0009] Particularly, among the sewing lines along the edges of the palm part of the gloves, the sewing line provided on the tip of the finger of the gloves causes a user to suffer great inconvenience because the sewing margin comes into contact with the tip of a user's nail or finger, and it makes a user's sense of touch of an object dull when a user holds an object, hindering holding of the object and thereby reducing work productivity. [0010] Despite these problems, these sewing lines across the palm part and the edges thereof of the gloves must exist. The reason for this will be described with reference to the cutting patterns of currently used sewn gloves as follows. [0011] Examining the cutting patterns of the conventional gloves shown in FIG. 1 , the reason is because the cutting patterns 1 to 6 all are cut in a planar form, and the planar cut members are sewn along cut lines thereof to thereby form sewing lines 10 and 11 on the palm part and the edges thereof of the gloves. [0012] As such, when the wearer of the gloves holds or grips an object, the sewing lines 10 and 11 formed on the palm part and the edges thereof of the gloves cause the user to suffer stress or inconvenience, or make the user feel sensations of being separated, to thereby reduce the wearing experience of the gloves, thereby reducing the functionality of the gloves. [0013] Meanwhile, as shown in FIG. 2 , a glove structure disclosed in U.S. Pat. No. 7,287,285 is constructed such that the cut member of the palm part extends and is sewn up to the cut member of the back part via the palm-side of the finger part, so as to prevent sewing lines from forming on tips of the finger parts. [0014] However, it can be seen from the construction that a sewing line 10 still exists across the palm part of the gloves, and a sewing line 11 also exists along an edge of the palm part excluding the tip portions of the finger parts, which reduces the sense of touch between an object and the palm part or the edge thereof so as to render it not easy to grip an object. [0015] Thus, a proposal has been made for sewing gloves and a manufacturing method thereof in which sewing lines to be formed on the palm part and an edge thereof which considerably take away from the wearing experience and functionality of the gloves are removed so that the palm part and the edge thereof become closer to an object to thereby improve the wearing experience and the functionality of the gloves. SUMMARY OF THE INVENTION [0016] Accordingly, the present invention has been made keeping in mind the above problems occurring in the related art, and the present invention is intended to propose sewn gloves and a manufacturing method thereof in which sewing lines to be formed on the palm part and a vertical edge thereof are removed to thereby improve the wearing experience and functionality of the gloves. [0017] In order to achieve the above object, according to one aspect of the present invention, there is provided a method of manufacturing sewn gloves to be sewn along cutting patterns, the method including the steps of forming a palm-forming section in a depressed form in a planar cutting member, the palm-forming section consisting of a palm part and a vertical edge part thereof, cutting the palm-forming section along a cutting line to form a palm-side cut portion, and sewing the palm-side cut portion and a back-side cut portion along a sewing line so as not to form sewing lines on the palm part and the edge thereof. [0018] According to the present invention, the sewing lines on the palm part and the edge thereof are removed, so that the gloves and an object to be griped come into close contact with each other, thereby improving the wearing experience and functionality of the gloves. BRIEF DESCRIPTION OF THE DRAWINGS [0019] The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawings will be provided by the office upon request and payment of the necessary fee. [0020] The above and other objects, features and advantages of the present invention will be more clearly understood from the following detailed description when taken in conjunction with the accompanying drawings, in which: [0021] FIGS. 1 and 2 are views illustrating a cutting pattern structure and sewn gloves using the same according to the prior art; [0022] FIG. 3 is a view illustrating a pattern structure of a finger cutting part of sewn gloves according to the present invention; and [0023] FIG. 4 is a perspective view illustrating sewn gloves according to the present invention. DETAILED DESCRIPTION OF THE INVENTION [0024] Reference will now be made in greater detail to a preferred embodiment of the invention, an example of which is illustrated in the accompanying drawings. [0025] FIG. 3 is a view illustrating a pattern structure of a finger cutting part of sewn gloves according to the present invention, and FIG. 4 is a perspective view illustrating sewn gloves according to the present invention. [0026] Generally, in the case of sewn gloves, a palm part thereof is composed of a relatively high strength and low elasticity material such as leather, composition leather (artificial suede), synthetic resin, rubber or the like, in order to protect the palm of the hand. However, when the gloves are manufactured using such a material, as set forth before, the gloves are only provided in a planar form. [0027] On the contrary, according to the present invention, when cutting such a material having high strength and low elasticity so as to form a palm part of gloves, the whole of the palm part is shaped in 3-dimension at a certain pressure and temperature so that a sewing line deviates from the palm part and the edge part thereof and is located towards the back of the gloves. [0028] That is, in an embodiment as illustrated in FIG. 3 , before a palm-side cut portion 30 is cut from a cutting member 1 , a palm-forming section 20 is first shaped in 3-dimensions. [0029] In other words, a palm-forming mold (not shown) is hot-pressed into the planar cutting member 1 at a proper pressure and temperature, thereby providing the palm-forming section 20 in a depressed form. [0030] Here, the palm-forming section 20 consists of a palm part 20 - 1 and a vertical edge part 20 - 2 thereof, the vertical edge part 20 - 2 forming a vertical curved face perpendicular to the palm part and having slightly larger height than an actual thickness of the hand. [0031] A palm edge 22 is formed along a portion where the palm part 20 - 1 and the vertical edge part 20 - 2 thereof are brought into contact with each other, and a sewing line 21 is formed along a portion where the vertical edge part 20 - 2 of the palm-forming section 20 is brought into contact with the planar cutting member 1 . [0032] A cutting line 23 is formed outwards along the sewing line 21 , and the palm-side cut portion 30 is formed in 3-dimensions by cutting along the cutting line. [0033] Then, when the 3-dimensional palm-side cut portion 30 and a planar back-side cut portion (not shown) are sewn together along the sewing line 21 , a portion between the cutting line 23 and the sewing line is provided in the gloves as a sewing margin. [0034] Here, as illustrated in FIG. 4 , it can be seen that the sewing line 21 moves towards the back of the gloves together with the sewing margin, and there is no sewing line on the palm-side cut portion 30 of the gloves. [0035] Unlike conventional sewn gloves, the sewn gloves of the invention have no sewing line 10 or 11 across the palm part 20 - 1 or along the palm edge 22 . [0036] In brief, according to the present invention, the palm-forming section 20 is formed in 3-dimensions in the planar cutting member 1 such that the vertical edge part 20 - 2 substantially perpendicular to the palm part 20 - 1 is of a larger height than an actual thickness of the hand. Then, when the palm-side cut portion 30 is sewn with the planar back-side cut portion (not shown) along the sewing line 21 , the sewing line 21 naturally moves towards the back of the gloves, thereby providing the gloves having no sewing line 21 on the palm part 20 - 1 and the palm edge 22 . [0037] Although preferred embodiments of the present invention have been described for illustrative purposes, those skilled in the art will appreciate that various modifications, additions and substitutions are possible, without departing from the scope and spirit of the invention as disclosed in the accompanying claims.

Sewn gloves and a manufacturing method thereof are provided. In the sewn gloves, a sewing line is removed from a palm part and an edge of the palm part so that the gloves and an object to be griped come into close contact with each other, thereby improving the wearing experience and functionality of the gloves.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a tooth used for a jaw and tooth model, using which students aspiring to become dentists can experience intraoral work and perform training related to treatment. A tooth for a jaw and tooth model is a tooth which is used for simulation of an intraoral remedial procedure or training related to treatment using a jaw and tooth model in a university. More particularly, the present invention relates to a tooth which is used to experience formation of an abutment tooth, formation of cavity or the like by grinding the tooth, and a method for producing the same. 2. Description of the Related Art In training related to dental treatment, teeth extracted from human bodies and animals have conventionally been used so as to experience the grinding feel of a natural tooth. However, there are hygienic problems associated with extracted teeth and infection may occur if hygiene control is not sufficiently conducted. Thus it was impossible to conduct training freely. Furthermore since extracted teeth comprise a natural living material, there arises a problem of corruption and it is necessary to pay a careful attention to storage. Therefore, there has been a need for a method which enables the experience of grinding feel of a tooth without using a natural tooth. Now a tooth for a jaw and tooth model, which is used for training related to intraoral treatment, is often produced using an epoxy resin or a melamine resin, and are well known in the art. However, a tooth for a jaw and tooth model formed of an epoxy resin or a melamine resin is in the form of a natural tooth, but exhibits grinding feel which is different from that of a natural tooth. Therefore, even when performing training related to the formation of an abutment tooth and formation of cavity, grinding feel and working properties are different from those of actual intraoral work, and thus the training effect could not be obtained. Specifically, a natural tooth comprises tooth enamel and dentin, and tooth enamel and dentin are harder than resin, whereas, epoxy resin and melamine resin are soft. Thus there is a tendency to over grind and even when performing training using such a model tooth, the grinding may not be similar to that of a hard natural tooth. Furthermore, tooth enamel and dentin, with which a crown portion of dentin is coated, have different hardnesses. As a result, in case of a transition during grinding from tooth enamel to dentin, the dentin may be excessively ground and thus a tooth may not be satisfactorily produced. As a result of the need for a harder material, a composite type tooth is commercially available. However even in case of a composite type tooth, since the dentin portion and the enamel portion exhibit the same grinding feel, the grinding feel of the tooth is different from that of a natural tooth. Therefore, even when performing training related to the formation of an abutment tooth and the formation of a cavity, the grinding feel and working properties are different from those in case of intraoral work in practice, and thus the training effect could not be obtained. To state the matter clearly, the grinding feel includes a sliding sensation and is substantially different from a natural tooth. That is, it is required that the grinding feel varies similarly to a natural tooth in the transition portion from the enamel portion to the dentin portion of a tooth for a jaw and tooth model. Therefore a mater of course, it is important that the enamel portion reproduces a grinding feel of tooth enamel, while the dentin portion reproduces a grinding feel of dentin. Japanese Unexamined Utility Model Publication (Kokai) 1-90068 discloses that a tooth enamel layer is formed of glass/ceramics having a Vickers hardness controlled within a range from 350 to 450, comprising a phlogopite crystal [NaMg 3 (Si 3 AlO 10 )F 2 ] and a lithia-alumina-silica-based crystal (Li 2 O.Al 2 O 3 .2SiO 2 , Li 2 O.Al 2 O 3 .4SiO 2 ) precipitated simultaneously; a tooth root layer is prepared in advance by adding white, red and yellow colorants to a polyol (base resin), mixing with an isocyanate prepolymer (curing agent), injecting the mixture into a silicone rubber mother mold under vacuum conditions and curing the mixture at a normal temperature; and a dentin recognition layer, which exists between the tooth enamel layer and the tooth root layer thereby bonding both layers, and is formed of an adhesive resin having an opaque color. However, the tooth comprising a tooth enamel layer formed of a phlogopite crystal or a lithia-alumina-silica-based crystal is not well adapted for use because it feels too hard when grinding as compared with a natural tooth, and also it is not well adapted for use because the dentin recognition layer is formed of an adhesive resin which feels too soft when grinding. Furthermore, dentin layer is formed of an adhesive layer is disclosed. It is described that an enamel layer portion and a tooth root layer portion are formed and bonded. It is recognized as the dentin layer formed of a thick adhesive layer. Japanese Unexamined Patent Publication (Kokai) No. (hereinafter referred to briefly as “JP-A-”) 5-224591 discloses a tooth model which has grinding properties extremely similar to those of a natural tooth, and is suited for the training of practical dental grinding. The tooth model comprises a crown portion whose surface has a Knoop hardness of at least 70 or more and a tooth root portion whose surface has a Knoop hardness of at least 10 to 40. The tooth model contains, as main components, an inorganic matter powder and a crosslinking resin in a weight ratio of 20%:80% to 70%: 30%. The above prior art discloses that “a tooth model may be formed of a raw material having any hardness, for example, metal, ceramics or a resin, or may be a cavity in view of the method for producing a tooth model and economic considerations”. However, this is not a tooth model which can exhibit a difference in grinding properties between the enamel portion and the dentin portion. JP-A-5-216395 discloses a tooth model which has grinding properties extremely similar to those of a natural tooth and is suited for the training of practical dental grinding, and a method for producing the same. The tooth model contains, as main components, a hydroxyapatite powder having a porosity of 40 to 80% and a (meth)acrylate ester-based resin in a weight ratio of 20%: 80% to 50%: 50%. However, this is not a tooth model which can exhibit a difference in grinding properties between the enamel portion and the dentin portion. JP-A-5-241498, JP-A-5-241499 and JP-A-5-241500 describe an inorganic filler and a hydroxyapatite filler. However, in all tooth models disclosed in these publications, a resin is used as a base material and thus the problem of the grinding feel is not solved. They are not tooth models which can exhibit a difference in grinding properties between the enamel portion and the dentin portion. JP-A-2004-94049 describes an invention which provides a model tooth for dental training, which enables an accurate shape measurement with laser beam. The specification discloses that “known materials can be used as a material constituting a surface of a crown portion of the model tooth of the present invention and there can be used porcelain materials such as ceramics; thermoplastic resin materials such as acryl, polystyrene, polycarbonate, an acrylonitrile-styrene-butadiene copolymer (ABS), polypropylene, polyethylene, and polyester; thermosetting resin materials such as melamine, urea, unsaturated polyester, phenol, and epoxy; and materials obtained by adding various organic and inorganic reinforcing fibers (for example, glass fiber, carbon fiber, pulp, synthetic resin fiber, etc.), various fillers (for example, talc, silica, mica, calcium carbonate, barium sulfate, alumina, etc.), colorants (for example, pigment, dye, etc.) and various additives (for example, weathering agents, antistatic agents, etc.) to these main raw materials”. However, there is no description about preferable materials, and thus the problem of grinding feel is not solved. As a result of a study, the present inventors have found that it is necessary to use a sintered body of an inorganic material so as to exhibit the grinding feel of a natural tooth. Because of the difficulty in controlling a hardness of an inorganic material, it is difficult to form an enamel portion and a dentin portion while controlling the hardness. In particular, when the enamel portion and the dentin portion of the tooth model are formed of a sintered body of the same inorganic material, it was difficult to reproduce a difference in the grinding feel between the enamel portion and the dentin portion. It is proposed that the enamel portion and the dentin portion are separately formed and a grinding feel of each portion is adjusted so as to reproduce a difference in grinding feel between the enamel portion and the dentin portion. It is necessary to unify the density, particle shape and firing temperature of the sintered body so as to adjust the grinding feel of the sintered body. The difference in a shrinkage rate and a thermal expansion coefficient between the enamel portion and the dentin portion upon firing results in breaking, peeling and cracking. In addition, a gap may be formed between the dentin portion and the enamel portion. Thus, chipping may occur upon grinding and the gap gives a feel different from the grinding feel of a natural tooth. Thus the resultant tooth was not well adapted for use. In particular, when the enamel portion and the dentin portion are formed as separate sintered bodies, adhesion between the enamel portion and the dentin portion is required and grinding feel largely varies in an interfacial region including the adhesion portion. That is, there is obtained a tooth model which causes a strange sensation during the transition from the enamel portion to the dentin portion, and which is very difference from a natural tooth. When a natural tooth is ground, a unique tough grinding feel upon grinding of a living body is obtained. Although various methods have been studied so as to obtain a tough grinding feel peculiar to a natural tooth, sufficient grinding feel cannot be obtained using resin, composite or the like and such a sensation can not be obtained while pouring water on a conventional tooth for a jaw and tooth model. A grinding feel is required in which users feel a tougher grinding feel than that of an inorganic material even in case of the tooth enamel because of a similar phenomenon. In view of the above, a conventional tooth model is not satisfactory with respect to grinding properties and, therefore, it is required to develop a tooth model having grinding properties similar to those of a natural tooth. However, the tooth models have not exhibit a sufficient grinding feel. It is particularly required to develop a tooth having toughness peculiar to a natural tooth, and there has never been obtained a tooth model capable of exhibiting a difference in grinding properties between the enamel portion and the dentin portion. However, neither a specific composition of a tooth model capable of realizing grinding feel of tooth enamel and dentin of a natural tooth, nor a method for producing the same has been studied or reported. Therefore, it is required to develop a tooth model, the enamel portion and the dentin portion being formed of the same inorganic material, which exhibits a tough grinding feel peculiar to a natural tooth and which also reproduces a difference in grinding feel between the enamel portion and the dentin portion. A method of reproducing tooth pulp peculiar to a natural tooth has not been developed heretofore, and thus dental students could not experience exposure to tooth pulp. Dental pulp exposure (grinding down the tooth pulp portion) is the most important technique in a dental treatment. In case where tooth pulp exposure was carried out by mistake, the subsequent treatment method must be learned at the same time. As a dental caries progresses in a natural tooth, the treatment position expands into the enamel layer, the dentin layer and the tooth pulp, and training for a root canal treatment such as a pulpectomy is most important. When a pulpectomy is carried out, since the tooth pulp is removed by a reamer and sensation of rubbing of the dentin wall surface with the reamer completely varies, training related to root canal filling could not be carried out. In a treatment of tooth pulp, a tooth designed for training of a root canal treatment is used, and also training of a root canal treatment (root canal cleaning, root canal extension, etc.) is carried out using a tooth with a small hole formed of a box-shaped acryl. However, sufficient training cannot be carried out since it is impossible to mount the tooth on a jaw and the hardness of dentin varies. It is required to develop a tooth for a jaw and tooth model, which enables these experiences. In particular, dental students learn by hand a sensation of whether or not tooth pulp is completely removed upto an apical foramen during root canal cleaning, and thus it is difficult for beginners. Therefore, it is required to perform training using a tooth for a jaw and tooth model in which tooth pulp in a natural tooth is reproduced. Although removal of dental caries is an important procedure in a dental treatment, a carious dental portion is softer than a usual dentin portion and thus it is difficult to grind the carious dental portion. Therefore, it is necessary to perform training using a tooth for a jaw and tooth model in which dental caries in a natural tooth are reproduced. It is also required to develop a method of confirming that a carious dental portion has been accurately removed. SUMMARY OF THE INVENTION An object of the present invention is to provide a tooth for a jaw and tooth model, which enables the experience of a sensation similar to that in treating a natural tooth. Particularly, an object of the present invention is to provide a tooth for a jaw and tooth model in which a difference in a grinding feel between tooth enamel and dentin of a natural tooth is reproduced in a tooth for a jaw and tooth model, comprising an enamel portion and a dentin portion. The present invention provides a tooth for a jaw and tooth model, which is used for training related to a treatment, comprising an enamel portion and a dentin portion, wherein the enamel portion and the dentin portion are formed of a sintered body of an inorganic powder, voids exist between particles of the inorganic powder, which constitutes the sintered body, and the voids in the enamel portion are impregnated with a resin or a low melting point glass. In the tooth for a jaw and tooth model of the present invention, the enamel portion and the dentin portion can be integrally formed of a sintered body of an inorganic powder. The enamel portion is formed by impregnating a part of the resultant sintered body with a resin or a low melting point glass. In the tooth for a jaw and tooth model of the present invention, a thermosetting resin such as a urea resin, a melamine resin, a phenol resin or an epoxy resin, or a thermoplastic resin containing a crosslinking agent can be used as the resin, and a glass capable of flowing at 200 to 600° C. can be used as the low melting point glass. Since the enamel portion and the dentin portion are integrally formed of a sintered body with the same composition, an adhesive layer of the enamel portion and the dentin portion is eliminated. As a result, a transition from the enamel portion to the dentin portion upon grinding is smoothly conducted. A powder of inorganic materials such as alumina, zirconia, titanium oxide and silica can be used for the tooth for a jaw and tooth model of the present invention, but is not limited thereto, and various inorganic powders and a mixture thereof can be used. A tooth for a jaw and tooth model is a substitute for a hardest natural tooth in a human body and a tooth formed from a conventional material exhibits a soft feel upon grinding, whereas, the tooth for a jaw and tooth model according to the present invention is formed of an inorganic material and therefore a grinding feel similar to that of a natural tooth can be obtained. It is possible to experience a grinding feel similar to that when using an intraoral diamond grinding material (using an air turbine) rotating at a high speed of 400,000 rpm. In the present invention, it is preferred that an inorganic powder is injection-molded using a ceramic injection molding (CIM) technique to form an injection molding having a desired shape and the resultant injection molding is fired. Since the injection molding is contacted with a grinding material rotating at a high speed and therefore adaptability between the tooth and the jaw is important, a CIM technique capable of accurately forming is preferably used. The shape of a dental crown of the tooth model is also important and it is important to serve as a target of formation of an abutment tooth and formation of a cavity and to accurately express a raised portion, fossa and cusp, and thus molding using a CIM technique is suitable. In the tooth for a jaw and tooth model of the present invention, a tooth pulp portion can be formed in the dentin portion. The tooth pulp portion is filled with a resin, a silicone rubber, a wax or a water-soluble material. In the tooth for a jaw and tooth model of the present invention, a false carious dental portion can be formed between the enamel portion and the dentin portion, or at the periphery thereof. The false carious dental portion is formed of a resin or a sintered body of an inorganic powder. The tooth for a jaw and tooth model of the present invention is a sintered body integrally molded by using an inorganic material, and includes an enamel portion and a dentin portion. Since the tooth is integrally molded, an adhesive layer does not exist between the enamel portion and the dentin portion and thus a transition upon grinding can be smoothly conducted without experiencing the soft feel of an adhesive. Since the enamel portion is formed by impregnating with a thermosetting resin, a thermoplastic resin containing a crosslinking agent, or a low melting point glass, a hard grinding feel similar to that of the enamel layer can be obtained as compared with the case when impregnation is not performed. Since a grinding feel similar to that of a natural tooth is obtained in both of the dentin portion and the enamel portion and a grinding feel transiting from the enamel portion to the dentin portion is similar to that of a natural tooth, training related to grinding a natural tooth can be easily conducted even when using a model. By forming an abutment tooth and cavity using the tooth for a jaw and tooth model of the present invention, it is possible to quickly experience grinding feel similar to that of natural tooth and to easily experience formation. Such a formation technique can be quickly mastered. It is also possible to experience a technique of a root canal treatment or dental caries treatment by forming a tooth pulp portion or a false carious dental portion on the tooth of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a sectional view showing a tooth for a jaw and tooth model of the present invention. FIG. 2 is a sectional view showing a tooth for a front tooth model before forming an enamel portion. FIG. 3 is an enlarged view showing an inorganic powder sintered body. FIG. 4 is a schematic view showing a method for producing a tooth for a jaw and tooth model of the present invention. FIG. 5 is a sectional view showing a tooth for a jaw and tooth model, which includes a tooth pulp portion, of the present invention. FIG. 6 is a sectional view showing a tooth for a jaw and tooth model, which includes a false carious dental portion, of the present invention. FIG. 7 is a sectional view showing a tooth for a jaw and tooth model, which includes a tooth pulp portion and a false carious dental portion, of the present invention. DETAILED DESCRIPTION OF THE INVENTION As shown in FIG. 1 , the tooth for a jaw and tooth model of the present invention includes at least an enamel portion 11 and a dentin portion 12 . As shown in FIG. 2 , the enamel portion 11 and the dentin portion 12 are integrally formed of a sintered body of an inorganic powder, and a desired region of the sintered body is impregnated with a resin or a low melting point glass to form an enamel portion 11 . The sintered body of an inorganic powder 2 , which constitutes the tooth for a jaw and tooth model of the present invention 1 , is formed by sintering particles 21 of an inorganic powder as shown in FIG. 3 . Furthermore, voids 22 exist between the particles 21 . These voids 22 are impregnated with a resin or a low melting point glass 3 to form an enamel portion 11 which is harder than the dentin portion 12 and also reproduces a tough grinding feel similar to that of a natural tooth. As shown in FIG. 4 , the inorganic powder is injection-molded to form an injection molding having a desired shape and the resultant injection molding is fired to obtain a sintered body ( FIG. 4A ), which is then immersed in a vessel filled with a resin or a low melting point glass 3 ( FIG. 4B ) thereby impregnating a desired portion, which would form the enamel portion 11 , with a resin or a low melting point glass ( FIG. 4C ). In a vacuum vessel, the sintered body is preferably impregnated with the resin or low melting point glass 3 . Impregnation can be easily conducted by extracting the air in the voids 22 of the sintered body 2 . In the tooth for a jaw and tooth model of the present invention 1 , a tooth pulp portion 13 can be formed in the dentin portion 12 ( FIG. 5 ). In order to form the tooth pulp portion 13 in the dentin portion 12 , a mold having a desired tooth pulp shape is formed using a combustible material such as an epoxy resin. The mold having a tooth pulp shape is set in a die and an injection molding is formed of an inorganic powder. The injection molding is fired thereby burning out the mold having a tooth pulp shape to obtain a tooth 1 including a space having a tooth pulp shape therein. The space of the resultant tooth pulp shape is filled with a resin, a silicone rubber, a wax or a water-soluble material to form the tooth pulp portion 13 . In the tooth for a jaw and tooth model of the present invention, a false carious dental portion 14 can be formed between the enamel portion 11 and the dentin portion 12 , or at the periphery thereof. FIG. 6 is a schematic view in which the false dental caries 14 is formed at a transition portion of the enamel portion 11 and the dentin portion 12 of a tooth for a jaw and tooth model. As shown in FIG. 7 , the false carious dental portion 14 can be formed so as to pierce through the dentin portion from an occlusal surface of the enamel portion, and also the false carious dental portion 14 can be formed together with the tooth pulp portion 13 . The false carious dental portion 14 is formed of a sintered body of an inorganic powder, a resin or a composite. When the false carious dental portion 14 is formed of the resin or composite, it is possible to visually confirm the degree of removal of the carious dental portion by adding a colorant, a fluorescent material or an X-ray contrast medium to the sintered body of an inorganic powder, the resin or composite. Since the tooth for a jaw and tooth model of the present invention can be colored white, ivory, milky-white or translucent by using an inorganic pigment, like a natural tooth, it is possible to experience more realistic grinding. The color is preferably white, ivory, or milky-white. In the tooth for a jaw and tooth model of the present invention, a jaw field and a mannequin portion can be appropriately selected. It is important carry out a procedure in order to confirm the suitability of the selection. For example, it is important to appropriately adjust the size of a tooth inserting inlet of a jaw and tooth model. Examples of the inorganic powder, which can be used to form a tooth for a jaw and tooth model of the present invention, include powders of alumina-based, zirconia-based, silica-based, aluminum nitride and silicon nitride ceramics, or glass. Among these, powders of alumina-based and zirconia-based ceramics are preferred. The alumina-based or zirconia-based ceramics mean that the content of alumina or zirconia is from 0 to 100%, preferably from 80 to 100%, and more preferably from 95 to 100%, based on the composition of the sintered body. Particularly, the content of alumina is from 50 to 100%, preferably from 70 to 100%, and more preferably from 90 to 100%. Powders of alumina-based ceramics are preferably used as the organic powder. When the tooth is formed of a sintered body of an inorganic powder, the hardness is adjusted by a method of increasing a particle size, a method of increasing voids, a method of varying the composition, a method of varying the firing temperature, or a method of varying the retention time. The average particle diameter of the inorganic powder sintered body is adjusted within a range from 0.1 to 10 μm, and preferably from 1.0 to 5.0 μm. The firing temperature varies depending on the composition. The firing temperature is from 800 to 1,200° C. when a large amount of a glass component such as silica is contained. In case of alumina, the firing temperature is from 1,200 to 1,600° C., and preferably from 1,400 to 1,550° C. The tooth for a jaw and tooth model of the present invention is preferably formed of a sintered body of an alumina powder. In this case, the primary particle diameter of the alumina powder is preferably from 0.2 to 5 μm. It is preferred to fire at a firing temperature of 1,300 to 1,600° C. The firing temperature has a close relation with the grinding feel and it must be adjusted according to the particle size or raw material. Similarly, the retention time at a firing temperature also has a close relation with the grinding feel and it must be adjusted according to the particle size and raw material. Vickers hardness of the sintered body constituting the tooth for a jaw and tooth model of the present invention is preferably from 300 to 1,000, and more preferably from 300 to 600. As long as the grinding feel of the alumina sintered body is not impaired, a metal oxide such as silica may be added to the tooth composition. An injection molding for obtaining a sintered body of the tooth for a jaw and tooth model of the present invention is preferably formed by using a CIM technique which is often used as a method for forming ceramics. The CIM technique is a technique of forming an inorganic powder and includes the following steps of: (1) kneading alumina with a binder (which is thermally decomposed at about 1,000° C. or lower) to form pellets; (2) making a die for an injection molding having a given shape and injection-molding the pellets obtained in the step (1); (3) removing the binder through degreasing (decomposing a binder component by raising the temperature) after molding; and (4) firing the degreased injection molding at a predetermined temperature to obtain a desired sintered body. Examples of the binder, which can be used in the present invention, include stearic acid, polyvinyl alcohol, a thermoplastic resin and wax. Stearic acid or polyvinyl alcohol is preferably used. The thermoplastic resin means a resin which can obtain sufficient thermoplasticity for the purposes of molding by applying heat. Specific examples of a thermoplastic resin, which can be used in the present invention, include acryl-based, styrene-based, olefin-based, vinyl chloride-based, urethane-based, polyamide-based, polybutadiene-based, polyacetal-based, unsaturated polyester-based, polycarbonate and polyphenylene ether resins. Polysulfone-based, polyimide, polyether imide and polyether ether ketone resins can also be appropriately used. Among these resins, an acryl-based resin is particularly preferred. Both natural wax and synthetic wax can be used as a wax. Typical examples of the natural wax include animal/vegetable wax, mineral wax and petroleum wax. As a synthetic wax, blended wax and polyethylene wax can be used, and paraffin wax is preferred. Fats and oils are also included in the wax. Fats and oils mean a glycerin ester of fatty acid, are insoluble in water and soluble in an alcohol. Fats and oils are preferably in the form of solid fat at a normal temperature (37° C., atmospheric pressure) and examples thereof include vegetable Japan tallow, animal beef tallow- and lard. Specifically, lauric acid, myristic acid, palmitic acid, behenic acid, stearic acid, and fats and oils extracted from a living body can be used, and fats and oils extracted from a living body are preferred. Among these, fats and oils extracted from a living body (for example, lard, tallow, etc.) are particularly preferred. A tooth of a sintered body obtained by injection molding using a CIM technique, followed by the steps of degreasing and firing is immersed in a resin or a molten low melting point glass thereby impregnating a desired portion with the resin or glass to form an enamel portion. It is preferred that the tooth of the sintered body is impregnated with the resin or molten glass under reduced pressure and then the pressure is returned to a normal pressure. A thermosetting resin and a thermoplastic resin can be used as the impregnating resin in the present invention. A thermosetting resin is better than a thermoplastic resin. A thermosetting resin means a resin which is not dissolved in a solvent after processing and is not softened even when heated again. A urea resin, a melamine resin, a phenol resin and an epoxy resin can be typically used, and a melamine resin and an epoxy resin are preferred. Among these, an epoxy resin is most preferred. The thermosetting resin is preferably a chemical polymerizable resin because the voids portion of the sintered body is impregnated with the resin and the resin can be easily cured. The chemical polymerizable resin means a resin which is polymerizable using a chemical catalyst even when it is originally included in the thermosetting resin or thermoplastic resin. A chemical polymerizable resin, which contains a crosslinking agent and has no thermoplasticity, is particularly preferred. The thermoplastic resin means a resin which can obtain sufficient thermoplasticity for the purposes of molding by applying heat. Specific examples of a thermoplastic resin, which can be used to form the enamel portion in the present invention, include acryl-based, styrene-based, olefin-based, vinyl chloride-based, urethane-based, polyamide-based, polybutadiene-based, polyacetal-based, saturated polyester-based, polycarbonate, and polyphenylene ether resins. Among these resins, acryl-based, styrene-based, urethane-based and polyamide-based resins are particularly preferred. A preferred aspect with respect to the thermosetting resin can be obtained by mixing the thermoplastic resin with a crosslinking agent. That is, it is possible to perform training of tooth grinding without the resin being dissolved by heat generated upon grinding. The glass which can be used to form the enamel portion of the present invention is not specifically limited, and is preferably a low melting point glass which flows at a temperature within a range from 200 to 600° C. The temperature at which the glass begins to flow is preferably 600° C. or lower because the sintered body formed of an inorganic powder is not deformed. The low melting point glass is preferably an alumina silicate glass. A preferable glass has the composition consisting of 5 to 40% of Al 2 O 3 and 20 to 90% of SiO 2 , more preferably 20 to 35% of Al 2 O 3 and 35 to 70% of SiO 2 , and still more preferably 25 to 33% of Al 2 O 3 and 50 to 65% of SiO 2 . In order to lower the melting point, it is preferred that the glass contains 1 to 15%, and preferably 3 to 10% of at least one of sodium oxide, potassium oxide, lithium oxide and lanthanoid oxide. It is particularly preferred to add 2 to 10% of LaO 2 . It is preferred to appropriately add other components such as boric acid, phosphoric acid, sodium oxide, potassium oxide, lithium oxide, lime, magnesia, strontium oxide, barium oxide, lead oxide, titania, zinc oxide, and zirconia. It is preferred to appropriately add additives such as burnt ocher, cobalt trioxide, nickel oxide, potassium dichromate, chromium oxide, manganese dioxide, potassium permanganate, vanadium pentoxide, metallic selenium, sodium selenite, cupric oxide, copper sulfate, cuprous oxide, gold chloride, silver nitrate, sublimed sulfur, sodium sulfide, fluorite, sodium fluorosilicate, and apatite. It is possible to only color an enamel portion by adding components having a coloring effect to a glass so as to enhance the visibility of the enamel portion. In order to reproduce the same tough grinding feel as that of a natural tooth, voids of the portion of the sintered body, which would form the dentin portion of the tooth for a jaw and tooth model of the present invention, can be impregnated with a water-soluble material, a thermosoluble material or an organic material after forming the enamel portion. Any water-soluble material can be used without any limitation as long as it is a water-soluble polymer with which voids of the sintered body can be impregnated. At least one of a polysaccharide or a protein is preferably used. Among these, a protein is preferred. When impregnated with the water-soluble material, the effect is exerted by water pouring or previously impregnating water. Dextrin, glycogen, cellulose, pectin, konjak mannan and glucomannan, and alginic acid are preferably used as polysaccharides. Among these, cellulose, pectin, konjak mannan and glucomannan are preferred because a certain viscosity is required. The protein may be a polymer compound consisting mainly of a polypeptide comprising about twenty kinds of L-α-amino acids. In view of the composition, a simple protein consisting only of amino acid and a conjugated protein containing nucleic acid, phosphoric acid, lipid, saccharide and metal are preferably used. Gelatin, an agar-based material, collagen and elastin are more preferred. Gelatin and an agar-based material are still more preferred because not only these materials easily dissolve in water, but also the shape must be retained at the voids portion of the sintered body. A wax-based material can be used as the thermosoluble material. When impregnated with the thermosoluble material, the effect is exerted by dissolving through frictional heat generated upon grinding. The wax exerts an effect similar to that of polysaccharides or protein without using water, and it is possible to easily perform training of tooth grinding without using a water pouring equipment. As a wax, both natural wax and synthetic wax can be used. Typical examples of natural waxes include animal/vegetable wax, mineral wax and petroleum wax. As synthetic wax, blended wax and polyethylene wax can be used, and paraffin wax is preferred. Fats and oils are also included in the wax. Fats and oils mean a glycerin ester of fatty acid and are insoluble in water and soluble in an alcohol. Fats and oils are preferably in the form of solid fat at a normal temperature (37° C., atmospheric pressure) and examples thereof include vegetable Japan tallow, animal beef tallow and lard. Specifically, lauric acid, myristic acid, palmitic acid, behenic acid, stearic acid, and fats and oils extracted from a living body can be used, and fats and oils extracted from a living body are preferred. Among these, fats and oils extracted from a living body (for example, lard, tallow, etc.) are particularly preferred. It is possible to help impregnation by mixing a surfactant upon impregnation. That is, an auxiliary of the surfactant plays an important role so as to impregnate a voids portion of a sintered body with a water-soluble material or a thermosoluble material. The surfactant can also be used as a water-soluble material. Anionic, nonionic, cationic and amphoteric surfactants can be appropriately used. Among these surfactants, anionic and nonionic surfactants are preferred. As the anionic surfactant, a fatty acid salt (soap) C 11 H 23 COONa, an alpha-sulfo fatty acid ester salt (α-SFE) C 10 H 21 —CH(SO 33 Na)COOCH 3 , an alkyl benzene sulfonate (ABS) C 12 H 25 —(C 6 H 4 )SO 3 Na, an alkyl sulfate (AS) [higher alcohol-based] C 12 H 25 —OSO 3 Na, an alkyl ether sulfate ester salt (AES) C 12 H 25 —O(CH 2 CH 2 O) 3 SO 3 Na, and a triethanolamine alkyl sulfate C 12 H 25 —OS − . + NH(CH 2 CH 2 OH) 3 are used. As the nonionic surfactant, a fatty acid diethanolamide C 11 H 23 —CON(CH 2 CH 2 OH) 2 , a polyoxyethylene alkyl ether (AE) C 12 H 25 —O(CH 2 CH 2 O) 8 H, and a polyoxyethylene alkyl phenyl ether (APE) C 9 H 19 —(C 6 H 4 )O(CH 2 CH 2 O) 8 H are used. As the cationic surfactant, an alkyltrimethyl ammonium salt C 12 H 25 —N + (CH 3 ) 3 .Cl − , a dialkyldimethyl ammonium chloride C 12 H 25 —N + (C 8 H 17 )(CH 3 ) 2 .Cl − , and an alkyl pyridinium chloride C 12 H 25 —(N + C 5 H 5 ).Cl − are used. As the amphoteric surfactant, an alkyl carboxybetaine [betaine-based] C 12 H 25 —N + (CH 3 ) 2 .CH 2 COO − is used. The method of impregnating with a water-soluble material or a thermosoluble material will now be described. The impregnating water-soluble material or thermosoluble material is charged in a beaker and heated to an appropriate temperature thereby reducing viscosity. A proper amount of a surfactant is added. After reducing the viscosity, a ceramic sintered body is put in the beaker, and the beaker is placed in a vacuum desiccator. The air in the vacuum desiccator is gradually extracted thereby discharging the air in the ceramic sintered body outside of the vacuum desiccator. As the evacuation progresses, air bubbles are formed on a surface of the sintered body, and thus it is found that the air in the sintered body has been extracted. After the completion of extraction of the air, impregnation is conducted by gently returning the air to the desiccator. The organic material is preferably at least one of a thermosetting resin a thermoplastic resin and a resin containing a crosslinking agent. An epoxy resin is more preferred. The method for forming false dental caries or a false tooth pulp in the tooth for a jaw and tooth model of the present invention will now be described. The carious dental site or tooth pulp portion is formed of a combustible thermosetting resin material. When a tooth is produced using a die, a CIM material is injection-molded so as to coat the carious dental site or tooth pulp portion formed of the combustible thermosetting resin material. Then, the carious dental site or tooth pulp portion fired to form a hollow carious dental site or tooth pulp portion. A silicone rubber is poured into the hollow carious dental site or tooth pulp portion to form false dental caries or false tooth pulp. A dental caries shape is formed at a portion of a fossa of an occlusal surface or an enamel-dentin transition portion. When it is formed of the portion of fossa, enamel is not drastically attacked, but the dentin portion is often drastically attacked. A method of reproducing a bag-shaped carious dental site has previous not been accomplished. Also in the tooth pulp shape, only small pores are opened outside like the apical foramen, similarly, and a method of reproducing a bag-shaped tooth pulp site having a large tooth pulp portion therein has previous not been accomplished. When the enamel portion of the tooth is impregnated with a resin, the carious dental portion or tooth pulp portion may be impregnated with a resin at the same time. Before the enamel portion of the tooth is impregnated with the resin, it is possible to prevent the resin from impregnating the inorganic powder sintered body at the dental caries and an inorganic powder sintered body at the tooth pulp side by impregnating the carious dental portion or tooth pulp portion with resin, the resin being previously cured by polymerization. Thus the grinding feel becomes more closely to that of a natural tooth and it is preferred. The material used for the carious dental portion or tooth pulp portion can be freely selected from an elastic resin, a foamed resin, a thermosetting resin, a thermoplastic resin, a resin containing a crosslinking agent, a water-soluble material, and a thermosoluble material. A foamed resin and a thermosetting resin are preferably used for the carious dental portion. A thermosetting resin or a resin containing a crosslinking agent is preferred. An epoxy resin is more preferred. An elastic resin, a foamed resin and a thermosetting resin are preferably used for the tooth pulp. The method of impregnating with a water-soluble material and a thermosoluble material, which can be used for the carious dental portion or tooth pulp portion, is the same as described above. Any silicone rubber can be used in the carious dental portion or tooth pulp portion in the ceramics sintered body of the tooth for a jaw and tooth model of the present invention without any limitation. It is particularly preferred to apply to the tooth pulp portion. Examples of the other usable rubber material include a chlorosulfonated polyethylene rubber; a Hypalon rubber, a fluororubber and an isobutene-isoprene rubber; a butyl rubber, a natural rubber and an acrylonitrile-butadiene rubber: a Hiker rubber, a urethane rubber, an ethylene-propylene rubber, a styrene-butadiene rubber and a chloroprene rubber; and neoprene. The rubber hardness (Durometer (JIS K 6253)) is from 10 to 70, and preferably from 20 to 50. As the wax of the carious dental portion or tooth pulp portion in ceramics sintered body of the tooth for a jaw and tooth model of the present invention, for example, animal-derived wax (beeswax, spermaceti, shellac wax, etc.), plant-derived wax (Carnauba wax, Japan tallow, rice bran wax (rice wax), Candelilla wax, etc.), petroleum-derived wax (paraffin wax, microcrystalline wax, etc.), mineral-derived wax (Montan wax, ozocerite, etc.), synthetic wax (Fischer-Tropsch wax, polyethylene wax, fats and oils-based synthetic wax (ester, ketones, amides), and hydrogenated wax can be used. It is particularly preferred to apply to the tooth pulp portion. Among these waxes, petroleum-derived wax is preferred and paraffin wax is particularly preferred. The water-soluble material of the carious dental portion or tooth pulp portion in the ceramics sintered body of the tooth for a jaw and tooth model of the present invention contains at least one of polysaccharides and protein-based material. The water-soluble material can exert the effect by water pouring or previously impregnating water. A protein is preferred. A hydrophilic polymer is also preferably used as the water-soluble material. For example, cellulose derivatives such as natural product-derived semisynthetic carboxymethyl cellulose (CMC) and methyl cellulose (MC); and synthetic water-soluble polymers such as polyvinyl alcohol (PVA), a polyacryl-based polymer, polyacrylamide (PAM) and polyethylene oxide (PEO) can be used. The combustible material is not specifically limited as long as it can be formed into a tooth pulp shape and is not deformed at the injection pressure and temperature upon formation of a tooth, and is also combusted upon firing of the tooth to form a tooth pulp space. Specifically, it is a resin and is particularly preferably a thermosetting resin. Specifically, it may be obtained by crosslinking a urea resin, a melamine resin, a phenol resin, an epoxy resin, an acryl-based resin or a styrene-based resin. The combustible tooth pulp forming step of forming a combustible material tooth pulp formed at a carious dental portion or a tooth pulp portion using a combustible material is the step of previously forming a carious dental portion or a tooth pulp portion using a combustible material upon firing of a tooth so as to form a tooth pulp shape of the tooth. Since the tooth formed of an inorganic material is subjected to the firing step, the combustible material is fired to form a space and then the space is filled with a material suited for a tooth pulp to complete a tooth. This step is the tooth pulp shape forming step. The die setting step of setting a carious dental portion or tooth pulp portion formed of a combustible material at a predetermined position in a tooth die is the step of setting a carious dental portion or tooth pulp portion formed of a combustible material in a die. A carious dental portion or tooth pulp portion formed previously of a combustible material may be set in a die, or a carious dental portion or tooth pulp portion formed continuously in-situ of a combustible material may be set in a die again. The injecting step of injecting pellets comprising an inorganic powder and a binder into a tooth die to obtain an inject-molded tooth is a step in which pellets are injected, the pellets obtained by mixing an inorganic powder comprising a dental composition with a binder with heating in a tooth die with a carious dental portion or tooth pulp portion formed of a combustible material. In this step, since the carious dental portion or tooth pulp portion formed of the combustible material is thin, injection must be conducted while paying careful attention. The firing step of firing an inject-molded tooth after greasing to obtain a fired tooth is a step in which the inject-molded tooth obtained in the injecting step is fired. The firing temperature in the firing step is from 800 to 1200° C. when a large amount of a glass component is contained. In case of alumina, the firing temperature is from 1,200 to 1,600° C., and preferably from 1,400 to 1,550° C. At this time, carious dental portion or tooth pulp portion formed of the combustible material is burned out to form a space portion. The tooth pulp production method of filling the fired carious dental portion or tooth pulp portion with a resin, a silicone rubber, a wax or a water-soluble material is the step of forming a false tooth pulp at the space portion of the fired tooth pulp using a resin, a silicone rubber, a wax or a water-soluble material. Examples of the method include a method of filling using a syringe, and a method of filling a tooth pulp portion of a sintered body with a false tooth pulp material by immersing in the false tooth pulp material and placing in a vacuum vessel, followed by evacuation. A method for producing a tooth for a jaw and tooth model of the present invention will now be described. EXAMPLES Production of Sintered Body of Tooth Sintered Body 1 A die capable of injection-molding into a tooth shape was produced. 1 kg of an alumina pellets for CIM (the content of Al 2 O 3 : 100%, average particle diameter: 5.0 μm, the content of stearic acid: 30%) as a raw material of a tooth were injection-molded in a die for tooth to obtain an injection molding 1 . The resultant injection molding having a tooth shape was degreased and then fired (1,500° C., retention time: 10 minutes) to obtain a sintered body 1 . Sintered Body 2 A die capable of injection-molding into a tooth shape was produced. 1 kg of an alumina pellets for CIM (the content of Al 2 O 3 : 100%, average particle diameter: 1.0 μm, the content of stearic acid: 30%) as a raw material of a tooth were injection-molded in a die for tooth to obtain an injection molding 2 . The resultant injection molding having a tooth shape was degreased and then fired (1,500° C., retention time: 10 minutes) to obtain a sintered body 2 . Impregnation with Resin The crown portion of the resultant sintered bodies 1 and 2 was immersed in each material shown below and placed in a vacuum vessel, followed by evacuation. After standing for 10 minutes, the pressure was returned to a normal pressure thereby impregnating with each material to form an enamel portion (Examples 1 to 6). The impregnation depth varies depending on the particle size of an alumina powder contained in alumina pellets and an impregnating resin material, and is from 0.5 to 5.0 mm. Thirty teeth were produced and the grinding feel of the teeth was confirmed. Tested Resin Epoxy resin (low viscosity epoxy resin Z-2/H-07): An epoxy resin containing a catalyst added therein was used. The pressure was returned to a normal pressure. 72 hours after standing, the grinding feel was confirmed using a diamond bar. Acrylic resin (MMA monomer, manufactured by KURARAY CO., LTD.): An acryl-based resin containing a chemical polymerization catalyst added therein was used. The pressure was returned to a normal pressure. 72 hours after standing, the grinding feel was confirmed using a diamond bar. Melamine resin (RTV silicone resin M8017, manufactured by Asahi Kasei Corporation): A silicone resin containing a catalyst added therein was used. The pressure was returned to a normal pressure. 72 hours after standing, the grinding feel was confirmed using a diamond bar. As Comparative Examples, non-impregnated sintered bodies 1 and 2 (Comparative Examples 1 to 2) were used. TABLE 1 Dentin-enamel Sintered Impregnating Grinding transition body resin feel feel Example 1 Sintered Epoxy resin A A Example 2 body 1 Acrylic A A resin Example 3 Melamine A A resin Comparative B C Example 1 Example 4 Sintered Epoxy resin A A Example 5 body 2 Acrylic A A resin Example 6 Melamine A A resin Comparative B C Example 2 Evaluation Criteria Grinding Feel A: Grinding feel of dentin portion and enamel portion could be sufficiently exhibited. B: Grinding feel of dentin portion and enamel portion could not be sufficiently exhibited. Dentin-Enamel Transition Feel A: Difference in grinding feel could be sufficiently exhibited upon transition between dentin portion and enamel portion. B: Difference in grinding feel could not be sufficiently exhibited upon transition between dentin portion and enamel portion. C: Difference in grinding feel could not be completely exhibited upon transition between dentin portion and enamel portion. In Examples 1 to 6, it was possible to obtain a grinding feel which is tough when compared with Comparative Examples 1 and 2 and is similar to that of a natural tooth. Crushing feel peculiar to ceramics upon grinding was scarcely confirmed and the feel closed to feel upon grinding of the living body tooth. It was possible to obtain a tooth comprising an enamel portion and a dentin portion, each having different grinding feel, similarly to a natural tooth by controlling the evacuation amount, evacuation time and immersion time thereby adjusting the resin impregnation depth. When dentin and enamel are separately formed, since chipping occurred between the dentin and enamel, training related to tooth grinding could not be easily conducted. Impregnation with Glass A paste prepared from each material shown below was built up on a crown portion of the resultant sintered bodies 1 and 2 and then fired at each temperature shown below thereby impregnating with each material to form an enamel portion (Examples 7 to 10). The impregnation depth varies depending on the particle size of an alumina powder contained in alumina pellets and an impregnating glass material, and is from 0.5 to 5.0 mm. Thirty teeth were produced and grinding feel of the teeth. Tested Glass PbO—SiO 2 —B 2 O 3 : firing temperature of 550° C. Alumina silicate glass: firing temperature of 950° C. TABLE 2 Dentin-enamel Sintered Impregnating Grinding transition body glass feel feel Example 7 Sintered PbO—SiO 2 —B 2 O 3 A A Example 8 body 1 Alumina silicate A A glass Example 9 Sintered PbO—SiO 2 —B 2 O 3 A A Example 10 body 2 Alumina silicate A A glass Evaluation Criteria Grinding Feel A: Grinding feel of dentin portion and enamel portion could be sufficiently exhibited. B: Grinding feel of dentin portion and enamel portion could not be sufficiently exhibited. Dentin-Enamel Transition Feel A: Difference in grinding feel could be sufficiently exhibited upon transition between dentin portion and enamel portion. B: Difference in grinding feel could not be sufficiently exhibited upon transition between dentin portion and enamel portion. C: Difference in grinding feel could not be completely exhibited upon transition between dentin portion and enamel portion. In Examples 7 to 8, it was possible to obtain grinding feel which is tough and is similar to that of a natural tooth. Crushing feel peculiar to ceramics upon grinding was scarcely confirmed and the feel was close to the feel upon grinding of the living body tooth. It was possible to obtain a tooth comprising an enamel portion and a dentin portion, each having a different grinding feel, similarly to a natural tooth by controlling the kind of glass and firing time after building up of the glass thereby adjusting the low melting point glass impregnation depth. The resultant tooth can be used as a tooth for training related to grinding of a natural tooth in universities for dentist training.

An object of the present invention is to provide a tooth model capable of exhibiting grinding feel similar to that of a natural tooth, with which students aspiring to become dentists experience intraoral work and perform training related to a treatment, and also experience formation of an abutment tooth, formation of cavity or the like. A difference in the grinding feel between tooth enamel and dentin, which constitute a natural tooth, is reproduced by impregnating a sintered body formed integrally of an inorganic powder such as alumina with a thermosetting resin or a low melting point glass to form an enamel portion.

FIELD OF THE INVENTION This invention relates to craps game tables and more particularly to such craps game tables which have electronic and electrical event summary displays as well as individual bet placement layouts. BACKGROUND OF THE INVENTION The gaming industry, sanctioned by increasing numbers of states, has experienced dynamic growth. Casinos, spurred by growing competition, are investing heavily in theme buildings and more elaborate equipment to compete for game players. In the industry there is a desire to enhance the attractiveness of the game tables to the game players. What is appreciated by the more experienced game player is more information upon which to base their betting decisions and hunches. Such information, comparable to a race horse's track history, makes the game more interesting to intelligent better informed patrons. From the casino's viewpoint, such historical event information allows for the possibility of heretobefore unavailable bet combinations; bet combinations which will challenge and entice game players with enormous long shot and pool payoffs which will be exceptionally profitable to the casino. OBJECTS AND STATEMENT OF THE INVENTION It is an object of this invention to disclose innovations to the craps game table which will stimulate the interest of veteran game players. It is an object of this invention to summarize historical event information. It is an object of this invention to disclose a new dimension to a craps game table by presenting the possibility of new bet combinations for the game player to consider. It is a further object of this invention to disclose an innovation to the craps game table which promotes interest among game players, offers exciting payoffs, and concurrently is exceptionally lucrative for casinos. It is an object of this invention to allow game players to wager on events sequentially occurring in two and more moves. It is yet a further object of this invention to disclose a format for a craps game table which provides individual bet placement areas for each game player to facilitate identification of their bets. One aspect of this invention provides for a craps game table comprising: a dice rolling area; event registration means for registering a combination rolled; an electronic recent event display; and, a computer programmed to display and summarize the most recent events. A preferred aspect of this invention provides for a craps game table as above wherein the table is configured with individual bet placement layouts each adapted to allow the placement of bets on two or more sequential bets. Various other objects, advantages and features of novelty which characterize this invention, are pointed out with particularity in the claims annexed to, and form part of this disclosure. For a better understanding of the invention, its operating advantages, and the specific objects attained by its users, reference should be made to the accompanying drawings and description, in which preferred embodiments of the invention are illustrated. FIGURES OF THE INVENTION The invention will be better understood and objects other than those set forth will become apparent to those skilled in the art when consideration is given to the following detailed description thereof. Such description make reference to the annexed drawings wherein: FIG. 1 is a plan view of a craps game table, having individual bet placement areas and an electronic event summary display. FIG. 2 is across sectional view of the craps table shown in FIG. 1 taken along line 2--2. FIG. 3 is an enlarged broken away view of the croupier display and event entry portion of the craps table shown in FIG. 1. FIG. 4 is an enlarged view of a top portion of the croupier display shown in FIG. 3. FIG. 5 is an enlarged view of a bottom portion of the croupier display shown in FIG. 3. FIG. 6 is an enlarged view of an individual bet placement layout as shown on FIG. 1. FIG. 7 is an enlarged view of an electronic event display as shown on FIG. 6. FIG. 8 is an enlarged view of a come/don't come bet placement area shown in the bet placement layout in FIG. 6. FIG. 9 is an enlarged view of a don't pass bet placement area shown in the bet placement layout in FIG. 6. FIG. 10 is an enlarged view of a pass bet placement area shown in the bet placement layout in FIG. 6. FIG. 11 is an enlarged view of an odd bet placement area shown in the bet placement layout in FIG. 6. FIG. 12 is an enlarged view of an even bet placement area shown in the bet placement layout in FIG. 6. FIG. 13 is an enlarged view of the combination rolled - event summary display shown on the interior sidewall of the craps table in FIGS. 1 and 2. FIG. 14 is an enlarged view of the outcome total - event summary display shown on the interior sidewall of the craps table in FIGS. 1 and 2. The following is a discussion and description of the preferred specific embodiments of this invention, such being made with reference to the drawings, wherein the same reference numerals are used to indicate the same or similar parts and/or structure. It should be noted that such discussion and description is not meant to unduly limit the scope of the invention. DESCRIPTION OF THE INVENTION Turning now to the drawings and more particularly to FIG. 1 we have a plan view of a craps game table 10, the subject of this invention. The craps game table 10 comprises a dice rolling area 11; event registration means (preferably a keyboard 19) for registering a combination rolled; an electronic recent event display 15,16,17,18; and, a computer(not shown) programmed to summarize and display the most recent events. A dice rolling area 10 forms the central part of the table 11. An upright wall 14, surrounding the dice rolling area 11, separates a peripheral portion of the table 10 therefrom. The peripheral portion of the table has individual bet placement layouts 8 on three sides therearound and a croupier's event summary 17, 18 and an event registration means therefor; preferably a condition event entry keyboard 19. A peripheral rail 13 extends around the most preferably oval shaped table 10. FIG. 2 is a cross sectional view of the craps table 10 shown in FIG. 1 taken along line 2--2. FIG. 2 best shows how the dice rolling area 11 and the upright sidewalls 14 together form a pit for throwing dice (not shown). Four electronic recent event displays 15,16,17,18 are positioned on the upright wall 14 at four locations around the table so that they may be viewed from the individual bet placement areas 8. FIG. 3 is an enlarged broken away view of the croupier display 17,18 and event entry portion 19 of the craps table 10. The event entry portion 19 comprises a keyboard 19 having a separate key for each possible dice combination which may be rolled. The keyboard 10 also includes a delete key to delete a combination entered in error. The keyboard 10 may be replaced by a computer aided scanning device for reading the top face of the dice after each roll and thereby, automatically identify and enter each dice combination defining an event. FIG. 4 is an enlarged view of a top portion 17 of the croupier display shown in FIG. 3. A similar type of display 17 is used on the interior sidewall 14 of the craps table 10 as shown in FIGS. 1 and 2. Top portion 17 comprises a row of nine--two digit displays, 17a through 17i each two digit display shows the total numerical value of a recent event. The 2 digit displays are chronologically arranged so that the last event is always displayed on the left display 17a and the ninth last event is displayed on the right display 17i. Intervening events are chronologically ordered therebetween. A lower portion of the display 17 comprises a digital display 17x recording the roll time of the last event. FIG. 5 is an enlarged view of a bottom portion 18 of the croupier display shown in FIG. 3. The top portion thereof comprises a row of nine--two digit event combination displays 18a through 18i, each two digit display shows the combination, e.g. 4+6 rolled on a recent event. These events are chronologically ordered so that the last combination appears on the left display 18a and the earliest appears on the most right display 18a. The lower section portion of the display 18 comprises a row of nine indicators. Each indicator 18j through 18r shows whether the come-out point (first roll of a turn) or craps was the outcome on one of the last nine events. As above these indicators 18j through 18r are chronologically ordered so that the last event appears on the left display 18a and the earliest appears on the most right indicator 18i. Between the top row of nine two displays 18a through 18i and the bottom row of nine indicators 18j through 18r there are eighteen identical digital time displays such as 18x. Each of these time displays indicates the time at which the adjacent event combination displays 18a through 18i or indicators 18j through 18r occurred. FIG. 6 is an enlarged view of an individual bet placement layout 8 shown on FIG. 1. The individual bet placement layout 8 comprises an electronic event display 22 (best seen enlarged on therefor FIG. 7 and a plurality of pressure sensitive bet placement areas 23, 24, 25, 26, and 27. Areas 23 through 27 include a come/don't come bet placement area 23 (best seen enlarged on FIG. 8); a don't pass bet placement area 24 (best seen enlarged on FIG. 9); a pass bet placement area 25 (best seen enlarged on FIG. 10); an odd bet placement area 26 (best seen enlarged on FIG. 11); and, an even bet placement area 27 (best seen enlarged on FIG. 12). A flag lamp 20 is positioned beside each individual bet placement area to alert the croupier when a bet is placed on one of the pressure sensitive bet placement areas 23, 24, 25, 26, or 27. Each of the bet placement areas 24, 25, 26, or 27 are electrically connected to a digital clock 28 (See FIG. 7) which will indicate the time at which the bet is placed on the bet placement area. A digital payout ratio display 21 is programmed to display the payoff, of an outcome based on events sequentially occurring over two or more moves, of the last touched bet placement area 23, 24, 25, 26, or 27. FIG. 7 is an enlarged view of the electronic event display 22 shown on FIG. 6. This display 22 summaries the total number of times each two dice combination has been rolled after a time which appears on digital display 30. FIG. 8 is an enlarged view of the come/don't come bet placement area 23 shown in the bet placement layout in FIG. 6. Flag lamp 20 shown thereon alerts the croupier when a bet is placed on the pressure sensitive bet placement layout 23. The bet placement layout 23 is marked to allow game players to wager on events sequentially occurring in two or more moves. FIG. 9 is an enlarged view of the don't pass bet placement area 24 shown in the bet placement layout in FIG. 6. When a bet is placed on the pressure sensitive bet placement area 24 flag lamp 20 is turned on and clock 35 records the time at which the bet is placed. In the configuration shown the game player may bet on the outcome of up to nine sequential moves. FIG. 10 is an enlarged view of the pass bet placement area 25 shown in the bet placement layout in FIG. 6. When a bet is placed on the pressure sensitive bet placement area 25 flag lamp 20 is turned on and clock 35 records the time at which the bet is placed. In the configuration shown the game player may bet on the outcome of up to nine sequential moves. FIG. 11 is an enlarged view of the odd bet placement area 26 shown in the bet placement layout in FIG. 6. FIG. 12 is an enlarged view of the even bet placement area 27 shown in the bet placement layout in FIG. 6. FIG. 13 is an enlarged view of the combination rolled - event summary display shown on the interior sidewall 14 of the craps table 10 in FIGS. 1 and 2. Twenty-one three digit displays, one of which is designated 15a, record the number of times each dice combination has been rolled after a recorded time shown on clock 15b. Number of rolls indicator 15c records the number of rolls which have occurred after the recorded time on clock 15b. The number of odd rolls after the recorded time on the clock 15b is shown on display 15x. The number of even rolls after the recorded time on the clock 15b is shown on display 15y. FIG. 14 is an enlarged view of the outcome total - event summary display 16 shown on the interior sidewall 14 of the craps table 10 in FIGS. 1 and 2. Eleven three digit displays, one of which is designated 16a record the number of times each two dice total has been rolled after a recorded time shown on clock 15b. Number of rolls indicator 16b records the number of rolls which have occurred after the recorded time on clock 15b. The number of field rolls after the recorded time on the clock 15b is shown on display 16c. The number of non-field rolls after the recorded time on the clock 15b is shown on display 16d. A field roll is generally one of the statistically less frequently rolled two dice totals such as 2, 3, 11, or 12. Some casinos define a field roll to include other less frequently occurring totals, in addition to the totals mentioned above. In the course of play, the craps-type gaming device is used as follows. Referring first to the shared information on displays 15 and 16, as shown in FIGS. 13 and 14, the host of the gaming device sets the clock 15b. This is entirely an arbitrary time which may coincide with any event such as a croupier start of shift. That clock is suitable for recording time for a period of several or more hours. Commencing with the first roll of dice after the clock is initiated, the croupier then enters the dice-roll related information through the keyboard 19 or from similar manual or automatic means for sensing the numeric value of each die on each roll of the dice. That information is immediately recorded in the computer and is then displayed on displays 15 and 16. For example, if the first roll of the dice showed the numerical values 6 and 4, the croupier would press the 6+4 key on the keyboard and this information would be immediately displayed in the third display window (6+4) of the top row of display 15 in a color, highlighted by the croupier to differentiate it as the point and remaining highlighted until the point is made or craps is thrown, and different from the color used by displaying past recorded rolls. Since 6+4 is an even number, a one (1), indicating a single occurrence, would be displayed on the three digit Even display 15y. Of course, if the value were odd, the numerical value of Odd display 15x would be incremented. Simultaneously, the Number of Rolls display 15c would also be incremented and being correlated with the clock, would show the numerical value one (1) indicating that since play began, as recorded in clock 15b, there has been a single roll. Simultaneously, since 6+4 equal 10, one of the three digit displays 16a would be incremented, namely, the display that indicates the number of occurrences of the numeral "10". The Number of Rolls display 16b would also be incremented. Assuming that the host has decided to offer betting on "field", the host would establish the values for Field such as the statistically less frequently rolled two dice total, 2, 3, 11 or 12. Of course, the casino may define a field roll to include other less frequently occurring totals including, for example, 4 and 10. Depending on how the host defines "field", and assuming that Field rolls comprise the above mentioned 2, 3, 11 or 12 values, then the roll in the example given above, namely 10, would be a "non-field" roll and would be recorded and displayed in Non-Field display 16d. Otherwise, it would be recorded and displayed in Field display 16c. It will be understood that as the game continues, with each succeeding roll of the dice, and regardless of whether a player's turn has ended, that is, in a cumulative manner commencing at the time at which the clock was started, each roll of the dice will be recorded by the croupier and will increment the appropriate digital display 15a, 15c, 15x, 15y, 16a, 16b, 16c, and/or 16d. Assume now that the game has been in progress so that the various displays indicate the cumulative occurrences of various dice-related information, and a player commences play at one of the stations 8. Referring now to FIGS. 6 through 12, play, as it relates to a single player, will be described. A player may place a bet by placing a chip on one of the pressure sensitive areas 23, 24, 25, 26 and/or 27. This placement records the time and type of the bet. Of course, area 23 is a common craps bet, namely, "Come"; a bet placed on Come wins if the first roll of a player's turn is 7 or 11 or if the player rolling the dice has made the Come Out point. Referring to areas 24 and 25 of Station 8, it will be seen that a player may also make a "Don't Pass" or a "Pass" bet as in a standard craps game. But to create further complexity and therefore generate interest in players, areas 24 and 25 at each station also have in the right hand portion of the area (shown as an ellipse) pressure sensitive spots at that station for numerals 2 through 9. Rather than simply making a Don't Pass or Pass bet, the player may place a chip on, for example, the pressure sensitive spot with the numeral 3 on area 25. That represents a wager by the player that the player rolling the dice will pass three consecutive times. If that occurs, the player wins at appropriate odds; if not, the player loses. When the bet is placed on spot 3 of area 25, it trips an electronic switch that records the time and begins the running of a clock to indicate the time at which the bet was commenced which must precede any player's roll of the dice which is recorded by the croupier. Continuing the description of the play, and using the same example as indicated above, and with attention drawn to FIGS. 4 and 5, dice-roll related information will be recorded and displayed on displays 17 and 18. Display 17 generally provides information regarding the last number rolled for each of the last 9 rolls. The most recent roll is shown in the left hand display 17a and the ninth last roll is displayed in display 17b. At the select ion of the host, this display may be reset at the beginning of each player's turn or may be cumulative since the initiation of clock 15b. In display 18, as in display 15, the information generally provides dice-roll related information regarding the "Point" and whether or not that point has been "made" or craps has occurred prior to making the point. This is in accordance with standard craps rules. By way of example, assuming the role of 6+4 has been completed and the croupier has electronically recorded that information through the keyboard 19. In display 17 the number then appearing in display 17a will immediately be transferred to the next right-adjacent display, and so on, until the number of the tenth previous roll is removed from display 17. Simultaneously, since this was the first roll of a player's turn, the value 10 constitutes the player's "Come Out Point" or simply, "Point" and this will be displayed in display 18a which is the left most display on display board 18. In the bottom row of displays on display board 18, display 18c will be blank until, on successive rolls of the player, the point 10 is either made or craps is thrown. Upon that occurrence, and of course the recording of that event by the croupier, display 18c will either display "Made" or "Craps". The timer in display board 17 indicates how current the displayed numbers have occurred. In other words, how long it has been since the last roll has occurred. In display board 18, one of the 18x time displays in the row closer to the top row of the displayed numbers will display the time at which the point was established. The time in the lower row corresponding to that same vertical column will show the time at which either that point was made or craps occurred. As will now be understood, one of the important features of the craps-type gaming device of the present invention is the correlation between the occurrence of some dice-roll related information to a particular time. Thus, not only will a gambler have access to a history of various events, i.e., dice-roll related information, over some finite but extended period of time, information as to the occurrence of that particular event may also be obtainable, depending upon the particular event. While the invention has been described with preferred specific embodiments thereof, it will be understood that this description is intended to illustrate and not to limit the scope of the invention. The optimal dimensional relationships for all parts of the invention are to include all variations in size, materials, shape, form, function, assembly, and operation, which are deemed readily apparent and obvious to one skilled in the art. All equivalent relationships to those illustrated in the drawings, and described in the specification, are intended to be encompassed in this invention. What is desired to be protected is defined by the following claims.

An electronically and physically improved craps game table designed to provoke and stimulate the interest of novice, occasional, and veteran craps game player is disclosed. The craps game table comprises: a dice rolling area; event registration means for registering a combination rolled; an electronic recent event display; and, a computer programmed to display historical and recent events. A preferred aspect of this invention provides for a craps game table as above wherein the computer is additionally programmed to summarize the most recent events, and wherein the computer is programmed to display the last nine events. The craps game table may additionally be marked to allow game players to wager on events sequentially occurring in two and more moves; and the computer may be programmed to display payoffs for those sequentially occurring events. The most preferred embodiment additionally provides for multiple individual bet placement layouts around the periphery of the table. The electronically improved craps game table provides for the possibility of heretobefore unavailable bet combinations; sequential bet possibilities which will attract game players with astronomical, ever changing and electronically posted payoffs; payoffs which will be exceptionally lucrative to the casinos.

RELATED APPLICATION This is a division of application Ser. No. 07/963,278, filed Oct. 19, 1992, now U.S. Pat. No. 5,372,996, which is in turn a continuation of U.S. application Ser. No. 07/376,710, filed Jul. 7, 1989, now abandoned. Priority under 35 U.S.C. §120 is claimed as to both. BACKGROUND OF THE INVENTION This invention relates to a method of treatment of androgen-related diseases such as prostate cancer in warm-blooded male animals (including humans) in need of such treatment, and in particular, to a combination therapy comprising administering an antiandrogen in association with an inhibitor of sex steroid biosynthesis to such animals. The invention also includes pharmaceutical compositions and kits useful for such treatment. Androgen-dependent diseases include diseases whose onset, maintenance or progress is, at least in part, dependent upon biological activities induced by androgens (e.g. testosterone and dihydrotestosterone). In one embodiment, the invention provides a treatment of hormone-dependent prostate cancer in warm-blooded male animals which comprises administering both an antiandrogen and at least one inhibitor of sex steroid biosynthesis capable of inhibiting conversion of dehydroepiandrosterone or 4-androstenedione to natural sex steroids in extra-testicular and extra-adrenal tissues. While various investigators have been studying hormone-dependent prostate cancer, none have proposed the combination therapy of this invention. A. V. Schally et al., Cancer Treatment Reports, 68 (No. 1) 281-289 (1984), summarize the results of animal and clinical studies on growth inhibition of hormone-dependent mammary and prostate tumors by use of analogues of luteinizing hormone-releasing hormones, the so-called LHRH agonists and suggest that LHRH analogs and/or antagonists may have potential for treating breast cancer. T. W. Redding and A. V. Schally, Proc. Natl Acad. Sci. UA 80, 1459-1462 (1983), relates to inhibition of prostate tumor growth in rats by chronic use of an LHRH agonist, [D-Trp 6 ]LHRH. U.S. Pat. No. 4,329,364 relates to use of the antiandrogen, 4'-nitro-3'trifluoromethyl isobutyranilide for treatment of prostatic cancer. U.S. Pat. No. 4,472,382 relates to treatment of prostate adenocarcinoma, benign prostate hypertrophy and hormone-dependent mammary tumors may with various LHRH agonists and treatment of prostate adenocarcinoma and benign hypertrophy by use of various LHRH agonists and an antiandrogen. U.S. Pat. No. 4,659,695 (Labrie) relates to treatment of prostate cancer in animals whose testicular hormonal secretions are blocked. The method of treatment includes administering an antiandrogen such as flutamide as an inhibitor of sex steroid biosynthesis such as aminoglutethimide and/or ketoconazole. Some clinical improvement in men with prostate cancer by use of the two LHRH agonists, Buserelin and Leuprolide, is also reported by N. Faure et al. at pages 337-350 and by R. J. Santen et al. at pages 351-364, respectively, LHRH and its Analogues--A new Class of Contraceptive and therapeutic Agents (B. H. Vickery and J. J. Nestor, Jr., and E. S. E. Hafez, eds), Lancaster, MTP Press, (1984). R. Santen et al., he Journal of Steroid Biochemistry, volume 20, no 6B, at page 1375 (1984), relates that the use of ketoconazole in combination with chronic administration of Leuprolide in rodents decreased basal and Leuprolide-stimulated testosterone levels. One of Applicant's Co-pending U.S. patent applications Ser. No. 07/321,926 filed Mar. 10, 1989, now abandoned, relates to a combination therapy for treatment of estrogen-related diseases by inhibiting ovarian hormonal secretions and administering an antiestrogen in combination with at least one of several enumerated activity blockers, sex steroid formation inhibitors and the like. D. Kerle et al., The Journal of Steroid Biochemistry, volume 20, no. 6B, at page 1395 (1984) relates to the combined use of a LHRH analogue and ketoconazole producing objective responses in some prostate cancer patients who have relapsed or failed to respond to treatment with a LHRH analogue alone. F. Labrie et al., The Prostate, 4, 579-594 (1983), disclose that use of a combination therapy of an LHRH agonist (Buserelin) and an antiandrogen (Anandron) to treat advanced prostate cancer in previously untreated patients effects simultaneous elimination of androgens of both testicular and adrenal origin. F. Labrie et al., J. Steroid Biochem., 19, 999-1007 (1983), disclose the treatment of prostate cancer by the combined administration of an LHRH agonist and an antiandrogen. Labrie et al. disclose animal and clinical data in support of the proposition that the combined LHRH/antiandrogen treatment neutralizes the stimulatory influence of all androgens on the development and growth of androgen-dependent prostatic cancer. F. Labrie et al., Abstracts of the 7th International Congress of Endocrinology, Excerpta Medica (1984) at page 98 disclose that treatment of prostate cancer patients with LHRH agonists alone causes a transient increase in serum androgen levels lasting for 5 to 15 days before castration levels are reached. While F. Labrie et al. recommend that orchiectomy, estrogen and LHRH agonists alone should not be further used for treatment of prostate cancer in the absence of a pure antiandrogen, there still is a need for a method of treatment of prostate cancer that effects more complete androgen blockage at the start as well as during the full period of treatment. There are many data indicating that estrogens have a stimulatory effect on prostatic growth (Lee et al., 1981; J. Androl. 2: 293-299; Belis et al., 1983; J. Androl. 4: 144-149; Walsh and Wilson, 1976; J. Clin. Invest. 57: 1093-1097; De Klerk et al., 1985; Prostate 7, 1-12; Habesucht et al., 1987; Prostate 11: 313-326). Estrogens have also been found to enhance the growth-promoting effect of androgens (Farnsworth, 1969; Invest. Urol. 6: 423-427; Groom et al., 1971; Biochem. J. 122: 125-126; Lee et al., 1973; Steroids 22: 677-683). Estrogen receptors have been demonstrated in human normal, hyperplastic and cancer prostatic tissue (Hobbs et al., 1989; Proc. 84th Endocrine Soc., Meeting, abst. No. 1410; Hobbs et al., 1983; J. Steroid Biochem. 19, 1279-1290; Wagner et al., 1975; Acta Endocrinol. (Kbh), suppl. 193, 52; and also in laboratory animal prostatic tissue (Swaneck et al., 1982; Biochem. Biophys. Res. Commun. 106: 1441-1447). Moreover, androgen receptor levels were found to be elevated in prostatic tissue of patients treated with estrogen, thus indicating a stimulatory effect of estrogen on the level of androgen receptors in prostatic tissue (Hobbs et al., 1983; J. Ster. Biochem. 19, 1279-1290). A similar stimulatory effect of estrogen has been observed in the dog prostate (Moore et al., 1979; J. Clin. Invest. 63, 351-357). In the prostate as well as in many other tissues, testosterone is irreversibly converted by 5α-reductase into the more potent androgen dihydrotestosterone (Bruchovsky and Wilson, J. Biol. Chem. 243: 2012-2021, 1968; Wilson, Handbook of Physiology 5 (section 7), pp. 491-508, 1975). inhibitors of 5α-reductase have been found to inhibit prostatic growth (Brooks et al., Endocrinology 109: 830, 1981; Brooks etal., Proc. Soc. Exp. Biol. Med. 169: 67, 1982 Brooks etal., Prostate 3: 35, 1982; Wenderoth etal., Endocrinology 113,569-573, 1983; McConnell et al., J. Urol. 141: 239A, 1989); Stoner, E., Lecture on the role of 5α-reductase inhibitor in benign prostatic hypertrophy, 84th AUA Annual Meeting, Dallas, May 8th, 1989. The inhibitory effect of the 5α-reductase inhibitor Merck L. 652,931 on prostatic and seminal vesicle development in the prepubertal rat was described in Proc. 71st annual Meeting of Endocrine Society, abst. #1165, p. 314, 1989. The inhibitory effect of MK-906 on dihydrotestosterone formation in men has been described in men by Gormley et al., in Proc. 71st Annual Meeting of Endocrine Society, abst. #1225, p. 329, 1989 Imperato-McGinley et al., in Proc. 71st Annual Meeting of Endocrine Society, abst. #1639, p. 432, 1989; Geller and Franson, in Proc. 71st Annual Meeting of Endocr. Soc., abst. #1640, p. 432, 1989, and Tenover et al., in Proc. 71st Annual Meeting of Endocr. Soc., abst. #583, p. 169, 1989. The activity of the 5α-reductase inhibitors N,N-diethyl-4-methyl-3-oxo-4-aza-5α-androstane-17β-carboxamide (4-MA) and 6-methylene-4-pregnene-3,20-dione (LY207320) has been described by Toomey et al., Proc. 71st Annual Meeting of Endocr. Sot., abst. #1226, p. 329, 1989. BRIEF DESCRIPTION OF THE DRAWING There is shown in FIG. 1 a schematic representation of the site(s) of action of various drugs, enzymes and hormones. The following abbreviations are used: ER: estrogen receptor; AR: androgen receptor; DHEA: dehydroepiandrosterone; Δ 5 -diol: androst-5-ene-3β, 17β-diol; Δ 4 -dione: androstenedione; DHT: dihydrotestosterone; Anti-A: antiandrogen; Anti-E: antiestrogen; ARO: aromatase; 3β-HSD: 3β-hydroxysteroid dehydrogenase, Δ 5 -Δ 4 isomerase; 17β-HSD: 17β-hydroxysteroid dehydrogenase; 1: antiandrogen; 2: inhibitor of 5α-reductase activity; 3: inhibitor of 17β-hydroxysteroid dehydrogenase activity; 4: antiestrogen; 5: inhibitor of aromatase activity; 6: inhibitor of 3β-HSD activity. SUMMARY OF THE INVENTION It is an object of the present invention to provide combination therapy for the treatment of prostate cancer wherein the treatment selectively inhibits the formation and/or action of hormones which would otherwise contribute to tumor growth. It is another object of the invention to provide combination therapy having increased effectiveness in slowing or reversing tumor growth. It is another object of the invention to provide therapy for treating prostate cancer having significantly reduced frequency of unwanted side effects. It is a further object of the invention to provide kits having a plurality of active ingredients (with or without diluent or carrier) which, together, may be effectively utilized for carrying out the novel combination therapies of the invention. It is another object of the invention to provide a novel pharmaceutical composition which is effective, in and of itself, for utilization in a beneficial combination therapy because it includes a plurality of active ingredients which may be utilized in accordance with the invention. In one aspect, the present invention provides a method for treating prostate cancer in humans or other warm-blooded animals in need of such treatment, said method comprising the steps of blocking androgen receptors by administering a therapeutically effective amount of an antiandrogen having as part of its molecular structure a substituted or unsubstituted androgenic nucleus of the formula: ##STR1## said antiandrogen having as another part of its molecular structure at lease one side chain represented by the formula: --R 1 [--B--R 2 --] x L--G wherein said side chain is substituted onto said androgenic nucleus at a position selected from the group consisting of 6α, 7α, 14α, 15α, 16α, 17α and 17β, and wherein: x is an integer from 0 to 6, wherein at least one of L and G is a polar moiety distanced from said ring carbon b 7 at least three intervening atoms, and wherein: R 1 and R 2 are independently either absent or selected from the group consisting of straight- or branched-chain alkylene, straight- or branched chain alkynylene, straight- or branched-chain alkenylene, phenylene and fluoro-substituted analogs of the foregoing; B is either absent or selected from the group consisting of --O--, --S--, --Se--, --SO--, --SO 2 --, --NR 3 , --SiR 3 --, --CR 3 OR 3 --, --NR 3 CO--, --NR 3 CS--, --CONR 3 --, --CSNR 3 --, --COO--, --COS--, --SCO--, --CSS--, --SCS--, --OCO-- and phenylene (R 3 being hydrogen or lower alkyl); L is either a moiety which together with G, forms a heterocyclic ring having at least one nitrogen atom or is selected from the group consisting of lower alkyl, --CONR 4 --, --CSNR 4 --, --NR 5 CO--, --NR 5 CS--, --NR 5 CONR 4 -- NR 6 --NR 5 C--NR 4 --, --SO 2 NR 4 --, --CSS--, --SCS--, --(NO)R 4 --, --(PO)R 4 --, --NR 5 COO--, --NR 5 SO 2 --, --O--, --NR 4 --, --S--, --SO-- and --SO 2 -- (R 4 and R 5 being independently selected from the group consisting of hydrogen and lower alkyl; and R 6 being selected from the group consisting of hydrogen, nitrile and nitro); and G is either a moiety which together with L forms a heterocyclic ring having at least one nitrogen atom or is selected from the group consisting of hydrogen, lower alkyl, lower alkenyl, lower alkynyl, (C 3 -C 7 )cycloalkyl, bromo(lower)alkyl, chloro(lower)alkyl, fluoro(lower)alkyl, cyano(lower)alkyl, carboxy(lower)alkyl, (lower)alkoxycarbonyl(lower)alkyl, (C 6 -C 10 )aryl, (C 7 -C 11 )arylalkyl, di(lower)alkylamino(lower)alkyl, fluoro-substituted analogs of the foregoing, said method of treatment further comprising the step of inhibiting sex steroid formation by administering a therapeutically effective amount of at least one sex steroid formation inhibitor. In another aspect, the present invention provides a method for treatment of prostate cancer in a human or other warm-blooded animal in need of such treatment, said method comprising the steps of inhibiting sex steroid formation by administering a therapeutically effect of amount of an inhibitor of sex steroid formation capable of blocking formation of natural sex steroids from dehydroepiandrosterone and from 4-androstenedione in peripheral tissues (extra-adrenal and extra-testicular), or an inhibitor of sex steroid formation having as part of its molecular structure a substituted or unsubstituted sex-steroid nucleus, and, as another part of its molecular structure at least one side chain of the formula --R 1 [--B--R 2 --] x L--G sustituted onto a ring atom of said sex steroid nucleur wherein: x is an integer from 0 to 6, wherein at least one of L and G is a polar moiety distanced from said ring carbon by at least three intervening atoms, and wherein: R 1 and R 2 are independently either absent or selected from the group consisting of straight- or branched-chain alkylene, straight- or branched chain alkynylene, straight- or branched-chain alkenylene, phenylene and fluoro-substituted analogs of the foregoing; B is either absent or selected from the group consisting of --O--, --S--, --Se--, --SO--, --SO 2 --, --NR 3 --, --SiR 3 2 --, --CR 3 OR 3 --, --NR 3 CO--, --NR 3 CS--, --CONR 3 --, --CSNR 3 --, --COO--, --COS--, --SCO--, --CSS--, --SCS--, --OCO-- and phenylene (R 3 being hydrogen or lower alkyl); L is either a moiety which together with G, forms a heterocyclic ring having at least one nitrogen atom or is selected from the group consisting of lower alkyl, --CONR 4 --, --CSNR 4 --, --NR 5 CO--, --NR 5 CS--, --NR 5 CONR 4 -- ##STR2## --SO 2 NR 4 --, --CSS--, --SCS--, --(NO)R 4 --, --(POR)R 4 --, --NR 5 COO--, --NR 5 SO 2 --, --O--, --NR 4 --, --S--, --SO-- and --SO 2 -- (R 4 and R 5 being independently selected from the group consisting of hydrogen and lower alkyl; and R 6 being selected from the group consisting of hydrogen, nitrile and nitro); and G is either a moiety which together with L forms a heterocyclic ring having at least one nitrogen atom or is selected from the group consisting of hydrogen, lower alkyl, lower alkenyl, lower alkynyl, (C 3 -C 7 )cycloalkyl, bromo(lower)alkyl, chloro(lower)alkyl, fluoro(lower) alkyl, cyano(lower)alkyl, carboxy(lower)alkyl, (lower)alkoxycarbonyl (lower)alkyl, (C 6 -C 10 )aryl, (C 7 -C 11 ) arylalkyl, di(lower)alkylamino (lower)alkyl, fluoro-substituted analogs of the foregoing; said method of treatment further comprising administering a therapeutically effective amount of an antiandrogen. In another aspect, the present invention provides a method for treating prostate cancer in a human or other warm-blooded animal in need of such treatment, said method including the steps of administering a therapeutically effective amount of an inhibitor of 5α-reductase activity and administering a therapeutically effective amount of an antiandrogen. In another aspect, the present invention provides a method for treating prostate cancer in a human or other warm-blooded animal in need of such treatment, said method including the steps of administering a therapeutically effective amount of an inhibitor of 17β-hydroxysteroid dehydrogenase and administering a therapeutically effective amount of an antiandrogen. In another aspect, the present invention provides a method for treating prostate cancer in a human or other warm-blooded animal in need of such treatment, said method including the steps of administering an effective amount of an antiandrogen and an least one sex steroid formation inhibitor from the groups consisting of inhibitors of extragonadal and inhibitors of extraadrenal sex steroid formation. The invention also provides kits or single packages combining two or more active ingredients useful in treating prostate cancer. A kit may provide (alone or in combination with a pharmaceutically acceptable diluent or carrier), an antiandrogen and at least one additional active ingredient (alone or in combination with diluent or carrier) selected from the group consisting of an LHRH agonist or LHRH antagonist, a sex steroid formation inhibitor (preferably an inhibitor of 5α-reductase activity, an inhibitor of 17β-hydroxysteroid dehydrogenase activity or an inhibitor of 3β-hydroxysteroid dehydrogenase activity) and an antiestrogen. The foregoing active ingredients may also be mixed in any of the foregoing combinations to form pharmaceutical compositions (with or without diluent or carrier) which, when administered, provide simultaneous administration of a combination of active ingredients resulting in the combination therapy of the invention. Preferably, when LHRH antagonist or agonist is used, it is administered parenterally. For this reason, it may be administered separately in instances where the other active ingredients are formulated for oral ingestion. The term "sex steroid nucleus" includes estrogenic and androgenic nuclei. As used herein, the term "androgenic nucleus" includes any compound which, in the absence of the side chain substituent specified herein (R 1 [--B--R 2 --] x L--G), is capable of acting as an androgen as determined by a weight increase of at least 35 percent over a seven-day period of the ventral prostate of castrated rats treated with the compound in question (15 milligrams twice daily per 100 grams of body weight) versus a control group of castrated rats. Treatment should start on the day of castration. The precise test, other than any parameters set forth in this paragraph, is that reported in Labrie et al., J. Ster. Biochem. 28, 379-384, 1987. As used herein, the term "estrogenic nucleus" includes any compound which, in the absence of the side chain substituent specified herein (R 1 [--B--R 2 --] x L--G), is capable of acting as an estrogen as determined by a weight increase of at least 100 percent over a seven-day period of the uterus of ovariectomized rats treated with the compound in question (0.5 mg twice daily per 100 grams of body weight) versus a control group of ovariectomized rats. Treatment should start on the day of castration. The precise test, other than any parameters set forth in this paragraph, is that reported in Simard et al., Mol. Endocrinol. 2:775-784 (1988). The following conventions apply to structural formulae set forth herein. Unless specifically designated to the contrary, substituents may have either α or β stereochemistry or, where valence permits, may represent one substituent in α position and another in β position. Presence of optional double bonds are independent of each other. All structures include salts thereof. Atoms of any sex steroid nucleus for which no substituent is shown or described may optionally be substituted or unsubstituted so long as such substitution does not prevent the nucleus from functioning as a "sex steroid nucleus" as defined herein. Those atoms having a defined substitutent may optionally be further substituted by other substituents where their valence permits such further substitution. As used herein, the term "lower", when describing a chemical moiety means a moiety having 8 or fewer atoms. For instance, a "lower alkyl" means a C 1 to C 8 alkyl. Any moiety of more than two atoms may be straight- or branched-chain unless otherwise specified. The term "sex steroid formation inhibitor" includes both androgen and estrogen formation inhibitors and encompasses any compound which inhibits the biosynthesis of active sex steroids or their precursors. One mechanism by which sex steroid formation inhibitors act is by blocking enzymes which catalyze production of natural sex steroids (e.g. dihydrotestosterone), 17β-estradiol and androst-5-ene-3β-17β-diol or precursors to such sex steroids (e.g. androstenedione). Examples of such sex steroid formation inhibitors are compounds capable of blocking the enzymatic activity of, for example, 5α-reductase, 3β-hydroxysteroid dehydrogenase, 17β-hydroxysteroid dehydrogenase or aromatase. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS In a preferred aspect, a combination therapy for prostate cancer includes administering active ingredients effective to inhibit a variety of different mechanisms which may, directly or indirectly, lead to prostatic cancer growth. Desirably, the inhibition of biological activity which leads to prostatic cancer growth proceeds selectively, without substantially inhibiting other desirable biological activity. Side effects of the treatment are therefore minimized. Activation of prostatic androgen receptors stimulates growth of prostatic cancer cells. Growth may be inhibited by blocking these receptors with antiandrogens as explained herein. Growth may also be inhibited by reducing the concentration of androgens available to activate the receptors by administering at least one sex steroid synthesis inhibitor. An inhibitor of 5α-reductase catalyzes conversion of testosterone to dihydrotestosterone (DHT). This is a particularly preferred sex steroid synthesis inhibitor because it selectively reduces DHT levels without reducing testosterone levels. DHT stimulates prostatic cancer growth to a much greater extent than does testosterone. Also absence of DHT forecloses fewer desirable biological functions than does absence of testosterone. For many patients, blocking of testosterone production is also appropriate. It is believed that estrogens may also increase prostatic cancer growth. Without intending to be bound by theory, estrogens appear to at least be involved in increasing the number of androgen receptors, and may stimulate prostatic cancer growth directly by binding estrogen receptors. Regardless of the mechanism by which estrogens contribute to prostatic cancer growth, it has now been found that a combination therapy which includes inhibition of estrogen activity can enhance effectiveness of treatment without inhibiting desirable biological functions which, in males, are largely independent of estrogen. There is shown in FIG. 1 a schematic representation of the site(s) of action of various drugs, enzymes and hormones. The following abbreviations are used: ER: estrogen receptor; AR: androgen receptor; DHEA: dehydroepiandrosterone; Δ 5 -diol; androst-5-ene-3β,17β-diol; Δ 4 -dione: androstenedione; DHT: dihydrotestosterone; Anti-A: antiandrogen; Anti-E: antiestrogen; ARO: aromatase; 3β-HSD: 3β-hydroxysteroid dehydrogenase, Δ 5 -Δ 4 isomerase; 17β-HSD: 17β-hydroxysteroid dehydrogenase; 1: antiandrogen; 2: inhibitor of 5α-reductase activity; 3: inhibitor of 17β-hydroxysteroid dehydrogenase activity; 4: antiestrogen; 5: inhibitor of aromatase activity; 6: inhibitor of 3β-HSD activity. Referring to FIG. 1, + means increase in androgen receptor levels. As may be seen from FIG. 1, stimulation of the androgen receptor is shown to stimulate prostatic cancer growth, and is therefore to be prevented. In addition, stimulation of the estrogen receptor leads to increased levels of androgen receptors and thus may, in addition, exert direct stimulatory effects on prostatic cancer growth. The action of estrogens is therefore to be prevented. Blockers of sex steroid formation from DHEA and Δ 4 -dione in peripheral tissues does not cause inhibition of adrenal glucocorticoid formation. For example, cortisol and aldosterone production is not inhibited and significant complications which could result from their inhibition are avoided. The desired inhibition of sex steroid formation is thus aimed selectively at androgens and estrogens. A method of inhibiting activation of the androgen receptor is treatment with an effective antiandrogen compound having an affinity for the receptor site such that it binds to the receptor site and prevents androgens from binding and activating the site. It is important to select antiandrogens which tend to be pure antagonists and which have no agonistic activity. Otherwise, the antiandrogen which blocks the receptor site from androgens, may itself activate the site. Preferred antiandrogens are discussed in detail below. Because it is extremely difficult to block all receptor sites, it is desirable to simultaneously decrease the concentration of androgens available to activate androgen receptors in the prostatic cancer tissue. Hence, it is desirable to inhibit secretion of androgens by the testis. This may be accomplished by a variety of known techniques including but not limited to surgical orchiectomy or by administering LHRH agonists or antagonists. For example, LHRH analogues act in a manner effective to stop the production of bioactive luteinizing hormone, the hormone necessary to cause the testis to produce and secrete androgens and other hormones which may be converted to androgens in peripheral tissues. For some patients, it may be unnecessary to inhibit testicular hormonal secretions where sufficiently potent antiandrogens and sex steroid biosynthesis inhibitors are administered. As may be seen from the scheme of FIG. 1, a number of hormones (especially DHEA and Δ 4 -dione) released by the adrenals may be converted by a variety of biological pathways into androgens and estrogens in peripheral tissues. The most potent androgen produced is DHT. It is therefore highly desirable to include an inhibitor of 5α-reductase which prevents the conversion of testosterone into the more potent androgen DHT. In peripheral tissues, in addition to DHT, the precursors DHEA and Δ 4 -dione can be converted into the estrogens Δ 5 -diol and estradiol. It is desirable to have an inhibitor of 17β-hydroxysteroid dehydrogenase which prevents the formation of testosterone as well as of Δ 5 -diol and estradiol. In addition, since Δ 4 -androstenedione can be converted into estrone and then to estradiol, it may be useful to block the activity of aromatase, the enzyme responsible for such conversion. Other sex steroid formation inhibitors, such as inhibitors of 3β-HSD can also be used. However, as mentioned earlier, when 3β-HSD is blocked in peripheral tissues, it is also likely that a similar inhibition will take place in the adrenals, thus leading to low secretion of glucocorticoids and mineralocorticoid's. When such compounds are used, essential glucocorticoids and sometimes mineralocorticoids should be added back as part of the therapy. Estrogens, at physiological concentrations, are known to stimulate the growth of the human prostatic cancer cell line LNCaP. This effect of estrogen may be inhibited, however, by antiestrogenic compounds described herein. In one embodiment, the present invention provides a method of treating prostate cancer comprising the step of administering a therapeutically effective amount of an antiandrogen, and of administering a therapeutically effective amount of an inhibitor of sex steroid formation which has, as part of its molecular structure, a substituted or unsusbstituted estrogen nucleus of general structure I: ##STR3## wherein the dotted lines represent optional pi bonds; and wherein said compound includes as another part of its molecular structure a side chain substitution onto a ring carbon of said general structure I in at least one position selected from the group consisting of 7, 14, 15, 16, 17 (preferably 7α, 15α, or 17α), said side chain being of the formula --R 1 [--B--R 2 --] L--G, as defined above, wherein general structure I further includes at least one substitution selected from the group consisting of 15-halo, 16-halo, a 15,16 bridge atom (preferably carbon), a 14,15 bridge atom (preferably oxygen), and a 16-pi-bonded lower alkyl. In certain embodiments, the antiandrogen utilized in the present invention may be represented by the general formula: ##STR4## wherein the dotted lines represent optional double bonds; wherein R 10 is hydrogen or lower alkyl, R 13 is absent, hydrogen or methyl in β position, R 17 .spsp.(α) is selected from the group consisting of hydrogen, hydroxyl, lower alkanoyloxy, lower alkyl, lower alkenyl, lower alkynyl, halo(lower)alkyl, halo(lower)alkenyl, halo(lower)alkynyl and fluoro-substituted aromatic ring, and a moiety which, together with R 7 .spsp.(β) forms ##STR5## R 17 .spsp.(β) is selected from the group consisting of hydroxyl, (C 1 -C 20 ) alkanoyloxy, (C 3 -C 7 )alkenoyloxy, (C 3 -C 7 )alkynoyloxy, aroyloxy, alkenoyloxy, cycloalkenyloxy, 1-alkyloxy-alkyloxy, 1-alkyloxycycloalkytoxy, alkylsilyloxy, carboxyl, alkanoyl and a moiety which together with R 17 .spsp.(α) forms ##STR6## Antiandrogens useful in the combination therapy of the invention also include but are not limited to flutamide (available from Schering-Plough Corp., Kenilworth, N.J., under trade name EULEXIN), Nilutamide (available from Roussel of Paris, France, under trade name ANANDRON), cyproterone acetate (available from Schering AG, Berlin under trade name ANDROCUR), Casodex available from ICI Pharmaceuticals, Macclesfield, England. Preferably, the antiandrogen has, as part of its molecular structure, a substituted or unsubstituted androgenic nucleus, and as another part of its molecular structure, the side-chain --R 1 [--B--R 2 --] x L--G as defined above. Numerous syntheses of the preferred compounds set forth in the U.S. patent application of Labrie and Merand entitled "Androgen Derivatives for use in the inhibition of sex steroid activity" which is being executed on even date herewith, the entire disclosure of which is hereby incorporated by reference as though fully set forth herein. A preferred antiandrogen is ##STR7## which may be synthesized as set forth below. EXAMPLE 1 Synthesis of N-butyl, N-methyl-11-(17'β-hydroxy-4'-androsten-3'-on-7'α-yl) undecanamide (EM 101) (5, x=10) (Scheme 1) 17β-acetoxy-7α-(11'-hydroxy undecanyl) -4-androsten-3-one (2) Under argon atmosphere, in a flame dried apparatus with magnetic stirrer, a solution of 11-bromo undecanol tetrahydropyranyl ether (25 g, 74 mmol) in anhydrous THF (150 ml) was added dropwise to iodine-activated magnesium (1.9 g).The mixture was kept at room temperature overnight and then was cooled to -30° C. and anhydrous cuprous chloride (0.3 g) was added quickly. After 45 min of strirring at this temperature, commercial 4,6-androstadien-17β-ol-3-one acetate (1) (10 g, 30.5 mmol) in anhydrous THF (100 ml) was added dropwise during 4 h. After 35 min, acetic acid (6 ml) and water (100 ml) was added. The mixture was allowed to reach room temperature and was stirred overnight. Afterwards, the organic compound was extracted with ether (3×). The organic layers were washed with water, dried on magnesium sulfate and evaporated. The residue was dissolved in acetic acid (35 ml) and water (100 ml) and kept 48 h at room temperature. And then, the organic compounds were extracted with ether (3×). The organic layers were washed with saturated sodium bicarbonate solution and water, dried on magnesium sulfate and evaporated. The product was purified by Silica gel dry column chromatography (Kieselgel, 60F254, Merk, 0.063-0.200 mm, 150 g). Elution with a mixture of methylene chloride and ethyl acetate (20:1 v/v) gave 17β-acetoxy-7α-(11'-hydroxy-undecanyl-4-androsten-3-one (2a, 1.46 g, 2.8 mmol, 9.2%) as a colorless oil;- IR ν max neat 3450, 1740, 1685, 1620 and 1245 cm -1 ; NMR 0.84 (s, 3H, 18'-CH 3 ), 1.21 (s, 3H, 19'-CH 3 ), 2.05 (s,3H, OCOCH 3 ), 3.61 (t, 2H, J=6.59 Hz, H--C.1'), 4.61 (t, 1H, J=7.69 Hz, H-C.17) and 5.73 (s, 1H, H--C.4) and 17β-acetoxy-7β-(11'-hydroxy undecanyl)-4-androsten-3-one (2b, 0.9 g, 1.7 mmol, 5.6%) as a colorless oil. 11-(17'β-acetoxy-4'-androsten-3'-on-7'α-yl) undecanoic acid (3) To 17β-acetoxy-7α-(11'-hydroxy undecanyl)-4-androsten-3-one (2a, 800 mg, 1.6 mmol) dissolved in acetone (50 ml) and cooled to 0° C. was added under stirring during 5 min, a solution of Jones' reagent (8N chromic acid solution) (0.283 ml). After 15 min, isopropanol (0.5 ml) was added followed by water and the mixture was extracted with ethyl acetate (3×). The organic layers were washed with brine, dried on magnesium sulfate and evaporated to dryness under reduced pressure. The crude 11-(17'β-acetoxy-4'-androsten-3'-on-7'α-yl) undecanoic acid (3) (740 mg) was used in the next step without purification. N-butyl, N-methyl-11-(17'β-acetoxy-4'-androsten-3'-on-7'α-yl) undecanamide (4) To a solution of the above undecanoic acid derivative 3 (390 mg, 0.78 mmol) in anhydrous methylene chloride (8 ml) cooled at -10° C. was added, under stirring, triisobutylamine (240 μl) and isobutylchloroformate (140 μl). After 30 min, N-methylbutylamine (1.8 ml) was added and the mixture was stirred at room temperature for 1 h. Methylene chloride was added. The organic solution was washed with 1N hydrochloric acid, water, saturated sodium bicarbonate solution and finally with water, dried on magnesium sulfate and evaporated to dryness. The residue was chromatographed on silica gel (Kieselgel, 60F254, Merck, 0.063-0.200 mm, 20 g). Elution with a mixture of diethyl ether and methylene chloride (1:20, v/v) gave N-butyl, N-methyl-11- (17'β-acetoxy-4'-androsten-3'-on-7'α-yl) undecanamide 4 (230 mg, 0.39 mmol, 46% for the alcohol (2a)) as a colorless oil; IR ν max neat 1740 1680 1640 and 1240 cm -1 ; NMR 0.84 (s, 3H, 18'-CH 3 ), 0.95 (t, 3H, J=6.93 Hz, N--(CH 2 ) 3 CH 3 ), 1.21 (s, 3H, 19'-CH 3 ), 2.04 (s, 3H, OCOCH 3 ), 2.91 and 2.97 (2s, 3H, N--CH 3 ), 3.26 and 3.36 (2t, 2H, J=7.86 Hz, N--CH 2 C 3 H 7 ), 4.61 (t, 1H, J=8.42 Hz, H--C.17') and 5.72 (s, 1H, H--C.4'). N-butyl, N-methyl-11-(17'β-hydroxy-4'-androsten-3'-on-7'α-yl ) undecanamide (5) (EM 101) The above acetoxy amide 4 (170 mg, 0.29 mmol) was dissolved in methanol (20 ml) and 6% potassium carbonate (2 ml) and heated at 65° C. for 200 min. After cooling, acetic acid (1 ml) and water (150 ml) were added and the mixture was extracted with ethyl acetate (3×). The organic layers were washed with water, dried on magnesium sulfate and evaporated to dryness. The residue was purified by Silica gel dry column chromatography (Kieselgel, 60F254, Merk, 0.063-0.200 mm, 20 g) . Elution with a mixture of diethyl ether and methylene chloride (1: 9, v/v) gave N-butyl-N-methyl-11-(17'β-hydroxy-4'-androsten-3'-on-7'α-yl) undecanamide (EM 101, 94 mg, 0.17 mmol, 58%) as a colorless oil; IR ν max (neat) 3400, 1670 and 1640 cm -1 ; NMR 0.80 (s, 3H, 18'-CH 3 ), 0.95 (t,3H, J=6.75 Hz, N--(CH 2 ) 3 CH 3 ), 1.21 (s, 3H, 19'-CH 3 ), 2.91 and 2.97 (2s, 3H, N--CH 3 ), 3.25 and 3.35 (2t, 2H, J=7.3 Hz, N--CH 2 C 3 H 7 ), 3.67 (t, 1H, J=8.18, H--C.17') and 5.72 (s, 1H, H--C.4'). ##STR8## Sex steroid formation inhibitors useful in the combination therapy of the invention include but are not limited to inhibitors of 5α-reductase activity, inhibitors of 17β-hydroxysteroid dehydrogenase activity, inhibitors of 3β-hydroxysteroid dehydrogenase activity and inhibitors of aromarase activity. A typically suitable 5a-reductase inhibitor is MK-906, a product of Merck, Sharp & Dohme (Mc Connell et al., J. Urol. 141: 239A, 1989). Another inhibitor of 5α-reductase is 17β-N,N-diethylcarbamoyl-4-methyl-4-aza-5α-androstan-3-one (4-MA) (Brooks et al., Endocrinology 109: 830, 1981; Liang et al., Endocrinology 112: 1460, 1983). Other 4-azasteroids acting as 5α-reductase inhibitors can be formed in Liang et al., J. Biol. chem. 259: 734-739, 1984 and in Brooks et al., Steroids 47: 1-19, 1986, 6-methylene-4-pregnene-3,20-dione has also been described as 5α-reductase inhibitor (Petrow et al., J. Endocrinol. 95: 311-313, 1982). Similar properties have been described for 4-methyl-3-oxo-4-aza-5α-pregnane-30(s) carboxylate (Kadohama et al., J. Natl. Cancer Inst. 74: 475-486, 1985). Trilostane and epostane have been described as inhibitors of 3β-hydroxysteroid dehydrogenase activity (Ernshaw et al., Clin. Endocrinol. 21, 13-21, 1984; Robinson et al., J. Steroid Biochem. 21,601-605, 1984; Lambert et al., Ann. Clin. Biochem. 23, 225-229, 1986; Potts et al., Steroids 32, 257-267, 1978) and have been successfully used for the treatment of breast cancer in combination with corticosteroids (Beardwell et al., Cancer Chemother. Pharmacol. 10: 158-160, 1983; Williams et al., Cancer Treat. Rep. 71, 1197-1201, 1987). 4-MA, (17β-N,N-diethylcarbamoyl-4-methyl-4-aza-5α-androstan-3-one) has been found to inhibit 3β-hydroxysteroid dehydrogenase activity in granulosa cells (Chan et al., Biochem. Biophys. Res. Commun. 144, 166-171, 1987). Epostane has been shown to inhibit 3β-hydroxysteroid dehydrogenase activity in pregnant goats (Taylor, J. Endocrinol. 113, 489-493, 1987). Preferred inhibitors of 17β-hydroxysteroid dehydrogenase activity include but are not limited to: N-butyl, N-methyl-11-(16'α-chloro-3',17'β-dihydroxy estra-1',3',5'(10')-trien-7'α-yl) undecanamide ("EM 139"). ##STR9## N-n-butyl-N-methyl-11-(16'α-chloro-3',17'α-dihydroxy-estra-1,3',5'(10') -trien-7'α-yl) undecanamide ("EM 170") ##STR10## N-n-butyl-N-methyl-11-(16'α-bromo-3',17'α-dihydroxy-estra-1',3',5'(10')-trien-7'α-yl) undecanamide ("EM 171") ##STR11## Examples of certain synthesis schemes for EM 139, EM 170 and EM 171 are set forth below (see example 2 and schemes 2 and 3). Those of skill in the art will recognize analogous schemes for synthesizing analogous compounds. EXAMPLE 2 SYNTHESIS OF PREFERRED SEX STEROID ACTIVITY INHIBITORS Synthesis of a starting compound, N-n-butyl, N-methyl-11-(3'-benzoyloxy-17'-oxo-estra-1,3',5'(10')-trien-7'α-yl)undecanamide (14a) (SCHEME 2) 19-nor-testosterone acetate 3-enolacetate (7) In an apparatus supplied with a drierite drying tube, a solution of 19-nor-testosterone (6) (100 g; 0.365 mole) in acetic anhydride (200 ml), pyridine (32 ml) and acetylchloride (320 ml) was heated at reflux under magnetic stirring, for 3 h and then concentrated to dryness under vacuum. The dry residue was triturated in absolute ethanol, filtered and washed with little portions of absolute ethanol. After drying, 19-nortestosterone acetate 3-enolacetate was obtained as a white powder (121.4 g, yield 93%) mp. 176°-177° C. The structure was confirmed by spectroscopic means. 17β-acetoxy-estra-4,6-dien-3-one (8) To a cooled suspension of enolacetate (121 g; 0.337 mole) in a mixture of DMF (330 ml) and water (7.2 ml) at 0° C. was added, under nitrogen, over a period of 1 h, N-bromosuccinimide (63 g). The resulting solution was stirred for an additional 0.5 h at 0° C. Then lithium carbonate (60.8 g) and lithium bromide (30.4 g) were added. The mixture was heated at 95° C. for 3 h and then poured into 1.7 l of ice-cold water containing 165 ml of glacial acetic acid. After stirring during 15 hours, the crude 17β-acetoxy-estra-4,6-dien-3-one (8) was filtered, washed with water, dried in a desiccating apparatus and recrystallized twice from isopropyl ether (72 g, yield 68%, mp 110° C.). The structure was confirmed by spectroscopic means. 7α-(11'-acetoxy-undecyl) 17β-acetoxy estra-4-en-3-one (9) A. Preparation of reagents and solvents 11-bromo undecanol tetrahydro pyranyl ether 11-bromo-undecanol (100 g, 398 mmol) was dissolved in dry ether (768 ml) and the solution was cooled to 0° C. using an ice/H 2 O bath. To this solution was added HCl as (2.13 g, 58.4 mmol, 26 ml of HCl/ether). To this mixture, a solution of 3,4-dihydro-2H-pyran (39.9 g, 43.3 ml) freshly distilled in dry ether (218 ml) was added over a period of 90 min. The solution was then stirred over a period of 16 hours at room temperature. Afterwards, sodium bicarbonate was added to the mixture. The residue was filtered and the solvent was evaporated under vacuum. The product was than filtered through basic alumina (250 g, Woelm, grade II) using petroleum ether (30-60) as solvent (112 g, 81%). B. Grignard reagent In a dry three-neck flask (1000 ml) under dry argon, magnesium (12.0 g, 494 mmol) was placed and activated with iodine. Magnesium was heated with the flame to remove iodine and to dry the apparatus. The system was then cooled to -20° C., and a solution of 11-bromo-undecanol tetrahydro pyranyl ether (73.8 g, 211 mmol) in dry THF (420 ml) was added dropwise. The mixture was stirred under dry argon during one day at -20° C. The mixture was cooled to -35° C. (±2° C.) using a dry ice/CCL 4 /acetone bath. The anhydrous cuprous chloride (1.18 g, 12 mmol) was added and the mixture was stirred over a period of 0.5 h. C. Addition of Grignard reagent After 0.5 h, using the same apparatus mentioned above (Ar, -35° C.), a solution of 17 β-acetoxy estra-4,6-diene-3-one (8) (32.0 g, 102 mmol) in dry THF (300 ml) was added dropwise over a period of 6 h to the Grignard reagent (red coloration appeared and disappeared). The mixture was stirred for an additional 1 h and, after removal the cooling bath, acidified (about 0° C.) with acetic acid (40 ml), diluted with water and extracted with ether (3×). The ether solution was washed with a saturated sodium bicarbonate solution and water. The organic layer was dried over anhydrous magnesium sulfate and evaporated under reduced pressure to dryness. The residue was dissolved in MeOH (660 ml) and 5N HCl (180 ml), refluxed for 1 h and 45 min, then concentrated under reduced pressure and cooled in an ice bath. The mixture was then filtered to remove the white precipitate. After the solution had been diluted with water and extracted with methylene chloride (3×), the organic layer was dried over anhydrous MgSO 4 and evaporated under reduced pressure to dryness. Finally, the product (55.9 g, brown oil) was chromatographed on silica gel (Kieselgel 60F254, Merck, 0.063-0.200 mm, 1500 g). Elution with mixtures of methylene chloride and ethyl acetate (4:1 to 1:2 v/v) and then pure ethyl acetate gave crude 7α-(11'-hydroxy-undecyl)-17β-hydroxy estra-4-en-3-one (34.8 g) which was dissolved in dry pyridine (200 ml) and dry acetic anhydride (200 ml), stirred 17 h at room temperature and then poured in ice-water. The product was extracted with methylene chloride (3×), washed with 1N hydrochloric acid, water, saturated sodium bicarbonate and water (3×), dried on anhydrous magnesium sulfate and filtered. After evaporation of solvent, the mixture (35 g) of 7α- and 7β-diacetoxyenones and degradation products of Grignard reagent were separated by flash chromatography on silica gel (Kieselgel 60, Merck, 230 mesh ASTM, 2.0 kg) developed with a mixture of hexane and diethyl ether (2:3 v/v). The first product eluted was pure amorphous 7α-(11'-acetoxy undecyl) 17β-acetoxy-estra-4-en-3-one, (9) (20.8 g, 39.4 mmol, yield from dienone was 39.0%). Further elution gave the 7 β-isomer (10) (5.4 g, 10.3 mmol, 10%). All structures were determined by spectroscopic means. 7α-(11'-hydroxy-undecyl) estra-1,3,5 (10) -trien-3,17β-diol (11a) Under dry argon, a solution of 7α-(11'-acetoxy undecyl) 17-acetoxy-estra-4-en-3-one (9) (17.0 g, 32.4 mmol) in dry acetonitrile (150 ml) was added rapidly to a suspension of cupric bromide (14.8 g, 66.2 mmol) and mmol) and lithium bromide (2.89 g, 33.6 mmol) in warm acetonitrile (75 ml). The mixture was heated to reflux over a period of 30 min and stirred vigorously, and then cooled to room temperature. A saturated aqueous solution of sodium bicarbonate (50 ml) was added, and then the organic compound was extracted with ethyl acetate (3×150 ml). The organic layers were washed with water, dried over anhydrous magnesium sulfate, filtered and evaporated under vacuum to dryness. The residue was chromatographed on silica gel (Kieselgel 60F254 Merck 0.063-0.200 mm; 1000 g). Elution with hexane-ethyl acetate (1:1 v/v) gave the 7α-(11'-acetoxy-undecyl) estra-1',3',5'(10')-trien-3,17β-diol, 17β-acetate (11b) (8.51 g; 50.3%) and the starting product (1.33 g; 15%). The above diacetate phenol (8.51 g, 16.2 mmol) was dissolved in methanol (90 ml) and sodium hydroxyde 30% (w/v) (9 ml). The mixture was refluxed for 90 min under dry nitrogen. The solution was then concentrated under vacuum and diluted with hydrochloric acid (10% v/v). The mixture was extracted using ethyl acetate (4×150 ml) and the ethyl acetate extract was washed with water, dried over anhydrous magnesium sulfate, filtered and evaporated under vacuum. The evaporation gave 7α-(11'-hydroxy undecyl) estra-1,3,5(10)-trien-3,17β-diol (11a) (6.99 g, 98% brut) as a yellow foam, the structure of which was confirmed by spectroscopic means. 3-benzoyloxy 7α-(11'-hydroxy undecyl) estra-1,3,5(10) -trien-17β-ol (12) The above triol (6.99 g; 15.8 mmol) was dissolved in acetone (25 ml) and an aqueous solution of sodium hydroxyde (1N, 19.1 ml). The mixture was cooled to 0° C. using an ice/water bath. Benzoyl chloride (2.22 ml, 19.1 mmol) was then added dropwise. The mixture was stirred for 40 min at 0° C. and then diluted with water. The solution was extracted using ethyl acetate (3×) and the organic layers were washed with a saturated aqueous solution of sodium bicarbonate and finally with water. The ethyl acetate solution was dried over anhydrous magnesium sulfate, filtered and evaporated under vacuum to dryness. Then, the residue was immediately chromatographed on silica gel (Kieselgel, 60F254, 0.063-0.200 mm; 500 g). The chromatography was carried out, first, using methylene chloride as solvent (about 1 liter) and secondly the pure 3-benzoyloxy 7α-(11'-hydroxy undecyl) estra-1,3,5(10)-trien-17β-ol (12), colorless oil (6.50 g, 75%) was eluted with methylene chloride-ethyl acetate (5:1 about 1 liter and 4:1; v/v). The structure was confirmed by spectroscopic means. 11-(3'-benzoyloxy-17'-oxo-estra-1',3',5'(10')-trien-7'α-yl) undecanoic acid (13) To a cooled solution of 3-benzoyloxy-7α-(11'-hydroxy undecyl)estra-1,3,5(10)-trien-17β-ol (12) (4.3 g) in acetone (100 ml) was added dropwise Jone's reagent (8N-chromic acid solution, 6.7 ml). After 30 min, isopropanol (40 ml) was added and the mixture was concentrated under vacuo. Water was added and the mixture was extracted four times with ethyl acetate. The organic layers were washed twice with brine, dried over magnesium sulfate and evaporated to dryness. The crude 11-(3'-benzoyloxy-17'-oxo-estra-1',3',5'(10')-trien-7'α-yl) undecanoic acid (13) (3.94 g) was used in the next step without purification. ##STR12## N-n-butyl, N-methyl-11- (3'-hydroxy-17'-oxo-estra-1',3',5'(10')-trien-7α-yl) undecanamide (14b) To 11-(3'-benzoyloxy-17'-oxo-estra-1',3',5'(10')-trien-7'α-yl) undecanoic acid (13) (3.94 g, 7.22 mmol), dissolved in anhydrous CH 2 Cl 2 (100 ml) and cooled at -10° C. was added tributylamine (2.18 ml, 9.15 mmol) and isobutylchloroformate (1.30 ml, 10.0 mmol). The solution was stirred during 35 min. and N-methylbutylamine (13 ml, 109.7 mmol) was added. The mixture was warmed to room temperature and stirred during 1 h. Afterward, CH 2 Cl 2 was added and the organic phase was washed with 1N HCl, water, saturated sodium bicarbonate solution and finally with water, dried with anhydrous MgSO 4 and the solvent was removed under reduced pressure. The residue was purified by chromatography on silica gel. Elution with mixture of EtOAc/hexane (1.5:8.5 v/v) yielded N-butyl, N-methyl-11-(3'- benzoyloxy-17'-oxo-estra-1',3',5'(10')-trien-7'α-yl) undecanamide (14a) (4.25 g, 96%) as colorless oil; IR ν (neat) 1750, 1725 and 1640 cm -1 . The above described benzoyloxy amide (341 mg, 0.54 mmol) was dissolved in methanol (10 ml) and cooled at 0° C. Following this 2N NaOH (5 ml) was added and the mixture was stirred during 60 min. at 0° C. The solution was neutralized with 1N HCl and extracted with CH 2 Cl 2 . The organic phase was dried with anhydrous MgSO 4 and the solvent was removed under reduced pressure. The residue was purified by chromatography on silica gel. Elution with mixture of EtOAc/hexane (3:7 v/v) yielded N-butyl, N-methyl-11-(3'- hydroxy-17'-oxo-estra-1',3',4'(10)-trien-7'α-yl) undecanamide (14b) (284 mg, 97%) as colorless oil; 1 H-NMR δ (CDCl 3 ) 0.91 (s,3H,18'-CH 3 ), 2.76 app(d,1HJ=16,3Hz, part of ABX system, 6'-H) 2.96 and 2.98 (2s,3H N-CH 3 ), 3.27 and 3.38 (2t app ,2H,J=7.5Hz,N--CH 2 --), 6.63 (broad s,1H,4'-H), 6.70 (broad d,1H,J=8.5 Hz,2'-H), 7.12 (d,1H,J=8.4 Hz,1'-H); IR ν max (neat) 3270, 1730, 1615 cm 1 ; MS m/e 523 (M + , 100%), 508 (M + --CH 3 , 32%), 142 (C 2 H 4 CON(CH 3 )C 4 H 9 + , 47%). 16-HALO-ESTRADIOL UNDECANAMIDE (SCHEME 3) N-n-butyl N-methyl-11-(3',17'-diacetoxy-estra-1',3',5'(10'),16'-tetraen-7'α-yl) undecanamide (15) The ketone amide 14b (163 mg, 0.50 mmol) was dissolved in isoprenyl acetate (10 ml). p-toluenesulfonic acid (44 mg) was then added and the solution was distilled to about two-thirds of the original volume in 7 h and was then stirred at reflux for 12 h. Afterwards, the solution was cooled with an ice-water bath and extracted with 50 ml of cooled ether. The ether was washed with a cooled satured sodium bicarbonate and water. The organic phase was dried with anhydrous MgSO 4 and the solvent was removed under reduced pressure. The residue was filtered through alumina (15 mm×50 mm alumina Woehlm neutral, activity II) using a mixture of benzene-diethyl ether (3:7 v/v) as eluant. The solvent was removed under reduced pressure and, the residue was purified by flash chromatography on silica gel. Elution with mixture of EtOAc/hexane (1:4 v/v) yielded the N-butyl, N-methyl-11-(3',17'-diacetoxy-estra-1',3',5'(10'), 16'-tetraen-7'α-yl) undecanamide (15) (244 mg, 80%) as colorless oil; 1 H-NMR δ m (CDCl 3 ) 0.92 (s,3H,18'-CH 3 ) 0.92 and 0.95 (2H,3H,J=7.0 Hz,N(CH 2 ) 3 CH 3 ), 2.18 (s,3H,17'-OCOCH 3 ), 2.28(s,3H,3'-OCOCH 3 ) , 2.76 app (d,1H,J=16.1 Hz, part of ABX system,6'-H), 2.90 and 2.96 (2s,3H,N--CH 3 ), 3.26 and 3.35 (2t app ,2H,J=7.6 Hz,N--CH 2 --), 5.52 (m,1H,16'-H), 6.80 (broad s,1H,4'-H), 6.85 (dd,1H,J 1 =9.1 Hz and J 2 =3.0 Hz,2'-H), 7.27 (d,1H,J=9.1 Hz,1'-H); IR ν max (neat) 1750, 1635, 1200 cm -1 ; MS m/e 607 (M + ,2%), 5(M + -COCH 2 ,100%), 550 (M + -COCH 2 --CH 3 ,13%), 523 (M + -2COCH 2 ,45%), 142 (C 2 H 4 CON(CH 3 )C 4 H 9 + ,55%), 129 (C 4 H 9 (CH 3 )NCOCH 3 + ,28%), 114 (C 4 H 9 (CH 3 )NCO + , 60%), 86 (C 4 H 9 (CH 3 )N + , 25%); EXACT MASS calcd for C 38 H 57 O 5 N 607. 4239, found 607.4234. N-butyl, N-methyl-11-(16'α-chloro-3'acetoxy-17'-oxo-estra-1',3',4' (10')-triene-7'α-yl) undecanamide (16, X=Cl) To diacetate amide 15, dissolved in 5 ml of acetone, was added a solution of sodium acetate (2.6 equivalents) in acetic acid and water (1:11.3 v/v) and then, was treated with tertbutyl hypochlorite (1 eq.) prepared from t-butanol (4 ml) and Javel water (Javex 6.1%, 50 ml). The clear solution was warmed to 55° C. and stirred for 1 h. Afterwards, the solvent was evaporated to dryness. The residue was dissolved in ether (100 ml) and water was added (20 ml). The organic phase was washed with water, dried with anhydrous MgSO 4 and evaporated to dryness. The residue was purified by chromatography on silica gel carried out with mixture of EtOAc/hexane (3: 7 v/v) to give the N-butyl, N-methyl- 11-(16'α-chloro-3'-acetoxy-17'-oxo-estra-1',3',4'(10')-trien-7'.alpha.-yl ) undecanamide 16, X=Cl) (115 mg, 89%) as colorless oil; 1 H-NMR ν (CDCl 3 ) 0.92 and 0.95 (2t,3H,J=7.0 Hz,N(CH 2 ) 3 CH 3 ), 0.96 (s,3H,18'-CH 3 ), 2.28 (s,3H,3'-OCOCH 3 ), 2.80 app (d,1H,J=16,6 Hz, part of ABX system, 6'-H) 2.90 and 2.96 (2s,3H N-CH 3 ), 3.24 and 3.35 (2t app ,2H,J=7.4 Hz,--N--CH 2 --), 4.46 (d,1H,J=6.6 Hz,16'β-H), 6.82 (broad s,1H,4'-H), 6.86 (dd,1H,J=9.1 Hz and J 2 =2.6 Hz,2'-H), 7.29 (d,1H,J=9.1 Hz,1'-H); IR ν max (neat) 1750, 1640, 1205 cm -1 ; MS m/e 601, 599 (M + , 24%, 68%), 142 (C 2 H 4 CON(CH 3 )C 4 H 9 + , 100%), 114 (C 4 H 9 (CH 3 )NCO + ,93%) N-butyl, N-methyl-11-(16α-chloro-3',17'-dihydroxy-estra-1',3',5'(10')-trien-7'α-yl) undecanamide ("EM 139") and ("EM 170") A stirred solution of haloketone amide (16, X=Cl) in anhydrous tetrahydrofuran (THF) (10 ml) under argon was chilled to -70° C. with 2-propanol/dry ice bath. A solution of 1.0M of lithium aluminium hybride (2 eq.) was then added dropwise. After 30 min, the reaction was allowed to return slowly at 0° C. for 5 min, then was quenched by the dropwise addition of a mixture of THF-EtOAc (5 ml) (1:1 v/v) and acidified at pH˜4 with (10%) HCl. The mixture was stirring for 5 min at room temperature and then extracted with EtOAc. ? he organic phase was washed with water, dried on anhydrous Na 2 SO 4 and evaporated under reduced pressure. The residue was chromatographed on silica gel with a mixture of EtoOAc/hexane (4:6 v/v) as eluant: N-butyl N-methyl-11-(16'α-chloro-3'17'α-dihydroxy-estra-1',3',5'(10')-trien-7'α-yl) undecanamide ("EM 170") (15 mg, 29%) as colorless oil; analytical sample was obtained by HPLC . purification; 1 H-NMR δ (CDCl 3 , 400 MHz) 0.79 (s,3H,18'-CH 3 ), 0.93 and 0.96 (2t, 3H,J=7.3 Hz,N(CH 2 ) 3 CH 3 ), 2.80 (2H,J 6 , 6 =17.1 Hz and J 6 ,7 =4.5 Hz, Δδ=24.34 (Hz, system ABX, 640-H), 2.94 and 2.99 (2s, 3H,N--CH 3 ), 3.26 (dd,J 1 =7.6 Hz and J 2 =7.4 Hz) and 3.32-3.43 (m)-[2H,--N--CH 3 ], 3.71 (d,1H,J=4.5 Hz,17'-H), 4.63 (ddd, 1H, J 16 ,15 =10.2 Hz, J 16 ,17 =4.5 Hz and J 16 ,15 3.9 Hz, 16'β-H), 6.50 (d, 1H, J=24 Hz, 3'-OH), 6.60 (d, 1H,J=2.5 Hz, 4'-H), 6.66 (dd,1H,J 2 =8.4 Hz and J 2 =2.5 Hz, 2'-H), 7.14 (d,1H,J=8.5 Hz, 1'-H); IR ν max (neat) 3300, 1615, 1495 cm -1 ; MS m/e 561,559 (M + , 40%, 100%), 523 (M + -HCl, 20%), 142 (C 2 H 4 CON(CH 3 )C 4 H 9 + , 44%). 114 (C 4 H 9 (CH 3 )CNO + , 37%); Exact mass calculated for C 34 H 54 O 3 N 35 Cl 559.3785, found 559.3821; and --N-butyl, N-methyl-11-(16'α-chloro-3',17'β-dihydroxy-estra-1'3',5'(10')-trien-7'α-yl) undecanamide ("EM 139") (25 mg, 55%) as a colorless oil; analytical sample was obtained by. HPLC purification; 1H-NMR δ (CDCl 3 , 400 MHz), 0.81 (s,3H, 18'-CH 3 ), 0.93 and 0.96 (2t, 3H,J=7.3 Hz, (CH 2 ) 3 CH 3 ), 2.78 (2H, J 6 , 6 =16.2 Hz and J 6 7 =4.5 Hz, Δ 5 =24.34 Hz, system ABX, 6'-H), 2.94 and 2.99 (2s, 3H,N--CH 3 ), 3.27 (dd, J 1 =7.6 Hz and J 2 =7.5 Hz) and 3.31-3.45 (M)[2H, --N--CH 2 --], 3.86 (dd, 1H, J 17 , 17 -- OH =3.4 Hz and J 17 , 16 =5.9 Hz. 17'α-H), 4.11 (ddd, 1H, J 16 , 15 =10.8 Hz, J 16 , 17 =5.9 Hz and 4.11 (ddd, 1H, J 16 , 15 =10.8 Hz, J 16 , 17 =5.9 Hz and J 16 , 15 =2.5 Hz, 16'β-H), 6.56 (d, 1H, J=19.7 Hz, 3'-OH), 6.61 (d, 1H, J=2.5 Hz, 4'-H), 6.66 (dd, 1H, J 1 =8.4 Hz and J 2 =2.6 Hz, 2'-H), 7.13 (d, 1H, J=8.4 Hz, 1'-H); IR ν max (neat) 3320, 1615, 1490 cm -1 ; MS m/e 561,559 (M + , 38%, 100%) , 523 (M + -HCl, 16%) , 142 (C 2 H 4 CON(CH 3 )C 4 H 9 + , 80%) , 114 (C 4 H 9 (CH 3 )NCO + ,76%); exact mass calculated for C 34 H 54 O 3 N 35 Cl 559.3785, found 559.3825. ##STR13## N-n-butyl, N-methyl-11-(16'α-bromo-3'-acetoxy-17'-oxo-estra-1',3',5'-(10') ,trien-7'α-yl) undecenamide (16, X=Br) To the above diacetate 15 (244 mg, 0.40 mmol) dissolved in 10 ml of acetic acid was added dropwise with stirring within 10 minutes and at room temperature, a brominating solution composed of 50 mg (0.6 mmol) of sodium acetate, 1.6 ml of acetic acid, 0.04 ml of water and 63.9 mg (0.02 ml, 0.40 mmol) of bromine. During the course of this reaction, a red coloration appeared and disappeared. To the solution, 50 ml of ether was added and the organic phase was washed with water (4×50 ml) followed by a saturated sodium bicarbonate solution (2×50 ml) and finally with water (3×50 ml). The combined phase was dried over anhydrous magnesium sulfate and the solvent was removed in vacuo. The residue was chromatographed on silica gel (Kieselgel, 60F254, Merck, 0.063-0.200 mm). Elution with a mixture of hexane-ethyl acetate (4:1 v/v) yielded N-butyl, N-methyl-11-(16α-bromo-3'-acetoxy-17'-oxo-estra-1',3',5'(10'),trien-7'-α-yl) undecanamide (16, X=Br) (201 mg, 78%) as colorless oil (201 mg, 78%), as colorless oil; 1 H-NMR o (CDCl 3 ), 0.94 (s, 3H,18'-CH 3 ), 2.28 (s, 3H, 3'-OCOCH 3 ), 2.82 app (d,1H,J=16.4 Hz, part of ABX system, 6'-H), 2.90 and 2.96 (2s, 3H,N--CH 3 ), 3.24 and 3.35 (2t app , 2H, J=7.7 Hz, --N--CH 2 --), 4.58 (t,1H,J=3.6 Hz, 16β-H), 6.82 (broad s,1H,4'-H), 6.88 (dd,1H, J=8.0 Hz and J 2 =4.0 Hz,2'-H), 7.29 (d,1H,J=8.0 Hz, 1'-H); MS m/e 644 (M + ,7%) , 565 (M + -Br, 77%), 522 (M + -Br--COCH 2 , 55%), 142 (C 2 H 4 CON(CH 3 )C 4 H 9 + , 67% 114 (C 4 H 9 (CH 3 )NCO + , 66%), 88 (100%). N-butyl, N-methyl-11-(16'α-bromo-3',17'-dihydroxy-estra-1',3,4'(10')-trien-7'α-yl) undecanamide ("EM 105") and ("EM 171") A solution of bromoketone amide 16 (X=Br) (295 mg, 0.46 mmol) in anhydrous tetrahydrofuran (10 mi) under argon was chilled to -70° C. and a solution of 1.0M of lithium aluminium hybride in ether (0.92 ml, 0.92 mmol) was added dropwise with rapid magnetic stirring. After 30 min, the reaction was quenched by the dropwise addition of a mixture of THF-ethyl acetate (1:1 v/v) and acidified by 10% hydrochloric acid. The mixture was stirring for 5 min at room temperature and then extracted with ethyl acetate. The organic phase was washed with water, dried on anhydrous sodium sulfate and evaporated to dryness under reduced pressure. The residue was purified by chromatography on silica gel. Elution with a mixture of hexane-ethyl acetate (7:3 v/v) gave: N-n-butyl, N-methyl-11-(16'α-bromo-3',17'α-dihydroxy-estra-1',3',5'(10')-trien-7'α-yl) undecanamide ("EM 171") (63 mg, 21%) as colorless oil; 1 H-NMR δ (CDCl 3 , 400 MHz) 0.81 (s, 3H, 18'-CH 3 ), 0.93 and 0.96 (2t, 3H,J=7.3 Hz,N(CH 2 ) 3 CH 3 ), 2.79 (2H,J 6 .6 =16.6 Hz, J 6 ,7 =4.7 Hz, =Δδ=24.34 Hz, system ABX,6'-H), 2.94 and 2.99 (2s,3H,N--CH 2 --), 3.27 (dd,2H,J 1 =7.7 Hz and J 2 =7.5 Hz, --N--CH 2 --), 3.31-3.44 (m,2H,--N--CH 2 --), 3.66 (dd,1H,J 17 ,17 =1.4 Hz, J 17 ,16 =4,3 Hz, 17'β-H), 4.68 (dt,1H,J 16 ,17 =4,3 Hz, m, J 16 ,15 =9.7Hz,16'β-H), 6.60 (d,1H,J=2.4 Hz, 4'-H), 6.65 (dd, 1H,J=8.5 Hz and J 2 =2.5 Hz, 2'-H), 7.14 (d,1H,J=8.5 Hz, 1'-H); IR ν max (neat) 3300, 1615, 1495 cm -1 ; MS m/e 605,603 (M + , 17%), 523 (M + -HBr, 81%), 142 (C 2 H 4 CON(CH 3 )C 4 H 9 + , 100%), 114 (C 4 H 9 (CH 3 )NCO + , 97%); Exact mass calculated for C 34 H 54 O 3 N 79 Br 603.8289, found 603.3304. and N-n-butyl, N-methyl-11-(16'α-bromo-3',17'β-dihydroxy-estra-1',3',5'(10')-trien-7α-yl) undecanamide ("EM 105") (170 mg, 50%) as a colorless oil; analytical sample was obtained by HPLC purification; 1 H-NMR 6 (CDCl 3 , 400 MHZ), 0.80 (s,3H,18,--CH 3 ), 0.93 and 0.96 (2t,3H,J=7.3 Hz,N(CH 2 ) 3 CH 3 ), 2.80 (2H,J 6 ,6 =16.4,J 6 ,7 =4.6 Hz, Δδ=24.34 Hz, system ABX, 6'-H), 2.94 and 2.99 (2s,3H,N--CH 3 ), 3.27 (dd, 2H,J 1 =7.7 Hz and J 2 =7 5 Hz, --N--CH 2 --) 3.31-3.45 (m,2H,--N--CH 2 --), 4.02 (dd,1H,J 17 ,17 =3.7 Hz, and J 17 ,16 =6.1 Hz, 17'α-H), 4.15 (ddd,1H,J 16 ,15 =10.2 Hz, J 16 ,17 =6.1 Hz and J 16 ,15 =2.9 Hz, 16'β-H), 6.61 (d,1H,J=2.5 Hz, 4'-H), 6.66 (dd,1H,J=8.4 Hz and J 2 2.5 Hz, 2'-H), 7.12 (d,1H,J=8.4 Hz, 1'-H); IR ν max (neat) 3320, 1610, 1490 cm -1 ; MS m/e 605,603 (M + , 29%), 523 (M + -HBr, 100%), 142 (C 2 H 4 CON(CH 3 )C 4 H 9 + , 70%), 114 (C 4 H 9 (CH 3 )NCO + , 60%); Exact mass calculated for C 34 H 54 O 3 N 79 Br 603.3289, found 603.3289. Antiestrogens useful in the combination therapy of the invention include but are not limited to Tamoxifen, commercially available from Imperial Chemical Industries, and EM 139, EM 170 and EM 171 whose synthesis are set forth above. Some steroidal antagonists also function as inhibitors of sex steroid formation. The antiestrogens EM 139, EM 170 and EM 171, for example, exhibit the dual function of acting as sex steroid formation inhibitors. For this reason, a combination therapy requiring both an inhibitor of sex steroid formation and a steroidal antagonist may be produced by administering a single active compound (alone or together with diluent) capable of performing both functions. Another example of a dual function active ingredient is the antiandrogen EM 101 which has also shown an inhibitiory effect on sex steroid formation. The inhibitor of sex steroid biosynthesis is preferably capable of acting at least in peripheral tissues (extra-testicular and extra-adrenal). In preferred embodiments, it is used in association with an antiandrogen, and with an LHRH agonist or LHRH antagonist. The use of an LHRH agonist is the more preferred method of chemical castration. Surgical castration may alternatively be used as a means of inhibiting testicular hormonal secretions, but chemical castration is preferred. By the term "LHRH agonist" is meant synthetic analogues of the natural luteinizing hormone-releasing hormone (LHRH), a decapeptide of the structure: L-pyroglutamyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-gly-cyl-L-leucyl-arginyl-L-prolylglycyl-NH 2 . Typical suitable LHRH agonists include nonapeptides and decapeptides represented by the formula: L-pyroglutamyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-X-Y-L-arginyl-L-prolyl-Z wherein X is D-tryptophyl, D-leucyl, D-alanyl, iminobenzyl-D-histidyl, 3-(2-naphthyl)-D-alanyl, O-ter-butyl-D-seryl, D-tyrosyl, D-lysyl, D-phenylalanyl or N-methyl-D- alanyl and Y is L-leucyl, D-leucyl, N.sup.α -methyl-D-leucyl, Ns-methyl-L- leucyl or D-alanyl and wherein Z is glycyl-NHR 1 or NHR 1 wherein R 1 is H, lower alkyl or lower haloalkyl. Lower alkyl includes, for example, methyl, ethyl, propyl, pentyl, hexyls, iso-butyl, neopentyl and the like. Haloloweralkyl includes, for example, --CF-- 3 , --CH 2 CF 3 , --CF 2 CH 3 , and the like. Fluorine is a preferred halogen. Preferred nonapeptides wherein Y is L-leucyl and X is an optically active D-form of selected amino acids and Z is NHC 2 H 5 are [D-Trp 6 , des-Gly-NH 2 10 ]LHRH ethylamide (X=D-Trp 6 ); [D-Ser-t-BuO) 6 , des-Gly-NH 2 10 ]LHRH, ethylamide [X-D-Ser(t-BuO 6 )]; [D-Leu 6 , des-Gly-NH 2 10 ]LHRH ethylamide (X=D-Leu 6 , [D-His(Bzl) 6 , des-Gly-NH 2 10 ]LHRH ethylamide (X=iminobenzyl-D-His 6 ) and [D-Ala 6 , des-Gly-NH 2 10 ]-LHRH ethylamide (X=D-Ala 6 ). Preferred decapeptides include [D-Trp 6 ]LHRH wherein X=D-Trp, Y=L-leucyl, Z=glycyl-NH 2 , [D-Phe 6 ]-LHRH wherein X=D-phenylalanyl, Y=L-leucyl and Z=glycyl-HN 2 ) or [D-Nal(2) 6 LHRH which is [ 93 -3-(2-naphthyl)-D-Ala 6 ]-LHRH wherein X=3(2-naphthyl)-D-alanyl, Y=L-leucyl and Z=glycyl-NH 2 . Other LHRH agonists useful within the scope of this invention are the α-aza analogues of the natural LHRH, especially, [D-Phe 6 , Azgly 10 ]-LHRH, [D-Tyr(-Me) 6 , Azgly 10 ]LHRH, and [D-Ser-(t-BuO) 6 , Azgly 10 ]LHRH disclosed by A. S. Dutta et al. in J. Med. Chem., 21, 1018 (1978) and U.S. Pat. No. 4,100,274 as well as those disclosed in U.S. Pat. Nos. 4,024,248 and 4,118,483. Typical suitable LHRH antagonists include [N-Ac-D-p-Cl-Phe 1 , 2 , D-Phe 3 , D-Arg 6 , D-Ala 10 ]-LHRH disclosed by J. Ercheggi et al., Biochem. Biophys. Res. Commun. 100 915-920 (1981); [N-Ac-D-p-Cl-Phe 1 , 2 , D-Trp 3 , D-Arg 6 , D-Ala 10 ]LHRH disclosed by D. H. Coy et al., Endocrinology, 110: 1445-1447 (1982): [N-Ac-D-(3-(2-naphthyl)-0Ala) 1 , D-p-Cl-Phe 2 , D-Trp 3 , D-hArg(Et 2 ) 6 , D-Ala 10 ]LHRH and [N-Ac-Pro 1 ∵D-pF-Phe 2 , D-(3-(2-naphthyl)-Ala 3 , 6 ]-LHRH disclosed by J. J. Nestor et al. J. Steroid Biochem., 20 9no. 6B), 1366 (1984); the nona- and decapeptide analogs of LHRH useful as LHRH antagonists disclosed in U.S. Pat. No. 4,481,190 (J. J. Nestor et al.).; analogs of the highly constrained cyclic antagonist, cycle [Δ 3 Pro 1 , D-p-Cl-Phe 2 , D-Trp 3 , 6 , N-Me-Leu 7 , β-Ala 10 ]-LHRH disclosed by J. Rivier, J. Steroid Biochem., 20 (no. 6B), 1365 (1984); and [N-Ac-D-(3(2-naphthpyl)-Ala 1 , D-p-F-Phe 2 , D-Trp 3 , D-Arg 6 ]LHRH disclosed by A. Corbin et al., J. Steroid Biochem. 20 (no. 6B) 1369 (1984). Preferred nonapeptides wherein Y is L-leucyl and X is an optically active D-form of selected amino acids and Z is NHC 2 H 5 are [D-Trp 6 , des-Gly-NH 2 10 ]LHRH ethylamide (X=D-Trp 6 ); [D-Ser-t-BuO) 6 , des-Gly-NH 2 10 ]LHRH ethylamide [X-D-Ser(t-BuO 6 ) ]; [D-Leu 6 , des-Gly-NH 2 10 ]LHRH ethylamide (X=D-Leu 6 , [D-His(Bzl) 6 , des-Gly-NH 2 10 ]LHRH ethylamide (X=iminobenzyl-D-His 6 ) and [D-Ala 6 , des-Gly-NH 2 10 ]-LHRH ethylamide (X=D-Ala 6 ). Preferred decapeptides include [D-Trp 6 ]LHRH wherein X=D-Trp, Y=L-leucyl, Z=glycyl-NH 2 , [D-Phe 6 ]-LHRH wherein X=D-phenylalanyl, Y=L-leucyl and Z=glycyl-HN 2 ) or [D-Nal(2) 6 LHRH which is [ 93 -3-(2-naphthyl)-D-Ala 6 ]-LHRH wherein X=3(2-naphthyl)-D-alanyl, Y-L-leucyl and Z=glycyl-NH 2 . Other LHRH agonists useful within the scope of this invention are the α-aza analogues of the natural LHRH, especially, [D-Phe 6 , Azgly 10 ]-LHRH [D-Tyr(-Me) 6 , Azgly 10 ]LHRH, and [D-Ser-(t-BuO) 6 , Azgly 10 ]LHRH disclosed by A. S. Dutta et al. in J. Med. Chem., 21, 1018 (1978) and U.S. Pat. No. 4,100,274 as well as those disclosed in U.S. Pat. Nos. 4,024,248 and 4,118,483. Typical suitable LHRH antagonists include [N-Ac-D-p-C1-Phe 1 , 2 , D-Phe 3 , D-Arg 6 , D-Ala 10 ]-LHRH disclosed by J. Ercheggi et al., Biochem. Biophys. Res. Commun. 100, 915-920 (1981); [N-Ac-D-p-Cl-Phe 1 , 2 , D-Trp 3 , D-Arg 6 , D-Ala 10 ]LHRH disclosed by D. H. Coy et al., Endocrinology, 110:1445-1447 (1982); [N-Ac-D-(3-(2-naphthyl)-0Ala) 1 , D-p-Cl-Phe 2 , D-Trp 3 , D-hArg(Et 2 ) 6 , D-Ala 10 ]LHRH and [N-Ac-Pro 1 , D-pF-Phe 2 , D-(3-(2-naphthyl)-Ala 3 , 6 ]-LHRH disclosed by J. J. Nestor et al. J. Steroid Biochem., 20 9no. 6B), 1366 (1984); the nona- and decapeptide analogs of LHRH useful as LHRH antagonists disclosed in U.S. Pat. No. 4,481,190 (J. J. Nestor et al.); analogs of the highly constrained cyclic antagonist, cycle [Δ 3 Pro 1 , D-p-Cl-Phe 2 , D-Trp 3 , 6 , N-Me-Leu 7 , β-Ala 10 ]-LHRH disclosed by J. Rivier, J. Steroid Biochem., 20 (no. 65), 1365 (1984); and [N-Ac-D-(3-(2-naphthyl)-Ala 1 , D-p-F-Phe 2 , D-Trp 3 , D-Arg 6 ]LHRH disclosed by A. Corbin et al., J. Steroid Biochem. 20 (no. 65) 1369 (1984). Other LHRH agonist and antagonist analogs are disclosed in LHRH and its Analogs (B. H. Vickery et al. eds, at pages 3-10 (J. J. Nestor), 11-22 (J. Rivier et al.) and 22-33 (J. J. Nestor et al.) as well as in The Case for LHRH agonists (Clinical Oncology, Furr and Denis, eds), Bailliere Tindall, vol. 2, no. 3, pp. 559-570, 1988). The LHRH agonists and antagonists useful in this invention may conveniently be prepared by the method described by Stewart et al. in "Solid Phase Peptide Synthesis" (published in 1969 by Freeman & Co., San Francisco, page 1) but solution phase synthesis may also be used. The nona- and decapeptides used in this invention are conveniently assembled on a solid resin support, such as 1% cross-linked Pro-merrifield resin by use of an automatic peptide synthesizer. Typically, side-chain protecting groups, well known to those in the peptide arts, are used during the dicyclohexylcarbodiimidecatalyzed coupling of a tert-butyloxycarbonylamino acid to the growing peptide attached to a benzhydrylamide resin. The tert-butyloxycarbonyl protecting groups are removed at each stage with trifluoroacetic acid. The nona- or decapeptide is cleaved from the resin and deprotected by use of HF. The crude peptide is purified by the usual techniques, e.g., gel filtration and partition chromatography and optionally lyophilization. See also D. H. Coy et al., J. Med. Chem. 19, pages 423-425 (1976). In this invention, the LHRH agonist or antagonist, the 5α-reductase inhibitor, the antiandrogen, the antiestrogen, and, where applicable, the inhibitor of 2β- and 17β-hydroxysteroid dehydrogenase activities are administered as pharmaceutical compositions via topical, parenteral or oral means. The LHRH agonist or antagonist is administered parenterally, i.e., intramuscularly, subcutaneously or intravenously by injection or infusion by nasal drops or by suppository. The LHRH agonist or antagonist may also be microencapsulated in or attached to a biocompatable, biodegradable polymer, e.g., poly(d,l-lactide-co-glycolide) and subcutaneously or intramuscularly injected by a technique called subcutaneous or intramuscular depot to provide continuous, slow release of the LHRH agonist or antagonist over a period of 30 days or longer. The most preferred route of administration of the LHRH agonist or antagonist is subcutaneous or intramuscular depot injection. Preferably the antiestrogen will be administered orally. Preferably, the 5α-reductase inhibitor, the antiandrogen, the antiestrogen, the inhibitor of 3β-HSD and the inhibitor of 17β-HSD can also be administered orally. The antiestrogen, an inhibitor of 3β-HSD and inhibitor of 17β-HSD can also be administered in a slow release formulation, e.g. poly(d,l-lactide-coglycolide) or as implants. The amount of each component administered is determined by the attending clinicians taking into consideration the etiology and severity of the disease, the patient's condition and age, the potency of each component and other factors. According to this invention, the following dosage ranges are suitable. The LHRH agonist or antagonist is generally administered at from about 10 to 5000 μg per day with contemplated dosage ranges of about 10 to 1500 μg per day and about 250 (preferably 50 μg to 500 μg per day) for the LHRH agonist and to about 100 to 2000 μg per day for the LHRH antagonist being preferred. In the most preferred embodiment of this invention, the LHRH agonist or antagonist is administered subcutaneously in a daily dose of 500 μg for the first 30 days and thereafter subcutaneously in a daily dose of 250 μg regardless of the patients' body weight. When the LHRH agonist or antagonist is administered, once every 30-day period is used, with a dose of 750 to 15,000 μg per 30-day period being preferred. Similar daily delivery doses are used for longer-term controlled release formulations. The inhibitors of 3β-HSD and 17β-HSD are preferably administered in dosages ranging from about 0.1 to 25 mg/kg per day with 200 mg per day in two equally divided doses being preferred. The antiestrogen compositions are administered in a dosage range of about 0.05 to 25 mg/kg body weight per day, with 20 mg, especially 40 mg, in two equally divided doses being preferred. The 5α-reductase inhibitor compositions are administered in a dosage ranging from 0.1 to 25 mg/kg per day with 50 mg per day in two equivalent doses being preferred. The antiandrogen and aromatase inhibitor compositions are administered in a dosage range of 0.5 to 25 mg/kg body weight per day with 750 mg per day in three equally divided doses being preferred. The LHRH agonist or antagonist, antiestrogen, antiandrogen, an inhibitor of aromarase, 17β-HSD and 3β-HSD each may be administered separately er when the modes of administration are the same, all or at least two of them may be administered in the same composition, but in any case the preferred ratio of LHRH agonist to antiestrogen, to antiandrogen to inhibitor of 17β-HSD and administered daily will be about 250 μg of LHRH agonist to about 750 mg of antiandrogen, about 40 mg of antiestrogen, to about 40 mg of inhibitor of 17β-HSD and about 40 mg of inhibitor of 3β-HSD. In the therapy of prostate cancer, combining the administration of an LHRH agonist or antagonist, an antiestrogen, an antiandrogen and an inhibitor of 17β-HSD, the dosages preferable are as follows: the LHRH agonist or antagonist is generally administered at from about 10 to 2000 μg per day, with contemplated dosage ranges of 10 to 500 μg per day, 50-250 μg per day and 250 to 500 μg per day being preferred. In the most preferred embodiment of this aspect of this invention, the LHRH agonist or antagonist is administered subcutaneously in a daily dose of 500 μg for the first 30 days and thereafter subcutaneously in a daily dose of 250 μg regardless of the patients' body weight. When the LHRH agonist or antagonist is administered, once every 30-day period, by intramuscular or subcutaneous depot injection, a dose from about 300 to 60000 (occasionally 10000) μg per 30-day period is used, with a dose of 750 to 2000 μg per 30-day period being preferred. The antiandrogen composition is generally administered in a dosage range of about 0.5 to 25 mg/kg (body weight) per day with 400 especially 750 mg per day in three equally divided doses being preferred. The antiestrogen and inhibitor of 17β-HSD and 3β-HSD activities are administered in a dosage range of about 0.1 to 25 mg/kg body weight per day, with 100 mg in two, preferably with 50 mg in two, equally divided doses being preferred. The LHRH agonist or antagonist, antiandrogen, antiestrogen, 5α-reductase inhibitor, inhibitor of 17β-HSD, inhibitor of 3β-HSD, inhibitor of aromatase, each may be administered separately or when the modes of administration are the same, all or two or three of them may be administered in the same composition, but in any case the preferred ratio of LHRH agonist to antiandrogen to antiestrogen administered daily will be about 750 μg of LHRH agonist to about 250 mg of antiandrogen to preferably 40 mg of antiestrogen. In the therapy of prostate cancer, according to this invention, it is preferred that the LHRH agonist is [D-Trp 6 , des-Gly-NH 2 10 ]LHRH ethylamide be administered subcutaneously in single daily dose of 500 μg for the first thirty (30) days of treatment and thereafter in a single daily dose of 250 μg. In the combination therapy of prostate cancer according to this invention, the administration of the antiandrogen, antiestrogen, inhibitor of 17β-HSD, inhibitor of 5α-reductase, inhibitor of aromatase, and inhibitor of 3β-HSD, LHRH agonist or LHRH antagonist can be started in any order of sequence. Preferably, the administration of the antiandrogen and 5α-reductase inhibitor, are started before (preferably two to four hours before) the administration of the LHRH agonist or LHRH antagonist is started. Orchiectomy can replace LHRH agonist or antagonist. Preferably, the administration of the inhibitor of 17β-HSD and inhibitor of 3β-HSD is started on the same day as the administration of the LHRH agonist or LHRH antagonist. However, the attending clinician may elect to start adminsitration of the LHRH agonist or antagonist simultaneously with the antiandrogen, antiestrogen inhibitor of 17β-HSD and inhibitor of 3β-HSD. When patients whose testes have already been surgically removed are treated according to this invention, the administration and dosage of the antiandrogen and the other components of the therapy (except the LHRH agonist or antagonist which is not used) are the same as indicated for the therapy in which the LHRH agonist or antagonist is used. The LHRH agonists or antagonists useful in the present invention are typically amorphous solids which are freely soluble in water or dilute acids, e.g., HCl, H 2 SO 4 , citric, acetic, mandelic or fumaric. The LHRH agonist or antagonist for subcutaneous injection is supplied in vials containing 5 ml of sterile solution with the LHRH agonist or antagonist at a concentration of about 1.0 mg/ml. A typical pharmaceutical composition of the LHRH agonist or antagonist includes the LHRH agonist or antagonist or a pharmaceutically acceptable acid salt thereof, benzyl alcohol, a phosphate buffer (pH 6.0-6.5) and sterile water. The LHRH agonist or antagonist for intramuscular or subcutaneous depot injection may be microencapsulated in a biocompatible, biodegradable polymer, e.g., poly (d,l-lactide-co-glycolide) by a phase separation process or formed into a pellet. The microspheres may then be suspended in a carrier to provide an injectable preparation or the depot may be injected in the form of a pellet. See also European patent application EPA No. 58,481 published Aug. 25, 1982 for solid compositions for subdermal injection or implantation or liquid formulations for intramuscular or subcutaneous injections containing biocompatible, biodegradable polymers such as lactide-glycolide copolymer and an LHRH agonist, e.g. D-Ser-t-BuO 6 , Azgly 10 -LHRH. These formulations permit controlled release of the peptide. The inhibitors of 17β-HSD, 3β-HSD, aromarase and 5α-reductase are typically compounded in customary ways for oral administration, e.g., in tablets, capsules and the like. These compounds useful in the present invention are typically formulated with conventional pharmaceutical excipients, e.g., spray dried lactose and magnesium stearate into tablets or capsules for oral administration. The antiestrogens, when used with the invention, are typically compounded in customary ways for oral administration, e.g., in capsules, tablets, as dragees or even in liquid form, e.g., suspensions or syrups. One or more of the active substances, with or without additional types of active agents, can be worked into tablets or dragee cores by being mixed with solid, pulverulent carrier substances, such as sodium citrate, calcium carbonate or dicalcium phosphate, and binders such as polyvinyl pyrrolidone, gelatin or cellulose derivatives, possibly by adding also lubricants such as magnesium stearate, sodium lauryl sulfate, "Carbowax" or polyethylene glycols. Of course, taste-improving substances can be added in the case of oral administration forms. The therapeutically active antiestrogen compound should be present in a concentration of about 0.5-90% by weight of the total mixture, i.e., in amounts that are sufficient for maintaining the above-mentioned dosage range. As further forms, one can use plug capsules, e.g., of hard gelatin, as well as closed soft-gelatin capsules comprising a softener or plasticizer, e.g. glycerine. The plug capsules contain the active substance preferably in the form of granulate, e.g., in mixture with fillers, such as lactose, saccharose, mannitol, starches, such as potato starch or amylopectin, cellulose derivatives or hightly-dispersed silicic acids. In soft-gelatin capsules, the active substance is preferably dissolved or suspended in suitable liquids, such as vegetable oils or liquid polyethylene glycols. In place of oral administration, the active compounds may be administered parenterally. In such case, one can use a solution of the active substance, e.g., in sesame oil or olive oil. One or more of the active substances (antiestrogen or inhibitor of 17β-HSD and 3β-HSD can be microencapsulated in or attached to a biocompatible, biodegradable polymer, e.g. poly(d,l-lactide-co-glycolide) and subcutaneously or intramuscularly injected by a technique called subcutaneous or intramuscular depot to provide continuous slow release of the compound(s) for a period of 2 weeks or longer. In the most preferred aspect of this invention, the LHRH agonist is [D-Trp 6 ,des-Gly-NH.sub. 2 10 ]LHRH ethylamide which is administered subcutaneously in single daily dose of 500 μg for the first thirty (30) days of treatment and thereafter in a single daily dose of 250 μg: the antiandrogen is EM 101 which is administered orally in three equally divided daily doses of 250 mg; and the inhibitor of sex steroid biosynthesis is EM 139 and/or MK 906 administered orally in two equally divided doses of 50 mg every 12 hours. The inhibitor(s) of sex steroid biosynthesis and the antiandrogen are preferably administered to a male in need of the prostate cancer treatment of this invention two to four hours before the LHRH agonist or antagonist is administered, but the at tending clinician may elect to start administration of the LHRH agonist or antagonist, the antiandrogen and the inhibitor of steroid biosynthesis simultaneously. When the antiandrogen and sex steroid inhibitor are particularly effective, both chemical (LHRH agonist or antagonist) and surgical castration may be avoided. Especially, when patients whose testes have already been surgically removed are treated according to this invention, no LHRH agonist or antagonist need to be used but other dosages remain the same. The terms and descriptions used herein are preferred embodiments set forth by way of illustration only, and are not intended as limitations on the many variations which those of skill in the art will recognize to be possible in practicing the present invention as defined by the following claims.

A method of treatment of androgen-related diseases such as prostate cancer in susceptible male animals, including humans, comprises administering novel antiandrogens and/or novel sex steroid biosynthesis inhibitors as part of a combination therapy. Sex steroid biosynthesis inhibitors, especially those capable of inhibiting conversion of dehydroepiandrosterone (DHEA) or 4-androstenedione (D 4 -dione) to natural sex steroida (and testosterone into dihydrotestosterone) in peripheral tissues, are used in combination with antiandrogens usually after blockade of testicular hormonal secretions. Antiestrogens can also be part of the combination therapy. Pharmaceutical compositions and two, three, four and five component kits are useful for such combination treatment.

This application is a continuation of application Ser. No. 07/030,386, filed on Mar. 26, 1987, now abandoned. BACKGROUND OF THE INVENTION 1. Field of the Invention: This invention relates to a carbonated beverage, and more specifically to a carbonated beverage containing a low-calorie sweetner which is low calorie, has a reduced tendency to cause dental caries, and possesses excellent palatability. 2. Discussion of the Background: In recent years, drinks and health foods which are low in calorie and have a reduced tendency to cause caries have proliferated, and there has thus been a tendency to utilize low-calorie sweetners such as aspartame in carbonated beverages. Carbonated beverages containing many low-calorie sweetening agents are frequently inferior in taste or flavor to those containing sugar. For example, carbonated beverages containing saccharin or a Stevia extract have considerably lower palatability than those which contain sugar because the former leaves a particularly bitter after-tase. In contrast to other low-calorie sweeteners, aspartame is sweet-tasting and possesses a flavor increasing effect. However, carbonated beverages which contain blends of saccharin or the Stevia extract with aspartame tend to be less organoleptically pleasing than those containing sugar. In order to remedy these organoleptic characteristics, attempts have been made to improve the sweetness of the compounds, and many reports have been made on the improvement of sweeteners such as saccharin, the Stevia extract, Acesultame and aspartame. In the course of studying the organoleptic characteristics of a carbonated beverage containing aspartame, the present inventors determined that improving sweetness alone does not remedy the difference of its organoleptic characteristics with that of a carbonated beverage containing sugar. Further investigations led to the discovery that in the carbonated beverage containing aspartame, carbon dioxide gas escapes more easily after bottle opening, than from the beverage containing sugar. Therefore, the refreshness which is ascribable to the dissolved carbon dioxide gas is more rapidly impaired and the palatability of the beverage is more rapidly reduced. SUMMARY OF THE INVENTION It is an object of this invention to provide a carbonated beverage containing a sweetening agent of a high degree of sweetness, such as aspartame, which possesses an excellent refreshness, is low calorie and has a low tendency to cause caries, and to prevent the rapid loss of dissolved carbon dioxide after bottle opening. The present inventors have made extensive investigations into the prevention of the rapid loss of the dissolved carbon dioxide gas in carbonated beverages containing low-calorie sweeteners, and have found that natural gums effectively prevent the decrease of carbon dioxide gas. Thus, according to this invention, there is provided a carbonated beverage which contains a low-calorie sweetener as a part or the whole of its sweetener content and a cold water-soluble natural gum. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The natural gum used in this invention includes edible gums such as ghatti gum, gum arabic, guargum, tamarind gum and xanthan gum, carragheenan and pectin. They may be used either singly or in combination. The optimum concentration of the natural gum differs depending upon its type, but generally its concentration in a carbonated beverage is about 5 to 50 mg/dl. If the concentration of the gum increases beyond this, the carbonated beverage increases in consistency, is viscous to the palate and its refreshness decreases. Furthermore, bubbling will thus persist during pouring into a glass or within the mouth, and thus its refreshness is reduced. On the other hand, if the concentration of the gum is too low, the effect of preventing a decrease of the concentration of dissolved carbon dioxide cannot be obtained. In a model system of a cider-like carbonated drink using various natural gums, the percent residue of dissolved carbon dioxide gas was determined. The measurement was made by opening a well-chilled (5°-8° C.) can of the carbonated beverage, and leaving it to stand for a fixed period of time in a constant-temperature vessel at 37° C. The concentrations of dissolved CO 2 before and after the can opening were measured by a carbon dioxide meter (Model AI-1003, made by Ishikawa Seisakusho). The results are expressed by ##EQU1## Smaller percent residue values indicate greater ease with which CO 2 escaped. The results are shown in Table 1. TABLE 1______________________________________ Percent of residueAmounts added of dis- Sugar Aspartame Natural gum solvedSample (g/dl) (mg/dl) (mg/dl) pH CO.sub.2 (%)*______________________________________1 10 -- -- 3.9 40.42 -- 50 -- 3.9 31.83 -- 50 pectin 10 3.9 36.94 -- 50 λ-carra- 3.9 36.8 gheenan 105 -- 50 xanthan 3.9 34.9 gum 106 -- 50 tamarind 10 3.9 34.3 gum7 -- 50 gum 10 3.9 39.1 arabic______________________________________ *On standing at 37° C. for 60 minutes. The above samples were subjected to an organoleptic test, and the results are shown in Table 2. TABLE 2______________________________________Organoleptic evaluation (n=5) Pleas- Relative ingness Degree of of feel Relative Overall Carbona- of carbon Degree of evalua-Sample tion* dioxide* Sweetness* tion**______________________________________1 0 0 0 5.82 1.4 0.4 -0.4 4.63 1.2 0.8 0 5.34 0.2 0.1 -0.4 4.65 0.4 -1.1 -0.4 2.96 0.8 -0.4 -0.6 3.77 0.6 0.2 0 5.4______________________________________ Ratings: *A rating of 0 is given to sample 1, and the strength is rated in ± 2 grades. **Ratings of 11 grades from 0 (bad taste) to 5 (ordinary) to 10 (good taste) are given. As shown by the results of Table 1, the percent residue of dissolved carbon gas is high in all systems containing natural gums, and a model system containing gum arabic is closest to one containing sugar. In respect of organoleptic pleasingness, a system containing gum arabic is best, and nearly the same evaluation as for one containing sugar is assigned to it. The carbonated beverage to which the present invention pertains includes clear carbonated beverages, such as cola, cider-like soft drinks and ginger ale, and turbid carbonated beverage which contain components such as pectin or pulp derived from fruit juices, namely carbonated beverages containing fruit juices. The present invention is especially effective on the clear carbonated beverages. A low-calorie sweetener having a high degree of sweetness such as aspartame, Acesultame, the Steavia extract and derivatives is used either as the sole or part of a blend in the sweetener used in the carbonated beverage. One or a combination of two or more low-calorie sweeteners may be used. The proportions of the low-calorie sweetener in the entire sweeteners is 30 to 90%, preferably 50 to 80%, in terms of sweetness based on the total sweetness. When used in combination with another sweetening agent, such as sucrose, glucose, fructose, isomerized sugar, sugar alcohols such as sorbitol, maltitol and xylitol, reduced maltose, and reduced starch decomposition products, its proportion is determined by considering the desired strength of sweetness and the respective stengths of the sweetness of these sweeteners. The carbonated beverage of this invention may be produced in accordance with a known method. For example, sweetners such as aspartame may be added as a powder and dissolved, or may be mixed in the form of a solution with other ingredients. The natural gum may also be added in the conventional manner, similar to aspartame addition. Carbon dioxide gas in a predetermined amount may be forced into bottles by a carbonator. By including a natural gum, particularly gum arabic, into a carbonated beverage containing a low-calorie sweetener in such a low concentration as to scarcely cause a thickening effect, there can be obtained a carbonated beverage having high palatability comparable to one containing sugar and a reduced tendency to decrease the amount of dissolved carbon dioxide gas after bottle opening. The following examples illustrate the present invention further. Other features of the invention will become apparent in the course of the following description of exemplary embodiments which are given for illustration of the invention and are not intended to be limiting thereof. EXAMPLE 1 A lemon-lime carbonated beverage was prepared in a customary manner in accordance with the recipe shown in Table 3. The samples obtained were evaluated, and the results are shown in Table 4. TABLE 3______________________________________ Lemon- Gum Citric Lime Sugar AP arabic acid flavorSample (g/dl) (mg/dl) (mg/dl) (g/dl) (ml/dl)______________________________________1 10 -- -- 0.22 0.12 -- 50 -- 0.22 0.23 -- 50 10 0.22 0.1 (pH 3.9)______________________________________ TABLE 4______________________________________ Percent residue Organoleptic of dissolved CO.sub.2 evaluationSample (%).sup.1 (overall)______________________________________1 51.1 6.42 41.3 53 49.3 5.4______________________________________ .sup.1 On standing at 37° C. for 30 minutes Sample 3 (containing gum arabic) showed nearly the same percent residue of dissolved CO 2 as sample 1 (containing sugar) without impairing the palatability of sample 2 (containing AP), and the escaping of dissolved CO 2 was prevented. EXAMPLE 2 A grapefruit carbonated beverage was prepared in a customary manner in accordance with the recipe shown in Table 5. The samples obtained were evaluated, and the results obtained are shown in Table 6. TABLE 5______________________________________Components Liquid sugar of fruc- Grape- tose and Gum Citric fruit glucose AP arabic acid flavorSample (g/dl) (mg/dl) (mg/dl) (g/dl) (ml/dl)______________________________________1 1.25 -- -- 0.22 0.22 1.25 45 -- 0.22 0.23 1.25 45 -- 0.22 0.2 (pH 3.9)______________________________________ TABLE 6______________________________________ Percent residue Organoleptic of dissolved CO.sub.2 evaluationSample (%).sup.1 (overall)______________________________________1 50.4 5.62 41.5 5.13 50.0 5.4______________________________________ .sup.1 On standing at 37° C. for 30 minutes Sample 3 (containing gum arabic) showed nearly the same percent residue of dissolved CO 2 as sample 1 (containing sugar) without impairing the palatability of sample 2 (containing AP-isomerized sugar), and the escaping of dissolved CO 2 was prevented. EXAMPLE 3 A cider-like carbonated beverage was prepared in a customary manner in accordance with the recipe shown in Table 7. The samples obtained were evaluated, and the results are shown in Table 8. TABLE 7______________________________________Components Gum Citric Cider- Sugar AP arabic acid flavorSample (g/dl) (mg/dl) (mg/dl) (g/dl) (ml/dl)______________________________________1 10 -- -- 0.14 0.12 -- 45 -- 0.14 0.13 -- 45 10 0.14 0.1 (pH 3.9)______________________________________ TABLE 8______________________________________ Percent residue Organoleptic of dissolved CO.sub.2 evaluationSample (%).sup.1 (overall)______________________________________1 40.4 6.42 31.8 53 39.1 5.8______________________________________ .sup.1 On standing at 37° C. for 30 minutes Sample 3 (containing gum arabic) had a higher organoleptic rating and a higher percent residue of dissolved CO 2 than sample (2) containing AP, and had the same dissolved CO 2 escape as sample 1 (containing sugar). EXAMPLE 4 A cider-like carbonated beverage was prepared in a customary manner in accordance with the recipe indicated in Table 9. The samples obtained were evaluated, and the results obtained are shown in Table 10. TABLE 9__________________________________________________________________________Components Glucosyl stevio- Gum Citric Cider-Sugar AP side arabic acid flavorSample(g/dl) (mg/dl) (mg/dl) (mg/dl) (g/dl) (ml/dl)__________________________________________________________________________1 10 -- -- -- 0.14 0.12 -- 30 36.4 -- 0.14 0.13 -- 30 36.4 10 0.14 0.1 (pH 3.9)__________________________________________________________________________ TABLE 10______________________________________ Percent residue Organoleptic of dissolved CO.sub.2 evaluationSample (%).sup.1 (overall)______________________________________1 50.8 62 42.4 4.63 50.2 5______________________________________ Sample 3 (containing gum arabic) had the same percent residue of dissolved CO 2 as sample 1 (containing sugar) without impairing the palatability of sample 2 containing AP-stevia derivative, and the escape of dissolved CO 2 was prevented. Obviously, numerous modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be undestood that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described herein.

A carbonated beverage is produced which comprises a low-calorie sweetener such as aspartame, and a cold water-soluble natural gum, particularly gum arabic. It is a low calorie beverage which possesses excellent palatability and a reduced tendency to cause dental caries.

FIELD OF THE INVENTION This invention relates to dental varnishes, more specifically varnishes comprising a resin and a solvent as are used to seal teeth. BACKGROUND OF THE INVENTION The oldest type of dental varnishes comprised solutions of copal resin, a fossilized plant-derived mined material, in chlorinated hydrocarbons and later in alcohols. These varnishes were almost exclusively used as coatings over the cavity walls prior to placement of amalgam-type restoratives. They were not suitable for use under the novel resin based restoratives because copal resin acts as an inhibitor of the polymerization process, negatively influencing the cure of the restorative material and, in consequence, the quality of the restoration. Incomplete cure of the material could also cause postoperative discomfort and, in case of vital teeth, serious damage to the pulp. Copal varnishes, although generally beneficial in preventing marginal leakage of new restorations, did not offer benefits of tooth fluoridation and, therefore, did not provide an important, additional measure of protection against secondary dental tissue decays. Copal resin based varnishes were followed by varnishes based primarily on polyamide-type polymers, representing reaction products of aliphatic diamines with long chain carboxylic acids. Examples of such varnishes are described in U.S. Pat. No. 4,396,378. Synthetic varnishes generally do not inhibit the polymerization process of resin based restorative materials and, therefore, were suitable for use under amalgam as well as under polymeric restoratives. Because of their light consistency and low viscosity, they were unable to maintain fluoride salts in suspension. Their role was, therefore, limited to sealing dentin tubulae without providing the benefits of fluoridizing potentially vulnerable tooth surfaces. Another type of dental varnish encompasses formulations comprising, in addition to film formers (natural or synthetic resin), therapeutic agents, to effect desirable changes in the chemistry of teeth, reduce tooth sensitivity and to protect vulnerable oral tissues against potentially damaging side effects resulting from contact with dental materials. The most common among therapeutic additives in modern dental varnishes are fluoride salts, particularly sodium fluoride. The most commonly known fluoride containing dental varnishes are those comprising colophony resins as a film former, ethyl alcohol as a medium/solvent and sodium fluoride as the main, or only, therapeutic agent. Colophony is a natural resin derived from living trees and, as such, its characteristics frequently vary from one lot of resin to another. The differences often include properties relevant for the performance or esthetics of the varnish made with such resins. A desirable consistency of the varnish is important to achieve proper film thickness of the coating, to facilitate handling and, most of all, to prevent sedimentation of fluoride salts and other dispersed components of the formulation. Other disadvantages of these varnishes include their slow solvent release, resulting in a slow cure, and their unpleasant taste. SUMMARY OF THE INVENTION In accordance with one embodiment, there is provided a dental varnish for preventing or alleviating tooth sensitivity and/or reducing incidences of decay, wherein the varnish comprises a film-forming resin or resin mixture and a solvent, preferably comprising at least one C 2 -C 4 aliphatic alcohol and at least one C 5 -C 7 hydrocarbon. The resin mixture preferably comprises natural rosin, acid-modified rosin, partially polymerized rosin and combinations thereof. Preferably at least one rosin is an esterified rosin. In a preferred embodiment, the rosin is esterified with one or more polyalcohols, such as glycerol or pentaerythritol. In one embodiment, the solvent comprises an azeotropic or near azeotropic mixture of solvents, including, but not limited to, ethyl alcohol and n-hexane. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The subject of this invention is a new type of dental varnish, which while preserving all the advantages and functions of the prior art materials, fully eliminates their shortcomings. Among the resin/film former components in the formulations disclosed herein are the esters of rosin with polyalcohols, including those with glycerol and pentaerythritol. Rosin, a plant-derived natural product, is a common ingredient in many dental products, particularly temporary cements and filling restorative materials. Chemical processing of rosin by its esterification results in a product of desirable and consistent characteristics. It was unexpectedly found that some of such esters dissolve in C 2 -C 4 alcohols, and even better, in their mixtures with C 5 -C 7 hydrocarbons. In one embodiment, the solvent component comprising a mixture of alcohol and hydrocarbon, are azeotropic or near azeotropic mixtures. Solutions of rosin esters in such mixtures resulted in fast curing, non-irritating varnishes. The mixtures of alcohols and hydrocarbons shown in the table below are among those azeotropic or near azeotropic mixtures that are suitable in formulating varnishes. The relative weights given in the table relate only to the azeotropic mixtures at the given boiling points, and are not intended to restrict the absolute or relative amounts of alcohol and hydrocarbon in the varnish formulations. Varnish formulations may include solvent mixtures using the solvents and solvent combinations listed below, and other solvents, that are not in azeotropic or near-azeotropic mixtures. In a preferred embodiment, the solvent mixture used in a varnish has a boiling point below about 100° C. TABLE 1 EXAMPLES OF ALCOHOLS/HYDROCARBON AZEOTROPIC MIXTURES Azeotropic Hydrocarbon Percentage Boiling Point Alcohol Co-Solvent (w/w) Alcohol (° C.) Isopropyl Alcohol Isopentane 5 27.8 n-Pentane 6 35.5 n-Hexane 23 62.7 Cyclohexene 37 70.5 Cyclohexane 33 68.6 n-Heptane 50.5 76.4 Methyl Cyclohexane 47.5 77.4 2,5-Dimethylhexane 62 79.0 n-Propyl Alcohol n-Hexane 4 65.6 Cyclohexane 20 74.3 n-Heptane 38 84.8 Ethyl Alcohol n-Pentane 5 34.3 n-Hexane 21 58.7 Cyclohexane 30 64.9 n-Heptane 49 70.9 n-Butyl Alcohol Cyclohexene 5 82.0 Cyclohexane 4 79.8 Methyl Cyclohexane 21 96.4 1-Heptene 13 90.0 n-Heptane 18 94.4 Isobutyl Alcohol n-Hexane 2.5 68.3 Cyclohexene 14.2 80.5 Cyclohexane 14 78.1 Methyl Cyclohexane 30 93.2 n-Heptane 27 90.8 sec-Butyl Alcohol n-Hexane 8 67.2 Cyclohexene 18 76.0 Cyclohexane 21 78.7 n-Heptane 38 89.0 Esterified rosins are available, unlike colophony, in highly desirable, light colors, enabling the production of varnishes virtually invisible after their placement on the teeth—a highly desirable feature in certain clinical applications. Rosin esters, and especially those using glycerol and pentaerythritol as esterfiying alcohols, allow for formulating desirable viscosity solutions at a concentration of 20%-75% by volume in the completed formulation. Such formulations feature fast solvent release combined with good mechanical characteristics of the coating. It was also found that the fluoride release (leaching) from such films is excellent and substantially better than that of prior art colophony varnishes. In preferred embodiments, the varnishes comprise a film forming resin or mixture of resins in a solvent system. Preferred film forming resins include natural rosin, acid-modified rosin, partially polymerized rosin and combinations thereof. Part or all of the rosin may be esterified with an alcohol, preferably a polyalcohol such as glycerol, pentaerythritol and/or alkylene glycols. Preferred varnishes comprise at least about 20% rosin by weight, including about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, and about 75%, and also including percentages between these recited percentages, as well as ranges bordered on each end by recited percentages, such as about 30-70%. In one embodiment, the resin mixtures includes one or more other natural or artificial resins, including but not limited to, colophony, cumarone, copal, and polyamide resins. Such other resins are preferably present at about 1-20%, including about 5%, about 10% and about 15%, including percentages between these recited percentages, as well as ranges bordered on each end by recited percentages. Preferred polyamides include those which are a reaction product of aliphatic diamines with fatty acids. Preferred solvent systems comprise an alcohol and a hydrocarbon. In one preferred embodiment, the solvent system comprises azeotropic or near-azeotropic mixtures of these components. Preferred alcohols for use in a solvent system include C 2 -C 4 alcohols, including C 3 alcohols, wherein said alcohols may be linear, branched and/or cyclic. Preferred alcohols include ethyl alcohol, propyl alcohol (including its isomers n-propyl alcohol and isopropyl alcohol), butyl alcohol (including its isomers, namely n-butyl alcohol, sec-butyl alcohol, iso-butyl alcohol, and t-butyl alcohol), and blends thereof. Preferred hydrocarbons include C 5 -C 7 hydrocarbons, including C 6 hydrocarbon compounds, wherein said hydrocarbons may be linear, branched and/or cyclic, and may be alkanes and/or alkenes. The hydrocarbon component may comprise a single hydrocarbon or a blend of two or more hydrocarbons. Specific preferred hydrocarbons include isopentane. n-pentane, n-hexane, isohexanes, cyclohexene, cyclohexane, methylcyclopentane, n-heptane, methyl cyclohexane, 2,5-dimethylhexane, cyclohexene, methyl cyclohexene, 1-heptene, and mixtures thereof. The solvent mixture may include hydrocarbons outside the C 5 -C 7 range. In a preferred embodiment, the varnish comprises at least about 15% solvent by weight, including about 18%, about 19%, about 20%, about 21%, about 22%, about 23%, about 24%, about 25%, about 30%, and about 35%, and also including percentages between these recited percentages, as well as ranges bordered on each end by recited percentages. In a preferred embodiment, the varnish comprises at least about 4% alcohol component by weight, including about 5%, about 6% about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, and about 14%, also including percentages between these recited percentages, as well as ranges bordered on each end by recited percentages. In a preferred embodiment, the varnish comprises at least about 10% hydrocarbon component by weight, including about 11%, about 12% about 13%, about 14%, about 15%, about 16%, about 17%, about 18%, about 19% and about 20%, also including percentages between these recited percentages, as well as ranges bordered on each end by recited percentages. Certain embodiments of the invention may include components present at concentrations above and below the concentrations recited. The varnish formulations optionally comprise a fluoridizing agent. Preferred fluoridizing agents include sodium fluoride, stannous fluoride, sodium monofluorophosphate, zinc hexafluorosilicate, and sodium hexafluorosilicate. When present, there is preferably about 0.1-10% fluoridizing agent by weight, including at least about 1%, about 2%, about 2.5%, about 3%, about 3.5% about 4%, about 4.5%, about 5%, about 5.5%, and about 6%, also including percentages between these recited percentages, as well as ranges bordered on each end by recited percentages, such as about 2.5%-6% and about 3-5%. The varnish formulations optionally comprise one or more of the following: sweeteners, such as xylitol, sorbitol, aspartame, sodium saccharin, and mixtures thereof; flavorings such as peppermint oil, cherry, citric acid, orange, strawberry, vanilla, coconut, bubble gum flavors and mixtures thereof; coloring agents; and organic and/or inorganic fillers or thickeners. When a sweetener is present, it is preferably present at about 0.5-3% by weight, including about 1%, 1.5%, 2%, and 2.5% by weight, or some other quantity sufficient to impart an improved palatability to the varnish. When flavorings are present, they are preferably present at about 1-4% by weight, including about 1.5-3%, including about 2% and about 2.5% and values therebetween. When a filler or thickener is present, such as silica, it is preferably present at about 2-5%, including about 3-4% by weight. The varnishes described herein may be applied to teeth using a suitable applicator, as is well-understood by those skilled in the art. Methods of using the varnish to seal a tooth include applying the varnish to a tooth and allowing the solvent to evaporate to leave behind a film which seals the tooth. The invention is further described in the examples which are given solely for the purpose of illustration, and are not intended to limit its scope as defined in the patent claims. Unless stated otherwise, all percentages given below, and elsewhere herein, are by weight. EXAMPLES OF FORMULATIONS AND PROPERTIES OF THE CEMENTS OF THIS INVENTION Example 1 The varnish formulation consisted of: Pentaerythritol rosin ester  68% Silica 3.5% Xylitol 2.7% Bubble Gum Flavor 3.0% Sodium Fluoride 4.2% Ethyl alcohol 5.8% n-Hexane 12.8%  The formulation has shown an adequate ability to maintain sodium fluoride and xylitol in suspension. Curing time at 37° C. was approximately five minutes. Fluoride leachability from the cured varnish was demonstrated. Example 2 The varnish formulation consisted of: Glycerol rosin ester  60% Polyamide (condensation product of   5% ethylenediamine with fatty acids) Silica   4% Aspartame 0.5% Peppermint Oil   2% Sodium Fluoride 4.5% Ethyl alcohol 5.4% n-Hexane 18.6%  The properties and performance of this formulation were substantially similar to this of Example 1. Example 3 The varnish formulation consisted of: Glycerol rosin ester 68% Partially polymerized rosin  6% Sodium Saccharin Blend 0.6%  Xylitol 1.4%  Cherry flavor  2% Stannous Fluoride 3.0%  Isopropyl alcohol  5% A blend of n-Hexane (85%) and 14% 2-methyl pentane (15%) The properties and performance of this formulation were substantially similar to this of Example 1. The curing time, however, was approximately 25% longer. Example 4 The varnish formulation consisted of: Glycerol rosin ester 30% Pentaerythritol rosin 30% Copal resin  5% Xylitol 2.5%  Wild Cherry flavor 2.5%  Sodium Monofluorophosphate  5% Ethyl alcohol 12.5%   n-Heptane 12.5%   The properties and performance of this formulation were generally similar to those of Example 1. The curing time, however, was approximately 30% slower. Example 5 The varnish formulation consisted of: Glycerol rosin ester  64% Silica 3.2% Xylitol 2.3% Wild Cherry flavor 1.5% Sodium Fluoride 3.8% Isopropyl alcohol 8.3% Cyclohexane 16.6%  The properties and performance of this formulation were generally similar to those of Example 1. The curing time at 37° C. was approximately 20 minutes.

Disclosed are dental varnishes comprising reaction products of rosins with polyalcohols dissolved in mixtures of C 2 -C 4 alcohols with C 5 -C 7 hydrocarbons which have been found effective in preventing tooth decay and alleviating tooth sensitivity. Such varnishes may, optionally, incorporate therapeutic, antimicrobial and sensory enhancing ingredients.

BACKGROUND OF THE INVENTION Skiers are normally provided with only one means of support to help maneuver their skis--the standard ski-pole. For the sake of lightness, it is usually unadjustable and single purpose in nature. The total weight of a pole is usually the prime selling point, not safety, versatility, or tip forces and velocities. This is caused by an over-simplified translation of the racer's edge to skiers who rarely worry about saving a few hundredths of a second in a race. While weight near the tip of a ski-pole has large effects on swing weight or the ability to flick the pole to a new position, weight near the handle has very little effect. A pound in the handle has little effect, while an ounce at the tip is noticeable in sluggish performance. The standard ski-pole is an excellent device for propelling in a forward direction as in nordic or cross country skiing. In downhill skiing it provides little supporting force, balancing force, or steering force when held in the normal manner. There are five ways to increase these forces known to be in use. First, is to place both poles between the legs and drag them while sitting lightly near the mid-point--a common practice in cross country skiing. The second way is to use a two-hand grip and to lever both poles at the side of the hip as a mountaineer would use an ice ax to glissade. Originally this was done with a single pole about eight feet long. The third way is to put the arms through the safety straps and grip the poles with a partial grip just below the normal grips. This is moderately effective, but seldom used. The fourth way is very effective, but is normally reserved for the handicapped, such as a one-legged skier. The device used is known as a crutch ski and is comprised of a forearm crutch with a small ski and cleats attached to the bottom. An example of this device is found in U.S. Pat. No. 3,738,674 issued to Edward A. Paul on June 12, 1973. The resulting tip swing weight is very heavy, but is of minor consequence to a non-racing amputee. The handle and yoke point forward in such a way that if the tip is snagged, the handle pulls out of the hand and recovery is difficult. The fifth way uses a standard ski-pole gripped in the normal way. The forearm is pointed toward the ground and the tip and basket are dragged with as much downward pressure as the hand can apply. It is used by most skiers when skiing near the limits of speed, terrain, or skill. In the case of downhill racers, it is often the main means of attitude control since the skis may be out of contact with the surface much of the time. The main effect is in pitch and yaw. SUMMARY OF THE INVENTION This invention relates to ski-poles, crutches and the like. One object of the invention is to provide a skier or the like with increased mobility and safety. Another object is to provide a ski-pole with a mount for various devices. The present invention uses a rear-facing yoke and inclined pistol-grip handle so that when the tip is snagged, the yoke unlocks or swings forward away from the forearm. The pistol-grip is forced up and into the hand so that there is little tendency to lose a grip. Since the present invention is intended for all types of skiing by able-bodied skiers, mainly various types of free style skiing, the impacts on the tip of the ski-pole can be large and at any angle. The upward or axial force could easily exceed the strength of a healthy arm. However, since the elbow bends back and the yoke unlocks forward, a tip overload results in a safe toggling action from forearm mode to cane mode. BRIEF DESCRIPTION OF DRAWINGS In the drawings I have shown in detail a preferred embodiment of the invention, but it will be understood that various changes may be made from the construction shown, and that the drawings are not to be construed as defining or limiting the scope of the invention, the claims forming a part of this specification being relied upon for that purpose. Other objects and advantages of the invention will become apparent in the following description of the accompanying drawings wherein: FIG. 1 is a side elevation of a ski-pole with an arm in cane and forearm mode. FIG. 2 is a front elevation of two ski-pole crutches clipped together with a hand shown in standard mode. FIG. 3 is a fragmentary front elevation of the pistol grip area showing a typical adjustment of the scales for left hand pole. FIG. 4 is a top fragmentary view of a left hand ski-pole. FIG. 5 is a partial cross sectional view of the interconnecting clip. FIG. 6 is a bottom view of two ski-poles clipped together. FIG. 7 is a fragmentary view of the lower portion of the ski-pole. FIG. 8 is a bottom view of the ice tip. FIG. 9 is a side view of a convertible forearm to shoulder crutch. FIG. 10 is a fragmentary view of the lower portion of the ski-pole. FIG. 11 is a side elevation of a ski-pole winglet. FIG. 12 is a bottom sectional view of the combination shown in FIG. 11. FIG. 13 is a side elevation of a typical combination of a ski-pole with a gun. FIG. 14 is a top view of the combination shown in FIG. 13 for right hand operation. FIG. 15 is a fragmentary end view of the pistol grip. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to the accompanying drawings in detail, FIG. 1-8 show a ski-pole used singularly or in pairs in various modes. A shaft 20 is inserted to various depths into the telescoping tube 22 to provide adjustable overall length. The telescoping tube 22 and the pistol grip tube 27 are slotted to allow for contraction when clamped by band clamps 28 and 30. The slots as shown in FIG. 3 may also provide windows for adjustment scales. Four scales are provided for fitting the poles to different users and uses. The upper scale 66 is used to set the yoke 32 to pistol grip 26 angle A and distance B. An angle of about ten degrees is needed to compensate for pole and arm deflection under hard braking in downhill skiing. If set incorrectly, hard stearing and/or wobbling will occur. A lower scale 68 is provided to set the overall length C of the poles and the angle D of the basket 42 to the pistol grip 26. Use as a standard ski-pole is provided for by a hand grip 24. Use as a cane, as shown in FIG. 1, is provided for by a pistol grip 26 that is adjustably clamped to the telescoping tube 22 by an upper band clamp 28 at the top of the pistol grip tube 27. Further clamping of the pistol grip 26 is provided by one or more lower band clamps 30 that also clamp the telescoping tube 22 to the shaft 20. One lower band clamp 30 will provide sufficient clamping; additional lower band clamps 30 will provide a margin of safety to this critical area. Use as a forearm ski-pole as shown in FIG. 1 is provided for by grasping the pistol grip 26 and swinging the forearm up into the yoke 32. The yoke 32 is attached to the yoke shock mount 34 by bolts 33. The yoke shock mount 34 is press fitted onto the telescoping tube 22 and pinned by the cross bolt 36. The yoke 32 and yoke shock mount 34 are covered by a leather cover 38 and foam rubber padding 40 to prevent injuries and provide comfort. A basket 42 is clamped by an elastic stop nut 44 to a serrated collar 45 on the shaft 22. Metal staples 46 are fastened to the basket 42 to prevent ski edges from cutting the basket 42. For two pole-one hand operation, the baskets 42 are provided with hooks 48 to engage the mating shaft 20 as shown in FIGS. 2 and 6. A hard rubber clip 50 secures the poles together near the middle of the shafts 20. Since the poles may be used on ice in a dragging and sweeping direction as well as the normal pushing direction, a multi-point tip 52 is provided. The tip 52, as shown in FIGS. 7 and 8, has upward cutting edges 54 and side cutting edges 56 and may have the form of a grooved hex washer head screw. Chips or chunks of ice are expelled from an area just ahead of the tip at considerable velocity, as illustrated by the arrows in FIG. 7. This can produce vibration or chatter. While not critical, the vibration can be lessened by filling the upper half of the shaft 20 with a wooden dowel 21 that is held in place by a high hysteresis glue. The wooden dowel 21 also increases the strength and reliability of the pole. When the poles are to be used on a very steep icy slope, an ice arrest pick 58 may be fitted to the pistol grip 26 in a jack knife manner by a pivot bolt 60. A large extractor groove 62 and extractor groove slot 64 are provided for use by a gloved hand. During a fall on ice or when traversing on steep icy slopes, as for example on the famous headwall in Tuckerman's Ravine on Mt. Washington, the blade of the arrest pick 58 can be exposed by pivoting it out of grip 26 to the position shown in FIG. 1. The upper edge of pick 58 can then be dragged along the ice with the forearm in the yoke 32, so that the skier can steady himself or slow himself down as he slides on the ice. Furthermore, during a fall on ice, an expert skier can keep his legs and skis below him by dragging the arrest pick on the ice, thereby making it possible to stop his fall completely or even to recover his balance and continue his decent on his skis. The arrest pick is only effective in forearm mode and the user should be protected from ice chip spray by heavy clothes. The shaft 20 may have two bends 70 and 72 near the basket to incline the tip 52 at a more favorable contact angle and to stiffen the pole in column compression in forearm mode and cane mode. In standard mode the pole has lowered stiffness. A shoulder crutch is provided for in FIG. 9 by making the telescoping tube 22 substantially longer than is required for a forearm crutch. A shoulder pad extension 74 is added to the yoke shock mount 34 and the pistol grip 26 is moved from the forearm position down to the shoulder crutch position. The longer telescoping tube 22 provides for the greater range of overall length adjustment required for conversion from forearm crutch to shoulder crutch. It is understood that a ski-pole is used for many non-skiing activities such as walking, skating, skate-boarding, unicycling and the like. A crutch tip 84 is, therefore, provided for off-snow use and safe transport. Since the intended use quickly ruins regular crutch tips, a reinforced type as shown in FIG. 10 is preferred. The exterior 86 is the normal soft, high traction elastomer. The interior liner 88 is bonded of a hard elastomer. A band clamp 90 provides adjustable retention in the small area available. An aerodynamic control surface or winglet is provided for in FIGS. 11 and 12 by the optional attachment of a trailing flap 76 and/or a leading flap 78 to the shaft 20 by means of several band clamps 80. By changing the angular position of the flaps 76 and 78, the camber, twist, and relative angle of attack can be varied. The actual angle of attack is chosen by arm rotation to vary the lift and drag. A STOL type wing section with a highly cambered or cupped blade is preferred. A rough leading edge helps in low speed control at high angles of attack. Several pounds of additional mass can be carried around the pistol grip 26 with relatively little loss of performance. If the mass is structurally rigid, such as the gun 82 shown in FIGS. 13 and 14, then it can replace a portion of the shaft 20, telescoping tube 22 and/or pistol grip 26. Various shape pistol grips 26 have been used with success. One particular shape has proven best for all-around use. FIGS. 13 and 15 show this shape with deep finger grooves 92. The skier in cane mode should be able to flick the pole laterally without the pole slipping in a gloved hand. The cross section of the grip should interlock with the hand in the same way that a bolt head interlocks with a wrench. An irregular or slightly elongated hexagonal cross section is preferred. It is important in all applications of the present invention, whether for carrying large masses, such as the gun 82 (FIG. 13) or for using the ice pick 58 (FIGS. 1 and 4), as well as for maneuvering in a more-or-less conventional manner while skiing, that the pistol grip 26 be inclined toward the forearm yoke 32 at an angle which is natural in the forearm mode--i.e. when the forearm of the skier is cradled in the yoke as illustrated in FIG. 1. The pistol grip rear angle E illustrated in FIG. 13 should be fairly steep. More than 60 degrees causes hand fatigue in forearm mode. This fatigue is caused by having to continually force the yoke onto the forearm. An angle less than 45 degrees tends to cause slipping along the grip. An angle of 50-55 degrees is preferred for all around use. The pistol grip front angle F is less critical, with an angle of 40 to 55 degrees preferred.

A ski-pole or crutch is provided with a forearm yoke at its upper end and a pistol grip spaced below it. Both the yoke and pistol grip face rearward so that when the pistol grip is held in one hand the yoke can be swung into and out of locking engagement with the upper side of the forearm simply by bending the wrist, thereby providing greater maneuverability of the pole and support of the arm when needed for balance, support of the body and steering by planting the pole or dragging it.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application is a continuation of U.S. application Ser. No. 12/380,483, filed Feb. 27, 2009 and titled “Prosthetic heart Valve Systems”, which claims priority to U.S. Provisional Application No. 61/032,185, filed Feb. 28, 2008, and titled “Prosthetic Heart Valve Systems,” the entire contents of which are incorporated herein by reference in their entireties. TECHNICAL FIELD [0002] The present invention relates to prosthetic heart valves. More particularly, it relates to transcatheter implants, methods, and delivery systems. BACKGROUND [0003] Heart valve replacement surgery involves the replacement of the native valves of the heart with a prosthetic valve. Prosthetic valves include mechanical valves involving only metals and polymers, and tissue valves that include non-synthetic, biocompatible materials such as pericardium, or bovine, equine or porcine tissue. Some patients have a relatively small aortic root due to their particular anatomy or excessive calcification. Some patients (e.g., young children) are likely to outgrow a prosthetic valve or outlive the useful life of a prosthetic valve. [0004] U.S. Pat. No. 5,383,926 (Lock et al.) discloses a re-expandable endoprosthesis. The endoprosthesis is said to be re-expandable to accommodate vessel change. [0005] U.S. Patent Application Publication Nos. 2003/0199971 A1 (Tower et al) and 2003/0199963 A1 (Tower et al.) describe a valved segment of bovine jugular vein mounted within an expandable stent, for use as a replacement heart valve. Replacement pulmonary valves may be implanted to replace native pulmonary valves or prosthetic pulmonary valves located in valved conduits as described, for example, in “Percutaneous Insertion of the Pulmonary Valve”, Bonhoeffer, et al., Journal of the American College of Cardiology 2002; 39: 1664-1669. [0006] Degenerated and stenotic valves in conduits or in valved stents potentially allow for a second valved stent implantation without the need for surgery, as described, for example, in “Transcatheter Replacement of a Bovine Valve in Pulmonary Position”, Bonhoeffer, et al., Circulation 2000; 102: 813-816. It has been proposed that sequential percutaneous pulmonary valve implantation is feasible and theoretically could delay the need for invasive surgery indefinitely, thus overcoming concerns regarding conduit longevity and risks associated with reoperation, as described, for example, in “The potential impact of percutaneous pulmonary valve stent implantation on right ventricular outflow tract re-intervention”, Coates, et al., European journal of Cardio-thoracic Surgery 27 (2005) 536-543. [0007] U.S. Patent Application Publication No. 2003/0199971 A1 (Tower et al.) discloses a stented valve with an ability to be reconfigured after implantation. This is identified as a feature useful in cases where a valve has been implanted in a growing patient (e.g., a child). Rather than replacing a valve periodically during the growth period, the supporting stent may be reconfigured to accommodate growth using a percutaneously introduced balloon catheter for re-engaging the stent to reconfigure the stent so that it will conform to the changes in the implantation site produced by the growth of the patient. In an article by Bonhoeffer, et al. entitled “Percutaneous Insertion of the Pulmonary Valve” J Am Coll Cardiol, 2002; 39:1664-1669, the percutaneous delivery of a biological valve is described. The valve is sutured to an expandable stent within a previously implanted valved or non-valved conduit, or a previously implanted valve. Again, radial expansion of the secondary valve stent is used for placing an maintaining the replacement valve. [0008] Stented valve systems involving two or more components are disclosed in U.S. Patent Application Nos. 2004/0030381 A1 (Shu et al.) and 2008/0004696 A1 (Vesely et al.); U.S. Pat. No. 6,530,052 (Khou et al.) and 7,011,681 (Vesely et al.) and PCT Publication Nos. WO 06/0127756 A2 (Rowe et al.), WO 07/0181820 (Nugent et al.) and WO 07/130537 (Lock et al.). Some of these valve systems describe the reuse of a portion of their system. Some of these valve systems require the removal of an element and its replacement by a different element. It is believed that transcatheter removal of a previously implanted stented valve component creates challenges such as damage to implant site, creation of sites for thrombus/emboli formation and release, paravalvular leakage, inability to access removable elements due to tissue ingrowth and/or complex navigation, and delivery difficulties. SUMMARY [0009] The present invention is directed to a heart valve that can be expanded following its implantation in a patient. In one aspect of the present invention, the expansion can accommodate the growth of a patient and the corresponding growth of the area where the valve is implanted. In another aspect, the present invention may maximize the orifice size of the surgical valve. The present invention includes expandable implantable conduits and expandable bioprosthetic stented valves. In one aspect of the invention, the valve may be adapted to accommodate growth of a patient to address limitation on bioprosthetic valve lifespans. [0010] The heart valves of the invention may also facilitate a subsequent minimally invasive intervention for replacement of all or part of the valve system. In another aspect, the heart valves of the invention may ease the implantation process and could accommodate the use of a larger valve, which is especially useful for a patient with a small annulus (e.g., a small aortic annulus). [0011] The heart valves of the invention have the capacity to overcome concerns regarding conduit longevity and risks associated with performing multiple surgeries in the same area of the patient. The heart valves of the present invention advantageously utilize the proven attributes of surgical valves (e.g., durability), while addressing sonic of the shortcomings of surgical valves. In particular, the heart valves of the invention provide the ability to expand a valve post implant, which provides a number of major advantages that have yet to be proven clinically in humans. First, surgical tissue valves are typically offered in a limited number of sizes/diameters. The post-implant transcatheter surgical valve expansion provided by the valves of the invention enables the orifice size for each surgical prosthetic valve patient to be maximized post-implant, thereby improving valve function. Second, the post-implant surgical valve transcatheter expansion provided by the valves of the invention enables the orifice for each surgical prosthetic valve pediatric patient to be adjusted post-implant, to thereby accommodate patient growth and eliminate unnecessary surgeries. Third, the post-implant transcatheter surgical valve expansion provided by the valves of the invention increases the orifice size of the surgical prosthetic valve patient to accommodate a larger transcatheter valve after failure of the surgical valve, thereby eliminating the need for surgical replacement. Fourth, the post-implant transcatheter surgical valve expansion provided by the valves of the invention enables clinicians to implant transcatheter valves inside small bioprosthetic valves with improved hemodynamic results. Fifth, the post-implant transcatheter surgical valve expansion provided by the valves of the invention may enable implantation of bioprosthetic valves into younger patients by facilitating transcatheter valve replacement once the bioprosthetic valve fails or presents severe risk of failure. [0012] In another aspect of the invention, surgical methods are provided. In one embodiment, the method comprises implanting a surgical valve in an efficient manner. For example, some patients have a small aortic annulus. The present invention affords implantation of a valve in an undersized condition, after which the valve may be expanded to be larger in size or diameter (e.g., with a balloon), such as after the patient grows, minimizing the need for re-operation due to inadequate orifice size. BRIEF DESCRIPTION OF THE DRAWINGS [0013] The present invention will be further explained with reference to the appended Figures, wherein like structure is referred to by like numerals throughout the several views, and wherein: [0014] FIG. 1 is a perspective view of an expandable valved conduit in its relatively compressed state, according to one aspect of the invention; [0015] FIG. 2 is a perspective view of the expandable valved conduit of FIG. 1 in its relatively expanded state, along with a balloon expandable member positioned within the conduit; [0016] FIG. 3 is a perspective view of an expandable stent or member or frame for a stented valve in its relatively compressed state, according to another aspect of the invention; [0017] FIG. 4 is a perspective view of the stent of FIG. 3 assembled to additional components of a valve assembly, with the stent in a first implantable configuration. The fabric covering is removed from the frame of the valve assembly in the area of an expansion joint for illustration purposes; [0018] FIG. 5 is a perspective view of the assembly of FIG. 4 with the stent or member or frame expanded from the first implantable configuration to a second implantable configuration; [0019] FIG. 6 is a perspective view of the stent or member or frame of FIG. 5 ; [0020] FIG. 7 is a perspective view of a balloon expandable member positioned within a valve assembly that is configured as is generally shown in FIGS. 3 and 4 ; [0021] FIG. 8 is a perspective view of an expandable component of another embodiment of the invention; [0022] FIG. 9 is an enlarged front schematic view of a portion of the expandable component of FIG. 8 ; [0023] FIG. 10 is a front schematic view of an embodiment of a heart valve of the invention that is implanted in a first, unexpanded condition; [0024] FIG. 11 is a front schematic view of a balloon being used to expand the heart valve of FIG. 10 toward an expanded condition; [0025] FIG. 12 is a front schematic view of the heart valve of FIG. 10 after it has been expanded; [0026] FIG. 13 is a top view of an expandable tubular component according to another aspect of the invention; [0027] FIG. 14 is a side view of a portion of the component of FIG. 13 ; [0028] FIG. 15 is an enlarged side view of a portion of FIG. 14 ; [0029] FIG. 16 is another embodiment of a side view of an expandable seam of the invention, with the seam in a relatively unexpanded condition; [0030] FIG. 17 is a side view of the seam of FIG. 16 in a relatively expanded condition; [0031] FIG. 18 is a partial cross-sectional view of a seam expansion member of the invention; [0032] FIG. 19 is a bottom perspective view of a portion of the expansion member of FIG. 18 ; [0033] FIG. 20 is a front view of the expansion member of FIG. 18 ; [0034] FIG. 21 is a side view of another embodiment of an expansion member of the invention; [0035] FIG. 22 is another side view of the expansion member of FIG. 21 ; [0036] FIG. 23 is a front view of another embodiment of an expandable conduit of the invention in a relatively unexpanded state; and [0037] FIG. 24 is a front view of the conduit of FIG. 23 in a relatively expanded state. DETAILED DESCRIPTION [0038] FIG. 1 shows an assembly 10 comprising a plurality of circumferential support structures 12 and a valved conduit 14 . The valved conduit 14 may comprise any suitable implantable valve conduit such as those utilizing bovine, equine, human, or porcine tissue, or other materials, such as polymeric and/or metallic materials. The conduit 14 may comprise an outer tubular structure within which multiple leaflets 16 are positioned. For example, the component of the valved conduit may comprise the Medtronic Freestyle (or Contegra) Implantable Valved Conduit, which is commercially available from Medtronic, Inc. of Minneapolis, Minn. However, it is also possible with the various embodiments of the invention that a valve having a single leaflet or moveable component is utilized within a valve conduit or other valve structure, including tissue valves or mechanical valves. [0039] The support structures 12 may be attached to the outside surface of the outer tubular structure of the valved conduit 14 using conventional means, such as sutures, clips, adhesives, molding, weaving, and the like. Alternatively, the support structures 12 can be attached inside or be positioned within the conduit 14 , such as can be accomplished with a molded elastomer or woven fabric. [0040] The support structures 12 described herein can comprise a series of synthetic elements, mesh wires or wire segments. They can be independent or connected to each other via a link that can be permanent or temporary. The support structures 12 may be constructed from a number of suitable biocompatible materials such as polyester, materials such as the membrane “Gore-Tex”, which is commercially available from W.L. Gore & Associates, Inc. of Elkton, Md., stainless steel, titanium, cobalt chromium alloy, platinum iridium, or other natural or man-made materials. Each support structure 12 may be unitary or homologous in composition or could comprise different segments made of different materials. The portion of each support structure 12 that allows or provides for its expansion may comprise a different geometry than the remaining portion of that support structure 12 , or it may comprise a more malleable or deflectable portion. Each support structure 12 of a particular assembly 10 may be identical or similar to at least one other support structure 12 of that same assembly 10 , or each support structure 12 of an assembly 10 may be different from the other support structures 12 of the assembly 10 in size, shape, material, and/or other characteristics. In one embodiment of an assembly 10 of the invention, all of the support structures 12 are identical in size, shape and composition. The support structures 12 will desirably be designed to provide sufficient support to hold the conduit diameter to a reasonably constant diameter, thereby enabling proper function and durability of the valve. Any number of configurations or structures can be used, such as those that can be laser cut, knitted, braided, or woven, for example. In addition, the support structures 12 will desirably be able to support the valve for changes in diameter at a minimum number of commissures and inflow regions of the valve. It is further desirable that the support structures are visible or detectable when using common medical imaging techniques, such as fluoroscopy, echocardiography, magnetic resonance imagery, and the like. [0041] The elements of the support structures in other embodiments can alternatively be formed from a shape memory material such as nickel titanium alloy (e.g., Nitinol). With this material, the support structure is self-expandable from a contracted state to an expanded state, such as by the application of heat, energy, and the like, or by the removal of external forces (e.g., compressive forces). [0042] The support structures 12 are adapted to be implanted in a patient in the generally cylindrical shape shown in FIG. 1 , although the support structures 12 may instead have an outer shape that is oval, elliptical, irregular, or another shape that is chosen to be appropriate for the location in the patient where it will be implanted. The assembly 10 is configured so that it can be altered at any time after it is initially implanted within a patient. For example, the assembly 10 can be expanded immediately after a procedure of suturing the assembly 10 to the patient's anatomy in order to maximize the size of the orifice in which it is implanted. Alternatively, the assembly 10 could be expanded at some period of time after the initial implantation procedure, such as at the end of the useful life of the tissue of the valved conduit 14 or upon growth of the patient. In another embodiment, a first assembly 10 is implanted in a patient using an initial implantation procedure, then after some period of time (e.g., several months or years), a second procedure may be performed to expand the support structures 12 to the configuration of FIG. 2 . This expanded configuration can then receive a second or replacement assembly 10 within its interior structure, if desired. [0043] In one embodiment, the support structures 12 should be sufficiently strong to withstand the foreseeable stresses that may be encountered at the implantation site after the assembly 10 is implanted without any undesirable degradation that would result in conduit rupture and/or valve failure. However, the support structure 12 may be designed so that it will deflect in vivo from the configuration shown in FIG. 1 to that shown in FIG. 2 under the influence of a force that can be provided by an expandable assembly 20 , for example. Expandable assembly 20 comprises an expandable balloon member 22 . The balloon member 22 can be a high pressure, non-compliant balloon, such as a Numed Z-Med or Mullins valvuloplasty balloon, for example, although a wide variety of other types and manufacturers of balloons can be used. The balloon member 22 can be sized to produce a desired expansion of the support structure 12 . The balloon member could be provided with various sizes and/or shapes to produce conduits of various sizes and/or shapes. The structure of the balloon member can be capable of expanding by various degrees and/or amounts within a prescribed range in order to provide for proper valve function. In one embodiment of the invention, the support structures 12 expand by deflection of the portions 11 from the configuration in FIG. 1 , to the configuration 11 ′ in FIG. 2 . In this case, the entire conduit is uniformly expanded via expansion of the assembly 20 . [0044] In another embodiment, the expandable assembly 20 includes an expansion member that is not a balloon, but is a system having other components that can exert radial forces on the support structures so that they can be expanded to a larger diameter. For example, the expandable assembly may include a self-expanding stent that is capable of being compressed, positioned within the interior area of the support structures, and then released within the support structures. The self-expanding stent is designed so that it can thereby exert sufficient outward radial force when positioned within the support structures to diametrically deform and/or expand the support structures, in accordance with the various embodiments of the invention. [0045] An alternative embodiment of a conduit 30 is illustrated in FIGS. 23 and 24 . Conduit 30 includes a central area 32 that is at least slightly smaller in diameter than the end portions 34 , 35 when the conduit is initially implanted. This central area 32 is the portion of conduit 30 in which valve leaflets can be positioned. Expandable support structures 36 are longitudinally spaced from each other in the central area 32 , where the structures 36 are in their relatively expanded condition in FIG. 23 and in their relatively expanded condition in FIG. 24 . An expansion mechanism (e.g., balloon) can be used to expand the central area 32 to a diameter that is closer to that of the end portions 34 , 35 , thereby making the conduit 30 more cylindrical in shape. [0046] FIGS. 3 through 7 disclose an expandable support structure component 42 of the invention, as positioned relative to a stent or valve structure 40 . Valve structure 40 includes a sewing ring 46 attached to three stent posts or commissural members 45 . It is noted that this structure would be provided for a tricuspid valve, but that only two of such commissural members would be provided for a bicuspid valve, in another embodiment. All or a portion of the valve structure 40 , including the sewing ring 46 and commissural members 45 , can be covered by a flexible covering, which may be a tissue, polymer, fabric, metal, or cloth material to which leaflets (not shown) of the heart valve can be sewn. Further, as is known in the art, the internal structure of each of the commissural members 45 can be formed of a stiff but resiliently bendable material. This construction allows the commissural members 45 to be deflected by the application of an external or internal radial force. [0047] The valve structure 40 is generally tubular in shape, defining an internal area that extends from an inflow end to an outflow end. Alternatively, the shape of the valve structure can be oval, elliptical, irregular, or any other desired shape. The internal area is essentially composed of the valve structure 40 , and the valve structure 40 selectively allows for fluid flow into or out of the lumen of the natural heart valve in which it is implanted. Thus, the internal area is alternatively open and closed to the lumen of the natural heart valve in which it is inserted via movement of leaflets. For ease of illustration, leaflets associated with valve structure 40 are not shown in FIGS. 4 and 5 . [0048] As referred to herein, the prosthetic heart valves (e.g., valves that utilize a valve structure 40 ) used in accordance with the devices and methods of the invention may include a wide variety of different configurations, such as a prosthetic heart valve having one or more tissue leaflets, a synthetic heart valve having polymeric leaflets, or a mechanical valve, and can be specifically configured for replacing any heart valve. That is, the prosthetic heart valves of the invention can generally be used for replacement of aortic, mitral, tricuspid, or pulmonic valves, for use as a venous valve, or to replace a failed bioprosthesis, such as in the area of an aortic valve or mitral valve, for example. The replacement prosthetic heart valves of the invention can be employed to functionally replace stentless bioprosthetic heart valves as well. [0049] The support structure 42 is part of the valve structure 40 and includes portions that generally follow the shape of the stent posts 45 . Arch or member 44 of the support structure 42 can be deformed or modified after the valve structure 40 has been implanted to effectively enlarge the size of the orifice of the valve structure 40 . In an initial implanted configuration, the support structure 42 may comprise the shape shown in FIGS. 3-4 and 7 . In a subsequent procedure (which could potentially be any period of time later, such as minutes, hours, days, months or years), the shape of the support structure 42 can be modified such that member 44 shown in FIGS. 3 and 4 assumes the shape shown as member 44 ′ in FIGS. 5 and 6 . In this way, the internal area or diameter of the support structure 42 will be larger in order to provide the maximum available orifice area based on the patient's anatomy. In addition, expansion of the support structure 42 can put the valve structure in closer contact with the vessel anatomy, thereby improving the paravalvular seal, which can thereby reduce the degree of paravalvular leakage. Expansion of the support structure can also improve the stability of the surgical valve implant, which can reduce the chances for dehiscence. It is contemplated that an intermediate deformation of the member 44 can also occur so that the internal area has a size that is between that shown in FIGS. 4 and 5 . It should be noted that the shape of member 44 shown in FIGS. 3-7 are not intended to be limiting. Any suitable shapes or mechanisms may be utilized that allow for expansion of the valve support structure 42 , such as sinusoidal, accordion, triangular or any combination of segments and/or arcuate shapes. [0050] It is noted that the gap in the sewing ring 46 shown in FIGS. 4 , 5 , and 7 , for example, is provided in the Figures for illustrative purposes. Such a gap would not typically be provided, although it is contemplated that such sewing ring 46 does include such a gap. When the base portion of the sewing ring 46 includes such a gap, cloth or another material that is used to cover the rest of the sewing ring 46 would preferably span such a gap to provide a continuous cover around the perimeter of the sewing ring 46 . In this way, the paravalvular seal can be maintained more easily once the device is implanted in a patient. This material may be stretchable or otherwise deformable to allow for expansion of the overall size of the valve, if desired. If the sewing ring 46 does not include a gap, the ring 46 can be expandable or deformable, such as can be accomplished with a deformable material (e.g., stretchable portions) and/or with one or more expandable portions. [0051] FIG. 3 further illustrates an optional restraining element 48 that is positioned around a portion of one of the members 44 . In this embodiment, support structure 42 can be a self-expanding component, where element 48 is positioned in such a way that it maintains the member 44 in an initial or unexpanded condition. The restraining element 48 can later be removed, deformed, or broken in order to allow the member 44 to deform or straighten, thereby allowing overall support structure 42 to expand to a larger diameter. One or more restraining elements 48 can be positioned relative to some or all of the members 44 , wherein if more than one restraining element is used, the number of elements 48 that are deformed or removed can be chosen to allow the desired amount of expansion of the support structure 42 . That is, only one element 48 may be removed in a first procedure to allow a first amount of expansion of the support structure 42 , and then one or more additional elements 48 can be removed in one or more subsequent procedures to allow additional expansion of the support structure 42 . [0052] The valve support structure can also be composed of multiple elements that function together in a similar manner as a single valve support structure of the type previously described. For one example, the valve support structure may include an outer tubular structural piece having a central opening into which a connector can be positioned. Such a connector can be slideable relative to the outer tubular structural piece to allow for expansion of the outer periphery of the support structure. In another embodiment, tracks or rails can be used to allow for enlargement or expansion of the outer perimeter of the support structure. [0053] A portion of a post-implant expansion system 50 is illustrated in FIG. 7 , which comprises an expandable member 52 (e.g., a balloon that can be made of nylon, polyurethane, polyethylene, or polyethylene terephthalate (PET)). The system 50 may be utilized to modify the valve structure 40 from its first, unexpanded or partially expanded position to its second, expanded or partially expanded position. When the assembly 10 and valve structure 40 are in their second, expanded positions or configurations, they may be configured to receive a replacement transcatheter valve assembly. For example, a replacement valve conduit may be placed between the balloon 22 and the inside of the expandable conduit 14 in FIG. 2 . In this embodiment, the assembly 10 is enlarged to its expanded condition and a replacement valve can be subsequently or simultaneously implanted therein. The native or existing valve can serve as a landing zone for a \l new heart valve implant. It is also possible to first expand the valve structure and to later insert a replacement transcatheter valve, where this can be performed either a relatively short time or a relatively long time after that expansion is performed. [0054] FIGS. 8 and 9 illustrate another conduit configuration that can be used with certain aspects of the invention. In particular, a conduit 60 is illustrated in FIG. 8 , which may comprise a specially designed expandable structure 62 . This conduit 60 may or may not include a valve, depending on the application. In the depicted embodiment, the structure 62 comprises a mesh or woven type of material configuration (e.g., biocompatible polymer, metal, or combination thereof). The expandable structure 62 may comprise multiple members 66 disposed between adjacent elongated member 68 , shown in FIG. 9 , which can withstand stresses and tension during expected use of the heart valve assembly. However, the members 66 are designed to permanently deform, stretch, and/or break under the applied load of an expandable balloon member (not shown in FIGS. 8 and 9 ) or another device that imparts radial force. These members 66 may be fabric fibers, wires, or polymer elements, for example, which can break or stretch when placed under stress. If the members 66 stretch, such a stretching will preferably cause permanent or semi-permanent deformation of the members 66 so that they do not contract all the way back to their original size once the stress or load is removed. Members 64 are longer than members 66 and are curved or bent when the conduit 60 is in its relatively unexpanded condition. In addition, members 64 are more robust and are designed to withstand more stress than members 66 . As a result, when a balloon or other expandable member is placed within the structure 62 and expanded, the members 66 will break or stretch and the members 64 will become straighter, thereby affording expansion of the expandable conduit 60 . Members 66 can be differently configured at various portions of the conduit (e.g., inflow, outflow, etc.) to allow various shapes upon application of loads. [0055] FIGS. 10-12 schematically illustrate a surgical method according to the invention. Specifically, FIG. 10 shows an aortic annulus 102 , which may be relatively small, either due to the patient's natural anatomy or excessive calcification. An implantable valve 100 according to the invention is implanted in the patient's vasculature 104 (e.g., encompassing the native valve or occupying the position of a removed valve). Prior to this step, a sizing balloon or surgical valve sizer can be utilized to identify a desired maximum size of the valve 100 . [0056] A valve can be relative easily sewn into the patient's anatomy in the condition illustrated in FIG. 10 . FIG. 11 then shows the use of a balloon 110 to expand the valve 100 to a larger circumference, which can be performed at any time after the initial valve implantation. FIG. 12 shows the valve 100 ′ after it has been enlarged to an expanded condition. In this manner, the present invention can be utilized to maximize the effective valve orifice for a particular patient following the initial implantation procedure. [0057] In another surgical embodiment, an expandable bioprosthetic valve may be implanted in the patient in an unexpanded, yet functional condition. That valve may be used until the useful life of its components reach an endpoint or the patient outgrows it. In this embodiment, an expandable member may then be utilized to modify or enlarge the valve to its expanded condition, and then a replacement transcatheter valve (which may itself be expandable) may be implanted with the first bioprosthetic valve. In this way, larger orifice areas following transcatheter valve procedures may be available than would be available with conventional surgical valves. [0058] FIGS. 13-15 illustrate another embodiment of a component 200 of the invention. The component 200 comprises a tubular conduit 204 with at least two releasable seams 202 , although it is possible that component 200 comprises more or less than two seams. The releasable seams 202 are positioned to essentially create a loop 206 of material from a tubular structure, where the seam 202 is sewn or otherwise secured (e.g., clips, sutures, and the like) along a seam line. When desired, the conduit 204 can be loaded radially, thereby breaking, deforming, stretching, or otherwise releasing material of the seams 202 (i,e., the loop 206 ) and allowing the component 200 to expand. That is, all or most of the material that makes up the loop 206 will be exposed to the inner area of the conduit 204 after expansion of the component 200 . As shown in FIG. 15 , the seam 202 may be created with a series of breakable or stretchable fibers (e.g., fabric fibers, wires, or polymeric elements), or discrete deformable elements 205 that can be broken or deformed by the application of a radial force, such as by a balloon expandable member. Although the loop 206 is shown on the exterior of the component 200 in FIG. 13 , it may alternatively be placed within the interior area of the component 200 . [0059] FIGS. 16 and 17 illustrate a portion of another embodiment of a seam of a tubular conduit, which includes a series of discrete deformable elements 207 , one of which is illustrated in these figures. Element 207 is shown in its unexpanded condition in FIG. 16 as having a diameter or dimension d 1 , then in its expanded condition in FIG. 17 as having a diameter or dimension d 2 . Diameter d 1 is at least somewhat smaller than the diameter d 2 , which thereby illustrates the expansion in the seam area of the conduit. This deformation of the element 207 is preferably permanent or semi-permanent after the force that was used to deform the element is removed. Similarly, FIGS. 21 and 22 illustrate another deformable element 214 . Element 214 is shown in its unexpanded condition in FIG. 21 as having a width or length d 1 , then in its expanded condition in FIG. 22 as having a width or length d 2 . Dimension d 1 is smaller than the dimension d 2 , which again illustrates the expansion of the seam area of the conduit. [0060] FIGS. 18-20 illustrate a portion of another embodiment of a loop 206 of a conduit seam, and further including a deformable element 208 . Deformable element 208 includes lobes 212 and a bar 210 extending from each lobe 212 . The lobes 212 are spaced from each other around the element 208 . As is best illustrated in FIG. 19 , material of the conduit 204 is looped relative to the bars 210 to create the loop of a seam. Application of radial force, such as the expansion of an internally positioned balloon, can deform the element 208 , thereby allowing expansion of the seam. [0061] The present invention has now been described with reference to several embodiments thereof. The entire disclosure of any patent or patent application identified herein is hereby incorporated by reference. The foregoing detailed description and examples have been given for clarity of understanding only. No unnecessary limitations are to be understood therefrom. It will be apparent to those skilled in the art that many changes can be made in the embodiments described without departing from the scope of the invention. Thus, the scope of the present invention should not be limited to the structures described herein, but only by the structures described by the language of the claims and the equivalents of those structures.

A heart valve that can be expanded following its implantation in a patient, such as to accommodate the growth of a patient and the corresponding growth of the area where the valve is implanted, and to minimize paravalvular leakage. In one aspect, the invention may maximize the orifice size of the surgical valve. The invention includes expandable implantable conduits and expandable bioprosthetic stented valves. In one aspect of the invention, the valve may be adapted to accommodate growth of a patient to address limitation on bioprosthetic valve lifespans.

FIELD OF THE INVENTION [0001] The present invention relates to a solid oral pharmaceutical compositions comprising fixed dose combination of metformin and sitagliptin or salts thereof. The composition is in the form of a multilayered coated pharmaceutical composition comprising at least two compartments of metformin or salts thereof exhibiting immediate and extended release and at least one compartment of sitagliptin and metformin or salts thereof exhibiting immediate release. By providing a particular combination of immediate and extended release compartments of metformin and sitagliptin, a composition providing coordinated drug release can be obtained. The invention also includes process of preparing such compositions and method of use of such compositions for treating type II diabetes. BACKGROUND OF THE INVENTION [0002] Type 2 diabetes is the most common form of diabetes and it is one of the most prevalent chronic diseases. Treatment of type 2 diabetes initially starts with diet and exercise, followed by oral antidiabetic monotherapy. During long-term treatment these regimens do not sufficiently control hyperglycemia in many patients, leading to a requirement for combination therapy within several years following diagnosis. However, co-prescription of two or more oral antidiabetic drugs may result in treatment regimens that are complex and difficult for many patients to follow. Combining two or more oral antidiabetic agents into a single tablet provides a potential means of delivering combination therapy without adding to the complexity of patients' daily regimens. Such formulations have been well accepted in other disease indications also, such as hypertension (Hyzaar®, a combination of losartan potassium and hydrochlorothiazide) and cholesterol lowering (Vytorin®, a combination of simvastatin and ezetimibe). Similarly, examples of marketed combination tablets containing two oral antidiabetic agents include Glucovance® (metformin and glyburide), and Metaglip® (metformin and glipizide). [0003] A key step in the design of a combination tablet is selection of effective and well-tolerated treatments. Moreover, it is essential that the components have complementary mechanisms of action and compatible pharmacokinetic profiles. [0004] Sitagliptin is an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Chemically, sitagliptin is 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8 tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate with the following structure: [0000] [0005] Sitagliptin phosphate is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is a DPP-4 inhibitor, which slows down the inactivation of incretin hormones. The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis. When blood glucose concentrations are normal or elevated, Glucagon like peptide-1 (GLP-1) and Gastric Inhibitory Peptide (GIP) increase insulin synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP. Sitagliptin is marketed in the United States in the form of tablets under brand name Januvia®. [0006] Metformin is the member of the biguanide class of an oral antihyperglycemics and available in various salt forms, e.g. hydrochloride. Metformin is used in the management of type 2 diabetes mellitus. It is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Chemically, metformin hydrochloride is 1-carbamimidamido-N,N-dimethylmethanimidamide hydrochloride with the following structure: [0000] [0007] Pharmacologic mechanism of action of metformin is different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects, except in special circumstances) and does not cause hyperinsulinemia. Metformin is marketed in the United States in the form of extended release tablets under brand names Fortamet®, Glucophage® and Glumetza®. [0008] A combination therapy of sitagliptin with metformin HCl (a well established active ingredient of diabetes management) provides even more effective treatment of type II diabetes. Although metformin is effective at lowering blood glucose levels, its use is associated with gastrointestinal (GI) adverse effects, particularly diarrhea and nausea. These adverse effects may limit the tolerated dose of metformin and cause patients to discontinue the therapy. [0009] Extended-release formulations of metformin have advantages over immediate-release in terms of affording a more uniform maintenance of blood plasma active drug concentrations and providing better patient compliance by reducing the frequency of administration required. [0010] Numerous studies have been conducted to address the formulation and drug release systems of combination of antidiabetic drugs and attempts have been made to improve the formulation stability. [0011] U.S. Pat. No. 6,340,475 discloses a controlled-release oral drug dosage formulation designed for gastric retention and controlled delivery of metformin into the gastric cavity. [0012] Extended-release formulations of metformin are disclosed in several other U.S. Pat. Nos. 6,635,280; 6,866,866; 6,475,521 and 6,660,300. [0013] European patent application No. EP 1537880 A1 discloses a sustained release formulation of DPP-IV inhibitors and a hydrophilic polymer. [0014] U.S. Application publication No. US 20070172525 and US 20080064701 discloses pharmaceutical composition comprising a DPP-4 inhibitor and a slow-release form of metformin. [0015] U.S. Application publication No. US 20100330177 discloses a fixed-dose combinations of an extended-release form of metformin coated with an immediate-release form of the DPP-4 inhibitor-sitagliptin. [0016] PCT publication No. WO 2009111200 discloses a formulation comprising an inner core comprising metformin hydrochloride. The inner core is coated with a sustained-release polymer and further comprises a coating comprising an immediate release composition of sitagliptin. [0017] PCT publication number WO 2009099734 discloses pharmaceutical composition comprising a tablet core comprised of metformin and an extended release excipient (HPMC). The tablet core is then coated with immediate release polymer comprising sitagliptin. [0018] Various types of formulations have been suggested in the art for fixed dose combination of metformin and sitagliptin composition. The art in the broad sense teaches to incorporate metformin with an extended release polymer and sitagliptin with immediate release polymer either in the core or the coating of the formulation. [0019] There still exists an enduring need for an alternate, improved and stable fixed dose combination formulation of metformin and sitagliptin. [0020] The present invention provides solid oral pharmaceutical compositions comprising combination of metformin and sitagliptin or salts thereof. In particular, the present invention relates to a multilayered coated pharmaceutical composition comprising at least two compartments of metformin or salts thereof exhibiting immediate and extended release and at least one compartment of sitagliptin and metformin or salts thereof exhibiting immediate release. The invention also includes process of preparing such compositions and method of use of such compositions for treating type II diabetes. [0021] In particular, the inventors have found that when the composition comprises multiple metformin compartments exhibiting immediate and extended release, and sitagliptin compartments exhibiting immediate release, the aforesaid objective can be achieved. SUMMARY OF THE INVENTION [0022] In one general aspect, there is provided a solid oral pharmaceutical composition comprising: [0023] (a) at least one first component comprising sitagliptin, metformin or salts thereof and one or more pharmaceutical excipients exhibiting immediate release; [0024] (b) at least one second component comprising metformin or salt thereof and one or more pharmaceutical excipients exhibiting extended release, and [0025] (c) at least one third component comprising metformin or salts thereof and one or more pharmaceutical excipients exhibiting immediate release, wherein the first and second components are at least partially coated with the third component. [0026] In another general aspect, the first and second compartments of the solid oral pharmaceutical composition constitute a layer. [0027] In another general aspect, the solid oral pharmaceutical composition is in the form of a multilayer tablet, a bilayer tablet or a trilayer tablet. [0028] In another general aspect, the second compartment of the solid oral pharmaceutical composition constitute either a matrix of metformin or salts thereof, one or more pharmaceutical excipients and one or more rate controlling agents, or a compressed layer of metformin or salts thereof and one or more pharmaceutical excipients coated with one or more rate controlling agents, or both. [0029] In another general aspect, the amount of metformin in the first and third compartment ranges from about 1% to about 20% by total amount of metformin or salt thereof in the composition. [0030] In another general aspect, the amount of metformin in the second compartment ranges from about 1% to about 95% by total amount of metformin in the composition. [0031] In another general aspect, there is provided a solid oral pharmaceutical composition comprising: [0032] (a) at least one first compartments comprising sitagliptin, metformin or salts thereof and one or more pharmaceutical excipients exhibiting immediate release; [0033] (b) at least one second compartment comprising metformin or salt thereof and one or more pharmaceutical excipients exhibiting extended release, and [0034] (c) at least one third compartment comprising metformin or salts thereof and one or more pharmaceutical excipients exhibiting immediate release, wherein the composition is devoid of glidant. [0035] In another general aspect, there is provided a solid oral pharmaceutical composition comprising: [0036] (a) at least one first compartments comprising sitagliptin, metformin or salts thereof and one or more pharmaceutical excipients exhibiting immediate release; [0037] (b) at least one second compartment comprising metformin or salt thereof and one or more pharmaceutical excipients exhibiting extended release, and [0038] (c) at least one third compartment comprising metformin or salts thereof and one or more pharmaceutical excipients exhibiting immediate release, wherein the second compartment is devoid of glidant. [0039] In another general aspect, there is provided a multilayered tablet comprising at least one first layer of sitagliptin, metformin or salts thereof exhibiting immediate release, at least one second layer of metformin or salts thereof exhibiting extended release, wherein the tablet is coated with one or more layers comprising metformin or salt thereof exhibiting immediate release. [0040] In another general aspect, there is provided a solid oral pharmaceutical composition comprising: [0041] (a) at least one first compartments comprising sitagliptin, metformin or salts thereof and one or more pharmaceutical excipients exhibiting immediate release; [0042] (b) at least one second compartment comprising metformin or salt thereof and one or more pharmaceutical excipients exhibiting extended release, and [0043] (c) at least one third compartment comprising metformin or salts thereof and one or more pharmaceutical excipients exhibiting immediate release, wherein the first and second compartments are either in direct contact with each other or separated by a barrier such as an isolating layer. [0044] In another general aspect, there is provided a solid oral pharmaceutical composition comprising: [0045] (a) at least one first compartments comprising sitagliptin, metformin or salts thereof and one or more pharmaceutical excipients exhibiting immediate release; [0046] (b) at least one second compartment comprising metformin or salt thereof and one or more pharmaceutical excipients exhibiting extended release, and [0047] (c) at least one third compartment comprising metformin or salts thereof and one or more pharmaceutical excipients exhibiting immediate release, wherein the composition retains at least 90% w/w of the total potency of metformin and sitagliptin or salts thereof after storage at 30° C. and 60% relative humidity for at least 3 months. [0048] In another general aspect, there is provides a bilayer coated tablet comprising: [0049] (a) first layer comprising sitagliptin, metformin or salts thereof and one or more pharmaceutical excipients exhibiting immediate release, and [0050] (b) second layer comprising metformin or salt thereof and one or more pharmaceutical excipients exhibiting extended release, [0051] wherein the first and second layers are coated with a coating composition comprising metformin or salts thereof, one or more polymers, and one or more pharmaceutical excipients exhibiting immediate release. [0052] In another general aspect, there is provides a solid oral pharmaceutical composition of metformin or salts thereof and sitagliptin or salts thereof prepared by dry granulation, wet granulation, slugging or direct compression. [0053] In another general aspect, there is provided a process of preparing the solid oral pharmaceutical composition of metformin and sitagliptin or salts thereof, which process comprises steps of: [0054] (a) mixing sitagliptin, metformin or salt thereof with one or more pharmaceutical excipients, optionally followed by compression to form first blend; [0055] (b) mixing metformin or salt thereof with one or more rate controlling agents and one or more pharmaceutical excipients, optionally followed by compression to form second blend; [0056] (c) mixing metformin or salt thereof with one or more polymer, one or more pharmaceutical excipients, and at least one vehicle to form third blend; [0057] (d) compressing the first and second blend to form a multilayer composition, and [0058] (e) coating the third blend over the multilayer composition. [0059] In another general aspect, there is provided a process of preparing the solid oral pharmaceutical composition of metformin and sitagliptin or salts thereof, which process comprises steps of: [0060] (a) mixing sitagliptin, metformin or salt thereof with one or more pharmaceutical excipients, optionally followed by compression to form first blend; [0061] (b) mixing metformin or salt thereof with one or more pharmaceutical excipients, followed by compression and coating with one or more rate controlling agents to form second blend; [0062] (c) mixing metformin or salt thereof with one or more polymer, one or more pharmaceutical excipients, and at least one vehicle to form third blend; [0063] (d) compressing the first and second blend to form a multilayer composition, and [0064] (e) coating the third blend over the multilayer composition. [0065] In another general aspect, there is provided a method of treating Type 2 diabetes in a patient which method comprises administering the solid oral pharmaceutical composition as substantially described herein. DETAILED DESCRIPTION OF THE INVENTION [0066] The inventors of the present invention have surprisingly found that by formulating the fixed dose combination of metformin and sitagliptin in particular structure, a composition providing coordinated drug release can be obtained. [0067] The term “compartment” used herein throughout the specification is used to intend a part of the dosage form comprising one or both of metformin and sitagliptin, and optional other active ingredients, optionally together with pharmaceutical excipients. Preferably, the compartments comprise a homogenous mixture of components. In each compartment, at least one type of active ingredient is contained. At least one compartment should be the form of a coating, meaning either or both first and second compartments, which comprise metformin and/or sitagliptin, are at least partially covered by the third compartment. [0068] In one embodiment, at least in one, optionally in two compartments both metformin and sitagliptin are present. The compartments can comprise immediate or extended release compositions. According to the invention, at least one of the compartments comprises an extended release composition. [0069] Preferably, the first and second compartments are provided in the form of a layer and the third compartment is in the form of a coating. The pharmaceutical dosage form comprising the compartments will then represent a bilayer tablet, a trilayer tablet or a multilayer tablet, preferably a bilayer tablet. [0070] The term “tablet” used throughout the specification refers to and intended to encompass compressed pharmaceutical dosage formulations of all shapes and sizes, whether coated or uncoated. [0071] The term “layer” used throughout the specification refers to denote a spatial part of the pharmaceutical composition or dosage form other than that formed by applying a coating. [0072] The term “coating” used throughout the specification refers to a layer which at least partly covers an object and is applied by various coating processes known in the art. [0073] The terms “metformin” and “sitagliptin” used throughout the specifications refers to any pharmaceutically acceptable salts of metformin and sitagliptin. The preferred salt of metformin is metformin hydrochloride. The preferred salt of sitagliptin is sitagliptin phosphate, more preferably its monohydrate. [0074] The term “immediate release” used throughout the specification refers that within 2 hours, preferably within 1.5 hour, more preferably within 1 hour and most preferably within 30 minutes, at least 80%, preferably at least 85%, more preferably at least 90% of the drug being present in the compartment is dissolved or released. [0075] The term “extended release” used throughout the specification refers that at least 95% of the drug being present in the component is not dissolved or released, not before 2 hours, preferably not before 3 hours, and more preferably not before 4 hours. [0076] A suitable test for determining the dissolution is the test using Apparatus 2 according to the US Pharmacopoeia 32-NF 27, described in General chapter 711 (Dissolution). Conditions chosen for the test were Apparatus 2 with 100 rpm in phosphate buffer medium pH 6.8. [0077] In another embodiment, the solid oral pharmaceutical composition is in the form of a multilayer tablet, a bilayer tablet or a trilayer tablet. [0078] In an embodiment, the first and second compartments employed in the composition of the invention may include polymers and pharmaceutically acceptable excipients to enable formation of a bilayer coated tablet. [0079] In another embodiment, the extended release compartment in the composition of the present invention may contain additional anti-diabetic agents other than metformin. [0080] The inventors of the present invention have further determined that if the composition of the present invention is formulated without using any glidant, particularly in the extended release providing component, the composition may exhibit the desired coordinated release profile. [0081] In another embodiment, the extended release compartment of the composition is substantially free of glidants. [0082] In another embodiment, the solid oral pharmaceutical composition of the invention is substantially free of glidants. [0083] In another embodiment, the extended release compartment according to present invention does not contain disintegrants and wherein the immediate release compartment contains one or more disintegrants but no rate controlling agent. [0084] In another embodiment, the first and third compartment according to the present invention does not comprise any rate controlling agent, in particular not the rate controlling agent that used in the first compartment. [0085] Suitable rate controlling agents may be selected from the group consisting of hydrophilic agents (e.g. water-soluble polymers), lipophilic agents (water-insoluble polymers) and inert matrix agents, wherein the hydrophilic agents are selected from the group of pharmaceutical excipients which generate a gel in contact with water, including cellulose derivatives such as hydroxypropyl methyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, methyl cellulose and the like; noncellulose polysaccharides such as galactomannanes, guar gum, carob gum, gum arabicum, alginates, pectins, and the like; polyvinylpyrrolidone; polyvinylacetate polymers and copolymers; acrylic acid polymers and copolymers, polyethylene oxide and mixtures thereof; the lipophilic agents are selected from the group consisting of waxes such as white wax, bees wax, carnauba wax and the like; fatty acids and alcohols such as stearic acid, palmitic acid, lauric acid and the like, and cetyl alcohol, cetostearyl alcohol, stearyl alcohol and the like; fatty acids esters such as monostearates of propylene glycol and fatty acid esters of sucrose, sucrose distearate and the like; and glycerides such as mono-, di- or triglycerides, e.g. palmitin, stearin, behenic, laurin, myristin, hydrogenated vegetable, castor, cottonseed oils, glyceril behenate and the like; ethyl cellulose; acrylic acid polymers and copolymers (available commercially under Eudragit® brand); and mixtures thereof; and the inert agents are selected from the group consisting of thermoplastic polymers, which are insoluble and indigestible in the gastrointestinal fluids, such as polyvinyl chloride, polyethylene, vinyl acetate/vinyl chloride copolymers, polymethylmethacrylates, polyamides, silicones, ethyl cellulose, polystyrene, and mixtures thereof. The amount of rate controlling agent in the composition ranges from about 10 to about 50% w/w, preferably from about 15% to about 45% by weight of the composition. [0086] The oral solid dosage form composition of the present invention further comprises various pharmaceutical excipients suitable for oral administration. Such excipients are selected from the group consisting of binding agents, fillers, filler-binders, disintegrants, lubricants, sweeteners, flavourings and colouring agents, preferably the excipients are selected from the group consisting of binding agents, filler-binders, and lubricants. [0087] The fillers and/or filler-binder are selected from the group consisting of different grades of starches, such as maize starch, potato starch, rice starch, wheat starch, pregelatinized starch, fully pregelatinized starch, cellulose, such as microcrystalline cellulose or silicified microcrystalline cellulose, mannitol, erythritol, lactose, such as lactose monohydrate and lactose anhydrous, calcium salts, such as calcium hydrogen phosphate dihydrate, anhydrous dibasic calcium phosphate, sorbitol, and xylitol, particularly preferred, the fillers and/or filler-binders are selected from the group consisting of pregelatinized starch, microcrystalline cellulose, lactose monohydrate, and lactose, even further preferred the filler and/or filler-binder is selected from the group consisting of microcrystalline cellulose and anhydrous dibasic calcium phosphate. [0088] The lubricants are selected from the group consisting of stearic acid, talc, sodium stearyl fumarate and magnesium stearate, particularly preferred, the lubricant is magnesium stearate. [0089] Binding agents are selected from the group consisting of polyvinyl pyrrolidone (Povidone), copolymers of vinylpyrrolidone with other vinylderivatives (Copovidone), hydroxypropyl methylcellulose, methylcellulose, hydroxypropylcellulose, powdered acacia, gelatin, guar gum, carbomer such as carbopol, polymethacrylates and starch. [0090] In an embodiment, the immediate release (second and/or third) compartment additionally comprises disintegrants. [0091] The solid oral pharmaceutical composition of the present invention can be prepared by methods known to the person skilled in the art. Preferably, first and second components comprising metformin or salts thereof and sitagliptin or salts thereof are formed by dry granulation, wet granulation, slugging or direct compression and the third compartment comprising metformin or salt thereof is formed by coating process. All the three compartments then can be processed in different orders and methods known to the person skilled in the art to form a dosage form. [0092] In a preferred embodiment, the third compartment of the composition of the invention comprises one or more vehicles so as to form a solution or dispersion of metformin, polymer and pharmaceutical excipients in order to enable coating. Suitable vehicle includes, but not limited to water, aliphatic alcohols and organic solvents, or their mixtures. [0093] In an embodiment, the process of preparing the solid oral pharmaceutical composition of metformin and sitagliptin or salts thereof comprises steps of: [0094] (a) mixing sitagliptin, metformin or salt thereof with one or more pharmaceutical excipients, optionally followed by compression to form first blend; [0095] (b) mixing metformin or salt thereof with one or more rate controlling agents and one or more pharmaceutical excipients, optionally followed by compression to form second blend; [0096] (c) mixing metformin or salt thereof with one or more polymer, one or more pharmaceutical excipients, and at least one vehicle to form third blend; [0097] (d) compressing the first and second blend to form a multilayer composition, and [0098] (e) coating the third blend over the multilayer composition. [0099] In another embodiment, the process of preparing the solid oral pharmaceutical composition of metformin and sitagliptin or salts thereof comprises steps of: [0100] (a) mixing sitagliptin, metformin or salt thereof with one or more pharmaceutical excipients, optionally followed by compression to form first blend; [0101] (b) mixing metformin or salt thereof with one or more pharmaceutical excipients, followed by compression and coating with one or more rate controlling agents to form second blend; [0102] (c) mixing metformin or salt thereof with one or more polymer, one or more pharmaceutical excipients, and at least one vehicle to form third blend; [0103] (d) compressing the first and second blend to form a multilayer composition, and [0104] (e) coating the third blend over the multilayer composition. [0105] In a further embodiment, granulation liquids can be added, especially in second compartment, if the composition comprises metformin or pharmaceutically acceptable salts thereof, as also described elsewhere herein. Granulation liquid is removed during further processing of the respective compositions, however, some residual water is required in order to render granulate compressible. [0106] In another preferred embodiment, the solid oral composition is in the form of a bilayer tablet and comprises a first layer comprising 90% of metformin or salts thereof exhibiting extended release, a second layer comprising sitagliptin or salts thereof and 5% metformin or salt thereof exhibiting immediate release and an immediate-release coating over the two layers comprising 5% of metformin or salts thereof. In a further preferred embodiment, the first layer is devoid of glidant. In a further preferred embodiment, the tablet is devoid of glidant. [0107] The present invention is further illustrated by the following examples which are provided merely to be exemplary of the invention and do not limit the scope of the invention. Certain modifications and equivalents will be apparent to those skilled in the art and are intended to be included within the scope of the present invention. EXAMPLE 1 Sitagliptin Phosphate and Metformin Extended Release Tablet [0108] [0000] TABLE 1 Sr. Qty per Tablet No. Ingredients (% w/w) First component (Extended Release Granules) 1 Metformin HCl 10-40 2 Microcrystalline Cellulose  5-50 3 Maize Starch  5-30 4 Hypromellose 2208 10-40 5 Carbopol  5-30 6 Water q. s. 7 Talc 1-3 Second component (Immediate Release Granules) 8 Metformin HCl  1-10 9 Sitagliptin Phosphate 10-50 10 PVP 10-70 11 Kollidon VA 64 10-70 12 Water q. s. 13 Magnesium stearate 1-3 Third Component (Coating) 14 Metformin HCl  1-10 15 Opadry White 20-60 16 PEG 4000 10-70 17 Water q. s. [0109] Process: First (Extended Release Granules) component of Metformin HCl was prepared by mixing Metformin, Microcrystalline cellulose, Maize starch, Hypromellose 2208, Carbopol with water. The mixture was granulated to form granules. The granules were then lubricated with Magnesium stearate. [0110] The second component (Immediate Release Granules) component of Metformin HCl and Sitagliptin Phosphate was prepared by mixing Metformin, Sitagliptin, PVP, Kollidon VA 64 with water. The mixture was granulated to form granules. The granules were then lubricated with Talc. [0111] The first (Extended Release Granules) and second components (Immediate Release Granules) were then compressed to form a tablet. [0112] The tablet was then further coated with a mixture of Metformin HCl, Opadry white, PEG 4000 and water.

The present invention provides solid oral pharmaceutical compositions comprising combination of metformin and sitagliptin or salts thereof. In particular, the present invention relates to a multilayered coated pharmaceutical composition comprising at least two compartments of metformin or salts thereof exhibiting immediate and extended release and at least one compartment of sitagliptin and metformin or salts thereof exhibiting immediate release. The invention also includes process of preparing such compositions and method of use of such compositions for treating type II diabetes.

FIELD OF THE INVENTION The field of the invention relates generally to powered lift devices, particularly to powered hunting tree stands, and more particularly to portable hunting tree stands. BACKGROUND OF THE INVENTION Tree stands are well known hunting devices used to elevate one or more hunters to allow them a wider range of vision over the area in which they are hunting. One problem associated with tree stands in general is that they require the user, typically a hunter with a weapon, to physically climb up from the ground onto the tree stand platform. This can be an awkward task as the hunter is most likely carrying a weapon such as a rifle, shotgun, or bow and arrow as well as one or more food and drink containers. More importantly, hunters who are disabled to the point where physically climbing up into or down from a tree stand is either extremely difficult or impossible, are deprived of an important and enjoyable part of the hunting experience. One other important problem of tree stands in the prior art is that they are often permanent structures. Because elevated tree stands are typically placed in trees or permanent structures, they are difficult to easily move from one location to another. Consequently, they are often left in place and exposed to weathering and other destructive effects that eventually lead to the deterioration of the tree stand. The prior art contains examples of mechanized tree stands and powered lifts. U.S. patent application Nos. 2004/0083660 to Atkins, 2003/0000769 to Pyle, 2002/0139613 to Hardy are examples of recent publications disclosing portable and elevating hunting stands. Also included in this group is U.S. Pat. No. 5,862,827 to Howze. While the devices disclosed in these publications are all portable and capable of mechanized elevation, in each case the user must climb a ladder to reach the elevated platform. Thus, even though the platforms disclosed can be elevated, they provide no benefit to either a disabled hunter or one overly burdened with equipment who is attempting to climb into the platform. U.S. patent application No. 2003/0178251 to Hewitt and U.S. Pat. No. 6,471,269 to Payne, U.S. Pat. No. 5,803,694 to Steele, U.S. Pat. No. 4,602,698 to Grant disclose tree stands which provide mechanized elevation for the user. In addition, U.S. Pat. No. 3,681,565 to Fisher discloses a suspended welding booth which mechanically raises the welder to a suspended position against a wall or other vertical structure. However, a review of these publications reveals an additional problem, namely the stability of the suspended platform. In each publication, the suspended platform, chair or booth is lifted off the ground and depends solely on the structural stability of a suspension system for safe support rather than using the actual ground as a foundation to support the elevated user. U.S. Pat. Nos. 2,943,708 to Sasgen and U.S. Pat. No. 4,183,423 to Lewis both disclose mechanized hoists that remain placed on the ground or floor. However, both have the lift mechanism positioned off the elevating platform requiring someone other than the rider to raise and lower the platform. U.S. Pat. No. 5,595,265 to Lebroquy discloses a powered vertical lift but its configuration severely limits the height to which the lift may ascend. In addition, it fails to provide lateral stability to the suspended lift. Therefore, there is a need in the field for a portable powered tree stand that is easily maneuverable, provides mechanized elevation to the user, and provides stability to a platform when it is the raised position. SUMMARY OF THE INVENTION The present invention comprises a powered lift platform that includes a platform, at least one guide rail section in operative contact with the platform, each of the at least one guide rail sections comprising at least one guide rail and in which a first end of each of the guide rail sections is configured to removably attach to a second end of a second guide rail section, a lift mechanism supported by the platform, a lift guide in operative contact with the lift mechanism and attached to the upper portion of the upper guide rail, a power supply to operate the lift mechanism. In a preferred embodiment, at least one wheel is operatively attached to the powered lift platform. The present invention further comprises a method of securing the powered lift platform to a vertical or sloping support. The present invention also includes an extendable standoff to adjustably support a device against a vertical or sloping support. An object of the invention is to provide a powered or mechanized lift operated by a user positioned on the platform. A second object of the invention is to provide a powered lift platform that is positioned on the ground or floor. A third object of the invention is to provide a powered lift platform with lateral stability when elevated off the ground. An additional object of the invention is to provide a powered lift platform in which the user may remain on the platform to secure the device to a vertical structure such as a tree or column. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS The nature and mode of the operation of the present invention will now be more fully described in the following detailed description of the invention taken with the accompanying drawing Figures, in which: FIG. 1 depicts a perspective view of the powered lift platform of the present invention; FIG. 2 is a magnified perspective view of the lower slider adjustment of the present invention; FIG. 2 a is a top view taken along line 2 A- 2 A of FIG. 2 showing the lower slider adjustment; FIG. 3 is a magnified perspective view of the upper slider adjustment and cable break stop of the present invention; FIG. 3 a is a top view of the upper slider adjustment and cable break stop of the present invention; FIG. 3 b is a magnified perspective view of an alternate embodiment of the upper slide adjustment; FIG. 3 c is a top view of the alternate embodiment of the upper slide adjustment; FIG. 4 is a rear view of the powered lift platform of the present invention; FIG. 4 a is a rear view of the powered lift platform depicting the activation of the cable break stop by the broken cable; FIG. 4 b is a magnified side view of the adjustment assembly for the base plate of the present invention; FIG. 5 is a side view of the powered lift platform of the present invention; FIG. 5 a is a side view of the present invention in which the safety lock is activated; FIG. 6 depicts an alternate embodiment of the lift guide used to lift the platform in the present invention; FIG. 6 a is a magnified perspective view of the alternate lift guide seen in FIG. 6 ; FIG. 7 demonstrates a second alternate embodiment of the lift guide for the powered lift platform of the present invention; FIG. 7 a is a magnified perspective view of the second alternate lift guide for the powered lift platform of the present invention; FIG. 8 is a top perspective view of the grippers of the present invention; FIG. 8 a is an exploded top perspective view of the grippers of the present invention; FIG. 9 is a side perspective view of the present invention attached to an upright support; FIG. 10 is a side view of the present invention in a disassembled mode for towing; FIG. 11 is a side perspective view of an alternate embodiment of the disassembled mode; FIG. 12 is an exploded view of the assembly arrangement of the alternate disassembled mode; and, FIG. 12 a is a side perspective view of the constructed assembly arrangement seen in FIG. 12 . DETAILED DESCRIPTION OF THE INVENTION At the outset, it should be appreciated that like drawing numbers on different drawing views identify identical structural elements of the invention. While the present invention is described with respect to what is presently considered to be the preferred embodiments, it is understood that the invention is not limited to the disclosed embodiments. The present invention is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims. Adverting to the drawings, FIG. 1 depicts a perspective view of powered lift platform 10 . Carriage 80 comprises the movable component of powered lift platform 10 and includes at a minimum platform 11 . Carriage 80 also includes other components found in various embodiments described and shown as attached directly or indirectly to platform 11 . Platform 11 is shown supporting power box 12 which houses a battery (not shown) and holds a battery switch 35 that is used as a power control. In a preferred embodiment, switch 35 is rotated in one direction to power platform 11 upward and rotated in the opposite direction to move platform 11 down. A suitable battery is a 12 volt all glass mat battery made by Universal Power Group. In addition, an AC inverter may be used. Preferably, a solar trickle charge device may be attached to the battery to constantly maintain battery charge when power lift platform 10 remains outdoors. In the preferred embodiment shown, seat 43 is supported by power box 12 . Also not shown in FIG. 1 is the housing for winch 32 which is secured to platform 11 and used to raise and lower platform 11 . Stop lever 28 includes safety stop blade 28 a and is also attached to a second safety stop blade 28 a (not shown in FIG. 1 ) by means of safety axle 30 . Stop lever 28 and safety stop blades 28 a are welded or otherwise securely attached to axle 30 as shown in FIGS. 3 and 3 a . Guide rails 13 are shown in operative attachment with platform 11 which is described in detail below and seen in FIGS. 2-3 c . By operative attachment or operative contact is meant the contacting of carriage 80 , platform 11 or a part of or a component of power lift platform 10 with guide rails 13 during at least a portion of the movement of platform 11 along guide rails 13 . Although a guide rail section having one guide rail 13 may be used to raise and lower platform 11 or carriage 80 , in the preferred mode shown in FIG. 1 , pairs of guide rails 13 comprise a guide rail section. In a preferred embodiment, guide rails 13 are approximately 6 feet in length. In a more preferred embodiment, more than one set of guide rails is used to allow platform 11 to be pulled to a greater heights if desired. In the more preferred embodiment shown in FIG. 1 , guide rail inserts 14 can be inserted into guide rail sockets 15 to enable platform 11 to be moved efficiently up and down more than one section or set of attached guide rails 13 . Alternatively, sets of guide rails 13 can be bolted together or attached by alternate means well known in the art to enable them to be placed into an upright position. In a preferred embodiment, guide rails 13 include attached standoffs or grippers 16 that rest against a vertical support such as a tree, lamp post, pole or other vertical support (not shown in FIG. 1 ). In a preferred embodiment, grippers 16 include teeth 17 to allow a more secure hold against vertical supports such as tree trunks. In a more preferred embodiment, gripper adjustments 18 are provided to extend or retract grippers 16 from or toward guide rails 13 . Use of gripper adjustment 18 allows guide rails 13 to be positioned in a more upright (nearly vertical) orientation even if the vertical support is itself in a comparatively more sloping (non-vertical) position. Powered lift platform 10 is operated by a lift mechanism attached to platform 11 and placed in operative contact with a lift guide that provides lift support for the lift mechanism and/or lift guide for the lift mechanism. FIGS. 1 , 2 , 2 a , 4 , 4 a , 5 , and 5 a show one type of lift mechanism, namely winch 32 attached to platform 11 through winch frame 32 a . Cable 33 is attached to winch 32 and to cable anchor 21 at an anchor point preferably located at the top of the highest guide rail 13 and acts as the lift guide for winch 32 . The anchor point is defined as the location where the lift guide (cable 33 in the embodiment shown in FIG. 1 ) is secured to guide rail section 13 . In a preferred embodiment, a second cable anchor 21 a is placed on a lower guide rail 13 section to enable platform 11 to be raised sufficiently on lower guide rails 13 to allow the operator to more easily attach an additional guide rail section 13 to the lower guide rail 13 section. Platform 11 is transported along guide rails 13 as winch 32 winds or unwinds cable 33 . Preferably, winch 32 is operated from platform 11 using switch 35 as it is raises or lowers platform 11 along guide rails 13 . Switch 35 may be located on power box 12 and is connected to the battery and winch 32 . In an alternate embodiment, switch 35 and power cord 34 may be located proximate to the ground to allow the operator to remain on the ground while operating powered lift platform 10 . It will be recognized that in this alternate embodiment, switch 35 and power cord 34 may be a hand-held control used by the operator positioned on platform 11 . Also shown in FIG. 1 are safety rails 44 which extend along the sides and front of platform 11 . In one embodiment, rails 44 comprise two sets of rails each possessing two risers supporting a crosspiece. Detachable front rail 44 a links the two sets of side rails. Base plates 23 are attached to the bottom of each of guide rail sections 13 and provide support for guide rail sections 13 against the ground. FIG. 2 is a magnified perspective view of lower slide adjustment 27 . Bolt 27 is shown extending through lower lever arm 27 b . Lower press pad 27 c is attached to lower lever arm 27 b . Lower guide pad 27 d is attached to lower press pad 27 c . As bolt 27 is tightened, it draws lower guide pad 27 d (attached to lower press pad 27 c ) against the internal side of guide rail section 13 by pivoting lever arm 27 b around pivot point 27 a .Preferably, lower press pad 27 c is made from a metal such as is used in typical angle iron and lower guide pad 27 d is made from a plastic with some resilience such as Teflon to reduce the friction between lower guide pad 27 d and the internal side of guide rail 13 . Pivot point 27 a can be a bolt rod or similar device that is placed through lever arm 27 b as shown to allow it to pivot or rotate. Gap 36 is established between lower lever arm 27 b and winch frame 32 a using lower adjustment spacer 27 e to allow lower lever arm 27 b to rotate freely. Gap 36 is exaggerated in FIG. 2 for clarity. FIG. 2 a is a top view of lower slide adjustment 27 . Ultimately, this lower adjustment mechanism presses lower guide pad 27 d against guide rail 13 to help stabilize platform 11 against guide rails 13 as it is raised and lowered. Also seen in FIG. 2 are wheels 22 operatively attached to powered lift platform 10 . By operative attachment is meant that at least one wheel 22 is attached to powered lift platform 10 to allow it to be towed or otherwise moved using a wheel, tire or equivalent device. In the embodiment shown, two wheels 22 are attached to guide rails 13 by means of wheel attachments 22 a . In an alternate embodiment, wheels 22 may be attached to platform 11 . FIG. 2 also shows base plate prong 23 a which is positioned into the ground to further support power lift platform 10 . FIG. 3 is a magnified perspective view of upper slide adjustment 26 . In this preferred embodiment, the head of bolt 26 is placed between upper lever arm 26 b and cable stop frame 37 a and extends through cable stop frame 37 a . In the embodiment shown, cable stop frame 37 a is threaded. In an alternate embodiment, a nut is secured to cable stop frame 37 a to secure bolt 26 . As bolt 26 is tightened or loosened, it decreases or increases pressure onto upper press pad 26 c , attached to upper lever arm 26 b and upper guide pad 26 d , attached to upper press pad 26 c . Ultimately, this enables pressure to be applied through upper guide pad 26 d against the internal surface of guide rail 13 . In this preferred embodiment, the end opposite the head of bolt 26 extends through cable stop frame 37 a and is not “mushroomed” by pressing against upper press pad 26 c . It should be recognized that this preferred embodiment can be used for the lower slide adjustment 27 and that the arrangement described above for lower slide adjustment 27 can be used for upper slide adjustment 26 . FIG. 3 a , taken along line 3 a - 3 a in FIG. 3 , is a top view of upper slider adjustment 26 . Similar to lower slide adjustment 27 described above, upper press pad 26 c may be made from angle iron while upper guide pad 26 d is made from a plastic such as Teflon to reduce friction with the internal surface of guide rail 13 . FIG. 3 b shows depicts an alternate embodiment in which upper guide pad 26 d is replaced by bearings 26 f . Bearings 26 f are biased against the internal surface of guide rail section 13 to reduce friction between platform 11 and guide rail section 13 as platform 11 moves along the guide rail section 13 . Bearings 26 f may also be used in lower slide adjustment 27 . FIG. 3 c is a top view of the embodiment seen in FIG. 3 b. Also shown in FIGS. 3 and 3 a is cable break stop 31 . Cable break stop 31 is attached to cable stop frame 37 a at pivot 38 and is functionally associated with cable 33 . By functional association is meant that the position of cable break stop 31 in relation to platform 11 and lock stop 19 or ladder step 20 is dependent on whether cable 33 is intact (or taut) or broken (or slack) as described below. When cable rest 39 of cable break stop 31 contacts cable 33 above pivot 38 , cable break stop 31 has insufficient length to reach to ladder step 20 , but can extend to ladder step 20 when it rotates to a more horizontal orientation. During operation, cable 33 is arranged to contact cable rest 39 on the opposite side from pivot 38 and cable break stop 31 is orientated so cable rest 39 is rotated away from ladder step 20 . As winch 32 winds cable 33 , cable stop 40 prevents cable 33 from losing contact with cable rest 39 as winding cable 33 travels back and forth along the spool of winch 33 . Cable break stop 31 functions to stop platform 11 from falling should cable 33 break or become slack. In the situation when platform 11 is stopped and cable 33 becomes slack, cable break stop 31 continues to rest against cable 33 . As cable 33 becomes taut when platform 11 starts to move, the snapping action will tend to push cable break stop 31 away from cable 33 . Cable pivot stop 46 , preferably located over pivot 38 prevents cable break stop 31 from rotating too far and ensures the cable rest 39 contacts cable 33 . FIG. 4 is a rear view of powered lift platform 10 depicting cable rest 39 (not shown in FIG. 4 ) of cable break stop 31 contacting cable 33 as platform 11 is being raised. FIG. 4 a demonstrates the action of cable break stop 31 after cable 33 breaks causing platform 11 to fall. In the event of such a break, while platform 11 falls, cable rest 39 will rotate until it contacts and rests against cable break frame 37 a thus preventing further rotation in that direction. Simultaneously, during the fall of platform 11 , the opposite end of cable break stop 31 rotates until it contact ladder step 20 (or lock stop 19 if cable break stop 31 is oriented toward the opposite side). Because cable break frame 37 a prevents rotation of the cable rest 39 end of cable break stop 31 and ladder step 20 prevents rotation of the opposite end of cable break stop 31 , platform 11 is prevented from falling by the wedged position of cable break stop 31 created during the fall. FIGS. 4 and 4 a also show paired lower slide adjustment 27 and paired upper slide adjustment 26 b each attached to opposite sides of platform 11 . FIG. 4 b depicts an adjustment assembly for base plate 23 . Telescoping slide 23 b includes adjustment holes 23 d and moves within guide rail section 13 . To provide more level support for power lift platform 10 on uneven ground, telescoping slide 23 b of each guide rail section 13 can be separately adjusted by moving adjustment holes 23 d to a desired level and then securing them in place by pin 23 c which is inserted through a hole in guide rail section 13 and through an appropriate adjustment hole 23 d to provide a firm support for each base plate 23 whether on even or uneven ground. In one embodiment, adjustment holes 23 d are placed approximately one inch apart, but different distances may be used if desired. FIG. 5 is a side view demonstrating the structure of safety stop lever 28 . Safety stop lever 28 and stop axle 30 pivot is seen in FIG. 3 to turn paired stop blades 28 a . Stop blocks 29 are positioned on each side of power box 12 to prevent complete rotation of stop lever 28 . Stop lever 28 functions as an emergency brake if platform 11 should unexpectedly fall. As platform 11 is raised up along guide rails 13 , stop blades 28 a contact the bottoms of safety stop 19 and ladder steps 20 located on opposite sides of guide rails 13 . The continued upward movement of platform 11 forces safety lever 28 , safety blades 28 a and axle 30 to rotate. After clearing safety block 19 and ladder step 20 , safety lever 28 rotates back to contact safety stop blocks 29 . It will be easily recognized that if the operator holds safety lever 28 up, safety blades 28 a rotate out of the contact path to prevent the intermittent contact with successive safety stops 19 and ladder steps 20 as platform 11 is raised or lowered. It will also be recognized that if platform 11 should fall, safety blades 28 a will contact the upper surface of either or both of safety stop 19 or ladder step 20 . Because safety block 29 is positioned in the rotational path of safety lever 28 , its presence prevents further rotation of safety blades 28 a off both safety stop 19 and ladder step 20 thus holding platform 11 and preventing the fall from continuing as seen in FIG. 5 a . Ladder steps 20 can also be used to climb down from platform 11 when it is stopped in a raised position off the ground. FIGS. 5 and 5 a also show a preferred embodiment in which switch 60 is positioned preferably on carriage 80 . Carriage 80 is defined as the entire movable component of powered lift platform 10 that moves up and down guide rail section(s) 13 . Switch 60 is a type of normally open, normally closed switch such that when activated, it shuts off power to the up drive of winch 32 or other powered lift mechanism and maintains power to the down drive. Switch 60 is activated by actuator 61 (see FIG. 9 ) placed toward the top of upper guide rail section 13 so that as platform 11 reaches an upper limit (such as when cable 33 is wound almost completely onto winch 32 , switch 60 is activated by actuator 61 to prevent platform 11 from moving further up guide rail sections 13 and allows platform 11 to move only down guide rail sections 13 . In a more preferred embodiment, lower actuator 61 a is movably attached to the lowest guide rail section 13 to prevent platform 11 from being lifted too high before upper guide rail section 13 is attached. After attachment, lower actuator 61 a is moved away from the lift path by hinges or other means known in the art. FIG. 6 depicts an alternate means of lifting platform 11 up and down along guide rails 13 . FIG. 6 shows gear-tooth rails 47 extending behind platform 11 which supports gear motor 48 (not shown in FIG. 6 ) and anchored at the top of guide rail section 13 . As seen in FIG. 6 a , gear motor 48 operates gears 49 to rotate them along gear-toothed rails 47 . Because gear motor 48 is attached to platform 11 , platform 11 is raised or lowered along gear-toothed rails 47 according to the direction of rotation of gears 49 Although two gear-tooth rails 47 are shown in FIG. 6 , it will be recognized that one or more than two gear-tooth rails 47 may be used although the use of only one gear tooth rail 47 is less preferred. Preferably, gear-toothed rails 47 are used with guide rails 13 although it will be recognized by those skilled in the art that gear-toothed rails 47 may replace guide rails 13 to supply both lift guide and lifting functions to powered lift platform 10 . FIG. 7 demonstrates a second alternate embodiment of the lift mechanism for powered lift platform 10 . Helical carry rod 50 extends from a base or bottom transverse bar 45 to an anchor point 21 . FIG. 7 a shows ball screw mechanism 51 attached to platform 11 and operated by ball screw motor 52 to traverse up and down helical carry rod 50 thereby lifting platform 11 up and down along helical carry rod 50 . Mechanisms able to convert rotational movement to vertical movement are well known in the art. FIG. 8 is a top perspective view of grippers 16 adjustably attached to guide rails 13 . As will be seen below, grippers 16 having at least one extension from guide rail section 13 are used to support powered lift platform 10 against an upright support such as a tree, pole, lamppost or similar device. In a preferred embodiment, gripper 16 includes teeth 17 and a pair of gripper extensions 18 c attached to the v-shaped gripper 16 and containing a plurality of position holes 18 d . In an alternate embodiment, gripper 16 may be U-shaped. Gripper 16 is arranged to extend from and retract into gripper adjustment sleeve 18 a . In operation, gripper 16 is pulled from gripper extensions 18 c and held in a desired position against an upright support by inserting gripper adjustment pin 18 b (“pin 18 b ”) through one of position holes 18 d and restraining hole 18 e . It will be recognized that each of the plurality of grippers 16 can be adjusted individually to establish a stable position for powered lift platform 10 even if the upright support is not straight or is at a sloping angle relative to the ground. In a preferred embodiment, transverse bar 45 extends between guide rails 13 to provide lateral rigidity between the paired guide rails 13 FIG. 9 shows power lift platform 10 supported against upright support 42 , in this case tree 42 . Straps 41 , preferably ratchet straps 41 , are seen wrapped around tree 42 and attached to both ends of transverse bar 45 . Powered lift platform 10 is supported substantially upright by placing base plates 23 as close to tree 42 as possible and positioning power lift platform 10 upright near or against tree 42 . Grippers 16 are extended to the desired length to produce a preferred vertical or near vertical position. After setting gripper 16 positions on lower guide rails 13 , ratchet straps 41 are wrapped around tree 42 , connected to gripper 16 , or preferably transverse bar 45 , and tightened. In a preferred embodiment, cable 33 is attached to lower cable anchor 21 a and platform 11 is raised to a desired height. A second set of guide rails 13 is attached to the first or bottom set of guide rails 13 by, for example, inserting guide rail inserts 14 into guide rail sockets 15 . The two sets of guide rails 13 may also be attached by bolts, hinges, or other suitable attachment devices known to those skilled in the art. Before attaching this second set, cable 33 is attached to cable anchor 21 . After attachment of upper guide rails 13 to lower guide rails 13 , winch 32 is operated to move platform 11 up guide rails 13 . At a suitable position(s), platform 11 is stopped, gripper 16 is adjusted and additional ratchet straps 41 are wrapped around tree 42 and attached at both ends of gripper 16 , or preferably transverse bar 45 , as shown in FIG. 9 . Once a sufficient number of grippers 16 are attached to tree 42 , powered lift platform 10 can be safely operated to move up and down the plurality of guide rails 13 . FIG. 10 depicts powered lift platform 10 in a disassembled mode with two wheels 22 and two sets of guide rails 13 secured to each other and towed by an individual user. Alternately, a towing attachment may be used to tow powered lift platform 10 using such vehicles as all terrain vehicles, trucks, cars, or other suitable equipment. Hold down straps 70 are used to hold separate guide rails 13 components together and to hold safety rails 44 onto platform 11 . Ratchet straps 41 may be used as hold down straps. FIGS. 11 , 12 and 12 a depict a preferred design of the disassembled mode in which safety stops 19 and ladder steps 20 of one guide rail section 13 align with grippers 16 of a second guide rail section 13 . FIG. 11 is a perspective view showing this preferred design. FIG. 12 is exploded view of this preferred embodiment in which ladder joiner 71 and safety stop joiner 72 each have a joining hole 71 a and 72 a , respectively. Ladder joiner 71 is inserted through ladder step 20 into gripper adjustment sleeve 18 a and is held in position with pin 71 b inserted through joining hole 71 a and ladder pin hole 71 c . Similarly, safety stop joiner 72 is inserted through safety stop 19 into gripper adjustment sleeve 18 a and is held in position with pin 72 b which extends through safety stop joining hole 72 a and safety stop pin hole 72 c . In this embodiment, the two guide rail sections 13 are then held securely in place by joining pins 71 b and 72 b. Thus it is seen that the objects of the invention are efficiently obtained, although changes and modifications to the invention should be readily apparent to those having ordinary skill in the art, which changes would not depart from the spirit and scope of the invention as claimed. 10 powered lift platform 11 platform 12 power box 13 guide rails 14 guide rail inserts 15 guide rail sockets 16 gripper 17 gripper teeth 18 gripper adjustment 18 a gripper adjustment sleeve 18 b gripper adjustment pin 18 c gripper adjustment extension 18 d position hole 18 e attachment hole 19 safety stop 20 ladder step 21 cable anchor/anchor point 21 a lower cable anchor 22 wheels 22 a wheel attachment 23 base plate 23 a base plate prongs 23 b telescoping slide 23 c telescoping slide pin 23 d telescoping slide adjustment hole 26 upper slide adjustment/bolt 26 a upper adjustment pivot 26 b upper adjustment lever arm 26 c upper adjustment press pad 26 d upper adjustment guide pad 26 f bearing 27 lower slide adjustment/bolt 27 a lower adjustment pivot 27 b lower adjustment lever arm 27 c lower adjustment press pad 27 d lower adjustment guide pad 27 e lower adjustment spacer 28 safety stop lever 28 a safety stop blade 29 safety stop block 30 safety stop axle 31 cable break stop 32 winch 32 a winch frame 33 cable 33 a cable hook 34 power cord 35 switch 36 gap 37 cable stop frame 38 cable break stop pivot 39 cable rest 40 cable stop 41 ratchet straps 42 tree 43 seat 44 safety rails 44 a detachable front rail 45 transverse bar 46 cable pivot stop 47 gear-toothed lift rails 48 gear motor 49 gear 50 helical carry rod 51 ball screw mechanism 52 ball screw motor 60 switch 61 actuator 61 a lower actuator 70 strap 71 ladder joiner 71 a ladder joiner hole 71 b ladder joiner pin 71 c ladder pin hole 72 safety stop joiner 72 a safety stop joiner hole 72 b safety stop joiner pin 72 c safety stop pin hole

The present invention is a powered lift platform including a platform, at least one guide rail section in operative contact with the platform, each of the at least one guide rail sections comprising at least one guide rail and in which a first end of each of the guide rail sections is configured to removably attach to a second end of a second guide rail section. The invention also includes a lift mechanism supported by the platform, a lift guide in operative contact with the lift mechanism and attached to the upper portion of the upper guide rail, a power supply to operate the lift mechanism. In a preferred embodiment, at least one wheel is operatively attached to the powered lift platform. Also presented is a method for securing the powered lift platform to a columnar-like support. Also presented is an extendable standoff.

NOTICE OF COPYRIGHT PROTECTION [0001] A portion of the disclosure of this patent document and its figures contain material subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, but otherwise reserves all copyrights whatsoever. BACKGROUND [0002] I. Field [0003] This invention relates to neck support devices. [0004] II. Co-Pending Applications [0005] This application claims priority to U.S. Provisional Application 61/497,502, which is related to U.S. Non-Provisional application Ser. No. 12/661,625, titled “Neck Support Device,” filed Mar. 19, 2010 , which claims priority to U.S. Provisional Application titled “Neck Support Device,” filed Mar. 21, 2009, each having the same inventor as the present application and each of which are hereby incorporated by reference herein as if set forth in full below. This application also claims priority to U.S. Design Pat. application Ser. No. 29/415,059 and U.S. Design Pat. application Ser. No. 29/415,060. [0006] III. Background [0007] The human spine comprises several regions. The cervical region corresponds to the neck and has a natural curvature. This curvature is lordotic, meaning that it is concave dorsally. The cervical lordotic curve is also known as a “C” curve. Positioning the head in a perpendicularly to the shoulders helps maintain a healthy C curve. Bending the cervical spine, especially for prolonged periods, is considered poor posture. Poor posture can lead to negative health and wellness effects, the more minor of which may include headaches, discomfort, muscle cramps, neck pain, and shoulder pain. Maintaining proper posture is often difficult during certain activities, such as, for example, resting, reading, watching television or movies, using a computer, traveling on an airplane or in a vehicle, or remaining in a static position for a prolonged period. Though muscles can help stabilize the cervical spine, they sometimes have a reduced capacity to do so, such as during sleep or rest, or as a result of muscular conditions (e.g., atrophy). As an example, an airplane traveler may wish to sleep or rest on a long flight, but may be restricted to the seated position. In this example, the traveler may experience difficulty finding a comfortable position or may experience negative effects as a result of improper neck positioning during sleep or rest. Thus, there is a need for a device that helps maintain proper neck posture. [0008] Currently, there are numerous neck support items available. The two primary types of neck-specific pillows include a neck collar shaped like a horseshoe and a cervical neck pillow. Each offers specific attention to the neck, while providing support in different ways. The horseshoe collar is intended for use while seated. The cervical neck pillow is intended for use while prone and provides a contoured pillow with a cradle for the head. Other neck support devices are found to be flimsy, insufficiently supportive, and uncomfortable. Thus, there is a need for a neck support device which is not flimsy, but is supportive and comfortable. [0009] None of these neck support items is adjustable and customizable for the user's comfort and support. Instead, the items provide a one-size-fits-all solution. For example, a horseshoe collar is not adjustable for the length of the user's neck or desired position of support. Neither is the point of support adjustable; the horseshoe collar provides support principally along the jaw and base of the skull. If the user prefers to choose the location of support, the existing devices are inadequate. Thus, there is a need for an adjustable, customizable, and supportive neck support item. [0010] Further, none of the neck support items available is easily collapsible or packable. Such a concern is especially relevant to those who use such devices while traveling. Contoured pillows often contain foams or stiff filling that resists compression. Horseshoe collars have similar problems. While some horseshoe collars comprise an inflatable bladder, such devices entail problems of their own. For example, users with a reduced lung capacity or reduced lung health may have difficulty inflating such devices. Further, the process of inflating and deflating the devices is an inconvenient step that reduces the collapsibility and packability of the device. Thus, there is a need for a portable, collapsible, or packable neck support item. [0011] Neither horseshoe collars nor cervical neck collars provide support in the forward direction. That is, neither type of neck support item prevents the user's head from tilting forward, which may happen naturally such as during sleep while seated. Similarly, the user's head is prone to wobbling. Thus, there is a need for a neck support item that prevents the user's head from unintentionally tilting forward or wobbling. [0012] The above problems, and others, are reduced by the invention as herein described and shown. SUMMARY [0013] The above problems, and others, are reduced, according to exemplary embodiments, by the neck support device. [0014] According to an exemplary embodiment, a neck supporting device comprises a bendable, padded disk lined on one side. Portions of the disk are incompletely separated from other portions of the disk by cuts in the material of the disk. Each portion is joined to one or more adjacent portions at edges. A user may bend the disk at the edges and may also bend the disk within each portion. The disk comprises three portions: a head portion, a neck portion, and a shoulder portion. The user bends the head portion until it is contoured to cradle the head. The user bends the shoulder portion until it is contoured to rest on the user's shoulder. The user will then position the neck portion against the side of the user's neck. The weight of the user's head will exert force upon the head portion, which weight will be translated via the neck portion to the shoulder portion, where it is in turn translated to the user's shoulder. Thus, the weight of the user's head is relieved from the user's neck, while the device facilitates proper positioning of the user's cervical spine. Multiple such neck supporting devices may be worn on opposing sides of the head, thereby translating the force exerted by the weight of the user's head to one or both of the user's shoulders. [0015] According to an exemplary embodiment, the head portion of the neck supporting device comprises padding such as foam or discrete pads. The padding may be homogenously distributed on the head portion, may be heterogeneously distributed, or may be contoured to provide added support in particular areas. For example, additional padding may be provided to support the distal aspects of the mandibular bodies and mentum (chin), referred to as the mental protuberance (hereinafter the “MEP”). A second comfort pad may be positioned on the head portion at a location configured to support the angles of the mandible (hereinafter the “MA”). A third comfort pad may be positioned on the head portion at a location configured to support the mastoid processes (hereinafter the “MAP”) posterior to the ear. A fourth comfort pad may be positioned on the head portion at a location configured to support the skull base and, specifically, the occipital protuberance (hereinafter the “OP”) at the posterior skull base of the wearer. [0016] An object of the invention is to provide a device to support the neck and head of a user while traveling. The device comprises an inner core which, when unbent, is flat and provides a thin profile for compact storage. When the user desires to use the device, the user can bend the inner core to a particular shape. The nature of the material of the inner core allows the user to bend the inner core with manual power alone, without the use of tools. However, it retains the shape once bent and is resistant to bending sufficiently to bear the weight of the user's head without unintentionally deforming. [0017] Other devices, methods, and/or products according to embodiments will be or will become apparent to one of ordinary skill in the art upon review of the following drawings and further description. It is intended that all such additional devices, methods, and/or products be included within this description, be within the scope of the present invention, and be protected by the accompanying claims. BRIEF DESCRIPTION OF THE DRAWINGS [0018] The exemplary embodiments, objects, uses, advantages, and novel features are more clearly understood by reference to the following description taken in connection with the accompanying figures wherein: [0019] FIG. 1 is a perspective view of an embodiment of the present invention. [0020] FIG. 2 is a perspective view of an aspect of the present invention. [0021] FIG. 3 is a perspective view of an embodiment of the present invention. [0022] FIG. 4 is a side view of an embodiment of the present invention. DETAILED DESCRIPTION [0023] FIG. 1 depicts a perspective view of an embodiment of the present invention. The neck support device 101 comprises a head portion 103 , a neck portion 105 , and a shoulder portion 107 . Head portion 103 and neck portion 105 join at top edge 109 . Neck portion 105 and shoulder portion 107 join at bottom edge 111 . The outer perimeter of the neck supporting device 101 may be roughly and irregularly circular or ovoid. The outer perimeter is made more irregular by cut lines 115 , which help define head portion 103 , neck portion 105 , and shoulder portion 107 . In some embodiments, the head portion 103 may directly or nearly contact the shoulder portion 107 . In other embodiments, cut lines 115 may be broad such that the head portion 103 cannot contact the shoulder portion 107 when the inner core 117 is unbent. However, the cut lines 115 transect the neck support device, but such transection is incomplete at least to the extent of the width of the neck portion 105 . [0024] The neck support device 101 comprises an inner core 117 . The inner core 117 comprises a bendable, pliable, or flexible material, such as, for example, a soft-temper metal. Such material may be, for example, steel, steel alloy, aluminum, or aluminum alloy that is of a stiffness that requires only moderate force to bend the core into a particular shape, yet preserves that shape once assumed. The core should bend easily enough for the user to be able to do so manually and without mechanical assistance, but resistant enough to avoid unintentional deformation, such as by the weight of the user's head on the head portion 103 when the device is in use. Within this range, the exact stiffness of the core or the exact amount of force required to shape it is immaterial. Further, the stiffness of the inner core 117 may be heterogeneous, particularly among the portions and edges. For example, the neck portion 105 may be stiffer than the head portion 103 or the shoulder portion 107 . As a further example, the inner core 117 may be more or less stiff at both of or either the top edge 109 or bottom edge 111 compared to elsewhere on the inner core 117 . The inner core is bendable, moldable, or shapeable, and those terms may be used interchangeably to describe the characteristics of the inner core. [0025] Further, mixed materials may be used throughout the inner core 117 . For example, some areas may be more frequently bent than others, in which case those frequently-bent areas may benefit more than the others from the use of material more resistant to metal fatigue. If top edge 109 or bottom edge 111 may be subject to more frequent bending than, e.g., the neck portion 105 . Other areas may benefit from stiffer, less flexible materials. Such variations in stiffness may be accomplished by variations in the type of material used, the treatment or preparation of the material used, or the thickness or amount of material used. [0026] Around and substantially encompassing the inner core 117 is the outer sheath material 119 . The outer sheath material 119 may completely encompass and enclose the inner core 117 . Conversely, the outer sheath material 119 may partially enclose the inner core 117 , for example by leaving the edges of the inner core 117 exposed as in FIG. 1 . For an example of an embodiment with full enclosure, see FIG. 3 , FIG. 4 , and the accompanying discussion. [0027] The outer sheath material 119 may comprise any of various types of padding, foam, cloth, fabric, or other flexible material. The outer sheath material 119 encompasses the head portion 103 , neck portion 105 , and shoulder portion 107 of the neck support device 101 . In an embodiment, the portion of the outer sheath material 119 encompassing the shoulder portion 107 comprises a gripping surface 113 . The gripping surface 113 helps prevent the neck support device 101 from slipping from the shoulder of the user when the neck support device is bent into its support shape. (See FIG. 3 , FIG. 4 , and the related discussions.) [0028] FIG. 2 depicts a perspective view of an aspect of the present invention. In an embodiment, the invention includes a shoulder strap 201 . The shoulder strap 201 is configured to help retain the neck support device upon a user's shoulder. The shoulder strap 201 comprises a belt 205 , a paddle 211 , and a harness 213 . The belt 205 comprises a first belt portion 217 and a second belt portion 219 joined by a buckle 203 . The strap 205 is configured to encompass a user's body (not shown) with the belt 205 passing under an arm and the paddle 211 positioned upon the top of the opposite shoulder. The second belt portion 219 comprises an adjustment region 209 , which partially passes through the buckle 203 and folds back upon itself. The adjustment region 209 may be removably attachable to itself or to the second belt portion 219 . Such attachment may be accomplished by, for example, hook and loop fasteners. Varying the amount of the adjustment region 209 of the second portion 209 which is passed through the buckle 203 varies the effective overall length of the belt 205 . Different users may prefer the belt 205 to be of different lengths. For example, users with greater chest circumference measurements or greater heights may require or prefer a greater effective length for the belt 205 . Further, users may prefer a certain tightness of fit, so even users with identical body measurements may prefer different effective lengths for the belt 205 . The shoulder strap 201 is configurable to fit a variety of users dependent on the preferences and requirements of the user. [0029] The belt 205 comprises a first belt portion 217 . The first belt portion 217 partially passes through the buckle 203 and folds back upon itself at first belt portion attachment point 207 . The first belt portion 217 , at first belt portion attachment point 207 , is secured to itself by one or more of various methods such as, for example, hook-and-loop fasteners, sewing, adhesive, or similar methods. [0030] The harness 213 comprises a plurality of portions removably attached to one another by the use of, for example, hook and loop fasteners. The harness 213 is configured to retain a portion of the neck support device (not shown) against the paddle 211 . [0031] The shoulder strap 201 is utilized by positioning the paddle upon the user's shoulder, passing part of the adjustment portion 209 through the buckle 203 until the desired effective belt length is attained, ensuring the plurality of portions of the harness 213 are detached from one another, positioning the neck support device (not shown) against the paddle 211 , and attaching the plurality of portions of the harness 213 to each other, thereby removably securing the neck support device (not shown) within the harness 213 , which is positioned upon the user's shoulder. [0032] FIG. 3 depicts a perspective view of an aspect of the present invention. A neck support device 301 is shown in a support configuration. The neck support device 301 comprises a head portion 309 , a neck portion 307 , and a shoulder portion 311 . The head portion 309 is attached to the neck portion 307 , which, in turn, is attached to the shoulder portion 311 . Thus, the head portion 309 is connected to the shoulder portion 311 via the neck portion 307 . When in use, a user positions the neck portion 307 against the side of the user's neck and the shoulder portion 311 atop the user's shoulder, with the head portion 309 being positioned to provide support to the user's head when, for example, sleeping or resting. [0033] The neck support device 301 comprises an inner core (not shown). The inner core is of similar construction to that described in connection with FIG. 1 and FIG. 2 . However, in the embodiment shown in FIG. 3 , the inner core is not visibly depicted as it is entirely encompassed and enclosed within the outer sheath material 313 . The outer sheath may be removable from the inner core. A user may remove the outer sheath to facilitate cleaning the outer sheath or inner core, to substitute the outer sheath with a different outer sheath of different aesthetics, or to substitute the outer sheath with a different outer sheath of different material, structure, or padding distribution. Thus, the replacement outer sheath may provide additional customizability of the neck support device for the user's aesthetic preference, fit preference, comfort, or other functionality. [0034] The shoulder portion 311 includes shoulder projections 305 , each of which is foldable and bendable to the user's preference. The shoulder portion 311 is configured to rest atop the shoulder of the user. More specifically, the shoulder portion 311 may rest primarily upon the top of the user's shoulder area, while the shoulder projections 305 may rest against the front and back of the shoulder area. [0035] The head portion 309 includes head projections 303 , each of which is foldable and bendable to the user's preference. The head projections 303 and head portion 309 may be bent to the user's preference in order to provide sufficient support to the various areas of the user's head. Such various areas include areas such as, for example, the MEP, MA, MAP, and OP. The head projections 303 can be bent to provide additional support to prevent the user's head from drooping forward or backward, while the center of the head portion 309 prevent the user's head from drooping laterally to at least one side. [0036] The outer sheath material 313 may comprise padding to provide support to various areas of the user's head. Further, the outer sheath material 313 at the head portion 309 may comprise circumaural padding, meaning padding which is circular, ellipsoid, or horse-shoe shaped to provide support the area of the user's head surrounding the ear, thereby removing pressure from the user's ear when the user's head is positioned upon or against the head portion 309 . [0037] The outer sheath material 313 may comprise any of various types of padding, foam, cloth, fabric, or other flexible material. The outer sheath material 313 encompasses the head portion 309 , neck portion 307 , and shoulder portion 311 of the neck support device 301 . In an embodiment, the portion of the outer sheath material 313 encompassing the shoulder portion 311 comprises a gripping surface to help prevent the neck support device 301 from slipping from the shoulder of the user when the neck support device is bent into its support shape. [0038] FIG. 4 depicts a side view of an aspect of the present invention. A neck support device 401 is shown in its support configuration. The neck support device 401 comprises a neck portion 413 which connects a head portion 405 to a shoulder portion 407 . The head portion 405 comprises head projections 403 . The shoulder portion 407 comprises shoulder projections 409 . The neck portion 413 is positioned against the neck of the user at a neck contact surface 411 . [0039] The head portion 405 includes head projections 403 , each of which is foldable and bendable to the user's preference. The head projections 403 and head portion 405 may be bent to the user's preference in order to provide sufficient support to the various areas of the user's head. Such various areas include areas such as, for example, the MEP, MA, MAP, and OP. The outer sheath material 415 may comprise padding to provide support to various areas of the user's head. Further, the outer sheath material 415 at the head portion 405 may comprise circumaural padding, meaning padding which is circular, ellipsoid, or horse-shoe shaped to provide support the area of the user's head surrounding the ear, thereby removing pressure from the user's ear when the user's head is positioned upon or against the head portion 405 . [0040] The outer sheath material 415 may comprise any of various types of padding, foam, cloth, fabric, or other flexible material. The outer sheath material 415 encompasses the head portion 405 , neck portion 413 , and shoulder portion 407 of the neck support device 401 . In an embodiment, the portion of the outer sheath material 415 encompassing the shoulder portion 407 comprises a gripping surface to help prevent the neck support device 401 from slipping from the shoulder of the user when the neck support device is bent into its support shape. [0041] The neck support device 401 comprises an inner core (not shown). The inner core is of similar construction to that described in connection with FIG. 1 and FIG. 2 . However, in the embodiment shown in FIG. 4 , the inner core is not visibly depicted as it is entirely encompassed and enclosed within the outer sheath material. [0042] Multiple neck support devices may be worn. Each of these multiple neck support devices may be used in conjunction with a shoulder strap. In this case, the shoulder straps may cross the user's chest in a crisscross fashion. [0043] Other systems, methods, and/or products according to the above embodiments will be or will become apparent to one of ordinary skill in the art upon review of the above description, the following drawings, and any further description. It is intended that all such additional systems, methods, and/or products be included within this description, be within the scope of the present invention, and be protected by the accompanying claims.

A neck support device comprises a flat, portable device comprised of a central malleable but supportive inner core or endoskeleton covered by a comfortable padded shell. The device shapes into a structure, supporting a user's head by translating the weight of the user' head to the user's shoulder, bypassing the neck, thus allowing relaxation of the supportive structures of the neck. The neck support device comprises a flexible and bendable inner core and an outer sheath material. Portions of the device may be bent into a support position by the user to support the user's head. The device may be bent into a substantially flat configuration for storage. The device may comprise contoured padding located for support or comfort and slip-resistant materials or surfaces. The device may translate the weight of the user's head from a head portion to a shoulder portion via a neck portion.

REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation-in-part claiming the benefit of U.S. Non-Provisional patent application Ser. No. 13/928,110, filed Jun. 26, 2013, entitled “System and method for disseminating information and implementing medical interventions to facilitate the safe emergence of users from crises.” BACKGROUND OF THE INVENTION [0002] Throughout history, millions of people faced life-threatening crises such as abductions, rape, sudden medical crises, car-jackings, robberies, and countless other dangerous situations. Historically, when a person found themselves in such a situation, it was impossible to instantly and discreetly alert loved ones and professional rescuers to the crisis, without alerting a potential attacker or abductor to the rescue attempt, and it was impossible to discreetly provide rescuers with data such as audio, video, geographical location, and instant communication amongst the various rescuers needed to understand the nature of the crisis, in order to enable rescuers to rapidly locate and rescue the user. Often, police lack the vital information and evidence needed to identify, capture and prosecute attackers, or to understand the detailed circumstances of any crisis from afar. Safety systems which require the user to engage in a verbal conversation with the rescuers are dangerous and not usable in a situation such as an abduction, because the attacker will hear the discussion with the dispatcher and terminate the communication. Safety systems which require users to interface with a smart phone screen to trigger a panic are impossible to discreetly and rapidly use during a sudden attack, because it takes too long for users to: A) awaken the phone screen, B) unlock the screen, C) locate the application, D) launch the application, and finally, E) trigger a panic within the application. No attacker would allow a user to retrieve their phone from their pocket and do the above actions during an attack. Throughout history, if a person was alone and lost consciousness, there was very little likelihood that they would have been rescued. Historically, victims of rape did not have available ways to deter a rapist from proceeding with the attack, by convincing the attacker that their identity and location is now known to the authorities. Historically, if a person experienced sudden cardiac arrest, there was a high likelihood that the person would die without immediate defibrillation. Historically, if a person needed a dose of medicine, it has been difficult for many users to administer the correct dosage at the correct times, particularly if a medical emergency rendered the user unconscious. Historically, if a person suffered a seizure, stroke or other brain related crisis, it was not possible to instantly notify rescuers of the crisis, and it was not possible to rapidly administer medicine needed to address the crisis. Historically, when a person embarked on any journey alone, including journeys on foot and in a car, if a sudden crisis emerged which caused the person to lose consciousness, subsequently causing the person to stop progressing towards their destination, it was not possible for help to be automatically summoned to the person's location. [0003] As can be seen, there is a need for solutions to these and other problems. SUMMARY OF THE INVENTION [0004] In one aspect of the present invention, a method for disseminating information regarding a problem, comprises: providing a mobile device wirelessly connectable to a network; receiving and storing contact information corresponding to a designated list of information recipients; receiving, via the mobile device, a signal indicating the problem; receiving, via the mobile device, information regarding the problem; transmitting an indication of the problem to a rescue clearinghouse via the network; prompting a participant of the rescue clearinghouse, different from the user, to make a decision about a course of action regarding the problem; and at least one of transmitting the information regarding the problem to the information recipients from the designated list and transmitting the information regarding the problem to a government rescue organization, based at least in part on the decision. [0005] In another aspect of the present invention, a method for disseminating information regarding a problem further comprising a primary panic trigger device comprising a button, wherein receiving the signal indicating the problem is activated by the user double pressing the button on the primary panic trigger device, which signals the mobile device wirelessly. [0006] In another aspect of the present invention, a method for disseminating information regarding a problem further comprising a head mounted camera comprising a button, wherein receiving the signal indicating the problem is activated by the user double pressing the button on the head mounted camera, which signals the mobile device wirelessly. [0007] In another aspect of the present invention, a method for disseminating information regarding a problem wherein receiving the signal indicating the problem is activated by the mobile device detecting a preprogrammed verbal phrase. [0008] In another aspect of the present invention, a method for disseminating information regarding a problem further comprising receiving and storing a specified area, wherein receiving the signal indicating the problem is activated by the mobile device either entering or exiting the specified area. [0009] In another aspect of the present invention, a method for disseminating information regarding a problem further comprising the step of providing a g-force detector attached to the cell phone; and receiving and storing information of a threshold g-force amount, wherein receiving the signal indicating the problem comprises the mobile phone reaching the threshold g-force amount. [0010] In another aspect of the present invention, a method for disseminating information regarding a problem further comprising providing a family plan comprising a plurality of mobile devices owned by multiple members of the same family. [0011] In another aspect of the present invention, a method for disseminating information regarding a problem further comprising the step of detecting the location of the plurality of mobile devices on the family plan and displaying the locations on a shared family Internet website. [0012] In another aspect of the present invention, a method for disseminating information regarding a problem further comprising providing a recording device connected to at bast one of the plurality mobile devices and configured to record at bast one of audio, video, and image; and recording at least one of audio, video, and image in real time via the recording device to produce recording information, wherein the information is displayed on the shared family Internet website. [0013] In another aspect of the present invention, a method for disseminating information regarding a problem wherein the signal indicating the problem activates a silent panic or a bud panic, wherein the silent panic comprises transmitting an indication of the problem to a rescue clearinghouse via the network without detection, wherein the bud panic comprises transmitting an indication of the problem to a rescue clearinghouse via the network while the mobile device produces at bast one of a bud spoken warning, and an emitting light. [0014] In another aspect of the present invention, a method for disseminating information regarding a problem wherein activating the bud panic comprises selecting a bud panic button icon displayed on a home screen of the mobile device. [0015] In another aspect of the present invention, a method for disseminating information regarding a problem, comprises: providing a mobile device wirelessly connectable to a network; receiving and storing contact information corresponding to a designated list of information recipients; receiving, via the mobile device, coordinates of an intended destination; tracking the movements of the mobile device from a current location to the intended destination; transmitting an indication of a problem to a rescue clearinghouse via the network when the mobile device is either no longer moving or is deviating from routes which lead to the intended destination; prompting a participant of the rescue clearinghouse, different from the user, to make a decision about a course of action regarding the problem; and at least one of transmitting the information regarding the problem to the information recipients from the designated list and transmitting the information regarding the problem to a government rescue organization, based at least in part on the decision. [0016] These and other features, aspects and advantages of the present invention will become better understood with reference to the following drawings, description and claims. BRIEF DESCRIPTION OF THE DRAWINGS [0017] FIG. 1 is an exemplary representation of the test panic home screen within the smartphone application; [0018] FIG. 2 is an exemplary representation of the application screen shown after a test silent panic of FIG. 1 has been triggered; [0019] FIG. 3 is an exemplary representation of the mobile rescue website of the present invention after a user has triggered a test panic of FIG. 1 ; [0020] FIG. 4 is an exemplary representation of the desktop rescue website after the user has triggered a test panic of FIG. 1 ; [0021] FIG. 5 is an exemplary representation of the application home screen of the present invention; [0022] FIG. 6 is an exemplary representation of the application screen which appears after a silent panic of FIG. 5 has been triggered; [0023] FIG. 7 is an exemplary representation of the application screen which appears after a loud panic of FIG. 5 has been triggered; [0024] FIG. 8 is an exemplary representation of the application screen which appears after a medical panic of FIG. 5 has been triggered; [0025] FIG. 9 is a perspective view of a designated physical panic trigger device of the present invention; [0026] FIG. 10 is an exemplary representation of the user triggering silent panic, from FIG. 5 ; [0027] FIG. 11 is a perspective view of a user selecting silent panic on an exemplary ear-mounted video camera of the present invention; [0028] FIG. 12 is an exemplary representation of the application screen which appears after a silent panic of FIGS. 9 through 12 has been triggered; [0029] FIG. 13 is an exemplary representation of the user's designated emergency contacts receiving a signal activated by the silent panic of FIGS. 9 through 12 ; [0030] FIG. 14 is an exemplary representation of a designated Rescue Center receiving a signal activated by the silent panic of FIG. 9 through 12 ; [0031] FIG. 15 is an exemplary representation of a user selecting the safe journey timer after the user selects the safe journey option from the application home screen of FIG. 5 ; [0032] FIG. 16 is an exemplary representation of the application screen which appears after the user selects the safe journey timer option of FIG. 15 ; [0033] FIG. 17 is an exemplary representation of the application screen which appears after the user starts the safe journey timer of FIG. 16 ; [0034] FIG. 18 is an exemplary representation of the safe journey timer countdown screen of FIG. 17 reaching a designated countdown time, at which time the user may be notified that the countdown is nearly complete; [0035] FIG. 19 is an exemplary representation of the silent panic screen which appears after the timer of FIG. 18 runs to zero; [0036] FIG. 20 is an exemplary representation of the user's designated emergency contacts receiving a signal activated by the timer of FIG. 18 ; [0037] FIG. 21 is an exemplary representation of a designated rescue center receiving a signal activated by the timer of FIG. 18 ; [0038] FIG. 22 is a front view of the panic trigger device of FIG. 9 ; [0039] FIG. 23 is a side view of the panic trigger device of FIG. 9 with an exemplary metal clip; [0040] FIG. 24 is a bottom view of the panic trigger device of FIG. 9 with an exemplary USB port; [0041] FIG. 25 is an perspective view of a a standard USB cord that may connect to USB port of the panic trigger device of FIG. 24 ; [0042] FIG. 26 is an exemplary representation of the rescue website component of the present invention; [0043] FIG. 27 is an exemplary representation of the rescue website displayed on a smart phone or other Internet-enabled device; [0044] FIG. 28 is an exemplary representation of the present invention after a user selects press for menu items of FIG. 27 ; [0045] FIG. 29 is an exemplary representation of the present invention after a user selects the user location history button of FIG. 28 ; [0046] FIG. 30 is an exemplary representation of the present invention after a user selects the audio from scene button of FIG. 28 ; [0047] FIG. 31 is an exemplary representation of the present invention after a user selects the help me button of HG. 28 ; [0048] FIG. 32 is an exemplary representation of the present invention providing directions to the user after a different user enters a street address into the field described in FIG. 31 ; [0049] FIG. 33 is an exemplary representation of the present invention after a user selects the photo/video button of FIG. 28 or FIG. 32 ; [0050] FIG. 34 is an exemplary representation of the present invention after a user selects the video currently streaming live of FIG. 33 ; [0051] FIG. 35 is a perspective view of the ear mounted video camera of FIG. 11 taking video of an exemplary attacker; [0052] FIG. 36 is an exemplary representation of the transdermal medicine distribution patch with the medicine shield dosed, sealing off the medicine reservoir; [0053] FIG. 37 is an exemplary representation of the transdermal medicine distribution patch of FIG. 36 with the medicine shield open, exposing the medicine reservoir; [0054] FIG. 38 is an exemplary representation of a user selecting the safe journey button of FIG. 5 and FIG. 15 ; [0055] FIG. 39 is an exemplary representation of a user selecting the safe journey monitor button; [0056] FIG. 40 is an exemplary representation of a user starting the safe journey monitor after entering their designated destination; [0057] FIG. 41 is an exemplary representation of a user ailing to continue traveling towards their designated destination; [0058] FIG. 42 is an exemplary representation of the user's smartphone vibrating to warn them of the imminent panic triggering as a result of FIG. 41 ; [0059] FIG. 43 is an exemplary representation of the users smartphone vibrating to warn them of the imminent panic triggering as a result of the smartphone detecting strong g-forces consistent with dangerous situations, such as a car accident; [0060] FIG. 44 is an exemplary representation of a silent panic triggering as a result of completed countdowns from FIG. 42 or FIG. 43 ; [0061] FIG. 45 is an exemplary representation of the user's designated emergency contacts receiving a signal activated by the silent panic of FIG. 44 ; [0062] FIG. 46 is an exemplary representation of a designated Rescue Center receiving a signal activated by the silent panic of FIG. 45 ; [0063] FIG. 47 is an exemplary representation of user speaking a designated phrase in order to trigger a silent panic; [0064] FIG. 48 is an exemplary representation of an attacker threatening the user of FIG. 47 ; [0065] FIG. 49 is an exemplary representation of the smartphone detecting the spoken designated panic trigger phrase, causing it to trigger a silent panic; [0066] FIG. 50 is an exemplary representation of a silent panic triggering as a result of FIG. 49 : [0067] FIG. 51 is an exemplary representation of the user's designated emergency contacts receiving a signal activated by the silent panic of FIG. 50 ; [0068] FIG. 52 is an exemplary representation of a designated rescue center receiving a signal activated by the silent panic of FIG. 50 ; [0069] FIG. 53 is an exemplary representation of the rescue website displaying the user to be located within a safe perimeter; [0070] FIG. 54 is an exemplary representation of the rescue website displaying the user to be located outside the designated safe perimeter; [0071] FIG. 55 is an exemplary representation of the rescue website displaying three members of one family, during a non-dangerous non-panic situation; [0072] FIG. 56 is an exemplary representation of the rescue website after one family member triggered a silent panic; [0073] FIG. 57 is an exemplary representation of a user selecting the instantly launched and activated loud panic from the smartphone screen; [0074] FIG. 58 is an exemplary representation of the loud panic from FIG. 57 , showing a camera flash and a loud audio alarm; [0075] FIG. 59 is an exemplary representation of the complete software application launching after the instant loud panic from FIG. 57 is triggered; [0076] FIG. 60 is an exemplary representation of the active loud panic screen; [0077] FIG. 61 is an exemplary representation of the user's designated emergency contacts receiving a signal activated by the loud panic of FIG. 60 ; and [0078] FIG. 62 is an exemplary representation of a designated Rescue Center receiving a signal activated by the loud panic of FIG. 60 . DETAILED DESCRIPTION OF THE INVENTION [0079] The following detailed description is of the best currently contemplated modes of carrying out exemplary embodiments of the invention. The description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention. [0080] The present invention is a safety/rescue system designed to facilitate the user's survival and rescue from any number of dangerous crises. The present invention may be referenced as the Ultimate Life Protector (ULP). In certain embodiments, the components of the present invention may include a smart phone software application, a panic button that may be a thumb sized bluetooth panic button which sends panic signals to the smart phone application, a server/cloud database, a rescue website, a dedicated 24/7 rescue center and additional optional accessories. [0081] In all cases herein, the following may describe the formula for entering text within the websites, emails, application, and the like, when words are shown in between the following symbols “[ ]”. In such cases, the content may be an unknown variable, and is meant to be automatically inserted when the variable becomes known. For instance, “Hi [EMERGENCY CONTACTS NAME],” In this example, the applicable message recipient's name is automatically inserted within the [ ]. For instance, “Hi Bob Johnson”. [0082] In certain embodiments, the smartphone software application is created in several coding languages required to be compatible with all widely used smart phone operating systems including but not limited to: Android, iOS, Blackberry, Java, Windows, Symbian, Bada, Maemo, Moblin, MeeGo, Palm and webOS. When new smartphone operating systems become widely used, the software code may be translated into the new language, enabling the algorithm of the present invention to function on the new smart phone. Regardless of the operating system, the algorithmic functions of the present invention may be utilized on all suitable smart phones and portable, internet-enabled devices, such as tablets. [0083] The following includes exemplary embodiments of the application of the algorithm of the present invention. After installation, during the first launch of ULP, the user may be prompted to do the following tasks below: [0084] If the user quits the application before entering the required information, when the user re-launches the application, the user may be automatically returned to the signup process described below, and the same continues to happen after application launch until the user enters certain identifying information. For example, the user may enter a unique username, their own contact info, and the contact information for at least one emergency contact who may be invited to participate to help facilitate the user's rescue during an emergency. [0085] The following may include the steps of an exemplary signup process. The user may be prompted to select a unique user name. If the entered user name is already in use, the user may be prompted to create a unique user name. The user name is what makes the user's web link unique. The user may be prompted to enter their own personal contact info, such as but not limited to, their cell phone number, email address, and physical home address. The user may be prompted to take a picture of themselves, so rescuers can know what the user looks like during the rescue. The user may be prompted to enter at least one emergency contact, for example, up to 10 emergency contacts. The emergency contacts may include trustworthy loved ones, campus security if applicable, a doctor if applicable, with phone numbers capable of receiving SMS in addition to email addresses. At the end of this initial sign up process, after all the user's information has been entered, the user may be sent to the test panic screen. A pop up message may inform the user that they must trigger a test panic before gaining the ability to trigger a real panic. If the user quits the application at this time, before a test panic has been triggered, when the user re-launches the ULP application, the user may be returned to the test panic screen. In certain embodiments, until the user triggers a test panic, the user may be brought to the test panic screen each time they launch the application. This may ensure that all users have at least one experience using the present invention, to gain a basic understanding of how it functions before experiencing a true emergency. When the user triggers the very first test panic, all emergency contacts may be sent an email which formally invites them to participate as this user's emergency contact in case of a crisis. [0086] An example of the invitation email may include the following: Hi [RECIPIENT'S NAME], [0087] It's [NAME OF USER] here. I'm writing because I just signed up for a safety/rescue service called Ultimate Life Protector™. I need to enter contact info for 10 emergency contacts and I'm hoping you won't mind being one of them. What I need is very simple. If I launch a panic to indicate that I'm in great danger, my contacts (like you) will receive an SMS text which has a web link. All I need you to do is to call 911 and tell them to go to that link. Simple! The link is http://www.LocateLovedOne.com/[UNIQUE USER NAME]. You can also click the link yourself right on your phone, to see where I am, hear live audio and much more. Professional rescuers like the police can use this web link to track my location, so they can rescue me. If you have any questions or you don't want to be one of my emergency contacts, please let me know. Thanks either way! [User's Full Name] [0088] [User's phone #] [user's email address] Learn more about this safety/rescue service and sign up yourself at http://www.UltimateLifeProtector.com [0089] After the first test panic described above, during which time the emergency contacts may be first invited via email and SMS to participate with the user, the user is able to continue to trigger test panics. Test panic may be located in the more menu of the application. Users may be encouraged to frequently trigger test panics before ever using ULP in a truly dangerous situation. This is encouraged to help users and their emergency contacts to learn all about the various functions and features within the present invention, without contacting the authorities. [0090] An exemplary embodiment of the test panic screen is illustrated in FIG. 1 . In certain embodiments, the test panic screen may contain six main button options, which may include but are not limited to, test silent panic 2, test loud panic 4, test medical panic 6, test safe journey 8, test call 911 10 , and more menu 12 . If the user triggers a test silent panic 2, the active panic screen 14 illustrated in FIG. 2 may appear, which may display the current panic status, and may contain four main button options, which may include but are not limited to, cancel panic 16 , test call 911 18 , sound alarm 20 , and false alarm 22 . [0091] The functions of the test silent panic active screen 14 may act as it normally would during a real panic, except the rescue center is never contacted during a test panic, and during a test panic, the panic SMS and email messages may convey that this is not a real emergency. The test panic may be used to give the user and the emergency contacts experience using the present invention, so they are prepared to assist with a rescue in case of a real emergency. Also, test panic allows the user to confirm that all of the phone numbers and email addresses for emergency contacts are current and correct. Recipients receive test panic messages, at which time they may click directly on the user's web link, with which they can repeatedly visit the website, to fully to understand all the various features available to aid with a rescue. Emergency contacts may click the web link on their web-enabled smart phones, as well as from within email on their desktop, laptop and tablet devices. [0092] In certain embodiments, the user's location may only be shown on the website during active panics, unless the user actively selects an option to share location during non-panics. If the SMS recipient clicks on the web link during the active test panic, the recipient may be taken to the user's personal mobile rescue website, and once the webpage opens, the recipient may view the user's current location, which may be displayed in the form of a blue icon which sits on the map, which may include a message, such as “HELP ME”. The HELP ME icon 24 illustrated in FIG. 3 may represent the present location of the user during a test panic on mobile smart phones. The HELP ME icon 24 illustrated in FIG. 4 . represents a larger test panic display for desktop, laptop and tablet devices. In certain embodiments, the user may cancel the active panic and the HELP ME icon may disappear from the website map, hence the website viewer may no longer view the user's current location after the user cancels a panic. However, in certain embodiments, emergency contacts may still be able to view the user's past locations, recorded video, audio, among several other data gathered during the active panic. [0093] An example of the test panic email may include the following: [0000] Subject—“TEST PANIC from [USER'S NAME] Hi [EMERGENCY CONTACT'S NAME], [0094] This email is a test panic message from my rescue service called Ultimate Life Protector. If this were a real emergency, I would need for you to immediately call 911 and tell them to locate and rescue me at the following website. You can click on it now to see where I'm located, to hear audio from my position, and to generally learn what the website can offer in case of a real emergency. [0000] http://www.LocateLovedOne.com/[UNIQUE USER NAME] [0095] In a real emergency, I need for you to call 911 if you ever get this panic message from me. Just tell 911 the web address above, and they'll be able to rescue me. In a real emergency, when you call me to confirm, you can ask me for my password. It is [INSERT PASSWORD] If I don't tell you the correct password, it means that I am under duress. [0000] Thank you for agreeing to help me if danger! [User's full name] [User's phone number] [User's email address] [0096] In certain embodiments, when the user first installs and signs up for the present invention, the default mode for the rescue center may be disarmed. In such embodiments, the user may actively arm the present invention by pressing the “ARM” button within the application. A pop up screen may appear which may convey that the present invention is armed, such as, “Warning! When rescue center is armed, the authorities will be notified when a panic is triggered, so arm rescue center with caution. Once armed, the rescue center will remain armed until you disarm it.” When the present invention is armed, the application may display “Rescue Center is currently ARMED” which may be at the top of the application screen. If the rescue center is disarmed, the application may display, “Rescue Center is currently DISARMED” which may be at the top of the application screen. [0097] As mentioned above, after arming the rescue center, the user may read the warning pop up message. In certain embodiments, the users may select either: “Arm Rescue Center” or “Cancel”. If the user chooses to arm the rescue center, the user may be prompted to enter their correct password. After the correct password is entered, the ULP rescue center may be armed. In certain embodiments, the program may remain armed every time the user uses the present invention, until the user actively disarms it. Even when the user quits the application of the present invention and turns off the phone, when the phone is powered on, and a panic is triggered, the previous armed or disarmed setting may remain in effect until the user changes the setting. [0098] Disarm mode may be intended for many uses beyond as a tutorial device. In certain embodiments, the user may use the present invention for non-emergency situations. For example, the user may select a “Non-Emergency” button which may be available in the menu items. When this mode is selected by the user and the user then triggers any panic mode, emergency contacts may receive SMS and email messages which may state that the panic is not life threatening, but the user does request their assistance. If users choose to use a panic in a non-emergency mode, before triggering a panic, users may be encouraged to notify the emergency contacts that the user is not facing a real crisis via a pop up screen which appears after the user presses the “non-emergency button”. The pop up screen may read, “If you intend to trigger a panic during a non-emergency, you are strongly encouraged to send a warning message to all contacts.” The two button options which appear underneath the pop up screen may read, “Send Warning” and “Cancel”. If the user selects “Cancel”, a new pop up screen appears which may read, “Non-Emergency Mode cancelled. All panics will be treated as real emergencies.” If the user selects, “Send Warning”, SMS and email messages may be sent to all emergency contacts, which may state that the user is currently safe, but intends to trigger a non-emergency panic. The contact's help might be requested by the user, but not for a life-threatening emergency. [0099] In certain embodiments, disarm mode may be used to give adults the ability to constantly monitor their young children in a variety of intuitive and useful ways, in non-life threatening situations, e.g., walking with a young child at an outdoor festival. For example, the parent may enable location sharing during non-panics on the children's ULP devices before entering an outdoor festival, shopping mall, or any number of other large places, where the guardian is concerned that they might lose sight of the children. With location sharing during non-panics active, the parents and children can walk around the large space confidently, because if they suddenly lose sight of their children, they simply awaken their smart phones, and instantly see exactly where the child or children are located on a map, in addition to various other vital data. Such embodiments, may be used with children or individuals suffering from mental illnesses such as dementia or other mental issues which call for constant monitoring. However, in most embodiments of the present invention, it is the user who controls whether or not their location and audio/video are being monitored. [0100] In certain embodiments, the disarm mode may be used with teen age children during non-life-threatening situations, such as an unchaperoned teen age party, for instance. In these cases, the user can double-press their designated panic trigger button if the user wishes to inform other friends who are present at the party that they are uncomfortable with a situation, perhaps involving an intoxicated, aggressive male classmate. The user may retain the power to determine whether or not they trigger a panic. Since the panic message recipients may be at the very same party or event, the friends may instantly rescue the user who may be in another room. If the user chooses, she can include her parents on the list of panic recipients. If a panic has been triggered, the parents may be able to listen to the audio and/or view video from the situation and determine their next course of action. [0101] In certain embodiments, the disarm mode may be used for a user who has no crisis whatsoever, but merely wishes to notify their nearby friend or associate that they are uncomfortable in a situation. For instance, one user might bring two friends to a social gathering. The user might wish to be “rescued” from the awkward conversation they are engaged in, or perhaps a celebrity discreetly triggers a disarmed panic to notify her publicist that she wants to stop giving an interview. In other words, in this case, the user wants the publicist to “rescue” her from the interview. Therefore, after the user has disarmed the rescue center, and notified her Emergency Contacts that she is planning to use ULP in a non-threatening situation, by using the non-dangerous warning feature described above, the user may double press a discreet button to be “rescued” from any socially delicate situation. [0102] In certain embodiments, the disarm mode may be used for first dates with a new acquaintance. Users might wish to have their close friends available, prepared to receive the ULP SMS if the user becomes uncomfortable with their situation, even if they don't necessarily initially perceive the situation to be physically dangerous. The friend receives the message and immediately hears audio, possibly live video, and the user's location. The message recipient may both call the user, and go to the user's location. In such a situation, where the user might originally have believed that there was no physical danger, but the panic message recipient listens to the ULP audio stream, and/or views the user's video stream, and believes that the user might be in actual physical danger, the message recipient simply calls the nearest professional rescue precinct shown on the rescue website, and tells the rescuers the user's unique web link. The nearby public rescuers may use the link to locate and rescue the user, while gathering all the timely data described herein. In other words, even if the user disarmed the rescue center, if emergency contacts/panic message recipients listen to the user's audio, and view the user's video, and these cause the emergency contacts to believe that the user faces a truly dangerous crisis, they may instantly contact professional rescuers, and by providing public rescuers with the user's web link, the rescuers treat the emergency as if the user intended for the rescue center to be armed. FIG. 5 illustrates the home screen of the present invention's application. At the top of the screen, the home screen may display whether or not the rescue center is armed or disarmed 26 . In this example, it reads, “Rescue Center is currently ARMED” 26 . Directly underneath the arming status, the silent panic button 28 may be displayed. When the user selects the silent panic button 28 , a silent panic mode is triggered. The present invention may further include a loud panic button 30 , a medical panic button 32 , and a safe journey button 34 displayed on the application home screen. [0103] In certain embodiments, there may be a call 911 button 36 . When the user presses this button, the user may have instant access to the outgoing phone call screen of the user's phone with 911 pre-dialed. In certain embodiments, 911 may be dialed with two taps of the screen. The first tap may be to select the call 911 button 36 , and the second tap may to select the call button on the standard phone outgoing call screen. The user may arm or disarm the present invention by selecting the arm or disarm button 38 . In certain embodiments, the user may select the more menu button 40 to view various available options as described below. [0104] In certain embodiments, there may be multiple panic modes within the application of the present invention. As mentioned above, there may be a silent panic, a loud panic, and a medical panic. FIG. 6 illustrates the silent panic active screen 42 , which may be accessed by selecting the silent panic button 28 on the application home screen. The status and type of the panic may be displayed in the upper half of the application screen. The user may cancel the active panic by selecting the cancel panic button 44 . The silent panic active screen 42 may further include a sound alarm button 46 , a call 911 button 36 , and a false alarm button 48 . In certain embodiments, prior to canceling any “real” panic, i.e. non-test panic, the user may have to enter their correct password for safety precautions. [0105] The loud panic active screen 42 is illustrated in FIG. 7 . The button options may be similar to the silent panic active screen 42 , however the alarm may sound automatically when the loud panic button 30 is triggered. In certain embodiments, the loud panic active screen 42 may further include a mute alarm button 50 . When the user selects the mute alarm button 50 , the alarm may be silenced. [0106] FIG. 8 illustrates the medical panic active screen 42 . This screen 42 may include the same button options as the silent panic active screen 42 from FIG. 6 . However, the color, text and graphics on the medical panic screen 42 may be different from the silent panic screen, which may be different from the silent panic screen 42 to easily distinguish them from each other. Further, the panic status may read medical panic active 42 . [0107] In certain embodiments, when the panic modes are activated, the user's location may be pinpointed and the map position may be sent immediately to the server/website. SMS and email messages may be sent to the user's emergency contacts, which may include campus security if applicable, as illustrated in FIG. 13 , and the designated ULP rescue center as illustrated in FIG. 14 , if the application of the present invention is in the armed mode. If the user has no cell phone signal when the panic is triggered, repeated automatic attempts to send the panic messages and other data may be made until adequate cell tower or WIFI signal becomes available. Within the SMS and email, a clickable web link may be displayed with the user's own unique web address configured, using the user's unique username within the URL. Rescuers may click the link on their smart phones to view the mobile website as well as a desktop website such as for rescue dispatchers. In certain embodiments, the URL format may be simple and easily shared verbally on the phone with professional rescuers. In certain embodiments, audio and video may begin to stream from the user, directly to the server/website for rescuers to hear and see in near real time. A photo may be taken at the moment the panic is triggered and may be uploaded to the server/website. [0108] In certain embodiments, on the application panic screens, buttons are available which read, “Take New Photo”, “Stop Video” and/or “Start Video. When pressed, new photos and/or video may be taken, and then sent to the website, and in the case of “Stop Video” the video stops recording and transmitting. In addition to these buttons, photos and/or video may be automatically captured and transmitted during typical use after a panic has been triggered, because the default setting may be such that video and/or photo are automatically captured and transmitted during any panic, without requiring that these screen buttons are selected. The user may have the option to disable the default video recording during panics in the application preferences, for instance, if the user's location is such that their phone signal is expected to be too weak to successfully carry the data-heavy video transmission. In such cases, the user may select the “Low Resolution Video” option within the application preferences, so that the default setting mandates that video may be recorded during all panics, with highly compressed, lower resolution, to minimize the amount of data that must be transmitted during a panic, to thusly maximize the successful transmission of the user's panic messages, location and audio. The user may also choose to select the “Automatically adjusting video resolution” option within the application settings. With this feature selected, the video may be set to always record and transmit during a panic, and the resolution of the video may be automatically determined by the user's available bandwidth and cell phone signal, with the video transmitting automatically at a lower resolution when the limited available bandwidth requires a smaller data size to be transmitted. The default setting may be such that, during an active panic, if the cell phone signal becomes significantly reduced, the first data to automatically cease transmission may be video. In such cases, video may continue to record on the user's phone if local memory is available, where it is stored until stronger bandwidth allows for the video transmission to the website to take place. If the available bandwidth has been reduced to such an extent where the audio recording is providing too much data transmission, as with the video, the audio may automatically continue to record on the user's local smart phone, to be transmitted to the website when enough bandwidth becomes available to the user. In other words, when available bandwidth becomes limited, video is the first data to be restricted, and after video, audio is the second data stream to be restricted. Therefore, the present invention may prioritize the sending of the panic messages, and the ascertainment and transmission of the user's current and previous location, above all other data-heavy functions. In such a low-bandwidth situation where video and audio are restricted, a still photograph may be taken and transmitted to the website. [0109] In certain embodiments, the present invention may include accessories that may be utilized. For example, the user may have a designated ear or head mounted video accessory 54 , in which live video from the user's vantage point may stream to the website for rescuers to view. In certain embodiments, the user may have a pulse monitor accessory, and in such cases the user's pulse rate may be displayed on the website. In such embodiments, a dangerously abnormal pulse reading may automatically trigger a Medical panic. In certain embodiments, the user may have a breathing monitor, and thereby the status of the user's breathing is shown on the website. In such embodiments, dangerous breathing levels may automatically trigger a medical panic. In certain embodiments, a user may have a brainwave monitor, such as a flexible cap which may be densely packed with electrodes. In such embodiments, potential brain related issues such as a seizure, stroke, blunt impact, or other such issues are displayed on the website. Serious brain related issues detected by the brainwave monitor may automatically trigger a medical panic. In certain embodiments, the present invention may further include automatically activated electrical cardiac resuscitation pads. In such embodiments, when the user experiences sudden cardiac arrest, the sensors recognize this, and the pads administer the correct amount of electrical impulse to defibrillate the user's heart. A medical panic may be triggered. The process may automatically cease as soon as the sensors determine that a safe heart rate has been restored. The user's heart may be monitored on the main home screen of the rescue website automatically, as soon as the irregular heart-related issue is discovered by the heart sensor; pads. [0110] In certain embodiments, the present invention may further include a transdermal medicine distribution patch, illustrated in FIGS. 36 and 37 . When a user (in consultation with her doctor) determines that essential medicine should be administered at particular times each day, the medicine may automatically administer according to a predetermined schedule. Medicine may also be withheld until designated nano-blood probes determine that the user is facing a potentially deadly crisis such as a bee sting for users who are allergic to bee stings. In a case such as an allergic user suffering a bee sting, the medicine distribution patch may release epinephrine automatically after the probes determine that it is medically necessary. A medical panic may be triggered when the probes determine that this crisis has begun. [0111] In certain embodiments, the silent panic mode, the bud panic mode and the medical panic mode may include the following differences. When the silent panic mode is triggered, no camera flash may appear, and the phone may remain silent unless the user selects the sound the alarm button 46 on the application screen. If the user selects the sound the alarm button 46 , a pop up message may appear to warn the user such as, “Are you sure? It will be loud.” The user may select cancel and no alarm may be sounded. If the user confirms the sound alarm, the alarm may be sounded. The user may silence the alarm by selecting mute alarm button 50 on the application screen. When silent panic is triggered, the user's phone ringer may switch to a vibrate mode. When the bud panic is triggered, the camera may flash brightly, and a bud noise may play such as a police siren, from the phone's speaker. A voice may also repeatedly play declaring that “Your pictures have been sent to the authorities.” The user may silence the alarm by selecting the mute alarm button 50 on the application screen. [0112] When the medical panic is triggered, in certain embodiments, no camera may flash and no noise may be made unless the user selects the sound alarm button 46 . If the user selects the sound alarm button 46 , audio from the phone's speaker may play such as a loud voice repeatedly declaring, “Help me! I'm having a medical emergency!” [0113] In certain embodiments, the silent panic may be triggered manually. Silent panic may be the default panic mode. In certain embodiments, the silent panic may be triggered when the user double dicks a physical Bluetooth®-enabled panic trigger button 52 as shown in FIG. 9 , may be triggered if the user double dicks the panic button on the ear/head-mounted video camera 54 as represented in FIG. 11 , may be triggered if the user double clicks any other designated physical panic trigger, may be triggered if the user selects the silent panic button 28 from within the ULP application as illustrated in FIG. 10 , may be triggered automatically during an active safe journey monitor if the user stops moving towards their designated destination as illustrated in FIG. 30 , FIG. 40 , FIG. 41 , FIG. 42 and FIG. 43 , may be triggered automatically when extreme g-forces are detected which could be consistent with a car accident or other potentially injurious event as illustrated in FIG. 44 , or may be triggered as a scheduled panic via the safe journey timer described below and illustrated in FIGS. 15 through 21 . The user's phone may make no sound when Silent Panic is triggered, and no camera flash may be seen. When Silent Panic is triggered, the user's phone ringer automatically switches to vibrate mode, to prevent unwanted attention directed to the user if the panic message recipients attempt to call or send SMS to the user. If the user chooses, they may select the sound alarm button 46 from the active panic screen as illustrated in FIG. 6 , if the user wishes to deter an attacker with sound of a police siren that may be coupled with a voice declaring, “Your pictures have been sent to the authorities.” When the user first selects the sound alarm button 46 , a pop up screen may warn the user that it will be loud. If the user confirms, the alarm may sound. This pop up warning may appear in order to prevent the user from accidentally sounding the alarm, for instance, if the user is hiding from an attacker. The user can mute the alarm by selecting the mute alarm button 50 . The same button may toggle between the sound alarm button 46 and the mute alarm button 50 , presenting the alternate option of the mode which is currently in effect. [0114] In certain embodiments, when the user triggers a loud panic 30 , either by selecting it from the ULP application as shown in FIG. 5 or by choosing for loud panic to be the default panic mode in the general preferences, in certain embodiments when one of the physical panic trigger devices is double pressed, all the sequential actions described above may take place. In addition to those above actions which may take place when a silent panic is triggered, when a loud panic is triggered, the phone's camera flash may shine brightly, the audio sound which simulates the taking of a photograph with a traditional physical camera may be played through the phone's sound speaker, and finally, a recording of an authentic American police siren may play through the phone's sound speaker, along with a loud voice which repeatedly may declare, “your pictures have been sent to the authorities”. This may be meant to deter a potential date rapist, or other possible assailant whom the user believes might be deterred by this camera flash and recorded warning. In such situations, the user may be advised to tell the attacker that his picture has been sent to the authorities, so he should not proceed with his illegal behavior if he wishes to avoid punishment. [0115] The user may have the option, within the smartphone application, to place a loud panic button icon 164 directly onto the home screen of the user's smartphone, as shown in FIG. 57 . This onscreen loud panic icon 164 may be distinct and separate from the onscreen icon which may be selected by the user to launch the main ULP application. This loud panic icon 164 may visibly be easily recognized by the user as the loud panic, visually different from the ULP application icon. [0116] When the user selects this loud panic button icon 164 which may reside on the home screen of the user's smartphone, the smartphone may immediately display a bright camera flash 168 as shown in the side view of the phone in FIG. 58 , a sound 172 which simulates the sound of a physical camera taking a picture from the phone's speaker as shown with simulated audio lines, a loud and authentic recording of an American police siren which may be repeatedly played, and a loud voice may repeatedly declare a statement such as, “Your pictures have been sent to the authorities. After the previous actions take place, the main ULP application may be fully launched as shown in FIG. 59 , and any audio, photos, video, location data or other data captured by the user's phone at the instant when the user selected the onscreen loud panic icon 164 may be transmitted to the rescue website, and all previously described functions which take place when loud panic is triggered may be executed. [0117] With the onscreen loud panic icon 164 present on the home screen of the user's smartphone, users may be able to rapidly deploy the loud panic as an instantly available deterrent against a potential attacker, without any requirement for the user to launch the main application first. In such a case where a user believes that an attack is imminent, the user may be able to trigger the onscreen loud panic in order to deter a potential attacker more quickly than if the user were to be required to launch the main application first. In such a case, it may be essential for the user to display the bright camera flash and other functions from loud panic immediately after selecting the onscreen icon, so the onscreen loud panic icon 164 may allow the user faster access to the loud panic trigger than if the user were to be required to launch the main application first, because it may take several seconds for the main application to launch, and then to trigger bud panic from within the main application. [0118] The user may have the option, within the smartphone application, to designate specific verbal phrases which, when spoken aloud by the user, the speaking of these designated phrases may cause specific panic modes to be triggered. For instance, if the user were to designate the phrase “Please don't hurt me” as a trigger phrase, when the user speaks this phrase as illustrated in FIG. 47 , via voice recognition software present within the application as illustrated in FIG. 49 , a silent panic may automatically be triggered as illustrated in FIG. 50 which notifies and shares all data with emergency contacts as illustrated in FIG. 51 and the rescue center as illustrated in FIG. 52 . When this panic is successfully triggered, pulse vibrations may take place on the user's phone and all related accessories to the ULP system such as the Bluetooth®-connected panic trigger button, and/or the ear mounted audio/video camera. These vibrations may serve to notify the user that their designated spoken phrase has successfully triggered a silent panic discreetly, without notifying a potential attacker. [0119] In certain embodiments, the user may trigger a medical panic in seven ways: Firstly, by selecting the medical panic button 32 in the application screen as illustrated in FIG. 5 , second, by choosing for medical panic to be the default panic in the general preferences, in which case the medical panic made may be triggered when the user double dicks any of the physical panic trigger devices such as the thumb sized button 66 as illustrated in FIG. 22 , thirdly, if a designated medical verbal phrase such as “I'm having chest pains” is spoken, it is detected by the voice recognition within the smartphone, fourthly, if general preferences are set to default to medical panic when the safe journey timer reaches zero, fifthly, if general preferences are set to default to medical panic when the safe journey monitor detects a problem, sixthly, when the g-force monitor detects a problem, medical panic may be triggered, and seventh, when one of the optional medical accessories such as pulse monitor or brainwave monitor detects a medical problem. [0120] As with all panic modes, the sequential actions described for the silent panic mode may occur, and in addition to those sequential actions, the SMS and email messages, along with the rescue website, may notify the rescuers that this is a medical emergency. If the user has certain preexisting medical conditions, rescuers may learn this key information on the website in the user's medical info section. If the user purchased any of the optional medical accessories listed above, the rescuers can do any of the following on the user's rescue website: monitor the user's pulse rate; monitor the user's breathing; monitor the user's key blood levels; monitor the user's brainwaves for possible seizures, stroke, blunt impact, or other electrode-detectable brain issues; determine the amount and timing of, and monitor the automatic administering of vital medicine; and monitor the activity of the automatically activated electrical cardiac resuscitation pads. With medical panic, the user may not be required to speak for assistance to be summoned. For instance, if a user is having an asthma attack which makes it impossible for them to speak, the user may simply press the medical panic button 32 and an ambulance may be set en route to rescue the user within seconds after pressing the button 32 . There may be no need to speak or remain conscious once the panic has been triggered. If the user has a serious recurring medical condition such as asthma, the user may be able to create a unique screen button of their choice, to reside on the medical panic screen. This may be offered in the general preferences. The user may press this button to trigger the medical panic, as an additional signal to rescuers. For example, the asthma sufferer creates an “asthma attack” button. If the user is unable to speak, she can press that button, instantly notifying rescuers of the nature of the emergency, without speaking. The user can create several different buttons for potential health crises which might be relevant to a particular user such as heart attack, stroke, asthma and the like. In certain embodiments, if the user selects the sound alarm button 46 as illustrated in FIG. 8 , a loud voice repeatedly declares, “Help me! I'm having a medical emergency!” [0121] In certain embodiments, the application of the present invention may further include a safe journey timer, which may set off an automatic panic trigger. When the user begins any journey, they may activate the safe journey timer mode by pressing the safe journey timer button 34 as illustrated in FIG. 15 . The user may then set the timer for the estimated time the journey will take. If it normally takes 10 minutes for a student to walk home from the library, for instance, the user may set the timer 56 for ten minutes as illustrated in FIG. 16 , select the start button 58 and then the user may put the phone back in their pocket while the timer counts down, as illustrated in FIG. 17 . When the timer reaches the final 30 seconds of the countdown, the smart phone may begin to pulse vibrate for each of the remaining 30 seconds of the countdown as illustrated in FIG. 18 . This may be done to warn the user that the countdown is almost finished. If the user is safe, when the vibrations begin, the user may select the arrived safely button 60 to cancel the countdown, or the user may select the reset timer button 62 , as illustrated in FIG. 18 . If, during the countdown, the user is conscious and suddenly discovers that they are facing a crisis, they may instantly trigger a silent panic by double pressing a physical panic trigger device 52 as illustrated in FIG. 22 . In certain embodiments, the users may double press the panic button on the ear mounted video camera 54 as illustrated in FIG. 11 and the user may also trigger a panic by selecting the silent panic button 64 from the safe journey timer screen during the countdown, as illustrated in FIG. 18 . If the user is unconscious or otherwise incapacitated, when the timer reaches zero, the silent panic mode may automatically trigger as illustrated in FIG. 19 , and the rescuers may be alerted with SMS and email as illustrated in FIG. 20 and FIG. 21 . As with other panic triggering, the sequential actions of the silent panic mode may be executed when the safe journey timer countdown reaches zero. Additional optional accessories mentioned herein may also contain physical panic buttons which the user can double-press to manually trigger a panic at any time, including during the safe journey timer countdown. [0122] Before the user embarks on any journey, the user may select the safe journey monitor from the application, as illustrated in FIG. 38 and FIG. 39 , and enter the address, location on a map, and/or latitude/longitude coordinates, of their intended destination in the safe journey monitor within the application, as illustrated in FIG. 40 . After the user activates the safe journey monitor, the user may begin to travel towards their destination. If the user either deviates away from routes which lead towards the intended destination, or if the user stops moving and stays in the same place for a designated period of time such as two minutes, as illustrated in FIG. 41 , the user's smartphone may begin to pulse vibrate for a designated period of time such as one minute, as illustrated in FIG. 42 . These vibrations may be meant as a warning to the user that the safe journey monitor will trigger a silent panic soon, because the user has stopped progressing towards their designated destination. If the user is safe and has stopped moving towards their designated destination for a reason not associated with a crisis, for instance if the user is stuck in gridlocked traffic, when the user notices the vibrating smartphone, the user may pause the safe journey monitor until they are ready to proceed with the remainder of their journey, as shown in FIG. 42 , example 148 . When the user is ready to continue with their journey, they may be able to re-activate the safe journey monitor by selecting the resume journey button as shown in FIG. 42 , example 152 . If the user wishes to cancel the safe journey monitor, they may press a button labeled cancel journey 150 . If the user wishes to trigger a silent panic, they may press the silent panic button 154 . The speed of the user's movement during the journey may be tracked and presented on the website. If the user successfully reaches their designated destination, the user may have the option of automatically messaging the emergency contacts upon the user's arrival at their designated destination, to notify the contacts that the user has safely arrived at their designated destination. [0123] In cases where the user has stopped progressing towards their designated destination while the safe journey monitor is active, after the designated vibration period has expired, if the user does not intervene, silent panic may be automatically triggered, as illustrated in FIGS. 44 through 46 . In cases such as car accidents, where the user may become unconscious or otherwise unable to access their phone, the automatic silent panic triggered by the safe journey monitor may inform all emergency contacts and rescuers that the user has failed to complete their journey, while providing the rescuers with the previously described vital data needed to rescue the user. [0124] As illustrated in FIG. 43 , in cases when the smartphone observes a sudden and extreme variation of g-forces on the phone, such as g-forces consistent with a moving car crashing into a tree for instance, the predetermined extreme g-force variation, when observed by the phone, may cause the phone to begin to vibrate for one minute. At the end of that minute, medical panic may be automatically triggered. If, during the minute of vibrations, the user selects the button labeled I am OK 156 , as shown in FIG. 43 , the safe journey monitor may be paused and no panic may be triggered. If the user takes no action after the phone begins to vibrate, at the end of the minute, medical panic may be automatically triggered. [0125] In cases where the user chooses to provide the emergency contacts with updates as to the user's location and speed of travel during the journey, regardless of whether or not the user has stopped progressing towards their designated destination, and regardless of whether or not a panic has been triggered, the user may be able to activate a function with which the user chooses to share their location data with the emergency contacts by transmitting the user's location data to the website at regular, designated intervals such as every 30 seconds, without any active panic. In such cases where the user may have chosen to transmit their location data to the rescue website during their journey, users may notify emergency contacts such as parents that they may have the ability to monitor and observe the user's location data on the rescue website as the user travels towards their designated destination, even when no panic mode is active, as illustrated in FIG. 55 , examples 158 , 160 and 162 . If the user does not choose to activate location data sharing during non-panics, it may not be possible for emergency contacts to view the user's location data unless a panic is triggered, and/or if the user chooses to activate the location data sharing option during non-panics. [0126] The user may have the option, within the smartphone application, to designate a specified area considered to be a safe zone by the user and the user's emergency contacts. The user may have the ability to set and reset the size and shape of the borders of this safe zone, to form the perimeter of a designated safe area 157 as illustrated in FIG. 53 . While the perimeter monitor is active, if the user remains within the designated safe perimeter as illustrated in FIG. 53 , no panic may be triggered. If the user crosses the border of the perimeter, exiting the designated safe perimeter as illustrated in FIG. 54 , a perimeter breach panic may be triggered, and the rescue website displays a large text statement which informs all rescuers that the user has exited the safe perimeter. Users can determine whether or not the perimeter breach results in contacting the ULP rescue center. For instance, in most cases, a user simply exiting the safe perimeter does not suggest that the user is in mortal danger. For this reason, the default mode may be for the emergency contacts to receive messages when the user breaches the safe perimeter. In other cases, such as a user with severe dementia, the settings may be selected so that the ULP rescue center as well as emergency contacts are notified of the safe perimeter breach. [0127] In cases when a user is currently outside the safe perimeter, the user may designate the safe perimeter as the designated destination. When the user arrives at the designated destination, if the user chooses, they may select an option which enables all emergency contacts to automatically receive messages such as SMS and email notifying the emergency contacts when the user has arrived at their designated safe destination. [0128] In certain embodiments of the present invention, a family mode may be incorporated. Multiple users of the present invention may have the ability to designate themselves as members of a single family unit. Each family member may possess their own unique username. If each user within the family has enabled the location data sharing during non-panics, all the participating users' location data may be transmitted to two distinct websites; a) The user's primary website with a unique URL such as www.LocateLovedOne.com/[USERMAME] as illustrated in FIG. 26 , and b) www.LocateTheFamily.com/[The shared family name] as illustrated in FIG. 56 . [0129] When the family initially enters their family name, if this name has already been entered into ULP by a different family, it may not be possible for the user to register this name. A unique family username may be required. For instance, “Smith77” may be used instead of “Smith”. [0130] If individual members of this family have activated the shared location data during non-panics, all family members may be able to navigate to their family's unique web URL such as www.LocateTheFamily.com/Nepo as illustrated in FIG. 56 . When any viewer chooses to view the locations of the various individual members of this family, it may only be possible for the viewer to see the locations of family members who have enabled the shared location data during non-panics. For such users who have activated this function, it is possible for family members such as parents to view the locations of all participating family members, on one website. Any viewer to this website may have the option to commence direct video and/or audio communications with any and all attendees on the website. For instance, a parent may have the ability to instantly video and/or audio communicate with a sibling and also a friend of the user, such as a conference call, all at the same time. [0131] In cases where young children or severe dementia patients may need constant monitoring, users may have the ability to choose to transmit audio, video, location data, and any other available data, regardless of whether or not a panic has been triggered. This may require large amounts of bandwidth, therefore users may be aware that transmitting such data might exceed their allotted monthly bandwidth allowance. [0132] More commonly, in other cases, it may be possible for users to choose to only transmit location data during non-panics, but not to transmit audio, video and other data during non-panics. This may be commonly used by families who wish to keep track of the users' locations, without using excessive bandwidth required to transmit vantage point video and other data-heavy transmissions. [0133] In other cases, such as severe dementia patients, it may be possible for users to transmit all available data, but this may require that the user actively select this option before it transmits the data. [0134] In a case where one or more family members trigger panics, the rescuers may view location and all other vital data from multiple family members on the same family website as illustrated in FIG. 56 . [0135] In a case where one or more family members enable the safe journey monitor, viewers of the website such as parents may have the ability to monitor the progress of multiple family members as they progress towards their respective destinations, all on the same website screen. [0136] In certain embodiments, the present application may include a more menu selection. The following options and functions may reside the in the more menu which may be reached by pressing the more menu button 12 within the application: quit ULP; I am okay/send false alarm message/non-dangerous emergency warning; conference call; panic message status; test panic; general preferences; 24/7 ULP rescue center; add/edit emergency contacts; edit personal info; add/edit profile picture; pair ULP with designated physical devices including panic triggers, medical monitoring devices, audio and video recorders, among other accessories; quick start instructions; complete instructions; about ULP; and the like. [0137] The following may include the description of the buttons which may be selected within the more menu. If no panic is currently active and the user selects quit ULP from the more menu, or quit at the bottom of the application screen, the application may quit without requiring a password. If the user is not quitting the application, but instead is merely canceling the active panic because they have emerged safely from a crisis, the user can select the cancel panic button 44 as illustrated in FIG. 6 . The user may be prompted to enter their password. When the correct password is entered, the following pop up notification may appear on the screen: “The panic has been canceled and ‘I AM SAFE!’ messages have been sent. Contact rescuers to confirm your safe status.” After the user confirms, the pop up message may disappear, the user's smart phone screen may automatically display the mobile internet browser, and the user may be automatically taken to their own rescue website where they may text and/or voice and/or video chat with rescuers and emergency contacts who were involved with the rescue. Finally, after the correct password has been entered in order to cancel an active panic, the user's phone ringer may automatically be turned to the highest volume. As explained previously, when a silent panic is triggered, the user's phone ringer automatically changes to vibrate mode, for the duration of the panic. When a panic is canceled, the phone ringer volume may automatically increase to the maximum volume, in anticipation of likely incoming phone calls from rescuers and emergency contacts who will wish to confirm the user's safe status, so the ringer volume increase prepares the user to receive the calls. An example of the “I AM SAFE!” SMS message is provided: “I AM SAFE! Situation is now stable but it was a crisis. U can call me to confirm. If u called 911, call them & say I'm safe.” [0000] An example of the “I AM SAFE!” email message is provided: Subject line—“I AM SAFE!” Email body—“[FULL NAME OF EMERGENCY CONTACT]! I am safe! My situation is now stable but this was a crisis. Call me ASAP to discuss it, and to confirm my safe status. If you called 911, call them back and tell them I'm safe. [USER'S FULL NAME] [USER'S PHONE #] [USER'S EMAIL] [0138] Learn more about this safety/rescue service and sign up yourself at http://www.UltimateLifeProtector.com.” [0139] If a panic is active, the panic may first be canceled before the application can quit, and as explained above, a password may be required to cancel active panics. If the user attempts to quit the application during an active panic, they may first be prompted to enter their password. If the correct password is entered, the same pop up notification as above may appear on the screen: “The panic has been canceled and ‘I AM SAFE!’ messages have been sent. Contact rescuers to confirm your safe status.” After the user confirms, the pop up message may disappear, the ULP application may quit, and the user's smart phone screen may switch to the Internet browser, where the user may be taken to their own rescue website where they can text and or voice and or video chat with rescuers and emergency contacts who were involved with the rescue. As further explained below, the user may also start an audio and/or video conference call which can involve multiple rescuers. [0140] Once the correct password has been entered in order to cancel an active panic, the user's phone ringer may be automatically raised to the highest volume. As explained previously, when a silent panic is triggered, the user's phone ringer may automatically change to vibrate mode for the duration of the panic. When a panic is canceled, the ringer volume may automatically increase to maximum volume. After the serious crisis has ended, it is no longer necessary for the user to maintain silence such as if the user were hiding from an attacker. After a serious crisis has ended, it is likely that the user's emergency contacts may wish to speak with the user, so that is the reason why the ringer may automatically increase to the maximum after the panic has been canceled, to ensure that the user doesn't miss these important calls, SMS and other communications. In certain embodiments, if the user attempts to quit ULP during an active panic, or if the user only attempts to cancel the active panic, and they enter a designated false password, for instance “1313”, a pop up message appears which reads, “False Alarm Messages Have Been Sent and the panic has been canceled.” Then the screen shows “ULP QUITTING . . . ,”, and finally the screen switches over to the standard home screen of the smart phone. As the ULP application screens disappear from view, the panic processes may continue. The user's location continues to update at regular intervals, audio, photo, video and all medical data continue to stream to the rescue website, and rescuers continue with the rescue attempt. In certain embodiments, if the user wishes to deceive an attacker by falsely shutting off the power of the phone, the user may select the “power phone off” button in the more menu. If the user enters the designated false password, the phone may appear to shut down as normal, with the standard shut-down process shown on the screen. The user may show this false power shutdown to an attacker, to convince them that the phone power has been turned off. As detailed above with the false quit, while the phone appears to have been powered off, all data including the user's location, audio, video, medical data and the like, continue to transmit to the website. This power-off deception is meant to convince an attacker that the phone has been turned off, when in reality, the phone may still be on and continuing to provide data to the website in order to continue to facilitate the rescue. [0141] The designated false password relating to quitting ULP, canceling the panic modes or powering off the phone, may be used to deceive a potential attacker into falsely believing that the user has canceled the panic, powered off the phone, or in the case of panic message status, to deceive the attacker into believing that no panic messages were ever sent. However, if the user simply enters an incorrect password, they may be prevented from canceling the panic, prevented from quitting the application, and continually prompted to enter the correct password until they either stop attempting to access password-restricted features, or until the correct password is entered. Only after the user enters the designated false password may any of the above deception take place. [0142] If the user suddenly discovers that they have accidentally triggered a panic while they are safe, the user may press the false alarm button 48 on the application screen. If the user enters the correct password, false alarm messages are sent to all contacts. [0143] The false alarm SMS message may be composed of the following information and may be sent to all contacts and, if armed, to the rescue center: “FALSE ALARM! Disregard emergency message I sent. I'm not in danger. If u called 911, call them & say I'm safe. U can call me 2 confirm.” [0144] Concurrently, the false alarm email message may be sent to all contacts and the rescue center, and reads as follows: “SUBJECT LINE—“PLEASE IGNORE THE PREVIOUS PANIC MESSAGE” [0145] Email body—“FALSE ALARM! IGNORE EMERGENCY MESSAGE! Please disregard the emergency message you received from me. I am not in danger. If you called 911, call them back and tell them I'm safe. Feel free to call or text me to confirm. [USER'S FULL NAME] [USER'S CELLPHONE NUMBER] [0146] Learn more about this safety/rescue service and sign up yourself at http://www.UltimateLifeProtector.com.” [0147] If the user did not accidentally trigger a panic, but the user simply wishes to inform their emergency contacts that they are indeed safe, they may select the “I am OK” button which is shown on the More Menu 2 area. When the user selects “I AM OK”, they are prompted to enter their password. If they enter the correct password, the following SMS may be sent to all contacts. “I AM OK. You can call if you wish to confirm.” The following email may be sent to the same emergency contacts: [0000] “Subject—I AM OK!” Email body, “[EMERGENCY CONTACTS FULL NAME], I am OK! If you want to confirm it, you can call or text. Don't worry! Love, [USER'S FULL NAME] [USER'S CELLPHONE NUMBER]” [0148] If the user wishes, either during and/or after an active panic, if the circumstances of their crisis are such that the user is able to speak out loud with the rescuers, the user may select conference call from the More Menu, within the ULP application. After selecting conference call, the user arrives at a screen which may list the user's emergency contacts, the rescue center, and the number of the nearest public rescue service to the user. Next to each contact, there may be a call button. After the user has selected one contact to call, the buttons next to each remaining emergency contact may change to add to call. When the user selects add to call next to any particular contact, that contact's phone may be dialed and added to the conference call. When available bandwidth is exceeded, the screen displays an option to incrementally reduce the bit rate of the current phone connections. The user and rescuers can either engage in a standard audio phone call, and additionally they can engage in a video conference call if the participants possess suitable devices capable of participating in video conference calls. If only certain rescuers possess a phone capable of conducting a video conference call but other participants in the conversation do not possess video conferencing capabilities, those participants may communicate with the video conferencing participants via their standard audio phone, and are able to hear the audio and contribute audio to the conference call. [0149] In addition to the user's capability to initiate a conference call, rescuers may also possess this capability via the mobile and desktop websites. On the emergency contact info screen, as with the user's application, rescuers may select a listed emergency contact and then press “add to call. If the rescuer's laptop or other computer is fitted with a microphone and speakers, (as with nearly all laptops), they may be able to orally speak with several fellow rescuers. As with the user application, on the website, rescuers may incrementally reduce the bit rate of the phone communication if the available bandwidth has been exceeded. [0150] In certain embodiments, when the user selects panic message status, they may be prompted to enter their password. If they enter the correct password, a pop up screen may appear showing whether or not the panic SMS and email messages were successfully sent. For instance, if the user is in an area with low or no cell phone signal, it is possible that the emergency messages were not yet successfully sent. In such cases, the application may constantly re-attempt to send the messages as soon as cell tower, WIFI or other signals become available. [0151] In certain embodiments, if the user enters the designated false password, when the user selects panic message status, a pop up screen may appear which may read, “No Panic Triggered. No Messages Sent.” This may be the case regardless of whether or not the user actually has adequate cell tower or WIFI signal to send a message. It is meant to deceive an attacker into believing that help is not on the way, regardless of the truth. [0152] In certain embodiments, when test panic mode is selected from the Menu Items, the user may be presented with the same panic modes as are normally present on the ULP application home screen, but in this case, it is only a test version of that panic mode. The test panic mode may include test silent panic 2, test loud panic 4, test medical panic 6, and a test safe journey 8. When the test panics are triggered, the functionality may be nearly identical to the non-test version of the same panic mode as mentioned above. However, in certain embodiments, the following may include a set of differences: [0153] A) Instead of the standard SMS panic message, in a Test Panic, the following SMS panic message may be sent to the emergency contacts, but not to the Rescue Center, and this message may contain the same unique clickable web link to locate the user: [0000] “Only a TEST. If I were in true danger I'd need you 2 call 911 & tell them 2 locate & rescue me @ http://www.LocateLovedOne.com/[UNIQUE USER NAME]” [0154] B) Instead of the standard email panic message, the following email may be sent to all emergency contacts, but not to the Rescue Center: [0000] Subject—“TEST PANIC from [USER'S FULL NAME]” Email Body—“Hello [NAME OF EMERGENCY CONTACT], [0155] This email is a test panic message from my rescue system called Ultimate Life Protector™. THIS IS NOT AN EMERGENCY. If this were a real emergency, I would need for you to immediately call 911 and tell them to locate and rescue me at the following website below. You can click on it now to learn my location, hear audio, among other resources which could be used in a real emergency. Please explore the website now so you can learn how you can help during an emergency. http://www.LocateLovedOne.comi[UNIQUE USER NAME] Thank you for agreeing to help me if I'm in danger! [USER'S FULL NAME] [USER'S CELL PHONE NUMBER] [USER'S EMAIL ADDRESS]” [0156] C) Even if the Rescue Center is armed, when the user triggers any panic from the test screen, no test panic messages are sent to the rescue center. [0157] D) If the user selects test safe journey, the timer and monitor work as normal, but if the countdown reaches zero, the above test panic messages may be sent to the emergency contacts, not to the rescue center. [0158] In certain embodiments the user may view and alter the general preferences by selecting “General Preferences” from the more menu within the ULP application: [0159] A) Screen sleep may be disabled during ULP use, to keep the ULP screen at the ready by deactivating screen sleep at the top of the general preferences. In this case, the screen may dim, but remains on, so that when the user simply taps the screen once, the brightness may return to the previous brightness setting. This may allow the user to tap loud panic on the app screen whenever the user has the need to deter an attacker, such as a date-rapist, for instance. With the screen sleep disabled, the user is not required to awaken the screen and unlock it before selecting loud panic, or any other function available on the screen. [0160] B) Default mode may be for a pop up screen to appear after the ULP application has been running for 60 minutes, to remind the user that ULP is still running. If the user is safe, they can quit the application. This notification can be deactivated in general preferences. [0161] C) Default mode may be for location pings to send every 30 seconds during normal use, during a panic. When the battery runs below ⅓ rd remaining power, a low battery conservation mode may take effect, which may restricts location pings to once every 3 minutes, and may restrict further video and/or audio transmission. Also, when conservation mode is in effect, the screen may sleep when the user is not using it, regardless of the screen sleep setting above in (A). The user can deactivate low battery mode in the general preferences. If deactivated, pings may continue to send every 30 seconds, and all other available functions continue to operate until the battery depletes fully. [0162] D) Default mode may be for safe journey timer to not require a password to cancel the countdown, when the user safely arrives at their destination. If the user wishes to require that the correct password be entered before canceling the safe journey timer countdown, they may choose to require a password in the general preferences. [0163] E) The default emergency service phone number may be 911. For users in countries other than the U.S. with different government emergency phone numbers, (such as 999 in the UK) users can enter the appropriate emergency phone number for their country within the general preferences. [0164] F) The default panic may be silent panic. If the user chooses, within the general preferences, they can select a different panic to trigger as the default. For instance, a user with a severe heart condition might choose medical panic as default. In this case, if the user double presses any available panic button, medical panic may be triggered, and if the user is wearing the optional pulse monitor accessory, for instance, medical professionals can monitor the user's pulse before they arrive on the scene. As an example of setting loud panic to be the default panic, a teen age girl can set loud panic as default before attending an unchaperoned party, to deter potentially intoxicated and aggressive males. [0165] G) The user may have the option to create custom buttons for the app screen, which describe anticipated crises. For instance, if the user suffers with a serious asthma condition, in these preferences, users are able to create a custom “asthma attack” button which appears on the screen. If the user is unable to speak during an asthma attack, they can press this button, instantly notifying rescuers of the nature of the emergency, without speaking. The user can create multiple buttons for several possible crises such as “peanut exposure” “bee sting”, “stroke” and the like. [0166] A predetermined SMS-capable phone number and an email address for the rescue center may appear by default in the application of the present invention, in the menu items. When new software versions of ULP are released, if the rescue center phone number and email has changed, the new contact info is updated into the software. ULP may establish the correct cell phone number and the correct email address with which the user can contact the provided rescue center. This contact info may be automatically present within the software, and if any contact info relating to the rescue center changes, the software may be automatically updated to include these changes, so the rescue center may always receive panic messages while the rescue center is armed. [0167] In certain embodiments, it is also possible for the user to alter the emergency phone and email address. One situation where it might be appropriate for users to decide to alter the rescue center contact info would be for a college student who has 24/7 campus security available. The user may input the contact information for her specific campus rescue authorities, so when her rescue center is armed, campus security is dispatched to rescue the user. [0168] When the user triggers their very first test panic after signing up for the service and entering emergency contact info, an invitation email may be sent to all the new emergency contacts. In the aforementioned case of a college student, campus security receives the invitation email, the security service may communicate with the user, and understand how to take advantage of ULP rescue features to rescue the user if campus security receives a real panic message from the user, during a true crisis. [0169] If the user determines her situation is such that she is able to orally speak with the rescue center during a crisis, she can call the rescue center directly by simply pressing the call rescue center button in the menu items, on the 24/7 ULP rescue center screen. In such cases, the rescue center may talk to and comfort the user while arranging for the rescue to proceed. [0170] In certain embodiments, there may be a light version. For users who sign up for so-called light service, the rescue center described above may not be available, but the user may be offered the ability to enter contact information for a primary rescuer. In cases where college students have 24/7 security available on their college campus, for instance, light users may enter contact information for their campus security as the designated primary rescuer. [0171] In certain embodiments, if the light user disarms the primary rescuer, when the user triggers a panic, only the regular emergency contacts may receive the panic messages. The primary rescuer, such as campus security if applicable, may not receive panic messages when the primary rescuer is disarmed. When the primary rescuer is armed, the designated primary rescuer may receive the panic messages. This disarm function may allow light users to trigger panics in non-dangerous situations, such as to be liberated from an unpleasant conversation at a party. If the user plans to use the panic in such a non-dangerous situation, the emergency contacts may be notified in advance, so it is not treated as a life-threatening emergency which requires professional rescuers. When light users arm the primary rescuer, for instance, if the user has a known severe medical condition, they can enter their doctor's contact info in the “Primary Rescuer” field, it may be understood by the panic message recipients that the user has declared that he is in serious danger. Many intended uses for the disarmed mode during non-dangerous situations are outlined above. [0172] In certain embodiments, when the user first installs the application of the present invention, the user may be prompted to enter the cell phone numbers and email addresses of their family and dose friends, who the user determines as the best people to receive panic messages if the user triggers a panic, and for these designated people to agree to act to rescue the user in such circumstances. Within the more menu section of the application, the user may add additional contacts to the list, and edit the existing contact information whenever they wish. When the user first installs the application of the present invention, the user may be prompted to enter their own key information, so it may be available to rescuers in case of emergency. Users can update this information at a later date from the more menu. The information which the user may be prompted to enter is as follows; a full name; a home address; an email address; a cell phone number; any pertinent medical information such as blood type, allergies, bee sting allergies, asthma and the like. [0173] When the user first installs the application of the present invention, the user may be prompted to take a picture of themselves with their phone. This user photo may be displayed on the rescue website, so rescuers may be able to identify the user during an emergency. After the user takes the picture, before submitting it to the ULP server, the user may be able to view the picture, to determine if it is suitable. If the user wishes, they can retake the picture until a satisfactory picture has been taken. [0174] Further, users may be able to return to the user photo section at a later time, to take a new picture of themselves. When the user is satisfied with the new picture, the user may upload the picture to the rescue website. For smart phones which include a self-facing camera, where the user can view themselves in the smart phone screen while taking the picture, this mode may automatically be used when such a self-facing camera is present, and when the user arrives at the user photo screen via the more menu, the existing user photo may be displayed. If the user selects a take a new photo button, the screen may change to become a live viewfinder, and when the user selects a snap photo button, the photo is taken. The most recent photo of the user remains on the screen. If the user is unhappy with that picture, the user can select take a new photo button again. Once the user approves of the photo, the user may upload the photo to the website, and the user photo is sent to the website, and the ULP application screen may return to the more menu section. [0175] For users with smart phones that do not include a self-facing camera, the main camera on the phone may be used. A pop up screen may appear which may read “It's easiest to take your photo in front of a mirror, so you can see the phone's screen in the mirror. This way, you can make sure your face is centered.” The user may close this popup window after reading the message. When the user selects a snap photo button from the screen, the new photo may be taken. All button options may be the same with the self-facing camera and the forward-facing-only cameras. Once the user uploads the approved photo, rescuers may see this photo on the user's website whenever a panic is triggered. [0176] In certain embodiments, when the user arrives at the “Pair with Bluetooth® accessories” more menu option, the user may be prompted to prepare all related Bluetooth® accessories for pairing. This may be done by placing the devices in pairing mode. Once the accessories are findable, the ULP smart phone application may locate and pair with the devices. Once the devices are paired for the first time, the smart phone may always recognize these accessories whenever the accessories enter the Bluetooth® range of the smart phone. For example, the range may be within 15-30 feet. [0177] The physical accessories which can be paired with the user's smartphone may include, but are not limited to: a main Bluetooth® panic trigger device 52 ; an ear-mounted video camera 54 with panic button; a pulse monitor bracelet with panic button; a brainwave monitor; a breathing monitor; a medicine distribution chamber; automatically activated electrical cardiac resuscitation pads; nano probe blood monitors; a wireless magnetic charging and blood probe interface pad; and a transdermal medicine distribution patch. [0178] The present invention may further include instruction. Below is an example of these brief instructions directing the user to experiment with the test panic function, and broadly explaining what ULP does, and how it works. It may provide the user with a basic overview of the system, and may contain key information needed to begin learning more about ULP, crucially without contacting the rescue center as the user experiments with the present invention. [0179] Detailed instructions via text, images and video which demonstrate the many ULP features and functions are offered. Users are provided with a web link which they can use to view the instructional videos, text and images on their desktop and laptop/tablet computers, for easier viewing. Within the instructions, an invitation is offered for users to join a blog where different users can communicate with each other, answer questions, and maintain a ULP community. A ULP webmaster may monitor the communications and provide solutions and insights to the user members. Users may also be offered an email address where they can send their queries directly to Ultimate Life Protector, LLC, and also a phone number for verbal technical or other assistance. [0180] The mission statement and contact info for the ULP company may appear as an option within the more menu. Frequently asked questions are listed along with answers. A web link may be provided to the ULP sales and company website which is a completely different website from the rescue website. [0181] The following describes in detail the main physical panic trigger device of the present invention. In certain embodiments, the device may include a thumb sized, rechargeable, portable panic trigger device. This device may be designed to be the “flagship” panic trigger device for most users to use as their primary panic trigger button with ULP. The device as illustrated in FIG. 22 , may be designed to be highly portable. In certain embodiments, the device may be around 2.75 inches in length or smaller, and may roughly resemble the size of a standard human thumb. As shown in FIG. 22 , a small LED 66 may be present in the center of the panic trigger device 68 . When the battery needs recharging, in addition to other actions described below, the LED may blink with a red light continuously until the user recharges the device. When the user successfully pairs the panic trigger device with their smart phone, the LED 66 may flash with a green light for several seconds. The panic trigger 52 is illustrated in FIG. 22 . This panic trigger or button may be the only button on the front of the device, so the user may never be confused as to which button to double-press during an emergency. [0182] The device may contain several physical elements with which the user can attach the device to their person. As illustrated in FIG. 23 , a metal clip 74 is attached to the rear of the device, allowing the user to clip it to their belt, pocket, waistband, shirtsleeve, pocketbook strap, backpack strap, or anywhere else a clip can be attached. A tightly wound spring 70 may reside at the top of the clip, exerting constant pressure to close (or seal) the clip. A snap button 76 , 78 may be present at the bottom of the clip 74 . For example, the button 76 , 78 may include a male snap button 76 , and a female snap button 78 , which may abut the electronic trigger device. The user may insert thin clothing in between the button snaps, and then snap the button closed over the users clothing. This firmly attaches the device to the user's clothing. A user may snap the button closed at the wrist area of their shirtsleeve, for instance, and the device may remain securely in place, and always readily available to trigger a panic. Another option is for users to insert a pocketbook or purse strap in-between the dip and close the button snaps. The device may be firmly attached to the pocketbook strap, backpack strap, or other object which the user always tends to have with them at most times. [0183] If the clothing material is too thick to enable the button snaps 76 , 78 to dose, for instance if dipped to the waist of a users denim jeans, the device remains relatively firmly in place because the dip 70 may have a tightly wound spring that may exert constant pressure to dose the dip. [0184] As illustrated in FIG. 23 , the metal clip 70 may also contain an opening 72 which the user can attach to their keychain. [0185] As illustrated in FIG. 24 , a female USB port 80 may be present at the bottom of the device. This port 80 may be used to recharge the device by connecting it to a computer or other USB charging station with a standard male-to-male USB cable as illustrated in FIG. 25 . In addition to recharging the battery, this USB port can also be used to upgrade the firmware of the device if and when company officials create and distribute improvements to the firmware to the users. [0186] The user may pair the device with their smart phone once, and after this precedent, the smart phone and designated trigger device may permanently recognize each other when the smart phone enters the range of the Bluetooth® signal, enabling the smart phone to rapidly receive and act upon panic signals sent to it by the panic trigger device. [0187] To trigger a panic with the physical button of the present invention, the user may double-press the panic button 52 . It may not be necessary to power the device on first, before pressing the panic button. This and other power related details are explained below. When the button is double-clicked, a panic signal may be sent to the pre-paired smart phone. Double-press (aka double-dick) may be used to prevent most accidental panic triggers. If the user sits on the button, for instance, a panic is not be triggered. Once the panic signal is successfully received by the smart phone, the Bluetooth® device 68 may vibrate. This vibration may serve as confirmation that the panic has been successfully triggered. With this feature, the user can be discreetly reassured that professional rescuers are on the way, without alerting a potential attacker. [0188] The panic button 52 on the device may be designed to be felt with the user's fingers, without looking at the button. In other words, the device can be attached to the user's belt or outer pocket, and the user can feel the button 52 without looking at it, because it may protrude and may be tactile and sharp edged for the user's finger, so they can locate it, feel it, and double press it to trigger a panic discreetly, without the user needing to turn their head to look at the button, so it can be pressed discreetly, without a potential attacker noticing. When the user double-presses the button 52 the button may click in a tactile, noticeable way. In other words, when the user presses the button, a physical click is felt by the user's fingers, so they can be aware that the button has been successfully pressed. [0189] In certain embodiments, the panic trigger device 68 of the present invention may be designed to be smaller than a standard adult thumb size. The size listed may enable it to conveniently attach to any desired part of the user's clothing, for instance the wrist area of a shirtsleeve, for easy and constant access to the device in case of emergency. [0190] The trigger device of the present invention may only be used to trigger the panic from the application on the smart phone. An additional advantage to housing the aforementioned features on the phone rather than on the trigger device is so, if a potential attacker notices the trigger device, they can seize it and destroy it, but this does not interfere with the rescue, because the location, audio and other data continue to stream from the user's smart phone, which may remain hidden in their pocket or purse during the entire crisis. It may not be necessary a user to physically interact with the user's smart phone during any portion of the crisis event, in order to trigger a panic which includes all the features described above. In short, attackers may be most likely to notice and destroy or throw away the trigger device because that is the device the user is using/interacting with, but after the panic has been triggered, there is no longer any need to posses the trigger device for the rest of the rescue. An attacker can throw away or destroy the trigger device, while the users smart phone may continue to silently gather and transmit all data needed to rescue the user. [0191] This panic trigger device of the present invention as illustrated in FIG. 22 may be designed to permanently remain in a deep hibernation, regarding the power. Therefore the device may never power off and may be always powered on, at an extremely low level of power usage, only using the power needed to maintain a running internal clock. When the user double clicks the panic trigger button 52 , the following sequential events, as an example, may begin: [0192] A) The device fully powers on. [0193] B) The device sends a panic signal to the pre-paired smart phone via Bluetooth®. [0194] C) The device vibrates when it receives confirmation from the smart phone that the signal has been successfully received. This vibration informs the user that the panic has been successfully triggered. [0195] D) The device reenters deep power hibernation. [0196] In certain embodiments, every 2 weeks, the device may be scheduled to automatically power itself fully on, to run a self-diagnostic process to assess the current state of the power supply. In certain embodiments, if the diagnostic process determines that the battery contains more than ⅓ rd remaining battery power, the button may reenter deep power hibernation. In such embodiments, if the button contains less than ⅓ rd remaining battery power, the device may not reenter power hibernation, and the LED light at the top of the device may constantly blink brightly with a red color, to notify the user that the battery is running low, and the device must be recharged. [0197] In certain embodiments, if the diagnostic test reveals that the battery has reached less than ⅓ rd remaining power, the panic button device may send a signal to the user's smart phone, instructing the smart phone to send an email and SMS to the user, reminding the user that it is time to recharge their panic button device or to add a new battery. After the panic button has been fully charged, a different SMS and email message is sent to the user, notifying them that the device is now fully charged. This deep power hibernation solution may enable the device to function without recharging for several months, which may enable the user to attach the device to an item which is with them at all times for several months. In short, the user's ability to instantly and discreetly summon assistance can be constantly available to a user, without the user having a requirement to interact with the system for several months. As mentioned above, since the user is automatically reminded when the device must be charged, the user may be free to ignore the existence of the device until it is needed, because the automatic reminders may help ensure that the device always contains adequate power with minimal user thought or intervention. [0198] In certain embodiments, the present invention may include a scalable server. A web server may be commissioned and configured to facilitate data exchange between the user, loved ones, the 24/7/365 rescue center and a dedicated mobile/desktop website. The server capacity may be predetermined to be instantly and automatically expandable, so that a sudden increase in usage causes an automatic transfer of the necessary resources to increase server capacity sufficient to serve the increased demand. [0199] In certain embodiments, a dedicated mobile and desktop website may serve as the central data clearinghouse, where all data useful in facilitating the user's rescue may be available to rescuers and loved ones. When the user triggers any panic, the registered loved ones and the 24/7/365 rescue center may receive an SMS and email nearly instantly, indicating that the user is in grave danger. [0200] Inside the SMS and email, the individual user's own unique clickable web link may be automatically provided. As illustrated at the top of FIG. 26 , the user's unique web link may bring them to the rescue website. An example of the format of the web link may include: “www.LocateLovedOne.com/[UNIQUE USER NAME]”. Those who receive the message with the embedded clickable web link may simply call either 911, or may also call the nearest governmental rescue precinct to the user if the user is in an area where the worldwide local database of governmental rescuers provides for the user's particular location, to instruct them to visit the user's website. In other words, the ULP database of local governmental rescue precincts, such as police and ambulance services, can provide the panic-message-recipient with the nearest police and ambulance contact info 104 to the user's current location, as illustrated in FIG. 26 . [0201] In certain embodiments, if the panic message recipient lacks access to the internet, the message recipient/rescuer can simply call 911, and instruct 911 to view the users unique web address because the user faces potential danger. Emergency contacts may explain to the 911 operator that all ULP users understand that triggering a panic is an indication that they face danger, and that they need to be rescued. [0202] Once professional rescuers have been rapidly notified of the crisis, and are given the user's unique web link, with their own smart phones and desktop or tablet computers, the rescuers may be instantly armed with the following array of data points and resources which can be used to rapidly facilitate the user's rescue from any number of dangerous crises: user's current location; a local emergency dispatch database; user's location history; user's previous route path; audio; directions to the user; photo/video from the scene; ear-mounted audio/video camera; photo of the user; emergency contact info; instant text chat amongst rescuers and/or users, instant verbal and video communications amongst rescuers and/or users; user medical info; panic status; user's home address; pulse monitor; brainwave monitor; breathing monitor; nano-blood probes; medicine distribution patches; electrical cardiac resuscitation pads; and the like. [0203] As illustrated in FIG. 26 , the user's location 24 may appear in the center of the desktop website as a brightly colored icon labeled “help me” which may appear in the center of the map. The mobile website with the same information is shown in FIG. 27 . Every few seconds, when the user's location is updated, the help me icon may move to the user's updated position. In certain embodiments, if the rescuer accidentally scrolls away from the help me icon on the map and loses track of the icon, the user may select user's current location button 82 , 108 on the desktop website, as illustrated in FIG. 26 and on the mobile website, as shown in FIG. 27 , after selecting the press for menu items button at the top of the mobile screen, the mobile website menu items 132 may be shown, as illustrated in FIG. 28 . [0204] When the user's current location button is selected, the HELP ME icon may center on the map. The local emergency dispatch database may include the following. A comprehensive database may be used which contains contact info for all local, professional, governmental emergency dispatchers, which data are stored on the dedicated server, for all localities worldwide. After the user's location has been determined during a panic, the nearest governmental rescue precinct contact info 104 may be gathered from the server, and the phone number for that local precinct may be displayed on the website, at the top of the map, as illustrated in FIG. 26 . Loved ones and the 24/7 ULP Rescue Center may immediately contact the local governmental rescue dispatcher nearest to the user, when they arrive at the website, after the panic has been triggered. [0205] In certain embodiments, when rescuers select the user location history button 84 , 130 on the mobile and desktop websites, as illustrated in FIG. 26 , and FIG. 28 , a screen may appear which shows the user's previous locations, in increments of several seconds. An approximate street address and the latitude/longitude coordinates for the user's location may be shown with each data ping, as illustrated in FIG. 29 . The user may be able to adjust the frequency of the sending of the location pings within the application preferences. A higher frequency of pings per minute may improve the rescuer's awareness of the user's location, but it may also use additional battery power. The default setting may be for the pings to be sent in 30 second increments. [0206] Using the present invention, rescuers may be able to see colored lines on the map which represent the user's past movements, beginning when the panic was first triggered. On the mobile website, as shown in FIG. 28 , the user selects view route path button 128 from the menu items, and the colored lines may appear on the map. On the desktop website, the colored lines representing the user's previous movements may appear on the map automatically. These colored lines may be easily seen on the website. [0207] When any panic is triggered, audio may be recorded live from the user's smart phone, and the audio signal may be streamed to the website. Each separate audio recording may be listed with the time and date of the audio recording. Rescuers may listen in near real-time to audio from the scene of the crisis, by selecting the audio from the scene button 86 , 126 on the desktop website, as illustrated in FIG. 26 and FIG. 28 . When the rescuer selects the audio from the websites, they may view all listed audio files with the time and date shown. When the rescuer selects any of the displayed audio files on the mobile and desktop websites, the audio player appears as illustrated in FIG. 30 . The audio counter on the audio player may appear as a clock. This may enable listeners to note the time of day when each moment of the audio recording took place, which can provide data to investigators, both during and after the crisis. When the rescuer rewinds the recording, the clock may also rewind, showing the time when that portion of audio took place. Rescuers may be able to listen to the near-live audio as it continues to stream, and may also be able to rewind to earlier portions of the recording, as new audio continues to record and transmit. The rescuer may return to the most recent, near-live audio by forwarding to the end of the available recording. From there, near-live audio continuously streams as long as the panic remains active, onto the rescuers mobile smart phone, tablet, desktop, laptop or any other internet-enabled computer. [0208] Rescuers and emergency contacts may be instantly given directions to the user's location. Rescuers may select/press the help me icon 24 on the map as illustrated in FIG. 26 . A blank address-field may appear after the help me icon 24 is pressed, as illustrated in FIG. 31 . The rescuer may enter their own current address, and the user may be provided with turn-by-turn directions to the user's current location, as illustrated in FIG. 32 . Colored lines on the map may represent the suggested route to the user. These colored lines may be easily seen on the website, but impossible to see in the submitted black & white drawings and screenshots. [0209] In certain embodiments, when the panic is first triggered, the user's smartphone may take a photo and send it to the website. If the user possesses the optional ear mounted video accessory, rescuers can view near real-time video from the user's vantage point. The video signal may be transmitted from the ear-mounted device via Bluetooth® to the user's smart phone, and the smart phone may stream the video data to the mobile and desktop websites. When the rescuer selects the photo/video from scene button 124 on the mobile and/or desktop websites, if video and/or photos are available, they may be displayed as thumbnails, as illustrated in FIG. 33 . When the rescuer selects one of the available video thumbnails on either website, the video player screen appears, as illustrated in FIG. 34 . On the desktop website, if the user has streamed video in a panic, the streaming video 98 may automatically appear on the website, as illustrated in FIG. 26 . [0210] If the user possesses the designated ear-mounted audio/video accessory, rescuers may be able to view near real-time video, from the user's precise vantage point. This may be achieved by providing a small, ear-mounted video accessory. In certain embodiments, the camera lens may be roughly the width of a paper dip, and may be designed to jut out in front of the user's ear, pointing forward. The device may snugly adhere to the wearer's ear. The camera angle may provide rescuers with video from the user's vantage point, which may greatly enhance the rescuer's understanding of the user's predicament. In addition to the audio and video, the ear-mounted device may also serve as an additional panic button. In certain embodiments, a panic trigger button may be available on the side of the device. The user may double-press the button for a panic signal to be transmitted to the user's smart phone via Bluetooth®. When the panic has been successfully triggered, the ear-mounted device may vibrate, to give the user confirmation that the panic was successfully triggered. [0211] In certain embodiments, the professional rescuers may be provided with a photo of the user on the website, which may enable them to identify the user during the rescue. As mentioned in the signup section, the user may be prompted to take a picture of themselves as they set up their profile. To view the user's photo, rescuers may select “Photo Of User” from the menu items on the mobile website. The user photo may appear automatically at the top of the desktop website. Underneath the photo, the time and date when the photo was taken may be listed. [0212] When rescuers select “Emergency Contact Info” on the mobile or desktop website, rescuers and loved ones may see the email addresses and cell phone numbers of all designated emergency contacts, the nearest police/ambulance and rescue center. When the rescuer taps on any phone number on their smart phones, the rescuer may be presented with the option to chat via text and or video, send an SMS or place a phone call to that person. If the rescuer selects SMS, they may be instantly transported to an outgoing SMS screen with the emergency contacts phone number automatically entered. If the rescuer selects phone call, the standard phone call screen may appear, and a call may be automatically placed to that contact. [0213] After receiving the SMS and email panic message, all emergency contacts and professional rescuers may instantly communicate with each other in the designated text area on the home screen of the website, to share vital information about the user's predicament and previous plans. On the mobile and desktop websites, rescuers may simply enter their name in the chat field and then select a start button 106 , as illustrated in FIG. 26 . After selecting the start button 106 , a standard chat window may appear. Various family, friends and professional rescuers may instantly share key information to help with the rescue. The emergency contacts may enter text at the bottom of the window, and after completing the message, they submit the text, and the message may be sent to the upper chat window, as is the standard format for instant messaging. [0214] In certain embodiments, the user may able to initiate an audio conference call between themselves and the various rescuers. In addition to the user's capability to initiate an audio or video conference call with rescuers, the rescuers may also possess the capability to initiate audio or video conference calls without the user's participation, via the mobile and desktop websites. On the emergency contact info screen, as with the user's application, rescuers may select a listed emergency contact and then press an add to call button. If the rescuer's laptop or other computer is fitted with a microphone, video camera and speakers, they may orally and/or visually converse with several fellow rescuers at once. As with the user application, on the website, rescuers can incrementally reduce the bit rate of the phone communication, if this becomes necessary for any reason. [0215] In certain embodiments, on the mobile and desktop websites, rescuers and loved ones may be able to see medical information relating to the user, such as blood type, ailments, known allergies, and the like, by selecting the medical info button from the menu items screen. After selecting medical info, a separate window may open which contains all medical information which the user previously entered via the smart phone application. As mentioned above, users may be instructed to enter relevant medical information when they first sign up for application of the present invention, and the users may also update the text for this screen in the preferences section of the application. [0216] As illustrated in FIG. 26 , at the top of the website in an informational display box 96 , the type of panic may be displayed (Silent, Loud or Medical Panic) the time the panic was triggered may be displayed, and it may be displayed whether or not the panic is currently active or inactive. It may also be displayed if the user sent a “false alarm message”, indicating that they accidentally triggered a panic. It may also be displayed if the user entered a “designated false password”, intended to mislead an attacker into believing that the user has canceled the panic. [0217] As mentioned above, when the user has launched an I am safe signal, the following may be displayed in the panic status section of the website: “I AM OK. at 7:36 AM, on Feb. 15, 2013”. Call to confirm if you wish.” [0218] The informational display box 96 may be shown in the same area as all panic status updates, in FIG. 26 . When the user selects the I am safe option or false alarm message option, the user's phone ringer may automatically increase to the maximum volume, to enable the user to hear phone calls from rescuers who will likely wish to call the user to confirm that the user is indeed safe. [0219] In certain embodiments, further information may be displayed on the website. For example, the user's home address may be listed at the top of the desktop website, in addition to the user's cell phone number. On the mobile website, rescuers can find the user's home address by selecting the address of user button 114 as illustrated in FIG. 28 . [0000] If the user has the optional pulse monitor, rescuers may be able to see the real time heart rate of the user in the medical info section of the website. When the user's pulse exits the safe range, a medical panic may be automatically triggered and the website may flash red, indicating that the user's pulse has reached a dangerous level. This may be displayed on the front page in the panic status section of the website, regardless of whether the rescuer has navigated to the medical info section of the website. Therefore, when the user's pulse reaches a dangerous level, the user's pulse status may be forced to the front of the website to instantly notify all rescuers of the user's current pulse status. [0220] If the user has the designated brain wave monitor, rescuers may be able to see if the user is having a seizure, a stroke, or many other brain conditions. The brainwave monitor may automatically send the user's current brain status to the website, so rescuers can understand the nature of the user's brain related issue. In addition to the visual brainwave monitor, a basic text description of the user's brain-related condition may be shown next to the brainwave monitor. As with the pulse monitor described above, if the user is experiencing a brain related crisis, a medical panic may be automatically triggered, and this issue may be displayed in the panic status section of the website, and the applicable visual monitor may be automatically pushed to the front page of the website, regardless of whether or not the site viewer selects medical info. [0221] If the user is wearing the optional breathing monitor, rescuers may be able to determine whether or not the user is breathing, in the medical info section of the website. If there is an indication that the user has stopped breathing, or is not breathing within a safe range, a medical panic may be triggered and the user's breathing status may be pushed to the front of the website. [0222] If the user has injected the designated nano blood probes, the rescuers may determine whether or not the user's vital blood levels are normal, including whether or not the user's blood reveals the need for a new dose of essential medication. This information may be shown on the website in the medical info section, and if the situation becomes urgent, the front of the website may be notified with the current urgent status. The multiple blood probe monitors, which may be roughly the size of red blood cells, may continue to travel throughout the user's blood stream until they are removed with a doctor's assistance. The blood probes and other optional accessories are detailed below. [0223] If the user is in need of a new dose of essential medication, and the user is wearing the designated transdermal medicine distribution patch, the users who have been instructed by their doctors to receive regular doses of prescribed medicine may be able to program the patch to release a predetermined dosage at predetermined time intervals. The user may also be able to receive medicine if the blood probe determines that a new dose is unexpectedly needed, and the blood probe communicates with the medicine patch, instructing it to release the correct dose of medicine to the user, which is distributed through the user's skin. The website may inform rescuers of the user's situation regarding their medicine in the panic status section of the website and also in the medical info section on the website. [0224] In certain embodiments, a medicine dispersal and containment chamber may be surgically implanted in the user. When the blood probe determines that the user urgently requires large doses of the medicine in question, (such as the commonly large doses needed for anti epileptic seizures) the medicine distribution chamber releases the designated amount of the drug. The chamber may be surgically positioned so that the refill entrance may be readily accessible beneath the skin. The doctor may inject the refill of the medicine directly through the users skin, into the distribution chamber. If, for instance, a user suffers from severe epileptic seizures, when the brainwave monitor determines that a seizure has begun, the brainwave monitor signals the ULP application, and from the smart phone, the application may direct the proper dose of medicine to be released from the implanted large dose medicine distribution chamber. When the chamber releases the medicine, the user's medicine status may be displayed in large type font at the top of the home screen of the website, informing all rescuers. Also, if the user's medicine status is in crisis, this info may be sent via SMS and email to all emergency contacts. [0225] In certain embodiments, two portable pads may adhere to the user's chest with an adhesive. The pads, which contain sensors and local CPU processing capabilities to receive and interpret the sensor readings, may be able to discern whether or not they are correctly fastened to the person's chest, and are also able to detect the user's heart rate at all times. When the heart stops beating, the sensors may recognize this, a medical panic may be automatically triggered, and the pads may administer the correct amount of electrical impulse to defibrillate the users heart. The process may automatically cease as soon as the sensors determine that a safe heart rate has been restored. The user's heart is monitored on the main home screen of the rescue website automatically as soon as the irregular heart-related issue is discovered by the heart sensor/pads. In addition to the visual heart monitor on the website, a basic text description of the user's medical issue may be shown on the front of the website, along with a visual monitor of the user's heart functions. All defibrillation activity may be listed in the panic status section of the website. [0226] In certain embodiments, trained personnel may be utilized and may be prepared to receive a panic signal via methods such as SMS or email from any user, at any hour, on any day, from the rescue center. These trained personnel may await the panic messages from multiple computer centers, located hundreds of miles apart throughout North America. This may be used for continuous service in case a severe local disaster strikes, potentially causing one particular rescue center to lose power. If power is lost in one or even several regional rescue centers, rescue service may not be disrupted because distantly located redundant centers seamlessly continue to provide service. In certain embodiments, the rescue personnel may be instructed to adhere to the following guidelines: [0227] A) When any panic message is received, rescuers first must click on the user's unique web link within the panic message, bringing them to the user's rescue website. [0228] B) Upon arriving at the website, rescuers should immediately begin listening to streaming audio from the scene, and if available, video and or photos. If it is impossible to discern any information useful in determining the severity of the user's situation, the rescuer should contact the nearest rescue precinct to the user, with the correct phone number for this precinct automatically provided on the header of the user's website. After the user's own location is determined, the nearest police and ambulance is displayed, with their contact info. [0229] C) The rescuer tells the local rescue dispatcher that the user is in potentially life threatening danger, and provides them with the user's unique location and information website, “http://www.LocateLovedOne.com/[UNIQUE USER NAME]”. The local professional rescue precinct is instructed to find and rescue the user immediately using the www.LocateLovedOne.com website. [0230] D) After notifying the local police precinct, designated rescuers remain available to communicate with the user's emergency contacts via multiple ways including the chat text, SMS, audio and/or video section on the home screen of the rescue website, described earlier. [0231] E) The rescue center maintains continuous communications with the public rescue dispatcher throughout the crisis and relays all status updates to the loved ones, emergency contacts, and campus security if applicable. [0232] F) In cases where the user is able to speak freely, under no duress, if the user wishes, they may be able to call the rescue center directly, and the rescue center may connect the user's phone call as with a conference call, as detailed above, so the user can simultaneously speak with the rescue center, the local 911 precinct, and possibly with the user's parent, guardian or other loved one if the user suggests it to the rescue center. If the user initially believes that it is safe to place a phone call to the rescue center and rescuers, but suddenly learns that it is not safe for this conference call to be audible, there is a large “MUTE” button on the user's screen during the call. When any participant selects mute, all audio from that participant's computer is silenced, and all other website attendees can see that this participant has silenced their audible audio. To be clear, if the user selects mute as described, audio from the user still continues to stream to the website where it is recorded for current and or later use. Therefore, when the user selects mute, they are silencing audible audio from being heard in their present location, on the user's own smart phone. When this mute mode is activated, as normal, sound from the user's position is discreetly transmitted to and recorded on the website for rescuers to examine in near-realtime, and also at a later time. [0233] G) If the rescue center receives a “False Alarm Message”, or if the user cancels the panic, the rescue center is directed to immediately call the user's cell phone, to confirm that the user is indeed safe. If the rescue center determines that the user is safe, all emergency contacts and 911 may be immediately notified by the rescue center. [0234] H) If the rescuer is able to reach the user via phone, the rescuer may ask the user to say their password. If the user says the correct password, the local public rescue precinct may be immediately notified that the user is now safe, and no longer in need of professional rescue services. [0235] I) If the user gives the designated “false” password, the rescuer notifies the public rescue precinct that the user is attempting to deceive an attacker, by pretending to cancel a panic, but in reality, the user has purposely given the designated false password, indicating that the user is under duress and is falsely attempting to convince an attacker that the user is canceling the panic mode. In reality, the rescuers continue to search for and rescue the user. Therefore, if the user enters a wrong password, the panic is not canceled, and the user is prompted to enter the correct password. Only when the user enters the designated false password do the actions described above take place. [0236] In certain embodiments, the present invention may include the flexible bracelet mentioned above. This flexible bracelet device may contain sensors which constantly monitor the user's pulse. If the user's pulse stops or becomes dangerously irregular, the bracelet sends a signal via Bluetooth® to trigger a medical panic on the user's phone. From the website, the rescuers may be able to view the user's pulse via a visual pulse monitor, which appears on the front of the website if the user's pulse enters a dangerous range. If the user's pulse is within a normal range, but the user suddenly finds themselves in a dangerous crisis, they can simply double-press the small panic trigger button which may be present on the pulse monitor, to trigger a panic. In addition to sensors which detect the user's pulse rate, the pulse monitor sensors also may be able to detect whether or not the monitor is being worn correctly by the user. In other words, if the user removes the pulse monitor from their wrist, no medical panic is triggered, because the device may detect that it is no longer correctly positioned on the user's wrist. [0237] In certain embodiments, the present invention may include a flexible hat containing electrodes which constantly monitor the user's brain activity. If the user has frequent seizures, for instance, when the user begins to have a seizure, the brainwave monitor may send a signal via Bluetooth® to the user's smart phone to trigger medical panic, and to display the user's real time brainwaves for medical personnel to study, to better understand the nature of the brain-related crisis. On the main screen of the website, in large red letters, it may be displayed that the user is currently having a seizure. The brainwave monitor may detect all brain-related crises such as stroke, blunt impact or seizure, and automatically triggers medical panic. Medical professionals may view the user's brain waves to better understand the type and severity of the brain issue. The sensors on the brainwave monitor also may be able to detect whether or not the monitor is being worn correctly by the user. Therefore, if the user removes the brainwave monitor from their head, no medical panic may be triggered, because the device has determined that it is no longer correctly positioned on the user's head. If the user's brainwaves are safely within a normal range, but the user suddenly finds themselves in a dangerous crisis, they may double-press the small panic button which may reside on the side of the brainwave monitor hat, and a panic is triggered. Therefore, as with other optional accessories, an alternate panic trigger device may be contained on this accessory. [0238] In certain embodiments, the present invention may include a breathing monitor as mentioned above. The breathing monitor may rest in the user's shirt pocket and remain in place with a sturdy metal clip. If the user stops moving/breathing, the device may send a medical panic signal to the user's smart phone. The user's breathing status may be shown on the front of the website if the breathing is dangerously abnormal or absent. The breathing monitor may contain sensors which are able to detect whether or not the monitor is correctly positioned on the user. If the user removes the breathing monitor, no panic may be triggered because the device may detect that it is not being worn. If the user is breathing normally, but they suddenly find themselves in a dangerous crisis, the user may double-press the small panic trigger button which resides on the breathing monitor and a panic is triggered. [0239] In certain embodiments, multiple nano blood probes may be surgically implanted into the user's bloodstream. When, for instance, the blood probes sense that the user is in need of large doses of a certain medicine, (such as anti-convulsant medicine to treat a seizure) the surgically implanted medicine distribution chamber may release the drug, using a similar mechanical procedure as the transdermal medicine distribution patch. Namely, the medicine reservoir remains sealed within the chamber until the robotic levers release the medicine directly into the user's bloodstream when it receives this instruction from the blood probes, brainwave monitor, other related health accessory, or at a predetermined time. If a doctor wishes to schedule a time for the medicine to be released, the user and/or doctor may interface with the device and program the desired instructions. The chamber may be surgically positioned so that the refill entrance may be readily accessible near the surface of the user's skin. The doctor may inject the refill of the drug directly through the user's skin, into the distribution chambers. There may be multiple, separate chambers designed to house different medicines, all separate from each other, and all sealed off from the user's bloodstream until the user needs them. The material surrounding the reservoir responds to the injection by forming a seal over the newly punctured hole. This is done to prevent medicine from seeping into the user's blood stream until it is desired. Therefore, after an injection is carried out, the puncture caused by the injection may be automatically re-sealed, to prevent any medicine from escaping the medicine reservoir until the chamber receives the command from the user and/or doctor. [0240] For example, if the user in question is allergic to bee stings, when the blood probe determines that the user has been stung by a bee, the probe signals the ULP application, and from the smart phone, the application directs the proper dose of epinephrine to be released from the implanted medicine chamber. The chamber may include several sub-chambers, which can each contain different medicines to be released on different schedules. For instance, one chamber may contain epinephrine, and 4 chambers may contain insulin. Regarding the power for the device, as with the blood probes, the medicine chamber may be recharged with a wireless platform. When the battery runs low on the chamber, the chamber sends a signal to the user's phone, directing the user to self-send an SMS and email, informing the user and/or doctor that it is necessary to recharge the medicine chamber. The user may hold the charging platform near the location of the implanted device, and when the charge is complete, the chamber may instruct the user's phone to send the user an SMS and email on their smart phone, notifying the user that the charge is complete. When the blood probes or other devices direct the chamber to release the medicine, the user's medicine status may be displayed on the home screen of the website, informing all rescuers. [0241] In certain embodiments, the present invention may include automatically enabled cardiac defibrillation pads. The two portable pads may stick to the user's chest with an adhesive. The pads, which contain sensitive sensors and local CPU processing capabilities to receive and interpret the sensor readings, may be able to sense whether or not they are correctly fastened to the person's chest, and also able to detect the user's heart rate. When the heart stops beating, the sensors detect this, and the pads administer the correct amount of electrical impulse to defibrillate the user's heart. The process may automatically cease as soon as the sensors determine that a safe heart rate has been restored. A medical panic may be triggered and all heart information may be pushed to the front of the rescue website. The pads may be recharged with the wireless charging pad. [0242] The ULP nano-blood-probes, as mentioned above, may circulate through the user's body continuously until removed. The probes may be roughly 5 micrometers in length, slightly smaller than standard red blood cells. The devices may be constructed with carbon atoms in a diamond pattern to maximize their strength. They may contain CPU, robotic arms capable of grasping and analyzing various cells and other objects; with sensors capable of detecting the presence and concentration of any physical substance. The probes may be able to seek out and destroy certain designated cells with a robotic drill and vise, such as designated cancer cells or designated bacteria, as directed by the user and their authorized medical advisors. In addition to recharging the battery via the magnetic charging pad, the blood probes may have the ability to harness energy present in glucose in the user's bloodstream. The probes may be able to replenish their batteries by converting the glucose into usable electricity. [0243] After injecting the blood probes, the user's blood levels may be constantly monitored by the probes to ensure that proper levels of all substances are within healthy ranges. If, for instance, the user requires a steady dose of medicine to prevent the onset of psychotic symptoms if the user suffers from severe Schizophrenia, when the blood probes detect that the user's blood is running low on the medicine in question, the probes may send a signal to the user's phone, which then signals the user's medicine distribution patch, or the implanted large dose medicine distribution chamber, to release the appropriate dose of medicine to the user. The blood probes may link with the surgically implanted large dose medicine distribution chamber to release larger doses of medicine than the transdermal medicine distribution patch can contain and administer. The large dose chamber can also slowly release medicine as is necessary to maintain symptom relief for a user with Schizophrenia, for instance, requiring fewer refills than the transdermal medicine patches. [0244] The blood probes may constantly monitor all key blood levels, and if a crisis is detected because, for instance, the user's oxygen or insulin levels are dangerously low, the probes may send a signal to the user's phone, which then triggers a medical panic, notifying all emergency contacts that the user is having a medical crisis. The specific, known details of the crisis as determined by the probes may be sent to the website for rescuers to understand the nature of the emergency. In certain embodiments users and doctors can interface with and recharge the blood probes by using the wireless charging and interface device in addition to the conversion of blood glucose mentioned above. [0245] To charge the battery inside the wireless charging pad, it can be plugged into a wall outlet. Once the charging pad's battery is full, the user may bring the charging pad with them, in a mobile fashion, enabling the user to recharge and/or interface with their blood probes and other accessories while they are away from stationary power. It is also possible to use the charger/interface pad if the battery is depleted, while the pad is plugged into the wall outlet. [0246] The blood probes may be magnetized to the opposite polarity of the charging/interface pad, hence, when the probes arrive at the user's arm during normal blood circulation, and the user's arm is resting on the charging and interface pad, the probes remain stationary when they reach the magnetic field from the charging interface pad. While the probes remain suspended in the magnetic field, the probes are recharged, and the probes may also be reprogrammed with new tasks by the user and their doctor. [0247] The charging and interface pad may link via WIFI to a computer terminal through a secure web portal, with which the user and doctor may be able to transmit new instructions to the probes, as the batteries are being recharged. When the power has been fully restored, the probe may send a signal to the user's phone via the charging pad. When the user's phone receives this signal, an SMS may be sent to the user's phone along with the designated medical contact, to notify them that the probes have been successfully recharged, and when applicable, when the probes have successfully received their new instructions. [0248] With the transdermal medicine distribution patches, users who have been instructed by their doctors to receive regular doses of prescribed medicine may be able to program the patches to release a predetermined dosage at predetermined time intervals. The patches may be attached to the user's skin via an adhesive 138 , and once correctly attached, the patches may remain in place, even if the user enters water. As illustrated in FIG. 37 , before the patch has been instructed to distribute the medicine, the medicine shield 140 may block the medicine reservoir 142 , from contacting the skin. As illustrated in FIG. 38 , when the user and their doctor instruct the medicine shield 146 to move to the side on the motorized levers, the medicine reservoir 142 may be directly exposed to the user's skin 144 where the medicine is absorbed into the skin at the predetermined dosage. After the desired amount of medicine has been dispersed, the motorized levers may re-seal the medicine shield 140 blocking further absorption. For example, with a Schizophrenic patient whose doctor prescribes a steady dosage of a medicine, the medicine distribution patch automatically withholds and releases medicine transdermally, according to the instructions entered by the doctor. [0249] The user, while consulting with his doctor, may be able to issue instructions for the transdermal medicine distribution patch through the user's individual web page such as, (www.LocateLovedOne.com/[UNIQUE USER NAME]). The following may include example instructions on how to use the patch: [0250] A) The user and doctor, or anyone who wishes to modify the medicine distribution settings, may prove that they are authorized to modify these settings, by subjecting them to multiple layers of password security. [0251] B) After the correct passwords have been entered, the user and doctor may determine the dosages to be released at appropriate time intervals, or to instantly release upon onset of designated symptoms. [0252] C) The doctor fills the drug reservoir for each patch. Users may utilize up to around twelve patches if there is enough skin available for patches without excessive amounts of body hair. The drug reservoirs can be refilled while they are still adhered to the user's skin, and can also be refilled before the user attaches the patches. [0253] D) Users can recharge the batteries in the patches without removing them from their skin, by holding the wireless charging pad next to each patch, until the patch sends an SMS to the user's phone, notifying them that the devices have been fully charged. [0254] E) The patches may be designed so that the medicine is kept in a separate compartment from the user's skin until it is needed. Therefore, the medicine may not make contact with the user's skin until the user has decided for their skin to make contact, and programmed the device to release the medicine at the desired times via the user's unique web page, such as (www.LocateLovedOne.com/[UNIQUE USER NAME]) [0255] When the patches receive an instruction to administer the medicine, a thin barrier slides to the side, enabling the drug reservoir to make contact with the user's skin. Multiple compartments may be available with separate sliding barriers, so the medicine can be deliberately administered in a staggered fashion, at whichever schedule the user and doctor have chosen through the web portal above. In certain embodiments, the patches may interface with the ULP application, website, emergency contacts and the rescue center. For example, the patches may do the following: [0256] A) When all doses are administered, the patches may send a signal to the user's cell phone, and the ULP application may notify emergency contacts, the website and the rescue center that the medicine has been successfully administered. [0257] B) After any dose is administered, the current remaining amount of medicine in the drug reservoirs may also be transmitted to the website. When the sensors in the drug reservoirs determine that a refill is urgently necessary, the patches trigger a medical panic, alerting all emergency contacts and the rescue center of the situation regarding the medicine. [0258] C) If the patch malfunctions and does not successfully administer the medicine, a medical panic may be triggered and the malfunction may be described on the front of the website. [0259] In certain embodiments, when users and doctors instruct the blood probes to assess levels of an important substance, and that substance has fallen below safe levels, the blood probe may signal the ULP application which then may signal the medicine distribution skin patches to release the desired dosage of the medicine in question, directly through the user's skin via the skin patches. For example, the sequential actions may include the following: [0260] A) Blood probe determines that the user is in need of a dose of the medicine available in the skin patch. [0261] B) The blood probe notifies the ULP application. [0262] C) The user's smartphone signals the patches via Bluetooth®, instructing it to administer the correct dose of medicine. [0263] D) When the blood probes observe that the optimal levels of the drug have entered the blood stream, the patch sliding barrier closes, sealing off the drug from the users skin. [0264] The computer-based data processing system and method described above is for purposes of example only, and may be implemented in any type of computer system or programming or processing environment, or in a computer program, alone or in conjunction with hardware. The present invention may also be implemented in software stored on a computer-readable medium and executed as a computer program on a general purpose or special purpose computer. For clarity, only those aspects of the system germane to the invention are described, and product details well known in the art are omitted. For the same reason, the computer hardware is not described in further detail. It should thus be understood that the invention is not limited to any specific computer language, program, or computer. It is further contemplated that the present invention may be run on a stand-alone computer system, or may be run from a server computer system that can be accessed by a plurality of client computer systems interconnected over an intranet network, or that is accessible to clients over the Internet. In addition, many embodiments of the present invention have application to a wide range of industries. To the extent the present application discloses a system, the method implemented by that system, as well as software stored on a computer-readable medium and executed as a computer program to perform the method on a general purpose or special purpose computer, are within the scope of the present invention. Further, to the extent the present application discloses a method, a system of apparatuses configured to implement the method are within the scope of the present invention. [0265] It should be understood, of course, that the foregoing relates to exemplary embodiments of the invention and that modifications may be made without departing from the spirit and scope of the invention.

A method for disseminating information regarding a problem and administering medical interventions comprises providing a mobile device wirelessly connectable to a network, receiving and storing contact information corresponding to a designated list of information recipients, receiving, via the mobile device, a signal from a user indicating the problem, receiving, via the mobile device, information regarding the problem, transmitting an indication of the problem to a rescue clearinghouse via the network, prompting a participant of the rescue clearinghouse, different from the user, to make a decision about a course of action regarding the problem, and at least one of transmitting the information regarding the problem to the information recipients from the designated list and transmitting the information regarding the problem to a government rescue organization, based at least in part on the decision.

DESCRIPTION 1. Object of the Description The present invention refers to a machine for automatically squeezing citrus fruits, which has improved features with respect to those known and used for this same purpose in the present state of the art. 2. Background of the Invention In the market, citrus juice squeezers are known, which are generally made up of a set of structural components among which are the following: a squeezer support, provided with helicoidal grooves, which may be moved in opposing alternating gyratory movements corresponding to the fruit-squeezing and rind-expulsion operations; vertical blades situated upon the squeezer support, although separated from the latter, usually arranged in two orthogonal planes, which are trapeziform so that they may form in their upper part a housing to accommodate the fruit during the juice-extraction process; a pressure cup, whose inner shape fits into the outer shape of the said squeezer support, which may make alternate vertical movements (downwards and upwards), driven by two threaded shafts which gyrate synchronously to maintain the position of the central shaft in symmetry with the cup during the latter's vertical movement, and in which there are slots in positions which correspond with the said blades, for the insertion of the latter in the former during the descending movement of the cup, so that the fruit is pressed against the said blades, which cut it into segments, pressing the latter against the grooves of the squeezer support. The conventional type of machine mentioned above, has practical drawbacks manifested in certain structural and/or operating deficiencies, which the improvements incorporated in the citrus juice squeezer of the present invention are intended to resolve. SUMMARY OF THE INVENTION Therefore, as stated above, the object of the present invention consists of the provision of a citrus juice squeezer of automatic operation, provided with greatly improved features which allow the drawbacks observed in conventional automatic machines to be remedied. Thus, the first improvement provided by the invention consists of improving and simplifying the operational conditions of the pressure cup of known juice squeezers, to which end one of the two threaded shafts which drive the alternate upwards and downwards movements of the pressure cup, has been replaced by a guide cylinder, along which the part holding the pressure cup slides when it is made to move vertically by the gyration of the screw in which it is threaded. In this way the transmission required by the presence of two endless shafts, intended to make their gyrations synchronous, is eliminated. Consequently, in the juice squeezer of the invention, the vertical movement of the pressure cup (upwards and downwards) is produced by means of a drive screw and guide column mechanism which drives the vertical movement of the part holding the said cup, parallel to itself, for which purpose it is provided with two orifices, namely, a threaded one for the drive screw to engage with, and a smooth one for the guide column to pass through. Another improvement of the present invention affects the pressure cup, in such a way that, while in known juice squeezers the said pressure cup is fixed with its holding elements, without the possibility of disassembling it for ease of cleaning, in the machine of the invention this cup may be separated from its holding part, as its connection to the same is effected by means of a grooved area which rests upon an axis of the said part, remaining fastened with respect to its gyratory movement by means of a trip element which may optionally be unfixed by means of a pressure catch. Another improvement incorporated in the machine of the present invention consists of having a predetermined number of blades on the squeezer support which, in the preferred embodiment, are to be five in number, angularly equidistant with a separation of 72°, in comparison to the four blades incorporated by conventional machines and every two consecutive blades separated by an angle of 90°. The arrangement in accordance with the invention allows an appreciable improvement in the feeding of fruit to the receptacle formed by the blades in their upper part, as they gain access to the same through the aperture of separation between every two consecutive blades; in effect, while in the case of conventional machines, the angular separation being 90°, the fruits encounter another equal separation in front of the entrance, through which they may leave without being squeezed, in the case of the proposed angular separation of 72° the fruits encounter in front of their entrance the upper part of the blade which is situated as a prolongation of the ideal bisecting plane of the dihedron through which they pass, which acts as an end stop, preventing the fruit from coming out. This improvement is especially useful when squeezing fruit of small diameter, which, as one knows, are precisely those which are most commonly intended for juice extraction. Another additional improvement incorporated in the juice squeezer of the present invention is intended to improve the juice extraction process, so that the process will be gradual and prevent the segments cut by the blades from undergoing abrupt compression which would deform their rinds and give rise to the expulsion of essential oils and thus a loss of juice quality. To this end, a helicoidal spring arrangement has been provided on the fixed gyrating shaft of the squeezer-filter support unit, which allows the gradual descent of the same as the spring yields to the pressure of the cup upon the fruit and of the latter upon the squeezer support. At the same time, so as not to lose the dynamic connection with the drive shaft during the movement of the unit, this connection is maintained by means of a gearing situated in the lower part of the juice collector, which pulls the squeezer-filter support unit with it as it gyrates, while it slides along an intermediate sprocket between the said gearing and the drive shaft, while the transmission remains active. Another improvement incorporated in the machine of the invention relates to the storage and supply system of the extracted juice. The said juice is collected initially in the collector, after passing through the slightly concave filter situated in the base of the squeezer support and joined to the latter, and the said collector may optionally be emptied into a juice dish which, on being introduced into its housing under the collector, opens a tilting plug situated in the base of the same and closes it when extracted. Yet another improvement affects the blade retention system, in such a way that these remain fixed in their working position while the cup ascends after having pressed, cut and squeezed the fruit, and these blades may, however, be withdrawn optionally for cleaning when the squeezer support and the cup are in their raised rest positions. To this end, the central conico-cylindrical nucleus which is grouped radially around the blades, ends below in elastic legs which prolong the side surface of the cylindrical area of the said nucleus and possess at their free ends inner strengthenings which fit under pressure into a peripheral neck with which, for this purpose, the fixed shaft is provided, around which the extractor support gyrates, close to its upper end, which penetrates tightly into the lower cylindrical part of the nucleus. During the support's ascent and reverse gyration, while the rind is expelled, the support itself prevents the legs from disengaging as it holds them by virtue of the passing cylindrical penetration of the gyratory shaft, retaining the blades in their working position, without their being pulled along by the support's ascending movement. Finally, another improvement incorporated in the machine of the invention affects the inner arrangement of the pressure cup which, in known juice squeezers, fits into the outside of the squeezer support, coinciding with the latter with strictly sufficient play to contain the rind of the squeezed fruit between both parts. However, as a consequence of the homothetic design of the said surfaces (inside of the cup and outside of the support) and of the vertical movement of the cup parallel to the former, following the common axis of longitudinal symmetry, when the cup is superposed upon the squeezer support a narrowing is produced in the separation between the two parts which gives rise to a compression of the fruit's rind, with the resulting extraction of essential oils from the said rind which reduce the quality of the squeezed juice. The improvement of the present invention provides for the design of a new inner shape for the cup, with a greater radius of curvature in its lower area, so that a diminution in the separation of the cup and the squeezer support is not produced in any relative position of the former upon the latter. BRIEF DESCRIPTION OF THE DRAWINGS These and other features and advantages of the invention will be more clearly understood from the detailed description which follows of an example of an embodiment of the same, given solely by way of illustrative and non-restrictive example, with reference to the accompanying drawings, in which: FIG. 1 shows an overview, in longitudinal section, of the squeezer of the invention in its assembled state, ready for use; FIGS. 2, 3 and 4 show a side elevation and, in different phases, the process of extraction of the pressure cup with, respectively, the said cup in working position, with the trip unfastened, and with the cup already withdrawn, after separating the grooved area from its supporting axis; FIGS. 5 to 8 show, in longitudinal section, different relative positions of the blades and of the extractor support, corresponding respectively to the initial working position; starting position for manual extraction of the blades, with the end protuberances of the legs of its nucleus partially outside and above the neck of the shaft into which they fit; a more advanced phase of blade extraction, and blades fitted into the working position, retained by means of the squeezer support collar, while the said support has descended in a similar way to when it supports the pressure of the cup and the fruit; FIG. 9 shows a transverse section of the improved juice squeezer of the invention, showing the relative arrangement of the components for transmitting the gyratory movement; FIGS. 10 to 13 show different positions of the juice dish corresponding, respectively, to the conditions of initial introduction of the dish into its housing; opening of the tilting plug for emptying the juice collector by virtue of the progressive introduction of the said dish; the dish in its final position, with the resulting emptying of the juice collector, and the dish extraction phase with the juice inside, with the resulting operation of closing the tilting plug to prevent possible dripping; FIG. 14 is a perspective view of the juice squeezer of the invention in operating position, but without the juice dish for reasons of representational clarity; and FIGS. 15, 16 and 17 show three successive positions relating to the process of superposition of the pressure cup upon the extractor support, from which it may be perfectly appreciated that, by virtue of the new design of the inner shape of the said cup, at no time during the process is there a diminution of the separation between both the said parts. DESCRIPTION OF THE PREFERRED EMBODIMENT OF THE INVENTION To show clearly the nature and scope of the features of the improved automatic juice squeezer of the invention and the advantages of its application, the structure and operation of the said juice squeezer are described below, making reference to the drawings which, as they represent only an example of a preferred embodiment, are to be understood merely as illustrative, and should therefore be considered in their broadest sense and in no case as restricting the content and application of the invention. The automatic citrus juice squeezer which is the object of the invention is of the type which includes, as structural elements, a squeezer support ( 1 ) which may gyrate alternately in opposite directions; blades ( 2 ) in a vertical position, of an advantageous trapeziform shape, situated above the squeezer support ( 1 ), and independent from the latter; a pressure cup ( 3 ), capable of making alternate vertical movements, provided with slots ( 4 ) for the insertion of the blades ( 2 ) when it descends. By virtue of this arrangement, the improvements provided with respect to known juice squeezers of the type described above, are as follows: The vertical movement of the pressure cup ( 3 ) is produced by means of a drive screw ( 5 ) and guide column ( 6 ) mechanism which drives the movement of the part ( 7 ) holding the cup ( 3 ), parallel to itself, for which purpose it is provided with two orifices, a threaded one ( 8 ) into which the screw ( 5 ) threads, and a smooth one ( 9 ), through which the column ( 6 ) passes tightly, as may clearly be observed in FIG. 1 . The pressure cup ( 3 ) is held removably-mounted but is detachable, and is connected to its holding part ( 7 ) by means of a grooved area ( 10 ) which rests upon an axis ( 11 ) of the said part ( 7 ), remaining fixed in respect of its gyratory movement by means of a trip ( 12 ) which may optionally be unfastened by means of a pressure catch ( 13 ) (see FIGS. 2, 3 and 4 ). The improved juice squeezer of the invention has, preferably, five vertical blades ( 2 ), situated above the squeezer support ( 1 ), with equal angular separations as shown more clearly in FIG. 14 of the drawings. Also, a helicoidal spring ( 14 ) has been provided, arranged on the fixed gyrating shaft ( 15 ) of the unit made up of the squeezer support ( 1 ) and the filter ( 16 ), which allows this unit to descend gradually as the spring ( 14 ) is compressed under the pressure exerted by the cup ( 3 ) upon the fruit and upon the said squeezer support ( 1 ) (see FIG. 1 ). So as not to lose the dynamic connection of the unit with the drive shaft during its vertical movement, this connection is maintained by means of gearing ( 18 ) situated in the lower part of the juice collector ( 17 ), which pulls the squeezer-filter support unit with it as it gyrates, while it slides along an intermediate sprocket ( 19 ) between the said gearing ( 18 ) and the drive shaft, without the geared gyration of the transmission components stopping (see FIG. 1 ). The extracted juice is collected in the collector ( 17 ) after passing through the slightly concave filter ( 16 ) situated in the base of the squeezer support ( 1 ) and joined to the latter, and the collector ( 17 ) may optionally be emptied into a juice dish which, on being introduced empty into the housing provided for this purpose under the collector ( 17 ), operates a tilting plug ( 12 ) situated in the base of the housing, opening it with the movement of introduction and closing it with the movement of extraction of the dish full of juice (see FIGS. 10 to 13 ). The central conico-cylindrical nucleus ( 22 ) which is grouped radially around the blades ( 2 ) ends below in elastic legs ( 23 ) which prolong the side surface of the cylindrical part of the said nucleus ( 22 ) and possess at their free ends inner strengthenings ( 24 ) which fit under pressure into a peripheral neck ( 25 ) with which, for this purpose, the fixed shaft ( 15 ) is provided, close to its upper end, which penetrates tightly into the lower cylindrical part of the nucleus ( 22 ), as may be observed in FIGS. 5 to 8 . Finally, the inner shape of the pressure cup ( 3 ), has an enlarged curvature in its lower area, so that during the process of superposition of the said cup ( 3 ) upon the squeezer support ( 1 ) a diminution in their separation is not produced in any relative position of the former upon the latter (see FIGS. 15 to 17 ).

The improvements to the automatic citrus juice squeezer consist of: a movement of the pressure cup ( 3) by means of a drive screw ( 5) and a guide column ( 6); the cup being removably-mounted and detachable from its holder ( 7) by raising a trip fastener ( 12) using a catch ( 13); it has five angularly equidistant blades ( 2); a squeezer-filter ( 16) and support assembly ( 1) can descend against the action of an axial spring ( 14), maintaining the dynamic connection with the drive shaft by means of gears ( 18) that may slide along an intermediate sprocket ( 19); the juice collector ( 17) empties into a dish ( 20) which opens/closes a tilting plug ( 21) as it is introduced/extracted: the blades ( 2) are connected to the fixed shaft ( 15) by elastic legs ( 23) with internal strengtheners ( 24) which fit into a peripheral neck ( 25) of the said shaft; and the cup's ( 3) profile has an enlarged lower curvature to prevent its separation from the squeezer support ( 1) from narrowing.

FIELD OF THE INVENTION [0001] The present invention relates to maintaining plants in a healthy state when the plant is stored at a nursery, during transportation, maintenance at a retail outlet or nursery and/or subsequent transplantation. In particular, this invention relates to selectively providing nutrients subterraneously to the plant thereby promoting root growth. BACKGROUND OF THE INVENTION [0002] Growing, transporting, and transplanting plants has become a large industry. The suppliers and sellers of such plants to the consuming public need to provide plants that are healthy and once transplanted will grow to the satisfaction of the buyer. In order for this to be done, the plant must be maintained in a healthy environment during transportation, maintenance at a nursery or other retail establishment, and during transplantation. If the plant is not maintained in a healthy state, the buyer will be dissatisfied and may even ask for a refund or another new plant to replace the original plant purchased. It is important therefore to provide plants in the healthiest environment to the purchaser such that once the plant is transplanted, it grows to the satisfaction of the purchaser. [0003] Many plants are transplanted and transported by surrounding the roots of the plant with a fabric, such as burlap, to form a ball structure. The quality and preparation of the root ball may very well determine how well the plant survives during transportation and transplantation. A typical scenario in transplanting a plant with a root ball is to leave the plant to its own survival once the root ball is placed in the planting hole. At best fertilizer is thrown into the hole or after the root ball is covered with dirt applied to the surface of the soil. [0004] Hand sprinkling fertilizer or other plant nutrients into the planting hole results in a majority of the fertilizer and other nutrients falling to the bottom of the hole and therefore not being available to the root ball in a way that the root ball (plant roots) can uptake the fertilizer or other plant nutrients in an efficient manner. Throwing fertilizer onto the top surface of the soil may help a little more, but again, the fertilizer and/or other nutrients have to reach the roots efficiently for optimizing uptake by the plant. SUMMARY [0005] This disclosure describes a method of promoting plant and/or root growth of a plant to be transplanted. The method comprises encompassing the roots of the plant within a base sheet of material containing at least one selected area on the base sheet facing the roots, the at least one selected area on the sheet containing selected nutrients for promoting plant and/or root growth [0006] This disclosure also describes a device for containing plant roots and promoting plant and/or root growth. The device comprises a base sheet of material comprising at least one selected area on the base sheet facing the roots, the at least one selected area on the sheet comprising selected nutrients for promoting plant and/or root growth. [0007] This disclosure further describes a plant suitable for transportation and transplantation. The plant comprises a root ball, whose roots are contained within a flexible fabric in the general form of a ball, the fabric comprising at least one area facing the roots of the plant, the at least one area including selected nutrients for promoting root growth and/or plant growth. DETAILED DESCRIPTION [0008] Providing nutrients, air and water to newly planted, transplanted or transported plants is important for expecting a high survival rate as well as vigorous, uniform and sustained plant growth. Over the past decades, it has been clearly demonstrated that the total environment of the plant must be considered if these goals are to have a reasonable promise of attainment. [0009] This disclosure describes a system of controlled nutrient delivery for plants. The system provides a predetermined and carefully measured quantity of nutrient, biological, organic and inorganic components to all plants intended to be planted, transplanted, or transported including trees, shrubs, vegetables, fruits, and flowers. Placement and adhesion of essential organisms on to a substrate are described. The substrate is composed of biodegradable (preferably) mesh such as burlap fabric, which is then wrapped around the roots of a plant and earth to form a “root ball.” The system described herein will “complete” nursery grown plants by introducing beneficial mycorrhiza (fungi), beneficial bacteria and other beneficial organic and inorganic components to the roots, which will be activated at the time of planting to provide the plants with a full, functioning system. For purposes of this application, such beneficial mycorrhiza (fungi), beneficial bacteria and other beneficial organic and inorganic components may be referred to as “inoculants”. [0010] The system described in this disclosure presents the inoculants in a manner such that the nutrients are automatically delivered to the root system of the plant in an optimal manner. The system can also be used to create a “cocktail” of seed, fertilizer, inoculants, air entrainment and water storage materials which will “re-seed” open earth excavation while preventing soil erosion until the seeds germinate. [0011] Another feature of this disclosure is to allow for the uniform inoculation, and even distribution around the root ball of biological components and organic fertilizers, which include mycorrhiza fungi and beneficial bacteria (nutrients). Other ingredients may be added or ingredients removed to create plant specific formulations. These materials create an environment that permits the establishment of a symbiotic relationship between mycorrhiza fungi and plant roots and promote the ability of the soil organisms to convert organic and inorganic compounds into a self sustaining source of continued plant nutrients. The even distribution of the inoculants assures uniform growth and a sustainable food supply. [0012] The need to further nurture plants by modifying the soil itself is vital and best served by introducing “inoculants” of soil bacteria, fungi and other compounds, which are essential to the establishment of healthy plants by breaking down existing organic and inorganic compounds and converting them to a source of sustainable food. A self cyclic and nourishing environment has to be created to produce a thriving and healthy plant for sale. Such a healthy plant is the result of placing the proper biological components in controlled amounts in the proper location, and with an adequate and uniform supply of water and air so that the plant roots can uptake in an optimal fashion. All of the following must be considered and accommodated if there is to be a high degree of healthy plants for sale to buyers: Blend of standard “fertilizers”; Controlled location and uniform water and air storage capacity of surrounding soil; The precise selective placement of soil “inoculants” to assist the plant's ability to associate symbiotically with organisms in the ground to reduce susceptibility to disease, provide fertilizer and water storage needs and to utilize the soil's natural organic and inorganic compounds by converting them to long as well as short term sources of food; and Careful control of the quantity and uniform placement of vital biological components are designed to nurture the plant through early growth and establishment. [0017] Bacteria are a vital additive in sustaining root growth and enhancing biological activity, the benefits of which include but are not limited to; Promoting nutrient solubilization and mineralization; Enhancing nutrient uptake; Enhancing photosynthetic capacity and reducing supplemental Nitrogen, Phosphorus and Potassium requirements; Bacteria contain L-Cystene, L-Glycine, L-Glutamate to facilitate production of Glutathione, a potent abiotic Stress Reducer; Bacteria contain L-Tryptophan to facilitate production of Indole Acetic Acid (IAA), a natural phyto-hormone responsible for triggering flowering mechanism; and Bacteria that contain high concentrations of sugars which supplement plant's increased requirement during the flowering phase. [0024] In current nursery production the root to plant symbiosis of beneficial and essential fungi and bacteria does not exist due to the intense management aimed at growing plants to specific physical specifications. Most nursery production follows the American Standard Nursery Stock, a specification almost entirely focused on the physical aspects of plant growth and production. In fact, the document, which is 129 pages in length, does not mention the word “healthy” until page 36. Plants and their roots that are grown in production nurseries have not developed the symbiotic relationships with natural fungi and bacteria. [0025] This disclosure also describes a method for making a root ball that maintains the health of a plant during transport and at a nursery and once planted continues providing the plant with nutrients to enhance its growth. Burlap is an exemplary material for surrounding the roots of a plant in a ball formation. The burlap that has been used is a coarse, loosely woven, fabric made from Jute or similar type plant material. Jute is plant fiber derived from plants belonging to the genus Corchorus . Such fiber is well-known and is second only to cotton in amount produced. Since the material is plant derived, it is inherently biodegradable. Burlap fabric is a basic component for almost all packaging of field-grown plants intended for transplant because burlap confines and contains the soil. Containing the soil around the root system minimizes “shock” to the plant during digging the plant up from its initial growth area and then during transportation. Burlap is flexible thereby permitting formation of a ball around the plant roots. The burlap is cut to size in order to accommodate varying root ball sizes. [0026] The burlap is buried when the plant is transplanted again minimizing disturbing the soil around the roots and continuing the friendly environment in which the root system was transported. Once the plant is transplanted, burlap permits the roots to grow through the burlap while the burlap slowly biodegrades during this stage of the growth all the while keeping the root ball intact. The burlap through its inherent properties minimizes disturbance of the plant's roots. [0027] The burlap base material provides a stable and flexible attachment base or substrate for the adhesive and blended nutrients that are part of this disclosure. Other materials besides burlap may be used. Such materials should contain the attributes of burlap that are described herein such as biodegradability, flexibility, permitting roots to grow through after transplantation and the ability to retain and hold nutrients in selected positions such that the nutrients are presented to the plant roots in a manner that optimizes plant growth and health. [0028] The base material is modified to retain the nutrients at selected positions. An adhesive emulsion base material is sprayed on the base material. The adhesive emulsion is, for example, an adhesive of biodegradable materials such as carboxyl methyl cellulose modified with sucrose or starch. Additionally, an acrylic emulsion has proven acceptable as an adhesive for the production needs of the system. [0029] Once prepared with a layer of the adhesive, a layer of blended nutrients or a fertilizer mixture is next deposited on the adhesive emulsion base material. For example, the fertilizer mixture can comprise beneficial fungi, beneficial bacteria and additional beneficial organic and inorganic compounds. The fertilizer mixture of essential organisms includes beneficial fungi which can be, but are not limited to; Diverse multi strains endomycorrhiza; Diverse multi-strains ectomycorrhiza; and Diverse multi-strains Trichoderma; and/or beneficial bacteria which can be, but is not limited to Bacillus firmus; Bacillus amyloliquefaciens; Bacillus subtilis; Bacillus licheniformis; Bacillus megaterium; Bacillus pumilus; Bacillus azotoformans; Bacillus coagulans; Geobacillus stearothermophilus; Paenibacillus polymyxa; Paenibacillus durum; Pseudomonas aureofaceans; Pseudomonas fluorescence; Pseudomonas putida; Streptomyces coelicolor; Streptomyces lydicus; and Streptomyces griseus; and/or beneficial organic and inorganic components which can be but no limited to; Humic acid; Amino acids; Proteins; Vitamin B Complex; Sea kelp extract; and Polyacrylamide copolymer superabsorbent [0056] For example, the following amounts of beneficial bacteria have proven to be effective; 100,000,000 Colony Forming Unit (CFU) per gram of the following organisms; Bacillus firmus, Bacillus amyloliquefaciens, Bacillus subtilis, Bacillus licheniformis, Bacillus megaterium, Bacillus pumilus, Bacillus coagulans, Geobacillus stearothermophilus, Paenibacillus polymyxa, and Paenibacillus durum; 100,000,000 CFU per lb of Bacillus azotoformans ; and 20,000,000 CFU per gram of Pseudomonas aureofaceans and Streptomyces lydicus , 22,000,000 CFU per gram of Pseudomonas fluorescence, Pseudomonas putida, and Streptomyces coelicolor, Streptomyces griseus, Trichoderma reesei, Trichoderma hamatum, Trichoderma harzianum. [0060] Other materials that may be added to create “plant specific” formulations include iron, calcium compounds, and organic fertilizers. These compounds will vary with the target plant and will be tailored to maximize establishment of a symbiotic mycorrhizal association. Inert particulate substances such as heat-treated vermiculites and/or perlite aerate the soil and optimize essential root respiratory processes, and so these “aerators” are also included in the mixture for maximum effectiveness. [0061] The predetermined nutrient mixture is adhered in a dry and unaltered form to the burlap mesh fabric by the adhesive emulsion base material to form a tough permeable layer of dry nutrients typically equally dispersed over the entire surface of the burlap wrapping material. For example, the amount of each ingredient is carefully measured and uniformly distributed over the entire surface. Alternatively, each ingredient may be distributed to selected individual or controlled areas of the base in order to target different nutrient contact with different areas of the root ball/root system. [0062] This procedure is repeated until a sufficient (effective) amount of biological organic, and inorganic components is deposited to form a composite product sheet. After manufacture, the composite product sheet may be further processed to form virtually any shape needed for the particular root system of the plant and/or for marketing purposes or convenience to the customer. Such shapes include but are not limited to sleeves, socks, or bags designed to hold the roots of various plants for transport, transplant, storage, or point-of-sale presentation to the buyer. The sleeves, socks and bags are designed to hold the roots of a plant during transport, watering, storage and planting cycles. [0063] Alternatively, the fertilizer mixture can be applied to targeted portions of the burlap depending on the needs of the plant species/variety. The mixture can be adjusted depending on the specific needs of the individual plant species/variety. The system allows for easily customized formulations to assist the plant's survival and prosperity in varied climates and/or soil conditions. For example, the amount of SAPs (super absorbent polymers) may be increased when planting in highly permeable soils (sand) and may be permanently enhanced by the addition of sodium montmorillonite clay (Bentonite), thus decreasing the permeability and increasing the water retention of the soil. Such a system is may then be “locked in” place by a final layer of a degradable adhesive polymer on a side of the nutrient system opposite from the burlap base material. [0064] The flexibility of the biodegradable burlap holds the soil firmly in place while holding the nutrients completely around the root ball and permitting water to enter the root ball and be retained by for example by SAP. The system of the present invention thus prevents erosion while watering the plant during transport and storage prior to sale by holding the soil, roots and nutrients in place. Additionally, the system of this disclosure also allows the growing roots to easily grow through and into the surrounding soil once the plant has been permanently transplanted in the ground. [0065] Similarly, tubes of paper, plastic and other composites may be used as base material to accomplish the even distribution of biological, organic, and other components in growing systems where plants are grown in cells, flats, containers, drums, boxes, and other configurations and a “sleeve” containing evenly distributed previously mentioned fertilizers, inoculums, super water absorbers, fungi, bacteria, etc. that are used to enhance plant health and growth. As with the burlap base material described previously, an adhesive layer is applied to the paper, plastic, or other composite that is used as the base material and the cocktail of nutrients is then applied continuously or in selected positions on the base material. The roots of the plant that are contained within the tube of paper, plastic, or other composite material can then partake in an optimal and efficient manner of the nutrient cocktail. It has been shown that plants grown in such an environment are much larger and healthier when compared to plants grown in a typical prior art growing container. [0066] 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.

A method and device for containing or encompassing the roots of the plant comprises a base sheet of material containing at least one selected area on the sheet facing the roots, the at least one selected area containing selected nutrients for promoting plant and/or root growth.

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. application Ser. No. 10/419,300, filed Apr. 22, 2003, the entire of which is incorporated herein by reference. FIELD OF THE INVENTION The present invention relates generally to a pain relief device, and more particularly, relating to electrical stimulus pain relief device and method of the same. BACKGROUND OF THE INVENTION Pain relieving devices are known in the art. However, a new and improved pain relief device of a new construction and method of the same is needed. SUMMARY OF THE INVENTION The pain relief device creates a type of electro-therapy for people who have a sore joint or muscle and want relief from pain. The device consists of two pad-type electrodes, or pads, wired to a DC power source such as a battery; one pad to the positive (+) pole and the other pad to the negative (−) pole. The pads are broad, flat, and thin, and could be any shape or size above a square inch in area, (See FIG. 1A ) and are placed flat against the body. One pad, the conducting pad, is placed on the skin of the body at the site of the injury. This pad consists of a single sheet of aluminum foil or other like material only, and this sheet of aluminum foil is large enough to completely cover the area of the injury. This sheet of aluminum foil is converted into a flat sheet like electrode after it is electrically connected to the positive (+) pole of a low voltage DC power source by insulated electrical wire. When on the body, in full contact with the skin of the injured area, and wired as above, the positive (+) charge of the DC power source is distributed equally throughout the sheet of aluminum foil as aluminum is an excellent conductor of electricity. Where the aluminum foil, thus charged up, is in contact with the skin, the positive (+) charge of the aluminum foil sets up a positive charge on the skin around the site of the injury. This affect, and how it is used will be explained below following the description of the insulated pad. The insulated pad is also a flat sheet like electrode such as a sheet of aluminum foil and has roughly the same area or is larger than the above mentioned conducting pad's conductive sheet. This electrode of aluminum foil is bard wired to the negative (−) pole of the same DC power source as the conducting pad above. Besides the polarity differences in wiring, to this point, the electrodes being used in the insulated pad and the conducting pad are basically the same, being flat sheets of aluminum foil with the same general shape and area. The insulated pad is fabricated by taking the negatively (−) charged, aluminum foil electrode and completely covering it, on both sides, of the aluminum foil sheet, by insulation. The flat, aluminum foil sheet electrode becomes completely shielded electrically, in that no current can pass from the electrode within the insulated pad to the outside of the insulated pad, thus earning its name. When the insulated pad is placed on the skin of the body, it produces a negatively (−) charged electric field in the body centered at the location of the insulated pad and radiating outward through the body. When these two pads, wired as above, are placed on the body simultaneously, an electric field is set up flowing through the body from the positively (+) charged pad to the negatively (−) charged pad. At the location of the insulated pad, no current can flow from the body to the negative (−) electrode within as it is completely electrically insulated. The negative (−) electric field created by the electrode will still, however, flow through the insulation and flow throughout the body. When the positively (+) charged conducting pad is placed on the skin on the injured region of a body when it is being charged by an insulated pad from the opposite side of the body from the injury, there is an interaction of the electric fields at the site of the conducting pad. The excess positive (+) charge build up in the conducting pad is drawn to the negative (−) field in the body produced by the insulated pad. When this negatively (−) charged field is set up in the body, charged particles in the body will be attracted to the appositely charged electrodes, or pads. Although none of these charged particles can pass from the body through the skin into the insulated pad, there is nothing to stop the appositely charged particles from passing through the skin of the body at the location of the conducting pad as it is a bare aluminum foil electrode on exposed, bare, skin. This minute flow of current at the site of the conducting pad creates an environment that relieves pain and promotes faster healing in the joint or muscle being treated. The effectiveness of the device will vary depending on the voltage used, the surface area of the pads, and the placement of the pads on the body, all which will affect the electric field set up between the two pads through the body. The best results occur when the pads arc as close as they can be to each other on the body while being on the opposite side of the body from each other. The electric field is perpendicular to the surface created by the flat pads. Having the pads directly facing each other from opposite sides of the body is ideal. The reason for this is because we are trying to focus the electric field so that it flows through the location of the injury to maximize the affect of the conducting pad. A large insulated pad placed on the stomach can be used as alternative way to create the negative (−) field in the body. From the stomach, it will cause a negatively (−) charged electric field to flow throughout the whole body. If the conducting pad is placed elsewhere on the body, (back, knee, elbow, hip, shoulder, etc.), to treat an injury, the electric field produced by the insulated pad on the stomach will produce an electric current in the conducting pad and produce a positive therapeutic affect on the injury being treated. The voltages being used for all these devices has ranged from 0.0 volts up to 7.0 volts DC. Devices using 1.5-3.0 volts are universally well tolerated and produce excellent results. Once the pads are positioned on the body as described above they should be left in this manner as long as is possible and comfortable to the subject, until the pain goes away. FIG. 3A , demonstrates the placement, configuration, and general dimensions of a device designed to treat lower back pain as one of many examples. To achieve these and other advantages, in general, and in one aspect, a method of relieving pain through electric stimulation is provided. The method includes contacting the skin surface of a patient with an electrically conductive pad and contacting the skin surface of a patient at a spaced location from the electrically conductive pad with an electrically insulated pad having an electrically conductive core that is electrically insulated against electrical current flowing therefrom into the skin surface. Applying a positive voltage to the electrically conductive pad from a power source and applying a negative voltage to the electrically conductive core from the power source. Generating a negative electric field in the skin surface about said electrically insulated pad and causing electrical current to flow from said electrically conductive pad towards said negative electric field, thereby providing therapeutic relief to the user. There has thus been outlined, rather broadly, the more important features of the invention in order that the detailed description thereof that follows may be better understood and in order that the present contribution to the art may be better appreciated. 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 presently preferred, but nonetheless illustrative, embodiments of the present invention when taken in conjunction with the accompanying drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of descriptions and should not be regarded as limiting. As such, those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention. 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 preferred embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are included to provide further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate preferred embodiments of the invention and together with the description serve to explain the principles of the invention, in which: FIG. 1 is a perspective view of the pain relief device constructed in accordance with the principles of the present invention; FIG. 2 is a perspective view of the pain relief device, illustrating the structure of the conducting pad and the insulated pad; FIG. 3A is a perspective view of the pain relief device, illustrating the conductive material of the insulated pad; FIG. 3B is a cross sectional view of the pain relief device taken along line 3 B- 3 B, showing the core and insulation layers of the insulated pad; FIG. 3C is a cross sectional view of the pain relief device taken along the line 3 C- 3 C, showing the structure of the insulated pad and conductive pad; FIG. 4 is a top plan view of the pain relief device, illustrating the pain relief device constructed as a belt in accordance with the principles of the present invention; FIG. 5 is a side elevation view of the pain relief device, illustrating the belt in use on a human; FIG. 6 is a rear elevation view of the pain relief device, illustrating the placement of the conducting pad and belt attached to a human; and FIG. 7 is a front elevation view of the pain relief device, illustrating the placement of the insulated pad and belt attached to a human. DETAILED DESCRIPTION OF THE INVENTION Reference will now be made in detail to the preferred embodiments of the present invention, examples of which are illustrated in the accompanying drawings. Referring now to the drawings, reference numeral 10 generally designates a pain relief device of the present invention. The device creates a type of electro-therapy for humans or animals for safely relieving pain and speeding recovery of an injury. The injury may be a sore joint or muscle. As shown in FIG. 1 the device includes two pad-type electrodes one being a thin flexible conducting pad 12 , the second being a thin flexible insulted pad 14 , a first insulated wire 16 , a second insulated wire 18 and a low voltage direct current (DC) power source 20 having a positive (+) pole 22 and a negative (−) pole 24 . The low voltage DC power source 20 may be any type of battery or multiple batteries, such as, conventional A, AA, AAA type batteries having a positive (+) pole 22 and a negative (−) pole 24 . The voltages being used for the device range from 0.0 volts up to 7.0 volts DC as an example the power source 20 can provide 1.5 to 7.0 volts. When in use both the conducting pad 12 and the insulated pad 14 will have the same voltage applied to them. Referring to FIGS. 1-4 , the conducting pad 14 includes a thin flexible sheet of conductive material 26 and a layer of insulation 28 covering one side of the conductive material and leaving one side of the conductive material exposed. The layer of insulation 28 is used for structurally supporting and strengthening the sheet of thin flexible conductive material 26 . The conductive material 26 of the conducting pad 14 is attached to the low voltage power source 20 by the first insulated wire 16 . One end of the first insulated wire 16 is connected to the conductive material 26 of the conducting pad 12 and a second end of the wire is connected to the positive (+) pole 22 of the power source 20 . Additionally, FIGS. 1-4 show the insulated pad 14 including a core 30 made of a thin flexible sheet of conductive material, a first layer of insulation 32 covering one side of the core and a second layer 34 of insulation covering a second side of the core. The negative pole 24 of the same power source 20 that is connected to the conducting pad 12 is connected to the insulated pad 14 by the second insulated wire 18 . One end of the second insulated wire 18 is connected to the core 30 of the insulated pad 14 and a second end of the wire connects to the negative (−) pole 24 of the power source 20 . The second insulted wire 18 is connected to the core 30 of the insulated pad 14 in such a way that no conductive material or electrical contact is exposed. The size and shape of the conducting and insulated pads 12 , 14 may be of any size and shaped which covers the injured part of the body and may even be a point electrode. The conductive material 26 and core 30 for both the conducting pad 12 and the insulated pad 14 is preferably made of aluminum but may be any type of thin flexible conductive material such as copper, silver, gold, platinum, or any other alloy of these or other metals shaped into a foil or screen or multiple thin layers. The layers of insulation 28 , 32 , 34 used for both the conducting and insulation pads 12 , 14 may be any flexible insulating material such as vinyl, latex, plastic, duct tape, fabric, cloth, leather, paper or felt. The conducting pad 12 is placed on the skin of the body at the site of the injury. The conducting pad 12 is sized large enough to completely cover the area of the injury. The exposed side of the conducting pad 12 is placed in direct contact on the skin so the exposed conductive material 26 is in direct contact with the skin of the body at the site of the injury. The sheet of conductive material 26 is converted into a flat sheet like electrode after it is electrically connected to the positive (+) pole 22 of the power source 20 by the first insulated wire 16 . When on the body, in full contact with the skin of the injured area, and wired as above, the positive (+) charge of the power source 20 is distributed equally throughout the sheet of conductive material 26 . Where the conductive material 26 , thus charged up, is in contact with the skin, the positive (+) charge of the conductive material 26 sets up a positive charge on the skin around the site of the injury. The insulated pad 14 is placed on the skin of the body at a position opposite side of the injury and the conducting pad 12 . The insulated pad 14 is roughly the same size or is larger than the conducting pad 12 . If a location opposite the placement of the conducting pad 12 is unavailable or difficult for the placement of the insulating pad 14 , the device will also work if the insulated pad is placed against the skin of the abdomen even though the injury may be the shoulder, neck etc. The devices will work as long as the conductive material 26 of the conducting pad 12 is connected to the positive (+) pole 22 of power source 20 and is in contact with the injured area and the core 30 of the insulated pad 14 is connected to the negative (−) pole 24 of the same power source and the insulated pad 14 is placed on another part of the body preferably but not necessarily opposite to the placement of the conducting pad. The core 30 of the insulated pad is converted into a flat sheet like electrode after it is electrically connected to the negative (−) pole 24 of the power source 20 by the second insulated wire 18 . When the insulated pad 14 is placed on the skin of the body, it produces a negatively (−) charged electric field in the body centered at the location of the insulated pad and radiates outward through the body. No current can flow at the site of the negatively charged core 30 of the insulated pad 14 because it is insulated and therefore the skin of the body can does not burn. When the conducting pad 12 and insulated pad 14 , wired as above, are placed on the body simultaneously, an electric field is set up flowing through the body from the positively (+) charged conducting pad to the negatively (−) charged insulated pad. At the location of the insulated pad 14 , no current can flow from the body to the negatively charged core 30 within, as it is completely electrically insulated. The negative (−) electric field created by the core 30 will still, however, flow through the insulation 32 , 34 and flow throughout the body. When the positively (+) charged conducting pad 12 is placed on the skin on the injured region of a body when it is being charged by an insulated pad 14 from the opposite side of the body from the injury, there is an interaction of the electric fields at the site of the conducting pad. The excess positive (+) charge build up in the conducting pad 12 is drawn to the negative (−) field in the body produced by the insulated pad 14 . When this negatively (−) charged field is set up in the body, charged particles in the body will be attracted to the oppositely charged electrodes, or pads 12 , 14 . Although, none of these charged particles can pass from the body through the skin into the insulated pad 14 , there is nothing to stop the oppositely charged particles from passing through the skin of the body at the location of the conducting pad 12 as it is a bare conducting material on exposed, bare, skin. This minute flow of current at the site of the conducting pad 12 creates an environment that relieves pain and promotes faster healing in the joint or muscle being treated. The effectiveness of the device will vary depending on the voltage used, the surface area of the pads 12 , 14 and the placement of the pads on the body, all which will affect the electric field set up between the two pads through the body. The best results occur when the pads 12 , 14 are as close as they can be to each other on the body while being on the opposite side of the body from each other. The electric field is perpendicular to the surface created by the flat pads 12 , 14 . Having the pads 12 , 14 directly facing each other from opposite sides of the body is ideal. The reason for this is because we are trying to focus the electric field so that it flows through the location of the injury to maximize the affect of the conducting pad 12 . Additionally, a large insulated pad 14 placed on the stomach can be used to create the negative (−) field in the body. From the stomach, it will cause a negatively (−) charged electric field to flow throughout the whole body. If the conducting pad 12 is placed elsewhere on the body, (back, knee, elbow, hip, shoulder, etc.), to treat an injury, the electric field produced by the insulated pad 14 on the stomach will produce an electric current in the conducting pad and produce a positive therapeutic affect on the injury being treated. Once the pads 12 , 14 are positioned on the body as described above they should be left in this manner as long as is possible and comfortable to the subject, until the pain goes away. FIGS. 4-7 demonstrates the placement, configuration, and general dimensions of a device designed to treat lower back pain as one of many examples. As an example, if the lower back is injured and one wishes to treat it with this device using this principle. The pads 12 , 14 of the device and the electrical wiring would be constructed and put together exactly as described and seen in FIG. 1-3C . This example is for a 200 LB. human 36 of average height, the x-y and x′-y′ dimensions of the respective pads 12 , 14 shown in FIG. 4 , would be 5 in. by 14 in. for both the conducting material 26 of the conducting pad 12 and the core 30 of the insulated pad 14 . This particular device uses two AA batteries in a battery pack wired in series providing approximately 3 volts DC. This device can be affixed easily to the human 36 if the pads 12 , 14 and power source 20 wired as above are held in place by a wide belt 38 , shown in FIG. 4-7 . The exposed conductive material 26 of the conducting pad 12 is placed against the skin of the lower back 40 while the insulated pad 14 is placed against the skin of the stomach or abdomen 42 as in FIGS. 5-7 . This configuration will relieve pain in the lower back and promote faster healing. Rather than using a separate belt, a large belt made from the same type of insulating material can be used instead of separate pieces of insulation for each pad 12 , 14 . Devices based on this principal have been adapted to ease pain and speed healing in the knee, shoulder, wrist, elbow, ankle, feet, and neck with positive results. Indeed any injured or strained muscle or joint in the body could benefit from this treatment. It has been used to treat the sore hip of a dog as well using a metal brush type adapter for the conducting pad 12 with each tooth of the brush charged with the same voltage used in the insulated pad 14 . The brush is used so that the fur on the animal can be penetrated so that the electrodes in the brush are in contact with the animal's skin. There is no reason why this technology wouldn't work just as well on any other mammal. A number of embodiments of the present invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. Accordingly, other embodiments are within the scope of the following claims.

The Pain relief device used to relieve pain and promote faster healing in the bodies of humans and animals safely. A positive electrode touches the skin at the site of an injury and a negative electrode completely shielded with insulation is place on the skin at a spaced distance form the positive electrode. A low voltage direct current power source supplies a positive voltage to the positive electrode and a negative voltage to the negative electrode. Electrical stimulation occurs harmlessly, because the shielded negatively charged electrode or insulated pad, being an insulated sheet of aluminum foil produces an electric field in the body that is strong enough to cause a current to flow into the body at the site of the positive electrode. However, no current can flow at the site of the negative electrode because it is insulated and therefore no burns to the skin.

BACKGROUND OF THE INVENTION The invention concerns a device for infrared (IR) spectroscopic investigation of internal surfaces of a body, for example of blood vessels with an IR spectrometer and with an endoscope with light guide means to illuminate the surfaces. Such a device is known from WO 95/11624. In endoscopes of such devices, scattered light is guided from internal surfaces of a body, mostly from blood vessels or internal body cavities via light guides to an external outside detector. Generally, glass fiber bundles are used as light guides. The light intensity of the detected scattered light and therefore the signal strength is thereby essentially proportional to the product of glass fiber cross sections which guide the light along the endoscope to the exposure, and the cross section of those glass fibers which collect the scattered light and guide it to the outside detector. These prior art devices have therefore the disadvantage that for a given total cross section of the glass fibers only a fraction of the cross section can be used for illumination of the internal surfaces since the remaining glass fibers serve for guiding the collected light to the outside. Apart from this, the collecting surface, i.e. the possible range of observation, is limited by the cross section of the collecting glass fibers and therefore relatively small in comparison to the total coating surface of the endoscope. The collecting fibers, suitable for spectroscopy (e.g. quartz) transfer the collected light only within a relatively narrow acceptance angle (generally a cone with ±10°), leading to an additional strong spatial limitation of the light acceptance of scattered light by the endoscope. From DE 27 46 614 A1, an endoscope is known with light guide means to illuminate investigated surfaces. The illuminating light for the endoscope comes from a cold light source or from illuminating diodes located at the distal end, but from a spectrometer. DE 27 46 614 A1 is only concerned with imaging, not with spectroscopy. In U.S. Pat. No. 4,403,273, a rod-shaped reflection unit for the illumination system of an endoscope is presented which allows a particularly large field of view of more than 100°. In DE-GM 19 20 775, at the distal end of an endoscope a fiber light guide is bent by about 90°, polished at its flat end and covered by an opal glass plate. Insertable optics enable sidewise directed observation. In U.S. Pat. No. 5,058,568, it is suggested to use the protective metal cover weave or other elements of a flexible endoscope for electric connections, which can lead e.g. to a video chip at the distal end. U.S. Pat. No. 4,674,515 describes a rotatable ultrasound head of an endoscope. U.S. Pat. No. 4,782,818, finally, discloses an endoscope to illuminate internal body surfaces with visible light for therapeutic reasons. It is therefore the purpose of the present invention to present an device of the kind described above which comprises, for otherwise equal conditions, an increased signal strength and thereby the possibility to reduce the measuring time for equal signal quality. SUMMARY OF THE INVENTION According to the invention, this aim is achieved in a way, equally surprisingly simple and effective, in that at the proximal end IR light is directed from the IR spectrometer into the light guide means and that at the distal end of the light guide means there is arranged a detector for detecting IR light scattered from the illuminated surface and transforming it into electric signals. By this detector arrangement no "return guide" for the collected scattered light is needed any more in the light guide means, so that the total light guiding cross section of the light guide means can fully be used to illuminate the surfaces under investigation. The accepting surface of the endoscope of the invention is merely limited by the detector design but not by the cross section of "return" glass fibers. The angular limitation of the acceptable scattered light due to the relatively small acceptance angle of glass fibers is also not relevant any more. In this way, for an equally large outer circumference of the endoscope, a considerably higher light yield can be achieved and thereby a considerably higher signal strength, so that for a comparable quality of the spectra a considerably shorter measuring time is required compared to conventional endoscopes. An embodiment of the device according to the invention is particularly preferred where the detector comprises a sensitive detector surface which is larger than the cross section of the light exit surface at the distal end of the light guide means. In this way, also the diffusively scattered light of the investigated surface can be collected and thereby the light and signal yield of the device according to the invention can be considerably improved over conventional ones. The IR spectrometer is preferably an FTIR spectrometer with an interferometer whose interfering light beam is coupled into the light guide means at their proximal end and which spectrometer converts the electric detector signals into an interferogram and by means of Fourier transformation into an IR spectrum. Since a detector at the distal end is used, the IR light has to pass the spectrometer prior to entering the light guide means. Fourier spectrometer have a much better light yield compared to monochromators. However, in embodiments, the IR spectrometer may also be a dispersive system, i.e. a grating or prism spectrometer with entrance and exit slits. The light guide means may comprise one or more commercially available glass fiber bundles. In a preferred improvement of these embodiments, means to deflect the light by about 90° are provided at the distal end of the light guide means. In this way, an investigation range can be illuminated extending crosswise to the longitudinal endoscope axis as is typically the case with blood vessels. The deflection may be effected by a tilted mirror or by a prism fitted onto the glass fiber bundle. In an improvement that can be manufactured particularly easily and therefore cheaply, the means to deflect the light are formed by a prismatic cut of the glass fiber ends at about 45°. The light deflection is based upon total reflection or a reflective coating of the tilted surfaces. In embodiments, the space between the fibers of the glass fiber bundle is filled with a material that, in the spectral range of interest, comprises a refractive index such that the refractive index difference between fiber and material is small enough for transmission of the IR light incident at nearly right angle and emerging from other fibers due to total reflection at their cut ends. In this way the light bundles emerging e.g. from the central fiber can pass the peripheral fibers largely without reflection losses. In order to ensure guidance of the IR light inside the fibers, their surfaces can be reflectively coated outside the distal region where the light leaves the fibers. Preferably, the space between the fibers of the glass fiber bundle are at least in the region where the light leaves the fibers filled with a material which, in the spectral range of interest, comprises a refractive index such that the refractive index difference between fiber and material is large enough to guide the IR light inside the fibers but small enough for transmission of the IR light incident at nearly right angle and emerging from other fibers due to total reflection at their cut ends. The problem that the outer fibers are in the way of the light deflected out of the inner fibers can be avoided in an elegant way by the following preparation procedure: After the prismatic (or cone shaped) cut and polishing, the longest fibers of the fiber bundle are pulled back in such a way that a staircase shaped arrangement is formed in the region of the light deflection in such a way that the light emerging out of a particular fiber deflected at an angel of about 90° is not blocked by other fibers. The fibers that during the cutting and polishing had still been the longest ones become the shortest ones at the distal end and vice versa. However, apart from this, any other optical means to deflect light can also be used. In a particularly preferred embodiment of the device according to the invention, the sensitive detector surface is placed directly on a coating surface of the light guide means. In this way, the detector practically requires no extra room and the endoscope of the device according to the invention can be constructed in a particularly compact manner. In an advantageous improvement of this embodiment, provision is made that at the distal end of the light guide means the deflected light emerges within a limited angular range essentially in one direction on one side of the light guide means and that the sensitive detector surface is arranged on that side of the coating surface of the light guide means. In this way, a defined location of the internal surface surrounding the endoscope can be investigated selectively, whereby the arrangement of the sensitive detector surface on the same side where the light emerges leads to a particularly high yield of scattered light in relation to the detector surface. A particularly advantageous improvement of this embodiment is characterized in that the deflected light emerges from a, preferably circular, mask on the side of the light guide means and that the sensitive detector surface is arranged on this side of the coating surface around the mask aperture. In particular, by using the mask, a collimation of the illuminating light and thereby a collimation onto a particularly small investigation surface precisely to the point can be achieved. Since the sensitive detector surface immediately surrounds the mask aperture, the detected light yield is further optimized. Alternatively, in another advantageous embodiment of the device according to the invention, the deflected light may emerge out of an annular mask encircling the coating surface of the light guide means and the sensitive detector surface is arranged annularly about the coating surface of the light guide means, preferably on both sides of the annular mask aperture. In this way, for fixed endoscope, a complete annular surface range around the endoscope can be investigated simultaneously. In a particularly preferred embodiment, the sensitive detector surface consists of a, preferably 1 to 10 μm thick, lead sulfide (PbS) layer which is particularly suited to accept infrared light. In a further embodiment of the device according to the invention, the detector comprises a commercially photo resistor available at low cost. The endoscope of the device according to the invention is particularly compact in embodiments where conducting strips are placed onto the coating surface of the light guide means, preferably by vapor deposition, to conduct the electric signals produced in the detector. In an alternative embodiment, thin wires are provided to conduct the electric signals produced in the detector, preferably inside a channel in the center of the light guide means. This embodiment, too, does not enlarge the outer circumference of the endoscope. In a particularly preferred improvement of this embodiment, the distal end of the light guide means can be mechanically manipulated by means of the thin wires. In this way, the signal wires serve a further function which had otherwise to be taken over by other components, so that, by this modification, the endoscope of the device according to the invention can again be designed in a particularly compact manner. In a further, alternative embodiment, commercially available metal coated glass fibers, in particular gold coated glass fibers, are provided to conduct the electric signals generated in the detector. Particularly preferred is also an embodiment of the device according to the invention, where the light guide means comprises at its distal end immediately after the detector a digitizing unit to digitize the electric signals generated by the detector. In this way, the signal received by the detector can be transported over far distances in digitized form even for small signal strengths. A further advantageous embodiment is characterized in that a rotatable component is arranged at the distal end of the light guide means which can be manipulated from the other end of the light guide means and which deflects the light emerging out of the light guide means in a direction corresponding to the respective rotation angle of the rotatable component. In this way, the azimuthal resolution of the endoscope of the device according to the invention can alternatively be limited to a small angular range or be extended to an annular range around the entire surrounding surface, for example a blood vessel wall. The same effect can be achieved by an alternative embodiment, where the endoscope of the device according to the invention is rotatable about its longitudinal axis. In comparison to the embodiment described above, there is, however, the disadvantage that the endoscope must be rotated over its entire length, which can lead to complications at locations with narrow passages, in particular during medical investigations at the point of insertion of the endoscope into the human body. Also advantageous is an embodiment where the detector can be translated along the longitudinal axis of the endoscope. In this way, for fixed endoscope, measurements reflecting a longitudinal dependence become nevertheless possible. In a particularly preferred embodiment, the light guide means comprises at its distal end an ultrasound head, preferably rotatable about the longitudinal endoscope axis. In this way, critical locations, for example narrow vessel passages, can be pre-localized by ultrasound measurements. Subsequently, specific infrared measurements can be performed, for example to identify the kind of tissue or depositions. In a particularly compact improvement of this embodiment, the signal leads for the ultrasound head coincide with the electric leads which conduct also the electric signals from the detector receiving IR light. Separation of the two signal kinds may for example be effected by using disjunct voltage, current or frequency ranges and possibly by transfer of the IR detector signal in digital form and of the ultrasound signal in analogue form. Further advantages of the invention result from the description and the drawing. The above mentioned features and those to be further described below in accordance with the invention can be utilized individually or collectively in arbitrary combination. The embodiments shown and described are not to be considered as exhaustive enumeration, rather have exemplary character only for the description of the invention. The invention is represented in the drawing and is further explained in connection with embodiments. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 shows a schematic three-dimensional representation of an endoscope of a device according to the invention with a circular mask; FIG. 2 shows an endoscope of a device according to the invention with a circumferential annular mask; FIG. 3 shows a detail of a schematic longitudinal cross section across an endoscope of a device according to the invention with sidewise deflection of the illuminating light in a direction as in FIG. 1; FIG. 4 shows a detail of a schematic longitudinal cross section across an endoscope of a device according to the invention with annular light deflection as in FIG. 2; FIG. 5a shows a schematic cross section across an endoscope of a device according to the invention with vapor deposited conducting strips; and FIG. 5b shows a schematic cross section across an endoscope of a device according to the invention with conducting wires running in a channel. DESCRIPTION OF THE PREFERRED EMBODIMENTS The three dimensional representation in FIG. 1 shows the distal end of the light guide means of an endoscope 10, serving to infrared (IR) spectroscopically investigate internal surfaces of a body, as for example internal walls of a blood vessel, stomach, intestines or the like. Not visible in FIG. 1, endoscope 10 internally contains light guide means, generally comprising glass fiber bundles. At the distal end of endoscope 10, the light, guided along the light guide means, is deflected by about 90° and emerges from a mask 11, being circular in the embodiment shown, in a direction at right angles to the endoscope 10 axis in the form of a light beam in a limited angular range and illuminates a corresponding spot of the surface under investigation. The light, back-scattered from there, is collected by means of a detector 12 at least to large extent and transformed into electric signals, which are transferred via leads 13 to a digitizing unit 14. From this, the digitized signals are conducted to the outside for further processing, via leads 15, which, in the embodiment shown, are vapor deposited onto the coating surface of the endoscope. At the lowest end of endoscope 10, an ultrasound head 16 is schematically represented, with which advance ultrasound measurements of the investigation area can be performed prior to the IR spectroscopic investigations. In this way, for example critical locations as e.g. narrow vessel passages or depositions can at first be pre-localized by the ultrasound measurements and subsequently a specific tissue identification or generally of substances at the investigation area can be performed. Preferably, ultrasound head 16 will be rotatable about the longitudinal endoscope 10 axis. In order to keep the endoscope 10 as compact a possible regarding its outer dimensions, the same electric leads 13, 15 can be used for both, the electric measuring signals from ultrasound head 16 as well as for the electric measuring signals from detector 12, whereby both electric signal kinds may for example be separated by using different voltage, current or frequency ranges. Detector 12 collecting IR light scattered by the illuminated surface, and converting it into electric signals, is flat in the presented embodiment, whereby the sensitive detector surface is attached to a coating surface of endoscope 10. The sensitive detector surface can for example consist of a, preferably 1 to 10 μm thick, PbS layer. In particular, detector 12 can comprise a photo resistor. In the embodiment shown in FIG. 1, the sensitive detector surface of detector 12 is arranged around mask aperture 11. Since back-scattered light from the object surface can only be collected on the side of the mask aperture, in this case the sensitive detector 12 surface is limited approximately to a half cylinder around the mask aperture 11. The sensitive detector surface is nevertheless still considerably larger than the light exit area at the distal end of the light guide means of endoscope 10, so that at least most of the IR light scattered at the examination surface can be collected. Moreover, the detector surface according to the invention does not lead to the usual angular limitations of glass fibers for the observed light due to the finite acceptance angle of glass fibers. In FIG. 2 a further embodiment is shown, where instead of a circular mask 11 the endoscope 20 comprises a circumferential annular mask 21, from which the light 27, deflected inside the endoscope 20 by about 90°, emerges to all sides. The sensitive detector 22 surface consists in this case of two circumferential annular strips arranged at both sides of annular mask aperture 21. With such an arrangement, an entire annular surface range around the endoscope 20 can be investigated simultaneously. The above mentioned light deflection at the illuminated end of light guide means of about 90° can for example be effected by a fitted prism or a prismatic cut of the light guide ends. In FIG. 3 an axial section at the distal end of an endoscope 30 of a device according to the invention is represented in a longitudinal cross section. IR light from a spectrometer 1 enters the light guide means. A central IR light beam 37 runs inside a glass fiber bundle 39 and impinges on a prism surface 38 at the distal end of the glass fiber bundle 39 and is deflected in the shown figure towards the left side. It exits sidewise out of the endoscope 30, through a mask aperture 31, formed by an e.g. circular hole in the sensitive surface of a detector 32. In combination with other light beams from neighboring fibers of glass fiber bundle 39 a collimated light beam is thereby formed being angularly limited, which illuminates a correspondingly limited investigation surface located sidewise from the endoscope 30. Insofar FIG. 3 represents the possible "interior" of an endoscope 10 according to FIG. 1. FIG. 4 shows also in a longitudinal cross section a detail of an endoscope 40, exhibiting similar annular circumferential illumination characteristics as endoscope 20 of FIG. 2. In a glass fiber bundle 49 there are schematically represented light beams 47 originating in spectrometer 1, impinging at the end of the light guide means onto a cone shaped tilted surface 48 of a correspondingly shaped deflecting component attached to the fiber bundle end, where they experience a sidewise total reflection by 90°. The tilted surface 48 may also be reflectively coated. The light beams 47 then exit through an annular mask aperture 41 in all directions perpendicular to the endoscope 40. Annular mask 41 is formed by the sensitive surfaces of a detector 42 which are arranged as strips above and below the aperture range around the coating surface of endoscope 40. FIGS. 5a and 5b, each show a schematic cross section across an endoscope of a device according to the invention. Tightly packed glass fiber bundles 59a, 59b can be recognized which serve to guide the illuminating light. The endoscope represented in FIG. 5a comprises conducting strips 55a which are vapor deposited sidewise onto the coating surface of endoscope 50a to conduct the measuring signals generated by the detector. In contrast thereto, endoscope 50b of FIG. 5b comprises two wires 55b in an internal channel between the glass fibers 59b, which wires 55b are represented with a rectangular cross section for better distinction which serve also to conduct the detector signals and which, in practice, would exhibit a round, considerably smaller cross section. In addition, the wires 55b, if correspondingly arranged, can take over mechanical tasks, e.g. effect a rotation of an ultrasound head at the distal end of endoscope 50b. The endoscope of the device according to the invention can be designed such that at the distal end of the light guide means a rotatable component is arranged which can be manipulated and which deflects the light emerging from the light guide means in a direction corresponding to the respective rotation angle of the rotatable component. By rotating this head piece of the endoscope, measuring of a sequential series of spectra across the entire circumference of the surrounding surface which has to be investigated becomes possible. In addition, a longitudinal shift of the optical system inside the endoscope can also be possible, whereby also a translatoric scan of the surface regions under investigation and from this a large scale investigation is possible. In particular if already data are generated in digital form at the distal end of the endoscope, the detector and/or a corresponding AD converter could also transmit these date in a wireless manner without electric leads. Detector and/or transmitter could be equipped with a microbattery, i.e. electric leads could be omitted completely.

A device for infrared (IR) spectroscopic investigation of internal surfaces of a body, for example of blood vessels, comprising an endoscope (10) with light guide means to illuminate the surfaces is characterized in that at the distal end of the light guide means there is arranged a detector (12) for detecting IR light scattered from the illuminated surface and transforming it into electric signals. For otherwise identical conditions, compared to comparable known devices, the device according to the invention offers a higher signal strength and thereby the possibility to shorten the measuring time for equal signal quality.

BACKGROUND OF THE INVENTION This invention relates to containers and hangers for poolside containment and organizing of swimming pool items. Increasing use of residential swimming pools has created a need for organized containment of items used frequently for swimming, playing and relaxing in and around them. There are known containers that could be used to contain items at a poolside, but none having the quick assembly, convenience, and organizational advantages specifically for poolside items in a manner made possible with this invention. Examples of the most closely related but different known organizers are described in the following patent documents. U.S. Pat. No. 5,833,334, issued to Harper on Nov. 10, 1998, described a home-entertainment organizer for TV-related items that would not be suitable for poolside items. U.S. Pat. No. 5,765,699, issued to Griffin on Jun. 16, 1998, described a holder of swimming-pool maintenance equipment in a garage or other building. U.S. Pat. No. 5,626,307, issued to Smith on May 6, 1997, described mobile holder of swimming-pool maintenance equipment. U.S. Pat. No. 5,249,857, issued to Suzuki on Oct, 5, 1993, described build-up furniture for homes. U.S. Pat. No. 3,887,103, issued to Spooner on Jun. 3, 1975, described a hand-tool box for carrying pool-maintenance tools. SUMMARY OF THE INVENTION Objects of patentable novelty and utility taught by this invention are to provide a poolside organizer which: holds such poolside items as floats, fins, snorkels, lotion, bathing suits, towels, toys, boogie boards, swim rings, sun glasses and hats with convenient organization and easy accessibility; can be packaged compactly unassembled for marketing; can be assembled quickly and easily; is sturdy for withstanding poolside uses and movement; and can be structured and designed attractively. This invention accomplishes these and other objectives with a poolside organizer having (a) a base with storage dividers and quick-assembly joints for upright structure, (b) a front wall supporting a plurality of hangers and one or more optional boxlike containers, (c) a rear wall supporting a plurality of hangers and one or more optional boxlike containers, (d) a left upright supporting a plurality of hangers and one or more optional boxlike containers, (e) a right upright supporting a plurality of hangers and one or more optional boxlike containers, and (f) one or more bottom end enclosures for containing items loose or in baskets. Quick-assemble and quick-disassemble fastener joints are provided for build-up structure. The above and other objects, features and advantages of the present invention should become even more readily apparent to those skilled in the art upon a reading of the following detailed description in conjunction with the drawings wherein there is shown and described illustrative embodiments of the invention. BRIEF DESCRIPTION OF DRAWINGS This invention is described by appended claims in relation to description of a preferred embodiment with reference to the following drawings which are explained briefly as follows: FIG. 1 is a top view of a poolside organizer with an extension enclosure and having an upright receptacle; FIG. 2 is a partially cutaway front view of the FIG. 1 illustration; FIG. 3 is a partially cutaway left-side view of the FIG. 1 illustration; FIG. 4 is a partially cutaway right-side view of the FIG. 1 illustration; FIG. 5 is an expanded top view of corners of a poolside organizer having fastener orifices for being joined together with fasteners; FIG. 6 is an expanded top view of corners of a poolside organizer having angle fasteners for being joined together; FIG. 7 is a top view of a poolside organizer joined together with angle fasteners; FIG. 8 is an expanded side view of an embedded overlap fastener on a corner of a poolside organizer; FIG. 9 is an expanded side view of a non-embedded overlap fastener on a corner of a poolside organizer; FIG. 10 is an expanded side view of an embedded overlap fastener on a side wall of a poolside organizer; FIG. 11 is an expanded top view of corners of a poolside organizer joined together with overlap fasteners; and FIG. 12 is a top view of a poolside organizer joined together with overlap fasteners. DESCRIPTION OF PREFERRED EMBODIMENT Listed numerically below with reference to the drawings are terms used to describe features of this invention. These terms and list numbers assigned to them designate the same features throughout this description.  1. Left upright 18. Rear hanger wall  2. Front bottom wall 19. Front-left hanger joint  3. Left-front upright joint 20. Front-right hanger joint  4. Rear bottom wall 21. Rear-left hanger joint  5. Left-rear upright joint 22. Rear-right hanger joint  6. Right upright 23. Top enclosure  7. Right-front upright joint 24. Tube hangers  8. Right-rear upright joint 25. Swimming-attire hangers  9. Left hanger wall 26. Poolside tray 10. Right hanger wall 27. Linear slots 11. Base enclosure 28. Slot walls 12. Upright receptacle 29. Extension enclosure 13. Angle bracket 30. Extension wall 14. Overlap bracket 31. Rear-wall struts 15. Left receptacle wall 32. Fastener orifices 16. Right receptacle wall 33. Fasteners 17. Front hanger wall 34. Left-upright support Reference is made first to FIGS. 1-5. A left upright 1 has a bottom end that is joined to a front bottom wall 2 proximate a left-front upright joint 3 and that is joined to a rear bottom wall 4 proximate a left-rear upright joint 5 . A right upright 6 has a bottom end that is joined to the front bottom wall 2 proximate a right-front upright joint 7 and that is joined to the rear bottom wall 4 proximate a right-rear upright joint 8 . The left upright 1 has a top end with a left hanger wall 9 and the right upright 6 has a top end with a right hanger wall 10 . The front bottom wall 2 , the rear bottom wall 4 , the bottom end of the left upright 1 and the bottom end of the right upright 6 are a base enclosure 11 having a length, a width and a breadth to enclose bottom ends of a predetermined volume of elongate poolside items in variously upright orientations. The left upright 1 and the right upright 6 are supported in a vertically upright orientation by at least one upright support such as an upright receptacle 12 as shown in FIGS. 1-4, at least one angle bracket 13 as shown in FIGS. 6-7 or at least one overlap bracket 14 as shown in FIGS. 8-12. The upright receptacle 12 provides upright support by rigid attachment of a left receptacle wall 15 and a right receptacle wall 16 to the front bottom wall 2 and to the rear bottom wall 4 . The right upright 6 positioned in the upright receptacle 12 between them provides upright rigidity to other structural elements attached directly or indirectly to the right upright 6 . Attachment of the left upright 1 and/or the right upright 6 to the front bottom wall 2 and to the rear bottom wall 4 with fastener members and fastener brackets such as the angle brackets 13 and the overlap brackets 14 provides upright support also, but with different requirement for fasteners in contrast to a drop-in method of build-up assembly. At the front, a front hanger wall 17 has a left end that is joined to a top of the left upright 1 and has a right end that is joined to a top of the right upright 6 . Similarly at the rear, a rear hanger wall 18 has a left end that is joined to a top of the left upright 1 and has a right end that is joined to a top of the right upright 6 . The front hanger wall 17 and the left hanger wall 9 have a front-left hanger joint 19 . The front hanger wall 17 and the right hanger wall 10 have a front-right hanger joint 20 . The rear hanger wall 18 and the left hanger wall 9 have a rear-left hanger joint 21 . The rear hanger wall 18 and the right hanger wall 10 have a rear-right hanger joint 22 . The front hanger wall 17 , the rear hanger wall 18 , the left hanger wall 9 and the right hanger wall 10 are a top enclosure 23 against which top portions of the elongate poolside items can lean. A plurality of predetermined poolside hangers are positioned on the front hanger wall 17 , the rear hanger wall 18 , the left hanger wall 9 and the right hanger wall 10 selectively. Preferably for most uses, there are no poolside hangers positioned on the rear hanger wall 18 in order for one side to be free of hangers or other protrusions for positioning against a poolside fence or other structure. The poolside hangers are preferably two tube hangers 24 on the left hanger wall 9 , four swimming-attire hangers 25 on the right hanger wall 10 and four swimming-attire hangers 25 on the front hanger wall 17 respectively. Preferably, the tube hangers 24 extend outwardly about ten-to-twelve inches and the swimming-attire hangers 25 extend out approximately three-to-six inches. A poolside tray 26 , preferably having a fluid-outlet bottom, is positioned preferably on only the right hanger wall 10 , but can be positioned also on the front hanger wall 17 , the rear hanger wall 18 and/or the left hanger wall 9 selectively. The poolside tray 26 is sized and shaped for holding suntan lotion, hair-care items, eye-care items and other body-care items. It is preferably three-to-five inches wide, three-to-five inches deep and about ten-to-fifteen inches long. At least one bottom-end enclosure is positioned in the base enclosure 11 for arresting lateral travel of bottom ends of elongate poolside items positioned uprightly within the top enclosure 23 . The bottom end enclosure is preferably a plurality of linear slots 27 that are juxtaposed intermediate the front bottom wall 2 and the rear bottom wall 4 . Preferably, slot walls 28 of the linear slots 27 are lower than the front bottom wall 2 and the rear bottom wall 4 , which are preferably about six inches high. Preferably, at least one extension enclosure 29 is extended horizontally from at least one bottom end wall, preferably from the right upright 6 at the base enclosure 11 . The extension enclosure 29 has an extension wall 30 between the front bottom wall 2 and the rear bottom wall 4 . The extension enclosure 29 is sized and shaped to contain poolside items such as poolside toys, poolside items that are not easily hangable on the poolside hangers and optionally baskets for containing same. Optionally, rear-wall struts 31 can be extended for vertical support between the rear bottom wall 4 and the rear hanger wall 18 . As depicted in FIG. 5, fastener orifices 32 can be pre-positioned for fasteners 33 proximate ends of the left upright 1 , a left-upright support 34 , the front bottom wall 2 , the rear bottom wall 4 , the front hanger wall 17 , the rear hanger wall 18 , the left receptacle wall 15 , the right receptacle wall 16 , the right upright 6 and the extension wall 30 . Referring to FIGS. 6-7, the angle brackets 13 employed for upright support can have length extended vertically along sides, edges and corners of the left upright 1 , the right upright 6 , the front bottom wall 2 , the front hanger wall 17 , the rear bottom wall 4 , the rear hanger wall 18 and the extension wall 30 for an angle-bracket embodiment. The front hanger wall 17 can be positioned directly above the front bottom wall 2 and the rear hanger wall 18 can be positioned directly above the rear bottom wall 4 as illustrated with breakaway lines for this embodiment. The angle brackets 13 can be adhered with adhesive or bolted to adjoining walls. Referring to FIGS. 8-12, the overlap brackets 14 employed for upright support also can have length extended vertically proximate sides of the left upright 1 , the right upright 6 , the front bottom wall 2 , the front hanger wall 17 , the rear bottom wall 4 , the rear hanger wall 18 and the extension wall 30 for an overlap-bracket embodiment. As for the angle-bracket embodiment described in relation to FIGS. 6-7, the front hanger wall 17 can be positioned directly above the front bottom wall 2 and the rear hanger wall 18 can be positioned directly above the rear bottom wall 4 as illustrated with breakaway lines for this embodiment. The overlap brackets 14 also can be adhered with adhesive or bolted to adjoining walls. A new and useful poolside organizer having been described, all such foreseeable modifications, adaptations, substitutions of equivalents, mathematical possibilities of combinations of parts, pluralities of parts, applications and forms thereof as described by the following claims and not precluded by prior art are included in this invention.

A poolside organizer has build-up structure with quick-and-easy assembly of a base enclosure ( 11) and a top enclosure ( 23) having upright support from the base enclosure. A front hanger wall ( 17) supports a plurality of hangers ( 25) for holding swimming attire and other items. A left upright ( 1) supports a plurality of tube hangers ( 24). A right upright ( 6) supports a plurality of the swimming-attire hangers in addition to one or more optional boxlike poolside trays ( 26). An extension closure ( 29) contains un-hangable poolside items loosely or in baskets.

[0001] This is a divisional application of co-pending U.S. patent application Ser. No. 09/627,261, filed Jul. 28, 2000, now U.S. Pat. No. 6,610,093, issued Aug. 26, 2003. BACKGROUND OF THE INVENTION [0002] The present invention relates to an intervertebral disk stabilizing implant and a method of stabilizing two adjacent vertebrae. More specifically, the present invention relates to upper and lower interlocking brackets which attach to adjacent vertebrae sufficiently to stabilize the vertebrae but allow for some forward flexion and rearward extension of the spine with slight lateral displacement. An alternative embodiment provides for stability of the spinal column, with flexion and extension with spinal shock absorption. [0003] The spine is a flexible structure comprised of thirty-three vertebrae. The vertebrae are separated and cushioned from each other by fibrous cartilage in structures called intervertebral disks. If the spine is injured or becomes diseased, surgical intervention involving removal of one or more of these disks and fusion of the adjacent vertebrae, may be indicated. Such disk injuries can happen in the neck, in the thoracic region and in the lumbar region. The more frequent injuries are in the lower lumbar and in the lower cervical regions. [0004] Treatment of a herniated disk in the neck and in the lumbar region continues to be a challenging field of medicine. The classical treatment for a ruptured disk continues to be removal of the disk from between the vertebrae. By this process of removing the disk, overall spinal instability is increased. This may aggravate the patient to some degree after the operation. Another procedure previously employed is to replace the disk space with a bone graft, bringing about fusion of the vertebrae above and below the disk, eliminating the empty space between the vertebrae and improving stability. [0005] Theoretically a diskectomy with fusion is a satisfactory procedure, though not ideal because the replaced bone does not have the principal functions of the cartilage tissue of the disk. This fusion procedure is technically demanding and has medical complications because of several physiological factors. [0006] It must be remembered that the disk primarily serves as a mechanical cushion while permitting limited mobility. For any replacement system for a disk to be truly effective, it must allow for mobility within the natural limits of the original disk. In other words, the replacement should match appropriate joint rheology (movement behavior). The natural disk allows about 11 degrees of flexion-extension, limited lateral bending of 3 to 5 degrees, and very restricted rotation of about 1 degree. [0007] Various prosthetic devices and implants are disclosed in the art, but all are characterized by compromises to the full functions of a natural disk discussed above. Examples of the prior art include the following U.S. Pat. Nos. 5,893,890; 5,693,100; 5,658,336; 5,653,761; 5,653,762; 5,390,683; 5,171,278; and 5,123,926. The present invention improves upon the state of the art including the inventor's own prior inventions by more closely approximating the natural function of the disk, including extension-flexion, slight lateral bending, and very slight rotation. SUMMARY OF THE INVENTION [0008] This present invention provides a method and apparatus for providing vertebral stabilization while further providing shock absorption; flexion and extension (mobility); slight lateral bending; and very slight rotation about the spinal column; and, still achieving spinal stability. The vertebral disk stabilizer of the present invention has upper and lower brackets with vertebral attachment plates. Arcuate surfaces on the brackets provide for a structural configuration which conforms to the shape of the intervertebral space. The upper and lower brackets are linked or attached to one another by complimentary ribs and rib receiving grooves or a “ball and socket” linkage. The stabilizer is vertically affixed to the outer cortial surface of adjacent vertebrae by conventional medical fasteners which extend through the bracket plates into the vertebrae bodies. [0009] An independent intervertebral disk member is disposed and retained between the upper and lower brackets. The disc member may be, alternatively: (a) a compressible composition; (b) a metal disk member with a mechanical spring mechanism affixed between the upper and lower brackets; or (c) a combination of compressible material and mechanical spring. BRIEF DESCRIPTION OF THE DRAWINGS [0010] [0010]FIG. 1 is a lateral view of a portion of a human spinal column having a preferred embodiment of the vertebral disk stabilizer of the present invention inserted therein. [0011] [0011]FIG. 2 is a side elevation view of the present invention illustrating the medical fasteners. [0012] [0012]FIG. 2A is a top plan view of the upper bracket of the present invention. [0013] [0013]FIG. 2B shows a top plan view of the intervertebral cushion member of the present invention. [0014] [0014]FIG. 2C is a top plan view of the lower bracket of the present invention. [0015] [0015]FIG. 3 illustrates an exploded perspective view of one embodiment of the present invention. [0016] [0016]FIG. 4 illustrates an exploded perspective view of another embodiment of the present invention. [0017] [0017]FIG. 4A illustrates an exploded perspective view of an alternative disk of the present invention. [0018] [0018]FIG. 4B illustrates an exploded perspective view of yet another disk of the present invention. [0019] [0019]FIG. 4C illustrates an exploded perspective view of an additional disk of the present invention. [0020] [0020]FIG. 5 illustrates an exploded perspective of an embodiment of the present invention with an arcuate rib having inwardly slanting side walls. [0021] [0021]FIG. 6 illustrates an exploded perspective of an embodiment of the present invention with a “ball and socket” linkage. [0022] [0022]FIG. 6A illustrates in detail the intervertebral disk of one embodiment of the present invention which utilizes the “ball and socket” linkage. [0023] [0023]FIG. 7 shows a partial cutaway perspective view of yet another embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0024] Referring now to the figures, a first embodiment of a disk stabilizer constructed in accordance with the teachings of the present invention is shown implanted in a human spinal column in FIG. 1. The vertebral disk stabilizer, indicated generally at reference numeral 10 , is implanted between the bodies 12 and 14 of adjacent vertebrae 16 and 18 , respectively, in the disk space (not numbered) from which a portion of the invertebral disk 20 is removed, i.e., by simple diskectomy and small laminotomy. [0025] In FIG. 2, the stabilizer 10 is comprised of an upper bracket 22 , a lower bracket 24 , and an invertebral disk 26 . Brackets 22 and 24 may be composed of a strong, thin, non-porous material. Suitable materials for the brackets include carbon fiber, modified carbon, titanium, surgically compatible steel, physiologically inert and/or medically compatible polymers such as urethane or DELRIN® polymers, or any surgical implant or any biologically compatible material. [0026] In the presently preferred embodiment shown, the means for mounting the invention to the spine takes the form of fasteners 30 passing through bores 32 in vertical vertebral attachment plates 34 and into the bodies 12 and 14 . The plate ends are tapered for a smooth contour fit to the bodies 12 and 14 . The brackets 22 and 24 are linked to the disk 26 by ribs 38 and 40 . Ribs 38 and 40 are generally cylindrical protrusions extending transversely partially across the bottom surface of the brackets. Alternatively, one rib could be affixed to the upper bracket 22 and one rib could be attached to the underside of the disk. Thus, the disk rib would be a generally cylindrical protrusion extending transversely partially across the bottom surface of the disk member 26 . [0027] Bracket rib 38 is received and retained in rib receiving groove 39 in the upper surface of disk 26 (FIG. 2B). The rib 38 and groove 39 act as hinge elements or bearing elements and are sized such that the rigid rib 38 is retained into engagement in the groove, but the cylindrical shapes of the rib and groove interlock to resist disengagement. In the alternative where a rib is affixed to the disk, the disk rib would be received and retained in a rib receiving groove in the upper surface of the lower bracket 24 . [0028] It is important to understand that the size of effective diameter d 1 of a rib 38 or 40 is less than the size or effective diameter d 2 of the grooves 39 or 41 . This allows for movement of the rib within the groove, but not so much movement as to result in vertebral instability. As will be seen below the groove depth must be sufficient to allow the rib to move vertically in a cushioning or shock absorbing mode of the device 10 . [0029] The intervertebral disk 26 may be composed of any number of compressible physiologically inert and/or medically compatible polymers. Again, only by way of example and not as a limitation, the disk could be made of urethane or a DELRIN® polymer. The purpose of the compressible composition is to provide shock absorption between the interlocked brackets 22 and 24 . Later it will be shown that mechanical springs may be substituted for the compressible disk composition. In such a case the disk may be constructed by carbon fiber, modified carbon, titanium, surgically compatible steel, or any other rigid material acceptable in such operations. [0030] It should be noted that the outer ends 42 and 44 of disk 26 may be chamfered to allow flexion and extension of the spine through movement of the stabilizer forwardly and rearwardly (shown by arrows in FIG. 2). The desired range of flexion and extension is adjusted by the angle of the chamfer, as the patient bends or leans forward or backwards. [0031] As may be seen in FIGS. 1, 2, 3 , and 4 , the disk ends 42 and 44 may be chamfered at both ends, one end, or no end. Where flexion and extension require, the bracket ends 17 and 19 may be chamfered and upon rotation the disk 26 will halt the degree of rotation as will be understood by on skilled in the art. For example, FIG. 2 shows bracket ends 17 and 19 chamfered and disk end 44 squared off. Again, the arrows in FIG. 2 illustrate that flexion and extension are available with the present invention. FIG. 2 further shows that when the present invention 22 is assembled the plates 34 align substantially along the same longitudinal axis L. [0032] In more detail, now referring to FIG. 3, it may be seen that the top arcuate side 23 of upper bracket 22 and the bottom arcuate side 25 of lower bracket 24 are roughened or textured. These bi-convex sides 23 and 25 of stabilizer 10 are provided with a plurality of teeth or ridges 50 for biting or gripping into the adjacent vertebrae 16 and 18 . Those skilled in the art who have the benefit of this disclosure will recognize the sides 23 and 25 of the stabilizer 10 need not define a true arch which is symmetrical. It will also be recognized that the sides 23 and 25 need not be provided with the serrations 50 to bite into the vertebrae. This biting function can also be accomplished by providing the sides 23 and 25 with multiple steps formed in right angles along sides 23 and 25 or by simply knurling the surfaces of these sides. [0033] Another feature of the present invention illustrated in FIG. 3 is the incorporation of bearing surfaces 52 and 54 in disk member rib receiving grooves 39 and 41 . These surfaces are intended to reduce friction and extend the life of the parts. It should be understood that low friction surface materials may be substituted for any type of mechanical bearing. [0034] An alternative preferred embodiment 10 A is illustrated in the exploded perspective view of FIG. 4. In most ways stabilizer 10 A is identical to stabilizer 10 except that a mechanical shock absorption mechanism is provided. Disk 26 A is provided with two central depressions 60 of sufficient depth and diameter to allow compression springs 64 and 65 to be fitted and retained in depressions 60 (the second depression is on the underside of the disk 26 A in FIG. 4). Spring 65 may be attached to bottom surface 69 of the lower bracket 24 A in complimentary depression 80 . Spring 64 may likewise be attached to the bottom surface 66 of upper bracket 22 A. Springs 64 and 65 thus result in a means for varying the degree of shock absorption which may be achieved by the stabilizer 10 A. [0035] FIGS. 4 A- 4 C illustrate alternative disk arrangements available to provide for shock absorption. In FIG. 4A, disk 26 C is provided with a multiplicity of depressions 80 A along its top surface 47 (and, if desired, bottom surface 37 ). The depressions are sized to accept and retain compression pillars 64 A. By varying the composition and quantity of pillars the physician is able to control the compressive force absorption in each stabilizer. Further, the pillars will allow for a slight degree of lateral vertebral movement. However, the relationship between the diameters d 1 and d 2 of the ribs and grooves, respectively, controls the total amount of movement available in any embodiment. [0036] [0036]FIG. 4B illustrates the utilization of leaf-type springs 64 B on this disk embodiment 26 D. Further, a unitary spring, a single pillar, or a combination may be used. FIG. 4C shows compression element 64 C passes through the disk member 26 E through opening 80 C and is attachable to the upper and lower brackets, as would be readily understood by one skilled in the art. [0037] Again, it should be understood that any combination of compressible materials and mechanical springs may be employed to absorb shock in the present invention The disk could be metal with compressible pillars; it could be a compressible composition with compressible pillars; or it could be a compressible composition with metal springs. [0038] Turning to FIG. 5, another embodiment of the present invention 10 F may be seen. The key distinction of this embodiment relates to the interlocking ribs 38 F and 40 F. The central height H c of the ribs on the bottom side 69 of brackets 34 is greater than the end height He of the inwardly slanting side walls 91 . The grooves 39 F and 41 F in disk 26 F have depths D g which are greater than the central height H c . This arrangement, in coordination with the slanting walls 91 , allows for the brackets (attached to the vertebrae) to flex, extend, and move laterally with a very slight twisting operation. At the same time, the spinal column is stabilized. As may be seen in FIG. 5, the grooves 39 F and 41 F may be fitted with roller bearings 52 and 54 to reduce frictional forces as previously discussed with FIG. 3 [0039] The embodiment 10 G of FIG. 6 utilizes a unique ball and socket linking arrangement. The brackets are provided with a ball 41 G at the end of a neck 96 G attached to the underside of the bracket. Also attached to the underside are rigid stop pegs 92 G and 94 G. The pegs 92 G and 94 G cooperate with stop notches 90 G in the invertebral disk 26 G to limit excessive lateral motion and rotation of the elements of the device 10 G. The pegs 94 G have diameters smaller than the diameters of the notches and generally do not contact the notches except when the lateral motion or rotation becomes excessive. [0040] The balls 41 G cooperate with the sockets 38 G to both receive and retain the interlocking relationship of the separate elements of the invention. The socket has a greater diameter than the ball. The socket wraps over half of the ball diameter to keep the ball from being dislocated during flexion/extension of the spine. [0041] [0041]FIG. 6A shows how the ball 38 G at the end of neck 96 G extends downwardly from the upper bracket into and is retained in the socket 39 G in the disk 26 G. [0042] It should be understood that the tolerances of the interlocking and cooperating parts are intended to allow for the normal range of movements discussed above. Thus the target range of flexion/extension is 9-12 degrees, lateral bending in the range of 3 to 5 degrees, and a very slight 0.5-1.5 degrees rotation of adjacent joined vertebrae. [0043] Yet another embodiment of the present invention 10 B is shown in FIG. 7. Upper bracket 22 B has a vertical vertebral attachment plate 34 B with bores 32 B for receiving fasteners to attach the stabilizer 10 B to the first vertebrae body 12 . A linking hook 70 is attached to the plate and is arcuated. A rib 72 is formed in the top side 74 of the hook 70 . Lower bracket 24 B also has a vertical disk attachment plate 34 B with bores 32 B. An opening 76 is formed in the lower bracket 24 B to receive and retain the linking hook 70 . An interlocking arcuate cavity 78 is also formed in lower bracket 24 B. A rib receiving groove 79 allows the flexion (shown in arrows in FIG. 5) of the stabilizer 10 B. There is sufficient “play” or clearances between the hook 70 and rib 72 within the rib receiving groove 79 to maintain stability but allow for limited mobility (flexion). [0044] In each embodiment of the present invention the separate parts are sized to facilitate insertion within the intervertebral space created and sustained between adjacent vertebrae during the medical insertion procedure. [0045] It is anticipated that the stabilizer 10 of the present invention will be fully assembled prior to insertion into the intervetebral space. Thus, by varying the compressive force mechanism and the size of the brackets and disk, the physician will be able to utilize the present invention with any number of different size patents. [0046] The use of the stabilizer 10 of the present invention in, for instance, a method of intervertebral disk stabilization is illustrated in FIG. 1. Surgery is performed as a simply diskectomy and the intervertebral disk 20 is exposed. The natural deteriorated disk material is removed and any nerve root compression is corrected. Any ligament, muscle, or cartilage covering the vertebrae are moved or removed until the surface of the bodies 12 and 14 of adjacent vertebrae 16 and 18 , respectively, are exposed above and below the disk space. [0047] Using spreaders the vertebrae 16 and 18 are distracted to open the disk space sufficient to inset the stabilizer. [0048] A stabilizer 10 having a height and width selected to fit the disk space is then mounted to an applicator (not shown) as is well known in the art. The appropriate sized stabilizer 10 is then inverted into the disk space with the stabilizer oriented so that the upper convex side 23 of bracket 22 and bottom convex side 25 of bracket 24 engage the bodies 12 and 14 of adjacent vertebrae 16 and 18 , respectively. The vertical attachment plates or plates 34 are vertically aligned with the vertebrae. Fasteners 30 are then passed through bores 32 thereby securing the upper and lower brackets to the spinal column. [0049] Although the invention has been described with reference to a specific embodiment, this description is not meant to be construed in a limiting sense. On the contrary, various modifications of the disclosed embodiments will become apparent to those skilled in the art upon reference to the description of the invention. It is therefore contemplated that the appended claims will cover such modifications, alternatives, and equivalents that fall within the true spirit and scope of the invention.

A method and apparatus for stabilizing adjacent vertebrae. Upper and lower interlocking brackets are insertable in a prepared intervertebral space between adjacent vertebrae. The brackets are affixed to the vertebrae at attachment plates. A rib on one side of one bracket interlocks with a rib receiving groove in the other bracket to stabilize the spinal column without eliminated mobility (forward and rearward flexion) of the column. Various embodiments include additional shock absorption features.

BACKGROUND OF THE INVENTION 1. Field of the Invention The invention is directed to an injection apparatus for injecting at least two components to be brought into reaction with one another, the apparatus including a hollow injection needle that can be coupled to a plurality of syringe coupling connections corresponding in number to the number of components. The apparatus is preferably used for endoscopic purposes and is displaceable in a catheter with a grip member, whereby the syringe coupling connections are provided on the catheter in this case. 2. Description of the Related Art Such injection apparatus are particularly employed for injecting two-component fibrin adhesives, whereby fibrin or fibrinogen is to be brought into reaction with thrombin at such locations within the human body whereat bleeding must be stopped by closing blood vessels. Such fibrin adhesive injection apparatus are commercially known and can be divided into two types. In the one type, the hollow injection needle is connected to a hose that discharges into the handle sections of a chamber into which the channels of the two syringe coupling connections in turn discharge. By actuating the two syringes, the two components of the fibrin adhesive are simultaneously introduced into the chamber and from the latter into the hose in which they should mix before they reach the hollow injection needle. On the one hand, a thorough blending of the two components is thereby not guaranteed; on the other hand, there is also the risk that the mixture of components will harden before reaching the hollow injection needle and thereby block the hose. In the other type of apparatus, two hollow injection needles are therefore employed that are bonded to one another side-by-side and are each respectively connected to the syringe coupling connections via a hose, whereby the two hoses proceed side-by-side in the catheter. A relatively large thickness of the composite needles in the directions of their diagonals which continue one another thereby derives, whereby the individual hollow needles have their side containing their tip arranged against one another, so that the aperture angle of the hollow needle arrangement is relatively large, this leading to an undesirably pronounced damage to the tissue. Moreover, a good blending of the two adhesive components is not guaranteed because the components emerge laterally side-by-side from the injection needles into the tissue to be treated and the axes of their discharge flows are at a relatively great distance from one another. SUMMARY OF THE INVENTION It is therefore the object of the invention to provide an injection apparatus of the type initially cited, whereby the puncture resistance of the hollow injection needle is kept low and a good blending of the components without risk of premature hardening is achieved. In an injection apparatus of this type, this object is achieved by the components being supplied to the injection needle through a corresponding plurality of hoses preferably proceeding through the catheter and each respectively connected to one of the syringe coupling connections in the gripping member, the components discharging in a common plane in which the reaction of the components is initiated. Advantageous developments of the invention provided by the hollow injection needle being connected to a first hose wherein a second hose having a smaller outside diameter than the inside diameter of the first hose proceeds coaxially therein up to the grip member, the second hose discharging at a slight distance preceding the proximal end of the hollow injection needle. The injection apparatus may further be characterized in that the injection needle is fixed to a sleeve secured in the first hose, the second hose ending in the sleeve. It is also contemplated that the injection apparatus include a plurality of injection channels corresponding in number to the number of components, the injection channels being formed in the hollow injection needle and discharging in the end plane of the injection needle. This injection apparatus is then preferable includes a first injection channel connected to a first hose wherein a second hose that is connected to a second injection channel and has a smaller outside diameter than the inside diameter of the first hose proceeds up to the grip member. As a further improvement, the injection apparatus includes an axially proceeding partition in the hollow injection needle and the two injection channels proceeding at the two sides of the partition. An injection apparatus of the type first described is further characterized in that the hollow injection needle is formed of a plurality of individual hollow needles corresponding in number to the number of components, the end planes of these individual hollow needles lying in a common plane. A preferred embodiment of such apparatus has the individual hollow needles being of different diameters. The injection apparatus may have the individual hollow needles joined to one another in parallel, or the individual hollow needles are at least partially flattened at their outside and are attached to one another along these flat sides. The individual hollow needles are attached to one another such that the tip of the needle of the hollow injection needle is formed by the tip of the individual hollow needle having the smallest diameter. At least one channel-shaped outwardly arced portion wherein a further individual hollow needle is introduced is fashioned along at least one of the individual hollow needles. The injection apparatus is also characterized in that the individual hollow needles are arranged coaxially relative to one another. In the invention, the components are supplied to the injection needle through a corresponding plurality of hoses proceeding through the catheter that are each respectively connected to one of the syringe coupling connections in the gripping member, whereby the components discharge in a common plane wherein the reaction of the components is initiated. In a preferred embodiment, the hollow injection needle is connected to a first hose wherein a second hose having a smaller outside diameter than the inside diameter of the first hose proceeds coaxially therein up to the gripping member, whereby the second hose discharges at a slight distance preceding the proximal end of the hollow injection needle. It is also preferred that the injection needle is fixed to a sleeve secured in the first hose, the second hose ending in the sleeve. A plurality of injection channels corresponding in number to the number of components are provided in the hollow injection needle, whereby the injection channels discharge at the end plane of the injection needle. A first injection channel is thereby again connected to a first hose wherein a second hose that is connected to a second injection channel and has a smaller outside diameter than the inside diameter of the first hose proceeding up to the gripping member. According to a preferred embodiment, an axially proceeding partition is fashioned in the hollow injection needle and the two injection needles proceed at the two sides of the partition. Further, the hollow injection needle is formed of a plurality of individual hollow needles corresponding in number to the number of components, the end planes or faces of these individual hollow needles lying in a common plane. The individual hollow needles thereby have different diameters. The individual hollow needles also are attached such to one another that the needle tip of the hollow injection needle is formed by the tip of the individual hollow needle having the smallest diameter. Further, at least one channel-shaped bulged portion wherein a further individual hollow needle is introduced proceeds along at least one of the individual hollow needles. Finally, a coaxial arrangement of the individual hollow needles is possible. In the invention, a single end plane of the injection hollow needles is provided for the injection means, regardless of the way in which the delivery of the components occurs. It has been shown that the tissue resistance given an angle of approximately 20% for the end plane relative to the axis of the hollow injection needle remains so low that an excessive damage to the tissue is largely impossible. Such an optimum, uniform angle is retained in every embodiment of the injection means of the invention. It is also defined at the same time that the delivered components discharge in a common plane, whereby the reaction of the components is initiated in this plane. The common plane can lie in one of the hoses preceding the injection needle; however, it can also coincide with the end plane of the injection needle. BRIEF DESCRIPTION OF THE DRAWINGS The invention shall be set forth in greater detail below with reference to the drawings merely by way of example. Shown are: FIG. 1 a side view of the injection means of the invention; FIG. 2 a partial longitudinal section through a first embodiment of the invention in the region of the hollow injection needle, shown in an enlarged scale; FIG. 3 a partial longitudinal section through a second embodiment of the invention in the region of the hollow injection needle; FIG. 4 a partial longitudinal section through a third embodiment of the invention in the region of the hollow injection needle, whereby the hollow injection needle comprises injection channels; FIG. 5 a partial longitudinal section through a fourth embodiment of the invention in the region of the hollow injection needle, whereby a fashioning of the injection channels modified in comparison to FIG. 4 is provided; FIG. 6 a plan view onto a further embodiment of the invention in the region of the hollow injection needle; FIG. 7 a cross section through the hollow injection needle of FIG. 6; FIG. 8 the plan view of a modified fashioning of the hollow injection needle; FIG. 9 a cross section through the hollow injection needle of FIG. 8; FIG. 10 a longitudinal section through a hollow injection needle conforming to a further embodiment of the invention; FIG. 11 a cross section through the hollow injection needle of FIG. 10; and FIG. 12 a partial longitudinal section through an embodiment of the present invention in the region of the hollow injection needle, whereby the individual hollow needles are coaxially arranged. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The injection apparatus shown in FIG. 1 comprises a T-shaped grip member 2 that is slipped over a slide sleeve 9 secured to it in a grip sleeve 10 to whose end facing away from the grip member 2 a flexible, hose-shaped catheter 1 is fixed. A hollow injection needle 3 is displaceable in the distal end of the catheter 1 by displacing the slide sleeve 9 in the grip sleeve 10. By pushing the slide sleeve 9 into the grip sleeve 10, thus, the hollow injection needle 3 is pushed out of the distal end of the catheter 1. According to FIG. 2, the injection needle 3 is lengthened by a sleeve 8 for this purpose, the distal end of a first hose 4 whose proximal end is anchored in the gripping member 2 being secured to this sleeve 8. The distal end of a second inside hose 5 discharges freely into the sleeve 8, the outside diameter of this second inside hose 5 being smaller than the inside diameter of the outer hose 2 and proceeding coaxially in the latter up to the grip member 2. At this location, the inner hose 5 is connected to a first syringe coupling connection, by contrast whereto the outer hose discharges into a transverse chamber 11 through which the first hose 4 passes and in which a second syringe coupling connection 7 discharges. The syringes (not shown) are filled with the adhesive components that, after the syringes have been coupled to the syringe coupling connections 6 and 7 given simultaneous actuation of the syringe piston, are pumped into the respectively allocated hose 4, 5 and meet intimately in a common plane 30 in the sleeve at a distance in front of the hollow injection needle 3 where the reaction of the components is initiated and being blended with one another subsequently until they emerge from the hollow injection needle 3. The initiation of the reaction and the blending ensues immediately in front of the hollow injection needle and in this needle itself, as a result whereof a premature curing of the components is avoided and a blending is nonetheless achieved before emergence from the hollow injection needle into the tissue to be treated. The single-channel hollow injection needle can be adequately thin, as a result whereof no complications can occur upon injection of the component mix. In the embodiment of FIG. 3, too, the hollow injection needle 3 is lengthened by a sleeve 8 to which the distal end of a first hose 4 is fixed, the proximal end of this first hose 4 being anchored in the grip member 2. A tube 18 is introduced into the hollow injection needle 3, the distal end of a second inner hose 5 whose outside diameter is smaller than the inside diameter of the outer hose 2 and that proceeds in the latter practically coaxially up to the grip member 2 discharging into this tube 18. The inner hose 5 is again connected to a first syringe coupling connector 6; by contrast thereto, the outer hose discharges into a transverse chamber 11, as set forth in conjunction with FIG. 2. The tube 18 is arranged concentrically relative to the injection needle 3 and is fixed for this purpose in the hose 8 with supporting mechanisms 15. The tube 18 ends at a slight distance before the discharge of the injection needle, whereby the reaction of the components delivered through the hoses 4, 5 is initiated in a plane 30. Embodiments (not shown) are also possible wherein the tube projects eccentrically into the hollow injection needle or is bonded thereto at one side. The tube can even be merely loosely introduced into the hollow injection needle. Which of the disclosed embodiments is selected also depends on the relative viscosity that the components to be mixed with one another have. Given employment as a fibrin adhesive injection means, one must note that fibrinogen is more viscous and therefore has a higher viscosity than the thrombin, so that an optimally large, uniform flow cross section must be available for the fibrinogen. Two injection channels 13 and 14 are provided in FIG. 4 by inserting a hollow needle 12 into the hollow injection needle 3. A hollow needle 12 thereby proceeds eccentrically in the hollow injection needle 3 and can be bonded thereto at one side. Its discharge terminates flush with the ground plane 30 of the hollow injection needle 3. The hollow needle 12 discharges into the distal end of the inner hose 5 that again proceeds roughly coaxially in the hose 4. The injection needle 3 is lengthened by the sleeve 8 and lies in the catheter 1 together with this sleeve 8. Two injection channels 13, 14 are formed in the embodiment of FIG. 5 in that an axially proceeding partition 16 is bonded into the hollow injection needle 3, so that the two injection channels 13 and 14 proceed at the two sides of the partition. They each respectively discharge into one of the hose channels of a two-lumen hose 17 fixed to the sleeve 8 but can also be connected to hoses having different diameters as in the above-described embodiments, whereby the hose having the smaller diameter is laterally inserted into that having the larger diameter. The partition 16 is placed such that it ends in the ground plane 30 of the hollow injection needle 3. The components to be brought into reaction meet immediately upon emergence from the hollow needle and are blended with one another. Further embodiments of the present invention are possible by employing individual hollow needles; it must be merely assured that the individual hollow needles end in a common ground plane. As a result thereof, the angle of the tip for a low puncture resistance is as small as that of every individual hollow needle; the blending of the ejected components is also promoted. In FIG. 6, the individual hollow needles 20, 21 are placed against one another in parallel and are inseparably joined to one another in their adjacent region, for example are bonded to one another. FIG. 7 shows a cross section through the hollow injection needle 3 formed in this way, whereby the overall cross section is formed of those of the individual hollow needles 20, 21 each of which has a circular cross section. The individual hollow needles 20, 21 shown in FIG. 7 that form the hollow injection needle 3 with one another each comprise respective flat sides 25, 26 that are placed against one another and along which the individual hollow needles 20, 21 are secured to one another. The cross-sectional areas of the individual hollow needles, as shown in FIG. 9, are semicircular, so that the overall cross section of the hollow injection needle 3 is essentially circular. According to FIG. 10, the hollow injection needle 3 is again composed of two individual hollow needles 20, 21, whereby one of the individual hollow needles 20 has one side provided with a longitudinally proceeding, channel-shaped inwardly arced portion 24 into which the other individual hollow needle 21 is introduced. FIG. 11 shows this arrangement in cross section. The beveled surfaces of the two individual hollow needles 20, 21 lie in a common ground plane 30 that, for forming the tip 23 of the needle, is placed at an angle of 15° through 25°, preferably 20°, with reference to the axis of the injection needle 3. FIG. 12 shows an embodiment of the hollow injection needle 3 for an injection means of the present invention wherein two individual hollow needles 20, 21 are placed such coaxially that their discharge surfaces discharge in a common plane 30. The inwardly disposed individual hollow needle 21 is thereby fixed with reference to the outer individual hollow needle 20 by a helically proceeding rib 27 that engages into corresponding grooves 28 at at least three locations at the inside wall of the outer individual hollow needle 20. Other fastening possibilities are also conceivable when it is merely assured that the inner individual hollow needle 21 retains its position with reference to the outer individual hollow needle 20. Both individually as well as in arbitrary combinations, the features of the invention disclosed in the above specification, in the drawings as well as in the claims can be critical for the realization of the various embodiments of the invention. Although other modifications and changes may be suggested by those skilled in the art, it is the intention of the inventors to embody within the patent warranted hereon all changes and modifications as reasonably and properly come within the scope of their contribution to the art.

Injection apparatus for injecting at least two components to be brought into reaction with one another, comprising a hollow injection needle that can be charged by a plurality of syringe coupling connections corresponding in number to the number of components, preferably for endoscopic purposes and fashioned displaceable in a catheter on the basis of a grip member, whereby the syringe coupling connections are provided at the catheter in this case, characterized in that the components can be supplied to the injection needle (3) through a corresponding plurality of hoses (4, 5; 17) preferably proceeding through the catheter (1) and respectively connected to one of the syringe coupling connections (6, 7) in the grip member (2), whereby the components discharge in a common plane (30) wherein the reaction of the components is initiated.

BACKGROUND OF THE INVENTION The present invention relates to method of producing an odorless soybean milk having no smell of soybean and a method of producing tofu (bean curd) using bittern. In the past, soybean milk has been produced by fully soaking soybeans in water, grinding the soaked soybeans, adding water to the thus ground soybeans (the resulting solution is referred to as a go-eki) and boiling and straining the go-eki through a piece of cloth. On the other hand, bean curd has been produced by coagulating the soybean milk with bittern (the principal component is magnesium chloride) which is a coagulant and the production of bean curd has been made by a workman by hand thus still considerably retaining the character of domestic industry up to quite recently. Because the reactivity of magnesium chloride has been so high that skill is required for the production of bean curd and therefore the production of bean curd has been considered to be unsuitable for mass production. However, due to the fact that there had been a time when it was difficult to obtain magnesium chloride and also due to the excessively high reactivity of the magnesium chloride, the use of calcium sulfate or glucono delta lactone as a coagulant has begun several tens years ago and quite different types of bean curd from those made by the old and traditional production method have been placed in large quantities on the market. Presently, the types of bean curd available in large quantities on the market can be divided broadly into three classes of so called cotton type bean curd of the rather tough kind, silk type bean curd of the soft kind and fill-in type bean curd of the kind filled in a sealed package. In recent years, there has been an increasing voice for natural food and therefore the demand for soybean milk as a natural drink or a raw material for bean curd has been increasing. Also, while mass-produced inexpensive packaged bean curds have become available in these modern days, there has been a rapid growth in the demand for bean curd of the conventional type employing bittern and containing no artificial additive. However, soybean milk made from soybeans has had a peculiar smell of soybean and spices, chemicals, etc., have been added to drown the smell of soybean, thus making the resulting soybean milk far from the one that can be considered as a natural drink. Also, with the bean curd of the type employing the bittern, the reactivity of the bittern has been so high as mentioned previously that the coagulation process requires skill. As a result, the production of such bean curd by machinery has not been realized as desired and the production has been effected by a hand method, thereby supplying bean curd made on a small scale and hence expensive only to the local market. In addition, the disposal of bean curd refuse resulting in the course of the production of bean curd has presented a problem in small-scale bean curd factories. Moreover, due to the high reactivity of bittern, the production of silk type bean curd has been made only by using calcium sulfate and glucono delta lactone as coagulating agents. Further, after the production of the bean curd, the long-distance transport has involved the danger of the bean curd getting out of shape during the transport due to it being so soft. SUMMARY OF THE INVENTION It is the primary object of the present invention to provide a method of producing soybean milk and bean curd capable of producing soybean milk free of a peculiar smell of soybean and producing bean curd of the type employing bittern, low in cost and producible by machinery as well as adapted for supply over far and wide areas. To accomplish the above object, in accordance with a first aspect of the invention there is provided a method of producing soybean milk comprising soaking soybeans in water and grinding the soaked soybeans to obtain a so-called go-eki, boiling the go-eki and straining the boiled go-eki to separate into soybean milk and bean-curd refuse. In the course of boiling the go-eki, the go-eki is boiled at 110° to 120° C., cooled by the addition of water and again boiled at 110° to 120° C. In accordance with a second aspect of the invention, there is provided a method of producing bean curd by coagulating soybean milk with a coagulating agent. The soybean milk used comprises the one obtained by the method of the first aspect and the coagulating agent consists of bittern mainly composed of magnesium chloride. When adding the bittern to the soybean milk, a given amount of the bittern is added at a time to the soybean milk being agitated in a container equipped with an agitator and simultaneously the agitated flow is stopped instantaneously, thereby coagulating the soybean milk. In accordance with a third aspect of the invention, there is provided a method of producing bean curd by coagulating soybean milk with a coagulating agent, in which using the soybean milk obtained by the method of the first aspect and a granular bittern consisting mainly of magnesium chloride as the coagulating agent, a given amount of the bittern is added at a time uniformly to the soybean milk in a container concurrently serving the purpose of shaping and the mixture is instantaneously agitated, thereby coagulating it. In accordance with a fourth aspect of the invention, there is provided a method of producing bean curd by coagulating soybean milk with a coagulating agent, in which bittern mainly consisting of magnesium chloride as the coagulating agent is used, the bittern is added in such a manner that while agitating the soybean milk in a container equipped with an agitator, a given amount of the bittern is added at a time and simultaneously the agitated flow is stopped instantaneously, thereby coagulating the soybean milk. In accordance with a fifth aspect of the invention, there is provided a method of producing bean curd by coagulating soybean milk with a coagulating agent, in which a granular bittern mainly consisting of magnesium chloride as the coagulating agent is used, a given amount of the bittern is added at a time uniformly to the soybean milk in a container concurrently serving the shaping purposes and the mixture is instantaneously agitated slowly, thereby effecting the coagulation. With the methods of producing bean curd according to the aspects 2 to 5, it is preferable to comprise additional steps such that after the coagulated soybean milk has been shaped, it is matured for 5 to 8 hours at 5° C. or less under the condition of water immersion. With the methods of producing bean curd according to the aspects 2 to 5, preferably a first place of production for making soybean milk and one or more places of production for making bean curd are arranged separately so that the soybean milk produced at the first place of production is transported to the second place of production where the soybean milk is made into bean curd. With the method of producing soybean milk according to the first aspect, the step of boiling the go-eki comprises boiling the go-eki at 110° to 120° C. for 7 to 10 minutes, cooling it by the addition of water and boiling it again at 110° to 120° C. for 3 to 4 minutes. By so doing, the odorous principle of soybean is evaporated or thermally decomposed. Withe the method of producing bean curd according to the second or fourth aspect, the coagulating step comprises adding a given required amount of bittern at a time to the soybean milk agitated voilently and stopping the agitated flow instantaneously, and thus there is the effect of uniformly mixing the bittern and making uniform cotton type bean curd. Also, with the method of producing bean curd according to the third or fifth aspect, the granular bittern is used in a manner that preferably the bittern is added at a time in such a manner that it is uniformly lined on the surface of the soybean milk and the soybean milk is agitated slowly before the granular bittern melts into the soybean milk, thereby making uniform silk type bean curd. Further, with the methods of producing bean curd according to the second to fifth aspects, after its shaping, the bean curd may be matured for 5 to 8 hours at 5° C. or less under the condition of immersion in water, thereby increasing the toughness and resilience of the bean curd. By so doing, particularly during the long-distance transport there is the less danger of the bean curd getting out of shape in transit even in the absence of any strict anti-vibration measure. Lastly, with the methods of producing bean curd according to the second to fifth aspects, by separately arranging a first place of production for soybean milk producing purposes and a second place of production for bean curd producing purposes to be apart from each other so that the soybean milk produced at the first place of production is transported to the second place of production to make the soybean milk into bean curd, it is possible to supply fresh bean curd to far and wide areas and also the elimination of the soybean milk production process at the second place of production makes it possible to produce and directly sell bean curd in a limited space such as a shop front or the booth at a corner of a supermarket. As described hereinabove, in accordance with the invention the step of producing soybean milk is such that the go-eki is boiled at about 120° C., watered for cooling, boiled again at about 120° C. and strained to obtain soybean milk, so that the soybean milk has no smell of soybean and the resulting bean curd is not easily rotten. Further, in the production of cotton type bean curd, after the soybean milk has been agitated in a container equipped with an agitator, bittern is added and simultaneously the agitated flow is stopped by a stop plate, thereby making possible the production by machinery of "cotton type bean curd employing bittern" which has hithertofore been considered difficult due to the coagulation rate of the bittern. Similarly, in the production of silk type bean curd, a crystalline-state bittern is added at a time uniformly and the soybean milk is slowly agitated with an agitating plate to coagulate it, thereby making possible the production by machinery of "silk type bean curd employing bitter" which has heretofore been considered difficult due to the coagulation rate of the bittern. Still further, after the coagulated soybean milk has been shaped, the bean curd is matured overnight at 5° C. or less with the result that the bean curd is coagulated to a greater degree and is increased in strength and resilience, thereby making the bean curd not easily get of shape and withstand the transportation to a long distance. Lastly, by separately arranging the place of soybean milk production and the place of bean curd production, it is possible to supply fresh bean curd to far and wide areas. BRIEF DESCRIPTION OF THE DRAWINGS FIG.1 is a flow sheet showing an embodiment of a method of producing odorless soybean milk according to the present invention. FIG.2 is a flow sheet showing an embodiment of a method of producing cotton type bean curd according to the invention. FIG.3A and 3B are respectively a front view and side view showing the construction of a cotton type bean curd coagulating apparatus. FIG.4 is a flow sheet showing an embodiment of a method of producing silk type bean curd according to the invention. FIG.5 is a perspective view showing the construction of a silk type bean curd coagulating apparatus. DESCRIPTION OF THE PREFERRED EMBODIMENTS Methods of producing soybean milk and bean curd according to preferred embodiments of the present invention will now be described. A: Production of odorless soybean milk Referring to FIG.1, there is illustrated a flow sheet showing an embodiment of a method of producing an odorless soybean milk according to the invention. 7.5kg of soybeans are thoroughly soaked overnight (8 to 13 hours) in water (about 34 liters) to get the resulting soaked soybeans of 11.25kg. The soaked soybeans are ground, and after the addition of water which is about 4 times (45 liters) or about 9 times (100 liters) the weight of soaked soybeans, the resulting solution (hereinafter referred to as a go-eki) (the total quantity is about 56.5 liters when the water is 4 times) is boiled at about 120° C. and at (1.2 atm.) for 7 minutes in a pressure cooker and then cold water (18 liters) is added in 2 to 3 minutes. At this time, the temperature of the go-eki is decreased temporarily to about 90° C. After the addition of the cold water, the go-eki is again increased in temperature to about 120° C., boiled for 3 to 4 minutes and then expressed and strained to remove bean-curd refuse. The resulting liquid is called as soybean milk (the total quantity is about 45 liters). As the result of this process, the miscellaneous bacteria in the soybean milk are destroyed and the odor peculiar to the soybeans is removed. Employing a panel including 7 random members, a comparative sampling test was made on the odorless soybean milk produced by the above-mentioned process and a conventional soybean milk of the type boiled at about 100° C. in the blind trial condition. The results obtained are shown in the following Table 1. TABLE 1______________________________________ Item Smell TastePanel member A B A B______________________________________1 ⊚ ○2 ○ Δ Δ3 ○ ○4 ⊚ ⊚5 ⊚ ○6 ○ Δ Δ7 ⊚ ⊚______________________________________ In the Table, A designates the conventional soybean milk and B designates the soybean milk of the invention. Each of marks, ⊚, ○ and Δ was attached to better one of the two. The mark ⊚ indicates and appraisal of very tasty, ○ an appraisal of tasty and Δ an appraisal of little difference between the two. In accordance with the invention, while the smell of soybean is removed and at the same time the miscellaneous bacteria are destroyed, the soybean milk in the sterile condition is subjected to closed cooling so that is may be effectively utilized later. The following Table 2 shows the results of a comparison between the number of general live bacterial in three samples No.1 to 3 of the soybean milk produced according to the invention, cooled to 20° C. in a container to which a cooling pipe was attached to supply running water and stored for 3 days in a refrigerator of 5° C. (open cooling) and the number of general live bacteria in three samples No.1 to 3 of the soybean milk produced according to the invention, cooled to 20° C. with a running water in a closed container shut off from the external air and stored for 3 days in a refrigerator of 5° C. (closed cooling). TABLE 2______________________________________Sample No. Open cooling Closed cooling______________________________________1 2.2 × 10.sup.4 /g Less than 100/g2 4.4 × 10.sup.3 /g Less than 100/g3 2.5 × 10.sup.3 /g Less than 100/g______________________________________ From Table 2 it will be seen that the soybean milk undergoing the closed cooling includes general live bacteria of less than 100/g even after 3 days showing that the soybean milk according to the invention can be sealed in and subjected to the closed cooling in a closed container so that it is shipped in a low temperature condition (5° C. or less) as a raw material for bean curd, and thus there is no restriction with respect to the place of production for the below-mentioned types of bean curd. B: Production of cotton type bean curd Referring to FIG.2, there is illustrated a flow sheet showing an embodiment of a method of producing cotton type bean curd according to the invention. FIGS.3A and 3B show respectively a front view and side view showing the construction of a cotton type bean curd coagulating apparatus. In the Figures, numeral 11 designates a coagulating container containing soybean milk, 12 an agitator provided with a screw at its forward end, 13 a motor for turning the agitator 12, 14 a stop plate for stopping the flow of the soybean milk stirred by the agitator 12, 16 a turning mechanism for turning the stop plate 14 about a supporting rod 15, and 17 a drive box incorporating the motor 13 and the turning mechanism 16 and movable vertically along a supporting rod 18. The soybean milk used was 10 liters of the previously mentioned odorless soybean milk produced by adding water about 9 times the weight of soybeans and it was poured into the coagulating container 11 after raising its temperature in the case of the low-temperature soybean milk. When the temperature of the soybean milk reached 72° to 76° C., the drive box 17 was lowered to a desired position thereby immersing the agitator 12 and the stop plate 14 in the soybean milk. The soybean milk was violently stirred by the agitator 12 until it swirled. At this time, the stop plate 14 was turned in a direction which would not impede the flow of the soybean milk. After the soybean milk had been agitated violently, 150ml of the commercially available bittern solution was added at a time (this is referred to as treating with the bittern) and simultaneously the agitator 12 was stopped and the stop plate 14 was turned to be perpendicular to the flow, thereby rapidly stopping the flow. In 2 to 3 seconds after the treatment with the bittern, the protein of the soybean milk 11 was separated from the water and resulted in a white mash-like mass (this is referred to as a mashed bean curd). In this condition, the mash-like mass was left at rest for about 20 minutes, thereby completing the production of the mashed bean curd. Then, the drive box 17 was raised so that the coagulating container 11 was taken out and the produced mashed bean curd was placed in a given former. Then, a plate having a pressure of about 5g per 1cm 2 was placed on the mashed bean curd to express and shape it for 20 minutes. The product was cut to pieces of a desired size, immersed in clear water for about 3 hours to cool them to 17° C. or below, cooled to 5° C. or less in a refrigerator and matured overnight (about 7 hours). As a result of this maturing, the solidification of the bean curds was facilitated thereby producing cotton type bean curds having less tendency to get out of shape. Also, in accordance with the present method of producing cotton type bean curd, the charging of a given amount of bittern required no skill and therefore even an utter 14 unskilled person can effect the production. C: Production of silk type bean curd Referring to FIG.4, there is illustrated a flow sheet showing an embodiment of a method of producing silk type bean curd according to the invention. FIG.5 is a perspective view showing the construction of a silk type bean curd coagulating apparatus. In the Figure, numeral 21 designates soybean milk, 22 a rectangular coagulating container concurrently serving as a forming container and containing the soybean milk 21, 23 a placing plate made slightly smaller than the internal shape of the coagulating container 22 and having a plurality of holes 24 opening to the inside of the container 22, and 25 a plate extended over the coagulating container 22 carrying bittern 26 thereon at regular intervals. Numeral 27 designates a drive box mounting therein a drive unit for vertically moving the placing plate 23. The soybean milk used was 15 liters of the previously mentioned odorless soybean milk obtained by adding water 4 times the weight of soybeans and it was introduced into the coagulating container 22 after raising the temperature in the case of the low temperature soybean milk. When the temperature of the soybean milk 21 reached 70° to 73° C., 35g of the commercially available granular bittern 26 having a particle size of 3.5 to 1mm was uniformaly arranged on the plate 25 and added at a time to the soybeam milk 21. Immediately the soybean milk 21 was agitated by slowly moving the placing plate 23 vertically once or twice and then left at rest for 10 to 15 minutes to coagulate it. After the coagulation, the resulting bean curd was cut to pieces of a desired size, immersed in clear water for 4 to 6 hours to cool them to 17° C. or less, cooled to 5° C. or less in a refrigerator and then matured overnight (about 7 hours). By virtue of this maturing, the solidification of the bean curds was promoted thereby producing silk type bean curds having less tendency to get out of shape. Also, in accordance with the present method of producing silk type bean curd, the charging of a given amount of bittern requires no skill and therefore the production can be effected by even an utter 14 unskilled person. D: Strength test of bean curds Bean curd strength tests were made on four types of bean curd, i.e., the conventional fill-in type bean curd (silk type employing glucono delta lactone), the silk type bean curd according to the invention embodiment, the conventional cotton type bean curd (employing calcium sulfate) and the cotton type bean curd according to the invention embodiment. With respect to each of the invention embodiments, the test was made on the two kinds of bean curd one of which was tested at 10 minutes after the production and the other was tested after the maturing overnight. The method consisted of using the six kinds (four types) of bean curd, cutting and shaping each piece of bean curd to a desired size (10cm×10cm×3.5cm), placing a plastic sheet of 2cm 2 (the thickness was 0.05mm) on the central portion of each piece of bean curd and placing weights one upon another on each plastic sheet. Also, after placing weights one upon another on each plastic sheet, the weights were removed to observe the restoration of the bean curd. The results of the tests are shown in the following Table 3. TABLE 3______________________________________Product type Conditions______________________________________Silk type bean curdConventionalFill-in type bean curd Depression of 2 mm after 1 minute under 45 g and no restorationInvention embodiment10 minutes after Depression of 1 mm after 1 minute undercompletion 55 g and restored after 5 minutesAfter maturing Depression of 2 mm after 1 minute underovernight 130 g and restored after 5 minutesCotton type bean curdConventionalCotton type bean curd Depression of 2 mm after 1 minute under 150 g and no restorationInvention embodiment10 minutes after Depression of 1 mm after 1 minute undercompletion 230 g and no restorationAfter maturing No depression under 300 g and moreovernight______________________________________ It was seen that the silk type bean curd and the cotton type bean curd according to the embodiments of the invention were higher in strength and also higher in resilience due to their restoration than the conventional silk type bean curd and cotton type bean curd. Also, it was seen that of the two types made according to each embodiment, the one matured overnight was higher in both strength and resilience than the other. Lastly, by virtue of the fact that the soybean milk produced by the method of producing soybean milk according to the invention is sealed in a sealed container and subjected to closed cooling thereby making it possible to ship the soybean milk in a low-temperature condition (5° C. or less) as a raw material for bean curd, the place of production for soybean milk and the place of bean curd production for performing the method of producing bean curd according to the invention may be separately selected perform the production thereby supplying bean curd to far and wide areas. In addition, the saving of labor and space for the production process of soybean milk can be realized at the place of bean curd production and there is no longer any elimination of bean curd refuse which has hitherto been eliminated during the production process of soybean milk thus giving rise to some environmental problem, whereas a way for collective reuse as a resource of the bean-curd refuse eliminated in a large quantity is found at the place of production for soybean milk.

There are disclosed a method of producing soybean milk having no smell of soybean and a method of producing bean curd from the soybean milk. The method of producing soybean milk includes a step of soaking soybeans in water and grinding the soaked soybeans to obtain a go-eki, a step of boiling, cooling and again boiling the go-eki, and a step of straining the boiled go-eki to obtain soybean milk. A magnesium chloride-type bittern is added to the soybean milk to coagulate and make it into bean curd. In this case, the whole quantity of the required bittern is added at a time to the soybean milk being agitated. The type of the bean curd produced is determined depending on whether the agitated flow of the soybean milk is immediately stopped or the agitation of the soybean milk is continued slowly after the bittern has been added.

This is a continuation-in-part of U.S. Ser. No. 608,511 filed Nov. 5, 1990, now U.S. Pat. No. 5,139,800. BACKGROUND OF THE INVENTION The present invention relates to a process for preparing a food browning composition. The composition may be used to brown foods cooked either by microwave radiation or by conventional means. When foods are prepared quickly, particularly in those cases wherein the food is either cooked by microwave radiation or warmed for short period of time in a conventional oven or by other means, the surface of the food lacks the brown color and often the associated aroma produced by conventional cooking methods. The pale appearance of foods such as chicken, pork, beef and cakes is unappealing to consumers. In the case of microwaved foods, browning has been achieved primarily by using packaging material containing metal susceptors for inducing local heating. These susceptors are in contact with the surface of the food and upon heating to a certain temperature, browning of the surface is accomplished. Such packaging is referred to in e.g. U.S. Pat. Nos. 4,833,007, 4,814,568, 4,626,641, 4,594,492, 4,590,349 and 4,555,605. One approach to browning microwaved meat products such as poultry, beef, pork, fish and other foods has been to apply a brown-colored sauce or topping to the food before cooking or serving. One such sauce is referred to in U.S. Pat. No. 4,252,832 to Moody. This is a thick syrup prepared by melting, caramelizing and foaming a granular disaccharide such as sucrose, maltose or lactose. U.S. Pat. No. 4,640,837 to Coleman et al. refers to a coating composition for imparting a crisp golden brown surface to microwaved foods. The coating comprises a toasted bread crumb/oil blend in amounts up to 66 percent by weight of the composition, maltodextrin, soy protein concentrate and pre-gelatinized starch. U.S. Pat. No. 4,518,618 to Hsia refers to a food coating composition comprising a combination of three salts, i.e. potassium acetate, potassium chloride and potassium bicarbonate or potassium acetate, potassium chloride and sodium bicarbonate. U.S. Pat. No. 4,448,791 to Fulde refers to a reactive dough surface which undergoes chemical surface browning upon exposure to microwave radiation. The reactive composition contains as the essential active ingredients a reducing sugar such as dextrose and an amino acid source such as a yeast extract. U.S. Pat. No. 4,735,812 to Bryson refers to a browning composition comprising collagen or gelatin hydrolyzed to its constituent amino acids plus one or more reducing sugars. U.S. Pat. No. 4,882,184 to Buckholz refers to a microwave browning process comprising Maillard reaction precursors such as proline and rhamnose or ribose, and a solvent which is a mixture of glycerin and ethyl alcohol. U.S. Pat. No. 4,904,490 to Buckholz refers to a microwave browning process comprising Maillard reaction precursors such as lysine and rhamnose or ribose, and a solvent which is a mixture of glycerin and ethyl alcohol. SUMMARY OF THE INVENTION In one embodiment, the present invention is directed to a process for the preparation of a browning composition comprising: (a) preparing an oil phase by mixing an edible emulsifier with an edible fat or oil at a temperature sufficient to form a clear solution; (b) maintaining the temperature of said oil phase above its cloud point; (c) mixing said oil phase with an aqueous phase, said aqueous phase comprising a solution or dispersion of a colorant in an aqueous medium, the temperature of said aqueous phase being above the cloud point of said oil phase; (d) subjecting the resulting mixture to high shear to form a solution or dispersion of said aqueous phase in said oil phase. Preferred also is the process wherein said colorant is selected from the group consisting of caramel, paprika, food grade dyes, beet powder, carmine, water-soluble annatto, turmeric, and saffron; and combinations thereof; with an especially preferred colorant being caramel. Also preferred is the process wherein said fat or oil is present at a concentration of from about 10 to about 99 percent by weight, preferably at from about 40 to about 70 percent by weight. Especially preferred is the process wherein said fat or oil is selected from the group consisting of canola oil, soybean oil, corn oil, olive oil, peanut oil, safflower oil, sunflower oil, vegetable oil, partially hydrogenated vegetable oils, animal fats, and milkfat; and combinations thereof; with preferred oils being canola oil and soybean oil. Preferred is the process wherein the emulsifier is selected from the group consisting of mono- and di-glycerides and diacetyltartaric acid esters of mono- and diglycerides; and combinations thereof; with said emulsifier present at a concentration of from about 0.1 to about 10 percent, preferably at from about 1 to about 8 percent. Also further preferred is the process further comprising the addition of a viscosifying agent, with the viscosifying agent present at a concentration of from about 0.01 to about 1 percent by weight, preferably at from about 0.05 to about 0.4 percent by weight. Preferred viscosifying agents are selected from the group consisting of xanthan gum, guar gum, starch, flour, gelatin, pectin, agar, carrageenan, alginates, locust bean gum, methyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, carboxymethyl cellulose, ethyl cellulose, and methylethyl cellulose; and combinations thereof; with especially preferred viscosifying agents being xanthan gum, guar gum, and starch. Still further preferred is the process further comprising the addition of a film-forming agent, with said film-forming agent present at a concentration of from about 0.01 to about 1.0 percent by weight, preferably at from about 0.05 to about 0.4 percent by weight. Preferred film-forming agents are selected from the group consisting of hydroxypropyl cellulose, methyl cellulose, arabinogalactan, hydroxypropylmethyl cellulose, ethyl cellulose, carboxymethyl cellulose, and zein; and combinations thereof; with especially preferred film forming agents being hydroxypropyl cellulose and methyl cellulose. Also further preferred is the process further comprising the addition of an oil-soluble colorant, with said colorant present at a concentration of from about 0.01 to about 2 percent of said composition. Preferred oil-soluble colorants are β-carotene, oil soluble annatto and paprika oleoresin. Preferred temperatures at which the process of the present invention may be carried out are from about 35° C. to about 70° C. with a preferred temperature being 40° C. Preferred conditions of high shear are those carried out in a blender. DETAILED DESCRIPTION OF THE INVENTION In one embodiment, the present invention is directed to a process for the preparation of an edible composition for imparting a brown color to foods cooked by microwave radiation or by conventional means. The composition will not substantially alter the color of the food surface before cooking, and upon microwaving or heating by conventional means, a brown color is developed. The process results in a composition wherein initial brown color is disguised by the use of a carrier. Upon cooking, the composition releases the desired color. Thus, the composition releases the desired color. Thus, the composition when applied does not substantially alter the surface color before cooking. The composition comprises a dispersed phase containing the colorant and a continuous phase consisting essentially of a fat or oil. The dispersed phase consists essentially of a colorant or a colorant substantially dissolved or dispersed in a substantially oil-immiscible medium. In those cases where the colorant is a liquid, it either by itself or dissolved in the substantially oil-immiscible medium will constitute the dispersed phase. In those instances where the colorant is a solid, it may be dispersed directly in the fat or oil comprising the continuous phase of the composition. Alternatively, it may be dissolved or dispersed in the substantially oil-immiscible medium which is itself dispersed in the continuous phase. By the term "substantially oil-immiscible medium" is meant a medium which is substantially insoluble in the fat or oil which forms the continuous phase of the composition, and forms a separate phase dispersed in said fat or oil. It will be appreciated by those skilled in the art that said medium and said fat or oil can have a low degree of mutual solubility and still form a multiphase system. A preferred oil-immiscible medium is water. In the process of the present invention, the colorant may be present at a concentration of from about 0.05 to about 10 percent by weight, preferably from about 0.2 to about 10 percent by weight. The process for producing the composition uses an edible colorant which is chosen so that upon cooking, the desired color, preferably a shade of orange, red, yellow, or brown, is achieved. Examples of colorants which fulfill this criterion are caramel, paprika, food grade dyes, beet powder, carmine, water soluble annatto, tumeric, and saffron. Combinations of the above colorants may also be used. An especially preferred colorant is caramel. All these colorants are commercially available. It will be appreciated by those skilled in the art to which this invention applies that some colorants, while substantially insoluble in the oil or fat which comprises the continuous phase of the present composition, contain oil-soluble components which may impart a color to said oil or fat phase. The resulting composition will impart a color to the uncooked food to which it is applied. Although less intense than the brown color which develops upon cooking, this visible color may be desirable since it may enhance the natural color of the uncooked food. In fact, in some cases such as when the uncooked food has an unappealing pale color, it has been found useful to add an oil-soluble colorant to the composition of the present invention. In these cases wherein the oil-soluble colorant is used, it is present at a concentration of from about 0.01 to about 2 percent of the composition of the present invention. Examples of oil-soluble colorants are paprika oleoresin, β-carotene nd oil-soluble annatto. Combinations of the above colorants may also be used. The fat or oil used in the process of the present invention to produce the continuous phase of the composition of the present invention can be any edible fat or oil. The edible fat or oil may be present at from about 10 to about 99 percent by weight, preferably at from about 40 to about 70 percent by weight. Non-limiting examples of preferred fats or oils which may be used are canola oil, soybean oil, corn oil, olive oil, peanut oil, safflower oil, sunflower oil, vegetable oil, partially hydrogenated vegetable oils, animal fats, and milkfats. Combinations of the above fats or oils may also be used. Preferred fats or oils are canola oil and soybean oil. An emulsifier is also used in the process of the present invention. Preferred emulsifiers are mono- and diglycerides and diacetyltartaric acid esters of mono- and diglycerides. The emulsifier is preferably present at a concentration of from about 0.5 to about 10 percent, preferably at from about 1 to 8 percent. Combinations of the above emulsifiers may also be used. To impart further viscosity, if desired, to the composition, a viscosifying agent, at a concentration of from about 0.01 to about 1 percent by weight, preferably from about 0.05 to about 0.4 percent by weight, may also be added to the composition prepared by the process of the present invention. Preferred viscosifying agents are xanthan gum, guar gum, starch, flour, gelatin, pectin, agar, carrageenan, alginates, locust bean gum, methyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, carboxymethyl cellulose, ethyl cellulose, and methylethyl cellulose; and combinations thereof. Especially preferred viscosifying agents are xanthan gum, guar gum, and starch. In some cases, a film-forming agent may be added to the composition prepared by the process of the present invention. While not wishing to be bound by theory, it is believed that the film-forming agent enhances adhesion of the compositions to foods and/or allows for adjustment of luster and moisture of the cooked foods. Those skilled in the art to which this invention applies will appreciate that some viscosifying agents also have a film-forming function. One skilled in the art would further appreciate that these functions may be balanced by routine procedures, e.g. adjustment of concentrations. If added, the film-forming agent is present at a concentration of from about 0.01 to about 1.0 percent by weight, preferably at from about 0.01 to about 1.0 percent by weight, preferably at from about 0.05 to about 0.4 percent by weight. Preferred film-forming agents are hydroxypropyl cellulose, methyl cellulose, arabinogalactan, hydroxypropyl methyl cellulose, ethyl cellulose, carboxymethyl cellulose and zein. Combinations of the above may also be used. The heating steps of the present invention may be carried out at a temperature of from about 35° C. to about 50° C., preferably about 40° C. The conditions of shear may be accomplished in a blender. The composition prepared by the process of the present invention may be used on a variety of foodstuffs. Non-limiting examples of foodstuffs include poultry, baked goods, pork, fish, beef, cheeses, fruits, vegetables, pasta and marshmallows. While the composition prepared by the process of the present invention is especially suitable for imparting a brown color to foods cooked by microwave radiation, it has also surprisingly been found that it can be used on foods cooked by conventional means. For instance, the composition may be applied to frozen TV dinners or pot pies and when these frozen dinners or pot pies are heated in a conventional oven, for example, a desirable brown color is achieved without overbrowning. The invention having been described in general terms, reference is now made to specific Examples. It is to be understood that these Examples are not meant to limit the present invention, the scope of which is determined by the appended claims. EXAMPLE 1 A mixture of 100 grams of a 1% aqueous solution of Keltrol (Kelco Division of Merck and Co. xanthan gum), 430 grams of water, and 30 grams of Sethness RT #175 caramel powder was stirred until homogenous and heated to about 40° C. A solution of emulsifier in oil was prepared by heating 2150 grams of canola oil to about 70° C. and adding 50 grams of Panodan 150 emulsifier (Grindsted Products, Inc.) with stirring. A 440-gram portion of the resulting solution was transferred to a blender, the temperature was adjusted to about 40° C., the 40° C. caramel solution was added while stirring at medium speed, and the resulting mixture was stirred for 3 minutes at high speed. EXAMPLE 2 A mixture of 170.5 grams of a 1% aqueous solution of Keltrol (Kelco Division of Merck and Co. xanthan gum), 732 grams of water, and 51 grams of Sethness RT #175 caramel powder at 40° C. was stirred until homogeneous. A solution of emulsifier in oil was prepared by heating 2150 grams of canola oil to about 70° C. and adding 50 grams of Panodan 150 emulsifier (Grindsted Products, Inc.) with stirring. A 750-gram portion of the resulting solution, maintained at 40° C., was added with stirring to 40° C. caramel solution during 1 minute, stirring was continued for 3 minutes, and the resulting emulsion was cooled to room temperature, adjusted to pH 3.4-3.5 with 85.8% phosphoric acid, and subjected to high shear by passage through a Gaulin laboratory homogenizer at 1500 pounds per square inch pressure.

A browning composition is prepared by mixing an oil phase containing an emulsifier with an aqueous phase containing a colorant under shear conditions to form a dispersion of the aqueous phase in the oil phase.

This is a continuation of U.S. patent application Ser. No. 08/767,001 filed Dec. 19, 1996 now U.S. Pat. No. 5,989,604. FIELD OF THE INVENTION The invention relates to edible pet foodstuff for dental caries prevention. The invention also relates to a process of preparing such edible pet foodstuff. BACKGROUND OF THE INVENTION Dental plaque acids, produced by Streptococus mutans and other acidogenic bacteria in an animal's mouth, are responsible for the formation and exacerbation of dental caries and the occurrence of malodorous breath in animals. It is believed that recently dental caries and malodorous breath have become more prevalent in pets. While not wishing to be bound by theory, it is believed that certain additives or materials in pet food may be responsible at least in part. A need exists for a pet foodstuff and a treatment method for treating pet's gums and teeth to reduce the incidence of caries and to control malodorous breath in pets. SUMMARY OF THE INVENTION In accordance with the present invention, it has been discovered that the incidence of caries in pets can be reduced by placing xylitol in contact with a pet's gums and teeth. In one aspect, this invention provides a range of materials containing various xylitol mixtures to place the xylitol into contact with an animal's teeth for the longest period of time possible. By doing so, xylitol reduces dental plaque acids and inhibits the growth of S. mutans, and other acidogenic bacteria responsible for the formation and exacerbation of dental caries in dogs, cats, horses, pets and other show animals. Another objective is to provide a dry biscuit or treat type of food that synergistically operates with the xylitol to lessen the incidence of dental plaque or tartar by chewing the dry biscuit material. In accordance with another aspect of the invention, a process is provided for preparing dry, solid animal food in biscuit or treat form with a topical additive onto which the xylitol combination is sprayed, brushed or dipped thereby permitting the topical coating to remain on the outside of the biscuit or treat but firmly adhered thereto. This will increase the time the xylitol combination is placed in direct contact with the animal's teeth increasing the time xylitol will affect any S. mutans present in the mouth. Another objective of the invention is to provide a means of controlling malodorous breath, especially in dogs and cats, by increasing salivation. Another objective of the invention is to prepare a xylitol containing gel that can be placed directly onto the animal's teeth. A further objective of this invention is to provide a powder to be placed in the animal's drinking water to provide further protection from plaque acids by increasing the contact of xylitol with the animal's teeth over the period of a day. This is especially important for "free feeders," that is, animals which continuously feed throughout the day and are not amenable to being fed the xylitol containing biscuits after scheduled meals. In accordance with still another aspect of the invention, a process is provided of preparing a chew rawhide with a topically applied and/or impregnated xylitol containing mixture. The goal is to maximize exposure during the day of the xylitol containing mixture to be in direct contact with the animal's teeth. All of the above applications of the invention taken together further describe another aspect of the invention, that is, this is a comprehensive delivery system of placing xylitol in contact with the animal's teeth for the greatest period of time during the day. In one aspect, the invention permits the use of a comprehensive method of exposing the animal's teeth to the xylitol product. As stated above, this is accomplished using a variety of delivery materials, that is, topically coated biscuits and treats, topically coated or impregnated rawhide chew bones or toys, "sandwich" style or "pocket" biscuits or treats, a powder soluble in water, and a topical gel application. The "sandwich" or "pocket" style biscuits or treats are made in such a way that the xylitol mixture is layered using a special process between flat biscuits to create a biscuit that serves a dual purpose of reducing tartar or plaque by the action of chewing against the teeth, and to release the xylitol mixture slowly after the "chewing" action is accomplished. In one aspect of the invention, novel dog biscuits and cat treats are provided. The farinaceous-based baked biscuits have certain constituents including xylitol suitable for animal consumption, generally food grade xylitol. Xylitol exhibits therapeutic properties for the amelioration of dental caries and conditions promoting the formation of dental caries. A suitable adherence material, such as gum arabic (or other suitable vegetable gum, may be present as a separate coating or in a mixture with the xylitol, for example. When used as a separate coating, the gum arabic is applied to the surface of the biscuit or treat and is allowed to dry or as otherwise required for that particular type of adherent material. This improves the adherence of the xylitol compound to the surface of the biscuit or treat for greater effectiveness. More than one coating layer may be used. The amount of xylitol in such coating should approximate one-half gram per biscuit. Generally, the xylitol will be applied to the surface of the biscuit (or treat) after preparation of the biscuit is otherwise completed. When the coated biscuit is consumed by the animal, release of the xylitol product into the animal's mouth and on the teeth is maintained for the longest time. Xylitol added to the bulk dough before the baking process can be done, but is not preferred because it does not place the maximum amount of xylitol in direct contact with the animal's teeth, a process important to maximize effectiveness. Another aspect of the invention involves the use of chew toys and bones or treats. These chew toys are made of rawhide, pigskin (in the form of "roll-ups") or other suitable material and are either coated with or impregnated with a xylitol mixture. Another aspect of the invention involves the use of a water soluble consumable mouthwash powder mix with xylitol in combination with other suitable materials such as aloe vera concentrate and/or zinc amino acid chelate designed to be placed into a pet's water bowl to provide continuous xylitol contact every time the animal drinks water. Another aspect of the invention involves the use of a topical gel containing a xylitol, lactitol, and HSH (hydrogenated starch hydrolyzate syrup) mixture. This is applied directly to an animal's teeth especially during periods when the animal is not likely to be fed. The term "dog biscuit" as used herein means a biscuit for a dog that is baked or otherwise processed to form a biscuit. These dog biscuits can be made from any suitable dough or other starting material. One such advantageous combination is a biscuit made from a dough consisting of whole wheat flour, brewer's yeast, wheat germ, edible bone meal, chicken broth, canola oil, and whole egg. There is a deliberate method to using only natural ingredients in these formulations. Added sugar, corn syrup, any sucrose or fructose product is completely avoided as that could compromise the efficacy of the cariostatic and anti-cariogenic effects of the xylitol compound as described herein. The term "cat treat" or treat as used herein means a treat for a cat that is baked or otherwise processed to form a treat. These cat treats can be made from any suitable dough or other starting material. One such advantageous combination consists of barley flour, ground chicken, whole eggs, edible bone meal, rye flour, canola oil, wheat germ, ascorbic acid, taurine, water, chicken or beef broth. The term "sandwich" as used herein means a pet foodstuff which is comprised of two biscuits, treats, or other bulk foodstuff which are joined with a xylitol mixture between the biscuits, treats or other foodstuff. The term "pocket" as used herein means a pet foodstuff which contains a xylitol mixture in the center of the pet foodstuff wherein the body of such pet foodstuff has been folded over and sealed to encompass the xylitol center. The invention compositions of xylitol and xylitol containing mixtures ameliorate the condition of dental caries and malodorous breath in animals, help heal inflamed gums, and otherwise re-mineralize teeth in which the formation of dental caries is incipient. As used in combination of biscuits or treats, powder added to drinking water, chew toys, freeze dried organ treats (e.g. liver, kidney, dried muscle chew treats, and gel, all of the products described herein comprise a comprehensive delivery system of xylitol and contribute to the dental health and well-being of animals using the invention. These "xylitol delivery systems" for pets can incorporate other ingredients that promote the health of hard and soft dental tissues. Examples of these ingredients are: zinc compound, parsley, and baking soda (dental malodor control), bone meal (supplies calcium and phosphate ions which promotes re-mineralization of teeth), Coenzyme Q10 (promotes periodontal health), folic acid (vitamin), the following botanicals: aloe vera, comfrey, rosemary, goldenseal, horsetail, arnica, calendula, barley grass, chamomile, bloodroot, siwak-miswak, pullulan, horse chestnut, neem, peelu, propolis, green tea, myrrh, birch bark, white oak bark, tea tree oil, grape seed extract and wheat germ, and the following enzymes: bromelain, papain and quercetin. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a xylitol-coated dog biscuit. FIG. 2 is a cross-sectional view of the biscuit of FIG. 1 taken along line 2--2 of FIG. 1. FIG. 3 is a cross-sectional view of an alternative embodiment of the biscuit with two layers of xylitol coating. FIG. 4 is a cross-sectional view of an alternative embodiment of the biscuit without a xylitol coating. FIG. 5 is a perspective view of a sandwich dog biscuit. FIG. 6 is a cross-sectional view of the biscuit in FIG. 5 taken along line 6--6 of FIG. 5. FIG. 7 is a perspective view of a pocket dog biscuit. FIG. 8 is a cross-sectional view of the biscuit in FIG. 7 taken along line 8--8 of FIG. 7. DETAILED DESCRIPTION OF THE INVENTION All parts, percentages, ratios and proportions are set forth on a weight basis in grams unless otherwise stated or otherwise obvious to one skilled in the art. As used herein, all temperatures are in degrees Fahrenheit unless otherwise stated herein or otherwise obvious to one skilled in the art. If desired, specific breath freshening agents may be added to any of the biscuits and treats. Agents such as zinc amino acid chelate, parsley (chlorophyll source) and baking soda may be used for breath freshening. A. Preparation of the Material 1. Biscuits and Treats The dog biscuits and cat treats must themselves be thoroughly dry after baking. The dog biscuits and cat treats are prepared by brushing, spraying or dipping each of the biscuits or treats with a xylitol and gum arabic mixture to coat the material. All such products are thoroughly dried either by heat or evaporation in a humidity controlled environment. The gum arabic and xylitol mixture gives the product a coating permitting the xylitol a greater ability to adhere to the outside of the biscuit or treat without penetrating or affecting the underlying material. Xylitol should comprise between 0.25% and 2.5% by weight of the total biscuit or treat. If a coating is utilized, the coating should preferably be between approximately 0.01 and 0.1 inches thick. The objective is to separate the xylitol compound from the biscuit or treat so that both may work independently, that is, chewing the treat will tend to scrape at built up plaque or tartar while the separate coating of xylitol will come into maximum contact with the animal's teeth to control S. mutans, bathe the gums, and aid in re-mineralization of certain dental caries. 2. Sandwich Biscuits/Treats and Pocket Biscuits In sandwich or pocket biscuits or treats, xylitol should be present in an amount from about 0.25% to 2.5% by total weight of the item. a. Sandwich Biscuits/Treats for Dogs and Cats Preferably, sandwich biscuits/treats for dogs and cats are generally flat, although they can be of any desired shape and usually are composed of two opposed outer biscuit/treat pieces, usually labeled, and joined together with a xylitol containing layer "sandwiched" between the two flat layers, appearing much the same as a cookie with a cream filling. This filling or layer can be the same for both dogs and cats and consists of, for example: powdered or granulated food grade xylitol, gum arabic, beef broth, chicken broth or distilled water, lecithin, Coenzyme Q10, folic acid, aloe vera, comfrey, rosemary, goldenseal, horsetail, arnica, calendula, barley grass, chamomile, bloodroot, siwak-miswak, pullulan, horse chestnut, neem, peelu, propolis, green tea, myrrh, birch bark, white oak bark, tea tree oil, grape seed extract, wheat germ, bromelain, papain and quercetin. If necessary, water may be added as a diluant. The xylitol-containing layer should contain material for maintaining the outer biscuit/treat layers together. The sandwich biscuit for dogs usually will be made from a dough. Preferably the dough will contain all-natural ingredients and can include whole wheat flour, buckwheat, brewer's yeast, wheat germ, corn meal, edible bone meal, chicken broth, canola oil, and whole egg. The flours used (whole wheat, barley, soy, corn, rye, buckwheat, potato, rice, etc.) can be varied to accommodate allergic reactions the pet may have to one or more of the above ingredients. Any suitable dough composition can be utilized. In one embodiment, the sandwich treat for cats consists of dough containing all-natural ingredients: one or more flours (e.g., barley, whole wheat flour, corn meal, rye flour, soy flour, etc.), ground chicken, whole eggs, edible bone meal, canola oil, wheat germ, ascorbic acid, taurine, water, chicken or beef broth. The combination of flour may consist of one or more of the specified flours depending on the allergic reaction of the animal. Other flour combinations or a single flour ingredient may be substituted. The dough mixture for either biscuits or treats is rolled flat or otherwise formed into a flat sheet and may be cut into assorted shapes and sizes. It is preferable that the portion of the sheets that will be opposed in the sandwich are flat to allow the xylitol-containing layer to be of uniform thickness in the finished sandwich. The individual cut shapes are suitably baked, such as at approximately 300 degrees for approximately 45 minutes and are thoroughly allowed to cool to room temperature. As is known in the art, the optimum baking temperature and time will depend on various factors, including dough composition and thickness, for example. Then the xylitol-containing layer or filling as stated above is applied in a suitable manner, such as by spreading, for example, on at least one of the two biscuit/treat layers making up the biscuit/treat. A top biscuit/treat layer is applied on top of and preferably in substantial registry with the bottom layer with the xylitol-containing layer or filling located between the two biscuit/treat layers. If desired the top and bottom biscuit/treat layers can be of the same or different size and shape. Optionally, the assembled biscuits/treats can be dried in a humidity controlled environment at room temperature (68 to 80 degrees) for at least eight (8) hours until thoroughly dry. b. Pocket Biscuits Using a biscuit dough or cat treat dough, the dough is rolled or otherwise formed into a sheet and while still wet the following ingredients are added: powdered xylitol, powdered lactitol and aloe vera. The dough is then folded in half and cut into assorted shapes crimping the edges (other than the fold edge when present) of each of the shapes to form a closed pocket and then suitably baked, such as at approximately 300 degrees for approximately 45 minutes. As is known in the art, the optimum baking temperature and time will depend on various factors, including dough composition and thickness, for example. During the baking process the powdered ingredients melt inside the two layers of dough forming a somewhat "sticky" or "tacky" substance that will adhere to the dog or cat's teeth when they chew the biscuit maximizing the delivery of xylitol to the teeth and gums. Preferably, when fully baked, the ingredients within the pocket remain "sticky" or "tacky" at the time of consumption by a pet. 3. Chews, Bones, Rawhide and Pigskins Preferably, chews, bones, rawhide and pigskins, contain at least about 0.25% xylitol by total weight of the item. One suitable preferred method is hereinafter described. The pigskin is preferably a flat sheet. One side of the pigskin is coated with powdered xylitol and powdered lactitol. The coated pigskin is heated to make it pliable and is rolled or otherwise formed into a tubular shape. It is then cooled, usually to room temperature to retain its tubular shape. If desired, the pigskin may be cut into smaller sizes. Alternatively, a mixture of xylitol, lactitol and HSH (hydrogenated starch hydrolyzate syrup) is heated to form a uniform solution. The resulting solution is applied to preferably one side of the pigskin. The coated pigskin is heated to make it pliable and is rolled or otherwise formed into a tubular shape. It is then cooled, usually to room temperature to retain its tubular shape. If desired, the pigskin may be cut into smaller sizes. For the bones, the same ingredients are used as those for the pigskin. The ingredients are heated to form a solution and are introduced into the bone cavity by any suitable method, including brushing or spraying, and are allowed to cool. For rawhides, preferably a flat sheet is utilized. Preferably one side of the rawhide is coated with powdered xylitol, powdered lactitol and HSH (hydrogenated starch hydrolyzate syrup). This rawhide is heated to make it pliable and is rolled or otherwise formed into a tubular shape. It is then cooled, usually to room temperature to retain its tubular shape. If desired, the rawhide may be cut into smaller sizes. Alternatively, a mixture of xylitol, lactitol and HSH (hydrogenated starch hydrolyzate syrup) is heated to form a uniform solution. The resulting solution is applied to preferably one side of the pigskin. The coated pigskin is heated to make it pliable and is rolled or otherwise formed into a tubular shape. It is then cooled, usually to room temperature to retain its tubular shape. If desired, the pigskin may be cut into smaller sizes. For chews (chew toys, freeze dried organ treats (e.g., liver, kidney), dried muscle chew treats), a xylitol mixture can be made with any number of compounds, such as xylitol and lactitol and sprayed, brushed or dipped onto the chew toy. 4. Xylitol Powdered Consumable Mouthwash Consistent with a comprehensive dental delivery system and in an effort to make the xylitol product available to the animal as frequently as possible, one gram of xylitol is placed into a pet's water bowl to keep xylitol available for distribution to the pet's mouth, teeth and gums. This powder may be in granular or powdered form but must consist of food grade xylitol. Additionally other ingredients (either singly or in combination) may be added such as aloe vera, zinc amino acid chelate, baking soda or various botanicals or enzymes. A typical formulation for a single serving per cup of water consists of a range of 2 grams to 4 grams of xylitol, 25 to 75 milligrams of aloe vera (a 200:1 concentrate), 1 to 5 milligrams of zinc amino acid chelate. Optionally, 1 to 5 milligrams of baking soda and flavorings may be added. 5. Xylitol Gel Three separate xylitol formulae may be used for the Xylitol Gel Product as follows: (1) Xylitol and lactitol heated together to form a gel. The amounts are to be determined by a ratio of at least 51% xylitol and the balance is made up of lactitol. (Xylitol at least 51% and lactitol). (2) Xylitol, lactitol and HSH (hydrogenated starch hydrolyzate syrup) are heated together. Typical proportions are Xylitol fifty percent (50%), Lactitol thirty percent (30%), and HSH twenty percent (20%). (3) Xylitol and HSH are heated together. Typical proportions must include at least fifty one (51%) percent xylitol and the balance is lactitol. C. Method of Administration Delivery of xylitol containing mixture is preferably made as follows: (1) Feeding a dog biscuit or cat treat immediately after the animal is fed a regularly scheduled meal. (2) Use of xylitol powder in the animal's water allowing the animal access to some concentration of xylitol throughout the day or if the animal is allowed to "free feed" which means that it has "on demand" feeding as it desires. (3) Use of chew toys or treats either coated or impregnated with the xylitol mixture. This places xylitol in contact with teeth and gums during the period of use. (4) Application of a topical gel containing xylitol with lactitol and/or HSH which "sticks" to the animal's teeth and gradually bathes the gums during the night or during times when the animal is not likely to feed or drink. D. Effectiveness and Use Xylitol and xylitol containing compounds have been the subject of extensive studies. For best results, from about 0.5 to 5 grams of xylitol in total should be consumed daily by dogs, and from about 0.25 to 3 grams of xylitol in total should be consumed by cats. Referring to the figures generally, and particularly to FIGS. 1 and 2, there is illustrated a pet foodstuff 10 which in this case is a dog biscuit, in accordance with the invention. Pet foodstuff 10 is composed of a solid body 12 of baked farinaceous material 12 and xylitol solid coating 14. Body 12 can be formed by any suitable method and can be composed of any conventional dog biscuit. For example, body 12 of pet foodstuff 10 can be made from the formulae set forth in Tables I and II which are disclosed for illustrative purposes only, not as a limitation on the present invention. The present product can be made by any suitable method, such as by first cooking a pet foodstuff with the following ingredients, and then applying a coating containing an effective amount of xylitol. TABLE I______________________________________Dog Biscuits______________________________________2 Cups Whole Wheat Flour 250 to 400 grams(or other suitable flour)1/2 Cup Buckwheat, rye or 40 to 70 gramsa barley flour1/2 Cup Brewer's Yeast 30 to 50 grams1 Cup Wheat Germ 80 to 110 grams1/2 Cup Corn Meal, Potato, Rice 40 to 70 gramsor Soy Flour1/2 Cup Parsley Flakes 0.3 to 0.7 grams1/4 teaspoon edible bone meal 0.5 to 1.2 grams11/4 Cup Distilled Water, Beef 200 to 300 gramsor Chicken Broth1/2 Cup of Canola, Olive or 70 to 100 gramsSunflower Oil1/4 Cup of Sunflower or Pumpkin 20 to 40 gramsSeeds1 Whole Egg 40 to 60 gramsPowdered Xylitol 3 to 7 gramsLecithin 0.75 to 1.25 gramsaloe vera 0.3 to 0.7 gramsCoenzyme Q10 50 to 150 milligramsGrape Seed Extract 0.3 to 0.7 grams______________________________________ TABLE II______________________________________Cat Treats______________________________________2 Cups Barley or Whole 250 to 400 gramsWheat FlourGround Chicken 75 to 100 grams2 Whole Eggs 80 to 120 grams1/8 teaspoon edible bone meal 0.25 to 0.7 grams1/2 Cup Corn Meal 40 to 70 grams1/2 Cup Rye or Soy Flour 250 to 400 grams1/2 Cup Canola Oil 70 to 100 grams1/2 Cup Wheat Germ 40 to 55 gramsAscorbic Acid 0.5 gramTaurine 0.5 gram11/4 Cups Distilled Water, 200 to 300 gramsChicken or Beef BrothPowdered Xylitol 3 to 7 gramsLecithin 0.75 to 1.25 gramsaloe vera 0.3 to 0.7 gramsCoenzyme Q10 50 to 150 milligramsGrape Seed Extract 0.3 to 0.7 grams______________________________________ Referring to FIG. 3, there is illustrated another pet foodstuff 16, in accordance with the present invention. Pet foodstuff 16 is in the form of a dog biscuit which is composed of a body 18, an adherent coating 20 and a xylitol containing coating 22. Body 18 can be produced in a manner similar to that used to produce body 12 of FIGS. 1 and 2. Adherent coating 20 is provided to improve the adherence of xylitol containing coating 22 to body 18. Adherent coating 20 is comprised of a vegetable gum (or other suitable material), which has been applied to body 18 by brushing, spraying, dipping or any other method known by those skilled in the art, and suitably dried. Any material that provides the desired adherence for coating 22 can be utilized provided such material does not produce any unwanted effect or is otherwise not suitable for ingestion by a pet. Reference to FIG. 4 illustrates another embodiment of the present invention, which is a pet foodstuff 24. Pet foodstuff 24 can be produced in a manner similar to that used to produce body 12 and contains xylitol dispersed throughout the bulk. Xylitol containing coating 14 is composed of xylitol and can be made as follows: E. Xylitol Coating or Filling Mixture The Xylitol Coating mixture is to be used with the above biscuits and treats and consists of seventy-five (75) to one hundred fifty (150) grams of xylitol, five (5) to fifteen (15) grams of gum arabic, and ten (10) to twenty-five (25) grams of water. Reference to FIGS. 5 and 6 illustrate a sandwich pet foodstuff 26, which in this case is a dog biscuit, in accordance with the invention. Sandwich pet foodstuff 26 is composed of a solid body 28 and solid body 30, both of baked farinaceous material, held together in substantial registry by a xylitol-containing filling or layer 32. Body 28 and body 30 of sandwich pet foodstuff 26 can be made in a manner similar to that used to produce body 12 in FIGS. 1 and 2. Xylitol filling 32 consists of xylitol, gum arabic and other ingredients and function to permanently bind or adhere together bodies 28 and 30 when layer 32 is substantially dried or cured. Reference to FIGS. 7 and 8 illustrate a pocket pet foodstuff 34, which in this case is a dog biscuit, in accordance with the invention. Pocket pet foodstuff 34 is composed of a solid body 36 of baked farinaceous material 36, crimped on edges 38 around an enclosed xylitol center 40. Body 36 of pocket pet foodstuff 34 can be made in a manner similar to that used to produce body 12 in FIGS. 1 and 2. Xylitol-containing layer 32 consists of xylitol, lactitol and other ingredients. While the invention has been described with respect to certain preferred embodiments and, as will be appreciated by those skilled in the art, it is to be understood that the invention is capable of numerous changes, modifications and rearrangements and such changes, modifications and rearrangements are intended to be covered by the following claims.

A pet foodstuff and treatment method for reducing the incidence of dental canes in non-human animals is provided. The treatment method includes orally administering the xylitol by allowing the pet to consume the xylitol containing foodstuff in an effective amount. The pet foodstuff is composed of an effective amount of xylitol and an edible pet food. The xylitol may be present as a coating or in bulk.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] The present application is a 371 national phase application of PCT Application No. PCT/CN2014/086034, filed Sep. 5, 2014. FIELD OF THE INVENTION [0002] The present invention discloses a new use of a compound in the preparation of a wound healing composition. Particularly, the present invention involves a new use of a flavonoid compound in the preparation of a wound healing composition. BACKGROUND OF THE INVENTION [0003] Flavonoids are refer generally to a series of compounds having two benzene rings containing phenolic hydroxyl groups, mutually connected with the central three-carbon atoms, having the structure shown as the general formula: [0000] [0004] They are generally found in fruits, vegetables, tea, grape wine, seeds, or plant roots etc. Although they are not belonged as vitamins, they are demonstrated to have anti-oxidation functions and anti-inflammatory reaction effects, and also confirmed to have the effects of resisting or relieving the formation of tumors, relieving pain and relieving cardiovascular diseases or malaemia. [0005] Flavonoids include flavones and flavonols. Flavones also include glycosylated flavones and non-glycosylated flavones. [0006] U.S. Pat. No. 7,471,973 B2 issued on Oct. 29, 2002 disclose that flavonoids can be used in cosmetics but does not mention other effects. In addition, U.S. Pat. No. 6,451,837B1 issued on Sep. 17, 2002 discloses the neuroprotective effects of flavonoids. SUMMARY OF THE INVENTION [0007] The purpose of the present invention is to provide a new use of flavonoids in the preparation of a wound healing composition. [0008] In one aspect, the present invention provides a method for wound healing comprising administering to a patient in need thereof a therapeutically effective amount of a compound of the structure as shown in the general formula I or an isomer thereof: [0000] [0000] wherein A is a hydrogen atom, R or —OH; n 1 and n 2 are the same or different, being an integer of 0 to 4, wherein the sum of n1 and n2 is equal to or less than 4; n 3 and n 4 are the same or different, being an integer of 0 to 5, wherein the sum of n3 and n4 is at most equal to 5; wherein R, R 1 , R 2 , R 3 or R 4 is a hydrogen atom, an alkyl group having 1 to 30 carbon atoms, an acyl group having an alkyl group having 1 to 30 carbon atoms, or a hydrocarbon chain having 1 to 30 carbon atoms; or a pharmaceutically acceptable ester or salt thereof. [0013] According to the present invention, the method is used for treating and/or healing wounds, including skin symptoms of trauma, burns and scalds and chronic wounds, and particularly diabetic wounds. [0014] According to one example of the present invention, the compound is a flavone, particularly a non-glycosylated flavone. [0015] According to the preferred embodiment of the present invention, the non-glycosylated flavone compound is cirsimaritin, and has the following structure: [0000] [0016] Those and other aspects of the present invention may be further clarified by the following descriptions and drawings of preferred embodiments. Although there may be changes or modifications therein, they would not betray the spirit and scope of the novel ideas disclosed in the present invention. DETAILED DESCRIPTION OF THE INVENTION [0017] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of skill in the art to which this invention belongs. [0018] Unless clearly specified herein, meanings of the articles “a,” “an,” and “said” all include the plural form of “more than one.” Therefore, for example, when the term “a component” is used, it includes multiple said components and equivalents known to those of common knowledge in said field. [0019] The present invention provides a method for wound healing comprising administering to a patient in need thereof a therapeutically effective amount of a compound of the structure as shown in the general formula I or an isomer thereof: [0000] [0000] wherein A is a hydrogen atom, R or —OH; n 1 and n 2 are the same or different, being an integer of 0 to 4, wherein the sum of n 1 and n 2 is equal to or less than 4; n 3 and n 4 are the same or different, being an integer of 0 to 5, wherein the sum of n3 and n4 is at most equal to 5; wherein R, R 1 , R 2 , R 3 or R 4 is a hydrogen atom, an alkyl group having 1 to 30 carbon atoms, an acyl group having an alkyl group having 1 to 30 carbon atoms, or a hydrocarbon chain having 1 to 30 carbon atoms; or a pharmaceutically acceptable ester or salt thereof. [0024] According to the present invention, the compound is a flavone, particularly a non-glycosylated flavone. The non-glycosylated flavone is cirsimaritin, and has the following structure: [0000] [0025] According to the invention, the composition of the present invention comprises a pharmaceutically acceptable carrier. [0026] According to the invention, the pharmaceutically acceptable carrier comprises an appropriate excipient and is prepared as an external medicament form, a cosmetic form or pharmaceutical form. [0027] According to the invention, the composition further comprises a therapeutic agent, for example, other anti-inflammatory agents, antibacterial agents or other therapeutic agents. [0028] As used herein, the term “skin symptoms” includes wounds or sores, including skin injuries such as incised injuries, lacerated injuries, stabbing injuries, wear injuries, etc. in skin. According to the present invention, the compounds show the effects in healing wounds for skin symptoms of trauma, burns and scalds and chronic wounds. In particular, the method of the invention in effective in treating diabetic wounds, for example, chronic wounds of diabetic present patients. [0029] As used herein, the term “treatment” includes the meaning of “treating” or “promoting” which means improving symptoms. [0030] As used herein, the term “patient” encompasses humans, and animals, particularly mammals. [0031] As used herein, the term “pharmaceutically acceptable carrier” refers to a diluent, excipient or the like as used in a commonly used technique for the preparation of a pharmaceutical composition. According to the present invention, a medicament form, a cosmetic form, or a pharmaceutical material form can be made. According to the present invention, a form for local application can be made for example, in the form of a spray. Spray forms include a spray agent and a liquid agent; or in a semi-solid form or a solid form, preferably a solid form with dynamic viscosity greater than that of water. Appropriate formulations include, but are not limited to, suspension, emulsion, cream, ointment, liniment, etc. Preferably, it is in the form of an ointment. The pharmaceutical composition of the present invention, no matter what form it is, can further include emollient, fragrances or pigments to improve their acceptability for various uses. [0032] As used herein, the term “therapeutically effective amount” refers to a dosage that can effectively treat injuries for treatment of symptoms. The appropriate dosage can be used based on the needs of patients or wounds and according to technologies and clinical knowledge commonly used in pharmaceutics, and adjusted according to the manners and treatment conditions of the application, including age, body weight, symptoms, treatment effects, application modes and treatment time. [0033] The present invention is illustrated in the above description of the invention and the following examples, which are not intended for limiting the scope of the present invention. EXAMPLE 1 Establishment of Animal Testing Mode [0034] After rats' body weight reach 300 g, the induction of hyperglycemia was carried out with streptozotocin (STZ) (65 mg/kg, ip administration). Choosing animals with successfully induced hyperglycemia (300 mg/DL), the hyperglycemic animals were subjected to diabetic wound healing tests two months after the onset of hyperglycemic symptoms. Hyperglycemic animals with a body weight less than 300 g were excluded, and random grouping was performed. Animals were anesthetized with pentobarbital and then their backs were shaved and disinfected. Three pieces of animal skin (full thickness) were harvested from the back of the animals at points 4, 6 and 8 cm from the midpoint of the two scapula with an 1- cm-diameter drilling round knife. [0035] Wounds of each animal were applied with testing agents. New skins were harvested for examination after the end of experiment. [0036] Analyzing the areas of the three wounds on the back of each rat by image pro with the area on day zero as the original wound area. The original wound area is subtracted by the wound area at each time point and then divided by the original wound area to serve as the percentage of wound healing. The average value of the three percentages of wound healing of each rat is considered as the respective would healing extent of each rat. The number of rats was 6 for each group of each test. Data is expressed as mean±SEM. P value is calculated for the test results by t-test against control group, where P<0.05 indicates significant differences, denoted *. [0037] A 0.5% cirsimaritin composition was prepared in an ointment form, and was applied to the rats as treated above. The results are as follows. The comparison between the percentages of wound healing at 9, 11, 13, and 15 days after administration, and the untreated control group is shown below. There were significant differences for each group. The wound half-closure time (CT50 value) was further calculated and also shows significant differences. [0000] Days after administration (%) 9 11 13 15 CT50 Control group 20.4 ± 4.1  35.0 ± 2.8  56.1 ± 2.8  67.7 ± 3.1  13.3 ± 0.4  cirsimaritin 37.2 ± 3.9* 51.5 ± 3.1* 70.6 ± 3.5* 83.3 ± 3.2* 10.7 ± 0.4* (0.5%) %: percentage of wound healing CT50: wound half-closure time *p < 0.05 Number of animals: n = 6 [0038] It is can be concluded from the results that the compounds of the present invention (taking cirsimaritin as an example) have the effects in healing of chronic wounds of diabetic patients.

Disclosed is a method for wound healing comprising administering a subject in need thereof a therapeutically effective amount of a flavonoid compound, wherein the compound is preferably nonglycosylated flavone. Specifically, the present invention can be used for treating skin symptoms of a trauma, a burn, a scald and a chronic wound, and can be particularly used for healing a wound of a diabetes patient.

FIELD OF THE INVENTION [0001] This invention relates to a package of disposable gloves and to a method and an apparatus which can use the package to enable the gloves to be applied to a user's hands. BACKGROUND OF THE INVENTION [0002] The use of disposable gloves is becoming common in a number of industries such as food handling establishments where food such as sandwiches or the like may be made and sold to a customer, or other open food products such as meats and the like are selected from a tray and wrapped for a customer to purchase. The use of such gloves is intended to improve hygiene and prevent the spread of germs which may take place if such food products are handled by the bare hands. [0003] Conventionally, when such gloves are used they are merely selected from a box and are applied by the user to the user's hands. This requires the user to have significant contact with the gloves prior to, and during, application of the gloves to the user's hands which means that the outer surface of the gloves can become contaminated with any other germs or other unwanted material already on the user's hands. SUMMARY OF THE INVENTION [0004] The object of the present invention is to provide a package of disposable gloves which may be used with a method and an apparatus to more hygienically apply the gloves to a user's hands, and to such a method and an apparatus. [0005] The invention in a first aspect may be said to reside in a package of disposable gloves, comprising: a plurality of gloves connected to one another in a line by a frangible connection which is breakable to separate one glove from the line; a glove edge transverse to the frangible connection to form an open cuff of each glove; and wherein each glove is formed from two layers which are joined together by a join to define the glove. [0009] Preferably the gloves are formed in glove panels with each panel being connected to an adjacent panel by the frangible connection, the join comprising a heat seal in each panel defining the shape of the glove. [0010] In one embodiment each panel is a rectangular panel and has webs outwardly of the join. [0011] In one embodiment the glove has defined fingers and cuts are formed through the webs between the fingers to separate the fingers. [0012] However, in other embodiments the webs between the fingers may be left intact. [0013] In another embodiment the glove has fingers and the join of the glove which defines the fingers forms the periphery of the panel at the fingers. [0014] Thus, in this embodiment no web is formed between the fingers of each glove. [0015] In other embodiments the glove may be a mitten without defined fingers. [0016] Preferably the package of disposable gloves is in the form of a roll of gloves. [0017] This aspect of the invention may also be said to reside in a package of disposable gloves for use with a glove applying machine for enabling the gloves to be applied to a user's hands, comprising: a plurality of gloves connected to one another in a line by a frangible connection which is breakable to separate one glove from the line; each glove being formed from two layers which are joined together by a join to define the glove; and locating indicia for allowing the gloves to be registered in the apparatus. [0021] In one embodiment the locating indicia comprises a marking. [0022] In another embodiment the locating indicia comprises a hole. [0023] In one embodiment of the invention at least one pin for location in the hole to register the package of gloves in the apparatus when a new package of gloves is loaded into the apparatus, to enable the gloves to be indexed through the apparatus. [0024] Preferably the gloves are formed in glove panels with each panel being joined to an adjacent panel by the frangible connection, the join comprising a heat seal in each panel defining the shape of the glove. [0025] Preferably each panel has a web portion outwardly of the join and the locating indicia is located on the web portion. [0026] According to one embodiment, preferably an open cuff of each glove is formed at the edge of each panel that is transverse to the frangible connection. In other words, the glove is oriented horizontally or “East to West” relative to the line. [0027] According to an alternative embodiment, preferably an open cuff of each glove is formed at an edge of the panel at the frangible connection between the panels. In other words, the glove is oriented vertically or “North to South” relative to the line. [0028] In the most preferred embodiment the marking indicia comprises two holes in each panel. [0029] Preferably the frangible connection comprises a perforated line. [0030] However, in other embodiments the frangible connection could comprise small attaching strips between each glove, the attaching strips being breakable when one glove is pulled away from an adjacent glove in the line of gloves. [0031] Preferably the package of disposable gloves comprises a roll of gloves. [0032] The invention in a second aspect may be said to reside in a method of hygienically locating a glove on a user's hand, comprising: mechanically locating the glove at a hand insertion location; opening the glove; and inserting a hand in the glove. [0036] Preferably the glove is opened at the hand insertion location. [0037] Preferably the glove is supplied as one glove in a line of gloves joined by a frangible connection, so that the glove when the user's hand is located in the glove is torn from the line by movement of the user's hand and the glove. [0038] Preferably the glove has an open cuff and a finger portion and the glove is located in an orientation such that a line between the cuff of the glove and the end of the finger portion of the glove is substantially horizontal. [0039] Preferably the glove has a first layer defining the back of the glove and a second layer defining the palm of the glove, and the glove is open by moving the first and second layers apart to enable a person to insert his/her hand through the cuff into the glove. [0040] Most preferably both the first and second layers are moved. However, in other embodiments only one of the layers could be moved whilst the other is substantially stationery. [0041] The invention may also be said to reside in an apparatus for enabling hygienic location of a glove on a hand, comprising: a storage for storing a package of disposable gloves; an indexing device for moving the gloves from the storage to a hand insertion station; and a glove opening device for opening a glove so a user can insert his or her hand into the glove at the hand insertion station. [0045] In one embodiment of the invention the storage is a compartment for storing a roll of gloves comprising a continuous line of gloves with the gloves being joined to one another by a frangible connection in the line. [0046] Preferably, the indexing device comprises a movable gripping device for movement between the hand insertion station and a line gripping station so that the device can move relative to the line between the insertion station and the gripping station, and can grip the line at the gripping station so the line is drawn with the device upon return movement from the gripping station to the hand insertion station. [0047] Preferably the gloves in the line have a first layer and a second layer and the glove opening device comprises a gripper for gripping at least one of the layers, and a gripper moving element for moving the gripper and the at least one of the layers relative to the other layer to open the glove. [0048] Preferably the glove is gripped and opened during movement of the gripper device between the gripping station and the hand insertion station. [0049] According to one embodiment, the gripper comprises a block of material through which air can flow, and the gripper mover element comprises a bladder, wherein upon inflation of the bladder the material is forced against at least one of the layers, and when vacuum is applied to the material air flows through the material to hold the layer against the material, and upon deflation of the bladder the material and the layer are drawn away from the other layer to thereby open the glove. [0050] Preferably the material comprises a open cell foam material. [0051] Preferably the bladder has a spring element for controlling inflation and deflation of the bladder to firstly move the material against the layer upon inflation of the bladder, and draw the material and the layer away from the other layer upon deflation of the bladder. [0052] According to an alternative embodiment, the gripper comprises an inflatable assembly and a sealing formation having one or more than one suction points, wherein upon inflation of the inflatable assembly, at least one of the suctions points of the sealing formation is located against at least one of the layers, and upon deflation of the inflatable assembly, the layer is drawn away from the other layer to thereby open the glove. [0053] Preferably, the inflatable assembly comprises a bellows. [0054] Preferably, the rate of inflation or deflation of the inflatable assembly is controlled by a piston and cylinder that supplies air into, or draws air from, the inflatable assembly, and suction of the suctions points is controlled by a separate piston and cylinder. [0055] Preferably, the or each piston and cylinder assembly is operable by a linear actuator controlled by a solenoid. [0056] Preferably the indexing device further comprises a pair of rollers, a gear attached to each roller the gears meshing together so the rollers are able to rotate in unison but in opposite directions, the rollers having a groove and rib so that when the groove of one roller engages with the rib of the other roller the line is gripped between the rollers, and so that upon movement of the indexing device from the gripping station to the hand insertion station the line is drawn off the package, and upon movement of the indexing device from the hand insertion station to the gripping station the rollers rotate relative to the line during movement of the indexing device until the groove and rib re-engage to thereby grip the line between the rollers. [0057] In one embodiment a driver is provided to rotate the rollers only during movement of the gripping device from the hand insertion station to the gripping station. [0058] In one embodiment the driver comprises a motor may be provided for facilitating rotation of the rollers during movement of the indexing device from the hand insertion station to the gripping station. [0059] The motor may have a clutch to prevent rotation of the rollers during movement of the indexing device from the gripping station to the hand insertion station. [0060] In another embodiment the driver comprises a rack and gear assembly, with the gear coupled to one of the rollers and the rack fixed and engaging the gear so that when the indexing device is moved from the hand insertion station to the gripping station engagement of the gear and the rack causes rotation of the gear and therefore rotation of the rollers. [0061] In this embodiment the gear also synchronises rotation of the rollers with movement of the indexing device between the hand insertion station and the gripping station. [0062] Preferably a sensor is provided for sensing the insertion of a user's hand into the glove at the hand insertion station, and then removal of the glove from the line at the hand insertion station, to thereby activate the indexing device to cause the indexing device to move from the hand insertion station, to the gripping station, and back to the hand insertion station so a new glove is open at the hand insertion station ready for insertion of a user's hand. [0063] Preferably the apparatus includes locating elements for engaging the line when a new package is located in the apparatus to correctly register the line in the apparatus. [0064] Preferably the line has holes and the locating elements comprise pins for passing through the holes when the package is loaded into the apparatus, and for withdrawal from the holes after the package is loaded in the apparatus. [0065] Preferably the pins are driven between a locating position where they can pass through the holes and a retracted position away from the line, by opening and closing movement of a door of the apparatus to provide access to the storage of the apparatus. [0066] Preferably at least one of the rollers is spring biased into engagement with the other of the rollers so that the rollers can be slightly separated to facilitate location of the line between the rollers during loading of a package into the apparatus. [0067] This aspect of the invention may also be said to reside in an apparatus for enabling hygienic location of a glove on a hand, comprising: a housing having a front opening and a bottom opening which provide access to a hand insertion station; a storage for storing a package of disposable gloves, so the gloves are presented at the hand insertion station in an orientation so that a line between a cuff portion of the gloves and a fingertip portion of the gloves is substantially horizontal, and with the cuff portion of the gloves facing the front opening; a glove indexing device for moving a glove from the storage to the hand insertion station so a user can insert his or her hand into the glove through the cuff portion; and wherein to locate the glove on the hand and remove the glove from the apparatus, a user inserts his or hand through the front opening into the glove and then moves his or her hand with the glove on his or her hand downwardly through the bottom opening. [0072] This aspect of the invention may also be said to reside in an apparatus for enabling hygienic location of the glove on a hand, comprising: a storage for storing a package of disposable gloves; an indexing device for moving the gloves from the storage to a hand insertion station; and a glove opening device comprising at least one block of material through which air can flow, an inflatable bladder, and at least one air supply and vacuum system for supplying air to the bladder to inflate the bladder to move the block to a position adjacent the glove, for drawing a vacuum through the block so a portion of the glove is drawn against the block, and for deflating the bladder so the block moves with the bladder to move a portion of the glove away from another portion of the glove to open the glove to enable a user to insert his or hand into the glove at the hand insertion station. BRIEF DESCRIPTION OF THE DRAWINGS [0076] Preferred embodiments of the invention will be described, by way of example, with reference to the accompanying drawings in which: [0077] FIG. 1 is a view of a line of gloves formed as a package according to one embodiment; [0078] FIG. 2 is a view similar to FIG. 1 of a second embodiment; [0079] FIG. 3 is a view along the line of FIG. 1 ; [0080] FIG. 4 is a side view of the package of gloves in the form of a roll of gloves; [0081] FIG. 5 is a more detailed view of one glove in the line of FIG. 1 ; [0082] FIG. 6 is a more detailed view of one glove of the type shown in FIG. 1 in a modified form; [0083] FIG. 7 is a side view of a machine for forming the package of gloves; [0084] FIG. 8 is a top view of the machine of FIG. 7 ; [0085] FIG. 9 is a side view of an apparatus according to one embodiment of the invention; [0086] FIG. 10 is a front view of the apparatus of FIG. 9 ; [0087] FIG. 11 is a perspective view of the apparatus of FIG. 9 ; [0088] FIG. 12 is a detailed view of a roller and gear assembly using the preferred embodiment of the invention; [0089] FIG. 13 is a schematic view of part of the apparatus of FIG. 9 ; [0090] FIG. 14 is a perspective view of part of the apparatus shown in FIG. 13 ; [0091] FIG. 15 is a schematic front view of an apparatus according to FIG. 9 ; [0092] FIG. 16 is a side view of part of the apparatus of FIG. 15 ; [0093] FIG. 17 is a schematic view of part of the apparatus of FIG. 9 ; [0094] FIG. 18 is a schematic view of a part of the apparatus according to another embodiment of the invention; [0095] FIG. 19 is a cross-sectional view of another part of the apparatus according to an embodiment of the invention; [0096] FIG. 20 is a perspective view of a section of the part of the apparatus shown in FIG. 18 ; and [0097] FIG. 21 is a schematic diagram of a control system used in the embodiment of the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0098] With reference to FIG. 1 a line of gloves 10 is shown which form a package of gloves such as a roll 15 as shown in FIG. 4 . In other embodiments the package could comprise a zigzag layering of the line of gloves or any other compact packaging of the gloves. [0099] The line of gloves 10 is formed from a first layer 18 and a second layer 20 (see FIG. 3 ). Each glove 11 in the line of gloves 10 is defined by a heat seal join 21 which defines the periphery of the glove (in other words the shape of the glove). Thus, the join heat seals the two layers 18 to 20 together along the outline 11 a of the gloves to thereby define the shape of the gloves. [0100] In the embodiment of FIG. 1 , the gloves are formed in glove panels 25 formed by the two layers 18 and 20 and the glove panels 25 are defined by a frangible connection 26 . The frangible connection 26 preferably comprises a perforated line so that one glove can be easily torn from the line 10 as will be described in more detail hereinafter. [0101] In the embodiment of FIG. 1 the glove panels 25 have opposite edges 27 and 29 which are not connected to one another except where the join 21 intersects or contacts the edges 27 and 29 . This therefore defines an open cuff 30 of each glove as is best shown in FIG. 3 . The edge 29 may be beaded so that the open cuff of each glove 11 has a bead 31 to slightly strengthen that part of the glove and make it easy for a person to insert his or her hand into the glove. [0102] Each panel 25 is also provided with two holes 33 which form locating indicia to facilitate location of the gloves in a glove applying apparatus to be described hereinafter. [0103] FIG. 2 shows a second embodiment in which the gloves are configured in an “north-south” configuration rather than the “east-west” configuration of FIG. 1 . Like reference numerals indicate like paths to those previously described. [0104] In this embodiment the open cut of the glove will be formed when the perforated line 26 is torn during the separation of one glove 11 from the line of gloves 10 . [0105] FIG. 5 is a more detailed view of one glove 11 formed in a panel 26 of the type shown in FIG. 1 . [0106] As will be apparent from both FIG. 1 and FIG. 5 webs 35 are left outwardly of the join 11 a, formed from the layers 18 and 20 of each panel 25 . [0107] If desired, cuts 37 can be made in the webs 35 between the fingers 11 b of the gloves to separate the fingers. However, in other embodiments the webs can remain intact because they will be relatively thin and will still allow sufficient degree of relative movement of the fingers form most applications. [0108] A cut 37 is also provided between the thumb 11 c of the glove 11 and the index finger 11 b adjacent the thumb 11 c. [0109] Since the disposable glove is usually only used for a very small amount of time, perhaps in the order of only 30 seconds or less, the webs will not interfere with movement of the hand or the work the person wearing the gloves is required to do. [0110] In still further embodiments of the invention the panels 25 may be of the type shown in FIG. 6 in which the panel is cut about the join 11 a defining the fingers 11 b so that no webs are provided between the fingers 11 b and the thumb 11 c . Webs 35 remain outwardly of the palm portion 11 d of the hand. [0111] In this embodiment the edge 27 is defined by the shape of the fingers as shown in FIG. 6 . [0112] In the embodiment of FIG. 6 the perforated line 26 extends from the edge 29 to the tip of the thumb 11 c and between the edge 29 and the tip of the small finger 11 b. [0113] FIGS. 7 and 8 show, schematically, an example of how the package of gloves is formed. [0114] Layers 18 and 20 are supplied from supply rolls 40 and 41 of the layer material and guided around one or more sets of idler rollers 42 to a heat sealing station 43 . At the heat sealing station 43 the join 21 defining the periphery of the glove 11 a is formed by applying heat along the line 11 a via appropriate parts of the station 43 to heat weld the layers 18 and 20 together along the line 11 a which defines the shape of the glove. Thus, the layers 18 and 20 are joined at the line 11 a. [0115] The layers 18 are then indexed to a cutting and perforating station 45 where the perforated line 26 is formed and also the holes 33 and cuts 37 , the formed line of gloves 10 is then rolled onto a roll to form the package of gloves 15 shown in FIG. 4 . [0116] It should be understood that the apparatus shown in FIGS. 7 and 8 is schematic and merely illustrative and not intended to show all componentry of the machine performing the package of gloves. In any event, it will be appreciated that the compoenentry not shown in detail in FIG. 7 may readily be constituted by a combination of commercially available components. [0117] FIGS. 9 to 14 , and 16 and 17 show parts of an apparatus according to one embodiment of the invention. FIG. 15 shows a schematic illustration of the assembled apparatus comprising the parts shown in FIGS. 9 to 14 , and 16 and 17 for hygienically applying the glove to a user's hand. [0118] With reference to FIGS. 9 , 10 and 11 , the apparatus has a glove line 10 indexing device 48 comprising a support frame 50 which supports a pair of glove opening devices 52 . Roll 15 of the gloves 11 is supported on a shaft (not shown) in a storage 49 and the line of gloves 10 is guided from the roll 15 through the devices 52 as is best shown in FIG. 10 and FIG. 11 . [0119] The frame 50 comprises two U-shaped frame members 51 which are supported on tracks 53 which, in turn, are supported by outer housing 55 (see FIG. 15 ). [0120] The frame 50 is also connected to a pair of linear bearings 56 for moving the frame 50 vertically on guide tracks 53 as will be explained in more detail hereinafter. [0121] The frame 50 also supports a line gripper 54 to gripping the line 10 . The line gripper 54 comprises a pair of rollers 58 between which the line 10 of gloves 11 is guided. The rollers 58 have gears 59 at one end and the gears 59 are meshed to synchronise rotation of the rollers 58 so that they rotate in unison with one another but in opposite directions. [0122] The outer housing 55 also supports two pressure pumps 60 for driving the devices 52 as will also be explained in more detail hereinafter. [0123] An encoder 61 is provided on shaft 62 on which one of the rollers 58 is mounted for monitoring rotation of the rollers 58 . [0124] Movement of the frame 50 and the rollers 59 and associated operation of the devices 52 is as follows. [0125] FIGS. 9 and 10 show the frame 50 in a raised upper gripping position at gripper station G in which the line of gloves 10 is gripped by the rollers 59 and extends between the devices 52 . The linear bearing 56 moves the frame and rollers 59 downwardly to the hand insertion station H shown in FIG. 11 thereby pulling the line of gloves 10 downwardly with the frame 50 off the roll 15 . [0126] During downward movement of the frame 50 pressure is supplied to the devices 52 to cause the devices 52 to grip one of the gloves 11 on the line 10 . After the glove has been gripped vacuum is then applied to the devices 52 to cause the devices 52 to separate thereby pulling the two layers 18 and 20 which make up the glove 11 away from one another to open the glove. At the same time as the vacuum is applied the pressure previously supplied to the devices 52 to cause gripping of the glove is released. [0127] The glove is therefore held open with the frame 50 in the lower position at hand insertion station H shown in FIG. 11 so that a user can then insert his hand through front opening 62 of the housing 55 into the glove and the user simply draws his or her hand downwardly through the open bottom 64 of the housing 55 to tear the glove from the line 10 along the perforation 26 above the glove 11 . Thus, the user's hand is removed from the apparatus with the glove on place without the user having to touch the outside of the glove. [0128] As is best shown in FIGS. 9 and 15 a light emitting array 66 is provided on the frame 50 opposite a linear array of photo detectors 68 . Light emitted by the emitters 66 is detected by the detectors 68 so that when a person's hand is located in the glove the light is blocked thereby providing an indication that a person's hand is in the apparatus and when the person tears the glove 11 from the line 10 by the downward movement of the hand previously mentioned, light is again detected by the array of photo detectors 68 . Thus, this provides a signal indicative of the fact that a user has inserted his or her hand into the apparatus and removed his or her hand with a glove on it. This signal is used to activate the linear bearings 56 to again drive the frame 50 upwardly. As the frame 50 is driven upwardly the friction between the line 10 and the rollers 58 causes the rollers 58 to rotate thereby rolling up relative to the station line 10 of gloves 11 . When the rollers 58 have rotated one full revolution as detected by the encoder 61 a signal is supplied to shut off the linear bearings 56 to prevent further upward movement of the frame 50 indicative of the fact that the frame 50 has returned to its starting station G shown in FIG. 10 . Rollers 58 grip the line 10 and the frame 50 moves downwardly back to the hand insertion station H shown in FIG. 11 where a glove is opened in the same manner as described above, ready for a user to insert his hand into the apparatus to locate the glove on the user's hand. Once this happens, and the user's hand is removed from the apparatus the sequence starts again and the frame 50 is driven upwardly so that the rollers rotate until the line is then gripped and the frame 50 moved downwardly to draw the line 10 from the roll 15 and open a fresh glove in the apparatus when the frame 50 returns to the station H as shown in FIG. 11 . Thus, the insertion of a user's hand into the apparatus and removal of the hand and glove provides the signal to operate the apparatus to open another glove ready for a user to place his hand into the glove. Thus, after a glove is removed from the line by a user a fresh glove is delivered to the hand insertion station H shown in FIG. 11 ready for another hand to be inserted into a glove. [0129] It will be noted from the above that the rollers 58 only rotate during the upward movement of the frame 50 . During the lowering of the frame 50 the rollers 58 grip the line of gloves 10 and do not rotate thereby drawing further gloves from the roll 15 . [0130] In order to facilitate rotation of the rollers 58 during movement of the indexing device 48 a driver is provided to rotate the rollers 58 during movement to the station G but which will allow the rollers to be locked against rotation during movement of the indexing device 48 back to the hand insertion station H. In one embodiment the driver comprises a motor 69 which has a clutch or ratchet mechanism so the motor can rotate the rollers during movement to the gripping station G but allow the rollers to remain locked against rotation during movement back to the hand insertion station H. [0131] The motor 69 (see FIG. 9 ) is provided on the shaft 62 to rotate the roller 58 on that shaft with the rotation being imparted to the other roller by meshing engagement of the gears 59 . [0132] In another embodiment as shown in FIG. 17 the driver comprises a gear 101 mounted on shaft 102 on which one of the rollers 58 is provided. The gear 101 meshes with a rack 103 fixed to housing 55 (shown in FIG. 16 ). The gear 101 is mounted to the shaft 102 via a ratchet, clutch or the like so that when the indexing device 48 is moved upwardly towards the gripping station G in the direction of arrow C in FIG. 17 the engagement of the gear 101 and the rack 103 causes rotation of the gear 101 and therefore the shaft 102 and roller 58 . Rotation is imparted to the other roller 58 by the gears 59 . Thus, the rollers 58 easily roll up the line 10 of the gloves 11 . During movement back towards the hand insertion station in the direction of arrow D the ratchet or clutch associated with the gear 101 allows the gear 101 to rotate freely on the shaft 102 so no rotation is imparted to the rollers 58 and the rollers remain in the locked position with the rib 70 located in the groove 71 as previously explained. [0133] The provision of the gear 101 also provides the additional advantage in that it synchronises the upward movement of the indexing device 48 in the direction of arrow C with the rotation of the rollers 58 so the rollers undergo one full revolution during complete movement of the indexing device from the hand insertion station H to the gripping station G. [0134] It will be appreciated from the previous description and drawings that the rollers 58 extend only part the distance of the space between the frame members 51 and therefore adequate space is provided for the motor 69 or the gear 101 and rack 103 . [0135] As shown in FIG. 12 the rollers 58 are configured to grip the line 10 when the frame 50 is in the upper position shown in FIG. 9 . To achieve this one of the rollers 58 (i.e. the left roller in FIG. 12 ) is provided with a longitudinal rib 70 and the other roller 58 is provided with a longitudinal groove 71 . When the frame 50 is the upper position at gripper station G the rib 70 locates in the groove 71 therefore jamming the line 10 between the rib 70 and groove 71 so that the rollers 58 firmly hold the line 10 . When the frame 50 is moved downwardly the rollers 58 therefore firmly grip the line 10 and the line 10 is drawn off the roll 15 with downward movement of the frame 50 . When the frame 50 is moved upwardly, the rollers 58 are able to rotate so the rib 70 moves out of the groove 71 so that the rollers 58 can effectively roll up the line 10 for one full rotation of the rollers 58 until the rib 70 relocates in groove 71 to again grip the line 10 . [0136] FIGS. 13 and 14 show in more detail the devices 52 according to a first embodiment for opening a glove 11 . The devices 52 are supported on plates 73 which form part of the frame 50 and extend between the frame members 51 . The plate 73 and the frame members 51 therefore form partial enclosures for securely supporting the devices 52 . [0137] Each device 52 is identical and therefore only one will be described in detail in FIGS. 13 and 14 . Each device 52 comprises a open cell foam block 75 which is in the general shape of the glove 11 except that the fingers are somewhat shorter than the fingers of the glove 11 . The block 75 has a layer of lacquer or other sealant applied to edges 75 a , 75 b and rear surface 75 c . End edges 75 d and the edges which define the finger portions 75 e also have the lacquer or sealant coating applied to them. A vacuum tube 78 is connected with the block 75 and in turn connects with one of the pressure pumps 60 . A bladder 80 is connected on the outside of the block 75 against surface 75 c and again has the same general shape as the block 75 . The bladder includes a plastic strip 81 within the bladder which acts as a spring as will be described in more detail hereinafter. A supply tube 83 is connected to the bladder 80 and also to the other of the pumps 60 . Thus, one of the pumps 60 enables vacuum to be applied to the two devices 52 (namely the blocks 75 of the two devices 52 ) and the other pump 60 supplies pressure to the two bladders 80 of the devices 52 . [0138] In order to open the glove 11 air is pumped from one of the pressure pumps 60 into the bladders 80 to cause the bladders 80 to expand. The spring generally holds the bladders 81 against spherical expansion of the bladders 80 and therefore when the bladders expand they push against the blocks 75 to push the blocks 75 into engagement with a closed glove 11 as is best shown in FIG. 10 . Thus, the open porous faces 75 g of the blocks 75 , which do not have lacquer or sealant applied to them, are pushed into gentle contact with the layers 18 and 20 which make up the glove 11 . Vacuum is then drawn by the other pump 60 through the tube 78 and through the open cellular structure of the foam block 75 so that the webs 18 and 20 are sucked against the surface of 75 g of the blocks 75 . At the same time, pressure is released from the bladders 80 causing the bladders to return to their generally flat deflated configuration shown in FIG. 14 pulling the block 75 with them in the direction of arrows A in FIG. 13 . This thereby cause layers 18 and 20 to separate and open the glove 11 sufficient for a person to insert his or her hand into the glove 11 through open door 62 of the housing 55 . [0139] FIGS. 18 to 20 show the devices 52 of an alternative embodiment for opening the glove 11 . The devices are supported on plates 73 , best seen in FIG. 17 , which form part of the frame 50 and extend between the frame members 51 shown in FIGS. 9 to 15 . The plate 73 and the frame members 51 therefore form partial enclosures for securely supporting the devices 52 . [0140] Each device 52 is the same and therefore only one will be described in detail. Each device 52 comprises a bellows 75 having a clamping ring 120 for securing the bellows 75 to the plate 73 , a flexible and inflatable diaphragm 121 having a side wall comprising a series of the folds and an engagement face 122 that approximates the size of the palm region of the glove 11 . Arranged about the perimeter of the engagement face 122 is a vacuum sealing lip 123 and central of the engagement face 122 are three suction holes 124 that are each connected to a vacuum source 60 a via a manifold and tubing 78 a . The diaphragm 121 of the bellows 75 is connected to an air delivery system comprising an air displacement pump 60 b . FIG. 19 shows an embodiment in which the vacuum source 60 a and air displacement pump 60 b are in the form of piston and cylinder assemblies located within rollers 58 for guiding the line 10 of gloves 11 . The inside of walls of the rollers 58 form the cylinder and a piston 126 having vacuum seals 125 or pump seals 128 and each is driven inside the cylinders by a solenoid controlled linear actuator 127 . The end wall of each roller 58 is equipped with a rotary air coupling for coupling to air supply tubing 78 a , 78 b . In the case of the vacuum source, tubing 78 a connects the cylinder of the vacuum source to the holes 124 in the face of the engagement face 122 via a manifold. In the case of the air displacement pump, tubing 78 b connects the cylinder to the inside of the diaphragm 121 . [0141] In order to open the glove 11 the liner actuator 127 of the air pump 60 b is operated to move the piston to the distal end of the roller 58 and thereby expand the bellows 75 in the direction of arrows A in FIG. 18 until the lip sealing formation 123 engages the palm region of a glove 11 at the insertion station H. Pressure release valves or flow regulates may be incorporated into the air pump 60 b or the tubing 78 b to limit over pressurisation or under pressurisation of the bellows 75 as deemed necessary. With the bellows 75 expanded and lip formations 123 contacting opposite layers or sides of the glove 11 , the vacuum source 60 a is operated to retain the each respective layer of the glove 11 to the bellows 75 . The linear actuator 127 of the vacuum 60 a is operated by moving the piston toward the proximal end of the roller 58 in FIG. 19 . Once the formation of an adequate vacuum has been established to retain the layers of the glove 11 to the engagement face 122 , the linear actuator 127 of the air displacement pump 60 b drives the piston from the distal end to proximal end of the cylinder, thereby deflating the bellows 75 and simultaneously opening the glove ready for hand insertion. The adequacy or inadequacy of inflation and deflation of the bellows 75 can be monitored by way of the pressure release valves or flow regulators. Similarly, the adequacy or inadequacy of the vacuum for retaining the layers of the glove 11 to the engagement face 122 of the bellows 75 can be monitored using suitable regulators. [0142] Irrespective of whether the devices 52 for opening the glove are in the form of the embodiment shown in FIGS. 13 and 14 , or the alternative embodiment shown in FIGS. 18 and 20 , insertion of a hand into the glove blocks the light from the emitter array 66 to the detector array 68 indicating a hand has been placed in the glove. As previously explained, the user then pulls his or her hand downwardly through open bottom 64 to tear the glove 11 along perforated line 26 with the glove on the user's hand. As the user's hand is removed from the apparatus light is again detected by the array 68 providing a signal for the frame 50 to be driven upwardly to again grip the line and move downwardly with another glove being opened as the frame 50 moves downwardly so that a user can insert his or her other hand into the next glove if desired. Otherwise, the glove is simply held in the open configuration in the device awaiting for the next hand to be inserted into that glove and for that glove to be torn from the line 10 before the sequence repeats to bring another glove to the hand insertion station H. [0143] Vacuum may be applied to hold a glove in the open position at the insertion station H for a predetermined time interval after which the vacuum is shut off. Thus, if a glove is not required for some time, the glove merely remains in a static position at the hand insertion station. A sensor (not shown) may be provided to activate the glove opening device to open the glove again when a hand is inserted into the apparatus. [0144] In another embodiment the cycle of retrieving a new glove and opening a new glove may be commenced by a start button 110 (see FIG. 15 ) and the sequence of operation may be that when the button 110 is pushed the indexing device 48 moves upwardly as previously explained to grip the line 10 and then moves back to the hand insertion station with the glove being opened as previously explained so the user can insert his or her hand into the glove. When another glove is required the button 110 is again pushed so the sequence repeats itself. This prevents the need to hold vacuum at the opening devices 52 for a great length of time. [0145] As is best shown in FIG. 15 , the housing 55 is provided with a door 90 which can be opened in the direction of arrow B to enable a new roll 15 to be loaded into the apparatus. To load a new roll the door 90 is opened and the remnants of the old roll 15 removed. A new roll is located in place in the apparatus. When the door 90 is opened, a mechanical linkage schematically shown at 91 causes two pins 92 to be driven forward. The locating holes 33 in one of the panels 25 of line 10 are located on the pins 92 so the pins 92 project through the holes 33 . This correctly registers the roll relative to the rollers 58 and part of the line 10 is located between the rollers 58 . To facilitate location of the line 10 between the rollers 58 one of the rollers 58 is mounted on a spring tensioning device 95 which, when the door 90 is opened, draws the respective roller 58 away from the other roller 58 to provide a space for the line 10 to be easily inserted between the rollers. Again a mechanical link 96 (schematically shown) may be used to achieve this. When the door 10 is closed the pins 92 are retracted out of the holes 33 away from the line 10 and the roller 58 is again spring biased against the other roller 58 with the line 10 between the rollers 58 . [0146] When the door 90 is closed the apparatus can be operated to locate a glove at the hand insertion station with the glove open ready for use by a user. [0147] FIG. 18 is a schematic block diagram of the control system for controlling the apparatus. A processor 99 is provided which receives signals from the encoder 61 to monitor the position of the rollers 58 relative to one another and to stop movement of linear bearings 56 when the rollers 58 have rotated one full revolution. Photo detector array 66 and 68 also provide signals to the processor 99 to indicate location removal of a user's hand to drive the linear bearings 56 to move the indexing device 48 upwardly and then back down to the hand insertion station H and at the same time operate the pumps and/or vacuum source to apply pressure and vacuum to the devices 52 to grip the glove and open the glove. In the event that the pressure release values or air regulators detect that inadequate or excessive air flow is created by pumps 60 , 60 a or 60 b , causing malfunction of the devices 52 , the processor 99 can activate an alarm 130 signalling that the apparatus requires maintenance or servicing. [0148] The processor 99 also receives a signal when the button 100 is pressed, should the button be provided, to commence the glove retrieval and opening sequence, and a signal from timer 111 for shutting off the vacuum to the opening devices 52 after a predetermined time period. [0149] If a motor 69 is provided for facilitating rotation of the rollers 58 during upward movement of the frame 50 the processor 99 can also control the motor 69 to drive the roller 68 during movement of the indexing device 48 from station H to station G until one full rotation of the rollers 58 has occurred. [0150] Other sensors may also be included in the apparatus to detect the location of the line 10 and is indexing through the apparatus from the roll 15 to the hand insertion station. Further markings or other indicia may be provided on the line 10 to facilitate detection of the line 10 by the other sensors. [0151] In order to provide additional rigidity to the line 10 of the gloves 11 , the layers 18 and 20 may be provided with additional rigidity such as by forming a double heat seal about the periphery of the glove 11 or providing a thickened heat seal bead along the line 11 . The additional rigidity will assist in ensuring that the line 10 moves vertically downwardly and does not tend to wrap around the rollers 58 during indexing of the line 10 through the apparatus. [0152] Since modifications within the spirit and scope of the invention may readily be effected by persons skilled within the art, it is to be understood that this invention is not limited to the particular embodiment described by way of example hereinabove. [0153] In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word “comprise” or variations such as “comprises” or “comprising” is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

The present invention relates to a package of disposable gloves and to a method and an apparatus which can use the package to enable the gloves to be applied to a user's hands. The gloves are stored in a roll and are unrolled and opened by the apparatus so that a user can hygienically insert their hand into a glove without touching the glove. The user, with their hand in the glove can then sever the glove from the roll of gloves by moving their hand downwardly and away from the apparatus. The apparatus can then unroll and open another glove for the user to insert their other hand.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a Continuation of U.S. Non-Provisional application Ser. No. 11/023,667, filed Dec. 28, 2004, which is hereby incorporated by reference as though fully set forth herein. BACKGROUND OF THE INVENTION [0002] a. Field of the Invention [0003] The present invention relates to catheters and sheaths and methods of using catheters and sheaths. More particularly, the present invention relates to a fixed dimensional control handle for steerable catheters and sheaths and methods of manufacturing and using such an handle, with the control handle generally maintaining its exterior dimensions during operation thereof. [0004] b. Background Art [0005] Catheters (i.e., catheters or sheaths) that have flexible tubular bodies with deflectable distal ends and control handles for controlling distal end deflection are used for many noninvasive medical procedures. For example, catheters having conductive electrodes along the distal ends of their bodies are commonly used for intra-cardiac electrophysiology studies. The distal end of a catheter body is typically placed into a patient's heart to monitor and/or record the intra-cardiac electrical signals during electrophysiology studies or during intra-cardiac mapping. The orientation or configuration of the distal end is controlled via an actuator located on the catheter's control handle, which remains outside the patient's body. The electrodes conduct cardiac electrical signals to appropriate monitoring and recording devices that are operatively connected at the control handle. [0006] Typically, a catheter body is cylindrical and electrically non-conductive. The catheter body includes a flexible tube constructed from polyurethane, nylon or other electrically non-conductive flexible material. The catheter body further includes braided steel wires or other non-metallic fibers in its wall as reinforcing elements. Each electrode has a relatively fine electrically conductive wire attached thereto and extending through the catheter body. The conductive wire extends from the distal end to a proximal end where electrical connectors such as plugs or jacks are provided to be plugged into a corresponding socket provided in a recording or monitoring device. [0007] The distal portion of the catheter body is selectively deformed into a variety of curved configurations using the actuator on the control handle. The actuator is commonly internally linked to the distal portion of the catheter body by at least one deflection wire. Some catheter bodies employ a single deflection wire, which is pulled (i.e., placed in tension) by the actuator in order to cause the distal portion of the catheter body to deform. Other catheter bodies have at least two deflection wires, where the displacement of one wire (i.e., placing one wire in tension) results in the other wire going slack (i.e., the wire does not carry a compressive load). In such catheters, where the deflection wires are not adapted to carry compressive loads (i.e., the deflection wires are only meant to be placed in tension), the deflection wires are commonly called pull or tension wires. [0008] To deform the distal end of the catheter body into a variety of configurations, a more recent catheter design employs a pair of deflection wires that are adapted such that one of the deflection wires carries a compressive force when the other deflection wire carries a tensile force. In such catheters, where the deflection wires are adapted to carry both compressive and tension loads, the deflection wires are commonly called push/pull or tension/compression wires and the corresponding catheter actuators are called push-pull actuators. U.S. Pat. No. 5,861,024 to Rashidi, which issued Jan. 19, 1999, is representative of a push-pull actuator of this type, and the details thereof are incorporated herein by reference. [0009] Prior art control handles for controlling distal end deflection of catheter bodies have several drawbacks that adversely impact the handles' ability to be operated precisely by a single hand. First, the control handles are often excessively bulky. Second, the control handles are often inadequate with respect to their ability to provide finely controlled deflection adjustment for the distal end of the catheter body. Third, the control handles often provide inadequate deflection wire travel for a desired medical procedure. Fourth, the control handles often have a mechanical advantage that is less than desirable and, as a result, require significant effort to operate on the part of a user. Fifth, once a desired body distal end deflection has been reached, the control handles typically require the physician to take a conscious step to maintain the catheter at the desired deflection. Sixth, the wire displacement mechanisms within the control handles have a tendency to permanently deform the deflection wires. Seventh, the wire displacement mechanisms within the control handles typically make it difficult, if not impossible, to provide a lumen that runs uninterrupted from the proximal end of the control handle to the distal end of the catheter body. [0010] There is a need in the art for a catheter control handle that offers improved single hand operation and deflection adjustment of the distal end of the catheter body. There is also a need in the art for such a handle with a lumen there through. There is also a need in the art for a method of manufacturing and using such a control handle. BRIEF SUMMARY OF INVENTION [0011] A fixed dimensional and bi-directional steerable catheter control handle may include an apparatus for imparting a tensile force to deflect a distal portion of a catheter while maintaining its exterior dimensions. The apparatus may include a handle grip including generally oval or circular cross-sections of generally predetermined exterior dimensions, and a longitudinal axis. A flexible elongate member may include proximal and distal end portions, with the proximal end portion being coupled to the handle grip. An adjustment knob may include a generally circular cross-section of generally predetermined exterior dimensions, and may be rotatably coupled to the handle grip around the longitudinal axis of the handle grip. One or more elongate deflection members may be operably coupled to the adjustment knob and to the distal end portion of the elongate member. Rotation of the adjustment knob may impart a tensile force to the elongate deflection member thereby causing the distal end portion of the elongate member to deflect from a prior configuration while maintaining the generally predetermined exterior dimensions of the handle grip and the adjustment knob. [0012] For the apparatus described above, in an embodiment, the elongate deflection member may include a filament, a braided cord, or a resin-based member. In an embodiment, the adjustment knob may be operably coupled to an intermediate body portion or a distal portion of the handle grip. In an embodiment, the elongate deflection member may include a first pull wire. The apparatus, in an embodiment, may include one or more additional pull wires operably coupled to the adjustment knob. [0013] For the apparatus described above, in an embodiment, the apparatus may include means for simultaneously imparting a tensile force to the first pull wire and releasing a tensile force on the additional pull wire. The adjustment knob may include an interior surface forming an aperture generally orthogonally oriented with respect to the longitudinal axis of the handle grip, with the interior surface including one or more sets of threaded grooves which cooperate with the means. The means may include a pair of generally axially displaceable members disposed within the handle grip, and rotation of the adjustment knob may impart opposing forces to the axially displaceable members. [0014] For the apparatus described above, in an embodiment, the elongate member may include one or more longitudinal lumens. In an embodiment, the apparatus may include one or more electrodes coupled to the elongate member. The elongate member, in an embodiment, may include a biocompatible electrically insulative material. The electrically insulative material may be a flexible material. Alternatively, the electrically insulative material may include a polyurethane material or a nylon material. The apparatus, in an embodiment, may include one or more reinforcing elements disposed within a portion of the elongate member. The reinforcing element may include braided members, which may include a conductive material. [0015] For the apparatus described above, in an embodiment, the elongate member may include a segment of a braided metallic wire and/or a non-metallic fiber. The apparatus, in an embodiment, may include a hemostasis valve coupled to the handle grip. In an embodiment, an exterior surface of the adjustment knob may includes a generally longitudinal groove and/or a generally longitudinal protuberance. [0016] For the apparatus described above, in an embodiment, the prior configuration may include a substantially straight configuration. In an embodiment, the elongate deflection member may include an elongate wire. In an embodiment, the apparatus may include an anchor ring coupled to the distal portion of the elongate member, and the elongate deflection member may include one or more elongate pull wires coupled to the anchor ring. [0017] In an embodiment, an apparatus for imparting a tensile force to deflect a distal portion of a catheter while maintaining its exterior dimensions may include a handle grip including a cross-section of generally predetermined exterior dimensions, and a longitudinal axis. A flexible elongate member may include proximal and distal end portions, with the proximal end portion being coupled to the handle grip. An adjustment knob may include a cross-section of generally predetermined exterior dimensions, and be rotatably coupled to the handle grip around the longitudinal axis of the handle grip. One or more elongate deflection members may be operably coupled to the adjustment knob and to the distal end portion of the elongate member. Rotation of the adjustment knob may impart a tensile force to the elongate deflection member thereby causing the distal end portion of the elongate member to deflect from a prior configuration while maintaining the generally predetermined exterior dimensions of the handle grip and the adjustment knob. [0018] For the apparatus described above, the handle grip may include a generally oval or circular cross-section, and in an embodiment, the adjustment knob may include a generally circular cross-section. [0019] In an embodiment, an apparatus for imparting a tensile force to deflect a distal portion of a catheter while maintaining its exterior dimensions may include a substantially hollow handle grip having a tactile outer surface having a longitudinal axis. An adjustment knob having a tactile outer surface may be coupled to the handle grip approximately equidistant from the longitudinal axis. A relatively thin elongated flexible body may have a distal end portion and a proximal portion, with the proximal portion coupled to the handle grip. One or more elongated members may be operatively coupled to the adjustment knob and to the distal end portion. Means may be disposed within the handle grip and operatively coupled to the adjustment knob for imparting a tensile force to the elongated member when the adjustment knob is rotated about the longitudinal axis so that the distal end portion of the flexible body deflects from a first configuration to a second configuration. The tactile outer surfaces of the handle grip and the adjustment knob may be substantially unchanged when the flexible body is disposed in the first and second configurations. [0020] For the apparatus described above, the handle grip may include a generally oval or circular cross-section, and in an embodiment, the adjustment knob may include a generally circular cross-section. [0021] The foregoing and other aspects, features, details, utilities, and advantages of the invention will be apparent from reading the following description and claims, and from reviewing the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0022] FIG. 1 is an isometric view of one embodiment of the present invention, which is a control handle for a catheter or sheath. [0023] FIG. 2 is an isometric view of the handle exploded to show its various components. [0024] FIG. 3 is a longitudinal sectional elevation of the handle taken along section line AA of FIG. 1 . [0025] FIG. 4 is an isometric view of the right and left slides with their respective deflection wires attached. [0026] FIG. 5 is a side elevation of an exemplary slide illustrating a means of securing a deflection wire to the proximal end of the slide. [0027] FIG. 6 is a longitudinal sectional elevation of the adjusting knob taken along section line AA of FIG. 1 . [0028] FIG. 7 is a plan view of another embodiment of the handle. [0029] FIG. 8 is a side elevation of the handle depicted in FIG. 7 . [0030] FIG. 9 is an isometric view of the distal end of the handle depicted in FIG. 7 . [0031] FIG. 10 is a longitudinal sectional plan view of the handle taken along section line BB of FIG. 9 . [0032] FIG. 11 is a longitudinal sectional plan view of the knob taken along section line BB in FIG. 9 . [0033] FIG. 12 is a right side isometric view of the slides displaced about the wire guide. [0034] FIG. 13 is a left side isometric view of the slides displaced about the wire guide. [0035] FIG. 14 is a longitudinal sectional elevation of the handle grip taken along section line CC in FIG. 7 . [0036] FIG. 15 is a latitudinal sectional elevation of the handle grip taken along section line DD in FIG. 8 . [0037] FIG. 16 is an isometric view of the distal end of a control handle for a catheter wherein the handle has a through lumen. [0038] FIG. 17 is an isometric view of the slides, the wire guide, the wire tubing, and the lumen illustrating the path the lumen takes through the handle. [0039] FIG. 18 is an elevation view of the extreme proximal end surfaces of the slides as viewed from arrow A in FIG. 17 and illustrating the path the lumen and wire tubing take into the passage formed by the channels of the slides. [0040] FIG. 19 is an isometric view of the lumen, deflection wires, and electrical wires of the tube exiting the catheter body-retaining nut on the distal end of the handle. [0041] FIG. 20 is an isometric view of another embodiment of the handle exploded to show its various components. [0042] FIG. 21 is a longitudinal sectional elevation taken along section line ZZ in FIG. 20 . [0043] FIG. 22 is isometric views of the slides oriented to show their respective portions of the passage and their planar slide faces. [0044] FIG. 23 is an isometric view of another embodiment of the handle exploded to show its various components. [0045] FIG. 24 is a longitudinal sectional elevation of the handle taken along section line YY of FIG. 23 . [0046] FIG. 25 is the same longitudinal sectional elevation of the adjusting knob as depicted in FIG. 24 , except the adjusting knob is shown by itself. [0047] FIG. 26 is a side elevation of the slides. [0048] FIG. 27A is a latitudinal sectional elevation of the handle, as taken along section line XX in FIG. 24 , wherein the wire guide has a square cross section. [0049] FIG. 27B is the same latitudinal sectional elevation depicted in FIG. 27A , except the wire guide has a circular cross section and a key/groove arrangement. [0050] FIG. 28 is a side elevation of one embodiment of the wire guide equipped with a groove. [0051] FIG. 29 is a longitudinal sectional elevation of another embodiment of the handle taken along section line YY of FIG. 23 . [0052] FIG. 30 is a longitudinal sectional plan view of the handle depicted in FIG. 29 taken along section line VV in FIG. 23 and wherein section line VV forms a plane that is perpendicular to the plane formed by section line YY in FIG. 23 . [0053] FIG. 31 is an isometric view of one embodiment of the wire guide. [0054] FIG. 32 is a latitudinal sectional elevation of the handle as taken along section line WW in FIG. 29 . [0055] FIG. 33 is a longitudinal sectional elevation of the handle taken along section line AA of FIG. 1 . [0056] FIG. 34 is a side elevation of an exemplary slide employed in the embodiment depicted in FIG. 33 . [0057] FIG. 35 is a longitudinal sectional elevation of the adjusting knob taken along section line AA of FIG. 1 . [0058] FIG. 36 is a diagrammatic illustration of the control handle of the subject invention being employed in a surgical procedure on a patient. DETAILED DESCRIPTION OF THE INVENTION [0059] Referring FIG. 1 is an isometric view of one embodiment of the present invention. which is a control handle 2 for a flexible tubular, body 4 of a catheter 5 . Throughout this specification, the term catheter is meant to include, without limitation, catheters, sheaths and similar medical devices. As shown in FIG. 1 , in one embodiment, the distal end of the handle 2 is connected to the catheter body 4 and the proximal end of the handle 2 is connected to tubing 6 that contains electrical wire and extends to an electrical connector 8 . The handle 2 includes an adjusting knob 10 and a handle grip 12 . As will become clear from this specification, the handle 2 of the present invention is advantageous in that it is compact and allows a user to manipulate the catheter body's extreme distal end 14 in a bi-directional manner by pivoting the adjusting knob 10 relative to the handle grip 12 in one direction or the other about the longitudinal axis of the handle 2 . Furthermore, in one embodiment, the handle 2 has a lumen that runs uninterrupted from the proximal end of the handle 2 to the extreme distal end 14 of the catheter body 4 . This lumen can be used to provide contrast injection for guide wire insertion. [0060] For a more detailed discussion of the handle 2 , reference is now made to FIGS. 2 and 3 . FIG. 2 is an isometric view of the handle 2 exploded to show its various components. FIG. 3 is a longitudinal sectional elevation of the handle 2 taken along section line AA of FIG. 1 . [0061] As shown in FIGS. 2 and 3 , the adjusting knob 10 is pivotally attached to a mounting shaft (i.e., a slide base or base portion) 16 contained within the handle grip 12 . To pivotally attach the knob 10 to the mounting shaft 16 , a dowel pin 18 is inserted into a pinhole 20 in the distal end of the shaft 16 and mates with a groove 22 in a hub portion 23 of the knob 10 . A silicone o-ring 24 exists between the hub portion 23 of the knob 10 and the distal end of the shaft 16 . [0062] As indicated in FIGS. 2 and 3 , a wire guide 26 is positioned within the adjusting knob 10 and is held in place by a retaining ring 28 . A right slide or member 30 and a left slide or member 32 are slideably positioned within a slot (i.e., a slide compartment) 34 in the mounting shaft 16 . A catheter body-retaining nut 36 is used to secure the catheter body 4 to the distal end of the wire guide 26 . [0063] As illustrated in FIG. 3 , a pair of deflection wires 38 extend from the extreme distal end 14 of the body 4 , through the body 4 , the wire guide 26 and a passage 40 formed between the two slides 30 , 32 , to a point near a proximal portion of the slides 30 , 32 . Each wire 38 then affixes to an individual slide 30 , 32 via a retention screw 42 . [0064] For a more detailed discussion of the slides 30 , 32 and their relationship to the deflection wires 38 , reference is now made to FIG. 4 , which is an isometric view of the deflection wires 38 a , 38 b attached to the right and left slides 30 , 32 . As shown in FIG. 4 , the slides 30 , 32 , which are mirror images of each other, each have a rectangular box-like proximal portion 44 and a half-cylinder distal portion 46 . Each proximal portion 44 has a generally planar outer sidewall and bottom wall. These planar surfaces slideably displace against the generally planar sides and bottom of the slot 34 , which act as thrust surfaces for the slides 30 , 32 . [0065] Each half-cylinder distal portion 46 is hollowed out along its longitudinal axis to form the passage 40 through which the deflection wires 38 a , 38 b and, as indicated in FIG. 3 , the narrow proximal portion of the wire guide 26 extend when the slides 30 , 32 are in the assembled handle 2 . Each slide 30 , 32 has a planar slide face 48 that is meant to slideably abut against the planar slide face 48 of the opposing slide 30 , 32 . Thus, as illustrated in FIG. 2 , when the planar slide faces 48 of the slides 30 , 32 abut against each other and the extreme proximal ends of each slide 30 , 32 are flush with each other, the half-cylinder distal portions 46 of each slide 30 , 32 combine to form a complete cylinder with a channel or passage 40 there through. [0066] As shown in FIG. 4 , in one embodiment, the proximal end of each deflection wire 38 a , 38 b forms a loop 50 through which a retention screw 42 passes to secure the wire 38 a , 38 b to the proximal portion of the respective slide 30 , 32 . As indicated in FIG. 5 , which is a side elevation of an exemplary slide 30 , in one embodiment, the proximal end of each deflection wire 38 forms a knot 52 . The wire 38 passes through a hollow tension adjustment screw 54 and the knot 52 abuts against the head 55 of the screw 54 , thereby preventing the wire 38 from being pulled back through the screw 54 . In one embodiment, the screw's longitudinal axis and the longitudinal axis of the slide 30 , 32 are generally parallel. Each tension adjustment screw 54 is threadably received in the proximal end of its respective slide 30 , 32 . Tension in a wire 38 may be increased by outwardly threading the wire's tension adjustment screw 54 . Conversely, tension in a wire 38 may be decreased by inwardly threading the wire's tension adjustment screw 54 . [0067] As can be understood from FIG. 4 , in one embodiment where the wires 38 a , 38 b are intended to only transmit tension forces, the wires 38 a , 38 b may deflect or flex within an open area 45 defined in the proximal portion 44 of each slide 30 , 32 when the slides 30 , 32 displace distally. Similarly, as can be understood from FIG. 5 , in another embodiment where the wires 38 are intended to only transmit tension forces, the wires 38 may slide proximally relative to the screw 54 when the slides 30 , 32 displace distally. [0068] As shown in FIG. 4 , in one embodiment, the outer circumference of the half-cylinder distal portion 46 of the right slide 30 is threaded with a right-hand thread 56 , and the outer circumference of the half-cylinder distal portion 46 of the left slide 32 is threaded with a left-hand thread 58 . In one embodiment, the outer circumference of the half-cylinder distal portion 46 of the right slide 30 is threaded with a left-hand thread, and the outer circumference of the half-cylinder distal portion 46 of the left slide 32 is threaded with a right-hand thread. [0069] For a better understanding of the relationship of the slide threads 56 , 58 to the rest of the handle 2 , reference is now made to FIG. 6 , which is a longitudinal sectional elevation of the adjusting knob 10 taken along section line AA of FIG. 1 . As indicated in FIG. 6 , a cylindrical hole or shaft 60 passes through the knob 10 along the knob's longitudinal axis. In the hub portion 23 of the knob 10 , the inner circumferential surface of the shaft 60 has both right hand threads 62 and left hand threads 64 . These internal threads 62 , 64 of the knob 10 mate with the corresponding external threads 56 , 58 of the slides 30 , 32 . More specifically, the right internal threads 62 of the knob 10 mate with the right external threads 56 of the right slide 30 , and the left internal threads 64 of the knob 10 mate with the left external threads 58 of the left slide 32 . [0070] Thus, as can be understood from FIGS. 2 , 3 , 4 and 6 , in one embodiment, as the knob 10 is rotated clockwise relative to the longitudinal axis of the handle 2 , the internal and external right threads 62 , 56 engage and the internal and external left threads 64 , 58 engage, thereby causing simultaneous opposed displacement of the right and left slides 30 , 32 longitudinally within the slot 34 in the handle 10 . Specifically, because of the threading arrangement of the knob 10 and the slides, 30 , 32 , the right slide 30 moves distally within the slot 34 and the left slide 32 moves proximally within the slot 34 when the knob 10 is rotated clockwise relative to the handle grip 12 of the handle 2 . Conversely, when the knob 10 is rotated in a counterclockwise manner relative to the handle grip 12 of the handle 2 , the right slide 30 moves proximally within the slot 34 and the left slide 32 moves distally within the slot 34 . [0071] As can be understood from FIGS. 4 and 6 , when the knob 10 is rotated such that the right slide 30 is urged distally and the left slide 32 is urged proximally, the deflection wire 38 a connected to the right slide 30 is placed into compression and the deflection wire 38 b connected to the left slide 32 is placed into tension. This causes the extreme distal end 14 of the catheter body 4 to deflect in a first direction. Conversely, when the knob 10 is rotated such that the right slide 30 is urged proximally and the left slide 32 is urged distally, the deflection wire 38 a connected to the right slide 30 is placed into tension and the deflection wire 38 b connected to the left slide 32 is placed into compression. This causes the extreme distal end 14 of the catheter body 4 to deflect in a second direction that is opposite the first direction. [0072] The control handle 2 of the present invention as described has several advantages. First, the handle 2 is compact and may be operated with a single hand. Second, the threaded slides 30 , 32 and knob 10 allow a physician to make fine, controlled adjustments to the bend in the distal end 14 of the catheter body 4 . Third, once the knob 10 is rotated so as to cause a bend in the distal end 14 of the catheter body 4 , the threads 56 , 58 , 62 , 64 interact to maintain the bend without requiring any action on the physician's part. Fourth, because the slides 30 , 32 simply displace distally and proximally along the longitudinal axis of the handle 2 , they are less likely to permanently deform the wires 38 as compared to the wire displacement mechanisms in some prior art handles. Fifth, the threads 56 , 58 , 62 , 64 are mechanically advantageous in that they provide increased deflection wire travel and reduced actuation effort for the physician, as compared to some prior art handles. [0073] While FIGS. 2-6 depict an embodiment where the slides 30 , 32 have external threads 56 , 58 and the knob 10 has internal threads 62 , 64 , in other embodiments the threading arrangement is reversed. For a discussion of one such embodiment, reference is made to FIGS. 33-35 . FIG. 33 is a longitudinal sectional elevation of the handle 2 taken along section line AA of FIG. 1 . FIG. 34 is a side elevation of an exemplary slide employed in the embodiment depicted in FIG. 33 . FIG. 35 is a longitudinal sectional elevation of the adjusting knob taken along section line AA of FIG. 1 . [0074] A comparison of the embodiment depicted in FIGS. 33-35 to the embodiment depicted in FIGS. 3 , 5 and 6 reveals that the two embodiments are generally the same, except as will be described in the following discussion of FIGS. 33-35 . Reference numbers utilized in FIGS. 33-35 pertain to the same or similar features identified by the same reference numbers in FIGS. 3 , 5 and 6 . [0075] As shown in FIG. 33 , the adjusting knob 10 is pivotally attached to a mounting shaft (i.e., a slide base or base portion) 16 contained within the handle grip 12 . A wire guide 26 is positioned within the adjusting knob 10 . Like the embodiment depicted in FIG. 2 , the embodiment illustrated in FIG. 33 includes a right slide or member 30 and a left slide or member 32 that are slideably positioned within a slot (i.e. a slide compartment) 34 in the mounting shaft 16 . [0076] As can be understood from FIG. 34 , the slides 30 , 32 , which are mirror images of each other, each have a rectangular box-like proximal portion 44 and a distal portion 46 that may be rectangular or half-cylindrical. Each proximal portion 44 has a generally planar outer sidewall and bottom wall. These planar surfaces slideably displace against the generally planar sides and bottom of the slot 34 , which act as thrust surfaces for the slides 30 , 32 . [0077] Each distal portion 46 is hollowed out to form half of a cylindrical passage 40 that is created when the slides 30 , 32 are abutted against each other in a side-by-side relationship. Thus, each distal portion 46 of each slide 30 , 32 includes an inner circumferential surface, which when combined with the inner circumferential surface of the other slide 30 , 32 , defines the cylindrical passage 40 . [0078] As indicated in FIG. 34 , in one embodiment, the inner circumferential surface of the right slide 30 is threaded with a right-hand thread 56 . Similarly, as can be understood from FIG. 34 , the inner circumferential surface of the left slide 32 is threaded with a left-hand thread 58 . Thus, the distal portion 46 of each slide 30 , 32 is equipped with internal threads. In another embodiment, the inner circumferential surface of the right slide 30 is threaded with a left-hand thread 58 . Similarly, the inner circumferential surface of the left slide 32 is threaded with a right-hand thread 56 . [0079] As indicated in FIG. 35 , the knob 10 includes an outer hub 23 a surrounding an inner hub 23 b . A space 65 exists between, and is defined by, the inner and outer hubs 23 a , 23 b . The space 65 is adapted to receive the distal ends 46 of each slide 30 , 32 . The outer circumferential surface of the inner hub 23 b has both right hand threads 62 and left hand threads 64 . These external threads 62 , 64 of the knob 10 mate with the corresponding internal threads 56 , 58 of the slides 30 , 32 . More specifically, the right external threads 62 of the knob 10 mate with the right internal threads 56 of the right slide 30 , and the left external threads 64 of the knob 10 mate with the left internal threads 58 of the left slide 32 . [0080] As can be understood from FIG. 33 , in one embodiment, as the knob 10 is rotated clockwise relative to the longitudinal axis of the handle 2 , the internal and external right threads 56 , 62 engage and the internal and external left threads 58 , 64 engage, thereby causing simultaneous opposed displacement of the right and left slides 30 , 32 longitudinally within the slot 34 in the handle 10 . Specifically, because of the threading arrangement of the knob 10 and the slides, 30 , 32 , the right slide 30 moves distally within the slot 34 and the left slide 32 moves proximally within the slot 34 when the knob 10 is rotated clockwise relative to the handle grip 12 of the handle 2 . Conversely, when the knob 10 is rotated in a counterclockwise manner relative to the handle grip 12 of the handle 2 , the right slide 30 moves proximally within the slot 34 and the left slide 32 moves distally within the slot 34 . [0081] As can be understood from FIG. 33 , when the knob 10 is rotated such that the right slide 30 is urged distally and the left slide 32 is urged proximally, the deflection wire 38 connected to the right slide 30 is placed into compression and the deflection wire 38 connected to the left slide 32 is placed into tension. This causes the extreme distal end 14 of the catheter body 4 to deflect in a first direction. Conversely, when the knob 10 is rotated such that the right slide 30 is urged proximally and the left slide 32 is urged distally, the deflection wire 38 connected to the right slide 30 is placed into tension and the deflection wire 38 connected to the left slide 32 is placed into compression. This causes the extreme distal end 14 of the catheter body 4 to deflect in a second direction that is opposite the first direction. [0082] For a detailed discussion of another embodiment of the handle 2 of the present invention, reference is now made to FIGS. 7 , 8 and 9 . FIG. 7 is a plan view of the handle 2 . FIG. 8 is a side elevation of the handle 2 . FIG. 9 is an isometric view of the distal end of the handle 1 [0083] As shown in FIGS. 7-9 , the handle 2 includes an adjusting knob 10 on its distal end and a handle grip 12 on its proximal end. As can be understood from FIGS. 7-9 , in one embodiment, the knob 10 has a generally circular cross-section and the handle grip 12 has a generally oval cross-section. In one embodiment, both the knob 10 and the handle grip 12 have generally circular cross-sections. The oval cross-section of the handle grip 12 is advantageous because it provides the physician with a tactile indication of the catheter's rotational position. [0084] For a more detailed discussion of the components of the handle 2 , reference is now made to FIG. 10 , which is a longitudinal sectional plan view of the handle 2 taken along section line BB of FIG. 9 . As shown in FIG. 10 , an o-ring 24 is located between the handle grip 12 and a groove in the knob 10 . The knob 10 is pivotally affixed to the handle grip 12 via a rotating retaining-ring 60 that resides within grooves in both the knob and the handle grip 12 . [0085] As illustrated in FIG. 10 , a catheter body-retaining nut 36 is threadably affixed to the distal end of a wire guide 26 that extends along the axial center of the knob 10 . As indicated in FIG. 10 and more clearly shown in FIG. 11 , which is a longitudinal sectional plan view of the knob 10 taken along section line BB in FIG. 9 , a cylindrical hole or shaft 60 passes through the knob 10 along the knob's longitudinal axis. The inner circumferential surface of the shaft 60 has both right hand threads 62 and left hand threads 64 that extend towards the distal end of the knob 10 from a hub portion 23 of the knob 10 . As shown in FIG. 11 , in one embodiment, the knob 10 is a singular integral piece. [0086] As indicated in FIG. 10 , a right slide 30 and a left slide 32 are longitudinally displaceable within the handle 2 and about the proximal end of the wire guide 26 . As shown in FIGS. 12 and 13 , which are, respectively, aright side isometric view of the slides 30 , 32 displaced about the wire guide 26 and a left side isometric view of the slides 30 , 32 displaced about the wire guide 26 , each slide 30 , 32 has a planar slide face 48 that abuts and slideably displaces against the slide face 48 of the opposed slide 30 , 32 . Also, each slide 30 , 32 has a channel 40 that combines with the channel 40 of the opposed slide 30 , 32 to form a passage 40 through which the proximal end of the wire guide 26 passes as the slides 30 , 32 displace about the wire guide 26 . As shown in FIG. 10 , the passage 40 formed by the channels 40 also provides a pathway along which the deflection wires 38 a , 38 b (represented by dashed lines in FIG. 10 ) travel from a proximal portion of the slides 30 , 32 , through the wire guide 26 , and onward to the extreme distal end 14 of the catheter body 4 . [0087] As indicated in FIGS. 12 and 13 , each slide 30 , 32 has a half-cylinder distal portion 46 and a shorter and wider half-cylinder proximal portion 47 . The right slide 30 has a right-handed thread 56 on its distal portion 46 . Similarly, the left slide 32 has a left-handed thread 58 on its distal portion 46 . Thus, as can be understood from FIG. 10 , when the knob 10 is rotated in a clockwise direction relative to the handle grip 12 , the right handed threads 62 within the knob 10 engage the right handed threads 56 of the right slide 30 , and the left handed threads 64 within the knob 10 engage the left handed threads 58 of the left slide 32 . As a result, the right slide 30 is distally displaced within the handle 2 and the left slide 32 is proximally displaced within the handle 2 . Accordingly, the deflection wire 38 a attached to the right slide 30 is pushed (i.e., subjected to a compressive force) and the deflection wire 38 b attached to the left slide 32 is pulled (i.e., subjected to a tension force). Conversely, if the knob is rotated counterclockwise, the opposite displacement of the slides 30 , 32 and deflection wires 38 a , 38 b will occur. [0088] As indicated in FIG. 10 , each deflection wire 38 a , 38 b is attached to the proximal portion 47 of its respective slide 30 , 32 via retention screws 42 . The retention screws, which are more clearly illustrated in FIGS. 12 and 13 , are threadably mounted in the proximal portions 47 . [0089] As shown in FIGS. 12 and 13 , each half-cylindrical proximal portion 47 of a slide 30 , 32 has an upper and lower planar notch 64 adjacent their respective planar slide faces 47 . The function of these notches 64 may be understood by referring to FIGS. 14 and 15 . [0090] FIG. 14 is a longitudinal section elevation of the handle grip 12 taken along section line CC in FIG. 7 . FIG. 15 is a latitudinal section elevation of the handle grip 12 taken along section line DD in FIG. 8 . As shown in FIGS. 14 and 15 , the handle grip 12 is one integral piece having an interior cylindrical void 66 in which the proximal portions 47 of the slides 30 , 32 may displace as indicated in FIG. 10 . [0091] As shown in FIGS. 14 and 15 , upper and lower ribs 68 extend from the walls that form the interior cylindrical void 66 . The ribs 68 run longitudinally along a substantial portion of the cylindrical void's length. As can be understood from FIGS. 12-15 , the upper planar notches 64 on the proximal portions 47 of the slides 30 , 32 interface with, and displace along, the upper rib 68 as the slides 30 , 32 displace within the cylindrical void 66 . Similarly, the lower planar notches 64 on the proximal portions 47 of the slides 30 , 32 interface with, and displace along, the lower rib 68 as the slides 30 , 32 displace within the cylindrical void 66 . Thus, the ribs 68 act as thrust surfaces for the slides 30 , 32 . [0092] For a detailed discussion of another embodiment of the handle 2 depicted in FIGS. 7-15 , reference is now made to FIG. 16 . FIG. 16 is an isometric view of the distal end of a control handle 2 for a catheter 5 wherein the handle 2 and catheter body 4 have a through lumen 70 . As shown in FIG. 16 , in one embodiment, the lumen 70 and the electrical wire tube 6 , which extends to the electrical connector 8 , pass through strain reliefs 71 and into the proximal end of the handle grip 12 . In one embodiment, the lumen 70 terminates at its proximal end with a stopcock 72 . In one embodiment, the stopcock 72 has a hemostasis seal 74 that can be utilized for guide wire insertion. While a long flexible length of lumen 70 , as depicted in FIG. 16 , provides motion isolation while inserting contrast from a syringe, in one embodiment, the lumen 70 does not extend from the handle grip 12 . Instead, the stopcock 72 or luer fitting is simply attached to the lumen 70 where it exits the proximal end of the handle 12 . [0093] For a better understanding of the path of the lumen 70 , reference is now made to FIGS. 17 , 18 and 19 . FIG. 17 is an isometric view of the slides 30 , 32 , the wire guide 26 , the wire tubing 6 , and the lumen 70 illustrating the path the lumen 70 takes through the handle 2 . FIG. 18 is an elevation view of the extreme proximal end surfaces of the slides 30 , 32 as viewed from arrow A in FIG. 17 and illustrating the path the lumen 70 and wire tubing 6 take into the passage 40 formed by the channels 40 of the slides 30 , 32 . FIG. 19 is an isometric view of the lumen 70 , deflection wires 38 a , 38 h , and electrical wires 76 of the wire tube 6 exiting the catheter body-retaining nut 36 on the distal end of the handle 2 . [0094] As shown in FIGS. 17 and 18 , the lumen 70 and the wire tubing 6 pass through their respective reliefs 71 and into the passage 40 formed by the channels 40 in each slide 30 , 32 . In one embodiment, soon after the wire tubing 6 and the lumen 70 enter the passage 40 , the wires 76 of the wire tubing 6 exit the wire tubing 6 and are dispersed about the outer circumference of the lumen 70 as depicted in FIG. 19 . [0095] As illustrated in FIG. 17 , in another embodiment, after the wire tube 6 and lumen 70 enter the passage 40 , the wire tube 6 and the lumen 70 continue on their pathway to the distal end 14 of the catheter body 4 by passing, in a side-by-side arrangement, through the remainder of the passage 40 formed into the slides 30 , 32 and into an internal passage that extends along the longitudinal axis of the wire guide 26 . Near the end of the wire guide 26 , the wire 76 exists the wire tube 6 . The wire 76 , lumen 70 and deflection wires 38 a , 38 b then pass into the catheter by exiting the catheter body-retaining nut 36 of the handle as indicated in FIG. 19 . [0096] For a detailed discussion of another embodiment of the handle 2 , reference is now made to FIG. 20 , which is an isometric view of the handle 2 exploded to show its various components. As can be understood from FIG. 20 , the features of the handle 2 depicted in FIG. 20 are similar to the features of the handle depicted in FIG. 2 , except the handle 2 depicted in FIG. 20 is configured to have a relatively large, generally uniform in diameter, pathway extend the full length of the handle 2 (i.e., from the distal opening 102 in the wire guide 26 , through the passage 40 defined in the slides 30 , 32 and through an exit hole 104 in the proximal end of the shaft 16 ). [0097] The configuration of the handle 2 that allows a relatively large generally uniform in diameter pathway to pass through the length of the handle 2 , as depicted in FIG. 20 , is more clearly shown in FIG. 21 , which is a longitudinal sectional elevation taken along section line ZZ in FIG. 20 . As illustrated in FIG. 21 , in one embodiment, the pathway 100 , which includes the passage through the wire guide 26 and the passage 40 through the slides 30 , 32 , is large enough that the catheter body 4 itself may pass through the pathway 100 and be connected to the proximal end of the shaft 16 at the exit hole 104 . Thus, in one embodiment, to prevent the catheter body 4 from rotating with the adjusting knob 10 , the catheter body 4 is affixed to the shaft 16 at the exit hole 104 . In one embodiment, the catheter body 4 runs the full length of the handle 4 as depicted in FIG. 21 , except the body 4 is affixed to the wire guide 26 at or near the distal opening 102 . In other embodiments, the catheter body 4 is affixed to both the wire guide 26 at or near the distal opening 102 and the shaft 16 at the exit hole 104 . [0098] As can be understood from FIG. 21 and as more clearly depicted in FIG. 22 , which is isometric views of the slides 30 , 32 oriented to show their portions of the passage 40 and their planar slide faces 48 , the passage 40 is large enough in diameter to displace over the outer diameter of the wire guide 26 . As shown in FIGS. 21 and 22 , a catheter body passage 110 passes through the proximal portion 44 of each slide 30 , 32 , thereby allowing the slides 30 , 32 to displace back and forth over the outer surface of the catheter body 4 . [0099] As indicated in FIG. 21 , in one embodiment, the catheter body 4 has an opening 111 in its wall that allows the wires 38 to exit the body 4 and connect to the slides 30 , 32 . In one embodiment, the wires 38 connect to the slides 30 , 32 via tension adjustment screws 54 as previously discussed. [0100] Due to the configuration of the slides 30 , 32 , the wire guide 26 and the shaft 16 , the catheter body 4 may run uninterrupted the full length of the handle 2 . As a result, electrical wiring 76 (see FIG. 19 ) and a lumen 70 may be routed the full length of the handle 2 by way of the body 4 . [0101] For a detailed discussion of another embodiment of the handle 2 of the present invention, reference is now made to FIGS. 23 and 24 . FIG. 23 is an isometric view of the handle 2 exploded to show its various components. FIG. 24 is a longitudinal sectional elevation of the handle 2 taken along section line YY of FIG. 23 . Generally speaking, the features of the handle 2 depicted in FIGS. 23 and 24 are similar to the features of the handle depicted in FIG. 20 , except the two embodiments employ different slider arrangements. For example, the embodiments depicted in FIGS. 1-22 employ parallel slides or members 30 , 32 (i.e., the slides 30 , 32 exist within the handle 2 in a parallel or side-by-side arrangement). As will be understood from FIGS. 23 and 24 and the following figures, in the embodiment of the handle 2 depicted in FIGS. 23 and 24 , the slides or members 150 , 152 exist within the adjustment knob 10 in a series arrangement (i.e., the slides 150 , 152 are not parallel or side-by-side to each other, but are oriented end-to-end along a longitudinal axis of the handle 2 ). [0102] As shown in FIGS. 23 and 24 , the adjusting knob 10 is pivotally coupled to the distal end of the mounting shaft (i.e., base portion) 16 . The wire guide 26 extends through the center of the adjusting knob 10 and the mounting shaft 16 . The catheter body 4 is coupled to the distal end of the wire guide 26 and, in one embodiment, extends through the wire guide 26 and out of the proximal end of the mounting shaft 16 . [0103] As shown in FIGS. 23 and 24 , a distal slide 150 is located in a distal portion of the adjusting knob 10 , and a proximal slide 152 is located in a proximal portion (i.e., hub portion 23 ) of the adjusting knob 10 . As illustrated in FIG. 24 , the outer surface of each slide 150 , 152 has threads 154 that mate with threads 156 on an interior surface of the adjusting knob 10 . [0104] As illustrated in FIG. 24 , each deflection wire 38 a , 38 b travels along the interior of the wire guide 26 until it exits the wire guide 26 at a hole 157 in the sidewall of the wire guide 26 . Each deflection wire 38 a , 38 b then extends to the slide 150 , 152 to which the deflection wire 38 a , 38 b is attached. In one embodiment, in order to attach to a slide 150 , 152 , a deflection wire 38 a , 38 b passes through a passage 159 in the slide 150 , 152 and attaches to a hollow tension adjustment screw 54 via a knot 52 as previously described in this Detailed Description. [0105] For a better understanding of the orientation of the threads 154 , 156 , reference is now made to FIGS. 25 and 26 . FIG. 25 is the same longitudinal sectional elevation of the adjusting knob 10 as it is depicted in FIG. 24 , except the adjusting knob 10 is shown by itself. FIG. 26 is a side elevation of the slides 150 , 152 . [0106] As shown in FIGS. 25 and 26 , in one embodiment, the distal slide 150 has right hand threads 154 that engage right hand threads 156 in the distal portion of the adjusting knob 10 , and the proximal slide 152 has left hand threads 154 that engage left hand threads 156 in the proximal portion of the adjusting knob 10 . Thus, as can be understood from FIGS. 23-26 , when the adjusting knob 10 is rotated relative to the mounting shaft 16 in a first direction about the longitudinal axis of the handle 2 , the slides 150 , 152 will converge along the wire guide 26 , thereby causing the first wire 38 to be placed into tension and the second wire 38 to be compressed. As a result, the distal end 14 of the catheter body 4 will deflect in a first direction. Similarly, when the adjusting knob 10 is rotated in a second direction that is opposite from the first direction, the slides 150 , 152 will diverge along the wire guide 26 , thereby causing the first wire 38 to be compressed and the second wire 38 to be placed into tension. As a result, the distal end 14 of the catheter body 4 will deflect in a second direction generally opposite from the first direction. [0107] In one embodiment, to prevent the slides 150 , 152 from simply rotating around the wire guide 26 when the adjusting knob 10 is rotated, the slides 150 , 152 and wire guide 26 are configured such that the slides 150 , 152 will displace along the wire guide 26 , but not rotationally around it. For example, as indicated in FIG. 27A , which is a latitudinal sectional elevation of the handle 2 as taken along section line XX in FIG. 24 , the wire guide 26 has a square cross section that mates with a square hole 162 running the length of the slide 150 , 152 . The interaction between the square hole 162 and the square cross section of the wire guide 26 prevents a slide 150 , 152 from rotating about the wire guide 26 , but still allows the slide 150 , 152 to displace along the length of the wire guide 26 . [0108] In another embodiment, as shown in FIG. 27B , which is the same latitudinal sectional elevation depicted in FIG. 27A , each slide 150 , 152 has a hole 162 with a circular cross section. Each hole 162 runs the length of its respective slide 150 , 152 and includes a key 160 that extends into the hole 162 from the interior circumferential surface of the hole 160 . The key 160 engages a groove or slot 158 that runs along the length of the wire guide 26 as depicted in FIG. 28 , which is a side elevation of one embodiment of the wire guide 26 . The interaction between the key 160 and the slot 158 prevents a slide 150 , 152 from rotating about the wire guide 26 , but still allows the slide 150 , 152 to displace along the length of the wire guide 26 . [0109] As shown in FIGS. 27A and 27B , a hollow shaft 165 extends through the wire guide 26 . This allows a catheter body 4 with a lumen to extend completely through the handle 2 as shown in FIG. 24 . [0110] For a detailed discussion of another embodiment of the handle 2 that is similar to the embodiment depicted in FIG. 23 , reference is now made to FIGS. 29 and 30 . FIG. 29 is a longitudinal sectional elevation of the handle 2 as if taken through section line YY of FIG. 23 . FIG. 30 is a longitudinal sectional plan view of the handle 2 as if taken through section line VV in FIG. 23 and wherein section line VV forms a plane that is perpendicular to the plane formed by section line YY in FIG. 23 . [0111] As illustrated in FIGS. 29 and 30 , the handle 2 includes an adjusting knob 10 pivotally coupled to the distal end of the mounting shaft (i.e., base portion) 16 . In one embodiment, the adjusting knob 10 includes a proximal end 170 , a distal end 172 and a threaded shaft 173 , which is connected to the proximal end 170 and extends distally along the longitudinal axis of the adjusting knob 10 . The threaded shaft 173 includes a distal end 174 , a proximal end 176 , a series of right hand threads 178 along a distal portion of the shaft 173 , and a series of left hand threads 180 along a proximal portion of the shaft 173 . [0112] As shown in FIGS. 29 and 30 , a distal slide 150 is located in a distal portion of the adjusting knob 10 , and a proximal slide 152 is located in a proximal portion (i.e., hub portion 23 ) of the adjusting knob 10 . Each slide has a hole 155 through which the threaded shaft 173 passes. The inner circumferential surface of the hole 155 for the distal slide 150 has right hand threads that mate with the right hand threads 178 on the distal portion of the shaft 173 . Similarly, the inner circumferential surface of the hole 155 for the proximal slide 152 has left hand threads that mate with the left hand threads 180 on the proximal portion of the shaft 173 . In other embodiments, the locations for the left and right threads are reversed. [0113] As can be understood from FIGS. 29 , 30 and 31 , which is an isometric view of one embodiment of the wire guide 26 , a hollow center shaft 182 extends from the distal end of the wire guide 26 , through the threaded shaft 173 of the adjustment knob 10 , and to the proximal end of the base shaft 16 . Thus, in one embodiment, a catheter body 4 may be routed through the lumen 165 of the wire guide's hollow center shaft 182 to exit the proximal end of the handle 2 , as illustrated in FIGS. 29 and 30 . [0114] As illustrated in FIG. 29 , each deflection wire 38 a , 386 travels along the interior of the wire guide 26 until it exits the wire guide 26 at a hole 157 in the sidewall of the wire guide 26 . Each deflection wire 38 a , 38 b then extends to the slide 150 , 152 to which the deflection wire 38 a , 38 h is attached. In one embodiment, in order to attach to a slide 150 , 152 , a deflection wire 38 a , 38 b passes through a passage 159 in the slide 150 , 152 and attaches to a hollow tension adjustment screw 54 via a knot 52 as previously described in this Detailed Description. [0115] In one embodiment, as shown in FIG. 29 , the deflection wire 38 b leading to the proximal slide 152 passes through a second passage 161 in the distal slide 150 . The second passage 161 has sufficient clearance that the passage 161 may easily displace along the wire 38 b when the distal slide 150 displaces distally and proximally. The second passage 161 serves as a guide that stiffens the wire 38 b and helps to reduce the likelihood that the wire 38 b will bend when compressed. [0116] As can be understood from FIGS. 29 and 30 , when the adjusting knob 10 is rotated relative to the mounting shaft 16 in a first direction about the longitudinal axis of the handle 2 , the slides 150 , 152 will converge along the threaded shaft 173 , thereby causing the first wire 38 a to be placed into tension and the second wire 38 b to be compressed. As a result, the distal end 14 of the catheter body 4 will deflect in a first direction. Similarly, when the adjusting knob 10 is rotated in a second direction that is opposite from the first direction, the slides 150 , 152 will diverge along the threaded shaft 173 , thereby causing the first wire 38 a to be compressed and the second wire 38 b to be placed into tension. As a result, the distal end 14 of the catheter body 4 will deflect in a second direction generally opposite from the first direction. [0117] In one embodiment, to prevent the slides 150 , 152 from simply rotating with the threaded shaft 173 within the adjusting knob 10 when the adjusting knob 10 is rotated, the slides 150 , 152 and wire guide 26 are configured such that the slides 150 , 152 will displace along the threaded shaft 173 , but not rotationally within the adjusting knob 10 . For example, as indicated in FIGS. 31 and 32 , which is a latitudinal sectional elevation of the handle 2 as taken along section line WW in FIG. 29 , the wire guide 26 has right and left semicircular portions 190 that oppose each other and extend along the length of the hollow center shaft 182 of the wire guide 26 . As shown in FIG. 32 , the generally planar opposed faces 192 of the semicircular portions 190 abut against the generally planar side faces 194 of the slides 150 , 152 . This interaction prevents a slide 150 , 152 from rotating within the adjustment knob 10 when the knob 10 is rotated, but still allows the slide 150 , 152 to displace along the length of the threaded shaft 173 . [0118] As can be understood from FIG. 36 , which is a diagrammatic illustration of the control handle 2 of the subject invention being employed in a surgical procedure on a patient 200 , the distal end 14 of the catheter body 4 is inserted into the patient 200 (e.g., intravenously via a body lumen 202 of the patient 200 , percutaneously, or via other avenues for entering the patient's body). The distal end 14 of the catheter body 4 is advanced until positioned in a selected location within the patient 200 (e.g., within a chamber 204 of the patient's heart 206 or other organ, with a body cavity of the patient, etc.). The distal end of the catheter body 4 is then deflected by rotating the adjustment knob 10 about a longitudinal axis of a base portion 16 . As can be understood from FIGS. 1-35 , this causes the slides 30 , 32 within the handle 2 to displace along the longitudinal axis in opposite directions. Since each slide 30 , 32 is coupled to its respective deflection wire 38 and each deflection wire 38 runs through the catheter body 4 and is coupled to the distal end 14 , the distal end 14 of the catheter body 4 is deflected. [0119] Although a number of embodiments of this invention have been described above with a certain degree of particularity, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of this invention. For example, all joinder references (e.g., attached, coupled, connected, and the like) are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative, only and not limiting. Changes in detail or structure may be made without departing from the spirit of the invention as defined in the appended claims.

An apparatus for imparting a tensile force to deflect a distal portion of a catheter while maintaining its exterior dimensions may include a handle grip including a cross-section of generally predetermined exterior dimensions, and a longitudinal axis. A flexible elongate member may include proximal and distal end portions, with the proximal end portion being coupled to the handle grip. An adjustment knob may include a cross-section of generally predetermined exterior dimensions, and is rotatably coupled to the handle grip around the longitudinal axis. An elongate deflection member may be operably coupled to the adjustment knob and to the distal end portion of the elongate member. Rotation of the adjustment knob may impart a tensile force to the deflection member thereby causing the distal end portion of the elongate member to deflect from a prior configuration while maintaining the generally predetermined exterior dimensions of the handle grip and the adjustment knob.

BACKGROUND OF THE INVENTION 1. Field of the Invention The field of invention relates to car seat constructions, and more particularly pertains to a new and improved child car seat pillow construction wherein the same provides a pillow organization for mounting in association with an associated car seat. 2. Description of the Prior Art Various pillows of differing configurations have been utilized by car seats to provide a stabilizing and support for a child during a sleeping interval while seated in position within a car seat. Prior art organization include U.S. Pat. No. 4,383,713 mounting a generally "U" shaped pillow to the seat to provide a stabilizing member for receiving a child's head therewithin. U.S. Pat. No. 4,440,443 utilizes a "U" shaped pillow member mounted to an upper terminal end of a car seat for providing a privacy and enclosing chamber for mounting a child's head therewithin. U.S. Pat. No. 4,154,478 sets forth head rest members mounted on a chair back to provide support for an individual's therebetween. U.S. Pat. No. 4,565,405 provides a back rest mat, with a pad, with the pad including a plurality of padded projections for securing a child's head therebetween. As such, it may be appreciated that there continues to be a need for a new and improved child car seat pillow construction as set forth by the instant invention which addresses both the problems of ease of use as well as effectiveness in construction and in this respect, the present invention substantially fulfills this need. SUMMARY OF THE INVENTION In view of the foregoing disadvantages inherent in the known types of child car seat apparatus now present in the prior art, the present invention provides a child car seat pillow construction wherein the same utilizes a pillow member that is readily and conveniently mounted within a child's car seat for providing a head support for a child. As such, the general purpose of the present invention, which will be described subsequently in greater detail, is to provide a new and improved child car seat pillow construction which has all the advantages of the prior art child car seat pillow members and none of the disadvantages. To attain this, the present invention provides a pillow construction for mounting and positioning adjacent a side rotating wall of an associated child car seat that includes an elongate tubular cushioned member mounting a pillow member at its upper terminal end. A modification of the invention includes the use of straps and clip members mounted to terminal ends of the straps for securement of the straps to the car seat organization. The flexible tube may be formed of separate pneumatic chambers, each employing an individual inflation valve. My invention resides not in any one of these features per se, but rather in the particular combination of all of them herein disclosed and claimed and it is distinguished from the prior art in this particular combination of all of its structures for the functions specified. There has thus been outlined, rather broadly, the more important features of the invention in order that the detailed description thereof that follows may be better understood, and in order that the present contribution to the art may be better appreciated. There are, of course, additional features of the invention that will be described hereinafter and which will form the subject matter of the claims appended hereto. Those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention. Further, the purpose of the foregoing abstract is to enable the U.S. Patent and Trademark Office and the public generally, and especially the scientists, engineers and practitioners in the art who are not familiar with patent or legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application. The abstract is neither intended to define the invention of the application, which is measured by the claims, nor is it intended to be limiting as to the scope of the invention in any way. It is therefore an object of the present invention to provide a new and improved child car seat pillow construction which has all the advantages of the prior art child car seat pillow members and none of the disadvantages. It is another object of the present invention to provide a new and improved child car seat pillow construction which may be easily and efficiently manufactured and marketed. It is a further object of the present invention to provide a new and improved child car seat pillow construction which is of a durable and reliable construction. An even further object of the present invention is to provide a new and improved child car seat pillow construction which is susceptible of a low cost of manufacture with regard to both materials and labor, and which accordingly is then susceptible of low prices of sale to the consuming public, thereby making such child car seat pillow constructions economically available to the buying public. Still yet another object of the present invention is to provide a new and improved child car seat pillow construction which provides in the apparatuses and methods of the prior art some of the advantages thereof, while simultaneously overcoming some of the disadvantages normally associated therewith. Still another object of the present invention is to provide a new and improved child car seat pillow construction wherein the same provides an elongate tubular child car seat pillow positionable against a side wall abutment formed by a child car seat member. These together with other objects of the invention, along with the various features of novelty which 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 preferred embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS The invention will be better understood and objects other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such description makes reference to the annexed drawings wherein: FIG. 1 an isometric illustration of a prior art seat pillow organization. FIG. 2 an orthographic view, taken in elevation, of a further prior art seat pillow organization. FIG. 3 is an isometric illustration of the instant invention. FIG. 4 an isometric illustration of the instant invention in use. FIG. 5 is an isometric illustration of a modified pillow construction utilized by the instant invention. FIG. 6 is an isometric illustration of a further modified pillow construction utilized by the instant invention. FIG. 7 an isometric illustration of a yet further modified pillow organization utilized by the instant invention. FIG. 8 is an isometric illustration of the pillow construction of FIG. 7 utilized in tandem. DESCRIPTION OF THE PREFERRED EMBODIMENT With reference now to the drawings, and in particular to FIGS. 1 to 8 thereof, a new and improved child car seat pillow construction embodying the principles and concepts of the present invention and generally designated by the reference numeral 10 will be described. FIG. 1 illustrates a prior art pillow organization 1, wherein a back rest 2 includes a plurality of spaced pillow members 3 mounted upon the strap for securement to the back rest, in a manner as set forth in U.S. Pat. No. 4,154,478. A further example of a support for a child is set forth in FIG. 2, wherein a back rest 4 or mat construction provides a bowl-shaped member 5 for receiving a child's head therewithin, as set forth in U.S. Pat. No. 4,383,713. More specifically, the child car seat pillow construction 10 of the instant invention essentially comprises the organization mounted and positioned within a car seat 11, that includes a seat member 12 and a back support member 13 defining a generally "L" shaped seat, with spaced "L" shaped right and left side retainer walls 14 and 15 coextensively formed to the car seat 11 to the sides of the seat and back members 12 and 13. The pillow construction includes an elongate deformable flexible cushion tube 16, including a closed and seamed lower end and a closed upper end 18 that in turn integrally and orthogonally mounts the rectangular cushion pillow member 19. The organization is arranged for mounting against the interior surface of either the left or right "L" shaped retainer wall for permitting a child, as illustrated in FIG. 4, to rest and position his head thereon to permit convenience and ease of sleeping within the car seat construction 11. FIG. 5 illustrates a modified pillow construction 10a, wherein at least one right side strap 20 and at least one or a plurality of left side straps 21 each include an alligator type clip 22 mounted at a free terminal end thereof, wherein each alligator clip is defined by spring-biased tooth jaws that are biased together to permit the clips to engage various portions of the child's clothing or portions of the car seat 11 to enhance positioning of the pillow during use, in a predetermined orientation relative to the car seat 11. FIG. 6 illustrates a modified pillow cushion 19a formed as an inflatable chamber, including an inflation valve 24 mounted at an end thereof to permit selective inflation to a desired degree of rigidity of the modified pillow member 19a. Further, the flexible tube 16 includes a series of inflatable bladders 23. The inflatable bladders are each selectively secured relative to each other by a connecting web 25, and each include inflation valve 24. The inflatable bladders 23 are coextensively positioned and contained within the pillow member 19, with each inflation valve 24 projecting therethrough. A further manner of securing the inflatable bladders 23 together is by providing a first hook and loop fastener surface 26 medially onto a bottom surface of the modified pillow member 19a to permit a securement of second hook and loop fastener surface 27 formed at each end of each inflatable bladders. This permits securement of a desired series of inflatable bladders together to selectively permit an individual to tailor a desired length of the tubular construction defined by inflatable bladders in conformity with the car seat 11 being utilized. FIG. 8 illustrates a further modified pillow construction 10b, wherein a plurality of the inflation bladders defined by the top and medial inflation bladder each include a lateral belt defined by a respective first upper and first lower lateral belt 28 and 29 respectively mounted orthogonally to the top and medial inflation bladder, with a hook and loop fastener surface formed at a free terminal end of the first upper and lower lateral belt. This permits securement to a second car seat organization of identical construction utilizing a second upper and a second lower lateral belt orthogonally mounted to a respective second upper and second medial inflatable bladder that also includes a hook and loop fastening surface at a free terminal end thereof to permit securement of the respective first and second upper belts together and the first and second lower belts together to provide a generally "H" shaped construction that permits positioning of a pillow member adjacent each side retainer wall 14 and 15 for use by a child positioned within the seat. Further, the child's torso is positioned against the connected lateral belts to assist in positioning the pillow members within the car seat construction. As to the manner of usage and operation of the instant invention, the same should be apparent from the above disclosure, and accordingly no further discussion relative to the manner of usage and operation of the instant invention shall be provided. With respect to the above description then, it is to be realized that the optimum dimensional relationships for the parts of the invention, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention. Therefore, the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

A pillow construction for mounting and positioning adjacent a side rotating wall of an associated child car seat that includes an elongate tubular cushioned member mounting a pillow member at its upper terminal end. A modification of the invention includes the use of straps and clip members mounted to terminal ends of the straps for securement of the straps to the car seat organization. The flexible tube may be formed of separate pneumatic chambers, each employing an individual inflation valve.

FIELD OF THE INVENTION [0001] The present invention is directed towards a multi-purpose piece of furniture; particularly towards a decorative, multi-purpose furniture; most particularly toward an assembly that includes a frame support constructed and arranged to convert a container into a table and vice versa. BACKGROUND OF THE INVENTION [0002] There is often a desire to provide furniture that acts to conserve valuable living space. For many individuals to whom indoor and/or outdoor living space is limited, modular furniture is the solution, in that it performs multiple functions while still remaining aesthetically pleasing. [0003] For example, decorative containers, which house artificial or real plants, colorful bulbs, sand, rock, candles and the like, are commonly used to decorate indoor and outdoor areas. In addition, multi-tiered stands are a common means to display various decorations. However, most of these containers and stands reduce living space or difficult to transport, while providing no additional functionality. [0004] While there are numerous commercially available stands, or tables, designed for displaying decorative items, many of these designs found in the prior art make no attempt to provide an assembly able to convert a container, such as decorative plant pot, into an attractive table when desired and vice versa, while still providing ready access to the decorative item(s) housed within the container. [0005] For example U.S. Pat. No. 6,622,638 and U.S. Pat. No. 6,237,508 both to Weiss discloses a stand with a planar tabletop with an opening provided therethough. The stand also includes a removable tabletop disposed within the opening such that the upper surface of the tabletop insert is generally planar with the upper surface of the tabletop. To convert the stand to a decorative container, the tabletop insert is removed and a container is lowered through the opening until it is positioned where the tabletop insert was located. The alternate embodiment features an urn supported upright by a pedestal. In this embodiment, narrow interstices are provided which allow isual access into the interior portion of the urn where a container housing the decorative items may be housed. However, unlike the instant assembly, when the tabletop is in place over the container it must be entirely, or at least partially, removed from atop the container to provide access into the interior cavity of the container. This can be particularly onerous should the table/container assembly be used to house a living thing (e.g. plants, fish, etc), therein, as these need tending and in some instances require a significant amount of exposure to the surrounding environment. [0006] U.S. Pat. No. 4,631,861 to Wuthrich describes a combination portable plant port and trellis for growing plants, flowers, vines and the like with a circumferential trellis extending above the pot and detachably attached thereto. The preferred attachment means having downwardly extending extensions on support posts of the trellis, and these extensions have a lip to engage ledges along the side of the pot and are reachable through apertures in the pot rim. This secures the trellis to the top and provides the necessary upper support for the branches and vines of growing plants to expose them to maximum sunlight and air. Unlike the present invention, the trellis framework would not provide the stability necessary to support a tabletop, as the framework does not teach or suggest any means to secure, or inhibit, a tabletop from sliding off if accidentally bumped or jostled. [0007] U.S. Pat. No. 425,745 to Brown discloses a vase-shaped skeleton frame of wire consisting of vertical rods bent to give the shape of the trellis and formed at their lower ends into hooks, or clasps, that embrace the rim of the pot, combined with circular extendible hoops or wire rings, which may be enlarged or reduced in size to admit the lower end of the trellis to the circumference of the pot to which it is attached. Again, the wire frame of Brown would not be suitable for supporting a tabletop. [0008] While the foregoing described prior art devices have advanced the art in a variety of ways, there nevertheless remains a need for an assembly which can be readily attached to a container, particularly a plant pot or the like, which easily coverts it into a table and vice versa, that is stable, economical to manufacture, simple to assemble, and permits an individual access to the interior cavity of the container therein without disassembling the stand. SUMMARY OF THE INVENTION [0009] While the use of decorative tables and containers, and the like are known, prior to the instantly disclosed invention there was no adequate means in the art by which one could effectively or stability convert containers into a table and back into a container, as desired. To address this lack of prior art, disclosed is a table for use in combination with a container such as a flower pot or vase. The decorative table is formed from a frame that couples to the open end of the container wherein the container operates as a support base. A decorative item, such as a plant, is placed in therein and operates as a weighted base. A larger container with a heavier plant, and associated planting mix, provides a base that can support larger tables. A frame is secured to the container having a spaced upper end forming an upper support member. A planar tabletop is then secured to the upper support member providing a tabletop that can be used in a conventional manner. [0010] Accordingly, it is the principle objective of this invention to provide a convenient, simple and safe means to convert a container into an aesthetically pleasing and functional table, while simultaneously providing easy access to the contents inside the container. Thus, the aforementioned problems of structural instability and inhibited access to the container contents are substantially reduced. [0011] It is a further object of this invention to disclose an assembly where there is a substantially unobstructed view to the decorative items inside the container. [0012] It is a further object of this invention to disclose an assembly, which can be used on commercially available, or supplied container. [0013] Still another objection of this invention is to disclose an assembly that requires little use of tools, thereby requiring little skill by the user. [0014] Another objective of the instant invention is to provide an assembly that is economical to manufacture in that it has few components. [0015] Yet an additional objective of the instant invention is to provide an assembly that is easy to construct, and which, once assembled, is ease to disassemble. Other objectives and advantages of this invention will become apparent from the accompanying descriptions taken in conjunction with the accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. The drawings constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof. It will be readily appreciated by those skilled in the art that the use of multi-functional furniture for is highly effective in saving living space and useful in the design art. BRIEF DESCRIPTION OF THE FIGURES [0016] FIG. 1 illustrates an upper perspective, exploded view of a first embodiment of the instant assembly; [0017] FIG. 2 is an upper perspective, partially exploded view of the embodiment of FIG. 1 , illustrating the attachment of the frame to the container; [0018] FIG. 3 is the partially exploded view of FIG. 2 with the container shown in phantom; [0019] FIG. 4 is a cross-sectional view of the instant assembly as seen along the longitudinal axis; [0020] FIG. 5 is a top view of the instant assembly as seen with a glass tabletop; [0021] FIG. 6 illustrates a second embodiment of the frame of the instant assembly with a urn-shaped container; [0022] FIG. 7 illustrates the frame of FIG. 6 attached to an urn-shaped container; [0023] FIG. 8 illustrates the frame of FIG. 7 housing a plant. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0024] Detailed embodiments of the instant invention are disclosed herein, however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific functional and structural details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure. [0025] Referring now to FIGS. 1-8 , wherein like elements are numbered consistently throughout, FIG. 1 shows an exploded view of one embodiment the instant multi-purpose decorative assembly, generally referenced as 10 . By way of an overview, the assembly 10 comprises a container 12 , a frame 14 and a table top 34 . [0026] The container 12 includes a first end 18 , a second end 20 , and at least one sidewall 22 . The first end and second end 18 , 20 of said container 12 are in spaced apart relation along a longitudinal axis thereof, thereby creating a cavity 24 constructed and arranged to receive said at least one decorative item 60 , (e.g. plants, fish, colorful glass bulbs, sand, rocks, etc.) therein. For example, FIG. 8 illustrates the container 12 adapted to house a plant. [0027] In addition, the first end 18 of the container 12 can include excess material, as commonly used in many plant containers as it reinforces the first end 18 of the container 12 . The container 12 can be made from any material known in the art, e.g. plastic, wood, metal, ceramic, glass, terracotta, or combinations thereof. [0028] While the shape of the container 12 is illustrated herein as cylindrical in FIGS, it is obvious that any shape can be used, (e.g. urn-shaped ( FIGS. 7-8 ), spherical, cubic, etc). Moreover, the container 12 can be provided with interstices, relief patterns and the like made from the same or a different material than that of other parts of the container 12 for enhanced ornamentation. [0029] As seen in FIGS. 1-8 , the frame 14 includes an upper end 26 and a lower end 28 in spaced apart relation along the longitudinal axis thereof. At the upper end 26 of the frame 14 an upper support member is disposed illustrated herein as, albeit not limited to, a first annular ring 30 . Similarly, a lower support member is disposed at said lower end 28 of the frame 14 illustrated herein as, albeit not limited to, a first annular ring 32 . The upper and lower support members provide enhanced stability to the frame 14 . [0030] Although the first and second rings 30 , 32 , are depicted herein as a substantially circular shape, it would be obvious to the skilled artisan to modify the shape of either or both of the first or second rings 30 , 32 as desired, (e.g. square, oval, triangular, etc). However, the second ring 32 should be shaped to correspond to the shape of the first end 18 of the container. [0031] In addition, the frame 14 includes a plurality of support braces 34 attached to both said upper support and said lower support members by any means of attachment known in the art, such as, adhesives, welding, rivets, clamps, nut and bolt, screws, etc. The plurality of support braces 34 are illustrated herein as three substantially equidistant members joined along the circumference of the first and second rings 30 , 32 . It has been discovered that this particular configuration lends both adequate clearance for the user to access the interior 24 of the container 12 , while providing structural integrity to the frame 14 . However, it is contemplated that any number of support braces 34 may be used, depending on the material of the tabletop 36 and amount of clearance to the container's interior cavity 24 . [0032] As shown in FIGS. 6-8 , at least one of the plurality of support braces 34 can include buttresses 50 attached thereto by any means known in the art (e.g. welding, adhesives, etc) These buttresses 50 act as both a decorative and stabilizing element. [0033] The ratio of the diameter of first ring 30 to second ring 32 can be from about 2:1 to about 1:1, wherein 1.5:1 is preferred. The spaced-apart distance between the first and second ring 30 , 32 , as measured along the longitudinal axis thereof, can be anywhere between about 12 inches to 24 inches, as desired, with 13.5 particularly preferred. Although not illustrated herein, it is contemplated that only a single or plurality of support members may be used. Employing a plurality of support members act to both ameliorate the structural integrity of the frame 14 and provide a trellis for a climbing plants. [0034] In addition, the upper end 26 of the frame 14 includes a plurality of inwardly (i.e. laterally) projecting tabletop supporting means 38 . The plurality of projecting tabletop supporting means 38 can be of any size or shape and can be either integrally formed with a support brace 34 as illustrated in FIGS. 1-3 , 5 ; otherwise, the support brace 34 can be attached at any point along the upper support member, i.e. first annular ring 30 . [0035] The lower end 28 of the frame support includes at least one downwardly (i.e. longitudinally) disposed extension means 44 . The extension means 44 can be either integrally formed with a corresponding support brace 34 as illustrated in FIGS. 1-3 ; otherwise, the support brace 34 can be integrally formed at any point along the lower support member, i.e. second annular ring 32 . As illustrated in FIGS. 2-3 , these extension means 44 can include apertures for receiving a removable attachment means shown here as, albeit not limited to, a bolt 52 and nut 54 . However, other means of removable attachment could be used, such as pin and coddle, screw, clamp and the like. [0036] Although not is illustrated herein, it is contemplated that an additional extension means could be disposed substantially parallel to the extension means 44 such that they simultaneously clasp the inner and outer surface of the sidewall 22 at the first end 18 of the container, thereby forming a stable attachment to the container 12 . Furthermore, both of these extension means 44 can include apertures for receiving any removable attachment means known to those of skill in the art. [0037] All of the aforementioned components of the frame 14 can be composed of any rigid or semi-rigid material desired, for instance, metal, wood, plastic, ceramic, and the like. [0038] The planar tabletop 36 has an upper surface 40 and a lower surface 42 ( FIG. 4 ), wherein said planar tabletop 36 is constructed and arranged for removable attachment thereto. Otherwise, the tabletop 36 can be pressed against the substantially laterally formed tabletop support means 38 by clips, clamps, and the like. [0039] In one preferred embodiment illustrated in the FIGS. 1-4 , albeit not limited to, the planar tabletop 36 can include a plurality of apertures formed therethrough, wherein the location of apertures correspond to the location of the plurality of support braces 34 , each of which having apertures therein, such that a bolt 52 and nut 54 configuration can be inserted substantially parallel to the longitudinal axis from either the upper or lower surface 40 , 42 of the table top 36 . [0040] In a preferred embodiment, the tabletop 36 is constructed and arranged such that its outer perimeter is less than the inner diameter of the first annular ring 30 , so that the bottom surface 42 of the table rests against the table top support means 38 , whereby most of the thickness of the tabletop 36 is surrounded by the annular ring 30 to prevent the table top from sliding off the support means 38 . [0041] The tabletop 36 can be composed of any rigid or semi-rigid material desired, for instance, metal, wood, plastic, ceramic, or the like. In a preferred embodiment, the tabletop 36 is comprises a clear, semi-opaque, or opaque glass or combinations thereof. Moreover, the upper surface 40 and lower surface 42 can be smooth, rough, provided with interstices, relief patterns and the like for enhanced ornamentation. [0042] In all of the above mentioned embodiments, the user can readily convert the container 12 , which may be empty or housing a decorate item therein, into a stable, multi-purpose table, as shown in FIGS. 7, 8 . Upon assembly, the user simply attaches and secures the extension means 44 to the first end 18 of the container 12 by any means of attachment known in the art. Next, the tabletop 36 is placed upon and secured to the tabletop support means 38 . The assembly procedure is simply reversed to convert the table back to the container 12 . [0043] 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. [0044] 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 various apparatus, 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.

A table for use in combination with a container such as a flower pot or vase. The decorative table is formed from a frame that couples to the open end of the container wherein the container operates as a support base. A decorative item, such as a plant, is placed in therein and operates as a weighted base. A frame is secured to the container having a spaced upper end forming an upper support member. A planar tabletop is then secured to the upper support member providing a tabletop that can be used in a conventional manner.

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of Application Ser. No. 313,907, filed Dec. 11, 1972, now abandoned. BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to thickened liquid shampoo compositions with conditioning properties, particularly those which are very mild. 2. Prior Art Compositions containing the reaction products of ethoxylated anionic surfactants and certain specific amphoteric surfactants and polyethoxylated nonionic surfactants have been disclosed in U.S. Pat. Nos. 2,999,069 and 3,055,836, Masci and Poirier. Similar disclosures are contained in the corresponding foreign patent applications such as British Pat. Nos. 850,514, 850,515, and 921,122; and Canadian Pat. No. 595,532. In each of these patents, the disclosure is of a reaction product formed between the anionic surfactant and the amphoteric surfactant which contains ternary nitrogen groups, and there is no disclosure of thickeners. Similarly, U.S. Pat. No. 3,580,853, Parran, discloses the cationic cellulose ether thickening and conditioning agents of this invention in shampoos to improve the deposition of particulate materials, but without a specific disclosure of the surfactant systems disclosed herein. The cationic cellulose ethers of this invention are known, having been generically disclosed in U.S. Pat. No. 3,472,840, Fred W. Stone and John M. Rutherford, Jr. The compositions of this invention are all mild. This is a very desirable characteristic. The mildness apparently results from having a combination of anionic and cationic species present. However, as a result, many anionic, cationic, and nonionic polymers are incompatible with such formulas. It is extremely difficult to thicken such formulas and keep a single-phase clear composition. It is even more difficult to prepare a thick clear shampoo composition comprising anionic, zwitterionic or amphoteric, and nonionic surfactants which has good conditioning properties. THE INVENTION This invention relates to the discovery of a thickened mild liquid shampoo composition having conditioning properties comprising: A. from about 4% to about 8% of an anionic surfactant selected from the group consisting of 1. A SURFACTANT OF THE FORMULA R(OC 2 H 4 ) n OSO 3 M, wherein R is a hydrophobic group selected from the group consisting of alkyl groups containing from about 8 to about 16 carbon atoms, alkylphenyl groups wherein the alkyl group contains from about 6 to about 15 carbon atoms, and fatty acid amido groups wherein the fatty acid contains from about 8 to about 16 carbon atoms, wherein n is a number from about 1 to about 10 (preferably 1 to 5) and M is a non-toxic cation which makes the surfactant water-soluble, preferably a cation selected from the group consisting of sodium, potassium, ammonium and triethanolammonium cations, (2) a water-soluble (e.g., sodium, potassium, ammonium or triethanolammonium) polyethoxylated fatty alcohol sulfosuccinate monoester wherein said fatty alcohol contains from about 8 to about 16 carbon atoms, preferably from about 10 to about 14 carbon atoms, and said polyethoxylated fatty alcohol contains from about 1 to about 10 (preferably 1 to 5) ethoxy moieties per molecule, (3) a water-soluble (e.g., sodium, potassium, ammonium, triethanolammonium, etc.) N-fatty acyl sarcosinate containing a fatty acyl group containing from about 8 to about 16 carbon atoms, (4) a water-soluble alkyl sulfate containing from about 8 to about 16 carbon atoms, and (5) a water-soluble N-fatty acyl-N-methyl taurine containing a fatty acyl group containing from about 8 to about 16 carbon atoms; B. a surfactant selected from the group consisting of (1) a zwitterionic surfactant having the formula (R.sup.2).sub.A N.sup.(.sup.-) (R.sup.3).sub.3.sub.-A CH.sub.2.sub.-B (R.sup.2).sub.B (R.sup.4).sub.C Y.sup.(.sup.-) wherein A, B, and C are each selected from the group consisting of 0 and 1, wherein A is 0 when B is 1 and A is 1 when B is 0, wherein C can only be 1 when Y is a sulfonate group, wherein each R 2 is selected from the group consisting of alkyl groups containing from about 8 to about 16 carbon atoms and a moiety having the formula R 5 -- C(O)NH -- R 6 -- wherein R 5 is an alkyl group containing from about 8 to about 16 carbon atoms and R 6 is an alkylene group containing from 1 to about 5 carbon atoms (preferably 2-4 carbon atoms and most preferably 3 carbon atoms), wherein each R 3 is selected from the group consisting of alkyl, hydroxyalkyl and alkoxyalkyl groups which can be connected to form a ring and each of which contains from 1 to about 3 carbon atoms, wherein Y is selected from the group consisting of sulfonate and carboxylate groups, and wherein R 4 is an alkylene group containing from 1 to about 5 carbon atoms when Y is a carboxylate group and is selected from the group consisting of alkylene and hydroxyalkylene groups containing from about 2 to about 5 carbon atoms when Y is a sulfonate group and wherein the hydroxy group is on a secondary carbon atom, 2. a water-soluble N-alkyl β-aminopropionate wherein the alkyl group contains from about 8 to about 16 carbon atoms, and (3) a water-soluble N-alkyl β-iminodipropionate wherein the alkyl group contains from about 8 to about 16 carbon atoms; C. a polyethoxylated nonionic surfactant selected from the group consisting of: (1) polyethoxylated alcohols, said alcohols containing an alkyl group either primary or secondary and either straight or branched chain, containing from about 8 to about 16 carbon atoms and said polyethoxylated alcohols containing from about 10 to about 45 ethoxy moieties per molecule, (2) polyethoxylated alkylphenols wherein the alkyl group contains from about 6 to about 15 carbon atoms and wherein the polyethoxylated alkylphenol contains from about 10 to about 45 ethoxy moieties per molecule, (3) polyethoxylated mono fatty acid esters of sorbitol wherein said fatty acids contain from about 8 to about 18 carbon atoms and said polyethoxylated mono fatty acid ester of sorbitol contains from about 10 to about 45 ethoxy moieties per molecule, (4) polyethoxylated polypropylene glycol having a molecular weight of from about 2,000 to about 6,000 and containing from about 40% to about 60% by weight of polyethoxy groups, and (5 ) polyethoxylated fatty acids wherein said fatty acid contains from about 8 to about 16 carbon atoms and said polyethoxylated fatty acid contains from about 10 to about 45 ethoxy moieties per molecule; D. from about 50% to about 85% water; and E. as a thickener and hair conditioning agent, from about 0.2% to about 4% (preferably from about 0.4% to about 2%) of a quaternary nitrogen-containing cellulose ether having substituent groups of the formula (C.sub.2 H.sub.4 O--).sub.m [--CH.sub.2 CHO(CH.sub.2 N.sup.(.sup.+) (R.sup.7).sub.3 Cl.sup.(.sup.-))--].sub.n (C.sub.2 H.sub.4 O--).sub.p H wherein each R 7 is selected from the group consisting of methyl and ethyl groups, m + p ranges from about 1 to about 10 (preferably from about 1 to about 4, most preferably from about 1 to about 2), n is from about 0.1 to about 0.5, the degree of substitution of the cationic group on the cellulose is from about 0.1 to about 0.5, and the viscosity of a 1% solution of the cellulose ether at 25°C. ranges from about 100 to about 2000 centipoises, the molecular ratio of (A) to (B) being from about 1:1 to about 4:1; the weight ratio of (A) + (B) to (C) being from about 2:1 to about 1:2; and the pH of the composition being from about 6.0 to about 8.0. DESCRIPTION OF THE INVENTION 1. The Thickener. The products of this invention are, in part, described in the copending application of Raymond Edward Bolich, Jr. and Robert Benson Aylor entitled "MILD SHAMPOO COMPOSITIONS," Ser. No. 313,908, filed Dec. 11, 1972. These compositions, and other compositions disclosed herein are very mild. However, it is very difficult to thicken such compositions while maintaining the composition in a clear, liquid single-phase form. Most anionic, cationic and nonionic polymers are incompatible with such formulas. It was discovered, however, that the quaternary nitrogen-containing cellulose ether described hereinbefore is unique in its ability to thicken the compositions of this invention while maintaining the clarity of these compositions. In addition, it has been discovered that a surprising result is obtained upon dilution of the compositions of this invention with water, as occurs during use of the shampoos. Upon dilution, an effective hair conditioning precipitate is obtained which conditions the hair to provide, e.g., superior wet-combing properties. Thus, the thickener is also a hair conditioner. Specific thickeners are described hereinafter. Those thickeners with lower degrees of substitution of the cationic group, e.g., from about 0.15 to about 0.25, are preferred. Also preferred are those thickeners having a value of m + p of about 1.5 and those thickeners whose 1% solutions have a viscosity of 125-1000 centipoises at 25°C. 2. The anionic surfactant. The polyethoxylated anionic surfactants of this invention are very mild. It is essential that the anionic surfactant be mild since it is used in a molar excess over the amount of zwitterionic surfactant present so as to minimize the amount of cationic species present. The anionic surfactant provides good lather properties. Typically, the composition will contain from about 4% to about 8% of the anionic surfactant. The sodium salts of the polyethoxylated anionic surfactants are preferred, but any non-toxic, water-soluble salt can be used, including potassium, triethanolammonium, and ammonium salts. The preferred polyethoxylated anionic surfactants are the sodium salt of C 10 -C 14 fatty alcohol polyethoxy(3) ether sulfate, the sodium salt of polyethoxylated(3) C 10 -C 14 mono fatty alcohol sulfosuccinate, the sodium salt of C 10 -C 14 fatty acyl amido polyethoxy(4) ether sulfate. Other suitable polyethoxylated anionic surfactants are disclosed hereinafter in the examples. 3. The zwitterionic surfactants. The zwitterionic surfactant provides major lather benefits while modifying the nature of the composition so that it is less strongly anionic. The molecular ratio of the anionic to zwitterionic surfactant is from about 1:1 to about 4:1, preferably from about 1:1 to about 3:1, most preferably from about 1:1 to about 2:1. Preferred zwitterionic surfactants are propylamido betaines derived from C 10 -C 16 fatty acids, and the corresponding propylamido sultaines, and C 10 -C 16 alkyl sultaines wherein the cationic and sulfonate anionic groups are separated by a propylene group and the remaining groups are methyl groups. Specifically, preferred zwitterionic surfactants are (a) those having the formula R.sup.6 CO--NH-- C.sub.3 H.sub.6 -- N.sup.(.sup.+) (R.sup.7).sub.2 -- R.sup.8 -- Y.sup.(.sup.-) wherein R 6 is an alkyl group containing from about 9 to about 15 carbon atoms, wherein each R 7 is selected from the group consisting of methyl, ethyl, and 2-hydroxyethyl groups, wherein Y is selected from the group consisting of sulfonate and carboxylate groups, and wherein R 8 is a methylene group when Y is a carboxylate group and is selected from the group consisting of propylene and 2-hydroxypropylene groups when Y is a sulfonate group; and (b) those having the formula R.sup.9 N.sup.(.sup.+) (R.sup.10).sub.2 CH.sub.2 CHXCH.sub.2 SO.sub.3.sup.(.sup.-) wherein R 9 contains from about 10 to about 16 carbon atoms, wherein each R 10 is selected from the group consisting of methyl, ethyl, and 2-hydroxyethyl groups, and wherein X is selected from the group consisting of hydrogen and hydroxyl groups. Examples of other zwitterionic surfactants are given in the examples hereinafter. 4. The polyethoxylated nonionic surfactant. The polyethoxylated nonionic surfactant provides a mildness benefit. It also contributes to the character of the lather, although in general, the nonionic surfactant tends to control and diminish the amount of the lather. The ratio of the polyethoxylated nonionic surfactant and zwitterionic surfactant to the polyethoxylated nonionic surfactant is from about 2:1 to about 1:2, preferably from about 1:1 to about 1:2, and most preferably from about 1:1 to about 1:1.2. Preferred nonionic surfactants include polyethoxylated (15-40) sorbitan monoacylate (C 10 -C 16 ; preferably monolaurate), polyethoxylated (40-80% by weight of the molecule) polypropylene glycol (M.W. about 3-5,000), and polyethoxylated (15-40) fatty alcohols (C 10 -C 14 ). Other examples of nonionic surfactants are disclosed hereinafter in the examples. 5. Water. Water is used to make up the shampoo compositions to the desired physical form. For liquid shampoos, there will normally be from about 50% to about 85% of water present, preferably from about 65% to about 80%. 6. Other ingredients. In addition to the ingredients described hereinbefore, the shampoo compositions of this invention can also contain other conventional shampoo components, including dyes, preservatives such as ethanol, perfumes, opacifiers, antibacterial agents, antidandruff agents, buffering agents, conditioning agents, etc. Desirably, only ingredients which are not irritating to the eye are added. It is especially desirable and preferred to have buffering agents present to maintain the pH of the composition within the range from about 6.0 to about 8.0, preferably from about 6.5 to about 7.5. Such buffering agents include NaOH, HCl, NaHPO 4 , boric acid, etc. It is also very desirable to include antidandruff agents such as zinc pyridinethiol N-oxide. The choice of a proper thickener is complicated by the fact that the ingredients react with many anionic thickeners and many nonionic thickeners fail to thicken the compositions. The compositions of this invention can also contain another nonionic thickener, e.g., a hydroxyethyl cellulose (e.g., one with a D.S. of about 2.5 whose 1% solution has a viscosity of 3-4,000 centipoises at 25°C.). This auxilary thickener is desirable in that it also tends to provide clear, single-phase compositions. All patents and applications referred to herein are specifically incorporated by reference. All percentages, ratios, and parts herein are by weight unless otherwise specified. EXAMPLE IIngredient Percent by Weight3-(N,N-dimethyl-N-laurylamino) propane- 4.5 1-sulfonate (sultaine)Sodium salt of sulfated polyethoxylated 7.0 coconut fatty alcohol (AE.sub.3 S)Polyethoxylated(20)tridecyl alcohol 14.0 (β-methyl dodecanol) (PTA)Ethanol 7.0Cationic thickener -2 (cationic cellulose 1.25 ether of Claim 7 of U.S. Pat. No. 3,472,840, wherein a is 2, b is 2, q is 0, m + p is about 1.5, n and the degree of substi- tution (D.S.) of the cationic group are about 0.2, and the viscosity of a 1% solu- tion is 125-1000 centipoises at 25°C.)Water balancepH adjusted to 7.0 with HClEXAMPLE IIIngredient Percent by WeightN-(3-coconutacylamidopropyl)-N,N- 5.0 di(2-hydroxyethyl)-3-aminopropane- sulfonateSodium salt of sulfated polyethoxylated(4) 8.0 lauroylamide (ethoxylated amido sulfate)Tween 20 13.0Natrosol 250 HH [A hydroxyethyl cellulose 0.5 (D.P. -- 2.5) having a viscosity at 1% in water at 25°C of 3-4,000 centipoises]Cationic thickener -2 0.5Ethanol 7.0Water balance Adjusted to pH of 7.0 with NaH.sub.2 PO.sub.3EXAMPLE IIIIngredient Percent by WeightSultaine 4.00AE.sub.3 S 5.50Polyethoxylated(50%)polypropyleneglycol 14.00 (molecular weight 3,000) (PPG)Cationic thickener -2 .60Ethanol 7.00Perfume 0.25Distilled water balanceAdjusted pH to 7.0 with HCl.EXAMPLE IVIngredient Percent by weightN-(3-coconutacylamidopropyl)-N,N- 3.00 dimethyl-2-aminoacetate (Amido betaine)Sodium polyethoxylated(3)lauryl sulfo- 7.00 succinate (Ethoxylated sulfosuccinate)Polyethoxylated(20)sorbitol monolaurate 15.00 (Tween 20)Cationic thickener -2 0.50Ethanol 7.00Distilled water balanceAdjusted pH to 7.0 with NaOH.EXAMPLE VIngredient Percent by Weight3-[N-undecyl-N-ethyl-N-(2-hydroxyethyl) 4.5 ammonio]-butyratePotassium polyethoxylated(3) 6.6 tridecanolether sulfatePolyethoxylated(30)sorbitol 17.0 monococonutacylateEthanol 6.0Cationic thickener -1 (same as thickener 1.0 of Example I except having a D.S. of the cationic group of 0.4 and a viscosity at 25°C. with a 1% solution of about 1,500-3,000)Water balanceAdjusted pH to 7.0 with HCl.EXAMPLE VIIngredient Percent by WeightAE.sub.3 S 6.50Tween 20 14.0Amido betaine 5.00Cationic thickener -1 1.00Water balanceEXAMPLE VIIIngredient Percent by WeightSultaine 4.90AE.sub.3 S 6.60Tween 20 14.0Cationic thickener -2 0.50Ethanol 7.00Water balanceEXAMPLE VIIIIngredient Percent by WeightAmido betaine 4.00Ethoxylated sulfosuccinate 8.15PTA 14.00Ethanol 7.00Cationic thickener -2 0.48Na.sub.3 HPO.sub.4.12H.sub.2 O 0.65NaH.sub.2 PO.sub.4.H.sub.2 O 0.35Water balanceEXAMPLE IXIngredient Percent by WeightAmido betaine 5.00AE.sub.3 S 7.15PTA 14.00Cationic thickener -1 0.50Water balanceEXAMPLE XIngredient Percent by WeightSultaine 4.90AE.sub.3 S 6.60PTA 14.00Ethanol 7.00Cationic thickener -1 0.50Water balanceEXAMPLE XIIngredient Percent by WeightAmido betaine 4.00Ethoxylated sulfosuccinate 8.15PTA 14.00Ethanol 7.00Cationic thickener -1 0.50Water balanceEXAMPLE XIIIngredient Percent by WeightSultaine 4.50AE.sub.3 S 7.00PTA 14.00Ethanol 7.00Cationic thickener -2 0.46Water balanceEXAMPLE XIIIIngredient Percent by WeightAmido betaine 4.00Ethoxylated sulfosuccinate 8.15Tween 20 14.00Ethanol 7.00Cationic thickener -2 0.46Water balanceEXAMPLE XIVIngredient Percent by WeightSodium N-alkyl(C.sub.12 ;C.sub.14) β-aminopropionate 4.00AE.sub.3 S 6.70Tween 20 14.00Ethanol 7.00Cationic thickener -2 0.50Water balanceEXAMPLE XVIngredient Percent by WeightSultaine 4.50AE.sub.3 S 7.00Tween 20 14.00Ethanol 7.00Natrosol 250 HH 0.30Cationic thickener -2 0.30Water balanceEXAMPLE XVIIngredient Percent by WeightSultaine 5.00Sodium N-coconut acyl-N-methyl taurate 5.50PTA 14.00Cationic thickener -2 0.50Distilled water balanceEXAMPLE XVIIIngredient Percent by WeightC-cetyl betaine 4.00AE.sub.3 S 7.50Tween 20 14.00Cationic thickener -2 0.50Water balanceEXAMPLE XVIIIIngredient Percent by WeightAmido betaine 5.40Na N-lauroyl sarcosinate 5.20PTA 14.00Cationic thickener -2 0.50Distilled water balanceEXAMPLE XIXIngredient Percent by WeightAmido betaine 5.00Sodium coconut alkyl sulfate 6.00Tween 20 14.00Cationic thickener -2 0.50Distilled water balance When in the above Examples I-XIX the following zwitterionic surfactants are substituted for the specifically named zwitterionic surfactants, substantially equivalent results are obtained in that the shampoos are exceptionally mild to the eyes. 1. 4-[N-coconutacylamidopropylene-N,N-di(2-hydroxypropyl)-ammonio]butane-1-sulfonate; 2. 2[N-pentadecylamidopropylene-N-(3-hydroxypropyl)-N-propylammonio]ethane-1-sulfonate; 3. 4(N-laurylmorpholino)2-hydroxybutanoate; 4. 3-(N-laurylmorpholino)propane-1-sulfonate; 5. 3-(N-tridecyl-N-methyl-N-propyl)-aminopropanoate; 6. 4-(N,N,N-trimethylammonio)stearate; 7.3-[N-methyl-N-(2-hydroxyethyl)-N-propylammonio]eicosane-1-sulfonate; 8. 5-[N,N-(3-hydroxypropyl)-N-methylammonio]-3-hydroxydocosane-1-carboxylate; 9. N-coconutalkyl betaine; 10. C-cetyl betaine; 11. C-hexadecyl betaine; 12. 3-(N,N-dimethyl-N-coconutalkylammonio)-2-hydroxypropane-1-sulfonate; 13. 6-coconutacylamido-3-trimethylammoniohexanoate; 14. 7-coconutacylamido-4-tri(2-hydroxyethyl)-heptane-1-sulfonate; 15. 3-[N-(3-coconutacylamidopropyl)-N,N-dimethylammonio]-propane-1-sulfonate; 16. 3-[N-(3-coconutacylamidopropyl)-N,N-di(2-hydroxyethyl)ammonio]-2-hydroxypropane-1-sulfonate; 17. 6-(N-coconutalkyl-N,N-dimethyl)hexanoate; 18. 5-(N,N-dipropyl-N-dodecylammonio)pentane-1-sulfonate; 19. 3-(N-methylmorpholino)stearate; 20. Potassium N-coconutalkyl β-aminopropionate; 21. Ammonium N-coconutalkyl β-iminodipropionate. When in the above Examples I-XIX, the following ethoxylated anionic surfactants are substituted for the specifically named ethoxylated anionic surfactants, either totally or in part (e.g., a 1:1 ratio), substantially equivalent results are obtained in that the shampoos are exceptionally mild to the eyes: 1. Ammonium polyethoxylated(10)octanol ether sulfate; 2. Triethanolammonium polyethoxylated(2)2-ethyltetradecanol sulfate; 3. Potassium polyethoxylated(4) octylphenol ether sulfate; 4. Sodium polyethoxylated(6)pentadecylphenol ether sulfate; 5. Diethanolammonium polyethoxylated(4)dodecane-2-ol ether sulfate; 6. Monoethanolammonium polyethoxylated(5)tetrapropylene phenol ether sulfate; 7. Sodium polyethoxylated(8)3-nonylphenol ether sulfate; 8. Potassium polyethoxylated(4)octoylamide ether sulfate; 9. Triethanolammonium polyethoxylated(5)hexadecoylamide ether sulfate; 10. Potassium polyethoxylated(2)octanol sulfosuccinate monoester; 11. Triethanolammonium polyethoxylated(10)hexadecanol sulfosuccinate monoester; 12. Potassium N-coconutacyl sarcosinate. When in the above Examples I-XIX, the following ethoxylated nonionic surfactants are substituted for the specifically named ethoxylated nonionic surfactants, either totally or in part (e.g., a 1:1 ratio), substantially equivalent results are obtained in that the shampoos are exceptionally mild to the eyes: 1. Polyethoxylated(40)octanol; 2. Polyethoxylated(10)hexadecanol; 3. Polyethoxylated(25)2-ethylnonanol; 4. Polyethoxylated(18)dodecane-2-ol; 5. Polyethoxylated(35)hexylphenol; 6. Polyethoxylated(30)pentadecylphenol; 7. Polyethoxylated(40)tetrapropylenephenol; 8. Polyethoxylated(25)3-nonylphenol; 9. Polyethoxylated(35)sorbitan monostearate; 10. Polyethoxylated(25)sorbitan monooctanoate; 11. Polyethoxylated(25)polypropylene glycol (M.W. 1000); 12. Polyethoxylated(25)octanoate; 13. Polyethoxylated(30)hexadecanoate.

Mild thickened liquid shampoo compositions with conditioning properties comprise anionic surfactants, specific zwitterionic and amphoteric surfactants, polyethoxylated nonionic surfactants and a cationic cellulose ether thickening and conditioning agent.

FIELD OF THE INVENTION This invention relates to disposable absorbent products for absorbing body fluids and, in particular, to sanitary napkins adapted to be worn against the perineal region of the body and held in place in the crotch portion of the undergarment when worn by the user. In a specific non-limiting example of the inventive principle, the sanitary napkin is provided with a pair of stiff flaps that are associated to the longitudinal sides of the sanitary napkin and cause the sides to bend upwardly as they are parted during placement of the sanitary napkin on the undergarment of the wearer. The upwardly bent sides form upstanding barriers that impede body exudate discharged on the sanitary napkin from leaking past the sides of the sanitary napkin. BACKGROUND OF THE INVENTION Sanitary napkins are prone to fail when body exudate is discharged on the napkin at a higher rate than that which the napkin can take up. When such failure occurs, body exudate usually leaks at the sides of the sanitary napkin and soils the undergarment. One approach to solve this problem has been described in the international patent application PCT/SE91/00735 filed on Oct. 31, 1991 and published on May 14, 1992 which teaches a sanitary napkin with side flaps that in use are folded over the edges of the crotch portion of the undergarment. A portion of each side flap is bonded in a face-to-face relationship with the flange seal of the sanitary napkin that surrounds the absorbent system. When the napkin is worn, the side flaps are pulled out from the sides of the central absorbent pad causing flange seal to raise into an upstanding barrier. However, in practice, the upstanding barrier may not always be created. For example, if the width of the central absorbent pad is not substantially less than the width of the user's undergarment, it will not be possible for the flaps to be pulled and maintained in an outward orientation with respect to the absorbent pad. If the flaps are not maintained in this position, the upstanding barrier will not be formed. Against this background, there exists a need in the industry to provide a sanitary napkin that offers a reduced likelihood of side failure. SUMMARY OF THE INVENTION In accordance with the present invention, there has been provided a sanitary napkin having a main body including at least three superposed functional layers, namely a fluid permeable body facing layer, an absorbent layer and a liquid impermeable undergarment facing layer. The main body has a pair of opposite longitudinal sides and a pair of opposite transverse sides. The sanitary napkin has at least one flap that is affixed to or otherwise physically associated with each longitudinal side of the main body. The flap is characterized as having a rigidity that is sufficient to cause the longitudinal side to fold upwardly when the flap is subjected to an effort causing outward displacement of the flap from a first position toward a second position, in the first position the flap acquiring a more acute angular relationship to the liquid impermeable undergarment facing layer than in the second position. One benefit of this sanitary napkin is the formation of an upstanding barrier on the main body that impedes the lateral flow of body exudate and can, therefore, reduce the likelihood of failures. The upstanding barrier results from the outward displacement of the flap that is normally effected when the sanitary napkin is installed on the undergarment of the wearer. The longitudinal side of the main body is maintained in the upwardly oriented position during the use of the sanitary napkin since the flap is restrained from moving back toward the liquid impermeable undergarment facing layer by the undergarment. Optionally, the main body is manufactured such that the longitudinal side has a resiliency sufficient to urge the flap into mechanical engagement with the crotch portion of the undergarment when the effort causing outward displacement of the flap from the first position toward the second position ceases. Another option is to provide the sanitary napkin with a pair of stiff flaps, each flap being associated with a respective longitudinal side. The upstanding barriers on the main body are formed when the flaps are parted to install the sanitary napkin on the crotch portion of the undergarment and they are maintained in this position during the use of the sanitary napkin. In a specific non-limiting example of implementation, the main body is generally rectangular with substantially rounded ends. When the main body is of such a conformation, the transverse sides are the shorter opposing sides and will generally have an arcuate shape. The longitudinal sides are the longer opposing sides and will generally be arcuate, typically inwardly arcuate. It should be understood, however, that the shape of such sides is not essential to the invention, and thus the transverse or the longitudinal sides could either be arcuate or straight. The main body is of a laminate construction and has at least three functional layers, namely: the fluid permeable body facing layer, the absorbent layer and a liquid impermeable undergarment facing layer. The fluid permeable body-facing layer is usually designated as “cover layer”. The cover layer is fluid-permeable, and thus will permit the body exudate discharged on the main body to pass through it and into the layers below. The absorbent layer underlies the cover layer and is often referred to as an “absorbent system”. The absorbent layer may comprise a single layer or a composite layer combining multiple layers or additional structures; the primary purpose of all of which being to absorb and retain body exudate. Many different absorbent systems are known in the art. Underneath the absorbent system is the liquid impermeable undergarment-facing layer, also called “barrier layer”. The primary purpose of the barrier layer is to prevent exudate absorbed within the sanitary napkin from egressing the sanitary napkin on the opposite side from which it was absorbed. The barrier layer is thus impervious to liquid but could be made pervious to gases to provide breathability. The cover layer and the barrier layer are joined to one another around the periphery of the sanitary napkin to form a flange seal enclosing the absorbent system, and thus forming a structurally integral sanitary napkin. Other conventional methods of adhering or uniting the various components of the article together, such as adhesive between the components, are all also within the scope of the present invention. The sanitary napkin has a pair of flaps each flap affixed to a respective opposite longitudinal side of the main body. Each flap has a proximal end portion and a distal end portion. The proximal end portion is the portion of the flap that is physically attached to the main body while the distal end portion is the opposite end portion of the flap that is remote from the main body. Each flap is attached to a portion of the flange seal that forms a respective longitudinal side of the main body. More specifically, the surface of the flap that faces the barrier layer is attached in a face to face relationship to the lower surface of the flange seal (the surface of the flange seal that is oriented toward the undergarment of the wearer). At least a portion of each flap is constructed of a material that is sufficiently rigid such that when the flaps are parted to allow the sanitary napkin to be installed on the crotch portion of the undergarment, they will raise the flange seal to form a pair of opposite upstanding barriers. The stiffness or rigidity of the flaps should be sufficient to cause the flange seal to fold upwardly when the flaps are parted. In general, the more rigid the flange seal, the stiffer the flaps should be. In a specific example, the flaps are formed from a foam material. Alternatively, the flaps can be formed of a material that is not inherently rigid but to which rigidity has been imparted by specific treatments or by addition of specific structures. One specific treatment to impart or enhance rigidity is embossing. Embossing has the effect of densifying the material and thus renders it less pliable. Alternatively, specific structures such as additional layers of material can be added to reinforce the tab. BRIEF DESCRIPTION OF THE DRAWINGS A detailed description of examples of implementation of the present invention is provided hereinbelow with reference to the following drawings, in which: FIG. 1 is a bottom perspective view of a sanitary napkin constructed in accordance with a specific example of implementation of the present invention; FIG. 2 is a top perspective view of the sanitary napkin shown in FIG. 1, the stiff flaps of the sanitary napkin being shown parted in a position allowing the installment of the sanitary napkin in the crotch portion of the undergarment; FIG. 3 is a cross-sectional view taken along lines 3 - 3 in FIG. 1, the cross-sectional illustration being inverted with relation to the orientation of the sanitary napkin in FIG. 1; FIG. 4 is a fragmentary cross-sectional view similar to the illustration shown in FIG. 3 with the exception that only a portion of the sanitary napkin is being shown, the sanitary napkin has a stiff flap that is shown as outwardly displaced to cause the flange seal of the sanitary napkin to bend upwardly; FIG. 5 is a bottom plan view of a sanitary napkin constructed in accordance with a variant; FIG. 6 is a bottom perspective view of a sanitary napkin constructed in accordance with a further variant; and FIG. 7 is a cross-sectional view of a sanitary napkin in accordance with a variant. FIG. 8 is a perspective view of a testing apparatus for measuring the cantilever authority of a tab. In the drawings, embodiments of the invention are illustrated by way of example. It is to be expressly understood that the description and drawings are only for purposes of illustration and as an aid to understanding, and are not intended to be a definition of the limits of the invention. DETAILED DESCRIPTION With reference to FIG. 1, there is shown an example of implementation of a sanitary absorbent article of the present invention, namely a disposable sanitary napkin 10 . The sanitary napkin 10 comprises a main body 12 . The main body 12 has two generally opposing longitudinal sides 14 , 16 and an imaginary longitudinal centerline 18 running down the center of the napkin 10 , generally equidistant from the longitudinal sides 14 , 16 and thus bisecting the main body 12 in two identical halves. The longitudinal sides 14 , 16 are concavely arcuate. The main body 12 also has two generally opposing transverse sides, 20 , 22 which are convexly arcuate. An imaginary transverse centerline 24 runs across the napkin 10 , perpendicular to the longitudinal centerline 18 , and thus bisects the main body 12 in two identical halves. With reference to FIGS. 1 and 3, the sanitary napkin 10 is a laminate structure and the main body 12 has a cover layer 26 which will face the body of a wearer when the napkin 10 is in use; a barrier layer 28 , which will face the environment (i.e. away from the body of the wearer, and in almost all cases the wearer's undergarment) when the sanitary napkin 10 is in use; and a layer-like absorbent system 30 therebetween. The absorbent system 30 comprises a first absorbent layer, commonly called “transfer layer” 32 positioned immediately underneath the cover layer 26 and a second absorbent layer, commonly called “absorbent core” 34 that is located between the first absorbent layer 32 and the barrier layer 28 . The cover layer 26 and the barrier layer 28 are joined along their marginal portions to form an enclosure or flange seal 40 that maintains the absorbent system 30 captive. The joint may be made by means of adhesives, heat-bonding, ultrasonic bonding, radio frequency sealing, mechanical crimping, and the like and combinations thereof. In the example of implementation depicted in the drawings, the flange seal 40 is continuous around the absorbent system 30 . Optionally, the flange seal 40 may be discontinuous, in other words the cover layer 26 and the barrier layer 28 remain unattached to one another at some peripheral areas of the sanitary napkin. The main body 12 is provided with a pair of flaps 36 , 38 that are affixed to the respective longitudinal sides 14 , 16 . The flaps may be either directly affixed to the sides of the main body or may be affixed through one or more intermediate components. Each of the constituent elements of the sanitary napkin 10 will be described in further detail hereinbelow. Cover Layer The cover layer 26 may be a relatively low density, bulky, high-loft non-woven web material. The cover layer 26 may be composed of only one type of fiber, such as polyester or polypropylene or it may be composed of bi-component or conjugate fibers having a low melting point component and a high melting point component. The fibers may be selected from a variety of natural and synthetic materials such as nylon, polyester, rayon (in combination with other fibers), cotton, acrylic fiber and the like and combinations thereof. An example is the non-woven cover layer of sanitary napkins sold by Johnson & Johnson Inc. of Montreal, Canada under the trademark Stayfree Ultra-Thin Cottony Dry Cover. Bi-component fibers may be made up of a polyester core and a polyethylene sheath. The use of appropriate bi-component materials results in a fusible non-woven fabric. Examples of such fusible fabrics are described in U.S. Pat. No. 4,555,432 issued Nov. 28, 1985 to Mays. Using a fusible fabric increases the ease with which the cover layer may be mounted to the underlying first absorbent layer and/or to the barrier layer. Although the individual fibers comprising the cover layer 26 may not be particularly hydrophilic, the cover layer 26 preferably has a relatively high degree of wettability. The cover material should also contain a great number of relatively large pores. This is so because the cover layer 26 is intended to take-up body fluid rapidly and transport it away from the body and the point of deposition. Advantageously, the fibers which make up the cover layer 26 should not lose their physical properties when they are wetted, in other words they should not collapse or lose their resiliency when subjected to water or body fluid. The cover layer 26 may be treated to allow fluid to readily pass through it. The cover layer 26 also functions to transfer the fluid quickly to the other layers of the absorbent system 30 . Thus, the cover layer 26 is advantageously wettable, hydrophilic, and porous. When composed of synthetic hydrophobic fibers such as polypropylene or bi-component fibers, the cover layer 26 may be treated with a surfactant to impart the desired degree of wettability. Alternatively, the cover layer 26 can also be made of polymeric film having large pores. Because of such high porosity, the film accomplishes the function of quickly transferring body fluid to the inner layers of the absorbent system. Apertured co-extruded films such as those described in U.S. Pat. No. 4,690,679 and available on sanitary napkins sold by Johnson & Johnson Inc. of Montreal, Canada could be useful as cover layers in the present invention. The cover layer 26 may be embossed to the absorbent system 30 in order to aid in promoting fluid transport by fusing the cover layer to the next layer. Such fusion may be effected locally, at a plurality of sites, or over the entire contact surface of cover layer 26 with absorbent system 30 . Alternatively, the cover layer 26 may be attached to the absorbent system 30 by other means such as with adhesive. Absorbent System—First Absorbent Layer (Transfer Layer) Adjacent to the cover layer 26 on its inner side and bonded to the cover layer 26 is the first absorbent layer 32 that forms part of the absorbent system 30 . The first absorbent layer 32 provides the means of receiving body fluid from the cover layer 26 and holding it until an underlying second absorbent layer has an opportunity to absorb the fluid. The first absorbent layer 32 is, preferably, more dense than and has a larger proportion of smaller pores than the cover layer 26 . These attributes allow the first absorbent layer 32 to contain body fluid and hold it away from the outer side of the cover layer 26 , thereby preventing the fluid from re-wetting the cover layer 26 and its surface. However, the first absorbent layer 32 is, preferably, not so dense as to prevent the passage of the fluid through it and into the underlying second absorbent layer 34 . These types of absorbent layers are commonly known as fluid transfer layers or acquisition layers. The first absorbent layer 32 may be composed of fibrous materials, such as wood pulp, polyester, rayon, flexible foam, or the like, or combinations thereof. The first absorbent layer 32 may also comprise thermoplastic fibers for the purpose of stabilizing the layer and maintaining its structural integrity. The first absorbent layer 32 may be treated with surfactant on one or both sides in order to increase its wettability, although generally the first absorbent layer 32 is relatively hydrophilic and may not require treatment. The first absorbent layer 32 is preferably bonded on both sides to the adjacent layers, i.e. the cover layer 26 and an underlying second absorbent layer 34 . An example of a suitable first absorbent layer is a through air bonded pulp sold by BUCKEYE of Memphis, Tenn. under the designation VIZORB 3008. Absorbent System—Second Absorbent Layer (Absorbent Core) Immediately adjacent to and bonded to the first absorbent layer 32 is the second absorbent layer 34 . In one non-limiting example of implementation, the second absorbent layer 34 is a blend or mixture of cellulosic fibers and superabsorbent disposed in and amongst fibers of that pulp. The second absorbent layer 34 can contain any superabsorbent polymer (SAP); SAPs being well known in the art. For the purposes of the present invention, the term “superabsorbent polymer” (or “SAP”) refers to materials which are capable of absorbing and retaining at least about 10 times their weight in body fluids under a 0.5 psi pressure. The superabsorbent polymer particles of the invention may be inorganic or organic crosslinked hydrophilic polymers, such as polyvinyl alcohols, polyethylene oxides, crosslinked starches, guar gum, xanthan gum, and the like. The particles may be in the form of a powder, grains, granules, or fibers. Superabsorbent polymer particles that could be used for the present invention are crosslinked polyacrylates, such as the product offered by Sumitomo Seika Chemicals Co., Ltd. Of Osaka, Japan, under the designation of SA60N Type II*, and the product offered by Chemdal International, Inc. of Palatine, Ill., under the designation of 2100A*. In one specific and non-limiting example of implementation, the cellulosic fiber for use in the second absorbent layer 34 is wood pulp. For further details on the structure and the method of construction of the second absorbent layer 34 , the reader is invited to refer to the U.S. Pat. No. 5,866,226 granted on Feb. 2, 1999 to Tan et al. The contents of this document are hereby incorporated by reference. Alternatively, the second absorbent layer 34 may include other absorbent materials such as sphagnum peat moss. Barrier Layer Underlying the absorbent system 30 is the barrier layer 28 comprising liquid-impervious film material so as to prevent liquid that is entrapped in the absorbent system 30 from egressing the sanitary napkin 10 and staining the wearer's undergarment. The barrier layer 28 is preferably made of polymeric film, such as polyethylene or polyethylene/ethylvinyl acetate (EVA), which are both inexpensive and readily available. The polymeric film is capable of fully blocking the passage of liquid or gas that may emanate from the absorbent system 30 . In a variant, breathable films, which allow passage of gases while blocking liquid, may be used. A suitable example is a combination polyethylene/ethylvinyl acetate (EVA) film sold by the Edison Plastics Company in the United States under the commercial designation XP-1167B. Flaps The sanitary napkin has flaps 36 , 38 extending laterally from the longitudinal sides of the main body and are adapted to be folded over the edges of a crotch portion of a user's undergarment. FIG. 3 illustrates the manner of attaching the flaps 36 , 38 to the main body 12 of the sanitary napkin 10 . Each flap has a proximal end portion 70 and a distal end portion 72 . The proximal end portion 70 is the area of the flap 36 , 38 that is adjacent the corresponding longitudinal side 14 , 16 of the sanitary napkin 10 . The distal end portion 72 is the portion of the flap 36 , 38 that is remote from the longitudinal side 14 , 16 with which the flap 36 , 38 is respectively associated. In addition, each flap 36 , 38 also has an outer face 76 and an inner face 74 . The inner face 74 is the side of the flap 36 , 38 that faces the barrier layer 28 when the flap 36 , 38 is in a position such as that shown in FIG. 3, in other words being adjacent or resting against the barrier layer 28 . The outer face 76 is the side of the flap 36 , 38 that faces away from the barrier layer 28 when the flap 36 , 38 rests against the barrier layer 28 . Each flap 36 , 38 is affixed to a corresponding longitudinal side 14 , 16 of the main body 12 in a cantilever arrangement and at least a portion of the flap possesses sufficient rigidity such as to cause the longitudinal side 14 , 16 to fold upwardly when the flap 36 , 38 is displaced from a position such as that shown in FIG. 3 to a position as shown in FIG. 4 . In the position shown in FIG. 3, the flap 36 , 38 acquires a more acute angular relationship with relation to the barrier layer 28 than in the position shown at FIG. 4 . FIG. 2 illustrates the configuration acquired by the main body 12 when both flaps 36 , 38 are parted to insert the crotch portion of the undergarment between them. Because of the outward cantilever pivotal displacement of each flap 36 , 38 , the longitudinal sides 14 , 16 fold upwardly as discussed above. The parting of the flaps 36 , 38 shown in FIG. 2 is somewhat exaggerated. In practice, it will not be required to part the flaps 36 , 38 as much to clear the crotch portion of the undergarment. When the sanitary napkin 10 is installed on the undergarment the flaps 36 , 38 are released. Due to the resiliency of the longitudinal sides 14 , 16 of the main body 12 , the flaps 36 , 38 have a tendency to at least partially return to their original position and abut the crotch portion of the undergarment. The position of the flaps 36 , 38 when they rest against the crotch portion of the undergarment generally corresponds to the position of the flap 36 , 38 as shown in FIG. 4 for flap 38 . In this position of the flaps 36 , 38 , two beneficial features arise. Firstly, each longitudinal side 14 , 16 is raised and forms an upstanding barrier on the main body 12 that impedes the lateral flow of body exudate and can, therefore, reduce the likelihood of failures. Secondly, the flaps 36 , 38 are urged against the crotch portion of the undergarment and thus engage the undergarment, which has the effect of stabilizing the sanitary napkin 10 on the undergarment. Three primary factors determine the extent to which these two beneficial features will manifest themselves, namely: the rigidity of the flaps 36 , 38 , the rigidity of the longitudinal sides 14 , 16 , and the manner of physical association between the flaps 36 , 38 and the longitudinal sides 14 , 16 . With regard to the first factor, at least a portion of each flap 36 , 38 should possess a rigidity or stiffness sufficient such that when it is displaced outwardly, such displacement causes the longitudinal side 14 , 16 physically associated with the flap 36 , 38 to fold upwardly. A sufficient rigidity can be obtained by using a material for manufacturing the flap 36 , 38 that is inherently rigid or by conditioning the material to enhance its rigidity. In a specific example of implementation, the flaps 36 , 38 are made of polymeric foam material. Polymeric foam is commercially available in a wide range of densities and thicknesses from Voltek in Lawrence Mass., USA. Conditioning a material to make it more rigid is generally known in the art and many possibilities exist. One possibility is to laminate a base material with another material to form a layered structure that is more rigid than the base material. Another possibility is to compress the material to densify it, which usually results in a more rigid structure. Yet another possibility is to emboss the base material to create a pattern of localized densification areas that impart additional rigidity. This possibility is illustrated in FIG. 5 . The flaps 36 , 38 are made of polymeric foam material that has been locally embossed at 100 to donate to the flaps 36 , 38 additional rigidity. A further possibility to increase the rigidity of the flap 36 , 38 is to impregnate the material of the flap 36 , 38 with a liquid, such as any suitable binder, that makes the base material more rigid when it sets. With regard to the second factor that is the rigidity of the longitudinal side 14 , 16 , if the longitudinal side is very soft and yields readily to bending pressure, a flap 36 , 38 of a lesser rigidity will be needed to cause formation of an upstanding barrier. At the same time the flap 36 , 38 will be urged against the undergarment with less intensity than if the longitudinal side 14 , 16 manifests a strong resiliency. The rigidity of the longitudinal sides 14 , 16 depends upon several factors, namely: the number of layers forming the lateral side 14 , 16 , the rigidity of the individual layers, the way those individual layers are bonded to one another, among others. With regard to the third factor that is the manner of physical association between the flaps 36 , 38 and the longitudinal sides 14 , 16 , the following observations can be made. Different possibilities exist to physically associate the flap 36 , 38 to the corresponding longitudinal side 14 , 16 such that when the flap 36 , 38 is displaced outwardly, its longitudinal side 14 , 16 is folded upwardly. One such possibility is to directly bond the flap 36 , 38 to the longitudinal side 14 , 16 . Another possibility is to fasten the flap 36 , 38 to the longitudinal side through an intermediate component. Under the first possibility, the inner face 74 of the proximal end portion of the flap 36 , 38 is bonded to the flange seal 40 . The joint may be made by means of adhesives, heat-bonding, ultrasonic bonding, radio frequency sealing, mechanical crimping, and the like and combinations thereof. The surface area of the bond between the flap 36 , 38 and the longitudinal side 14 , 16 along flange seal 40 influences to what extend the longitudinal side 14 , 16 will fold upwardly when the flap 36 , 38 is displaced outwardly. In particular, the width of the bond surface area (the width is measured along an imaginary line that is transverse to the longitudinal side 14 , 16 ) should be sufficient to cause the formation of an upstanding barrier. Under a specific and non-limitative example of implementation, the width of the bond surface area generally corresponds to the width of the flange seal 40 . A possible variant under the first possibility is illustrated in FIG. 7 that shows the sanitary napkin 10 in cross section. It that figure, all the components of the sanitary napkin 10 that are identical of similar to the components previously illustrated and described will be designated by the same reference numerals. Under this variant, the flaps 200 are also associated with the longitudinal sides 14 , 16 in a cantilever arrangement but the proximal end portion 208 of each flap 200 is folded over the cover layer 26 such that the proximal end portion 208 forms a loop receiving the respective longitudinal side 14 , 16 . More specifically, the inner face 204 of each flap 200 is first bonded at the barrier layer 28 at location 210 , then folded upwardly so as to overlay the cover layer 26 and bond with the cover layer 26 at location 212 . This realization offers the benefit of a stronger attachment between the flaps 200 and the longitudinal sides 14 , 16 . The reader skilled in the art will recognize that by varying the three factors discussed earlier, the behavior of the sanitary napkin 10 can be altered to suit specific applications. Referring back to FIG. 1, the flaps 36 , 38 are bonded to the main body 12 with their respective distal end portions 72 retained to one another by a frangible bond. This allows the sanitary napkin 10 to be placed on the undergarment without using the flaps, if the user so desires. Alternatively, by separating the distal end portions 72 from one another, the flaps 36 , 38 become operational. In practice, the flaps 36 , 38 can be manufactured as a single unit having across its center a line of weakness 102 that allows the wearer to separate the unit in two identical halves. The line of weakness 102 can be a line of perforations or any other physical treatment of the material that creates a local fragile area that will rupture when pulled apart. In order to enhance the comfort potential of the sanitary napkin 10 the flaps 36 , 38 may be provided with specific materials or treatments designed to reduce the possibility of irritation of the skin at the area where the flaps 36 , 38 contact the thighs of the wearer. One possibility is to laminate the outer face 76 of the flaps 36 , 38 with a material that is soft and non-irritating. One such example is a non-woven fabric. Another possibility is to treat the outer face 76 such that it presents a non-irritating surface. Such a treatment may be designed to create a very smooth surface or a surface that is soft and compliant. At the same time, a different treatment may be provided on the inner face 74 to make that surface rougher such as to reduce slippage between the flap 36 , 38 and the undergarment. It is within the reach of a person skilled in the art to select the treatment method to create the desired surface finishes described above. Another possible refinement that can be considered is to apply on the inner face 74 a release coating such as silicone coating to prevent accidental bonding between the flap 36 , 38 and the positioning adhesive of the main body 12 . The positioning adhesive is discussed below. Adhesives Referring back to FIG. 1, the barrier layer 28 is provided with an area of adhesive material 25 to retain the sanitary napkin 10 on the undergarment of the wearer. The area of adhesive material 25 is rectangular and extends over the major part of the length of the main body 12 . Release paper 104 covers the adhesive material 25 . A suitable adhesive is the composition designated HL-1491 XZP commercially available from H. B. Fuller Canada, Toronto, Ontario, Canada. The release paper is of conventional construction (silicone coated wet-laid Kraft wood pulp) and suitable papers are available from Tekkote Corporation (Leonia, N.J., USA), and bear the designation FRASER 30#/61629. In the example of implementation of the invention illustrated in FIG. 1, the adhesive material 25 and the release paper 104 pass under the flaps 36 , 38 . In a possible variant shown in FIG. 6, the flaps 36 , 38 are shorter such that a space is defined between their distal end portions 72 . A zone of adhesive material 22 extends in that space. The advantage of this form of implementation is that there is little risk of accidentally adhering the flaps 36 , 38 to the zone of adhesive material 22 . In addition to this zone of adhesive material 22 , the sanitary napkin 10 is provided with two additional zones of adhesive material 52 and 54 near the transverse end portions 20 and 22 of the main body 12 . The zones of adhesive material 22 , 52 and 54 are covered by release papers, not shown in the drawings. Test Procedures FIG. 8 illustrates a test set-up to measure the cantilever authority of the flap 36 , 38 . The test set-up includes a suitable support (not shown) to hold the sanitary napkin 10 in a vertical position. An angled probe 42 is slipped under the flap 36 and the dimension A noted. A is the length of the flap 36 (measured along the centerline 18 ) at the area where it contacts the horizontal segment of the probe 42 . To properly assess the dimension A, the horizontal segment of the probe 42 should be placed as close as possible to the barrier layer 28 without rubbing too much against the barrier layer. The objective is to avoid that friction between the horizontal segment of the probe 42 and the barrier layer 28 influences significantly the test results. In addition, the horizontal segment of the probe 42 is placed vertically as close as possible to the location where the flap 36 is attached to the main body 12 . The probe 42 is then displaced vertically at a constant speed and the force at different vertical positions of the probe 42 recorded. The movement is stopped when the horizontal segment of the probe 42 has cleared the distal end portion 72 . The peak force value is extracted and divided by the dimension A to obtain a result expressed in grams per centimeter. The test is performed a total of ten times and the results averaged to obtain the cantilever authority for the flap 36 . Although various embodiments have been illustrated, this was for the purpose of describing, but not limiting, the invention. Various modifications will become apparent to those skilled in the art and are within the scope of this invention, which is defined more particularly by the attached claims.

A sanitary napkin having a main body including at least three superposed functional layers, namely a fluid permeable body facing layer, an absorbent layer and a liquid impermeable undergarment facing layer. The sanitary napkin has flaps adapted to be folded around the edges of an undergarment of a wearer. The flaps are physically associated with respective longitudinal sides of the main body and are characterized by a rigidity sufficient to cause the longitudinal sides to fold upwardly when the flaps are parted to receive between them the crotch portion of the undergarment of the user. The upwardly folded longitudinal sides form upstanding barriers to limit the likelihood of failure as a result of side leakage.

BACKGROUND OF THE INVENTION Lancing devices are typically handheld units that permit users to draw blood for testing and diagnostic purposes. These devices include a housing with a piercing aperture, a lancet that contains one or more needles, and a firing mechanism. The firing mechanism typically includes a spring or other biasing means which can be cocked either by insertion of the lancet or by movement of a cocking member. Once the lancing device is cocked, it is placed against the user's skin, often the fingertip. The user can then press a trigger to actuate the firing mechanism, which momentarily drives the sharp tip of the needle through the piercing aperture to puncture the user's skin and draw blood. A myriad of lancing devices have been proposed and/or commercialized. Whereas these devices are generally satisfactory, the cocking mechanism tends to be rather complex and expensive and the devices do not provide a storage facility to store the lancets prior to use. SUMMARY OF THE INVENTION Embodiments disclosed herein concern a lancing device of the type including an elongated housing; a lancet holder receiving the lancet and mounted for axial movement in the housing between a retracted position and operative position and a cocked position; a cocking mechanism operative to move the lancet holder from its retracted position to its cocked position; and a trigger mounted on the housing and operative to release the lancet holder for movement from the cocked position to the operative position. In accordance with some embodiments of the invention, a lancing device is disclosed comprising an elongated housing, a lancet, a lancet holder receiving the lancet and configured to move axially in the housing between a retracted position, an extended position, and a cocked position, and a cocking mechanism mounted on the housing and configured to move first inward relative to the housing and subsequently outward relative to the housing. The lancet holder is further configured to move from its retracted position to its cocked position in response to the outward movement of the cocking mechanism. The device also comprises a trigger mounted on the housing and operative to release the lancet holder for movement from the cocked position to the extended position. In accordance with other embodiments of the invention, a lancing device is disclosed comprising a lancet, a lancet holder configured to receive the lancet and mounted for axial movement in the housing between a retracted position, an extended position, and a cocked position, a lancet storage compartment defined within the housing and sized to accommodate a plurality of lancets, a door configured to move between an open position allowing access to the storage compartment and a closed position preventing access to the storage compartment, a cocking mechanism engaged with the door and configured to move the lancet holder from its retracted position to its cocked position when the door is moved from the open position to the closed position and a trigger mounted on the housing and configured to release the lancet holder to move from the cocked position to the extended position. In accordance with yet other embodiments of the invention, a method of cocking a lancing device is disclosed. The method, for use with a housing having a lancet holder disposed therein and a storage compartment to accommodate a plurality of lancets, comprises opening a door of the storage compartment to remove or deposit one or more of the plurality of lancets, and closing the door of the storage compartment to cock the lancing device, wherein closing the door of the storage compartment moves the lancet holder from a neutral position to a cocked position. BRIEF DESCRIPTION OF THE DRAWINGS The description herein makes reference to the accompanying drawings wherein like reference numerals refer to like parts throughout the several views, and wherein: FIG. 1 is a perspective view of a lancing device according to a first embodiment of the invention; FIGS. 2 , 3 , 4 , 5 and 6 are schematic cross-sectional views of the lancing device of FIG. 1 showing successive steps in the usage of the invention lancing device; FIG. 7 is an exploded perspective view showing a cocking mechanism, a lancet holder, and a trigger employed in the FIG. 1 embodiment; FIG. 8 is a perspective view of a second embodiment of the invention; FIG. 9 is a somewhat schematic longitudinal cross-sectional view of the lancing device of FIG. 8 ; FIG. 10 is a somewhat schematic cross-sectional view taken on line 10 - 10 of FIG. 9 ; FIG. 11 is a perspective view of a third embodiment of the invention; and FIG. 12 is a somewhat schematic cross-sectional view of the lancing device of FIG. 11 . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The lancing device 10 seen in FIGS. 1-7 embodiment, broadly considered, includes a housing 12 , a lancet 16 , a lancet holder 18 , a cocking mechanism 20 and a trigger mechanism 22 . Housing 10 includes a main body housing member 24 and a front cap 26 . Main body housing member 24 is elongated, has a generally rectangular cross-sectional configuration, and includes a top wall 24 a , a bottom wall 24 b , side walls 24 c , 24 d and a rear end wall 24 e . Top wall 24 a includes an aperture 24 f to accommodate the trigger mechanism. Front cap 26 is sized to be secured to the front end of housing member 24 and includes a front wall 26 a defining a piercing aperture 26 b. Lancet 16 is of known form and includes a generally cylindrical body 16 a carrying one or more needles 16 b. Lancet holder 18 comprises a rod suitably mounted for axial movement in the housing and having a notch 18 a. Cocking mechanism 20 includes a button 28 mounted in housing end wall 24 e for inward and outward movement relative to the housing end wall and an actuator 30 . Actuator 30 includes a rearward rod portion 30 a , a forward guide portion 30 b and a central resilient portion 30 c. The rear end 30 b of rod portion 36 is fixedly secured in a socket 28 a of button 28 . Guide portion 30 b has a generally planar configuration. Resilient portion 30 c includes an upper resilient arm 30 e interconnecting rod portion 30 a and guide portion 30 b and a lower resilient arm structure 30 f further interconnecting rod portion 30 a and guide portion 30 b . Lower resilient arm structure 30 f defines a button 30 g and is bifurcated at its forward end to form a window 30 h to accommodate axial movement of lancet holder 18 . Trigger mechanism 22 is in the form of a trigger button sized to fit in housing aperture 24 f and defining guide structure 22 a on the underface of the button for slidable receipt of guide portion 30 b of actuator 30 . In assembled relation of the components of the lancing device, button 28 is slidably received in end wall 24 e , lancet 16 is suitably mounted on the front end of lancet holder 18 , the rear end of actuator rod portion 30 a is coupled to button 28 , the front planar guide portion 30 b of actuator 30 is slidably received in guide structure 22 a of trigger 22 , and button 30 g is resiliently positioned proximate the underside of lancet holder 18 . Lancet holder 18 is suitably slidably guided in housing 12 for axial movement between a retracted position seen in FIGS. 2 , 3 and 6 , a cocked position seen in FIG. 4 , and an operative puncturing position seen in FIG. 5 . With initial reference to FIG. 2 , showing the device with the lancet holder in its retracted position, button 28 is slidably mounted in housing end wall 24 e , the upper face 22 b of trigger 22 is flush with the upper face of housing upper wall 24 a , and button 30 g of actuator 30 is resiliently pressed against the underface of lancet holder 18 rearwardly of notch 18 a. In the transitory position seen in FIG. 3 , button 28 has been pressed inwardly or forwardly to move button 30 g into alignment with notch 18 a with this forward movement of the actuator accommodated by sliding movement of actuator guide portion 30 b in trigger guide structure 22 a. When button 30 g moves forwardly to a position of alignment with notch 18 a the resilient nature of actuator guide portion 30 c presses the button into the notch 18 a whereupon, following release of button 28 , the actuator and lancet holder move rearwardly within the housing under the impetus of, for example, a suitable coil compression spring 30 to the cocked position seen in FIG. 4 , wherein the needle 16 b of the lancet is, for example, positioned proximate the interface of cap 26 and main body housing member 24 and the upper face 22 b of trigger 22 is positioned above the upper face of housing upper wall 24 a . This rearward movement of the lancet holder is accompanied by compression of a suitable compression spring mechanism such as shown schematically at 34 , the spring device 34 being understood to exert a lesser biasing force than the spring 32 so as not to impede the rearward movement of the actuator and the lancet holder under the bias of spring 32 . Once the lancing device has achieved the cocked position seen in FIG. 4 , trigger 22 may be depressed as seen in FIG. 5 to resiliently displace knob 13 g from notch 13 a and allow the lancet holder and lancet to be fired forwardly under the impetus of spring device 34 to achieve the piercing or puncture position of FIG. 5 wherein a needle 16 b extends marginally forwardly of the front wall 26 a of cap 26 to achieve the patient piercing function whereafter the lancet and lancet holder retreat to the retracted position seen in FIG. 6 , corresponding to the initial position of FIG. 2 . As the lancet holder and lancet are fired forwardly, and as seen in FIG. 5 , actuator 30 and button 28 undergo a slight rebound movement but thereafter return to their initial retracted position of FIGS. 2 and 6 . The lancing device of the FIGS. 1-7 of the embodiment will be seen to provide a simple effective and inexpensive cocking mechanism. The lancing device 40 of the FIGS. 8-10 embodiment, broadly considered, includes a housing 42 , a lancet 16 , a lancet holder 44 , a cocking mechanism 46 , and a trigger mechanism 48 . Housing mechanism 42 includes a main body housing member 50 and a front cap 52 defining a piercing aperture 52 a. Main body housing member 24 includes a top wall 50 a , a bottom wall 50 b , side walls 50 c , 50 d , and an end wall 50 e . Top wall 50 a includes an aperture 50 f to accommodate trigger mechanism 48 . Main body housing member 50 defines a lancet storage compartment 50 g defined by end wall 50 e , a longitudinal partition 50 h , a transverse partition 50 i , and overlying and underlying portions 50 a , 50 b of top wall 50 a and bottom wall 50 b , respectively. As seen, compartment 50 g is of a size to accommodate a large plurality of lancets 16 . Main body housing member 50 further defines a door 54 pivotally mounted about a vertical axis 56 proximate a rear end of the lancing device for movement between an open position, as seen in FIGS. 8 and 9 and a closed position in which access to the lancets is precluded. Lancet holder 44 has a rod configuration and includes a detent notch 44 a and a radial arm 44 b. Lancet holder 44 , as seen in FIG. 9 , is suitably mounted for axial movement within housing 42 between a retracted position seen in solid lines, a cocked position, and an operative or piercing position. Cocking mechanism 46 includes an arcuate rack 60 and a pinion 62 mounted for rotation in housing member 50 by a post 50 j and having an eccentric portion 62 a for coaction with radial arm 44 b of lancet holder 44 . Trigger mechanism 48 is schematically illustrated and may, for example, include a trigger member 66 positioned in housing aperture 50 f and a detent mechanism 68 biased downwardly against lancet holder 44 via a suitable spring mechanism 70 . With the lancet holder 18 in the solid line retracted position, and with reference to FIG. 9 , closing movement of door 54 has the effect of moving the lancet holder to its cocked position. Specifically, as the door 54 is moved from its open to its closed position, arcuate rack 60 meshingly engages pinion 62 to rotate the pinion and bring eccentric portions 62 a into engagement with lancet holder radial arm 44 b to move the lancet holder rearwardly within the housing against the resistance of a coil spring 72 . The parameters of the device are chosen such that as eccentric portion 62 a clears radial arm 44 b , detent 68 moves into detented engagement with notch 44 a so that the lancet holder is held in its cocked position whereafter, upon depression of trigger mechanism 66 to release detent 68 from engagement with notch 44 a , the lancet holder is free to move forwardly under the urging of spring 72 to achieve the piercing position. Note that in this position, since radial arm 44 b has now moved forwardly to a position in the path of radial movement of eccentric portion 62 a of pinion 62 , door 54 cannot be opened to allow access to the lancets without a specific operation on the part of the user to take the arm 44 b out of the path of movement of eccentric portion 62 a . This may be done, for example, as shown in FIG. 9 by attaching a knob 74 to the rear end of lancet holder 18 via a shaft 76 passing through housing end wall 50 e . With this arrangement, knob 74 may be turned to rotate lancet holder 44 within the housing to move radial arm 44 b out of the path of eccentric portion 62 a and allow the door 54 to be opened to allow access to the lancet storage compartment. The lancing device of the FIGS. 8-10 embodiment will be seen to provide a convenient arrangement for storing lancets, allow access to the storage compartment to be coordinated with cocking of the lancet holder, and provide a safety feature in the sense that unauthorized or inadvertent access to the stored lancets is discouraged by requiring a specific user operation to allow unlocking of the access door to the lancet storage compartment. The lancing device of the FIGS. 11 and 12 embodiment is generally similar to the FIG. 8-10 embodiment with the exception that the lancet storage compartment, rather than being defined within the housing by walls of the housing, is defined as an integral part of the door 54 and moves inwardly and outwardly with the door. Specifically, the lancet storage compartment 80 of the FIGS. 11 and 12 embodiment is constituted as a drawer carried by the door 54 and is defined by the door, as the drawer face, by a floor 82 , an arcuate end wall 84 , and a partition 86 . With this construction, as the door 54 is moved to its open position, the lancets positioned in the storage compartment 80 are moved outwardly of the housing to a position wherein they can be readily accessed from the open upper end of compartment 80 . A method of cocking the lancing device 40 disclosed with reference to FIGS. 8-12 comprises opening a door 54 of the storage compartment 50 g to remove or deposit one or more of the plurality of lancets 16 and closing the door 54 of the storage compartment 50 g to cock the lancing device 40 , wherein closing the door 54 of the storage compartment 50 g moves the lancet holder 44 from a neutral position to a cocked position. The step of closing the door can operate a cocking mechanism 46 , for example, having a rack mounted within the housing on the door and a pinion driven by the rack engaging the lancet holder. The door 54 can be configured to pivot between the open and closed positions. The door 54 can be further configured to pivot about an axis on one edge of the door proximate a rear end wall of the housing. The lancet storage compartment 50 g can be a drawer and the door 54 can be the drawer face. The above-mentioned embodiments have been described in order to allow easy understanding of the present invention. The invention is not to be 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, which scope is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures as is permitted under the law.

A lancing device is disclosed in which cocking of the lancet holder is achieved in response to retraction of a push member. A lancing device is also disclosed in which a lancet storage compartment is provided in the housing of the lancing device and closing movement of a closure member for the storage compartment has the effect of cocking the lancet holder. Methods of cocking lancing devices are also disclosed.

BACKGROUND OF THE INVENTION This invention relates to a device for transporting and positioning dough triangles in crescent shaped dough rolls forming machines. The technique for preparing crescents, also called "croissants", consists in preparing a strip of dough which is rolled on a roller machine. After some dough strip calibration operations, the strip is transferred into a machine which cuts out triangles. In order to waste no materials and reduce costs, the triangles are arranged, after the cutting thereof, in parallel rows with opposing orientations, as shown in FIG. 1. After cutting, the triangles or at least one half of them must be orientated such that they are all presented to the rolling machine with their bases onwards. On commercially available machines, these orientation operations are carried out by simply turning upside down alternately one half of the triangles, as shown diagramatically in FIG. 2. The triangles will then enter the rolling machine which comprises essentially a main roller A which carries the dough triangle 2, an upper roller B which guides the dough triangle 1, and two roll-up belts C and D which perform the rolling operation with the aid of the roller A (FIG. 3). The problem encountered with this processing originates from the fact that the dough, upstream of the cutting station, is located on a continuous conveyor belt, thereby the top face, being exposed to air, is drier than the bottom face which bears onto the belt and is thus prevented from losing moisture. This position is also satisfactory on the roll-up machine, because the wetter face will adhere on the roller A which transfers it onto the roll-up belts C and D without problems, since a weak adhesion engagement is established between the dough and roller B. However, when the triangles 1 which have been upturned arrive, the higher adhesion due to higher moisture will occur on the roller B, so that the dough triangle 1 readily separates from the roller A and is not inserted in between the roll-up belts C and D and is instead ejected, as shown in dotted lines in FIG. 3. This situation produces considerable inconvenience, accompanied by a reduced output, and requires constant attention by an operator for recovering the high number of dough triangles which are not processed. SUMMARY OF THE INVENTION It is an object of this invention to remove the drawbacks exhibited by the machines currently in use. A consequent object of the invention is to provide a device which allows the dough triangles to be taken to the rolling machine all oriented and arranged in the same position. A further object is to provide a device which enables this orientation to be carried out without the dough triangles being overturned with respect to the position which they occupied on the conveyer belt prior to cutting. A not unimportant object is to provide a simple and automatic device. These and other objects, such as will be apparent hereinafter, are achieved by a device arranged in a crescent shaped dough rolls forming machine, wherein dough triangles are arrayed on cutting station leaving conveyor means in at least two rows of triangles with vertices pointing in opposite directions and are transported from said cutting station leaving conveyor means to a rolling station supplying conveyor, a device arranged between said cutting station leaving conveyor means and said rolling station supplying conveyor, characterized in that the device comprises at least two intermediate conveyor means operated with opposite conveying directions for receiving each one of said oppositely pointing triangle rows, each of said intermediate conveyor means having oppositely arranged exit ends where the dough triangles leave the conveyor means, means defining an arcuated conveyor path at each of said exit ends of the intermediate conveyor means, said arcuated conveyor paths converging towards said rolling station supplying conveyor to deliver thereon at least two juxtaposed rows of equaly pointing triangles rows. BRIEF DESCRIPTION OF THE DRAWINGS Further features and advantages of the invention wil be more apparent from the following detailed description of a preferred embodiment, given herein by way of example and not of limitation and illustrated in the accompanying drawings, where: FIG. 1 shows a series of dough triangles as they appear upon leaving the per se known cutting station; FIG. 2 is a diagram of how the reversal of the product takes place according to the prior art; FIG. 3 shows diagramatically a per se known triangle rolling machine; FIG. 4 is a perspective view of the inventive device; FIG. 5 is a plan view of the device according to the invention; and FIG. 6 is a detail view of the device. DESCRIPTION OF THE PREFERRED EMBODIMENT FIGS. 1, 2 and 3 shown some main component parts of a known machine, which may be of the type manufactured by the Italian Firm Tecknomatik S.n.c. of 35030 Selvazzano Dentro (Padova) Italy and illustrated in the catalogue of the firm. Since these component parts are well known at least from the above identified machine, the details thereof are not further described. With reference to the drawing figures, and as already explained in introducing the prior art, the dough is cut into triangles indicated at 1 and 2, being identifiable by the opposite orientation of the arrayed vertices caused to advance and spread apart on a belt 3. Said belt 3 alternately feeds two cross belts 4 and 5 which are driven in opposite directions and overlie a wide belt 6 moving toward the rolling machine, not shown. The triangles of the type 1 are dropped from the belt 4 onto the belt 6 through the stage 1' shown like stage 2' in an enlarged scale in a dislocated position for the sake of clarity which, as may be noted, involves turning of the product upside down, whereas the triangles of the type 2 are dropped onto the belt 6 according to the stage 2', i.e. without being turned upside down. The triangles 1 are turned upside down owing to the fact that the direction of motion of belt 4 is opposite to the one of belt 6, so that at the moment in which a triangle 1 falls edge on onto the belt 6 the inertial forces and the drag of belt 6 cause the turning upside down. Since in case of belt 5 the inertial forces and the drag of belt 6 act in the same direction, no overturning occurs. In the inventive device (FIGS. 4-6), a conveyor belt 101 causes the cut off triangles to advance, now indicated at 102 with vertex arrayed in one direction, and at 103 with vertex arrayed in the opposite direction. A device 104, of conventional design and already provided in ordinary machines e.g. the above identified one, transfers the rows of triangles 102 and 103 onto two parallel cross belts 105 and 106, respectively. The belt 105, driven in the direction of the arrow 107, only receives triangles of the 102 type, and moves them to an arched conveyor 108 which causes the triangles 102 to perform a planar rotational movement through an angle of about 120°. Arched conveyors are well known in the art so that the same are not described here more in detail, it being sufficient to mention that the belt member of the conveyor is made of usual flexible material having the shape of the periphery of a flattened truncated cone. A successive rectilinear belt 109 located downstream of the former, transports the dough triangles 102 to a first cone 110 or series of cones, which rotates the triangles so as to drop them onto a common conveyor belt 111 with the base 112 lying orthogonally to the mid-axis of the belt 111. That arrangement is made necessary in order to have the belt 111 bring the triangles to a rolling machine of the type shown schematically in FIG. 3, with one base parallel to the external surface of the cylinder indicated at A. In order to control or correct the position of the base 112 of the triangle such that it is exactly perpendicular to the mid-axis, and accordingly to the direction of advance of the belt 111, the cone 110 is supported at the vertex by means of a bearing support 113 independently from a second support 114, also of the bearing type, located at the center of the base 115 of the cone 110. It should be noted that the support 113 is part of a transmission gearing through which rotation is transmitted to the cone 110. Only a gear 213 and the casing 313 of the transmission gearing is diagrammatically shown. Gear 213 is in mash with a ring gear provided on the support shaft 113 of the cone. The transmission gearing 313 is supported in an adjustable manner, allowing angular and translatory adjustments by lever and screw mechanisms not shown, similar to those hereinafter described in connection with support 114. Support 114 is supported by a fixed upright 214 having an elongated hole (not shown) through which a threaded rod 314 is passed, fixed on the upright 214 by means of screw nuts 414. On the end of rod 314 opposite to the upright 214 an elbow shaped lever 514 is fixed on which the support proper 114 is supported. Upon unloosing the screws nuts 414, rod 314 may be shifted upwards within the vertically elongated hole provided in the upright 214 in which the screw nuts 414 and rod 314 are seated and the support 114 may be adjusted in height such that the axis of the cone 110 can be rotated about the support 113. This enables the triangle being transported on the belt 104 to be intercepted on a desired generatrix and moved through a more or less wide angle prior to discharging it onto the belt 111, so that the base of the triangle is arranged precisely along a perpendicular to the axis of the belt 111. By rotating the threaded rod 314 about its axis and maintaining the screw nuts 414 fixed, the rod 314 together with the support 114 may be horizontally shifted to adjust the spacing between the cone 110 and conveyor 109. The triangles of the type 103 are discharged on said belt 106, which moves in the direction of the arrow 116, oppositely to the belt 107. Said belt 106 takes the triangles 103 to a second angled conveyor 117, similar to conveyor 108, and hence to a rectilinear conveyor belt 118 which with the aid of an additional cone 119 transports the triangles to the belt 111, still with the base oriented and arranged along a perpendicular to the axis of the belt 111. As may be seen, the triangles of the types 102 and 103 which are laid on the belt 101 with reversed bases and vertices, are arranged equi-oriented and side-by-side on the belt 111, having being re-oriented by rotation on a plane and not by overturning. That being the manner in which the device operates, the dough triangles always maintain, through any transportation phase, one and the same face in contact with the conveyor belt, so that no situations can be originated of different or anomalous adhesion during the rolling up step, which brings about a reduced labor input for controlling the correct arrangement of the triangles fed into the rolling machine. In practice, the invention affords the possibility of letting the triangle roll-up machine to always work in the same position, thus avoiding any waste problems due to the triangles taking unwanted orientations in the rolling machine. The advantages of this device will be readily appreciated, as is apparent the technical problem which has been solved thereby. Of course, based on the same inventive concept which consists of rotating a certain element while keeping it coplanar throughout and without overturning it, through the use of flat conveyor belts, the invention may be embodied differently without departing from the scope thereof. The materials and dimensions may be any suitable ones to meet individual requirements.

The device forms an operative station located downstream of the machine which cuts out dough triangles for the production of crescent shaped rolls of dough. Through the use of parallel conveyors across the direction of advance of the cut dough, which are continued in tracks through a 180deg arc, it becomes possible to realign the dough cut into triangles with the same orientation without turning the triangles upside down.

FIELD OF INVENTION This invention relates to a vision prosthesis, and in particular, to actuators for assisting in vision accommodation. BACKGROUND In the course of daily life, one typically regards objects located at different distances from the eye. To selectively focus on such objects, the focal length of the eye's lens must change. In a healthy eye, this is achieved through the contraction of a ciliary muscle that is mechanically coupled to the lens. To the extent that the ciliary muscle contracts, it deforms the lens. This deformation changes the focal length of the lens. By selectively deforming the lens in this manner, it becomes possible to focus on objects that are at different distances from the eye. This process of selectively focusing on objects at different distances by deforming the lens is referred to as “accommodation.” As a person ages, the lens gradually loses its plasticity. As a result, it becomes increasingly difficult to deform the lens sufficiently to focus on objects at different distances of regard. To compensate for this loss of function, it is necessary to provide different optical corrections for focusing on objects at different distances. One approach to applying different optical corrections is to carry different pairs of glasses and to swap glasses as the need arises. For example, one might carry reading glasses for reading and a separate pair of distance glasses for driving. This is inconvenient both because of the need to carry more than one pair of glasses and because of the need to swap glasses frequently. Bifocal lenses assist accommodation by integrating two different optical corrections onto different portions of the same lens. The lower part of the bifocal lens is ground to provide a correction suitable for reading or other close-up work, while the remainder of the lens is ground to provide a correction for distance vision. To regard an object, a wearer of a bifocal lens need only maneuver the head so that rays extending between the object-of-regard and the pupil pass through that portion of the bifocal lens having an optical correction appropriate for the range to that object. The concept of a bifocal lens, in which different optical corrections are integrated into the same lens, has been generalized to include trifocal lenses, in which three different optical corrections are integrated into the same lens, and continuous gradient lenses in which a continuum of optical corrections are integrated into the same lens. However, just as in the case of bifocal lenses, optical correction for different ranges of distance using these multifocal lenses relies extensively on relative motion between the pupil and the lens. Once a lens is implanted in the eye, the lens and the pupil move together as a unit. Thus, no matter how the patient's head is tilted, rays extending between the object-of-regard and the pupil cannot be made to pass through a selected portion of the implanted lens. As a result, multifocal lenses are generally unsuitable for intraocular implantation. Once the lens is implanted into the eye, there can no longer be relative motion between the lens and the pupil. A lens suitable for intraocular implantation is therefore generally restricted to being a single focus lens. Such a lens can provide optical correction for only a single range of distances. A patient who has had such a lens implanted into the eye may therefore have to continue wearing glasses to provide optical corrections for those distances that are not accommodated by the intraocular lens. SUMMARY In one aspect, the invention includes a visual prosthesis having an artificial muscle configured to deform in response to a focusing signal. The artificial muscle is coupled to at least a portion of an optical system for changing a focal point thereof. An optional range finder can be included to provide a focusing signal to an object of regard. In some embodiments, the artificial muscle is coupled to a natural lens. However, the muscle can also be coupled to an artificial lens. The artificial muscle can be any of a variety of electrically responsive materials. For example, in some embodiments, the artificial muscle includes an electro-active polymer. The artificial muscle can alter the refractive properties of the lens in various ways. For example, in some embodiments, the artificial muscle is configured to cause translation of at least a portion of the optical system in response to the focusing signal. In other embodiments the artificial muscle is configured to deform at least a portion of the optical system in response to the focusing signal. Deformation of the lens can be achieved by directly or indirectly applying pressure on the lens. For example, in some embodiments, the artificial muscle includes an expandable ring disposed on a periphery of the lens. In others, a plate is coupled to the artificial muscle. The plate is configured to press against at least a portion of the optical system in response to the focusing signal. The plate can be flat plate or a plate having a peripheral portion that contacts a first portion of the optical system and a central portion that defines an expansion cavity between the plate and a second portion of the optical system. Other embodiments include those in which movement of fluid into or out of the lens causes a change in refractive properties of the lens. For example, the optical system can be a reservoir and a lens in fluid communication with the reservoir. In such embodiments, the artificial muscle can be configured to cause fluid to move between the reservoir and the lens. This can be achieved by positioning the artificial muscle so that it can squeeze the reservoir, thereby pumping fluid from the reservoir to the lens. Alternatively, the artificial muscle is disposed to exert pressure against the lens, thereby pumping fluid from the lens to the reservoir. The artificial muscle can also be integral with the reservoir. In such embodiments, when the artificial muscle contracts, the reservoir squeezes fluid into the lens, thereby changing its refractive properties. In other embodiments of the visual prosthesis, the optical system includes an artificial muscle that is integral with a lens surface of a lens in the optical system. In these embodiments, contraction of the artificial muscle causes a change in optical properties of the lens. An optional biasing element can be provided for urging the lens surface to deform in a preferred direction. Additional embodiments include those in which there is local control over the refractive properties of the lens. For example, in some embodiments, the pillars of artificial muscle extend across a lens in the optical system. Each of the pillars is individually addressable. When one of these pillars contracts, it causes deformation of a local portion of the lens. In other embodiments, the optical system includes a lens having lenslets. In this case, individually addressable artificial muscle elements are each configured to deform the surface of a corresponding lenslet. Embodiments of the visual prosthesis include those in which the lens is an intraocular lens, or a contact lens, or a lens from a pair of eyeglasses. These and other features and advantages of the invention will be apparent from the following detailed description and the accompanying figures, in which: BRIEF DESCRIPTION OF THE FIGURES FIGS. 1 and 2 show artificial muscles configured to deform a lens; FIGS. 3 and 4 show artificial muscles coupled to translate a plate toward a lens; FIGS. 5-7 , FIG. 13 , and FIG. 14 show artificial muscles configured to pump fluid between a reservoir and a lens; FIGS. 8-10 show artificial muscles configured to translate a lens; FIG. 11 shows an artificial muscle made with two different electro-active polymers; FIG. 12 shows a lens having an artificial muscle integral with a lens surface thereof; FIG. 15 shows a lens having internal artificial muscles configured to locally deform its surface; FIGS. 16-17 show exemplary layouts for the locations of artificial muscles in the lens shown in FIG. 15 ; FIGS. 18-19 are cross-section and planar views respectively of a lens having lenslets that can be selectively deformed by artificial muscles; FIG. 20 is a close-up view of a lenslet from FIG. 18 ; and FIG. 21 is a block diagram of a vision prosthesis. DETAILED DESCRIPTION FIG. 21 shows a block diagram of a vision prosthesis 100 having a lens 120 whose index of refraction can be made to vary in response to a focusing signal provided to the lens 120 by an actuator 140 . The lens 120 has refractive properties that vary in response to an applied electric field. The actuator 140 includes structures that change shape in response to applied electrical signals. These structures are in mechanical communication with the lens 120 . Throughout this specification, the terms “lens” and “intraocular lens” refer to the prosthetic lens that is part of the vision prosthesis 100 . The lens that is an anatomical structure within the eye is referred to as the “natural lens.” The nature of the focusing signal provided by the actuator 140 controls the extent to which the refractive properties of the lens are changed. The actuator 140 generates a focusing signal in response to instructions from a controller 160 in communication with the actuator 140 . The controller 160 is typically a microcontroller having instructions encoded therein. These instructions can be implemented as software or firmware. However, the instructions can also be encoded directly in hardware in, for example, an application-specific integrated circuit. The instructions provided to the microcontroller include instructions for receiving, from a range finder 180 , data indicative of the distance to an object-of-regard, and instructions for processing that data to obtain a focusing signal. The focusing signal alters the lens refractive properties to focus an image of the object-of-regard on the retina. The rangefinder 180 typically includes a transducer 190 for detecting a stimulus from which a range to an object can be inferred. The signal generated by the transducer 190 often requires amplification before it is of sufficient power to provide to the controller 160 . Additionally, the signal may require some preliminary signal conditioning. Accordingly, in addition to a transducer 190 , the rangefinder 180 includes an amplifier 210 to amplify the signal, an A/D converter 230 to sample the resultant amplified signal, and a digital signal processor 250 to receive the sampled signal. The output of the digital signal processor 250 is provided to the controller 160 . A power source 200 supplies power to the controller 160 , the range finder 180 , and the actuator 140 . A single power source 200 can provide power to all three components. However, the vision prosthesis 100 can also include a separate power source 200 for any combination of those components that require power. A vision prosthesis thus includes an optical element whose refractive properties can be selectively changed by an actuator in response to a focusing signal. The focusing signal is provided by a controller that determines, on the basis of various cues, how far away an object of regard is. Examples of visual prostheses are described in Azar, U.S. Pat. No. 6,638,304, the contents of which are herein incorporated by reference. One configuration for an actuator, shown in FIG. 1 includes first and second EAP (“electro-active polymer”) rings 10 , 12 resting on peripheral portions of opposed surfaces 16 , 18 of a lens 14 . The lens 14 can be an artificial lens, or the patient's natural crystalline lens. In response to a focusing signal provided by a controller 19 , the EAP rings 10 , 12 deform. This, in turn, causes the lens 14 to deform. As is well known, a muscle is an anatomical structure that contracts in response to an electrical signal, typically carried by a nerve. The EAP structures described herein can thus be viewed as “artificial muscles” that responds to electrical signals provided by a controller 19 . The controller 19 , in turn, decides what electrical signals to provide on the basis of a feed back signal. This feedback signal is derived from cues as to how far way an object-of-regard is. Artificial muscles can be used to change the shape of a lens in other ways. For example, the lens shown in FIG. 2 uses a single EAP ring 12 . In this case an inner rim of the EAP ring 12 rests on a haptic 20 of a lens 14 , and an outer rim of the EAP ring 12 rests on a stationary surface 22 . In response to a focusing signal provided by a controller 19 , the ring 12 expands. In so doing, the outer rim braces the ring 12 against the stationary surface 22 and the inner rim presses against the lens 14 , causing it to bulge outward. Another embodiment, shown in FIG. 3 , features a transparent flat plate 24 sandwiched between a lens 14 and an EAP ring 12 . In this embodiment, a focusing signal provided by a controller 19 causes the EAP ring 12 to expand, thereby causing the plate 24 to press against, and to thereby flatten, the lens 14 . Pressing a plate 24 against the lens 14 can also cause the lens 14 to bulge outwards. For example, the embodiment shown in FIG. 4 features a plate 24 having a peripheral portion 26 that contacts a peripheral portion of a lens 14 , and a central portion 28 that bulges outward, away from the lens 14 . The lens 14 and the central portion of the plate 24 together define an expansion cavity 30 . The peripheral portion 26 of the plate 24 is attached to an inner rim of an EAP ring 12 . The outer rim of the EAP ring 12 is attached to a stationary surface 22 . In response to a focusing signal provided by a controller 19 , the EAP ring 12 expands, thereby forcing the plate 24 toward the lens 14 . In this case, the lens 14 bulges outward into the expansion cavity 30 . Additional embodiments feature a reservoir in fluid communication with a lens. In these embodiments, movement of a clear fluid from the reservoir and into the lens causes the lens to bulge outward. Conversely, movement of the fluid from the lens into the reservoir tends to flatten the lens. Various configurations of artificial muscles are available for driving motion of fluid between the reservoir and the lens. For example, in FIG. 5 , an EAP ring 12 surrounds a reservoir 32 in fluid communication with a lens 14 through a neck 34 . In response to a focusing signal provided by a controller 19 , the EAP ring 12 expands, thereby squeezing the reservoir 32 . This pumps fluid from the reservoir 32 and into the lens 14 . When the focusing signal is removed, the reservoir 32 expands, drawing fluid out of the lens 14 and back into itself. In another embodiment, shown in FIG. 6 , a transparent jacket 36 surrounds the lens 14 , but not the reservoir 32 . A pair of EAP rings 10 , 12 is disposed on opposed outer surfaces of the jacket 36 . In this embodiment, a focusing signal provided by a controller 19 causes the EAP rings 10 , 12 to expand. This exerts a pressure against the jacket 36 . The jacket 36 transmits the pressure to the lens 14 , thereby pumping fluid from the lens 14 , through a neck 34 , and into the reservoir 32 . FIG. 7 shows an embodiment in which the reservoir 32 itself is made of an EAP 12 . When a voltage is applied across flexible electrodes 38 , 40 on opposite sides of the EAP reservoir 32 , the reservoir 32 changes its shape so as to squeeze fluid within the reservoir 32 through a neck 34 and into a lens 14 . Removing the voltage causes the reservoir 32 to relax and expand, thereby drawing fluid out of the lens 14 and into the reservoir 32 . In this embodiment, the reservoir 32 functions essentially as a single-chamber artificial heart. In the embodiments discussed thus far, artificial muscles are used to cause a shape change in a lens. However, there also exist embodiments in which an artificial muscle causes translation, rather then deformation, of a lens. For example, in FIG. 8 , first and second EAP rings 10 , 12 have inner rims 42 attached to a periphery of a lens 14 and outer rims 44 anchored to a stationary surface 22 . The outer rims 44 of the EAP rings 10 , 12 are longitudinally displaced from the inner ring 42 thereof. As a result, when voltages are selectively applied to the EAP rings 10 , 12 , the lens 14 translates longitudinally. For example, a voltage that causes contraction of the first ring 10 and relaxation of the second ring 12 will translate the lens 14 forward, while the converse will translate the lens 14 backward. A disadvantage of the arrangement shown in FIG. 8 is that a great deal of translation is often necessary to effect a significant change in the patient's vision. This disadvantage is addressed by the embodiment of FIG. 9 , in which a translating lens 14 like that shown in FIG. 8 is mounted within a frame 46 that includes one or more stationary optical elements 48 . A variety of ways are available for configuring artificial muscles to move a lens 14 in addition to those already shown in FIGS. 8 and 9 . For example, in FIG. 10 , the haptic 50 of the lens 14 includes a genue 52 that buckles in a preferred direction. An outer rim of the haptic 50 is coupled to an inner rim of an EAP ring 10 , the outer rim of which is fixed to a stationary surface 22 . In this embodiment, expansion of the EAP ring 10 causes the genue 52 to buckle, thereby shifting the lens 14 in the axial direction. Another configuration for an EAP ring 10 , shown in FIG. 11 , makes use of the same principle as a bimetallic strip in a thermostat. In this configuration, the EAP ring 10 has two different layers 54 , 56 , each made of a different type EAP. In response to a voltage, both EAP layers 54 , 56 will expand by different amounts, thereby causing the EAP ring 10 to bend in a preferred direction. In another embodiment, shown in FIG. 12 , the lens 14 can be made of an optically transmissive EAP 10 . In this case, the front and rear surfaces of the lens 14 can be coated with flexible, optically transmissive electrodes 58 , 60 . In response to a voltage applied between the electrodes 58 , 60 , the lens 14 changes shape. A variation of the embodiment shown in FIG. 7 is one in which it is the lens 14 rather than the reservoir 32 that is made an EAP. Referring to FIG. 13 , a reservoir 32 is again placed in fluid communication with a lens 14 though a neck 34 . At least one surface 10 of the lens 14 is made of an EAP that expands in response to voltage applied between a pair of electrodes 58 , 60 . Another embodiment, shown in FIG. 14 , includes the structures shown in the embodiment of FIG. 13 but with the addition of a biasing structure 62 to urge deformation of the EAP surfaces in a preferred direction. The biasing structure 62 can include springs, as shown, or foam blocks that extend from a midline of the lens 14 toward the EAP lens surface 10 . In the embodiments presented thus far, artificial muscles alter the shape of the entire lens. However, in other embodiments, artificial muscles can be used to locally alter the shapes of selected portions of a lens 14 and to do so in different ways. For example, in FIG. 16 individually addressable pillars 10 made of an EAP are distributed throughout a lens 14 in a grid. The grid can be a rectangular grid (as shown in FIG. 16 ) or a grid of concentric circles (as shown in FIG. 17 ). Each pillar 10 extends across the lens 14 , with the ends of the pillars 10 being attached to opposed surfaces 64 , 66 thereof. In response to a focusing signal, a particular pillar 10 will change its length. This, in turn, will change the thickness of the lens 14 in a region local to that pillar 10 . Since the pillars 10 are individually addressable, the controller 19 can vary the shape of the lens 14 in an essentially arbitrary way. Another way to provide localized control over the shape of a lens 14 is to make the lens 14 from a honeycomb of lenslets 68 as shown in FIGS. 18 and 19 . Each lenslet 68 has a flexible surface 78 that is coupled to a rigid surface 22 by an individually addressable EAP ring 10 . In response to an applied voltage, the EAP material in the ring 10 expands, thereby reducing the ring's inner diameter. This causes the upper surface 78 to flatten, which in turn locally changes the curvature of the lens 14 . A variety of EAP materials can be used in the embodiments described herein. One class of materials includes piezoelectric materials. These materials offer the advantage of high actuation pressures (ranging from 7 to 70 kilopascals meter 3 /kg). However, piezoelectric materials undergo only a limited strain of, which in many cases is less than 1%. Another class of EAPs includes ionic EAPs, such as polymer gels, ionomeric polymer-metal composites, conductive polymers, and carbon nanotubes. These materials undergo strain even at low voltages (less than or equal to approximately 9 volts). A disadvantage of ionic EAPs is that they are best kept wet, and hence sealed within a flexible coating. Another class of EAPs for use in a vision prosthesis includes electronic EAPs, such as ferroelectric polymers, electrets, dielectric elastomers, and electrostictive graft elastomers. These materials require high voltages for actuation. However they can deliver considerable force in a short time. Unlike the ionic EAPs, these materials can function without a protective coating and require only a minimal current to maintain their position. Vision prosthesis that include EAP actuators can be used in a variety of applications. These include intraocular lenses, contact lenses, and spectacle lenses. These applications are fully described in U.S. Pat. No. 6,638,304.

A visual prosthesis includes an artificial muscle configured to deform in response to a focusing signal. The artificial muscle is coupled to at least a portion of an optical system for changing a focal point thereof.

BACKGROUND OF THE INVENTION Field of the Invention The invention relates in general to a game apparatus for use by two or more individuals who alternate in active participation. in particular, the invention relates to a game for use by at least two players where dice are thrown to fill certain spaces upon a play board. In known prior art games where a pair of dice are utilized by the participants in an alternate play mode and, where markers and numbers are placed upon a play board in certain spaces comprising rows, columns, and diagonals of a checkerboard-like game board, no showing has been found that demonstrates a relationship between the board numbers with the numbers on the side faces of the dice. Furthermore, there are no known games in the marketplace or prior art where a winner's score is determined by a summation of the above mentioned board numbers with the first player to fill rows, columns, or diagonals with markers after a series of thrown dice has been executed. SUMMARY OF THE INVENTION The invention relates to a game apparatus for recreational activity that utilizes an appropriately divided checkerboard-like game board in conjunction with a pair of dice and markers. The purpose of the apparatus is for any one of a plurality of players to Complete a game by filling a predetermined number of row, column, and diagonal spaces with markers as the dice are alternately thrown by any of the participants. The up faces of the thrown dice locate the markers on the row, column, and diagonal spaces on the play board and the summation of the numbers in the locations comprising the completed spaces determine the total score achieved. Several games may be played to produce a predetermined grand score total. The basic structure of the game design permits numerous optional variations such that interest may be maintained after playing several rounds of the same game. One variation of the game apparatus of this invention requires that the rows and columns comprising the outside perimeter of the play board be completed with markers for a participant to win the game. In another variation, the game may be played such that only diagonals may be completed with markers. In these game variations, the score is determined upon a game completion by summing the preassigned numbers assigned to each space upon which a marker is located. It is therefore an object of the invention to provide a new and improved game apparatus for two or more persons. It is a further object of the invention to furnish a game apparatus which is adapted to be played in different formats using dice, markers, divided checkerboard-like play card where values are assigned that relate to the dice faces. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a plan view of the play board of the invention which is divided into row, column, and diagonal locations and a front elevational view of a pair of dice and markers as used with the play of the game to complete the various locations. FIG. 2 is another plan view of the game board of the invention wherein a variation of the game of FIG. 1 is depicted. FIG. 3 is another plan of the game board of the invention wherein still another variation of the game of FIG. 1 is illustrated. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to the drawings and in particular to FIG. 1 there is depicted a play card or board 10 which is divided into rows 22 to 27 and columns 15 to 20; and, each area of the rows and columns is designated, for example, as space 50. The divided game board 10 includes six basic rows and columns which are identified by an appropriate single digit in row 30 and column 40. The row and column identifiers aid the player in locating particular spaces on the board 10 as will become apparent upon further discussion hereinbelow. The game apparatus of the invention further includes a pair of dice 12 and a plurality of markers 14. The dice are thrown alternately by each player and markers 14 are positioned on the appropriate spaces 50 of the play board 10. It is noted that each space 50 of the play board 10 includes a numeric in the form of an indicia that is consecutively located across row 22, for example. The numbered indicia in the upper left space corresponding to the intersection of row 1, column 1 is thirty. This number is derived by adding all of the digits of the pair of dice when the up faces are both one which correspond to row 1, column 1. The sum of the dice faces under this circumstance is the number thirty as indicated. As may be readily seen, each adjacent consecutive space beginning with space 50 increases by one numerical count until the indicia thirty-five is reached. The number thirty-two by way of further example is derived by positioning the up faces of a pair of dice 12 with the one and three digits facing upwardly and then adding all of the digits upon the remaining visible faces. The number thirty-two is therefore located in column three, row one. In column 21 and row 28, there are located a plurality of numbers that represent the summation of a particular row and column. The column 21 and opposite row 22, for example, the indicia 195 is indicated which represents the summation of all of the numbers in the above-mentioned row. Similarly, in row 28, the number indicia 207 is located under column three. As above stated, this indicia represents the summation of all of the numbers in column three. It should also be noted that at the top of and bottom of column 21 the number 210 with a slanted arrow is depicted. The indicia 210 represents the numerical summation of either diagonal each of which includes six spaces 50. The instant game may be played by a plurality of players where the minimum number is two. Each player is required to use at least one play card 10 for which a plurality of markers 14 is furnished; in addition, a one pair of dice 12 is supplied which may be utilized by all of the players. The strategy of the game employing the game apparatus 10, 12, 14 requires that any player complete any row, column, or diagonal with the placement of markers that totals three; or in other words, any three completed columns or rows would satisfy this requirement as well as any combination of three where columns, rows, and diagonals are mixed. As an example, the first player to satisfy the completion of two diagonals and one row or, one diagonal, one row and one column would be declared a winner. The score that the winner achieved would be the summation of the total scores for the particular rows, columns, or diagonals that were filled with markers. The game disclosed herein may be structured so that the winner would be determined by achieving a grand total score of, for example, one-thousand. In that event, a series of plays would be required where the winning score of each game would be cumulative. In this arrangement, the loser would be allowed to accumulate a score for any completed columns, rows, or diagonals. The markers 14 are positioned by the particular players on the various spaces 50 by the numbers produced by a throw of the dice 12. As an illustration, if a one and three were thrown by a particular player in the manner shown in FIG. 1, markers 13, 14 would be respectively positioned at the intersections of column one and row three as well as column three and row one. However, if identical numbers such as one, one and three, three were thrown by a player, only one space 50, namely, the intersection of row one and column one and the intersection of row three, column three would receive respective markers (dotted) 31, 39. In the event that doubles are thrown by the player, another turn is allowed. Another embodiment of the invention is illustrated in FIG. 2 where the perimeter columns and rows only are completed with the various markers 12. In all other respects, the game 10 is played in the same manner as above described except that the score total achieved by a player only relate to the outside columns and rows. In this form of the game play, the loser may receive the score total of the rows and columns that have been completed. Another embodiment of the invention is illustrated in FIG. 3 where the game is played in a form called doubles and sevens. By doubles is meant both up faces on the thrown dice 12 must have the same digit such, for example, as one, one or four, four. The diagonal beginning with the intersection one, one and ending with six, six can only be formed with markers 14 by throwing doubles. The diagonal beginning with the intersection one, six and ending with six, one can only be developed by throwing sevens. Sevens are defined as any throw of the dice where the up faces represent the following combinations: four, three; five, two; six, one. This invention has been described by reference to precise embodiments, but it will be appreciated by those skilled in the art that this invention is subject to various modifications and to the extent that those modifications would be obvious to one of ordinary skill they are considered as being within the scope of the appended claims.

A game apparatus for alternative participation by a plurality of players using a pair of dice, markers, and a game card formed into intersecting columns, rows, and diagonal locations. A game object requires that any row, column, or diagonal locations be appropriately designated with markers upon a series of throws of the dice; and, a winner is determined by the first player to complete a required number of such locations each one of which has an assigned value for calculating a score.

FIELD OF THE INVENTION [0001] This invention relates to a method for treating and preventing neurological disorders related to rapid-eye-movement (REM) sleep disturbances in a mammal comprising administering to the mammal an amount of an NPY Y5 receptor antagonist which effectively reduces REM sleep. As used herein, the term REM sleep is defined as the period of sleep during which rapid eye movements are seen and the brain waves are fast and of low voltage as seen in the electroencephalogram (EEG) recording. BACKGROUND OF THE INVENTION [0002] During sleep, a mammal experiences two types—REM and NREM (non-REM) sleep—defined by their morphology in the EEG. During REM sleep the brain waves are fast and of low voltage; this period of sleep is associated with rapid eye movements—hence the name—and with dreaming, involuntary muscle movements and irregular autonomic responses such as heart rate and respiration. These latter activities account for other commonly used nomenclature, for example, paradoxical or desynchronized sleep. REM sleep occurs 3-4 times during each night at 80 to 120 minute intervals with each occurrence lasting from 5 minutes to an hour. NREM sleep is also called slow wave and synchronized sleep and is characterized by slow brain waves of high voltage consisting of four stages of succeeding depth and is a period of sleep without dreaming. During NREM sleep, the autonomic activities such as heart rate and blood pressure are low and regular. In humans, about 20% of sleep is REM sleep and 80% is NREM sleep. Both REM sleep and NREM sleep are necessary for homeostasis and survival of all mammals. [0003] Abnormalities in sleep architecture, sleep maintenance, impaired sleep continuity, sleep fragmentation, and brain wave distribution have been described in many psychiatric sleep disorders and psychiatric diseases such as depression, including major depression, unipolar depression, bipolar disorder, seasonal affective disorders, winter depression and dysthymia; premenstrual dysphoric disorder, obsessive compulsive disease, generalized anxiety, mania, panic, post-traumatic stress disorder, obesity and eating disorders including anorexia and bulimia; phobias, borderline personality, schizophrenia, dementia and cognitive dysfunction including Alzheimer type and Parkinson's disease and Parkinson's disease associated with depression, processing of emotional memory, fibromyalgia, rheumatoid arthritis and osteoarthritis, REM sleep behavior disorders, insomnia, hypersomnia, parasomnia, narcolepsy, sleep-related breathing disorders, sleep apnea, sleep walking, nocturnal enuresis, restless-leg syndrome, periodic limb movement in sleep and seizure disorders, including nocturnal seizures. Circadian rhythms related disorders are also associated with sleep disturbances including jet travel Get lag), especially between time zones, artificial light, delayed and advanced sleep phase syndrome, non-24-hour sleep-wake disorder and shift work hours may be poorly synchronized with internal circadian clocks. As a consequence of modern life schedules, performance degradation may manifest in loss of manual dexterity, reflexes, memory, winter depression, and general fatigue derived from lack of enough sleep. [0004] Observations of major depressed patients, war related anxieties, post traumatic disorders, state of bereavement, suicidal patients with depression, schizo-affective disorder and schizophrenia, have indicated increased frequency and duration of disturbances due to REM sleep and a general reduction in slow wave states. Major depression is associated with REM sleep disturbances, in particular, disinhibition of REM sleep including shortenings of REM latency (defined as the time between sleep onset and occurrence of the first REM period) and increases in REM density and about 90% of patients with major depression have some form of sleep abnormality read in EEG. Accordingly, the majority of antidepressant drugs have been found to reduce REM sleep at therapeutic doses (Winokur) and many clinicians regard the beneficial effect of a selected antidepressant on suppressing REM sleep when making therapeutic options for treating depression in patients. The effect of antidepressant drugs on REM sleep suppression has been shown for representative agents of antidepressant mechanistic classes including tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOs), and selective serotonin re-uptake inhibitors (SSRI). TCAs and SSRIs have been shown to produce immediate (40-85%) and sustained (30-50%) suppression in REM sleep while the MAOs totally suppress REM sleep. Additionally, total or partial sleep deprivation or phase advance of the sleep cycle are effective treatments in patients with unipolar depression and other forms of depression including premenstrual dysphoric disorder. Therefore there is a strong correlation between sleep and manipulations sleep cycles and depression disorders. There is a clear need to continue the search for new and effective drugs for the treatment and prevention of REM sleep disorders. [0005] Neuropeptide Y (NPY), a 36 amino acid peptide neurotransmitter, is a member of the pancreatic class of neurotransmitters/neurohormones which has been shown to be present in the central and peripheral nervous system and mediate numerous biological responses, including food intake, pain, homeostasis, seizure, anxiety, alcohol intake, endocrine responses, sleep, sedation, via NPY specific receptors (e.g. Y1, Y2, Y5 receptors). In laboratory animals, NPY has been shown to have sleep-promoting activity, shortening sleep latency, stimulate NREM sleep and modulates secretion of endocrine hormones associated with increased REM sleep. In normal humans, intravenous administration of NPY enhanced sleep period time and stage 2 sleep, reduced sleep latency and time awake and modulated REM sleep (Antonijevic et al. 2000). Therefore, agents capable of blocking NPY receptor binding and inhibiting the activity of NPY are expected to modulate sleep, including REM and NREM sleep in mammals having neurological and sleep disorders. [0006] WO 03/051356 discloses the use of certain NPY Y5 antagonists for enhancing and improving the quality of sleep through increases in the duration or amount of REM sleep. The foregoing patents and patent applications are incorporated by reference herein in their entirety. SUMMARY OF THE INVENTION [0007] The present invention provides a method of reducing REM sleep in a mammal comprising administering to a mammal an amount of an NPY Y5 antagonist, which is effective in reducing REM sleep. [0008] In a preferred embodiment, the NPY Y5 antagonist is a compound of the formula or a pharmaceutically acceptable salt, solvate or prodrug thereof or of any of the foregoing, wherein X is selected from the group consisting of chlorine, bromine, iodine, trifluoromethyl, hydrogen, cyano, C 1 to C 6 alkyl, C 1 to C 6 alkoxy, C 5 or C 6 cycloalkyl, ester, amido, aryl, and heteroaryl. [0010] Most preferably, the NPY Y5 antagonist of the formula I is a compound of formula or a pharmaceutically acceptable salt, solvate or prodrug thereof or of any of the foregoing, [0011] In another preferred embodiment, the NPY Y5 antagonist is a compound of the formula or a pharmaceutically acceptable salt, solvate or prodrug thereof or any of the foregoing; wherein A is oxygen or hydrogen; W, X, Y and Z are independently N or CR 1 wherein R 1 is independently selected at each occurrence from hydrogen, halogen, hydroxy, nitro, cyano, amino, (C 1 -C 6 )alkyl, (C 1 -C 6 )alkoxy, (C 1 -C 6 )alkoxy substituted with amino, mono-or di-(C 1 -C 6 )alkylamino or (C 1 -C 6 )alkoxy, (C 3 -C 7 )cycloalkyl, (C 3 -C 7 )cycloalkyl(C 1 -C 4 )alkyl, (C 2 -C 6 )alkenyl, (C 3 -C 7 )cycloalkenyl, (C 2 -C 6 )alkynyl, (C 3 -C 7 )cycloalkynyl, halo(C 1 -C 6 )alkyl, halo(C 1 -C 6 )alkyl, halo(C 1 -C 6 )alkoxy, mono and di(C 1 -C 6 )alkylamino, amino(C 1 -C 6 )alkyl, and mono-and di(C 1 -C 6 )alkylamino(C 1 -C6)alkyl. or a pharmaceutically acceptable salt, solvate or prodrug thereof or of any of the foregoing. Most preferably the compound of formula II is a compound of the formula [0014] This invention provides a method of treating and preventing neurological disorders characterized by excessive rapid-eye movement (REM) sleep in mammals including humans by administering to the mammal an amount of an NPY Y5 receptor antagonist which is effective in reducing REM sleep. [0015] Neurological disorders characterized by abnormalities and/or excessive rapid-eye movement (REM) sleep which are contemplated for treatment by the present invention include many psychiatric disorders and psychiatric diseases such as depression, including major depression, unipolar depression, bipolar disorder, seasonal affective depressive disorders, winter depression, dysthymia; premenstrual dysphoric disorder, suicidal patients with depression; obsessive compulsive disease, generalized anxiety, panic, post-traumatic stress disorder, obesity and eating disorders including anorexia and bulimia, phobias, borderline personality, schizo-affective disorder and schizophrenia, dementia and cognitive dysfunction including Alzheimer type and Parkinson's disease and Parkinson's disease associated with depression, processing of emotional memory, fibromyalgia, rheumatoid arthritis and osteoarthritis, narcolepsy, sleep-related breathing disorders, nocturnal enuresis, restless-leg syndrome, seizures and circadian rhythms related disorders including jet travel Get lag), especially between time zones. Decreases in REM latency and increases in REM density have been reported in major depression and post traumatic stress disorders, including anxieties related to war. In a preferred embodiment the disorder is a depression disorder selected from the group consisting of major depression, unipolar depression, bipolar disorder, seasonal affective depressive disorder, winter depression, dysthymia, suicidal patients with depression, Alzheimer and Parkinson's disease associated with depression. [0016] In one embodiment of the present invention, the NPY Y5 antagonist is administered to the mammal prior to experiencing the neurological disorder. [0017] In another embodiment, the NPY Y5 antagonist is administered to a mammal predisposed to or at risk of experiencing the neurological disorders. [0018] This invention also provides a method for treating neurological disorders characterized by excessive REM sleep in a mammal by administering to a mammal an amount of an NPY Y5 antagonist effective in reducing REM sleep wherein the antagonist is a compound of formula or a pharmaceutically acceptable salt, solvate or prodrug thereof or of any of the foregoing, wherein X is selected from the group consisting of chlorine, bromine, iodine, trifluoromethyl, hydrogen, cyano, C 1 to C 6 alkyl, C 1 to C 6 alkoxy, C 5 or C 6 cycloalkyl, ester, amido, aryl, and heteroaryl. [0020] In a preferred embodiment, the NPY Y5 antagonist is a compound of formula or a pharmaceutically acceptable salt, solvate or prodrug thereof or of any of the foregoing, [0021] This invention further provides a method for treating neurological disorders characterized by excessive REM sleep in a mammal by administering to a mammal an amount of an NPY Y5 antagonist wherein the antagonist is a compound of formula or a pharmaceutically acceptable salt, solvate or prodrug thereof or any of the foregoing; wherein A is oxygen or H 2 . W, X, Y and Z are independently N or CR 1 wherein R 1 is independently selected at each occurrence from hydrogen, halogen, hydroxy, nitro, cyano, amino, (C 1 -C 6 )alkyl, (C 1 -C 6 )alkoxy, (C 1 -C 6 )alkoxy substituted with amino, mono-or di-(C 1 -C 6 )alkylamino or (C 1 -C 6 )alkoxy, (C 3 -C 7 )cycloalkyl, (C 3 -C 7 )cyCloalkyl(C 1 -C 4 )alkyl, (C 2 -C 6 )alkenyl, (C 3 -C 7 )cycloalkenyl, (C 2 -C 6 )alkynyl, (C 3 -C 7 )cycloalkynyl, halo(C 1 -C 6 )alkyl, halo(C 1 -C 6 )alkyl, halo(C 1 -C 6 )alkoxy, mono and di(C 1 -C 6 )alkylamino, amino(C 1 -C 6 )alkyl, and mono- and di(C 1 -C 6 )alkylamino(C 1 -C 6 )alkyl. [0023] In a preferred embodiment, the NPY Y5 antagonist is a compound of the formula or a pharmaceutically acceptable salt, solvate or prodrug thereof or of any of the foregoing. [0024] For compounds having asymmetric centers, all optical isomers, racemates and mixtures thereof are encompassed in the present invention. [0025] Where a compound exists in various tautomeric forms, the invention is not limited to any one of the specific tautomers. [0026] The present invention further provides a pharmaceutical composition comprising a compound or modulator as described above in combination with a physiologically acceptable carrier or excipient. [0027] In one embodiment of the above-cited method, the NPY Y5 antagonist is administered to the mammal prior to experiencing REM sleep disorder. [0028] In another embodiment of the above-cited method, the NPY Y5 antagonist is administered to a mammal predisposed to or at risk of experiencing REM sleep disorders. [0029] The present invention provides a method of modulating REM sleep which comprises decreasing the rate of eye movement, reducing the density and latency of REM sleep, disrupting REM sleep and increasing non-REM sleep and total sleep consolidation. [0030] In another embodiment the present invention provides a method of reducing REM sleep in a dose-related manner in a mammal which comprises administering to the mammal an amount of an NPY Y5 antagonist of formula I or 11 which is effective in reducing REM sleep. [0031] “Latency of REM” as used herein refers to time from first occurrence of stage 2 sleep to first occurrence of REM sleep. [0032] The term “density of REM” as used herein refers to number of REM movements per time and the amount of time spent in REM sleep. [0033] The term “sleep latency” as used herein refers to time from lights out or ‘falling asleep’ to first occurrence of stage 2 sleep. [0034] The term “disruption of REM sleep” as used refers to any situation that adversely interferences with a normal REM latency and density. [0035] The term “consolidation of sleep” as used herein refers to bouts of sleep throughout the 24-hour day: roughly every 20 minutes, a laboratory animal completes a sleep/wake cycle while a human consolidate sleep into a single period per day, normally interrupted by only very short bouts of wakefulness. DETAILED DESCRIPTION OF THE INVENTION [0036] The compounds of Formula I and Formula II can be prepared by the synthetic methods described and referred to in WO 02/48152 which is hereby incorporated by reference-herein in its entirety. [0037] Representative compounds of Formula I include, but are not limited to: 1′-(4-t-butyl-pyridylcarbamoyl)-spiroisobenzofuran-1,4′-piperidine-3-one; 1′-(4-isopropyl-pyridylcarbamoyl)-spiroisobenzofuran-1,4′-piperidine-3-one; 1′-(4-trifluoromethyl-pyridylcarbamoyl)-spiroisobenzofuran-1,4′-piperdine-3-one; [0041] Representative compounds of Formula II include but are not limited to 1′-(1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-cyano-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-acetyl-1H-benzimidazol-2-yl )-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-carboxy-1H-benzimidazol-2-yl )-spiro[isobenzofuran-1,4′-piperidin]-3-one methyl ester; 1′-(5′-pyridin-3-yl-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-methyl-1H-benzimidazol-2-yl )-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-methoxy-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-chloro-1H-benzimidazol-2-yl )-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-fluoro-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; and 1′-(5-trifluoromethyl-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; [0052] Representative compounds of Formula II include, but are not limited to, (1) ′-(6-trifluoromethyl-3-H-imidazo[4,5-b]pyridine-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(7-chloro-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-n-propylsulfonyl-1H-benzimidazol-2-yl)-spiro[isobenzofuram-1,4′-piperidin]-3-one; 1′-(5 cyano-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-acetyl-1-H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-carboxy-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one, methyl ester; 1′-(5′pyrazin-2-yl-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; ′-(5′pyridin-3-yl-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-trifluorometoxy-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-methyl-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-benzoyl-1H-benzimidazol-2-yl)spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-methoxy-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-chloro-1H-benzimidazol-2-yl )-spiro[isobenzofuran-1,4′-piperidin]-3-one; 6-bromo-7-chloro-2-(spiro[isobenzofuran-1,4′-piperidin]-3-one-3H-imidazo[4,5-b]pyridine; 1′-(5-fluoro-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-methyl-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-methylsulfonyl-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-oxazol-2-yl-1H-benzimidazol-2-yl )-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5,6-difluoro-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5phenyl-1H-imidazo[4,5-b]pyrazin-2-yl )-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-trifluoromethyl-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5,7-dichloro-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5,6-dimethoxy-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-trifluoromethylsulfonyl-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-(3,5-dimelthyl-isoxazol-4-yl )-1H-benzimidazol-2-yl)-spiro[isobenzofuran-1,4′-piperidin]-3-one; 1′-(5-ethoxy-1H-benzimidazol-2-yl )-spiro[isobenzofuran-1,4′-piporidin]-3-one; and 5-chloro-2-(spiro[isobenzofuran-1,4′-piperidin]-3-one-3H-imidazo[4,5-b]pyridine. [0081] The compounds of Formula I and II which are basic in nature are capable of forming a wide variety of different salts with various inorganic and organic acids. Although such salts must be pharmaceutically acceptable for administration to animals, it is often desirable in practice to initially isolate a compound of the Formula I and 11 from the reaction mixture as a pharmaceutically unacceptable salt and then simply convert the later back to the free base compound by treatment with an alkaline reagent, and subsequently convert the free base to a pharmaceutically acceptable acid addition salt. The acid addition salts of the base compounds of this invention are readily prepared by treating the base compound with a substantially equivalent amount of the chosen mineral or organic acid in an aqueous solvent medium or in a suitable organic solvent such as methanol or ethanol. Upon careful evaporation of the solvent, the desired solid salt is obtained. [0082] The acids which are used to prepare the pharmaceutically acceptable acid addition salts of the base compounds of this invention are those which form non-toxic acid addition salts, e.g. salts containing pharmacologically acceptable anions, such as hydrochloride, hydrobromide, hydroiodide, nitrate, sulfate or bisulfate, phosphate or acid phosphate, acetate, lactate, citrate or acid citrate, tartrate or bitartrate, succinate, maleate, fumarate, gluconate, saccharate, benzoate, methanesulfonate and pamoate, i.e., 1,1′-methylene-bis-(2-hydroxy-3-naphthoate), salts. [0083] The compounds of Formula I and 11 may advantageously be used in conjunction with one or more other therapeutic agents, for instance, different antidepressant agents such as tricyclic antidepressants (e.g. amitriptyline, dothiepin, doxepin, trimipramine, butripyline, clomipramine, desipramine, imipramine, iprindole, lofepramine, nortriptyline or protriptyline), monoamine oxidase inhibitors (e.g. isocarboxazid, phenelzine or tranylcyclopramine) or 5-HT re-uptake inhibitors (e.g. fluvoxamine, sertraline, fluoxetine or paroxetine), and/or with antiparkinsonian agents such as dopaminergic antiparkinsonian agents (e.g. levodopa, preferably in combination with a peripheral decarboxylase inhibitor e.g., benserazide or carbidopa, or with a dopamine agonist e.g., bromocriptine, lysuride or pergolide). It may also be used with acetocholinesterases such as donepezil. It is to be understood that the present invention covers the use of a compound of Formula I and 11 or a physiologically acceptable salt or solvate thereof in combination with one or more other therapeutic agents. [0084] Biological activity of the NPY Y5 antagonist compounds of the present invention was determined in vivo sleep studies in laboratory experiments described herein below. Results presented herein showed that the NPY Y5 receptor antagonists of formula la and IIa affected sleep (REM and NREM) in a laboratory animal while the NPY Y1 antagonist had only slight effects on sleep variables. [0085] The compounds of the invention are generally administered as pharmaceutical compositions in which the active principle is mixed with a pharmaceutical excipient or carrier. The active compound or principle may be formulated for oral, buccal, intramuscular, parenteral (e.g. intravenous, intramuscular or subcutaneous) or rectal administration or in a form suitable for administration by inhalation or insufflation. [0086] Suitable forms of oral administration include tablets, capsules, powders, granules and oral solutions or suspensions, sublingual and buccal forms of administration. [0087] When a solid composition is prepared in tablet form, the main excipient is mixed with a pharmaceutical excipient such as gelatin, starch, lactose, magnesium stearate, talc or gem arabic. Tablets may be coated with a suitable substance like sugar so that a given quantity of the active compound is released over a prolonged period of time. [0088] Liquid preparations for oral administration may be in the form of a solution, syrup, or suspension. Such liquids may be prepared by conventional methods using pharmaceutically acceptable ingredients such as suspending agents (e.g. sorbitol syrup); emulsifying agents (e.g. lecithin); non-aqueous vehicles (e.g. ethyl alcohol); and preservatives (e.g. sorbic acid). [0089] Formulations for parenteral administration by injection or a infusion may be presented in unit dosage form e.g. in ampules in the form of solutions or emulsions in oily or aqueous vehicles. [0090] The compositions may also be formulated in rectal formulations such as suppositories or retention enemas. [0091] For intranasal or inhalation administration, the compounds are delivered in the form of a solution or suspension from a pump spray or a container pressurized with suitable propellant. [0092] In connection with the use of compounds of Formulas I or II it is to be noted that these compounds may be administered either alone or in combination with a pharmaceutically acceptable carrier. Such administration may be carried out in single or multiple doses. More particularly the composition may be combined with various pharmaceutically acceptable inert carriers in the form of tablets, capsules, lozenges, hard candies, powders, syrup, aqueous suspension, injectable solutions, elixirs, syrups, and the like. [0093] A proposed dose of the active compounds of the invention for oral, parenteral or buccal administration to the average adult human for the treatment of the conditions referred to above (e.g. depression) is about 0.1 to about 200 mg of the active ingredient per unit dose which could be administered, for example, 1 to 4 times per day. [0094] Aerosol formulations for treatment of the conditions referred to above (e.g. migraine) in the average adult human are preferably arranged so that each metered dose or “puff” of aerosol contains about 20 mg to about 1000 mg of the compound of the invention. The overall daily dose with an aerosol will be within the range of about 100 mg to about 10 mg. Administration may be several times daily, e.g. 2, 3, 4 or 8 times, giving for example, 1, 2 or 3 doses each time. [0095] This invention is based upon the discovery that NPY Y5 antagonists can suppress REM sleep. Accordingly, this invention provides a method of treating and preventing sleep disorders characterized by REM in a mammal, which method comprises administering to the mammal an amount of an NPY Y5 antagonist effective in treating and preventing REM sleep disorders. [0096] The present invention also provides a method for treating and preventing REM sleep disorders in a mammal by administering to the mammal therapeutically effective amount of an NPY Y5 antagonist wherein the NPY Y5 antagonist are compounds of the formula la and IIa. [0097] The present invention also provides a method for treating and preventing REM sleep disorders in a mammal by administering to the mammal therapeutically effective amount of an NPY Y5 antagonist wherein the NPY Y5 antagonist are compounds of the formula la and IIa. EXAMPLES [0098] Considerations of rat and human sleep study: Rat sleep and human sleep have all of the necessary fundamental similarities to permit the rat to be used as a model. First, all compounds that are hypnotics in human have hypnotic effects in rats, and all compounds that are hypnotics in rats have hypnotic effects in humans. Second, both rats and humans exhibit robust circadian modulation of sleep tendency. Third, the “homeostatic” control of sleep shares the fundamental similarity in that loss of sleep increases the amount of low-frequency EEG (“delta waves”) during subsequent compensatory NREM sleep. That is, the “depth” of sleep is characterized by the abundance of slow-wave sleep. The depth of sleep sub serves “sleep continuity” or sleep consolidation, which is the principal determinant of sleep quality. In the context of the latter, it has been argued that and higher-amplitude EEG slow-waves in NREM sleep reflects an “intensity” function of NREM because slow-wave activity in NREM sleep increases as a function of prior wake duration and is a concomitant of sleep consolidation during normal baseline sleep. Fourth, in both rats and humans, all hypnotics affect NREM sleep by decreasing the latency to sleep onset, increasing sleep time, increasing sleep depth and/or consolidation, or some combination of these effects. Fifth, during behavioral sleep, NREM and REM sleep alternate in what may be called the NREM-REM cycle. In both rats and humans, the proportion of time spent in NREM versus REM is about 4:1, and NREM sleep always precedes REM (that is, REM normally does not occur at sleep onset). Sixth, most hypnotics reduce REM sleep to some degree, and several classes of hypnotics strongly suppress REM sleep. Although the relevance is debated, REM-suppression is generally considered desirable in the case of antidepressants. Further, the relative effect of all classes of hypnotics on REM sleep is similar in rats and humans. [0099] There are two principal differences in rat and human sleep. First, rats are night-active, whereas humans are day-active. Although striking, this difference probably has no importance per se for testing hypnotic drug effects. It is important, however, that for either species, the timing of the dose relative to the normal sleep period be taken into account when judging hypnotic efficacy. The second difference is sleep-bout length, or what we call “sleep continuity.” Humans consolidate sleep into a single period per day, normally interrupted by only very short bouts of wakefulness. Rats have bouts of sleep throughout the 24-hour day: roughly every 20 minutes, a rat completes a sleep/wake cycle. During the night (when the rat is active), sleep occupies about ⅓ of each 20-minute cycle, and REM sleep is rare. During the day (lights-on), the rat sleeps about ⅔ of each 20-minute cycle. Sleep bout-length is an extraordinarily sensitive measure of physiological sleepiness and is an important pre-clinical predictor of soporific efficacy in humans. [0100] Sleep measurement by EEG: For the EEG sleep measurements, adult, male Wistar rats were anesthetized and surgically implanted with a cranial implant for chronic electro-encephalogram (EEG) and electromyogram (EMG) recording. At least three weeks were allowed for the animal to recover from surgery. Food and water were available ad libitum and the ambient temperature was 24±1° C. A 24-hr light-dark cycle (LD 12:12) was maintained throughout the study using fluorescent light. Light intensity averaged 35-40 lux at mid-level inside the cage. Animals were undisturbed for two days before and after each treatment. Sleep and wakefulness were determined using a microcomputer-based sleep-wake and physiological monitoring system. The system monitored amplified EEG (×10,000, bandpass 1-30 Hz; digitization rate 100 Hz, integrated EMG (bandpass 10-100 Hz, RMS integration), and telemetered body temperature and non-specific locomotor activity and drinking activity, from 16 rodents simultaneously. Arousal states were classified on-line as NREM sleep, REM sleep, wake, or theta-domihated wake every 10 seconds using EEG period and amplitude feature extraction and ranked membership algorithms. Individually taught EEG-arousal-state templates and EMG criteria differentiated REM sleep from theta-dominated wake. Drinking and locomotor activity were automatically recorded as discrete events every 10 seconds, and body temperature was recorded each minute. Data quality was assured by frequent on-line inspection of the EEG and EMG signals. [0101] Drug Treatment: A NPY Y1 receptor antagonist was administered at 5, 10, 20 or 40 mg/kg in 0.25% methylcellulose vehicle. The NPY Y5 receptor antagonist of Formula la was administered at 5, 10 or 40 mg/kg and the NPY Y5 receptor antagonist of Formula IIa was administered at 10 and 40 mg/kg (both in 32% hydroxypropyl-betacyclodextrin vehicle). Drugs and vehicles were administered by oral gavage. Rats were randomly assigned to receive treatments in parallel groups. The recording duration for the bioassay was 30 hours before and after treatment. At least 7 days “washout” elapsed between each treatment. [0102] Variables recorded by EEG sleep-wake variables included NREM, REM, total sleep, and duration of sleep and wake bouts and were defined and computed as follows: Wakefulness, NREM sleep, and REM sleep: percent time in state per hour or per 5 minute bin. Cumulation of total sleep, NREM sleep, REM sleep, locomotor activity, and drink activity: post-treatment accumulated change over baseline. Change—from-baseline scores were computed by subtracting from the post-treatment value the baseline value at the corresponding circadian time. The change-from-baseline scores were then cumulated in hourly bins, and these values were plotted. Sleep, wakefulness, and REM sleep bouts: The longest bout and the average bout of uninterrupted sleep each hour, measured in minutes. “Interruption” is defined as 3 or more consecutive 10 sec epochs of wakefulness. An analogous quantification is carried out for bouts of wakefulness and REM sleep. Sleep bout length is of interest because it may parallel the human tendency to awaken periodically through the night (such awakenings are normally not recalled), which in turn has been shown to be an important factor determining the restorative value of sleep in humans. Pre-clinical measures of sleep bout length are also strong predictors of soporific efficacy in humans. Locomotor activity: counts per hour or counts per 5 minute bin. Locomotor activity intensity: locomotor activity counts per minute of EEG-defined wakefulness. This variate allows an assessment of locomotor activity that is independent of the amount of time awake, thus, it may be used to quantify the specificity of a wake- or sleep-promoting effect (Edgar et al. 1997). [0108] Statistical Analysis—Mixed Model: Treatment effects were analyzed by a mixed model for repeated measures data. Mixed models were performed comparing each active-treatment with vehicle. For all models analysis was based on post-treatment hours with each hour adjusted for the corresponding baseline hour. Adjusting for baseline takes into account any differences between groups during baseline. The mixed model includes the fixed effects of HOUR, TREATMENT, and TREATMENT×HOUR interaction; RATS were treated as random effects. A heterogeneous autoregressive covariance structure was modeled. This covariance structure is unique to repeated measures in which variance changes over time and measurements taken closer in time are more highly correlated than those taken further apart. [0109] Results: The NPY Y5 receptor antagonist of formula la (5, 10 and 40 mg/kg) significantly reduced REM sleep in a dose-related manner and increased NPEM sleep and sleep continuity (sleep bout length). After 40 mg/kg, REM sleep inhibiting and NREM sleep promoting effects persisted for at least 48 hours, and were still observed at 4.5 days after dosing. The extremely long duration of action observed for this compound appeared to correlate with drug exposure. The NPY Y5 receptor antagonist of formula IIa (10 and 40 mg/kg) dose dependently significantly inhibited REM sleep. A NPY Y1 receptor antagonist tested at 5, 10, 20 and 40 mg/kg, had only slight effects on sleep variables (Table 1). TABLE 1 Maximal change in REM sleep Treatment Dose (minutes) Formula Ia 5 −23.8* 10 −42.6* 40 −74.4* Formula IIa 10 −10.5 40 −19.0* “Maximal change in REM sleep” is the cumulative time spent in REM sleep compared to vehicle controls during the first 24 hours after the drug dose. Negative values indicate a decrease or an inhibition of REM sleep in minutes. All values indicated by * are statistically different at p < 0.025 (mixed model for repeated measures).

This invention relates to a method for treating and preventing neurological disorders related to rapid-eye-movement (REM) sleep disturbances in a mammal comprising administering to the mammal an amount of an NPY Y5 receptor antagonist which effectively reduces REM sleep.

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of application Ser. No. 10/053,022, filed Nov. 2, 2001, U.S. Pat. No. 6,527,343 issued Mar. 4, 2003, which is a continuation of application Ser. No. 09/447,173, filed Nov. 22, 1999, U.S. Pat. No. 6,312,054, issued Nov. 6, 2001, which is a continuation-in-part of application Ser. No. 09/178,818 filed Oct. 26, 1998, U.S. Pat. No. 6,086,150 issued Jul. 11, 2000. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not applicable BACKGROUND OF THE INVENTION This invention relates generally to swimming pool accessories, and in particular to a buoyant lounge chair for supporting a person in a seated position while the chair is floating in water. Swimming pools offer personal recreation and relaxation in a variety of settings, for example in private homes, apartment complexes, motels, resorts and country clubs. Various flotation devices including buoyant chairs, rafts, water wings, floating cushions, body floats and air mattresses are used by swimmers as an aid for floating and relaxing on the surface of the water, while remaining seated upright, reclining or lounging, either partially or completely submerged. These items of pool furniture include flotation cushions made of a buoyant material such as open cell foam, closed cell foam, cork, kapok, fiberglass or balsa wood, which are sealed within a protective outer covering. A popular item of pool furniture is the buoyant lounge chair that permits a swimmer to relax on the surface of the water in a seated, semi-reclining orientation. In some lounge chair designs, the angle of recline is fixed and determined by the form of the rigid frame on which buoyancy cushions are attached, for example as shown in U.S. Pat. No. 6,086,150, which is incorporated herein by reference. In other lounge chair designs, the chair back is pivotably coupled to the frame on which buoyancy cushions are attached, for example as shown in U.S. Pat. No. 6,312,054, which is incorporated herein by reference. Those buoyant lounge chairs, manufactured and sold by Texas Recreation Corporation of Wichita Falls, Tex. have met with considerable commercial success. The present invention was stimulated by the need for a buoyant lounge chair having pivotal chair back that can be set in an upright, semi-reclining sitting position, in which the pool chair functions essentially as a buoyant chair, to a fully folded, minimum profile configuration for storage purposes, and to facilitate handling and shipment. For convenience and comfort, the back rest should be easily set in the standard angle of recline provided by conventional fixed-back lounge chairs. According to another conventional buoyant lounge chair arrangement, as shown in U.S. Pat. No. 4,662,852, the back rest frame is pivotally connected to the seat frame and is inclined against a rear cross bar, and the seat frame is braced by releasable engagement of a slotted bracket with a forward cross bar. The angle of recline is adjusted by extending and retracting the slotted bracket relative to the forward cross bar. This movement translates into angle of recline adjustment as the two sections pivot about a common hinge axis. An important consideration in the design and construction of buoyant lounge chairs, including those including a foldable back, is the maintenance of a water-tight seal about the cushion material and around the welded metal frame. The interlocking components of the foldable seat back coupling apparatus should also be protected. The external surface of the lounge chair is susceptible to attack by mildew, fungus, surface hardening, cracking and shrinking that are caused by long-term exposure to water, pool chemicals and solar radiation. Consequently, lounge chairs as well as other buoyant flotation devices are desirably protected by a durable, non-reactive coating of plastic material, such as vinyl. The protective coating must be soft, pliable and able to withstand rough handling and high shear forces along the joinder lines between the chair arms, the chair seat, and along the flex lines between the chair back and chair seat. The protective coating is applied by various processes, including dipping and spraying, preferably as set forth in our U.S. Pat. No. 6,086,150, incorporated herein by reference. Another limitation imposed by the construction of conventional lounge chairs is that the buoyant arm support sections are subject to tearing or deformation, and are also subject to collapse and separation from the chair frame at the interface between the arm support sections and the chair seat. Special care should be taken in the construction of buoyant lounge chairs to provide sufficient buoyancy material to maintain a stable upright orientation while the occupant is in a semi-reclining or sitting orientation. The buoyant lounge chair can overturn in response to shifting of its center of buoyancy as the occupant turns or moves about. SUMMARY OF THE INVENTION The buoyant lounge chair of the present invention provides stable support for a swimmer in an upright, semi-reclining or sitting position while the chair is floating in a swimming pool. Interconnected rigid frame members collectively form an open chair frame. In the preferred embodiment, the frame members include a seat frame, left and right side arm frames attached to the seat frame, and a movable back frame. The back frame is pivotally coupled to the seat frame on opposite sides by dual axle shafts. A manually operable clutch is mounted on each axle shaft for releasably connecting the seat frame to the back frame. Each clutch is manually releasable to permit pivotal movement of the back frame relative to the seat frame, and is manually engagable to fix the angle of recline of the back frame relative to the seat frame, for example for use in the upright sitting position. Buoyant cushions are attached to the frame members, thereby forming a chair seat, a chair back, left and right chair arms and a bolster block. The buoyant cushions forming the chair seat, the chair arms, the chair back and the bolster block each include layers of buoyant cushion material secured and sealed together by an adhesive deposit in overlapping relation, with each chair frame member being enclosed and sealed between a pair of buoyant layers. Each axle shaft and clutch are also enclosed between a pair of the buoyant layers. Each clutch includes a manual actuator that extends laterally through a passage formed in a pair of buoyant arm cushions, and projects externally of each chair arm at a side location in which it can be conveniently manipulated for engaging and releasing the clutch while the operator is seated or reclining on the lounge chair. Each buoyant arm support section is reinforced by an upright arm support riser that is laterally offset from the seat frame and by a horizontal arm rest segment that is vertically offset from the seat frame. The left and right buoyant chair arms are stabilized and reinforced against collapse and separation from the chair frame by the upright arm support risers and the horizontal arm rest segments that are sandwiched between the buoyant arm support cushions. In the preferred embodiment, the left and right arm support cushions project aft of the pivotal union between the chair seat the chair back. According to this arrangement, the aft projecting portions of the arm support cushions overlap the laterally opposite end portions of the bolster block. The arm support cushions are reinforced against deflection and separation from the chair frame by an aft extension bar attached to the arm rest frame. The extension bar is laterally offset from the seat frame and from the back frame, and projects aft of the pivotal clutch union. The buoyant arm support cushions are further reinforced and stabilized against vertical deflection by the clutch actuator which extends laterally through the buoyant arm cushions. According to another aspect of the invention, the upright floating stability of the lounge chair is improved by extension portions of the buoyant arm cushions that project aft of the chair seat, substantially overlapping the opposite end portions of the bolster block. The upright floating stability of the lounge chair is also improved by a seat frame assembly including left and right seat frame segments each including an angled connecting portion attached to a central seat frame segment. The angled connecting portions slope downwardly relative to the seat frame segments, whereby the buoyant cushions in combination with the seat frame segments form a leg support section that slopes downwardly relative to the chair seat and buoyant arm cushions. The floating stability of the lounge chair is further improved by buoyant arm rest cushions which are mounted on top of the left arm and right arm support cushions. The arm rest cushions extend aft of the seat frame/back frame pivotal clutch union, substantially in flush alignment with the bolster block when the seat back is set in the upright lounging position. BRIEF DESCRIPTION OF THE DRAWING The accompanying drawing is incorporated into and forms a part of the specification to illustrate the preferred embodiments of the present invention. Various advantages and features of the invention will be understood from the following detailed description taken in connection with the appended claims and with reference to the attached drawing figures in which: FIG. 1 is perspective view of a buoyant lounge chair constructed according to the preferred embodiment of the present invention; FIG. 2 is a perspective view thereof showing interconnected rigid frame members including a pivotally coupled back frame collectively forming an open chair frame; FIG. 3 is a perspective view showing first and second layers of buoyant cushion material secured together in overlapping relation, with the seat frame and back frame of the chair being sandwiched between the buoyant layers, the top layer forming a continuous body support surface that transitions through the pivotal union between the seat frame and the back frame; FIG. 4 is a perspective view of a portion of the seat frame, showing a threaded coupling nut welded onto a central seat frame segment; FIG. 5 is a perspective view similar to FIG. 3, showing the assembly of buoyant arm support cushions onto the left and right arm frames; FIG. 6 is a rear perspective view of the buoyant lounge chair showing a bolster frame sandwiched between a pair of buoyant cushions; FIG. 7 is a rear elevational view of the buoyant lounge chair shown in FIG. 1; FIG. 8 is a perspective view of the open chair frame of FIG. 2 with the pivotal back frame in the extended, fully reclining (body float) position; FIG. 9 is a perspective view of the open chair frame of FIG. 2, showing the back frame in the folded, minimum profile (storage/shipping) position; FIG. 10 is a perspective view of the fully assembled buoyant lounge chair of FIG. 1 with the back unfolded to the fully reclining (body float) position; FIG. 11 is a perspective view of the buoyant lounge chair of FIG. 1 with the back folded forward in the minimum profile (storage/shipping) position; FIG. 12 is a perspective view of the buoyant lounge chair shown in FIG. 1, partially broken away, showing details of the pivotal coupling and clutch assembly which connect the foldable back frame to the seat frame; FIG. 13 is a sectional view, partially broken away, taken along the line 13 — 13 of FIG. 1 showing abutting cushion layers that are adhesively sealed together around a portion of the back frame; FIG. 14 is a perspective view, partially broken away, of the pivotal coupling and clutch assembly shown in FIG. 12; FIG. 15 is a perspective view, partially broken away, of an alternative embodiment of the pivotal coupling and clutch assembly; FIG. 16 is an exploded, perspective view of the pivotal coupling and clutch assembly of the present invention; FIG. 17 is an exploded, perspective view similar to FIG. 16, illustrating an alternative embodiment of the pivotal coupling and clutch assembly; FIG. 18 is a perspective view, partially broken away, of the inside coupling clutch member shown in FIG. 17; FIG. 19 is a sectional view of the pivotal coupling and clutch assembly shown in FIG. 17, with the clutch assembly in the engaged operative position; FIG. 20 is a perspective view of the tubular steel coupling sleeve shown in FIG. 19; FIG. 21 is a left side elevational view thereof; FIG. 22 is a right side elevational view thereof; and, FIG. 23 is a perspective view of an alternative embodiment of the buoyant lounge chair of FIG. 1 which includes an extended leg support section. DETAILED DESCRIPTION OF THE INVENTION Preferred embodiments of the invention will now be described with reference to various examples of how the invention can best be made and used. Like reference numerals are used throughout the description and several views of the drawing to indicate like or corresponding parts. Referring now to FIG. 1 -FIG. 7, there is illustrated an exemplary embodiment of a light-weight buoyant lounge chair 10 for selectively supporting a person in seated, semi-reclining and fully reclining lounge positions while the chair is floating in water. The lounge chair 10 includes an adjustable chair back 12 , chair arms 14 , 16 , a chair seat 18 and arm rest cushions 20 , 22 which provide full body support in the seated, upright, semi-reclining, reclining and fully reclining lounge positions. The operative upright floating position refers to the flotation orientation of the lounge chair 10 with the chair back 12 and chair arms 14 , 16 generally upright while the chair seat 18 is generally horizontal and at least partially submerged as indicated in FIG. 1 . When the lounge chair is floating in water, the occupant is supported in a comfortable lounging orientation, with his arms being supported by the left arm rest cushion 20 , the right arm rest cushion 22 and his head is supported by a head support cushion 24 . The occupant's legs are supported by a leg support section 26 which projects forwardly from the chair seat 18 . Buoyancy sufficient to support an adult occupant having a body weight up to 250 lbs. is provided by multiple pairs of overlapping buoyant cushions that are attached to an open chair frame 28 shown in FIG. 2 . The open chair frame 28 is a skeleton frame formed by interconnected rigid frame members, preferably {fraction (5/16)} inch diameter steel rod segments that are welded together. The rigid steel rod segments form a seat frame 30 , a back frame 32 that is pivotally coupled to the seat frame along a pivotal axis A and is adjustable through an incline angle α, which ranges from about 10° in the folded configuration (FIG. 11) to about 180° in the fully extended, body float configuration (FIG. 10 ). A left arm frame 34 and a right arm frame 36 are attached to the seat frame but are separated from the back frame to permit free movement of the back frame during adjustment of the recline angle α. A bolster frame 38 is welded onto the back frame 32 , projecting aft of the chair frame and extending laterally substantially from the left side to the right side of the chair frame 28 . Buoyant cushions formed by overlapping layers of buoyant cushion material are attached to the individual steel rod frame segments, thereby forming the buoyant chair back 12 , the left chair arm 14 , the right chair arm 16 , the chair seat 18 and a bolster block 40 . Each buoyant cushion is formed by a pair of overlapping layers of buoyant material, preferably slabs of closed cell polyurethane foam F having a density in the range of 1-6 lbs./cu.ft. Each closed cell foam layer is in the form of a rectangular slab, having a typical thickness in the range of 1-2 inches, and is cut to form a lounge chair having an assembled height of 27 inches, a length of 30 inches and a width of 30 inches. Referring again to FIG. 2, FIG. 3, FIG. 5, FIG. 6 and FIG. 13, overlapping pairs of buoyant cushions are attached and secured onto the chair frame members by an adhesive bonding agent, for example a deposit 42 of a fast setting contact cement, with the frame members being enclosed and sealed between the layers, thereby providing structural reinforcement for the soft, buoyant cushions. For this purpose, the chair seat 18 is formed by a pair of overlapping cushion layers 18 A, 18 B; the left chair arm is formed by a pair of overlapping arm support cushions 14 A, 14 B, with the left arm frame 34 being enclosed and sealed between the overlapping layers 14 A, 14 B. Likewise, the right arm 16 is formed by a pair of overlapping cushion layers 16 A, 16 B that are adhesively bonded together with the right arm frame 36 being enclosed and sealed between the overlapping layers. The chair back 12 is also formed by overlapping cushion layers 12 A, 12 B which are adhesively bonded together, with the back frame 32 being enclosed and sealed between the overlapping cushion layers. The bolster block 40 is also formed by overlapping buoyant cushion layers 40 A, 40 B that are adhesively bonded together with the bolster frame 38 being enclosed and sealed between the overlapping cushion layers. Referring again to FIG. 1 and FIG. 5, the left and right chair arms 14 , 16 are stabilized further by adhesive attachment to the left and right side edge portions of the chair seat 18 . The chair arms overlap the laterally opposite sides of the chair back 12 , but are not attached to it. The left and right arm support cushions are further stabilized by adhesive attachment to the left arm rest cushion 20 and right arm rest cushion 22 which bridge across the overlapping cushion layers 14 A, 14 B and 16 A, 16 B, respectively. As shown in FIG. 5 and FIG. 7, aft projecting end portions 14 C, 14 D and 16 C, 16 D of the left arm support 14 and right arm support 16 overlap the opposite ends of the bolster block 40 , which further improves the buoyancy and floating stability of the lounge chair. The buoyant arm support sections 14 , 16 are reinforced by the side arm frames 34 , 36 . The side arm frame 34 includes an upright arm support riser segment 34 B that is laterally offset from the seat frame by an angled linking segment 34 C. The side arm frame also includes a horizontal arm rest segment 34 A that is vertically offset from the seat frame. The right side arm frame is identically reinforced by a horizontal arm rest segment 36 A, an upright arm support riser 36 B and an angled linking segment 36 C attached to the seat frame 30 B. The left and right arm support cushions are thus stabilized and supported against collapse and separation from the chair frame by the rigid support provided by the left and right arm segments that are enclosed and sealed between the buoyant arm support cushions, as indicated in FIG. 13 . The aft projecting arm support cushions 14 C, 14 D and 16 C, 16 D are reinforced against deflection and separation from the chair frame by extension bars 34 E, 36 E, respectively. The extension bars 34 E, 36 E are welded onto the side arm frames 34 , 36 , respectively. The extension bars are laterally offset from the seat frame 30 , and project aft of the pivotal union between the back frame 32 and the seat frame 30 . The upright floating stability of the lounge chair is improved by the aft extending portions of the buoyant arm cushions which project aft of the pivotal union, whereby the aft projecting portions substantially overlap the laterally opposite end portions of the bolster block 40 . The upright floating stability of the lounge chair 10 is further improved by the seat frame assembly 30 which includes left and right seat frame segments 30 A, 30 B and a central seat frame segment 30 C. The central seat frame segment 30 C is connected on opposite ends to the seat frame side segments by angled connecting segments 30 D, 30 E. The seat frame segments are enclosed and sealed between the buoyant chair seat cushions 18 A, 18 B. The floating stability of the lounge chair is improved by the leg support section 26 that slopes downwardly from the chair seat 18 , as shown in FIG. 1 . The downward slope is provided by the angled seat frame segments 30 D, 30 E, as shown in FIG. 2 . The floating stability of the lounge chair is also improved by attaching the bolster block 40 onto the back frame 32 so that its moment arm spacing relative to the pivotal axis A remains constant as the chair back is adjusted throughout its angle of incline range. Referring to FIG. 2, FIG. 5 and FIG. 6, the bolster frame 38 includes left and right bolster frame segments 38 A, 38 B that project downwardly from the back frame 32 , and are sandwiched between the lower and upper buoyant bolster cushions 40 A, 40 B. The bolster frame segments 38 A, 38 B maintain the bolster block 40 in a transverse orientation relative to the chair back 32 as the incline angle α is adjusted from one position to another. Preferably, the bolster frame segments 38 A, 38 B slope transversely so that the bolster block 40 is inclined by about 20° relative to the horizontal arm support segments 34 A, 36 A when the lounge chair back is in the upright floating position. Referring now to FIG. 1 and FIG. 13, the overlapping buoyant cushions are bonded and sealed together by a thin layer of adhesive 42 . Additionally, the surface portions of the buoyant cushions bordering the lines of abutting engagement between the chair seat and the left and right chair arms, and between the chair back and the bolster block are further bonded together and sealed by a layer of flexible caulking material 44 . Preferably, the caulking material is a high grade, 15-25 year acrylic material that provides good adhesion to the surface of the closed cell foam, and can withstand high shear forces arising along the interface surfaces. After the caulking material 44 has been applied and cured, a layer of solvent-based vinyl coating material 46 is applied to the exposed external surfaces of the lounge chair. Preferably, the protective vinyl coating 46 is applied over the external surfaces of the lounge chair 10 while it is suspended on a threaded weldment 48 from a hanger strap as described and claimed in our co-pending application Ser. No. 09/178,818 filed Oct. 26, 1998. Referring again to FIG. 1, FIG. 3 and FIG. 12, the buoyant cushions forming the chair seat 18 and the chair back 12 are preferably formed by first and second layers of buoyant cushion material 18 A, 18 B that are bonded together in overlapping relation by an adhesive deposit 42 . According to this arrangement, the layers of buoyant cushion material forming the chair seat 18 and the chair back 12 are integrally formed together, with the seat frame 30 and the back frame 32 being captured and sandwiched between the overlapping layers. The top buoyant layer 18 A forms a continuous body support surface that transitions smoothly through the incline angle α. The incline angle α can be varied through a range of from approximately 10° when the seat back is folded forward in the minimum profile position as shown in FIG. 11, to approximately 90° when the seat back 12 is in the upright position as shown in FIG. 1, and through approximately 180° when the seat back 12 is in the fully extended (body float) position as shown in FIG. 10 . Referring again to FIG. 6, FIG. 7 and FIG. 11, a flexible tie-off grommet 50 is attached to the bolster frame 38 . The tie-off grommet 50 is enclosed and sealed between the lower and upper buoyant bolster layers 40 A, 40 B. An externally projecting portion of the tie-off grommet includes an eyelet for attachment to a tether line whereby the lounge chair 10 can be secured to a fixed structure such as a pool ladder so that the lounge chair will not be blown away during high winds. Also, the tie-off grommet can be used to hang the lounge chair from an overhead hook for inside sheltered storage, preferably with the lounge chair folded into its minimum profile configuration as shown in FIG. 11 . According to an important feature of the present invention, the back frame 32 is pivotally coupled to the seat frame 30 by a pair of clutch assemblies 60 , 80 as shown in FIG. 2, FIG. 8 and FIG. 16 . The construction of the clutch assembly 80 is identical to the clutch assembly 80 . Referring in particular to FIG. 14 and FIG. 16, the clutch assembly 60 includes a fixed clutch member 62 attached to the seat frame 30 A and a rotatable clutch member 64 attached to the back frame 32 A. The fixed clutch member 62 and the rotatable clutch member 64 include complementary male and female end portions 62 A, 62 B and 64 A, 64 B that are adapted for mating engagement with each other when the clutch members are in the engaged position as shown in FIG. 14 . Preferably, the male and female end portions consist of V-shaped ribs 62 A, 64 A and V-shaped pockets 62 B, 64 B that alternate with each other, wherein the V-shaped ribs on each clutch member are dimensioned and conformed for nesting engagement within the V-shaped pockets on the other clutch member. Each clutch member is intersected by a coupling aperture 62 C, 64 C, respectively, which are in concentric alignment with each other when the clutch members are engaged as shown in FIG. 14 . The fixed clutch member 62 and the rotatable clutch member 64 are mounted on a threaded axle shaft 66 which extends through the coupling apertures 62 C, 64 C. The rotatable clutch member is mounted for rotation on and axial movement along the axle shaft 66 from an engaged position, as shown in FIG. 14, in which the fixed clutch member and the movable clutch member are in contact with each other, to a disengaged position, as shown in FIG. 17, in which the fixed clutch member 62 and the rotatable clutch member 64 are separated from each other. The angular position of the rotatable clutch member 64 relative to the fixed clutch member 62 is maintained by a manually operable actuator 68 and a compression tube 70 . Referring to FIG. 14, FIG. 17 and FIG. 18, the axle shaft 66 extends through the coupling apertures 62 C, 64 C of the fixed clutch member and rotatable clutch member, and also through the compression tube 70 . The threaded end 66 T of the axle shaft is engaged by a complementary threaded retainer 68 R coaxially embedded, preferably by molding, within the actuator knob 68 . As the actuator knob 68 is turned clockwise or counterclockwise, the actuator knob travels axially along the threaded end portion 66 T against or away from the compression tube 70 . The fixed clutch member 62 and the rotatable clutch member 64 are forced together in compressive engagement as the actuator knob 68 is rotated clockwise against the compression tube, and the clutch members 62 , 64 are permitted to pull apart as the actuator knob 68 is rotated counterclockwise and travels away from the compression tube. Rotation of the axle shaft 66 is prevented by engagement of a hex head portion 66 H within a complementary hex pocket 64 H formed in the rotatable clutch member 64 , as shown in FIG. 18 . Preferably, the axle shaft 66 includes a smooth, cylindrical bearing surface 66 S which is in registration with the coupling aperture 64 C. This permits the rotatable clutch member 64 to ride on a smooth bearing surface during rotation of the back frame. The length of the compression tube 70 and the length of the threaded portion 66 T of the axle shaft 66 are selected appropriately so that the compression tube 70 extends through the side arm cushions 14 A, 14 B, with the threaded end portion 66 T and the actuator knob 68 projecting externally of the side arm frame cushion 14 B, as shown in FIG. 1 and FIG. 5 . The actuator knob 68 is conveniently located so that the operator can manually release and set each clutch to permit pivotal movement of the back frame 32 relative to the seat frame 30 , and to adjust and fix the angle of recline according to personal preference. Referring to FIG. 1, FIG. 5 and FIG. 12, it will be appreciated that each clutch assembly 60 , 80 is covered by the overlapping buoyant cushions that form the chair seat and the chair back. Preferably, the clutch members are constructed of a high strength, moldable plastic material such as polyvinyl chloride (PVC) or nylon which does not corrode when exposed to water. The frame rod segments, which are made of steel, should be sealed and protected from exposure to water to prevent rust. For this purpose, the seat frame segments 30 A, 30 B and the back frame segments 32 A, 32 B are adhesively sealed between the overlapping buoyant cushions 12 A, 12 B as shown in FIG. 13 . The water-tight seal is intensified and reinforced around the steel rod frame segments at the union with the clutch members by a first surface augmentation collar 72 and a second surface augmentation collar 74 . The augmentation collars 72 , 74 are formed as integrally molded parts of the clutch members 62 , 64 , and present enlarged side surfaces 72 S, 74 S, respectively, for adhesively bonding and forming a water-tight seal with the overlapping buoyant seat cushions 18 A, 18 B and overlapping buoyant back cushions 12 A, 12 B, as shown in FIG. 12 and FIG. 13 . Referring now to FIG. 13, FIG. 15, FIG. 16, FIG. 17 and FIG. 19, the union between each clutch member and the frame segment is reinforced by a tubular steel coupling sleeve 76 which is molded into and embedded within the fixed clutch member 62 , and a tubular steel coupling sleeve 78 which is molded into and embedded within the body of the rotatable clutch member 64 . According to this arrangement, the tubular coupling sleeves 76 , 78 are preassembled and molded within the clutch members, and the surface augmentation collars 72 , 74 are integrally molded around the tubular body portions 76 C, 78 C which project externally of the clutch members, as shown in FIG. 19 . During assembly, the steel rod seat frame segment 30 A is inserted into the bore 76 B of the tubular steel coupling sleeve 76 , and is then welded to the tubular steel coupling sleeve. Likewise, the steel rod seat frame segment 32 A is inserted into the bore 78 B tubular steel coupling sleeve 78 and then is also welded to the tubular coupling sleeve. This arrangement facilitates assembly of the buoyant lounge chair, and provides a more reliable water-tight seal around the chair frame segments that are subject to corrosion. The weldment bead W between the chair frame segments and the tubular coupling sleeves, together with the embedded end portions 76 A, 78 A assure a permanent bond between the chair frame and each clutch member, and prevents separation of the back frame from the seat frame. Referring now to FIG. 19, FIG. 20, FIG. 21 and FIG. 22, one end portion 76 A of the tubular steel coupling sleeve 76 is flattened or crimped with a swage tool, as shown in FIG. 20, which causes the end portion to be radially enlarged and flare radially outwardly from the tubular sleeve body portion 76 C. The radially enlarged end portion 76 A is totally embedded and molded within the clutch body 62 , thereby preventing twisting movement or axial movement of any kind of the tubular steel coupling sleeve with respect to the clutch body 62 , thus firmly locking it into place. After the steel rod seat frame segment 30 A is inserted into the cylindrical bore 76 B of the steel coupling sleeve 76 , as shown in FIG. 19, the two pieces are welded together by a weld bead W. The back frame segment 32 A is secured in a welded union W with a tubular steel coupling sleeve 78 which is identically formed with a radially enlarged, flared end portion 78 A. The result is a high strength union which can withstand rough handling without separation and is protected against corrosion. Referring now to FIG. 23, an alternative lounge chair embodiment 100 includes an extended buoyant cushion portion 26 E that projects forward of and in cantilevered relation to the central seat frame segment 30 C. The extended length of the leg support section provides complete support for the swimmer's entire body, including his legs and feet, when the seat back 12 is set in the fully extended, body float position as shown in FIG. 10 . The lounge chair 100 shown in FIG. 12 is identical in construction with the lounge chair 10 shown in FIG. 1, except for the additional leg support length. Although the invention has been described with reference to certain exemplary arrangements, it is to be understood that the forms of the invention shown and described are to be treated as preferred embodiments. Various changes, substitutions and modifications can be realized without departing from the spirit and scope of the invention as defined by the appended claims.

A buoyant pool chair supports a swimmer in an upright, semi-reclining or sitting position while the chair is floating in a swimming pool. Interconnected rigid frame members collectively form an open chair frame including a seat frame, left and right arm frames attached to the seat frame, and a back frame pivotally coupled to the seat frame. The back frame can be manually rotated to a folded, minimum profile position in which the chair back overlaps the chair seat, for example for shipping and storage, and rotatable to an upright, fixed position to accommodate lounging in a semi-reclining or sitting position. Stop apparatus on the chair frame is engagable with one of the seat frame and the back frame for fixing the back frame in the upright position, and releasable therefrom to permit closing rotational movement of the back frame to the folded position.

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a continuation application of U.S. application Ser. No. 13/611,572 (the “'572 Application”), filed on Sep. 12, 2012. The '572 Application is a continuation application of U.S. application Ser. No. 12/796,251 (the “'251 Application”), filed on Jun. 8, 2010, the entire contents of which is hereby incorporated by reference. The '251 Application claims priority to U.S. Provisional Patent Application Ser. No. 61/226,556, filed Jul. 17, 2009, the entire contents of which is hereby incorporated by reference. This application is also related to U.S. patent application Ser. No. 12/605,624, filed Oct. 26, 2009, U.S. Provisional Patent Application Ser. No. 61/108,552, filed Oct. 27, 2008, and U.S. Provisional Patent Application Ser. No. 61/226,533, filed Jul. 17, 2009, the entire contents of which are hereby incorporated by reference. BACKGROUND The present invention relates to x-ray imaging, including dental x-ray imaging. More particularly, embodiments of the invention relate to a data transfer cable for an intraoral sensor with improved mechanical strength and heat transfer properties X-rays have been used in dentistry to image teeth and parts of the mouth for many years. In general, the process involves generating x-rays and directing the x-rays at the patient's mouth. The x-rays are attenuated differently by different parts of the mouth (e.g., bone versus tissue) and this difference in attenuation is used to create an image, such as on film or by using electronic image sensor. SUMMARY One challenge associated with electronic intraoral x-ray systems relates to the mechanical stress on a cable coupling the sensor capturing images and an output device, such as a computer. To capture dental x-ray images, the intraoral sensor is positioned within the oral cavity of each patient, which often includes twisting and tugging forces being exerted on the cable. The repeated and continuous positioning of the intraoral sensor for each patient results in increased mechanical stress, which wears the cable. With increased use and wear, the cable can malfunction and become unusable. An additional challenge relates to the environment in which the intraoral sensor operates: the oral cavity of a patient. The electronics within the intraoral sensor generate heat and, if left unchecked, can result in injury to the patient. Certain governmental regulations or other standards apply to devices, such as intraoral sensors, that limit the maximum operating temperature. For instance, safety standard 60601-1 2 nd edition from the International Electrotechnical Commission (IEC) limits the outside temperature of such intraoral sensors to 41 degrees Celsius. In one embodiment, the invention provides, among other things, an intraoral x-ray sensor including a sensor housing and a universal serial bus (USB) data cable. The sensor housing has an opening. The USB data cable includes an outer sheath and a first data line, a second data line, a ground line, a power line, and at least two independent fillers positioned within the outer sheath. At least two lines of the first data line, the second data line, the ground line, and the power line are twisted together to form a single bundle. The opening is configured to receive the data cable. Additionally, some embodiments of the invention provide, among other things, an intraoral sensor including a sensor housing having a top portion and a bottom portion. The sensor further includes a twisted-quad universal serial bus (USB) cable coupled to the top portion. The twisted-quad USB cable includes an outer sheath and, within the outer sheath, a first data line, a second data line, a ground line, a power line, and four fillers that are twisted together to form a single bundle. The sensor also includes circuitry within the sensor housing. The circuitry converts x-rays received through the bottom portion into x-ray data and outputs the x-ray data along the twisted-quad USB cable. In some embodiments, the first data line, the second data line, the ground line, the power line, and the four fillers are symmetrically organized about a centerline of the twisted-quad USB cable. Additionally, in some embodiments, the four fillers includes a first filler, a second filler, a third filler, and a fourth filler. The first filler abuts the ground line and the first data line; the second filler abuts the ground line and the second data line; the third filler abuts the power line and the first data line; and the fourth filler abuts the power line and the second data line. In some embodiments, the four fillers are made of a plastic, electrically insulating material. In some embodiments, the outer sheath includes a braided shield and is coupled via a heat-conducting wire to a metallic layer substantially covering an inner surface of the top portion. In some embodiments, the outer sheath further comprises a jacket layer outside of the braided shield and a tape layer inside of the braided shield. Additionally, in some embodiments, the sensor includes an isolation layer within the sensor housing. The isolation layer is between the circuitry and the top portion and wherein the isolation layer is electrically insulating and heat conducting. In some embodiments, the isolation layer is coupled to one of the metallic layer and the braided shield via one of a second heat-conducting wire and direct contact to provide heat transfer from within the sensor housing to the twisted-quad USB cable. Additionally, embodiments of the invention provide an intraoral x-ray sensor including a housing and circuitry within the housing. The housing includes a top portion and a bottom portion. The top portion has a first inner surface and a first thermal resistance. The first inner surface is substantially covered by a metallic layer with a second thermal resistance that is lower than the first thermal resistance. The circuitry converts x-rays received through the bottom portion into x-ray data and outputs the x-ray data along a data cable. The data cable includes wires within a metallic shield. The metallic shield is coupled to the metallic layer by a thermally conductive path that has a thermal resistance that is less than the thermal resistance of air. In some embodiments, the bottom portion includes a second inner surface substantially covered by a second metallic layer that is coupled to the metallic layer either directly or via another thermally conductive path. The circuitry is contained on a printed circuit board (PCB) that is isolated from the metallic layer by an isolation layer. The isolation layer is thermally conductive and electrically insulating, and includes (in some implementations) an opening through which the circuitry and the wires are connected. Additionally, in some embodiments, the circuitry includes an array of pixels on a first side of the PCB and, on a second side of the PCB, a processor and an input/output module. The sensor includes x-ray attenuation components between the second side and a surface of the bottom portion through which x-rays are received. The x-ray attenuation components may include: a lead layer, a fiber optic covered by a scintillating layer, and copper planes. The top portion includes a dome (with the shape of a partial, elliptical paraboloid) having a face with a circular opening. The circular opening receives the data cable. Other aspects of the invention will become apparent by consideration of the detailed description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic illustration of a dental x-ray system including an x-ray source, an intraoral sensor located in a patient's mouth, and a computer connected to the intraoral sensor. FIG. 1 a is a schematic illustration of the intraoral sensor shown in FIG. 1 showing internal components of the sensor. FIG. 2 depicts an exploded view of the intraoral sensor shown in FIG. 1 . FIG. 3 depicts a cross section along line A of FIG. 4 . FIG. 4 depicts a top view of the intraoral sensor shown in FIG. 1 and a cable connector. FIG. 5 a depicts a cross section of a prior-art universal serial bus (USB) cable. FIG. 5 b depicts a wiring diagram of a prior-art universal serial bus (USB) cable. FIG. 6 a depicts a cross section of a cable according to embodiments of the invention. FIG. 6 b depicts a wiring diagram of a cable according to embodiments of the invention. FIG. 7 depicts the underside of the top cover of the intraoral sensor of FIG. 1 . DETAILED DESCRIPTION Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. FIG. 1 illustrates a dental x-ray system 10 . The system includes an x-ray source 12 . In the embodiment shown, the source is located on an end 13 of a mechanical arm 15 . When activated, the x-ray source 12 generates an x-ray stream 16 that has a generally circular cross-section. (Of course, x-rays are generally invisible, but a representation of a stream is illustrated to facilitate understanding of the invention.) In many applications, a collimator is used to reduce the size of the stream and generate a smaller x-ray stream having a rectangular cross-section. A collimator may be used with a mechanical positioning device to help align the x-ray stream with an x-ray sensor. As shown in FIG. 1 , x-ray source 12 is positioned (e.g., by an operator) so that the x-ray stream 16 is directed to an intraoral sensor 20 . The intraoral sensor 20 is shown located in the mouth of a patient 21 . In some embodiments, the intraoral sensor 20 includes a scintillator that coverts x-ray radiation to visible light. In other embodiments, the sensor 20 is configured to convert x-rays into electric charge without a scintillator. Unless otherwise specified, the term pixel refers both to a pixel in the array of pixels that converts x-rays to electrons without a scintillator and a pixel in the array of pixels and its associated scintillator or portion of a scintillator. As best seen by reference to FIG. 1 a , the sensor 20 also includes an array of pixels 22 . The components of FIG. 1 a , including the array of pixels 22 , are not drawn to scale relative to the outline of the sensor 20 . Each pixel produces an electric signal in response to light (from the scintillator) or x-ray radiation impinged upon it. In one embodiment, the sensor 20 includes one or more “on-board” analog-to-digital converters to covert analog signals generated by the pixels to digital signals. These signals are provided to a processor 23 (such as a programmable, electronic microprocessor, field programmable gate array, erasable programmable logic device(s), or similar device(s)). In the embodiment shown, the processor 23 is connected to memory 24 (ROM and RAM) and an input-output interface 25 . The sensor 20 also includes one or more electronic circuits for power supply, driving the array of pixels, and driving the output (e.g., circuits located in the I/O interface 25 ). In some embodiments, the I/O interface 25 is a universal serial bus (“USB”) interface. In some embodiments, the processor 23 controls image capture or triggering of the sensor 20 . In other embodiments, the x-ray source 12 is coupled to the sensor 20 , e.g., via computer 30 , such that when the x-ray source 12 is activated, a command is sent (simultaneously or nearly simultaneously) to the sensor 20 to perform an image capture. Thus, it is possible to generate a burst of x-ray radiation and be assured that an image will be captured by the sensor 20 during the relatively short period of x-ray exposure either through automatic triggering or via a specific capture command sent to the intraoral sensor 20 . Referring back to FIG. 1 , a wire, cable, or similar connector 27 of the sensor 20 connects the sensor 20 to a computer 30 . The computer 30 includes various components, including a processor or similar electronic device 32 , an input/output interface 34 , and memory 36 (e.g., RAM and ROM). In some embodiments, the input/output interface 34 is a USB connection and the cable 27 is a USB cable. FIG. 1 illustrates that image data captured by the sensor 20 and processed by the computer 30 is sent to a display 38 and viewed as image 40 . (Image 40 is drawn more distinctly than an x-ray image would typically appear.) The location of the intraoral sensor 20 in the patient's mouth determines what part of the patient's anatomy can be imaged (e.g., the upper jaw versus the lower jaw or the incisors versus the molars.) An x-ray operator places (or assists the patient in placing) the intraoral sensor 20 at a desired location with the patient's mouth. Various sensor holders (including those that are used with or that include a collimator) may be used to keep the sensor 20 in the desired location until an image is created or captured. For example, some holders are designed so that the patient bites the holder with his or her teeth and maintain the position of the sensor 20 by maintaining a bite on the holder. After the sensor 20 is positioned behind the desired anatomical structure, and the x-ray field to be generated by the x-ray source 12 is aligned with the sensor 20 , it is possible that the source 12 and sensor 20 will, nevertheless, become misaligned. Misalignment can be caused by the patient moving his or her head, moving the intraoral sensor 20 (by re-biting the holder, moving his or her tongue, etc.), and other causes. FIG. 2 depicts an exploded view of the intraoral sensor 20 . The sensor 20 includes a housing 45 . The housing 45 has a top portion 50 and a bottom portion 55 . Within the housing 45 is an insulator 60 , a printed circuit board (“PCB”) 65 , a silicon detecting layer 67 , an x-ray converter 70 , and a cushioning layer 71 , which protects against mechanical shocks. Some embodiments of the sensor 20 do not include the cushioning layer 71 . The top portion 50 includes a dome 75 that receives cable 27 . The dome 75 has a shape that approximates an elliptical paraboloid divided in half by the surface 76 of the top portion 50 (a partial, elliptical paraboloid shape). Other dome shapes are contemplated for use in embodiments of the invention. The dome 75 includes a face with an approximately circular opening through which the cable 27 passes. The cable 27 includes connectors (e.g., wires), a portion of which pass through an opening 79 of the insulator 60 to connect to the PCB 65 . In some embodiments, a ribbon or other connector passes through the opening 79 to couple the wires of cable 27 to the PCB 65 . The insulator 60 provide electrical isolation between the PCB 65 and the housing 45 of the sensor 20 . In some embodiments, the insulator 60 also secures the PCB 65 and x-ray converter 70 in position and protects each against mechanical shocks. Although the insulator 60 resists conducting electricity it is a conductor of heat, which assists in transferring heat away from the PCB 65 . The PCB 65 , silicon detecting layer 67 , and converter 70 include the components of the sensor 20 illustrated in FIG. 1 a , namely the array of pixels 22 , the processor 23 , the memory 24 , and I/O interface 25 . In the embodiment depicted in FIG. 2 , the array of pixels 22 includes a plurality of pixels, each pixel including a converting portion (i.e., a portion of converter 70 ) and a detecting portion (i.e., a portion of silicon detecting layer 67 ). The PCB 65 supports the silicon detecting layer 67 (e.g., a CMOS die) and converter 70 , with the silicon detecting layer 67 being secured, e.g., using a glue or epoxy, to the PCB 65 . The converter 70 converts x-rays received through the bottom portion 55 into light. The light travels to the silicon detecting layer 67 , which converts the received light into charge. The charge is integrated at each pixel and the quantity of charge integrated represents the amount of x-rays received (although some of the integrated charge is attributable to noise and dark current). During a read-out of the array of pixels 22 , the processor 23 determines the quantity of charge integrated at each pixel in the array of pixels 22 . In some embodiments, the converter 70 and silicon detecting layer 67 include a fiber optic with scintillator. In some embodiments, the array of pixels 22 converts x-rays directly to charge without an intermediate step of converting x-ray to light. In such embodiments, among other possible alterations, an additional insulator (similar to insulator 60 ) is positioned in place of converter 70 , and is used to provide electrical isolation between the housing 45 and the PCB 65 and help transfer heat away from the PCB 65 . FIG. 3 depicts a cross section of the sensor 20 along line A as shown in FIG. 4 . The top portion 50 is secured to the bottom portion 55 for instance, using ultrasonic welding and machining. The welding bonds the top portion 50 to the bottom portion 55 , and machining smoothes the surface. Additionally, the top portion 50 and bottom portion 55 include interlocking portions 56 . The converter 70 , PCB 65 , silicon detecting layer 67 , and insulator 60 are shown within the housing 45 . Also depicted is the cable 27 including stress relief portion 77 . The stress relief portion 77 is secured to the cable 27 , for instance, using an adhesive. Additionally, the stress relief portion 77 includes a circumferential notch 80 that matches up with ridge 85 on the dome 75 . The stress relief portion 77 is secured to the dome 75 using the interlocking notch 80 and ridge 85 . An adhesive may also be used to secure stress relief portion 77 to the dome 75 . The stress relief portion 77 alleviates mechanical stress on the cable-to-housing coupling 81 created from twisting, pulling, and other forces on cable 27 and housing 45 . Thus, the stress relief portion 77 extends the life of the cable-to-housing coupling 81 , preventing or delaying malfunction of the sensor 20 caused by breaking the connection between the cable 27 and the housing 45 . FIG. 4 depicts a top view of the sensor 20 and a USB connector 82 at the end of cable 27 . FIG. 5 a depicts a cross section of a standard universal serial bus (USB) cable 100 capable of high speed USB version 2.0 communication. The standard USB cable 100 includes four main wires: data line 105 (D+), data line 110 (D−), power line 115 , and ground line 120 . Additionally, surrounding the four main wires is an isolating jacket 125 , an outer shield 130 made of 65% interwoven tinned copper braid, and an inner shield 135 made of aluminum metallized polyester. The isolating jacket 125 is made of polyvinyl chloride (PVC) in some embodiments. Running lengthwise along with wire between the inner shield 135 and the outer shield 130 is a copper drain wire 140 . The standard USB cable 100 is not symmetrical. Rather, the standard USB cable 100 has an internal, non-circular, oval structure, although fillers and plastic (not shown) may be used to create an external, circular shape of the cable. The external, circular shape can be approximately 4 mm in diameter. FIG. 5 b depicts a wiring diagram of the standard USB cable 100 . As illustrated, the standard USB cable 100 has one twisted signaling pair including the data line 105 (D+) and data line 110 (D−). In some implementations, the power line 115 and ground line 120 are twisted (possibly to a lesser extent) or, as shown in FIG. 5 b , not twisted at all. FIG. 6 a depicts a cross section of a cable 150 according to embodiments of the invention. The cable 150 includes four main wires 210 and four fillers 175 a - d . The four main wires 210 include data line 155 (D+), data line 160 (D−), power line 165 , and ground line 170 , which provide data transmission, power transmission, and grounding, respectively. The data line 155 (D+), data line 160 (D−), power line 165 , and ground line 170 each include a metal conductor encapsulated by a co-axial insulator. The four fillers 175 a - d are made of plastic and are twisted along with the four main wires 210 to form a twisted quad cable. The four mains wires 210 and four fillers 175 a - d are surrounded by three layers that run the length of the cable 150 . The three layers include polytetrafluoroethylene (“PTFE”) tape 180 , a braided shield 185 , and a polyurethane jacket 190 . In some embodiments, other materials are used for the jacket 190 and the tape 180 (e.g., another material similar to PTFE with a low surface roughness). The braided shield 185 is made up of, for instance, tinned copper wires with 0.08 mm diameter (40 AWG). As will be discussed further below, in some embodiments, the braided shield 185 is a heat conductor. In some embodiments, the polyurethane jacket 190 is approximately 0.432 mm thick. The total diameter of the cable 150 is less than 3.0 mm. In some embodiments, additional or fewer layers surround the four main wires 210 and fillers 175 a - d used within cable 27 . The wiring diagram of FIG. 6 b illustrates the main wires 210 and fillers 175 a - d twisted together to form a single bundle 195 . Although not shown in FIG. 6 b , the (“PTFE”) tape 180 , a braided shield 185 , and a polyurethane jacket 190 encapsulate the single bundle 195 as shown in FIG. 6 a . The twisted quad cable is symmetrical about center line 197 , as shown in FIG. 6 a . The symmetrical characteristic of the cable 150 provides increased strength and resistance to mechanical stress with a lower outside diameter, relative to the standard USB cable. That is, the cable 150 is less susceptible to damage from twisting, pulling, and other forces on the cable 150 , despite the reduced diameter of the cable 150 . In particular, the cable 150 is less susceptible to damage due to rotational mechanical stress, which is often present during use of an intraoral sensor cable. FIG. 7 depicts the inside 200 of the top portion 50 . The inside 200 includes a metallization layer 205 . The cable 27 is shown inserted into the dome 75 . The four main wires 210 (i.e., the data line 155 (D+), data line 160 (D−), power line 165 , and ground line 170 ) are attached to a PCB connector 215 , which is connected to the PCB 65 . In some embodiments, the four main wires 210 are coupled or soldered directly to the PCB 65 . The braided shield 185 is coupled to the metallization layer 205 via a heat conducting wire 220 . The heat conducting wire 220 is coupled to the braided shield 185 and metallization layer 205 by, for instance, soldering. As the PCB 65 generates heat while in operation, a substantial portion of the generated heat is transferred through the insulator 60 to the metallization layer 205 . The portion of generated heat is then transferred to the braided shield 185 via the heat conducting wire 220 . The level of thermal resistance may vary by application. For instance, the more heat the PCB 65 generates in a particular embodiment, the lower the thermal resistances are of the materials chosen for the metallization layer 205 , heat conducting wire 220 , and insulator 60 . In general, however, the insulator 60 and heat conducting wire 220 have a thermal resistance that is lower than the thermal resistance of air (which is approximately 1/0.025 W/(mK) at 20 degrees Celsius). Additionally, the metallization layer 205 has a thermal resistance that is less than the thermal resistance of the top portion 50 of the housing 45 and less than the thermal resistance of air. Thus, the sensor 20 provides improved heat transfer away from the sensor 20 along the cable 27 . Although not shown, in some embodiments the inside of the bottom portion 55 also includes a metallization layer, which is similar to the metallization layer 205 in form and function. The bottom metallization layer is coupled to the braided shield 185 as well. In some embodiments, the coupling is provided by an additional heat conductor connection between the bottom metallization layer and either the braided shield 185 or the metallization layer 205 . In other embodiments, the coupling is provided by direct contact between the bottom metallization layer and the metallization layer 205 . Thus, the invention provides, among other things, an intraoral sensor with a cable providing greater resistance to mechanical stress. Additionally, the invention provides an intraoral sensor with improved heat transfer. Various features and advantages of the invention are set forth in the following claims.

An intraoral x-ray sensor including a sensor housing and a universal serial bus (USB) data cable. The sensor housing has an opening. The USB data cable includes an outer sheath and a first data line, a second data line, a ground line, a power line, and at least two independent fillers positioned within the outer sheath. In one embodiment, at least two lines selected from the group including the first data line, the second data line, the ground line, and the power line are twisted together to form a single bundle. The opening receives the data cable.

RELATED APPLICATION [0001] This application is a continuation-in-part of application Ser. No. 09/648,920 filed Aug. 25, 2000. TECHNICAL FIELD [0002] The present invention is related to the field of footwear worn over other footwear. More particularly, the present invention relates to anti-slippage footwear and to a spike assembly for use with such footwear. BACKGROUND OF THE INVENTION [0003] Shoes, including athletic shoes, work boots, dress shoes, ski boots, overshoes, and all manner of footwear, provide poor traction on many surfaces, including slippery, icy, and wet surfaces. The difficulties of moving across a slippery surface, including walking, running, and jogging, result in inconvenience and injury. Slips, falls, and resultant injuries are typically caused by a lack of good footing. And even if a person does not actually fall, the need to walk slowly or with small steps over a slippery surface is inconvenient, slows movement, and is a distraction that interferes with a person's ability to be aware of their surroundings and to be alert to non-slip hazards. [0004] The inconvenience of walking on slippery surfaces interferes with businesses that require outdoor work to be done when conditions are icy. Postal and parcel delivery, for instance, is hampered, as well as baggage handling, road repair, ambulance and emergency work, police work, and any outdoor work that cannot be stopped for inclement weather. [0005] Runners, joggers, and persons that exercise outdoors are hampered by the loss of traction on slippery surfaces. For example, even if outdoor surfaces are slightly slippery, a jogger must take smaller strides to avoid slipping. Activities that require movement faster than a slow walk are greatly hindered in inclement conditions by a lack of suitable footwear. [0006] Further, even the knowledge that roads and sidewalks are slippery can be detrimental. The knowledge that outdoor walking conditions are hazardous may discourage persons from engaging in normal activities. For instance, a person is more likely to choose not to walk to a store, to take a pet for a walk, or otherwise leave home if the person knows that walking conditions are slippery. [0007] This problem is especially acute for the elderly or persons with disabilities that interfere with a standard gait. Many elderly persons experience impediments to walking that make them more likely to slip and fall under normal conditions; and in climates where snow and ice persists through a significant portion of the winter, some elderly persons become essentially home-bound. Similarly, a disability that causes an irregular gait may discourage a person from undertaking normal activities when outdoor walkways provide sub-par traction; for example, the loss of a leg may create an irregular gait that leads to added vulnerability to slipping. [0008] Ideally, footwear that provides good traction in all weather would minimize the inconvenience of changing or removing shoes every time a person comes indoors. Further, a device that is versatile and works with many size shoes or foot-sizes is desirable so that a user, especially an organization that serves multiple persons, may stock a minimal number. SUMMARY OF THE INVENTION [0009] The invention solves the difficulties described above by providing footwear that is worn over other footwear, and is referred to herein as an overshoe. The overshoe easily slips on and off of shoes and provides excellent grip and traction on slippery surfaces. The improvement in grip and traction results in greater safety, efficiency, and confidence for a person moving across a surface. Walking or jogging is safer and the wearer of the overshoe may move with an increased stride length that is faster and more comfortable. [0010] The overshoe has spikes that help the wearer have grip and traction on a surface; the weight of the wearer pushes the spikes into the surface so that they grip. The spikes may be made of a durable material—for instance, carbide—which resists wear and maintains a sharp point, or stainless steel. The spikes are under the heel, the ball of the foot, and forward and rearward of the ball of the foot. Thus, they are arranged so that the heel or the ball of the foot pushes spikes into the ground while walking. The forwardmost spike is pushed into the ground when the user's weight is shifted far forward—for example when running, standing on tip-toe, or leaning back with the toes pointed—a position that is naturally assumed in some situations, for instance when leaning far back while pulling a rope tied to a heavy object. [0011] The spikes may be readily removed from the overshoe for use on surfaces that might be damaged by the spikes. Readily removing the spikes facilitates worn spike replacement, and is a safety feature that, for instance, allows a user to be freed when a spike is inadvertently wedged into a crevice in a rigid surface. As will be appreciated, the overshoe has gripping features in addition to the spikes. These features enhance traction and a user may wear the overshoe without the spikes and enjoy greatly increased traction, although maximum traction on ice is achieved with the use of the spikes. Removing the spikes is particularly useful when the overshoe is worn indoors as many household surfaces would be damaged by the spikes. [0012] The material of the overshoe is a durable elastic material that is tough, lightweight, and flexible even in temperatures below 0° F. The term “elastic material,” as used herein, includes natural and synthetic polymers, including rubbers and reinforced rubbers, TRP, and other suitable materials. [0013] The overshoe has a front-gripping portion that substantially encloses and grips the front toe portion of the user's shoe and a back-gripping portion that grips the back heel portion of a user's shoe. The front-gripping portion of the overshoe has an opening that accepts the user's shoe; this opening is formed in the overshoe and stays open, and therefore does not have to be held open. The user may insert the user's shoe into the opening and stretch the front-gripping portion to fit around the shoe's front. The back-gripping portion is similarly stretched around the back of the shoe to provide a secure fit. The overshoe is preferably made available in several sizes to accommodate a wide range of shoe sizes over which the overshoe is to be worn. [0014] The back-gripping portion includes a hole that allows the overshoe to be easily put on a shoe. A user may insert a finger into a finger hole and easily stretch the overshoe by pulling. This feature is especially useful for users with limited use of their hands or reduced strength, including disabled, arthritic, and elderly persons. This feature is superior to a tab or a tab-type feature because the finger hole does not require a grip; it merely requires that the finger hole be hooked with a finger or implement. [0015] The overshoe has an outersole that joins the front- and back-gripping portions. The top of the outersole contacts the user's shoe and the bottom is the tread surface; the spikes project from the tread surface, which also has gripping ridges. [0016] The gripping ridges work with the spikes to provide extra traction and increase the coefficient of friction between the outersole and the surface. The gripping ridges may have a triangular shape: one side of the triangle is a push-face that is vertical to the walking surface, generally referred to as the ground herein; and another side of the triangle, the hypotenuse face, slopes back to the outersole surface and serves as a brace to the push-face. The push-face may be a forward-pushing push-face that is oriented to the front of the oversole so that it directly resists forces that tend to pull the overshoe forward. Or the push-face may be a backward-pushing push face that faces the rear of the oversole and provides a surface that resists forces that move the overshoe backward. The triangular shape distributes the force effectively to provide strength, durability, and surface area to resist movement. [0017] The overshoe is configured so that it fits snugly and conforms to the shape of the shoe but is easy to put on and remove. The shoe material ideally is elastic so that it may be stretched by applying tension, but returns to its original shape when the tension is removed. Thus, the overshoe may be stretched by a user to fit around a shoe and its elastic force provides for a snug fit that conforms to the user's shoe. If the material is too easily stretched, however, it stretches and moves while the user is walking so that walking is more difficult. The invention reconciles these competing design needs by strategically incorporating stretch zones into the overshoe. The stretch zones are placed so that the overshoe is readily stretched by a user in the course of putting on or removing the shoe. [0018] The stretch zones are placed in the front-gripping portion and in the back-gripping portion so that these portions may be readily stretched by the user. A stretch zone is a portion of the overshoe that is made in the shape of a narrow strip: since the ease of stretching the plastic is proportional to its cross-sectional area—the product of the zone width and thickness—control of the zone's cross-sectional area allows for control of its stretch; a small area increases stretchability. But the cross-sectional area of the zone is related to the durability and longevity of the stretch zone; a larger area increases longevity. The zones are created by introducing holes or cut-outs that reduce the amount of plastic in the overshoe. The invention includes placing these zones in areas that need to be stretched to fit over a shoe but restricting their use in overshoe areas that experience stretching loads during a user's movement. The need for ease in stretching these zones must be balanced against the need for durability and strength. [0019] The incorporation of the stretch zones increases the versatility of the overshoe. Since the overshoe can be more readily stretched by a user than would otherwise be possible, the overshoe may be stretched to fit around a greater variety of shoe sizes. Therefore a user may accommodate all of their shoes with a minimal number of overshoes. The placement of the stretch zones allows for a better fit and for a better stretchability when the user needs it: stretchability is great when the overshoe is being put on but small when it is being worn. [0020] The outer sole has a forward portion, a central opening, and a rearward portion. The forward portion generally underlies the front of the shoe and the rearward portion generally underlies the heel of the user. The central opening is an opening between the forward and rearward portions. The central opening minimizes the amount of material used to form the overshoe and avoids creating a space between the outersole and user's shoe that could trap unwanted material such as ice, mud, and rocks. [0021] In an embodiment of the rearward portion of the outer sole, the rearward portion is a band of material that includes both gripping ridges and spikes. It has a surface area that contacts the ground. The rearward portion of the present invention has a rearward portion that is improved over the prior art because it has a greater surface area and has an increased thickness. Furthermore, the increased thickness allows for a plurality of gripping ridges to be incorporated so that traction is greatly improved compared to a narrower rearward portion. [0022] The overshoe has a greater thickness in critical areas. Other anti-slip overshoes have a thickness that is essentially uniform throughout. This makes it easier to mass-produce the prior art overshoes, but the durability of such overshoes is compromised. The longevity of the overshoe of the present invention has been improved by adding extra material thickness at key areas. For instance, the rearward portion is thicker than most of the rest of the outersole; this increased thickness improves the longevity of the rearward portion. The areas around the spikes are also reinforced with extra thickness; the extra thickness increases the longevity of the overshoe because the hard material of the spikes, such as metal, tends to cause the material of the overshoe to wear down. Other areas of increased thickness are generally the stretch zones. Manipulating the thickness of the stretch zones allows their cross-sectional area to be optimized to balance longevity with stretchability. [0023] The invention is further a spike assembly for use with an overshoe that fits over a person's shoe and enhances a person's contact with the ground and includes a spike having a head operably coupled to a shank and a button overmolded on the spike and having a neck for removable engagement in a bore defined in the overshoe. BRIEF DESCRIPTION OF THE DRAWINGS [0024] [0024]FIG. 1 is a perspective view of an anti-slip overshoe attached to a shoe that is shown in phantom; [0025] [0025]FIG. 2 is a right side elevational view of an anti-slip overshoe; [0026] [0026]FIG. 3 is a top plan view of an anti-slip overshoe; [0027] [0027]FIG. 3 a is a top plan view of an anti-slip overshoe with spikes removed; [0028] [0028]FIG. 4 is a bottom plan view of an anti-slip overshoe; [0029] [0029]FIG. 4 a is a bottom plan view of an anti-slip overshoe with spikes removed; [0030] [0030]FIG. 5 is a front plan view of an anti-slip overshoe; [0031] [0031]FIG. 6 is a rear plan view of an anti-slip overshoe; [0032] [0032]FIG. 7 is a plan view of the Section A-A′ shown in FIG. 4; [0033] [0033]FIG. 8 is a sectional view of an alternative embodiment of a spike molded into a supporting button; [0034] [0034]FIG. 9 is a bottom planform view of the spike of FIG. 8; [0035] [0035]FIG. 10 is a sectional view of an alternative embodiment of a spike having a serrated shank; [0036] [0036]FIG. 11 is a top plan view of an alternative embodiment of an anti-slip overshoe; [0037] [0037]FIG. 12 is a section of the outersole only taken along the section line 12 - 12 of FIG. 11; [0038] [0038]FIG. 13 is a perspective view of another embodiment of the anti-slip overshoe of the present invention depicted turned inside out such that the tread pattern is shown on the inside of the ball and heel portions of the overshoe; [0039] [0039]FIG. 14 is a top plan view of the overshoe of FIG. 13; [0040] [0040]FIG. 15 is a side elevational view of the overshoe of FIG. 13; [0041] [0041]FIG. 14 is a bottom plan view of the overshoe of FIG. 13 showing the inside of the ball and heel portions of the overshoe; [0042] [0042]FIG. 17 is a perspective view of an alternative pattern of the tread imposed on the ball of the overshoe; [0043] [0043]FIG. 18 is a plan view of the tread pattern of FIG. 17; [0044] [0044]FIG. 19 is a sectional view of the tread pattern taken along the section line A-A of FIG. 18; [0045] [0045]FIG. 20 is a perspective view of an alternative pattern of the tread imposed on the ball of the overshoe; [0046] [0046]FIG. 21 is a plan view of the tread pattern of FIG. 20; [0047] [0047]FIG. 22 is a sectional view of the tread pattern taken along the section line A-A of FIG. 21; [0048] [0048]FIG. 23 is a perspective view of an alternative pattern of the tread imposed on the ball of the overshoe; [0049] [0049]FIG. 24 is a plan view of the tread pattern of FIG. 23; [0050] [0050]FIG. 25 is a sectional view of the tread pattern taken along the section line A-A of FIG. 24; [0051] [0051]FIG. 26 is a perspective view of an alternative pattern of the tread imposed on the ball of the overshoe; [0052] [0052]FIG. 27 is a plan view of the tread pattern of FIG. 26; and [0053] [0053]FIG. 28 is a sectional view of the tread pattern taken along the section line A-A of FIG. 27. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0054] The overshoe of the present invention is shown generally at 10 in the figures. The overshoe 10 is configured to fit around exemplary shoe 5 . Shoe 5 may be any manner of footwear, including but not limited to shoes, boots, ski-boots, and athletic shoes. Shoe 5 has a forward toe portion 7 , a heel portion 8 , and a bottom 9 . Forward toe portion 7 accommodates the user's toes and the ball of the foot. Heel 8 accommodates the user's heel, and bottom 9 of shoe 5 contacts the ground when the overshoe 10 is not being used. The user walks or moves on the ground, such movement including walking, jumping, running, jogging, and similar movement. [0055] The overshoe 10 has a front-gripping portion 50 , a back-gripping portion 40 , and an outersole 20 . The front-gripping portion 50 grips the forward toe portion 7 of shoe 5 and back-gripping portion 40 grips the heel portion 8 of shoe 5 . The overshoe 10 has an outersole 20 that joins the front-gripping portion 50 and back-gripping portion 40 . [0056] The outersole 20 has a forward portion 26 , a rearward portion 28 , a central opening 34 , a top 22 , and a tread surface 24 . The forward portion 26 is generally disposable under the forward toe portion 7 of the shoe 5 and is continuous with the rearward portion 28 , which is generally disposed under heel 8 of shoe 5 . Forward portion 26 and rearward portion 28 together define central opening 34 . The top of the outersole 22 generally contacts the bottom of shoe 9 and the opposing bottom of the outersole is tread surface 24 . [0057] Spikes 25 project downward from tread surface 24 . The spikes 25 may be carbide, stainless steel, or other suitable materials. The spikes 25 may additionally be conventional golf spikes as used in conjunction with golf shoes. Such spikes 25 are especially useful where the overshoe 10 is intended for use in areas of grass and dirt. The spikes 25 are set in a spike assembly that has a top 23 in the top of the outersole 20 and are replaceable by the user. The spike assembly is disposed in a bore 23 (see FIGS. 3 a and 4 a ) formed in the material forming overshoe 10 . [0058] The spikes 25 may be arranged in the outersole forward portion 26 as shown in FIG. 4. For example, the spikes 25 may be arranged as a four-spike diamond shape with one spike 25 approximately on the longitudinal axis of the outersole 20 , in a position more forward than the other three spikes 25 and slightly forward of the ball of the foot. The spike 25 on the opposing corner of the diamond is on the same axis and is more rearward than the other three spikes 25 and to the rear of the ball of the foot. The other two spikes 25 are disposed approximately beneath the ball of the foot and placed closer to the outer edge of tread surface 24 . Two additional spikes 25 may be placed in rearward portion of outersole 28 (FIG. 4). These two spikes 25 are disposed to be approximately under the user's heel. [0059] [0059]FIGS. 3 a and 4 a depict the overshoe 10 with spikes 25 removed from the bores 23 . The removal may be removed for replacement of the spikes 25 . Further, the spikes 25 are readily removed for use on surfaces that would otherwise be marked by the spikes 25 . FIGS. 3 a and 3 b depict the reinforcing ridges 21 surrounding the bores 23 . The ridges 21 have increased thickness of the elastic material forming the overshoe 10 . [0060] Tread surface 24 includes gripping ridges 27 (FIGS. 2, 4, 4 a , and 7 ). The gripping ridges 27 may be forward-pushing gripping ridges 29 and rearward-pushing gripping ridges 30 . The gripping ridges 27 have a push-face 32 and a hypotenuse face 31 . The height of the gripping ridge 27 is its maximum length perpendicular from the tread surface. Referring to FIG. 7, the gripping ridge 27 has a push-face 32 that is perpendicular to the outersole 20 and a hypotenuse face 31 that joins the push-face 32 to the outersole 20 . The hypotenuse face 31 of a forward-pushing gripping ridge 29 faces substantially to the rear of shoe 5 so that push-face 32 is oriented to provide a surface area that gives much more traction to the user as they push their foot forward, as when attempting to stop or walk backwards. Hypotenuse face 31 of a rearward-pushing gripping ridge 30 faces substantially to the forward of shoe 5 so that push-face 32 is oriented to provide a surface area that gives traction to the user as the user pushes the foot rearward, as when walking forwards. The combination of opposite-facing directions of forward-pushing 29 and rearward-pushing 30 gripping ridges supply a higher degree of traction than if the ridges faced only one direction. [0061] Gripping ridge 27 preferably has a height in the range of approximately three- to ten- sixty-fourths of an inch. The gripping ridges 27 may be shaped to have the cross-sectional profile of a right triangle (FIGS. 4, 4 a and 7 ). The push-face 32 defines the height of the triangle and the hypotenuse face 31 joins the push-face 32 to the outersole 20 . [0062] The rearward portion of the outersole 28 includes an under-heel portion 50 that is disposed substantially beneath the heel of the shoe 8 . The under-heel portion 50 may include two spikes 25 and gripping ridges 27 (FIG. 4). The width of the under-heel portion 50 , the width being measured in the plane of the outersole 20 , approximately along the outersole's longitudinal axis (see FIG. 4 a ), is preferably in the range of 0.85 to 1.5 inches. [0063] Rearward portion 28 and forward portions 26 of outersole define central opening 34 (FIG. 4). Central opening 34 may be roughly square-shaped and configured to minimize the space between outersole 20 and shoe 5 that would otherwise form a pocket that might entrap ice or other unwanted debris. [0064] Front-gripping portion 50 of the overshoe is configured to grip the forward toe portion 7 of the shoe and to be form-fitting to the shoe. It is continuous with outersole 20 and is shaped so that it maintains a shape that does not require a user to hold it open when inserting the toe of shoe 5 (FIGS. 1, 3, 5 ). [0065] Front-gripping portion 50 is generally stretchable by a user because it is made of an elastic material. Front-gripping portion 50 includes stretch zones 57 that are sized to be especially elastically deformable by a user. The stretch zones 57 are disposed so that a user may readily stretch them while putting the overshoe 20 onto a shoe but so that the stretch zones 57 are not readily stretched in use while the user is walking. Openings 56 are used to define stretch zones 57 . [0066] Front-gripping portion 50 may have five openings 56 that define six stretch zones 57 that are disposed at the region where the outersole 20 meets the front-gripping portion 50 (FIGS. 3 - 5 ). The stretch zones 57 are sized to allow optimal stretching and snugness of fit and are optimally approximately 0.5 inches in width at their narrowest points. Stretch zones 57 that allow for adjustment of the overshoe 20 in the shoe forward toe area 7 are also incorporated into the upper surface of the front-gripping portion 50 (FIG. 3). [0067] The back-gripping portion 40 of the overshoe 20 is configured to grip the heel portion 8 of the shoe 5 and to be form-fitting to the shoe. It is continuous with the outersole 20 and is shaped so that it maintains a shape that does not require a user to hold it open when inserting the heel 8 of a shoe (FIGS. 1, 3, 6 ). The back-gripping portion 40 is generally stretchable by a user because it is made of an elastic material. The back-gripping portion 40 includes stretch zones 57 that are sized to be especially elastically deformable by a user. [0068] The zones 57 are disposed so that a user may readily stretch the zone 57 while putting the overshoe 10 onto a shoe 5 but so that the zones 57 are not readily stretched while the user is walking. Openings 56 are used to define approximately seven stretch zones 57 . [0069] Referring to FIG. 6, with the left side of the diagram being the left side of shoe 5 ; stretch zones 57 are defined between left opening 42 and the left edge; between the left opening 42 and the bottom edge, between the left opening 42 and the opening 42 that is placed centrally in the back-gripping portion; right opening 42 and the right edge; between the right opening 42 and the bottom edge, between the right opening 42 and the opening 42 that is placed centrally in the back-gripping portion; and between the same central opening 42 in the back edge and the upper edge of the back gripping portion 40 (see also FIGS. 1, 2, and 5 ). The stretch zones 57 of the back portion 40 are sized to allow optimal stretching and snugness of fit and are preferably approximately three-eights inch in width at their narrowest points. [0070] The width dimension, W in FIG. 4 a , of the under-heel band 29 and the thickness, dimension T of FIG. 6 of the under-heel portion 54 and the under-ball portion 52 are preferably greater to increase durability of these critical areas. [0071] Referring to FIGS. 8 - 10 , two further embodiments of a spike 25 are depicted. The spike of FIGS. 8, 9 is formed of suitable material as indicated above that exhibits good grip and has good wear resistant qualities. The spike 25 has a head 70 and a shank 72 . The head 70 presents a preferably circular outer margin 74 and has a generally flat top margin 76 . The diameter of the head 70 is expanded to help prevent the spike 25 from pushing upward through to the shoe of the user as a result of use on hard surfaces. The spike 25 is molded into a button 78 of resilient material, such as nylon or the like. The button 78 has an expanded head 80 to support the spike 25 against the underside of the shoe of the user. The head 80 tapers to a reduced diameter neck 82 . The diameter of the neck 82 is substantially equal to that of the bore 23 formed in the outer sole 20 . The neck 82 expands to a rim 84 , the rim 84 having a greater diameter than the neck 82 . [0072] In assembly, the spike 25 is set into the button 78 when the button is in a molten state. Upon setting of the button 78 , the spike is fixed in the button 78 . Referring to FIG. 10, the shank 72 of the spike 25 has serrations 86 formed on the surface thereof, the serrations 86 acting to form a better engagement with the surrounding button 78 . [0073] The button 78 /spike 25 combination, comprising a spike assembly 88 , is coupled to the outersole 20 by slightly stretching the bore 23 , the button 78 with the spike embedded therein may be readily disposed in the bore 23 by pushing the rim 84 through the stretched bore 23 . When the spike 25 has worn through use, the button 78 may be simply popped out of the bore 23 and a replacement button 78 with embedded spike 25 popped in. [0074] Referring to FIGS. 11 and 12, a modified embodiment of the overshoe 10 is depicted. The overshoe 10 has an opening 34 that extends forward from the under-heel portion 54 in a generally elliptical shape. The front gripping portion 50 terminates in a rearward-most margin 90 that is radiused, as distinct from having a point in the above embodiments. The outersole 20 is formed of material having at least two different thicknesses. The thickness T 2 in the region of greatest contact with the ground is formed in greater thickness than the thickness T 1 . This is true in both the under ball portion 52 and the under heel portion 54 of the overshoe 10 . [0075] A further embodiment of the anti-slip overshoe of the present invention is shown generally at 100 in FIGS. 13 - 16 . The anti-slip overshoe 100 of this embodiment is particularly suited for use with boots. The anti-slip overshoe 100 has five major subcomponents: ball 102 , heel 104 , connecting portion 106 , overtoe 108 , and overheel 110 . [0076] The ball 102 has a tread pattern 112 formed thereon. The tread pattern 112 is comprised of two chevrons, 112 a, b , and a triangle 112 c . The chevrons 112 a, b and the triangle 112 c each have a pattern of spaced apart ridges 114 . Preferably, the ridges 114 of the chevron 112 a and the triangle 112 c face forward while the ridges 114 of the chevron 112 b faces rearward in order to provide traction in both directions. [0077] Four spike apertures 116 are disposed about the tread pattern 112 . Each of the spike apertures 112 facilitates removably fixing a downward directed spike (not shown) in the respective aperture 116 in a manner as noted above. The spikes 116 are preferably oriented in a trapezoid configuration with a spacing between two forward spikes being less than spacing between two rearward spikes. [0078] The heel 104 is disposed immediately rearward of the ball 102 . While the ball 102 is designed to generally underlie the ball of the foot of a wearer of the anti-slip overshoe 100 , the heel 104 is designed to underlie the heel of a wearer of the anti-slip overshoe 100 . [0079] The heel 104 has a downward directed tread pattern 118 . The tread pattern 118 in a preferred embodiment has a rectangle pattern 118 a flanked by two triangular patterns 118 b, c . Each of the rectangular pattern 118 a and triangular patterns 118 b, c has a plurality of spaced apart, angled ridges 120 . The ridges 120 of the rectangular pattern 118 a are directed in the same direction as the ridges 114 of chevron 112 a and triangle 112 c . The ridges 120 of the triangular patterns 118 b, c are directed in the same direction as the ridges 114 of the chevron 112 b . In this manner, the ridges complement the forward and rearward traction characteristics exhibited by the tread pattern 112 . [0080] A pair of spaced apart spike apertures 122 are disposed in the rectangular pattern 118 a and have the same function as the spike apertures 116 described above. [0081] The connecting portion 106 extends between the ball 102 and the heel 104 . The connecting portion 106 is comprised of two spaced apart side straps 124 . Each side strap 124 is at an integral with the ball 102 and heel 104 , respectively. The side straps 124 define a generally triangular shaped aperture 126 therebetween. [0082] The next major subcomponent of the anti-slip overshoe 100 is the overtoe component 108 . The overtoe component is coupled to the ball 102 by a plurality of spaced apart straps 130 . As compared with prior art overshoes, the straps 130 are relatively narrow to accommodate stretching such that the anti-slip overshoe 100 may be used with a plurality of different types of shoes, including the rounded, bulbous pac type boots and including more pointed cowboy type boots. [0083] A plurality of apertures 132 are defined between the straps 130 . Preferably, there are five apertures 132 defined by six straps 130 . A first aperture is centered on the center line 134 of the anti-slip overshoe 100 at the apex of the anti-slip overshoe 100 . [0084] Two additional apertures 132 are arrayed on either side of the apex aperture 132 . Preferably, the overtoe body 128 is a shape that is generally semi-circular, defined by a semi-circle 136 centered on an origin 138 . The two apertures 132 deployed on either side of the apex aperture 132 are preferably equiangularly displaced from the center line 134 . A first aperture 132 on either side of the center line 134 are disposed at an angle between 30 and 50 degrees and preferably substantially 39 degrees from the center line 134 . The second aperture 132 on either side of the center line 134 is preferably disposed at angle of between 30 and 50 degrees from the first aperture and is preferably disposed at an angle of substantially 39 degrees from the first aperture 132 . [0085] The top portion 140 of the overtoe body 128 additionally includes a plurality of apertures defined therein. The first such aperture is a center aperture 142 defined around the origin 138 . In addition to facilitating stretching, the center aperture is useful for pulling the overheel 108 over the heel portion of a shoe by extending a finger at least partially into the first aperture. [0086] Three radial apertures 134 are centered on radaii extending from the origin 138 . A first radial aperture 144 is centered on the center line 134 . A further radial aperture 144 is equiangularly disposed on either side of the first radial aperture 144 . Preferably, the radius on which the second two radial apertures 144 are disposed is coincident with the radius on which the first two apertures 132 are displaced from the center line 134 . A first two side apertures 146 are defined adjacent to a respective angularly displaced radial aperture 144 . Inclusion of the circular aperture 142 , radial apertures 144 , and side apertures 146 in the top portion 140 defines a plurality of stretch zones between the aforementioned apertures that aid in the overtoe component 108 stretching to accommodate a great variety of different shoe toe shapes are previously discussed. [0087] The final major subcomponent of the anti-slip overshoe 100 is the overheel component 110 . The overheel 110 is comprised of a single strap 148 that is displaced from the heel 104 . An aperture 150 is defined between the heel 104 and the strap 148 . [0088] The strap 148 is comprised of a rear portion 152 and two descending connecting portions 154 that are connected to the heel 104 . [0089] The rear portion 152 , which rides on the rear of the heel area of the shoe on which the anti-slip overshoe 100 is disposed, includes a center aperture 156 that is preferably disposed on the centerline 134 . The center aperture 156 is preferably circular in shape. In addition to facilitating stretching, the center aperture is useful for pulling the overheel 108 over the heel portion of a shoe by extending a finger at least partially into the first aperture. [0090] A plurality of curved ridges 158 are disposed adjacent to the center aperture 156 . The ridges 158 facilitate grasping the rear portion 152 and pulling it up over the rear portion of the heel of the shoe. A pair of oval apertures 160 are displaced from the center aperture 156 , one oval aperture 160 on each side of the center aperture 156 . [0091] The connecting portion 154 has a tapering margin 162 that widens as the side portion 154 joins the connecting portion 106 . Each of the side portions 154 has an oval aperture 164 defined therein. [0092] FIGS. 17 - 28 depict four different embodiments of an alternate grip pattern formed on the ball 102 of the anti-slip overshoe 100 . Each of the tread patterns 112 is circular in shape having a plurality of generally circular ridges 114 . Preferably, the tread pattern 112 of FIGS. 17 - 28 is concentric with the origin 138 . The tread patterns 112 of FIGS. 17 - 28 include four spike apertures 116 generally disposed in a rectangular shape and fifth spike aperture 116 a disposed at the origin of the tread pattern 112 . An advantage of the tread patterns 112 of FIGS. 17 - 28 is that the ridges 114 are in all cases angled outward with respect to the origin 138 and thereby provide for improved traction in all quadrants radiating from the origin 138 . Additionally, traction on ice is improved by including a fifth spike disposed in the spike aperture 116 a. [0093] Referring to the embodiment of FIGS. 17 - 19 , the ridges 114 are circular concentric the spike aperture 116 a . Two of the concentric ridges 114 are interrupted by the spike apertures 116 . [0094] FIGS. 20 - 22 depict a second circular tread pattern 112 . In the embodiment of FIGS. 20 - 22 , every other concentric ridge 114 is interrupted by spaces 166 . The spaces 166 emanate radially from the center of the circular tread pattern 112 . There are six radial sets of spaces 166 disposed equiangularly around the origin of the circular tread pattern 112 . [0095] A second set of spaces 168 also radiates from the origin of the circular tread pattern 112 . There are also six sets of spaces 168 radiating from the origin. The spaces 168 intersect every other circular ridge 114 , but not the circular ridges 114 that are intersected by the spaces 166 . [0096] FIGS. 23 - 25 depict a further embodiment of a circular tread pattern 112 . In this circular tread pattern 112 , the spaces 166 , 168 intersect adjacent pairs of circular ridges 114 , the spaces 166 intersecting a first pair and the spaces 168 intersecting an adjacent pair of circular ridges 114 . A final circular tread pattern 112 is depicted in FIGS. 26 - 28 . In this embodiment, circular spaces 170 are included in addition to the spaces 166 , 168 of the embodiment of FIGS. 23 - 25 . The circular spaces 170 are concentric with the origin of the circular tread pattern 112 and are disposed between adjacent pairs of ridges 114 . [0097] It will be obvious to those skilled in the art that other embodiments in addition to the ones described herein are indicated to be within the scope and breadth of the present application. Accordingly, the applicant intends to be limited only by the claims appended hereto.

An overshoe that is removably disposable on a user's shoe and provides a tread surface that enhances the user's footing on slippery surfaces. The tread surface has removable spikes that penetrate surfaces and forward-oriented and rearwards-oriented gripping ridges that grip the surface. The ease of pulling on and removing the overshoe is enhanced by using stretch zones that are placed to allow stretching of the overshoe to fit over a shoe or the like without compromising the snugness of the overshoe fit. A spike assembly for use with an overshoe that fits over a person's shoe and enhances a person's contact with the ground, includes a spike having a head operably coupled to a shank; and a button overmolded on the spike and having a neck for removable engagement in a bore defined in the overshoe. A method of minimizing slippage on a ground surface is further included.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to picture hanging devices. More particularly, the present invention relates to adjustable picture hanging devices. 2. Description of the Prior Art Pictures hanging from a wall typically are supported from a hanger by a wire hanging wire which is attached at opposite ends to the frame. This method, though simple lacks a feature to keep a picture level. Consequently, the picture owner must frequently adjust the frame to bring it back to level. Professional offices and Museums require the pictures to remain straight and hold considerable more load than the home user. While one method is to secure the picture to the wall with a fastening device, this lacks the flexibility of replacement of the picture. What is needed is a simple, secure yet adjustable device for hanging a variety of pictures that prevents the frames from rotating. Numerous innovations for a picture frame hanger have been provided in the prior art that are adapted to be used. Even though these innovations may be suitable for the specific individual purposes to which they address, they would not be suitable for the purposes of the present invention as heretofore described. SUMMARY OF THE INVENTION The present invention is a simple `C` channel cross section which has a plurality of threaded adjusters extending from one side of the channel to the other. The threaded adjuster further has an adjusting nut which is adapted to receive a picture hanging wire or cord. A preselected set of configurations provides for a picture hanger which provides horizontal, and vertical movement in one or several devices. The present invention is adaptable to include large pictures and small. The types of problems encountered in the prior art are that pictures hung from a single or double support tend to not be at the desired location on the wall. In the prior art, unsuccessful attempts to solve this problem were attempted namely: single supports in conjunction with a wire and double hangers using a single wire. In both cases the wire is permitted to slide through the hangers. However, the problem was solved by the present invention because the wire is securely attached to the hanger and can only be moved by adjusting the threaded adjuster. The present invention went contrary to the teaching of the art which permits the wire to slide on the hanger, by securing the wire to the hanging device and providing an adjustment device. The present invention solved a long felt need for a simple secure way of preventing picture from tilting. Accordingly, it is an object of the present invention to provide secure non-tilting hanging of pictures. More particularly, it is an object of the present invention to provide a device which is adjustable permitting a picture to be leveled and positioned horizontally and vertically. In keeping with these objects, and with others which will become apparent hereinafter, one feature of the present invention resides, briefly stated, in a first housing which may be fastened to a mounting surface or the picture frame. In accordance with another feature of the present invention, a wire is securely attached at one end to the housing. Another feature of the present invention is that a threaded adjuster having an adjustable nut is provided to adjust the length of the wire so that the picture can be up to the desired level position. Yet another feature of the present invention is that the weight of the wire causes tension around the adjustable nuts which prevent the wire from slipping. Still another feature of the present invention is that a wire is attached to a picture frame at both ends and intertwined through the present invention to permit both vertical and horizontal adjustment. Yet still another feature of the present invention is that a plurality of the present invention in cooperation with a picture provides adjustment in vertical and horizontal. The novel features which are considered characteristic for the invention are set forth in the appended claims. The invention itself, however, both as to its construction and its method of operation, together with additional objects and advantages thereof, will be best understood from the following description of the specific embodiments when read and understood in connection with the accompanying drawings. LIST OF REFERENCE NUMERALS UTILIZED IN THE DRAWINGS COMMON COMPONENTS TO EMBODIMENTS 12A--fastener (12A) 14A--threaded adjuster (14A) 14AA--first threaded adjuster cord holder (14AA) 14ABA--first threaded adjuster outer nut (14ABA) 14ABB--first threaded adjuster inner nut (14ABB) 14B--second fastener (14B) 14BA--second threaded fastener cord holder (14BA) 16--picture frame (16) 16T--picture frame top (16T) 6B--picture frame bottom (16B) 16L--picture frame left side (16L) 16R--picture frame right side (16R) FIRST EMBODIMENT 110--first picture frame hanger (110) 112--first housing (112) 112A--first housing backing (112A) 112O--first housing outer lip (112O) 112OA--first housing outer lip first opening (112OA) 112OB--first housing outer lip second opening (112OB) 112I--first housing inner lip (112I) 112IA--first housing inner lip first opening (112IA) 112IB--first housing inner lip second opening (112IB) 112IC--first housing inner lip third opening (112IC) 112ID--first housing inner lip fourth opening (112ID) 112IE--first housing inner lip fifth opening (112IE) 116--first cord (116) 116A--first cord knot (116A) 116B--first cord end (116B) 118--first clip (118) SECOND EMBODIMENT 210--second picture frame hanger (210) 212L--second left clip (212L) 212R--second right clip (212R) 214--second cord (214) 214A--second cord first knot (214A) 214B--second cord second knot (214B) THIRD EMBODIMENT 310--third picture frame hanger (310) 312--third housing (312) 312A--third housing backing (312A) 312O--third housing outer lip (312O) 312OA--third housing outer lip first opening (312OA) 312OB--third housing outer lip second opening (312OB) 312I--third housing inner lip (312I) 312IA--third housing inner lip first opening (312IA) 312IB--third housing inner lip second opening (312IB) 312IC--third housing inner lip third opening (312IC) 312ID--third housing inner lip fourth opening (312ID) 312M--third housing middle lip (312M) 312MA--third housing middle lip opening (312MA) 314--third cord (314) 314A--third cord first end (314A) 314B--third cord second end (314B) 316--third fastener (316) FOURTH EMBODIMENT 410--fourth picture frame hanger (410) 412--fourth bracket (412) 412T--fourth bracket top (412T) 412B--fourth bracket back (412B) 412L--fourth bracket left side (412L) 412R--fourth bracket right side (412R) 412A--fourth bracket bottom (412A) FIFTH EMBODIMENT 510--fifth picture frame hanger (510) 512--fifth bracket (512) 512A--fifth bracket plate (512A) 512L--fifth bracket left hook (512L) 512R--fifth bracket right hook (512R) 514--fifth cord (514) 514A--fifth cord knot (514A) SIXTH EMBODIMENT 610--sixth picture frame hanger (610) 612--sixth bracket (612) 612A--sixth bracket plate (612A) 612LO--sixth left outer eyelet (612LO) 612LI--sixth left inner eyelet (612LI) 612RO--sixth right outer eyelet (612RO) 612RI--sixth right inner eyelet (612RI) 614L--sixth left adjuster (614L) 614LA--sixth left adjuster holder (614LA) 614R--sixth right adjuster (614R) 614RA--sixth right adjuster holder (614RA) BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a front view of a first picture frame hanger. FIG. 2 is a rear view of a second picture frame hanger showing a picture frame exhibiting a first picture frame hanger securely mounted on a picture frame left side and a picture frame right side. The second left clip and the second right clip are wall mountable. FIG. 3 is a rear view of a third picture frame hanger. The third cord first end and the third cord second end are securely attached to the picture frame top. FIG. 4 is a rear view of a fourth picture frame hanger showing a first picture frame hanger securely attached to a picture frame left side and a first picture frame hanger securely attached to a picture frame right side. The fourth bracket is wall mountable. FIG. 5 is a rear view of a fifth picture frame hanger showing a first picture frame hanger securely attached to a picture frame left side and a first picture frame hanger securely attached to a picture frame right side and a fifth bracket that is wall mountable. FIG. 6 is a front view of a sixth picture frame hanger (610). The sixth bracket (612) is wall mountable and the first clip (118) is attached to a standard picture frame or picture frame wire. DESCRIPTION OF THE PREFERRED EMBODIMENT Firstly, referring to FIG. 1 which is a front view of a first picture frame hanger (110). The first picture frame hanger (110) comprises a first housing (112). The first housing (112) comprises a first housing backing (112A) having a first housing outer lip (112O) disposed along an edge extending outwardly therefrom and a first housing inner lip (112I) disposed along an opposite edge extending outwardly therefrorm The first housing outer lip (112O) comprises a first housing outer lip first opening (112OA) and a first housing outer lip second opening (112OB) therethrough. The first housing inner lip (112I) comprises a first housing inner lip first opening (112IA) and a first housing inner lip second opening (112IB) and a first housing inner lip third opening (112IC) and a first housing inner lip fourth opening (112ID) and a first housing inner lip fifth opening (112IE) therethrough. The first housing backing (112A) is mountable to a wall by at least one fastener (12A). The first picture frame hanger (110) further comprises a first threaded adjuster (14A). The first threaded adjuster (14A) is positioned through the first housing outer lip first opening (112OA) and the first housing inner lip second opening (112IB). The first threaded adjuster (14A) comprises a first threaded adjuster cord holder (14AA) engagably mounted on an end of the first threaded adjuster (14A) outside the first housing inner lip (112I). At least one threaded adjuster outer nut is engagably mounted on the first threaded adjuster (14A) on an outside the first housing inner lip (112I) adjacent thereto. The first threaded adjuster outer nut comprises a first threaded adjuster outer nut (14ABA) and a first threaded adjuster inner nut (14ABB). The first picture frame hanger (110) further comprises a second threaded adjuster (14B) is positioned through the second housing outer lip second opening (112OB) and the second housing inner lip fifth opening (112IE). The second threaded adjuster (14B) comprises a second threaded adjuster cord holder (14BA) engagably mounted on an end of the second threaded adjuster (14B) between the second housing inner lip (112I) and the first housing outer lip (112O). The first picture frame hanger (110) further comprises a first cord (116) comprises a first cord knot (116A) positioned on an inside of the first housing inner lip (112I). The first cord (116) passes through the first housing inner lip first opening (112IA) then around the first threaded adjuster cord holder (14AA), through the first housing inner lip fourth opening (112ID), and around the second threaded fastener cord holder (14BA). A first clip (118) is attached to a first cord end (116B). When a user turns the threaded adjuster (14A) clockwise the first clip (118) which is attached to a hanging wire of a picture frame (16) is lowered. When the user turns the threaded adjuster (14A) counterclockwise the first clip (118) which is attached to the hanging wire of a picture frame (16) is raised. When a user turns the threaded adjuster (14B) clockwise the first clip (118) which is attached to a hanging wire of a frame (16) moves horizontally toward the first housing outer lip second opening (112OB) and is raised. When a user turns the threaded adjuster (14B) counter clockwise the first clip (118) which is attached to a hanging wire of a picture frame (16) moves horizontally toward the first housing inner lip fifth opening (112IE) and is lowered. The combined action of the threaded adjuster (14A) and the threaded adjuster (14B) functions to position the picture frame (16) in a vertical and horizontal direction. The first picture frame hanger (110) is manufactured from a material selected from a group consisting of plastic, plastic composite, metal, metal alloy, wood, fiberglass, epoxy, carbon-graphite, rubber and rubber composite. Secondly, referring to FIG. 2 which is a rear view of a second picture frame hanger (210) showing a picture frame (16) exhibiting a first picture frame hanger (110) securely mounted on a picture frame left side (16L) and a picture frame right side (16R). A second picture frame hanger (210) comprises a primary first picture frame hanger (110) securely attached to a picture frame left side (16L). The first picture frame hanger (110) comprises a first housing (112). The first housing (112) comprises a first housing backing (112A) having a first housing outer lip (112O) disposed along an edge extending outwardly therefrom and a first housing inner lip (112I) disposed along an opposite edge extending outwardly therefrom. The first housing outer lip (112O) comprises a first housing outer lip first opening (112OA) and a first housing outer lip second opening (112OB) therethrough. The first housing inner lip (112I) comprises a first housing inner lip first opening (112IA) and a first housing inner lip second opening (112IB) and a first housing inner lip third opening (112IC) and a first housing inner lip fourth opening (112ID) and a first housing inner lip fifth opening (112IE) therethrough. The first picture frame hanger (110) is mounted upside down onto the picture frame left side (16L) and further comprises a first threaded adjuster (14A) is positioned through the first housing outer lip first opening (112OA) and the first housing inner lip second opening (112IB). The first threaded adjuster (14A) comprises a first threaded adjuster cord holder (14AA) engagably mounted on an end of the first threaded adjuster (14A) outside the first housing inner lip (112I). At least one threaded adjuster outer nut is engagably mounted on the first threaded adjuster (14A) on an outside of the first housing inner lip (112I) and adjacent thereto. The first threaded adjuster outer nut comprises a first threaded adjuster outer nut (14ABA) and a first threaded adjuster inner nut (14ABB). The first picture frame hanger (110) further comprises a first threaded adjuster (14B) which is positioned through the first housing outer lip second opening (112OB) and the first housing inner lip fifth opening (112IE). The first threaded adjuster (14B) comprises a first threaded adjuster cord holder (14BA) which is engagably mounted on an end of the first threaded adjuster (14B) between the second housing inner lip (112I) and the first housing outer lip (112O). The second picture frame hanger (210) further comprises a secondary first picture frame hanger (110)securely attached to a picture frame right side (16R). The secondary picture hanger (110) is mounted upside down onto the picture frame right side (16R) of the picture frame (16) and further comprises a threaded adjuster (14A) which is positioned through the second housing outer lip first opening (112OA) and the second housing inner lip second opening (112IB). The threaded adjuster (14A) comprises a first threaded adjuster cord holder (14AA) engagably mounted on an end of the threaded adjuster (14A) between the second housing inner lip (112I) and the first housing outer lip (112O). The second picture frame hanger (210) further comprises a second threaded adjuster (14B) which is positioned through the second housing outer hp second opening (112OB) and the second housing inner lip fifth opening (112EE). The second threaded adjuster (14B) comprises a second threaded fastener cord holder (14BA) which is engageably mounted on an end of the second fastener (14B) between the second housing inner lip (112I) and the second housing outer lip (112O). The second picture frame hanger (210) further comprises at least one second clip (212L, 212R) securely mounted on a wall. The second picture frame hanger (210) further comprises a second cord (214). The second cord (214) comprises a second cord first knot (214A) positioned on an inside of the first housing inner lip (112I). The second cord (214) passes through the first housing inner lip first opening (112IA), around the first threaded adjuster cord holder (14AA), through the first housing inner hp fourth opening (112ID), and around the second threaded fastener cord holder (14BA) of the primary first picture frame hanger (110). The second cord (214) further comprises a second cord second knot (214B) positioned on an outside of the first housing inner lip (112I). The second cord (214) passes through the first housing inner hp first opening (112IA), around the first threaded adjuster cord holder (14AA), out through the first housing inner lip third opening (112IC), and in through the first housing inner lip fourth opening (112ID), around the second threaded fastener cord holder (14BA) of the primary first picture frame hanger (110). When a user turns the threaded adjuster (14A) and the second fastener (14B) of the primary first picture frame hanger (110) clockwise the picture frame (16) is lowered and moves its level center to a right. When the user turns the threaded adjuster (14A) and the second fastener (14B) counterclockwise the picture frame (16) is raised and moves its level center to a left. When a user turns the threaded adjuster (14A) and the second fastener (14B) of the secondary first picture frame hanger (110) clockwise the picture frame (16) is raised and moves its level center to a left. When the user turns the threaded adjuster (14A) and the second fastener (14B) counterclockwise the first clip (118) the picture frame (16) is lowered and moves its level center to a right. Fourthly, referring to FIG. 3 is a rear view of a third picture frame hanger (310). The third cord first end (314A) and the third cord second end (314B) are securely attached to the picture frame top (16T). A third picture frame hanger (310) comprises a third housing (312). The third housing (312) comprises a third housing backing (312A) having a third housing outer lip (312O) disposed along an edge extending outwardly therefrom and a third housing inner lip (312I) disposed along an opposite edge extending outwardly therefrom and a third housing middle lip (312M) disposed along a middle edge extending outwardly therefrom The third housing outer lip (312O) comprises a third housing outer lip first opening (312OA) and a third housing outer lip second opening (312OB) therethrough. The third housing inner lip (312I) comprises a third housing inner lip first opening (312IA) and a third housing inner lip second opening (312IB) and a third housing inner lip third opening (312IC) and a third housing inner lip fourth opening (312ID) therethrough. The third housing middle lip (312M) comprises a third housing middle lip opening (312MA) therethrough. The third housing backing (312A) is mountable to a wall by at least one fastener (12A); The third picture frame hanger (310) further comprises a first threaded adjuster (14A) is positioned through the third housing outer lip first opening (312OA) and the third housing inner lip second opening (312IB). The first threaded adjuster (14A) comprises a first threaded adjuster cord holder (14AA) engagably mounted on an end of the first threaded adjuster (14A) outside the third housing inner lip (312I). At least one threaded adjuster outer nut (14ABA) engagably mounted on the first threaded adjuster (14A) on an outside the third housing inner lip (312I) adjacent thereto. The third picture frame hanger (310) further comprises a second threaded adjuster (14B) which is positioned through the third housing outer lip second opening (312OB) and the third housing inner lip fourth opening (312ID). The second threaded adjuster (14B) comprises a second threaded adjuster cord holder (14BA) engagably mounted on an end of the second threaded adjuster (14B) between the third housing outer lip (312O) and the third housing inner lip (312I). The third picture frame hanger (310) further comprises a third cord (314). The third cord (314) comprises a third cord first end (314A) and a third cord second end (314B) each securely attached to a picture frame top (16T) by a third fastener (316). The third cord (314) passes through the third housing middle hp opening (312MA), 11 the third housing inner lip first opening (312IA) around the first threaded adjuster cord holder (14AA) through the third housing inner lip third opening (312IC) around the second threaded fastener cord holder (14BA). When a user turns the threaded adjuster (14A) clockwise the picture frame (16) is lowered. When the user turns the threaded adjuster (14A) counterclockwise the picture frame (16) is raised. Turning the second fastener (14B) clockwise raises the position of the third cord (314) on second threaded fastener cord holder (14BA) and tilts the picture frame (16) below horizontal. Turning the second fastener (14B) counterclockwise lowers the position of the third cord (314) on the second threaded fastener cord holder (14BA) and tilts the picture frame (16) above horizontal. When the tension on the third cord (314) is removed the third cord (314) is easily slid through the third picture frame hanger (310) to align the picture frame (16) to a preselected horizontal orientation. The further turning of the threaded adjuster (14A) and the second fastener (14B) together raises and levels the picture frame (16). The third picture frame hanger (310) is manufactured from a material selected from a group consisting of plastic, plastic composite, metal, metal alloy, wood, fiberglass, epoxy, carbon-graphite, rubber and rubber composite. Fourthly, referring to FIG. 4 which is a rear view of a fourth picture frame hanger (410) showing a first picture frame hanger (110) securely attached to a picture frame left side (16L) and a first picture frame hanger (110) securely attached to a picture frame right side (16R). The fourth bracket (412) is wall mountable. The first picture frame hanger (110) comprises a first housing (112). The first housing (112) comprises a first housing backing (112A) having a first housing outer lip (112O) disposed along an edge extending outwardly therefrom and a first housing inner lip (112I) disposed along an opposite edge extending outwardly therefrom. The first housing outer lip (112O) comprises a first housing outer lip second opening (112OB) therethrough. The first housing inner lip (112I) comprises a first housing inner lip first opening (112IA) and a first housing inner lip fifth opening (112IE) therethrough. The first picture frame hanger (110) further comprises a second threaded adjuster (14B) which is positioned through the first housing outer lip second opening (112OB) and the first housing inner lip fifth opening (112IE). The second threaded adjuster (14B) comprises a second threaded adjuster cord holder (14BA) engagably mounted between the first housing outer lip (112O) and the first housing inner lip (112I). The first picture frame hanger (110) further comprises a secondary first picture frame hanger (110)securely attached to a picture frame right side (16R). The fourth picture frame hanger (410) further comprises a fourth bracket (412) securely mounted on a wall. The fourth bracket (412) comprises a fourth bracket top (412T) having an opening therethrough. The fourth bracket (412) further comprises a fourth bracket back (412B). The fourth bracket (412) further comprises a fourth bracket left side (412L) having an opening therethrough, a fourth bracket right side (412R) having an opening therethrough, and a fourth bracket bottom (412A) having an opening therethrough. The fourth bracket (412) further comprises a threaded adjuster (14A) positioned through the fourth bracket top (412T) opening and the fourth bracket bottom (412A) opening. A first threaded adjuster cord holder (14AA) is engagably mounted on an end of the threaded adjuster (14A) below the fourth bracket bottom (412A). At least one first threaded adjuster nut is engagably positioned between the first threaded adjuster cord holder (14AA) and the fourth bracket bottom (412A). The first threaded adjuster nut comprises a first threaded adjuster outer nut (14ABA) and a first threaded adjuster inner nut (14ABB). The fourth picture frame hanger (410) further comprises a second cord (216), a second cord first knot (216A) positioned on an outside of the first housing inner lip (112I). The second cord (216) passes through the first housing inner lip first opening (112IA) around the first threaded adjuster cord holder (14AA) through the fourth bracket left side (412L) opening over the first threaded adjuster cord holder (14AA) through the fourth bracket right side (412R) opening over the first threaded adjuster cord holder (14AA) through the first housing inner lip first opening (112IA) terminating in a second cord second knot (216B). When a user turns the threaded adjuster (14A) of the primary first picture frame hanger (110) clockwise the first threaded adjuster cord holder (14AA) moves to the left and the picture frame (16) moves to a upwardly to the right. When the user turns the threaded adjuster (14B) of the primary first picture frame hanger (110) counterclockwise the picture frame (16) is lowered and moves to a left. When the user turns the threaded adjuster (14B) of the secondary first picture frame hanger (110) clockwise the first threaded adjuster cord holder (14BA) moves to the right the picture frame (16) moves to a upwardly to the left. When the user turns the threaded adjuster (14B) of the secondary first picture frame hanger (110) counterclockwise the threaded adjuster cord holder (14BA) moves to the left and the picture frame (16) moves downwardly and to the right. When the user turns the threaded adjuster (14A) of the fourth bracket (412) clockwise the first threaded adjuster cord holder (14AA) moves upwardly and the picture frame (16) is lowered. When the user turns the threaded adjuster (14A) of the fourth bracket (412) counterclockwise the first threaded adjuster cord holder (14AA) moves downwardly and the picture frame (16) is raised. The combined action of the first picture frame hanger (110) and the fourth bracket (412) functions to provide horizontal and vertical positioning of the picture frame (16). The fourth picture frame hanger (410) is manufactured from a material selected from a group consisting of plastic, plastic composite, metal, metal alloy, wood, fiberglass, epoxy, carbon-graphite, rubber and rubber composite. Next referring to FIG. 5 which is a rear view of a fifth picture frame hanger (510) showing a first picture frame hanger (110) securely attached to a picture frame left side (16L) and a first picture frame hanger (110) securely attached to a picture frame right side (16R). The fifth bracket (512) is wall mountable. A fifth picture frame hanger (510) comprises a primary first picture frame hanger (110) securely attached to a picture frame left side (16L). The first picture frame hanger (110) comprises a first housing (112) which comprises a first housing backing (112A) having a first housing outer lip (112O) disposed along an edge extending outwardly therefrom and a first housing inner lip (112I) disposed along an opposite edge extending outwardly therefrom. The first housing outer lip (112O) comprises a first housing outer lip first opening (112OA) therethrough. The first housing inner lip (112I) comprises a first housing inner lip first opening (112IA), and a first housing inner lip second opening (112IB), and a first housing inner lip fourth opening (112ID), therethrough. The first picture frame hanger (110) further comprises a first threaded adjuster (14A) is positioned through the first housing outer hp first opening (112OA) and the first housing inner lip second opening (112IB). The first threaded adjuster (14A) comprises a first threaded adjuster cord holder (14AA) engagably mounted between the first housing outer lip (112O) and the first housing inner lip (112I). The first picture frame hanger (110) further comprises a secondary first picture frame hanger (110) which is securely attached to a picture frame right side (16R). The fifth picture frame hanger (510) further comprises a fifth bracket (512) securely mounted on a wall. The fifth bracket (512) comprises a fifth bracket plate (512A) having a fifth bracket left hook (512L) and a fifth bracket right hook (512R) extending therefrorm. The fifth picture frame hanger (510) further comprises a looped fifth cord (514) which is a continuous loop. The looped fifth cord (514) passes through the first housing inner lip first opening (112IA) of the primary first picture frame hanger (110) around the first threaded adjuster cord holder (14AA) through the first housing inner lip fourth opening (112ID), over the fifth bracket left hook (512L) through the secondary first housing inner lip first opening (112IA) of the secondary first picture frame hanger (110) around the first threaded adjuster cord holder (14AA) through the secondary first housing inner lip fourth opening (112ID) and over the fifth bracket right hook (512R). When a user turns the threaded adjuster (14A) of the primary first picture frame hanger (110) clockwise the first threaded adjuster cord holder (14AA) moves to the left and the picture frame (16) moves upward. When the user turns the threaded adjuster (14A) of the primary first picture frame hanger (110) counterclockwise first threaded adjuster cord holder (14AA) moves right and the picture frame (16) moves downward. When the user turns the threaded adjuster (14A) of the secondary first picture frame hanger (110) clockwise the first threaded adjuster cord holder (14AA) moves left and the picture frame (16) moves upward. When the user turns the threaded adjuster (14A) of the secondary first picture frame hanger (110) counterclockwise the first threaded adjuster cord holder (14AA) moves left and the picture frame (16) moves downward. The double looped fifth cord (514) in conjunction with the fifth bracket left hook (512L) and the fifth bracket right hook (512R) function to provide side to side adjustability of the picture frame (16). The fifth picture frame hanger (510) is manufactured from a material selected from a group consisting of plastic, plastic composite, metal, metal alloy, wood, fiberglass, epoxy, carbon-graphite, rubber and rubber composite. Lastly, referring to FIG. 6 which is a front view of a sixth picture frame hanger (610). The sixth bracket (612) is wall mountable and the first clip (118) attaches to a standard picture frame. A sixth picture frame hanger (610) comprises a sixth bracket (612) which comprises a sixth bracket plate (612A). The sixth bracket (612) further comprises a sixth left outer eyelet (612LO) and a sixth left inner eyelet (612LI) and a sixth right outer eyelet (612RO) and a sixth right inner eyelet (612RI) extending downwardly therefrom. The sixth picture frame hanger (610) further comprises a sixth left adjuster (614L) which is positioned through the sixth left outer eyelet (612LO) and the sixth left inner eyelet (612LI). The sixth left adjuster (614L) comprises a sixth left adjuster holder (614LA) having an opening therethrough engagably mounted thereon between the sixth left outer eyelet (612LO) and the sixth left inner eyelet (612LI). The sixth picture frame hanger (610) further comprises a sixth right adjuster (614R). The sixth right adjuster (614R) is positioned through the sixth right outer eyelet (612RO) and the sixth right inner eyelet (612RI). The sixth right adjuster (614R) comprises a sixth right adjuster holder (614RA) having an opening therethrough engagably mounted thereon between the sixth right outer eyelet (612RO) and the sixth right inner eyelet (612RI). The sixth picture frame hanger (610) further comprises a first cord (116). The first cord (116) comprises a first cord knot (116A) which is positioned on the outside of the sixth left adjuster holder (614LA). The first cord (116) passes through the sixth left adjuster holder (614LA), through the sixth right adjuster holder (614RA) and a first clip (118) attached at a first cord end (116B). When a user turns the sixth left adjuster (614L) in a clockwise direction, the first clip (118) engages a hanging wire of a picture frame which moves upwardly. When the user turns the sixth left adjuster (614L) in a counter clockwise direction, the first clip (118) moves downwardly. When the user turns the sixth right adjuster (614R) in a clockwise direction, the first clip (118) moves upwardly and to the right. When the user turns the sixth right adjuster (614R) in a counter clockwise direction, the first clip (118) moves downwardly and leftwardly. A sixth picture frame hanger (610) is manufactured from a material selected from a group consisting of plastic, plastic composite, metal, metal alloy, wood, fiberglass, epoxy, carbon-graphite, rubber and rubber composite. It will be understood that each of the elements described above, or two or more together, may also find a useful application in other types of constructions differing from the type described above. While the invention has been illustrated and described as embodied in a picture frame hanger, it is not intended to be limited to the details shown, since it will be understood that various omissions, modifications, substitutions and changes in the forms and details of the device illustrated and in its operation can be made by those skilled in the art without departing in any way from the spirit of the present invention. Without further analysis, the foregoing will so fully reveal the gist of the present invention that others can, by applying current knowledge, readily adapt it for various applications without omitting features that, from the standpoint of prior art, fairly constitute essential characteristics of the generic or specific aspects of this invention. What is claimed as new and desired to be protected by Letters Patent is set forth in the appended claims.

The present invention is a simple 'U' channel cross section which has a plurality of threaded adjusters extending from one side of the channel to the other. The threaded adjuster further has an adjusting nut which is adapted to receive a picture hanging wire or cord. A preselected set of configurations provides for a picture hanger which provides horizontal, and vertical movement in one or several devices. The present invention is adaptable to include large pictures and small.

The present invention is a continuation of co-pending International Patent Appln. No. PCT/US01/11970, filed Apr. 13, 2001 and designating the United States of America, which application claims the benefit of Provisional U.S. application Ser. No. 60/197,766, filed Apr. 14, 2000; the entire disclosures of both of which are incorporated herein by reference. FIELD OF THE INVENTION The present invention is directed to the field of hair care products. BACKGROUND OF THE INVENTION Human hair, like animal wool, horn, nails, skin, and feathers, etc., comprises proteinaceous helices known as keratins. Such structural proteins degrade with prolonged exposure to sunlight, harsh chemicals such as dyes and bleach, and air-borne pollutants. Hair follicles also stop producing the requisite melanin as a person ages; thus, the hair turns gray. To preserve a youthful appearance or for fashion purposes, the cosmetic industry has developed conditioners and coloring agents for hair. In addition, fragrances and UV blockers have been incorporated into shampoos and conditioners to further impart desirable attributes. However, the technical approaches traditionally adopted to achieve these objectives have been developed in an ad hoc fashion. Current hair dyes and dying systems involve harsh chemicals, such as oxidizing agents, to convert pigment precursors into colored species after such precursors are first applied to the hair. This basic approach requires the precursors to penetrate deeply into the hair shaft, whereupon the oxidative conversion takes place in a subsequent operation. Similarly, when lighter colors or shades are desired, the bleaching agents must diffuse deeply into the hair to destroy the intrinsic melanin deposits. Repeated dying or bleaching using harsh chemicals tends to damage the hair significantly. Scalp exposure to the chemicals also may induce allergic reactions in sensitive individuals. SUMMARY OF THE INVENTION This invention provides a systematic nanoscopic platform to enable a comprehensive list of hair care products. In one embodiment, this invention provides a technology platform for developing hair-coloring products that do not require oxidizing or bleaching chemicals. The nano-technology platform is based on an entirely different premise for coloring. In a similar manner, conditioning effects, UV-blocking abilities, and prolonged fragrance release can be achieved with this invention. The nano-technology platform offers advantages that have not been achievable by other means to date. More particularly, this invention is directed to a hair treatment preparation comprising a dye or other payload with an intimate relationship to a polymeric nanostructure, the nanostructure having hair-reactive functional groups or other characteristics that allow it to be covalently bound to or otherwise immobilized onto or in the hair. This invention describes a systematic approach where nanoscopic objects or structures are either shaped as a miniature sphere or particle that can be attached to a hair, referred to herein as a “nanosphere” or a “nanoparticle”; or as an invisibly small, molecular-dimensioned net surrounding a hair, referred to herein as a “nanoscopic macromolecular network” or “nanoscopic polymer network”. The nanospheres and nanoscopic networks are constructed out of polymeric materials, which can be either naturally occurring or synthetic. The natural kind can be modified or derivatized by well-established organic chemistry. The synthetic type can be specially designed to exhibit custom-tailored properties. The above geometries are merely examples of the whole spectrum of nano-technology that is applicable to the hair product industry. Many variations of the two basic schemes can be envisioned and are intended to be covered by this invention. For example, mixtures of nets and spheres can be developed to give more than one attribute per treatment. In addition, the nets can be fully crosslinked (either chemically or physically) or partially crosslinked. They can even be an entangled but not crosslinked network. The net may further be attached to the hair or to another polymeric species deposited on the hair surface at sparsely distributed points, so that the molecular network resembles a collection of nanoscopic whiskers. The spheres may be formed as micelles, where a group of surfactant molecules capture a payload, the resulting micelle being crosslinked after or upon deposition onto hair through a mordant or a polyelectrolyte. Regardless of the geometrical features, the nanoscopic nature of the entities being engineered ensures three distinct characteristics. First, the imparted attribute can be either nearly permanent or semi-permanent, depending on the attachment chemistry. In the semi-permanent version, the intended effect can be controllably erased by removal of the nano-structure by simple chemical or physical means. Second, the nanoscopic entities are invisibly small. Their presence does not deteriorate the hand or feel of the hair. The impact of the nanoscopic objects or structures can at most be felt as enhanced smoothness or softness. Third, the nano-technology approach is infinitely flexible and adaptable. It can be coupled with many existing dyes, colorants, UV absorbers, fragrances, and softening agents for hair treatment. The present invention is further directed to methods of treating hair which comprise applying a hair treatment preparation to the hair, the hair treatment preparation comprising a payload in an intimate relationship to a polymeric nanostructure, the polymeric nanostructure being reactive to hair or capable of being immobilized onto or in the hair; and changing the conditions such that the payload and nanostructure are attached to the hair. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a schematic representation of one embodiment of a nanoparticle of the present invention, and the method of preparing it by the sequestration of a payload of dyes, fragrances, softeners, medicines (drugs), monomers and the like, into a micelle by polymerizable surfactants, which are then polymerized to make the nanoparticle with a specified interior. DETAILED DESCRIPTION OF THE INVENTION The hair treatment preparations of the invention comprise an agent or payload in permanent or semi-permanent intimate relationship with a polymeric nanostructure, the polymeric nanostructure being reactive to (such as by covalent bonding) or capable of being immobilized onto or in hair. In one embodiment, the polymeric nanostructure may include hair-reactive functional groups for binding or attachment of the nanostructure to the hair to be treated. By “intimate relationship” is meant that the payload is surrounded by, contained within, chemically attached to or otherwise in permanent or semi-permanent relationship with the polymeric nanostructure. By “hair-reactive” is meant that the payload-containing nanostructure will form a covalent bond with the hair. The terms “payload” and “payload agent” as used herein refer collectively to any material or agent that would be desirable for permanent or semi-permanent attachment to or treatment of human or animal hair. It may modify a property of hair or may add new and desirable properties to the hair. The payloads are also referred to herein as “pendant groups”. The payload may be, but is not limited to, dyes or coloring agents, pigments, opacifying agents, scents and fragrances, drugs and pharmaceuticals, softeners, insect repellents, antibacterials and antimicrobials, and the like. While the following discussions herein are directed to certain exemplary agents, it is important to note that other materials having any desirable activity or characteristic suitable for hair treatments may also be incorporated into polymeric nanostructures according to the teachings herein and are included within the scope of this invention. By “dye” is meant a molecule that can absorb wavelengths in the visible or ultraviolet region of the electromagnetic spectrum. Nano-technology is an emerging field of study, where the objects/structures are nanoscopic in dimension. The word “nano” means one-billionth. Therefore, objects characterized by dimensions of 1 nanometer to 1 micron (1 micrometer, or 1000 nanometers) fall within the range of nano-technology. Nano-Technology Based Coloring Systems The power of nano-technology is evidenced by its ability to allow the designed products to segregate or partition engineering requirements into different parts of the system. Instead of requiring the coloring agents or their precursors to penetrate deeply into the hair shaft, the nanoscopic entities may simply be deposited on the surface of the hair strand or only partially penetrate into the interior. Durability or semi-permanency may be the result of, for example, how the nanoscopic structure attaches itself to the hair or crosslinks amongst neighboring entities or crosslinks through a fixative. In the latter two versions, the nanoscopic entities do not have to form direct linkages with the hair itself. In all versions, the nanoparticles or nanoscopic networks are only carriers for the active ingredients (e.g., hair dye). They themselves do not have to be colored intrinsically. Their primary functions are two-fold. First, they must provide a means to anchor themselves on the surface or shallow interior of hair. Second, they must encase or encapsulate the correct dosage of dyestuff (in the case of nanospheres or nanoparticles) or have the dyestuff linked to the carrier (in the case of nanoscopic networks). Note that nanoparticles may assume other, non-spherical shapes, yet may be equally capable of performing the same functions. In either direct attachment or indirect anchoring, the nano-technology approach does not resort to high temperature or extreme pH or harsh chemicals, the use of which will compromise the goal of this invention. Examples of attachment/anchoring are presented below. Those who are skilled in the art of polymer precipitation and complexation will undoubtedly envision additional means of securing the nanospheres based on the teachings herein. These are all intended to be covered by the spirit and scope of this disclosure. The above concepts are illustrated by the examples below. First, with respect to nanospheres or nanoparticles, the payload, for example dye molecules or their aggregates (referred to collectively herein as “dyestuff”), is entrapped, that is, surrounded by or contained within a polymer shell or matrix. The nanoparticle of the invention may comprise a polymeric shell surrounding the payload or it may comprise a three-dimensional polymeric network entrapping the payload, both of which are referred to herein as a “polymer shell”. Alternatively, in the case of hair dyes, if a lighter color/shade is desired, some or most of the particles will contain blocking agents, such as colloidal white pigments (e.g., titanium oxide or zinc oxide). Mixed with these whitening or opacifying agents are nanoparticles containing dyestuff. The overall system yields the desired color/shade, once the mixed particles are deposited on the hair. The nanospheres may be made of non-toxic, non-allergenic polymers. Many polymers have been approved by the FDA for topical usage. Silicones and cellulosics, among many others, are salient examples. Synthetic hydrocarbon-based polymeric systems are equally suitable alternatives. Proteins or synthetic peptides can also be used for this purpose. Well-established encapsulation techniques exist to encase the right amount of dye in particles of controlled size distribution. Literature abounds in both processing and material information to achieve this objective. However, in the present invention, the surface of the nanoparticles contain functional groups for binding or attachment to the hair, to provide permanent or semi-permanent attachment of the payload to the hair. Alternatively, the surface of the nanoparticle includes functional groups that can bind to a linker molecule that will in turn bind or attach the particle to the hair. In either case, these functional groups are referred to herein as “hair-reactive functional groups”. The chemical linkage on the surface of the nanoparticle does not involve the molecules of the payload. The payload agents are physically entrapped within the nanoparticle, thus requiring no chemical modifications of the payload molecules themselves. The resulting encapsulated payload preparations or nanoparticles have improved retention within and on the hair structure without changing the inherent character of the payload agent. The payload-containing nanoparticles may be formed via one of several methods of encapsulation known in the art, such as interfacial polymerization, microemulsion polymerization, precipitation polymerization, and diffusion. Multi-component mixture preparation followed by atomization/spraying into a drying chamber is yet another processing scheme. Reactive functional groups on the polymer shell provide a means for attaching the hair treatment nanoparticles to human hair. The nanoparticles of the invention are formed by contacting a payload with a set of monomers, oligomers, or polymers (referred to herein as a “polymeric set”). The monomers, oligomers, or polymers assemble around the payload and then are polymerized, with or without crosslinking, into a polymeric network or shell surrounding the payload. The polymeric set in one embodiment includes at least some components that provide reactive functional groups on the surface of the final polymeric bead, which will bind to the hairs to be treated. Alternatively, a nanoparticle optionally having hair-reactive functional groups on its surface can first be prepared by polymerizing a polymeric set, after which a payload can be exposed to the bead under suitable conditions such that the payload is absorbed into and entrapped in the polymeric network or shell, to provide the hair-reactive payload nanoparticle. Particular monomers, oligomers, or polymers useful in forming the nanoparticles of the present invention are those that contain amine, hydroxyl, or sulfhydryl monomers or polymers combined with amine-, hydroxyl-, or sulfhydryl-reactive monomers or polymers. Along the backbone of the polymer constituting the nanospheres, hair-reactive functional groups may be introduced that may either be chemically reactive under mild conditions or be electrostatically interactive with complementary groups on the surface of the hair when the ionic strength or surfactant content of the medium is shifted by rinsing. Example interactions include charge-charge, dipolar, hydrogen-bonding, hydrophobic, or dehydration interactions. The nanospheres may be made of a polyelectrolyte with an isoelectric point in the range of alkaline pH. These particles may be effectively precipitated or aggregated by using another polyelectrolyte (linear or branched polymer fixative) that possesses an acidic isoelectric point. When the hair is first exposed to the nanospheres and then is re-exposed to the second polyelectrolyte fixative, a complex forms in situ, coating the treated hair. Another route is the use of a potent surfactant formulation to carry the payload-containing nanoparticles to the hair surface in a finely divided dispersion. Once in place, the surfactant is rinsed away, leaving the nanoparticles adhering strongly to the treated hair. An example is silicone-based nanoparticles. Such particles can be easily dispersed in a block or graft copolymer of poly(dimethylsiloxane-ethylene glycol) liquid. The latter medium may be rinsed away by water, as the component is water-soluble, leaving the insoluble nanoparticle as an adherent precipitate. Functionalized siloxanes can further refine this precipitation principle by utilizing complexation as well. For example, siloxanes with carboxylate side groups may be precipitated by the dual use of removing the surfactant and adding a polyamine (such as polyethyleneimine in the aqueous rinse solution). Conversely, amino-substituted siloxanes can form an in situ crosslinked network with the nanoparticles embedded within by the addition of polyacids (such as polyacrylic acid or polymaleic acid or copolymers thereof. Complexation can also be induced by addition of polyvalent cations or anions, each reactive towards the complementary charged surface groups. The principle of thermodynamics-induced and complexation-induced precipitation/anchoring on hair surfaces can be equally applied to other synthetic or naturally occurring nanostructures. For example, the payload can first be chemically coupled onto a protein carrier. This protein-payload complex is dispersed in a medium, which is then applied to the hair. A change in the thermodynamic balance of the medium causes deposition of the complex on the surface of hair. The hair is thus treated. Since coupling is carried out chemically outside the presence of hair, traditional chemical means can be used without fear of hair degradation or skin sensitivity. Protein deposition can then be effected by simpler, milder fixative reactions. We reiterate the power of delegating different engineering requirements to different parts of the system. The color comes from the dyestuff contained within the nanoparticles. Yet, the controlled degree of permanency stems from the attachment methodology. The above precipitation/complexation approach can be made difficult to reverse or it can be easily reversible. Reversibility can be engineered to occur only in the presence of certain specific agents. Therefore, normal hair wash or shampoo does not cause fading of the color. For example, functionalized silicones are difficult to wash away, unless specific siloxane-containing surfactants such as block or graft copolymers of siloxane-polyethylene glycol are used. Equivalently, complex or precipitate dissolution may or may not occur under similarly engineered rinsing conditions. Thus, the artificially-created hair color can be either preserved in a prolonged manner or reversed when desired. Note that derivatized cellulosics can be made to function in a similar way. Synthetic polypeptides can also be used for dyestuff encapsulation. Such cellulosic or proteinaceous surfaces can be modified to exhibit varying isoelectric points, which can be exploited to tailor their precipitation/coagulation/complexation properties. Nanospheres are but one geometry as a possible dye or other payload carrier. Dye molecules can also be attached to linear, branched, or lightly crosslinked polymer carriers, as long as they remain soluble or dispersible in a suitable (aqueous or mixed aqueous) and chemically mild liquid. Dye fixation onto hair is implemented through reaction/precipitation/complexation on the surface of hair via any of the above-illustrated and many other schemes. Imagine the dye-attached polymer having a tree-like architecture. As long as residual functional groups exist after the dye is attached onto the tree, the whole ensemble may be deposited on the surface of hair in a subsequent operation (removal of surfactant, addition of precipitant, introduction of coagulating or complexing agent, etc.). Even if no discernible functional groups remain after the initial dye attachment, the carrier still may have great utility simply due to its ability to adhere firmly to hair as a consequence of a shift in the thermodynamic environment of the medium. One group of polymers useful as nanostructures in the present invention are the dendrimers and other highly branched polymers. Dendrimers also have a high degree of symmetry. Because such polymers are branched, they are compact and so good penetration, and thus permanency, into hair is expected. Dendrimers and highly branched polymers can be designed to have one or more different types of functional groups on them. Using these functional groups, dye molecules, alkyl or siloxane chains to add softness, or other molecules of interest can be attached to the dendrimer so that it becomes a compact carrier. The payload-containing linear, branched, or lightly crosslinked polymer carriers may be attached to the hair via a mordant or cationic fixing agent. Carboxyl-, phosphate-, phosphonate-, sulfate-, and sulfonate-containing polymers can be complexed with alkaline earth metal that have very low toxicity, such as Mg 2+ , Ca 2+ , and Sr 2+ . Thus, for example, a soluble polymer that contains, for example, carboxyl groups and one or more payloads, such as dye molecules or compounds that add softness, is applied to the hair. In a next step, a soluble calcium or magnesium salt is added to the hair to precipitate the polymer on and in the hair. In short, the nanoscopic carrier approach provides a flexible, invisible system to color hair. In contrast to traditional chemical assaults, the system is gentle to the hair and the color may be long-lasting or reversed by custom-tailored means. Nano-Technology Based Softener, Fragrance, and UV Blocking Treatments for Hair In a manner similar to the dying process described above, the nanoscopic carriers described in this invention may also be used to deposit fragrances, UV absorbers/blockers, and other desirable agents on hair. The carriers may be particulate in shape or simply be a polymer of arbitrary architecture. The use of methods of fixation enabled through the carriers is one part of the innovation. Silicones and polyolefins impart a soft hand on hair. They may be deposited on hair simply as the carrier itself in the context of this invention. The fixative step is then part of the innovation. For example, in the first rinse a cationic silicone is applied. This coating is then fixed in place in a subsequent rinse containing an anionic silicone, resulting in a complex formation that creates a silicone network on the surface of the hair. Charged polyolefins can be substituted for the silicones in the above example. In certain instances, such as for example when the payload is a fragrance or a pharmaceutical agent, it is desirable for the payload to be controllably released from the nanostructure on or into the hair. Nanoparticles can be designed so that the payload agent is embedded or entrapped within the polymeric shell or matrix of the nanoparticle but is also able to be released from the nanoparticle in a prolonged or otherwise controllable fashion. The release profile is programmed via the chemistry of the polymer network of the nanoparticle. The nanoparticle can be formulated with an almost infinite degree of designed characteristics via structural features, such as crosslinking density, hydrophilic-hydrophobic balance of the copolymer repeat units, and the stiffness/elasticity of the polymer network (for example, the glass transition temperature). In addition, erodible nanoparticles or other nanostructures can be developed to controllably release the payload. Furthermore, the polymer matrix may contain components that react or respond to environmental stimuli to cause increased/decreased content release. “Smart polymers” are polymers that can be induced to undergo a distinct thermodynamic transition by the adjustment of any of a number of environmental parameters (e.g., pH, temperature, ionic strength, co-solvent composition, pressure, electric field, etc.). For example, smart polymers based on the lower critical solution temperature (LCST) transition may cut off release when exposed to warm or to hot water during washing. When cooled back to room temperature, sustained release resumes. Smart polymers may be selected from, but are not limited to, N-isopropyl acrylamide and acrylamide; polyethylene glycol, di-acrylate and hydroxyethylmethacrylate; octyl/decyl acrylate; acrylated aromatic and urethane oligomers; vinylsilicones and silicone acrylate; polypropylene glycols, polyvinylmethyl ether; polyvinylethyl ether; polyvinyl alcohol; polyvinyl acetate; polyvinyl pyrrolidone; polyhydroxypropyl acrylate; ethylene, acrylate and methylmethacrylate; nonyl phenol; cellulose; methyl cellulose; hydroxyethyl cellulose; hydroxypropyl methyl cellulose; hydroxypropyl cellulose; ethyl hydroxyethyl cellulose; hydrophobically-modified cellulose; dextran; hydrophobically-modified dextran; agarose; low-gelling-temperature agarose; and copolymers thereof. If crosslinking is desired between the polymers, multifunctional compounds such as bis-acrylamide and ethoxylated trimethylol propane triacrylate and sulfonated styrene may be employed. In presently preferred embodiments, the smart polymers comprise polyacrylamides, substituted polyacrylamides, polyvinylmethyl ethers, and modified celluloses. Where it is desirable for the payload to be visible (when it is a dye or a UV protector, for example), the nanoparticle will be constructed of optically transparent or translucent material, allowing light to come into contact with the payload and be reflected, refracted or absorbed. The polymeric set can be chosen to give either hydrophobic or oleophilic nanoparticles, allowing a wider array of bioactive compounds or drugs to be comfortably entrapped within. Where the particles are hydrophilic, they are easily dispersible in a stable aqueous suspension or emulsion by surfactants, which can subsequently be washed away without affecting the performance of the payload agent within. The inherent thermodynamic compatibility of the agents and the polymeric shell or matrix material can increase the loading level per particle. The following examples are intended to illustrate some, but not all, of the concepts described in this disclosure, and are in no way intended to limit it. One skilled in the art would also see that different ideas from different examples or from the above explanation could be combined to yield other possible ways of treating hair. EXAMPLES Example 1 One or more of the same or different dye molecules are covalently bonded, by methods known in the art, to an amine-containing polymer or oligomer such as poly(ethylenimine), poly(allylamine hydrochloride), or poly(lysine). (An oligomer or polymer of arginine would be expected to behave similarly.) Hair is wet with a solution containing this polymer or oligomer with dye molecules pendant on it (a polymeric or oligomeric dye). In some cases it may be necessary to rinse away excess material. To set or cure the amine-containing polymer, the hair is then exposed to a polymer that contains carboxyl, sulfate, sulfonate, phosphate, or phosphonate moieties. Examples of such polymers include DNA, poly(acrylic acid), poly(itaconic acid), poly(maleic anhydride), copolymers containing maleic anhydride units, a polymer with —C 6 H 5 COOH groups, poly(methacrylic acid), or poly(styrene sulfonate, sodium salt). Excess material is then rinsed away. An electrostatic interaction holds the two polymers together, greatly decreasing the solubility of the complex. This and all other formulations and solutions mentioned in this document may additionally contain fragrances, wetting agents, oxidizing agents, antioxidants, opacifiers, thickeners, reducing agents, defoamers, surfactants (anionic, cationic, nonionic, amphoteric, zwitterionic, or mixtures thereof), sequestering agents, medicines (drugs), dispersing agents, conditioners, limited quantities of organic solvents, antibacterial agents, preserving agents, and the like, as well as mixtures thereof. Example 2 One or more dye molecules are covalently bonded to a carboxyl-containing polymer or oligomer such as poly(acrylic acid), poly(itaconic acid), poly(maleic anhydride), a copolymer containing maleic anhydride units, a polymer with —C 6 H 5 COOH groups, or poly(methacrylic acid). Hair is wet with a solution containing this oligomeric or polymeric dye. Excess material is then rinsed away. To set this polymer, the hair is exposed to a polycation (polymer or oligomer), such as poly(ethylenimine), poly(allylamine hydrochloride), poly(lysine), poly(arginine), or poly(diallyldimethylammonium chloride). Example 3 Hair is exposed to a solution containing one or more polymeric or oligomeric dyes, as described in Example 1 (polycations). It may be necessary to rinse the hair after this first treatment. The hair is then exposed to a solution that contains one or more polymeric or oligomeric dyes (polyanions), as described in Example 2 and it is rinsed. Example 4 An alkyl chain, which is defined herein as a linear or branched molecule that contains primarily C, CH, CH 2 , and CH 3 units, is tethered to an amine-containing polymer or oligomer, such as poly(ethylenimine), poly(allylamine hydrochloride), or poly(lysine). Linear or branched siloxane chains may also be added to the amine-containing polymer or oligomer. One or more of the same or different dye molecules may also be added to the polymer, by methods known in the art. Hair is then exposed to this polycation and excess reagent may be rinsed away. The hair is then exposed to a polyanion, which may have alkyl chains, siloxane chains, or dyes tethered to it. One possible polyanion, which may act as a softener, is a copolymer of maleic anhydride and a vinyl ether of the form: CH 2 ═CHO(CH 2 ) n CH 3 , where n is at least 2, and is preferably greater than 4. Example 5 An amine-containing dye is reacted with benzoquinone, naphthoquinone, anthraquinone or a derivative thereof to form a polymeric or oligomeric dye. The following are three of the numerous possible adducts. Example 6 An amine-containing dye is reacted with a dye that contains one or more reactive groups such as acid chlorides (—C(O)Cl), sulfonyl chlorides (—SO 2 Cl), vinyl sulfones (—SO 2 CH═CH 2 ), or an active derivative of cyanuric chloride. Examples of each of these four possible linking chemistries for dyes and polymers is shown below. Any other amine-reactive functional groups that may appear on a reactive dye molecule, such as epoxides or acid anhydrides, could be used as well. Example 7 A polyelectrolyte containing pendant groups, which modify a property of hair or which add new and desirable properties, is deposited on hair. An oppositely charged polyelectrolyte, which also may contain one or more pendant groups that modify a property of hair or that add a desirable property to hair, is added to the hair, condensing with the first polymer to immobilize it. Example 8 A polymer or oligomer that contains one or more pendant groups, which modify one or more properties of hair or which add one ore more desirable properties, is deposited on hair. Excess reagent may be washed away from the hair. A mordant, which we define as a species that contains a metal atom with an oxidation number of 2 or higher, is added to the deposited polymer, immobilizing the polymer. Example 9 A mordant is deposited on hair. Excess reagent may be washed away from the hair. A polymer or oligomer that contains one or more pendant groups which modify one or more properties of hair or which adds one or more desirable properties is deposited on hair. The mordant complexes with the polymer to immobilize the polymer. Example 10 One or more dye molecules is covalently attached to a polymer or oligomer of ethylenimine, such as triethylenetetraamine (see Reaction Scheme 1). In addition to an ethylenimine, any polymer with free amine groups may be used, including poly(allylamine hydrochloride) and poly(lysine). Additional starting materials include small molecules with multiple amines, such as ethylenediamine, and large polymers of ethylenimine (branched or linear). Amines are well know to react with a variety of dyes. For example, U.S. Pat. No. 6,203,578 shows reactions of amines with benzoquinone, naphthoquinone, and anthraquinone, and some of their derivatives, as well as with dyes that have amine-reactive groups. Other amine-reactive groups that are found on commercially-available reactive dyes include moieties based on vinyl sulfone and cyanuric chloride. After introduction of the dye to the polymer, a group capable of chelating a metal is introduced. One of the possible ways of doing this is by reaction of the remaining amines on the molecule with an ester of α-chloro, α-bromo, or α-iodoacetic acid. The ester is a protecting group that is removed after addition of the molecule to the polymer. Thus, this triethylenetetraamine-dye adduct is then allowed to react with an ester of α-haloacetic acid (ClCH 2 C(O)OR, BrCH 2 C(O)OR, lCH 2 C(O)OR) (see Reaction Scheme 1). The ester group is then removed by a method known in the art (deprotection), leaving a metal-chelating polymeric dye. Methods for the introduction of the protected metal chelating group and its deprotection are known in the art; see, U.S. Pat. No. 6,080,785. In a preferred embodiment, the ester of the α-haloacetic acid is a methyl ester. For example, ClCH 2 C(O)OCH 3 is an inexpensive chemical that is available in bulk quantities. Note that the carboxymethyl group can be introduced by reaction of formaldehyde and hydrogen cyanide with an amine. The addition of these two reagents to ethylenediamine (the Strecker synthesis) yields ethylenediaminetetraacetic acid (EDTA) (see Beyer and Walter in Handbook of Organic Chemistry , Prentice Hall, 1996). Also note that the chelating polymeric dye shown in Reaction Scheme 1 is a close analog of EDTA and nitrilotriacetic acid (N(CH 2 COOH) 3 ), both of which are effective metal chelators. Example 11 This example (see Reaction Scheme 2) demonstrates two important features of the chemistry disclosed herein. First is the ability to immobilize a polymeric dye with a mordant using groups that can chelate a metal. Second is the extraction of the metal atoms from the polymer with EDTA or NTA, which reverses the initial dyeing process. Note that the exact geometry of the metal-polymer complex will vary from metal to metal. Both intramolecular (shown in Reaction Scheme 2) and intermolecular crosslinks between polymeric or oligomeric dye molecules are expected. As is the case for all of the processes shown here, the depth of penetration of the dye into the fiber could be controlled, in part, by the size of the molecule. One or more surfactants or other additives may also be present in this and other formulations (see Example 1). Example 12 In this example (see Reaction Scheme 3), a polymeric dye is first created, a softening agent is then added to the oligomeric or polymeric dye, and a chelating group is introduced. Siloxane and alkyl chains are expected to act as softeners, but another important feature of these long chains is to reduce the solubility of the polymeric or oligomeric dye. Thus, when any surfactants in the formulation are removed by rinsing, the polymeric dye may be deposited onto the hair. Addition of metal (shown in Reaction Scheme 4) would act to increase its durability. As was the case in Example 11, the process of adding a metal is reversible using EDTA and NTA (see Reaction Scheme 5). Reaction Scheme 3 shows introduction of an alkyl or siloxane chain with an epoxide group. While epoxide chemistry is a preferred embodiment of the ideas in this example, other possible reactive groups that could be used to introduce long-chain alkyl or siloxane groups by means known in the art include, but are not limited to, anhydrides, acid chlorides, carboxylic acids, sulfonyl chlorides (to make sulfonamides), etc. Example 13 A variety of molecules that impart desirable properties to hair or to the formulation can be incorporated into reactive monomers, such as in the reaction between an amine and an acid chloride (see Reaction Schemes 6 and 7). Later it will be possible to polymerize such monomers into polymers that have desirable properties, where the level or concentration of certain groups is carefully controlled. Example 14 N-isopropylacrylamide (NIPA) (see Reaction Scheme 7b) will make a polymer thermally sensitive. In other words, at low temperatures, a polymer that has NIPA (or an analogous monomer) will have a higher water solubility than at higher temperatures. Thus, a polymer can be designed that precipitates when the hair is washed with warm or hot water. Example 15 In this example (see FIG. 1 ), a set of molecules, which may be dyes, fragrances, softeners, medicines (drugs), monomers, or other molecules which modify a property of hair or which add new and desirable properties, is emulsified with a polymerizable surfactant. The resulting micelles are then polymerized into a nanoparticle, which can be applied to hair and then, depending on the head group of the surfactant, set with a mordant or a polyelectrolyte with a charge opposite that of the surfactant's head groups. The head groups may be designed to be analogs of EDTA or NTA so that the surfactant will be particularly effective in chelating a metal ion. Example 16 Derivatives of itaconic anhydride and maleic anhydride can be used as polymerizable surfactants (see Reaction Scheme 8). To produce such surfactants, a fatty alcohol (or amine, which is not shown) can be reacted with the anhydride to produce a surfactant. A carboxyl group is the head group. In its deprotonated form, it will impart a high degree of solubility to the alkyl chain in the surfactant. This head group can be precipitated with an appropriate mordant. In some cases, it may be desirable to create an anionic surfactant by addition of ethylene oxide units to the carboxyl group of the polymerizable surfactant (bottom four structures in Reaction Scheme 8). It is not intended that the present invention be limited to the polymerizable surfactants described in this document. A variety of other polymerizable surfactants have been developed and may be applicable to the situations described herein. A few references showing the syntheses, use, and properties of these materials include: Stähler, et al., Langmuir 1998, 14, 4765-4775; Stähler, et al., Langmuir 1999, 15, 7565-7576; Kline, Langmuir 1999, 15, 2726-2732; Soula and Guyot, Langmuir 1999, 15, 7956-7962; Shen, et al., Langmuir 2000, 16, 9907-9911; Viitala, et al., Langmuir 2000, 16, 4953-4961; Jung, et al., Langmuir 2000, 16, 4185-4195; Gargallo, et al., Langmuir 1998, 14, 5314-5316; Liu, et al., Langmuir 1997, 13, 4988-4994; Xu, et al., Langmuir 1999, 15, 4812-4819. Example 17 A polyamine, which contains two or more amine groups (the amines could be pendant or the spacing between the amines could be three or more carbons, although it is two in the preferred embodiment), is reacted with one or more alkyl or siloxane chains to produce a surfactant (see Reaction Scheme 9). The amines are then derivatized with carboxymethyl groups to form a surfactant that can chelate metals. Thus, a set of dyes, fragrances, softeners, medicines (drugs), or other small molecules or polymers could be brought into solution with this surfactant and the resulting micelles could be precipitated onto hair by using an appropriate mordant. A particularly useful embodiment of this idea is the reaction of ethylenediamine with an oxirane ring (epoxide) on an alkyl or siloxane chain. Carboxymethyl groups are then introduced into the resulting molecule. One or more of the carboxyl groups or the hydroxyl group may be functionalized with ethylene oxide units, as is commonly done with nonionic surfactants. Example 18 A variety of molecules that add desirable properties to a polymer are added to poly(acryloyl chloride), which acts as a scaffold. See Reaction Scheme 10 for examples of a few of the many possible species (amines and alcohols in the preferred embodiment), which could react with poly(acryloyl chloride) to create a functionalized polymer with tailored properties. Example 19 A variety of molecules that add desirable properties to a polymer are added to poly(acrylic anhydride), which acts as a scaffold. See Reaction Scheme 11 for examples of a few of the many possible species (amines and alcohols in the preferred embodiment), which could react with poly(acrylic acid) to create a functionalized polymer with tailored properties. Copolymers of maleic anhydride would be expected to react similarly to the polymer shown in Reaction Scheme 11. Example 20 A fatty amine with the general formula CH 3 (CH 2 ) n NH 2 , although branched alkyl chains are also possible, is derivatized with carboxymethyl groups according to the methods described in this document to yield a surfactant with the formula: CH 3 (CH 2 ) n N(CH 2 COOH) 2 . One or both of the carboxyl groups in this surfactant can be deprotonated. A set of small molecules, which may include dyes, fragrances, softeners, medicines (drugs), monomers, etc., is made soluble with this surfactant. The resulting micelles are then precipitated onto hair with a mordant. Because this surfactant can be rendered insoluble by chelating it with an appropriate metal, this surfactant could be generally useful in any situation where it is desirable to remove a surfactant from a formulation. As is the case for nonionic surfactants, some ethylene oxide units may be added to this surfactant. It is expected that mordant crosslinking with chelating surfactants will be of intermediate effect in limiting the release of small molecules captured in micelles by these surfactants. Thus, capture and immobilization of small molecules by this method may provide an effective means of allowing time release of certain small molecules such as fragrances and medicines (drugs). Surfactants with different chelating powers (note those in Example 17 and Reaction Scheme 9) could be combined to fine tune properties of time-release formulations. Example 21 A set of one or more surfactants is used to bring one or more insoluble or quite insoluble species, including polymers and oligomers, into aqueous solution. Upon rinsing away the material, the insoluble or nearly insoluble species are deposited onto hair. Example 22 A known dye molecule, including, but not limited to acid dyes, direct dyes, reactive dyes, mordant dyes, sulfur dyes, and vat dyes, is reacted with a polymer and the polymer is deposited on hair by one of the methods described in this document. Example 23 A mordant dye is coupled to a polymer or oligomer and this material is deposited on hair. Addition of a mordant causes crosslinking of the polymer molecules through the mordant dye pendant groups. Example 24 A protein, which acts as a scaffold, is derivatized with dye molecules, softeners, a polyelectrolyte oligomer chain, carboxymethyl groups or other species that may impart a desirable property to hair. The resulting protein complex is then precipitated onto hair and immobilized to one degree or another with the methods described herein, e.g., a polyelectrolyte or a mordant.

The present invention is directed to a hair treatment preparation comprising a payload in an intimate relationship to a polymeric nanostructure, the polymeric nanostructure being reactive to hair or capable of being immobilized onto or in hair. The nanoscopic nature of the entities being engineered ensures three distinct characteristics. First, the imparted attribute can be either nearly permanent or semi-permanent, depending on the attachment chemistry. In the semi-permanent version, the intended effect can be controllably erased by removal of the nanostructure by simple chemical or physical means. Second, the nanoscopic entities are invisibly small. Their presence does not deteriorate the hand or feel of the hair. Third, the nano-technology approach is infinitely flexible and adaptable. It can be coupled with many existing dyes, colorants, UV absorbers, fragrances, softening agents and the like for hair treatment. Methods for treating hair with the hair treatment preparations of the invention are also encompassed.

[0001] The present invention refers to a method of infiltrating enamel, in particular for the prevention and/or treatment of carious lesions. The present invention further refers to a kit for carrying out said method of infiltrating enamel, which comprises a conditioner comprising hydrochloric acid and an infiltrant comprising at least one low viscous dental resin. FIELD OF THE INVENTION [0002] In industrial countries, about 98% of the adult population exhibits one or more carious lesions or are already provided with fillings. Any carious lesion which eventually may lead to cavitation is initiated by demineralization of the hard tooth substance. At an early stage, referred to as “initial enamel caries”, the tooth surface remains intact without visible signs of erosion but the demineralized area below the surface becomes more and more porous. [0003] Today, the only non-operative ways to treat approximal caries are to enhance remineralization by application of fluorides and to arrest lesion progress by improvement of patient's oral hygiene. While smooth surfaces of the tooth are more susceptible for improved cleaning strategies, approximal surfaces are particularly difficult to clean. Nevertheless, remineralization in approximal lesions that have reached the dentin seems to be hardly achievable, since several clinical studies showed that from this threshold a visible cavitation of the lesion is established in most cases (Rugg-Gunn, A J. Approximal carious lesions. A comparison of the radiological and clinical appearances. Br Dent J, 1972, 133:481-484; De Araujo, F B et al. Diagnosis of approximal caries: radiographic versus clinical examination using tooth separation. Am J Dent, 1992, 5:245-248; Ratledge et al. A clinical and microbiological study of approximal carious lesions. Part 1: The relationship between cavitation, radiographic lesion depth, the site-specific gingival index and the level of infection of the dentine. Caries Res, 2001, 35:3-7). Moreover, in vitro studies even found many cavitations in lesions confined to enamel. A cavitated enamel lesion cannot be cleaned sufficiently by the patient and will progress (Marthaler, T M and Germann, M. Radiographic and visual appearance of small smooth surface caries lesions studied on extracted teeth. Caries Res, 1970, 4:224-242; Kogon, S L et al. Can radiographic criteria be used to distinguish between cavitated and noncavitated approximal enamel caries? Dentomaillofac Radiol, 1987, 16:33-36). Therefore, if a cavitation occurs even at such an early stage of the caries process, a remineralization seems very unlikely under clinical conditions. This could explain clinical findings, that fluoridation and improved oral hygiene can only slow down the progression of approximal caries but are not capable of reversing it (Mejare, I et al. Caries development from 11 to 22 years of age: A prospective radiographic study. Prevalence and distribution. Caries Res, 1998, 32:10-16). [0004] Once a cavitation has developed, invasive methods of treatment are generally indicated. However, drilling out carious tooth material is always accompanied by the removal of non-carious, i.e. sound, hard tooth substance. In approximal carious lesions which are difficult to reach, the ratio of carious and intact substance being removed is particularly unfavorable. Moreover, the connection between an inserted filling and the endogenous tooth material is susceptible for carious lesions itself, and renewal of fillings due to the ageing process leads to further removal of sound tooth material. Therefore, methods of treating caries at an early stage, and in particular approximal initial carious lesions, are highly desirable in order to prevent later requirement for invasive procedures. [0005] One apparent indication of initial enamel caries are white spot lesions. Such a lesion is characterized by a loss of mineral in the bulk of enamel, whereas the surface of the lesion remains relatively intact (so-called “pseudo-intact surface layer”). A promising approach of non-operative dentistry might be the sealing of enamel lesions with low viscous light curing resins such as dental adhesives and fissure sealants. The tiny pores within the lesion body act as diffusion pathways for acids and minerals and, therefore, enable the dissolution of enamel at the advancing front of the lesion. The aim of the proposed regimen is not only to seal the surface but to infiltrate these pores, thereby withdrawing the lesion body from further attack. Moreover, after curing the resin material, a mechanical support of the fragile enamel framework in the lesion will be achieved. [0006] The idea to arrest caries by sealing with low viscous resins has been followed in a few in vitro experiments since the seventies of the last century (Robinson, C et al. Arrest and control of carious lesions: A study based on preliminary experiments with resorcinol-formaldehyde resin. J Dent Res, 1976, 55:812-818; Davila, J M et al. Adhesive penetration in human artificial and natural white spots. J Dent Res, 1975, 54:999-1008; Gray, G B and Shellis, P. Infiltration of resin into white spot caries-like lesions of enamel: An in vitro study. Eur J Prosthodont Restor Dent, 2002, 10:27-32; Garcia-Godoy, F et al. Caries progression of whit spot lesions sealed with an unfilled resin. J Clin Pediatr Dent, 1997, 21:141-143; Robinson, C et al. In vitro studies of the penetration of adhesive resins into artificial caries-like lesions. Caries Res, 2001, 35:136-141; Schmidlin, P R et al. Penetration of a bonding agent into de- and remineralized enamel in vitro. J Adhes Dent, 2004, 6:111-115). It could be shown that sealants penetrate the body of artificial lesions up to 95% (Gray, G B and Shellis, P. Infiltration of resin into white spot caries-like lesions of enamel: An in vitro study. Eur J Prosthodont Restor Dent, 2002, 10:27-32), and reduce the accessible pore volumes within the lesions significantly (Robinson, C et al. In vitro studies of the penetration of adhesive resins into artificial caries-like lesions. Caries Res, 2001, 35:136-141). Moreover, it has been observed that sealants are capable to inhibit further lesion progress under demineralizing conditions (Robinson, C et al. Arrest and control of carious lesions: A study based on preliminary experiments with resorcinol-formaldehyde resin. J Dent Res, 1976, 55:812-818; Garcia-Godoy, F et al. Caries progression of whit spot lesions sealed with an unfilled resin. J Clin Pediatr Dent, 1997, 21:141-143; Robinson et al. In vitro studies of the penetration of adhesive resins into artificial caries-like lesions. Caries Res, 2001, 35:136-141). [0007] However, one of the problems in sealing natural enamel lesions is that “pseudo-intact surface layers” have higher mineral contents compared to carious bodies of lesion. As a consequence, these layers inhibit the penetration of the lesion body by the sealing material and may even function as a barrier. In the end, the surface layer may be superficially sealed, but the carious body may be insufficiently penetrated by the resin. At worst, the carious process further proceeds below the “seal”. [0008] Efforts have been made to enhance the penetration of an enamel lesion. In an in vitro model, extracted bovine incisors were treated to produce an intact surface layer, a body of lesion and a progressive demineralization front. It has been shown that a 5-second etching of those artificially induced lesions with phosphoric acid resulted in deeper penetration depths (Gray, G B and Shellis, P. Infiltration of resin into white spot caries-like lesions of enamel: An in vitro study. Eur Prosthodont Restor Dent, 2002, 10:27-32). Thus, such a pre-treatment or “conditioning” of an enamel area by etching could also improve the penetration of sealant in vivo. However, artificially induced enamel lesions differ from natural lesions in that they comprise regular and relatively thin “pseudo-intact surface layers”. Natural enamel lesions, in contrast, usually show higher mineralized surface layers of varying thickness. Thus, conditioning with phosphoric acid, although demonstrated as successful in vitro, must not necessarily provide for a benefit in vivo. [0009] Nevertheless, an in vivo study reported that the application of a conventional adhesive onto enamel lesions pre-treated with phosphoric acid gel resulted in retardation of caries progression compared to controls (Ekstrand et al. Caries Res, 2004, 38:361). However, patients were monitored for two years only and diagnosis was done by x-raying, a rather insensitive method for analyzing successful penetration. Therefore, the results of this study should be regarded with some caution, as even the authors concede. Moreover, it remains unclear whether this initial success would be seen after longer periods since the rather superficial “seal” might be destroyed due to the physical load in vivo. [0010] Thus, there is still a strong need for an improved non-operative procedure of treating initial enamel lesions in order to inhibit caries progression. [0011] It is therefore an object of the present invention to provide for a method and means enabling improved resin penetration of initial enamel lesions. SUMMARY OF THE INVENTION [0012] The object of the present invention is solved by a method of infiltrating enamel, comprising the following steps: (a) exposing an enamel area to be infiltrated to a conditioner comprising hydrochloric acid; (b) exposing the enamel area conditioned in step (a) to an infiltrant; (c) curing the infiltrant. [0016] In one embodiment, the conditioner is based on a gel comprising about 1-30% (w/w) of hydrochloric acid. [0017] In a preferred embodiment, the conditioner is based on a gel comprising about 5-15% (w/w) of hydrochloric acid. [0018] In a further embodiment, the conditioner further comprises additives selected from the group comprising glycerol, highly dispersed silicon dioxide and methylene blue. [0019] In one embodiment, the infiltrant comprises at least one low viscous resin. [0020] In a preferred embodiment, the low viscous resin is selected from the group comprising bis-GMA, 2,2-bis[4-(2-hydroxy-3-methacryloxypropoxy)phenyl]propane; bis-PMA, propoxylated bisphenol-A-dimethacrylate; bis-EMA, ethoxylated bisphenol-A-dimethacrylate; bis-MA, bisphenol-A-dimethacrylate; UDMA, 1,6-bis(methacryloxy-2-ethoxycarbonylamino)-2,4,4-trimethylhexan; UPGMA, urethane bisphenol-A-dimethacrylate; TEGDMA, triethylene glycol dimethacrylate; TEGMMA triethylene glycol monomethacrylate; TEEGDMA, tetraethylene glycol dimethacrylate; DEGDMA, diethylene glycol dimethacrylate; EGDMA, ethylene glycol dimethacrylate; DDDMA, 1,10-decanediol dimethacrylate; HDDMA, 1,6-hexanediol dimethacrylate; PDDMA, 1,5-pentanediol dimethacrylate; BDDMA, 1,4-butanediol dimethacrylate; MBDDMA ½, BDDMA-methanol-adduct ½; DBDDMA ½, BDDMA-auto-adduct ½; PRDMA, 1,2-propanediol dimethacrylate; DMTCDDA, Bis(acryloxymethyl) triclodecane; BEMA, benzyl methacrylate; SIMA, 3-trimethoxysilane propylmethacrylate; SYHEMA ½, ½- cyclohexene methacrylate; TYMPTMA, trimethylolpropane trimethacrylate; MMA, methyl methacrylate; MAA, methacrylic acid; and HEMA, 2-hydroxyethyl methacrylate. [0021] In a particularly preferred embodiment, the low viscous resin is selected from the group comprising polymethacrylic acid and derivatives thereof. [0022] In a most preferred embodiment, the low viscous resin is selected form the group comprising bis-GMA, 2,2-bis[4-(2-hydroxy-3-methacryloxypropoxy)phenyl]propane; UDMA, 1,6-bis(methacryloxy-2-ethoxycarbonylamino)-2,4,4-trimethylhexan; TEGDMA, triethylene glycol dimethacrylate; and HEMA, 2-hydroxyethyl methacrylate. [0023] In a further embodiment, the infiltrant further comprises additives selected from the group comprising CQ, camphoroquinone; BL, benzil; DMBZ, dimethoxybenzoin; CEMA, N-(2-cyanoethyl)N-methylanilin; DMABEE, 4-N,N-diethylaminobenzoic acid ethyl ester; DMABBEE, 4-N,N-diethylaminobenzoic acid butyl ethoxy ester; DMABEHE, 4-N,N-diethylaminobenzoic acid 2-ethylhexyl ester; DMAEMA, N,N-diethyl aminoethyl methacrylate; DEMAEEA, N,N-(bis-ethylmetacrylate)-2-ethoxyethylamine; HMBP, 2-hydroxy-4-methoxy benzophenone; TINP, 2(2′-hydroxy-5′-methylphenyl) benzotriazol; TIN326, Tinuvin 326; TIN350, Tinuvin 350; Tin328, Tinuvin 328; HQME, hydroxyquinone monomethyl ester; BHT 2,6-di-t-butyl-4-methyl phenol; MBP 2,2-methylene-bis(6-t-butylphenol); MBEP, 2,2-methylenebis(6-t-butyl-4-ethylphenol); BPE, benzoic acid phenylester; MMMA, methyl methacrylate methanol adduct; CA, camphoric anhydride; HC ½, 2(3)-endo-hydroxyepicamphor; TPP, triphenyl phosphane; TPSb, triphenyl stibane; DMDDA, dimethyl dodecylamine; DMTDA, dimethyl tetradecylamine; DCHP, dicyclohexyl phthalate; DEHP, bis-(2-ethylhexyl) phthalate; and formaldehyde. [0024] The object of the present invention is further solved by a use of a method of infiltrating enamel according to any of the preceding claims for the prevention and/or treatment of a carious lesion in a subject in need thereof. [0025] In one embodiment, the subject is a mammal, preferably human. [0026] The object of the present invention is also solved by a kit for infiltrating enamel, comprising at least the following: [0027] (a) a conditioner comprising hydrochloric acid; [0028] (b) an infiltrant. [0029] In one embodiment, the conditioner is based on a gel comprising about 1-30% (w/w) of hydrochloric acid. [0030] In a preferred embodiment, the conditioner is based on a gel comprising about 5-15% (w/w) of hydrochloric acid. [0031] In a further embodiment, the conditioner further comprises additives selected from the group comprising glycerol, highly dispersed silicon dioxide and methylene blue. [0032] In one embodiment, the infiltrant comprises at least one low viscous resin. [0033] In a preferred embodiment, the low viscous resin is selected from the group comprising bis-GMA, 2,2-bis[4-(2-hydroxy-3-methacryloxypropoxy)phenyl]propane; bis-PMA, propoxylated bisphenol-A-dimethacrylate; bis-EMA, ethoxylated bisphenol-A-dimethacrylate; bis-MA, bisphenol-A-dimethacrylate; UDMA, 1,6-bis(methacryloxy-2-ethoxycarbonylamino)-2,4,4-trimethylhexan; UPGMA, urethane bisphenol-A-dimethacrylate; TEGDMA, triethylene glycol dimethacrylate; TEGMMA triethylene glycol monomethacrylate; TEEGDMA, tetraethylene glycol dimethacrylate; DEGDMA, diethylene glycol dimethacrylate; EGDMA, ethylene glycol dimethacrylate; DDDMA, 1,10-decanediol dimethacrylate; HDDMA, 1,6-hexanediol dimethacrylate; PDDMA, 1,5-pentanediol dimethacrylate; BDDMA, 1,4-butanediol dimethacrylate; MBDDMA ½, BDDMA-methanol-adduct ½; DBDDMA ½, BDDMA-auto-adduct ½; PRDMA, 1,2-propanediol dimethacrylate; DMTCDDA, bis(acryloxymethyl) triclodecane; BEMA, benzyl methacrylate; SIMA, 3-trimethoxysilane propylmethacrylate; SYHEMA ½, ½-cyclohexene methacrylate; TYMPTMA, trimethylolpropane trimethacrylate; MMA, methyl methacrylate; MAA, methacrylic acid; and HEMA, 2-hydroxyethyl methacrylate. [0034] In a particularly preferred embodiment, the low viscous resin is selected from the group comprising polymethacrylic acid and derivatives thereof. [0035] In a most preferred embodiment, the low viscous resin is selected form the group comprising bis-GMA, 2,2-bis[4-(2-hydroxy-3-methacryloxypropoxy)phenyl]propane; UDMA, 1,6-bis(methacryloxy-2-ethoxycarbonylamino)-2,4,4-trimethylhexan; TEGDMA, triethylene glycol dimethacrylate; and HEMA, 2-hydroxyethyl methacrylate. [0036] In a further embodiment, the infiltrant further comprises additives selected from the group comprising CQ, camphoroquinone; BL, benzil; DMBZ, dimethoxybenzoin; CEMA, N-(2-cyanoethyl)N-methylanilin; DMABEE, 4-N,N-diethylaminobenzoic acid ethyl ester; DMABBEE, 4-N,N-diethylaminobenzoic acid butyl ethoxy ester; DMABEHE, 4-N,N-diethylaminobenzoic acid 2-ethylhexyl ester; DMAEMA, N,N-diethyl aminoethyl methacrylate; DEMAEEA, N,N-(bis-ethylmetacrylate)-2-ethoxyethylamine; HMBP, 2-hydroxy-4-methoxy benzophenone; TINP, 2(2′-hydroxy-5′-methylphenyl) benzotriazol; TIN326, Tinuvin 326; TIN350, Tinuvin 350; Tin328, Tinuvin 328; HQME, hydroxyquinone monomethyl ester; BHT 2,6-di-t-butyl-4-methyl phenol; MBP 2,2-methylene-bis(6-t-butylphenol); MBEP, 2,2-Methylenebis(6-t-butyl-4-ethylphenol); BPE, benzoic acid phenylester; MMMA, methyl methacrylate methanol adduct; CA, camphoric anhydride; HC ½, 2(3)-endo-hydroxyepicamphor; TPP, triphenyl phosphane; TPSb, triphenyl stibane; DMDDA, dimethyl dodecylamine; DMTDA, dimethyl tetradecylamine; DCHP, dicyclohexyl phthalate; DEHP, bis-(2-ethylhexyl) phthalate; and formaldehyde. [0037] The object of the present invention is also solved by a use of a kit for infiltrating enamel for the prevention and/or treatment of a caries lesion in a subject in need thereof. [0038] In one embodiment, the subject is a mammal, preferably human. [0039] The object of the present invention is also solved by a method for preparing the kit. [0040] The object of the present invention is also solved by the use of hydrochloric acid for the manufacture of a medical product for the prevention and/or treatment of a carious lesion. [0041] In one embodiment, the medical product is based on a gel comprising about 1-30% (w/w) of hydrochloric acid. [0042] In a preferred embodiment, the medical product is based on a gel comprising about 5-15% (w/w) of hydrochloric acid. [0043] In a further embodiment, the medical product further comprises additives selected from the group comprising glycerol, highly dispersed silicon dioxide and methylene blue. [0044] The object of the present invention is also solved by a method for manufacturing the medical product. [0045] The object of the present invention is also solved by an infiltrant comprising at least one low viscous resin. [0046] In one embodiment, the low viscous resin is selected from the group comprising bis-GMA, 2,2-bis[4-(2-hydroxy-3-methacryloxypropoxy)phenyl]propane; bis-PMA, propoxylated bisphenol-A-dimethacrylate; bis-EMA, ethoxylated bisphenol-A-dimethacrylate; bis-MA, bisphenol-A-dimethacrylate; UDMA, 1,6-bis(methacryloxy-2-ethoxycarbonylamino)-2,4,4-trimethylhexan; UPGMA, urethane bisphenol-A-dimethacrylate; TEGDMA, triethylene glycol dimethacrylate; TEGMMA triethylene glycol monomethacrylate; TEEGDMA, tetraethylene glycol dimethacrylate; DEGDMA, diethylene glycol dimethacrylate; EGDMA, ethylene glycol dimethacrylate; DDDMA, 1,10-decanediol dimethacrylate; HDDMA, 1,6-hexanediol dimethacrylate; PDDMA, 1,5-pentanediol dimethacrylate; BDDMA, 1,4-butanediol dimethacrylate; MBDDMA ½, BDDMA-methanol-adduct ½; DBDDMA ½, BDDMA-auto-adduct ½; PRDMA, 1,2-propanediol dimethacrylate; DMTCDDA, bis(acryloxymethyl) triclodecane; BEMA, benzyl methacrylate; SIMA, 3-trimethoxysilane propylmethacrylate; SYHEMA ½, ½-cyclohexene methacrylate; TYMPTMA, trimethylolpropane trimethacrylate; MMA, methyl methacrylate; MAA, methacrylic acid; and HEMA, 2-hydroxyethyl methacrylate. [0047] In a preferred embodiment, the low viscous resin is selected from the group comprising polymethacrylic acid and derivatives thereof. [0048] In a particularly preferred embodiment, the low viscous resin is selected form the group comprising bis-GMA, 2,2-bis[4-(2-hydroxy-3-methacryloxypropoxy)phenyl]propane; UDMA, 1,6-bis(methacryloxy-2-ethoxycarbonylamino)-2,4,4-trimethylhexan; TEGDMA, triethylene glycol dimethacrylate; and HEMA, 2-hydroxyethyl methacrylate. [0049] In a further embodiment, the infiltrant further comprises additives selected from the group comprising CQ, camphoroquinone; BL, benzil; DMBZ, dimethoxybenzoin; CEMA, N-(2-cyanoethyl)N-methylanilin; DMABEE, 4-N,N-diethylaminobenzoic acid ethyl ester; DMABBEE, 4-N,N-diethylaminobenzoic acid butyl ethoxy ester; DMABEHE, 4-N,N-diethylaminobenzoic acid 2-ethylhexyl ester; DMAEMA, N,N-diethyl aminoethyl methacrylate; DEMAEEA, N,N-(bis-ethylmetacrylate)-2-ethoxyethylamine; HMBP, 2-hydroxy-4-methoxy benzophenone; TINP, 2(2′-hydroxy-5′-methylphenyl) benzotriazol; TIN326, Tinuvin 326; TIN350, Tinuvin 350; Tin328, Tinuvin 328; HQME, hydroxyquinone monomethyl ester; BHT 2,6-di-t-butyl-4-methyl phenol; MBP 2,2-methylene-bis(6-t-butylphenol); MBEP, 2,2-Methylenebis(6-t-butyl-4-ethylphenol); BPE, benzoic acid phenylester; MMMA, methyl methacrylate methanol adduct; CA, camphoric anhydride; HC ½, 2(3)-endo-hydroxyepicamphor; TPP, triphenyl phosphane; TPSb, triphenyl stibane; DMDDA, dimethyl dodecylamine; DMTDA, dimethyl tetradecylamine; DCHP, dicyclohexyl phthalate; DEHP, bis-(2-ethylhexyl) phthalate; and formaldehyde. [0050] The object of the present invention is further solved by a method for preparing an infiltrant. [0051] The term “exposing” as used herein refers to any procedure by which the enamel is provided with the conditioner or the infiltrant. Mostly, an exposure will be achieved by simple application, e.g. by spreading. For that purpose, the kit may additionally comprise one or more devices suitable for supporting the application, e.g. a brush, a sponge, a tissue, a pipette, a syringe or such. [0052] It is considered by the present invention that the conditioner may be removed prior to application of the infiltrant. Thus, the kit may additionally comprise any device for that purpose. [0053] It is further considered by the present invention that surplus infiltrant may be removed. Thus, the kit may additionally comprise any device for that purpose. [0054] Preferably, the conditioner is allowed to remain applied for about 90-120 seconds, more preferably, the conditioner is allowed to remain applied for about 120 seconds. [0055] Preferably, the infiltrant is allowed to remain applied for up to about 120 seconds, more preferably, the infiltrant is allowed to remain applied for about 120 seconds. [0056] Preferably, the infiltrant is applied twice. [0057] An “enamel area to be infiltrated” preferably is an area comprising a carious lesion. However, in order to prevent such lesions, i.e. for prophylaxis, any carious damage may be also absent in this area. [0058] The conditioner may alternatively be based on an aqueous solution or may also be embedded in a plaster. [0059] It is also considered by the present invention that the conditioner may additionally comprise phosphoric acid up to about 40% (w/w), preferably in the range of about 20% to 37% (w/w). [0060] “Curing of the infiltrant” is preferably achieved by light-induced polymerization. [0061] To enable access to the approximal surface, a separation of the carious teeth could be performed using orthodontic elastics. This technique is well documented for diagnostic purposes. [0062] The resins according to the present invention are further considered for use as dental adhesives and/or fissure sealants. [0063] Said resins cited above may be used, e.g. within the infiltrant of the present invention, either separately or in any combination thereof. [0064] In conclusion, the present invention provides for an improved penetration of initial enamel lesions by an infiltrant. Within the prior art, methods of sealing enamel are available which, however, bear the risk of only superficially sealing the “pseudo-intact surface layer” but leaving the body of lesion insufficiently penetrated by the resin. Using the method and means, e.g. the conditioner and/or the low viscous resins, according to the present invention, occlusion of the body of lesion becomes possible. [0065] First, by exposing an enamel area to be infiltrated to the conditioner comprising hydrochloric acid, the “pseudo-intact surface layer” is removed such that infiltration of carious areas by the infiltrant is greatly facilitated. Second, the resins cited above exhibit very low viscosity properties, and thus the infiltrant readily reaches the pores of the lesion to occlude them. [0066] By using the method and means according to the present invention, invasive treatment of an enamel lesion may be prevented or at least delayed. Due to the non-operative character of the sealing procedure, the patient's compliance will be greatly enhanced. The method is well practicable with low costs. Finally, the inventive method may represent a therapeutic link between pure prophylaxis and invasive treatment of caries. [0067] As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural reference unless the context clearly dictates otherwise. DETAILED DESCRIPTION OF THE INVENTION [0068] In the following, the invention should be further illustrated by making reference to FIGS. 1-3 and to Examples 1 and 2. [0069] FIGS. 1-3 show results obtained by the Confocal Laser Scanning Microscope (CLSM) imaging technique. [0070] FIG. 1 shows an initial enamel carious lesion after conditioning with 37% of phosphoric acid gel for 30 seconds. [0071] FIG. 2 shows an initial enamel carious lesion after conditioning with 15% hydrochloric acid gel for 120 seconds. [0072] FIG. 3 shows a partially infiltrated initial enamel carious lesion. EXAMPLES Example 1 Effect of the Pre-treatment with a Conditioner Comprising Hydrochloric Acid [0000] 1. Material and Methods [0000] 1.1 Sample Preparation [0073] Extracted human molars and premolars, showing approximal white spots were cut across the demineralizations. One-hundred-twenty lesions confined to the outer enamel were selected. The cut surface as well as half of each lesion, thus serving as control, was covered with nail varnish. Subsequently, the lesions were etched with either phosphoric (37%) or hydrochloric (5% or 15%) acid gel for 30 to 120 seconds (n=10). [0000] 1.2 Visualization [0074] The specimens were dried for 5 minutes in a silicone hose, closed at one end with a stopper, and separated with silicone rings. Subsequently, Spurr's resin (Spurr, A R. A low-viscosity epoxy resin embedding medium for electron microscopy. J Ultrastruct Res, 1969, 26:31-43), labeled with 0.1 mmol/l of the fluorescent dye Rhodamine B Isothiocyanate (RITC), was doused over the specimens and the hose was closed with another stopper. The resin was cured in an autoclave (Ivomat IP3; Ivoclar Vivadent, Schaan, Liechtenstein) at 0.8 MPa and 70° C. for 8 hours. Under this pressure, the very low viscous resin penetrated into the remaining pores of the lesion. After curing, the specimens were cut, fixed on object holders, parallelized and polished up to 4000 grit (Exakt Mikroschleifsystem; ExaktApparatebau). This infiltration technique was termed VIsualisation by Resin INfiltration (VIRIN). [0000] 1.3 CLSM Imaging [0075] The specimens were studied using a Confocal Laser Scanning Microscope (CLSM) (Leica TCS NT; Leica, Heidelberg, Germany). The excitation light was generated with an Ar/Kr-Laser and had a maximum wavelength at 560 nm. The images were recorded in fluorescent mode. The emitted light was conducted through a 590 nm long pass filter to make sure that only fluorescent light was detected and reflected light was suppressed. Specimens were observed with a 40× objective using oil immersion. The observed layer was approximately 10 μm below the surface. Laser beam intensity and photo multiplier amplification were kept constant during the investigation. The images (250×250 μm) were taken with a resolution of 1024×1024 pixels and 256 pseudo color steps (red/black) and analyzed using the ImageJ Program (NIH; Rockville Pike, Md., USA). [0000] 2. Results [0076] The thickness of the surface layers in the control and the etched parts as well as the erosions in the sound and diseased tissues were measured. Etching with H 3 PO 4 gel for 30 seconds did not alter the thickness of the surface layer significantly (p>0.05; t-test). However, the surface layer reduction was significantly increased in lesions etched with 15% HCl gel for 90 seconds compared to those etched with H 3 PO 4 gel for 30 seconds or 90 seconds (p<0.05; ANOVA). No significant differences in the depths of erosion in the lesions compared to sound enamel could be observed (p>0.05; t-test). [0077] In FIG. 1 , it is shown that pre-treatment of initial enamel carious lesions with 37% of phosphoric acid gel for 30 seconds resulted in only insufficient etching of the “pseudo-intact surface layer”. Thus, this kind of pre-treatment is not capable of destabilizing the surface layer to an extent necessary for optimal penetration of the infiltrant. In consequence, sealing will be only superficial. Incomplete infiltration, however, does not protect from organic acids and dissolution of enamel and erosion will further proceed. In FIG. 2 , it is shown that pre-treatment with 15% of hydrochloric acid gel for 120 seconds resulted in complete removal of the “pseudo-intact surface layer”. [0078] It can be concluded that a reliable reduction of the surface layer can be achieved by etching with 15% hydrochloric acid gel for 90-120 seconds. Example 2 Penetration of Infiltrant in the Presence or Absence of a “Pseudo-Intact Surface Layer” [0000] 1. Material and Methods [0079] Natural enamel lesions were etched with 15% hydrochloric acid for 30 seconds. Several experimental infiltrants and the commercial adhesive Excite (Vivadent, Schaan, Lichtenstein), respectively, each labeled with the fluorescent dye RITC, were applied on the lesions using a micro brush. After a penetration time of 120 seconds the overlying material was wiped away using a cotton roll and the resins were light cured for 15 seconds (Translux CL; Heraeus Kulzer). The preparation for the CLSM observation was carried out as described above, except that the embedding resin was labeled with the fluorescent dye Fluoresceine Isothiocyanate (FITC). The CLSM observation was carried out as described above except that the double fluorescence mode was used for RITC/FITC observation. [0000] 2. Results [0080] In FIG. 3 , it is shown that enamel areas covered by a “pseudo-intact surface layer” (A, dark surface zone) are not penetrated by the infiltrant (arrows). In contrast, in the absence of this layer (B) the infiltrant readily has penetrated the area below (double-arrow). [0081] Thus, in areas where the “pseudo-intact surface layer” was removed by the etching gel, an infiltration of the lesion could be achieved. In areas where the “pseudo intact surface layer was not completely removed by the conditioning agent no significant infiltration of the lesion was observed. [0082] All patents, patent applications, provisional applications, and publications referred to or cited herein are incorporated by reference in their entirety, including all figures and tables, to the extent they are not inconsistent with the explicit teachings of this specification. [0083] It should be understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and purview of this application.

The present invention refers to a method of infiltrating enamel, in particular for the prevention and/or treatment of carious lesions. Said method of infiltrating enamel comprises the steps of (a) exposing an enamel area to be infiltrated to a conditioner comprising hydrochloric acid; (b) exposing the enamel area conditioned in step (a) to an infiltrant comprising at least one low viscous dental resin; and (c) curing the infiltrant. The present invention further refers to a kit for carrying out said method.

BACKGROUND OF THE INVENTION [0001] Field of the Invention [0002] The invention relates generally to exercise equipment and in particular to a body alignment and correction device. [0003] Background Art [0004] Exercise equipment, particularly when used in an athletic club, has become very popular. Unfortunately, to put it simply, most people who are working out are doing it wrong. They hold their bodies and limbs in incorrect positions, resulting in repetitive motion injuries, imbalanced development of their muscle groups, and other long-term problems that are easily avoided with the correct posture and limb positioning. A body alignment and correction device, which secures the user's body and limbs in the correct positions when working out, would resolve this problem. SUMMARY OF THE INVENTION [0005] Accordingly, the invention is directed to a body alignment and correction device. The device provides a rectangular platform, with a front post and a rear post which unfold and telescope into position. Carabiner clips are provided along the sides of the platform. Various elastic and other workout attachments may be clipped to the carabiner clips, and to the upper ends of the front post and rear post, providing resistance for the user during a workout. An adjustable, removable claw attachment on the rear post secures the user's shoulders and upper body in the correct alignment during the workout. Four retractable caster wheels at the corners of the platform enable the user to easily move the device around the workout area as desired. [0006] Additional features and advantages of the invention will be set forth in the description which follows, and will be apparent from the description, or may be learned by practice of the invention. The foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0007] The accompanying drawings are included to provide a further understanding of the invention and are incorporated into and constitute a part of the specification. They illustrate one embodiment of the invention and, together with the description, serve to explain the principles of the invention, [0008] FIG. 1 is a side perspective view of the first exemplary embodiment in the unfolded position, displaying the platform 10 , the front post 11 , the rear post 12 , the claw attachment 12 A, the carabiner clips 13 , the barbell table 14 , and the workout attachments 15 ; [0009] FIG. 2 is a side perspective view of the platform component of the first exemplary embodiment in the folded position, displaying the platform 10 , and the caster wheels 10 A; [0010] FIG. 3 is a rear view of a portion of the belt component of the first exemplary embodiment; [0011] FIG. 4 is a rear view of the belt component of the first exemplary embodiment; [0012] FIG. 5 is a front view of belt component of the first exemplary embodiment in a reverse bent position; [0013] FIG. 6 is a perspective view of an embodiment of the belt of the invention, without blocks. [0014] FIG. 7 is a perspective view of an embodiment of the belt of the invention with a pair of blocks positioned on the rear or inside surface of the belt. [0015] FIG. 8 is a top view of the belt with blocks positioned on the abdomen of the user. [0016] FIG. 9 is a perspective view of a block with an enclosure and attachment assembly. [0017] FIG. 10 is a side elevation view of the block of FIG. 9 , with breakouts showing composition of the block. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0018] Referring now to the invention in more detail, the invention is directed to a body alignment and correction device. [0019] The first exemplary embodiment is comprised of a body alignment and correction device for use during workouts. The device provides a rectangular platform 10 , with a front post 11 and a rear post 12 which unfold and telescope into position, rotate fully through a 180° arc, and may be locked into position at any length or angle as desired. Carabiner clips 13 are provided along the sides of the platform 10 . Various elastic and other workout attachments 15 may be clipped to the carabiner clips 13 , and to the upper ends of the front post 11 and rear post 12 , providing resistance for the user during a workout. [0020] An adjustable, removable claw attachment 12 A on the rear post secures the user's shoulders and upper body in the correct alignment during the workout. A removable barbell table 14 may be secured to the platform 10 , enabling the user to work out with barbells or other hand weights while secured in the correct posture by the claw attachment 12 A. Four retractable caster wheels 10 A at the corners of the platform 10 enable the user to easily move the device around the workout area as desired. The platform 10 is hinged in the center such that it may be folded in half for easy transport and storage. [0021] A broad, padded belt 16 is provided, with hook-and-loop fasteners 21 at either end. The belt 16 is preferably 3-4 inches wide. The layers of the belt 16 are affixed to each other with snaps 17 . The layers of the belt 16 may also be fastened with other fastening devices such as zippers and hook and loop fasteners. The layers of the belt 16 may also be sewn together with stitching. Flat bands 19 , terminating in rings or carabiner style belt clips 18 , are provided on the front and rear surfaces of the belt 16 , which may be used as drawstrings to tighten and secure the belt 16 around the user's waist, or secure the user's body to the device. [0022] In other embodiments the bands 19 may each terminate in a complimentary buckle member 30 a and 30 b as shown in FIGS. 6 and 7 , so that the bands 19 may be fastened in front of the user when worn. The bands 19 may also include adjustment buckles 35 so that the bands 19 may be adjusted in length. In other embodiments, the buckles 35 may be used to join or connect portions of the bands that have different characteristics, such as elasticity. A ring 36 may also be attached near the buckle members 30 a and 30 b on each band 19 . The bands 19 are preferably 1.5 inches wide, and covered for two-thirds of their length with neoprene sleeves. Divots and snaps 17 hold the neoprene sleeves together. However, in some embodiments, the bands need not be covered. [0023] The snaps 17 enable the user to remove and replace the bands 19 if they are broken or worn out, or if the belt 16 needs to be laundered. The foam blocks 20 may be positioned such that they are just above the kidneys on the back for users who are flexion intolerant. This allows the belt 16 to only contact the user's abdomen, not the lower back. Alternatively, the foam blocks 20 may be positioned such that they are just above the hip bones in front for users who are extension intolerant. This allows the belt 16 to only contact the user's lower back, not the abdomen. [0024] In other embodiments, as shown in FIG. 6 , the bands 19 may include an elastic portion 40 . The elastic portion 40 is preferably attached to the belt 16 at the midpoint of the belt length. The elastic portion 40 may be secured to the belt by any means known. As shown in FIG. 6 , the elastic portion 40 is secured to the midpoint of the belt 16 by stitching 45 . While the entire band 19 may be made of elastic, in the most preferred embodiment the elastic portion 40 is attached to an inelastic portion 41 . The elastic and inelastic portions may be attached to one another by stitching, snaps, buckles, or any other mechanism known to attach bands. As shown in FIG. 6 , each band portion includes a loop, which is fitted through a buckle 35 . In the most preferred embodiment, buckles 35 is an adjustment buckle which allows the user to adjust the overall length of the bands 19 . In other embodiments, the length of the bands 19 may be adjusted at the buckles 30 a and 30 b . In other embodiments, buckle 35 may be omitted and the portions of the bands may be joined to each other with stitching. [0025] As shown in FIG. 6 , the belt 16 may include an additional piece of material about a portion of its length to partially conceal the bands 19 . In the preferred embodiment shown in FIG. 6 , the additional piece of material 60 is approximately ¼ of the length of the belt 16 , and is located about the midpoint of the belt's length. With such a location, it is generally to the rear of the user when the belt is worn. As shown in FIG. 6 , the additional piece of material 60 is fastened to the outer or front surface 32 of the belt 16 so as to form a tunnel in which a portion of the band 19 , may run or reside. The outer or front surface 32 of the belt is the surface that is away from the user when the belt is worn. Specifically as shown in FIG. 6 , the elastic portion 40 of the bands 19 is partially covered by the additional piece of material 60 . In the preferred embodiment shown in FIG. 6 , the upper and lower perimeter edges of the additional piece of material 60 are sewn or otherwise fastened to the front surface 32 of the belt 16 . In other embodiments, the additional piece of material 60 may be omitted and the tunnel created between the front surface 32 and the rear surface 31 of the belt. In other words, the bands 19 are positioned for part of their length, between the front surface 32 and rear surface 31 of the belt 16 . [0026] Foam blocks 20 are also provided, and affixed to the belt 16 such that when the belt 16 is worn, the foam blocks 20 are located on or below the user's kidney area. In the preferred embodiment, the dimensions of the foam blocks 20 are approximately 2.5″ (thickness)×3″ (width)×4.5″ (length). The foam blocks 20 are preferably made of at least two types of foam to provide a firmer base of support nearer the belt 16 . In the most preferred embodiment, the foam blocks 20 are constructed of a first layer of high density foam 22 , and a second layer of lower density foam 23 . The high density foam 22 is preferably 0.5 inches thick, and the lower density foam 23 is approximately 2 inches thick. The high density foam is positioned nearer the rear surface 31 of the belt 16 . Such positioning helps the foam block 20 maintain its shape and resist rolling or the formation about the belt 16 . [0027] The foam blocks 20 are removable in the event that the user wishes to rely on the pull of the bands 19 . In the most preferred embodiment, the rear surface 31 of the belt 16 which is the surface that faces the user when the belt 16 is worn, may include hook and loop fastener 70 material on a portion of its length to allow the foam blocks 20 , or enclosures or coverings 37 for the foam blocks, to be selectively attached at various positions along the belt 16 . In such an embodiment, the surface of the foam block 20 or its enclosure or covering 37 has a hook or loop fastener on the outer surface that is complimentary to the fastener on the rear surface of the belt 16 . In some embodiments, the front surface 31 of the belt will include hook and loop fastener 70 material on substantially the entire length of the belt 16 . The presence of the hook and loop fastener 70 material on substantially the entire length of the belt 16 , allows the foam blocks 20 or the enclosure 37 having complementary hook and loop fastener 70 material placed on its exterior, to be positioned anywhere on the rear surface 31 of the belt 16 . With such positioning options, the user may easily move the foam blocks 22 to contact the users back or abdomen as desired. [0028] The foam blocks 20 are preferably placed in an enclosure or covering 37 , as shown in FIGS. 9 and 10 . This prevents deterioration of the foam blocks 20 from abrasion or contact with the user's perspiration. The enclosure or covering 37 preferably covers all sides of the blocks 20 and includes a closure such as a zipper 38 to allow a block to be inserted and removed. This is of benefit if the enclosure or covering 37 becomes soiled and needs laundering. As shown in FIGS. 9 and 10 , the zipper 38 is preferably placed about the perimeter of a surface of the enclosure 37 . In the most preferred embodiment, the zipper 38 is about the surface of the enclosure that attaches or abuts the belt 16 when the block is placed on the belt 16 . In the most preferred embodiment, the zipper 38 ends adjacent to a block securing assembly that is used to attach and further secure the enclosure or covering 37 to the belt. In such an arrangement, when the zipper is closed, the zipper pull or tab is placed underneath a portion of the securing assembly so that the zipper pull is restrained and does not move about as the user exercises. [0029] The enclosure or covering 37 preferably also includes hook or oop fasteners 70 on at least one outer surface so that it may be attached to selected locations about the rear surface of the belt 16 . In the preferred embodiment, the loop portion of the fasteners are located on the rear surface 31 of the belt 16 , and the complimentary loop portions are on the block enclosure or covering 37 . [0030] The enclosure or covering 37 may also include a block securing assembly to further secure the blocks 20 to the belt 16 . The block securing assembly generally connects the top and bottom of a block, enclosure, or covering 37 , and is positioned so that the belt 16 is captured between a strap 52 of the assembly and a block 20 and its enclosure or covering 37 . The strap 52 of the preferred embodiment is a length of webbing approximately 2 inches wide and 7 inches in length. The block securing assembly includes a slotted loop or buckle 39 attached directly, or by a web 57 , to the top of the enclosure or covering 37 , and an end 51 of the strap 52 is attached to the bottom of the enclosure or covering 37 . In the preferred embodiment shown in FIGS. 9 and 10 , the web 57 is attached to the top surface of the enclosure 37 with two lines of stitching so as to form a tunnel into which the zipper pull may be placed when the zipper 38 is closed. The web 57 may be made of an elastic material. In such an event, the tunnel may be easily stretched and lifted by the user, allowing the zipper pull to be inserted into the tunnel and held secure. With the enclosure or covering 37 positioned on the rear surface 31 of the belt 16 , the strap 52 is positioned so that it is proximate to the front surface 32 of the belt 16 , and the free end 51 of the strap 52 is fed through the slotted loop 39 . The strap 52 is then pulled tight and secured against itself with fasteners, such as snaps or complimentary hook and loop fasteners as shown in FIGS. 7, 9, and 10 . [0031] In such an embodiment, the strap 52 has an inner surface 53 and an outer surface 54 . On a first portion of the outer surface 44 is attached the hook, portion 70 a of the hook and loop fasteners 70 , and on a second portion of the outer surface 54 is attached the loop portion 70 b of the hook and loop fasteners. In the preferred embodiment the portions of the strap 52 each occupy approximately ½ of the entire length of the strap 52 . With this arrangement, when the strap 52 is pulled tight, the first portion of the strap 52 is pulled through the slotted loop 39 to and is then folded about the slotted loop 39 allowing the hook fasteners 70 a on the first portion to be secured against the loop fasteners 70 b on the second portion of the strap 52 . The free end 51 of the strap 52 is thereby positioned at or near the lower end of the block 20 or enclosure or covering 37 . In the most preferred embodiment, the free end 51 extends no more than a half inch below the lower end of the enclosure 37 . One skilled in the art will recognize that the hook and loop fasteners may be substituted for one another. However one skilled in the art will also realize that it is preferable to have the loop fasteners 70 b positioned in areas that will be exposed to the user or the user's clothing, as the hook fasteners 70 a can be rough and abrasive. This observation holds true not just for the coverings or enclosures 37 but also for the positioning of the hook and loop fasteners 70 on the belt 16 . [0032] To use the first exemplary embodiment, the user may place the platform 10 in the workout area, extend the front pole 11 and the rear pole 12 at any angle and to any length desired, and lock them into position. The user may then attach one or more workout attachments 15 to the carabiner clips 13 , or the upper ends of the front pole 11 and the rear pole 12 as desired. The user may secure the claw attachment 12 A to the rear pole 12 at the desired height, then secure the claw attachment 12 A to the shoulders and upper body, pick up the workout attachments 15 , and being the workout. Alternately, the user may secure the barbell table 14 to the platform 10 and work out with barbells or other hand weights, or the user may wear the belt 16 around the waist and secure the claw attachment 12 A to the belt 16 , [0033] When finished with the workout, the user may extend the caster wheels 10 A and roll the platform 10 wherever desired. Alternately, the user may detach the barbell table 14 or the workout attachments 15 , and remove the claw attachment 12 A. Then the user may unlock, retract, and fold the front post 11 and the rear post 12 , and fold up the platform 10 for transport or storage, [0034] The device is a flexion extension dominant system, which determines the environment wherein a particular human body will function at its highest level. This theory was derived from the rehabilitation concepts of flexion intolerance and extension intolerance. Flexion intolerance is posterior chain weakness, while extension intolerance is anterior chain weakness. When the intolerance is observed, the therapist can determine the injury trail a patient may have and lifestyle influences such as employment and sports wherein the patient would excel. This information could substantially impact future wear and tear on joints, direction of an athlete in particular sports, and which employment career is best suited for an individual. It is also observed that this may have an influence on the learning styles of various people based on environments. [0035] It is found that flexion intolerant people have possible damage to the spine where it is advised for them not to crunch or flex the spine. However, they need to keep their abdominal muscles stimulated by weight behind them, such as a backpack or band, or pressure against the lower abdominal muscles. If not stimulated, their posterior muscles will not activate. These people tend to prefer standing more than sitting, and they tend to lean on objects such as tables and counters for relief. These, people like to sleep on the side or the stomach. They tend to have weak hamstrings, biceps, shoulders, upper trapezius, upper chest, lower back, and calves. The common overuse injuries are plantar fasciitis, ACL tears, bicipital tendinitis, low back injuries like herniations, lordosis, and neck issues. Diastasis is also noted. These people tend to prefer activities where they push down, lift a knee, or use their abdominal muscles, such as mopping floors, massage, hiking uphill, and picking up items from the floor or lower shelves. Sports these people excel in are sprinting, hockey, wrestling, kickboxing, and soccer. Careers these people excel in are massage therapy, construction, flooring installation, and cleaning. These people tend to comprehend best while looking down or writing, such as highlighting a book or using an iPad. The belt 16 of the device is worn where it touches the abdominal muscles and not the lower back, or a band can be worn touching the abdominal muscles and pulling the hips backward where a flexion intolerant person must engage the posterior chain. This pull allows for the shoulders and hamstrings to activate properly and develop. The belt 16 , the device, and the cardio attachments can help elicit this force to produce proper body mechanics that traditional exercises are missing. [0036] It is found that extension intolerant people have possible damage to the spine where it is advised for them not to hyperextend the spine or dead lift. However, they need to keep their lower back or extensor muscles stimulated by weight in front of them, such as a front pack below the neck, or by a band, or pressure against the lower back. If not stimulated, their posterior muscles will not activate. These people tend to like to sit and sleep on their sides or their backs. They tend to have weak quadriceps, latissimus dorsi, lower chest, abdominals, gluteus, and triceps. The common overuse injuries are Achilles tendinitis, Achilles rupture, meniscus tears, quadriceps tears, hip pain, slipped discs, torn rotator cuffs, cervical problems, kyphosis, tennis elbow, and carpal tunnel. Hernias are also noted. These people tend to like activities where they stand tall, extend their arms above the head, sit up straight, and hold weight in front of them. Sports these people tend to excel in are gymnastics, basketball, baseball, golf, distance running, tennis, and dance. Careers these people excel in are hairdressing, computer jobs, servers, drivers, and painters. These people tend to comprehend best while looking up or leaning back in a chair or bed. They tend to do better with desktop computers. The belt 16 of the device is worn where it touches the lower back and not the abdominal muscles, or a band can be worn touching the lower back and pulling the hips forward where an extension intolerant person must engage their anterior chain. This pull allows for the latissimus dorsi, abdominals, gluteus and quadriceps to properly activate and develop. The belt 16 , the device, and the cardio attachments can help elicit this force to produce proper body mechanics that traditional exercises are missing. [0037] The device will improve health care, injury prevention, and rehabilitation, lowering incidences of injury and speeding up rehabilitation. Work related injuries which will be reduced include lower back, knees, carpal tunnel, neck, and headaches. The device will assist in directing people into sports and careers, including military specialties, that are compatible with their body type. The device may help improve sexual enjoyment and fertility, indicating which positions may be most suitable. The device will help with exercise and obesity control, since people do not like to experience pain when working out, and a pain-free workout is more likely to be completed regularly. The device will help with sleep positions and the selection of vehicles, chairs, and other furniture to prevent discomfort, generally improving comfort and quality of life. The device will also improve cognition and learning by informing the user regarding the best positions for reading. [0038] The platform 10 and the barbell table 14 are preferably manufactured from a rigid, durable material, such as steel, aluminum alloy, or wood. The caster wheels 10 A are preferably manufactured from a rigid, durable material such as steel or aluminum alloy, providing solid tires which are preferably manufactured from a flexible, durable material such as rubber or silicone. The front post 11 , the rear post 12 , and the carabiner clips 13 are preferably manufactured from a rigid, durable material such as steel or aluminum alloy. The claw attachment 12 A is preferably manufactured from a rigid, durable material such as steel or aluminum alloy, coated with a flexible, durable material such as rubber or silicone. [0039] The workout attachments 15 are preferably manufactured from a variety of rigid, durable materials such as steel, aluminum alloy, plastic, and wood, and flexible, durable materials such as rubber and nylon webbing. The belt 16 is preferably manufactured from a flexible, durable material such as nylon webbing. The snaps 17 and the belt clips 18 are preferably manufactured from a rigid, durable material such as plastic or steel. The bands 19 are preferably manufactured from a flexible, durable material with a substantial elastic quality, such as rubber, covered for two-thirds of their length by sleeves which are preferably manufactured from a flexible, durable material such as neoprene. [0040] The foam blocks 20 are preferably manufactured from a semi-rigid, durable material such as foam rubber. The fasteners 21 are preferably manufactured from a flexible, durable material such as plastic or nylon. Components, component sizes, and materials listed above are preferable, but artisans will recognize that alternate components and materials could be selected without altering the scope of the invention. Further on skilled in the art will recognize that when the application refers to foam blocks or block, the reference can refer to foam block alone, or foam blocks with an enclosure or covering or other assemblies to allow the blocks to be secured on the belt 16 . [0041] While the foregoing written description of the invention enables' one of ordinary skill to make and use what is presently considered tube the best mode thereof, those or ordinary skill in the art will understand and appreciate the existence of variations, combinations, and equivalents of the specific embodiment, method, and examples herein. The invention should, therefore, not be limited by the above described embodiment, method, and examples, but by all embodiments and methods within the scope and spirit of the invention.

The body alignment and correction device disclosed herein includes a belt for wearing about the waist of a user. The device further includes removable and repositionable foam blocks to displace portions of the belt away from the user's body. A method of stimulating abdominal or back muscles of a user of the device by selectively placing foam blocks to space a portion of the belt away from a user's body is also disclosed.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates to a method of indicating the probability of non-epileptic seizures, such as psychogenic non-epileptic seizures (PNES), wherein the method comprises the steps: [0003] automatically recording data on a patient by means of a first device placed on the body of the patient, wherein at least one sensor unit in the device measures at least one parameter on the body of the patient, and wherein the data is recorded over a predetermined time period; [0004] transmitting the data from the first device to a computer unit for further analysis; and [0005] manually logging data comprising at least a first time stamp of at least one seizure within that time period. [0006] The present invention further relates to a system for indicating the probability of non-epileptic seizures, such as psychogenic non-epileptic seizures, comprising: [0007] a first device configured to be placed on the body of a patient, wherein the first device comprises at least one sensor unit configured to measure at least one parameter on the body of the patient, wherein the first device is configured to automatically record data over a predetermined time period; [0008] a computer unit configured to be coupled to the first device and comprising data processing means configured to analyze the recorded data; and [0009] means for manually logging data comprising at least a first time stamp of at least one seizure within that time period. [0010] 2. Description of Related Art [0011] Today, seizures are a symptom for several diseases, which may make it hard for the doctors to diagnose the cause, especially due to the seizures resemblance with epileptic seizures. In particular psychogenic non-epileptic seizures (called PNES or NEAD) look very similar to epileptic seizures. This means that patients are often misdiagnosed, and resent studies have indicated that up to one-fourth of patients have been misdiagnosed. Correcting the diagnosis often involves a time-consuming and costly process. Especially, PNES similar to generalized tonic-clonic epileptic seizures (called GTCS) are hard to distinguish from actual GTCS without video and EEG (electroencephalography) recordings of the seizures. [0012] Therefore, people suffering from PNES are often admitted to special clinics or hospitals where the medical staffs, such as physician, primary caregivers, doctors or neurologists, are able to monitor and record such seizures in order to determine the type of seizure and prepare a treatment. Once admitted, the patient is often coupled to an epilepsy monitoring unit (called an EMU) where seizures may be recorded on video combined with EEG-measurements. Such admissions in an EMU are very expensive and may cost as much as DKK 60,000 (about US$ 8,750), and requires the patient to be admitted for several hours or days in order to record a suitable amount of seizures. Provocative tests may be used by the staff to trigger seizures, if the seizures do not occur naturally during admission. [0013] Today, video-EEG monitoring (called video-EEG) is the gold standard for detecting epilepsy and PNES. Both modalities are needed, and video monitoring alone does not provide an accurate way of detecting seizures. The EEG measurement involves the use a plurality of electrodes attached to the brain of the patient which are then coupled to a data logger or a data processing unit. Today, small portable EEG-devices may be coupled to the electrodes so that the patient is able to move around, but the multiple electrodes still provides some discomfort for the patient and increases the risk that one or more of the electrodes accidently fall off or are pulled off. Video-EEG is also used for verifying the accuracy (false detection rate) of seizure detection systems, however they still require the patient to be admitted and coupled to an EEG system. [0014] The article “Can Cortical Silent period and Motor Threshold be Practical Parameters in the Comparison of Patients with Generalized Epilepsy and Patients with Psychogenic Non-Epileptic Seizures?”, Ipekdal et al., Eur Neurol, 2013, discloses a method of distinguishing between a GTCS and a PNES where the patients were coupled to an EEG-device with a plurality of electrodes. The patients were admitted to a hospital and magnetically stimulated in the area controlling the ABP muscles of the brain by TMS. EMG electrodes placed on the ABP muscles are used to regulate the applied stimulate. The article teaches that cortical silent periods in the recorded EEG-signals are prolonged for patients with GTCS compared to patients with PNES. The article does not teach or suggest that the amplitude of the muscle activity may be used to detect PNES, since they found no significant differences in the recorded motor thresholds. This method requires patients to be admitted for at least two days which presents a time-consuming and costly process. The patients have to be subjected to a stimulant in the TSM test which may lead to some discomfort for the patient, as mentioned in the article. [0015] The article “Use of postictal respiratory pattern to discriminate between convulsive psychogenic nonepileptic seizures and generalized tonic-clonic seizures”, Rosemergy et al., Epilepsy Behav., April 2013, discloses a method of distinguishing between a GTCS and a PNES where the patients were admitted to a hospital and coupled to a video-monitoring unit. The postictal phase was then recorded at each seizure. This article teaches that the postictal respiratory response (rate and pattern) is significantly longer for patients with GTCS compared to patients with PNES. As mentioned in the article, the patient needs to be placed relative to the camera so that the respiratory response can be recorded, which is not always possible. The patient still needs to be admitted in order to get a proper video-recording of the patient. [0016] The article “Detection of generalized tonic-clonic seizures by a wireless wrist accelerometer: A prospective, multicenter study”, Beniczky et al., Epilepsia, April 2013, pg. 58-61, discloses a wristband comprising a three-axis accelerometer and a wireless Bluetooth module. A generic seizure detection algorithm for detecting a GTCS is implemented in the device and the recorded data is transmitted to a control unit which then generates an alarm. This article does not teach or suggest that the implemented algorithm and the recorded acceleration data may be used to detect a PNES or other non-epileptic seizures. Furthermore, the article does not teach or suggest how a GTCS may be distinguished from a PNES. [0017] U.S. Patent Application Publication 2012/0116183 A1 discloses a device for automatically distinguishing between an epileptic and non-epileptic seizure by measuring two signals on a body and comparing the signals with two index classes respectively in order to determine a first and second index value. The index values are used to determine whether the sensed seizure is an epileptic or non-epileptic seizure. Each seizure is automatically detected using a seizure detection algorithm, and a manual input from the patient or a caregiver is used to confirm whether the patient is having a seizure or not. This configuration provides a complex solution which requires a large amount of data processing as the classification process is performed each time a seizure is detected. The device is operated in an alarm mode informing the patient/caregiver of every detected seizure onset, thereby influencing the patient's assessment of when he/she is having a seizure. [0018] International Patent Application Publication WO 2009/020880 A1 discloses a system for detecting epileptic seizures and PNES where the motor activity of the patient is continuously recorded using a sensor device and transferred to a computer unit that extracts features from the data stream using two dedicated analysis algorithms. Continuous video-EEG monitoring is used to determine when the seizures are occurring which are then used by the computer unit to define the time windows in which the data stream should be analyzed. The extracted features are then evaluated according to standard classification guidelines in order to determine whether the seizure is an epileptic seizure or a PNES. This solution requires the patient to be coupled to a conventional video-EEG monitoring system for logging seizures which in turn increases the cost for diagnosing a patient. The sensor device acts as a simple recording device, it is not able to detect when a seizure is occurring. SUMMARY OF THE INVENTION [0019] It is an object of the invention to provide a cheaper and simpler method of detecting psychogenic non-epileptic seizures. [0020] It is an object of the invention to provide a method of detecting tonic-clonic seizures and psychogenic non-epileptic seizures which does not involve admitting the patient. [0021] It is an object of the invention to provide the use of a portable seizure detection device to distinguish between tonic-clonic seizures and psychogenic non-epileptic seizures. [0022] As mentioned above the invention relates to a method of indicating the probability of non-epileptic seizures, such as psychogenic non-epileptic seizures, characterised by: [0023] detecting at least one seizure within that time period using the device and recording at least a second time stamp of that seizure; [0024] comparing the recorded data to the logged data in the computer unit, and [0025] determining if the second time stamps match the first time stamps or not. [0026] This provides a simple and cheap method of indicating the probability of PNES as well as GTCS in a patient. The present invention does not require the patient to be admitted to a hospital or a special clinic (e.g., an EMU) and coupled to an EEG system. Data may be automatically recorded by any small battery powered device configured to be placed on the body of the patient, e.g., on an arm, a leg or the torso. This allows the patient to be situated in his or hers normal environment thus providing a more accurate indication of the factors triggering the seizures. The patient may not act normally, if he or she was admitted thus providing a less accurate indication of the factors triggering the seizures. “Automatic recording” is defined as any device, either placed on the patient or coupled to a sensing unit placed on the patient, configured to store the sensed parameters without any human interaction, while “manually logging” is defined as any human interaction that requires the patient or subject to actively record or log the data either physically or electronically. [0027] In one embodiment, the first device may continuously log or record data during the time period, e.g., up to seven days. The data may be stored in a memory unit in the first device or transmitted to a third device, such as a base unit, which then stores the data. The data file comprises at least a time stamp of each detected seizure. The size and weight of the device may be reduced, if the data is stored in the base unit. After the time period has lapsed, data may be transmitted to a second device, such as a central computer unit, via a wired or wireless connection. The data may instead be transferred to the second device via a temporary storage unit, such as a memory stick. [0028] The patient may physically log the seizures by noting at least a time stamp on a list or electronically log the seizures, e.g., by activating a data logging device by means of a push of a button. The medical staff, such as physicians, primary caregivers, doctors, or neurologists, may then analyze the recorded data or time stamps from the first device and compare it to the logged data or time stamps from the patient. [0029] The present invention is able to log seizures that are only registered by the device and not the patient, and vice versa. This configuration allows PNES to be distinguished from GTCS by comparing the two lists of time stamps with each other. If the first device has not recorded any seizures and the patient has logged one or more seizures, then the patient may suffer from PNES. If the first device has recorded one or more seizures and the patient has logged the same seizures, then the patient suffers from epileptic GTCS. If the patient has logged more seizures than those recorded by the device, then the patient may suffer from both PNES and epilepsy. In the event that the patient has not experienced any seizures, a new measuring time period may be performed. This provides an alternative method for distinguishing between PNES and GTCS that does not require the use of video-EEG to log seizures or a manual input to confirm the onset of a seizure. [0030] In one embodiment, the two sets of data may be electrically compared in the second device. The second device may visually indicate each recorded or logged seizure and/or any matches or mismatches between the two sets of data. This allows for a simple and quick identification of each registered seizure and any mismatches between the two lists. [0031] According to one embodiment, the first device compares the measured parameter to at least one threshold value and determines whether a seizure is present or not in a non-alarm mode. [0032] The data may advantageously be recorded using any seizure detection devices comprising an algorithm for detecting GTCS or any seizures having a tonic and/or a clonic phase or any seizures having at least tonic activity. Detecting whether a seizure is present or not is defined as comparing the sensed and optionally filtered parameters to one or more sets of threshold values or reference patterns, and indicating by means of an event signal, such a high or low binary signal, whether these parameters fall within the intervals defined by the threshold values or patterns or not. The data recording may be activated when the device detects a seizure onset. Alternatively, the seizure detection algorithm may be implemented in the base unit instead. This allows the device, or the base unit, to record or log any seizure, such as any epileptic seizures, occurring within the time period. The amount of stored and processed data may be reduced by only recording data once a seizure has been detected. This allows the power consumption of the device to be reduced, thus increasing the operation time of the device. [0033] In one embodiment, the seizure detection device may operate in a non-alarm mode, which defines a mode in which the device or the base unit does not activate or generate any audio and/or visual alarm or warning directing the patient's attention to an occurring seizure. This allows the manual data logging not to be influenced by the automatic data logging, thereby ensuring that the patient only logs data when he or she believes that a seizure has occurred. Unlike the device of U.S. patent application publication 2012/0116183 A1, which is operated in an alarm mode in which it informs the patient once a seizure is detected and allows the patient to confirm or disconfirm that he/she is having a seizure. The non-alarm operating mode is particularly advantage for patients suffering from PNES, as their subjective assessment of when he or she is having a seizure is likely to influence by the generated alarm or warning. [0034] In one embodiment, seizures may be detected using the seizure detection algorithm disclosed in DK 201100556 A and corresponding U.S. patent application publication 2014/0163413, which may be implemented in a body worn device operated in the non-alarm mode. The seizure detection algorithm of DK 201100556 A and corresponding U.S. patent application publication 2014/0163413 is hereby incorporated by reference in this application. The algorithm may count the number of zero-crossings of the sensed signal, when it alternately exceeds the positive and the negative value of a predetermined hysteresis value within a plurality of predetermined time windows. The number of time windows having a count above a first threshold value may then be compared to a second threshold value, if these two values (count and amount of time windows) exceed the two threshold values then a seizure is occurring. [0035] According to one embodiment, the sensor unit measures an electromyographic signal or an acceleration signal, e.g., on at least one limb or skeletal muscle of the patient. [0036] The data may advantageously be measured using an EMG-sensor and/or an accelerometer arranged or coupled to the device. This eliminates the need for attaching multiple EEG-electrodes to the head of the patient and does not require the device to have multiple measuring channels, such as the sixteen channels used in Ipektal et al. The use of at least one EMG-sensor or accelerometer allows the first device to be implemented as a simple and cheap device that allows data to be measured using very few measuring channels, such as one, two, three or four. Two or more sensor units may be arranged in or coupled to the first device, wherein the device may be configured to analyze and evaluate the sensed data in order to determine if a seizure is occurring or not. This allows the device to more accurately detect the seizure onset by measuring two or more different parameters on the patient. [0037] In one embodiment, the data may be measured by an sEMG-sensor with at least two electrodes configured to be placed on a limb muscle or another skeletal muscle of the patient. In one embodiment, the data may be measured by an analogue or digital accelerometer capable of sensing the acceleration in one, two or three directions. The accelerometer may be a capacitive or piezoelectric device. The accelerometer may be placed on a limb muscle or another skeletal muscle of the patient. This allows seizures to be detected by monitoring the movement or muscle activity of the patient's body. The signals are preferably measured where the signals are most prominent thus increasing the measured range of the signals, i.e., the frequency and/or the amplitude. In one embodiment, the sensor unit may be placed on the arm, e.g., the deltoid and/or biceps muscle, or on the chest of the patient. [0038] According to one embodiment, the first device either calculates a root-mean-square value of the sensed signal within at least one time window and compares the RMS-value to the threshold value, or transforms the sensed signal into both the frequency domain and the time domain and compares at least one calculated value from each of the domains to at least one threshold value. [0039] This allows the algorithm to detect the onset of a seizure by applying a predetermined number of time windows, such overlapping time windows, to the sensed signal, and then calculate an RMS-value for each of the time windows. The algorithm may then evaluate the RMS-values and determine if a seizure onset is present or not, e.g., by determining the slope of the RMS-values and comparing it to at least one threshold value. This allows the implemented algorithm to determine whether the measured muscle activity or movements are a GTCS or not. [0040] The algorithm may transform the sensed signal into both the frequency and time domains and extract one or more values, e.g., within a predetermined number of time windows. The algorithm may determine the frequency of the sensed signal and/or the amplitude, such as an RMS-value, of the sensed signal. The values of the time and/or frequency domain may then be compared to at least one threshold value in order to determine whether a seizure onset is present or not. This allows the implemented algorithm to determine whether the measured muscle activity or movements are a GTCS or not. [0041] According to one embodiment, the first device extracts at least one predetermined pattern from the sensed signal, and compares the extracted pattern to the threshold value. [0042] The algorithm may extract one or more patterns from the sensed signal, e.g., the acceleration data, in the time or frequency domain. The extracted pattern may be compared to one or more reference patterns or one or more sets of parameters defining these patterns. In one embodiment, the device may determine the length (time period) of the cloni, i.e., each individual contraction, and/or the length (time period) between each of the cloni. Clinical studies have suggested that the time periods of the cloni in a GTCS are very much alike and of equal length. The studies have suggested that the time periods, i.e., silent periods, increase exponentially for a GTCS. This allows the device to distinguish between a GTCS and a PNES by evaluating the pattern of the measured signal to at least one distinct reference pattern. [0043] According to one embodiment, the measured data from the sensor unit is transmitted directly to a third device and recorded in the third device. [0044] Seizures may be detected by placing at least one set of sensor electrodes, such as electromyography sensor electrodes, on one or more muscles of the patient in predetermined positions. The measured set of data may be transmitted directly to the base unit via a wired connection comprising an optionally plug-and-socket coupling. The measured set of data may instead be transmitted via a wireless communications module in the first device to a mating communications module in the base unit, e.g., as raw data or pre-processed (filtered and/amplified) data. In this embodiment, the third device may be configured to act as an EMG-unit that record the measured/pre-processed data and/or displays the data for further analysis. [0045] The raw or pre-processed data may be continuously measured and recorded in another data file during the time period. This data may be stored in the first device or the base unit, and then transferred or transmitted to the third device for further analysis. This allows the medical staff to evaluate the raw data to confirm that the patient is suffering from PNES, e.g., by analyzing the raw data using another analysis algorithm dedicated for extracting one or more features characteristic of PNES or by using standard evaluation guidelines to determine that the patient is suffering from PNES. This analysis algorithm may differ from the seizure detection algorithm. [0046] According to one embodiment, the patient manually logs the data or at least one subject monitors the patient and manually logs the data. [0047] In one embodiment, seizures may be logged by any subjects monitoring and/or interacting with the patient during the time period. If the patient is placed in his or hers normal environment, then subjects, such as family members, friends and/or colleagues, may log any detected seizures within that time period. If the patient is admitted, then subjects, such as the medical staff, visually monitoring the patient may log any seizures within that time period, e.g., by inputting the data directly into the second device, This allows the patient to be monitored more or less continuously during the time period and allows the number of missing seizures to be reduced. [0048] According to an alternative embodiment, the patient manually logs the data by activating the first device using user input means. [0049] In this configuration, the patient or optionally the subject monitoring the patient is able to manually log each registered seizure by activating user input means located on the first device. The first device, or optionally the base unit, then log at least a time stamp each time the input means is activated. These data are stored in a data file separately from the data file comprising the automatically recorded data and the data file comprising the raw/pre-processed data. The two data files with the lists of time stamps are then transmitted or transferred to the second device for further analysis. This allows the patient/subject to log seizures without having to update a physical list. [0050] As mentioned above, the invention also relates to a system for detecting seizures, such as tonic-clonic seizures, characterized in that: [0051] the first device is configured to detect at least one seizure within that time period and record at least a second time stamp of that seizure; and [0052] that the computer unit is configured to compare the recorded data with the logged data and determine if the second time stamps matches the first time stamps or not. [0053] This provides a simple and cheap system for indicating the probability of PNES as well as GTCS which does not require the patient to be admitted to a hospital or a special clinic (e.g., an EMU) and coupled to an EEG system. The first device may be a small battery powered device configured to be placed on the body of the patient by means of a band, a clip or an adhesive layer located on the device. This allows the patient to be situated in his or hers normal environment thus providing a more accurate indication of the factors triggering the seizures. The patient may not act normally, if he or she was admitted thus providing a less accurate indication of the factors triggering the seizures. [0054] In one embodiment, the first device may be configured to a data logger which continuously logs or records data during the time period. The data file may be stored in a memory unit located in the first device or in a third device, such as a base unit. The size and weight of the device may be reduced, if the data is transmitted and stored in the base unit. The recorded data may then be transmitted to the second device, such as a central computer unit, via a wired connection, such as a data cable configured to be removable coupled to at least one of the two devices, or a wireless connection, such as a Bluetooth, WIFI, IR, RF, NFC, ZigBee, or another communications module. The data may instead be transferred to a temporary storage unit, such as a memory stick, which may be coupled to the second device. The connection between the first and third device may be a wired or wireless connection, such as electrical cables, Bluetooth, WIFI, RF, IR, or any other suitable connection. [0055] A physical list or a computer unit, a laptop, a tablet computer, a PDA or a smartphone may be used by the patient or the subject to manually log the time stamp of each seizure. In one embodiment, a data logging device may be configured to record the time stamp when the device is activated, e.g., by the push of a button. The two sets of data may be loaded in the second device which may be configured to electrically compare the data sets, e.g., at least the two lists of time stamps. The second device may be configured to visually indicate or generate an event signal for each recorded or logged seizure and/or any matches or mismatches between the two sets of data. This allows for a quick and simple indication of each registered seizure. [0056] The automatic and manual logging of seizures enables the present system to log seizures only registered by the first device and not the patient/subject, and vice versa. This allows PNES to be distinguished from GTCS by comparing the two lists of time stamps with each other. If no seizures have been recorded by the device and the patient has logged one or more seizures, then the patient may suffer from PNES. If one or more seizures have been recorded by the device and the patient has logged the same seizures, then the patient suffer from epileptic GTCS. If only some of the logged seizures match the recorded seizures, then the patient may suffer from both PNES and epilepsy. This allows PNES to be distinguished from GTCS without the use of video-EEG or index classes. The raw or pre-processed data may be used as back-up or to confirm or disconfirm that the patient is suffering from PNES. [0057] According to one embodiment, the first device is configured to compare the measured parameter to at least one threshold value and determine if a seizure is present or not in a non-alarm mode. [0058] Seizure detection devices are well-suitable to be implemented in the system according to the invention. The device may advantageously comprise an algorithm configured to detect tonic-clonic seizures, such as GTCS, or any seizures having a tonic and/or a clonic phase or any seizures at least having tonic activity. The device may be configured to generate an event signal that may trigger the recording of the data when a seizure onset is detected. Alternatively, the seizure detection algorithm may be implemented in the base unit instead. This allows the device, or the base unit, to record or log any seizures, such as any epileptic seizures, occurring within the time period. The amount of stored and processed data may be reduced by only recording data once a seizure has been detected. This allows the power consumption of the device to be reduced thus increasing the operation time of the device. [0059] In one embodiment, the seizure detection device may be configured to operate in a non-alarm mode. This allows the manual data logging to be uninfluenced by the automatic data logging, thereby ensuring that the patient or subject observing the patient only logs data when he or she believes that a seizure has occurred. This is particularly relevant for patients suffering from PNES. The device is able to detect and record seizures which are not registered by the patient or subject, and vice versa, which in turn increases the reliability of the system. [0060] In one embodiment, the seizure detection algorithm disclosed in DK 201100556 A and corresponding U.S. patent application publication 2014/0163413 may be implemented in a self-adhesive device or a device coupled to a band which is configured to operate in the non-alarm mode. The seizure detection algorithm of DK 201100556 A and corresponding U.S. patent application publication 2014/0163413 is thereby incorporated by reference in this application. The algorithm may be configured to count the number of zero-crossings of the sensed signal, when it alternately exceeds the positive and the negative value of a predetermined hysteresis value within a plurality of predetermined number of time windows. The algorithm may be configured to compare the number of time windows having a count above a first threshold value to a second threshold value. The algorithm may then generate an event signal that may trigger the data recording, if these two values (count and amount of time windows) exceed the two threshold values. [0061] According to one embodiment, the sensor unit is an electromyographic sensor or an accelerometer, and wherein the first device is configured to detect a seizure based on the measured electromyographic signal or the acceleration data. [0062] The first device may advantageously comprise at least one EMG-sensor and/or an accelerometer which eliminates the need for multiple EEG-electrodes and does not require the device to have multiple measuring channels, such as the sixteen channels used in Ipektal et al. article mentioned above. This allows the first device to be implemented as a simple and cheap device that allows data to be measured using very few measuring channels, such as one, two, three or four. Two or more sensor units may be arranged in or coupled to the first device, wherein the device may be configured to analyze and evaluate the sensed data in order to determine whether a seizure is occurring or not. This allows the device to more accurately detect the seizure onset by measuring two or more different parameters on the patient. The second sensor unit may be an EEG-unit, a heart rate sensor, a respiratory sensor, or another suitable sensor unit. [0063] The EMG-sensor unit may be configured as an sEMG-sensor with one or two electrodes configured to be placed on a limb muscle or another skeletal muscle of the patient. The accelerometer may be configured as an analogue or digital accelerometer capable of sensing the acceleration in one, two or three directions. The accelerometer may be a capacitive or piezoelectric device. The accelerometer may be configured to be placed on a limb muscle or another skeletal muscle of the patient. This allows the signal to be measured where the movement or muscle activity is most prominent thus increasing the measured range of the signal, i.e., the frequency and/or the amplitude. In one embodiment, the sensor unit may be placed on the arm, e.g., the deltoid and/or biceps muscle, or on the chest of the patient. [0064] In one embodiment, the algorithm may be configured to apply a predetermined number of time windows, such overlapping time windows, to the sensed signal, and then calculate an RMS-value for each of the time windows. The algorithm may be configured to evaluate the RMS-values and determine if a seizure onset is present, e.g., by determining the slope of the RMS-values and comparing it to at least one threshold value. In one embodiment, the algorithm may be configured to transform the sensed signal into the frequency and/or time domain and extract one or more values, e.g., within a predetermined number of time windows. The algorithm may be configured to determine the frequency and/or amplitude, such as an RMS-value, of the sensed signal. The two values and/or a sum of at least one of these values may be configured to be compared to one or two individual threshold values in order to determine whether a seizure onset is present or not. The device or algorithm may be configured to filter the measured signal by means of a filter function before the parameters are extracted. This allows the implemented algorithm to determine whether the measured muscle activity or movements are a GTCS or not. [0065] In one embodiment, the algorithm may be configured to extract one or more patterns from the sensed signal, e.g., the acceleration data, in the time and/or frequency domain. The algorithm may be configured to compare the extracted pattern to one or more reference patterns or one or more sets of parameters defining these patterns. In one embodiment, the device may be configured to determine the length (time period) of the cloni, i.e., each individual contraction, and/or the length (time period) between each of the cloni. This allows the device to distinguish between a GTCS and a PNES by evaluating the pattern of the measured signal to at least one distinct reference pattern. [0066] According to one embodiment, the first device is configured to transmit the measured data directly to a third device which is configured to record the data. [0067] The device may comprise at least one set of sensor electrodes, such as electromyography sensor electrodes, configured to be placed on one or more muscles of the patient in predetermined positions. The set of sensor electrodes may be coupled directly to the third device via a wired connection comprising an optionally plug-and-socket coupling. The set of sensor electrodes may instead be coupled to a wireless communications module in the first device configured to transmit the measured set of data to a mating communications module in the third device. The first device may be configured to record the data as raw data or comprise means (such as filter means and/or an amplifying means) for pre-processing the data before the transmission. The second device may instead be configured as an EMG-unit configured to record the measured data and/or comprise a display for visually displaying the data. [0068] The first or third device may be configured to record the raw or pre-processed data continuously in a separately data file during the time period. This data may then be transferred or transmitted to the third device for further analysis. The raw data may be evaluated by the medical staff to confirm or disconfirm that the patient is suffering from PNES, e.g., by applying an analysis algorithm dedicated for extracting one or more features characteristic of PNES to the set of data or by using standard evaluation guidelines to determine if the patient is suffering from PNES. The comparator module located in the second device may generate an output signal indicating the probability of the patient suffering from PNES, e.g., a binary value (zero or one) or a value between 0 and 100. The output signal may optionally be transmitted to an evaluation module which generates the indication signal based on the number of mismatches between the two lists of time stamps. The indication signal may also be used to indicate that the patient is not suffering from GTCS, but another type of seizure. [0069] According to one embodiment, the second device comprises user input means for manually logging the data. [0070] The second device may comprise user input means, such as a keyboard, a mouse, or a touch-sensitive display, for manually inputting data into the second device. Subjects, such as the medical staff that visually monitors the patient, may use the user input means to log any seizure with the time period. This allows the patient to be monitored more or less continuously during the time period and allows the number of missing seizures to be reduced. [0071] According to an alternative embodiment, the first device further comprises user input means for manually logging the data. [0072] In this configuration, the first device may be configured to electronically log at least a time stamp every time the input means is activated. The input means may be one or more buttons, touch sensitive areas, or any suitable input means. This allows the patient or subject to manually input data into the device each time a seizure is registered by the patient or the subject monitoring the patient. These data are stored in a data file in the first device or in the base unit separately from the automatically recorded data stored in the first device or the base unit. The two data files are then transmitted or transferred to the second device for further analysis. This allows the patient/subject to log seizures without having to update a physical list. [0073] According to one particular use of the invention, a seizure detection device comprising an electromyographic sensor unit is coupled to a limb or skeletal muscle of a patient to detect an indication of psychogenic non-epileptic seizures. [0074] A portable battery powered device, such as a seizure detection device, comprising one or more EMG-sensor units is particularly suited to be implemented in the above described method and/or system. The EMG-sensor or electrodes thereof may advantageously be placed on a limb muscle or skeletal muscle of the patient. This allows the device to indicate the probability of a PNES by only measuring the muscle activity of that limb. [0075] According to one particular use of the invention, a seizure detection device comprising an accelerometer is coupled to a body of a patient to detect an indication of psychogenic non-epileptic seizures. [0076] A portable battery powered device, such as a seizure detection device, comprising at least one accelerometer is particularly suited to be implemented in the above described method and/or system. The accelerometer may advantageously be placed on a limb muscle or skeletal muscle of the patient. This allows the device to indicate the probability of a PNES by only measuring the movement (acceleration) of that limb. [0077] An embodiment of the invention will now be described by way of an example only and with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0078] FIG. 1 shows a block diagram of a first exemplary embodiment of the system according to the invention; and [0079] FIG. 2 shows a block diagram of a second exemplary embodiment of the system according to the invention. DETAILED DESCRIPTION OF THE INVENTION [0080] In the following text, the figures will be described one by one and the different parts and positions seen in the figures will be numbered with the same numbers in the different figures. Not all parts and positions indicated in a specific figure will necessarily be discussed together with that figure. [0081] FIG. 1 shows a block diagram of a first exemplary embodiment of the system. A portable device I may be placed on the body of a patient 2 and held in place by means of a band (not shown) or an adhesive layer on the device 1 . The device 1 may be placed on a limb muscle or skeletal muscle of the body, e.g., on an arm of the patient 2 . [0082] The device 1 may comprise a removable power source (not shown) in the form of one or more batteries coupled to a power circuit arranged inside the device 1 . The power circuit may be configured to power the electrical components located in the device 1 . [0083] At least one sensor unit 3 may be arranged in the device 1 and configured to measure at least one parameter on the body of the patient 2 . The sensor unit 3 may be configured as an EMG-sensor comprising at least two electrodes configured to measure an electromyographic signal on the body of the patient 2 . The measuring electrodes may be positioned on one muscle, such as the deltoid and/or tibial anterior muscle, wherein one of the electrodes may be used as a reference electrode for the other electrode. The sensor unit 3 may instead be configured as an accelerometer configured to measure the acceleration in one, two or three directions. [0084] The device 1 may comprise a microprocessor unit in which a seizure detection algorithm may be implemented for detecting a tonic-clonic seizure, such as a GTCS. The microprocessor unit may be coupled to the sensor unit 3 and may be configured to filter out any noise and other unwanted signals. The algorithm may be configured to extract or calculate one or more parameters from the measured data and compare the extracted or calculated data to at least one threshold value. If the measured data exceeds the threshold values, a seizure is detected and the algorithm may generate an event signal that activates the recording of the data and/or indicates that a seizure is detected. [0085] In one embodiment, the seizure detection algorithm disclosed in DK 201100556 A and corresponding U.S. patent application publication 2014/0163413 may be implemented in the device 1 and configured to operate in a non-alarm mode. The seizure detection algorithm of DK 201100556 A and corresponding U.S. patent application publication 2014/0163413 is thereby incorporated by reference in this application. The algorithm may be configured to count the number of zero-crossings of the sensed signal, when it alternately exceeds the positive and the negative value of a predetermined hysteresis value within a predetermined number of time windows. The algorithm may be configured to compare the number of time windows having a count above a first threshold value to a second threshold value. The algorithm may in the non-alarm mode generate an event signal that may trigger the data recording, e.g., recording the time stamp for each seizure, if these two values exceed the two threshold values. The event signal may not trigger any alarm or warning that alert the patient 2 to the onset of a seizure. The device 1 may be configured to record data over a predetermined time period, e.g., ranging from one hour to seven days. [0086] A second device 4 in the form of a central computer unit may be configured to be coupled to the first device 1 , e.g., via a wired or wireless connection 5 . The connection 5 may be a data cable or a BLUETOOTH®, RF or WIFI connection. The recorded data may then be transferred from the first device 1 to the second device 2 for further analysis. [0087] In one embodiment, the first device 1 may be configured to be coupled to a third device 6 via another wired or wireless connection 7 . The connection 7 may be a wireless BLUETOOTH® or WIFI connection. The third device 6 may be configured as a base unit located within a predetermined distance from the patient 2 . The base unit 6 may be configured to be coupled to the second device 4 via yet another wired or wireless connection 8 . The connection 8 may be a data cable or a BLUETOOTH®, RF or WIFI connection. The seizure detection algorithm may instead be implemented in the third device 6 so that the first device 1 acts as a simple sensing unit that transmits the measured data to the third device 6 via the connection 7 for storage. The third device 6 may then be configured to detect the seizures in the non-alarm mode. [0088] One of the devices 1 , 6 may be configured to continuously record the raw or pre-processed data in a separate data file which may be transmitted or transferred directly to the second device 4 or indirectly via the third device 6 . [0089] The system may comprise means 9 for manually logging data, e.g., the time stamp for each seizure, descriptive of a seizure over the time period. The patient may log 10 the time stamp for any detected seizure within the time period on a physical list 9 managed by the patient 2 . The list 9 may instead be an electrical list configured to be loaded and executed on a computer unit 11 , a laptop, a tablet computer, a PDA or a smartphone. If the data have been logged 10 electronically, the logged data may then be loaded into the second device 4 via a wireless or wired connection 12 . The connection 12 may be a data cable or a Bluetooth or WIFI connection. If the data have been logged 10 physically, the logged data may then be inputted into the second device 4 via a keyboard, touch-sensitive display or the like. [0090] The second device 4 may be configured to compare the two sets of data, e.g., the two lists of time stamps, with each other. The second device 4 may be configured to match a time stamp recorded by the first device 1 to a time stamp manually logged by the patient 2 . The second device 4 may comprise a display configured to graphically display the two sets of data. The second device 4 may be configured to graphically indicate each recorded and/or logged seizure. [0091] The second device 4 may be configured to graphically indicate any matches and/or mismatches between the recorded time stamps and the logged time stamps. If the first device 1 has not recorded any seizures and the patient 2 has logged one or more seizures, then the patient 2 may suffer from PNES. If the first device 1 has recorded one or more seizures and the patient 2 has logged the same seizures, then the patient 2 may have epilepsy. If the patient 2 has logged more seizures than those recorded by the device 1 , where some of the logged seizures correspond to those logged by the device 1 , then the patient 2 may suffer from both PNES and epilepsy. This allows the device 4 or the medical staff operating the device 4 to distinguish PNES from GTCS in a simple and cheap manner. [0092] FIG. 2 shows a block diagram of a second exemplary embodiment of the system. In this embodiment, the data may be manually logged by any subject 13 that monitors and/or interacts 14 with the patient 2 . The patient 2 may be admitted to a hospital or special clinic for observation. The patient 2 may be continuously monitored by the subject 13 , e.g., the medical staff, during the admission. The subject 13 may manually log 15 the data, e.g., the time stamp for each seizure, on a physical list 9 . The list 9 may instead be an electrical list configured to be loaded and executed on a computer unit 11 , a laptop, a tablet computer, a PDA or a smartphone. If the data have been logged 15 electronically, the logged data may then be loaded into the second device 4 ′ via a wireless or wired connection 16 . The connection 16 may be a data cable or a BLUETOOTH®, RF or WIFI connection. If the data have been logged 15 physically, the logged data may then be inputted into the second device 4 ′ via a keyboard, touch-sensitive display or the like. The subject 13 may instead log 17 the data directly into the second device 4 ′ using user input means 18 in form a keyboard or a touch-sensitive display. [0093] The first device 1 may be configured as a sensing unit 1 ′ comprising at least one set of sensor electrodes (not shown) configured to be placed on the body of the patient 2 . The sensing unit 1 ′ may comprise up to twenty-five sensor electrodes or more. The sensor electrodes may be coupled directly to the second device 4 via a wired connection 5 ′. The connection 5 ′ may be a data cable comprising an optional plug-and-socket coupling for separating the two devices 1 ′, 4 ′. The second device 4 ′ may be configured as an electromyographic unit 4 ′ configured to record the measured data from the sensing unit 1 ′. The second device 4 ′ may comprise a display module configured to display the recorded data from the device 1 ′ and/or the data logged 15 , 17 by the subject 13 . [0094] The invention is not limited to the embodiments described herein and may be modified or adapted without departing from the scope of the present invention as described in the patent claims below.

A method and system for detecting a probability of psychogenic non-epileptic seizures using a portable battery powered device placed on the body of a patient and a device for manually logging detected seizures within a time period. The device may, advantageously, have a seizure detection algorithm which automatically records seizures detected within that time period. The two sets of data may then be transferred to a another device where the logged time stamps are matched to the recorded time stamps for determining if the detected seizure is a generalized tonic-clonic seizure (GTCS) or might be a psychogenic nonepileptic seizure (PNES). This provides a cheap and simple method for registering a probability of PNES by using a seizure detection device having an EMG-sensor or an accelerometer.

FIELD OF THE INVENTION The claimed invention relates to devices and methods for the stimulation of a patient's muscles using a probe. BACKGROUND Anorectal malformations are variety birth defects that may include (1) the absence of an anal opening, (2) the anal opening in the wrong place, (3), a connection, or fistula, joining the intestine and the urinary system, (4) a connection joining the intestine and vagina, or (5) the intestine can join with the urinary system and vagina in a single opening. During repair of the anorectal malformations, the colon is pulled down to a newly created anal opening, which must be properly situated between the anal sphincter muscles. Repair of anorectal malformations (ARM) using either posterior sagittal anorectoplasty (PSARP) or Georgeson's laparoscopic technique is optimally performed using a muscle stimulator to clearly delineate the anal and pelvic muscle complexes for precise anatomic placement of the rectal pull-through segment. Unfortunately, commercially available muscle stimulators for ARM surgery can be prohibitively expensive for many regions of the globe due as their cost may exceed 10,000 USD. Not surprisingly, this cost barrier limits the use of this critically important tool by surgeons in communities with limited resources to purchase this device. BRIEF DESCRIPTION OF THE FIGURES Exemplary embodiments are illustrated in referenced figures. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive. FIG. 1 depicts, in accordance with various embodiments of the present invention, a cross sectional view of a probe and stimulator; FIG. 2 depicts, in accordance with various embodiments of the present invention, a top view of a probe and stimulator; and. FIG. 3 depicts, in accordance with various embodiments of the prevent invention, a method for performing a surgery with the disclosed devices. SUMMARY OF THE INVENTION Through various forms of experimentation, the inventors have determined that a suitable muscle stimulator may be constructed from (1) a widely available low cost (e.g., $200 per unit) peripheral nerve stimulators or similar stimulator and (2) a relatively simple, handheld surgical probe to provide a low cost muscle stimulator that is adequate for ARM surgeries. These two components could provide a low cost solution to allow doctors in developing countries feasibly perform ARM surgeries with minimal cost and manufacturing. Furthermore, a simple and durable probe stimulator may be easily detached from the device and sterilized using a steam (e.g. autoclave) sterilization procedure that is harsh but inexpensive. This is a drastic improvement over current muscle stimulators which have complex probes that cannot be steam sterilized and therefore require sterilization at a centralized hospital using potentially time intensive procedures. Stimulator In some embodiments, a commercially available “Peripheral Nerve Stimulator” commonly designed for use as a tool for anesthesiologists to determine the appropriate sedation levels for a given patient during surgery may be utilized to provide the appropriate electrical stimulation. There are various manufacturers of these devices, and they typically consist of an electronic device that is battery operated with some type of user interface controlling the amount of current that is delivered through various forms of metallic external connectors to the patient. The stimulator is activated through a button that delivers electrical current from the stimulator when depressed. Probe The second component of the presently disclosed device is the handheld surgery probe that may include a probe tool and an electrical connection to the stimulator that delivers the electrical current from the stimulator to the patient's skin. In some embodiments, such a handle held probe may include an electrically insulated handle with two metallic leads that protrude through the top of the device and deliver the electrical stimulation to a patient's skin. The probe may include a handle portion or casing that is made of an electrically insulating material to prevent the flow of current between the two metallic leads when not in contact with the patient's skin. The probe could be constructed from a material that can endure sterilization temperatures and is resistant to corrosion caused by the steam sterilization. In some embodiments, the probe is connected to the stimulator through a pair of electrically insulated wires that connect from metallic leads on the pen probe to the two pins on the stimulator. The wires connecting the pen probe to the stimulation device may also be made of heat resistant and corrosion resistant materials so that the entire surgery probe unit can be separated from the stimulator device and sterilized and reused for multiple surgeries. DETAILED DESCRIPTION OF THE INVENTION All references cited herein are incorporated by reference in their entirety as though fully set forth. Unless defined otherwise, technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. One skilled in the art will recognize many methods and materials similar or equivalent to those described herein, which could be used in the practice of the present invention. Indeed, the present invention is in no way limited to the methods described herein. For purposes of the present invention, the following terms are defined below. Overview FIG. 1 illustrates an embodiment of the present disclosure that includes a simulator 100 and a probe 105 . The stimulator 100 may be connected to the probe 105 through a wire 130 and connector 150 or directly with just a wire 130 . The probe 105 includes an electrically insulated casing 110 that house two leads 120 that conduct electricity to the patient's skin or soft tissue in order to stimulate muscles and/or nerves. In some embodiments, the leads 120 may contain a spacer 140 to ensure separation of the two leads 120 on the patient's skin. During usage for example in an ARM surgery, a surgeon may place the probe leads 120 on a patient's skin and activate the simulator 100 to deliver a sufficient amount of electricity to a localized area in order to cause a contraction of muscle in the vicinity of the probe leads 120 . If sufficiently electricity is delivered, the surgeon or a detector (for example with an EMG device) may record muscle contractions. Thus the surgeon will then be able to determine the location of certain muscles. For example, the device may be utilized to detect the location of the anal and pelvic muscles, so an appropriate placed incision can be made for the ARM surgery. If a contraction is detected, the intensity and direction of contraction will provide a surgeon or other caregiver with information regarding the location and orientation of muscles. Stimulator In some embodiments, stimulator 100 may be a conventional “Peripheral Nerve Stimulator” commonly designed for use as a tool for anesthesiologists to determine the appropriate sedation levels for a given patient during surgery. For example, the commercially available Micro Stim or SunStim peripheral nerve stimulators may be implemented. In other embodiments, any suitable stimulator 100 may be utilized that delivers an appropriate electrical pulse to two different leads as described herein. The stimulator 100 may deliver a suitable pulse to cause contraction of muscles with a certain range of the leads 120 of the probe 105 . For instance, the stimulator 100 may deliver a constant mode 100 Hz square wave that ranges between 0-70 milliamps. In other embodiments, other shapes of waves may be utilized that various in amplitude and frequency. In some embodiments, the amplitude may be varied to compensate for different ages of patients' that require a different threshold of stimulation to contract local muscles. The amplitude of current may also determine the maximum distance from the leads 120 that will precipitate muscular contraction. In some embodiments, the stimulator 100 may be able to vary the amplitude to allow a doctor to customize the pulse for a particular patient. FIG. 2 illustrates an embodiment of the stimulator 100 including the available options for waveforms. As illustrated, the options available for stimulation are relatively basic and include a 100 Hz and TDF wave. Probe The probe 105 may be simply constructed from durable materials in order to allow for harsher sterilization methods that may be employed in developing countries. For instance, the probe 105 may include leads 120 for delivering the electrical current to a patient's skin from the wires 130 . In some embodiments, the leads 120 may be elongated rods constructed of corrosion resistant metal or other conductors. In some embodiments, the leads 120 may be constructed from brass rods. In some embodiments, the ends of the leads 120 may be rounded at the tip 125 to avoid damaging a patient's skin. In some embodiments, the leads 120 may be 2-5 inches, 4 inches, 3 inches, 2 inches, or 1 inch, or other suitable lengths. FIG. 2 illustrates an embodiment of probe 105 that includes a relatively straight casing 110 . As illustrated in FIG. 1 , casing 110 or other electrical insulating covering may enclose the leads 120 for handling by the physician and for preventing current from exiting the leads other than at the tip portion 125 of the leads. Various materials may be utilized for casing 110 that are preferably resistant to corrosive methods of sterilization, durable, and provide electrical insulation. For example, a polytretrafluoroethylene (PTFE) tube may be utilized, with holes or a channel for the leads 120 to be inserted through. In other embodiments, other materials may be utilized that are suitable. In some embodiments, the casing 110 will have a channel 160 or hole that runs the longitudinal length of the tube. The leads 120 may be inserted through the hole and then a spacer 140 provided near the tip 125 to keep the leads 120 separated from each other. In some embodiments, spacer 140 may run the length of the casing 110 , a third of the casing 110 , or may be placed between the two leads 120 . In other embodiments, the leads 120 may be glued to the side or spacer 140 with a cement or adhesive. In some embodiments, a filler may be packed into the hole 160 that could harden and keep leads 120 in place. In some embodiments, to lengthwise holes 160 may be drilled, machined, or otherwise made that are sized to fit leads 120 . Casing may be rounded or sanded on the end nearest the tip 125 of the probes 120 to avoid a sharp protrusion. The probes may be connected to connectors 150 or stimulator 100 through wires 130 . Wires 130 may be any suitable wires that are resistant to certain types of corrosive and/or harsh sterilization techniques. For instance, 24 AWG, stranded wire may be utilizes that is rated for high heat, for example up to 150 C, 160 C, 170 c, or 200 C, and 600V with FEB insulation. The wire 130 may be connected to probe 120 and connector 150 by any suitable connection, including for example wrapping and soldering the wire to the leads 120 and the connector. In other embodiments, simple heat shrink tubing may additionally or alternatively be utilized that is rated for 140 C, 150 C, 160 C or other suitable temperatures. Methods The device as presently disclosed may be utilized for the stimulation of muscles during surgeries or in other appropriate contexts. For example, the stimulator 100 and probe 105 may be utilized to perform (1) repair of anorectal malformations (ARM) or (2) precise identification of facial nerve branches when performing head and neck surgery. Other examples and methods of utilizing a probe and stimulator as disclosed herein may be utilized for the stimulation of muscles of a patient. Repair of anorectal malformations (ARM) using either posterior sagittal anorectoplasty (PSARP) or Georgeson's laparoscopic technique are optimally performed using a muscle stimulator to clearly delineate the anal and pelvic muscle complexes for precise anatomic placement of the rectal pull-through segment. Examples of these operations are described in detail in: Georgeson K E, Inge T H, Albanese Conn. (2000) Laparoscopically-assisted anorectal pull-through for high imperforate-anus—a new technique. J. Pediatr. Surg. 35:927-931. Operations in which the identification of nerve branches is essential to safe operation include superficial parotidectomy and complete parotidectomy particularly in cases of parotid tumors. An example of this surgery is described in: Spiro R H., The parotid gland. In Baker R J, Fischer J E, eds. Mastery of Surgery. Vol. 14th ed. Philadelphia: Lippincott Williams & Wilkins; 2001: 320-327; and Pena A (1988) Posterior Sagittal anorectoplasty: results in the management of 332 cases of anorectal malformations. Pediatr. Surg. Int. 3:94-104. FIG. 3 illustrates an example of a method disclosed herein for utilizing the disclosed stimulating system. The methods disclosed may include providing a stimulator 100 that may be a conventional peripheral nerve stimulator, providing a probe as described herein. The stimulator 100 may be connected 200 to the probe 105 through a wire 130 and connector 150 or directly with just a wire 130 . The probe 105 and stimulator 100 may be utilized to map out the limits of the anal and pelvic muscle complexes for precise anatomic placement of the rectal pull-through segment. Accordingly, the probe 105 includes an electrically insulated casing 110 that house two leads 120 that conduct electricity to the patient's skin or soft tissue in order to stimulate muscles and/or nerves. In some embodiments, the leads 120 may contain a spacer 140 to ensure separation of the two leads 120 on the patient's skin. During usage, for example in an ARM surgery, a surgeon may place the probe leads 120 on a patient's skin or soft tissue 210 and activate the simulator 220 to deliver a sufficient amount of electricity to a localized area in order to cause a contraction of muscle in the vicinity of the probe leads 120 . If sufficiently electricity is delivered, the surgeon or a detector (for example with an EMG device), may record muscle contractions 230 . Thus, the surgeon will then be able to determine the location of certain muscles. For example, the device may be utilized to detect the location of the anal and pelvic muscles, so an appropriate placed incision can be made for the ARM surgery. If a contraction is detected, the intensity and direction of contraction will provide a surgeon or other caregiver with information regarding the location and orientation of muscles. After a contraction is detected 230 , the surgeon may relocate the probe on the patient 240 and repeat the process to map out the limits of the anal and pelvic muscles. CONCLUSIONS The various methods and techniques described above provide a number of ways to carry out the invention. Of course, it is to be understood that not necessarily all objectives or advantages described may be achieved in accordance with any particular embodiment described herein. Thus, for example, those skilled in the art will recognize that the methods can be performed in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other objectives or advantages as may be taught or suggested herein. A variety of advantageous and disadvantageous alternatives are mentioned herein. It is to be understood that some preferred embodiments specifically include one, another, or several advantageous features, while others specifically exclude one, another, or several disadvantageous features, while still others specifically mitigate a present disadvantageous feature by inclusion of one, another, or several advantageous features. Furthermore, the skilled artisan will recognize the applicability of various features from different embodiments. Similarly, the various elements, features and steps discussed above, as well as other known equivalents for each such element, feature or step, can be mixed and matched by one of ordinary skill in this art to perform methods in accordance with principles described herein. Among the various elements, features, and steps some will be specifically included and others specifically excluded in diverse embodiments. Although the invention has been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the embodiments of the invention extend beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and modifications and equivalents thereof. In some embodiments, the numbers expressing quantities of ingredients, properties such as concentration, reaction conditions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term “about.” Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements. In some embodiments, the terms “a” and “an” and “the” and similar references used in the context of describing a particular embodiment of the invention (especially in the context of certain of the following claims) can be construed to cover both the singular and the plural. The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual 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 with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention. Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims. Preferred embodiments of this invention are described herein, including the best mode known to the inventor for carrying out the invention. Variations on those preferred embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. It is contemplated that skilled artisans can employ such variations as appropriate, and the invention can be practiced otherwise than specifically described herein. Accordingly, many embodiments of this invention include 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. Furthermore, numerous references have been made to patents and printed publications throughout this specification. Each of the above cited references and printed publications are herein individually incorporated by reference in their entirety. In closing, it is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present invention. Other modifications that can be employed can be within the scope of the invention. Thus, by way of example, but not of limitation, alternative configurations of the present invention can be utilized in accordance with the teachings herein. Accordingly, embodiments of the present invention are not limited to that precisely as shown and described.

A muscle stimulator that may be used during ARM surgeries is disclosed that may be constructed from (1) a widely available low cost (e.g., $200 per unit) peripheral nerve stimulators or similar stimulator and (2) a relatively simple, handheld surgical probe to provide a low cost muscle stimulator that is adequate for ARM surgeries. These two components could provide a low cost solution to allow doctors in developing countries feasibly perform ARM surgeries with relatively minimal manufacturing and inexpensive maintenance.

FIELD OF THE INVENTION The present invention relates to fluid body padding used for fall protection. BACKGROUND OF THE INVENTION Injuries from falls are a common and serious problem for the elderly. Many such injuries could be prevented if thick body padding were worn. However, most elderly persons are too proud to wear body padding, if the fact that they are wearing such body padding is readily apparent to a casual observer. Whether the fluid medium used is a liquid or a gas, in order to function as fall protection a fluid filled body pad must be fully inflated, like a balloon. If the fluid filled body pad is not fully inflated, they are still suitable for preventing bed sores, but are no longer suitable as fall protection. The reason for this is that in order for a fluid filled body pad to function when it is not fully inflated, pressure must be exerted evenly upon the pad. When a person falls, against a sharp object such as a stone, or the edge of a curb, localized pressure is applied. In response to such localized pressure, the fluid in the fluid filled body pad will be displaced. SUMMARY OF THE INVENTION What is required is fluid filled body padding which can provide effective fall protection. According to the present invention there is provided a fluid filled body padding for fall protection which includes a flexible inner pouch holding a shock absorbing fluid. A flexible outer pouch encapsulates the inner pouch. A fluid interface is provided between the inner pouch and the outer pouch. The fluid interface serves to pressurize and rigidify the inner pouch containing the shock absorbing fluid when a localized force is exerted upon the outer pouch. With the body padding, as described above, a localized force exerted upon the outer pouch is converted by the liquid interface into an even force which acts uniformly upon the inner pouch. The inner pouch becomes rigid in response to the pressure applied via the liquid interface and is better able to withstanding the localized force resulting from the fall. If the impacting force is sufficiently large, the membrane containing the fluid ruptures to eject the excess localized force resulting from the fall. Although beneficial results may be obtained through the use of the body padding, as described above, when air is used as a fluid the volume of air required in order to be effective tends to be bulky and when a liquid is used as a fluid the liquid tends to flow to the bottom of the pouch causing the pouch to sag. Even more beneficial results may, therefore, be obtained when the shock absorbing fluid is a viscous gel-like liquid. The viscous gel-like liquid tends to hold its position and reduce sagging. For the same reason, it is preferred that the fluid interface be a viscous gel-like liquid. Although beneficial results may be obtained through the use of the body padding, as described above, even more beneficial results may be obtained when polymer beads are mixed with the viscous gel-like liquid in the inner pouch. The polymer beads serve to reduce the weight of the fall protection without any significant adverse affect upon its performance. BRIEF DESCRIPTION OF THE DRAWINGS These and other features of the invention will become more apparent from the following description in which reference is made to the appended drawings, the drawings are for the purpose of illustration only and are not intended to in any way limit the scope of the invention to the particular embodiment or embodiments shown, wherein: THE FIGURE is a side elevation view, in section, of body padding for fall protection constructed in accordance with the teachings of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The preferred embodiment, fluid filled body padding generally identified by reference numeral 10 , will now be described with reference to THE FIGURE. Structure and Relationship of Parts: Fluid filled body padding 10 has a flexible inner pouch 12 that holds a viscous gel-like shock absorbing liquid 14 . In the illustrated embodiment, polymer beads 16 are mixed with gel-like liquid 14 . Body padding 10 is further adapted with a flexible outer pouch 18 that encapsulates inner pouch 12 . Foam padding 28 surrounds outer pouch 18 . A viscous gel-like liquid interface 20 , also shown mixed with polymer beads 16 , is interposed between inner pouch 12 and outer pouch 18 such that inner pouch 12 is pressurized and rigidified when a localized force 22 is exerted upon outer pouch 18 . Inner and outer pouches 12 and 18 are of materials such that they will break or rupture when excessive force is applied. Operation: The use and operation of fluid filled body padding 10 will now be described with reference to THE FIGURE. Where a user desires protection from a possible fall, fluid filled body padding 10 is positioned along the desired body form 24 . Due to the flexibility of both inner pouch 12 and outer pouch 18 , body padding 10 substantially conforms to the shape. Should the user fall and be struck by a sharp, localized force 22 , the force is received by outer pouch 18 and dissipated and converted by viscous gel-like liquid interface 20 and polymer beads 16 into an even force 26 that is applied uniformly to inner pouch 12 . Inner pouch 12 is, in turn, rigidified over its area. If an excessive force is applied, inner and outer pouches 12 and 18 may rupture to further reduce the impact. The effect on the user is a neutralization of damaging, localized force and the avoidance of serious injury. Test Results: Tested Protectors The protectors, or fluid filled body padding 10 that were tested consisted of one 6 mm thick foam pad 28 and one 3 mm thick foam pad 28 which enveloped the force reducing device, or FRD. The FRD as described above is comprised of two individual gel packs; a small inner gel pack, inner pouch 12 , which is encased inside of a larger gel pack, outer pouch 18 . The main structure of the protector is 17.8 cm wide by 25.4 cm in length. The inner FRD is 7.6 cm wide by 15.2 cm in length. The purpose of the testing was to observe what amount of force attenuation the protectors could provide. Testing System The impact testing system consisted of a Charpy materials impact tester, which was modified so that it could be used as an impact pendulum. The pendulum had a mass of 40 kg and a center of mass 81.0 cm from its axis of rotation. A striking plate was affixed to the base of the charpy tester, which consisted of a steel plate and some rubber matting. The matting was added to introduce compliance into the system so that there would not be any extremely sharp impulses occurring. A Bruel and Kjaer 4344 accelerometer in conjunction with a Bruel and Kjaer 2511 vibration meter measured the accelerations. The conditioned signal output was monitored by an INSTRUNET model 100 analog/digital data acquisition system and then recorded on a Toshiba satellite A10 laptop. The data-sampling interval was 6 μs. Impact Experiments The impact pendulum was setup to have three nominal peak force settings of 2000 N, 4000 N, and 7000 N with no protectors present. The calibration tests showed the actual peak impact force for the lowest setting of 2000 N, to be 2056 N±58 N. The second peak force setting of 4000 N gave an actual peak impact of 4293 N±74 N. The highest impact setting of 7000 N showed the peak impact to be 7317 N±87 N. During these three experiments the mass of the pendulum remained the same, only the height from which the pendulum was released was altered. A total of 14 hip protectors were tested. The first set of testing was performed on protectors 1 – 6 , which were struck 5 times at the three peak impact force levels. While testing at the 4000 N peak impact force level, four of the six protectors FRD's ruptured along the seams of the outermost casing. These four protectors were tested after the ruptures occurred in order to see what effect a broken FRD had on the force attenuation characteristics of the protector. A second set of testing was done with protectors 7 – 14 with each protector having a single strike at either the 4000 N or the 7000 N setting. Finally, a protector without the FRD was tested a total of 5 times at each of the impact settings so that a comparison could be made to see what effect the addition of the FRD had. Results and Discussion 2000 N Tests Protectors 1 – 6 were each struck five separate times at this setting. None of the FRD's failed at the 2000 N setting. The hip protectors had an average reduction of force of 921 N (44%) for the first strike compared to the fifth strike average, which produced a decrease of 789 N (38%), and an overall average decrease of 842 N (40%). The average reduction of force for the foam padding (the protector without the FRD) was 674 N (30%). The 6% difference between the average force reduction for the first strike as compared to the fifth strike shows a slight trend wherein the more strikes that the protectors were subjected too, the less their ability to attenuate the impact force. Some variability between the amounts of force attenuated by each protector was also found. For example, protector 1 had an average force attenuation of 791 N while protector 6 had an average force attenuation of 885 N. This variability is most likely attributed to the repeatability of the protector construction process. 4000 N Tests There were a total of eight separate protectors tested at the 4000 N setting. Protectors 1 – 6 were struck a total of five separate times at this setting. A second set of testing was performed with protectors 13 and 14 , although these protectors were struck only once at the 4000 N setting. The FRD's of protectors 3 , 4 , 5 , 6 , 13 and 14 , all failed at the 4000 N setting. Protectors 1 – 6 had an average reduction force of 2008 N (48%) for the first strike compared to the fifth strike average reduction of 1752 N (41%). Protectors 13 and 14 had an average reduction force of 2018 N (51%) for the first and only strike. The average reduction of force for the foam padding was 1451 N (37%). It should be noted that the greatest attenuation of force for protectors 1 – 6 occurred on the strikes wherein the FRD was ruptured. For example the first strike broke protector 5 's FRD and resulted in a force reduction of 2220 N (54%). In comparison the first strike on protector 1 , which did not cause the FRD to fail, resulted in a force reduction of 1943 N (45%). Thus the failure of a protector's FRD's will account for some of the variation observed between the average of the first and fifth strikes on protectors 1 – 6 . The FRD's of protectors 3 – 6 ruptured along the seam of the outer casing during the testing at the 4000 N level. The ruptures varied in size, but were all under 2 cm in length and only allowed a very small portion of the gel to escape. Thus a decision was made to keep testing these protectors to see if there would be a noticeable change in their force attenuation. The results varied considerably between the four protectors. Protector 3 had a first strike reduction of 1720 N (43%) at which point the gel pack broke, but the fifth strike had a force reduction of 1712 N (40%) for only a 3% difference. However, protector 5 had a first strike reduction of 2220 N (54%) and a fifth strike force reduction of 1785 N (44%) for a difference of 10%. The differences are likely due to the manner in which the FRD's failed; if the rupture propagated upon impact a larger amount of gel would be expelled from the FRD, thus attenuating more force than a small rupture in which only a small amount of gel would be expelled. 7000 N Tests There were a total of seven separate protectors tested at the 7000 N setting. Protectors 1 and 2 , which FRD's were still intact after the earlier tests, and five new protectors ( 8 – 12 ) were tested. All of the protectors FRD's failed at this setting. Protectors 1 and 2 had an average force reduction of 3532 N (52%), while protectors 8 – 12 had an average force reduction of 4059 N (58%). The average reduction of force for the foam padding was 3936 N (43%). Protectors 1 and 2 had significantly lower force attenuation than protectors 8 – 12 . This could be attributed to damage sustained to the FRD's of protectors 1 and 2 in previous tests (a thorough visual inspection of the gel packs was not possible as they were sewn inside the protector padding). Protectors 8 – 12 provided a measure between protectors that had not been hit before while protectors 1 and 2 had undergone testing at both the 2000 N and 4000 N peak impact force levels. At the 7000 N peak impact force level the FRD's have a greater effect on the force attenuation than at the other force settings as a reduction of force of 58% was observed compared to a reduction of force of 44% at 2000 N and 48% for 4000 N. This greater increase in force attenuation can be attributed to the failure of the FRD's at the 7000 N impacts. All seven of the protectors FRD's burst quite explosively as the contents of the FRD's often burst forth from the protector. In a few cases the FRD's inner gel pack itself as well as the gel from the outer casing was ejected. Thus a portion of the impact energy was being transferred into ejecting the gel or inner gel pack. CONCLUSIONS The average force reduction for the first strike on each of the protectors with the FRD's with the foam padding is shown in Table 1. TABLE 1 Average Force Reductions Protectors: Foam Padding: Impact 1 st Strike Average Average force Forces Force Reduction Reduction (N) (%) (%) 2000 44 30 4000 48 37 7000 58 43 From the above results the FRD's do improve the attenuation of force of the protectors with the foam padding only. However, this attenuation is at most 15% greater than just the protector alone (this occurred at the 7000 N testing). THis increased attenuation was particularly dependent upon whether or not the gel pack ruptured during the test. Force Reducing Device Tested Protector The FRD is comprised of two individual gel packs; a small inner gel pack which is encased inside of a larger gel pack. The main structure of the protector is 17.8 cm wide by 25.4 cm in length. The inner FRD is 7.6 cm wide by 15.2 cm in length. Testing System The same system that was used in testing the hip protectors was once again employed. Impact Experiments The impact pendulum was setup to have four nominal peak force level settings of 1600 N, 2000 N, 4000 N and 6000 N. The calibration tests showed that the actual peak forces to be: 1601 N:±41 N, 2020±10 N, 4040±23 N, 5960±60 N, for the nominal peak force levels, respectively. The FRD's were struck only once with the exception of FRD #2. Results and Discussion The results of the FRD testing are summarized in the Table 2 on the next page. TABLE 2 FRD Testing Results Impact Gel pack % FRD Force Force Force # (kN) (kN) Absorbed Notes 1 2.02 1.75 13.3% Small rupture along seam at top corner of outer gel pack. 2 2.02 1.62 19.8% FRD remained intact, no ruptures. 3 2.02 1.04 48.5% The outer gel packs seam blew out along the bottom and sides. 4 2.02 1.57 22.3% Inner gel pack was blown through the top seam of outer gel pack. 5 2.02 1.40 30.5% Top left seam of outer gel pack ruptured. 6 2.02 1.37 32.3% Inner gel pack was blown through the top seam of outer gel pack. 7 1.60 1.27 20.5% Top left seam of outer gel pack ruptured. 8 1.60 1.09 31.9% Inner gel pack was blown through the top seam of outer gel pack. 9 1.60 1.15 28.1% A small hole (approx 1/8/1) appeared at the right corner seam of outer gel pack. 10  4.04 1.51 62.7% Inner gel pack was blown through the top seam of outer gel pack. 11  4.04 1.35 66.6% Inner gel pack was blown through the top seam of outer gel pack. 12  6.00 2.59 56.9% Inner gel pack was blown through the top seam of outer gel pack. 2 6.00 2.16 64.0% Inner gel pack was blown through the top seam of outer gel pack. ? 6.00 2.62 56.3% Seams burst along top and sides. *** *** There was no inner gel pack in this FRD. (It was not included in the results as it was only tested for curiosity's sake It was observed that the FRD's failed even at the lowest setting (1600 N). The percentage of force attenuation at the nominal peak forces of 1600 N and 2000 N do not differ by much as the average percentage of force attenuated was 26.9% and 27.8% for the 1600 N and 2000 N nominal peak impact forces respectively. At the highest nominal peak impact force levels of 4000 N and 6000 N the FRD's all failed quite spectacularly. In most cases most of the gel in the outer casing as well as the inner gel pack itself was ejected, thus leading too much larger force attenuations. For the 4000 N setting the average percentage of force attenuated was 64.6% while for the 6000 N setting the average percentage of force attenuated was 59.0%. The average percentage of force attenuated at each peak impact force level is shown in Table 3. TABLE 3 Gel Pack Force Attenuation In this patent document, the word “comprising” is used in its non-limiting sense to mean that items following the word are included, but items not specifically mentioned are not excluded. A reference to an element by the indefinite article “a” does not exclude the possibility that more than one of the element is present, unless the context clearly requires that there be one and only one of the elements. It will be apparent to one skilled in the art that modifications may be made to the illustrated embodiment without departing from the spirit and scope of the invention as hereinafter defined in the claims.

A fluid filled body padding for fall protection includes a flexible inner pouch holding a shock absorbing fluid. A flexible outer pouch encapsulates the inner pouch. A fluid interface is provided between the inner pouch and the outer pouch. The fluid interface serves to pressurize and rigidify the inner pouch containing the shock absorbing fluid when a localized force is exerted upon the outer pouch. This body padding is suitable for a variety of fall protection applications, such as hip protectors for senior citizens.

BACKGROUND OF THE INVENTION The present invention relates to a phenylhydrazone derivative of oxamide useful as active ingredient of herbicidal composition and to the herbicidal compositions containing said derivatives as active ingredient. Hitherto, 1-(2-tolyl)hydrazone of N-benzoyloxamide and 1-(3-tolyl)hydrazone of N-benzoyloxamide have been reported as phenylhydrazone derivatives of oxamide (Journal of the Chemical Society, 575, 1962). However, no disclosure has ever been made about the phenylhydrazone derivatives of oxamide represented by the following formula (I): ##STR2## (wherein R 1 is straight-chain alkyl group having 2 to 10 carbon atoms, branched alkyl group or cyclic alkyl group having 3 to 10 carbon atoms, alkyl group having 1 to 3 carbon atoms which is substituted with an alicyclic structure having 3 to 7 carbon atoms, phenyl group, halogen-substituted phenyl group, aralkyl group having 7 to 9 carbon atoms, alkenyl group having 3 to 6 carbon atoms alkyl group having 2 to 4 carbon atoms which is subsutituted with alkoxy group having 1 to 4 carbon atoms, or alkyl group having 2 to 10 carbon atoms which is substituted with 1 to 19 fluorine atoms; and R 2 is hydrogen, fluorine, chlorine, methyl group or methoxy group, and the fact that such derivatives have an excellent selective herbicidal activity. Rice, wheat and corn are the important crops, and use of a herbicide is essential for increasing the yield of such crops by protecting them against harm by weeds. Thus, the development of the herbicides, especially the ones having a selective herbicidal activity enabling killing of weeds alone without doing any practical harm to the crops even if applied to the crops and weeds at the same time, has been strongly desired. The present inventors have made extensive studies on the compounds showing an excellent herbicidal effect but not doing any practical harm to the useful crops such as rice, wheat and corn, and found that the phenylhydrazone derivatives of oxamide represented by the following formula (I) have the excellent selective herbicidal activities: ##STR3## wherein R 1 is straight-chain alkyl group having 2 to 10 carbon atoms, branched alkyl group or cyclic alkyl group having 3 to 10 carbon atoms, alkyl group having 1 to 3 carbon atoms which is substituted with an alicyclic structure having 3 to 7 carbon atoms, phenyl group, halogen-substituted phenyl group aralkyl group having 7 to 9 carbon atoms, alkenyl group having 3 to 6 carbon atoms, alkyl group having 2 to 4 carbon atoms which is substituted with alkoxy group having 1 to 4 carbon atoms, or alkyl group having 2 to 10 carbon atoms which is substituted with 1 to 19 fluorine atoms; and R 2 is hydrogen, fluorine, chlorine, methyl group or methoxy group. The present invention was attained on the basis of this finding. Thus, the present invention has for its object to provide a phenylhydrazone derivative of oxamide having a selective herbicidal activity, that is, showing excellent herbicidal activities against the gramineous weeds and, in particular, broadleaf weeds, while doing no harm to the crops such as rice, wheat and corn, and a herbicidal composition containing such derivatives as active ingredient. SUMMARY OF THE INVENTION In a first aspect of the present invention, there is provided a phenylhydrazone derivative of oxamide represented by the formula (I): ##STR4## wherein R 1 is straight-chain alkyl group having 2 to 10 carbon atoms, branched alkyl group or cyclic alkyl group having 3 to 10 carbon atoms, alkyl group having 1 to 3 carbon atoms which is substituted with an alicyclic structure having 3 to 7 carbon atoms, phenyl group, halogen-substituted phenyl group, aralkyl group having 7 to 9 carbon atoms, alkenyl group having 3 to 6 carbon atoms, alkyl group having 2 to 4 carbon atoms which is substituted with alkoxy group having 1 to 4 carbon atoms, or alkyl group having 2 to 10 carbon atoms which is substituted with 1 to 19 fluorine atoms; and R 2 is hydrogen, fluorine, chlorine, methyl group or methoxy group. In a second aspect of the present invention, there is provided a herbicidal composition comprising as active ingredient a herbicidally effective amount of a phenylhydrazone derivative of oxamide represented by the formula (I): ##STR5## wherein R 1 and R 2 are as defined above, and herbicidally acceptable carrier or adjuvant. In a third aspect of the present invention, there is provided a process for producing a phenylhydrazone derivative of oxamide represented by the formula (I): ##STR6## wherein R 1 and R 2 are as defined above, which comprises reacting phenylhydrazone derivative of 2-oxazoline-4,5-dione represented by the formula (II): ##STR7## wherein R 1 and R 2 are as defined above, with ammonia in an organic solvent at a temperature of -10° to 100° C. DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a phenylhydrazone derivative of oxamide represented by the formula (I): ##STR8## and a herbicidal composition containing such derivative as active ingredient. In the above-shown formula (I), R 1 represents straight-chain alkyl group having 2 to 10, preferably 3 to 6 carbon atoms, branched alkyl or cyclic alkyl group having 3 to 10, preferably 3 to 7 carbon atoms, alkyl group having 1 to 3, preferably 1 to 2 carbon atoms, which is substituted with an alicyclic structure having 3 to 7, preferably 3 to 6 carbon atoms, phenyl group, phenyl group substituted with preferably 1 to 3 halogens, aralkyl group having 7 to 9 carbon atoms, alkenyl group having 3 to 6 carbon atoms, alkyl group having 2 to 4, preferably 2 carbon atoms, which is substituted with alkoxyl group having 1 to 4, preferably 4 carbon atoms, or alkyl group having 2 to 10, preferably 2 to 6 carbon atoms, which is substituted with 1 to 19, preferably 3 to 12 fluorine atoms; and R 2 represents hydrogen, fluorine, chlorine, methyl or methoxyl group. The compounds represented by the formula (I) of the present invention, their physicochemical properties and the results of their elemental analyses are shown in Tables 1 and 2. TABLE 1______________________________________ ##STR9## (I) StructureNo. R.sup.1 R.sup.2______________________________________1 (CH.sub.2).sub.3 CH.sub.3 H2 (CH.sub.2).sub.4 CH.sub.3 H ##STR10## H4 CH.sub.2 C(CH.sub.3).sub.3 H5 ##STR11## H6 ##STR12## H7 ##STR13## H8 ##STR14## H9 CH.sub.2 CHCH.sub.2 H10 CH.sub.2 CF.sub.3 H11 CH.sub.2 CF.sub.2 CHF.sub.2 H12 CH.sub.2 (CF.sub.2).sub.3 CHF.sub.2 H13 CH.sub.2 (CF.sub.2).sub.5 CHF.sub.2 H14 (CH.sub.2).sub.2 O(CH.sub. 2).sub.3 CH.sub.3 H15 (CH.sub.2).sub.3 CH.sub.3 2-F16 (CH.sub.2).sub.4 CH.sub.3 2-F17 (CH.sub.2).sub.2 CH(CH.sub.3).sub.2 2-F18 (CH.sub.2).sub.2 CH(CH.sub.3).sub.2 3-F19 (CH.sub.2).sub.2 CH(CH.sub.3).sub.2 4-F20 ##STR15## 2-F21 CH.sub.2 C(CH.sub.3).sub.3 2-F22 (CH.sub.2).sub.5 CH.sub.3 2-F23 ##STR16## 2-F24 ##STR17## 2-F25 ##STR18## 2-F26 ##STR19## 2-F27 ##STR20## 2-F28 CH.sub.2 CHCH.sub.2 2-F29 CH.sub.2 CF.sub.3 2-F30 CH.sub.2 CF.sub.2 CHF.sub.2 2-F31 CH.sub.2 CF.sub.2 CF.sub.3 2-F32 CH.sub.2 CF.sub.2 CF.sub.3 3-F33 CH.sub.2 CF.sub.2 CF.sub.3 4-F34 CH.sub.2 CF.sub.2 CHFCF.sub.3 2-F35 CH.sub.2 (CF.sub.2).sub.2 CF.sub.3 2-F36 CH.sub.2 (CF.sub.2).sub.2 CF.sub.3 3-F37 CH.sub.2 (CF.sub.2).sub.2 CF.sub.3 4-F38 CH.sub.2 (CF.sub.2).sub.3 CHF.sub.2 2-F39 CH.sub.2 (CF.sub.2).sub.5 CHF.sub.2 2-F40 (CH.sub.2).sub.2 CH(CH.sub.3).sub.2 4-Cl41 CH.sub.2 CF.sub.2 CF.sub.3 4-Cl42 CH.sub.2 (CF.sub.2).sub.2 CF.sub.3 4-Cl43 (CH.sub.2).sub.2 CH(CH.sub.3).sub.2 4-CH.sub.344 CH.sub.2 CF.sub.2 CF.sub.3 4-CH.sub.345 CH.sub.2 (CF.sub.2).sub.2 CF.sub.3 4-CH.sub.346 (CH.sub.2).sub.2 CH(CH.sub.3).sub.2 4-OCH.sub.347 CH.sub.2 (CF.sub.2).sub.2 CF.sub.3 4-OCH.sub.3______________________________________ TABLE 2__________________________________________________________________________Com- Melting Elemental analysispound point IR (KBr,cm.sup.-1) and Found C (%) H (%) N (%)No. (°C.) NMR [d.sub.6 -DMSO, δ, ppm, 60 MHz) (*CDCl.sub.3 was used) Calcd. C (%) H (%) N (%)__________________________________________________________________________ 1 145-6 IR: 3460 3310 3250 1680 1630 Found 65.00% 6.63% 15.40% NMR: 0.83 (3H, t, 6 Hz) 0.91-1.66 (4H, m) Calcd. 65.20% 6.57% 15.21% 3.36 (2H, t, 6 Hz) 4.35 (2H, s) 6.63-6.96 (1H, bs) 6.98-7.66 (8H, m) 7.83-8.1 (2H, m) 9.56 (1H, s) 9.73 (1H, s) 2 128-31 IR: 3460 3310 3250 1680 1635 Found 65.90% 6.74% 14.83% NMR: 0.83 (3H, t, 7 Hz) 1.0-1.73 (6H, m) Calcd. 65.95% 6.85% 14.65% 3.36 (2H, t, 7 Hz) 4.36 (2H, s) 6.6-6.88 (1H, bs) 6.88-7.68 (8H, m) 7.83-8.1 (2H, m) 9.56 (1H, s) 9.7 (1H, s) 3 135-7 IR: 3460 3310 3250 1680 1635 NMR: 0.8 Found 65.91% 6.65% 14.49% (3H, t, 6 Hz) 0.86 (3H, d, 6 Hz) 1-1.93 (3H, Calcd. 65.95% 6.85% 14.65% m), 3.23 (2H, d, 6 Hz) 4.36 (2H, s) 6.65-6.95 (1H, bs) 6.97-7.66 (8H, m) 7.83-8.13 (2H, m) 9.6 (1H, s) 9.73 (1H, s) 4 118-20 IR: 3470 3310 3260 2950 2850 1685 Found 65.93% 7.00% 14.83% 1640 NMR: 0.88 (9H, s) 3.08 (2H, s) Calcd. 65.95% 6.85% 14.65% 4.41 (2H, s) 6.63-6.95 (1H, bs) 6.95-7.68 (8H, m) 7.85-8.1 (2H, m) 9.6 (1H, bs) 9.75 (1H, bs) 5 157-8 IR: 3460 3320 3260 2910 2840 1680 Found 67.48% 6.90% 13.54% 1640 NMR: 0.55-1.95 (11H, m) 3.15 (2H, m) Calcd. 67.63% 6.91% 13.71% 4.33 (2H, s) 6.58-6.9 (1H, bs) 7.0-7.66 (8H, m) 7.8-8.1 (2H, m) 9.55 (1H, s) 9.7 (1H, s) 6 185-7 IR: 3470 3320 3250 1680 1630 Found 68.23% 5.39% 14.37% NMR: 5.0 (2H, s) 6.36-6.73 (1H, bs) Calcd. 68.03% 5.19% 14.42% 6.73-7.63 (13H, m) 7.76-8.06 (2H, m) 9.6 (1H, s) 9.76 (1H, s) 7 181-2 IR: 3440 3340 3170 1680 1657 Found 62.55% 4.72% 13.35% NMR: 5.0 (2H, s) 6.6-7.66 (9H, m) Calcd. 62.49% 4.53% 13.25% 6.73 (2H, d, 9 Hz) 7.26 (2H, d, 9 Hz) 7.76-8.11 (2H, m) 9.56 (1H, s) 9.73 (1H, s) 8 131-3 IR: 3460 3310 3250 1680 1635 Found 68.84% 5.31% 14.09% NMR: 4.45 (2H, s) 4.5 (2H, s) 6.71-6.96 Calcd. 68.64% 5.51% 13.92% (1H, bs) 6.97-7.66 (13H, m) 7.86-8.11 (2H, m) 9.6 (1H, s) 9.76 (1H, s) 9 162-3 IR: 3470 3310 3250 1680 1635 Found 64.85% 5.84% 16.09% NMR: 3.93 (2H, d, 5 Hz) 4.38 (2H, s) Calcd. 64.76% 5.72% 15.90% 4.96-5.41 (2H, m) 5.51-6.2 (1H, m) 6.6-6.96 (1H, bs) 7.0-7.7 (8H, m) 7.86-8.1 (2H, m) 9.5 (1H, s) 9.7 (1H, s)10 171-2 IR: 3460 3260 1680 1630 Found 55.02% 4.24% 14.08% NMR: 4.0 (2H, q, 9 Hz) 4.56 (2H, s) Calcd. 54.82% 4.35% 14.21% 6.63-6.96 (1H, bs) 6.96-7.66 (8H, m) 7.83-8.1 (2H, m) 9.58 (1H, bs) 9.75 (1H, bs)11 126-8 IR: 3450 3340 3260 1675 1635 Found 53.71% 4.06% 13.04% NMR: 3.92 (2H, tt, 14 Hz, 2 Hz) 4.58 (2H, s) Calcd. 53.52% 4.26% 13.14% 6.50 (1H, tt, 53 Hz, 6 Hz) 6.72-8.18 (11H, m) 9.68 (1H, s) 9.82 (1H, s)12 96-8 IR: 3460 3390 3250 1680 1635 Found 48.12% 3.46% 10.57% NMR: 4.08 (2H, tt, 15 Hz, 2 Hz) 5.08 (2H, s) Calcd. 47.92% 3.45% 10.64% 6.08 (1H, tt, 54 Hz, 6 Hz) 6.50-8.25 (11H, m) 9.65 (1H, s) 9.80 (1H, s)13 104-6 IR: 3460 3390 3270 1680 1635 Found 44.29% 2.77% 9.14% NMR: 4.15 (2H, tt, 15 Hz, 2 Hz) 4.60 (2H, s) Calcd. 44.10% 2.90% 8.94% 6.28 (1H, tt, 51 Hz, 5 Hz) 6.6-8.33 (11H, m) 9.70 (1H, s) 9.85 (1H, s)14 110 IR: 3460 3310 3250 1680 1630 Found 64.01% 6.71% 13.45% NMR: 0.85 (3H, t, 7 Hz) 1-1.63 (4H, m) Calcd. 64.06% 6.84% 13.58% 3.3-3.6 (6H, m) 4.41 (2H, s) 6.53-6.93 (1H, bs) 6.93-7.65 (8H, m) 7.78-8.1 (2H, m) 9.6 (1H, bs) 9.73 (1H, bs)15 133-5 IR: 3460 3330 3240 1680 1630 Found 62.09% 5.94% 14.59% NMR: 0.9 (3H, t, 6 Hz) 1.13-1.9 (4H, m) Calcd. 62.17% 6.00% 14.50% 3.45 (2H, t, 6 Hz) 4.45 (2H, s) 5.6 (1H, bs) 6.75-7.7 (8H, m) 7.93-8.3 (1H, m) 9.6-10.3 (2H, m)16 125-8 IR: 3470 3350 3240 1680 1635 Found 63.19% 6.31% 14.19% NMR: 0.85 (3H, t, 5 Hz) 1.06-1.76 (6H, m) Calcd. 62.99% 6.29% 13.99% 3.26-3.53 (2H, m) 4.38 (2H, s) 6.6-8.03 (10H, m) 9.46 (1H, bs) 9.7 (1H, bs)17 138-40 IR: 3475 3350 3250 1680 1640 Found 63.18% 6.29% 14.12% NMR*: 0.88 (6H, d, 6 Hz) 1.33-2 (3H, m) Calcd. 62.99% 6.29% 13.99% 3.5 (2H, t, 6 Hz) 4.45 (2H, s) 5.56 (1H, bs) 6.8-7.75 (8H, m) 7.96-8.36 (1H, m) 9.8-10.3 (2H, m)18 110-5 IR: 3450 3260 1680 1630 1460 Found 63.12% 6.31% 14.16% NMR: 0.83 (6H, d, 6 Hz) 1.16-1.8 (3H, m) Calcd. 62.99% 6.29% 13.99% 3.4 (2H, t, 6 Hz) 4.33 (2H, s) 6.58-7.9 (10H, m) 9.63 (1H, bs) 9.66 (1H, bs)19 126-8 IR: 3450 3250 1680 1630 Found 63.15% 6.30% 14.14% NMR: 0.85 (6H, d, 6 Hz) 1.1-1.71 (3H, m) Calcd. 62.99% 6.29% 13.99% 3.38 (2H, t, 6 Hz) 4.33 (2H, s) 6.5-7.53 (8H, m) 7.83-8.16 (2H, m) 9.53 (1H, bs) 9.63 (1H, bs)20 131-3 IR: 3470 3345 3250 1685 1640 Found 63.18% 6.31% 13.81% NMR: 0.8 (3H, t, 6 Hz) 0.86 (3H, d, 6 Hz) Calcd. 62.99% 6.29% 13.99% 1-1.93 (3H, m) 3.20 (2H, d, 6 Hz) 4.33 (2H, s) 6.63-7.83 (10H, m) 9.63 (1H, s) 9.60 (1H, s)21 155-6 IR: 3460 3340 3240 1680 1635 Found 63.10% 6.30% 13.88% NMR: 0.9 (9H, s) 3.08 (2H, s) 4.43 (2H, s) Calcd. 62.99% 6.29% 13.99% 6.6-7 (1H, m) 7-7.93 (9H, m) 9.46 (1H, bs) 9.66 (1H, bs)22 127-9 IR: 3480 3350 3250 2920 2850 1680 Found 63.79% 6.63% 13.50% 1630 NMR: 0.87 (3H, t, 6 Hz) 1.07-1.77 Calcd. 63.75% 6.57% 13.52% (8H, m) 3.38 (2H, d, 7 Hz) 4.45 (2H, s) 6.7-8.23 (10H, m) 9.67 (1H, bs) 9.87 (1H, s)23 148-50 IR: 3470 3370 3270 1685 1645 Found 64.88% 6.55% 13.03% NMR: 0.55-1.91 (11H, m) 3.13 (2H, d, 6 Hz) Calcd. 64.77% 6.38% 13.14% 4.30 (2H, s) 6.34-8.02 (10H, m) 9.33 (1H, s) 9.52 (1H, s)24 194-5 IR: 3460 3340 3250 1680 1630 1230 Found 65.04% 4.71% 13.71% NMR*: 4.99 (2H, s) 6.82-7.87 (15H, m) Calcd. 65.02% 4.71% 13.79% 9.4 (1H, s) 9.67 (1H, s)25 186-8 IR: 3450 3410 3340 3240 1678 1630 Found 62.37% 4.09% 13.21% NMR*: 4.97 (2H, s) 6.91-7.97 (14H, m) Calcd. 62.26% 4.27% 13.20% 9.4 (1H, s) 9.65 (1H, s)26 202-4 IR: 3430 3300 1690 1650 Found 60.06% 4.05% 12.91% NMR: 5.05 (2H, s) 6.8-8.1 (14H, m) Calcd. 59.94% 4.12% 12.71% 9.55 (1H, bs) 9.79 (1H, s)27 129-131 IR: 3460 3340 3240 1680 1630 Found 65.62% 5.05% 13.52% NMR: 4.46 (4H, s) 6.6-7 (1H, m) Calcd. 65.71% 5.03% 13.33% 7-8.08 (14H, m) 9.46 (1H, bs) 9.7 (1H, bs)28 163-4 IR: 3475 3350 3250 1685 1635 Found 61.69% 5.37% 15.22% NMR: 3.87 (2H, d, 5 Hz) 4.33 (2H, s) Calcd. 61.62% 5.17% 15.13% 4.87-5.37 (2H, m) 5.43-6.07 (1H, m) 6.40-7.93 (10H, m) 9.30 (1H, s) 9.50 (1H, s)29 169-70 IR: 3460 3340 3240 1680 1630 1470 Found 52.50% 4.11% 13.45% NMR*: 3.77 (2H, q, 9 Hz) 4.58 (2H, s) Calcd. 52.43% 3.91% 13.59% 5.4 (1H, bs) 6.7-7.57 (8H, m) 7.87-8.2 (1H, m) 9.87-10.27 (2H, m)30 133-5 IR: 3460 3320 3230 1680 1630 Found 51.16% 4.01% 12.69% NMR*: 3.76 (2H, tt, 13 Hz, 2 Hz) 4.56 (2H, s) Calcd. 51.36% 3.86% 12.61% 5.56 (1H, bs) 5.9 (1H, tt, 53 Hz, 6 Hz) 6.8-7.63 (8H, m) 7.8-8.3 (1H, m) 9.66-10.3 (2H, m)31 112-4 IR: 3450 3320 3220 1680 1630 Found 49.32% 3.41% 12.29% NMR*: 3.86 (2H, tq, 13 Hz, 2 Hz) 4.61 (2H, s) Calcd. 49.36% 3.49% 12.12% 5.53 (1H, bs) 6.73-7.73 (8H, m) 7.91-8.3 (1H, m) 9.63-10.3 (2H, m)32 103-5 IR: 3460 3270 1680 1640 Found 49.26% 3.43% 12.33% NMR: 4.13 (2H, tq, 14 Hz, 2 Hz) 4.65 (2H, s) Calcd. 49.36% 3.49% 12.12% 6.73-8.03 (10H, m) 9.83 (1H, s) 6.89 (1H, s)33 130-1 IR: 3460 3260 1680 1630 Found 49.29% 3.42% 12.31% NMR: 4.09 (2H, tq, 14 Hz, 2 Hz) 4.6 (2H, s) Calcd. 49.36% 3.49% 12.12% 6.57-7.73 (8H, m) 8.23 (2H, dd, 9 Hz, 6 Hz) 9.7 (1H, s) 9.82 (1H, s)34 125-7 IR: 3460 3340 3220 1680 1630 Found 48.76% 3.45% 11.38% NMR*: 3.53-4.08 (2H, m) 4.8 (2H, s) Calcd. 48.59% 3.47% 11.33% 4.93 (1H, d, 6-plet, 50 Hz, 6 Hz) 5.8 (1H, bs) 6.73-7.6 (8H, m) 7.91-8.31 (1H, m) 9.71-10.4 (2H)35 114-5 IR: 3460 3350 3240 1680 1638 Found 46.75% 3.16% 11.05% NMR: 4.13 (2H, tt, 14 Hz, 2 Hz) 4.64 (2H, s) Calcd. 46.89% 3.15% 10.93% 6.7-8.07 (10H, m) 9.3-9.93 (2H)36 110-2 IR: 3460 3260 1680 1640 1580 1470 Found 46.78% 3.15% 11.03% 1220 NMR: 4.13 (2H, tt, 14 Hz, 2 Hz) Calcd. 46.89% 3.15% 10.93% 4.63 (2H, s) 6.7-8.07 (10H, m) 9.77 (1H, s) 9.83 (1H, s)37 124-6 IR: 3470 3260 1680 1640 1600 1470 Found 46.72% 3.17% 11.07% 1230 NMR: 4.08 (2H, tt, 14 Hz, 2 Hz) Calcd. 46.89% 3.15% 10.93% 4.59 (2H, s) 6.63-7.63 (8H, m) 8.0 (2H, dd, 9 Hz, 6 Hz) 9.63 (1H, s) 9.73 (1H, s)38 101-3 IR: 3460 3350 3240 1680 1635 1265 Found 46.14% 3.16% 10.43% NMR: 4.13 (2H, tt, 14 Hz, 2 Hz) 4.65 (2H, s) Calcd. 46.33% 3.15% 10.29% 6.13 (1H, tt, 52 Hz, 6 Hz) 6.73-8.1 (10H, m) 9.47-9.9 (2H, m)39 108-10 IR: 3475 3350 3240 1685 1635 Found 43.07% 2.86% 8.52% NMR: 4.17 (2H, tt, 14 Hz, 2 Hz) Calcd. 42.87% 2.66% 8.69% 4.66 (2H, s) 6.32 (1H, tt, 55 Hz, 5 Hz) 6.6-8.23 (10H, m) 9.61 (1H, s) 9.87 (1H, s)40 124-5 IR;3450 3260 1680 1635 Found 60.30% 5.85% 13.26% NMR*: 0.86 (6H, d, 6 Hz) 1.1-1.83 (3H, m) Calcd. 60.50% 6.04% 13.44% 3.45 (2H, t, 6 Hz) 4.41 (2H, s) 5.5-5.83 (1H, bs) 6.65-7.3 (5H, m) 7.4 (2H, d, 9 Hz) 7.81 (2H, d, 9 Hz) 9.5 (1H, bs) 10.28 (1H, s)41 106-8 IR: 3460 3310 1680 1640 1470 1200 Found 47.51% 3.52% 11.56% NMR: 3.98 (2H, tq, 14 Hz, 2 Hz) 4.33 (2H, s) Calcd. 47.66% 3.37% 11.70% 6.63-7.57 (8H, m) 7.87 (2H, d, 8 Hz) 9.47-9.87 (2H, m)42 123-5 IR: 3480 3270 1670 1640 1470 1220 Found 45.62% 2.89% 10.44% NMR: 4.12 (2H, tt, 13 Hz, 2 Hz) 4.61 (2H, s) Calcd. 45.43% 3.05% 10.59% 6.83 (1H, bs) 6.97-7.27 (7H, m) 8.0 (2H, d, 8 Hz) 9.7 (1H, s) 9.77 (1H, s)43 97-100 IR: 3460 3310 3250 1680 1630 1460 NMR*. Found 66.49% 6.93% 14.14% 0.9 (6H, d, 6 Hz) 1.23-1.83 (3H, m) 2.41 (3H, Calcd. 66.65% 7.12% 14.13% s) 3.46 (2H, t, 6 Hz) 4.45 (2H, s) 5.13-5.7 (1H, bs) 6.68-7.2 (5H, m) 7.26 (2H, d, 9 Hz) 7.81 (2H, d, 9 Hz) 9.5 (1H, bs) 10.4 (1H, bs)44 110-2 IR: 3470 3320 3250 1680 1640 1470 Found 52.52% 4.02% 12.28% 1200 NMR: 2.37 (3H, s) 4.12 (2H, tq, 14 Hz, Calcd. 52.41% 4.18% 12.22% 2 Hz) 4.61 (2H, s) 6.67-7.63 (8H, m) 7.87 (2H, d, 8 Hz) 9.52 (1H, s) 9.73 (1H, s)45 110-2 IR: 3470 3250 1680 1640 1470 1220 Found 49.57% 3.76% 10.97% NMR: 2.3 (3H, s) 4.11 (2H, tt, 14 Hz, 2 Hz) Calcd. 49.61% 3.77% 11.02% 4.6 (2H, s) 6.67 (1H, bs) 6.97-7.67 (7H, m) 7.87 (2H, d, 8 Hz) 9.51 (1H, s) 9.7 (1H, s)46 100-2 IR: 3460 3320 3240 1680 1630 Found 64.21% 6.94% 13.48% NMR: 0.85 (6H, d, 6 Hz) 1.16-1.66 (3H, m) Calcd. 64.06% 6.84% 13.58% 3.41 (2H, t, 6 Hz) 3.81 (3H, s) 4.33 (2H, s) 6.6-7.65 (6H, m) 7.16 (2H, d, 9 Hz) 7.98 (2H, d, 9 Hz) 9.46 (1H, bs) 9.7 (1H, bs)47 128-30 IR: 3460 3280 1680 1640 1600 1470 Found 4823% 3.51% 10.69% 1320 NMR: 3.81 (3H, s) 4.12 (2H, tt, 15 Hz, Calcd. 48.10% 3.65% 10.68% 2 Hz) 4.6 (2H, s) 6.7-7.73 (8H, m) 8.0 (2H, d, 8 Hz) 9.55 (1H, s) 9.77 (1H, s)__________________________________________________________________________ The compounds of the present invention represented by the formula (I) can be easily synthesized from a process according to the following Reaction Scheme 1, which comprises reacting phenylhydrazone derivative (II) of 2-oxazoline-4,5-dione with ammonia in an organic solvent such as acetone at a temperature of preferably -10° to 100° C. for 0.1 to 10 hours. ##STR21## The phenylhydrazone derivatives (II) of 2-oxazoline-4,5-dione used as starting compound of the compounds of the present invention can be synthesized from a process according to the following Reaction Scheme 2: ##STR22## Nitrobenzyl chloride (III) is etherified by reacting with R 1 OH (VI) in the presence of a hydrogen chloride acceptor such as KOH at a temperature of preferably -10° to 150° C. and then reduced by suitable method such as catalytic reduction to form an aniline derivative (V), and the aniline derivative (V) is then diazotized by a conventional method to synthesize a diazonium compound (VII). Separately, a hippuric acid derivative (VIII) is subjected to dehydrating-cyclization by, for instance, reacting with acetic anhydride to synthesize a 2-oxazoline-5-one derivative (IX), and this derivative (IX) and the diazonium compound (VII) are subjected to diazo coupling at a temperature of preferably -50° to 100° C. to synthesize a phenylhydrazone derivative of 2-oxazoline-4,5-dione represented by the formula (II). The phenylhydrazone derivative of oxamide according to the present invention can be used either singly or in combination with various types of carrier (diluent) and/or adjuvants commonly used in the preparation of agricultural chemicals, in the various forms of composition such as wettable powder, emulsion, granules, powder, etc. The concentration of phenylhydrazone derivative of oxamide of the present invention in the compositions is preferably in the range of 0.1 to 50% by weight. The phenylhydrazone derivatives of oxamide of the present invention and the herbicidal composition containing this compound as active ingredient can be sprayed on the field soil and/or to the stalks and leaves of plants by a conventional method so that the compound will be applied at a rate of preferably 0.1 to 500 g per 10 ares. The present invention will hereinafter be described more precisely while referring to the following non-limitative examples. SYNTHESIS EXAMPLE 1 Synthesis of 1-(3-methylbutoxy)methyl-3-nitrobenzene ##STR23## Seventy-eight g (1.39 mol, 1.5 equivalent) of KOH pellets were added into a solution prepared by dissolving 158.1 g (0.92 mol) of 3-nitrobenzyl chloride into a mixture of 500ml (4.59 mol, 5 equivalents) of 3-methyl-1-butanol and 140 ml of dimethylformamide under vigorous stirring while cooling the solution with a water bath. The temperature rose up to 43° C. but thereafter it lowered gradually to return to room temperature. The solution was stirred at room temperature for 7 hours to complete the reaction. The solids in the reaction solution were filtered out. The filtrate was adjusted to pH 2 with hydrochloric acid and then excess alcohol and dimethylformamide were distilled off. The residue was dissolved in a mixed solvent of 450 ml of n-hexane and 50 ml of ethyl acetate, then washed with 1N HCl and a saturated sodium chloride solution successively and dried over magnesium sulfate. The solvent was distilled off and the residue was fractionally distilled. The fraction having a boiling point of 116°-117° C. (at 0.08 mmHg) was collected and 185.2 g of 1-(3-methylbutoxy)methyl-3-nitrobenzene was obtained in a 90.1% yield. SYNTHESIS EXAMPLE 2 Synthesis of 3-[(3-methylbutoxy)methyl]aniline ##STR24## A hundred and thirty g (0.58 mol) of the nitrobenzene derivative obtained in Synthesis Example 1 was dissolved in 150 ml of ethanol, followed by the addition of 0.6 g of 10% palladium carbon. Under stirring, 89 ml (1.84 mol) of hydrazine hydrate was added dropwise to the solution at a rate which would not cause violent foaming. Thereafter, the mixed solution was refluxed on a hot water bath for 3 hours to complete the reaction. The filtrate was allowed to cool by itself and, after filtering out the catalyst, washed with ethanol. The filtrate was concentrated, dissolved in 300 ml of dichloromethane, washed with a 10% sodium carbonate solution and a saturated sodium chloride solution successively, and dried over anhydrous potassium carbonate. The solvent was distilled off and the residue was fractionally distilled. The fraction having a boiling point of 105°-106° C. (at 0.19 mmHg) was collected and 109.2 g of 3-[(3-methylbutoxy)methyl]aniline was obtained in a 97.1% yield. SYNTHESIS EXAMPLE 3 Synthesis of 4-[3-[(3-methylbutoxy)methyl]phenyl]hydrazone of 2-(2-fluorophenyl)-2-oxazoline-4,5-dione ##STR25## A solution of 3.94 g of 2-fluorohippuric acid and 3.28 g of sodium acetate in 17.4 ml of acetic anhydride was stirred at 60° C. for 20 minutes to prepare 2-(2-fluorophenyl)-2-oxazoline-5-one, and was quickly cooled with ice-water. Separately, 3.48 g (18 mmol) of 3-[(3-methylbutoxy)methyl]aniline obtained in Synthesis Example 2 was dissolved in a mixture of 3.4 ml of 35% hydrochloric acid and 12 ml of acetic acid, and the solution was stirred under cooling with ice-water Then, the solution was added with 2.8 ml of isopentyl nitrite and further stirred for 10 minutes to prepare a diazonium salt. The previously prepared mixture containing 2-(2-fluorophenyl)-2-oxazoline-5-one was stirred under cooling with ice-water, and the diazonium salt prepared above was added thereto over a period of 2 minutes, followed by stirring for 30 minutes. The solution was further stirred for 1.5 hour and then added with 40 ml of ice-water and 20 ml of petroleum ether, followed by 2-hour stirring. The orange-colored precipitate was filtered out and air-dried to obtain 2.45 g of the objective compound in a 35.5% yield. EXAMPLE 1 Synthesis of 1-[3- [(3-methylbutoxy)methyl]phenyl]hydrazone of 1-(2-fluorobenzoyl)oxamide (Compound No. 17) One and a half g of phenylhydrazone derivative of 2-oxazoline-4,5-dione synthesized in Synthesis Example 3 was added to 30 ml of ether and stirred at room temperature. The solution was added with 0.5 ml of a 35% NH 3 solution, stirred for 30 minutes and then added with 60 ml of hexane. The precipitate was filtered out and air dried to obtain 1.22 g of the objective compound having a melting point of 138°-140° C. in a 78% yield. The phenyldyrazone derivatives of oxamide synthesized in the same way as described above from the various types of phenylhydrazone derivatives of 2-oxazoline-4,5-dione synthesized by the same process as Synthesis Examples 1-3 are shown in Table 1. EXAMPLE 2 Preparation of wettable powder Fifty parts of Compound No. 3, 5 parts of a salt of lignin sulfonic acid, 3 parts of a salt of alkylsulfonic acid and 42 parts of diatomaceous earth are mixed and pulverized to prepare a wettable powder. This wettable powder is diluted with water when used. EXAMPLE 3 Preparation of emulsion Twenty-five parts of Compound No. 10, 65 parts of xylene and 10 parts of polyoxyethylene alkylaryl ether are uniformly mixed to form an emulsion. This emulsion is diluted with water when used. EXAMPLE 4 Preparation of granules Eight parts of Compound No. 17, 40 parts of bentonite, 45 parts of clay and 7 parts of a salt of lignin sulfonic acid are uniformly mixed, further kneaded by adding water, granulated by an extrusion granulator and dried. EXAMPLE 5 Effect on crop field weeds (pre-emergence treatment) Soil was placed in a planters (650×210×220 mm) and flattened at the surface simulating a crop field. A prescribed amount of the seeds of Amaranthus retroflexus, Bidens pilosa var. pilosa, Brassica arvensis, Stellaria media, Solanum nigrum, Abutilon theophrasti, Echinochloa Crus-galli var. frumentacea, Digitaria sanguinalis, wheat and corn were sown and covered up with soil. Then the wettable powder prepared in the same way as Example 2 and diluted with water to a predetermined concentration was uniformly sprayed over the soil surface by a spray gun so that the active ingredient would be applied at a rate of 200 g/10 a. The planters were then left in a glasshouse to allow growth of the plants under control. Twenty-one days after said treatment, the herbicidal effect of the compounds on the weeds and the phytotoxicity of the crops from the compounds were observed and evaluated according to the following ratings. The results are shown in Table 3. ______________________________________Ratings for evaluation0 . . . no effect1 . . . less than 30% herbicidal effect2 . . . 31-50% herbicidal effect3 . . . 51-70% herbicidal effect4 . . . 71-90% herbicidal effect5 . . . 91-100% herbicidal effectDegree of damage- : none, ± : slight, + : medium,++ : great, +++ : serious______________________________________ TABLE 3__________________________________________________________________________ Echino- chloa Bidens Crus- Digita-Com- pilosa Abutilon galli var. riapound Amaranthus var. Brassica Stellaria Solanum theoph- frumenta- sangui-No. retroflexus pilosa arvensis media nigrum rasti cea nalis Wheat Corn__________________________________________________________________________ 1 5 5 5 5 5 5 5 5 - - 2 5 5 5 5 5 5 5 5 - - 3 5 5 5 5 5 5 5 5 - - 4 5 5 5 5 5 5 5 5 - - 5 4 4 5 5 5 5 4 5 - - 6 5 4 5 5 5 4 4 4 - - 7 5 4 5 5 4 5 4 5 - - 8 5 5 5 5 5 5 4 4 - - 9 5 5 5 5 5 5 5 5 - -10 5 5 5 5 5 5 5 5 ± ±11 5 5 5 5 5 5 5 5 ± +12 5 5 5 5 5 5 5 5 ± +13 5 5 5 5 5 5 5 5 ± +14 5 5 5 5 5 5 5 5 - ±15 5 5 5 5 5 5 5 5 - ±16 5 5 5 5 5 5 5 5 - ±17 5 5 5 5 5 5 4 5 - -18 5 5 5 5 5 5 5 5 - ±19 5 5 5 5 5 5 5 5 - ±20 5 5 5 5 5 5 4 5 - -21 5 5 5 5 5 5 5 5 - ±22 5 5 5 5 5 5 5 5 - ±23 5 5 5 5 5 5 5 5 - ±24 5 5 5 5 2 3 4 3 - -25 5 5 5 5 3 4 5 5 - -26 5 5 5 5 3 4 4 5 - -27 5 5 5 5 5 5 5 5 - ±28 5 5 5 5 5 5 5 5 - -29 5 5 5 5 5 5 5 5 - -30 5 5 5 5 5 5 5 5 - -31 5 5 5 5 5 5 5 5 - -32 5 5 5 5 5 5 5 5 - -33 5 5 5 5 5 5 5 5 - -34 5 5 5 5 5 5 5 5 - -35 5 5 5 5 5 5 5 5 - -36 5 5 5 5 5 5 5 5 - -37 5 5 5 5 5 5 5 5 - -38 5 5 5 5 5 5 5 5 - -39 5 5 5 5 5 5 5 5 - -40 5 5 5 5 4 4 5 5 - -41 5 5 5 5 4 4 5 5 - -42 5 5 5 5 5 5 5 5 - -43 4 5 5 5 3 5 4 5 - -44 5 5 5 5 4 4 4 5 - -45 4 5 5 5 4 5 4 5 - -46 3 4 4 4 2 3 2 2 - -47 3 4 4 5 3 4 3 3 - -__________________________________________________________________________ EXAMPLE 6 Effect on crop field weeds (by post-emergence treatment) The seeds of the specified plants were sown by following the same procedure as Example 5. When the plants have grown to the one- to two-foliage stage, the wettable powder prepared in the same way as Example 2 and diluted with water was uniformly sprayed to the stalks and leaves of the plants and on the soil surface by a spray gun so that the active ingredient would be applied at a rate of 200 g/10 a. Then the planters were left in a glasshouse to allow growth of the plants under control. Twenty-one days after the treatment, the herbicidal effect of the compounds and phytotoxicity of the crops were observed and evaluated in the same way as in Example 5. The results are shown in Table 4. TABLE 4__________________________________________________________________________ Echino- chloa Bidens Crus- Digita-Com- pilosa Abutilon galli var. riapound Amaranthus var. Brassica Stellaria Solanum theoph- frumenta- sangui-No. retroflexus pilosa arvensis media nigrum rasti cea nalis Wheat Corn__________________________________________________________________________ 1 5 5 5 5 5 5 2 2 - - 2 5 5 5 5 5 5 2 3 - ± 3 5 5 5 5 4 4 2 2 - - 4 5 5 5 5 4 3 2 2 - - 5 5 5 5 4 4 3 1 2 - - 6 3 4 5 4 2 4 1 2 - - 7 5 5 5 5 3 5 2 2 - - 8 5 5 5 5 5 5 2 2 - - 9 3 5 4 4 3 4 1 2 - -10 5 5 5 5 5 5 3 2 - ±11 5 5 5 5 5 5 3 4 - ±12 5 5 5 5 5 5 3 3 - ±13 5 5 5 5 5 5 3 3 - ±14 3 5 5 5 3 4 2 2 - -15 5 5 5 5 4 5 2 2 - -16 5 5 5 5 4 5 2 2 - -17 4 5 4 3 5 5 2 2 - -18 4 5 5 5 5 5 2 2 - -19 5 5 5 5 4 5 2 2 - -20 4 5 4 3 5 5 2 2 - -21 5 5 5 5 4 4 2 2 - -22 5 5 5 4 3 3 2 2 - -23 4 5 5 4 4 3 2 2 - -24 3 2 5 3 2 5 1 2 - -25 5 5 5 5 3 5 2 2 - -26 5 5 5 5 4 5 3 3 - -27 5 5 5 5 5 5 3 3 - -28 5 5 5 5 5 5 3 3 - -29 5 5 5 5 4 5 2 2 - -30 5 3 5 5 5 5 2 2 - -31 5 5 5 5 5 5 3 3 - -32 5 5 5 5 5 5 4 3 - -33 5 5 5 5 4 5 3 3 - -34 5 3 5 5 5 5 2 2 - -35 5 5 5 5 5 5 3 3 - -36 5 5 5 5 5 5 4 4 - -37 5 5 5 5 5 5 3 4 - -38 5 5 5 5 5 5 3 3 - -39 5 5 5 5 4 5 3 2 - -40 5 5 5 5 3 4 2 2 - -41 5 5 5 5 4 4 2 3 - -42 5 5 5 5 5 4 3 4 - -43 3 5 5 5 2 5 2 2 - -44 4 5 5 5 3 5 2 2 - -45 4 5 5 5 2 5 2 2 - -46 2 2 2 2 1 3 1 2 - -47 2 2 2 2 2 3 2 2 - -__________________________________________________________________________ EXAMPLE 7 Effect on paddy field weeds and phytotoxicity to rice plant In the 1/2000-are Wagner pots packed with paddy field soil and watered to simulate a paddy field, the seeds of Echinochloa Crus-galli var. hispidula, Scirpus juncoides subsp. Hotarui, Alisma canaliculatum. Monochoria vaginalis and Cyperus difformis were sown and the tubers of Sagittaria pygmaea and Cyperus serotinus were planted. Further, two 2-foliage seedlings of rice plant (variety: Sasanishiki) were transplanted in the pots. Then the pots were left in a glass house to allow growth of the plants for three days. Then the emulsions prepared in the same way as Example 3 and diluted with water to a predetermined concentration were uniformly trickled down to the water surface in each pot so that the active ingredient would be applied at a rate of 200 g/10 a. Twenty-one days after said treatment, the herbicidal effect of the compounds and the degree of phytotoxicity of the rice plants were examined and evaluated according to the same ratings as in Example 5. TABLE 5__________________________________________________________________________ Echinochloa ScirpusCom- Crus-galli juncoides Alismapound var. subsp. canali- Monochoria Cyperus Sagittaria CyperusNo. hispidula Hotarui culatum vaginalis difformis pygmaea serotinus rice plant__________________________________________________________________________ 1 5 5 5 5 5 5 5 - 2 5 5 5 5 5 5 5 - 3 5 5 5 5 5 5 5 - 4 5 5 5 5 5 5 5 - 5 5 5 5 5 5 5 5 - 6 5 1 2 2 1 3 2 - 7 5 2 5 5 5 5 4 - 8 5 5 5 5 5 5 5 - 9 5 3 5 4 2 4 4 -10 5 5 5 5 5 5 5 -11 5 5 5 5 5 5 5 -12 5 5 5 5 5 5 5 -13 5 5 5 5 5 5 5 -14 5 3 5 4 3 4 4 -15 5 5 5 5 5 5 5 -16 5 5 5 5 5 5 5 -17 5 5 5 5 5 5 5 -18 5 5 5 5 5 5 5 -19 5 5 5 5 5 5 5 -20 5 5 5 5 5 5 5 -21 5 5 5 5 5 5 5 -22 5 5 5 5 5 4 4 -23 5 5 5 5 5 4 4 -24 5 2 3 5 3 3 2 -25 5 4 5 5 5 5 5 -26 5 4 5 5 5 5 4 -27 5 5 5 5 5 5 5 -28 5 5 5 5 5 5 5 -29 5 4 5 5 5 5 4 -30 5 5 5 5 5 5 5 -31 5 5 5 5 5 5 5 -32 5 5 5 5 5 5 5 -33 5 5 5 5 5 5 5 -34 5 5 5 5 5 5 5 -35 5 5 5 5 5 5 5 -36 5 5 5 5 5 4 5 -37 5 5 5 5 5 4 5 -38 5 5 5 5 5 5 5 -39 5 5 5 5 5 5 5 -40 5 5 5 5 5 4 5 -41 5 5 5 5 5 5 5 -42 5 5 5 5 5 5 5 -43 5 4 3 5 5 5 4 -44 5 4 4 5 5 4 4 -45 5 4 4 5 5 5 4 -46 2 3 2 2 2 3 2 -47 2 3 3 3 2 3 3 -__________________________________________________________________________

Disclosed herein is a phenylhydrazone derivative of oxamide represented by the formula (I): ##STR1## wherein R 1 is straight-chain alkyl group having 2 to 10 carbon atoms, branched alkyl group or cyclic alkyl group having 3 to 10 carbon atoms, alkyl group having 1 to 3 carbon atoms which is substituted with an alicyclic structure having 3 to 7 carbon atoms, phenyl group, halogen-substituted phenyl group, aralkyl group having 7 to 9 carbon atoms, alkenyl group having 3 to 6 carbon atoms, alkyl group having 2 to 4 carbon atoms which is substituted with alkoxy group having 1 to 4 carbon atoms, or alkyl group having 2 to 10 carbon atoms which is substituted with 1 to 19 fluorine atoms; and R 2 is hydrogen, fluorine, chlorine, methyl group or methoxy group, and a herbicidal composition containing the derivative as active ingredient. The phenylhydrazone derivative of oxamide represented by the formula (I) of the present invention shows a high herbicidal activity and also have an excellent selectivity allowing killing of weeds alone without doing any practical harm to the crops such as rice, wheat and corn.

CROSS-REFERENCE TO RELATED APPLICATION [0001] The present patent document claims priority to earlier filed U.S. Provisional Patent Application Ser. No. 61/448,266, filed on Mar. 2, 2011, the entire contents of which are incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present patent document relates generally to input devices for personal computing devices and more particularly to an arcade-style game controller for a tablet computing device. [0004] 2. Background of the Related Art [0005] Tablet computing devices with touch screen interfaces, such as Apple®'s iPad brand tablet computing device, have become popular platforms for video games. However, the touch screen input is not ideal for many types of games that might require joystick, buttons with tactile feedback, track balls, and other types of arcade-style game controllers. Accordingly there is a perceived need in the industry for an improved input device for playing video games on tablet computing devices with touch screen interfaces. SUMMARY OF THE INVENTION [0006] The present invention provides a solution to the problems of the prior art by providing a way to have traditional arcade-style game controls for tablet computing devices. [0007] Accordingly, an object of the present invention is the provision for a game controller for tablet computing devices that includes arcade-style game controls. BRIEF DESCRIPTION OF THE DRAWINGS [0008] These and other features, aspects, and advantages of the present invention will become better understood with reference to the following description, appended claims, and accompanying drawings where: [0009] FIG. 1 a is a left side perspective view of a first embodiment of the arcade-style game controller for a tablet computing device of the present invention; [0010] FIG. 1 b is a right side perspective view of a first embodiment of the arcade-style game controller for a tablet computing device of the present invention; [0011] FIG. 2 is a diagram of a first variation of the operation of a first embodiment of an arcade-style game controller for a tablet computing device of the present invention using direct serial port communication of game control inputs to the tablet computing device; [0012] FIG. 3 is a diagram of a second variation of the operation of a first embodiment of an arcade-style game controller for a tablet computing device of the present invention using universal serial bus (“USB”) communication of game control inputs to the tablet computing device; [0013] FIG. 4 is a perspective view of a second embodiment of an arcade-style game controller for a tablet computing device of the present invention; [0014] FIG. 5 is a diagram of the operation of a second embodiment of an arcade-style game controller for a tablet computing device of the present invention using wireless communication of game control inputs to the tablet computing device; [0015] FIG. 6 is a left side perspective view of a third embodiment of an arcade-style game controller for a tablet computing device of the present invention showing the control surface with a track-ball control and buttons; and [0016] FIG. 7 is a diagram of the operation of a third embodiment of an arcade-style game controller for a tablet computing device of the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENT [0017] Referring now to FIG. 1 , a first embodiment of the game controller of the present invention is shown generally at 10 . The first embodiment of the game controller 10 of the present invention includes an aesthetic cabinet with arcade-style game controls. The cabinet generally includes a left side 12 , right side 14 , rear, top, bottom, and front portion 16 and is sized and dimensioned to fit on top of a typical desktop. The front portion 16 further includes a control console 18 extending from the front portion 16 . [0018] The control console 18 further includes a number of game controls 20 . The game controls primarily include mechanical on/off switches, which may be further configured as buttons 20 a and joysticks 20 b . For instance, a joystick 20 b can be implemented with four switches, one for each direction (i.e., up, down, left right). An “eight” position joystick 20 b may be achieved by sensing two switches “on” at the same time. [0019] The front portion 16 of the cabinet is further configured to receive and support a tablet computing device 22 . Specifically, extending forward from the left and right sides 12 , 14 is a pair of spaced apart wings 12 a , 14 a . The wings 12 a , 14 a , top 24 of the control console 18 and forward portion 16 of the cabinet form a cavity sized and dimensioned to receive and hold a tablet computing device 22 . Extending inwardly from the wings 12 a , 14 a and spaced forward from the front portion 16 is a pair of support pins 25 . The support pins 25 prevent the tablet computing device 22 rom tipping forward and out of the cabinet. As seen in FIG. 1 , the user may slide the tablet computing device 22 from the top of the cabinet and into the cavity. [0020] Extending upwardly from the control console 18 is a dock connector 26 configured to connect to the tablet computing device 22 . Control inputs from the game controls 20 are transmitted to the tablet computing device 22 through the dock connector 26 . [0021] In the case of an iPad brand tablet computing device 22 , a direct connection from the game controller 10 to the iPad brand tablet computing device 22 is made through the dock connector 26 to the 30-pin connector of the bottom of the iPad brand tablet computing device 22 . There are two variations to implement this embodiment. In the first variation, shown in FIG. 2 , slow-speed serial port communication is used to do authentication and data communication of game control inputs. In the second variation, shown in FIG. 3 , universal serial bus (“USB”) communication is used for authentication and communication of game control inputs. [0022] Referring now to FIG. 2 , a microprocessor 28 communicates with the tablet computing device 22 through a serial connector on the bottom of the tablet computing device 22 , and with an authentication chip 30 . The microprocessor receives authentication from the authentication chip 30 and transmits the authorization to the tablet computing device 22 , which enables game control inputs to be sent and received by the iPad brand tablet computing device 22 . [0023] The game controls 20 are wired to the microprocessor 28 through the microprocessor's serial port pins. The switches of the game controls 20 can be wired in many possible arrangements of rows and columns electrically to the microprocessor 28 . One possible format for sending the game control inputs is Core MIDI, where the game controls 20 would be mapped to note numbers. However, this is only one possibility. A completely custom messaging format could be used as well as described further below. [0024] There are several ways to handle the messaging between the game controls 20 and the tablet computing device 22 . [0025] If the tablet computing device 22 is capable of interpreting the state transitions of individual keys on a keyboard, the microprocessor 28 may be configured to send key down and key up commands to the tablet computing device 22 . For example, if the joystick 20 b is pushed up, the microprocessor 28 generates and sends a message to the tablet computing device 22 that the switch placed in the up position on the joystick 20 b was pressed (i.e., a key down command). When the joystick 20 b is returned to center, the microprocessor 28 generates a message telling the tablet computing device 22 that the switch in the up position on the joystick 20 b was released (i.e., a key up command). [0026] Some tablet computing devices 22 might not be able to interpret key press transitions in this manner, or as is often the case, a particular device may not be able to interpret key up commands. Thus, another way to accomplish the messaging would be to continuously send the key press message until the game control 20 is released. In the example above with the joystick 20 b deflected to the up position, the microprocessor 28 would continuously send the key press message until the joystick 20 b was released. The tablet computing device 22 would continuously poll the game controller 10 to determine the state of the game controls 20 . [0027] A third way to implement the game control messaging is to send a separate key message when an event happens and another message when the event stops happening. For example, if the joystick 20 b is pushed up, the microprocessor 28 would send a message informing the tablet computing devices 22 that a particular keyboard key was pressed (i.e., a key down message for a particular keyboard key). When the joystick 20 b is returned to center, the microprocessor 28 would send a message informing the tablet computing device 22 that a different keyboard key was pressed (i.e., a key down message for a different keyboard key). In this manner, the tablet computing device 22 would not need to interpret when keys are released (key up messages). The tablet computing device 22 only needs to be configured to recognize key down messages. [0028] A fourth method is to continuously send a status message which has the entire state of the all the game controls 20 of the game controller 10 encoded into it. For example, the four joystick directions and 8 buttons could be encoded into 12 bits of data, 1 meaning the joystick 20 b or button 20 a is activated, and 0 meaning the joystick 20 b or button 20 a is not activated. This message could be encoded into less than two bytes of Bluetooth data. [0029] Any of the above methods work well for controls which can be reduced to switches (i.e., switch-type joysticks 20 b and buttons 20 a ). However, analog type controls, such as analog joysticks, track balls, and control wheels, cannot be reduced to binary values without losing their fidelity. There are several methods to encode analog signals from these types of controls. One method is to encode the analog value to a number of keyboard keys. For example, a control wheel with 16 positions could be encoded to 16 different keyboard key press messages or even Bluetooth keyboard key press messages, as described further below, to retain the fidelity of the control wheel. [0030] Regardless of which method is used, the video game software operating on the tablet computing device 22 must be configured to receive the messages and translate the content of the message into an input useable by the video game software. [0031] The microprocessor 28 can be any one of many microprocessors available that include 12C serial interfaces, such as the 8051 manufactured by Intel, Inc. [0032] Referring now to FIG. 3 , as noted above earlier, a variation of the embodiment shown in FIG. 1 uses USB communication for authentication and communication of game control inputs to the tablet computing device 22 . The microprocessor 28 can be any one of a variety of microprocessors with USB capability. One example is the STM32 microprocessor manufactured by STMicroelectronics N.V. [0033] The microprocessor 28 communicates with the tablet computing device 22 through the universal serial bus interface on the tablet computing device 22 and an authentication chip 30 . The microprocessor 28 receives authentication from the authentication chip 30 and communicates the authorization to the tablet computing device 22 , which enables game control inputs to be sent and received by the tablet computing device 22 . [0034] As mentioned earlier, one possible format for sending the game control inputs is Core MIDI, in which case the game controls 20 would be mapped to note numbers. The note numbers are transmitted over USB protocol to the tablet computing device 22 . [0035] In both variations shown in FIGS. 1-3 which use a dock connector 26 to directly connect to the tablet computing device 22 , electric power may be supplied to the tablet computing device 22 through the dock connector 26 to the serial connector on the tablet computing device 22 to charge a battery on the tablet computing device 22 , where support for charging is provided. In addition, line out audio can be taken from the tablet computing device 22 and amplified for playback through optional onboard speakers placed in the cabinet of the game controller 10 of the present invention. These features may be authenticated by the microprocessor 28 as described above. [0036] Referring now to FIGS. 4 and 5 , a second embodiment of the game controller of the present invention is shown generally at 100 . The second embodiment 100 of the game controller of the present invention includes a cabinet with an arcade-style appearance. The cabinet generally includes a left side 114 , right side 112 , rear, top 117 , bottom, and front portion 116 and is sized and dimensioned to fit on top of a typical desktop. The front portion 116 further includes a control console 118 extending from the front portion 116 . [0037] The control console 118 further includes a number of game controls 120 . The game controls 120 primarily include mechanical on/off switches, which may be further configured as buttons 120 a and joysticks 120 b . For instance, a joystick 120 b can be implemented with four switches, one for each direction (i.e., up, down, left right). An “eight” position joystick may be achieved by sensing two switches “on” at the same time. As mentioned above, the game controls 120 may be encoded into any number of keyboard key press message formats by a microprocessor 128 , which transmits the encoded message to the tablet computing device 22 . [0038] The front portion 116 of the cabinet is further configured to receive and support a tablet computing device 22 . The top 124 of the control console 118 and forward portion 116 of the cabinet form a cavity sized and dimensioned to receive and hold a tablet computing device 22 . The top 126 of the control console 118 further includes a groove 102 to receive the bottom edge of the tablet computing device 22 . The forward portion 116 of the cabinet is pitched slightly rearward. When place in the cabinet, the tablet computing device 22 is stable and will not slide out because the bottom edge of the tablet computing device 22 is captured in the groove 102 on the top 126 of the control console 118 and the tablet computing device 22 is supported by the forward portion 116 of the cabinet. [0039] The cabinet may further include right and left wings 112 a , 114 a extending from the right and left sides 112 , 114 , respectively, and connected to a portion of the top 117 extending forward from the forward portion 116 of the cabinet. The wings 112 a , 114 a and top 117 together form a shade to prevent excess light from causing glare on the screen of the tablet computing device 22 . Furthermore, the wings 112 a , 114 a and top 117 are further sculpted to accentuate the arcade-style appearance of the cabinet. [0040] The second embodiment 100 utilizes a microprocessor 128 with a Bluetooth keyboard integrated circuit to send the game control inputs wirelessly to the tablet computing device 22 . Of course, this embodiment requires that the tablet computing device 22 support wireless communications and more specifically, Bluetooth wireless communication. In one variation, the switches from the game controls 120 on the control console 118 are wired into a Bluetooth keyboard switch matrix, as alluded to above in the description of the first embodiment. [0041] All communication between the game controls 120 on the control console 118 and the tablet computing device 22 occur wirelessly without a need for a direct connection through the dock 26 . One example of a microprocessor 128 with an Bluetooth integrated circuit is the BCM2042 manufactured by Broadcom, Inc. [0042] Only two buttons 120 b are shown, in FIG. 5 , but more may be added as not in FIG. 5 and as shown in the embodiment in FIG. 4 . As noted above, there are many ways to wire up the switch matrix. The above is shown with the joystick 120 b switches on a separate column from the buttons 120 a . The rows and columns can be wired up arbitrarily, as long as there are enough rows and columns to accommodate the game controls 120 (this is generally the case, since these Bluetooth enabled microprocessor chips can accommodate full-sized QWERTY keyboard layouts with many more switches). The second embodiment 100 may be powered either by battery or AC adapter. [0043] Referring now to FIGS. 6 and 7 , show a third embodiment 200 of the game controller of the present invention that implements a trackball control 220 c . The third embodiment 200 also include an arcade-style cabinet that includes left 214 and right 212 sides, top 217 , bottom and forward portions 216 , a control console 218 with a top 224 for game controls 220 , and a groove 202 to capture the tablet computing device 22 , like the earlier embodiments described above. [0044] As mentioned earlier, encoding an analog input device such as a trackball 220 c must be converted into a digital format suitable for transmission to a tablet computing device 22 . One method of converting the trackball 220 c movements is using a microprocessor 228 with a Bluetooth integrated circuit, such as a Broadcom BCM2042. The Broadcom BCM2042, like many microprocessors 228 with Bluetooth integrated circuits, also includes quadrature inputs 204 to accommodate a ball encoder, which is usually for use in a mechanical mouse. However, the quadrature inputs 204 can be inverted and re-sized to provide a track ball control surface. A track ball control 220 c is used in arcade games like “Centipede”, “Millipede”, and “Missile Command” games created by Atari Inc. that are now considered arcade classics. [0045] Therefore, it can be seen that the present invention provides a unique solution to the problem of providing an improved input device for playing video games on tablet computing devices with touch screen interfaces. [0046] It would be appreciated by those skilled in the art that various changes and modifications can be made to the illustrated embodiments without departing from the spirit of the present invention. All such modifications and changes are intended to be within the scope of the present invention.

A game controller for a tablet computing device is disclosed. The controller includes a control console. A groove on a top portion of the control console configured and arranged to capture an edge of a tablet computing device in an upright orientation. A number of controls are included on the control console for transmitting game control inputs to the tablet computing device.

RELATED APPLICATION DATA [0001] The present patent is related to co-pending U.S. Provisional patent application Serial No. 60/329,418, which was filed on Oct. 15, 2001. FIELD OF THE INVENTION [0002] The invention is generally related to dolls, and more particularly to a soft posable doll with a circular body. BACKGROUND OF THE INVENTION [0003] Dolls and other toy objects have been known for thousands of years and can take on many different forms, configurations, and constructions. Many of these objects, such as stuffed dolls and toys including teddy bears, are intended essentially for children and are known to have a soft feel and structure. These types of dolls are stuffed with a resilient filler material or stuffing and are sewn to a particular shape. Dolls and toys often include limbs extending from a body. In some instances, the limbs simply hang freely or limp from the body. In other instances, the limbs are sewn in a fixed position extending from the body. When the limbs or the body are manually moved or reoriented, they will return to their original shape and position upon release. [0004] Posable toy action figures are also known. One type of posable figure has a rubber or plastic exterior material layer with a posable internal skeleton structure embedded within the exterior layer. When the body or a limb of the figure is moved to an alternate position or shape, the position or shape is retained by the skeleton structure until further manual reorientation. BRIEF DESCRIPTION OF THE DRAWINGS [0005] Exemplary dolls in accordance with the teachings of the present invention are described and explained in greater detail below with the aid of the drawing figures in which: [0006] [0006]FIG. 1 is a perspective view of one example of a posable doll constructed in accordance with the teachings of the present invention. [0007] [0007]FIG. 2 is a front view of the posable doll substantially similar to the doll shown in FIG. 1, but having various stylistic differences. [0008] [0008]FIGS. 3 and 4 are front views of posable dolls substantially similar to the doll shown in FIG. 1, but having alternative stylistic differences and having arms positioned in different physical orientations. [0009] [0009]FIG. 5 is a front view of a posable doll substantially similar to the doll shown in FIG. 1, but having alternative stylistic differences and having the legs positioned in a different orientation and showing a wire skeleton structure in phantom view. [0010] [0010]FIG. 6 is a cross section of a posable doll substantially similar to that shown in FIG. 5 and taken along line VI-VI shown therein. [0011] [0011]FIG. 7 is a full side view of the posable doll shown in FIG. 6. [0012] [0012]FIGS. 8 and 9 are front views of a portion of the doll shown in FIG. 1 and illustrating other alternative posable hair styles. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0013] Referring now to the drawings, FIGS. 1 - 9 illustrate various examples of a soft, posable doll 20 constructed in accordance with the teachings of the present invention. As shown in FIG. 1, the doll 20 generally has a body 22 arranged in a circular shape resembling a doughnut or a bagel. The body 22 thus has a center opening 24 that can define a mouth opening of the doll 20 , as shown in each of the illustrated examples. The center opening 24 in the present example also defines a center axis of the body 22 . [0014] A pair of legs 26 extend radially outward from the body 22 and are positioned generally next to one another on the body. A pair of arms 28 extend radially outward from the body 22 , one each generally near a respective one of the legs. The region of the body 22 extending between the arms 28 and opposite the legs 26 defines a head region 30 of the doll. The region in which the legs 26 are attached is a bottom region 32 of the doll. The body 22 also has a front side 34 and a back side 36 . [0015] In one example, the front side 34 has a pair of stylized eyes 38 provided on a single piece of plastic 40 that is adhered in any suitable manner to the body 22 . The eyes 38 can alternatively be provided having a variety of different constructions and configurations without departing from the spirit and scope of the invention. In another example, a two dimensional representation of the eyes 38 can be drawn or sewn onto the front side 34 of the body 22 , if desired. [0016] The doll can also have a pair of hands 42 , one each disposed at the distal end of a respective one of the arms 28 . The hands 42 are connected to the arms at corresponding wrist regions 44 . The doll can further have a pair of feet 46 , one each disposed at a distal end of a respective one of the legs 26 . The feet 46 are connected to the legs 26 at corresponding ankle regions 48 . [0017] The doll 20 can also have a nose 50 attached to a front side 34 of the body 22 . In this example, the nose 50 is a ball which can be constructed in the same manner as the body 22 described below, or can be of many different alternative constructions. In another example, a two-dimensional representative nose can simply be drawn or sewn to the body 22 . The doll 20 also has a plurality of strands of hair 52 extending from the head region 30 of the body 22 . The hair 52 is described in greater detail below. [0018] As shown in FIGS. 5 - 7 , the body 22 has an exterior layer of soft, pliable material 60 . In one example, the exterior layer 60 is a fabric. A resilient filler material or stuffing 62 is encased within the exterior layer 60 . In one example, the stuffing can be packed loose fibers or strands of material, such as cotton wadding or padding. The exterior layer 60 and stuffing 62 , in combination, provide a soft or plush feel for the doll 20 . However, the stuffing 62 within the exterior layer 60 of the body 22 , legs 26 , and arms 28 is packed densely enough to generally retain the three dimensional shapes of the doll 20 . [0019] [0019]FIGS. 5 and 6 illustrate a skeleton structure 70 embedded in the stuffing 62 within parts of the body 22 , arms 28 , and legs 26 . The skeleton structure can take on various forms and configurations from that disclosed herein and yet fall within the scope of the invention. In the disclosed example, the skeleton structure 70 has a primary segment 72 and a pair of arm segments 74 . The primary segment 72 is bent to follow the contour of the body 22 from a leg position in the bottom region 32 , around the body 22 through the head region 30 , and to the other leg position at the bottom region. The distal ends of the primary segment 72 each terminate near a respective one of the feet 46 . A U-shaped loop 76 is provided in the distal ends of the primary segment 72 adjacent each foot to prevent contact of the sharp end of the wire with the bottom of the foot. Each arm segment 74 has a proximal end coupled to the primary segment 72 via a U-shaped loop 78 at a corresponding arm position within the body 22 . The distal ends of the arm segments 74 terminate near each hand 42 . [0020] The skeleton structure 70 is comprised of a bendable wire 80 that has a flexible plastic coating 82 . The wire 80 can be bent and can retain the selected position. As shown in FIGS. 2 - 5 , the arms and legs can be repositioned and the selected positions will be retained by the skeleton structure 70 . Though not shown, the body 22 can also be reconfigured to change the mouth opening or body shape and the primary segment 72 will retain the selected body orientation. The plastic coating 82 protects the wire from corrosion and assists in preventing injury to those using the doll. The plastic coating 82 also assists in increasing surface friction of the skeleton structure 70 so that the skeleton does not easily slide and reposition within the body 22 . [0021] In one example, the loops 76 or the distal ends of the primary segment terminate slightly into each foot 46 beyond the ankle regions 48 . In this way, the feet can be repositioned relative to the legs at the ankle region 48 , if desired. Similarly, the distal ends of the arm segments 74 each terminate slightly into the hands 42 beyond the wrist regions 44 . In this way, the hands can be repositioned relative to the arms at the wrist regions 44 . [0022] As shown in each of the various FIGS. 1 - 9 , the hair 50 is posable. It can be repositioned or manipulated into any one of many different styles. The hair is fabricated so that it can retain the selected style. Thus, the look of the doll 20 can be varied as desired by a doll user. To render the hair 50 posable, the strands are fabricated from a material that is flexible and yet substantially holds a selected position. The strands can be captured and sewn between front and back layers of the exterior fabric layer 60 . The strands can alternatively be spread over an area of the head region 30 and attached by means of looping an elongate strand through the fabric to form two hair strands. [0023] Also as shown in the various FIGS. 1 - 9 , the style and look of the doll can vary considerably and yet fall within the scope of the present invention. The fabric materials of the body 22 , arms 28 , and legs 26 can be selected, combined, and sewn so as to make the doll appear to be wearing clothing. For example, the doll in FIG. 1 appears to have sleeves and the doll in FIGS. 4 and 5 is wearing a hat. The dolls can also be provided in a variety of colors. Additionally, as shown in FIGS. 1 and 4, the front side 34 of the body 22 can include various markings or features so as to give the appearance of a beard 84 , a mustache 86 , freckles 88 , and the like. The hands can be fabricated in a variety of hand positions or gestures. The feet can be fabricated to appear to be wearing shoes as shown in FIG. 1. As shown in FIG. 6, the feet can also be fabricated to include a relatively rigid pad 90 of plastic or the like to define a foot bottom. Such a foot bottom can assist the doll in standing on a surface, if desired. [0024] Although certain dolls have been disclosed and described herein in accordance with the teachings of the present invention, the scope of coverage of this patent is not limited thereto. On the contrary, this patent covers all embodiments of the teachings of the invention fairly falling within the scope of the appended claims, either literally or under the doctrine of equivalents.

A posable doll has a generally tubular body arranged in a circular shape with a center opening. A pair of legs extend radially outward from the tubular body and each of the legs has a length. A pair of arms extend radially outward from the tubular body and each of the arms has a length. A filler material is stuffed in the tubular body, the arms, and the legs. A wire skeleton extends around the circular shape within the tubular body and extends over a substantial portion of the length through each of the arms and the legs. The wire skeleton is capable of being bent to various positions and of retaining each of the various positions as desired.

CLAIM OF PRIORITY The following application is a continuation of U.S. patent application Ser. No. 12/646,899, which was filed on Dec. 23, 2009, now U.S. Pat. No. 7,963,885 which claims priority to U.S. Provisional Patent Application No. 61/140,358, filed Dec. 23, 2008, the complete contents of each of which are incorporated by reference herein. BACKGROUND 1. Field of the Invention The invention relates generally to athletic training devices and more particularly to an erratically and rapidly moving device configured such that in order to be captured an athlete must exhibit a required level of speed and agility. 2. Background Speed and agility are critical in numerous sports and other activities. However, motion in predictable patterns and/or on agility courses can be seen in advance and can be quickly learned by athletes. Existing training systems include stationary courses such as ladder drills, running through tires, or basketball “suicide” drills. Further systems exist, such as targeted chasing systems wherein an athlete moves as rapidly as possible towards a selected one of a set of illuminable lights. However, the selectively illuminable lights are stationary and thus the athlete can quickly adapt and/or anticipate the illumination sequence and/or memorize the locations of the fixed number of illuminable lights. In actual play, however, the motion may be unpredictable, and athletes must be able to still move quickly. What is needed is a system that provides unpredictable speed and agility training for athletes. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 depicts a perspective view of the exterior of an embodiment of the present device. FIG. 1 a depicts a bottom view of the exterior of an embodiment of the present device. FIG. 1 b depicts a top view of the interior of an embodiment of the present device. FIG. 2 depicts a detail perspective view of an embodiment of a shut-off device in the present device. FIG. 3 depicts another embodiment of the present device further comprising a remote-control unit. FIG. 4 depicts a schematic diagram of one embodiment of the present device. FIG. 5 depicts a bottom view of another embodiment of the present device that can operate in an aquatic environment. FIG. 6 depicts a side view of an alternative embodiment of the present device. DETAILED DESCRIPTION FIGS. 1-1B depict various views of embodiments of the present device. FIG. 1 depicts a perspective exterior view of one embodiment of the present device. In some embodiments, a housing 102 can comprise a plurality of sections 104 , which can be coupled together and substantially vertically arranged. In such embodiments, sections 104 can move independently of each other, or in coordinated movements with each other. However, in other embodiments, a housing 102 can comprise a single hollow member. As shown in FIG. 1 , a housing 102 can be substantially circular in shape, but in other embodiments can have any other known and/or convenient geometry. In some embodiments, a housing 102 can be made of a resilient plastic, polymer, polycarbonate, metal, alloy, or any other known and/or convenient material. As shown in FIG. 1 , a housing 102 can be coupled with a time mechanism 120 , such as but not limited to, a timer, stopwatch, clock, and/or any other known and/or convenient mechanism for timing a user and/or displaying time. As shown in FIG. 1 a, a plurality of moving agencies 106 can be coupled with a housing 102 . Moving agencies 106 can be wheels, casters, bearings, or any other known and/or convenient device. In some embodiments, moving agencies 106 can have a rotational range of motion of 360 degrees, or any other known and/or convenient range. As shown in FIG. 1 a , moving agencies 106 can be coupled with a housing 102 at points on the underside of and, in some embodiments, substantially proximal to the periphery of a housing 102 . However, in other embodiments, moving agencies 106 can be coupled with a housing 102 in any known and/or convenient locations. In some embodiments, one of the moving agencies 106 can be configured to drive a housing 102 in any desired direction. In some embodiments, the moving agencies 106 can be configured to randomly drive a housing 102 in any direction. In alternate embodiments, more than one of the moving agencies 106 can be configured to drive the housing 102 either separately and/or simultaneously. In some embodiments, a switch 108 can be located on the top surface of a housing 102 , but in other embodiments can be located on a side or underside surface. An on-off switch 108 can be adapted to selectively control the operation of the moving agencies 106 , drive system 114 , and/or power the device on and off. In the embodiment depicted in FIG. 1 , a housing 102 can include an opening 110 adapted to receive a shut-off unit 112 . In some embodiments, an opening 110 can be substantially circular, but in other embodiments can have any other known and/or convenient geometry. In the embodiment depicted in FIG. 1 , a shut-off unit 112 can be selectively and operatively mated with an opening 110 such that a device will not be propelled when a shut-off unit 112 is not mated with an opening 110 . A shut-off unit 112 can have a substantially cylindrical shape, as shown in FIG. 1 , but in other embodiments can have any other known and/or convenient geometry. In some embodiments a shut-off unit 112 can be magnetized in a desired configuration and an opening 110 can include a magnetic reader such that the pattern and/or random sequence can be defined by the magnetic configuration of a shut-off unit 112 and/or the speed of insertion of a shut-off unit 112 into an opening 110 . As shown in FIG. 1 a, a drive device 114 can be coupled to a drive agency 116 and coupled to a power supply 118 . In some embodiments, a power supply 118 can be a battery, but in other embodiments can be a solar cell or any other known and/or convenient device. In some embodiments, a drive device 114 can be a motor, but in other embodiments can be any other known and/or convenient mechanism. In the embodiment shown in FIG. 1 a , a drive agency 116 can be at least one wheel, but in other embodiments can be a caster, bearing, or any other known and/or convenient device. In alternate embodiments, a drive device 114 can further comprise a pump and/or turbine system. In such embodiments, a drive agency 116 can be a nozzle, propeller, or any other known and/or convenient device to produce thrust. In such embodiments, moving agencies 106 can be fins or any other known and/or convenient device. FIG. 2 depicts a detail view of one embodiment of a shut-off device 112 . As shown in FIG. 2 , a shut-off device 112 can further comprise a visual enhancement device 202 that can be a flag, two-dimensional or three-dimensional graphic, or any other known and/or convenient device. A shut-off unit 112 can further comprise a control mechanism 204 that can control stop-and-go motion of the device. In some embodiments, a control mechanism 204 can comprise an electrical coupling 206 that when disrupted causes the device to cease motion. In some embodiments, an electrical coupling 206 can further comprise magnetic components. However, in other embodiments, any other known and/or convenient control mechanism can be used. In some embodiments, as shown in FIG. 2 , a shut-off unit 112 can further comprise a motion-control device 208 , which can further comprise at least one magnet 210 . In some embodiments, a motion-control device 208 can be a magnetostatic device with said at least one magnet 210 capable of producing an electrical current that can be used to create a seed value for input into a random-pattern generator. A reader 212 can be located in an opening 110 such that a pattern and/or random sequence can be defined by a magnetic configuration of at least one magnet 210 on a shut-off unit 112 and/or the speed of insertion of a shut-off unit into an opening 110 . FIG. 3 depicts another embodiment of the present device, further comprising a remote-control unit 302 . A remote-control unit 302 can operate via a wireless connection or any other known and/or convenient mechanism. FIG. 4 depicts an electro-mechanical schematic of one embodiment of the present device. A drive-control circuit 402 and a directional-control circuit 404 can both be connected to a central processing unit (CPU) 406 . A CPU 406 can be connected to an input device/receiver 408 , which can be connected to a power supply 410 . A motion-control device 208 can be connected to an input device/receiver 408 via an op-amp circuit 412 . A remote-control 302 can also provide input to an input device/receiver 408 via a wireless connection or any other known and/or convenient method. In some embodiments, a CPU 406 can also be capable of collecting motion information from the device and connecting to an external personal computer to download such information. Further, in some alternate embodiments, a device can include a timing mechanism 120 (as shown in FIG. 1 ) to record and optionally display chronological information regarding motion of the device. In a drive-control circuit 402 , a power supply 118 can be connected to a shut-off device 112 , an on-off switch 108 , a drive device 114 , and a resistor 414 , In some embodiments, a drive device 114 can be a motor, but in other embodiments can be any other known and/or convenient device. As shown in FIG. 2 , a power supply 118 can be a variable power supply, or in other embodiments can be any other known and/or convenient device. In a directional-control circuit 404 , a power supply 416 can be connected to a resistor 418 and a drive device 420 . In some embodiments, a drive device 420 can be a motor, but in other embodiments can be any other known and/or convenient device. A CPU 406 can be connected to a power supply 118 for a drive circuit 402 via an amplifier 422 , and also to a power supply 416 for a directional-control circuit 404 via and amplifier 242 . In such embodiments, a CPU can, therefore, provide input to control a drive circuit 402 and a directional-control circuit 404 . A remote-control unit 302 can provide input concerning direction, speed, on/off status, or any other known and/or desired parameters to an input device/receiver 408 . As shown in FIG. 4 , a motion-control device 208 can, in some embodiments, be incorporated into a shut-off device 112 . A magnet 210 on a shut-off device 112 can, when in motion, produce a current that can be read by a reader 212 . An induced current can vary depending upon the orientation of magnets 210 in relation to readers 212 and the speed of magnets 210 in moving past readers 212 . In embodiments having multiple magnets 210 and readers 212 , as shown in FIG. 4 , the electrical signals resulting from an induced current can be summed in an op-amp circuit 412 and sent to a CPU 406 via an input device/receiver 408 . A CPU 406 can process these electrical signals to provide control information to a drive-control circuit 402 and a directional-control circuit 404 by using electrical signals to establish a seed value for a random-number generator in a CPU 406 . In some embodiments, a random number generator can translate an electrical signal into numerical values. In such embodiments, a numerical value can be parsed into separate values, each of which can be used to control speed and direction. For example, in some embodiments, a numerical value can have a plurality of digits. One or more digits can correspond to a seed value for speed control, one or more other digits can correspond to a seed value for the control time period, and at least one remaining digit can correspond to a seed value for directional control. FIG. 5 depicts another embodiment of the present device that can operate in an aquatic environment. Such embodiments can further comprise a flotation device 502 , which can be located circumferentially around a housing 102 , or in any other known and/or convenient position. In some embodiments, a housing 102 can be comprised of a buoyant material. FIG. 6 depicts a side view of another embodiment of the present device. In some embodiments, a housing 102 can include extension arms 602 adapted to reduce the likelihood of overturning the device. Moreover, in some embodiments the shut-off unit 112 can be coupled with an object 604 . In some embodiments, an object 604 can have the shape of a rabbit and/or any desired shape. In some embodiments, a shut-off unit 112 can include a depression 216 that can mate with a protrusion at the base of the opening 110 . In some embodiments, the protrusion can be coupled with a rotational motor 608 such that as the motor rotates, both the drive agency 116 and the object 604 can rotate in unison. In alternate embodiments, the object 604 and drive agency 116 can move and/or rotate independently. In use, a user can turn a switch 108 to the “on” position and insert a shut-off unit 112 into an opening 110 . The present device can then begin to move about and be chased by a person, who could have the goal of overtaking the device and removing the shut-off unit 112 , which would cause the device to stop moving. A person can also chase the device without the goal of removing a shut-off unit 112 , but rather to follow a prescribed pattern. In some embodiments, motion of the device can be determined by a magnetostatic device that produces a random movement pattern. In other embodiments, motion can be controlled by a remote user via a remote-control unit 302 . Either way, the erratic movement of the present device can require the person chasing the device to change motion quickly, and, therefore, develop speed and agility. Although the method 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 method 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.

An athletic training device to develop speed and agility. A robot can be programmed or remote controlled to move in an erratic manner so that it can be chased by an athlete. An on-board shut-off unit stops the device when it is removed by the athlete chasing the device.

BACKGROUND OF THE INVENTION The present invention relates to a suction pump for draining body fluids from body cavities, the suction pump comprising a bottom portion and a domed resilient pump body having a substantially smooth inner surface, the pump body being connected to the bottom portion along its rim and forming a pumping chamber between the bottom portion and pump body, which suction pump further comprises an inlet valve and an outlet valve, the resilient pump body being resiliently deformable by manual action from its domed configuration towards the bottom portion for the provision of the pressure stroke of the suction pump and due to its elasticity returning to its domed configuration when relieved for the provision of the suction stroke of the pump. A pump of the type mentioned above is disclosed in EP patent application No. 87307362.1 (publication No. 0270205). The domed pump body of the noted pump has a flat top which may be supported along its inner surface by means of two sets of intersecting ridges and the bottom portion is flat and may be provided with a set of upwardly extending ridges. In its deformed state the bottom and the inner surface of the pump body are spaced, and hence the pump has a large pump clearance volume, which means that only a relatively small part of the pump chamber is used in the pumping operation. The prior art pump is implantable and serves to transport body fluid from one cavity of the body into another when activated. Furthermore, the ridges of the pump body, if provided, serve to quickly return the pump body to its starting position. Similar pumps having an internally smooth domed pump body and a flat bottom portion are disclosed in GB 1,146,413 and GB 1,173,071. SUMMARY OF THE INVENTION It is the object of the present invention to provide a pump of the above-mentioned type in which the pump chamber is utilized so efficiently that the pump obtains a large capacity in relation to its size and which allows the suction pressure produced by the pump to be maintained for relatively long periods between consecutive pressure strokes, the object being obtained according to the invention by the bottom portion having a concave portion which substantially corresponds to the inner configuration of the pump body in the deformed state thereof. As a result, it is possible to manually place at least the major part of the inner surface of the pump body in the deformed position thereof close to or in contact with the concave part of the bottom portion, thereby forming a very small clearance volume in the pump, and consequently it is possible to use approximately the entire volume of the pump chamber for the pumping function, thereby allowing the suction pressure to be maintained for relatively long periods. In tests forming the basis of the present invention it was found that if the inner surface of the pump body according to a preferred embodiment of the invention in the domed state of the pump body substantially has the form of a spherical segment, the suction pressure produced by the pump will only vary relatively little during the suction stroke, i.e., in the period during which the pump body returns from its deformed state to its domed configuration. In a preferred embodiment of the pump according to the invention the spherical segment has an arc measure ranging between about 100° and 140°, expediently between 110° and 130°, and preferably being about 120°. A further embodiment of the pump according to the invention is characterized in that at its top the spherical segment has a slightly smaller radius of curvature than at its sides. This embodiment has been found to provide a satisfactory equalization of the variations in pressure which may occur during the suction stroke. According to a still further embodiment of the pump of the invention the inlet valve and the outlet valve are offset in relation to the rim of the pump body and connected to the pump chamber through channels in the concave portion of the bottom portion. This results in that the valves and the inlets of the valves are prevented from hindering the aimed deformation of the pump body. The invention will now be explained in further detail with reference to the drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a front view of an embodiment of the pump according to the invention, FIG. 2 shows a rear view of the pump of FIG. 1, FIG. 3 shows a side view of the pump of FIG. 1, FIG. 4 shows a top view of the pump of FIG. 1, FIG. 5 shows a bottom view of the pump of FIG. 1, FIG. 6 shows a vertical sectional view of the pump shown on an enlarged scale, and FIG. 7 shows a graph illustrating variations in the suction pressure as a function of the volume of the pump chamber during the suction stroke. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT In the drawings 1 designates a bottom portion of the pump shown and 2 a pump body. The pump body has a domed configuration and substantially the form of a spherical segment. The inner surface of the pump body is substantially smooth as will appear from FIG. 6, and along the circumference of the pump body a bead construction 3 is provided which is embedded in a rim portion 4 of the bottom portion, as will also appear from FIG. 6, the rim portion being profiled so as to correspond to the bead construction 3. The latter is kept in position in relation to the rim portion 4 by means of a holding ring 5 running along the entire circumference of the pump body 2 and being provided at its top with a suspension hook 6. Additional hooks 6a and 6b are provided at either side of the hook 6. The bottom portion 1 has substantially the form of a cup 7, the inner surface of the cup having a concave configuration along the portion 8 of the bottom portion located within the rim portion 4. The back of the cup 7 has two bulges 9 and 10, respectively, cf. FIG. 3, which extend flush with each other along a diameter of the cup. These bulges substantially have a U-shape and thus form internal channels 11 and 12, respectively, FIG. 6, which debouch along the concave inner surface of the portion 8. At the bottom the bulge 9 is provided with a collar 15 which is offset on one side of a center plane P defined by the rim of the pump body and comprises therein a valve holder 16 for an outlet valve 17. The holder 16 is provided with a nozzle 18 which is intended for mounting of a hose which is connected to a collection reservoir. The valve 17 only allows flow from the pump chamber 19 formed between the bottom portion 1 and the pump body 2. The valve is made of an elastic plastics material and has a tubular form at the top which downwardly passes into converging sides 20, 21 having adjoining downward facing edges 22, 23, which in case of overpressure in the pump chamber 19 are moved away from each other to allow discharge of fluid from the pump chamber. In case of underpressure in the pump chamber the edges 22, 23 are pressed together. At its interior end the valve 17 has a circumferential flange 24 which is maintained by the corresponding upward facing edge of the holder 16. The valve 17 communicates with the channel 11 through an aperture 25 and the width of the channel 11 (as seen perpendicularly to the plane of the drawing in FIG. 6) corresponds substantially to the diameter of the aperture 25, the channel 11 thus being very narrow. At the top the bulge 10 is provided with an inlet valve corresponding substantially to the outlet valve described above and consisting of a collar 26 in which a valve 27 having the same construction as the valve 17 is mounted, but which serves as an inlet valve, the edges 29,30 at the ends of the side walls 31, 32 of the valve turning inwards towards the pump chamber 19. The inlet valve is offset backwards in relation to the rim of the pump body and communicates with the channel 12 through an aperture 34, and the width of the channel 12 (seen perpendicularly to the plane of the drawing in FIG. 6) corresponds substantially to the diameter of the aperture. The inlet valve is also provided with a nozzle 35 which is intended for securing one end of a connecting hose, the other end of which is coupled to a drainage tube in which a underpressure is generated after it has been positioned in the body cavity to drain the body cavity of body fluids. It will immediately be understood that the suction pressure in the pump chamber causes the inlet valve to be opened and the overpressure in the pump chamber causes the valve to be closed. The pump shown is provided with a suspension arrangement 37 in the form of a hook, which, e.g., can be suspended from a hospital bed or equipment provided therefor. The hook is provided with a shank 38 having its upper end provided with a hole in which a spigot 39 engages on a protrusion 40 on the valve holder 41, whereas the lower end 42 of the shank is supported by means of a cam arrangement 43 engaging with recesses in a projection 44 on the outside of the bottom of the cup approximately at the centre of the latter. The cam arrangement is arranged in a manner which allows the hook 37 to be swung to one side or the other towards the pump so as to take up only little space. At the position shown in the drawing the hook is maintained by the elastically releasable engagement of one of the cams in the cam arrangement with a corresponding recess in the projection 44. Between the bulges 9, 10 the interior of the bottom portion has substantially a spherical segment-shaped surface 8a. As mentioned above, the inner surface of the pump body 2 has approximately the configuration of a spherical segment. In the embodiment shown in the drawing the spherical segment has a central angle of about 120°, but it may vary between 100° and 140°, expediently between 110° and 130°. In the embodiment shown in the drawing the pump body does not have the exact form of a spherical segment, the radius of curvature at the top of the pump body being slightly smaller than the radius of curvature along the sides of the pump body. The concave inner surface of the portion 8 extends approximately along a central arc measure of about 115°. It is noted that this inner surface does not have the exact form of a spherical segment either, the inner side also having a slightly smaller radius of curvature along its centre area 8a than along its sides. The arc measure of the inner surface of the portion 8 may also vary, expediently between 95° and 135°, preferably between 105° and 115°. The pump shown operates in the following manner: After the above-mentioned drainage tube has been installed and the pump has been connected to the collection reservoir as explained above, the pump body 2 is manually pressed inwards. The configuration of the inner surface of the pump body and the configuration of the inner surface of the portion 8 allow the pump body to be pressed into close engagement with the inner surface of the portion 8 so that a pump clearance volume is formed corresponding substantially to the volume of the channels 11,12, which are relatively narrow as explained above. When relieved the pump body 2 gradually returns to the shape shown in FIG. 6, during which it is removed from the inner surface of the portion 8 while producing a constant suction. FIG. 7 shows variations in the suction pressure as a function of the increase in the volume of the pump chamber during the suction stroke, and from the figure it appears that at the beginning of the suction the pump produces a relatively high suction pressure in the order of about 1300 mm water head which subsequently falls steadily until the middle of the suction stroke is reached where the pressure has been reduced to about 800 mm water head. During the remaining part of the suction stroke the pressure initially increases slightly as indicated and then it falls and rises again to about 1850 mm water head and finally it falls vigorously, viz. when the suction stroke ends. However, the above mentioned variation in suction pressure does not exceed what can reasonably be tolerated for the purpose explained above. The abrupt increase at the end of the suction stroke is very short in relation to the time during which the suction stroke is effective and is caused by the straightening out of the central part of the pump body 2 before reaching the configuration shown in FIG. 6.

A suction pump is used for draining body fluids from body cavities and has a bottom portion (1) and a resilient pump body (2) with a domed shape. The pump also has an inlet valve (27) and an outlet valve (17). The pump stroke is provided by the elastic deformation of the pump body (2) towards the bottom (1) and the suction stroke is provided due to the elasticity of the pump body (2). In order to achieve only a small pump clearance volume the pump body (2) has a smooth inner surface and the bottom has a concave inner side (8) corresponding to the inner configuration of the pump body (2) when it has been deformed for starting the suction stroke of the pump.

CROSS-REFERENCE TO RELATED APPLICATION [0001] This non-provisional patent application claims priority to co-pending Provisional Application Ser. No. 60/840,758, filed Aug. 28, 2006. FIELD OF THE INVENTION [0002] The present invention relates to golf and indoor putting. More particularly, the present invention relates to bases for standing golf bags and for indoor putting greens. BACKGROUND [0003] Golf is a very popular sport. People who golf like to have their golf bags near them, and they like to practice putting. Golf bags are not stable when standing without support. There is a need for a golf bag stand base that allows a golf bag to be stably leaned against a support, such as a wall, and which can also serve as a putting green. SUMMARY AND ADVANTAGES [0004] A convertible golf bag base and putting green includes a base plate, a ramp surface, a raised lip, a sidewall and a cup. A convertible golf bag base and putting green includes a circular incline with a perimeter rim wherein said perimeter rim defines a circle with an open arc and a depression within said incline within the perimeter of said rim. A convertible golf bag base and putting green includes a base, an incline rising up from said base, said incline including a rectangular ramp rising from the level of said base and spreading into a circular incline upon said base, a perimeter rim along two parallel edges of said rectangular ramp and encircling a portion of said circular incline; and a depression within said incline within the perimeter of said rim. [0005] The convertible golf bag base and putting green of the present invention presents numerous advantages, including: (1) storage of golf bags, (2) portability, (3) user can practice putting, (4) ease in switching from storage use to putting use, (5) invention itself is easy to store, and (6) durability. Additional 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 advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims. Further benefits and advantages of the embodiments of the invention will become apparent from consideration of the following detailed description given with reference to the accompanying drawings, which specify and show preferred embodiments of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS [0006] The accompanying drawings, which are incorporated into and constitute a part of this specification, illustrate one or more embodiments of the present invention and, together with the detailed description, serve to explain the principles and implementations of the invention. [0007] FIG. 1A shows a top view of an embodiment of the invention. [0008] FIG. 1B shows a cross-sectional view of an embodiment of the invention, based on the cutting plane line, labeled 1 B, in FIG. 1A . [0009] FIG. 1C shows a perspective view of an embodiment of the invention. DETAILED DESCRIPTION [0010] Before beginning a detailed description of the subject invention, mention of the following is in order. When appropriate, like reference materials and characters are used to designate identical, corresponding, or similar components in differing figure drawings. The figure drawings associated with this disclosure typically are not drawn with dimensional accuracy to scale, i.e., such drawings have been drafted with a focus on clarity of viewing and understanding rather than dimensional accuracy. [0011] In the interest of clarity, not all of the routine features of the implementations described herein are shown and described. It will, of course, be appreciated that in the development of any such actual implementation, numerous implementation-specific decisions-must be made in order to achieve the developer's specific goals, such as compliance with application- and business-related constraints, and that these specific goals will vary from one implementation to another and from one developer to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking of engineering for those of ordinary skill in the art having the benefit of this disclosure. [0012] As shown in FIGS. 1A-1C , a convertible golf bag base and putting green 10 is provided. As shown in FIGS. 1A-1C , a convertible golf bag base and putting green 10 includes a base plate 20 , a ramp surface 22 , a raised lip 24 , a sidewall 26 and a cup 28 . In an alternate embodiment, a convertible golf bag base and putting green 10 includes a base plate 20 , a ramp surface 22 , a raised lip 24 , a sidewall 26 , but lacks a cup 28 . Consequently, the user may continue to use the invention to hold the golf bag and to practice putting skills but the golf ball B will roll back down the ramp surface 22 towards the user. Any portion of the convertible golf bag base and putting green 10 may be constructed of fiberglass, plastic, or aluminum but is preferably constructed of rigid plastic. [0013] The base plate 20 is a thin, flat surface, preferably lightweight and portable. The base plate 20 may rest upon any hard surface, including a floor, the ground, concrete, blacktop, or a lawn. [0014] The ramp surface 22 slopes upward from its unenclosed end to the opposite, enclosed end, as shown in FIGS. 1A-1C . As a result, the ramp surface 22 at the unenclosed end, i.e., the portion of the ramp surface 22 lacking a raised lip 24 , and adjacent to the base plate 20 edge is planar to the base plate 20 . The ramp surface 22 then begins to slope up from the base plate 20 and is at its greatest height from the base plate 20 at the enclosed end opposite the unenclosed end and adjacent to the raised lip 24 . The ramp surface 22 has a substantially circular portion, preferably of sufficient diameter upon which to place a golf bag. [0015] The raised lip 24 is located on the peripheral edge of the ramp surface 22 . The raised lip 24 helps support the golf bag when in place and prevents the golf ball B from falling off the ramp surface 22 during putting practice. The raised lip 24 is preferably rounded on top so as to not scratch the golf bag when used for storage. The raised lip extends beyond the ramp surface 22 to form two parallel ridges on the base plate 20 . This configuration guides the golf ball B up the ramp surface 22 during putting practice. [0016] The sidewall 26 connects the raised lip 24 to the base plate 20 . Thus, as the raised lip 24 slopes upward with the ramp surface 22 , the sidewall 26 extends upward correspondingly as shown in FIGS. 1B and 1C . Preferably, the sidewall 26 is approximately 0.25 inches (0.64 cm) at its shortest height to approximately 1.0 inch (2.54 cm) at its tallest height to create a challenging but not impossible slope for putting practice as well as a slope for golf bag storage that permits the bag to lean, even up against a wall or other surface, but not topple over. [0017] The cup 28 is located preferably at the midpoint of the slope of the ramp surface 22 and equidistant from the curved portions of the raised lip 24 . The cup 28 is preferably at least 0.5 inches (1.27) cm deep at its shallowest end and preferably at least 1.0 inches (2.54 cm) deep at its deepest end to prevent a golf ball B that lands in the cup 28 from leaving the cup 28 . [0018] In operation in one embodiment, a golf bag is placed on top of the ramp surface 22 . Because of the slope of the ramp surface 22 , the golf bag will tilt slightly. Preferably, the convertible golf bag base and putting green 10 is positioned with one edge against a wall, such that when the golf bag is placed on top of the ramp surface 22 the golf bag tilts but is secured by the raised lip 24 and the wall. In fact, the golf bag's upper portion may lean against a wall. The wall may be a room wall, a building wall, a cabinet wall or door, or a similar sturdy surface perpendicular to the convertible golf bag base and putting green 10 of sufficient height to support the golf bag. [0019] In operation in one embodiment, the user places the convertible golf bag base and putting green 10 in an open area, such as on an open clearing within a room, and uses a golf club to strike a golf ball B, aiming for the open end of the ramp surface 22 in between the straight, parallel portions of the raised lip 24 . Ideally, the user is successful in hitting the golf ball B up the ramp surface 22 and into the cup 28 . The user may then retrieve the golf ball B from the cup 28 and continue practicing or place the golf bag on top of the ramp surface 22 for storage. [0020] However, if the user misses the cup, the golf ball B may roll down the ramp surface 22 and into the cup 28 , or down the ramp surface 22 , between the straight, parallel portions of the raised lip 24 , and back onto the floor or surface area upon which the convertible golf bag base and putting green 10 rests. If the golf ball B does not enter the cup 28 or jumps out of the cup 28 due to excessive striking force, the golf ball B may hit a curved portion of the raised lip 24 . The golf ball B will hit the curved portion of the raised lip 24 and then either go down the ramp surface 22 between the straight, parallel portions of the raised lip 24 , or continue to hit the curved portion of the raised lip 24 until reaching the open portion of the ramp surface 22 and then exiting the convertible golf bag base and putting green 10 between the straight, parallel portions of the raised lip 24 . The user may then retrieve the golf ball B from the floor or surface area upon which the convertible golf bag base and putting green 10 rests and continue practicing or place the golf bag on top of the ramp surface 22 for storage. [0021] In an alternate embodiment, the convertible golf bag base and putting green 10 lacks a cup 28 but the user can continue to practice hitting the golf ball B up the ramp surface 22 between the straight, parallel portions of the raised lip 24 . The golf ball B will then roll down the ramp surface 22 and out the straight, parallel portions of the raised lip 24 until the golf ball B is back onto the floor or surface area upon which the convertible golf bag base and putting green 10 rests. The user may then retrieve the golf ball B from the floor or surface area upon which the convertible golf bag base and putting green 10 rests and continue practicing or place the golf bag on top of the ramp surface 22 for storage. [0022] Those skilled in the art will recognize that numerous modifications and changes may be made to the preferred embodiment without departing from the scope of the claimed invention. It will, of course, be understood that modifications of the invention, in its various aspects, will be apparent to those skilled in the art, some being apparent only after study, others being matters of routine mechanical, chemical and electronic design. No single feature, function or property of the preferred embodiment is essential. Other embodiments are possible, their specific designs depending upon the particular application. As such, the scope of the invention should not be limited by the particular embodiments herein described but should be defined only by the appended claims and equivalents thereof.

A convertible golf bag base and putting green includes a base plate, a ramp surface, a raised lip, a sidewall and a cup. A convertible golf bag base and putting green includes a circular incline with a perimeter rim wherein said perimeter rim defines a circle with an open arc and a depression within said incline within the perimeter of said rim. A convertible golf bag base and putting green includes a base, an incline rising up from said base, said incline including a rectangular ramp rising from the level of said base and spreading into a circular incline upon said base, a perimeter rim along two parallel edges of said rectangular ramp and encircling a portion of said circular incline; and a depression within said incline within the perimeter of said rim.

This is a continuation of U.S. application Ser. No. 08/238,959 filed May 6, 1994 which issued as U.S. Pat. No. 5,545,150 on Aug. 13, 1996. BACKGROUND OF THE INVENTION The present invention relates to a surgical instrument commonly referred to as a trocar, or an obturator and cannula, often used in laparoscopic or arthroscopic surgery. More particularly, the invention relates to a new and improved design for a flapper valve, seal, and to the use of disposable seal assemblies on an otherwise reusable instrument. Many surgical procedures are now being performed with the use of trocars and cannulas. Originally these devices were used for making a puncture and leaving a tube to drain fluids. As technology and surgical techniques have advanced, it is now possible to insert surgical instruments through the cannulas and perform invasive procedures through openings less than half an inch in diameter. Previously these procedures required incisions of many inches. By minimizing the incision, the stress and loss of blood suffered by patients is reduced and the patients' recovery times are dramatically reduced. Surgical trocars are most commonly used in laparoscopic surgery. Prior to use of the trocar, the surgeon will usually introduce a Veress needle into the patient's abdominal cavity. The Veress needle has a stylet which permits the introduction of gas into the abdominal cavity. After the Veress needle is properly inserted, it is connected to a gas source and the abdominal cavity is insufflated to an approximate abdominal pressure of 15 mm Hg. By insufflating the abdominal cavity, pneumoperitoneum is created separating the wall of the body cavity from the internal organs. A trocar is then used to puncture the body cavity. The piercing tip or obturator of the trocar is inserted through the cannula or sheath and the cannula partially enters the body cavity through the incision made by the trocar. The obturator can then be removed from the cannula and an elongated endoscope or camera may be inserted through the cannula to view the body cavity, or surgical instruments may be inserted to perform ligations or other procedures. Once the cannula has been introduced into the opening in the body cavity wall, the pneumoperitoneum may be maintained by introducing gas into the abdominal cavity through the cannula. Various seals and valves have been utilized to allow abdominal pressure to be maintained in this fashion. Maintaining abdominal pressure is important both to allow working room in the body cavity for instruments introduced through the cannula, and to provide free space for the puncturing of the body cavity wall by one or more additional trocars as may be required for some procedures. While the existing trocars and cannulas have proven useful, several disadvantages remain. Also, with the current emphasis on cost controls in health care, it is desirable to utilize reusable medical instruments whenever possible. The difficulties of cleansing, disinfecting and otherwise decontaminating used trocars has made this a time consuming or impossible task, especially for the mechanisms contained in shielded trocars. Therefore, a need exists for an improved apparatus for performing laparoscopic and similar surgical procedures. SUMMARY OF THE INVENTION Accordingly, it is an object of the invention to provide a cannula which may be substantially reused without the need for excessive labor in cleaning and decontamination. It is another object of the invention to provide a seal or valve which permits easy insertion of surgical and exploratory instruments through the cannula yet still operates effectively to maintain the pneumoperitoneum in the body cavity. It is yet another object of the invention to provide an inexpensive and easily assembled seal or valve assembly. Accordingly, the present invention provides a cannula with a detachable cap and disposable seal assembly. A novel and inexpensive flexible valve is also provided which facilitates insertion of surgical instruments. BRIEF DESCRIPTIONS OF THE DRAWINGS FIG. 1A is a cross sectional side view of an improved cannula according to the invention with a disposable gland retainer and end cap. FIG. 1B is a side view of a conventional obturator which is adapted for use with the cannula of FIG. 1A. FIG. 2 is an exploded perspective view of the improved cannula of FIG. 1. FIG. 3A is a cross sectional side view of the end cap of the improved cannula of FIG. 1 in isolation. FIG. 3B is an end view of the end cap of the improved cannula of FIG. 1. FIG. 4A is a cross sectional side view of the flexible flapper valve of the improved cannula of FIG. 1 in isolation. FIG. 4B is an enlarged side plan view of the button which is mounted in the center of the preferred embodiment of the flexible flapper valve. FIG. 4C is an end view of the flexible flapper valve of the improved cannula of FIG. 1. FIG. 5 is a cross sectional side view of the gland retainer of the improved cannula of FIG. 1 shown in isolation. DESCRIPTION OF THE PREFERRED EMBODIMENTS The invention commonly known as a trocar is comprised of two major components. These are a cannula 13 such as those illustrated in FIG. 1A, and an obturator such as the traditional obturator 11 with handle 35 in FIG. 1B. The obturator 11 of FIG. 1B and cannula 13 of FIG. 1A are interfitting and as explained below are used together to penetrate a body cavity wall. Once the body cavity wall is penetrated, however, the obturator 11 may be removed and other medical instruments may be introduced into a lumen 19 of the cannula 13. The cannula 13 of FIG. 1A consists of three components and two seal assemblies. The components are the cannula tube 14, the gland retainer 42 and the cap 44. The outer surface of the cannula tube 14 of FIG. 1A is shown with a helically wound thread 49 preferably beginning at a reduced height a short distance from the distal end 68 of the cannula tube 14 and gradually increasing to its full height as it proceeds toward the proximate end 69. At the proximate end 69 of the cannula tube 14, there is a raised flange 36 for convenience in handling the cannula 13. Above the flange 36 is a gas port 16 which can be connected to a gas supply, not shown, to supply gas through the lumen 19 of the cannula tube 14 into a body cavity to create or maintain pneumoperitoneum. Above the gas port 16 are male threads 65 which allow the cannula tube 14 to be securely coupled with cap 44 which has corresponding female threads 66. The cap 44 also has an aperture 55 to permit insertion of an obturator 11, and gripping protrusions 67 to facilitate fastening and unfastening the cap 44. Mounted concentrically mostly within the proximate end 69 of the cannula tube 14 and held in place by the cap 44 is the gland retainer 42. The cap 44 is shown in isolation in FIGS. 3A and 3B. It will be noted that at the proximate end 69 of cannula tube 14, the lumen 19 is of larger diameter than at the distal end 68, and forms a proximate cavity 37 that both receives the gland retainer 42 and extends somewhat further toward the distal end 68. The gland retainer 42 shown in isolation in FIG. 5, holds two seals, 43 and 41, in place. Flexible flapper seal 43 shown in FIG. 4A has a fastening section such as the illustrated annular outer casing 56 which engages the gland retainer. A raised edge 45 at the distal end of the gland retainer 42 fits within a channel 47 shown in FIG. 4A formed by the lips 51, 52 of the C shaped edge comprising the outer casing 56 of flexible flapper seal 43, shown in FIGS. 1A and 2. A corresponding groove 48 located toward the distal end of the gland retainer 42 receives the first lip 51 of the flexible flapper seal 43. A second raised edge 46 at the proximate end of the gland retainer 42 fits with a channel formed by a similar C shaped edge of the outer casing wiper seal 41 opposite that shown in FIG. 4A. Both the membrane seal 41 and flexible flapper seal 43 are fabricated from materials having sufficient elasticity that the edges of the seals 41 and 43 can be stretched over ridges 46 and 45 respectively. The wiper seal 41 is of conventional design, however, the flexible flapper valve 43 is of novel construction. As shown in FIGS. 4A and 4C, a hinge 57 extends inward from the outer casing 56 of the flexible flapper valve 43 and mounted on the hinge is the generally circular flapper portion 58. The flapper portion 58 of flapper valves 43 according to present invention are of greater width than the hinge 57. To prevent the flapper portion 58 from binding with the outer casing 56, an annular slot 50 separates those elements except at hinge 57. The flapper 58 is preferably molded or stamped in one piece with the hinge 57 and outer casing 56 of an elastomeric material. In the preferred embodiment a hard plastic or metal button 59 is mounted on or through the flapper. Preferably the button 59 has an upper surface 63, a post 62 penetrating the flapper portion 58, and a bottom surface 61. When the piercing tip 80, shown in FIG. 1A, of an obturator 11 is inserted through the opening 55 in the cap 44, and through the wiper seal 41, the piercing tip contacts the hard button 59 of the flexible flapper valve 43 and begins to deflect the flapper 58 from its normal closed position flush against the distal end surface 30 of the gland retainer 42. In the absence of button 59, the piercing tip of the obturator might otherwise penetrate or cut into the flapper 58 which could cause resistance to entry of the obturator or damage the flapper 58 so that it would no longer seal the cannula 13 or gland retainer 42 effectively against loss of air through the opening 55 in the cap 44. The hard button 59 alleviates these possible problems and also adds rigidity to the flapper 58. The end surface 30 of the gland retainer is substantially planar defining a shelf within the cannula tube lumen around an opening or flapper valve aperture 31 at least as large as the cannula lumen 19, but smaller than flapper 58. When assembled in the proximate end 69 of the cannula 13, the end surface 30 forms a shelf around opening 31. Proceeding toward the end cap 44 at the proximal end of the cannula, the opening 31 in the illustrated gland retainer 42 tapers to a fitted aperture 32 of substantially equal diameter to the cannula lumen 19. The proximal opening 33 of the gland retainer 42 is preferably slightly larger than the cannula lumen 19 so that the obturator 11 or other instrument being inserted will be guided through the fitted aperture 32 and on through the gland retainer 42 into contact with button 59 on the flapper 58. When the obturator 11 or other endoscopic instrument is removed from the cannula 13, the resiliency of the hinge 57 causes the flapper 58 to move to a partially closed position. The flapper 58 is then firmly closed and sealed against the distal end surface 30 of gland retainer 42 by action of the air pressure from the inflated body cavity. The air pressure pushing the flapper 58 against the distal end surface 30 of the gland retainer 42 thereby closes opening 31 and forms an effective seal against further loss of gas. In its preferred embodiment, the cannula tube 14 portion is manufactured of a durable material such as stainless steel or titanium alloys, capable of withstanding repeated high temperature cleaning and sterilization, while the gland retainer 42 is made of an inexpensive plastic. The cap 44 may be made of either type of material. The gland retainer 42, containing the flapper valve 43 and possibly also containing a wiper seal 41, is difficult to clean and sterilize. However, the gland retainer 42 and seals 41 and 43 are relatively inexpensive to manufacture and can be discarded after each use. The cannula tube 14, and optionally the cap 44, are relatively easy to clean and sterilize and need not be discarded. By reusing the cannula tube 14, and the cap 44 if manufactured of an appropriate material, cost and waste can be minimized. If desired the cap 44 can also be manufactured of inexpensive plastic and discarded with the gland retainer 42 after use. Numerous alterations of the structures herein described will suggest themselves to those skilled in the art. It will be understood that the details and arrangements of the parts that have been described and illustrated in order to explain the nature of the invention are not to be construed as any limitation of the invention. All such alterations which do not depart from the spirit of the invention are intended to be included within the scope of the appended claims.

A trocar is formed from a cannula and an interfitting obturator for penetrating body cavity walls in laparoscopic and endoscopic surgery. The cannula has an improved inexpensive flexible flapper valve and can be manufactured with a reusable cannula tube but disposable flapper valve assembly to minimize cost.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of application Ser. No. 09/214,836 filed Oct. 4, 1999, which was the National Stage of International Application No. PCT/EP97/03712 filed Jul. 8, 1997 and having a priority date of Jul. 11, 1996. The disclosure of each of these related applications is incorporated herein in their entireties. BACKGROUND OF THE INVENTION [0002] The present invention is concerned with cancer treatment and diagnosis, especially with melanoma associated peptide analogues, epitopes thereof, vaccines against and diagnostics for the detection of melanoma and for the monitoring of vaccination. [0003] During the stepwise changes from normal to tumor tissue, tumor-associated antigens appear. The characteristics of tumor-associated antigens are very much dependent on the origin of the tumor carrying them. The existence of antigens associated with animal tumors was documented in the last century, and the antigenic character of human cancers has been well established, primarily through recent studies with monoclonal antibodies. [0004] Attempts to isolate and chemically characterize these antigens have encountered serious difficulties, many having to do with a lack of reagents suitable for precipitation of the antigen-bearing molecules from a solution. [0005] Like many other stimuli, the tumor-associated antigens activate not one but a whole set of defense mechanisms—both specific and unspecific, humoral and cellular. The dominant role in in vivo resistance to tumor growth is played by T lymphocytes. These cells recognize tumor-associated antigens presented to them by antigen presenting cells (APCs), and will be activated by this recognition, and upon activation and differentiation, attack and kill the tumor cells. [0006] Cytotoxic T lymphocytes (CTL) recognize short peptide fragments of 9-11 amino acids in length, which are presented in the antigen-binding groove of Major Histocompatibility Complex (MHC) class 1 molecules (Townsend et al., 1986 , Cell 44.959; Bjorkman et al., 1987 , Nature 329:512). These peptides are usually derived from intracellular protein pools and associate in the lumen of the endoplasmic reticulum with MHC class I heavy chain and 132-microglobulin molecules, followed by transportation of the MHC-peptide complex to the cell surface. Despite the presence of many putative antigenic peptides within the same antigen, only a few peptides are selected for recognition by CTL. [0007] MHC Class I/II antigens are often down regulated in solid tumors. This may affect all class I/II antigens, or only part of them. Viral and cellular peptides that can sensitize appropriate target cells for cytotoxic T lymphocyte mediated lysis may fail to do so when produced in cells with a low level of expression of MHC class I antigen. Cytotoxic sensitivity may be induced, at least in some cases by raising the level of MHC class I/II antigen expression by interferon γ and tumor necrosis factor α. [0008] The MHC class I binding-affinity of an epitope is an important parameter determining the immunogenicity of the peptide-MHC complex. Analysis of Human histocompatibility antigen (HLA-A *0201)-restricted epitopes recognized by anti-viral CTL demonstrated that several peptides bind to HLA-A *0201 with high affinity. Furthermore, immunogenicity analysis of motif containing potential epitopes using HLA-A *0201 transgenic mice revealed that a threshold MHC class I affinity was required for a peptide in order to elicit a CTL response (Ressing et al., 1995 , J. Immunol. 154:5934; Sette et al., 1994 , J. Immunol. 153:5586). In addition to the MHC class I-binding affinity, stability of peptide-MHC complexes at the cell surface contributes to the immunogenicity of a CTL epitope. Consequently, MHC class I binding-affinity and stability of peptide-MHC complexes are important criteria in the selection of specific peptide determinants for development of CTL-epitope based therapeutic vaccines. [0009] Recently, a number of antigens have been identified as target antigens for anti-melanoma CTL. Using a genetic approach, the tumor specific antigens MAGE-1 and -3, as well as the melanocyte-lineage specific antigen tyrosinase, were identified (van der Bruggen et al., 1991 , Science 254:1643; Gaugler et al., 1994 , J. Exp. Med. 179:921; Brichard et al., 1993 , J. Exp. Med. 178:489). [0010] In the co-owned and co-pending patent-application (EP 0 668 350), the gp100 melanocyte-specific protein was identified as a target antigen for melanoma tumor infiltrating lymphocytes. [0011] Recently, two other melanocyte differentiation antigens, Melan-A/MART-1 and gp75, were identified as target antigens for anti-melanoma CTL (Coulie et al., 1994 , J. Exp. Med. 180:35; Kawakami et al., 1994 , Proc. Natl. Acad. Sci. USA. 91:3515; Wang et al., 1995, (vol 181, pg 799, 1995). J. Exp. Med. 181:1261. 10-12). Eight HLA-A *0201 restricted epitopes derived from these antigens have now been characterized, displaying varying affinities for HLA-A *0201 (Wolfel et al., 1994 , Eur. J. Immunol. 24:759; Cox et al, 1994 , Science 264:716; Kawakami et al. 1995. J. Immunol. 154:3961; Bakker et al., 1995 , Int. J. Cancer 62:97; Kawakami et al., 1994 , J. Exp. Med. 180:347; Castelli et al., 1995 , J. Exp. Med. 181:363). DISCLOSURE OF THE INVENTION [0012] In an attempt to improve the immunogenicity of two HLA-A *0201 presented epitopes derived from the melanocyte differentiation antigens gp 100 and Melan-A/MART-1, amino acid substitutions within the epitopes to improve HLA-A *0201-binding affinity were performed. [0013] Surprisingly, it was found that these epitope-analogues have an improved immunogenicity in view of the original epitope. Furthermore, in the present invention it is demonstrated that the epitope-analogues allow the induction of peptide-specific CTL displaying cross-reactivity with target cells endogenously processing and presenting the native epitope. [0014] Usage of these epitope-analogues according to the present invention with improved immunogenicity may contribute to the development of CTL-epitope based vaccines in chronic viral disease and cancer. [0015] In more detail, since MHC class I-affinity and peptide-MHC complex-stability are important parameters determining the immunogenicity of an MHC class I presented epitope, the possibility to improve the capacity of two melanocyte differentiation antigen-derived epitopes to bind to HLA-A *0201 without affecting interactions with the T-cell receptor (TCR) is explored. Detailed analysis of the Melan-AIMART-1 27-35 and gp100 154-162 epitopes using alanine substitutions revealed that amino acids at positions 4 to 7 (Melan-A/MART-1 27-35) or 5 to 7 (gp100 154-162) are critical residues for TCR recognition. These data are in line with X-ray crystallography studies of the HLA-A *0201 molecule (Saper et al., 1991 , J. Mol. Biol. 219:277; Latron et al., 1992, Science 257:964); implying a role for the more permissive residues at position 4 and 5 of the peptide oriented towards the outside of the MHC molecule, as prominent TCR contact sites. It is demonstrated that for HLA-A *0201 the amino acids at positions 6 and 7 of the Melan-A/MART-1 27-35 and gp100 154-162 epitopes do not only interact with secondary pockets in the MHC peptide-binding cleft, but that they are also critical residues for TCR interaction (Ruppert et al., 1993, Cell 74:929; Madden et al., 1993, Cell 75:693). [0016] Surprisingly, the alanine substitution at position 8 in the gp100 154-162 epitope, KTWGQYW A V (SEQ ID NO: 1), resulted in a peptide that displayed increased HLA-A *0201 affinity. Moreover, this epitope-analogue was recognized by gp100-reactive CTL at tenfold lower concentrations compared to the native epitope. These data demonstrate that amino acid substitutions at a non-anchor position can result in increased MHC class I affinity and T cell recognition. [0017] By N-terminal anchor replacements with V, L, M or I towards the HLA-A *0201 binding-motifs were set out to identify epitope-analogues for both epitopes with improved affinity for HLA-A *0201 that were still recognized by wild type epitope-reactive CTL. For the Melan-A/MART-1 epitope, epitope-analogues were obtained with comparable (M) or improved (V, L and I) affinity for HLA-A *0201. However, all N-terminal anchor replacements resulted in decreased T cell reactivity. Apparently, in case of this epitope, the N-terminal anchoring residue affects the positioning of the side chains in the center of the peptide, thereby abrogating TCR interactions. Recently, a similar observation has been described involving an HLA-B*3501 restricted epitope of the influenza A matrix protein (Dong et al., 1996, Eur. J. Immunol. 26:335). Substitution of a serine residue at position 2 of the peptide for the more common HLA-B*3501 N-terminal anchor proline, considerably enhanced binding to HLA-B*3501, but the epitope-analogue was not recognized by CTL reactive with the native epitope. Moreover, this peptide behaved as a peptide-antagonist as was demonstrated for T cell recognition of both MEC class II and class I-presented peptides (Dong et al., 1996, Eur. J. Immunol. 26:335; De Magistris et al., 1992, Cell 68:625; Klenerman et al., 1994 , Nature 369:403). These findings illustrate that anchor residue substitutions not only affect MHC class I binding, but in some cases they may also result in a conformational change of the peptide-MHC complex, leading to an altered interaction with the TCR. [0018] However, in case of the gp100 154-162 epitope, in addition to the alanine substituted analogue KTWGQYW A V (SEQ ID NO: 1), three anchor substituted epitope-analogues K V WGQYWQV (SEQ ID NO: 2), K L WGQYWQV (SEQ ID NO: 3), and K I WGQYWQV (SEQ ID NO: 4), with improved HLA-A*0201-affinity that were recognized by anti-gp100 CTL at tenfold lower concentrations compared to the wild type epitope were obtained. In vivo immunization experiments using HLA-A*0201/K b transgenic mice demonstrated that these epitope-analogues were immunogenic, resulting in the induction of murine CTL reactive with both the epitope-analogues and the native epitope. The immunogenicity of the epitope-analogues was expected since the peptide-MHC complex stability of both the epitope-analogues and the native epitope was comparably high. [0019] In vitro CTL induction experiments using donor derived PBL demonstrated that epitope-analogue specific CTL could be obtained displaying cross-reactivity with tumor cells endogenously presenting the wild type epitope. In addition to T lymphocytes reactive with the wild type epitope, the T cell repertoire of healthy donors apparently also contains T cells reactive with the gp100 154-162 epitope-analogues. Analysis of TCR usage of cloned CTL reactive with the different gp100 154-162 epitope-analogues and with, wild type gp100 154-162 will be informative of the spectrum of the T cell repertoire that can be used to induce CTL reactivity towards the wild type epitope. With respect to immunotherapy of cancer, activation of multiple specificities in the T cell repertoire against an antigenic tumor epitope using epitope-analogues may increase the possibility of a patient to mount a successful anti-tumor response upon immunization. In addition, modified epitopes might still elicit immune responses if tolerance against the wild-type epitope is observed. [0020] Employment of “improved” epitopes in immunotherapy protocols increases the amount of peptide-MHC complexes at the cell surface of antigen presenting cells in vivo, and will result in enhanced priming of antigen-specific CTL. Apart from their potential in cancer immunotherapy, usage of epitope-analogues with improved immunogenicity may contribute to the development of CTL-epitope based vaccines in chronic viral disease. [0021] Therefore, the present invention includes peptides, immunogenic with lymphocytes directed against metastatic melanomas, characterized in that it comprises at least part of the amino-acid sequence of SEQ ID NO: 9 wherein the amino-acid at position 2 or 8 is substituted. [0022] A preferred embodiment of the present invention are peptides, wherein at position 2 Threonine is substituted by Isoleucine, Leucine or Valine. [0023] Another preferred embodiment of the present invention are peptides, wherein at position 8 Glutamine is substituted by Alanine. [0024] A specific preferred embodiment of the present invention are peptides, characterized in that it comprises the amino-acid sequence of any of SEQ ID NOS: 1-4 or 32-34. [0025] The term “peptide” refers to a molecular chain of amino acids, does not refer to a specific length of the product and if required can be modified in vivo or in vitro, for example by manosylation, glycosylation, amidation, carboxylation or phosphorylation: thus inter alia polypeptides, oligopeptides and proteins are included within the definition of peptide. In addition, peptides can be part of a (chimeric) protein or can be (part of) an RNA or DNA sequence encoding the peptide or protein. [0026] Of course, functional derivatives as well as fragments of the peptide according to the invention are also included in the present invention. Functional derivatives are meant to include peptides which differ in one or more amino acids in the overall sequence, which have deletions, substitutions, inversions or additions. Amino acid substitutions which can be expected not to essentially alter biological and immunological activities have been described. Amino acid replacements between related amino acids or replacements which have occurred frequently in evolution are, inter alia Ser/Ala, Ser/Gly, Asp/Gly, Asp/Asn, Ile/Val (see Dayhof, M.D., Atlas of protein sequence and structure, Nat. Biomed. Res. Found., Washington D.C., 1978, vol. 5, suppl. 3). Based on this information, Lipman and Pearson developed a method for rapid and sensitive protein comparison (Science 227, 1435-1441, 1985) and determining the functional similarity between homologous polypeptides. [0027] Furthermore, as functional derivatives of these peptides are also meant to include other peptide-analogues derived from gp100 (or Melan) that are able to induce target cell lysis by tumor infiltrating lymphocytes. [0028] In addition, with functional derivatives of these peptides are also meant addition salts of the peptides, amides of the peptides and specifically the C-terminal amides, esters and specifically the C-terminal esters and N-acyl derivatives specifically N-terminal acyl derivatives and N-acetyl derivatives. [0029] The peptides according to the invention can be produced synthetically, by recombinant DNA technology or by viruses, if the amino acid sequence of the peptide is encoded by a DNA sequence which is part of the virus DNA. Methods for producing synthetic peptides are well known in the art. [0030] The organic chemical methods for peptide synthesis are considered to include the coupling of the required amino acids by means of a condensation reaction, either in homogenous phase or with the aid of a so-called solid phase. The condensation reaction can be carried out as follows: [0031] condensation of a compound (amino acid, peptide) with a free carboxyl group and protected other reactive groups with a compound (amino acid, peptide) with a free amino group and protected other reactive groups, in the presence of a condensation agent; [0032] condensation of a compound (amino acid, peptide) with an activated carboxyl group and free or protected other reaction groups with a compound (amino acid, peptide) with a free amino group and free or protected other reactive groups. [0033] Activation of the carboxyl group can take place, inter alia, by converting the carboxyl group to an acid halide, azide, anhydride, imidazolide or an activated ester, such as the N-hydroxy-succinimide, N-hydroxy-benzotriazole or p-nitrophenyl ester. [0034] The most common methods for the above condensation reactions are: the carbodiimide method, the azide method, the mixed anhydride method and the method using activated esters, such as described in The Peptides, Analysis, Synthesis, Biology Vol. 1-3 (Ed. Gross, E. and Meienhofer, J.) 1979, 1980, 1981 (Academic Press, Inc.). [0035] Production of peptides by recombinant DNA techniques is a general method which is known, but which has a lot of possibilities all leading to somewhat different results. The polypeptide to be expressed is coded for by a DNA sequence or more accurately by a nucleic acid sequence. [0036] Also part of the invention is the nucleic acid sequence comprising the sequence encoding the peptides according to the present invention. [0037] Preferably, the sequence encoding the peptides according to the present invention are the sequences shown in SEQ ID NOS: 1-4 and 32-34. [0038] As is well known in the art, the degeneracy of the genetic code permits substitution of bases in a codon to result in another codon still coding for the same amino acid, e.g., the codon for the amino acid glutamic acid is both GAT and GAA. Consequently, it is clear that for the expression of a polypeptide with an amino acid sequence as shown in SEQ ID NO: 1-4, 9 or 32-34 use can be made of a derivate nucleic acid sequence with such an alternative codon composition thereby different nucleic acid sequences can be found. [0039] “Nucleotide sequence” as used herein refers to a polymeric form of nucleotides of any length, both to ribonucleic acid (RNA) sequences and to deoxyribonucleic acid (DNA) sequences. In principle, this term refers to the primary structure of the molecule. Thus, this term includes double and single stranded DNA, as well as double and single stranded RNA, and modifications thereof. [0040] A further part of the invention are peptides, which are immunogenic fragments of the peptide-analogues. [0041] Immunogenic fragments are fragments which still have the ability to induce an immunogenic response, i.e., that it is either possible to evoke antibodies recognizing the fragments specifically, or that it is possible to find T lymphocytes which have been activated by the fragments. Another possibility is a DNA vaccine. [0042] As has been said above, it has been known that the immunogenic action of tumor associated antigens is often elicited through a T cell activating mechanism (Townsend et al., 1989 , H., Ann. Rev. Immunol. 1601-624). Cytotoxic T lymphocytes (CTLs) recognizing melanoma cells in a T-cell receptor (TCR)-dependent and MHC-restricted manner have been isolated from tumor-bearing patients (Knuth et al., 1992, Cancer surveys, 39-52). It has been shown that a peptide derived from tyrosinase, another melanocyte-specific antigen, is recognized by a CTL clone (Brichard et al., 1993, J. Exp. Med., 178, 489-495). [0043] It is known that the activation of T cells through the MHC molecule necessitates processing of the antigen of which short pieces (for example 8-12 mers) are presented to the T lymphocyte. [0044] Preferably, the peptides according to the present invention are flanked by non-related sequences, i.e., sequences with which they are not connected in nature, because it has been found that such flanking enhances the immunogenic properties of these peptides, probably through a better processing and presentation by APCs. [0045] Another part of the invention is formed by nucleotide sequences comprising the nucleotide sequences coding for the above mentioned peptides or an array of peptides. [0046] Next to the use of these sequences for the production of the peptides with recombinant DNA techniques, which will be exemplified further, the sequence information disclosed in the sequence listings for the peptides according to the present invention can be used for diagnostic purposes. [0047] From these sequences primers can be derived as basis for a diagnostic test to detect gp100 or gp100-like proteins by a nucleic acid amplification technique for instance the polymerase chain reaction (PCR) or the nucleic acid sequence based amplification (NASBA) as described in U.S. Pat. No. 4,683,202 and EP 329,822, respectively. [0048] These nucleotide sequences can be used for the production of the peptides according to the present invention with recombinant DNA techniques. For this, the nucleotide sequence must be comprised in a cloning vehicle which can be used to transform or transfect a suitable host cell. [0049] A wide variety of host cell and cloning vehicle combinations may be usefully employed in cloning the nucleic acid sequence. For example, useful cloning vehicles may include chromosomal, non-chromosomal and synthetic DNA sequences such as various known bacterial plasmids, and wider host range plasmids such as pBR 322, the various pUC, pGEM and pBluescript plasmids, bacteriophages, e.g. lambda-gt-Wes, Charon 28 and the M13 derived phages and vectors derived from combinations of plasmids and phage or virus DNA, such as SV40, adenovirus or polyoma virus DNA (Rodriquez et al., 1988, ed. Vectors, Butterworths; Lenstra et al., 1990, Arch. Vivol., 110, 1-24). [0050] Useful hosts may include bacterial hosts, yeasts and other fungi, plant or animal hosts, such as Chinese Hamster Ovary (CHO) cells, melanoma cells, dendritic cells, monkey cells and other hosts. [0051] Vehicles for use in expression of the peptides may further comprise control sequences operably linked to the nucleic acid sequence coding for the peptide. Such control sequences generally comprise a promoter sequence and sequences which regulate and/or enhance expression levels. Furthermore, an origin of replication and/or a dominant selection marker are often present in such vehicles. Of course, control and other sequences can vary depending on the host cell selected. [0052] Techniques for transforming or transfecting host cells are quite known in the art (for instance, Maniatis et al., 1982/1989 , Molecular cloning: A laboratory Manual , Cold Spring Harbor Lab.). [0053] It is extremely practical if, next to the information for the peptide, also the host cell is co-transformed or co-transfected with a vector which carries the information for an MHC molecule to which said peptide is known to bind. Preferably, the MHC molecule is HLA-A2.1, HLA-A1 or HLA-A3.1, or any other HLA allele which is known to be present in melanoma patients. HLA-A2.1 is especially preferred because it has been established (Anichini et al., 1993 , J. Exp. Med., 177, 989-998) that melanoma cells carry antigens recognized by HLA-A2.1 restricted cytotoxic T cell clones from melanoma patients. [0054] Host cells especially suited for the expression of the peptides according to the present invention are the murine EL4 and P8.15 cells. For expression of said peptides human BLM cells (Katano et al., 1984 , J. Cancer Res. Clin. Oncol. 108, 197) are especially suited because they already are able to express the MHC molecule HLA-A2.1. [0055] The peptides according to the present invention can be used in a vaccine for the treatment of melanoma. [0056] In addition to an immunogenically effective amount of the active peptide, the vaccine may contain a pharmaceutically acceptable carrier or diluent. [0057] The immunogenicity of the peptides of the invention, especially the oligopeptides, can be enhanced by cross-linking or by coupling to an immunogenic carrier molecule (i.e., a macromolecule having the property of independently eliciting an immunological response in a patient, to which the peptides of the invention can be covalently linked) or if part of a protein. [0058] Covalent coupling to the carrier molecule can be carried out using methods well known in the art, the exact choice of which will be dictated by the nature of the carrier molecule used. When the immunogenic carrier molecule is a protein, the peptides of the invention can be coupled, e.g., using water soluble carbodiimides such as dicyclohexylcarbodiimide, or glutaraldehyde. [0059] Coupling agents such as these can also be used to cross-link the peptides to themselves without the use of a separate carrier molecule. Such cross-linking into polypeptides or peptide aggregates can also increase immunogenicity. [0060] Examples of pharmaceutically acceptable carriers or diluents useful in the present invention include stabilizers such as SPGA, carbohydrates (e.g., mannose, sorbitol, mannitol, starch, sucrose, glucose, dextran), proteins such as albumin or casein, protein containing agents such as bovine serum or skimmed milk and buffers (e.g., phosphate buffer). [0061] Optionally, one or more compounds having adjuvant activity may be added to the vaccine. Suitable adjuvants are for example aluminium hydroxide, phosphate or oxide, oil-emulsions (e.g. of Bayol F® or Marcol 52®), saponins or vitamin-E solubilisate. [0062] Dendritic cells are professional APC that express mannose receptor used to take up antigen thus facilitating antigen processing. [0063] The vaccine according to the present invention can be given inter alia intravenously, intraperitoneally, intranasally, intradermally, subcutaneously or intramuscularly. [0064] The useful effective amount to be administered will vary depending on the age and weight of the patient and mode of administration of the vaccine. [0065] The vaccine can be employed to specifically obtain a T cell response, but it is also possible that a B cell response is elicited after vaccination. If so, the B cell response leads to the formation of antibodies against the peptide of the vaccine, which antibodies will be directed to the source of the antigen production, i.e., the tumor cells. This is an advantageous feature, because in this way the tumor cells are combated by responses of both the immunological systems. [0066] Both immunological systems will even be more effectively triggered when the vaccine comprises the peptides as presented in an MHC molecule by an antigen presenting cell (APC). Antigen presentation can be achieved by using monocytes, macrophages, interdigitating cells, Langerhans cells and especially dendritic cells, loaded with one of the peptides of the invention or loading with protein including peptide or manosylated protein. Loading of the APCs can be accomplished by bringing the peptides of the invention into or in the neighborhood of the APC, but it is more preferable to let the APC process the complete gp100 antigen. In this way a presentation is achieved which mimics the in vivo situation most realistically. Furthermore, the MHC used by the cell is of the type which is suited to present the epitope. [0067] An overall advantage of using APCs for the presentation of the epitopes is the choice of APC cell that is used in this respect. It is known from different types of APCs that there are stimulating APCs and inhibiting APCs. [0068] Preferred APCs include, but are not limited to, the listed cell types, which are so-called “professional” antigen presenting cells, characterized in that they have co-stimulating molecules, which have an important function in the process of antigen presentation. Such co-stimulating molecules are, for example, B7, CD25, CD40, CD70, CTLA-4 or heat stable antigen (Schwartz, 1992 , Cell 71, 1065-1068). [0069] Fibroblasts, which have also been shown to be able to act as an antigen presenting cell, lack these co-stimulating molecules. [0070] It is also possible to use cells already transfected with a cloning vehicle harboring the information for the melanocyte peptide analogues and which are cotransfected with a cloning vehicle which comprises the nucleotide sequence for an MHC class I molecule, for instance the sequence coding for HLA A2.1, HLA A1 or HLA A3.1. These cells will act as an antigen presenting cell and will present peptide analogues in the MHC class I molecules which are expressed on their surface. It is envisaged that this presentation will be enhanced, when the cell is also capable of expressing one of the above-mentioned co-stimulating molecules (in particular B7 (B7.1, B7.2), CD40), or a molecule with a similar function (e.g., cytokines transfected in cell line). This expression can be the result of transformation or transfection of the cell with a third cloning vehicle having the sequence information coding for such a co-stimulating molecule, but it can also be that the cell already was capable of production of co-stimulating molecules. [0071] Instead of a vaccine with these cells, which next to the desired expression products, also harbor many elements which are also expressed and which can negatively affect the desired immunogenic reaction of the cell, it is also possible that a vaccine is composed with liposomes which expose MHC molecules loaded with peptides, and which, for instance, are filled with lymphokines. Such liposomes will trigger an immunologic T cell reaction. [0072] By presenting the peptide in the same way as it is also presented in vivo, an enhanced T cell response will be evoked. Furthermore, by the natural adjuvant working of the relatively large, antigen presenting cells also a B cell response is triggered. This B cell response will also lead to the formation of antibodies directed to the peptide-MHC complex. This complex is especially found in tumor cells, where it has been shown that in the patient epitopes of gp100 are presented naturally, which are thus able to elicit a T cell response. It is this naturally occurring phenomenon which is enlarged by the vaccination of APCs already presenting the peptides of the invention. By enlarging not only an enlarged T cell response will be evoked, but also a B cell response which leads to antibodies directed to the MHC-peptide complex will be initiated. [0073] The vaccines according to the invention can be enriched by numerous compounds which have an enhancing effect on the initiation and the maintenance of both the T cell and the B cell response after vaccination. [0074] In this way, addition of cytokines to the vaccine will enhance the T cell response. Suitable cytokines are for instance interleukins, such as IL-2, IL-4, IL-7, or IL-12, GM-CSF, RANTES, MIP-α, and tumor necrosis factor, and interferons, such as IFN- or the chemokins. [0075] In a similar way, antibodies against T cell surface antigens, such as CD2, CD3, CD27 and CD28 will enhance the immunogenic reaction. [0076] Also, the addition of helper epitopes to stimulate CD4 + helper cells or CD8 + killer cells augments the immunogenic reaction. Alternatively, also helper epitopes from other antigens can be used, for instance from heat shock derived proteins or cholera toxin. [0077] Another part of the invention is formed by using reactive tumor infiltrating lymphocytes (TILs) directed against the peptides according to the present invention. In this method, the first step is taking a sample from a patient. This is usually done by resection of a tumor deposit under local anesthesia. The TILs present in this specimen are then expanded in culture for four to eight weeks, according to known methods (Topalian et al., 1987 , J. Immunol. Meth. 102, 127-141). During this culture, the TILs are then checked for reactivity with the peptides according to the present invention or gp100-protein. The TILs which recognize the antigen are isolated and cultured further. [0078] The reactive tumor infiltrating lymphocytes which are obtained through this method, also form part of the invention. An example of such TIL cell line, designated TIL 1200, has been found which specifically reacts with gp100 and its epitopes. This TIL 1200 cell line also expresses the MHC molecule HLA-A2.1. Furthermore, expression of TCR α/β, CD3 and CD8 by this cell line has been demonstrated. Furthermore, TIL 1200 recognizes transfectants expressing both HLA-A2.1 and gp100. [0079] TIL 1200 and other TILs recognizing gp100 are suited for treatment of melanoma patients. For such treatment, TILs may be cultured as stated above, and they are given back to the patients by an intravenous infusion. The success of treatment can be enhanced by pre-treatment of the tumor bearing host with either total body radiation or treatment with cyclophosphamide and by the simultaneous administration of interleukin-2 (Rosenberg et al., 1986 , Science 223, 1318-1321). [0080] The TILs infused back to the patient are preferably autologous TILs (i.e., derived from the patient's own tumor) but also infusion with allogenic TILs can be imagined. [0081] A further use of the TILs obtained by the method as described above is for in vivo diagnosis. Labeling of the TILs, for instance with 111 In (Fisher et al., 1989 , J. Clin. Oncol. 7, 250-261) or any other suitable diagnostic marker, renders them suited for identification of tumor deposits in melanoma patients. [0082] Another part of the invention is formed by the T cell receptor (TCR) expressed by reactive CTLs directed against the peptides according to this invention or the gp100-protein. As is well known in the art, the TCR determines the specificity of a CTL. Therefore, the cDNA encoding the TCR, especially its variable region, can be isolated and introduced into T cells, thereby transferring anti-tumor activity to any T cell. Especially introduction of such a TCR into autologous T cells and subsequent expansion of these T cells will result in large numbers of CTL suitable for adoptive transfer into the autologous patient. [0083] Cells harboring this T cell receptor can also be used for vaccination purposes. [0084] A vaccine can also be composed from melanoma cells capable of expression of the peptides according to the present invention. It is possible to isolate these cells from a patient, using specific antibodies, such as NKI-beteb (directed against gp100), but is also possible to produce such melanoma cells from cultured melanoma cell lines, which either are natural gp100-producers or have been manipulated genetically to produce the peptides according to the present invention. These cells can be irradiated to be non-tumorogenic and infused (back) into the patient. To enhance the immunologic effect of these melanoma cells it is preferred to alter them genetically to produce a lymphokine, preferably interleukin-2 (IL-2) or granulocyte-macrophage colony stimulation factor (GM-CSF). Peptide + /gp100 + melanoma cells can be transfected with a cloning vehicle having the sequence coding for the production of IL-2 or GM-CSF. [0085] Infusion of such a vaccine into a patient will stimulate the formation of CTLs. [0086] Another type of vaccination having a similar effect is vaccination with pure DNA, for instance the DNA of a vector or a vector virus having the DNA sequence encoding the peptides according the present invention (both homologues and heterologues (chimeric protein) or repetitive). Once injected, the virus will infect or the DNA will be transformed to cells which express the antigen or the peptide(s). [0087] Antibodies directed against the peptides according to the present invention are also part of the invention. [0088] Monospecific antibodies to these peptides can be obtained by affinity purification from polyspecific antisera by a modification of the method of Hall et al. (1984 , Nature 311, 379-387). Polyspecific antisera can be obtained by immunizing rabbits according to standard immunization schemes. [0089] Monospecific antibody as used herein is defined as a single antibody species or multiple antibody species with homogeneous binding characteristics for the relevant antigen. Homogeneous binding as used herein refers to the ability of the antibody species to bind to ligand binding domain of the invention. [0090] The antibody is preferably a monoclonal antibody, more preferably a humanized monoclonal antibody. [0091] Monoclonal antibodies can be prepared by immunizing inbred mice, preferably Balb/c with the appropriate protein by techniques known in the art (Köhler, G. and Milstein C., 1975 , Nature 256, 495-497). Hybridoma cells are subsequently selected by growth in hypoxanthine, thymidine and aminopterin in an appropriate cell culture medium such as Dulbecco's modified Eagle's medium (DMEM). Antibody producing hybridomas are cloned, preferably using the soft agar technique of MacPherson (1973, Tissue Culture Methods and Applications , Kruse and Paterson, eds., Academic Press). Discrete colonies are transferred into individual wells of culture plates for cultivation in an appropriate culture medium. Antibody producing cells are identified by screening with the appropriate immunogen. Immunogen positive hybridoma cells are maintained by techniques known in the art. Specific anti-monoclonal antibodies are produced by cultivating the hybridomas in vitro or preparing ascites fluid in mice following hybridoma injection by procedures known in the art. [0092] It may be preferred to use humanized antibodies. Methods for humanizing antibodies, such as CDR-grafting, are known (Jones et al., 1986, Nature 321, 522-525). Another possibility to avoid antigenic response to antibodies reactive with polypeptides according to the invention is the use of human antibodies or fragments or derivatives thereof. [0093] Human antibodies can be produced by in vitro stimulation of isolated B-lymphocytes, or they can be isolated from (immortalized) B-lymphocytes which have been harvested from a human being immunized with at least one ligand binding domain according to the invention. [0094] Antibodies as described above can be used for the passive vaccination of melanoma patients. A preferred type of antibodies for this kind of vaccine are antibodies directed against the above-mentioned peptides presented in connection with the MHC molecule. To produce these kind of antibodies immunization of peptides presented by APCs is required. Such an immunization can be performed as described above. Alternatively, human antibodies to peptide-MHC complexes can be isolated from patients treated with a vaccine consisting of APCs loaded with one of said peptides. [0095] The antibodies, which are formed after treatment with one of the vaccines of the invention can also be used for the monitoring of said vaccination. For such a method, serum of the patients is obtained and the antibodies directed to the peptide with which has been vaccinated are detected. Knowing the antibody titre from this detection, it can be judged if there is need for a boost vaccination. [0096] Specific detection of said antibodies in the serum can be achieved by labeled peptides. The label can be any diagnostic marker known in the field of in vitro diagnosis, but most preferred (and widely used) are enzymes, dyes, metals and radionuclides, such as 67 Ga, 99m Tc, 111 In, 113m In, 123 I, 125 I, or 131 I. [0097] The radiodiagnostic markers can be coupled directly to the peptides of the invention or through chelating moieties which have been coupled to the peptide directly or through linker or spacer molecules. The technique of coupling of radionuclides to peptides or peptide-like structures is already known in the field of (tumor) diagnostics from the numerous applications of labeled antibodies used both in in vivo and in in vitro tests. [0098] Direct labeling of peptides can, for instance, be performed as described in the one-vial method (Haisma et al., 1986, J. Nucl. Med. 27, 1890). A general method for labeling of peptides through chelators, with or without linker or spacer molecules, has, for instance, been described in U.S. Pat. Nos. 4,472,509 and 4,485,086. Chelators using a bicyclic anhydride of DTPA have been disclosed in Hnatowich et al. (1983 , J. Immunol. Meth. 65, 147-157). Coupling through diamide dimercaptide compounds has been disclosed in EP 188,256. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0099] The present invention is further described by way of examples with reference to the accompanying figures, in which: [0100] FIG. 1 . Target cell sensitization of alanine replacement epitopes. (A) Chromium labeled T2 target cells were preincubated for 1 hour with various amounts of the indicated alanine-substituted epitope-analogues. Melan-A/MART-1 27-35-reactive TIL 1235 lymphocytes were added at an effector to target ratio of 20. (B) Target cell sensitization of alanine-substituted gp100 154-162-analogues was analyzed using gp100-reactive TIL 1200 lymphocytes at an effector to target ratio of 20. [0101] FIG. 2 . Target cell sensitization of N-terminal anchor-replacement epitopes. Chromium release experiments were performed as in FIG. 1 . (A) Melan-A/MART-1 27-35-reactive TIL 1235 lymphocytes were used to assay target cell sensitization by the Melan-A/MART-1 27-35 analogues. (B) Gp100 154-162-reactive TIL 1200 lymphocytes were used to assay target cell sensitization by the gp100 154-162-analogues. [0102] FIG. 3 . Immunogenicity of gp100 154-162 epitope-analogues in HLA-A*0201/K b transgenic mice. Bulk CTL obtained from immunized mice were tested for lytic activity using chromium labeled Jurkat A2/K b target cells that were preincubated with no peptide, 10 mM wild type gp100 154-162 or 10 mM of the epitope-analogue used to immunize the mice. For each peptide the mean specific lysis of bulk CTL of the responding mice is shown. Standard deviations never exceeded 15% of the mean value. One representative experiment out of two is shown. [0103] FIG. 4 . Peptide specific reactivity of in vitro induced epitope-analogue specific CTL cultures. Chromium-labeled HLA-A*0201 + T2 target cells were pre-incubated with 10 mM of an irrelevant HLA-A*0201-binding peptide, 10 mM wild type gp100 154-162 or 10 mM of the epitope-analogue used for CTL induction. The different CTL cultures were added at an effector to target ratio of 20:1. One representative experiment out of two is shown. [0104] FIG. 5 . Epitope-analogue induced CTL cultures specifically lyse melanoma cells endogenously presenting the wild type epitope. Chromium-labeled HLA-A2.1 + BLM and Mel 624 melanoma cells were used as target cells. BLM cells lack expression of gp100. The different CTL cultures were added at an effector to target ratio of 20:1. One representative experiment out of two is shown. DETAILED DESCRIPTION OF THE INVENTION Materials and Methods Cell Culture. [0105] The HLA-A*0201 + melanoma line BLM was cultured as described previously (Bakker et al, 1994, J. Exp. Med. 179:1005). TIL 1200 and TIL 1235 lymphocytes were cultured as was reported previously (Kawakami et al., 1992 , J. Immunol. 148:638). T2 cells (Salter et al., 1985 , Immunogenetics. 21:235) and HLA-A*0201 + B lymphoblastoid JY cells were maintained in Iscoves medium (Gibco, Paisley, Scotland UK) supplemented with 5% FCS (BioWhittaker, Verviers, Belgium). Jurkat A*0201/K b cells (Irwin et al., 1989, J. Exp. Med. 170:1091) expressing the HLA-A*0201/K b chimeric molecule were cultured in Iscoves medium with 5% FCS supplemented with 0.8 mg/ml G418 (Gibco, Paisley, Scotland UK). HLA-A*0201 + Lymphocytes. [0106] Healthy caucasian volunteers were phenotyped HLA-A2 by flow cytometry using mAbs BB7.2 (Parham et al., 1981, Hum. Immunol. 3:277) and MA2.1 (Parham et al., 1978 , Nature 276:397). The donors underwent leukapheresis and PBMC were isolated by Ficoll/Hypaque density gradient centrifugation. The cells were cryopreserved in aliquots of 4×10 7 PBMC. Transgenic Mice [0107] HLA-A*0201/K b transgenic mice were used (animal distributor Harlan Sprague Dawley, Inc., Indianapolis, USA). Mice were held under clean conventional conditions. The transgenic mice express the product of the HLA-A*0201/K b chimeric gene in which the α3 domain of the heavy chain is replaced by the corresponding murine H-2 K b domain while leaving the HLA-A*0201 at and a2 domains unaffected (Vitiello et al., 1991, J. Exp. Med. 1007). This allows the murine CD8 molecule on the murine CD8 + T lymphocytes to interact with the syngeneic α3 domain of the hybrid MHC class I molecule. Peptides. [0108] For induction of CTL and chromium-release assays, peptides were synthesized with a free carboxy-terminus by Fmoc peptide chemistry using an ABIMED multiple synthesizer. All peptides were >90% pure as indicated by analytical HPLC. Peptides were dissolved in DMSO and stored at −20° C. HLA-A*0201 Upregulation on T2 Cells. [0109] Peptide-induced HLA-A*0201 upregulation on T2 cells was performed as described previously (Nijman et al., 1993, Eur. J. Immunol. 23:1215). Briefly, peptides were diluted from DMSO stocks to various concentrations (final DMSO concentration 0.5%) and were incubated together with 10 5 T2 cells for 14 hours at 37° C., 5% C0 2 in serum-free Iscoves medium in a volume of 100 ml in the presence of 3 mg/ml human β2-microglobulin (Sigma, St Louis, Mo.). Stabilization of HLA-A*0201 molecules at the cell surface of T2 cells was analyzed by flow cytometry using anti-HLA-A2 mAb BB7.2 (Parham et al., 1981, Hum. Immunol. 3:277). The Fluorescence Index is expressed as: (experimental mean fluorescence÷ background mean fluorescence)−1. The background mean fluorescence values were obtained by incubating T2 cells with a HLA-A*0201 non-binding peptide at similar concentrations. Competition Based HLA-A*0201 Peptide-Binding Assay. [0110] Peptide-binding to HLA-A*0201 was analyzed using HLA-A*0201 + JY cells as was described previously (van der Burg et al., 1995, Hum. Immunol. 44:189). Briefly, mild-acid treated JY cells were incubated with 150 nM Fluorescein (FL)-labeled reference peptide (FLPSDC(-FL)FPSV) and with several concentrations of competitor peptide for 24 hours at 4° in the presence of 1.0 mg/ml β2-microglobulin (Sigma, St. Louis, Mo.). Subsequently, the cells were washed, fixed with paraformaldehyde and analyzed by flow cytometry. The mean-fluorescence (MF) obtained in the absence of competitor peptide was regarded as maximal binding and equated to 0%; the MF obtained without reference peptide was equated to 100% inhibition. % inhibition of binding was calculated using the formula: (1-(MF 150 nM reference & competitor peptide−MF no reference peptide)÷(MF 150 nM reference peptide-MF no reference peptide))×100%. The binding capacity of competitor peptides is expressed as the concentration needed to inhibit 50% of binding of the FL-labeled reference peptide (IC 50 . Measurement of MHC-Peptide Complex Stability at 37° C. [0111] Measurement of MHC-peptide complex stability was performed. HLA-A*0201 + homozygous JY cells were treated with 10 4 M emetine (Sigma, St. Louis, USA) for 1 hour at 37° C. to stop de novo synthesis of MHC class I molecules. The cells were then mild-acid treated and subsequently loaded with 200 mM of peptide for 1 hour at room temperature. Thereafter, the cells were washed twice to remove free peptide and were incubated at 37° C. for 0, 2, 4 and 6 hours. Subsequently, the cells were stained using mAb BB7.2 (Parham et al., 1981 , Hum. Immunol. 3:277), fixed with paraformaldehyde and analyzed by flow cytometry. [0000] CTL Induction in HLA-A*0201/K b Transgenic Mice. Groups of 3 HLA-A*0201/K b transgenic mice were injected subcutaneously in the base of the tail vein with 100 mg peptide emulsified in WA in the presence of 140 mg of the H-2 I-A b -restricted HBV core antigen-derived T helper epitope (128-140; sequence TPPAYRPPNAPIL) (Milich et al., 1988, Proc. Natl. Acad. Sci. U.S.A. 85:1610). After 11 days, mice were sacrificed and spleen cells (30×10 6 cells in 10 ml) were restimulated in vitro with peptide-loaded syngeneic irradiated LPS-stimulated B cell lymphoblasts (ratio 4:1). At day 6 of culture, the bulk responder populations were tested for specific lytic activity. HLA-A*0201 + Donor Derived CTL Induction In Vitro [0112] Using thawed PBMC, dendritic cells were generated according the procedure of Romani et al. (Romani et al., 1994, J. Exp. Med. 180:83) as was described previously (Bakker et al., 1995 , Cancer Res. 55:5330). Before the onset of culture, dendritic cells were loaded with 50 mM of peptide. Autologous CM + enriched responder T lymphocytes were prepared by adhering thawed PBMC for 2 hours and by subsequent partial depletion of the non-adherent fraction of CD4 + T cells using the anti-CD4 mAb RIV-7 (Leerling et al., 1990 , Dev. Biol. Stand. 71:191) and Sheep-anti-Mouse-IgG coated magnetic beads (Dynal, Oslo, Sweden). At the onset of stimulation, 2×10 5 peptide-loaded DC and 2×10 6 responder cells were co-cultured per well of a 24-well tissue culture plate (Costar, Badhoevedorp, The Netherlands) in 2 ml of Iscoves medium containing 5% pooled human AB + serum, 10 3 U/ml IL-6 (Sandoz, Basel, Switzerland) and 5 ng/ml IL-12. [0113] On day 8 and day 15, the responder populations were restimulated using peptide-pulsed dendritic cells as stimulator cells. The cultures were propagated in medium containing IL-2 (Cetus Corp., Emeryville, Calif.) and IL-7 (Genzyme, Cambridge, Mass.) at final concentrations of 10 U/ml and 5 ng/ml respectively. Weekly hereafter the cultures were restimulated using adherent peptide-pulsed PBMC as was described previously (Bakker et al., 1995 , Cancer Res. 55:5330). Responder populations were tested for specific lytic activity after at least 4 rounds of restimulation. Chromium-Release Assay. [0114] Chromium release assays were performed as described previously (Bakker et al., 1994, J. Exp. Med. 179:1005). Briefly, 10 6 target cells were incubated with 100 mCi Na 2 51 CrO 4 (Amersham, Bucks, UK) for 1 hour. Various amounts of effector cells were then added to the target cells in triplicate wells of U bottomed microliter plates (Costar, Badhoevedorp, The Netherlands) in a final volume of 150 ml. In peptide recognition assays, target cells were pre-incubated with various concentrations of peptide for 30 or 60 min at 37° C. in a volume of 100 ml prior to the addition of effector cells. After 5 h of incubation, part of the supernatant was harvested and its radioactive content was measured. The mean percentage specific lysis of triplicate wells was calculated using the formula: % specific lysis=((experimental release−spontaneous release)÷(maximal release−spontaneous release))×100. Example 1 Identification of Amino Acid Residues Engaged in HLA-A*0201 Binding and/or TCR Interactions for the Melan-A/MART-1 27-35 and the gp100 154-162 Epitopes [0115] The Melan-A/MART-1 27-35 and the gp100 154-162 epitopes have been identified using HLA-A*0201 restricted TIL lines derived from metastatic melanomas. The Melan-A/MART-1 27-35 epitope was found to be the nominal epitope capable of triggering the Melan-A/MART-1 specific TIL 1235 line when presented on HLA-A*0201 + target cells (Kawakami et al., 1994 . J. Exp. Med. 180:347). Among a panel of peptides ranging from 8-mers to 11-mers located around gp100 amino acids 155-161, we identified the 9-mer 154-162 as the peptide most efficient in sensitizing HLA-A*0201 + target cells for lysis by the gp100 reactive TIL 1200 line (Bakker et al., 1995 , Int. J. Cancer 62:97). Both the Melan-A/MART-1 27-35 9-mer and the gp100 154-162 9-mer have now been eluted from the cell surface of HLA-A*0201 + melanoma cells, and were identified by tandem mass-spectroscopy, indicating that they are indeed the nominal epitopes endogenously presented in HLA-A*0201. To identify amino acid residues in both epitopes engaged in HLA-A*0201 binding and/or TCR interactions, epitope-analogues were synthesized in which the native amino acid was replaced by an alanine residue. In case alanine residues were present in the wild type epitope, they were substituted for the amino acid glycine. The substituted peptides were assayed for binding to HLA-A*0201 by means of an indirect binding assay using the processing defective cell line T2 (Nijman et al., 1993 , Eur. J. Immunol. 23:1215). All substitutions in the Melan-A/MART-1 epitope resulted in a nearly complete loss in the capability to stabilize HLA-A*0201 molecules at the cell surface of T2 cells (Table I). When the Melan-A/MART-1 27-35 analogues were used at micromolar concentrations to sensitize HLA-A*0201 + target cells for lysis by Melan-A/MART-1-specific CTL, we observed a decrease in target cell lysis for the alanine replacements at positions 4 to 7 of the epitope (Table I). In addition, the glycine substitution at position 2 resulted in decreased CTL reactivity. The amino acids at these positions in the Melan-A/MART-1 27-35 epitope are therefore most likely involved in TCR interactions. [0116] In case of the gp100 154-162 epitope decreased HLA-A*0201 affinity of epitope-analogues was only observed for the alanine substitutions at position 3 and 9 (Table 1). With respect to T cell recognition, alanine substitutions at positions 5, 6 and 7 of the epitope were not allowed, indicating that amino acids at these positions are critical contact residues within this epitope for the TCR. [0117] Subsequently, the epitope-analogues that induced reactivity at micromolar concentrations were titrated to evaluate their relative ability to sensitize T2 target cells for lysis by the relevant CTL ( FIG. 1 ). In all cases the epitope-analogues were similar or inferior compared to the wild type epitope in their sensitizing capacity, except for the alanine substitution at position 8 of the gp100 154-162 epitope. Surprisingly, this peptide was able to induce target cell lysis by gp100-reactive CTL even at a tenfold lower concentration. Example 2 N-Terminal Anchor Residue Replacements in Both the gp100 154-162 and the Melan-A/MART-1 27-35 Epitopes Result in Improved Affinity for HLA-A*0201 [0118] Since both the Melan-A/MART-1 27-35 and the gp100 154-162 epitopes have non-conventional N-terminal anchoring residues, we replaced these residues for the common HLA-A*0201 anchoring residues V, L, I or M (Drijthout et al., 1995 , Hum. Immunol. 43:1). Subsequently, we tested these peptides for HLA-A*0201 binding and their ability to sensitize target cells for lysis by the relevant CTL. Apart from the methionine substitution, all anchor residue replacements in the Melan-A/MART-1 epitope resulted in significantly improved binding to HLA-A*0201 (Table II). HLA-A*0201 + target cells loaded with these peptides at a concentration of 1 mM were recognized by the Melan-A/MART-1 reactive CTL, except for the methionine substituted epitope (Table II). Although this peptide did bind to HLA-A*0201 at a level comparable to the wild type epitope, it failed to induce CTL reactivity. Titration experiments using the Melan-A/MART-1 anchor replacement peptides demonstrated that these epitope-analogues were inferior to wild type in sensitizing target cells for lysis by TIL 1235 ( FIG. 2 ). [0119] Using the T2 assay all gp100 154-162 anchor replacement peptides except the methionine substituted epitope showed HLA-A*0201 binding comparable to the wild type epitope (Table II). Interestingly, these peptides were recognized by TIL 1200 when loaded on target cells at tenfold lower concentrations compared to the wild type peptide ( FIG. 2 ), while the methionine substituted peptide showed no difference. These findings demonstrate that amino acid substitutions within the native epitope can result in improved T cell recognition. Example 3 Improved Target Cell Sensitization by gp100 154-162 Epitope Analogues Correlates with Increased Affinity for HLA-A*0201 [0120] To assess whether the augmented CTL recognition of the substituted gp100 154-162 epitopes could be attributed to improved HLA-A*0201 affinity, the HLA-A*0201 binding capacity of these peptides was tested now using a more sensitive cell-bound HLA-A*0201 binding assay based on competition of a labeled reference peptide with the peptides of interest (van der Burg et al., 1995 , Hum. Immunol. 44:189). HLA-A*0201 binding-affinities obtained with this assay demonstrated that all peptides that were able to sensitize target cells for lysis by TIL 1200 at tenfold lower concentrations compared to wild type, also bound with higher affinity to HLA-A*0201 (Table III). In addition to the N-terminal anchor substitutions, replacement of a polar residue for a hydrophobic residue adjacent to the C-terminal anchoring position also resulted in an epitope-analogue with improved HLA-A*0201 affinity (KTWGQYW A V (SEQ ID NO: 1)), apparently without affecting TCR recognition. Measurement of MHC class I-peptide complex dissociation rates demonstrated that the epitope-analogues tested are at least equally stable when compared to wild type (Table III). All peptides tested showed a DT 50 (the time required for 50% of the complexes to decay) longer than 4 hours. Peptides with DT 50 values of ≧3 hours were immunogenic in HLA-A*0201/K b transgenic mice. Taken together, these data indicate that the gp100 154-162 epitope-analogues may have similar or increased immunogenicity compared to wild type gp100 154-162. Example 4 Immunogenicity of gp100 154-162 Epitope-Analogues in HLA-A*0201/K b Transgenic Mice [0121] In order to determine the in vivo immunogenicity of the gp100 154-162 epitope-analogues of which the MHC class I binding-affinity and dissociation rate was measured. HLA-A*0201/K b transgenic mice were vaccinated with the gp100 154-162 wild type epitope, with the epitope-analogues KTWGQYW A V (SEQ ID NO: 1), K V WGQYWQV (SEQ ID NO: 2), K L WGQYWQV (SEQ ID NO: 3) or K I WGQYWQV (SEQ ID NO: 4), or with a control peptide (HBV core 18-27: FLPSDDFPSV (SEQ ID NO: 6)). The generation of these transgenic mice (Vitiello et al., 1991 . J. Exp. Med. 173:1007) and their use to analyze in vivo immunogenicity have been described previously (Ressing et al., 1995 , J. Immunol. 154:5934; Sette et al., 1994 , J. Immunol. 153:5586). As shown in FIG. 3 , the gp100 154-162 epitope-analogues KTWGQYW A V (SEQ ID NO: 1), K V WGQYWQV (SEQ ID NO: 2), and K L WGQYWQV (SEQ ID NO: 3), very efficiently induced a CTL response. To a lesser extent also the epitope-analogue K I WGQYWQV (SEQ ID NO: 4) and the wild type gp100 154-162 were able to elicit a CTL response. Bulk CTL derived from mice vaccinated with the gp100 154-162 epitope-analogues specifically lysed Jurkat A*0201/K b cells loaded with both the peptide used for vaccination and the wild type epitope. Interestingly, CTL bulk cultures raised against the epitope-analogues all recognized target cells pulsed with the wild type epitope equally well or better compared to target cells pulsed with epitope-analogues used for vaccination. Thus, all gp100 154-162 epitope-analogues tested were immunogenic in HLA-A*0201/K b transgenic mice, and elicited CTL displaying cross-reactivity with the native gp100 154-162 epitope. Example 5 In Vitro Induction of gp100 154-162 Epitope-Analogue Specific Human CTL Displaying Cross-Reactivity with Endogenously HLA-A*9201 Presented Wild Type gp100 154-162 [0122] Next, we performed in vitro CTL induction assays to assess whether within the T cell repertoire of HLA-A*0201 + healthy donors precursor T lymphocytes were present capable of recognizing gp100 154-162 epitope-analogues. In order to achieve this, we initiated cultures of peptide-loaded dendritic cells together with autologous responder T lymphocytes as described previously (Bakker et al., 1995, Cancer Res. 55:5330). After several rounds of restimulation, responder T cells were tested for cytotoxic activity ( FIG. 4 ). All bulk CTL populations raised against the gp100 154-162 epitope-analogues, KTWGQYW A V (SEQ ID NO: 1), K V WGQYWQV (SEQ ID NO: 2), K L WGQYWQV (SEQ ID NO: 3) and K I WGQYWQV (SEQ ID NO: 4), efficiently lysed HLA-A*0201 + T2 target cells incubated with the peptides used for CTL induction. Only low background lysis was observed in the presence of an irrelevant peptide. In addition, these gp100 154-162 epitope-analogue reactive CTL efficiently lysed T2 target cells incubated with wild type gp100 154-162. To address the question whether these CTL responder populations could also recognize endogenously processed and presented wild type epitope, we performed chromium-release experiments using HLA-A*0201 + melanoma cell lines BLM and MeI 624 as targets. BLM cells have lost expression of the gp100 antigen, both at the protein and at the mRNA level (Adema et al., 1993 , Am. J. Pathol. 143:1579). As shown in FIG. 5 , all peptide-induced CTL cultures lysed the antigen expressing MeI 624 cells, whereas no or background lysis was observed against antigen negative BLM cells. TNF release by the anti-gp100 154-162 analogue CTL further demonstrated the reactivity of these CTL with endogenously presented wild type gp100 154-162 (data not shown). These data show that the four different CTL cultures induced using gp100 154-162 epitope-analogue loaded dendritic cells, all recognized the native gp100 154-162 epitope endogenously processed and presented by HLA-A*0201 + Mel 624 cells. [0000] TABLE I HLA-A*0201-binding and target cell sensitization of alanine-replacement epitopes. target cell target HLA-A*0201 lysis by HLA-A*0201 cell stabilization a TIL stabilization lysis by Melan A/MART-1 27-35 50 μM 25 μM 1235 b gp100 154-162 50 μM 25 μM TIL 1200 YLEPGPVTA c  (SEQ ID NO: 7) 2.26 2.12 −3 YLEPGPVTA (SEQ ID NO: 7) 3 AAGIGILTV (SEQ ID NO: 8) 1.20 1.11 40 KTWGQYWQV (SEQ ID NO: 6) 2.06 1.40 67 G AGIGILTV (SEQ ID NO: 10) 1.07 1.11 52 ATWGQYWQV (SEQ ID NO: 11) 1.94 1.42 75 A G GIGILTV (SEQ ID NO: 12) 0.96 1.05 6 KAWGQYWQV (SEQ ID NO: 13) 1.57 1.20 64 AA AI GILTV (SEQ ID NO: 14) 0.98 0.99 13 KTAGQYWQV (SEQ ID NO: 15) 1.17 1.02 58 AAG A GILTV (SEQ ID NO: 16) 0.93 0.97 0 KTWAQYWQV (SEQ ID NO: 17) 1.45 1.13 63 AAG IA ILTV (SEQ ID NO: 18) 1.01 1.01 4 KTWGAYWQV (SEQ ID NO: 19) 1.59 1.25 9 AAGIG A LTV (SEQ ID NO: 20) 0.93 1.00 2 KTWGQAWQV (SEQ ID NO: 21) 1.42 1.15 7 AAGIGI A TV (SEQ ID NO: 22) 1.10 1.13 6 KTWGQYAQV (SEQ ID NO: 23) 1.31 1.14 −2 AAGIGIL A V (SEQ ID NO: 24) 1.05 1.01 11 KTWGQYWAV (SEQ ID NO: 1) 1.72 1.35 73 AAGIGILT A  (SEQ ID NO: 25) 1.00 1.03 26 KTWGQYWQA (SEQ ID NO: 26) 1.08 1.02 76 a Binding of peptides to HLA-A2.1 was analyzed using the processing-defective T2 cell line at the indicated peptide concentrations. Numbers indicate Fluorescence Index: experimental mean fluorescence divided by the mean fluorescence that is obtained when T2 cells are incubated with an HLA-A2.1 non-binding peptide at a similar concentration. b Numbers indicate % specific lysis by the relevant TIL lines at an E:T ratio of 20:1. Chromium-labeled T2 target cells were preincubated for 90 min with 1 μM of peptide. Chromium release was measured after 5 hours of incubation. c gp100 280-288. [0000] TABLE II HLA-A*0201-binding and target cell sensitization of N-terminal anchor-replacement epitopes. HLA-A*0201 HLA-A*0201 stabilization a target cell stabilization target cell 50 25 lysis by  50 25 lysis by Melan A/MART-1 27-35 μM μM TIL 1235 b gp100 154-162 μM μM TIL 1200 YLEPGPVTA c  (SEQ ID NO: 7) 2.26 2.12 −1 YLEPGPVTA (SEQ ID NO: 7) 3 AAGIGILTV (SEQ ID NO: 8) 1.20 1.11 40 KTWGQYWQV (SEQ ID NO: 9) 2.06 1.40 67 AVGIGILTV (SEQ ID NO: 27) 1.62 1.36 27 KVWGQYWQV (SEQ ID NO: 2) 2.13 1.57 69 ALGIGILTV (SEQ ID NO: 28) 2.21 1.93 16 KLWGQYWQV (SEQ ID NO: 3) 2.19 1.55 65 AMGIGILTV (SEQ ID NO: 29) 1.18 1.05 6 KMWGQYWQV (SEQ ID NO: 35) 1.73 1.28 57 AIGIGLTV (SEQ ID NO: 30) 1.58 1.29 27 KIWGQYWQV (SEQ ID NO: 4) 2.00 1.43 68 a Binding of peptides to HLA-A2.1 was analyzed using the processing-defective T2 cell line at the indicated peptide concentrations. Numbers indicate Fluorescence Index: experimental mean fluorescence divided by the mean fluorescence that is obtained when T2 cells are incubated with an HLA-A2.1 non-binding peptide at a similar concentration. b Numbers indicate % specific lysis by the relevant TIL lines at an E:T ratio of 20:1. Chromium-labeled T2 target cells were preincubated for 90 min with 1 μM of peptide. Chromium release was measured after 5 hours of incubation. c gp100 280-288. [0000] TABLE III HLA-A*0201 binding and complex stability of gp100 154-162 epitope-analogues Affinity Stability peptide IC50 (μM) a (DT 50%) b FLPSDFFPSV C  (SEQ ID NO: 31) 0.5 >4 hr KTWGQYWQV (SEQ ID NO: 9) 1.4 >4 hr KTWGQYWAV (SEQ ID NO: 1) 0.5 >4 hr KVWGQYWQV (SEQ ID NO: 2) 0.8 >4 hr KTWGQYWQV (SEQ ID NO: 3) 0.4 >4 hr KIWGQYWQV (SEQ ID NO: 4) 0.6 >4 hr a Binding of peptides to HLA-A*0201 was analyzed in a competition away at 4° C. using mild acid treated HLA-A*0201 + B-LCL. The binding capacity of the peptides is shown as the concentration of peptide needed to inhibit 50% of binding of the Fluorescein labeled reference peptide. b The dissociation rate of HLA-A*0201-peptide complexes was measured using emetine pretreated HLA-A*0201 + B-LCL. After mild acid treatment, empty cell surface HLA-A*0201 molecules were loaded with peptide at room temperature and B-LCL were then put at 37° C. The decay of cell surface HLA-A*0201 molecules was analyzed by flow cytometry. The dissociation rate is depicted as the time required for 50% of the MHC class I-peptide complexes to decay at 37° C. c HBC 18-27, unlabeled reference peptide.

The present invention is concerned with cancer treatment and diagnosis, especially with melanoma associated peptide analogues with improved immunogenicity, epitopes thereof; vaccines against melanoma, tumor infiltrating T lymphocytes recognizing the antigen and diagnostics for the detection of melanoma and for the monitoring of vaccination. The peptides according to the invention can be exploited to elicit native epitope-reactive Cm. Usage of the peptides with improved immunogenicity may contribute to the development of CTL-epitope based vaccines in viral disease and cancer.

RELATED PATENT DATA This patent resulted from a divisional application of U.S. patent application Ser. No. 11/745,843, which claims priority under 35 U.S.C. §119 to U.S. Provisional Application No. 60/747,606, which was filed May 18, 2006; and to U.S. Provisional Application No. 60/842,194, which was filed Aug. 31, 2006, and claims priority to U.S. Provisional Application No. 60/895,621, which was filed Mar. 19, 2007. TECHNICAL FIELD The invention pertains to intravascular port access devices, intravascular port cleaning devices, methods of cleaning an intravascular port, methods of administering an agent into an intravascular line port, methods of obtaining a blood sample from an individual, and sets of intravascular line port caps. BACKGROUND OF THE INVENTION Intravenous lines, such as peripheral IV lines and central IV lines, are common intravenous access methods for administering medicants, nutrient solutions, blood products, or other substances into a vein. Arterial lines are used, for example, in monitoring physiological parameters by arterial blood sampling during coronary, intensive or critical care. However, microorganism intravascular device colonization or infection can occur as a result from a patients' own endogenous flora or from microorganisms introduced from contaminated equipment or other environmental contamination sources. As a result, localized or systemic infection or septicemia can occur and can be life threatening. Introduction of microorganisms into an intravenous line can be initiated or facilitated during handling of a catheter, hub, associated tubing, equipment, or injection ports, especially during manipulation of lines in preparation and during initiation of fluid administration into or withdrawal from the line. Microorganisms present on a surface of an injection port can be introduced through the port during administration. Microorganisms present on contaminated equipment utilized for administration can be introduced through the port causing colonization or infection. Bacterial growth and/or aggregation in a port or catheter can serve as the nidus for clotting, embolization and/or occlusion of the port or catheter. Further manipulation or administration through the port can facilitate spreading of microorganisms within the port, catheter, and lines, and ultimately into the patient's vein/artery and/or surrounding tissue. Accordingly, it would be advantageous to develop methods and devices for cleaning of external surfaces of intravascular access ports and/or internal port areas to reduce risks of colonization and infection. Another complication that can occur in association with an intravascular line, catheter or access port is clot formation due to blood return. Initial clot formation could extend and/or embolize into the superior vena cava and/or the right atrium and/or right ventricle of the heart, and subsequently into the pulmonary system circulating to the lungs. It would be advantageous to develop methodology and devices to deliver clot dissolving or clot inhibitory agents through intravascular ports to minimize or eliminate intravascular port associated clotting. Yet another issue that can be associated with intravascular lines is lipid accumulation or build-up within the line or port. It would be advantageous to develop methodology and devices to deliver lipolytic agents through intravascular ports to minimize or eliminate port associated lipid build up. SUMMARY OF THE INVENTION In one aspect the invention pertains to an intravascular port access device. The device includes a first component having a chamber and being configured to attach reversibly to an intravenous line port. The second component reversibly attaches to the first component and contains a disinfecting agent and an applicator material selected from the group consisting of polyethylene felt sponge, polyethylene foam sponge, plastic foam sponge and silicon foam sponge. The second component is configured to be reversibly received over external surfaces of the intravenous line port. In one aspect the invention encompasses an intravascular line port cleaner including a syringe barrel having a first end and a second end. A slideable piston is received into the barrel through the second end. The line port cleaner includes a first cap containing a cleansing agent and a second cap containing a microbiocidal agent. In one aspect the invention encompasses a method of cleansing an intravenous line port. The method includes providing a port cleaning device comprising a first component having a chamber with a first cleaning agent. A second component includes a second cleaning agent. A third component has a microbiocidal agent and is reversibly attached to the first component. The method includes removing a second component from the device, contacting the external surfaces of the port with the second cleaning agent, injecting the first cleaning agent from the chamber into the port, removing the third component from the device, and capping the port with the third component. In one aspect the invention encompasses a method of obtaining a blood sample from an individual. The method includes providing a port access device having a first component including a chamber, a second component containing a cleaning agent and a third component comprising a microbiocidal agent. The third component is reversibly attached to the first component. The method includes removing the second component from the device and contacting the external surfaces of the port with the cleaning agent. The method further includes drawing blood from the individual through the port into the chamber of the first component removing the third component from the device and capping the port with the third component. In one aspect the invention includes a set of intravascular line port caps. The set of caps includes a first port cap containing a first agent and a first applicator material. The set further includes a second port cap containing a second agent and a second applicator material. BRIEF DESCRIPTION OF THE DRAWINGS Preferred embodiments of the invention are described below with reference to the following accompanying drawings. FIG. 1 is a diagrammatic isometric view of a device in accordance with one aspect of the invention. FIG. 2 is a diagrammatic side view of the device shown in FIG. 1 . FIG. 3 is a diagrammatic exploded view of the device shown in FIG. 1 . FIG. 4 is a diagrammatic cross-sectional view of the device shown in FIG. 1 . FIG. 5 is a diagrammatic cross-sectional view of the device shown in FIG. 1 after repositioning relative to the positioning depicted in FIG. 4 . FIG. 6 is a diagrammatic isometric view of a device in accordance with another aspect of the invention. FIG. 7 is a diagrammatic side view of the device shown in FIG. 6 . FIG. 8 is a diagrammatic exploded view of the device of FIG. 6 . FIG. 9 is a diagrammatic cross-sectional view of the device shown in FIG. 6 . FIG. 10 is a diagrammatic view of an exemplary packaging concept for the device shown in FIG. 6 . FIG. 11 shows a multi-pack packaging concept for the device shown in FIG. 6 . FIG. 12 is a diagrammatic exploded view of a device in accordance with another aspect of the invention. FIG. 13 is a diagrammatic cross-sectional view of the device shown in FIG. 12 . FIG. 14 is a diagrammatic exploded view of a device in accordance with another aspect of the invention. FIG. 15 is a diagrammatic exploded view of a device in accordance with another aspect of the invention. FIG. 16 is a diagrammatic cross-sectional side view of the device shown in FIG. 15 . FIG. 17 is a diagrammatic isometric view of a packaging concept in accordance with one aspect of the invention. FIG. 18 is a diagrammatic isometric view of the packaging concept shown in FIG. 17 . FIG. 19 is another diagrammatic isometric view of the packaging concept shown in FIG. 17 . FIG. 20 is a diagrammatic isometric view of a set of components in accordance with one aspect of the invention. FIG. 21 is an exploded view of the set of components depicted in FIG. 20 . FIG. 22 is a diagrammatic exploded view of a packaging concept in accordance with one aspect of the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS This disclosure of the invention is submitted in furtherance of the constitutional purposes of the U.S. Patent Laws “to promote the progress of science and useful arts” (Article 1, Section 8). In general the invention includes devices and methodology for cleaning and/or accessing intravascular line ports. In particular applications devices of the invention can be used for cleaning external surfaces of a intravascular line port followed by cleaning of the port itself and in particular instances cleaning of intravascular lines. In other applications devices of the invention can be utilized for administering an agent intravascularly. During these applications, the devices in accordance with the invention can typically be utilized to cleanse external surfaces of the port prior to utilizing the device for administering of an agent intravascularly. In another application devices of the invention can be utilized to obtain a blood sample from an individual. A device in accordance with the invention is typically utilized to cleanse external surfaces of a port prior to utilizing the device to withdraw a sample of blood from the port. The invention also includes methodology for such port cleansing agent administration and blood sampling techniques. In one embodiment, the device comprises two components. An example two component device is described with reference to FIGS. 1-5 . Referring initially to FIG. 1 , a port access device 10 comprises a first component 12 at a first end 14 of the device, and a second component 16 at a second end 18 of the device. Second component 16 can have a tab 20 or other extension feature for assisting removal of the second component from the first component. First component 12 has a chamber housing 22 which can be a collapsible housing. First component 12 can also comprise an extension portion 24 . Referring to FIG. 2 , as depicted device 10 can have second portion 16 insertable within connector portion 24 . It is to be understood however that the invention contemplates other configurations wherein second portion 16 fits over or caps extension portion 24 . It is also to be understood that the shape and dimension of collapsible housing 22 is but an example with alternative shapes, sizes and configurations contemplated. Referring to FIG. 3 such shows an exploded view of the device depicted in FIGS. 1 and 2 . As illustrated chamber housing 22 of device 10 can house a chamber 23 . Connector 24 can comprise a separator 25 having an opening 29 passing therethrough. Connector 24 can further comprise a receiving port 30 for receiving a dispenser 26 . Dispenser 26 in turn can comprise a valve portion 28 . Second component 16 can comprise a container 21 . Referring next to FIG. 4 , such shows dispenser 26 with valve 28 seated within receiving port 30 . As depicted such valve mechanism is in the “closed” position where contents of chamber 23 are blocked from passing into or through connector 24 . Referring next to FIG. 5 , application of force upon collapsible housing 22 such as a downward pressure upon a top surface of the housing can be utilized to displace valve device 28 from receiving port 30 as illustrated. Such displacement can allow passage of the contents of chamber 23 into or through connector portion 24 . As depicted in FIG. 4 , second component 16 can contain an applicator material 32 . Such applicator material can be for example, a sponge or sponge-type material. Exemplary sponge-type materials can include but are not limited to polyethylene felt sponge, polyethylene foam sponge, plastic foam sponge and silicon foam sponge. Where device 10 is to be utilized for port cleansing applications, container 21 of second component 16 will typically contain a cleansing agent. The cleansing agent can be a disinfecting agent for cleansing external port surfaces. The agent is not limited to a particular cleaning or disinfecting agent and can comprise for example alcohol, preferably contained in an alcohol solution comprising from about 5% to about 99% alcohol. In particular applications the alcohol solution will comprise 25% to 90% alcohol. The sponge-type applicator material can be utilized to assist in containing the cleansing agent and can further assist in applying the agent to external surfaces of the intravascular port. Second component 16 is removably attached to the device 10 . For cleansing of the port, removable component 16 is removed from first component 12 and is utilized to contact external port surfaces for cleansing of external portions of an intravascular line port. After cleansing of external portions of the port, the first component of the device, which in cleansing/disinfecting applications can be utilized for internal cleansing of the intravascular port, can be reversibly attached to the port to be cleansed. The chamber volume can be for example up to 3.5 ml; a preferred volume range can be from about 1 to about 3 ml. although alternative chamber sizes for smaller or larger volumes are contemplated. The chamber can have appropriate calibration marks relative to the total volume of the chamber. For example, a 3.5 ml. fluid volume chamber can have volume markings every 1 ml, every 0.5 ml, every 0.1 ml, etc. In particular embodiments, the connector portion can have a LEUR-LOK® (Becton, Dickinson and Company Corp., Franklin Lakes N.J.) fitting (not shown) for connection to a LEUR-LOK® type port. A cleansing agent can be provided within chamber 23 and can be an antibiotic or an alternative appropriate disinfectant. An exemplary agent can be an alcohol or alcohol solution such as described above relative to the second component container 21 . In cleansing applications chamber 22 can alternatively or additionally contain chemical agents including ethylene diamine tretaacetic acid (EDTA) and/or sodium citrate. Once connected to the line port external pressure can be applied to collapsible housing 22 by for example squeezing, pinching, or pushing inward on the housing to displace dispenser 26 thereby opening or displacing valve 28 from receiving port 30 . Continued squeezing or external force can be utilized to dispel or eject contents of chamber 23 through connector 24 and into the connected port. Depending upon the volume of chamber 23 the injected cleansing solution may extend into the intravascular line itself. After dispelling the contents of chamber 23 device component 12 can be removed from the port to allow administration of fluids to be delivered intravascularly (for example). If such delivery is not to be performed immediately upon cleansing, component 12 of the cleansing device can be retained on the port until such time as intravascular delivery is desired. In another aspect, the above-described device and methodology can be utilized for administering an anti-clot agent to minimize or prevent intravascular associated clot formation or to dissolve an existing clot. In this aspect, rather than or in addition to the antimicrobial agent, chamber 23 can contain an appropriate anticoagulant agent or clot dissolving agent. Exemplary anti-clot agents which can be utilized include but are not limited to anticoagulants such as EDTA, sodium citrate, heparin and heparin derivatives, and anti-thrombolytic agents such as tissue plasminogen activator. Where lipid accumulation is an issue an appropriate dispersion or lipolytic agent can be administered, either independently or in combination with antimicrobial agent and/or anti-clot agent. Injection of any such agents can be achieved in a manner analogous to that described above relative to the cleansing agent. These applications may also be accomplished utilizing the embodiments illustrated and described below. An alternative embodiment of a device in accordance with the invention is illustrated and described with reference to FIGS. 6-11 . Referring to FIG. 6 , such illustrates an alternative example port access device 40 having a syringe-like first component 42 and a second component 44 . Referring to FIG. 7 syringe-like first component 42 includes a plunger 46 . An exploded view of the port access device is depicted in FIG. 8 . First component 42 includes a syringe barrel-like housing 48 having a first end 50 and a second end 52 with an internal chamber 54 . Chamber 54 can preferably have a fluid volume of from 1 to about 3.5 ml. Housing 48 can have appropriate calibration marks as discussed above with respect to the earlier embodiment. Plunger 46 can include a stem portion 56 having a seal 57 . Plunger 46 can be insertable into second end 52 of housing 48 . A second seal 59 can be associated with the larger diameter body of the plunger. Seal 59 is preferably present to form a seal between the plunger and an internal surface of the device chamber. Seal 59 can preferably be an elastameric seal which is over molded onto the piston (which can preferably be a molded hard plastic material). However, the invention contemplates alternative seal material and use of non-overmolded techniques. Seal 57 can be a single seal or a set of seals and can be for example a set of two o-rings, a single broad overmolded elastameric o-ring or sleeve or a hard plastic seal molded integrally with the piston stem. The presence of seal 57 can advantageously inhibit or prevent unwanted or unintentional backflow of fluid into the device chamber thereby decreasing the risk of contamination of the device and/or its contents. Alternatively relative to the depicted configuration a single seal can be over molded to have a base portion which forms the seal between an internal wall of the device chamber and the large diameter portion of the piston and a sleeve portion which covers the walls of the smaller diameter portion of the piston (not shown). The second component 44 is a removable cap portion having a housing 60 and an internal container 62 . Container 62 can contain an applicator material 64 . The applicator material can be, for example, any of those materials discussed above with respect to the earlier embodiment. The second component 44 can additionally contain a cleansing agent such as those cleansing agents discussed above. Second component 44 preferably can be configured to fit over or onto an intravascular port such that the cleansing agent can be applied to external surfaces of the port. Such cleaning preferably can be conducted prior to administering the contents of chamber 54 (for example, an anti-clot, antimicrobial or other cleansing agent) into the port. However, the invention contemplates post-administration cleansing of the port utilizing the removable cap portion. Referring next to FIG. 9 , such shows a cross-sectional view of the embodied device 40 in an intact configuration. For utilization second component 44 can be removed and utilized to cleanse external surface of the port. Subsequently, first end 50 of the second component can be attached to the port and contents of the chamber 54 can be administered into the port by application of force to plunger 46 . Alternatively, chamber 54 can be provided empty or can be provided to contain, for example, an anticoagulant agent and device 40 can be provided with plunger 46 in a forward position. Thus device 40 can be utilized for applications such as obtaining and/or testing of a blood sample from an individual by attaching first end 50 of the device to the port and repositioning of plunger 46 to draw fluid through the port into chamber 54 . Referring to FIG. 10 packaging 70 for delivery, storage and/or disposal of the component for access device 40 is illustrated. Such packaging includes a lid 72 and a tray portion 74 . Tray portion 74 has a cavity 76 with molded retainers 78 for positioning/retaining of the device and assisting in maintaining the integrity of the device and proper positioning of the plunger relative to the device chamber. Such packaging can be sealed and can be utilized to provide a sterile environment for device 40 . As shown in FIG. 11 a series 71 of individual packaging unit 70 can be provided with individually sealed units to allow individual removal of units while maintaining sterility of additional units in the series. Another alternative embodiment is described with reference to FIGS. 12-13 . In this embodiment first component 42 a is the same as the immediately preceding embodiment. However, referring to FIG. 12 second component 44 a comprises a “dual cap” system. Cap housing 60 a includes container portion 62 and a second cap extension 65 which houses a second container 66 . Container 62 can contain an applicator material 64 such as the sponge-like materials described above. Similarly container 66 can also contain a sponge or other applicator material 67 . Container 62 can further contain a cleansing agent such as those described above. Container 66 can preferably contain one or more microbiocidal agents that differ in composition from the cleaning solution contained in the cleansing cap 62 . An example agent composition within cap portion 65 can include from about 3% to about 11% H 2 O 2 . Additional components of the agent can include for example ethanol (from about 30% to about 40%) sodium citrate (from about 1% to about 4%), EDTA, and/or peracetic acid (less than or equal to about 11%). Preferably, the pH will be between 5 and 10 and can be adjusted with NaOH or other appropriate base/acid to about ph 7.4 as needed based upon the physiological pH and biocidal activity. The presence of EDTA can provide sporocidal activity against for example bacillus spores by complexing Mn and can additionally help stabilize H 2 O 2 . In combination with H 2 O 2 in the solution a synergistic and/or additive effect can be achieved. The invention does contemplate use of alternative chelators and pH stabilizers relative to those indicated. It is to be noted that in some instances a similar solution having lower peroxide content may be included within the first container 62 and in particular instances may be present within the chamber of the first component. Referring to FIG. 13 such shows an intact device prior to use. In port cleansing applications second component 44 a is removed from the device and portion 60 a is utilized to cover a port thereby contacting the port with the contents of container 62 . Applicator material 64 can assist in applying the cleaning agent to external port surfaces. When the contents of chamber 54 are to be administered, component 44 a is removed from the port and first component is attached to the port. Plunger 46 is depressed thereby injecting the contents of chamber 54 into the port. The syringe component is then removed from the port. A removable seal 68 can then be removed from second cap portion 65 . Cap portion 65 can be placed over the port such that the contents of container 66 contact the port. Second component 44 can then be removed from the port or can be retained on the port until further port access or manipulation is desired. Referring to FIG. 14 such shows an alternative embodiment wherein port access device 40 b comprises a first component 42 b , a second component 44 b and a third component 45 b where second component 44 b and third component 45 b are independently removable caps. As illustrated the caps are disposed initially at opposing ends of the device and are of differing size. However, alternative relative size and positioning of the caps on the device is contemplated. For example, first component 44 b and second 45 b can be disposed on top-side or bottom-side of wing extensions 51 , 53 of chamber housing 48 b. For the example configuration illustrated, the larger cap (first component 44 b ) can be removed from the device and can be utilized for external port cleaning in a manner analogous to that described above. The second smaller cap (third component 45 b ) can be removed from the device after administration of the chamber contents and can be subsequently utilized as a port cap to protect the port until subsequent port access is desired as described above. Third component 45 b optionally can contain an applicator material 82 and/or cleansing agent or microbiocidal agent as described above. Alternative two-cap configurations include a device having a larger cap external to a smaller internal cap, the first cap being removable from the second cap where one of the first and second caps is configured for utilization as a port cap. In the device shown in FIG. 14 , cap housing 60 b of second component 44 b and cap housing 80 of third component 45 b can be of differing colors. As such, the caps can be color coded (or otherwise coded) to notify the user or other personnel of the status of the port or intravascular line. For example, a first color such as green can be utilized on all or a portion of cap housing 80 which will be retained on the port after use of the device to signify a properly sterilized port. Cap housing 60 b can be a second color (e.g., yellow or red) signifying the cleansing or other procedure being performed has not yet been completed. Accordingly, the caps can be utilized as an added safety measure to help ensure proper use and assist in maintaining sterility and appropriate record keeping. For example, the caps can allow visual monitoring and can be tracked by hospital pharmacy and/or central auditing software. In addition to visual auditing of compliance to proper cleaning and maintenance of sterility, a barcode, radio frequency identification (RFID) and/or other pharmacy dispensary or inventory control system associated with the device can be utilized to provide an independent audit/compliance system. Referring next to FIG. 15 such depicts an additional alternate embodiment which can utilize a conventional type syringe and plunger design and can utilize caps in accordance with the invention. Accordingly, first component 42 c comprises a syringe housing 48 c and can have a LEUR-LOK® fitting at first end 50 . Plunger 46 c can have a conventional type piston seal 57 c configured to insert into second end 52 of housing 48 c and form a seal with the walls of chamber 54 c . Second component 44 c can comprise a housing 60 c which can for example have an internal receiving port which fits either internally relative to the LEUR-LOK® fitting or which fits over and covers the LEUR-LOK® fitting at first end 50 of first component housing 48 c . Third component 45 c can also have housing 80 c configured such that it comprises an internal receiving port which fits either internally relative to a LEUR-LOK® fitting or which fits over and covers the LEUR-LOK® fitting (or which can have an alternative type fitting) based upon the type of port being cleansed. A cross-sectional view of the device shown in FIG. 15 is illustrated in FIG. 16 . Such shows the exemplary type of cap housings for covering LEUR-LOK®-type fittings. For example third component 45 c has housing 80 c comprising a portion of such housing which fits internally within a LEUR-LOK® type fitting thereby capping such fitting. In contrast second component 44 c has housing 60 c which is threaded to thread onto LEUR-LOK® type fitting. It is to be understood that the depiction is for illustrative purposes only and that either or both caps can have the threaded configuration or the snap in configuration. Cap housing 60 c and 80 c can further be color coded as described above. The invention also contemplates dual cap system disposed at the distal (non-administration) end of the port cleaner device (not shown). In this dual cap system a first “green” cap can be reversibly joined to both the device and also back to front in a stack relationship relative to a second “yellow” cap. Each of the two caps can be, for example, a LEUR-LOK® type fitting cap, friction fit cap, etc. The green cap can contain the microbiocide composition described above. The yellow cap can contain for example the cleaning compositions discussed earlier or the microbiocide composition as contained in the green cap since in this configuration the yellow cap is not in contact with the administration end of the device. Possible materials for caps include, but are not limited to, polyethylene, polypropylene, and/or copolymer materials. Further, the caps can preferably comprise a material or agent that is UV protective to preserve the integrity of hydrogen peroxide during storage, shipping, etc. Packaging may also contain UV protective materials to inhibit peroxide breakdown. As mentioned above, devices of the invention can be utilized for withdrawing blood from an individual through an intravascular catheter or intravascular port. In particular applications, the device can be utilized directly for blood testing purposes. The device chamber can preferably have a chamber size in the range of 1 to 3 ml, with appropriate calibration marks as discussed above. Where whole blood is desired, depending upon the particular purpose for drawing, blood can be drawn into either a device having an empty chamber or into a device containing an anticoagulant such as EDTA, sodium citrate or alternative coagulant (such as discussed above). The device containing blood and anticoagulant can then be utilized directly in blood testing equipment or blood can be transferred to an alternative device for testing. In applications where serum is desired, whole blood can be drawn into the device chamber and, after coagulation, the device containing the blood sample can be spun to separate the serum from the red blood cells. If anticoagulant is present in the device chamber, further separation can occur to isolate plasma. Alternatively, a filter such as a MILLIPORE® (Millipore Corp., Bedford Mass.) filter can be fitted onto the device after a sample is drawn into the device chamber. Such technique can filter out red blood cells, white blood cells and platelets allowing serum to flow from the chamber while retaining the blood cells within the filter. Anticoagulants can optionally be provided within the chamber to allow transfer of blood cells or plasma if such is desired based upon the testing or other procedure to be performed (i.e., complete blood count, CBC, platelet count, reticulocyte count, T and B lymphocyte assays and chemistries). An appropriate filter can also be utilized to filter out particulates during drawing of a blood sample from an individual into the chamber. It is to be understood that any of the devices above can be utilized for cleansing purposes, for administration purposes or for blood drawing/testing purposes. Methodology will be analogous with variation based upon the particular device utilized as described above. Example device packaging is illustrated in FIGS. 17-19 . Packaging 100 can include a lid portion 102 and a packaging tray 104 as shown in FIG. 17 . Referring to FIGS. 18 and 19 packaging tray 104 can be a molded tray which has integrally molded retaining features which conform to the shape of a device 40 c in accordance with the invention. Preferably the molded features conform to the shape of the device in the non-deployed position for shipment, storage, etc. Accordingly tray 104 can have one or more integrally molded retainer features 106 , 107 , 108 and 109 . Tray 104 can also comprise an integrally molded receiving stand 110 which can be configured to receive device 40 c in an upright position as depicted in FIG. 18 . Such receiving stand can allow device 40 c to be inserted and retained during administrative procedures or after use. Tray 104 may also be used for device disposal purposes. Device caps in accordance with the invention can be utilized independent of the devices for cleansing and protection of alternative access catheters and ports such as intravascular, peritoneal dialysis, urinary ports and catheters, etc. Accordingly, the caps can be packaged independently in pairs (one each of two differing sizes, colors, etc., in groups or in bulk, of one or more colors). FIGS. 20-21 show an example two cap packaging system 115 having a first cap 117 which can be for example a yellow cap and which can preferably be a LEUR-LOK® type cap and a second cap 118 which can be, for example, a green cap and which can also be a LEUR-LOK®. Packaging system 115 can comprise a packaging tray 120 and as illustrated in FIG. 21 can include integrally molded appropriate receiving ports/receiving rings 122 , 124 . Where additional or fewer caps are to be packaged together tray 120 can have an appropriate number of receiving ports for receiving and reversibly retaining the caps. Where the caps differ in size (diametric), the ports can also be of differing size as appropriate. It is to be understood that the caps may be provided in groups such as one green and four yellow caps per package or any other appropriate number depending upon the particular procedure for which they will be utilized with the number and size of package ports corresponding to the number and size of various caps. Referring next to FIG. 22 an alternative packaging system 130 is illustrated. Packaging system 130 comprises a lid 132 and a tray 130 having integral receiving ports 136 and 138 for receiving caps 117 and 118 . As discussed above alternative numbers and sizes of receiving ports can be provided based upon the number and sizes of caps to be utilized. Where caps are provided in bulk, such may be individually packaged and may be provided individually in sheets or on strips. Caps can alternatively be provided with catheter or line/import devices. Such can be included in common packaging either loose or attached to a port catheter or line to be used for port cleaning and/or protection after package opening and/or while the device is in use. In some instances the cap(s) can be packaged in one or more sub-packages included within a larger package enclosing the catheter device. In compliance with the statute, the invention has been described in language more or less specific as to structural and methodical features. It is to be understood, however, that the invention is not limited to the specific features shown and described, since the means herein disclosed comprise preferred forms of putting the invention into effect. The invention is, therefore, claimed in any of its forms or modifications within the proper scope of the appended claims appropriately interpreted in accordance with the doctrine of equivalents.

An intravascular port access device includes a first component having a chamber configured to attach reversibly to an intravenous line port. A second component reversibly attaches to the first component and contains a disinfecting agent and an applicator material. The second component is configured to be reversibly received over external surfaces of the intravenous line port. A method of cleansing an intravenous line port includes providing a port cleaning device having a first component with a chamber containing a first cleaning agent. A second component includes a second cleaning agent. A third component has a microbiocidal agent and is reversibly attached to the first component. The second component is removed from the device, the external surfaces of the port are contacted with the second cleaning agent, the first cleaning agent is ejected from the chamber into the port, and the third component is used to cap the port.

This is a continuation of abandoned application Ser. No. 09/873,004, filed Jun. 1. 2001. FIELD OF THE INVENTION The present invention is directed to an intake and plucking arrangement, having a rotating intake device and an additional conveying element driven by a first stalk roll for directing standing plants into a plucking slot. BACKGROUND OF THE INVENTION DE 197 34 747 A describes a corn harvesting implement for attachment to a self-propelled harvesting machine that mows plants standing on a field independent of rows and plucks the ears of corn from the plants. For grasping and mowing of the plants independent of rows, the implement is equipped with a mower head with a rotating drum provided on its outer circumference with recesses and a knife rotating below it, as is known practice from corn heads. The plants are conducted to conventional plucking assemblies attached downstream of the mower head. Clean-up disks or points of the plucking rolls penetrating into the operating area of the mower head are provided, in order to remove the plants that are to be processed from the mower head and to conduct them to the plucking assembly. The ears of corn that have been removed from the plants are transported away by two chain conveyors arranged above the plucking slot. The disadvantage here is seen in the fact that the transition of overripe and soft stalks into the plucking assembly may prove to be problematic. SUMMARY OF THE INVENTION It is an object of the present invention of making available an improved intake and plucking arrangement for a crop harvesting arrangement. The present intake and plucking arrangement comprises a rotatable intake device that grasps parts of the standing plants and directs them into a plucking slot. The intake device is preferably provided with a relatively broad operating width; it thereby operates independent of rows. In addition to the intake device, a driven conveying element is arranged upstream and above the intake end of the plucking slot. The plants transported by the intake device to the intake end of the plucking slot come into contact with the conveying element, before they have reached the plucking slot. The conveying element conveys the plants, in conjunction with the intake device, into the plucking slot. Preferably the direction of conveying of the conveying element and the longitudinal direction of the plucking slot are parallel, so that the conveying element can introduce the plants into the plucking slot without any problems. The conveying element facilitates the introduction of the plants into the plucking slot. This is especially important respecting plants having soft stalks as the conveying element provides additional support and conveying action to the plants. Due to the supporting effect of the conveying element, a buckling or squashing of the plants between the intake device and the edge of the plucking slot need not be feared. The conveying element is preferably a screw conveyor that extends over a region (with respect to the direction of movement of the plants) upstream of the plucking slot and over at least a portion of the length of the plucking slot. It would be conceivable to let it extend over the entire length of the plucking slot in order to transport the plants along the length of the plucking slot, however, this is not absolutely necessary, since the transport of the plants over the length of the plucking slot can be performed by the intake device. For reasons of cost and weight, a relatively short screw conveyor is therefore preferred, that covers only the intake end of the plucking slot and a region (as seen in the direction of movement of the plant) ahead and behind it. In place of a screw conveyor, a chain conveyor with drivers of the type used on corn pickers, but shortened in comparison and offset opposite to the direction of movement of the plants (that is, upstream) could be applied to the grasping and introduction of the plants into the plucking slot. An obvious solution is to arrange the conveying element on the side of the plucking slot that is opposite to the intake device. If the plants move outward relative to the intake device, they come into contact with the conveying element. Then the conveying element conducts them into the plucking slot. To drive the conveying element, a gearbox can be used that makes a drive connection between a driven stalk roll of the plucking device and the conveying element. It is advantageous that the gearbox be arranged on the upstream side of the stalk roll and the conveying element. As a rule, this side is located in front in the forward direction of operation of the intake and plucking arrangement. It would be conceivable to support the conveying element at both ends on a stationary element (directly or indirectly). As a rule, however, it is sufficient to support it at only one end and to support it in bearings. Here the concern is appropriately the end of the conveying element facing the gearbox. In a preferred embodiment the conveying element is arranged above the intake device, in particular, directly above it. This leads to the result that the plants do not bend significantly between the conveying element and the intake device, which would make the introduction into the plucking slot more difficult. In order to further improve the introduction of the plants into the plucking slot it is proposed that the plucking device be equipped with a stalk roll that is provided with a region arranged upstream in the direction of movement of the plants in which a screw conveyor is arranged, which also transports the plants that come into contact with it into the plucking slot. The conveying element is arranged above the screw conveyor. As a result, a plant is conducted into the plucking slot by the screw conveyor of the stalk roll, by the conveying element and by the intake device. Therefore the plant is supported at three points so that a buckling even of soft plants need not be feared. As a rule, the conveying speed of the conveying arrangement, of the screw conveyor and of the intake device coincide, so that the plant is conveyed in a vertical position and is not bent due to differing conveying speeds. The screw conveyor in the upstream region of the plucking roll and the conveying element are preferably located directly above one another. At this location the plucking rolls begin to act upon the plants and to draw them in downward. The intake device can also be utilized to transport the plants over the effective length of the plucking device, that is, that part of the length of the plucking device in which the plucking device processes the plant, that is, draws it in and separates the useful components from the remainder of the plant. The intake device can rotate about an approximately vertical axis and be equipped with radially extending fingers that are used to grasp and transport parts of the plants, particularly stalks. The fingers of the intake device are preferably provided with leading surfaces with rejecting conveying performance, that is, they have a trailing configuration. This conveying performance can be attained by a curvature of the fingers of the intake device that is trailing, opposite to the direction of rotation. Thereby this results in the stalks of the plants being forced outward by the intake device and prevents the stalk from being drawn inward aggressively and becoming clamped between the edge of the sheet metal stripper plate and the finger. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a top view of an intake and plucking arrangement of a crop harvesting arrangement. FIG. 2 is a side view of the intake and plucking arrangement of FIG. 1 . FIG. 3 is a front view of the intake and plucking arrangement of FIG. 1 . DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 shows an intake and plucking arrangement 10 of a crop harvesting arrangement. Typically, a full crop harvesting arrangement is provided with a multitude of intake and plucking arrangements 10 . However, it is conceivable that a crop harvesting arrangement could be provided with only a single intake and plucking arrangement 10 . If several intake and plucking arrangements 10 are applied, they may be configured identically or symmetrically about the longitudinal center plane of the crop harvesting arrangement. The intake and plucking arrangement 10 is provided with an upper intake device 12 , that is used for grasping and drawing in the plants that are to be harvested, a rotating chopper knife 14 , a first stalk roll 16 , a second stalk roll 18 and a sheet metal stripper plate 20 having a plucking slot 22 formed therein. Both stalk rolls 16 and 18 are located below the plucking slot 22 . The upper intake device 12 is arranged so as to rotate about a vertical axis and is rotated by a drive, not shown. The upper intake device is driven in a clockwise direction when viewing FIG 1 . The intake device 12 is arranged above the sheet metal stripper plate 20 and has an axis of rotation that is inclined slightly to the front. Line B in FIG. 1 corresponds to the surface of the ground. In its basic configuration the intake device 12 comprises a central disk 24 with radially extending fingers 26 distributed around its circumference. The fingers 26 are also curved in the plane of the disk 24 opposite to the direction of rotation, in a trailing configuration. Therefore the fingers 26 have a rejecting conveying performance. Alternatively or in addition to the curvature of the fingers 26 , a controlled, radial or azimuth-like movement of the fingers 26 relative to the disk 24 would be possible, as is known from harvesting reels or screw conveyors of mower heads, and can be attained by an eccentric drive, in order to attain a rejecting conveying performance. As can be seen in FIG. 1 , the intake and plucking arrangement 10 is further provided with stalk dividers 28 and 30 that are arranged ahead of the intake devices 12 and 16 in the direction of forward movement V of the crop harvesting arrangement. Intake devices 12 of the intake and plucking arrangement 10 direct or bend the stalks of plants 32 into the intake 23 of the plucking slot 22 as the crop harvesting arrangement moves in the forward direction V across a field. As illustrated in FIG. 2 , the leading edge of the sheet metal stripper plate 20 in the forward operating direction is curved in such a way that the stalks of the plants 32 are directed into the operating region of the intake device 12 . The operating region of the intake device 12 is so large that the intake and plucking arrangement 10 interacting with the curved leading edge of the sheet metal stripper plate 20 , and/or the stalk dividers 28 and 30 , allows the intake and plucking arrangement 10 to operate independently of rows. Hence the operating width of the intake and plucking arrangement corresponds to the sideways distance between the points of the stalk dividers 28 and 30 . As shown in FIG. 1 , the stalk of a standing plant 32 comes into contact with a finger 26 of the intake device 12 (independent of its sideways position). The stalk of the standing plant 32 is directed by the finger 26 towards the plucking slot 22 . If necessary the finger 26 is assisted by the stalk dividers 28 and 30 and/or the leading edge of the sheet metal stripper plate 20 . The stalk is carried along by the leading surface of the finger 26 and is forced outwardly because of the trailing configuration of the finger 26 . In this way the stalk of the plant 32 is directed by the finger 26 into the plucking slot 22 . The plucking slot 22 extends approximately parallel to the forward operating direction V and is formed into the sheet metal stripper plate 20 between the first plucking roll 16 and the intake device 12 . The first stalk roll 16 is arranged on the side of the plucking slot 22 away from the intake device 12 and is inclined slightly to the front and downward when viewed from the side. The first stalk roll 16 is oriented parallel to the forward direction of operation V when viewed from the top. In the vertical direction the first stalk roll 16 is arranged underneath the sheet metal stripper plate 20 . In the forward region of the first stalk roll 16 , located upstream relative to the direction of movement of the plants 32 , a screw conveyor 34 is located that draws in the stalk of the plant 32 into the plucking slot 22 , interacting with the intake device 12 . The inlet end 23 of the plucking slot 22 is located ahead of the axis of rotation of the intake device 12 . The plucking gap 22 initially narrows and then has takes on a constant gap over the length of the plucking slot 22 . The rearmost end region of the plucking slot 22 is curved in the direction towards the axis of rotation for the intake device 12 . When the plant 32 enters the plucking slot 22 , the fingers 26 form an acute angle with the edge of the plucking gap 22 (that is shown at the bottom in FIG. 1 ). By reason of this acute angle between the edge of the plucking gap 22 and the fingers 26 , the stalk of the plant 32 can be squashed, particularly if the stalks of the corn plants are strongly overripe and therefore soft. In this case, the plant 32 is not transported further and the intake and plucking arrangement 10 becomes jammed. To solve this problem a conveying element 52 in the form of a screw conveyor is arranged above the inlet end 23 of the plucking slot 22 and above the intake device 12 . The longitudinal direction and the direction of conveying of the conveying element 52 extends parallel to the first stalk roll 16 . The conveying element 52 has approximately one-third the length of the first stalk roll 16 and is brought into rotation by a gearbox 54 which establishes a drive connection with the forward end face of the first stalk roll 16 . Hence the first stalk roll 16 transmits the driving torque from the shaft 46 to the conveying element 52 . The housing of the gearbox 54 is fastened to the sheet metal stripper plate 20 . The conveying element 52 is supported in bearings only on its forward end face, as seen in the forward operating direction V, on the gearbox 54 , but it is not supported or provided with bearings on its rear end face. The stalk of a plant 32 grasped by the finger 26 of the intake device 12 is pressed against the conveying element 52 . The conveying speed of the conveying element 52 conforms to the conveying speed of the screw conveyor 34 and the intake device 12 , so that the plant 32 is conducted synchronously into the plucking slot 22 by the screw conveyors 34 and 52 and the intake device 12 . The conveying element 52 provides support and conveying above the finger 26 of the intake device 12 . Due to the interaction of the two screw conveyors and the finger 26 the plant 32 is held securely and conducted in a straight line into the plucking slot 22 and between the stalk rolls 16 and 18 . The plant is supported at three points so that a buckling or squashing is not to be feared. In addition, due to the action of the conveying element 52 , the intake performance of the intake and plucking arrangement 10 has become considerably more aggressive. The screw conveyor 34 , the conveying element 52 and the intake device 12 direct the stalk of the standing plant 32 into the operating region of the second stalk roll 18 . The forward point of the second stalk roll 18 lies ahead of the axis of rotation of the intake device 12 . The second stalk roll 18 is parallel to the first stalk roll 16 and is arranged between the latter and the axis of rotation of the intake device 12 . The slot defined between the first stalk roll 16 and the second stalk roll 18 is located vertically underneath the plucking slot 22 . The rear region 36 of the first stalk roll 16 , whose length corresponds to the length of the second stalk roll 18 . Both stalk rolls 16 and 18 are equipped radially extending drivers 38 , which are best illustrated in FIG. 3 . As seen in FIG. 3 , the first stalk roll 16 rotates in clockwise direction and the second stalk roll 18 rotates in counterclockwise direction. The first stalk roll 16 and the rear region 36 of the second plucking roll 18 draw in the stalk of the plant 32 downward. At the same time the sheet metal stripper plate 20 on both sides of the plucking slot 22 is used to strip off useful components of the plant 32 . The conveying element 52 ends precisely above the forward end of the second stalk roll 18 and the beginning of the rear region 36 of the first stalk roll 16 . As soon as the plant 32 is drawn downwardly by the stalk rolls 16 and 18 , the conveying action by the conveying element 52 and the screw conveyor 34 of the first stalk roll 16 ceases. During the plucking process the fingers 26 of the intake device 12 provide assurance that the plant 32 is transported over the length of the plucking slot 22 . The rotational speeds of the stalk rolls 16 and 18 and the intake device 12 are preferably designed in such a way that the entire plant 32 has been drawn downwardly into the plucking slot 22 when the end of the plucking slot 22 is reached. The useful components of the plant 32 , ears of corn, sunflower heads, etc., are separated from the plant 32 by the plucking device. The useful components are conveyed by the intake device 12 into a trough 40 arranged at the rear of the intake and plucking arrangement 10 . A cover 42 on both sides of the plucking slot 22 defines a channel leading to the trough 40 , through which the useful components of the plants 32 are conveyed. The cover 42 partially covers the intake device 12 and the conveying element 52 and due to its shielding effect enhances the performance and operating safety of the intake and plucking arrangement 10 . The trough 40 may be a one-piece unit with the sheet metal stripper plate 20 , or it may be a separate element. A transverse screw conveyor 44 is arranged above the trough 40 and transports the useful components to a harvesting machine (for example, a combine or forage harvester) or to a trailer. A shaft 46 extends beneath the trough 40 and provides a drive for the two stalk rolls 16 and 18 , the chopper knife 14 , the conveying element 52 and the intake device 12 . The shaft 46 is driven by the engine propelling the crop harvesting arrangement. A frame 48 carries the intake and plucking arrangement 10 of the crop harvesting arrangement, all of which are driven by the shaft 46 . The remainder of the plants 32 , that are transported away downward by the stalk rolls 16 and 18 , reach the operating region of the rotating, four-armed chopper knife 14 and are cut by this into individual pieces. Hence chopped plant remains are deposited on the field. During the chopping, the stalk rolls 16 and 18 hold the plant 32 . The chopper knife 14 rotates about a vertical axis of rotation 50 . The vertical axis 50 is located between the axis of rotation of the intake device 12 and the screw conveyor 44 , as can be seen in FIG. 2 . The chopper knife 14 is driven by the shaft 46 through an angular gearbox 56 . As seen in FIG. 1 , the chopper knife 14 is positioned beneath the stalk rolls 16 and 18 . The direction of rotation of the chopper knife 14 is clockwise, so that the chopped crop is thrown to the side and the rear. Having described the preferred embodiment, it will become apparent that various modifications can be made without departing from the scope of the invention as defined in the accompanying claims.

An intake and plucking arrangement comprises a rotatable intake device that grasps a standing plant and directs it to a plucking gap. The plucking gap is located above parallel first and second stalk rolls that pull the stalk of the plant downwardly so that the plucking gap can separate the useful parts of the plant from the stalk. The upstream end of the first stalk roll is provided with a lower screw conveyor. A conveyor element is drivingly connected to the screw conveyor. The conveying element comprises an upper screw conveyor that is located above the lower screw conveyor. Both screw conveyors are located upstream from and above the inlet end of the plucking slot. The conveying element working in conjunction with the rotatable intake device direct standing plants into the plucking slot.

CROSS-REFERENCES TO RELATED APPLICATIONS [0001] NOT APPLICABLE STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] NOT APPLICABLE REFERENCE TO A “SEQUENCE LISTING,” A TABLE, OR A COMPUTER PROGRAM LISTING APPENDIX SUBMITTED ON A COMPACT DISK [0003] NOT APPLICABLE BACKGROUND OF THE INVENTION [0004] 1. Field of the Invention [0005] The present invention is related generally to the field of orthodontics. More particularly, the present invention is related to methods and systems for dispensing a series of orthodontic appliances in a sequence to a patient. [0006] Repositioning teeth for aesthetic or other reasons is accomplished conventionally by wearing what are commonly referred to as “braces.” Braces comprise a variety of appliances such as brackets, archwires, ligatures, and O-rings. Attaching the appliances to a patient's teeth is a tedious and time consuming enterprise requiring many meetings with the treating orthodontist. Consequently, conventional orthodontic treatment limits an orthodontist's patient capacity and makes orthodontic treatment quite expensive. Moreover, from the patient's perspective, the use of braces is unsightly, uncomfortable, presents a risk of infection, and makes brushing, flossing, and other dental hygiene procedures difficult. [0007] As a result, alternative methods and systems for repositioning teeth have been developed. For example, repositioning may be accomplished with a system comprising a series of appliances configured to receive the teeth in a cavity and incrementally reposition individual teeth in a series of at least three successive steps. Most often, the methods and systems reposition teeth in from ten to twenty-five successive steps, although complex cases involving many of the patient's teeth may take forty or more steps. The individual appliances are typically comprised of a polymeric shell having the teeth-receiving cavity formed therein, typically by molding. The successive use of a number of such appliances permits each appliance to be configured to move individual teeth in small increments. [0008] Typically the systems are planned and all individual appliances are fabricated at the outset of treatment. Thus, the appliances may be provided to the patient as a single package or system. The order in which the appliances are to be used can be marked by sequential numbering directly on the appliances or on tags, pouches or other items which are affixed to or which enclose each appliance so that the patient can place the appliances over his or her teeth in an order and at a frequency prescribed by the orthodontist or other treating professional. Successive appliances will be replaced when the teeth either approach (within a preselected tolerance) or have reached the target end arrangement for that stage of treatment, typically being replaced at an interval in the range from 2 days to 20 days, usually at an interval in the range from 5 days to 10 days. [0009] In general, it is preferable to simplify procedures for the patient to increase patient compliance and reduce patient errors in carrying out the treatment protocol. Therefore, it is desirable to utilize a packaging or ordering system which will provide appliances to a patient in a manner which is clearly discernable to the patient the order of the appliances. In addition, such packaging or ordering system should be amenable to mid-treatment changes to the treatment protocol, possibly adding or eliminating appliances after the initial set of appliances has been produced and packaged. At least some of these objectives will be met by the methods and systems of the present invention described hereinafter. [0010] 2. Description of the Background Art [0011] Tooth positioners for finishing orthodontic treatment are described by Kesling in the Am. J. Orthod. Oral. Surg. 31:297-304 (1945) and 32:285-293 (1946). The use of silicone positioners for the comprehensive orthodontic realignment of a patient's teeth is described in Warunek et al. (1989) J. Clin. Orthod. 23:694-700. Clear plastic retainers for finishing and maintaining tooth positions are commercially available from R AINTREE E ssix , I NC ., New Orleans, La. 70125, and T RU -T AIN P LASTICS , Rochester, Minn. 55902. The manufacture of orthodontic positioners is described in U.S. Pat. Nos. 5,186,623; 5,059,118; 5,055,039; 5,035,613; 4,856,991; 4,798,534; and 4,755,139. [0012] Other publications describing the fabrication and use of dental positioners include Kleemann and Janssen (1996) J. Clin. Orthodon. 30:673-680; Cureton (1996) J. Clin. Orthodon. 30:390-395; Chiappone (1980) J. Clin. Orthodon. 14:121-133; Shilliday (1971) Am. J. Orthodontics 59:596-599; Wells (1970) Am. J. Orthodontics 58:351-366; and Cottingham (1969) Am. J. Orthodontics 55:23-31. BRIEF SUMMARY OF THE INVENTION [0013] The present invention provides systems and methods for providing dental appliances, particularly orthodontic appliances, to a patient wherein the patient is easily able to determine the order or sequence in which the appliances should be worn. Typically the appliances are to be worn in a particular sequence to provide desired treatment, such as a progressive movement of teeth through a variety of arrangements to a final desired arrangement. [0014] In a first aspect of the present invention, a system of dental appliances is provided comprising a plurality of dental appliances wherein at least some of the plurality include a non-numeric indicia designating an order in which each of the at least some of the plurality are to be worn by a patient to provide dental treatment. Typically, each of the plurality of dental appliances comprise a polymeric shell having cavities shaped to receive and resiliently reposition teeth from one arrangement to a successive arrangement. Exemplary embodiments of such dental appliances are described in U.S. Pat. No. 5,975,893, incorporated herein by reference for all purposes. In some embodiments, each of the polymeric shells has at least one terminal tooth cavity and the indicia comprises a terminal tooth cavity of differing length in each of the polymeric shells. In other embodiments, each of the polymeric shell has a height and the indicia comprises a different height in each of the polymeric shells. [0015] In still other embodiments, the indicia comprises one or more cutouts so that each polymeric shell has a different cutout pattern. Sometimes the cutout comprises a notch in an edge of the appliance. [0016] In yet other embodiments, the indicia comprises a color wherein each appliance has different color. The color of the appliances may have the same hue and vary by intensity, for example. The color may comprise a dissolvable dye. Or, the system may further comprise a wrapper removably attachable to each of the appliances, wherein each wrapper has the color. [0017] In another aspect of the present invention, a system of packaged dental appliances is provided comprising a plurality of packages each containing a dental appliance, wherein the plurality of packages are joined in a continuous chain designating an order in which each of the dental appliances are to be worn by a patient to provide dental treatment. In some instances, the packages are each joined by a perforation wherein the packages can be separated by breaking the perforation. In other instances, the packages are joined by, for example, a heat seal. Further, the system may include a marking on a package at an end of the chain indicating the dental appliance to be worn first. Again, each of the plurality of dental appliances may comprise a polymeric shell having cavities shaped to receive and resiliently reposition teeth from one arrangement to a successive arrangement. [0018] In a further aspect of the present invention, a system of dental appliances is provided comprising a plurality of dental appliances to be worn by a patient to provide dental treatment, and a framework, wherein each of the plurality of dental appliances are removably attached to a portion of the framework. In some embodiments, each of the plurality of dental appliances comprise a polymeric shell having cavities shaped to receive and resiliently reposition teeth from one arrangement to a successive arrangement. Further, the system may comprise at least one marking on the framework indicating the order in which the appliances are to be worn by a patient. [0019] In still another aspect of the present invention, method of dispensing dental appliances to a patient is provided. The method including the step of providing a plurality of packages wherein each of the packages includes a polymeric shell having cavities shaped to receive and resiliently reposition teeth from one arrangement to a successive arrangement, the plurality of package including a first package containing a first shell to be worn by the patient to reposition the teeth from the one arrangement to the successive arrangement and a second package containing a second shell to be worn by the patient to reposition the teeth from the successive arrangement to another successive arrangement. The method further including the steps of delivering the first package to the patient at a designated time through a remote delivery system, and delivering the second package to the patient at a later designated time through the remote delivery system. In most embodiments, the remote delivery system comprises a mail delivery system. [0020] In another aspect of the present invention, a method is provided of dispensing dental appliances to a patient including providing a dispenser including a plurality of dental appliances, wherein each of the appliances comprises a polymeric shell having cavities shaped to receive and resiliently reposition teeth from one arrangement to a successive arrangement, the plurality of appliances including a first shell to be worn by the patient to reposition the teeth from the one arrangement to the successive arrangement and a second shell to be worn by the patient to reposition the teeth from the successive arrangement to another successive arrangement, and removing the first shell from the dispenser wherein removal of the first shell dispenses the second shell. [0021] In a further aspect of the present invention, a method of dispensing dental appliances to a patient is provided including providing a dispenser including a plurality of dental appliances, wherein each of the appliances comprises a polymeric shell having cavities shaped to receive and resiliently reposition teeth from one arrangement to a successive arrangement, the plurality of appliances including a first shell to be worn by the patient to reposition the teeth from the one arrangement to the successive arrangement and a second shell to be worn by the patient to reposition the teeth from the successive arrangement to another successive arrangement. The method further includes removing the first shell from the dispenser, and actuating an actuator that subsequently dispenses the second shell. In most embodiments, the actuator comprises a lever, knob, or button. BRIEF DESCRIPTION OF THE DRAWINGS [0022] FIG. 1 is a schematic illustration of a series of appliances dispensed in a chain. [0023] FIG. 2 illustrates a series of appliances disposed on a framework. [0024] FIG. 3 illustrates a series of appliances provided to a patient in a dispenser. [0025] FIGS. 4A-4B illustrate a change in length of a terminal tooth cavity between appliances in a series. [0026] FIGS. 5A-5B illustrate a change in height between appliances in a series. [0027] FIGS. 6A-6B illustrate the addition of cutouts in each appliance to indicate an order. [0028] FIGS. 7A-7C illustrate a change in color to indicate an order. [0029] FIG. 8 illustrate an embodiment of a method of delivering appliances in a desired order. [0030] FIG. 9 illustrates an appliance which includes a readable element embedded in the appliance. [0031] FIG. 10 illustrates a series of packages 12 , each having a label which includes at least one non-numeric indicia. [0032] FIG. 11 illustrates a package of dental appliances of the present invention. DETAILED DESCRIPTION OF THE INVENTION [0033] It may be appreciated that the orthodontic appliances may be dispensed to the patient in its entirety, in groups or individually. Providing the patient with the entire series at the outset of treatment may be desirable if the treatment plan is relatively short, the patient is particularly compliant, or it is particularly convenient, to name a few. In this case, the series should be ordered so that the patient can easily selected the next appliance in the sequence when needed. Such ordering may be designated through packaging or the appliance itself. In some situations, the patient may receive additional appliances during the treatment protocol for inclusion in the sequence and/or the patient may receive instructions to eliminate some of the original appliances from the treatment protocol. Therefore, such ordering should allow easy incorporation of additional appliances or deletion of appliances. [0034] Alternatively, the patient may be provided with a subset of the entire series, such as the first ten appliances. In this case, the subset should be ordered so that the patient can easily selected the next appliance in the sequence when needed. Again, such ordering may be designated through packaging or the appliance itself. The patient may receive additional appliances during the use of the subset for inclusion in the sequence and/or the patient may receive instructions to eliminate some of the original appliances from the subset. Alternatively, the next subset of appliances may differ from that which was initial determined at the outset of the treatment protocol. Therefore, such ordering should allow easy incorporation of additional appliances or deletion of appliances within or between subsets. [0035] Further, the patient may be provided with individual appliances in the order in which they should be used. In this case, the appliances should be ordered so that the patient can easily differentiate the appliance they are receiving from the appliances already received. Again, such ordering may be designated through packaging or the appliance itself. In addition, such ordering should allow the appliances to be stored and distributed to the patient in the correct sequence with minimal attention from the orthodontic practitioner. [0036] A variety of embodiments of ordering systems and methods will be described. In a first embodiment, a series of appliances are dispensed to the patient in a continuous chain, wherein the appliances are to be used in the sequence of the chain. An example of such a chain is schematically illustrated in FIG. 1 . Here, each appliance 10 is disposed within a package 12 , wherein the packages 12 are joined together in a continuous chain. In this embodiment, each package 12 is separable at a perforation 14 from the remaining packages 12 in the chain. It may be appreciated that the packages may be joined and/or are separable in any suitable manner including with the use of adhesives, heat sealing, ultrasonic welding, linkages or simply indications where to cut, break or separate, to name a few. To indicate the end of the chain in which it begin use, a marking may be located on the package 12 or on the appliance 10 . For example, a colored marking 16 may be located on an end package 12 a , as shown. This would indicate that a first appliance 10 a is enclosed. Once the first appliance 10 a has been removed from the package 12 a and worn for a given amount of time, the patient may then open a next package 12 b in the chain and remove a second appliance 10 b for wearing. This may be repeated throughout the chain. [0037] In another embodiment, illustrated in FIG. 2 , a series of appliances 10 are disposed on a framework 20 , such as a sprue. Sprues typically secure objects, such as molded objects, before their first use. The appliances 10 are secured to the framework 20 in any suitable manner. The appliances 10 are then removed from the framework 20 according to a the treatment protocol. For example, the first appliance 10 a to be used may be disposed at one end of the framework 20 , the second appliance 10 b disposed next to the first appliance 10 a , the sequence continuing along the framework 20 . Alternatively or in addition, markings may be disposed on the framework 20 or the appliances 10 themselves indicating an ordering of use. [0038] In another embodiment, illustrated in FIG. 3 , a series of appliances 10 are provided to a patient in a dispenser 30 . The dispenser 30 dispenses the appliances 10 in the order to be used. Each appliance 10 may be individually dispensed, as shown, or each appliance 10 may be contained in a package wherein the packages are individually dispensed. The dispenser 30 may include an actuator 32 , such as a lever, button, switch, etc, so that actuation of the actuator 32 dispenses the appliance 10 or package containing the appliance 10 . Alternatively, removal of an appliance 10 from the dispenser 30 may actuate dispensing of the next appliance 10 . In this way, the patient is systematically dispensed appliances in a predetermined order of use. [0039] In some situations it may be desired to specifically mark the appliances themselves. Such markings ensure that ordering of the appliances is distinguishable after removal of the appliances from any packaging and during use. For example, a portion of each appliance may be changed to indicate a sequence or order. FIGS. 4A-4B illustrate a change in length of the appliance 10 by changing the length of a terminal tooth cavity 40 . A terminal tooth cavity 40 is one of the last teeth in the appliance. FIG. 4A illustrates a first appliance 10 a wherein a marked terminal tooth cavity 40 a has a given length. FIG. 4B illustrates a second appliance 10 b wherein a marked terminal tooth cavity 40 b has a length which differs from the first appliance 10 a . Here, the marked terminal tooth cavity 40 b has a shorter length. The lengths can continue to differ throughout the sequence of appliances. Alternatively or in addition, the lengths of other terminal teeth may differ. [0040] FIGS. 5A-5B illustrate a change in the height of each appliance 10 to indicate a sequence or order. The height of the appliance 10 is the distance from the occlusal surfaces 46 to the edges 48 of the appliance 10 . FIG. 5A illustrates a first appliance 10 a having a given height. FIG. 5B illustrates a second appliance 10 b having a height which differs from the first appliance 10 a . Here, the second appliance 10 b has a shorter height. The heights can continue to differ throughout the sequence of appliances indicating an order. It may be appreciate that the overall height of the appliance may differ or the height of specific portions of the appliance may differ through the sequence. [0041] FIGS. 6A-6B illustrate the addition of notches or cutouts 56 in each appliance 10 to indicate a sequence or order. The cut outs may be of any size, shape, orientation, or number forming any pattern. Further, the cut outs may be located on an edge 48 of the appliance 10 or on any surface, including an occlusal surface 46 . FIG. 6A illustrates a first appliance 10 a having a first cut out 56 a . The first cut out 56 a has a rectangular shape and is located near an edge 48 . FIG. 5B illustrates a second appliance 10 b having a second cut out 56 b so that the cut out pattern of the first appliance 10 a differs from that of the second appliance 10 b . Here, the second cut out 56 b also has a rectangular shape and is located near the edge 48 adjacent to the first cut out 56 a . The cut out patterns can continue to differ throughout the sequence of appliances indicating an order. [0042] FIGS. 7A-7C illustrate a change in color, such as a hue, gradation of hues, shade, tint or intensity, for each appliance 10 to indicate a sequence or order. For example, the appliances 10 may appear darker or lighter in color through the series, such as ranging from dark red to light pink or vice versa. Or, the sequence may follow the color of the rainbow, such as red, orange, yellow, green, etc. Or, the sequence may follow any other prescribed order of colors. FIG. 7A illustrates a first appliance 10 a having a first color 60 a . FIG. 7B illustrates a second appliance 10 b having a second color 60 b so that the color of the first appliance 10 a differs from that of the second appliance 10 b . The color changes can continue to differ throughout the sequence of appliances indicating an order. It may be appreciated that the appliances 10 a , 10 b may have the color over their entirety, as shown, or the appliances may be colored in some areas and not in others. Or multiple colors may be used on a single appliance, such as in stripes, blocks or various shapes. The color may be embedded in the appliance, such as with the use of a colored plastic rather than the typical clear plastic. Or, the color may be in the form of a dissolvable dye which dissolves in contact with air, such as upon removal from a package, or contact with liquid, such as when rinsed with water or placed in the patient's mouth. Alternatively, as illustrated in FIG. 7C , the color may be present in a peel-away wrapper 62 . The colored wrapper 62 may be attached to the appliance 10 by lamination or other methods. In this example, the wrapper 62 covers the occlusal surfaces 46 of the appliance 10 , however any portion of the appliance 10 may be covered. When the appliance 10 is to be used, the wrapper 62 is peeled away, as shown, and removed. In this way, the appliances may be ordered by color but worn in a transparent state. [0043] Alternatively or in addition, the patient may be provided with individual appliances in the order in which they should be used. To provide such ordering while allowing the appliances to be stored and distributed to the patient in the correct sequence with minimal attention from the orthodontic practitioner, a method may be used in which the appliances are delivered by mail in a specific sequence. FIG. 8 illustrates an embodiment of such a method. As shown, the appliances 10 are individually packaged so that a first package 80 contains a first appliance, a second package 82 contains a second appliance, a third package 84 contains a third appliance, etc. The packages 80 , 82 , 84 are sent through the mail or any delivery system so that they are delivered to the patient P according to a desired schedule. For example, the first package 80 is delivered to the patient P at day 1, the second package 82 is delivered at day 7, the third package 84 is delivered at day 14, etc. It may be appreciated that the individual packages may alternatively be comprises of series of appliances, such as subsets of the entire series of the treatment plan. In such a case, the patient P is delivered a package of appliances 10 at each interval, wherein each package includes a series of appliances. The series may itself also be ordered by any given system, including any of those mentioned above. [0044] FIG. 9 illustrates one appliance 10 of a series of appliances wherein the appliance 10 includes a readable element 100 embedded in the appliance 10 . Alternatively, the readable element 100 may be affixed to the appliance 10 or to a package enclosing the appliance. The readable element 100 may comprise a chip, a bar code or other element that is computer readable, including identification by wireless means, including radiofrequency (rf) identification. When a reader 102 passes over the element 100 , the reader 102 translates the information into a word, symbol or other identifying feature. When translated into a word, the word may include, “first”, “second”, “third”, or “last” to name a few. Also, the word may be in any language, including English, Spanish, French, German, Japanese, etc. The word or identifying feature may be auditory, such as a recording or generation of a spoken voice, or visual, such as a print display. Alternatively, the feature may be transmitted by tactile means, such as by vibration. [0045] FIG. 10 illustrates a series of packages 12 , each package 12 including at least one appliance 10 . Affixed to or incorporated in each package 12 is a label 100 . The label 100 includes at least one non-numeric indicia. For example, a first package 102 shows a label 100 having a series of numbers wherein one number is marked, in this case stamped with a colored dot 103 . This indicates which appliance 10 the first package 102 contains in the treatment sequence. It may be appreciated that the number can be marked with any symbol by any method, including removing the number by erasure, punch-out or notching. It may also be appreciated that other symbols may be used other than numbers, wherein one of the symbols is marked. This is illustrated in a second package 104 which shows such a label 100 . A third package 106 shows a label 100 having a series of symbols, such as shapes, in this case, trianglesl 20 . The symbols themselves or the color, number, or arrangement may indicate which appliance 10 the third package 106 contains in the treatment series. It may be appreciated that such symbols may include stripes, as illustrated on a fourth package 108 which shows such a label 100 . The stripes may be human readable or computer readable, such as a barcode. [0046] FIG. 11 illustrates an embodiment of a package of dental appliances comprising a package 12 including a plurality of dental appliances 10 positioned in an arrangement within the package 12 which indicates an order of usage. In this embodiment, the arrangement comprises stacking of the appliances. [0047] 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 obvious that various alternatives, modifications and equivalents may be used and the above description should not be taken as limiting in scope of the invention which is defined by the appended claims.

The present invention provides systems and methods for providing dental appliances, particularly orthodontic appliances, to a patient wherein the patient is easily able to determine the order or sequence in which the appliances should be worn. Typically the appliances are to be worn in a particular sequence to provide desired treatment, such as a progressive movement of teeth through a variety of arrangements to a final desired arrangement.

FIELD OF THE INVENTION This invention relates to a method of forming a dental coping for use in the preparation of a dental restoration. BACKGROUND OF THE INVENTION A metal coping is used in dentistry in the construction of a dental crown and/or a bridge. The metal coping functions as the under structure of the crown and is usually covered, for reasons of aesthetics, with a fired-on coating of a ceramic porcelain composition or a polymer based veneering material. The metal coping supports the coating and provides the required structural strength and rigidity for the restored tooth to resist the forces of mastication. A metal coping may be cast from an investment of a wax or plastic pattern of the tooth to be restored. An alternative procedure for forming a precious metal coping which does not require waxing, investing or casting has currently been gaining wide acceptance in the dental profession by both dentists and dental laboratories. This alternative procedure requires the use of a moldable material composition formed from a base material composed of a mixture of high and low fusing temperature metal particles and a binder preferably of dental wax as is disclosed, for example, in U.S. Pat. Nos.: 5,234,343, 5,593,305 and 5,730,600 respectively, each disclosure of which is herein incorporated by reference. The dental material is molded over a die into the shape of the tooth to be restored and heat treated at an elevated temperature above the melting temperature of the low fusing temperature metal particles and below the melting temperature of the high fusing temperature metal particles. Heat treatment transforms the molded structure into a porous metallic shell having the same shape as before heat treatment without suffering any significant shrinkage. The dental wax in the molded material vaporizes during heat treatment leaving the porous metallic shell with a high void volume of preferably above at least 20%. A filler material of metal or ceramic is melted into the porous shell to densify and solidify the shell into a dental coping having the identical shape of the die and in the tooth preparation as prepared by the dentist or dental laboratory. The filler material may be added either in a secondary heat treatment operation or during the primary heat treatment of the dental material. The base material of high and low fusing temperature metal particles and wax binder may be configured into any geometrical shape for use by the dental laboratory such as, for example, in the form of a thin compacted strip of rectangular geometry. Likewise the filler material which is preferably of a precious metal such as gold or a gold alloy and wax binder may be configured into any geometrical shape preferably corresponding to the shape of the base material. The method currently employed to form a coping from separate strips of base material and filler material is a labor intensive hand molding procedure in which the base material is cut into pieces each of which is applied by hand to the die. Thereafter the base material is adapted to the die by hand alone or in combination with a hand burnishing tool. An automated mechanism may also be used to adapt the base and filler materials to the die and to mold them over the die. These steps to adapt and mold the material to the die may be accomplished with the help of air pressure, water pressure, mechanical pressure or vacuum. The molded structure of base material is then heat treated to transform the molded structure into a porous metallic shell. Filler material is then melted into the porous shell in a heat treatment operation which may be performed independent of the heat treatment of the base material or alternatively by heat treating both the base and filler materials sequentially in a single heat treatment operation. The hand molding operation is time consuming and labor intensive. Since the base material is a composition of precious metals and/or alloys the adaptation procedure is carried out in a way to minimize the loss of base material into waste. Moreover, once the base material is placed into contact against the die it may be contaminated and, if so, cannot be readily recycled. SUMMARY OF THE INVENTION An automated method has been discovered in accordance with the present invention to form a dental coping from a sheet of metallic material and preferably from a first sheet of a base composition of high and low fusing temperature metal particles and a binder and a second sheet of a filler material or a laminate of a base material and filler material with the method resulting in reducing the need for human intervention. The first and second sheets of material may be placed on top of one another to form an single sheet of two layers and/or the base and filler may themselves be represented by multiple layers. The filler material should be of precious metal or ceramic and the base material composition should preferably be relatively soft and malleable and of metal(s) or metal alloys which are compatible for use by the dental profession to restore teeth. The base material and filler material composition taught in the aforementioned patents are the preferred materials. The automated method of the present invention for forming a dental coping comprises: scanning a three dimensional image of the die of the tooth or teeth to be restored; digitizing the scanned three dimensional image into digital information, storing the digital information in a computer; feeding the digital information from the computer into a computerized numerical control cutting machine; cutting out a section of material of metallic composition into a two dimensional configuration representing a two dimensional lay out of the scanned three dimensional image, adapting the cut out section of material over the die so that the material covers the die surface in close engagement therewith to form a single three dimensional structure having the shape of the die and heat treating the structure into a coping conforming in shape to the die. In accordance with the present invention when two separate sheets of base and filler material are used a section of each sheet is cut out to form a two dimensional lay out of of the scanned three dimensional image of the die with the cut out section of filler material placed over the molded structure of base material before or after heat treatment. The cut out section of filler material should be equal or different in dimension so that the surface area of the cut out section will fill the porous structure of base material after heat treatment leaving slightly less filler material around the rim which forms the margin. In a preferred alternative embodiment of the method of the present invention the die of the tooth or teeth to be restored may be formed having at least one reference marker such that the two dimensional lay out of base material will have a complementary reference marker to assist in providing a starting location or for establishing alignment when wrapping the cut out section of base material over the die. In this way the reference marker may be used to facilitate the adaptation of the two dimensional cut out section to the die. An additional reference marker may be formed in the two dimensional cut out section either manually or automatically to provide accuracy during placement and proper alignment in the adaptation of the cut out section of base material to the die. BRIEF DESCRIPTION OF THE DRAWINGS Additional advantages of the present invention will become apparent from the following detailed description of the invention when read in conjunction with the accompanying drawings of which: FIG. 1 is a schematic diagram of an arrangement for scanning a three dimensional image of a die prepared from an impression of a tooth for forming a coping in accordance with the present invention; FIG. 2 ( a ) is a typical die configuration for a prepared premolar tooth shown from the buccal side of the tooth; FIG. 2 ( b ) is a similar view of the prepared die for the premolar tooth of FIG. 2 ( a ) shown from the distall or mesial side of the tooth; FIG. 3 ( a ) is a typical die configuration for a prepared central tooth shown from the buccal side of the tooth; FIG. 3 ( b ) is a similar view of the prepared die for the central tooth of FIG. 3 ( a ) shown from the distal or mesial side of the tooth; FIG. 4 ( a ) is a typical die configuration for a prepared canine tooth shown from the buccal side of the tooth; FIG. 4 ( b ) is a similar view of the prepared die for the canine tooth of FIG. 4 ( a ) shown from the distal or mesial side of the tooth; FIG. 5 ( a ) is a typical die configuration for a prepared molar tooth shown from the buccal side of the tooth; FIG. 5 ( b ) is a similar view of the prepared die for the molar tooth of FIG. 5 ( a ) shown from the distal or mesial side of the tooth; FIG. 6 ( a ) is a plan view of a two dimensional layout of the surface configuration for a typical premolar tooth in accordance with the present invention; FIG. 6 ( b ) is plan view of another two dimensional layout of the surface configuration for a typical premolar tooth in accordance with the present invention; FIG. 6 ( c ) is yet another plan view of another two dimensional layout of the surface configuration for a typical premolar tooth in accordance with the present invention; FIG. 7 ( a ) is a plan view of a two dimensional layout of the surface configuration for a typical central tooth in accordance with the present invention; FIG. 7 ( b ) is a view similar to that of FIG. 7 ( a ) showing the two dimensional layout with its outer edge beveled and showing a reference projection in accordance with the present invention; FIG. 7 ( c ) is plan view of another two dimensional layout of the surface configuration for a typical central tooth in accordance with the present invention; FIG. 8 ( a ) is a plan view of a two dimensional layout of the surface configuration for a typical canine tooth in accordance with the present invention; FIG. 8 ( b ) is plan view of another two dimensional layout of the surface configuration for a typical canine tooth in accordance with the present invention; FIG. 9 ( a ) is a plan view of a two dimensional layout of the surface configuration for a typical molar tooth in accordance with the present invention; FIG. 9 ( b ) is a plan view of another two dimensional layout of the surface configuration for a typical molar tooth in accordance with the present invention; FIG. 9 ( c ) is yet another plan view of a two dimensional layout of the surface configuration for a typical canine tooth in accordance with the present invention; FIG. 9 ( d ) is a view substantially similar to that of FIG. 9 ( c ) showing the two dimensional layout with its outer edge beveled and showing two reference projections in accordance with the present invention; and FIGS. 10 ( a ), ( b ) and ( c ) show a number of different configurations for the mating ends of the cut out sections so as to form seams either in an abutting relationship as in FIG. 10 ( a ) or in an overlapping relationship as in FIGS. 10 ( b ) and 10 ( c ) respectively. DETAILED DESCRIPTION OF THE INVENTION A schematic diagram of a preferred arrangement for scanning a three dimensional image of a stone or refractory die 10 prepared from an impression of a tooth to be restored is shown in FIG. 1 . The die 10 is positioned in juxtaposition relative to three CCD cameras or diode lasers 12 , 14 and 16 and is spatially separated 90° or more apart from one another along three coordinate axes x, y and z respectively so that the cameras or lasers 12 , 14 and 16 face opposite surfaces surrounding the die 10 . The diode lasers 12 , 14 and 16 are moved relative to the die 10 or vice versa to scan the surface of the die 10 on all sides thereof to generate coordinate data representative of the three dimensional image of the die. The coordinate data corresponding to the three dimensional image of the die 10 is stored in digital form in the memory of a computer 18 . As an alternative to the arrangement shown in FIG. 1 a single laser beam may be arranged in a plane lying preferably at an angle such as 45° to the die while the die is rotated a complete 360°. The latter is equivalent to the operation of an electromechanical stylus placed in physical contact with the die as the die is rotated. Another alternative is to form a shadow of the die by a projection from a light source and to scan the projection while rotating the die. It is to be understood that many alternatives are conventionally known to form a three dimensional image of an object such as a die and to convert the coordinates into digital information. Moreover, although FIG. 1 shows the use of three cameras or three lasers it is to be understood the subject invention is not limited to any specific number of cameras or lasers and that an electromechanical scanning device may equally be used. Moreover any conventional method may be used to scan the die to form a three dimensional image and any conventional method may be used for converting the three dimensional image into digital data for storage in a computer. In accordance with the present invention the digital data corresponding to the three dimensional image of the die 10 is used to form a two dimensional rendering of the surface topography of the die 10 hereafter referred to as a two dimensional lay out which is automatically cut out from a sheet of material using a conventional computer controlled CC mill or conventional CC lathe (not shown) or other such conventional computer controlled cutting device hereafter referred to as a numerical controlled cutting machine. The material used to form a cut out of the three dimensional image may be a single sheet of dental material representing a laminate of a base material and filler material as taught earlier or may be cut out from separate sheets of base and filler material as taught in the aforementioned patents. The base and filler materials may each be divided into two or more layers to form multilayers of the base and filler materials. The preferred base material is composed of high and low fusing temperature metal particles selected from one or more metal or metal alloys, preferably of precious metals such as platinum and palladium in any desired proportion relative to one another from zero to one hundred percent in addition to a binder preferably of wax. Additional constituents may be added such as gold, silver, copper, magnesium, aluminum, zinc, gallium, indium and other metals selected from the third, fourth or fifth group of elements of the periodic table. The total weight percent of the metallic elements other than gold, silver, and the platinum group metals should not exceed ten percent. The filler material is composed primarily or entirely of low fusing temperature metal particles preferably of gold or a gold alloy and the wax binder may vary widely although preferably between about twenty percent by volume and up to eighty percent by volume of the base material composition. Any wax may be used which is relatively soft and tacky to form the binder and may be selected from any natural wax, mineral wax, or organic wax composition. As indicated above the base and filler materials may constitute separate sheets of material or a dual laminate. When two sheets are used a cut out of each is formed in accordance with the present invention with the cut out of filler metal placed over the cut out of base material after the base material cut out is heat treated or before it is heat treated. In the latter case both may be heat treated in sequence in a dental furnace. When the base and filler material are separate sheets the cut out sections may be identical in dimension or different in dimension. When a dual sheet of base and filler material is used only one cut out is necessary. The coordinate data corresponding to the three dimensional image of the die 10 is fed from the computer 18 to the numerical controlled cutting machine (not shown) for performing a conventional CAD-CAM routine so that the numerical controlled cutting machine will cut out a section from a thin sheet of material having a geometry with a surface area resulting in a two-dimensional rendering of the topography of the die 10 . Typical die configurations for different typical tooth preparations for a premolar, central, canine and molar tooth is shown in FIGS. 2-5 respectively with FIGS. 6-9 representing a plan view of different two-dimensional renderings of the surface configuration corresponding to the different die configurations of FIGS. 2-5. Each plan view shows a cut out section which is cut out by the numerically controlled cutting machine from the base and filler materials respectively. Accordingly, FIG. 6 ( a ) shows one configuration of a cut out section 20 representing a two dimensional layout of the surface configuration for a typical premolar tooth which is intended to be adapted to the die 10 by placing the center 21 of the cut out section 20 over the occlusal surface of the die and folding back the flap portions 22 . Alternatively, the cut out section 20 for the same premolar tooth of FIG. 6 ( a ) may be configured as shown in FIGS. 6 ( b ) and 6 ( c ) so that the cut out section 20 may be wrapped about the circumference of the die 10 before folding over the cut out section flaps 23 or 24 over the occlusal surface of the die 10 . The configuration of the cut out section 20 will depend on the surface geometry of the tooth preparation which is determined by the dentist before the die 10 of the tooth is taken. The configuration which will result in causing the least number of seams needed to adapt the cut out section 20 to the die 10 and with minimal pleats is preferred. The selection of the configuration can be determined by mathematical calculation and/or after repeated experimentation and experience and written into the software for controlling the numerical cutting machine. The cut out sections 20 of FIGS. 7, 8 and 9 are plan views for a typical central, canine and molar tooth respectively and although of different shape and surface configuration from that of FIG. 6 they all represent two-dimensional renderings in accordance with the present invention of the surface configuration corresponding to the different die configurations. Once again the cut out section 20 may be configured to form sectors 25 and 26 which as shown in FIG. 7 ( a ) will readily fold over the occlusal surface of the die 10 or wrapped as one section about the circumference of the die 10 as shown in FIG. 7 ( c ) with the cut out section 20 having flaps 27 and 28 which fold over the occlusal surface of the die 10 . A cut out section 20 may be cut out to form a beveled edge 29 around the outer rim as shown in FIG. 7 ( b ). Moreover, the die 10 may be formed with a reference/alignment marker (not shown) to identify the proper placement for the cut out section 20 when adapting it to the die 10 . The reference/alignment marker (not shown) can be of any shape and in any form representing, for example, a slit or groove located on the die 10 preferably at a position extending from the margin of the die 10 . When the die 10 is formed with a reference marker the cut out section 20 will automatically form a corresponding marker 30 which may appear as a projection extending from the cut out section 20 . The marker 30 may also be used for alignment. However to provide both reference and alignment two markers 30 and 32 are preferred with the different markers having different shapes as shown in FIG. 9 ( d ). In this way no error can be made in alignment particularly if the cut out section 20 is adapted to the die 10 by use of a robot. The two dimensional cut out section(s) 20 of all of the different configurations shown in FIGS. 2-9 have mating ends 35 which form one or more seams when the cut out section 20 is placed or wrapped over the die 10 . The seams are formed by abutting the mating ends 35 together as shown in FIG. 10 ( a ). In many instances an overlap of the mating ends is preferred and the thickness of the seam formed at the overlapping mating ends may be reduced by mechanical or automatic means. To minimize the thickness formed by an overlapping seam the mating ends 35 can be beveled as shown in FIG. 10 ( b ) or otherwise contoured as for example as shown in FIG. 10 ( c ) to form an interlock at the mating ends 35 . Where the tooth preparation results in a cut out section 20 having a complicated surface configuration and/or where many seams will be necessary the mating ends 35 should be beveled to accommodate an overlap. Moreover, by overlapping the mating ends 35 the thickness of the seam can be controlled. The mating ends 35 may abut one another in which case there is no difference in thickness at the abutting seam. To control the formation of seams at the mating ends 35 and to control the thickness of the seams a burnishing tool may be used. The burnishing tool may be applied after placement of the cut out section 20 over the die. Alternatively, the thickness can be smoothed out with the use of fingers or a swedger may be used. The burnishing tool or hand may be used in conjunction with the application of hot air and/or vacuum. One edge of the seam may be beveled with the mating edge placed over it and unified using a mechical burnisher. The cut out section of base material may be more easily fitted over the die by applying heat to the cut out section. Heat may be applied from a hot air applicator or from a lamp or from any other applicator which will provide a source of heat at a temperature within a temperature range of e.g. 25° C.-60° C. sufficent to soften the cut out section and render more pliable and tacky without causing it to become too soft and limp. In this way the warmed cut out section will easily adapt to the geometry of the die and will simplify any reduction in seam thickness, if necessary. Thereafter the molded cut out section is allowed to reharden upon the die. The molded cut out section can be removed from the die, particularly if hard waxes were used in the base composition, and heat treated as a self supporting structure at an elevated temperature for forming a coping or for forming a porous shell depending upon whether the cut out section is a dual layer of base and filler material or only a base material. Alternatively the cut out section may be heat treated on a refractory die. If the cut out section is composed only of base material a cut out of filler material may also be formed from the three dimensional information of the die and adapted to the die over the base cut out. Alternatively, the cut out of base material after it is heat treated can be dipped into a molten filler material bath.

An automated method for forming a dental coping which comprises: scanning a three dimensional image of the die of the tooth or teeth to be restored; digitizing the scanned three dimensional image into digital information, storing the digital information in a computer; feeding the digital information from the computer into a computerized numerical control cutting machine; cutting out a section of material of metallic composition into a two dimensional configuration representing a two dimensional lay out of the scanned three dimensional image, adapting the cut out section of material over the die so that the material covers the die surface in close engagement therewith to form a single three dimensional structure having the shape of the die and heat treating the structure into a coping conforming in shape to the die.

CROSS-REFERENCE TO RELATED APPLICATION [0001] The present application is a continuation-in-part of U.S. Ser. No. 12/263,310, filed Nov. 6, 2008. BACKGROUND OF THE INVENTION [0002] The present invention relates generally to agricultural implements and, more particularly, to a seed boot for use with a disc opener that collectively provides a double-shoot, single pass deposition of fertilizer and seed onto a planting surface. [0003] Fertilizer and seed are generally deposited onto a planting surface in either a single shoot or double shoot manner. With a single shoot planting technique, a mixture of seed and fertilizer is deposited into a single furrow and subsequently packed. With a double shoot planting technique, seed and fertilizer are deposited into separate furrows, which may or may not be closely spaced, and then packed. [0004] A single shoot planting device typically has a single delivery hose through which the mixture of granular fertilizer and seed is delivered to the furrow. More particularly, a single shoot planting device will typically include a cutting tip that is dragged at a depth just below the planting surface. The delivery hose extends along a backside of the cutting tip, or knife, so that the fertilizer and seed mixture is deposited into the furrow immediately after the cutting tip cuts into the planting surface. Ideally, the mixture is deposited in to the furrow before the furrow collapses. The furrow is typically packed by a trailing packing or press wheel. [0005] Another configuration of a single shoot planting device replaces the knife with a disc or coulter that rotates at an angle relative to a line of travel to form a furrow or trench in the planting surface. Because of the angling of the disc, the leading face of the disc pushes soil to one side and creates the furrow while the opposite, trailing face of the disc runs in the “shadow” of the leading face. The seed/fertilizer mixture is dropped to the bottom of the furrow while the furrow is held open by the disc and a cooperating plate (or scraper or seed boot) on the other side. The penetration depth of the disc controls the seed depth. A trailing packer wheel closes the furrow after the mixture is deposited and firms the planting surface (soil). [0006] While single shoot planting units are less complex, it is generally preferred to use a double shoot planting unit which allows seed and fertilizer to be separately deposited into the furrow. When the fertilizer and seed are mixed, reduced concentrations of fertilizer must be used to prevent the seed from becoming damaged, i.e., “burnt”. In one exemplary double shoot planting unit, a knife has a side tip (side bander) that trails the leading knife as the planting unit is towed along the planting surface. The knife creates a furrow or fertilizer trench and the side bander forms a ledge in the sidewall of the furrow to effectively form a seed trench or seed bed. The fertilizer and seed trenches are separated from one another both horizontally and vertically. This separation provides a fertilizer/seed stratification that has been found to provide better growing conditions, i.e., higher concentrations of fertilizer may be used without seed “burning”. [0007] In yet another type of double shoot planting unit a pair of rotating discs are used to form separate fertilizer and seed trenches having horizontal and vertical stratification. The leading disc cuts through the planting surface at an angle to cut a furrow or fertilizer trench. A trailing disc cuts through the side of the furrow formed by the leading disc to cut a seed trench that is generally horizontally and vertical offset from the fertilizer trench. U.S. Pat. No. 5,752,454 describes a dual disc, double shoot planting unit. [0008] Dual disc units, such as that described in U.S. Pat. No. 5,752,454, are relatively complex structures with multiple rotating parts such as the discs themselves and associated bearings. This complexity also adds to the overall cost of the planting unit and the implement. Dual disc units, such as those described in the aforementioned patent, have also been found to perform unsatisfactorily in soft soil conditions. More particularly, the discs are generally angled to essentially “dig” into the soil surface to cut a furrow. Since the discs dig into the surface, less down pressure is needed. In harder soil conditions, the disc will effectively dig into the soil as the soil itself provides bias against which the disc can leverage. However, in soft soil conditions, the disc will essentially “plow” through the soil rather than cut an open furrow. Furthermore, to accommodate the space needed for two rotational elements, the distance between the leading and trailing discs is relatively substantial and can led to disturbance of the furrow before the seed is planted. That is, depending upon soil conditions, the furrow may collapse upon itself before the trailing disc cuts a seed bed into the furrow formed by the leading disc. The spacing between the discs also reduces seeding accuracy in rolling terrain, as well as adding to the overall size, weight, and cost of the carrying frame. SUMMARY OF THE INVENTION [0009] The present invention is directed to a planting unit for depositing fertilizer and seed in a single pass, double shoot manner in which a rotating disc cuts a furrow in a planting surface and a trailing seed boot, having a cutting edge, cuts a vertically and offset trench in the furrow to form a seed bed in the planting surface. The disc has a mounting frame for mounting the disc to a linkage assembly that is, in turn, coupled to a toolbar mount. The seed boot is also attached to the mounting frame. This common attachment provides a relatively short and compact device without sacrificing fertilizer and seed stratification. [0010] In operation, the rotating disc, which sits at an angle relative to a line of travel, is pulled through the planting surface along the planting surface to cut a furrow into the planting surface. The furrow effectively defines a fertilizer trench into which fertilizer may be deposited from a fertilizer source through a fertilizer tube. The seed boot has a cutting edge that when pulled through the planting surface cuts a seeding trench in the furrow that is offset both vertically and horizontally from the fertilizer trench. Rearward of the cutting edge is a seed tube through which seed is passed and deposited into the seed trench. In one embodiment, a tab extends from a rearward edge of the seed tube that is designed to reduce the fall of seed into the fertilizer trench. In addition, the tab is also operative to reduce the ingress of soil or residue into the seed tube. [0011] It is therefore an object of the invention to provide a planting unit that furrows a planting surface into separate fertilizer and seed trenches with minimal soil disturbance. [0012] It is another object of the invention to provide fertilizer and seed stratification with a rotating disc and a seed boot having a cutting edge, wherein the seed boot and the rotating disc are coupled to a shared mount. [0013] Therefore, in accordance with one aspect of the invention, a planting unit for use with a planting implement having a frame and configured to travel along a line of travel is disclosed. The planting unit has a disc mount configured to be coupled to the frame and a rotatable disc coupled to the disc mount and angled relative to the line of travel of the planting implement. The disc is configured to cut a furrow into a planting surface. A fertilizer tube is mounted to the disc mount and configured to deposit fertilizer into a fertilizer trench formed in the furrow. The planting unit further includes a seed boot coupled to the disc mount rearward of the fertilizer tube and the disc. The seed boot includes a hollow tubular member through which seed may be passed and deposited onto the planting surface, and a cutting edge configured to cut a ledge into the furrow onto which seed may be deposited. [0014] In accordance with another aspect of the invention, a double-shoot, single pass implement for separately depositing fertilizer and seed with horizontal and vertical stratification onto a planting surface includes a toolbar configured to be coupled to a towing vehicle which is designed to pull the frame along the planting surface with a generally longitudinal line of travel. A plurality of disc openers are provided with each opener connected to the toolbar by a respective linkage assembly. Each disc opener includes a disc mount coupled to a corresponding linkage assembly and a rotatable disc mounted to the disc mount and configured to cut at an angle into the planting surface to form a fertilizer trench. A fertilizer tube is provided and is mounted to the disc mount generally adjacent the rotatable disc. Each opener also has a seed boot mounted to the disc mount and configured to cut a seed trench offset from the fertilizer trench. The seed boot includes a seed tube having a forward cutting edge and an outlet rearward of the fertilizer tube, and a tab connected to the seed tube generally opposite the forward cutting edge and extending rearward of the seed tube outlet. [0015] According to yet another aspect of the invention, a furrowing and planting apparatus for use with an agricultural implement has a rotating disc configured to furrow a planting surface to define a fertilizer trench and a fertilizer source adapted to deposit fertilizer onto the fertilizer trench. The apparatus also has a seed boot disposed rearward of the rotating disc that includes a tubular member having a forward cutting edge that cuts a seed trench in the furrow. A deflector is mounted to a rearward edge of the seed boot and is operative to reduce the ingress of soil into the tubular member of the seed boot, particularly during roll back of the agricultural implement. [0016] Other objects, features, aspects, and advantages of the invention will become apparent to those skilled in the art from the following detailed description and accompanying drawings. It should be understood, however, that the detailed description and specific examples, while indicating preferred embodiments of the present invention, are given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the present invention without departing from the spirit thereof, and the invention includes all such modifications. BRIEF DESCRIPTION OF THE FIGURES [0017] Preferred exemplary embodiments of the invention are illustrated in the accompanying drawings in which like reference numerals represent like parts throughout. [0018] In the drawings: [0019] FIG. 1 is a side elevation view of a planting unit according to one embodiment of the invention that includes a tool bar mount for coupling the planting unit to a toolbar of an agricultural implement; [0020] FIG. 2 is a schematic view of the disc of the plating unit shown in FIG. 1 shown relative to a furrow formed along a line of travel; [0021] FIG. 3 is a bottom view of the planting unit shown in FIG. 1 ; [0022] FIG. 4 is a rear elevation view of the planting unit shown in FIG. 1 ; [0023] FIG. 5 is a rear elevation view of the planting unit shown in FIG. 1 with a seed boot and packing system removed; [0024] FIG. 6 is a partial exploded view of the planting unit shown in FIG. 1 ; [0025] FIG. 7 is an isometric view of the seed boot of the planting unit shown in FIG. 1 ; [0026] FIG. 8 is an end view of the seed boot shown in FIG. 7 ; [0027] FIG. 9 is an exploded view of the depth adjustment assembly of the planting unit shown in FIG. 1 ; [0028] FIG. 10 is an isometric view of a planting unit having a clamped on secondary seed boot according to another embodiment of the invention; [0029] FIG. 11 is a side elevation view of a planting unit having a secondary seed boot clamped to a trailing arm according to a further embodiment of the invention; and [0030] FIG. 12 is a side elevation view of a planting unit having a secondary seed boot fastened to a trailing arm according to yet another embodiment of the invention. DETAILED DESCRIPTION OF THE INVENTION [0031] The present invention is generally directed to a planting unit for us with an agricultural implement. While only one planting unit will be described, it is understood that the agricultural implement may include a plurality of such planting units [0032] FIG. 1 shows a planting unit 10 according to one embodiment of the invention. The planting unit 10 generally includes a forward disc 12 that is angled relative to a line of travel. As known in the art, the forward disc 12 rotates about a center hub 14 to cut a furrow into the planting surface, S. A seed boot 16 is mounted rearward of the disc 12 , and as will be described, is designed to cut a seed trench into the furrow formed by the disc 12 . The disc 12 is coupled to a parallel linkage 18 by a disc mount 20 which has a mount arm 22 extending upwardly from the disc mount 20 . A trailing arm 24 is also coupled to the parallel linkage 18 and a press or packing wheel 26 is coupled to the trailing arm 24 . The press wheel 26 trails the disc 12 and the seed boot 16 , and as known in the art, applies a packing pressure to the furrow. The downward force is applied by spring 28 , but it is understood that other biasing devices may be used. In addition, the amount of downward force can be varied via lever 30 which has a selector member 32 that can be selectively positioned in one of a series of notches 34 of curved member 36 . [0033] The parallel linkage 18 is also coupled to a toolbar mount 38 that is operative to couple the planting unit to a toolbar 40 of an agricultural implement. A hydraulic cylinder 42 is pivotably coupled to the toolbar mount 38 and the mount arm 22 by a bracket 44 , but it is understood other devices such as a spring or air bag could be used. The cylinder 42 is operative to apply a downward pressure on the disc 12 to force the disc 12 into contact with the planting surface. With additional reference to FIG. 9 , the depth at which the disc 12 cuts into the planting surface is variably set by a gauge wheel 46 and a cooperating gauge wheel arm 48 and a control lever 50 . The control lever 50 controls the gauge wheel arm 48 by a crankshaft 52 that extends through the center of the disc 12 . The gauge wheel arm 48 is held in place by teeth 54 that interface with a mating fan shaped member 56 , which includes a series of notches 58 that individually define a different depth the disc 12 can be set via positioning of the control lever 50 . Various fasteners 57 , e.g., nuts, bearing 59 , washers 61 and seal 63 are used to secure the crankshaft 52 to the disc 12 via a hub 65 that is coupled to the disc 12 by fasteners 67 . [0034] In addition to setting the depth at which the disc 12 cuts into the planting surface, the depth gauge wheel 46 keeps the outer surface of the disc 12 generally clear of mud and debris. A scraper blade 60 is mounted opposite the depth gauge wheel 46 is designed to remove dirt, mud, and other debris from the inner surface of the disc 12 . [0035] The planting unit 10 is designed to separately drop fertilizer and seed into the furrow in a single pass. In this regard, a fertilizer tube 62 is mounted rearward of the center hub of the disc 12 but forward of the seed boot 16 . The seed boot 16 generally includes a seed tube 64 and a cutting member 66 that is forward of the seed tube 64 . In operation, as the disc 12 forms a furrow having a relatively deep fertilizer trench in the planting surface, fertilizer is dropped into the fertilizer trench from a fertilizer source (not shown) that communicates with the aforementioned fertilizer tube 62 . The cutting member 66 is offset from the disc 12 and cuts into a sidewall of the furrow to form a ledge or seed bed. Seed is then dropped via the seed tube 64 onto the ledge. The seed is fed to the seed tube 64 from a seed source in a known manner. [0036] The cutting member 66 cuts into the sidewall of the furrow such that the ledge is offset horizontally and vertically from the fertilizer trench, i.e., bottom of the furrow. In this regard, the seed is deposited at a position that is spaced horizontally and vertically from the fertilizer that is dropped into the fertilizer trench. As noted above, it is generally preferred to plant seed and drop fertilizer into a furrow with stratification between the fertilizer and the seed. [0037] In one preferred embodiment, the cutting member 66 is angled to lift the soil as the cutting member 66 is urged through the sidewall of the furrow. Thus, as the disc 12 and the cutting member 66 cut through the planting surface, the soil is temporarily displaced and lifted to form trenches for the deposition of fertilizer and seed. However, when disc 12 and the cutting member 66 pass, the soil will tend to fall back onto itself and effectively fill-in the furrow and thus the fertilizer and seed trenches. The press wheel 26 , which trails the seed boot 16 , then packs the fertilizer and the seed. Alternately, the cutting member 66 may be angled downward to force the soil down onto the fertilizer before the seed is deposited onto the seed bed. [0038] In one preferred embodiment, a defector tab 68 extends from the backside of the seed tube 64 . The deflector tab 68 generally provides two separate functions. First, the deflector tab 68 is angled, as shown in FIGS. 6 and 7 , as is the lower ends of the seed tube 64 and the cutting member 66 . With this angled orientation, the deflector tab 68 is operative to encourage seed toward the seed trench. Second, because of its proximity to the seed tube 64 , the deflector tab 68 reduces the ingress of soil and debris into the seed tube 64 during roll back of the planting unit 10 . [0039] Referring now to FIG. 2 , the disc 12 is angled relative to the furrow F that is formed by the disc 12 as it is rotated. The furrow F is formed generally in-line with the line of travel for the agricultural implement. The disc 12 is angled such that the angle formed between the leading edge 12 a of the disc 12 and the line of travel, which generally bisects the furrow F, is approximately 7 degrees. While other angles are contemplated, it is generally preferred that the angle fall between 5 and 10 degrees, and more preferably between 6 and 8 degrees. It will be appreciated that while the disc is angled relative to the line of travel, the disc is normal to the plane of the planting surface. [0040] Turning now to FIGS. 3-5 , the fertilizer tube 62 is arranged such that the fertilizer falls generally centered in the furrow. The seed tube 64 has an outlet 70 that is angled generally rearward and laterally offset from the outlet (not numbered) of the fertilizer tube. As noted above, the seed trench is formed laterally offset from the fertilizer trench. This offset is formed because the seed boot 16 is generally angled away from disc 12 , as particularly shown in FIG. 4 , such that the cutting member 66 forms a side bander. The angle defined between the leading edge 66 a of the cutting member 66 and an axis transverse to the line of travel is preferably between approximately 5 to approximately 45 degrees. The depth of the seed tube outlet 70 is less than the lower most edge of the disc 12 and the seed tube outlet 70 is laterally offset from the disc 12 clearly illustrating the vertical and horizontal spacing of the fertilizer and seed trenches. [0041] As shown in FIGS. 6 and 7 , the seed boot 16 includes a header 72 that may be coupled to the disc mount 20 via fasteners 74 . Since the header 72 is mounted to the same mount 20 as the disc 12 , the combined assembly is relatively compact when compared to conventional double shoot, single pass planting units. [0042] As shown in FIG. 8 , the seed boot 16 is constructed such that seed tube outlet 70 sits behind the cutting member 66 . With this construction, the cutting member 66 cuts a ledge into the sidewall of the furrow and seed is placed onto the ledge as the seed drops through the seed tube outlet 70 . The cutting member 66 generally includes an angled cutting face 76 that in one embodiment includes a wear resistant insert 78 , such as a carbide insert. In one preferred embodiment, the seed tube 64 and the cutting member 66 , and its header 72 are formed as a single assembly. [0043] As described above, in one embodiment, the seed boot 16 has a generally flat header 72 with mounting holes (not numbered) formed therein that align with mounting holes in the disc mount 20 and fasteners 74 , such as bolts, may be used to couple the seed boot 16 to the disc mount 20 . It is understood however that the seed boot 16 could be mounted to the disc mount 20 in other ways. For example, as shown in FIG. 10 , a clamp 80 could be used. Similarly, as shown in FIG. 11 , clamp 80 could be used to mount the seed boot 16 to the trailing arm 24 of the press wheel 26 . In yet another embodiment and referring to FIG. 12 , holes (not shown) could be formed in the trailing arm 24 to allow the header 72 of the seed boot 16 to be fastened to the trailing arm 24 using fasteners 74 in a manner similar to the mounting to the disc mount 20 shown in FIG. 6 . Whether by a clamp or by fasteners, mounting the seed boot 16 to the trailing arm 24 would allow the seed depth (the depth at which seed or other particulate matter is deposited from the seed boot 16 ) to be set by the press wheel 26 . It will be appreciated that clamps other than the types shown in the figures could be used to clamp the seed boot 16 to either the disc mount 20 or the trailing arm 24 . [0044] The present invention provides a planting unit of relatively compact design in which a seed boot and a rotatable disc are mounted to the same disc mount. The seed boot has an angled cutting tip that cuts a ledge into the sidewall of a furrow formed by the rotatable disc. A seed tube rearward of the cutting tip deposits seed onto the ledge. A trailing press wheel then packs the fertilizer and seed. The ledge is cut vertically and horizontally spaced from the bottom of the furrow (fertilizer trench). In this regard, seed and fertilizer are deposited with vertical and horizontal stratification allowing higher concentrations of fertilizer to be used. In addition to providing a compact design, the present invention avoids the complexities associated with double shoot planting units that have multiple discs to cut fertilizer and seed trenches. In addition, the present invention provides less soil disturbance compared to conventional knife style double shoot, single pass planting units, especially when furrowing at faster speeds, e.g., greater than 5 m.p.h. [0045] Many changes and modifications could be made to the invention without departing from the spirit thereof. The scope of these changes will become apparent from the appended claims.

A planting unit for depositing fertilizer and seed in a single pass, double shoot manner includes a rotating disc that cuts a furrow in a planting surface and a trailing seed boot, having a cutting edge, that cuts a vertically and horizontally offset trench in the furrow to form a seed bed in the planting surface. The disc has a mounting frame for mounting the disc to a linkage assembly that is, in turn, coupled to a toolbar mount. The seed boot is also attached to the mounting frame. This common attachment provides a relatively short and compact device without sacrificing fertilizer and seed stratification.

BACKGROUND OF THE INVENTION The present invention relates to a portable aspirator, and in particular, to an aspirator having a suction pump and a container or canister for storing collected fluid. In recent years, portable aspirators have gained popularity, in part due to increased awareness of the need for sanitary aspiration techniques to avoid the spread of disease. These aspirators are often used by fire fighters, paramedics, and other rescue and health workers. Desirable characteristics for a portable aspirator are that it be lightweight and easy to carry. Such aspirators must also be shock proof, especially when used by fire fighters and paramedics where it is very likely to be continually jostled. It is further desirable that the canister in which fluid from the patient is collected be quickly and easily replaceable, so that multiple patients can be handled in rapid succession. While many pre-hospital users will remove, empty and replace the canister, it is best to discard and replace the canister after each use, otherwise sanitary conditions are jeopardized. In any event, it has been difficult to achieve an aspirator device with a canister holder that is shock proof, yet enables the canister to be quickly and easily removed and replaced. SUMMARY OF THE INVENTION The present invention is a portable aspirator having a soft pack housing with a shock resistant externally mounted container support. In one embodiment, the aspirator has a housing of a soft, but durable, material, such as nylon. A vacuum pump for generating suction and a battery pack for powering the pump are disposed in the housing. An on/off switch for the device, and a regulator to regulate the suction force, are mounted to the outside of the housing for quick and easy operation. The soft pack housing has a container support also made of a soft, but durable, material and fixed to the housing. The support has a closed cell foam material snugly fitted in it for providing a shook resistant seat for a removable container. The vacuum pump is connected to the container to evacuate it. A tube having a suction tip also communicates with the interior of the container to provide suction force to drain fluid from a patient. The interior of the housing is quickly and easily accessible, as the nylon material is provided with a zippered flap. The battery pack is mounted in a U-shaped slotted support and is electrically connected, using snapfit connectors for quick and easy replacement. BRIEF DESCRIPTION OF THE DRAWINGS The above features and advantages as well as additional features and advantages of the invention will be more evident upon reading the detailed description in conjunction with the drawings, in which: FIG. 1 is a perspective view of a portable aspirator with a container support attached to the outside of the aspirator's housing, in accordance with the invention; FIG. 2 is a top view of the inside of the device, without showing wires therein; FIG. 3 is a schematic view of the components disposed inside the device, including the wires; FIG. 4 is a top view of the device; FIG. 5 is a first side view of the device; FIG. 6 is a second side view of the device; FIG. 7 is a front view of the device; FIG. 8 is a rear view of the device; and FIG. 9 is a bottom view of the device. DETAILED DESCRIPTION The invention is an aspirator having a soft pack material housing with a shock absorbent externally mounted support for a container. FIG. 1 is a perspective view of the exterior of the device, and FIG. 2 is a top view of the device, with the exterior partially removed to show components inside the device. The aspirator according to the invention has a housing 2 made of a soft, but durable, material such as a fabric, e.g., nylon. Other non-rigid but strong and durable materials may be used. A strap 2a is attached to the top of the housing so that one can carry the device over the shoulder. Housing 2 has a rectangular flap 8 that is permanently attached to housing 2 at one end of the flap and releasably attached to the housing at the other end. The housing has two parallel zippers 4,6 which run about half way around the housing and thus define the sides of flap 8 (shown closed in FIG. 1 and folded back in FIG. 2). Flap 8 opens for access to the inside of the housing. To releasably close flap 8, there is a velcro (RM) strip 8a (FIG. 2) on the inside of flap 8 and another such strip 8b (see bottom view of FIG. 9) on a corresponding portion of the housing. This construction allows the housing to be quickly opened and closed without the need for a third zipper or sharp turns in the path of zippers 4,6. The housing encloses a battery pack 10 and suction generator 12 (vacuum pump). Battery pack 10 is supported in the housing by a rigid U-shaped battery holder 16 with slots 16a and a side wall 16b to separate the battery pack from pump 12. The slotted U-shaped holder 16 enables the battery pack to be quickly and easily slid into and out of the holder. FIG. 3 is a schematic view of the working components of the device. Battery pack 10 is preferably rechargeable, such as a sealed lead acid battery or two Lifepack (RM) 5 batteries by Physio-Control, and connects to pump 12 and an on/off switch 20 using first and second snap-fit connectors 22, 24. These connectors 22, 24 each have male and female plastic connectors 22a, 24a and 22b, 24b, respectively, which allow the battery pack to be quickly and easily connected and disconnected. The housing has a rigid plate 26 (FIG. 2) positioned at its bottom to support battery holder 16 and pump 12. The holder and pump are both fixed to plate 26 by screws, bolts, or other suitable means. Plate 26 is in turn similarly secured through the housing to plastic or rubber feet 30 (FIG. 9). Plastic liners 32, 34, preferably stitched to walls of housing 2, provide some rigidity to the housing. This is especially useful for rear wall 2b (FIG. 8), which has a plastic protective plate 35 secured through the wall to liner 34. Plate 35 surrounds on/off switch 20 and a recharge socket 36 connected to the battery pack, and has arms 35a, 35b (which extend out of the plane of the drawing toward the viewer) with respect to which the switch and socket are recessed, to prevent accidental triggering or deenergizing of the device. Another small and more rigid plate 37 mounts on the inside of liner 34, protective plate 35 being secured by suitable bolts (shown but unnumbered in FIG. 8) to the rigid plate 37. As best shown in FIG. 2, liner 34 and the rear wall also have an aperture 38 through which a regulator 40 connects to a switch 42. Regulator 40 is preferably a two-position, vented regulator, preset to produce 80mm Hg (regulated pressure relative to sea level) at its low setting, which is for intubated patients or infants, and 550mm Hg or more at its high setting for other patients. With renewed reference to FIG. 3, wiring between the pump, battery pack, switch and socket is shown. A circuit is formed between switch wire 20a, pump wire 12a, pump 12, pump wire 12b, battery pack wire 10a, battery pack 10, battery pack wire 10b, and switch wire 20b, for operating the device. A recharge circuit is formed by socket 36, socket wire 36a, wire 10a, battery pack 10, wire 10b, and socket wire 36b. As best shown in FIG. 1, canister holder 46, also preferably of nylon, integrally attaches to front wall 2c of the housing. A canister 48, such as a plastic disposable canister (e.g. a catalogue #42-04-1-0 canister manufactured by Bemis Health Care) is supported in holder 46 and surrounded by a resilient, preferably closed cell foam layer 50 (e.g. 3/4") snugly fitted into the holder. This protects the canister from jostling, while at the same time allowing a used canister to be quickly and easily replaced. (Preferably discarded and replaced, rather than emptied and replaced.) Moreover, this externally mounted holder keeps the canister, and thus all patient fluids, away from the wires, battery pack, pump and other working components of the device stored in the housing, for sanitary reasons as well as for protection of the working components. The closed cell foam confines any leaking patient fluids to the area where the canister is supported. A bore 52 (FIG. 1) through the foam is shaped to fit and receive the canister 48. Preferably, the canister is tapered, and so is the foam. Top 54 of canister 48 has a first tube 58 in communication with it and regulator 40, via an aperture 60 in the front top of the housing. Accordingly, during operation of the device, the pump evacuates the canister. With reference to FIGS. 4-7, which are top, first side, second (flap) side, and front views, respectively, a second tube 62 connects to the top of the canister. The second tube has a lot of slack, e.g. it is shown wrapped around the outside of housing 2, and has an open end 62a (suction tip) for insertion into a patient's mouth. Straps 66, some with snaps and some without, hold the second tube 62 and suction tip 62a in place. With the above construction, the suction device according to the invention has many advantages. The canister is outside of the housing for quick and easy replacement, and for minimizing the possibility that leakage of fluid from the container can damage or contaminate the working components of the device. In addition, any such leakage is easy to clean up with the canister mounted outside the housing. The canister is supported and protected by the foam layer to minimize the effect of any mechanical shock, which is quite likely when the device is used by fire fighters, paramedics, or the like. The non-rigid housing and container holder minimize the effect of shock on the device as a whole, while the bottom support plate supplies a rigid surface on which to mount the battery pack holder and pump. The zipper and velcro (RM) flap, together with the slotted U-shaped battery pack holder and the snap connectors enable quick and easy replacement of the battery pack. The controls, i.e., the on/off switch, recharge socket and regulator switch are mounted on the outside of the housing for quick and easy access, and the on/off switch is protected from accidental engagement or disengagement. The regulator has two positions preset at appropriate low and high settings for quickly setting the appropriate pressure depending on the patient. The tubing and its suction tip for insertion into the patient are located outside of the housing for quick and easy access. The above described embodiment of the invention is one example of the device, and is not intended to limit the scope of the claims, as there will be many variations of the disclosed embodiment which will be covered by the claims. For example, instead of a zippered flap with velcro (RM), a flap with snaps and velcro (RM), or just snaps, is suitable.

A portable suction device for removing fluids blocking aspiration of a patient is disclosed. The device has a housing formed of a soft, but durable, material, a vacuum pump for generating suction, a battery pack for powering the pump, and a fluid container. A tube communicates the pump with the container to evacuate it, and another tube connects the evacuated container with the fluids blocking aspiration of the patient. The housing has a container support integrally attached thereto for supporting the container outside of the housing. The means for supporting is a non-rigid material like that of the housing, and has a closed cell material disposed in the non-rigid material for absorbing shocks to the container.

BACKGROUND OF THE INVENTION (1) Field of the Invention The invention relates to a method for making a functional dental element and to a dental element obtainable by such method. (2) Description of Related Art Dental elements, such as crowns, are used in clinical practice mainly for replacing or correcting dental structures. This can involve partly or wholly lost teeth or molars. To date, materials for such elements have been examined in particular for technological/physical and chemical properties. Currently, in addition, the biological aspect plays an increasing role. Dental elements can be fabricated from different materials. Examples include polymers, metals, composites, combinations of porcelain and metal, porcelain and other ceramic materials. Glass and ceramic materials form an ideal group of materials for dental elements, because they are hard, have a high wear resistance, are chemically inert in many media (biocompatibility), and can be simply formed into an aesthetic dental element. A broad application of these materials, however, is impeded by the inherent brittleness which is often the result of limitations in the fabricating process and of the material choice. Recent developments have led to different ceramic systems, such as sintered ceramic, glass-infiltrated ceramic and glass-ceramic of various compositions, which are less brittle. The fabrication of dental elements in practice is a complex and time consuming affair. The products involved are fabricated on an individual basis since the exact form of the element is different for every tooth or molar in every individual. Conventional techniques that have been used often utilize a mold. Since this mold can typically be used only once, it will be clear that these techniques are very costly. In the past, techniques have been proposed which supposedly enable simplification of the fabricating process of dental elements. Thus, Abe et al., in Int. J. Japan Soc. Prec. Eng., vol. 30, no. 3, 1996, pp. 278–279, have proposed to carry out a selective laser sintering (SLS) with titanium. This technique, however, often gives rise to shrinkage. Also, microcracks may be formed, which renders the technique unsuitable for the fabrication of functional dental elements. In European patent application 0 311 214 it has been proposed to make a crown by milling. Milling does not provide the possibility of making colored elements. Moreover, the choice of suitable materials that can be processed by milling is limited. As noted, ceramic materials form an ideal group of materials for fabricating dental elements, because they are hard, highly wear-resistant and inert under many conditions. U.S. Pat. No. 5,690,490 describes a method for fabricating a concept model for a dental element by so-called pinhead molding. The method concerns the use of a kind of matrix printing technique, whereby material is sprayed on. The printer is controlled with a CAD/CAM program. The data which this program utilizes have been obtained from a laser scan of the tooth or the molar to be replaced. In U.S. Pat. No. 5,823,778, a method is described for the fabrication of a dental element whereby an impression of the teeth of a patient is obtained, which is subsequently used as a mold to make a copy of a dental element. This element is broken down in layers and each layer is scanned to obtain a three-dimensional computer model of the dental element. SUMMARY OF THE INVENTION One object of the present invention is to provide a technique whereby functional dental elements can be fabricated in a flexible and efficient manner. Another object is for the technique not to utilize a mold, and to enable making dental elements of polymeric, metallic or ceramic material, or of combinations thereof. Surprisingly, it has presently been found that the stated objects are achieved by fabricating a dental element utilizing a three-dimensional printing technique. Three-dimensional printing techniques are known per se, and described inter alia in European patent application 0 431 924, U.S. Pat. No. 5,902,441 and international patent applications 94/19112, 97/26302 and 98/51747. For a description of the details of the technique, reference is made to the documents mentioned, which are therefore to be understood to be inserted herein. The method according to the invention is in principle suitable for fabricating all types of dental elements. Examples include crowns (front and lateral teeth), inlays, overlays, onlays, partial crowns, fixations and veneers. DETAILED DESCRIPTION OF THE INVENTION Preferably, in a patient in whom a dental element is to be replaced/placed, it is first accurately measured what shape the element is to have. Often, if possible, the starting point will be the shape of the tooth or molar, or the portion thereof that is to be replaced. It is preferred that measurement can take place in a manner which causes the patient as little inconvenience as possible. Particularly suitable techniques for measuring the shape for the dental element make use of optical scan techniques, in particular the use of lasers. In electronic form, data about the desired shape and dimensions are thereby obtained, which can be directly visualized in a computer. The electronic data about the shape and dimensions of the dental element are preferably used by a computer to control the execution of the three-dimensional printing technique. Another suitable method for measuring is by the CEREC-technique, Sirona Dental Systems GmbH, Bensheim, Germany. In the three-dimensional printing technique, a suitable material is applied successively in layers, while specific steps are taken to ensure that each layer adheres to the preceding layer only at particular desired points. These specific steps are determined by the desired shape of the dental element and preferably controlled by the above-mentioned electronic data. According to the invention, in the specific steps mentioned, use is made of a binder. This binder is applied to a preceding layer only at the desired specific points. When to the binder a layer of, for instance, ceramic material from which the dental element is to be shaped, is applied, this will adhere only to the desired points. The non-adhering powder, which, accordingly, does not come into contact with the binder, can be simply removed. The binder is preferably applied to the desired points by means of a print head, controlled by the computer on the basis of the data obtained upon measurement. Thereafter, a powder of the material that has been selected for the fabrication of the dental element is applied. It is also possible to work upside down and to provide a layer of binder on the bottom side of a plate and subsequently to dip the binder in the powder. In this last variant, in a simple manner, different kids of powder can be used for different layers. In both cases, the powder will bind only at points where binder has been applied. By repeating these steps sufficiently often, eventually the desired shape of the dental element is obtained. Finally, the binder can be removed by sintering. According to an alternative to this method, first loose powder is laid in a powder bed, and thereafter binder is applied locally to obtain binding at the desired points. So, in fact, binder and powder can be applied in any sequential order. The substrate on which work is done can be formed by a few layers of loose powder, so that the dental element to be formed can be readily detached from the substrate. In sintering, preferably a non-adhering substrate, for instance a metal plate, is used. By virtue of the accuracy of the data that can be obtained by measuring with the aid of a laser technique, and by virtue of the accuracy with which a computer, on the basis of those data, can control a print head, the desired shape and dimensions of the dental element can be obtained in a highly accurate manner. While in the old-fashioned techniques it was necessary to additionally shape a dental element several times after it had been formed in a mold, in the method according to the invention it normally suffices to carry out additional shaping a single time. Depending on the material that has been selected for the dental element, this additional shaping can be carried out by grinding, filing, polishing, sanding, blatting or by using a ball bed (a vibrating box containing abrasive balls). The binder that is used in a method according to the invention should be soluble in a suitable solvent to a solution having a viscosity of 1–40 mPas, preferably about 3 mPas, and a loading degree of 3–10 wt. %. Thus the binder preferably has a relatively low molecular weight. Examples of suitable binders are colloidal silica, polyvinyl acetate (PVA), starch adhesives, acrylates, polyvinyl alcohol, polyethylene oxide (PEO), ethylenevinyl acetate (EVA) and derivatives thereof. In the binder, often a colorant will be used. Suitable colorants are normally based on inorganic pigments having a high content of SiO 2 , which renders them heat-resistant. These substances are known per se and commercially available, for instance, from Carmen, Esprident GmbH, Ispringen, Germany, or VITA Zahnfabrik H. Rauter GmbH & co., Bad Zäckingen, Germany. Preferably, one or more of the following colorants are used: SiO, CoO, ZnO, Cr 2 O 8 , TiO 2 , Sb 2 O 3 , Fe 2 O 3 and MnO 2 . Depending on the desired dental color, colorants are preferably used in amounts of up to 10% by weight, based on the weight of the powder. It is a particular advantage of the invention that at different points in the dental element, different colors can be used, if desired with a transparent outer layer, yielding a natural optical depth action. By virtue of these and other advantages, a dental element resembles a real tooth or molar extremely faithfully. As noted, this binder can be applied to a suitable substrate with a print head. The print head is controlled by a computer on the basis of the data which have been obtained through prior measurements on the patient for the purpose of the dental element. Examples of suitable print heads are, for instance, inkjet heads of the continuous or of the drop-on-demand type. The print head preferably has a spray nozzle of a diameter between 10 and 100 μm, more preferably between 25 and 75 μm and a length between 50 and 150 μm. The powder that is used is selected on the basis of the material of which the dental element is eventually to be made. The powder can be used both in dry form and in dispersed form (slurry). Dispersions are preferably prepared in water or an aqueous solution. In addition, some organic solvents, such as isopropanol, can be used. The skilled person will be able to choose a suitable solvent on the basis of his normal knowledge. Depending on the particle size of the powder, it may be desirable to prepare a colloidal solution of the powder, for instance by addition of a base, salt and/or surfactant. When the powder is applied in dispersed form, preferably a drying step takes place each time before a next layer is applied. According to a preferred embodiment of the invention, in each layer, several materials, of a different nature, are used. It is also possible, and highly favorable under certain circumstances, to modify the composition of the powder per layer to be applied. If per layer one type of material is applied, often a doctor blade (slurry) or counter rotating roller (dry powder) is used. If per layer more than one type of material is applied, this is applied locally, preferably by means of one or more computer-controlled nozzles capable of applying one or several materials. The materials can differ from each other in color or in properties. To be considered here are, for instance, (di)electric or piezoelectric properties. According to this embodiment, the material is preferably applied in the form of a slurry. According to the invention, different kinds of materials, in particular both ceramic materials and metals, can be used. To be able to properly apply the material to the binder, the material is preferably in powder form. Depending on the size of the powder particles, the powder will be applied in dry form or in dispersed form (slurry). A finer powder leads to a greater accuracy in achieving the desired shape of the dental element. Preferably, the powder has an average particle size (diameter) between 1 nm and 50 μl, more preferably smaller than 50 nm, still more preferably between 10 nm and 25 nm. The advantage of this is that sintering can be carried out in a short time and at a relatively low temperature. It has been found that the particle size referred to has a positive effect on the shape and sinterability of the dental element to be formed. The powder can be made of any material that is conventionally used for forming dental elements. For this purpose, in particular metals and ceramic materials and combinations thereof are suitable. When a ceramic material is used for forming the dental element, this is preferably selected from the group of SiO 2 , Al 2 O 3 , K 2 O, Na 2 O, CaO, Ba 2 O, CrO 2 , TiO 2 , BaO, CeO 2 , La 2 O 3 , MgO, ZnO, Li 2 O and combinations thereof. Optionally, ceramic compositions can further contain F or P 2 O 5 . Particularly suitable ceramic materials are the commercially available compositions. VITADUR®, IPS EMPRESS®, DICOR®, IPS EMPRESS II®, CERESTONE®, CEREPHARAL®, and IN-CERAM®. When a metal is used for forming the dental element, this is preferably selected from the group of alloys of gold, platinum, palladium, nickel, chromium, iron, aluminum, molybdenum, beryllium, copper, magnesium cobalt and tin. Optionally, such an alloy can contain silicon. For a description of suitable alloys, reference is made to J. P. Moffa, Alternatives to Gold Alloys in Dentistry, DHEW Publication N. (NIH), 77–1227. If desired, a lubricant can be added to the powder to facilitate applying the powder in layers. Examples of suitable lubricants are stearic acid or derived stearates, such as zinc or calcium stearate. A lubricant is preferably used in an amount of 1–2% by weight, based on the weight of the powder. As mentioned, preferably, in alternation a layer of binder is applied and a layer of powder is applied thereto. The thickness of the layers of powder is preferably between 0.01 and 0.3 mm, more preferably between 20 and 100 μm, which is beneficial to the surface quality in the case of slight differences in height contour of the layers. The amount of binder per unit area of powder is fairly critical, but can simply be adjusted by a skilled person to the nature of the binder and powder used. Normally, the amount of binder will be between 0.005 and 0.3 grams per square centimeter of powder. Thus, layer by layer the desired dental element is built up. When the last layer has been applied, excess powder which has not been bound is removed. This can be done by taking out the entire powder bed, turning it upside down and shaking gently. Residues can be removed by blowing, for instance with compressed ir. Thereafter the powder particles can be bonded together by sintering. Preferably, prior to sintering, a debinding step is carried out, i.e., a treatment to remove the binder. Debinding can be carried out by means of heat or a suitable solvent, such as hexane. Because most binders have a relatively complex composition, debinding preferably takes place by heating using a temperature path (for instance from 20 to 500° C.). Such a heating scheme can be simply coupled to a sintering step. The duration and temperature at which sintering takes place will depend on the nature of the binder used and the powder. Normally, the duration of sintering will be between 10 minutes and 3 hours, while the temperature will typically be between 400 and 800° C. By sintering in such a way that only necks are formed, shrinkage due to the sintering step is minimal/negligible. Optionally, such shrinkage can be compensated by scaling the CAD model. After sintering, the product obtained is preferably infiltrated, whereby a second phase is introduced into the product. As a result, the porosity of the product is considerably reduced. Densities in excess of 99% are feasible. The infiltration can be ed out, for instance, in an oven, whereby the infiltration material is laid against the dental element. The infiltration material melts at a lower temperature than the material of the dental element. Through capillary action, the liquid infiltration material is infused (adsorbed). This step lasts a relatively short time and gives the dental element the desired properties. A suitable material or this is, for instance, glass-ceramic or a polymer. Preferably, a material is used which has been approved for use in dental elements, as described in the standard ADA no. 15 ANSY MD156.15-1962, which is to be understood to be inserted herein. In particular cases, it has been found to be advantageous to subject the dental element to a thermal/chemical post-treatment, so that all optimum material (micro)structure is achieved. Thus, preferably, the dental element is briefly heated to a temperature between 60 and 150° C., more preferably between 80 and 130° C. Instead thereof, or supplemental thereto, preferably a thermal compaction is accomplished. To that end, the dental element is heated to a temperature of at least 250° C., preferably at least 400° C. and more preferably at least 500° C. This treatment contributes to the dental element obtaining particularly favorable properties. When by one of the procedures described above the dental element has been formed, it may happen that it still needs to be additionally shaped to some extent. As has already been indicated, it is an advantage of the invention that it enables work to be done very accurately. Additional shaping will therefore be less laborious than in the techniques used heretofore. Ways in which additional shaping can be carried out include inter alia grinding, filing, polishing, sanding, blasting or treatment with a ball bed, depending on the selected material of the dental element. The invention will presently be elucidated in and by the following examples. Example 1 Two binders were prepared, having the following compositions: A: polyvinyl acetate (Optapix PA 4 G) 2 wt. % alcohol content 36 wt. % (ethanol) glycol 2 wt. % water balance B: polyvinyl acetate (Optapix PA 4 G) 2 wt. % alcohol content 34 wt. % (ethanol) glycol 1 wt. % water balance. The compositions were prepared by manually adding the ingredients and stirring. Dissolving the polyvinyl acetate took 6 to 10 hours. Through the alcohol content, the surface tension could be set (a low surface tension proved favorable). Example 2 With a bindjet printer (Z402 of the firm Z Corporation, Burlington Mass. USA) two cylinders were fabricated, using aluminum powder (type CT 3000SG) in combination with, successively, binder A and binder B (see Example 1). The properties of the powder are as follows: TABLE 1 Chemical purity (% by weight) Al 2 O 3 >=99.7 Na 2 O 0.09 SiO 2 0.02 Fe 2 O 3 0.02 CaO 0.02 MgO 0.10 Physical properties of the powder: Specific surface energy range BET: 5.5 to 7.5 m 2 /g Median particle size (MPS) d50: 0.5 to 0.7 μm Cilas 850 Particle size d90: 1.0 to 2.0 μm Cilas 850 Ceramic properties of the powder: Green density: 2.22 g/cm 3 Sintered density: 3.90 g/cm 3 Shrinkage: 16.5% The alumina powder is distributed homogeneously over the building platform by means of a divider (kind of razor blade/snow shovel/doctor blade). Thereafter, the layer of loose powder applied is compacted with a coated roller (teflon roller with polyester top layer), so that a smooth and flat layer of loose powder is formed (like flattened castor sugar). Through this compaction step, the initial porosity is rendered substantially lower, which is beneficial to the so-called green strength. The layer thickness of this powder layer is adjustable and has been set at 0.0625 mm (the size of this step determines the accuracy of following the product contours, and may be still smaller). After the entire building surface has been provided with a new compacted powder layer, binder is locally applied to the loose powder by means of a binder jet printer (Z402 of the firm Z Corp., see also WO-A-97/26802). The location where the binder substance is to be printed has been determined beforehand by software. The binder penetrates so deeply into the loose powder that the powder particles in the new layer are bound to each other and that further the new layer is bonded to the preceding one. With the cartridge and binder substance used, an optimum in binder amount has been found to be 10× printing per 100 g. The amount of binder at a given layer thickness is 0.0017 g/cm 2 per inkjet run. Accordingly, at 10× ink jetting this is 0.017 g/cm 2 , which leads to a good consistency of the products (they can be handled). By repeating the recoating and inkjet steps, eventually the entire product is built up in the green (=with binder) form. The cylindrical products which have been produced had a diameter of 16.4 mm and a height of 18 mm; the mass is 5.3 g. The experiments were carried out in triplicate. The porosity of the alumina cylinders is 45% at a maximum (in the absence of compacting). Compacting leads to a lower porosity (estimate 55–70%). The intermediate products were subsequently subjected to debinding and sintering according to a specific temperature-time path, whereby heating was done at a rate of 120° C. per hour to a temperature of 1200° C. This temperature was maintained for 120 minutes, followed by cooling to room temperature, again at a rate of 120° C. per hour. The sintered products were subsequently infiltrated with a glass ceramic to obtain the eventual strength and mechanical properties. The obtained properties satisfy the standard imposed on the functional dental elements.

The present invention relates to a method for fabricating a functional dental element, such as a crown. According to the invention, use is made of a three-dimensional printing technique. The major advantages of the invention are that no mold is needed anymore, which entails a considerable saving of costs, that a great accuracy is achieved, and that the element can be made of different materials.

RELATED APPLICATIONS [0001] This application claims the benefit of co-pending U.S. Provisional Patent Application Ser. No. 60/867,424 filed Nov. 28, 2006, which is incorporated by reference herein. BACKGROUND [0002] 1. The Field of the Invention [0003] This invention relates to electromagnetic simulation of bone stress, and more particularly to methods and apparatus to stimulate or otherwise induce electrical activity in bones of a subject in order to elicit a positive response such as natural generation of increased bone density. [0004] 2. The Background Art [0005] Human tissues are electrical apparatus. Likewise animal tissues are electrical apparatus. A complex assembly of structure, chemistry, and electrical connection controls and implements the activity, growth, healing, and other functions of living tissues of the animal kingdom. Manipulating the structures of tissues, whether soft tissue or bone tissue has been purview of the surgical portion of the medical community. Manipulation of chemistry has been the purview the drug portion of the medical community. Manipulation of the electrical activities of body tissues has largely been left to the other two fields, surgical and chemical treatments. [0006] There has been a development of an electrical treatment community in the medical field, particularly, dealing with electro-stimulation. However, many researchers in the field often claim a lack of understanding of the specific phenomena that affect the correlation between electrical stimulation and organic functioning of live animal tissues. Nevertheless, electrical stimulation therapy has been used in both invasive and noninvasive systems for directly applying electrical potential to stimulate a response. [0007] Within the medical community, selected, time-varying electric and magnetic fields have played an increasingly successful role in the care of several challenging medical problems, mainly fractures that have failed to heal, in both children and adults, as well as chronic skin wounds. This progress has been made over the past decades. [0008] Bioelectromagnetics is a term applied to a field developing in the biological sciences and devoted to the interaction between living organisms and electromagnetic fields. Electrical phenomenon are inherent in most living organisms, and certainly in all animal organisms. For example bones, nerves, cartilage, muscle, and the like have been considered to contain electrical connections and circuits for their normal operation. Accordingly, these electrical circuits can be influenced by external magnetic fields and electromagnetic fields. Publications indicate that electromagnetic fields operating at frequencies below 300 hertz can influence biological functions. Some controversy exists regarding the mechanics of operation of these interactions. [0009] Pulsed electromagnetic fields in medicine are not new. Static magnets and electrical current have been used for years. In modern medicine however, it was in about the 1970's that the United States FDA approved a pulsed electromagnetic field device to assist in the healing of non-union fractures. Doctor C.A.L. Basset pioneered work leading to an 80% success rate in the healing of non-union fractures without any side effects. Accordingly, therapy by pulsed electromagnetic fields is recognized as effective in bone healing in the medical profession. [0010] Meanwhile, additional detailed work has been done on a cellular level in vitro and in vivo to evaluate the efficacy of pulsed electromagnetic fields on bone density. Much of the work seems to be devoted to establishing a specific biological mechanisms by which electromagnetic fields couple to body chemistry and cellular activity. [0011] With the magnetic fields induced by an MRI machine, molecular dipoles orient along the magnetic field lines. Once the magnetic field is collapsed, the dipoles, actual physical molecules, rotate back to their original positions. The return to the original positions generates another magnetic pulse, which pulse is detected and used to reconstruct in a computer an image of the tissues within the MRI field. [0012] Thus, electromagnetic fields are not only known to affect body tissues, but body tissues themselves generate magnetic fields by their own motion, which magnetic fields are sufficiently strong to be detected and analyzed by sophisticated signal processing in order to image tissues and boundaries of tissues in the body. [0013] Likewise, the bone structures of a body are known to have a piezoelectric characteristic. That is, they respond to stress by creating an electrical potential. Likewise, however, since piezoelectric events are symmetric. The application of electrical potential will then cause stress. [0014] What is needed is a system implementing a method and apparatus for coupling, non-invasively, an external electromagnetic field to the body tissues that may provide electrical stimulation to bones. [0015] It would be an advance in the art to improve non-invasive electro-stimulation by magnetic coupling of an electrical system outside of a subject with the electrical system within a subject. BRIEF SUMMARY OF THE INVENTION [0016] In view of the foregoing, in accordance with the invention as embodied and broadly described herein, a method and apparatus are disclosed in one embodiment of the present invention as including a distributor comprising a plurality of electromagnetic coils. A controller may control the operation of the distributor. The controller may include a processor and a memory device operably connected to one another, the memory device storing code executable by the processor. The controller may be connected to a source of electrical current. During operation, a user may be positioned proximate the distributor (e.g., recline or lie over or below the distributor). The controller may then control, according to the code, delivery of electrical current to the coils. In one embodiment, the controller may deliver current sequentially and exclusively to each coil to generate a magnetic field extending into the user. [0017] In accordance with the foregoing, an apparatus and method in accordance with the invention implement a magnetic coil providing a magnetic field penetrating a depth into a body sufficient to provide the designated field strength near a bone thereof. Accordingly, in an apparatus and method in accordance with the invention, the magnetic field acts in several ways. [0018] First, as the field is established, and as it collapses, it is effectively capable of inducing currents in circuits within the field. That is, whenever a circuit moves through a magnetic field, or a magnetic field moves across a circuit current is induced in the circuit. Thus, electrical circuits within the magnetic field generated by an apparatus will obey the law of physics and generate currents. Whether a circuit is formed of wire or of animal tissues, relative motion between the circuit and the magnetic field will generate electrical currents in the circuit. [0019] Second, by generating a magnetic field, certain molecular dipoles in cells within the body will undergo alignment or a tendency to align with the field lines of the applied magnetic field. This provides an actual mechanical displacement stimulation. [0020] Third, any generation of an electrical potential across a piezoelectric element causes stress and typically strains at a “micro” level. This stress and strain is not distinguishable from “macro” level stresses and strains corresponding to exercise. [0021] Applicants observed in the use of electromagnetic stimulation for bone healing of fractures in persons having poor bone repair function (e.g., smokers, diabetics, poor circulation subjects, etc.) that electromagnetic stimulation aided both fracture healing and joinder of fused constituents. However, following treatments effective to aid the bone healing, it was observed that even on the gross scale provided by X-ray images, an increase in bone density was apparent. Thus, Applicants engineered a system to augment bone density increase over the entire body. Applying a local electromagnetic field to one location of the body is not scalable by simply adding more devices, to treat the entire body with a mechanism of electromagnetic therapy. BRIEF DESCRIPTION OF THE DRAWINGS [0022] The foregoing features of the present invention will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only typical embodiments of the invention and are, therefore, not to be considered limiting of its scope, the invention will be described with additional specificity and detail through use of the accompanying drawings in which: [0023] FIG. 1 is a schematic diagram of an apparatus in accordance with the invention; [0024] FIG. 2 is a schematic top plan view of a coil in the apparatus of FIG. 1 ; [0025] FIG. 3 is an end view of the coil of FIG. 2 ; [0026] FIG. 4 is a plan view of one embodiment of the distributor portion of the apparatus of FIG. 1 ; [0027] FIG. 5 is a schematic block diagram of one embodiment of a method in accordance with the invention in a very simplified form; [0028] FIG. 6 is a diagram of a side elevation view of the distributor of FIG. 4 illustrating application of current and thus magnetic field as applied to each coil in sequence in accordance with the invention; [0029] FIG. 7 is a schematic block diagram of a method in accordance with the invention for controlling treatment and recording therapy session data; [0030] FIG. 8 is a schematic block diagram of a more sophisticated process in accordance with the invention identifying various decisions and options as well as the effect of sensing as a means to control operation of an apparatus in accordance with the present invention; [0031] FIG. 9 is a diagram of top plan view of a sensor-equipped distributor with coils of various alternative configurations; and [0032] FIG. 10 illustrates one example of an embodiment of a distributor of an apparatus in accordance with the invention, illustrating one implementation for a double bed cover, blanket, mattress-cover, or the like. DETAILED DESCRIPTION OF THE INVENTION [0033] It will be readily understood that the components of the present invention, as generally described and illustrated in the drawings herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the system and methods of the present invention, as represented in the drawings, is not intended to limit the scope of the invention, as claimed, but is merely representative of various embodiments of the invention. The illustrated embodiments of the invention will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout. [0034] Referring to FIG. 1 , an apparatus 10 in accordance with the invention may include a distributor 12 effective to distribute electromagnetic flux through a subject or user. The distributor 12 may be controlled by a controller 14 . The controller 14 may control current, duration, frequency, and the like for the electromagnetic flux provided by the distributor 12 to a subject. [0035] A power supply 16 may provide conditioned power to the controller 14 . The power supply 16 may be adapted to receive electric power from a power source 18 such as conventional wall current, multi-phase current available on distribution in a building, a generator, or the like. In selected embodiments, a power supply 16 may convert alternating current (AC) received from the power source 18 into low voltage DC power suitable for operating the controller 14 . A power supply 16 may also condition power to be provided to the distributor 12 . [0036] In certain embodiments, a distributor 12 may include multiple coils 20 a , 20 b , 20 c , each formed of several turns of an electrical conductor. When energized with current, each coil 20 may become an electromagnetic coil creating an electromagnetic field. A distributor 12 in accordance with the present invention may also include one or more feedback devices 22 . [0037] A feedback device 22 may provide information assisting the controller 14 in controlling the distributor 12 . For example, various types of feedback devices 22 may be implemented including human actuated controls, detectors for detecting the presence of a user, temperature sensors, current sensors, or the like. In selected embodiments, the feedback devices 22 may insure safety, proper operation, limit duty cycles, and so forth. [0038] In addition to controller feedback devices 22 , a distributor 12 may include user feedback devices 24 . A user feedback device 24 may provide confirmation to the user that the apparatus or distributor 10 is functioning properly. That is, a user without additional aids may be unable to perceive the electromagnetic field or fields being generated by a system 10 in accordance with the present invention. Accordingly, a system 10 may include one or more feedback devices 24 providing visual confirmation of activity. Such devices 24 may include light-emitting diodes (LEDs), displays, lights, or the like to encourage or sustain a user in his or her use of the system 10 . [0039] In selected embodiments, a controller 14 may include a processor 26 operably connected to a memory device 28 . A memory device 28 may store the applications, programs, or code executed by the processor 26 during operation of the system 10 . In selected embodiments, a processor 26 and memory device 28 may collectively be embodied as a microprocessor. [0040] In certain embodiments, a controller 14 may include a user interface 30 receiving inputs from a user. For example, certain interfaces 30 may include keypads, switches, knobs, buttons, touch screens, monitors, or other mechanisms for interaction with a user in generating electrical signals to be received by a processor 26 . Accordingly, a user may enter program parameters, timing information, duration information, frequency control information, current information, or the like and thereby influence or control operation of the distributor 12 . Likewise, a user may select a particular intensity of electromagnetic field, frequency thereof, or the like. Alternatively, certain parameters may be “hardwired” into a controller 14 while others may be controlled through a user interface 30 . [0041] In selected embodiments, a user interface 30 may accept inputs that are more qualitative then quantitative to a user. Such inputs may be translated by a processor 26 into specific engineering and physics terms or variables suitable for implementation. For example, a user may input selection of a long or short session. A user may input a request for a weak, medium, or strong intensity, and the like. Accordingly, preselected ranges may be programmed into the processor 26 in order to comply with the user's qualitative requirements with quantitative data that will be used by the processor 26 when controlling the distributor 12 . [0042] A user interface 30 in accordance with the present invention may also provide selected feedback or information to a user. For example, a user interface 30 may include one or more displays. In certain embodiments, the operating conditions of a controller 14 may show in a display. The display may show simultaneously, sequentially (e.g., cycle through), or as instructed by a user any or all parameters. Parameters may include repetition frequency, pulse current, duty cycle, magnetic field values, or other parameters of the system 10 . A display may also show treatment progress, time elapsed, time to end of treatment, or the like, and may include audio or other outputs to signal various stages of the session (e.g., the end of the session). [0043] In selected embodiments, a controller 14 may include one or more control devices 32 . A control device 32 may implement the control functions specified by the processor 26 of the controller 14 . For example, a control device 32 may include control circuitry (e.g., logic, switches, various relays, etc.) translating a control signal from the processor 26 into an actual current delivered to a specific coil 20 of the distributor 12 . [0044] A controller 14 , through a processor 26 , may dictate the current waveforms supplied to the coils 20 of a distributor 12 . Parameters dictated by a controller 14 may include pulse repetition frequency, pulse amplitude, duty cycle of pulse current, duration of treatment sessions, or the like. Such parameters may be fixed at the time of manufacture or be selectable by a user or treatment controller (e.g., medical personnel). [0045] Referring to FIGS. 2-3 , an apparatus 10 in accordance with the invention may include several coils 20 each having a specified interior width 34 as well as an exterior width 35 . Typically, it is good magnetic design to maintain the interior width 34 as close to the exterior width 35 as possible. Nevertheless, to be more comfortable for a user, it may be preferable to distribute wires or cables further apart in order to avoid a sensation or feel of too much weight or stiffness in a particular area of the distributor 12 . [0046] Likewise, the coils 20 may each have an interior length 36 as well as an exterior length 37 . The interior width 34 and interior length 36 may establish a flux window through which the magnetic flux of the coil 20 passes. The dimensions 34 , 35 , 36 , 37 of the coil 20 , as well as the number of turns 38 of the coil 20 , may be used to control the magnetic strength of flux generated by the coil 20 . The current passing through the turns 38 of the coil 20 may also provide a degree of control over the magnetic flux. [0047] Accordingly, a window 40 or aperture 40 may represent the area filled with the flux of the magnetic field generated by current through the turns 38 of the coil 20 . In general, the coil 20 will extend in a longitudinal direction 42 and the lateral direction 44 , corresponding, typically, to the width 34 and the length 36 , respectively. Thus the flux through the aperture 40 or window 40 passes in the transverse direction 46 through the window 40 . [0048] As can be determined by the directional arrows 42 , 44 , 46 , the illustration of FIG. 3 represents an end view of the coil 20 of FIG. 2 . Thus, the direction of current flowing through the coil 20 or through the turns 38 of the coil 20 is illustrated by the arrow 48 . The direction 48 of current controls, according to the respective laws of physics, the direction of the magnetic field 50 passing through the window 40 . [0049] Meanwhile, the depth 52 of the magnetic field 50 may characterize the strength of a field 50 at a certain distance from the coil 20 . That is, for example, the earth has a magnetic field that extends from pole to pole and extends out through a large volume of space. Similarly, the coil 20 has the ability to create flux lines 50 that extend far away. Nevertheless, at greater distances 52 , the intensity or strength of the flux 50 may be less. [0050] For example, near the actual wires forming the turns 38 of the coil 20 , a very tightly turned flux 50 may be generated. Meanwhile, near the center of the coil 20 , the flux lines may be substantially perpendicular or “normal” to the plane of the coil 20 . While lines of flux 50 near the turns 38 themselves may close in a comparatively “tight” loop, the lines of flux 50 nearer to the center may extend a far distance before they eventually turn back and enclose on themselves in a loop. Necessarily, the flux density out in that large expanse of space may be commensurately small. [0051] By contrast, the flux density within the window 40 containing the same amount of flux will be comparatively higher. Thus, the width 34 and length 36 of a coil 20 may create a flux distribution of a desired intensity within the window 40 and a desired intensity at a distance 52 corresponding to the depth of a human body. [0052] Referring to FIG. 4 , in certain embodiments, when treatment is commenced, repetitive current pulses may be transferred (e.g., through cabling) to a distributor 12 . A distributor 12 may include one or more coils 20 , typically one to six. The coils 20 may cover a significant portion of the distributor. For example, in selected embodiments, coils 20 may consume about 60% to about 90% of the surface area of the distributor 12 . [0053] In certain embodiments, the coils 20 may be connected in series. When so connected, the overall effect is that the pulse current circulates unidirectionally around the periphery of the array of coils 20 . This ensures that a patient or user will experience at least a minimum value of the electromagnetic field, typically about 25% to about 30% of the maximum field produced in the middle of the user's body. Alternatively, coils 20 may be divided into sets of one or more, with each set being sequentially pulsed. This may avoid the partial field cancellation that may otherwise occur when coils 20 (or the electromagnetic fields produced by the coils 20 ) overlap. [0054] In selected embodiments, each cycle of the current waveform may include an equal number of current pulses in each directions. This may permit a distributor 12 to be positioned easily, without any preferred or required orientation. Additionally, if any area of the body is more responsive to an electromagnetic field in one direction more than in the other, that area will receive adequate stimulation. [0055] In one embodiment of an apparatus 10 in accordance with the invention, a distributor 12 may be formed as an article of bedding. For example, a distributor 12 may comprise a matrix 54 of fabric or similar materials suitable for use as a blanket, mattress cover, layer within a mattress, or the like. The matrix 54 may provide a soft feel, warmth, or other sensory and tactile features desired by a user. [0056] In selected embodiments, a matrix 54 may connect, stabilize, and secure the various coils 20 a , 20 b , 20 c , 20 d , 20 e . Since electromagnetic flux 50 can directly interfere with and cancel other electromagnetic flux, two conditions may be maintained with respect to the coils 20 . First, the coils 20 may be set in a non-overlapping arrangement in space. For example, the coils 20 may be positioned so as to be substantially coplanar (e.g., distributed in a longitudinal direction 42 along the matrix 54 ). Second, the coils 20 may be activated in a non-overlapping arrangement in time. That is, in selected embodiments, the controller 14 may ensure that no coil 20 is building, sustaining, or collapsing an electromagnetic field 50 at the same time that another coil 20 is building, sustaining, or collapsing an electromagnetic field 50 . Thus, there is no interference between the coils 20 and no negation of the effectiveness thereof. [0057] As a practical matter, the sequencing of energy delivery or current delivery to each of the coils 20 a , 20 b , 20 c , 20 d , 20 e may be in any suitable sequence. For example, a strict sequential alternating between coils or from one coil to the next, adjacent coil may be appropriate. Likewise, a completely random distribution or sequencing between coils 20 may be acceptable and provided by the controller 14 . [0058] Moreover, since the strength of an electromagnetic field 50 may be dependent upon the electrical current and the number of turns 38 in a coil 20 , electrical heating may occur if the duty cycle for a coil 20 is too high. It has been found that a duty cycle in the range of from about 2% to about 10% is adequate. With variations in current, the duty cycle may be manipulated. That is, for example, with a lower current the same magnetic flux may be obtained with more turns 38 in a coil 20 . Thus, the dynamic flux 50 desired through the aperture 40 of a coil 20 may be designed to control the heat losses and the appropriate duty cycle for the apparatus 10 , and for the individual coils 20 . [0059] Referring to FIGS. 5 and 6 , one approach to sequencing the current through the individual coils 20 may be to rely on a process 60 dictated by the controller 14 . For example, upon starting 62 , the process 60 may apply 64 power to the system 10 . Thereafter, inputs may be received 66 by the system 10 . Such inputs may include any parameters used by the processor 26 in controlling operation of the coils 20 (e.g., times, durations, intensities, frequencies, currents, or other similar values on a quantitative, qualitative, or comparable basis). [0060] In accordance with the input received 66 or other pre-set instructions or code, the controller 14 may apply 68 current to a particular coil 20 . After a preselected time, or a calculated time based on other parameters such a flux density, current, and time, or the like, the controller 14 may dictate removal 72 (termination) of the current from the coil 20 . [0061] Next, the controller 14 may advance 74 to the next coil 20 in the sequence. The controller 14 may then return 70 to application 68 of current to a coil 20 , followed by a removal 72 of the current and advancing 74 to the next coil 20 . The cycle of applying current 68 , removing 72 current, and then advancing 74 to the next coil 20 may continue for some period of time (e.g., a session duration), in accordance with an appropriate duty cycle. [0062] A duty cycle that is too great for a power supply 16 or for a coil 20 may cause failure of the power supply 16 or overheating of the coils 20 . Accordingly, power may be removed 76 from the system 10 between activation of individual coils 20 for some extended period of time in order to enforce a duty cycle. Alternatively, power may be removed 76 from the system after cycling through all the coils 20 within the distributor 12 . In yet another alternative embodiment, power may be removed 76 from the system 10 after a preselected or sensed number of cycles of applying 68 and removing 72 current from the coils 20 . [0063] The end 78 of a treatment session may be controlled by time, or by a net effective dosage of electromagnetic fields 50 . For example, a user may have an exposure to higher field strength of flux 50 for a lower time or have an exposure to a lower strength of flux 50 for a greater amount of time. In certain embodiments, the field 50 or the flux density 50 and field strength may not be changeable by user, and the time may be fixed at some appropriate amount of time (e.g., one to three hours). In other embodiments, these parameters may all be changed and exchanged in order to approach the therapy desired. [0064] Referring to FIG. 6 , a sequence 80 illustrates the generation of magnetic flux 50 consequent to applying current 68 to each coil 20 in sequence. Accordingly, during a first time period, an electromagnetic field 50 may be generated from one coil 20 a . In a subsequent time period, an electromagnetic field 50 may be generated from another coil 20 b . In yet other subsequent time periods, electromagnetic fields 50 may be generated sequentially or in turn from the remaining coils 20 c , 20 d , and 20 e . Thus, FIG. 6 illustrates the application 68 of current to a coil 20 , followed by removal 72 thereof and advancing 74 to the next loop 20 . [0065] Referring to FIG. 7 , an alternative method 60 in accordance with the invention may include additional optional steps with respect to the basic process 60 of FIG. 5 . For example, after application 64 of power to the system 10 , receipt 66 of inputs thereto, application 68 of current to a coil 20 , and removal 72 thereof, the return 70 may include additional steps. A decision 82 may be made as to whether continued treatment is to be implemented. This may be accomplished in any suitable manner. [0066] For example, in one embodiment, a controller 14 may include a timer establishing a therapy duration. The controller 14 may enforce that duration by any mechanical, electrical, or electromechanical timer that will shut off current to the coils 20 after a specified duration. For example, a time period from about half an hour to about three hours may be an adequate duration. Times up to ten hours may be effective. Nevertheless, for the use in stabilizing or reversing osteoporosis, between one and a half and two and a half hours may be a suitable duration. [0067] Thus, at the end of a predetermined duration or by any other suitable parameter, the decision 82 may be made to continue or discontinue the present treatment session. If treatment is to be continued, an affirmative answer may result in advancement 74 to the next coil 20 . Alternatively, an affirmative answer may lead to an additional decision 84 as to whether a cycle of all the coils 20 within a distributor 12 has been completed. If a cycle of all the coils 20 has not been completed, then an advance 74 may occur, returning to the application 68 of current to the next coil 20 in the sequence. Alternatively, if the cycle has been completed, then a change 86 in the direction of current may be applied. [0068] Certain molecules in the cells of the body are dipoles. They act as small bar magnets rotating to align with a magnetic field 50 . Accordingly, it may be beneficial to change 86 the direction of current and thus reverse the polarity of the magnetic field 50 induced by the various coils 20 . A change 86 in the direction of the current applied to a coil 20 may be done on every alternate cycle, or after a number of cycles. For example, the direction of current may be changed with each cycle, or with every five cycles, every ten cycles, etc. as determined to be most beneficial. Alternatively, each application 68 of current to a coil 20 may include application of current in both directions (e.g., one followed by the other). [0069] For example, current may be applied 68 at a step function 85 , “on” followed by “off” followed by “on.” The direction of the current may then be changed 86 and the step function 85 may continue. Alternatively, the current may be applied 68 in an alternating manner (e.g., in a sinusoidal pattern 87 ) where the current transitions from a maximum peak in one direction to zero to a maximum peak in the opposite direction. When the current is applied 68 in such an alternating manner, there may be no need to determine 84 whether a cycle has been completed, and the process 60 may simply advance 74 to the next coil 20 . [0070] When the decision 82 of whether a treatment session should be continued is answered in the negative, application 68 of current to the coils 20 may cease. If desired, certain data characterizing the treatment session may be recorded 88 , output 90 , or both. In one embodiment, recording 88 the treatment session data may include recording user identification, session duration, current or magnetic field strength, waveform characteristics, or the like. [0071] Such data may assist in determining effectiveness of treatment and monitoring whether the prescribed treatment has been completed. Output 90 of session data may be provided to a centralized computer, printed, or simply displayed so that it may be logged by user patient. Accordingly, information characterizing a treatment session may be used for more general parametric evaluation of the efficacy of treatments over a broad population of patients. Finally, removal 76 of power from the system 10 or disconnection 76 of power from the system 10 results in an end 78 of the treatment. [0072] Referring to FIG. 8 , in various applications of medical treatments or other therapies, patient compliance is often a concern. Patient compliance may be limited due to memory issues, confusion, fatigue, or the like. Thus, everything from aptitude to attitude may affect the efficacy or the administration of any treatment. [0073] Accordingly, a method 60 in accordance with the invention may provide for certain user-system interactivity that may aid in compliance. For example, in selected embodiments, a process 60 may include detecting 92 whether a user is present. This may be accomplished by implementation of a sensor of any several types. In one embodiment, a distributor 12 may be installed on a bed as a mattress or mattress cover. [0074] The distributor 12 may include one or more sensors using capacitance, contact, inductance, or the like to detect the presence of a user. A simple pressure contact or capacitance change sensor may detect 92 the presence of a user lying on the bed. When that presence is detected 92 , the apparatus 10 may proceed to apply current to the coils 20 . [0075] By contrast, if a user is not detected 92 , the apparatus 10 may enter 94 a holding pattern and wait unit a user is present (e.g., enter 94 a pattern of periodically polling one or more sensors to determine whether a user is present). [0076] In some embodiments, a controller 14 may utilize an algorithm to determine 92 whether a user is present in a manner suitable for treatment. For example, a user sitting on a bed to put on a pair of shoes, may not be suited for treatment. Accordingly, in selected embodiments, both a particular time of day or night or a particular duration of presence may be required to move on within the process 60 . Likewise, if a user is seated, it may be that only sensors near one or two coils may be activated. Accordingly, the controller 14 may determine 92 that the user is not present for treatment. Thus, an algorithm may assist in interpreting the various parameter indicating that a user is present, leading to a better decision 92 as to whether treatment should begin or continue. [0077] In selected embodiments, once the decision 82 has been made to end a treatment session, a system 10 may wait 96 for the next treatment session to begin. The duration of that waiting period 96 may depend upon one or more factors. For example, if a system 10 is dedicated to a particular user (e.g., positioned on the bed of a particular user), the wait 96 may be preprogrammed by a delay time, time of day, or the like. [0078] For example, a typical user will may undergo a period of therapy perhaps once every evening (or every other evening) shortly after retiring. Accordingly, the wait 96 may begin with the end of one treatment session and end the evening of a later day. At that time, the sensors may be activated, permitting the system 10 to again apply 68 current when it is determined 92 that a user is present. [0079] Referring to FIG. 9 , a distributor 12 may include one or more user feedback devices 24 . In certain embodiments, user feedback devices 24 may be embodied as one or more light emitting diodes 98 (LEDs) arranged on a distributor 12 . The LEDs 98 may be configured in any suitable arrangement and be illuminated in any suitable degree, pattern, sequence, or the like. [0080] For example, in one embodiments, LEDs 98 may be positioned along the borders of a distributor 12 . The LEDs 98 may be illuminated by a controller 14 whenever current is being applied 68 to the coils 20 . Alternatively, certain LEDs 98 may be illuminated whenever to the overall system 10 is powered, while other may be illuminated whenever current is being applied 68 to the coils 20 . In one embodiment, LEDs 98 may illuminate only when the coil 20 most proximate thereto is receiving current. [0081] In selected embodiments, a distributor 12 may include one or more sensors 100 distributed throughout the matrix 54 . In certain embodiments, the sensors 100 may all be identical. In other embodiments, an array of sensors 100 may include various sensors for different parameters. For example, in selected embodiments, one or more sensors 100 may represent a capacitance detector for pressure. Accordingly, if a user is present, then pressure on one side of a flexible capacitive sensor 100 may decrease capacitance and thereby indicate the presence of a user. [0082] In other embodiments, one or more sensors 100 may be simple contact sensors that indicate pressure as a digital “yes” or “no” (“on” or “off”) condition. In still other embodiments, one or more sensors 100 may sense temperature, heart rate, inductance, or the like to detect, monitor, or otherwise provide information to the controller 14 . In more sophisticated systems, a pulse, represented by either a repetitive motion or cyclical pressure, or a temperature increase due to the presence of a living person may serve to trigger a sensor 100 to activate the apparatus 10 . [0083] Meanwhile, the insets illustrate alternative embodiments of the coils 20 in accordance with the invention. For example, the orientation of the coils 20 may be with their long direction extending in the longitudinal direction of the distributor 12 . Likewise, in certain embodiments, the coils 20 may be circular. In other embodiments, the coils 20 may have an aspect ratio closer to one. That is, in certain embodiments, the ratio of width 34 to the length 36 of a coil 20 may approximate a value of unity. In other embodiments, the ratio of the width 34 to the length 36 of a coil 20 may be significantly less then one. [0084] Referring to FIG. 10 , an apparatus 10 in accordance with the invention may include a distributor 12 sized to fit a double bed (i.e., double, queen, king, etc.). The matrix 54 may be provided with coils 20 distributed to be separately controllable between two individuals. Accordingly, one array may be aligned with one side of a double bed, whereas another array of coils may be aligned with the other side of the same double bed. [0085] In a simplified embodiment, both sides may be controlled at the same time. Nevertheless, the embodiment of FIG. 10 illustrates one reason why individual controls such as those illustrated in FIGS. 7-8 may efficaciously apply the electromagnetic therapy only when a user is present. [0086] In one embodiment, an apparatus as illustrated in FIGS. 1-4 was configured with the matrix being a blanket containing five coils. The interior width of each coil had a value of 18 cm and the interior length had a value of 48 cm. Each coil included ten turns. The field strength at 30 cm from the blanket surface, was controllable or presetable at from about zero to about 100 micro Tesla (uT), for an effective range of from about 1 to about 100 micro Tesla. The duty cycle target was in the range of from about 5% to about 15%, depending on current flow, with a target of about 7%. [0087] Coils may be connected in series, so long as the direction of current is the same in each, avoiding cancellation. Series connection, or individually activated in sequence, they provided relatively uniform coverage over the dimensions of a whole body covered by the blanket. Field cancellation was largely avoided. In one embodiment, additional coils were added around the periphery of the entire array of the five coils. The overall effect of the peripheral current in the peripheral coil was about one fifth the field strength of the regular coils 20 at 30 cm from the blanket. [0088] Thus, even a simple series connection of the coils can provide a good coverage of the whole volume of the body with the difference between minimum and maximum exposure generally varying by less that about one third. [0089] Typically from about five to about twenty turns make a suitable coil, with ten to twelve turns forming a good design target. However, it was found that the turns per coil can realistically be varied from about one to about 100 or even more with proper engineering. The magnetic field produced is directly proportional to the product of current and number of turns, a small number of turns requires a high current, which requires heavy duty circuitry and robust connectors, but a large number of turns has a high resistance and so requires a high voltage and good quality insulation. [0090] From about 15 to about 60 volts may be preferable for safety, but many countries use 240 volts, while the U.S. uses 115 volts (often characterized as 110 or 120 volt outlet power). For not more than 50 volts, a good compromise is around 10 turns per coil. [0091] With respect to coil dimensions, the field of a circular coil of diameter D at a distance D normal (perpendicular) to the plane of the coil, the field strength is about 45% of the field at the center of the coil in the plane of the coil. With rectangular coils 60 cm×30 cm, the field strength 30 cm from the center of the coil along its axis of symmetry is slightly above 50% of the field at the center of the coil. Thus dimensions of 60 cm×30 cm are adequate for good field penetration and even distribution to a depth of at least about 40 cm. Coils 50 cm×25 cm are adequate but might be regarded as the smaller end of the size range effective for full body exposure. However, they require proportionately less current for the same field strength exposure. [0092] In one engineered design, a single peripheral coil of from about 15 to about 40 turns, having a (maximum) pulsed current from about 10 to about 15 amperes provides about the same weight of conductor as a five-coil distributor. Fabrication is simpler, cheaper and field exposure is more uniform. However, user perception has a psychological effect. A user may think (incorrectly) that the absence of coils in the main area of the blanket is a disadvantage. [0093] High frequencies such as radio frequency (RF) waves produce heating but no known, physio-chemical response in mammalian tissue. However, an apparatus and method in accordance with the invention induces currents in circuits within its fields. Likewise, those currents distribute voltages across all elements of tissue circuits that conduct. Accordingly, all circuits that include bone cells as elements expose that piezoelectric bone to a potential, e.g. voltage, inducing a stress (load force per unit area) and a strain (displacement length per unit length), prompting a response by the organism. The stress, strain, and potential appear to be consistent with exercise, and the physiology of the organism (e.g. person, animal) may respond as if it were. Thus, frequencies of from about 1 Hertz (i.e. low values, single digits or fractions) up to about 100 Hertz may trigger or otherwise couple with such physiological responses. [0094] In addition, a mammalian body has immune and nervous systems having chemical reactions that generate electrical signals. These may respond repetitively at a communication frequency of from about 10 to about 100 Hertz. On the other hand, a single response may often be triggered by pulses of much shorter duration. Thus, a repetition rate in the range of from about 10 Hertz to about 1000 Hertz may rely on comparatively shorter pulses. [0095] A duty cycle in the range of 2 to 15% with the above pulse repetition rates may cause a repetitive electrochemical stimulation in the body simulating use of parts by communicating as much, even without actually loading these tissues. [0096] For stimulation effect caused by induced potential, the pulse shape may be sharp, i.e. a square or rectangular pulse waveform, or a comparatively short duration sinusoidal waveform at frequencies corresponding to bodily electrical functions. A very much slower rise is not contemplated to be effective for this type of coupling. [0097] A repetition rate of from about 100 Hertz to about 300 Hertz provides a frequency similar to that of the immune system, relevant body mechanisms, or both, in vigorous exercise. It is contemplated that a duration of from about one half hour to about 2 hours per day. A repetition frequency of 3 to 5 sessions (days of treatment) per week is consistent with exercise rates known to be effective in maintaining general health. [0098] In one embodiment, a magnetic field of up to 100 uT may be supplied to the bulk of a human body at a pulse repetition rate of from about 50 to about 500 Hz. A duty cycle of over 1% and preferably from about 5% to about 15% may ensure a magnetic pulse long enough for the body electrochemical processes to be stimulated. A rectangular or rapidly rising and falling current pulse shape or waveform from a large, single magnetic coil having from about 5 to about 50 turns extending around a blanket, proximate the perimeter thereof may serve well. Sequencing current delivery to an array of from 1 to about 6 coils, each having from about 5 to about 15 coils, and preferably about 10 turns each may cover the same area. [0099] A treatment period may operate with power inputs greater than 1 VA, and typically may draw from about 5 to about 10 VA of power. During each cycle, the pulses may be reversed in a manner to provide about an equal number of magnetic pulses in the forward and reverse directions. For this and other reason there need be no requirement for any specific orientation of the blanket. [0100] The frequency and field range provided by the coils of a distributor, such as one with a blanket or mattress pad acting as a matrix, may be fixed or adjustable by a user or caretaker. It may also be regularly cycled, or timed by calendar or computer clock as to repetition of sessions, or the like. [0101] 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.

A method of increasing bone mass throughout the body of a user. The method may include the steps of obtaining a distributor comprising a plurality of electromagnetic coils, obtaining a controller comprising a processor and a memory device, operably connected to one another, the memory device storing code executable by the processor, selecting a source of electrical current, connecting the source to the controller, and positioning a user proximate the distributor. The method may further include controlling, by the controller in accordance with the code, delivery of electrical current sequentially and exclusively to each coil of the plurality of electromagnetic coils to generate a magnetic field extending into the user.

FIELD OF THE INVENTION [0001] This invention relates to a training device for rehabilitation of individuals suffering from neurological injuries. More particularly, the present invention relates to a device that utilizes both mechanical and electrical stimulation of individual's muscles. DESCRIPTION OF THE BACKGROUND [0002] The recovery of walking is one of the main goals of patients after a neurological impairment (including stroke, multiple sclerosis, cerebral palsy and spinal cord injury (SCI)) as limitations in mobility can adversely affect most activities of daily living. Following a neurological injury, there is often impaired control of balance, paralysis, or weakness of lower extremity muscles including commonly those that activate the ankle. This often has a substantial adverse impact on walking. Specifically, individuals may suffer difficulties supporting their body weight during the stance phase, or shifting weight during the transition to swing, or lifting their foot for toe clearance during the swing phase due to the weakness associated with the injury. Gait training can be done i. with therapist-assisted over ground ambulation (with or without assistive device) ii. in a Body Weight Supported Treadmill Training (BWSTT) environment, where assistance for the movement of legs and the pelvis is provided manually by a therapist or iii. by a robotic device (Lokomat, Auto-Ambulator or Gait Trainer), or in water (weight supported environment, with or without a treadmill). Over ground gait training (with or without a Functional Electrical Stimulation (FES) orthosis) can only be used for individuals with already able to support body weight in an upright position. [0006] BWSTT, robotic device gait training and aquatherapy gait training (training in water) can potentially be used to enhance loco-motor abilities in neurologically impaired individuals, as lack of trunk balance and ability to bear weight in an upright position are replaced by the supporting abilities of the device or environment used (harness, exoskeleton or water). But they are not typically used in clinical practice to aid in locomotor training in individuals with motor complete impairments as this training would need specialized, center based, expensive environment (i.e. therapeutic pool, robotic exoskeleton) or is very labor intensive (sometimes requiring 2-3 therapists' sustained effort over long periods of time). [0007] BWSTT with manual or robotic assistance of the legs and the pelvis has been used as a promising rehabilitation method designed to improve motor function and ambulation in people with SCI (Behrman and Harkema 2000; Dietz et al. 1995; Wernig and Muller 1992; Wirz et al. 2005; Dobkin et al. 2006; Field-Fote et al. 2005). However, while BWSTT has been shown to provide improvements in locomotor ability, motor function, and balance for some patients, the current technology used to assist with the training is typically very expensive, requires trained therapists for utilization and can only be used in a rehabilitation center. Several robotic BWSTT systems have been developed for automating locomotor training, including the Lokomat (Colomboet al. 2000) and Gait Trainer (GT) (Hesse and Uhlenbrock 2000). [0008] The Lokomat is a motorized exoskeleton that drives hip and knee motion with fixed trajectory using four DC motors (Colombo et al. 2000). One limitation is that it is difficult to back drive the Lokomat because it uses high advantage, ball screw actuator. The GT rigidly drives the patient's feet through a stepping motion using a crank-and-rocker mechanism attached to foot platforms (Hesse and Uhlenbrock 2000). These robotic systems have their basic design goal to assist patients in producing correctly shaped and timed locomotor movements. This approach is effective in reducing therapist labor in locomotor training and increasing the total duration of training, but shows relatively limited functional gains for some patients (Wirz et al. 2005; Field-Fote et al. 2005). For instance, only 0.11 m/s gait speed improvement is obtained following prolonged training using the Lokomat (Wirz et al. 2005). [0009] FES has been previously used to enhance the quality of gait training whether as an assistive device (FES orthosis for foot drop) or to enhance muscle strength and improve cardiovascular resistance (FES ergometer), thus decreasing gait induced fatigue. FES has also been used extensively in the rehabilitation of individuals with SCI to: i. improve muscle mass and strength (Frotzler A, Coupaud S, Perret C, Kakebeeke T H, Hunt K J, Eser P. Effect of detraining on bone and muscle tissue in subjects with chronic spinal cord injury after a period of electrically-stimulated cycling: a small cohort study. Swiss Paraplegic Research, Nottwil, Switzerland; Thomas Mohr, Jesper L Andersen, Fin Biering-Sùrensen, Henrik Galbo, Jens Bangsbo, Aase Wagner and Michael Kjaer. Long term adaptation to electrically induced cycle training in severe spinal cord injured individuals. Spinal Cord (1997) 35, 1±16) ii. control spasticity (Maria Knikou, PhD, and Bernard A. Conway, PhD. Reflex Effects Of Induced Muscle Contraction In Normal And Spinal Cord Injured Subjects. Muscle Nerve 26: 374-382, 2002; Daly J., et al. Therapeutic neural effects of electrical stimulation. IEEE Trans Rehabil Eng 4:218-230, 1996; Robinson C. J., et al. Spasticity in Spinal-Cord Injured Patients 0.1. Short-Term Effects of Surface Electrical-Stimulation. Arch Phys Med Rehab 69:598-604, 1988) iii. improve cardiovascular endurance and respiratory function (Puran D Faghri, Roger M Glaser, Stephen F Figoni. Functional Electrical Stimulation Leg Cycle Ergometer Exercise: Training Effects on Carriorespiratory Responses of Spinal Cord Injured Subjects at Rest and During Submaximal Exercise. Arch Phys Med Rehabil 73:1085-1093) iv. improve bone mass (Belanger M, Stein R B, Wheeler G D, Gordon T, Leduc B. Electrical stimulation: can it increase muscle strength and reverse osteopenia in spinal cord injured individuals? Arch Phys Med Rehabil 2000; 81(8):1090-1098; McDonald J W, Becker D, Sadowsky C L, Jane J A, Sr., Conturo T E, Schultz L M. Late recovery following spinal cord injury. Case report and review of the literature. J Neurosurg 2002; 97(2 Suppl):252-265) and v. improve body composition (L. Griffin, M. J. Decker, J. Y. Hwang, B. Wang, K. Kitchen, Z. Ding, J. L. Ivy. Functional electrical stimulation cycling improves body composition, metabolic and neural factors in persons with spinal cord injury. J Electromyography and Kinesiol 2008: 1-8). [0015] FES has been postulated to even alter neuronal control, altering central nervous system plasticity and improving functional tasks performance (Richard K. Shields and Shauna Dudley-Javoroski. Musculoskeletal Plasticity After Acute Spinal Cord Injury: Effects of Long-Term Neuromuscular Electrical Stimulation Training. J Neurophysiol 95: 2380-2390, 2006). [0016] Combining gait training with FES activation of selected muscles involved in stepping has been already achieved and there are several commercially available FES driven orthosis for utilization in individuals with SCI, mainly to correct foot drop (Bioness L300, Walk Aid). In addition, in clinical practice, therapists are frequently utilizing hand held triggered neuromuscular electrically stimulated (NMES) devices to aid in foot/toe clearing during the swing phase of the gait when working with individuals with neurologic lower limb weakness. SUMMARY OF THE INVENTION [0017] One object of the present invention is to provide a functional electrical stimulation step and stand system comprising two footplates (left and right) connected to a primary drive motor that cause the footplates to move in a reciprocal motion. The footplates are further connected to corresponding servos, which allow for control of the movement of the footplate with respect to an axis. The ability to control the movement of the footplate is defined as the firmness of the footplate. [0018] In a further object of the present invention, the system comprises an electrical stimulation control unit. The control unit has electrical stimulation leads that connect to electrodes that deliver an electrical impulse to a patient's muscles. In a further embodiment, the control unit has one or more wireless stimulators. [0019] In yet an additional object of the present invention, the system has a hoist and harness that helps a patient stand upright on the footplates. In one preferred embodiment, the hoist and harness provide weight control measurements to the control unit. The control unit, in turn, utilizes that information to controls the electrical stimulation delivered to the patient's muscles. BRIEF DESCRIPTION OF THE DRAWINGS [0020] The above and other features, aspects, and advantages of the present invention are considered in more detail, in relation to the following description of embodiments thereof shown in the accompanying drawings, in which: [0021] FIG. 1 is a picture of a device in accordance with one embodiment of the invention. [0022] FIG. 2 is a graphical representation of a stepper assembly in accordance with one embodiment of the present invention. [0023] FIG. 3 is a graphical representation of the stepper assembly in the standing position. [0024] FIG. 4 is a perspective view of the stepper assembly. [0025] FIG. 5 is a detailed view of the foot plate. [0026] FIG. 6 is a detailed view of the foot plate with the servo plate removed. [0027] FIG. 7 is a detailed view of the foot plate showing the servo drive belt. [0028] FIG. 8 is a graphical representation of the control unit. [0029] FIG. 9 is a front view of the patient hoist. [0030] FIG. 10 is a front view of the harness. [0031] FIG. 11 is a graph showing the displacement of the pedals with and without servo input. [0032] FIG. 12 is a graph that shows the various positions of the servo can be commanded. [0033] FIG. 13 is a graph that shows the result of commanding the servo to move the foot plate for a normal gait. DETAILED DESCRIPTION [0034] The invention summarized above may be better understood by referring to the following description, the accompanying drawings, and the claims listed below. This description of an embodiment, set out below to enable one to practice an implementation of the invention, is not intended to limit the preferred embodiment, but to serve as a particular example thereof. Those skilled in the art should appreciate that they may readily use the conception and specific embodiments disclosed as a basis for modifying or designing other methods and systems for carrying out the same purposes of the present invention. Those skilled in the art should also realize that such equivalent assemblies do not depart from the spirit and scope of the invention in its broadest form. [0035] As shown in FIG. 1 , one embodiment of the invention is a trainer 100 that combines a robotic device that simulates stepping and standing with FES while the individual 110 is safely supported in a harness 120 . This design has the potential to tap into neuro-plasticity driven loco-motor patterning while increasing muscle strength and cardiovascular endurance and be safely applied in a center or home-based environment. [0036] The motion of the individual's feet is controlled by a foot assembly 200 as shown in FIG. 2 . The foot assembly 200 (also referred to as the stepper assembly) incorporates three motors. The primary drive motor 210 provides for transverse motion of foot plates 220 while a servo 230 built into both the left and right footplate 220 allow the software to independently control the motion of the foot about the ankle in the sagittal plane. This control can either assist the foot movement being evoked volitionally or electrically or it can resist such movement. [0037] In one further embodiment of the present invention, a stand training mode allows the foot plates to be brought together helping the individual patient to develop standing skills utilizing a combination of electrically evoked peripheral muscle contractions or volitional and or electrically evoked centrally driven muscle contractions. In this mode the footplate servos 230 can be used to induce perturbations, which the individual can train to counteract. [0038] The motors controlling each footplate 220 can also be commanded to produce a vibration motion of the footplates in the sagittal plane either during standing or stepping motions. This vibration can be used to deliver therapeutic benefits including the reduction of spasticity. FES driven gait training utilizing the training device 100 will be safe for both motor complete and incomplete neurologically impaired individuals. In addition, the training device 100 can increase the walking abilities of individuals with many types of neurological impairments. Given this the training device 100 can be safely used in a home based environment to perform long term gait training in individuals with varying degrees of neurological related paralysis. [0039] As shown in FIG. 1 , training device 100 is composed of a stepper assembly 200 , a control unit 130 , and a patient hoist 150 and harness 120 . The stepper assembly 200 , as shown in FIG. 2 , has a drive motor 210 connected to the drive assembly 250 . The drive assembly 250 is connected to the foot plates 220 by cranks 260 (left and right respectively) through a drive arm 280 . The cranks 220 are connected to the drive arm 280 at different positions 270 and held in place by a magnet. The positions 270 determine the step lengths for the foot plates 220 . In one particular embodiment, the drive arm 280 has three positions 270 resulting in 18″, 15″, and 12″ steps. An additional position 290 brings the footplates 220 together proving a standing position to the individual, as shown in FIG. 3 . [0040] As shown in FIG. 4 , the stepper assembly 200 further comprises an emergency stop 277 that allows a technician to stop the drive assembly 250 from moving the foot plates 220 . FIG. 5 shows a close up view of the right side foot plate 220 and servo 230 . In FIG. 6 , the servo cover 600 has been removed and the servo 230 is shown. The servo 230 motor connects to a drive belt 700 that controls the foot plate 220 as shown in FIG. 7 . Left unpowered, each footplate moves through a range of plantar and dorsi flexion movement that is a natural product of the transverse motion. [0041] The hoist 150 and harness 120 as shown in FIGS. 9 and 10 are used to position the patient over the stepper assembly 200 in partial body weight. The hoist 150 and harness 120 are connected to load cells that provide weight measurements to the control unit 130 . The control unit 130 utilizes the weight measurements in an electrical stimulation control algorithm that controls the electrical stimulation sent to the leads and stimulators. [0042] In one particular embodiment, the trainer 100 has a control unit 130 , as shown in FIG. 8 , which includes a computer and a 6 channel stimulator. The stimulator produces the functional electrical stimulation to evoke muscle contractions. The computer controls the operation of the stimulator, the drive motor 210 and the two footplate servos 230 . Software controlling the servo motors which power the left and right footplates can be used to guide a patient's foot through a normal range of motion in the sagittal plane during stepping training. [0043] When in use, the trainer 100 can be utilized to track the appropriate travel of the individual's feet. FIG. 11 is a graph that shows how the footplate pedal moves with respect to gravity when unpowered (pedal trace) compared with how the ankle of an able bodied individual moves when stepping (target pedal trace) vs. percentage of phase of the gait cycle. Furthermore, in FIG. 12 shows one way in which a footplate servo motor may be commanded to make the footplate's position coincident with normal gait. For example, commanding the motor to move 2452 positions results in a 1 degree movement of the footplate. Superimposing this motor driven footplate movement with the unpowered footplate movement that arises from the transverse motion brings the footplate motion (corrected pedal trace) coincident with the ankle movement of normal gait (target pedal trace) vs. percent of the gait cycle as shown in FIG. 13 . [0044] Producing this normal ankle movement on this trainer 100 is one of the possible uses of the footplate servo motors. In one exemplary embodiment, the motors are also used to produce vibration while standing or an exaggerated ankle motion for motor skill relearning purposes or a reduced ankle motion to accommodate patients with reduced range of motion in one or both ankle joints. In one exemplary embodiment, software varies the current supplied to each footplate servo which has the effect of varying the firmness of the footplate. Footplate firmness can be varied during a therapy session for example to gradually overcome plantar flexion muscle tone. [0045] In one embodiment of the present invention, the control unit 130 provides up to 10 channels of electrical stimulation. It is contemplated that any number of channels may be utilized to provide electrical stimulation. In one alternative embodiment, the control unit 130 further includes a 6 channel electrical stimulator and a BlueTooth communications link that allows it to control up to four additional single channel stimulators. [0046] The muscle groups to be stimulated are selected based upon how the patient presents. For example a hemiparetic patient may only require muscles on one side to be electrically stimulated. [0047] Our invention allows the following muscle groups to be selected for electrical stimulation each either bilaterally or unilaterally: Gluteals Quadriceps Hamstrings Gastrocnemius Anterior tibialis Erector spinae Abdominals The electrical stimulation is delivered to each muscle group via adhesive skin surface electrodes at the appropriate time in the gait cycle as determined by the position of drive arms in their circular path. [0055] A further embodiment of the invention allows the electrical stimulation angles to be adjusted. The following is a table of default angles that can be provided in one particular embodiment of the present invention. The 0 degree position is the left drive arm at top dead center. [0000] Stimulation Stimulation Muscle group on angle off angle Left quadriceps 50 285 Right quadriceps 230 105 Left hamstring 235 70 Right hamstring 55 250 Left gluteal 90 245 Right gluteal 270 65 Left gastroc 235 70 Right gastroc 55 250 Left anterior tibialis 50 285 Right tibialis 230 105 Left abdominal 340 180 Right abdominal 160 359 Left erector spinae 190 290 Right erector spinae 10 110 [0056] The invention has been described with references to a preferred embodiment. While specific values, relationships, materials and steps have been set forth for purposes of describing concepts of the invention, it will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the basic concepts and operating principles of the invention as broadly described. It should be recognized that, in the light of the above teachings, those skilled in the art can modify those specifics without departing from the invention taught herein. Having now fully set forth the preferred embodiments and certain modifications of the concept underlying the present invention, various other embodiments as well as certain variations and modifications of the embodiments herein shown and described will obviously occur to those skilled in the art upon becoming familiar with such underlying concept. It is intended to include all such modifications, alternatives and other embodiments insofar as they come within the scope of the appended claims or equivalents thereof. It should be understood, therefore, that the invention may be practiced otherwise than as specifically set forth herein. Consequently, the present embodiments are to be considered in all respects as illustrative and not restrictive.

A functional electrical stimulation step and stand system comprising two footplates (left and right) connected to a primary drive motor that cause the footplates to move in a reciprocal motion. The footplates are further connected to corresponding servos, which allow for control of the movement of the footplate with respect to an axis. System comprises an electrical stimulation control unit. The stimulation step and stand system further comprises a control unit that has electrical stimulation leads connected to electrodes that deliver an electrical impulse to a patient's muscles. In a further embodiment, the control unit has one or more wireless stimulators.

This is a division of application Ser. No. 08/272,968, filed Jul. 11, 1994, now U.S. Pat. No. 5,454,801, which is a continuation of application Ser. No. 07/959,196, filed Oct. 9, 1992, abandoned, all of which are hereby incorporated by reference. This invention relates to polymer film coatings for absorbent articles and more particularly to in situ foamed polymer coatings which give an opaque, soft, dry and clean appearing water-permeable cover to absorbent products such as sanitary napkins, underpads, tampons, diapers and the top sheet construction thereof. DESCRIPTION OF THE PRIOR ART Absorbent products such as sanitary napkins and the like are generally constructed to include an absorbent core located with a top or outer cover of water-permeable material. Many absorbent products contain a garment-facing barrier layer composed of a water impervious film material. The absorbent material usually also contains a body-facing cover made of woven or non-woven fabric which prevents the absorbent core from sloughing off or disintegrating during use. In recent years, many products have contained cover material made of two- or three-dimensional apertured polymeric film. These films permit fluid to flow into the absorbent core material without being absorbed into the cover fabric itself. Should fluid be absorbed in the cover fabric, the cover is aesthetically unpleasing to the wearer. The apertured polymeric film materials give the absorbent a clean and dry appearance. U.S. Pat. No. 4,585,449 (Karami) describes a disposable absorbent product having a water impervious lower layer, an absorbent pad and a top hydrophobic sheet containing surfactant to improve fluid penetration. U.S. Pat. No. 4,622,036 (Goodrum) describes an absorbent structure having a top sheet that is a liquid-permeable material formed from particles of non-dissolvable polymeric material partially fused together to form a continuous sheet. Another example of such a clean, dry cover made with a hydrophobic material is set forth in U.S. Pat. No. 4,629,457. This patent describes an absorbent facing having "one-way valve" characteristics for aqueous fluid. The one-way valve characteristics are produced by superimposing a thin polymer film and a first web comprising absorbent fibers to form a second web, heating the second web to a temperature such that the polymer is in a formable state, and simultaneously applying shearing and compressive forces to the second web to form the polymer into a coating on the first web. The coating has a fine pattern of continuous areas which lie between and interconnect discontinuous layers. The use of polymer foams in the manufacture of absorbent products such as sanitary napkins and diapers has been heretofore known. For example, U.S. Pat. No. 3,901,240 (Hoey) describes a laminate containing a crushed, polymeric foam, bonded to non-woven and absorbent layers of an absorbent article. U.S. Pat. No. 4,067,832 (DesMarais) describes flexible polyurethane foam useful as absorbent materials. U.S. Pat. No. 4,100,276 (DesMarais) describes a stable, resilient, polyester foam useful in catamenial tampons. Thermoplastic materials such as thermoplastic particles, films or fibers have been used in making absorbent products. U.S. Pat. No. 4,054,141 (Schwaiger et al.), U.S. Pat. No. 4,233,345, U.S. Pat. No. 4,360,021 (Stima), U.S. Pat. No. 4,590,114 and U.S. Pat. No. 4,184,902 (Karami) are exemplary of such absorbent products. Many women find hydrophobic apertured polymer films to be uncomfortable and irritating in comparison with fabric covers. This invention is directed to improvements in the outer surface coatings which contact the human body and may be applied directly to the absorbent core or to woven or non-woven fabrics covering the absorbent core. Pending U.S. patent application Ser. No. 07/684,629 relates to a process for making a low cost absorbent pad through the use of low cost manufacturing techniques including a continuous production technique in which all necessary raw material components are incorporated in a stepwise fashion and are bound together in a unitary design not employing adhesive. During the course of this method, a polymer cover formulation is applied in a pattern to a nonwoven web. SUMMARY OF THE INVENTION In accordance with this invention, absorbent products are made with a patterned film of polymeric material which has been formed on woven or nonwoven fabric material covering a substrate of absorbent material. According to one embodiment of the method of this invention, a polymer material is deposited on the woven or nonwoven web with an etched print roll in a geometric pattern determined by the roll etching. Alternatively, a geometric pattern of polymer may be obtained by using a patterned print screen. Screen printing is especially useful in when a heavy addition of polymer is desired. Preferably, the polymer contains one or more blowing agents which cause the polymer to expand or foam in situ to approximately 5 to 10 times the original volume of polymer prior to or during curing. The foam is then cured by crosslinking the foamed polymer into an opaque, outwardly extending, mounded, knobby, non-reticulated, repeating pattern of geometric shapes or units which are bonded to one another and to the substrate such that the vertical portion of the geometric shape extending from the substrate surface is about 5 to about 10 times the original polymer height. Curing may be accomplished by any means known to those of skill in the art. For example, radiant energy such as heat, ultraviolet light or electron beam or the like may be used. The resulting coating has a clean appearance in use, with the upper portion of the vertical geometric shapes remaining clean and dry in a moist environment due to their hydrophobic characteristics. The pattern is designed in such a way that some areas of the substrate are free of polymer or may be coated with thin layers of hydrophilic polymer such that body fluids can pass through the cover into the absorbent core. The resulting cover maintains its clean appearance and dry feeling even after body fluids flow through it because the body fluid will be repelled by the hydrophobic polymer material. Advantageously, however, the substrate on which the hydrophobic polymer is deposited is a fabric material and more acceptable to the touch to many women. In another embodiment of this invention is a low-cost panty shield-type product with a cover made in accordance with the foregoing process, i.e., forming the cover in situ, as well as forming a barrier layer in situ. A low cost, stabilized fibrous web can be printed with polymer material and cured. The web can then be turned over such that the printed side faces down, away from the side from which the printing roll is located, and an in situ polymer barrier layer can be extruded onto the side opposite that already printed. Prior to extruding the barrier layer, additional active elements such as superabsorbent particles or odor control agents may be incorporated into the web. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a roll-over-roll etched printing station used to apply polymer to a substrate moving through the rolls to a curing station which sets or hardens the polymer. FIG. 2 is a partial sectional plan view of the etched geometric configuration of the roll and the resulting polymer coated substrate. FIG. 3 is a view taken above the plane 2--2 in FIG. 2 after passing through the curing station. FIG. 4 is a view of a polymer foam coated on a substrate similar to FIG. 3, using the same printing roll shown in FIG. 2 which polymer foam is allowed to collapse somewhat during curing to fill the valley with polymer foam and completely coat the underlying substrate. FIGS. 5A and 5B are perspective views of apparatus used in making a panty shield having a printed cover and extruded barrier. FIG. 6 shows three preferred patterns for the polymer to be printed onto the cover of the products of this invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS With reference to the accompanying drawings, in FIG. 1 there is a non-woven fibrous substrate 1 which is continuously passed between an etching roll 2 and support roll 5. Polymer is coated onto the etching roll surface 12 using a die or hopper (not shown) and deposited on substrate 1 as the roll turns and contacts substrate surface 6. The coated substrate surface 1 continues moving in the direction of the arrow to a curing station 4 where the polymer is cured. The curing step may be accomplished by means of radiant or thermal energy, e.g., heat, ultraviolet light, electron-beam or other means known to those of skill in the art. The possible shapes of the set geometric units of polymer at position 14 are shown in FIGS. 3 and 4. The polymer may, optionally, contain blowing agents, which cause the polymer to expand just before and/or during curing to develop the final foamed geometric shapes 4b and 8 shown in FIGS. 3 and 4. In the cases in which foaming is not employed the cured polymer resembles the solid geometric shape shown in FIG. 3 as 4a. FIG. 2 is a plan view of a portion of the surface of print roll 2 at position 3 and also a plan view of a portion of the surface of the polymer 15 applied to surface 6 of substrate 1 at position 13. Closer inspection of the Figures will indicate that the foamed and set polymer 4b of FIG. 3 and 8 of FIG. 4 has a mounded shape that is somewhat wider at the base of the pattern where the polymer contacts the substrate than at the substrate top surface 7. Top surface 7 and vertically extending side walls 8 of the cured foamed polymer in FIGS. 3 and 4 have a "knobby" surface. The "knobs" are achieved by the formation of small bubbles or foam during the outgassing stage of the curing process. The bubbles are stabilized in the curing process and the "knobby" appearance is thereby achieved. The geometrically formed units 4a, 4b and 8 are firmly adhered to each other as is shown in FIG. 2 and firmly adhered to substrate surface 6 of FIG. 1. Turning to FIG. 3, there are open areas 9, provided for the transfer of body fluid through the substrate to a core of absorbent material. The polymeric pattern thus gives the appearance of an apertured polymeric "clean, dry" facing. However, the facing-material is a fabric, thus adding to the comfort of the wearer. Substrate 6 may be a woven fabric or a nonwoven stabilized web of fiber, laid in a random orientation with no preformed apertures. The substrate can be hydrophilic or hydrophobic or have intermediate characteristics produced by mixing hydrophilic and hydrophobic fibers such as rayon and nylon or the like. The characteristics of the fibers may also be modified by the addition of surfactants to render the fibers more hydrophilic. A hydrophobic, apertured, non-woven web having a repeating geometric pattern of openings designed to pass fluid is useful as a substrate in the products of this invention. The substrate can also be a film if desired, or a pad of absorbent material. The polymer should be applied to the substrate and allowed to partially or totally saturate or coat the substrate to insure a solid bond upon curing. The polymer can be applied as a plastisol or organosol or otherwise, such as a solid, to the fiber substrate. The polymer may then be cured or foamed prior to curing. The polymer may be foamed by employing a blowing agent. The blowing agent expands and evaporates, leaving a grossly-increased volume of polymer, preferably about 5 to about 10 times the volume of unfoamed polymer. Prior to foaming, the polymer is placed on a fabric, film or fibrous web substrate in a uniform, repeating, geometric design which on foaming and curing results in a cover material which is flexible, resistant to wear, soft to the skin and mucosa and dry to the touch in moist environments. The polymer may be applied to the substrate of means of printing, coating, etching, silk screening, or any other method known to those of skill in the art. The polymer can be any hydrophilic or hydrophobic polymer which can be formed into a geometric design, particularly a polymer which can be foamed and solidified to produce a geometric shape having a vertical height between at least about 5 and about 10 times the height of unfoamed polymer. Most preferably, the height should be equal to or greater than the width of the area of the vertical plane 10 in FIGS. 3 and 4 of the geometric foamed polymer taken at a point one-half of the vertical height of the wall of the foamed polymer. Referring to FIG. 5A, a low cost, stabilized, fibrous web 20, such as Scotts High Loft SPP (available from Scott Paper Company of Philadelphia, Pa.) is brought through a rotary screen printing station 25. At the printing station, the in situ cover is pattern-applied. The rotary screen is used to apply a relatively heavy amount of polymer, between about 0.4 oz./yd. to about 1.2 oz./yd. The pattern should be aesthetically pleasing (FIG. 6A), can aid in pad placement (FIG. 6B), and or can be effective in providing surface channels and reservoirs to aid in fluid management (FIG. 6C). The polymer cover is heat-cured as it passes through an infrared tunnel 30. The cured cover serves to improve the structural integrity of the web. The web is then turned over by inverting bars 35 in order to present the underlying surface, which will become the garment-facing side of the product, to be processed. Optionally, particulate or other types of materials may be added to the now-exposed side of the web at this point in the process. As depicted in FIG. 5A, particulate material, such as superabsorbent, may be added to the web using a hopper 40 or any other apparatus known to those of skill in the art. Referring now to FIG. 5B, the in situ barrier may be applied by direct extrusion 45 onto the web. The extruder delivers a hydrophobic barrier such as polyethylene directly to the surface of the web. The barrier material should be compatible with the material in the web in order to insure that the barrier and web are adequately adhered to one another. After extrusion onto the web, the barrier may be "texturized" or imparted with a pattern in order to reduce plastic noise and feel. The barrier may also be cured, if necessary. A placement adhesive may be placed on the barrier using a roll print process 50 which distributes the adhesive in a controlled pattern. The printed adhesive may then be cross-linked and cured using an ultraviolet curing unit 55. Release paper such as silicone-coated Kraft paper is then applied to the bare adhesive in order to protect the adhesive from dust and dirt. The product can then be die cut at a die cutting station 60. The polymer used for the printed cover can be a flexible, preferably white, polyurethane foam obtained by reacting an aliphatic diisocyanate and polyether polyol with an admixture of polyfunctional, crosslinking agents, stannous octoate catalyst, inorganic hydroxide strong base catalyst and water such as described in U.S. Pat. No. 4,067,832, which is hereby incorporated herein by reference, or a resilient polyester foam material such as disclosed in U.S. Pat. No. 4,110,276, which is hereby incorporated herein by reference, prepared by reacting an acyl halide, polyol and polyhydroxy crosslinking agents in the presence of an alkali metal carbonate to prepare a flexible, resilient foam. The coating may, alternatively, be a polyester foam as taught in U.S. Pat. No. 4,239,043, which is hereby incorporated herein by reference, or foamed latex or other monomers, polymers and terpolymers as disclosed in U.S. Pat. No. 3,901,240, which is hereby incorporated herein by reference. Any foamable plastic polymer-which forms a flexible open celled or closed celled foam may be employed in the products and process of this invention. For example, latex foams are most preferable, however other foams such as polyvinyl chloride foams, polystyrene foams, crosslinked polyethylene foams, polypropylene foams, polyurethane foams, polypropylene foams, polyurethane foams, acrylic and methacrylic polymer foams or foamed rubber may be employed. While the foam can be formed by preparing a gasified monomer before curing it is much preferred to employ monomer compatible blowing agents known to those of skill in the art such as air, carbon dioxide, volatile alkanes such a 2-methyl propane, volatile halo alkanes such as methyl chloride, dichloromethane and the like, volatile alcohols and ethers and various halocarbons including fluorocarbons. Preferably the process of this invention entails forming the polymer of choice into a fluid polymer phase and bringing that fluid polymer phase to a low density cellular state. This low density cellular state should be preserved by setting the polymer into a flexible, resilient, soft, foamed coating. This is accomplished by creating small discontinuities or cells in the plastic phase, causing the cells to grow to the desired five fold or preferably ten fold increase in volume from unfoamed polymer. The cellular structure should then be stabilized by physical or chemical means. Preferably, the pressure inside the cell that causes the polymer to foam is generated by the blowing agent dispersed or dissolved in the polymer mixture. For example, a fluorocarbon blowing agent can be uniformly dispersed in the polymer. Heating this mixture causes a rapid and controllable expansion of the polymer mixture. Similar expansion can be obtained by reacting compounds in the deposited polymer during curing, to cause evolutions of a gas such as carbon dioxide which causes the polymer to expand. The expanded polymer is then set or solidified by heat or other known means. Alternatively, the foamable composition may be deposited on the substrate under pressure from a die or an extruder and thereafter expanded at atmospheric or reduced pressure. Polyethylene and polypropylene foams can be prepared by crosslinking the polyethylene chemically using peroxides or by radiation which is preferred using an electron gun or other means. The expanded polyethylene foam is prepared by mixing polyethylene, a chemical blowing agent and optionally a crosslinking agent at low or medium temperature, shaping the polymer by applying it to the substrate using an engraving, screen or other known depositing process, chemically treating or radiating to polymer to crosslink the polymer and heating the polymer and heating the polymer to expand. The polymer is then cooled to form a solid foamed coating. Polyurethane foams can be prepared from a polyfunctional isocyanate and a hydroxyl-containing polymer along with a catalyst and blowing agent as a halocarbon. Polystyrene foams can be produced by decompression of polymer as it leaves a die, which is used to coat the engraving roll or silk screen. The engraving roll or silk screen then prints the polymer onto the substrate. Latex rubber foams can be made by dispersing a gas or solid in a liquid phase, stabilizing the liquid polymer phase and subsequently treating the polymer after its application to the fiber substrate by heat. The heat then causes the gas to expand the rubber to cure. Expanded acrylonitride-butadiene rubber, expanded butyl rubber, expanded natural rubber, expanded neoprene, expanded latex foam, polyethylene, polypropylene, polyurethane, polyvinyl chloride and silicon foams and compatible mixtures thereof, are all useful in forming the geometric foamed coating of this invention. Most preferably, the polymer material useful in the products of this invention is polyvinyl chloride. Most preferably, it is combined with various plasticizers known to those of skill in the art to form a plastisol. This plastisol is combined further with blowing agents, such as nitrogen or another inert gas and encapsulated carbon dioxide to form a foaming composition. The plastisol is then applied to an etched printing roll which in turn applied the plastisol to a nonwoven substrate made of staple synthetic or natural fibers and/or stabilized paper pulp fibers. The substrate moves under a curing station which directs heat at the plastisol-coated substrate in order to cure the polymer and cause it to foam. The curing temperature and curing time is dependent upon the formulation of the plastisol as well as upon the heat source used during the cure. Using the preferable composition of polyvinyl chloride in a plastisol composition, the formulation should be cured at a temperature of from about 300° F. to about 475° F. for a time period of between about 15 and about 45 seconds. In one preferred embodiment of the process and products of this invention, a fibrous web material such as Scotts High Loft SPP is brought through a printing station. This web is preferably made up of various blends containing thermoplastic fibers such as Enka bicomponent fiber having a polyester core and a polyethylene sheath, and Dupont Pulplus®, a polyethylene microfiber available from E. I. dupont de Nemours of Wilmington, Del. A preferred plastisol cover formulation contains 50% by weight polyvinyl chloride resin, such as Geon® 180×5 available from B. F. Goodrich and 50% plasticizer such as butyl benzyl phthalate, such as Santicizer 160, available from Monsanto Corporation of St. Louis, Mo. This plastisol cover formulation should be applied to the web in amounts between about 0.4 and about 1.2 ounces/yd 2 . The polymer film or foam covers of this invention are particularly useful for their appearance and comfort. Not only are the coatings soft, flexible and compressive, they offer a clean, fresh appearance and provide an easy means of controlling moisture transfer to the absorbent areas of diapers, sanitary napkins, tampons and the like. The flexible and compressive urethanes, vinyl, latex, foam rubber and olefin foams are particularly useful for comfort and cushioning. The film or foam coating of this invention can be whitened to improve its appearance and enhance its stain-masking characteristics by incorporating in the polymer mix prior to transfer to the substrate, various pigments such as clays, calcium carbonate, talc, titanium dioxide and the like. The addition of white pigment is particularly useful for the absorbent articles of this invention in improving the appearance, both before and after use, of the article. The coated foamed surface of the absorbent article has a clean, white appearance which is very desirable and is a preferred embodiment of the products of this invention. The surface geometry of this invention is controlled by the plastisol or foamed plastisol while the white appearance is due to the high opacity of the foamed polymer and preferably by the addition of white pigment. The foamed plastisol allows the formation of an infinitely variable variety of designs of porous film in situ on fiber substrates. The degree of moisture penetration is easily controlled by the geometric design, the hydrophobic-hydrophilic characteristics of the foam and by the physical properties of the polymer as its is expanded and then cured. Less sharply defined, geometric patterns are also possible to create by modifying the polymer viscosity or cure time. This causes the sharply defined printed shape to slump. The shape can then cover all or a portion of the underlying substrate. A particular advantage of the foamed in situ process of this invention, however, is to produce rather sharply defined geometric designs of white surfaces which have high vertical walls extending from the fabric substrate which insures that the upper surface of such walls remains dry while fluid is passed through uncovered or lightly covered areas of the substrate in the valleys between the vertical walls of the geometric design and then into the absorbent core. The in situ foam covers of this invention are an extremely cost effective way of manufacturing foam covered absorbent products. The foamed geometric design increases the cover's working surface and allows further control of the cover's absorption properties as well as improving the appearance of the surface. The foamed polymer film also forms surface channels, which encourage vertical fluid penetration into the absorbent core of pads. This maintains dry upper surfaces and discourages side failures. The foam cover of this invention is also an excellent method by which to combine a cover film and absorbent fiber in a hybrid structure. The method of this invention strengthens the fiber web by coating the surface fibers and interstices with film or foam. Fiber substrate interstices therefore do not trap fluids and become stained. The open fiber portions in the valleys created by the pattern pass fluid to the absorbent core while the vertical walls of the foam hide any staining in the valley. The cover, once hybridized with a foamed film, becomes more structurally stable and resists bunching of the surface cover. The foamed cover retains its cured appearance during and after use.

This invention relates to polymer film or foam coatings for the covers of absorbent articles. More particularly, this invention relates to absorbent products and processes for making in situ foamed polymer coatings which give an opaque, soft, dry and clean-appearing water-permeable cover to absorbent products such as sanitary napkins, diapers and the like.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation and claims the priority benefit of U.S. patent application Ser. No. 12/218,581, filed Jul. 15, 2008, now U.S. Pat. No. ______ and entitled “Creating and Interactive Gaming Environment,” which is a divisional and claims the priority benefit of U.S. patent application Ser. No. 10/359,359, filed Feb. 4, 2003, now U.S. Pat. No. 7,711,847 and entitled “Managing Users in a Multi-User Network Game Environment.” U.S. patent application Ser. No. 10/359,359 claims the priority benefit of U.S. provisional patent application Ser. No. 60/376,115, filed Apr. 26, 2002 and entitled “Multi-User Application Program Interface.” The disclosure of each of the aforementioned applications is incorporated by reference. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates generally to computer networks and, more particularly, to creating an interactive gaming environment over a computer network. [0004] 2. Description of the Related Art [0005] Computer networks, such as local area networks and the Internet, are increasingly being used as the backbone for various transactions and interactions between parties. From online banking, where bank customers can initiate financial transactions over a computer network, to online gaming, where garners can participate in real-time gaming over the Internet, service providers are increasingly supporting a variety of services over computer networks. There are currently a variety of different computer network configurations that facilitate the transactions and interactions that take place. [0006] Many of the online applications involve multi-user applications, which are computer programs that are executed on a computer system and which allow multiple geographically separated participants to interact with the computer program and other participating users in an application environment. For example, gaming is a popular multi-user application that is increasing in popularity. An aircraft simulation game can enable multiple participants to pilot their respective virtual aircraft within an airspace, and can enable the participants to interact with other participants in their aircraft in the same airspace. Thus, the online gaming application provides a single application environment or universe in which multiple participants maneuver. [0007] To support multi-user applications, such as online gaming, with geographically dispersed application users, such as game participants, and to support real-time interaction among the users in the application environment, it has been necessary to share information about every participant in the environment. For example, in an aircraft simulation application, it becomes necessary to share information about the airplanes for each of the participants, including aircraft size, speed, altitude in three-dimensional space, appearance details, virtual environment details (such as buildings and terrain), and the like. Such information permits the computer at each participant to properly keep track of game developments and determine the actions being performed by each of the participants. This permits each participant to obtain properly rendered visual images on the participant's viewing display. [0008] The amount of information that must be shared among all of the participants can become daunting and can result in bandwidth difficulties. The amount of information that must be shared among participants is so great that it has inhibited the development of online gaming and other online multi-user applications. A technique for distributing the management of online applications is described in U.S. Pat. No. 5,841,980 to R. Waters et al. entitled Distributed System for Communication Networks in Multi-User Applications. [0009] The '980 patent describes a system configuration in which the functionality of a monolithic server is distributed across multiple servers, each of which services a number of local users. Thus, whereas a single server previously served as the source of all application information, such as game state, the '980 patent describes a situation in which the game server functionality is distributed across multiple computers. Users (on-line participants) are free to login to their most convenient server. In this way, there is no single “choke point” that might inhibit game play, and the bandwidth requirements for the online game community are reduced. Even with the reduction in overall bandwidth demands, the sheer volume of data that must be transmitted between users to support the online environment can result in local pockets of strained bandwidth capacity. [0010] Other multi-user applications provide a somewhat cumbersome user interface and can be inefficient for operation of the application server. For example, some online gaming portals provide links to game sites of interest. The server that provides the gaming portal Web site only provides links to game pages or game Web sites. Thus, the gaming portal will redirect a user to the appropriate game server or host for information about ongoing games. This places additional operational burdens on the game servers. [0011] Unfortunately, current multi-user applications are not configured for maximum efficiency of operation and cannot support a number of application users to make online gaming a viable opportunity. Thus, there is a need for an improved, more efficient online multi-user application environment. The present invention satisfies this need. SUMMARY OF THE INVENTION [0012] The present invention provides for creating an interactive gaming environment. In various embodiments, methods of the present invention may include initializing an interactive game application at a game server which is then characterized as having an active status, notifying a lobby server concerning the active status of the game server, registering the application with a universe management server via the lobby server, and allowing users to join the interactive gaming environment. The users joining the interactive gaming environment may be identified by a server key obtained from the game server. BRIEF DESCRIPTION OF THE DRAWINGS [0013] FIG. 1 is an illustration of a computer network system on which is run a multi-user application configured in accordance with the present invention. [0014] FIG. 2 is a detail block of the system shown in FIG. 1 . [0015] FIG. 3 is a flow diagram of the operations performed by the system of FIG. 1 . [0016] FIG. 4 is a flow diagram that shows further system operations in addition to those shown in FIG. 3 . [0017] FIG. 5 is a flow diagram that shows further system operations in addition to those shown in FIG. 3 . [0018] FIG. 6 is a block diagram of a computer in the network illustrated in FIG. 4 , illustrating the hardware components. [0019] FIG. 7 is a block diagram of a computer entertainment system in the network illustrated in FIG. 1 , illustrating the hardware components. DETAILED DESCRIPTION System Construction [0020] FIG. 1 is a block diagram of a computer network system 100 comprised of one or more network devices including one or more client computers 102 who communicate with an authorization server 104 to gain access to the system, including participation with multi-user online applications. As described further below, the client computers can comprise computers 102 ( a ) configured in a classic client-server configuration, or in a peer-to-peer configuration, or can comprise computers 102 ( b ) configured in an integrated server configuration that combine the functionality of other computers with the client computer functions. References to client computers 102 will be understood to be a collective reference to either configuration, or references to one configuration subgroup 102 ( a ), 102 ( b ) or the other will be to the specific subgroup specified. An authentication server determines whether authorization is warranted by consulting a database server 106 for user records. The authentication server also communicates with a universe manager computer 108 that maintains records about online users and helps manage the online application environment, or universe. [0021] After an authentication server 104 authorizes a user 102 to continue, the user can participate in an online multi-user application by first communicating with lobby servers 110 to obtain application-level information. The application-level information can include information about an application and its participating users. In the context of an online game application, for example, the lobby server 110 can provide information about the game and about currently participating users. After selection of an online multi-user application, the user is redirected to an appropriate application server 112 , from which the user receives information sufficient to permit the user to join the online environment of the multi-user application. Thus, application level information is maintained at a lobby server 110 , rather than at each individual application server or host machine 112 . Users can therefore learn about and select a desired application, such as an aircraft online game, through communication with the lobby server, leaving the application servers free to host their particular applications. [0022] In FIG. 1 , the lobby servers 108 and application servers 112 are depicted as cloud shapes to indicate that the functionality of these servers can be distributed across multiple computers who collectively provide the functionality or can be provided by one or more independent network computers. For example, the application servers 112 can comprise dedicated application server computers 114 that function as a distributed memory engine (DME). As an alternative, as described further below, the application servers can comprise a combination of integrated servers 102 ( b ) and application servers 112 acting in a proxy capacity to provide an interface to the universe manager 108 . Similarly, the function of the lobby servers 110 can be provided by dedicated lobby servers that communicate directly with the clients 102 , or the lobby server functions can be provided by other computers that communicate with the clients, such as the authentication server or universe manager 108 . [0023] Thus, the functionality of the game server is split between the lobby server and the application server. The lobby server can therefore reduce the bandwidth requirements and other operating demands on the application server. The application can comprise, for example, a multi-user interactive gaming application. This improves efficiency of operation. [0024] In accordance with the invention, cross-user communications as well as cross-application communications in real-time are facilitated through the lobby server concept. A user who is participating with one application can communicate with a user who is participating with a different application. Thus, a first user can be logged in to lobby server and can be participating in an aircraft online game environment through an application server, while a second user can be logged in to the same lobby server, but can be participating with a different application in a different programming environment, such as a financial package or a different online game. The first user and the second user can communicate with each other, if they wish, or they can choose to participate in their respective environments, isolated from each other in terms of communications. [0025] The universe manager 108 acts in an overall supervisory role, maintaining information about the users (clients) 102 who are registered with the system and logged on, communicating with the users via the authorization servers 104 , lobby servers 110 , and application servers 112 . The lobby servers 110 provide application level information to the users, thereby acting as an application portal and source of application information to the clients 102 . For example, unlike typical game portal servers that merely provide links to game sites, the lobby servers provide information about games in progress and can provide game-level information, such as information about the players who are actively participating in a game. The application servers 112 provide the actual application environment. For example, in the situation where the online application is a game, the application servers provide the actual game play environment comprising player participants, audio and graphics information, and other data necessary for a client 102 to fully participate in the online gaming experience for the game administered by the particular application server 112 . In this way, many tasks that must be performed to support system operation can be performed according to the most appropriate machine to perform the task. [0026] As noted above, the authentication servers 104 communicate with database servers 106 for authentication, application information, and the like. FIG. 2 illustrates details of the database servers and shows that the database servers can comprise multiple servers and associated database storage. For example, FIG. 2 shows a database server 106 that includes an authentication data server 202 and an associated authentication database 204 , a transaction data server 206 and associated transaction database 208 , and an application data server 210 and associated application database 212 . The operation and configuration of these components will be better understood with reference to the following description. [0027] System Operation [0028] FIGS. 3 , 4 , and 5 are flow diagrams that illustrate the functioning of the system constructed in accordance with the invention to provide improved operation of online multi-user applications. [0029] In the first operation, represented by the flow diagram block 301 , a user connects to a network domain name, such as a game portal or other Internet site to attempt access and login to a multi-user application, such as an online game. In the next operation, the user is redirected to one of the authentication servers. This operation (represented by block 302 ) can include operation through a load balancer or similar configuration for server workload management. At the next block 303 , the user is assigned a session key by an authentication server. The session key will remain active during the current online session by the user and will be associated with a privilege level, thereby providing a means for the various system components (illustrated in FIG. 1 ) to determine the level of access to be granted to the user. The user then supplies account login information to the authentication server, at block 304 , and then the authentication server forwards an authentication request to the authentication data server (of the database servers), as indicated at the block 305 . The account login involves a user's registered account number or other identifier against which a user's right to access can be determined. At the next operation (block 306 ), the authentication request is processed with appropriate load balancing and is directed to a particular one of the authentication servers. [0030] At the next block 307 , the authentication data server communicates directly with the authentication database to determine whether the user's login should be accepted. This operation can involve, for example, checking the user's account history to ensure all appropriate fees have been paid and to ensure the user has all authorizations or qualifications to proceed. To maintain the user's history, this operation 307 also involves sending the transaction record (login attempt) to the transaction data server for non-volatile storage. This recording operation also can involve a load balancing operation. [0031] The success or failure of the login attempt is reported back to the authentication server, at the next block 308 . The login result is forwarded back to the user and also to the transaction data server. At the next block 309 , similar processing operations are repeated for the user name login procedure. Yet another similar login sequence occurs for the user's screen name, along with an application identification, as indicated at the block 310 . If the screen name login is successful, then the authentication server will assign the user to a lobby server and will also promote the session privilege level to the Universe Manager, so that the user will be granted all appropriate access during the session. It should be noted that the authentication server is aware of the lobby servers that are available corresponding to the application ID provided by the user, by requesting an appropriate application server from the Universe Manager. The Universe Manager keeps track of the available lobby servers via “heartbeat” reports that are sent by lobby servers to the Universe Manager continuously while the lobby servers are operational. This processing is represented by the next block 310 . [0032] Next, at the block 311 , the user disconnects from the authentication server and establishes communication with the assigned lobby server. At the block 312 , the user verifies the session key that was obtained from the authentication server at block 303 and also verifies the application ID with the assigned lobby server. The lobby server verifies the data, as well as the privilege level, with the Universe Manager. The user's privilege is upgraded upon successful verification. [0033] In the next phase of system operation, at block 313 , the user has successfully completed login with a lobby server and therefore is entitled to participate in system-wide functions. These functions can include, for example, chat, group or community management, player-matching activities such as team or clan tasks, and outcome or competitive standings and ladder progress. Any requests from the user for information regarding available chat channels, available games, location of other users, messaging functions, and the like, the request is forwarded from the lobby server to the Universe Manager. If a request for information involves the non-volatile storage, then the request is forwarded to the appropriate database server ( FIG. 2 ). [0034] One of the system-wide functions that a user might want to participate in following successful connection with a lobby server can comprise using an application. In the context of an online gaming environment, that application is a game. Those skilled in the art will appreciate that other online multi-user applications can be involved. As noted above, the clients can participate in online gaming as either part of a client-server configuration or peer-to-peer configuration, or as part of an integrated application server and client configuration. FIG. 4 relates to users who are operating in a client-server or peer-to-peer configuration, and FIG. 5 relates to users who are operating in an integrated application server configuration. [0035] In FIG. 4 , the first operation (which occurs upon the user wanting to join a game after completion of the last block in FIG. 3 ), is for the lobby server to forward the user's application (game) request to the Universe Manager. In the FIG. 4 processing, the client is configured as a classic client-server configuration or as a peer-to-peer configuration. The Universe Manager assigns the user to a game server that is appropriate for the requested game. The game servers keep the Universe Manager apprised of their status via continuous, periodic heartbeat reports, in a fashion similar to that of the lobby servers. In this way, the Universe Manager is aware of system status and can manage and respond to requests from the lobby servers and application servers. After the first processing operation shown in FIG. 4 (block 414 ), the assigned application server assigns a server specific key to the user (block 415 ). The key provides an extra measure of security to prevent unauthorized access. The authentication server asks either the Universe Manager or the assigned application server for the key, and forwards the key to the user through the Universe Manager and to the lobby server. [0036] In the next block 416 , the user is connected with the assigned application server, providing it with the server-specific key it received from block 415 . The user will be disconnected from the application server if the server-specific key does not match the records at the application server. If there is a match, the user is allowed to remain connected with the application server. It should be noted that the user remains connected to a lobby server throughout use of the application, such as during a game playing session. At block 417 , periodic user reports are sent from an application-participating user back to the user's lobby server. In addition, the application server who is hosting the application for all participants (such as the game host) sends periodic reports on the status of the application to the application host. The lobby server and application server do not directly communicate, thereby better managing the processing load on the lobby server. [0037] At the conclusion of the application session (block 418 ), the user disconnects from the application server and returns to normal activities, including all available lobby functions through the lobby server. As noted, these functions can include chat, group or community management, messaging, and the like. It should be noted that these functions are available to the user at all times when the user is connected to the lobby server, including during application use (e.g., during game play). [0038] If the user performs a logout procedure, or if the user is timed out from an active connection because of inactivity, the user's session is cleared from the active records of the Universe Manager. This is indicated at the next block, 419 . If the user wishes to participate in another application, the user must go through the authentication process once again, including the login process. [0039] Rather than operate in a network configuration in which applications are provided by dedicated application servers, the network can also operate in a configuration in which the multi-user application is provided by integrated servers. An integrated server refers to a user (client) machine that has been configured with an integrated server application that provides the user machine with application server functionality. A system that implements this method of operation is described in co-pending U.S. patent application Ser. No. 09/704,514 by C. Guy, G. Van Datta, and J. Fernandes entitled “Application Development Interface for Multi-User Applications Executable Over Communication Networks” filed Nov. 1, 2000. The disclosure of this application is hereby incorporated by reference. As noted above, when a user wants to join a game, the system operation moves from the description of FIG. 3 to the description of either FIG. 4 (dedicated application server) or FIG. 5 (integrated server). [0040] Turning now to FIG. 5 , the first operation under the integrated server configuration is for a user who wants to host an application (such as an online game) to initialize an integrated server application that has been installed on the user's computer. The integrated server application makes a connection to an appropriate domain name, such as a game portal Web site. The integrated server then executes an authentication process with an authentication server, in a process similar to the initial login process described in conjunction with FIG. 3 . These operations are represented by the first block 514 of FIG. 5 . [0041] Upon successful authentication with the authentication server, the hosting user's integrated server application causes periodic server reports to be transmitted to a proxy application server. As noted above, the proxy application server is included within the application server cloud 112 of FIG. 1 . The proxy application server can comprise an application in addition to or integrated with the integrated server application at the hosting user, or the proxy application server can comprise a separate server that is another node of the FIG. 1 network and that communicates with the hosting user's computer. In any case, the user's integrated server application provides periodic, regular “heartbeat” reports to the proxy application server to confirm the operation of the hosted application and to provide status information to the proxy application server. The proxy application server communicates with the Universe Manager, providing the Universe Manager with the application status information received from the hosting user machine. The Universe Manager includes these reports in its data collection, just as it would with similar reports from dedicated application servers and from any other integrated servers. These reporting operations are represented by the second block 515 of FIG. 5 . [0042] In the next operation, block 516 , the user notifies its assigned lobby server of its status as an active application server. This new executing application will now be available over the network. The lobby server then registers this new application with the Universe Manager, which adds the appropriate application information to its data collection. This operation is performed by the Universe Manager in a manner similar to what it would perform in response to any other server becoming available with a network application. [0043] After the new application has been registered with the Universe Manager, the network nodes will become aware of the application through respective lobby servers. Therefore, the application becomes available for network users, who can join the program environment established by the integrated server. For example, if the application is a multi-user game, then other network users can join the on-going game, as managed by the hosting user's integrated server. The process of joining a game in progress involves the same operations as described above in conjunction with blocks 414 , 415 , 416 , and 417 of FIG. 4 . These operations involve communicating with an appropriate application server, receiving a server-specific key, providing the server with that key, becoming authorized and providing regular “heartbeat” reports to the lobby server. These integrated server operations are represented by the “join” block 517 of FIG. 5 . [0044] At the conclusion of the application session (block 518 ), a participating user can disconnect from the integrated server and return to normal activities, including all available lobby functions through the lobby server. As noted, these functions can include chat, group or community management, messaging, and the like. As noted above, these functions are available to the user at all times when the user is connected to the lobby server, including during application use (e.g., during game play). If a hosting user (the integrated server) wishes to withdraw from hosting the application, the network system ( FIG. 1 ) can implement procedures as desired to ensure an orderly shut down of the application or an orderly transition to a different integrated server that continues on with the program environment of the hosted application. [0045] If the user performs a logout procedure, or if the user is timed out from an active connection because of inactivity, the user's session is cleared from the active records of the Universe Manager. This is indicated at the next block, 519 . If the user wishes to participate in another application, the user must go through the authentication process once again, including the login process. [0046] Ladder Ranking [0047] The application program interface that is shared in common with all the components illustrated in FIG. 1 also includes provision for a ladder ranking engine. A ladder ranking is a list of users that is organized or sorted according to a predetermined variable or metric. The ladder ranking is most easily understood in the context of a gaming application, where the predetermined variable likely refers to wins, losses, points scored, and the like. As a user improves his or her performance, the user's ranking will improve, meaning that the user will move up a “ladder” of ranked users. Thus, the ladder ranking information can be used for various competitive purposes, such as contests and tournaments. [0048] The ladder ranking information is collected via functionality in each multi-user application that periodically reports the application status to the corresponding application server. The status can include information such as progress of players in the game. The application servers then store the information to a system database that is indexed according to a user's account information and application currently being used. This information is managed by a ladder engine that can operate at any location of the network, for example, at the Universe Manager, and the data can be stored at data storage of the Universe Manager or in the database servers ( FIG. 1 ). [0049] The system interface preferably provides for any registered user to request a ladder ranking, which will be provided through the ladder ranking engine. The request can come from a user via an application with which the user is currently participating. This ensures that non-participants cannot falsely obtain the ladder ranking information. The ladder ranking requests can be received by a lobby server or application server from a user, and the request can be forwarded to the ladder ranking engine at the Universe Manager or whatever other network entity that manages the ladder rankings. When a ladder ranking list is requested, all of the user accounts for the specified application are sorted based on the stored user performance data. The application status information preferably includes multiple statistics, which can be stored simultaneously in the database. For example, a gaming application can track wins, losses, points scored, points allowed, and other performance statistics of interest. Each metric can be sorted on, thus generating a ladder ranking according to the metric chosen by the user who requests the ladder ranking. Moreover, the ladder ranking engine provides sorting and retrieving of a ladder ranking in ascending or descending order. For example, a ladder ranking can be provided in order from most points to least points, or from least points to most points. [0050] The various servers and databases of the system have no knowledge about the nature of the statistics. That is, the servers do not examine the underlying data to understand the difference between wins and losses or points and goals. Rather, the various applications define the data set to be collected for that application, and the servers and databases simply store the collected data in the database. Thus, each application will define its own data collection format, which will be supported by the database servers. [0051] The data can be included in a 256-byte data field that is assigned to each user's account for each application with which the system interfaces. For example, the application code can execute the ladder ranking function by specifying data parameters of sort order, start byte, end byte. Upon receiving a ladder ranking message with these parameters, a server or database of the system will retrieve all data fields for all accounts associated with the calling application. The data in each data record between the start byte location and the end byte location will be treated as an integer value. The sort operation will then be performed on the retrieved data, in ascending or descending order depending on the value of a user-supplied sort order parameter. The sorted integer numbers can then be displayed to a user in accordance with known headings for the integer data. For example, a particular application might store performance data as number of wins, followed by number of losses, followed by points scored, followed by points allowed. When the performance data is retrieved, the data can be parsed to extract the requested data for proper display. Other applications can store different performance parameters in a different order, which will be known to the corresponding application server. In this way, the ladder ranking engine provides a powerful generic, cross-application ladder rankings system. [0052] Clans Engine [0053] Another feature of the system described herein is a clans engine that allows a designated user of any trusted application, a user referred to as a “leader”, to name and create a clan. The leader can then issue invitations to other users for joining the clan. The system will queue up any invitations sent to registered users who are not online at the time the invitation is sent, for delivery at the invitee's next login. A user who receives a clan invitation can respond affirmatively or negatively and, if desired, can become a member of the clan. [0054] The system supports a variety of clan features. Members of a clan can send private electronic messages to the members of the clan. The clan messages can be stored on the servers of the system until delivery, which occurs as each member completes the next login process. The system permits clans to elect new leaders and set up various organizational structures for their clan. Examples of organizational structures include dictatorships, where one leader is in charge of all decisions of the clan, or a democracy, where all members and the leader have equal votes in the clan decision making. The leader who initiates the clan can select which of these, or other, configurations will be utilized. [0055] All of the various clan data, including the clan membership list, clan activity tracking, clan electronic messaging, and the like are saved by database servers of the system. The clan functionality is accessed through the program interface in accordance with the present invention, in a manner similar to that described above for the ladder ranking data. This permits many discrete functions to be provided and specified or deleted for each clan, making the composition rules and operation of each clan potentially exclusive. Moreover, the program interface permits the clan functionality to be used in a generic way for multiple applications. For example, in a gaming context, the same team or clan functionality can be applied whether the application is a flight simulator, car racing game, or action-shooter game. [0056] In addition, multiple applications can share the same clans and membership servers and databases at the same time, without interfering with each other. User accounts can be associated with more than one clan in the same application or in clans that extend across multiple applications, without any impact to the user account or to the clan functionality. [0057] The clan engine in accordance with the present invention manages the clan data using server-side processing, rather than relying on offline, Web-based clan management techniques or client-side arbitration, with nothing built into the actual application itself. Thus, any application developed for the program interface described herein can utilize the clan processing that is built into the interface specification, servers, and databases of the FIG. 1 system. [0058] Network Device Construction [0059] The network computer devices (clients and servers) shown in the block diagram of FIG. 1 comprise nodes of a computer network system 100 . FIG. 6 is a block diagram of a computer in the system 100 of FIG. 1 , illustrating the hardware components included in one of the computers that provide the functionality of the servers and clients. Those skilled in the art will appreciate that the servers and clients illustrated in FIG. 1 can all have a similar computer construction, or can have alternative constructions consistent with the capabilities and respective functions described herein. [0060] FIG. 6 shows an exemplary computer 600 such as might comprise any of the network computers. Each computer 600 operates under control of a central processor unit (CPU) 602 , such as a “Pentium” microprocessor and associated integrated circuit chips, available from Intel Corporation of Santa Clara, Calif., USA. A computer user can input commands and data from a keyboard and computer mouse 604 , and can view inputs and computer output at a display 606 . The display is typically a video monitor or flat panel display. The computer 600 also includes a direct access storage device (DASD) 608 , such as a hard disk drive. The memory 610 typically comprises volatile semiconductor random access memory (RAM). Each computer preferably includes a program product reader 612 that accepts a program product storage device 614 , from which the program product reader can read data (and to which it can optionally write data). The program product reader can comprise, for example, a disk drive, and the program product storage device can comprise removable storage media such as a magnetic floppy disk, a CD-R disc, a CD-RW disc, or DVD disc. [0061] Each computer 600 can communicate with the others over a computer network 620 (such as the Internet or an intranet) through a network interface 618 that enables communication over a connection 622 between the network 620 and the computer. The network interface 618 typically comprises, for example, a Network Interface Card (NIC) or a modem that permits communications over a variety of networks. [0062] The CPU 602 operates under control of programming steps that are temporarily stored in the memory 610 of the computer 600 . When the programming steps are executed, the computer performs its functions. Thus, the programming steps implement the functionality of the respective client or server. The programming steps can be received from the DASD 608 , through the program product storage device 614 , or through the network connection 622 . The program product storage drive 612 can receive a program product 614 , read programming steps recorded thereon, and transfer the programming steps into the memory 610 for execution by the CPU 602 . As noted above, the program product storage device can comprise any one of multiple removable media having recorded computer-readable instructions, including magnetic floppy disks and CD-ROM storage discs. Other suitable program product storage devices can include magnetic tape and semiconductor memory chips. In this way, the processing steps necessary for operation in accordance with the invention can be embodied on a program product. [0063] Alternatively, the program steps can be received into the operating memory 610 over the network 620 . In the network method, the computer receives data including program steps into the memory 610 through the network interface 618 after network communication has been established over the network connection 622 by well-known methods that will be understood by those skilled in the art without further explanation. The program steps are then executed by the CPU 602 thereby comprising a computer process. [0064] It should be understood that all of the network computers of the network system 100 illustrated in FIG. 1 can have a construction similar to that shown in FIG. 6 , so that details described with respect to the FIG. 6 computer 600 will be understood to apply to all computers of the system 100 . It should be appreciated that any of the network computers can have an alternative construction, so long as the computer can communicate with the other computers illustrated in FIG. 4 and can support the functionality described herein. [0065] For example, with reference to FIG. 7 , the client computers 102 can comprise a computer entertainment system, such as a video game console system 700 . FIG. 7 is a block diagram of an exemplary hardware configuration of the video game console system 700 . [0066] The video game console system 700 includes a central processing unit (CPU) 701 that is associated with a main memory 705 . The CPU 701 operates under control of programming steps that are stored in the OS-ROM 760 or transferred from a game program storage medium to the main memory 705 . The CPU 701 is configured to process information and execute instructions in accordance with the programming steps. [0067] The CPU 701 is communicatively coupled to an input/output processor (IOP) 720 via a dedicated bus 725 . The IOP 720 couples the CPU 701 to an OS ROM 760 comprised of a non-volatile memory that stores program instructions, such as an operating system. The instructions are preferably transferred to the CPU via the IOP 720 at start-up of the main unit 700 . [0068] The CPU 701 is communicatively coupled to a graphics processing unit (GPU) 710 via a dedicated bus 715 . The GPU 710 is a drawing processor that is configured to perform drawing processes and formulate images in accordance with instructions received from the CPU 701 . For example, the GPU 710 can render a graphics image based on display lists that are generated by and received from the CPU 701 . The GPU can include a buffer for storing graphics data. The GPU 710 outputs images to an AV output device 790 that is connected to the console system 700 . [0069] The IOP 720 controls the exchange of data among the CPU 700 and a plurality of peripheral components in accordance with instructions that are stored in an IOP memory 730 . The peripheral components can include one or more input controllers 722 , a memory card 740 , a USB 745 , and an IEEE 1394 serial bus 750 . Additionally, a bus 755 is communicatively coupled to the IOP 720 . The bus 755 is linked to several additional components, including the OS ROM 760 , a sound processor unit (SPU) 765 , an optical disc control unit 775 , and a hard disk drive (HDD) 780 . [0070] The SPU 765 is configured to generate sounds, such as music, sound effects, and voices, in accordance with commands received from the CPU 701 and the IOP 720 . The SPU 765 can include a sound buffer in which waveform data is stored. The SPU 765 generates sound signals and transmits the signals to speakers. [0071] The disc control unit 775 is configured to control a program reader, which can comprise, for example, an optical disk drive that accepts removable storage media such as a magnetic floppy disk, an optical CD-ROM disc, a CD-R disc, a CD-RW disc, a DVD disk, or the like. [0072] The memory card 740 can comprise a storage medium to which the CPU 701 can write and store data. Preferably, the memory card 740 can be inserted and removed from the IOP 720 . A user can store or save data using the memory card 740 . In addition, the video game system 700 is preferably provided with at least one hard disk drive (HDD) 780 to which data can be written and stored. [0073] A data I/O interface, such as an IEEE 1394 serial bus 750 or a universal serial bus (USB) 745 interface, is preferably communicatively coupled to the IOP 720 in order to allow data to be transferred into and out of the video game system 700 , such as to the network illustrated in FIG. 1 . [0074] The present invention has been described above in terms of a presently preferred embodiment so that an understanding of the present invention can be conveyed. There are, however, many configurations for the system and application not specifically described herein but with which the present invention is applicable. The present invention should therefore not be seen as limited to the particular embodiment described herein, but rather, it should be understood that the present invention has wide applicability with respect to multi-user applications generally. All modifications, variations, or equivalent arrangements and implementations that are within the scope of the attached claims should therefore be considered within the scope of the invention.

Methods for creating an interactive gaming environment are provided. In various embodiments, methods of the present invention may include initializing an interactive game application at a game server which is then characterized as having an active status, notifying a lobby server concerning the active status of the game server, registering the application with a universe management server via the lobby server, and allowing users to join the interactive gaming environment. The users joining the interactive gaming environment may be identified by a server key obtained from the game server.

CROSS REFERENCE TO RELATED APPLICATIONS This application is a divisional patent application of its co-pending parent patent application, Ser. No. 792,513 filed Nov. 13, 1991, now U.S. Pat. 5,242,353, issued Sep. 7, 1993. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to physical exercise apparatus in general, to a biasing element for providing resistance to movement of the members of the physical exercise apparatus and to methods of making the biasing element. 2. Prior Art Statement It is known to provide an exercising machine comprising a fixed support member and a movable lever arm pivotally disposed on the support member, a biasing means having a first end member attached to the support member and a second end member attached to the lever arm, wherein the biasing means such as a tension spring, selectively provides resistance to motion of the lever arm in the plane of motion, for instance, see U.S. Pat. No. 3,638,941 to Kulkens. It is also known to provide an exercising machine wherein the biasing means comprises elastic means such as aero shock cords, for instance, see the U.S. Pat. No. 4,072,309 to Wilson. It is also known to provide an exercising machine wherein the biasing means comprises elastic means such as weight straps, for instance, see the SOLOFLEX® brochure wherein said weight straps comprise elastomeric band means with end means molded thereon. It is also known to provide biasing means comprising elastic means similar to the weight straps as cited in the above brochure wherein the elastic means is a molded elastomeric slab with integrally molded ends as depicted in FIG. 7. SUMMARY OF THE INVENTION It is one feature of this invention to provide new elastic biasing means comprising at least one polymeric band means having end means within said polymeric band means. It is another feature of this invention to provide new elastic biasing means wherein a polymeric band means is selected from elastomeric band means of differing tensile strength. It is another feature of this invention to provide new elastic biasing means having containing means mounted on the elastomeric band approximately centrally located between the end means or separable end members disposed within said end means. It is another feature of this invention to provide new elastic biasing means wherein said cross-sectional area of said polymeric band is in the shape of a regular polygon or the sector of a circle. It is another feature of this invention to provide new elastic biasing means wherein the cross-sectional area of said polymeric band means is preselected from the modulus of the material selected. It is another feature of this invention to provide new elastic biasing means wherein the end members are provided with flange means which is contiguous with at least one surface of said elastomeric band. It is another feature of this invention to provide a novel method of assembling the biasing means of the instant invention wherein the end members are initially separate from the elastomeric band means and the containing means. It is another feature of this invention to provide new elastic biasing means wherein the containing means comprises a tubular material selected from the group containing metals, thermoplastic, thermoset elastomers, woven or non-woven textiles. It is another feature of this invention to provide new biasing means wherein said containing means is provided with reference characters indicating the relative strength, safety warnings, manufacturers identification or advertising markings. Other objects, uses and advantages of this invention are apparent from a reading of this description which proceeds with reference to the accompanying drawings forming a part thereof and wherein: BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an exploded isometric view of an exercising machine showing the various parts thereof including the elastomeric band means of the instant invention; the machine being shown in three parts as FIGS. 1A, 1B, and 1C. FIG. 2 is a plan view of the biasing means of the instant invention. FIG. 3 is a isometric view of the elastomeric band means of the instant invention in an oval configuration prior to assembly. FIG. 4 is a isometric view of the end member of the instant invention. FIG. 5 is a plan view of the containing means of the instant invention showing customer's name located thereon. FIG. 6 is a plan view of one of the biasing means of the prior art. FIG. 7 is a isometric view of another of the biasing means of the prior art. FIG. 8 is a plan view of the elastomeric band means of the instant invention disposed upon an assembly pin for assembly of the containment means. FIG. 9 is an isometric view of the biasing means of the instant invention showing one end member disposed on an assembly pin and a bight in the other end means of the elastomeric band means for insertion of another end member. FIGS. 10-15 are views of various sections of the elastomeric band means which may be used for the instant invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to FIG. 1, the exercising machine employing the biasing means of this invention is generally indicated by the reference numeral 40. A base portion generally indicated by reference numeral 41 comprising base means 3, lateral support means 4 and support foot means 2 is assembled using bolts 27, washers 30 and nuts 34. Upright support means 1 is similarly attached to support foot means 2 while bench means 6 is fitted to support foot means 2 and brace means 5 with removable pins means 18 and 20. An upper body exercise apparatus, generally indicated by reference numeral 42, comprises upper head means 7 with biasing support means 8 and arm lever means 9 mounted thereto with mounting pins 21 and 22 respectively and handlebar lever means 10 with handlebar means 11 attached thereto with bolts 27, washers 31 and nuts 33 fitted to upper head means 7 using handlebar lever pivot means 19 inserted through hole means 25 in pivot tube means 26 or opposite pivot tube means 24 welded to upper head means 7. Upper body exercising apparatus 42 is slidably mounted upon upright support means 1 by inserting removable bolt means (not shown) through hole means 36 in upper head means 7 and through hole means 35 in upright support means 1. Handlebar grips 29 are fitted over the ends of handlebar means 11 and handles 32 on arm lever means 9. Foam grips 16 cover the ends of arm lever means 9 and foam pads 17 are fitted over fulcrum means 14 on leg lifting lever means 13 and lower head means 12. Lower head means 12 is slidably disposed in slot means 46 between bench rails 47 and secured thereto with bench brace mounting pin 20 through holes (not shown) in bench rails 47 and hole means 55 in lower head means 12. Bracket means 44 is disposed on the under side of lower head means 12. Bracket means 48 including fulcrum mounting means 49 is disposed on the end of lower head means 12 opposite the end thereof which is slidably disposed within slot means 46. Leg lifting lever means 13 is rotatably mounted upon lower head means 12 with bolt 28 inserted through hole means 50 in bracket means 48 and hole means 52 in leg lifting frame pivot tube 51 and secured thereto with nut 34. Foam pads 17 are disposed on fulcrum means 14 inserted through fulcrum mounting means 49 and fulcrum means 14 on both ends of leg lifting lever means 13. Biasing means 15 are mounted upon support pins 38 and lever pins 39 on either side of upper head means 7 wherein said biasing means 15 provide resistance to the movement of arm lever means 9 in a horizontal plane of motion indicated by reference arrow 37. Biasing means 15 may alternately be fitted over handlebar lever means pins 43 and removable pin means 18 which has been inserted into pivot tube means 26 in upper head means 7 providing resistance to motion of handlebar lever means 10 in a vertical plane as indicated by the double ended reference arrow 53. Removable pin means 18 may also be placed in opposite pivot tube means 24 above handlebar lever pin means 43 with handlebar lever means 10 pivotably mounted in pivot tube 26 providing resistance to motion of handlebar lever means 10 in a downward vertical direction as well. Similarly, biasing means 15 may alternately be placed within bracket means 44 on lower head means 12 and bracket means 45 on leg lifting lever means 13 securing same with biasing means mounting pins 23 providing resistance to motion of leg lifting lever in a vertical plane as indicated by reference arrow 54. Referring now to FIG. 2 through 5, biasing means 15 comprises elastomeric band means 60 of FIG. 3, end member 70 of FIG. 4 and containing means 80 of FIG. 5. Elastomeric band means 15 is taken transverse the longitudinal axis of each leg 68 and may be of any desired cross sectional configuration as shown in FIGS. 10-15, whereas in FIG. 3 inside surface 61 opposes outside surface 62 and first side edge 63 opposes second side edge (not shown), defining thereby a generally rectangular cross section elastomeric band means 60. End member 70 comprises hub means 71, an outer portion consisting of flange means 72 and 73, pulley surface 74, mounting hole means 75, and web means 76. Containing means 80 comprises a tube of elastomeric material with inside surface 81, outside surface 82, first end 83 and second end 84. Containing means 80 may also be provided with labeling means 85 disposed on outside surface 82 in any manner known in the art. Referring now to FIG. 8 and FIG. 9, biasing means 15 is assembled by placing one end member 70 within bight 65 of elastomeric means 60 wherein the portion of inside surface 61 disposed within bight 65 of elastomeric band means 60 abuts a portion of pulley surface 74, and wherein first side edge 63 and second side edge (not shown) are contained between and contiguous with flange means 72 and 73 of end member 70. The opposite bight 65 is then placed over an assembly pin 90 which has containing means 80 placed thereon, elastomeric band means 60 is elongated by pulling upon end member 70 while containing means 80 is slidably moved from the position on assembly pin 90 toward end member 70 such that first end 83 of containing means 80 is adjacent end member 70. Inside surface 81 of containing means 80 is therefore contiguous with outside surfaces 62 and side edges 63 thereby containing elastomeric band means 60 in an oval configuration as shown in FIG. 10 when removed from assembly pin 90. Finally, a second end member 70 is placed within the open bight 65 of partially assembled biasing means 15 to produce the fully assembled biasing means 15 of FIG. 2. Assembly pin 90 may be utilized as shown in FIG. 10 to move containing means 80 toward the first end member 70 such that the second end member 70 may be more readily placed in bight 65 and to move containing means 80 to the final central position of biasing means 15. Alternately, each bight 65 of elastomeric band means 60 may be placed upon mounting pins 90 and elongated to facilitate placement of containing means 80 in the central portion between bights 65 and then end member 70 may be separately placed within each bight 65 to provide the fully assembled biasing means 15. Separate biasing means 15 of the instant invention may be constructed in a similar manner wherein the cross-sectional area of elastomeric band means 60 may be varied to provide a different amount of resistance to motion. For instance, the thickness of elastomeric band means 60 of FIG. 3 between outside surface 62 and inside surface 61 may be approximately 0.184 inch to provide a biasing means 15 which produces a resistance to movement of approximately 30 pounds when extended to 150% of the original distance from centerline 66 to centerline 67 which represents essentially the mid range of extension of any of the lever means of exercising means 40. Similarly, elastomeric band means 60 of FIG. 3 with a thickness between outside surface 62 and inside surface 61 of 0.368 inch will provide resistance of approximately 60 pounds when biasing means 15 is extended to 150% of the original distance between centerline 66 and 67. Therefore, biasing means 15 of FIG. 2 may be constructed of differing resisting strengths by changing the thickness of elastomeric band means 60 to provide a complete set of biasing means 15 for exercise apparatus 40 of FIG. 1. Similarly, biasing means 15 of differing resisting strengths may be provided by altering the cross-sectional shape where said elastomeric band means 60 is other than rectangular in cross-section. For instance, see FIGS. 10-15 wherein various crossectional configurations of elastomeric band means 60 are shown. End member 70 may then also be altered to conform to the peripheral surface contour of elastomeric band means 60 such that elastomeric band means 60 is contained within first and second flange means 72 and 73 respectively while inside surface 61 of elastomeric band means 60 is supported by pulley surface 74 of end member 70. The resisting strengths of the various elastomeric band means 60 of the instant invention are determined from the modulus of elasticity of the material selected. A modulus of elasticity curve of the material to be used for the elastomeric band means is determined by subjecting a tensile slab of the material to extension while measuring the force required to extend the material as is well known in the art. For instance, the force required to extend the material of elastomeric band means 60 to a length which is 33.3% greater than the original length was 1.089 pounds for a slab of material 0.250 inches wide by 0.040 inches thick. This yields a force per unit area of 108.9 pounds per square inch (psi). Therefore, in order to develop thirty pounds of force in biasing means 15 at an extension of 50% between the centerlines 66 and 67 which represents a 33.33 percent length extension of the entire length of elastomeric band means 60, the total crossectional area of each leg 68 would be 0.1377 square inches. Similarly, to develop ninety pounds of force in biasing means 15, the total cross-sectional area would be 0.413 square inches. Where elastomeric band means 60 is rectangular in cross-section and the width between flange means 72 and 73 of end member 70 is 0.750 inches, the thickness of elastomeric band means 60 would be the aforementioned 0.184 inches to develop thirty pounds whereas the thickness for elastomeric band means 60 would be 0.551 inches to develop ninety pounds. The biasing means 60 of the present invention overcomes the limitations of biasing means 92 of the prior art as shown in FIG. 6 which can readily rupture by a quickly propagating crack developing from any of the discontinuities present in the molding operation of the flat slab. For instance, the biasing means 92 of FIG. 6 is prone to such rupture at the recess shown by arrow 91 because the highest stress is concentrated at this location when the biasing means 92 of FIG. 6 is extended. This high stress is created because the end section 93 of biasing means 92 does not extend and hence all the elongation of biasing means 92 must take place between the points 94 and 95. In the instant invention, inside surface 61 of elastomeric band means 60 contained within the bights 65 of biasing means 15 contacts surface 74 of each end member 70 and therefore biasing means 15 is free to move thereon, hence the entire length of elastomeric band means 60 extends substantially equally since the cross-sectional area of each segment of elastomeric band means 60 is uniform throughout the entire length thereof. This unique combination of elastomeric band means 60, end member 70 and containment means 80 provide biasing means 15 free of stress concentrations present in the prior art biasing means. The unique combination of elastomeric band means 60, end member 70 and containment means 80 further provide the user with an early warning of any impending failure as elastomeric band means 60 moves about end member 70 during each extension thereof. Since the cross-sectional area is constant throughout elastomeric band means 60, no undue stress concentrations are present but any small crack which may occur on the outer surface thereof, where the highest stress during extension occurs, due to age of the elastomeric means 60 will be visible upon simple inspection prior to use. The user can then replace biasing means 15 or the elastomeric band means 60 at a convenient time without fear of sudden rupture of biasing means 15 during exercise. The biasing means 15 of the present invention further provides a margin of safety to the user as the full resisting force of the biasing means is developed near the mid point of extension of the biasing means 15 rather than at the lesser extension of the prior art biasing means. For instance, the biasing means 15 with a thickness of 0.184 inch develops approximately 13.5 Kg at an extension of 150% of the original distance between centerlines 66 and 67 while biasing means 110 of FIG. 7 labeled 15 Kg develops approximately 63.5 kg at the same extension. At full extension of the lever means of machine 40, the biasing means of FIG. 7 develops approximately 100 Kg whereas the biasing means 15 develops only 30 Kg. Since the user will usually extend the biasing means to 80 to 100% of the full extension of the lever means, the biasing means of the prior art could cause over exertion and possible injury to the user. The biasing means 15 of the instant invention is therefore a much safer biasing means for the casual user of the machine 40. The biasing means 15 of the instant invention may be provided with reference characters disposed upon the outside surface 82 of containing means 80 indicating the relative strength of the biasing means 15 without units of measurement thereon as in the prior art biasing means of FIG. 6. The reference characters may be numeric, alphabetic, symbolic or a combination thereof. The user of the exercising device 40 can then select biasing means 15 as desired for the exercise to be performed based upon previous experience eliminating the transfer of heavy weights from a weight rack. The containing means 80 may be constructed of a material selected from the group comprising metals, thermoplastic or thermoset elastomers, woven or non-woven textile fabrics. The containing means 80 may be extruded, molded, woven, cast or formed by any means known in the art. The outer surface 82 of containing means 80 may be provided with labeling means 85 disposed thereon in a manner well known in the art. For instance, the containing means 80 of the instant invention has labeling means 85 disposed on the outer surface 82 by pad printing. The labeling means 85 comprises the company name, country of origin and an effort reference character of the biasing means 15. The labeling means 85 may further include safety information as desired by the customer or supplier or as required by Governmental agencies. While the forms and methods of this invention now preferred have been illustrated and described as required by the Patent Statute, it is to be understood that other forms and method steps can be utilized and still fall within the scope of the appended claims wherein each claim sets forth what is believed to be known in each claim prior to this invention in the portion of each claim that is disposed before the terms "the improvement" and sets forth what is believed to be new in each claim according to this invention in the portion of each claim that is disposed after the terms "the improvement" whereby it is believed that each claim sets forth a novel, useful and unobvious invention within the purview of the Patent Statute.

A biasing means for an exercising machine is provided where one end of the biasing means is removably disposed on a lever arm of the exercising machine and the opposite end of the biasing means is disposed on a fixed support member of the exercising machine. The biasing means provides resistance to the movement of the lever arm in the plane of motion wherein the biasing means comprises at least one elastomeric band and a containing means to provide a bight on the ends of the biasing means for disposing on the respective portions of the machine. The biasing means may also have end members of support means placed within the bights. The biasing means, the containing means and the end members or support means may be initially separate and separable such that in the event of damage to any one of said means it may readily be replaced with another such elastomeric band means.

BACKGROUND OF THE INVENTION 1. The Field of the Invention This invention relates to the art of preparing foods which need not be cooked or heated to temperatures in excess of 212° Fahrenheit by emersion of closed containers of food into water as the heating medium. 2. Description of the Prior Art Many versions of electrically heated coffee or tea pots or plain water pots are available. None of these currently available devices have the ability to additionally function adequately as a water bath heater for containers of pre-prepared food in either liquid, semi-liquid or solid form. SUMMARY OF THE INVENTION The present invention is a multi-purpose food heating device utilized in its simplest form to heat water for later external use or to brew beverages in water by heating and to heat containers of food such as closed containers of cans, jars, baby bottles, plastic pouches of pre-prepared foods and the like. A primary object of the instant invention is to provide a means of heating closed containers of food. Another object is to provide a means of heating water in the apparatus. Still another object is to provide an apparatus capable of heating a multiple number of containers at one time. A further object is to provide uniform heating at all external surfaces of the container thereby avoiding over-heated and under-heated portions of the food in the best mode available. Another object is to provide an apparatus capable of providing a simple method of removing the heated containers without endangerment to the user by coming into contact with the hot container. Still another object is to provide a convenient multi-purpose heating apparatus in pseudo-conventional appearance utilizing electrical heating means. A further object is a heating apparatus utilizing a power source to utility line voltage as well as automobile batteries and the like. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a fragmented elevation view of the heating apparatus. FIG. 2 is a cross section taken through line 2--2 of FIG. 1 looking in the direction of arrows 2--2 illustrating the interior plan view of the bottom of the apparatus claimed. FIG. 3 is a cross-section taken through line 3--3 of FIG. 1 viewed in the direction of arrows 3--3 illustrating the interior elevation view of the upper portions of the apparatus, lid, and removal device claimed. DESCRIPTION OF THE PREFERRED EMBODIMENTS The structure and method of fabrication of the present invention is applicable to a water heater complete with a cover or lid and a water pouring spout. An insulating protuberance is permanently affixed to the interior bottom surface of the water compartment. The apparatus has, as an accessory, a food container removal instrument which extends around and below the uppermost surface of the protuberance and is available to the user by emerging beyond the surface of the heating apparatus through a slot in the side outer surface which is located above the aforementioned pouring spout. Another accessory which may be used in combination with the basic heating apparatus and the removal instrument is a thermally insulated container separator constructed in a fashion permitting the water heating medium to exist within and around this accessory whilst mechanically supporting another container. Now referring to the Figures, and more particularly to the embodiment illustrated in FIG. 1 showing the food heating apparatus 1 with an electrical heating device 7 situated below the water compartment 11, an electrical cord 8 is adapted to provide electrical energy from a source not shown. The apparatus 7 is comprised of any conventional electrical heater which may be powered by energy available from wall utility outlets of nominally 120 volts AC or automobile batteries providing energy at nominal voltages of 12 volts, direct current. A selector switch, not shown, may be utilized to prepare the apparatus to accommodate to the appropriate power source or, various models can be adapted to operate at a fixed voltage. Pouring spout 12 is formed or attached near the uppermost edge of the heating compartment 11 and has a series of openings providing communication for the water contained within the compartment. A protuberance 6 is obtained by fastening an insulating material such as polytetrofluoroethlene, commonly called Teflon, a product of E. I. Du Pont de Namours Co., Inc., to the uppermost surface of the floor of the heating compartment. This protrusion serves as a platform to support any rigid container placed within the compartment so that uniform heating is obtained by preventing intimate thermal contact of a substantial nature with the heating apparatus 7. Thus, substantially, the only means of heating is obtained through the use of water or other liquid which couples uniformly the heat generated by the heater to the containers 16 and 2 as shown. In use, the container 16 is inserted into the compartment 11 and water is poured into the compartment. After a desired period of time the lid 13 is removed by use of the insulating handle 14 exposing a container removal device 5. The device extends over a substantial portion of the cross sectional area internal to the compartment 11 and has radial fingers to accommodate a variety of sizes of food containers. In its rest position the device extends below the uppermost surface of the insulating protrusion 6. A handle 9, comprised of an insulating material, extends beyond the exterior surface of the apparatus heating device and is grasped by the user. The upper edge of the water compartment 11 is provided with a slot extending downwards to a point directly above pouring spout 12 to accommodate vertical removal of the removal device 5. Correspondingly, a vertical slot is cut into the vertical walls of the lid 13 insuring horizontal placement of the lid around the horizontal portion of the removal device. An upward motion raises the container above the liquid level of the heating medium and makes the food container readily available for removal. The horizontal platform created by fingers 15 is fashioned so that the platform can drop below the uppermost surface of the protrusion 6. Another accessory is an insulating spacer 4 which is used to isolate thermally additional food containers when it is desired to heat them. This spacer supports container 2 without substantially upsetting the thermal distribution of heat within the water heating medium by virtue of its low thermal mass and the ability to allow the water to circulate around and through it. FIG. 2 illustrates how a container 16 rests upon the fingers 15. The protrusion 6 is shown to emerge through an area centrally located within the removal device 5. FIG. 3 illustrates lid 13 displaced upwardly from the food heating apparatus 1 and having a slot 17 cut in a portion of food heating apparatus engaging rim 20. Slot 18 extends downwardly from the uppermost rim 21 of food heating apparatus 1. The horizontal portion of food removal device 5 resides in slot 18 adjacent handle 9. Spout 12 is aligned directly below slot 18. Thus water surrounds the entire exterior surface of one or more closed food containers. The heating affect of the water is uniform upon these external surfaces and there is virtually no temperature differential between supporting elements of the heating device and the containers to be heated within it. The device can be utilized in conventional fashion to heat water and brew beverages by the removal of insulating spacer accessory 4 and the food container removal device 5. One of the advantages of this apparatus is a simple, inexpensive means of heating closed containers of food. Another advantage lies in the additional ability of the apparatus to heat water or brew beverages. A further advantage includes the ability to heat more than one food container at one time. Still another advantage pertains to uniform heating of the entire external surface of the food container creating substantially uniform heating of the contents therein. Another advantage lies in the use of a convenient removal device which can be stored within the heating apparatus. A further advantage pertains to the ability of the heating apparatus to serve many heating purposes yet appearing to be conventional in its construction and utilizing electrical energy as a means of heating. Still another advantage is in the ability of the electrical heating mechanism to be utilized at various voltage levels for the electrical source of energy supplied thereto. Thus, there is disclosed in the above description and in the drawings embodiments of the invention which fully and effectively accomplish the objects thereof. However, it will be apparent to those skilled in the art, how to make variations and modifications to the instant invention. Therefore, this invention is to be limited not by the specific disclosure herein, but only by the appending claims.

This disclosure pertains to an apparatus for use in heating containers of food, as in cans, bottles, plastic pouches and the like by emersion into water adapted to insure uniform heating thereof by substantially insulating the containers from thermal contact with all the parts of the heating apparatus except the water in contact with the container. The apparatus can also be used to heat water alone, brew coffee, tea or other beverages.

RELATED APPLICATION This application is a continuation-in-part of application Ser. No. 07/958,279, filed on Oct. 8, 1992, now U.S. Pat. No. 5,271,744, which is a divisional application of application Ser. No. 07/692,674, filed on Apr. 29, 1991, and which issued as U.S. Pat. No. 5,176,643 on Jan. 5, 1993. BACKGROUND OF THE INVENTION 1. Field of the Invention This invention involves an interactive external defibrillation and drug injection system for use by a human operator for treating cardiac conditions in a patient, particularly in an out-of-hospital or pre-hospital environment. The present invention may also be used within hospitals as well, particularly where intravenous (IV) access has not been established. More specifically, this invention comprises devices capable of measuring and monitoring various physiological indicators in a patient and an expert system capable of analyzing the measured data and making recommendations to an operator for treatment of the patient using any combination of defibrillation, cardioversion, transcutaneous pacing, or intraosseous drug injection. This invention is designed to enable first responders to cardiac emergencies to provide care up to the standard of at least the beginning stages of Advanced Cardiac Life Support (ACLS). 2. Description of the Prior Art Patients experiencing cardiac emergencies need immediate care. Survival rates for patients experiencing a cardiac emergency improve with early delivery of ACLS care. Defibrillation and the initiation of drug therapies are important components of ACLS. Unfortunately, beneficial drug therapies may be delayed by factors such as delays between the time of arrival of skilled paramedics or other advanced care providers qualified to initiate drug therapies; delays resulting from transportation of a patient to a hospital or other facility where drug therapy may be initiated; and difficulty or failure to establish IV access to a patient experiencing a cardiac emergency. Treatment of cardiac emergencies may encompass cardiopulmonary resuscitation (CPR), cardioversion, defibrillation, transcutaneous pacing, and/or drug delivery via intraosseous injection. First responders to medical emergencies are frequently not physicians. Such first responders lack the training to make an independent evaluation regarding treatment of the patient with cardioversion, defibrillation, transcutaneous pacing, or drugs. Delays in administering such treatment can result in brain damage or death to the patient. Prior art defibrillators include microprocessor controlled or "smart" defibrillators comprising algorithms or expert systems capable of receiving and analyzing physiological data from a patient and making a decision or recommendation as to the type of corrective action that should be administered. One type of smart defibrillator is disclosed in U.S. Pat. No. 4,619,265 to Morgan, et al. Morgan discloses an interactive portable smart defibrillator which processes physiological data from the patient and then sends messages or "prompts" to an operator, allowing the human operator to make the final decision regarding the delivery of defibrillation therapy. The device disclosed in Morgan is limited to treatment of the patient with a defibrillator. As explained above, a patient experiencing an emergency cardiac condition often requires drug delivery in addition to defibrillation or cardioversion. Another type of smart defibrillator is the Heartstart® 3000, manufactured by Laerdal Medical Corporation of Armonk, N.Y. Use of the Heartstart® 3000 is contraindicated where the patient is conscious or breathing or where the patient has a pulse or a pacemaker. In general, consciousness, breathing, pulse, and pacemaker are contraindications precluding the use of automatic external defibrillators of the prior art. Patients in need of emergency cardiac care often exhibit one or more of these contraindications. Another type of smart defibrillator is disclosed in U.S. Pat. No. 5,156,148 to Cohen. The system disclosed in Cohen comprises a central processing unit (CPU) that controls drug delivery devices, cardioverting apparatus, defibrillating apparatus, pacers, and heart assist pumps. However, the system disclosed in Cohen must be attached or implanted into the patient with vascular access devices in place. This presupposes that a cardiac emergency is likely. Such a system would likely be used in intensive care unit or for a very select group of very sick patients. Unfortunately, many, if not most, cardiac emergencies are unexpected and it is unlikely that such system would be in place with pre-existing vascular access for drug delivery. A system of the type disclosed in Cohen does not require the presence of a physician for its operation, nor does it allow for human intervention in the treatment process. The system disclosed in Cohen is an automatic system where the machine or CPU makes a decision on the treatment to be administered and then administers such treatment without allowing for human input or intervention. The absence of human input or intervention from the operation of the system disclosed in Cohen raises ethical and legal concerns which may limit the application or acceptance of such a system. There is a critical need for better and more rapid methods of vascular delivery of drugs. The development of new, life saving drugs and better knowledge of how specific drugs work has established that many drugs can prevent death or reduce morbidity if given in a timely manner. Unfortunately, most drugs need to be infused directly into the blood of the general circulation to be effective, and this is not always easily accomplished. Vascular injections and cannulations are procedures requiring professional skills and training that are usually only possessed by doctors, nurses and paramedics. Even these professionals have a significant failure rate and generate time delays for drug delivery in emergency conditions, when veins are often collapsed due to low blood pressure, and several procedures need to be accomplished as soon as possible. Many other professionals and lay personnel, such as flight attendants, police, life guards and teachers, are trained in advanced first aid and CPR, but cannot deliver drugs, due to lack of an effective method that does not require more medical training. Clearly, there is a need for a simple, better and more rapid means of drug delivery to aid both skilled professionals and para-professionals to expand the utility of life saving drugs. It has long been known that the marrow sinuses of bones are virtual non-collapsible veins. Fluids and drugs have been shown to enter the central circulation after intraosseous (IO) infusions as rapidly or even more rapidly than peripheral vein infusions. This IO method can be used to deliver drugs via the long leg bones, the sternum, or other bones. Many special needles and devices have been made both to sample marrow and to infuse fluids into the marrow. All of these needles require substantial training and skill for their correct and safe use and take several seconds to minutes to use them properly. Examples of such prior art devices are disclosed in U.S. Pat. Nos. 2,426,535, issued Aug. 26, 1947 to Turkel; 2,773,500, issued Jan. 26, 1955 to Young; 3,750,667, issued Aug. 7, 1973 to Pshenichny et al.; 4,969,870, issued Nov. 13, 1990 to Kramer et al., and in the following articles: Tocantins, L. M. and O'Neill, J. F., "Infusion of Blood and Other Fluids into the General Circulation Via the Bone Marrow," Surg. Gynecol. Obstet., 73, 281-287 (1941); Turkel, H. and Bethell, F. H., "A New and Simple Instrument for Administration of Fluids Through Bone Marrow," War Medicine, 5, 222-225 (1944); Glaeser, P. W. and Losek, J. D. "Intraosseous Needles: New and Improved," 38 Pediat. Emerg. Care. 4, 135-136 (1989); Sacchetti, A. D., Linkenheimer, R., Lieberman, M., Haviland, P., Kryszozak, L. B., "Intraosseous Drug Administration: Successful Resuscitation from Asystole," Pediat. Emerg. Care, 5, 97-98 (1989); Halvorsen, L., Bay, B. K., Perron, P. R., Gunther, R. A., Holcroft, J. W., Blaisdell, F. W., Kramer, G. C., "Evaluation of an Intraosseous Infusion Device for the Resuscitation of Hypovolemic Shock," J. Traum., 30, 652-659 (1990). The above references describe manually inserted needles and techniques which require skill and training for proper use and necessitate many seconds to minutes in use. An automated needle system for delivery of drugs into the marrow would have great utility. A variety of auto-injection syringes for intramuscular or subcutaneous injections are also known in the art. Examples of such syringes are disclosed in the following U.S. Pat. Nos.: 3,396,726, issued Aug. 13, 1968 to Sarnoff; 3,712,301, issued Jan. 23, 1973 to Sarnoff; 3,882,863, issued May 13, 1975 to Sarnoff et al.; 4,031,893, issued Jun. 28, 1977 to Kaplan et al. However, these syringes are not designed, nor could they be effectively or safely used for injecting into the marrow sinuses of bones, nor do they prevent needles used in the procedures from being exposed so that there is a danger of accidental needle punctures in use of these syringes. The present invention overcomes the drawbacks of the prior art by providing an interactive external defibrillation and vascular drug injection system comprising an expert system., thereby enabling the system to be operated by a first responder who is not a physician. The expert system of the present invention receives physiological input data from measuring devices attached to the patient, analyzes the data, and issues instructions to the operator regarding patient treatment, including defibrillation, cardioversion, and drug injection. The present invention may also be used with a patient in need of emergency cardiac care who is conscious, breathing, or who has a pulse or a pacemaker. SUMMARY OF THE INVENTION The present invention provides an interactive external defibrillation and drug injection system for use by a human operator for treating cardiac conditions in a patient. The system of the present invention comprises a measuring device attachable to a patient and capable of measuring or recording a patient's electrocardiogram (ECG). The system further comprises a CPU connected to receive input signals from the measuring devices indicative of measurements taken by those devices. The CPU is capable of analyzing these measurements and is further capable of transmitting control signals. The CPU is capable of deriving the patient's heart rate and heart rhythm from the ECG. The CPU also comprises a communication system capable of communicating information and instructions in a manner perceivable by a human operator. The communication system is also capable of receiving and analyzing input from a human operator relating to the cardiological treatment and condition of a patient. It is the intent of the present invention that the information and instructions communicated by the CPU will be consistent with updated versions of the American Heart Association's current "Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiac Care Recommendations of the 1992 National Conference," as recently published in the Journal of the American Medical Association, Oct. 28, 1992, Vol. 268, No. 16, pp. 2171-2302 and periodic updates. These guidelines will hereinafter be referred to as the "AHA Guidelines for CPR/ECC." In addition to these guidelines, it is the intent of the present invention that the CPU will also communicate instructions regarding the use of intraosseous autoinjectors to inject drugs into a patient. The system of the present invention further comprises at least two electrical leads connectable to a patient and capable of delivering a sufficient amount of electrical energy to a patient to cardiovert or defibrillate a patient's heart. The system further comprises an electrical source comprising a discharge outlet electrically connected to the electrical leads and a control signal input electrically connected to the CPU. The electrical source is capable of storing and discharging electrical energy through the leads in sufficient predetermined selectable quantities and at sufficient predetermined selectable rates to defibrillate or cardiovert a patient's heart in a manner consistent with selected control signals and instructions from the CPU. The system of the present invention further comprises one or more intraosseous autoinjector devices, each containing a premeasured amount of a predetermined drug. Each autoinjector device also comprises one or more identifiers such that each autoinjector drug can be promptly identified by a human operator in response to an instruction from the CPU. Through use of the autoinjector of the present invention, a device and method is provided for very rapid, automated, and safe infusion of fluid and drugs into the circulatory system, e.g., into bone marrow. The autoinjector of the present invention further provides a device and method that will automatically puncture a bone, place a needle into the marrow, and infuse fluid into the circulatory system via the marrow. The autoinjector of the present invention automatically covers the needle before and after use to prevent accidental needle punctures. This autoinjector can be used either with the sternum or the tibia. The autoinjector of the present invention reduces the anatomical variability of skin thickness by compressing the skin over the bone in use. The autoinjector of the present invention also provides a device and method that imparts velocity to a needle and syringe component such that the momentum rapidly places the needle through the skin and bone and into the marrow. The needle of the autoinjector of the present invention is adapted for use with such an autoinjector. This needle also facilitates drug delivery into the marrow, yet prevents backflow of fluids out of the bone. In a first aspect of the autoinjector of the present invention, the autoinjector has a main housing with a front end. There is a forward directed aperture on the front end of the main housing. A syringe body has a front end and a rear end. The syringe body is slidably positioned in the main housing. A needle has a central bore communicating with at least one opening proximate to a tip of the needle. The needle is attached to the front end of the syringe body, communicates with an interior of the syringe, and is positioned to extend through the aperture of the main housing. A drive plunger extends from the rear of the syringe body. A means on the main housing and engaging the drive plunger locks and unlocks the drive plunger in position at the rear end of the syringe body. A means is connected to the drive plunger for applying propelling force to the drive plunger to move the syringe body along the main housing in a first direction to extend the needle from the aperture when the device is pressed against a patient to expel the drug from the syringe body into the patient. A means is connected to the syringe body to move the syringe body in a second direction opposite to the first direction for withdrawing the needle into the aperture when the device is no longer pressed against a patient. In a second aspect of the autoinjector of the present invention, a device for delivery of a drug in liquid to bone marrow comprising a main housing with a front end is provided. There is a forward directed aperture on the front end of the main housing. The syringe body of the present invention has a front end and a rear one° The syringe is slidably positioned in the main housing. A needle having a central bore communicating with at least one opening proximate to a tip of the needle is attached to the front end of the syringe body, communicates with an interior of the syringe body, and is positioned to extend through the aperture of the main housing in appropriate distance for passing through a patient's skin, penetrating a bone and entering the marrow inside the bone. A means imparts a force to the syringe body and to the needle, to extend the needle through the aperture of the main housing the appropriate distance at a sufficient velocity to pass through the patient's skin, penetrate the bone and enter the marrow. A means discharges the drug in liquid form from the autoinjector of the present invention through the needle and into the marrow. In a third aspect of the autoinjector of the present invention, a needle for use in a device for delivery of a drug in liquid form with a taper along its length and a conical, orifice-free tip, is provided. A central bore communicates with a plurality of orifices proximate to the tip. The plurality of orifices are positioned circumferentially on the needle at different distances from the tip. In a fourth aspect of the autoinjector of the present invention, a method for delivering a drug in liquid form to bone marrow includes positioning a syringe including a needle above a patient's skin at a location over a bone containing marrow. Sufficient velocity is imparted to the syringe so that the needle will have sufficient momentum to pass through the patient's skin, penetrate the bone and enter the marrow. The drug in liquid form is discharged from the syringe, through the needle and into the bone marrow. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a cross-section view of a first embodiment of a device for rapid vascular drug delivery of the invention. FIGS. 2-5 are similar cross-section views of the device of FIG. 1 at different stages in its use. FIG. 6 is an external perspective view of a second embodiment of a device for rapid vascular drug delivery of the invention. FIG. 7 is an exploded perspective view of the device of FIG. 6. FIGS. 8-12 are cross-section views of a portion of the device of FIGS. 6-7. FIG. 13 is an enlarged side view of a portion of the devices of FIGS. 1-12 in use. FIG. 14 is a block diagram of one embodiment of the present invention. FIG. 15 is a more detailed illustration of the internal configuration of the CPU of the present invention. FIG. 16 is a block diagram of one embodiment of the autoinjector housing of the present invention. FIG. 17 is an isometric view of one embodiment of the present invention. FIGS. 18A-18I, when taken together, constitute a flow chart of algorithms employed by the expert system of the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS Turning now to the drawings, more particularly to FIG. 1, there is shown a an intraosseous autoinjector 10 for rapid vascular drug delivery. The intraosseous autoinjector 10 incorporates a cylindrical syringe body 12, fitted with a double side-holed pencil point needle 14. The syringe body is held in a cylindrical main housing 16 having a front barrel 18 with an orifice 20 through which the needle 14 may be extended. A cylindrical actuation handle 48 fits over end 24 of the main housing 16 for sliding movement along the main housing. A syringe plunger 26 contacts drive plunger 28 and extends into the syringe body 12 to confine liquid medication 32 in the syringe body 12. A main spring 34 extends between the drive plunger 28 and partition 36 on the actuation handle 48 to bias the actuation handle 48 in its extended position along the main housing 16 as shown in FIG. 1. A needle return spring 38 extends between the front barrel 18 and a collar 40 on the syringe body 12 to bias the needle to its retracted position as shown in FIG. 1. The main spring 34 exerts a stronger biasing force when compressed than the needle return spring 38. The drive plunger 28 has an annular peripheral socket 42 for one or more lock balls 44, which engage one or more openings 45 on the main housing 16 to lock the drive plunger in position with respect to the syringe body 12. A mating annular lock ball trip pocket 46 is positioned on inside surface of the actuation handle 48 to allow the intraosseous autoinjector 10 to be fired when the lock ball(s) in socket 42 reach the pocket 46. In FIG. 1, the intraosseous autoinjector 10 is shown in its uncocked position. In use, the intraosseous autoinjector 10 is placed with the end of the front barrel 18 on the midline of the sternum at the second or third intercostal space, and then the intraosseous autoinjector 10 is pushed against the sternum. Compression of the spring 34 behind the syringe body 12 occurs as the front barrel 18 is pushed toward the actuation handle 48 and generates a force that will be used for needle 14 advancement and drug 32 injection. When an adequate force has been stored in the spring 34, the front barrel 18 has been pushed back to a point so that the lock ball(s) 44 are able to enter the trip pocket 46, as shown in FIG. 2. This entry releases the lock ball(s) 44, so that the main spring 34 is free to drive the syringe body 12 and the needle 14 forward with a force of approximately 25 to 40 pounds until collar 40 rests against ridge 50, as shown in FIG. 3. The needle 14 is extended from about 8 mm to about 25 mm in order to ensure that side holes in the needle are in the marrow. The main spring 34 then pushes the syringe plunger 26 forward to the position shown in FIG. 4 to deliver the drug 32 through the extended needle 14 to the marrow in the sternum. Needle placement takes about 1/10th of a second, while drug delivery usually occurs in less than a second. Operation in this manner causes the syringe body 12 to reach a sufficient velocity so that the penetration of the needle 14 into the marrow occurs in a single, rapid, uninterrupted motion due to momentum of the syringe body 12 and needle 14. Relying on momentum in this manner means that a smaller diameter needle can be used than would be required if the penetration resulted from application of penetrating force on the needle while it was at rest against the skin or bone. Upon completion of drug delivery, the operator releases the pressure against the sternum, and the needle retraction spring 38 withdraws the needle 14 into the barrel 18 of the main housing 16 to the position shown in FIG. 5. FIGS. 6-12 show another intraosseous autoinjector 100 for the rapid delivery of a drug to the marrow. The intraosseous autoinjector 100 incorporates a locking, cylindrical protective cover 102 over front barrel 104 to ensure that needle 14 is never exposed except when the intraosseous autoinjector 100 is both pressed against the patient's body and actuated. A cover return spring 106 is positioned between the protective cover 102 and shoulder 108 on cylindrical main housing 110 of the device. The protective cover 102 has an end 112 that extends into actuation handle 114 of the intraosseous autoinjector 100. End 112 is equipped with a tab locking mechanism 116 that, once actuated, prevents the protective cover 102 from being moved from its extended position as shown in FIG. 8 to its withdrawn position, against the barrel 104, as shown in FIG. 9. The locking mechanism 116 consists of two parts: a lock 118 circumferentially positioned around the end 112 between the protective cover 102 and the actuation handle 114, and a sleeve 120 concentrically positioned over the lock 118. The lock 118 has a plurality of spring tabs 122 extending rearward of the actuation handle 114 from a cylindrical base 124. The sleeve 120 has a plurality of projections 126, which are not springs, extending rearward beyond the tabs 122 from a similar cylindrical base 128. With the parts of the intraosseous autoinjector 100 in the positions shown in FIG. 8, prior to use of the intraosseous autoinjector 100, the cylindrical base 128 of the sleeve 120 rests over the spring fingers 122 of the lock 118, holding them down. A sealing membrane 134 is provided inside the barrel 104, over orifice 136, to protect the needle 14 prior to use of the device. In use of the intraosseous autoinjector 100, with the spring fingers 122 in their down position, the protective cover 102 is free to retract against the barrel 104 to the position shown in FIG. 9, when the protective cover 102 is pressed downward against, e.g., the sternum or the tibia. As the protective cover 102 moves toward the barrel 104, the projections 126 of the sleeve 120 engage shoulder 130 of the actuating handle 114, so that the base 128 of the sleeve 120 is pushed down over the base 124 of the lock 118, allowing the spring fingers 122 of the lock 118 to spring outward, as shown in FIG. 9. Continued downward pressure of the intraosseous autoinjector 100 on the sternum or tibia moves the protective cover 102 and the barrel 104 into the actuating handle 114, as shown in FIG. 10, until the main body 108 and the actuating handle reach the firing position, as in the FIGS. 1-5 embodiment. At that time, firing occurs, the needle 14 is extended into the sternum or tibia, and the drug is ejected into the marrow through the needle 14, as shown in FIG. 11 in the same manner as in the FIGS. 1-5 embodiment. When the intraosseous autoinjector 100 is no longer pressed against the patient, the protective cover 102 is returned to its original position by the force of spring 106, as shown in FIG. 12. Because the spring tabs 122 have sprung outward, they engage shoulder 132, on the actuating handle, to lock the protective cover 102 over the needle 14. Thus, the needle is never exposed except when the intraosseous autoinjector 100 is actually pressed against the patient, and the needle 14 cannot be re-exposed after actuation, even if the device is again pressed against the patient or any object. In addition to the main spring 34, a secondary spring 138, separated from the main spring by member 140, is provided to ensure that there is still a spring force urging the needle 14 forward when it is fully extended. Except as shown and described, the construction and operation of the FIGS. 6-10 embodiment of the invention is the same as that of the FIGS. 1-5 embodiment. FIG. 13 shows details of the needle 14 used in the devices 10 and 100. The needle 14 has a slight taper along its length toward a conical, orifice free tip 150. The taper promotes a good seal between the needle 14 and bone 156. The tip 150 of the needle 14 is free of an orifice because orifices located there would tend to clog during penetration of the bone 156. Orifices 158 are located behind the conical tip 150 and communicate with a central bore 160 extending the length of the needle to communicate with the reservoir of drug 32 (FIG. 1). The orifices 158 are staggered around the circumference of the needle 14 and connect to slits 162 extending vertically along the side of the needle. This configuration and placement of the orifices 158 and the slits 162 allow discharge of the drug 32 from an orifice 158, even if it is partially blocked by a tissue globule 164 in the marrow 166. Examples of drugs that can be life saving for specific medical and cardiac emergencies if administered into the circulation in a timely manner, and hence, candidates for packaging in the devices 10 and 100, are shown in the following table: __________________________________________________________________________DRUG MEDICAL EMERGENCY__________________________________________________________________________Adenosine Symptomatic Paroxysmal Supra Ventricular Tachycardia (PSVT)Aminophylline Asthma, congestive heart failure (CHF)Amrinone CHF not associated with myocardial infarction (MI)Atropine Bradycardia, organophosphate poisoning, third degree heart block, asystoleBretylium Ventricular fibrillationBumetanide CHF, pulmonary edemaButorphanol Moderate to severe painCalcium Chloride Acute hyperkalemia, hypocalcemiaChlorpromazine (Thorazine ®) Acute psychotic episodesDexamethasone AnaphylaxisDiazepam (Valium ®) SeizuresDiazoxide (Hyperstat ®) Hypertensive emergencyDigoxin CHF, atrial flutter/fibrillationDiphenhydramine (Benadryl ®) AnaphylaxisDobutamine CHFDopamine Cardiogenic shock, hypovolemic shockEdrophonium Cardiac arrest, shock, anaphylaxis, etc.Esmolol Symptomatic supraventricular tachycardiaFurosemide CHF, pulmonary edemaGlucagon HypoglycemiaHaloperidol (Haldol ®) Acute psychotic episodesHydralazine Hypertiesive emergencyHydrocortisone Severe anaphylaxisInsulin Diabetic ketoacidosisIsoproterenol BradycardiasLabetalol Hypertensive crisisLidocaine Ventricular arrhythmias, MIMagnesium sulfate EclampsiaMannitol Acute cerebral edema, blood transfusion reactionsMeperidine (Demerol ®) Severe painMetaraminol Cardiogenic shockMethylprednisolone Severe anaphylaxisMetoprolol (Lopressor ®) Acute MIMorphine Severe pain, pulmonary edemaNalbuphine Moderate to severe painNaloxone (Narcan ®) Narcotic overdose, comaNorepinephrine (Levophed ®) Hypotension, neurogenic shockOxytocin Postpartum vaginal bleedingPhenobarbitol Seizures, acute anxietyPhenytoin (Dillantin ®) Major seizuresPhysostigmine Tricyclic overdose, belladonna or atropine overdosePralidoxime (2-PAM, Organophosphate poisoningProtopam ®)Procainamide Ventricular arrhythmiasPromethazine (Phenergan ®) Nausea and vomitingPropanolol (Inderal ®) Cardiac arrhythmiasSodium Bicarbonate Cardiac arrest, antidepressant overdoseSodium Nitroprusside Hypertensive emergencySuccinylcholine To induce paralysisThiamine (vitamin B1) Coma, alcoholism, delirium tremorsVerapamil PSVT__________________________________________________________________________ Many of the above medical emergencies are and can be life threatening. The vascular delivery of the above drugs can be life saving. Even a few seconds delay in therapy can be a matter of life or death in a medical emergency. The intraosseous autoinjector of the present invention can be used to administer these drugs into the central circulation, often in less than 1 or 2 seconds. The administration of drugs in this manner can be safely and effectively performed by a lay person with minimal training and, overall, offers a safe, effective, and extremely rapid means to treat medical emergencies. Because momentum is used to advance the needle through the cortical bone and into the marrow, even a small gauge needle, such as a 20 to 25 gauge simple pencil-point with side holes, could be properly placed. Because the effective dose of most of the previously listed drugs could be carried in exceedingly small volumes, such as 0.1 to 0.2 ml or less, such a small gauged needle could be used for rapid drug delivery. Alternatively, a larger needle (12 to 18 gauge), either a simple pencil-point or the design previously described, could be used to administer rapidly 1.0 to 5.0 ml of fluid. The invention and these needles can be used to effectively deliver drugs into circulation in as short a time as 1 to 2 seconds or less. While the intraosseous autoinjector of the present invention has been shown in two preferred forms, various modifications of it could be made. For example, the device could be construed so that it is cocked or loaded prior to placing it in contact with the patient, and merely fired after it is pressed against the patient with a suitable pressure. The devices 10 and 100 have been shown and described as configured for IO infusion. The same principle of an automatic syringe that is automatically spring loaded for injection by pressing against the patient could be adapted to an automatic syringe for subcutaneous or intramuscular injection as well. The intraosseous autoinjector of the present invention punctures a bone containing marrow, places a needle into the marrow, and infuses fluid into the circulatory system via the marrow. The device covers the needle before and after use to prevent accidental needle punctures. A block diagram of an interactive external defibrillation and drug injection system for use by a human operator for treating cardiac conditions or other medical emergencies in a patient is shown in FIG. 14. A measuring device 220 is attached to a patient 200. The measuring device is capable of measuring a patient's ECG. In a preferred embodiment, the measuring device is also capable of measuring a patient's blood pressure. A CPU 230 is connected to receive input signals from the measuring device indicative of measurements taken by the measuring device. As shown in FIG. 15, these input signals may include an ECG input 222 and a blood pressure input 224. The CPU is capable of analyzing the measurements received from the measuring device and of transmitting control signals. In a preferred embodiment, the CPU comprises a programmable expert system 234 that is capable of analyzing measurements from the measuring devices to identify cardiac dysrhythmias, and a signal processor 233 capable of receiving an input signal indicative of a patient's ECG. The expert system is also capable of receiving ECG data from the signal processor and identifying the QRS complex and the R wave. The expert system is further capable of analyzing inputs from the measuring devices to determine heart rate and heart rhythm, or to diagnose atrial contraction, or a ventricular contraction. The signal processor is further capable of transmitting a control signal to the electrical source. The dysrhythmias and conditions that the expert system is capable of identifying include ventricular fibrillation (VF), ventricular tachycardia (VT), acute myocardial infarction (MI), bradycardia, tachycardia, pulseless electrical activity (PEA), asystole, hypotension, shock, and acute pulmonary edema (APE). In a preferred embodiment, the expert system comprises a multiplicity of cardiological treatment and diagnostic algorithms capable of receiving input data from the measuring device and from a human operator, and further capable of Generating instructions to a human operator via the communication system 235. These algorithms are depicted in FIGS. 18A-18I. In the embodiment shown in FIG. 17, the buttons labeled "1" and "2" are intended for use by a qualified person, such as a medical director of an emergency medical services department, to program the expert system of the present invention. In a preferred embodiment the programming means is located in the back of the device in a compartment that is masked by a locked panel. FIG. 18A is a block diagram depicting the scope of treatment and diagnostic algorithms encompassed by the expert system of the present invention. These algorithms may be modified to conform with the most current standards of CPR/ECC, as published by The American Heart Association in journals known in the art, such as the Journal of the American Medical Association. Additionally, some modifications to these algorithms may be programmed by the end user under the direction of qualified medical personnel, to reflect "standing orders" or standards of practice of CPR/ECC of an end user EMS system. The interactive nature of this expert system is illustrated by block 300, depicting an assessment of a patient's responsiveness by a first respondence and by block 360 depicting various instructions or prompts Generated by the expert system to the first responder regarding treatment to be administered to a patient. The assessments depicted by blocks 315-345 in FIG. 18A, reflect action that a first responder would be trained to take without the assistance of an expert system. Block 350 depicts the attachment of measuring devices of the present invention such that the expert system can perform the analysis and provide the instructions depicted in block 360. The various dysrhythmias that may be diagnosed by the expert system are depicted at blocks 361-367 of FIG. 18A. Each of these dysrhythmias is shown in greater detail in FIGS. 18B-18I. FIG. 18B depicts the general algorithm for use in treating VF and VT. The interactive nature of the present invention is illustrated by the prompts and instructions shown at blocks 410, 420, 440, and 450. These instructions encompass the use of electrical shocks, as well as the administration of drugs. It is the intent of the present invention that where instructions to administer drugs, such as those shown in blocks 440 and 450 are given, the first responder would administer such drugs using the autoinjectors of the present invention. The instruction depicted by block 445 is an instruction to perform the analysis depicted at block 360 at FIG. 18A. The algorithm of the expert system for the treatment of PEA is shown in FIG. 18C. PEA is also known as electromechanical dissociation to those of ordinary skill in the cardiological art. Block 520 illustrates an instruction from the expert system to administer a drug using the autoinjector, as well as CPR. The algorithm of the expert system for the treatment of asystole is illustrated in FIG. 18D. Block 620 and 630 illustrate instructions from the expert system to administer drugs to a patient using the autoinjector. Block 650 and 655 instruct the operator to perform the analysis shown in block 360 of FIG. 18A. The algorithm of the expert system for the treatment for acute MI is illustrated in FIG. 18E. As shown in block 710, this algorithm utilizes blood pressure input 224, as also depicted in FIG. 15. Block 720 illustrates prompts from the CPU to the operator to administer drugs to a patient, using the autoinjectors of the present invention. The algorithm of the expert system for the treatment of bradycardia is illustrated in FIG. 18F. As shown in block 800, this algorithm utilizes heart rate. In response to the prompts shown in block 810, it is the intent of the present invention that the operator would input data into the CPU using data input terminal 238 of FIG. 15. The expert system would then use this data to proceed with the algorithm, as shown in blocks 820-850. The algorithm of the expert system for the treatment of tachycardia where the heart rate of the patient is greater than 150 beats per minute, is illustrated in FIG. 18G. As shown in block 910, this algorithm utilizes heart rate input or blood pressure input 224, as also depicted in FIG. 15. The synchronized cardioversion referred to in block 920 is performed in conjunction with the output of a control signal from signal processor 233 to electrical source 240. The algorithm of the expert system for the treatment of tachycardia where the heart rate of the patient is less than 150 beats per minute as measured by measuring devices 200 is illustrated in FIG. 18H. In contrast to treatment for tachycardia where the heart rate of the patient is greater than 150 beats per minute, treatment for tachycardia where the heart rate of the patient is less than 150 beats per minute, initially includes drugs rather than cardioversion. The algorithm of the expert system for the treatment of hypotension, shock, or acute pulmonary edema is illustrated by FIG. 18I. As shown in blocks 1133-1139, blood pressure input 224 is used by this algorithm to determine which drugs are to be administered by the autoinjectors. In a preferred embodiment, the communication system of the CPU comprises a data display device 236 capable of displaying data from the measuring device and instructions generated by the algorithms of the expert system, as shown in FIGS. 15 and 17. In a preferred embodiment, the data display device comprises an LCD visual display 239 and an audio communicator 237. Input from a human operator 231 is received via a data input terminal 238. In a preferred embodiment, the data input terminal is a keyboard, or, alternatively, one or more buttons that can be pushed by a human operator to signal an affirmative or a negative response to an inquiry or "prompt" generated by the expert system. The buttons labeled "yes" and "no," 238 in FIG. 17, may be pushed by a human operator to indicate an affirmative or negative response, respectively, to a query generated by the CPU. The audio communicator is capable of communicating data and instructions to a human operator in an audibly perceivable manner. In a preferred embodiment, the invention comprises a data storage device 262 that stores all data received by the CPU from the measuring devices or from an operator and all instructions and control signals generated by the CPU, as shown in FIG. 14. This data is stored in a retrievable fashion such that an operator can later determine what measurements and input were received by the CPU, as well as what instructions were given by the CPU. In a preferred embodiment, the data storage device further comprises a clock capable of storing the time at which all data was received by and all instructions were generated by the CPU, in a retrievable fashion. The invention may further comprise an audio recorder 227, capable of recording audible events occurring near the CPU. Such events would include audio commands from the communication system of the CPU and statements made to and from the operator of the invention. In a preferred embodiment, a printer 260 may be attached to the CPU such that any retrievably stored data in the CPU can be printed out on a "hard copy." In another embodiment of the present invention, the data storage device 262 is a digital data recorder 262, which is electrically coupled to the CPU, as shown in FIG. 15. In a preferred embodiment, the digital data recorder is automatically activated whenever the CPU is turned on. The digital data recorder records all signals transmitted by measuring devices to the CPU, all input from an operator to the CPU, all instructions generated by the CPU, and the times that all data inputs, operator inputs, control signals, and instructions were received or generated by the CPU, in a retrievable fashion. The interactive external defibrillation and drug injection system of the present invention further comprises at least two electrical leads 244 connectable to a patient 200 and capable of delivering a sufficient amount of electrical energy to a patient to cardiovert or defibrillate a patient's heart. These leads may be repositioned on the patient, or an additional lead may be used, to confirm the presence of asystole. In a preferred embodiment, the present invention comprises more than two electrical leads. Such an embodiment is particularly useful when the operator wishes to diagnose MI. The system of the present invention further comprises an electrical source 240 comprising a discharge outlet 242 electrically connected to the electrical leads. The electrical source further comprises a control signal input 246 electrically connected to the CPU. The electrical source is capable of storing and discharging electrical energy through the discharge outlet to the leads in sufficient predetermined selectable quantities and at sufficient predetermined selectable rates to defibrillate or cardiovert a patient's heart in a manner consistent with selected control signals and instructions from the CPU. In a preferred embodiment, the electrical source is further capable of discharging electrical energy through the discharge outlet to the leads in sufficient predetermined selectable quantities and at sufficient predetermined selectable rates to transcutaneously pace a patient's heart in a manner consistent with selective control signals and instructions from the CPU. In this embodiment, the control signal generated by the CPU to regulate the transcutaneous pacing is indicative of the P wave, the QRS complex, the R wave, atrial contraction, and/or ventricular contraction of a patient's heart. In one embodiment of the present invention, the electrical source and CPU are housed in a portable console 245 as shown in FIG. 17. In another embodiment, the electrical source and communication system are configured in a housing like that of the Heartstart® 3000 system. In the preferred embodiment of FIG. 17, the electrical source further comprises a rechargeable battery 241 and a multiplicity of control devices 243 operable to permit a human operator to select the magnitude and duration of electrical energy discharged by the electrical source. Alternatively, this selection can be made by the expert system, and transmitted to the electrical source. The human operator would merely push button 256 on the console to deliver an electrical shock of the magnitude and duration selected by the expert system. A console of the type shown in FIG. 17 may contain receptacles at its rear to receive leads from the measuring devices. In a preferred embodiment, this console would comprise at least three connections for three ECG leads. In another preferred embodiment, the console shown in FIG. 17 comprises an audio recorder, located at its rear. The audio recorder would automatically be activated anytime inputs are received by the CPU or instructions are generated by the CPU. In the preferred embodiment shown in FIG. 17, the autoinjector housing 250 comprises a multiplicity of autoinjectors, including an autoinjector containing a premeasured amount of epinephrine (EPI), an autoinjector containing a premeasured amount of atropine (ATR), an autoinjector containing a premeasured amount of morphine (MOR), an autoinjector containing a premeasured amount of tissue plasminogen activator (tPA), an autoinjector containing a premeasured amount of lidocaine (LID), and an autoinjector containing a premeasured amount of adenosine (ADE). Each of these autoinjectors is an intraosseous autoinjector. The embodiment of the invention shown in FIG. 17 shows the preferred number of autoinjectors containing each drug. The system of the present invention further comprises at least one intraosseous autoinjector which contains a premeasured amount of a predetermined drug. Each autoinjector device comprises an identifier, such that it can be promptly identified by a human operator in response to an instruction from the CPU. In a preferred embodiment, each autoinjector is removably housed in a portable autoinjector housing 250 comprising a visual labeling system 254 such that the drug contained within each autoinjector is readily perceivable by a human operator. It is envisioned that the present invention is particularly applicable to pre-hospital or out-of-hospital treatment of a patient experiencing a cardiac emergency. When such a patient is delivered to a hospital or to the care of a person more highly trained than a first responder, such as a paramedic or a physician, it is particularly important for the paramedic or physician to known what drugs have been administered to the patient. The autoinjector housing embodiment of the present invention provides a means for a paramedic or other professional to readily ascertain what drugs have been administered from the number and color of empty autoinjector receptacles in the housing, as well as from a printout of all data and first responder or operator inputs recorded by the CPU. In one embodiment of the present invention, the portable autoinjector housing is electrically coupled to the CPU, as shown in FIG. 15, such that it can receive a signal from the CPU indicative of which drug to administer to a patient. In this embodiment of the present invention, an electrical light 253 is situated in close proximity to each autoinjector and electrically connected to the CPU such that each light may be selectively illuminated by the CPU pursuant to instructions from the expert system to visually indicate which drug should be administered to a patient, as shown in FIG. 17. In one embodiment, these lights may be LEDs. These lights may be electrically coupled to the CPU such that they blink to indicate that an autoinjector should be used to administer drugs to a patient and they remain illuminated to indicate that an autoinjector has already been used to administer drugs. In another embodiment of the present: invention, each autoinjector may be a unique color indicative of the drug it contains. In this embodiment, the unique color associated with each drug is programmed into the expert system such that the expert system can issue instructions regarding drug injection that identify a particular autoinjector by its color. This embodiment is not preferred when the operator is color blind; however, color coding may be used in conjunction with other forms of autoinjector identification, such as the electrical lights, described above, in order to provide redundant means of autoinjector identification. In yet another embodiment, the autoinjector housing comprises a multiplicity of extendable jacks 251. One extendable jack is installed in each compartment, directly adjacent an autoinjector, as shown in FIG. 16. Each jack is mechanically coupled to a transducer 257 that is electrically coupled to the CPU such that each transducer can receive an extension signal for a specific autoinjector from the CPU, and transmit the signal to a specific jack, causing it to telescopically extend, thereby extending the adjacent autoinjector to a more prominent position relative to the other auto:injectors in the autoinjector housing. This extension provides a visual signal to a human operator to remove the extended autoinjector from the housing and administer the drug contained within that autoinjector to a patient. In this embodiment, the CPU memory records which jack was actuated, the time it was actuated and the particular drug contained within the autoinjector stored adjacent that Jack. The CPU is also capable of providing prompts from its visual display in conjunction with the operation of the jack, instructing a human operator to remove the autoinjector that has been extended by operation of the jack. In this embodiment, the CPU would send inquiries to the human operator asking him to verify whether he has administered the drug contained within the extended autoinjector to a patient. The CPU memory would be capable of retrievably storing a human operator's answer and the time of the answer to such an inquiry. Many modifications and variations may be made in the embodiments described herein and depicted in the accompanying drawings without departing from the concept of the present invention. Accordingly, it is clearly understood that the embodiments described and illustrated herein are illustrative only and are not intended as a limitation upon the scope of the present invention.

This invention involves an interactive external defibrillation and drug injection system for use by a human operator for treating cardiac conditions in a patient, particularly in an out-of-hospital or pre-hospital environment. The present invention may also be used within hospitals as well as where intravenous (IV) access has not been established. More specifically, this invention comprises measuring devices capable of measuring and monitoring various physiological indicators in a patient and an expert system capable of analyzing the measured data and making recommendations to an operator for treatment of the patient using any combination of defibrillation, cardioversion, transcutaneous pacing, or vascular drug delivery via intraosseous drug injection. This invention is designed to enable first responders to cardiac emergencies to provide care up to the standard of at least the beginning stages of Advanced Cardiac Life Support (ACLS).

This patent application claims priority under 35 U.S.C. 119(e) from provisional application Ser. No. 60/341,890, filed Dec. 18, 2001, which is incorporated herein by reference in its entirety. The present invention is directed to a composite handle suitable for grooming implements used in cosmetic and beauty processes. Examples of such implements include nail files, nail clippers, combs, brushes, mirrors, etc. Such handle facilitates and improves gripping and control of the implement during use. BACKGROUND OF THE INVENTION In the past, grooming implements for performing, assisting, and/or viewing cosmetic and beauty processes, such as manicures, pedicures, brushing, combing, styling, clipping, cutting, applying cosmetics, etc., have been provided with and without handles. The same situation pertains to related grooming implements, such as mirrors. Handles function to enhance or facilitate gripping by the user and thus offer the ability for the user to improve control of cosmetic and beauty processes. Typically, such handles have a smooth, flat plastic surface and are rigid when gripped by a user. Such handles may contain a slot to receive and secure an end portion of a grooming implement. Such implement end portion may be inserted into the opening and then affixed, thereby connecting the implement end to the handle. An adhesive affords a convenient means of affixing the respective parts. The present invention offers an improvement to the above-mentioned grooming implements through use of a handle, which provides improved gripping ability, and hence, control, by the user. The improved gripping ability of the handle can be important if the user suffers from hand weakness or impairment, which would reduce, or even impede, the ability to efficiently use the implement. As can be appreciated, overall ease of use is enhanced by the invention. SUMMARY OF THE INVENTION The present invention generally comprises a composite handle for grooming implements. The composite handle is connected to an end of a functional portion of the implement. Such implements may be a nail file, a brush, a comb, a nail clipper, a mirror, or the like. The composite handle has at least two portions—a rigid portion and a flexible portion. Such composite handle functions to facilitate gripping and control by the user. More specifically, the composite handle contains a rigid portion and a flexible portion, with the flexible portion located at a central area of the rigid portion. Such combination and location facilitates gripping and control when used. The flexible portion may comprise a plug, which may be inserted into the rigid portion of the handle. Desirably, the plug may extend completely through the rigid portion and thus forming flexible surfaces on opposite sides of the rigid portion thereby permitting a user to grip said handle at its flexible portion with at least one finger and a thumb. The plug may contain a slot, which is adapted to receive and become affixed, and thereby connected to, an end portion of a grooming implement. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a top view of a nail file. FIG. 2 is a side view of a nail file. FIG. 3 is a cross-sectional view of a nail file taken along line a—a of FIG. 1 . FIG. 4 is a side view of a plug adapted to be inserted and snapped into the handle of a grooming implement. DETAILED DESCRIPTION OF THE INVENTION The grooming implement of the present invention contains a handle that provides improved gripping and hence control of the implement by the user. Such ability to control the movement of the implement is a beneficial attribute of the invention. This benefit is illustrated by considering a nail file. Improved control of nail filing processes result in the achievement of desired nail shape and smoothness of fingernails and/or toenails. Also, potentially harmful contact with skin adjacent to the nail is thereby minimized. Obviously, improved control of a nail clipper would also achieve the above benefits. Improved gripping may become important should a user have weakened or impaired hands and thus would otherwise have difficulty in exercising the necessary control of the implement. FIG. 1 is a top view of a nail file, which was chosen to illustrate one of the grooming implements of the invention. The nail file comprises file member 11 which has an end inserted into and connected to or affixed to handle 12 . Rigid portion 14 of handle 12 may desirably be bulbous in shape to further facilitate gripping by the user. Oval shaped area 13 in handle 12 is comprised of a flexible material thereby creating a flexible surface portion. Such flexible surface portion may be contoured to be compatible with the surface contour of rigid portion 14 . Typical flexible materials include but are not limited to rubber, foams, and spongy material, etc. Typical rigid materials include but are not limited to plastic, metal, glass, wood, ceramic, etc. Such materials may be coated if desired. The combination of rigidity and flexibility serves to create a handle having sufficient overall rigidity to control the filing or other desired process but yet having flexibility to obtain improved gripping. Such flexible portion is desirably located at a central area on opposing surfaces of the handle whereby contact at the flexible portion by at least one finger and the thumb of a user is facilitated. As may be seen, the composite handle of the invention possesses a highly desirable combination of rigidity and gripping ability, as contrasted to a handle comprised solely of a rigid or flexible material. FIG. 2 is a side view of a nail file illustrating one technique for connecting the file end member to the handle. As may be seen, file member 21 is inserted into slot 23 of handle 22 . Connection then may be conveniently accomplished with use of an adhesive, bonding, pressure fitting, or any other means. File member 21 may be comprised of metal, emery board, or any other type of desired abrasive material. File member 21 may be inserted into a slot of a plug (not shown in this Figure) to enable file member 21 to be received and then adhered to become connected in said slot. FIG. 3 is a cross-sectional view of a nail file as viewed along line 3 — 3 of FIG. 1 . Portion 31 is the rigid portion of the handle, and flexible portion 32 is the flexible portion. Flexible portion 32 comprises a plug inserted into such rigid portion of the handle. FIG. 4 depicts a side view of a snap-in plug that is adapted to be inserted and snap fitted into an opening of the handle. Plug 41 may be comprised of a flexible material such as rubber, and contains flexible lips 42 and 43 and insert opening 44 . Such opening is adapted to receive and retain the file member. Once snapped into place, the plug is retained in the handle by lips 42 and 43 . Top 45 and bottom 46 of plug 41 are rounded, and thus may be adapted to conform to a bulbous rigid surface portion of the handle. Such rounded surface further enhances gripping by the user. It is also possible to improve gripping by providing indentations or suitably roughening the surfaces 45 and 46 of plug 41 . The composite handle of the invention comprises providing a rigid handle with an opening and then placing and affixing a plug made from a flexible material such as rubber or the like in such opening to create the desired composite handle. The plug may extend completely through the rigid handle or only through a portion thereof. It is preferred to extend the opening through the handle to result in flexible material on opposing sides of the handle. The plug may be affixed by an adhesive or the like. However, it is preferred to utilize a snap-in plug, such as illustrated in FIG. 4 . While it is shown in FIG. 3 that the surfaces of the rigid members and the plug are essentially flush and smooth, it is contemplated that the plug could be recessed in the handle opening or extend above the rigid material. The latter structure would further enhance gripping by the user by assisting in the formation of a bulbous-shaped handle.

A composite handle for grooming implements provides improved control during use. Such handle has a rigid and a flexible portion that facilitates use of the implement, especially when a user has a weak or impaired grip.

TECHNICAL FIELD [0001] The present invention relates to a helmet. The helmet is primarily intended as a cycling helmet to provide head protection in the event of a cycling accident. However, it also finds application at any time when head protection is needed, for example ice skating, roller skating, skateboarding, caving, climbing, e.g. indoor climbing or mountain climbing, skiing, baseball, American football, ice hockey and head protection at work or when working at heights, e.g. in the construction industry. Technical Background [0002] Most bicycle helmets available have (a) a thin outer layer, which may be made, for example, out of polypropylene that is able to absorb initial peak impact forces, (b) a shell within the thin layer and composed of expanded polystyrene that absorbs both initial and subsequent impact forces and (c) padding within the expanded polystyrene shell both to provide comfort to the user and to adjust the shape of the internal cavity within the shell for different shaped and sized heads. [0003] In general, a cycling helmet should fit closely over the cyclist's head so that any impact force is spread over as wide an area of the head as possible. The impact forces are absorbed by the thin polypropylene layer and the expanded polystyrene shell. In addition, some helmets fracture under impact, which also absorbs energy and reduces the energy transferred to the head. [0004] Cycling helmets are often treated roughly and such rough treatment can impair the effectiveness of the helmet. However, there is often no outward visible sign of such impairment. [0005] As mentioned, cycling helmets and helmets for other uses are generally made of synthetic plastics. Although it would be desirable to make the helmets at least partly out of natural material that could be recycled, it is counter-intuitive to use such materials in applications requiring the resistance of such strong forces. [0006] Helmets should generally be light to be acceptable to wearers. Sports protective helmets should also be well ventilated so that sweat does not accumulate around the user's head and so that body heat generated due to the exertion of cycling or other sport can be displaced through the head. [0007] Although the materials used for making the cycling helmets are not particularly expensive, it would advantageous to use cheaper materials, if possible. DISCLOSURE OF THE INVENTION [0008] The present invention uses the strength of flutes or hollow tubes, e.g. hollow cylinders, hollow cells and hollow frusto-cones, in a helmet to resist impact and also to crumple on impact, such crumpling absorbing significant energy which is thereby not transferred to the user's head. [0009] In one embodiment, the flutes may be those present in corrugated material, e.g. corrugated fibre board can be used to absorb impact energy. In this case, an impact resistant shell of the helmet of the present invention can be made of such corrugated material, which may be in the form of intersecting arc shaped ribs overlying a head cavity of the helmet and extending outwards, optionally radially outwards, from the cavity. In this case, the arc-shaped ribs may be arranged to extend generally axially (front to back) and laterally (side to side). The arrangement of the flutes may be such that at the front, top and sides of the helmet, at least some of the flutes extend radially outwards from the cavity (e.g. forwardly and optionally also upwardly at the front and sideways and optionally also upwardly at the respective sides). The positioning of the flutes can be brought about by suitably locating the arc-shaped ribs and by selecting the direction of the flutes within those ribs. [0010] However, sufficient impact resistance can be achieved using the above intersecting arc-shaped ribs but without the use of flutes. The arc-shaped ribs may each be made of one or more sheets. When two or more such sheets are present in a single rib, they will generally lie parallel to each other and may be joined together in a spaced apart relationship. When each rib has three or more sheets, each spaced may be apart from, and connected to, its neighbouring sheet. The material joining the sheets together and maintaining the sheets in a parallel spaced-apart configuration may be composed of cells. Such cells may be formed by a corrugated sheet, as discussed above, or by cells having walls and or axes that extend generally orthogonal to the planes of the sheets. For example, the sheets may be connected by an array of honeycomb cells where the individual cells are hexagonal, square or rectangle in cross-section. The honeycomb cells, which are connected to the sheets overlying them, increase the resistance to flexing of the ribs and thereby make them stiffer. They also maintain the sheets in a parallel spaced-apart configuration, which means that the sheets themselves can absorb greater impact forces than if the sheets were connected together by flutes that have lower ability to maintain the sheets in parallel. [0011] The sheets are preferably semi-rigid, where the term “semi-rigid” material is used in the present specification in relation to a sheet to denote a material that will remain in a planar configuration but can be crumpled by a substantial force applied within the plane of the sheet. The force it can withstand before crumpling will depend on the nature of the ribs, and the arrangement of the sheets within each rib and the number and arrangement of the ribs within a helmet. The semi-rigid material should be such that the helmet overall can withstand the force required for the application concerned and the various standard that apply to these helmets. Typical materials include cardboard and stiff but flexible plastics. [0012] The arc-shaped ribs may together form an intersecting array or lattice, with ribs extending axially between the front and the back of the head cavity and laterally between the two opposed sides of the head cavity; they can also extend diagonally. Naturally, the ribs will intersect in such an arrangement and, at the intersection point, the ribs preferably form crossed halved joints, which are made by forming a groove in the lower part of one rib and another groove in the upper part of the other rib so that the two ribs can be slotted into each other without severing either rib completely. The joint can be an interference fit between the two ribs or adhesive can be used to cement the two ribs at the joint. Alternatively, some of the grooves in the ribs may be larger than is necessary to accommodate the intersecting ribs, partly to make manufacture easier and partly to allow a limited amount of movement or play between the ribs, which helps absorb energy in a crash. [0013] As mentioned above, when corrugations are provided, the corrugations provide the impact strength along the direction of the flutes. Therefore, at the centre of each arc-shaped rib, it is preferred that the flutes extend either parallel to the edge of the rib or at right angles to the edge of the ribs. The latter arrangement absorbs impact forces exerted on the centre of the rib at a right angle to the edge. The former arrangement provides strength at the ends of the rib rather than in the centre and can absorb impact forces exerted at right angles of the ends of the ribs. The flutes in adjacent ribs need not be parallel to each other and indeed it may be advantageous if that is not the case so that adjacent ribs can absorb impact forces applied from different directions. Thus, for example, the flutes of one arc-shaped rib can extend at right angles to the flutes on the adjacent rib. [0014] The helmet may include a rim encircling the head cavity that may also be made of the same material as the ribs; if made of corrugated material containing flutes, the flutes preferably extend from the front to the back of the head cavity so as to absorb front impact forces. [0015] Although the corrugated material may be made of plastic, it is preferred to use fibre board (e.g. corrugated cardboard) since the materials for making fibre board are natural and the helmet can be recycled after use. Corrugated fibreboard can be obtained commercially in a large number of different qualities but all qualities are relatively cheap. Honeycombed fibreboard can be made by forming a layer of honeycomb cells and adhering to this layer to the face sheets. [0016] In a second embodiment, instead of flutes in corrugated boards, the strength of the impact resisting shell may be provided by an array of hollow tubes, e.g. cylinders or frusto-cones, typically made from sheet material, especially paper and cardboard. The ends of the cones or cylinders should point outwardly from the head cavity so that they are able to absorb impact and also crumple under that impact, thereby absorbing energy and reducing the force that is transmitted to the user's head in the event of an accident. [0017] Cylinders, when packed together in a dome-shaped array, may not present a smooth external surface or a smooth inner surface that outlines the head cavity. In order to address this, it is possible to machine the external or internal surfaces to provide such a smooth domed shape. However, it is not necessary to produce a smooth dome shape to the outside surface. [0018] Furthermore, an uneven dome shape within the cavity of the impact resistant shell can be tolerated if an inner shell is provided that has a matching outer surface; the inner shell may then provide a smooth domed inner surface. The role of the inner shell will be discussed below. A domed shape can be achieved more easily by using hollow frusto-cones instead of cylinders with the larger end face of the cones pointing outwardly while the smaller faces point inwardly. [0019] The tubes (hollow frusto-cones or cylinders) can be held in a bundle or array with each tube being in contact with a neighbouring tube. A mixture of cones and cylinders can be used. Alternatively, the tubes can be held in position by a matrix material in which they are captured within the matrix material. [0020] Hollow cylinders can be made by winding strips of flexible sheet material into a closed shape and retaining the closed shape, for example, by adhesive. The strips used to form such tubes will generally extend helically around the axis of the tube. The manufacture of hollow cylinders is widely practiced in the manufacture of the cores of paper rolls. Frusto-conical shapes can also be made by a similar winding technique. [0021] The greater the number of tubes (cylinders or frusto-cones) used to make up the impact resistant shell, the greater is the impact strength of the shell. Therefore, the outside diameter of the cylinders or frusto-cones will generally not exceed 4 cm and, for example, will generally not exceed 3 cm. On the other hand, a greater number of tubes will increase the complexity of manufacturing the shell and accordingly the outside diameter of the cylinder should preferably be at least 0.5 cm, e.g. 1 cm. In the case of frusto-cones, the mean diameter of the cones should generally lie in the above ranges. [0022] The tubes (cylinders or frusto-cones) should crumple on impact. In order to control the degree of crumpling, a line of weakness may be provided in the walls of the hollow tubes along which they can collapse. The lines of weakness are preferably helical in shape so that the crumpling will occur within the boundary of the tubes and the lines of weakness may be provided in the form of holes or openings spaced along the line of weakness. [0023] As is the case in the first embodiment, cheap material used to make the tubes, which material may be plastic but preferably is paper or cardboard. Cork could also be used. [0024] In fact, the distinction between the first embodiments and the second embodiment is not clear-cut since the above-described arrangement of intersecting ribs can also be seen as falling within the scope of the second embodiment since the intersecting ribs form an array of cells that are tubes having a 4 -sided cross-section. [0025] In order to waterproof the helmet of the present invention, at least the outside edge regions of the crushable bodies may be covered with a waterproofing material, although optionally an outer shell may be provided that will provide such waterproofing, in which case it is preferred that ventilation openings are provided in the outer shell. The waterproofing material/outer shell is preferably made of a material having a stiffness coefficient higher than that of the material used for forming the crushable bodies so that it is less elastic. In this way, it can assist in resisting the peak force exerted on impact. The preferred materials are polypropylene, acrylic or ABS. [0026] The helmet may include an inner shell, which may perform a number of functions. Firstly, it can add extra impact resistance to the impact resistant shell of the present invention, for example it could be made of moulded expanded polystyrene. Secondly, it can be used to tailor the helmets to the size of a particular user's head. This can be achieved by making the cavity within the impact resistant shell of the present invention in one standard size and providing an inner shell with an outside that matches the size of the impact resistant shell cavity and an inside that has a head cavity that is matched to the size of a user's head; thus a number of inner shells could be manufactured having variously sized internal cavities to fit various head sizes and shapes. Padding may also be provided for additional comfort and/or ensuring that a tight or snug fit is maintained between the user's head and the helmet, e.g. using insertable padding that can be adhered to the inside surface of the inner shell cavity, as is widely practiced with cycling helmets currently available. [0027] A further use of the inner shell is to dissipate the impact forces that are transmitted to the inner ends of the crushable bodies, i.e. the ends lying in the head cavity, so they are not transmitted directly on the user's head. In addition, the shape of the cavity within the impact resistant shell may not be uniformly smooth and the outer surface of the inner shell can, as discussed above, be shaped to match the uneven surface of the cavity in the impact resistant shell. This avoids having to shape the head cavity of the impact resistant shell in an expensive manner. The inner shell may be permanently attached to the impact resistant shell of the present invention or may be releasable attached, e.g. using loop-and-hook fastenings, e.g. Velcro®, so that the impact resistant shell of the present invention is replaceable if dented. [0028] Instead of a continuous inner shell, a series of pads may be used that lie between the array of crushable bodies and the user's head. Such pads may be made of relatively rigid foam material to provide a cushion between the crushable bodies and the user's head. The series of pads may be viewed as a discontinuous inner shell. [0029] Generally, because the outside surface of the impact resistant shell (even with the waterproofing layer or outer shell), is made up of an array of crushable bodies rather than a uniform smooth surface, it will be more evident when the impact resistant shell has been damaged and therefore needs replacing. [0030] The impact resistant shell can be recycled, if made of fibre based materials, such as paper or cardboard. The strength of the crushable bodies will depend on the nature and thickness of the sheet material used and so it is possible to adjust the impact strength and crumpling properties of the helmet by the choice of the sheet material used. in the present specification, the term “outer” shell does not necessarily mean that it forms the outermost layer of the helmet (although it can) and likewise the term “inner” shell does not necessarily mean that it forms the innermost layer of the helmet (although again it can). However, the outer shell will always lie outside the impact resistant shell and any inner shell in the helmet will always lie inside the impact resistant shell. [0031] According to a further aspect of the present invention, there is provided a head protecting helmet comprising a shock indicator that gives it an indication when the helmet has been subject to a shock in excess of a threshold value, thereby indicating that the helmet or at least the shock absorbing part of the helmet should be replaced. Often, for convenience, the magnitude of a shock, which is a force exerted as a result of acceleration or deceleration, is stated as a multiple of the acceleration caused by earth's gravity, which is indicated by the symbol “G”. During a bicycle accident, the helmet can suffer shocks of 150 G and after any shock of 150 G should preferably be replaced. [0032] The accelerometer contains at least five tubes or flasks each containing a viscous coloured liquid held in a chamber of the flask by a wall having a capillary bore extending through it that normally retains the liquid within the chamber as a result of the surface tension of the liquid and the small size of the bore. However, if a sufficient force is exerted on the liquid due to shocks, the liquid passes through the capillary into a further chamber; the presence of the coloured liquid in the further chamber indicates that the accelerometer has suffered a shock in excess of a threshold value. The at least five tubes or flasks communicate with a common further chamber and so the present of the coloured liquid in the common further chamber indicates that the helmet needs replacing. Tubes or flasks of the above type are already known and sold under the trademark “Shockwatch”. The viscosity of the liquid and the size of the capillary bore are preferably designed to allow the liquid to pass into the common chamber when subjected to a threshold shock that is selected from the range of 75-100 G. [0033] We have found that at least five such tubes or flasks are needed to ensure that shock exerted in any direction on the helmet is captured and triggers the release of liquid into the common chamber and the use of a larger number is preferred, e.g. six, eight or more. [0034] The common chamber may be located behind a magnified lens, which could be clear or diffusing, thereby making it easier to detect the triggering of accelerometer. BRIEF DESCRIPTION OF DRAWINGS [0035] There will now be described, by way of example only, several embodiments of the present invention by reference to the accompanying drawings in which: [0036] FIG. 1 shows part of a helmet, that is to say an impact resistant shell in accordance with the present invention, viewed from the front and one side; [0037] FIG. 2 shows the helmet of FIG. 1 viewed from below; [0038] FIG. 3 is an end view of corrugated fibre board that may be used in the helmet of FIGS. 1 and 2 ; [0039] FIG. 4 is a partly cutaway view of part of an arc-shaped rib made of fibre board having a honeycomb core that may be used in the helmet of FIGS. 1 and 2 ; [0040] FIG. 5 shows the joint between two arc-shaped ribs used in the helmet of FIGS. 1 and 2 . [0041] FIG. 6 is a schematic view of a helmet in accordance with the present invention using the shell shown in FIGS. 1 and 2 ; [0042] FIGS. 7 and 8 show, schematically, an alternative arrangement to the impact resistant shell of FIGS. 1 and 2 ; and [0043] FIGS. 9 a and 9 b shows schematically a shock indicator for use as a helmet. DETAILED DESCRIPTION [0044] The helmet of the present invention includes an impact resistant shell that is able to absorb some of the forces exerted on a helmet during a collision with another object, which may be the road, a pavement, a pedestrian or another vehicle. As mentioned above, the present invention is not limited to a cycling helmet but cycling will be used to exemplify the diverse applications for which the helmet may be used, some of which are set out above. [0045] Referring initially to FIGS. 1 and 2 , which show the shell from one side and from below, respectively, the impact resistant shell 10 of the helmet includes a rim 12 made of a solid fibre board. The rim may be made in a single piece or in multiple pieces (as shown in FIGS. 1 and 2 ) that are joined together at connection 13 , which is most clearly shown in FIG. 2 . The joint 13 is a simple tongue-and-groove joint that includes a tongue 13 a on one piece of the rim that slots into a groove 13 b cut into the end of a second piece of the rim. [0046] The rest of the impact resistant shell 10 is made up (a) of series of axial ribs 14 extending between the front 18 and the back 19 of the helmet and (b) a series of lateral ribs 16 extending between the two sides 20 of the helmet. As can be seen, the ribs are arranged in planes that extend radially outwards from the helmet and form an intersecting lattice of shock absorbing ribs; the lattice can be seen as an array of 4-sided shock-absorbing cells 23 . The axial ribs 1 of FIGS. 1 and 2 come together at the front 18 and the rear 1 of the helmet. Likewise, the lateral ribs 16 come together at the two sides 20 of the helmet. The ends of the ribs 14 , 16 slot into grooves 21 in the rim 12 . They may be held in the grooves 21 by adhesive. [0047] The ribs 14 , 16 are arc shaped and the insides of the ribs forms a head cavity 30 . As is clear from FIGS. 1 and 2 , the ribs 14 , 16 intersect with each other. The joints at these intersecting points are shown in an exploded view in FIG. 5 . The axial ribs 14 have a groove 34 cut in the concave side of the rib while the lateral ribs 14 have a groove 32 cut in their convex faces. The grooves 32 , 34 can then be slotted into each other together to form a halved cross joint, which means that neither of the ribs 14 , 16 is cut completely through in order to provide the intersection. The grooves in the ribs 14 , 16 can extend radially from the centre of the cavity 30 . In FIG. 5 , the grooves 32 , 34 are shown to extend at right angles to the plane of the respective ribs but, as can be seen in FIG. 1 , the groove may extend in a non-orthogonal direction to the plane of the ribs that forming an intersection. The sizes of the grooves 32 , 34 should accommodate the other rib and the ribs may be held in place either by friction or by adhesive or by a mechanical element. As can be seen in FIG. 1 , some of the grooves 34 in the ribs 14 (as indicated by the reference number 34 a in FIG. 1 ) are larger than necessary to accommodate the corresponding lateral ribs 16 and this provides some play between the ribs which can therefore absorb more impact energy in the case of an accident. Furthermore, it assists in assembling the shell 10 . [0048] The ribs 14 , 16 may be made of corrugated fibre board, as shown in FIG. 3 . Corrugated fibreboard includes at least one undulating section 28 sandwiched between flat fibre board layers 31 to form a series of flutes 29 . It possible to build up a number of such layers in a unitary corrugated fibre board ( FIG. 3 includes two such undulating sections). The thickness of the material forming the undulations 28 and the thickness of the flat board 1 should be chosen to give the degree of shock resistance and crumpling need to absorb the type of forces exerted during a collision. [0049] Alternatively, the ribs can be made from honeycomb fibreboard, which is shown in FIG. 4 and has a pair of fibreboard face sheets 31 ; only one face sheets is shown in FIG. 4 and that face sheet is shown partly cut away so that the internal honeycomb array 33 is visible. The honeycomb connects together the face sheets 31 and may be made of plastic or paper or cardboard. It is glued to the face sheets 31 in a known manner. Again, it possible to build up a number of sheets and honeycomb layers in a unitary corrugated fibre board so that three or more sheets 31 are included in each rib, each adjacent pair of sheets sandwiching between them a honeycomb layer. [0050] Turning back to FIGS. 1 and 2 and dealing with the case in which the ribs are made of corrugated fibreboard, the flutes 29 in the ribs may extend in horizontal, vertical, axial or lateral directions or diagonally within the helmet. The flutes in alternate lateral ribs 1 extend horizontally (i.e. in the direction between the two sides of the helmet) and such flutes resist especially lateral forces on the helmet. The flutes in the other lateral ribs 16 extend vertically and such flutes resist vertically acting forces. Likewise in some of the axial ribs 14 , the flutes extend horizontally which are resistant to forces impacting on the front or rear of the helmet while the flutes on the other ribs extend vertically and such flutes resist vertically acting forces. Generally, alternate ribs should have vertically-extending flutes and the remaining ribs should have horizontally-extending flutes, although the two central axial ribs 14 may have vertically extending ribs to resist forces exerted down onto the crown of the helmet. [0051] When the ribs are made of the honeycomb material shown in FIG. 4 , the honeycomb cells will extend at right angles to the plane of the ribs. [0052] The impact resistant shell shown in FIGS. 1 and 2 can absorb impact forces from any direction and can crumple as a result, thereby absorbing the energy of the impact and protecting the user's head. [0053] In order to provide waterproofing to the fibre board, an outer shell or layer 50 (see FIG. 6 ) can overlay the shell 10 shown in FIGS. 1 and 2 and which can be fastened to the shell 10 , either permanently or temporary. The outer shell 50 should be provided with ventilation holes (not shown) that preferably line up with the spaces between the ribs 14 , 16 of the shell 10 . In addition, the cardboard used to make the shell 10 may be waterproof by the application of a waterproofing or water resistance layer (not shown). [0054] The outer shell 50 may be made of acrylic material but it could also be made of other materials for example, polypropylene or ABS having a stiffness coefficient higher than that of the material used to make the impact resistant shell 10 and so absorbs part of the initial shock waves when an impact occurs. Slots 52 may he provided in the outer shell in order to attach straps (not shown) that can be secured under the user's chin to hold the helmet on the user's head [0055] An inner shell 55 may be provided between the user's head and the cavity 30 within the impact resistant shell 10 in order to provide comfort to the user, to dissipate forces being transmitted through the edges of the ribs 14 , 16 directly to the user's head and to ensure that the helmet fits snugly. The inner shell may be made of padding, for example a layer of foam and or woven or non-woven fabric. [0056] As is evident from the discussion above, the impact resistant shell 10 shown in FIGS. 1 and 2 , when made with the ribs of corrugated fibreboard, provides strength and impact resistance by means of the flutes within corrugated material. In addition impact strength is provided by holding the ribs in a fixed array of 4-sided cells 23 , each cell having an axis that extends away from the inner cavity 30 of the helmet and generally radially outward from the cavity. In the case of the ribs being made of the honeycomb material shown in FIG. 4 , the strength of the helmet will mostly be provided by this array of 4-sided cells, with the honeycomb pattern within the ribs resisting the collapse of the ribs and thereby maintaining the face sheets 31 in a space-apart parallel configuration, which increases the impact resistance of the individual ribs. In a variant of the cellular structure just described, the shell 10 may be made of an array of cylindrical tubes (see FIGS. 7 and 8 ) that are arranged in a dome shape and the under surface (not shown) forms a head cavity. The tubes 100 are collected in array with the inner ends of the tubes lying at different elevations in order to provide the shell with a hollow dome-shape. The axis of the various tubes shown in FIG. 9 all extend vertically and are intended to resist vertical forces. However, they can be embedded in a matrix so that they extend in different directions from the head in order to provide protection against forces from different directions. [0057] The tubes, instead of being cylindrical, may be frustoconical, which has the advantage that, when the tubes are gathered together with the larger faces φx (see FIG. 8 ) pointing outwardly and the smaller faces φy pointing inwardly, the axes of the frusto cones point in different radial directions. [0058] The tubes 100 are hollow and are generally made of fibre board such as paper or cardboard. Tubes made of this configuration can be incredibly strong and can transmit an impact force directly to the user's head without absorbing it. In order to provide some measure of impact absorption, a crumple zone may be introduced in the side walls of the tubes. So that the tubes crumple within their own diameter, it is preferred that the crumple zone is helical in shape and may be formed, as can be seen in FIG. 8 , by helically arranged holes 102 . [0059] The tubes 100 formed into an impact resistant shell may be incorporated into a helmet with an outer shell 50 and padding 55 (see FIG. 6 ). [0060] The outside and inside surfaces of an impact resistant shell formed from an array of tubes 100 may be sanded to provide the hollow dome shape. [0061] Turning finally to FIGS. 9 a and 9 b, an arrangement is shown that can detect when a helmet has been subject to impact forces (or shock) exceeding a threshold, indicating that the helmet should be replaced or at least the impact resistant shell 10 should be replaced. As shown in FIG. 9 a, which shows the whole shock indicator; the indicator includes a central chamber 124 having a number of shock indicator flasks 120 spaced around it and preferably evenly spaced around it. FIG. 9 b, is a schematic drawing showing one of the flasks 120 and part of the central chamber 124 . Each flask includes a space 122 that is filled with coloured liquid that communicates with the central chamber 124 via a capillary bore 128 . The common chamber 124 is initially empty. Because of the size of the capillary bore 128 and the viscosity of the liquid, the liquid is generally retained within the space 122 . However, if a particular flask is subject to an acceleration or deceleration (in the case of the orientation shown in FIG. 9 a in the vertical direction), the coloured liquid can be forced through the capillary bore into the previously empty common chamber 124 . The presence of the coloured liquid within the chamber 124 indicates that the flask has been subject to excessive shock and that the helmet therefore needs replacing. The liquid may be such that it adheres to the walls in the common chamber 124 thereby clearly showing that one of the flasks 120 has been subject to an excessive shock. The indicator of FIGS. 9 a and 9 b can be incorporated into a holder that fits into a cavity within the helmet (not shown) and is held within that cavity by latches (again not shown). The indicator 120 can be small (of the order of a few centimetres) and so it can easily be accommodated in a relatively small cavity within a helmet. The common chamber 124 can be smaller than shown. A transparent or translucent lens (not shown) may be provided on the outside of the helmet to view the common indicator chamber 124 ; the magnification makes it easier to see whether or not liquid is located within the chamber 124 .

The present invention provides a head protection helmet comprising an impact resistant shell comprising: a cavity for accommodating a user's head and an array of crushable bodies having a hollow closed configuration, e.g. Flutes in corrugated material 14,16, the crushable bodies each having an axis that extends outwardly from the cavity to absorb impact forces exerted along the direction of the axis.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation-in-part of application Ser. No. 10/230,085, filed Aug. 29, 2002, pending; which is a continuation-in-part of application Ser. No. 09/537,118, filed Mar. 29, 2000; which is a continuation-in-part of the U.S. national phase designation of PCT/US97/17899, filed Oct. 1, 1997, the disclosures of which are incorporated by reference herein in their entirety. BACKGROUND OF THE INVENTION [0002] It is known that certain biologically active compounds are better absorbed through the oral mucosa than through other routes of administration, such as through the stomach or intestine. However, formulations suitable for such administration by these latter routes present their own problems. For example, the biologically active compound must be compatible with the other components of the composition such as propellants, solvents, etc. Many such formulations have been proposed. For example, U.S. Pat. No. 4,689,233, Dvorsky et al., describes a soft gelatin capsule for the administration of the anti-coronary drug nifedipine dissolved in a mixture of polyether alcohols. U.S. Pat. No. 4,755,389, Jones et al., describes a hard gelatin chewable capsule containing nifedipine. A chewable gelatin capsule containing a solution or dispersion of a drug is described in U.S. Pat. No. 4,935,243, Borkan et al. U.S. Pat. No. 4,919,919, Aouda et al, and U.S. Pat. No. 5,370,862, Klokkers-Bethke, describe a nitroglycerin spray for administration to the oral mucosa comprising nitroglycerin, ethanol, and other components. An orally administered pump spray is described by Cholcha in U.S. Pat. No. 5,186,925. Aerosol compositions containing a hydrocarbon propellant and a drug for administration to a mucosal surface are described in U.K. 2,082,457, Su, U.S. Pat. No. 3,155,574, Silson et al., U.S. Pat. No. 5,011,678, Wang et al., and by Parnell in U.S. Pat. No. 5,128,132. It should be noted that these references discuss bioavailability of solutions by inhalation rather than through the membranes to which they are administered. [0003] Atropine is a naturally occurring anticholinergic alkaloid found in the plant atropa belladona and has the structure depicted below: [0004] Atropine is a competitive antagonist of muscarinic cholinergic receptors and blocks the effects of acetylcholine at muscarine receptors, including muscarine receptors in exocrine glands, smooth muscle, cardiac muscle, ganglia, and intramural neurons. Muscarinic receptor antagonists, such as atropine, have been employed to treat a wide variety of clinical conditions. Atropine can be administered intravenously, intramuscularly, or orally. When administered orally, atropine is absorbed from the gastrointestinal tract and is eventually excreted in the urine. Atropine undergoes hepatic metabolism and has a plasma half life of between 2 and 3 hours. [0005] Atropine reduces secretion of gastric acid and, accordingly, has found use in the management of peptic ulcers. Atropine also reduces gastric motility and is therefore used to treat disorders resulting from excessive smooth muscle contraction in the gastrointestinal tract, such as irritable-bowel syndrome. Intestinal hypermotility and increased frequency of stools associated with antihypertensive agents, such as guanethidine, can also be controlled with atropine. Diarrhea associated with irritative conditions of the lower bowel, such as mild dysenteries and diverticulitis, also responds to atropine. [0006] Atropine has also been used to treat parkinsonism. [0007] Atropine has also found use in ophthamology, when locally administered to the eye, atropine, produces mydriasis and cycloplegia. [0008] Atropine reduces secretions in the upper and lower respiratory tract. This effect in the nasopharynx can provide symptomatic relief of acute rhinitis such as associated with coryza or hay fever. [0009] Atropine is used as a specific antidote for cardiovascular collapse that can result from administration of a choline ester or an inhibitor of cholinesterase. Atropine also antagonizes vagal cardiac slowing and can be used in the initial treatment of acute myocardial infarction where excessive vagal tone causes sinus or nodal bradycardia or atrioventricular block. When administered to treat bradycardias a dose of about 250-500 mcg is generally effective in adults and a dose of about 10-20 mcg/kg is generally effective in children. [0010] Atropine is used as a pre-medication for anaesthesia since it decreases bronchial and salivary secretions; blocks bradycardia associated with various anesthetics, such as halothane, suxamethonium, and neostigmine; and prevents bradycardia from excessive vagal stimulation. When administered as a premedication for anaesthesia the typical dose for adults is about 500-600 mcg administered intramuscularly 30-60 minutes before surgery. Alternatively it may be given intravenously at induction of anaesthesia. Children should receive only about 20 mcg/kg. [0011] Atropine is also effective at reducing excessive salivation, such as associated with heavy metal poisoning or parkinsonism, and for blocking salivation in patients unable to swallow from esophageal obstruction such as from tumors or stricture. [0012] Atropine also acts as a muscle relaxant and finds application as an anti-spasmodic which may be used as a pretreatment before abdominal surgery. [0013] Atropine has been administered in conjunction with an opioid for the treatment of renal colic. Atropine lowers intravesicular pressure, increases capacity, and reduces the frequency for urinary bladder contractions by antagonizing the parasympathetic control of the bladder. Atropine is used to treat enuresis in children, particularly when progressive increase in bladder capacity is the objective; to reduce urinary frequency in spastic paraplegia; and to increase the capacity of the bladder in conditions where irritation has led to hypertonicity. [0014] Atropine is also used to treat intoxication from poisonous mushrooms where the toxic agent is a muscarine-like compound, such as Amanita nuscaria , and as an antidote for intoxication by anti-cholinesterase inhibitors such as the organophosphorous pesticides and “nerve gases.” Organophosphorous agents account for as much as 80% of pesticide related hospital admissions and is considered by the World Health Organization as a widespread global problem, particularly in developing countries. Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9 th ed., pp. 141-154 and 169-170. SUMMARY OF THE INVENTION [0015] A buccal aerosol spray or soft bite gelatin capsule using a polar or non-polar solvent has now been developed which provides biologically active compounds for rapid absorption through the oral mucosa, resulting in fast onset of effect. [0016] The buccal aerosol spray compositions of the present invention, for transmucosal administration of a pharmacologically active compound soluble in a pharmacologically acceptable non-polar solvent comprise in weight % of total composition: pharmaceutically acceptable propellant 5-80%, nonpolar solvent 19-85%, active compound 0.05-50%, suitably additionally comprising, by weight of total composition a taste mask and/or flavoring agent 0.01-10%. Preferably the composition comprises: propellant 10-70%, non-polar solvent 25-89.9%, active compound 0.01-40%, taste mask and/or flavoring agent 1-8%; most suitably propellant 20-70%, non-polar solvent 25-74.75%, active compound 0.25-35%, taste mask and/or flavoring agent 2-7.5%. [0017] The buccal polar aerosol spray compositions of the present invention, for transmucosal administration of a pharmacologically active compound soluble in a pharmacologically acceptable polar solvent are also administrable in aerosol form driven by a propellant. In this case, the composition comprises in weight % of total composition: aqueous polar solvent 10-97%, active compound 0.1-25%, suitably additionally comprising, by weight of total composition a taste mask and/or flavoring agent 0.05-10% and propellant: 2-10%. Preferably the composition comprises: polar solvent 20-97%, active compound 0.1-15%, taste mask and/or flavoring agent 0.1-5% and propellant 2-5%; most suitably polar solvent 25-97%, active compound 0.2-25%, taste mask and/or flavoring agent 0.1-2.5% and propellant 2-4%. [0018] In another embodiment, the buccal polar aerosol spray compositions of the present invention for transmucosal administration of a pharmacologically active compound (i.e., those administrable in aerosol form driven by a propellant) comprises a mixture of a polar and a non-polar solvent comprising in weight % of total composition: solvent 10-97%, active compound 0.05-50%, propellant 5-80%, and optionally a taste mask and/or flavoring agent 0.01-10%. Preferably the composition comprises: solvent 20-97%, active compound 0.1-40%, propellant 10-70%, and taste mask and/or flavoring agent 1-8%; most suitably solvent 25-97%, active compound 0.25-35%, propellant 20-70%, and taste mask and/or flavoring agent 2-7.5%. The ratio of the polar solvent to the non-polar solvent can range from about 1:99 to about 99:1, preferable from about 60:40 to about 40:60, and more preferably about 50:50. [0019] The buccal pump spray composition of the present invention, i.e., the propellant free composition, for transmucosal administration of a pharmacologically active compound wherein said active compound is soluble in a pharmacologically acceptable non-polar solvent comprises in weight % of total composition: non-polar solvent 30-99.69%, active compound 0.005-55%, and suitably additionally, a taste mask and/or flavoring agent 0.1-10%. [0020] The buccal polar pump spray compositions of the present invention, i.e., the propellant free composition, for transmucosal administration of a pharmacologically active compound soluble in a pharmacologically acceptable polar solvent comprises in weight % of total composition: aqueous polar solvent 30-99.69%, active compound 0.001-60%, suitably additionally comprising, by weight of total composition a taste mask and/or flavoring agent 0.1-10%. Preferably the composition comprises: polar solvent 37-98.58%, active compound 0.005-55%, taste mask and/or flavoring agent 0.5-8%; most suitably polar solvent 60.9-97.06%, active compound 0.01-40%, taste mask and/or flavoring agent 0.75-7.5%. [0021] In another embodiment, the buccal pump spray composition (i.e., the propellant free composition) for transmucosal administration of a pharmacologically active compound comprises a mixture of a polar solvent and a non-polar solvent comprising in weight % of total composition solvent 30-99.69%, active compound 0.001-60%, and optionally a taste mask and/or flavoring agent 0.1-10%. Preferably the composition comprises: solvent 37-98.58%, active compound 0.005-55%, taste mask and/or flavoring agent 0.5-8%; more preferably the composition comprises solvent 60.9-97.06%, active compound 0.01-40%, and taste mask and/or flavoring agent 0.75-7.5%. The ratio of the polar solvent to the non-polar solvent can range from about 1:99 to about 99:1, preferable about 60:40 to about 40:60, and more preferably about 50:50. [0022] The soft bite gelatin capsules of the present invention for transmucosal administration of a pharmacologically active compound, at least partially soluble in a pharmacologically acceptable non-polar solvent, having charged thereto a fill composition comprise in weight % of total composition: non-polar solvent 4-99.99%, emulsifier 0-20%, active compound 0.01-80%, provided that said fill composition contains less than 10% of water, suitably additionally comprising, by weight of the composition: taste mask and/or flavoring agent 0.01-10%. Preferably, the soft bite gelatin capsule comprises: non-polar solvent 21.5-99.975%, emulsifier 0-15%, active compound 0.025-70%, tatse mask and/or flavoring agent 1-8%; most suitably: nonpolar solvent 28.5-97.9%, emulsifier 0-10%, active compound 0.1-65.0%, taste mask and/or flavoring agent 2-6%. [0023] The soft bite polar gelatin capsules of the present invention for transmucosal administration of a pharmacologically active compound, at least partially soluble in a pharmacologically acceptable polar solvent, having charged thereto a composition comprising in weight % of total composition: polar solvent 25-99.89%, emulsifier 0-20%, active compound 0.01-65%, provided that said composition contains less than 10% of water, suitably additionally comprising, by weight of the composition: taste mask and/or flavoring agent 01-10%. Preferably, the soft bite gelatin capsule comprises: polar solvent 37-99.95%, emulsifier 0-15%, active compound 0.025-55%, taste mask and/or flavoring agent 1-8%; most suitably: polar solvent 44-96.925%, emulsifier 0-10%, active compound 0.075-50%, taste mask and/or flavoring agent 2-6%. [0024] It is an object of the invention to coat the mucosal membranes either with fine droplets of spray containing the active compounds or a solution or paste thereof from bite capsules. [0025] It is also an object of the invention to administer to the oral mucosa of a mammalian in need of same, preferably man, by spray or bite capsule, a predetermined amount of a biologically active compound by this method or from a soft gelatin capsule. [0026] A further object is a sealed aerosol spray container containing a composition of the non polar or polar aerosol spray formulation, and a metered valve suitable for releasing from said container a predetermined amount of said composition. [0027] As the propellant evaporates after activation of the aerosol valve, a mist of fine droplets is formed which contains solvent and active compound. [0028] The propellant is a non-Freon material, preferably a C 3-8 hydrocarbon of a linear or branched configuration. The propellant should be substantially non-aqueous. The propellant produces a pressure in the aerosol container such that under expected normal usage it will produce sufficient pressure to expel the solvent from the container when the valve is activated but not excessive pressure such as to damage the container or valve seals. [0029] The non-polar solvent is a non-polar hydrocarbon, preferably a C 7-18 hydrocarbon of a linear or branched configuration, fatty acid esters, and triglycerides, such as miglyol. The solvent must dissolve the active compound and be miscible with the propellant, i.e., solvent and propellant must form a single phase at a temperature of 0-40° C. a pressure range of between 1-3 atm. [0030] The polar and non-polar aerosol spray compositions of the invention are intended to be administered from a sealed, pressurized container. Unlike a pump spray, which allows the entry of air into the container after every activation, the aerosol container of the invention is sealed at the time of manufacture. The contents of the container are released by activation of a metered valve, which does not allow entry of atmospheric gasses with each activation. Such containers are commercially available. [0031] A further object is a pump spray container containing a composition of the pump spray formulation, and a metered valve suitable for releasing from said container a predetermined amount of said composition. [0032] A further object is a soft gelatin bite capsule containing a composition of as set forth above. The formulation may be in the form of a viscous solution or paste containing the active compounds. Although solutions are preferred, paste fills may also be used where the active compound is not soluble or only partially soluble in the solvent of choice. Where water is used to form part of the paste composition, it should not exceed 10% thereof. (All percentages herein are by weight unless otherwise indicated.) [0033] The polar or non-polar solvent is chosen such that it is compatible with the gelatin shell and the active compound. The solvent preferably dissolves the active compound. However, other components wherein the active compound is not soluble or only slightly soluble may be used and will form a paste fill. [0034] Soft gelatin capsules are well known in the art. See, for example, U.S. Pat. No. 4,935,243, Borkan et al., for its teaching of such capsules. The capsules of the present invention are intended to be bitten into to release the low viscosity solution or paste therein, which will then coat the buccal mucosa with the active compounds. Typical capsules, which are swallowed whole or bitten and then swallowed, deliver the active compounds to the stomach, which results in significant lag time before maximum blood levels can be achieved or subject the compound to a large first pass effect. Because of the enhanced absorption of the compounds through the oral mucosa and no chance of a first pass effect, use of the bite capsules of the invention will eliminate much of the lag time, resulting in hastened onset of biological effect. The shell of a soft gelatin capsule of the invention may comprise, for example: gelatin: 50-75%, glycerin 20-30%, colorants 0.5-1.5%, water 5-10%, and sorbitol 2-10%. [0035] The active compound may include, biologically active peptides, central nervous system active amines, sulfonyl ureas, antibiotics, antifingals, antivirals, sleep inducers, antiasthmatics, bronchial dilators, antiemetics, histamine H-2 receptor antagonists, barbiturates, prostaglandins and neutraceuticals. [0036] The active compounds may also include antihistamines, alkaloids, hormones, benzodiazepines and narcotic analgesics. While not limited thereto, these active compounds are particularly suitable for non-polar pump spray formulation and application. [0037] The active compounds may also include anti-diuretics, anti-muscle spasm agents, anti-spasmodics, agents for treating urinary incontinence, anti-diarrheal agents, agents for treating nausea and/or vomiting, smooth muscle contractile agents, anti-secretory agents, enzymes, anti-diuretics, anti-ulcerants, bile acid replacement and/or gallstone solubilizing drugs, or mixtures thereof. [0038] In one embodiment, the active compound is atropine or a pharmaceutically acceptable salt thereof. BRIEF DESCRIPTION OF THE DRAWING [0039] [0039]FIG. 1. is a schematic diagram showing routes of absorption and processing of pharmacologically active substances in a mammalian system. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0040] The preferred active compounds of the present invention are in an ionized, salt form or as the free base of the pharmaceutically acceptable salts thereof (provided, for the aerosol or pump spray compositions, they are soluble in the spray solvent). These compounds are soluble in the non-polar solvents of the invention at useful concentrations or can be prepared as pastes at useful concentrations. These concentrations may be less than the standard accepted dose for these compounds since there is enhanced absorption of the compounds through the oral mucosa. This aspect of the invention is especially important when there is a large (40-99.99%) first pass effect. [0041] As propellants for the non polar sprays, propane, N-butane, iso-butane, N-pentane, iso-pentane, and neo-pentane, and mixtures thereof may be used. N-butane and iso-butane, as single gases, are the preferred propellants. It is permissible for the propellant to have a water content of no more than 0.2%, typically 0.1-0.2%. All percentages herein are by weight unless otherwise indicated. It is also preferable that the propellant be synthetically produced to minimize the presence of contaminants which are harmful to the active compounds. These contaminants include oxidizing agents, reducing agents, Lewis acids or bases, and water. The concentration of each of these should be less than 0.1%, except that water may be as high as 0.2%. [0042] Suitable non-polar solvents for the capsules and the non-polar sprays include (C 2 -C 24 ) fatty acid (C 2 -C 6 ) esters, C 7 -C 18 hydrocarbon, C 2 -C 6 alkanoyl esters, and the triglycerides of the corresponding acids. When the capsule fill is a paste, other liquid components may be used instead of the above low molecular weight solvents. These include soya oil, corn oil, other vegetable oils. [0043] As solvents for the polar capsules or sprays there may be used low molecular weight polyethyleneglycols (PEG) of 400-1000 Mw (preferably 400-600), low molecular weight (C 2 -C 8 ) mono and polyols and alcohols of C 7 -C 18 linear or branch chain hydrocarbons, glycerin may also be present and water may also be used in the sprays, but only in limited amount in the capsules. [0044] It is expected that some glycerin and water used to make the gelatin shell will migrate from the shell to the fill during the curing of the shell. Likewise, there may be some migration of components from the fill to the shell during curing and even throughout the shelf-life of the capsule. [0045] Therefore, the values given herein are for the compositions as prepared, it being within the scope of the invention that minor variations will occur. [0046] The preferred flavoring agents are synthetic or natural oil of peppermint, oil of spearmint, citrus oil, fruit flavors, sweeteners (sugars, aspartame, saccharin, etc.), and combinations thereof. [0047] The compositions may further include a taste mask. The term “taste mask” as used herein means an agent that can hide or minimize an undesirable flavor such as a bitter or sour flavor. A representative taste masks is a combination of vanillin, ethyl vanillin, maltol, iso-amyl acetate, ethyl oxyhydrate, anisic aldehyde, and propylene glycol (commercially available as “PFC 9885 Bitter Mask” from Pharmaceutical Flavor Clinic of Camden, N.J.). A taste mask in combination with a flavoring agent is particularly advantageous when the active compound is an alkaloid since alkaloids often have a bitter taste. [0048] The active substances include the active compounds selected from the group consisting of cyclosporine, sermorelin, octreotide acetate, calcitonin-salmon, insulin lispro, sumatriptan succinate, clozepine, cyclobenzaprine, dexfenfluramine hydrochloride, glyburide, zidovudine, erythromycin, ciprofloxacin, ondansetron hydrochloride, dimenhydrinate, cimetidine hydrochloride, famotidine, phenytoin sodium, phenytoin, carboprost thromethamine, carboprost, diphenhydramine hydrochloride, isoproterenol hydrochloride, terbutaline sulfate, terbutaline, theophylline, albuterol sulfate and neutraceuticals, that is to say nutrients with pharmacological action such as but not limited to carnitine, valerian, echinacea, and the like. [0049] In another embodiment, the active compound is an anti-diuretic, anti-muscle spasm agent, anti-spasmodic, agent for treating urinary incontinence, anti-diarrheal agent, agent for treating nausea and/or vomiting, smooth muscle contractile agent, anti-secretory agent, enzyme, anti-diuretic, anti-ulcerant, bile acid replacement and/or gallstone solubilizing drug, or a mixture thereof [0050] In one embodiment the active compound is an anti-diuretic. Suitable anti-diuretics for use in the buccal sprays of the invention include, but are not limited to, acetazolamide, benzthiazide, bendroflumethazide, bumetanide, chlorthalidone, chlorothiazide, ethacrynic acid, furosemide, hydrochlorothiazide, hydroflumethiazide, methyclothiazide, polythiazide, quinethazone, spironolactone, triamterene, torsemide, trichlomethiazide, and mixtures thereof. [0051] In one embodiment the active compound is an anti-muscle spasm agent. Suitable anti-muscle spasm agents for use in the buccal sprays of the invention include, but are not limited to, baclofen, botulinum toxin, carisoprodol, chlorphenesin, chlorzoxazone, cyclobenzaprine, dantrolene, diazepam, metaxalone, methocarbamol, orphenadrine, tizanidine, and mixtures thereof. [0052] In one embodiment the active compound is an anti-spasmodic. Suitable anti-spasmodics for use in the buccal sprays of the invention include, but are not limited to, atropine, baclofen, dicyclomine, hyoscine, propatheline, oxybutynin, S-oxybutynin, tizanidine, and mixtures thereof. [0053] In one embodiment the active compound is an agent for treating urinary incontinence. Suitable agents for treating urinary incontinence for use in the buccal sprays of the invention include, but are not limited to, darifenacin, vamicamide, detrol, ditropan, imipramine, and mixtures thereof. [0054] In one embodiment the active compound is an anti-diarrheal agent. Suitable anti-diarrheal agents for use in the buccal sprays of the invention include, but are not limited to, ondansetron, palnosetron, tropisetron, attapulgite, atropine, bismuth, diphenoxylate, loperamide, and mixtures thereof. [0055] In one embodiment the active compound is an agent for treating nausea and/or vomiting. Suitable agents for treating nausea and/or vomiting for use in the buccal sprays of the invention include, but are not limited to, alosetron, dolasetron, granisetron, meclizine, metoclopramide, ondansetron, palnosetron, prochloperazine, promethazine, trimethobenzamiode, tropisetron, and mixtures thereof. [0056] In one embodiment the active compound is a smooth muscle contractile agent. A suitable smooth muscle contractile agents for use in the buccal sprays of the invention includes, but is not limited to hyoscine. [0057] In one embodiment the active compound is an anti-secretory agent. Suitable anti-secretory agents for use in the buccal sprays of the invention include, but are not limited to, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, tenetoprazole, ecabet, misoprostol, teprenone, and mixtures thereof. [0058] In one embodiment the active compound is an enzyme. Suitable enzymes for use in the buccal sprays of the invention include, but are not limited to, alpha-galactosidase, alpha-L-iduronidase, imiglucerase/alglucerase, amylase, lipase, protease, pancreatin, olsalazine, and mixtures thereof. [0059] In one embodiment the active compound is an anti-diuretic. Suitable anti-diuretics for use in the buccal sprays of the invention include, but are not limited to, desmopressin, oxytocin, and mixtures thereof. [0060] In one embodiment the active compound is an anti-ulcerant. Suitable anti-ulcerants for use in the buccal sprays of the invention include, but are not limited to, cimetidine, ranitidine, famotidine, misoprostol, sucralfate, pantoprazole, lansoprazole, omeprazole, and mixtures thereof. [0061] In one embodiment the active compound is a bile acid replacement and/or gallstone solubilizing drug. A suitable bile acid replacement and/or gallstone solubilizing drug for use in the buccal sprays of the invention includes, but is not limited to ursodiol. [0062] In a another embodiment, the active compound is atropine or a pharmaceutically acceptable salt thereof. In one embodiment, the active compound is atropine sulfate. [0063] Typically, when atropine is the active compound the buccal spray contains from about 0.2 to 20 weight/weight (w/w) percent atropine, more preferably 1 to 15 w/w percent atropine, and most preferably 2 to 10 w/w percent atropine. [0064] The invention further relates to a method of blocking the effects of acetylcholine at muscarine receptors in a patient by spraying the oral mucosa of the patient with a therapeutically effective amount of a buccal spray comprising atropine or a pharmaceutically acceptable salt thereof. [0065] The invention further relates to a method of treating an ulcer in a patient by spraying the oral mucosa of the patient with a therapeutically effective amount of a buccal spray comprising atropine or a pharmaceutically acceptable salt thereof. [0066] The invention further relates to a method of treating a disorder resulting from excessive smooth muscle contraction in the gastrointestinal tract in a patient by spraying the oral mucosa of the patient with a therapeutically effective amount of a buccal spray comprising atropine or a pharmaceutically acceptable salt thereof. [0067] The invention further relates to a method of treating irritable-bowel syndrome in a patient by spraying the oral mucosa of the patient with a therapeutically effective amount of a buccal spray comprising atropine or a pharmaceutically acceptable salt thereof. [0068] The invention further relates to a method of treating intestinal hypermotility and increased frequency of stools associated with administration of an antihypertensive agent in a patient by spraying the oral mucosa of the patient with a therapeutically effective amount of a buccal spray comprising atropine or a pharmaceutically acceptable salt thereof. [0069] The invention further relates to a method of treating diarrhea associated with mild dysentery or diverticulitis in a patient by spraying the oral mucosa of the patient with a therapeutically effective amount of a buccal spray comprising atropine or a pharmaceutically acceptable salt thereof. [0070] The invention further relates to a method of reducing excessive salivation in a patient by spraying the oral mucosa of the patient with a therapeutically effective amount of a buccal spray comprising atropine or a pharmaceutically acceptable salt thereof. In another embodiment, the excessive salivation is caused by heavy metal poisoning. In another embodiment, the excessive salivation is caused by parkinsonism. [0071] The invention further relates to a method of reducing secretions in the upper and lower respiratory tract of a patient by spraying the oral mucosa of the patient with a therapeutically effective amount of a buccal spray comprising atropine or a pharmaceutically acceptable salt thereof. In one embodiment, the secretions in the upper and lower respiratory tract are caused by acute rhinitis, such as is associated with coryza or hay fever. [0072] The invention further relates to a method of treating parkinsonism in a patient by spraying the oral mucosa of the patient with a therapeutically effective amount of a buccal spray comprising atropine or a pharmaceutically acceptable salt thereof. [0073] The invention further relates to a method of treating cardiovascular collapse resulting from the administration of a choline ester or an inhibitor of cholinesterase in a patient by spraying the oral mucosa of the patient with a therapeutically effective amount of a buccal spray comprising atropine or a pharmaceutically acceptable salt thereof. [0074] The invention further relates to a method of antagonizing vagal cardiac slowing in a patient by spraying the oral mucosa of the patient with a therapeutically effective amount of a buccal spray comprising atropine or a pharmaceutically acceptable salt thereof. [0075] The invention further relates to a method of treating acute myocardial infarction where excessive vagal tone causes sinus or nodal bradycardia or atrioventricular block in a patient by spraying the oral mucosa of the patient with a therapeutically effective amount of a buccal spray comprising atropine or a pharmaceutically acceptable salt thereof. [0076] The invention further relates to a method of administering anaesthesia to a patient comprising pre-medicating the patient with atropine before administering the anaesthesia by spraying the oral mucosa of the patient with a therapeutically effective amount of a buccal spray comprising atropine or a pharmaceutically acceptable salt thereof. In one embodiment, pre-medicating the patient decreases bronchial and salivary secretions; blocks bradycardia associated with various anesthetics, such as halothane, suxamethonium, and neostigmine; or prevents bradycardia from excessive vagal stimulation. [0077] The invention further relates to a method of relaxing muscles in the gastrointestinal tract of a patient by spraying the oral mucosa of the patient with a therapeutically effective amount of a buccal spray comprising atropine or a pharmaceutically acceptable salt thereof. [0078] The invention further relates to a method of treating renal colic in a patient by spraying the oral mucosa of the patient with a therapeutically effective amount of a buccal spray comprising atropine or a pharmaceutically acceptable salt thereof. In one embodiment, the method for treating renal cholic further comprises administering an opioid. [0079] The invention further relates to a method of treating intoxication from exposure to an anticholinesterase agent in a patient by spraying the oral mucosa of the patient with a therapeutically effective amount of a buccal spray comprising atropine or a pharmaceutically acceptable salt thereof. [0080] The term “anticholinesterase agent” as used herein means any agent that inhibits cholinesterase, i.e., the enzyme responsible for terminating the action of acetylcholinesterase at the junction of various cholinergic nerve endings ( Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9 th ed., pp. 161.) [0081] Representative anticholinesterase agents include, but are not limited to tetraethylpyrophosphate (“TEPP”), diethoxyphosphinylthiocholine iodide (echothiophate, phospholine iodide), O,O-diethyl O-(4-nitrophenyl)-phosphorothioate (parathion), O,O-dimethyl S-(1, 2-dicarbethoxyethyl) phosphorodithioate (malathion), isopropyl methylphosphonofluoridate (sarin, GB), pinacolyl methylphosphonofluoridate (soman), ethyl N-dimethylphosphoramidocyanidate (tabun), O,O-diethyl2-isopropyl-6-methyl-4-pyrimidinyl phosphorothioate (dimpylate, diazinon), O,O, dimethyl O-4-methylthio-m-tolyl phosphorothioate (fenthion), O,O-diethyl O-(4-nitrophenyl)-phosphate (paraoxon, mintacol), diisopropyl phosphorofluoridate (diisopropyl fluorophosphate, DFP), 1-napthyl N-methylcarbamate (carbaril, carbaryl, sevin), and 2-isopropoxyphenyl N-methylcarbamate (Baygon). [0082] Anticholinesterase agents are known to be used as nerve gases and bioterrorism agents. Buccal sprays containing atropine or a pharmaceutically acceptable salt thereof can be an effective antidote to nerve gases. [0083] The formulations of the present invention comprise an active compound or a pharmaceutically acceptable salt thereof. The term “pharmaceutically acceptable salts” refers to salts prepared from pharmaceutically acceptable non-toxic acids or bases including organic and inorganic acids or bases. [0084] When an active compound of the present invention is acidic, salts may be prepared from pharmaceutically acceptable non-toxic bases. Salts derived from all stable forms of inorganic bases include aluminum, ammonium, calcium, copper, iron, lithium, magnesium, manganese, potassium, sodium, zinc, etc. Particularly preferred are the ammonium, calcium, magnesium, potassium, and sodium salts. Salts derived from pharmaceutically acceptable organic non-toxic bases include salts of primary, secondary, and tertiary amines, substituted amines including naturally occurring substituted amines, cyclic amines and basic ion-exchange resins such as arginine, betaine, caffeine, choline, N,N dibenzylethylenediamine, diethylamine, 2-diethylaminoethanol, 2-dimethyl-aminoethanol, ethanolamine, ethylenediamine, N-ethylmorpholine, N-ethylpiperidine, glucamine, glucosamine, histidine, isopropylamine, lysine, methyl-glucosamine, morpholine, piperazine, piperidine, polyarnine resins, procaine, purine, theobromine, triethylamine, trimethylamine, tripropylamine, etc. [0085] When an active compound of the present invention is basic, salts may be prepared from pharmaceutically acceptable non-toxic acids. Such acids include acetic, benzenesulfonic, benzoic, camphorsulfonic, citric, ethane-sulfonic, fumaric, gluconic, glutamic, hydrobromic, hydrochloric, isethionic, lactic, maleic, mandelic, methanesulfonic, mucic, nitric, pamoic, pantothenic, phosphoric, succinic, sulfuric, tartaric, p-toluenesulfonic, etc. Particularly preferred are citric, hydrobromic, maleic, phosphoric, sulfuric, and tartaric acids. [0086] In the discussion of methods of treatment herein, reference to the active compounds is meant to also include the pharmaceutically acceptable salts thereof. While certain formulations are set forth herein, the actual amounts to be administered to the mammal or man in need of same are to be determined by the treating physician. [0087] The invention is further defined by reference to the following examples, which are intended to be illustrative and not limiting. [0088] The following are examples of certain classes. All values unless otherwise specified are in weight percent. EXAMPLES Example 1 Biologically Active Peptides Including Peptide Hormones [0089] A. Cyclosporine Lingual Spray most Amounts preferred amount preferred amount cyclosporine 5-50 10-35 15-25 water 5-20 7.5-50  9.5-12  ethanol 5-60 7.5-50  10-20 polyethylene glycol 20-60  30-45 35-40 flavors 0.1-5   1-4 2-3 [0090] B. Cyclosporine Non-Polar Lingual Spray preferred most Amounts amount preferred amount cyclosporine  1-50  3-40  5-30 Migylol 20 25 30-40 Polyoxyethylated castor oil 20 25 30-40 Butane 25-80 30-70 33-50 flavors 0.1-5   1-4 2-3 [0091] C. Cyclosporine Non-Polar Bite Capsule Amounts preferred amount most preferred amount cyclosporine  1-35  5-25 10-20 olive oil 25-60 35-55 30-45 polyoxyethylated 25-60 35-55 30-45 oleic glycerides flavors 0.1-5   1-4 2-3 [0092] D. Cyclosporine Bite Capsule most Amounts preferred amount preferred amount cyclosporine 5-50 10-35 15-25 polyethylene glycol 20-60  30-45 35-40 glycerin 5-30 7.5-25  10-20 propylene glycol 5-30 7.5-25  10-20 flavors 0.1-10   1-8 3-6 [0093] E. Sermorelin (as the Acetate) Lingual Spray preferred Amounts amount most preferred sermorelin (as the acetate) .01-5   .1-3   .2-1.0 mannitol  1-25  5-20 10-15 monobasic sodium phosphate, 0.1-5    1-31  .5-2.5 dibasic sodium phosphate water 0.01-5   .05-3   0.1-0.5 ethanol  5-30 7.5-25  9.5-15  polyethylene glycol 20-60 30-45 35-40 propylene glycol  5-25 10-20 12-17 flavors 0.1-5   1-4 2-3 [0094] F. Octreotide Acetate (Sandostatin) Lingual Spray most Amounts preferred amount preferred amount octreotide acetate 0.001-0.5  0.005-0.250 0.01-0.10 acetic acid  1-10 2-8 4-6 sodium acetate  1-10 2-8 4-6 sodium chloride  3-30  .5-25  15-20 flavors 0.1-5   0.5-.4  2-3 ethanol  5-30 7.5-20  9.5-15  water 15-95 35-90 65-85 flavors 0.1-5   1-4 2-3 [0095] G. Calcitonin-Salmon Lingual Spray most Amounts preferred amount preferred amount calcitonin-salmon 0.001-5    0.005-2     01-1.5 ethanol  2-15  3-10   7-9.5 water 30-95 50-90 60-80 polyethylene glycol  2-15  3-10   7-9.5 sodium chloride 2.5-20   5-15   10-12.5 flavors 0.1-5   1-4 2-3 [0096] H. Insulin Lispro, Lingual Spray most preferred Amounts preferred amount amount insulin 20-60  4-55  5-50 glycerin 0.1-10  0.25-5   0.1-1.5 dibasic sodium  1-15 2.5-10  4-8 phosphate m-cresol,  1-25  5-25  7.5-12.5 zinc oxide 0.01-0.25  .05-0.15 0.075-0.10  m-cresol 0.1-1   0.2-0.8 0.4-0.6 phenol trace amounts trace amounts trace amounts ethanol  5-20 7.5-15   9-12 water 30-90 40-80 50-75 propylene glycol  5-20 7.5-15   9-12 flavors 0.1-5   0.5-3   0.75-2   Example 2 CNS Active Amines and their Salts: Including but not Limited to Tricyclic Amines, GABA Analogues, Thiazides, Phenothiazine Derivatives, Serotonin Antagonists and Serotonin Reuptake Inhibitors [0097] A. Sumatriptan Succinate Lingual Spray most Amounts preferred amount preferred amount sumatriptan succinate 0.5-30    1-20 10-15 ethanol 5-60 7.5-50  10-20 propylene glycol 5-30 7.5-20  10-15 polyethylene glycol 0-60 30-45 35-40 water 5-30 7.5-20  10-15 flavors 0.1-5   1-4 2-3 [0098] B. Sumatriptan Succinate Bite Capsule most Amounts preferred amount preferred amount sumatriptan succinate 0.01-5   0.05-3.5  0.075-1.75  polyethylene glycol 25-70 30-60 35-50 glycerin 25-70 30-60 35-50 flavors 0.1-10  1-8 3-6 [0099] C. Clozepine Lingual Spray most Amounts preferred amount preferred amount clozepine 0.5-30     1-20 10-15 ethanol 5-60 7.5-50 10-20 propylene glycol 5-30 7.5-20 10-15 polyethylene glycol 0-60  30-45 35-40 water 5-30 7.5-20 10-15 flavors 0.1-5    1-4 2-3 [0100] D. Clozepine Non-Polar Lingual Spray with Propellant Amounts preferred amount most preferred amount clozepine 0.5-30  1-20 10-15 Migylol  20-85 25-70 30-40 Butanol   5-80 30-75 60-70 flavors 0.1-5   1-4 2-3 [0101] E. Clozepine Non-Polar Lingual Spray without Propellant Amounts preferred amount most preferred amount clozepine 0.5-30   1-20 10-15 Migylol   70-99.5 80-99 85-90 flavors 0.1-5   1-4 2-3 [0102] F. Cyclobenzaprine Non-Polar Lingual Spray most Amounts preferred amount preferred amount cyclobenzaprine (base) 0.5-30   1-20 10-15 Migylol 20-85 25-70 30-40 Iso-butane 15-80 30-75 60-70 flavors 0.1-5   1-4 2-3 [0103] G. Dexfenfluramine Hydrochloride Lingual Spray most Amounts preferred amount preferred amount dexfenfluramine Hcl 5-30 7.5-20 10-15 ethanol 5-60 7.5-50 10-20 propylene glycol 5-30 7.5-20 10-15 polyethylene glycol 0-60  30-45 35-40 water 5-30 7.5-20 10-15 flavors 0.1-5    1-4 2-3 Example 3 Sulfonylureas [0104] A. Glyburide Lingual Spray most Amounts preferred amount preferred amount glyburide 0.25-25   0.5-20  0.75-15   ethanol  5-60 −7.5-50   10-20 propylene glycol  5-30 7.5-20  10-15 polyethylene glycol  0-60 30-45 35-40 water 2.5-30   5-20  6-15 flavors 0.1-5   1-4 2-3 [0105] B. Glyburide Non-Polar Bite Capsule most Amounts preferred amount preferred amount glyburide 0.01-10   0.025-7.5  0.1-4   olive oil 30-60 35-55 30-50 polyoxyethylated oleic 30-60 35-55 30-50 glycerides flavors 0.1-5   1-4 2-3 Example 4 Antibiotics Anti-Fungals and Anti-Virals [0106] A. Zidovudine [Formerly Called Azidothymidine (AZT) (Retrovir)] Non-Polar Lingual Spray (AZT) (Retrovir)] non-polar lingual spray Amounts preferred amount most preferred amount zidovudine 10-50 15-40 25-35 Soya oil 20-85 25-70 30-40 Butane 15-80 30-75 60-70 flavors 0.1-5   1-4 2-3 [0107] B. Erythromycin Bite Capsule Bite Capsule most preferred Amounts preferred amount amount erythromycin 25-65  30-50 35-45 polyoxyethylene glycol 5-70 30-60 45-55 glycerin 5-20 7.5-15    10-12.5 flavors 1-10 2-8 3-6 [0108] C. Ciprofloxacin Hydrochloride Bite Capsule preferred most preferred Amounts amount amount ciprofloxacin hydrochloride 25-65  35-55 40-50 glycerin 5-20 7.5-15   10-12.5 polyethylene glycol 120-75  30-65 40-60 flavors 1-10 2-8 3-6 [0109] D. Zidovudine [Formerly Called Azidothymidine (AZT) (Retrovir)] Lingual Spray most preferred preferred Amounts amount amount zidovudine 10-50 15-40 25-35 water 30-80 40-75 45-70 ethanol  5-20 7.5-15   9.5-12.5 polyethylene glycol  5-20 7.5-15   9.5-12.5 flavors 0.1-5   1-4 2-3 Example 5 Anti-Emetics [0110] A. Ondansetron Hydrochloride Lingual Spray most preferred preferred Amounts amount amount ondansetron hydrochloride 1-25 2-20 2.5-15 citric acid monohydrate 1-10 2-8  2.5-5  sodium citrate dihydrate 0.5-5   1-4    1.25-2.5   water 1-90 5-85  10-75 ethanol 5-30 7.5-20   9.5-15 propylene glycol 5-30 7.5-20   9.5-15 polyethylene glycol 5-30 7.5-20   9.5-15 flavors 1-10 3-8       5-7.5  [0111] B. Dimenhydrinate Bite Capsule most preferred preferred Amounts amount amount dimenhydrinate 0.5-30   2-25 3-15 glycerin 5-20 7.5-15    10-12.5 polyethylene glycol 45-95  50-90  55-85  flavors 1-10 2-8  3-6  [0112] C. Dimenhydrinate Polar Lingual Spray most preferred preferred Amounts amount amount dimenhydrinate 3-50 4-40 5-35 water 5-90 10-80  15-75  ethanol 1-80 3-50 5-10 polyethylene glycol 1-80 3-50 5-15 sorbitol 0.1-5   0.2-40   0.4-1.0  aspartame 0.01-0.5  0.02-0.4  0.04-0.1  flavors 0.1-5   1-4  2-3  Example 6 Histamine H-2 Receptor Antagonists [0113] A. Cimetidine Hydrochloride Bite Capsule t, 0250 [0114] B. Famotidine Lingual Spray most preferred preferred Amounts amount amount famotidine   1-35 5-30 7-20 water 2.5-25 3-20 5-10 L-aspartic acid 0.1-20 1-15 5-10 polyethylene glycol  20-97 30-95  50-85  flavors 0.1-10  1-7.5 2-5  [0115] C. Famotidine Non-Polar Lingual Spray most preferred preferred Amounts amount amount famotidine 1-35  5-30  7-20 Soya oil 10-50  15-40 15-20 Butane 1 5-80 30-75 45-70 polyoxyethylated 10-50  15-40 15-20 oleic glycerides flavors 0.1-5   1-4 2-3 Example 7 Barbiturates [0116] A. Phenytoin Sodium Lingual Spray most preferred preferred Amounts amount amount phenytoin sodium 10-60   15-55  20-40 water 2.5-25     3-20   5-10 ethanol 5-30 7.5-20 9.5-15 propylene glycol 5-30 7.5-20 9.5-15 polyethylene glycol 5-30 7.5-20 9.5-15 flavors 1-10  3-8      5-7.5  [0117] B. Phenytoin Non-Polar Lingual Spray most preferred preferred Amounts amount amount phenytoin  5-45 10-40 15-35 migylol 10-50 15-40 15-20 Butane 15-80 30-75 60-70 polyoxyethylated 10-50 15-40 15-20 oleic glycerides flavors 0.1-10  1-8   5-7.5 Example 8 Prostaglandins [0118] A. Carboprost Thromethamine Lingual Spray most preferred preferred Amounts amount amount carboprost thromethamine 0.05-5    0.1-3  0.25-2.5  water 50-95   60-80 65-75  ethanol 5-20 7.5-15 9.5-12.5 polyethylene glycol 5-20 7.5-15 9.5-12.5 sodium chloride 1-20   3-15 4-8  flavors 0.1-5    1-4 2-3  [0119] B. Carboprost Non-Polar Lingual Spray Amounts preferred amount most preferred amount carboprost 0.05-5   0.1-3   0.25-2.5  migylol 25-50 30-45 35-40 Butane  5-60 10-50 20-35 polyoxyethylated 25-50 30-45 35-40 oleic glycerides flavors 0.1-10  1-8   5-7.5 Example 9 Neutraceuticals [0120] A. Carnitine as Bite Capsule (Contents are a Paste) Amounts preferred amount most preferred amount carnitine  6-80 30-70 45-65 fumarate soya oil 7.5-50  10-40 12.5-35   soya lecithin 0.001-1.0  0.005-0.5  .01-0.1 Soya fats 7.5-50  10-40 12.5-35   flavors  1-10 2-8 3-6 [0121] B. Valerian as Lingual Spray Amounts preferred amount most preferred amount valerian extract 0.1-10   0.2-7  0.25-5   water 50-95   60-80 65-75 ethanol 5-20 7.5-15  9.5-12.5 polyethylene 5-20 7.5-15  9.5-12.5 glycol flavors 1-10  2-8 3-6 [0122] C. Echinacea as Bite Capsule Amounts preferred amount most preferred amount echinacea 30-85 40-75 45-55 extract soya oil 7.5-50  10-40 12.5-35   soya lecithin 0.001-1.0  0.005-0.5  .01-0.1 Soya fats 7.5-50  10-40 12.5-35   flavors  1-10 2-8 3-6 [0123] D. Mixtures of Ingredients Amounts preferred amount most preferred amount magnesium oxide 15-40 20-35 25-30 chromium 0.01-1.0  0.02-0.5  .025-0.75 picolinate folic acid .025-3.0  0.05-2.0  0.25-0.5  vitamin B-12 0.01-1.0  0.02-0.5  .025-0.75 vitamin E 15-40 20-35 25-30 Soya oil 10-40 12.5-35   15-20 soya lecithin 0.1-5   0.2-4   0.5-1.5 soya fat 10-40 15-35 17.5-20   Example 10 Sleep Inducers (Also CNS Active Amine) [0124] A. Diphenhydramine Hydrochloride Lingual Spray most preferred Amounts preferred amount amount diphenhydramine  3-50. 4-40 5-35 HCl water 5-90 10-80  50-75  ethanol 1-80 3-50 5-10 polyethylene 1-80 3-50 5-15 glycol Sorbitol 0.1-5   0.2-4   0.4-1.0  aspartame 0.01-0.5  0.02-0.4  0.04-0.1  flavors 0.1-5   1-4  2-3  Example 11 Anti-Asthmatics-Bronchodilators [0125] A. Isoproterenol Hydrochloride as Polar Lingual Spray Amounts preferred amount most preferred amount isoproterenol 0.1-10   0.2-7.5 0.5-6   Hydrochloride water 5-90 10-80 50-75 ethanol 1-80  3-50  5-10 polyethylene 1-80  3-50  5-15 glycol Sorbitol 0.1-5   0.2-4   0.4-1.0 aspartame 0.01-0.5  0.02-0.4  0.04-0.1  flavors 0.1-5   1-4 2-3 [0126] B. Terbutaline Sulfate as Polar Lingual Spray Amounts preferred amount most preferred amount terbutaline sulfate 0.1-10  0.2-7.5 0.5-6   water  5-90 10-80 50-75 ethanol  1-10 2-8 2.5-5   Sorbitol 0.1-5   0.2-4   0.4-1.0 aspartame 0.01-0.5  0.02-0.4  0.04-0.1  flavors 0.1-5   1-4 2-3 [0127] C. Terbutaline as Non-Polar Lingual Spray Amounts preferred amount most preferred amount terbutaline 0.1-10  0.2-7.5 0.5-6   migylol 25-50 30-45 35-40 isobutane  5-60 10-50 20-35 polyoxyethylated 25-50 30-45 35-40 oleic glycerides flavors 0.1-0.1 1-8   5-7.5 [0128] D. Theophylline Polar Bite Capsule Amounts preferred amount most preferred amount theophylline  5-50 10-40 15-30 polyethylene 20-60 25-50 30-40 glycol glycerin 25-50 35-45 30-40 propylene glycol 25-50 35-45 30-40 flavors 0.1-5   1-4 2-3 [0129] E. Albuterol Sulfate as Polar Lingual Spray most preferred preferred Amounts amount amount albuterol sulfate 0.1-10   0.2-7.5 0.5-6 water   5-90   10-80   50-75 ethanol   1-10   2-8 2.5-5 Sorbitol 0.1-5  0.2-4   0.4-1.0 aspartame   0.01-0.5    0.02-0.4  0.04-0.1 flavors 0.1-5    1-4   2-3 Example 12 Polar Solvent Formulations Using a Propellant [0130] A. Sulfonylurea Most- Preferred Preferred Amount Amount Amount glyburide 0.1-25% 0.5-15%  0.6-10% Ethanol  40-99%   60-97%    70-97% Water 0.01-5% 0.1-4%  0.2-2% Flavors 0.05-10%  0.1-5% 0.1-2.5%  Propellant   2-10%   3-5%   3-4% [0131] B. Prostaglandin E (Vasodilator) Most- Preferred Preferred Amount Amount Amount prostaglandin E 1 0.01-10% 0.1-5% 0.2-3% Ethanol   10-90%   20-75%     25-50%   Propylene glycol   1-90%  5-80%   10-75%   Water  0.01-5% 0.1-4% 0.2-2% Flavors 0.05-10% 0.1-5% 0.1-2.5%   Propellant   2-10%   3-5%   3-4% [0132] C. Promethazine (Antiemetic, Sleep Inducer, and CNS Active Amine) Most- Preferred Preferred Amount Amount Amount promethazine 1-25% 3-15%  5-12% Ethanol 10-90%  20-75%  25-50% Propylene glycol 1-90% 5-80% 10-75% Water 0.01-5%   0.1-4%    0.2-2%   Flavors 0.05-10%   0.1-5%  0.1-2.5%   Propellant 2-10%  3-5%  3-4% [0133] D. Meclizine Most- Preferred Preferred Amount Amount Amount meclizine 1-25% 3-15% 5-12% Ethanol 1-15% 2-10% 3-6 Propylene glycol 20-98%  5-90% 10-85%  Water 0.01-5%   0.1-4%  0.2-2%  Flavors 0.05-10%   0.1-5%   0.1-2.5%     Propellant 2-10%  3-5%  3-4% Example 13 Atropine Formulations [0134] A. Propellant Free Atropine Formulations in a Polar Solvent: Most- Preferred Preferred Amount Amount Amount % w/w % w/w % w/w Atropine sulfate 0.2-20   1-15   2-10 Propylene glycol  30-65  35-60  30-50 ethylenediamine- 0.005-0.1     0.0075-0.05       0.01-0.025 tetraacetate (EDTA) Benzalkonium chloride 0.005-0.1     0.0075-0.05       0.01-0.025 Flavoring agent   0-15 0.15-10  0.1-5  glycerol 0.1-2  0.2-1   0.3-0.6 Tween 80 0.1-2  0.2-1   0.3-0.6 water 0.5-10 0.8-5   1-3 ethanol Qs to 100 mL 100 mL 100 mL [0135] B. A Propellant Free Atropine Formulation in a Polar Solvent has the Following Formula: Amount % w/w Atropine sulfate 5 Propylene glycol 50 Ethylenediamine- 0.02 tetraacetate (EDTA) Benzalkonium chloride 0.02 Flavoring agent 0.1 Glycerol 0.5 Tween 80 0.5 Water 2 Ethanol Qs to 100 mL [0136] C. An Atropine Formulation in a Non-Polar Solvent with a Propellant can be made According to the Following Formula: Percent Component (w/w) Atropine 5% Miglyol 810 40%  Flavoring agent 1% Butane to 100 g [0137] D. An Atropine Formulation in a Polar Solvent with a Propellant has the Following Formula: Percent Component (w/w) Atropine sulfate 5% Ethanol 40%  Flavoring agent 1% Butane 54%  [0138] E. A Propellant Free Atropine Formulation in a Non-Polar Solvent can be made According to the Following Formula: Percent Component (w/w) Atropine 5% Miglyol 46%  Flavoring agent 1% Light liquid paraffin 48%  [0139] F. A Propellant Free Atropine Formulation in a Mixture of a Non-Polar Solvent and a Polar Solvent has the Following Formula: Percent Component (w/w) Atropine 5 Miglyol 46  Flavor 1 Ethanol Qs to 100 [0140] G. Atropine Formulation in a Mixture of a Non-Polar Solvent and a Polar Solvent with a Propellant has the Following Formula: Component Percent (w/w) Atropine Sulfate 5 Ethanol 30 Flavor 1 Miglyol 10 Butane 54

Buccal aerosol sprays or capsules using polar and non-polar solvent have now been developed which provide atropine for rapid absorption through the oral mucosa, resulting in fast onset of effect. The buccal polar compositions of the invention comprise formulation I: aqueous polar solvent, atropine, and optional taste mask and/or flavoring agent; formulation II: aqueous polar solvent, atropine, optionally flavoring agent, and propellant; formulation III: non-polar solvent, atropine, and optional flavoring agent; and formulation IV: non-polar solvent, atropine, optional flavoring agent, and propellant; formulation V: a mixture of a polar and a non-polar solvent, atropine, and optional flavoring agent; formulation VI: a mixture of a polar and a non-polar solvent, atropine, optional flavoring agent, and propellant.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention generally relates to image processing technology to be employed with so-called 3D game devices and action puzzle games, and particularly relates to the improvement in image processing devices for displaying realistic scenes of structures such as buildings being destroyed. 2. Description of the Related Art A typical 3D game device is capable of displaying numerous objects (an aggregate of bitmaps displayed on the screen; hereinafter referred to as “object”) arranged in a three-dimensional virtual apace. Buildings and game characters (hereinafter referred to as “character”), for example, are displayed as objects, and by changing the display position of these objects in vertical synchronization units, a moving image simulating battle scenes in the city can be displayed. Conventionally, as a building object had the likes of a simple cube shape, texture mapping was performed by applying a single polygon to each of the walls of such building. When the building object and another object (bullet, character, etc.) collide, images suggestive of an explosion such as a flash, flame, and smoke are displayed at the collision point. With respect to the display of the building object after the collision, the same image prior to the collision without making any changes to the building itself is displayed, or a previously prepared image of the building object after the collapse is displayed. Moreover, restrictions were sometimes added to the range is which the “character”) is able to move. This was in order to prevent the display of arena is which buildings were not established when a character approaches an area where the building object was established. For example, by displaying walls of buildings or rivers, or by making the operation impossible, characters could not proceed any further. One purpose of a game, however, is to have the player experience an invigorating feeling, and it is important to realistically express pictures of the collapse or explosion of objects. In a game share a monster is rampaging in a city, for example, an important factor in determining the value of a game is how the monster destroys the buildings. In other words, it is preferable that the buildings is destroyed realistically as though watching a scene from a monster movie. If no change is made to the building or the destroyed condition of such building is suddenly displayed as in conventional game devices, the resulting image becomes dull and unattractive. In this type of game, there are also demands of producing a gruesome feeling in which a monster destroys buildings one after another. The distinctive feature is that the monster wrecks any and all buildings in its path. Therefore, the amusement is diminished when adding restrictions to the operation for the range in which the character, i.e., the monster may move as in conventional game devices. Further, when this type of monster object is attacked, it is preferable to reflect the degree of damage to the monster's posture and to display an image as though a living creature is actually injured. In view of the foregoing problems, the inventors of the present invention have arrived at this invention with as object of displaying images, as though a monster movie, in a realistic manner. SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to provide image processing technology capable of destroying objects such as buildings in a realistic manner. Another object of the present invention is to provide image processing technology capable of naturally restricting the range in which the character may move. Still another object of the present invention is to provide image processing technology capable of expressing the degree of damage to the character in a realistic manner. The present invention is an image processing device for displaying a moving image of an object collapsing, wherein the image processing device sets in advance each of the display blocks to be scattered after the collapse as collective movable display elements, structures an object with the display elements, and displays such object. Here, “object” shall include displayed images such as models, characters and segments, still life such as buildings and landforms, and living/nonliving objects with motion such as fighter planes, monsters, people, robots and cars. “Collapse” shall mean the transition of a single object into a plurality of parts or a smaller shape, and includes situations of simulating physical phenomenon such as collisions in the virtual space as well as changing the form by oneself with settings ouch as earthquakes and suicidal explosions. “Scattering” shall include situations of each of the display elements being separated from each other, as well as situations where a plurality of display elements move without separating, and detach from other display elements. A group of display elements that separate collectively can be further collapsed. The display elements, for example, are set to shapes simulating block clods created upon an actual collapse of a building. When each of the display elements approaches a specific object within a predetermined distance, such display element may be erased. “(Approach) within a predetermined distance” is a concept including contact. When a certain display element is erased, an image of a display element positioned directly thereabove falling at a prescribed speed may be displayed. Here, “directly thereabove” and “falling” are definitions of directions along the virtual gravitational direction set forth in the virtual space for reasons of convenience. When a certain display element is erased, an image of a display element adjacent thereto moving at a speed in accordance with the intensity of the impact inflicted upon the object may be displayed. Here, “impact” shall mean the virtual external force inflicted upon the object or display element for reasons of convenience, and is specified by defining the strength and direction of the external force. When a certain display element is erased, an image of a display element adjacent thereto moving in a direction in accordance with the direction of the impact inflicted upon the object may be displayed. Here, “adjacent” shall include cases where a display element is in contact with a side of one part of a display element as well as being within a prescribed distance from the side or center of gravity of a display element. When a certain display element is erased, an image of a display element adjacent thereto rotating at a rotation speed in accordance with the size of the display element may be displayed. Here, “rotation” shall mean rotating around the rotation axis defined within the virtual space appropriately set forth in the display element. When the intensity of the impact inflicted upon the object exceeds a prescribed value, the display position of the image of the display element adjacent to the erased display element map be changed. In addition, whey a certain display element is erased and therefore the remaining display elements are arranged in a horizontal row and supporting the object in a virtual space, and when the number of supporting display elements are less than a prescribed number, an image of these display elements and/or the display elements supported thereby falling at a prescribed speed may be displayed. Here, display elements “supporting the object” shall mean those display elements structuring the neck portion of a constriction part of a display element, which has changed in comparison to the original shape, upon a part of the object collapsing. When another impact is to be inflicted upon a part of the object remaining without being erased during or after the fall, a display element structuring a part of the object may be farther erased, moved, or rotated. In other words, additional second and third attacks may be made to the blocks that have collapsed after the first attack. When the display element structuring the object is separated with the whole or part thereof remaining upon the infliction of an impact, these display elements are erased. That is, the display elements are erased after being determined that the display elements have separated. The present invention is an image processing device capable of displaying a movable character within a virtual space, wherein when the character goes out of the area set in the virtual apace, the image processing device displays a uniformly changing image of the degree of brightness and/or color of the picture element displaying the character. Here, it is preferable that the degree of brightness and/or color of the picture element be changed in accordance with the distance between the character and the boundary of the area. It is further preferable that it is structured to be capable of performing completion processing when the time in which the character is out of the area reaches a prescribed time. The present invention is an image processing device capable of displaying a movable character in a virtual space, wherein when it is determined that a character collided with another object, the image processing device displays an image of a change in the character's posture until a prescribed condition is fulfilled. Hare, it is preferable that the character's posture be a posture protecting the point of collision. Here, a prescribed condition is the character making a predetermined motion, and a prescribed condition is the lapse of the predetermined time. The present invention is an image processing method for displaying a moving image of an object collapsing, wherein the image processing method sets in advance each of the display blocks to be scattered after the collapse as collective movable display elements, structures an object with the display elements, and displays such object. The present invention is an image processing method capable of displaying a movable character within a virtual space comprising the steps of determining whether or not the character has gone out of the area set in the virtual space, cad displaying as image of the degree of brightness and/or color of the picture element displaying the character being changed uniformly when the character goes out of the area set in the virtual space. The present invention is an image processing method capable of displaying a movable character within a virtual space comprising the steps of determining whether or not the character collided with another object, determining whether or not a prescribed condition has been fulfilled when it is determined that the character has collided with another object, and displaying an image of a change in the character's posture when the condition is not fulfilled. The present invention is a machine-readable recording medium storing a program for making a computer execute the aforementioned image processing method. Here, “recording medium” shall mean any physical means storing information (mainly digital data, programs) and capable of making processing devices such as computers and dedicated processors perform prescribed functions. In other words, any means capable of downloading a program to the computer and making it perform prescribed functions will suffice. Examples of such medium include flexible disc, secured disc, magnetic tape, optical magnetic disc, CD, CD-ROM, CD-R, DVD-RAM, DVD-ROM, DVD-R, PD, MD, DCC, ROM cartridge, RAM memory cartridge with battery backup, flash memory cartridge, non-volatile RAM cartridge, and so on. This includes asses when receiving data transmission from a host computer via a wire- or wireless-communication circuit (public circuits, data dedicated lines, satellite circuits, etc.). The so-called Internet is also included in the recording medium mentioned above. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a conceptual diagram of the connection of the game device in the present embodiment; FIG. 2 is a block diagram of the game device in the present embodiment: FIG. 3 is a flowchart explaining the method of displaying buildings in the present embodiment; FIG. 4 is a flowchart explaining the area-out processing in the present embodiments; FIG. 5 is a flowchart explaining the damage processing in the present embodiment; FIG. 6 is a conceptual diagram of the display of the building object in the present embodiment; FIG. 7 is a conceptual diagram of the display upon the collision of a building object: FIG. 8 is a first conceptual diagram of the display upon the collapse of the building object; FIG. 9 is a second conceptual diagram of the display upon the collapse of the building object; FIG. 10 is a third conceptual diagram of the display upon the collapse of the building object; FIG. 11 in a conceptual diagram of the display upon completion of the collapse (first collapse) of the building object; FIG. 12 is a conceptual diagram of the display upon a second attack on the building abject; FIG. 13 is a conceptual diagram of the display during the collapse after the second attack on the building object; FIG. 14 is a conceptual diagram of the display upon completion of the second attack on the building object; FIG. 15 is a first example of the actual display of an image in the present embodiment; FIG. 16 is a second example of the actual display of an image in the present embodiment; FIG. 17 is a diagram of the position relationship explaining the area-out processing of a character; FIG. 18 is a conceptual diagram of the display of the area-out processing; FIG. 19 is a conceptual diagram of the display of the character at the moment it is damaged; FIG. 20 is a conceptual diagram of the display of the character while it is sustaining damage; and FIG. 21 is a display example of the evaluation image in the present embodiment. DESCRIPTION OF THE PREFERRED EMBODIMENT The preferred embodiment of the present invention is hereinafter described with reference to the relevant drawings. (Structure) FIG. 1 is a conceptual diagram of the connection of a game device employing the image processing device in the present embodiment. This game device is structured by mutually connecting a game device body 1 and a controller 2 . The game device body 1 is the main controlling device for managing the game progress. The game device body 1 is capable of connecting a plurality of controllers 2 , and thereby comprises a plurality of connectors 141 and a modular jack 131 for a communication circuit. The game device body 1 further comprises a CD-ROM holder 105 and is capable of freely installing/removing a recording medium such as a CD-ROM. The controller 2 is structured as an operation portion for each of the players to operate, and comprises an operation button group 22 , a cross-shaped key 23 , and a connector for connection with the game device body 1 . The controller 2 further comprises a slot for freely installing/removing a sub-unit 21 . The sub-unit 21 is for displaying a sub-image display and for a player to play a sub-game, and comprises a sub-monitor 211 , an operation button group 212 , end a connector for connection to the slot of the controller 2 . A connection cable 150 comprises connectors 151 and 152 , and in capable of mutually connecting the game device main body 1 and the controller 2 . The video signal output and audio signal output of the game device bode are, for example, output to a TV device. FIG. 2 shows a block diagram of the present game device. The game device body 1 , as shown in FIG. 2, comprises a CPU block 10 , a video black 11 , a sound block 12 and so on. The CPU block 10 comprises a bus arbiter 100 , CPU 101 , main memory 102 , ROM 103 and CD-ROM drive 104 . The bus arbiter 100 is capable of controlling data transmission/reception by assigning a bus-occupancy time to the mutually connected devices via a bus. The CPU 101 is capable of accessing the main memory 102 , ROM 103 , CD-ROM drive 104 , video block 11 , sound block 12 and, via the controller 2 , sub-unit 21 . The CPU 201 implements the initial program stored in the ROM 103 upon the power source being turned on and performs initialization of the entire device, When the CPU 101 detects that a CD-ROM has been installed into the CD-ROM drive 104 , it transfers the program data for the operating system stored in the CD-ROM to the main memory 102 . Thereafter, the CPU 101 operates is accordance with the operating system and continues transferring the program of the image processing method of the present invention stored in the CD-ROM to the main memory 102 and implements such program. In addition, the CPU 101 transfers the image data for image processing of the, present invention to a graphics memory 121 , and is capable of transferring audio data to the sound memory 121 . The program processing implemented by the CPU 101 are, for example, input of operation signals from the controller 2 or communication data from a communication device, command output to the sub-unit 21 based on such signals and data, control of the image output to be performed by the video block ii and control of audio output to be performed by the sound block 12 . The main memory 102 mainly stores program data and programs for the aforementioned operating system and is also capable of providing a work area for storing the likes of static variables and dynamic variables. The ROM 103 is a storage region for an initial program loader. The CD-ROM drive 104 is structured such that a CD-ROM is freely installable/removable, outputs data to the CPU 141 notifying the installation of a CD-ROM, and is capable of data transfer by the control of the CPU 101 . The CD-ROM stores a program for making the game device implement the image processing method of the present invention, image data for displaying images, dad audio data for audio output. The recording medium in not limited to a CD-ROM, and may be other various recording mediums structured to be readable. The data group stored in the CD-ROM may be transferred to each memory via the communication device 130 . By this, data transfer from a secure disc of a distant server is possible. The video block 11 comprises a VDP (Video Display Processor) 110 , graphic memory 111 , and video encoder 112 . The graphics memory 111 comprises a storage region of image data read from the CD-ROM and a frame memory region. In the image data storage region, stored collectively in object units is polygon data for prescribing each of the vertex coordinates of polygons for displaying an object in a virtual space. The present invention is characterized in the special setting to the polygon data for displaying buildings as objects, which will be explained in detail later. The VDP 110 refers to a portion of the image data stored in the graphite memory 111 based on the control of the CPU 101 , generates bitmap data, and stores this in the frame memory region. As information necessary for displaying images supplied from the CPU 101 , there is command data, viewpoint position data, light source position data, polygon designation data, object designation data, polygon position data, polygon method data, texture designation data, texture density data, visual field conversion matrix data, and so on. Based on this information, the VDP 110 is capable of implementing coordinate conversion (geometry operation) to polygons, texture mapping processing, display priority processing, shooting processing, and the like. The video encoder 112 converts the image data generated by the VDP 110 to a prescribed video signal such as an NTSC format, and outputs this to the main monitor 113 of the TV device connected externally. The sound block 12 comprises a sound processor 120 , sound memory 121 , and D/A converter 122 . Stored in the sound memory 121 is audio data read from a CD-ROM as mentioned above. The sound processor 120 , based on command data supplied from the CPU 101 , reads audio data such as waveform data stored in the sound memory 121 sad performs various effects processing pursuant to the DSP (Digital Signal Processor) function and digital/analog conversion processing. The D/A converter 122 converts the audio data generated by the sound processor 120 into analog signals and outputs these to the speakers 123 of the TV device connected externally. The communication device 130 is, for example, a modem or a terminal adapter, and functions as an adapter that connects the game device body 1 and external circuits. The communication device 130 receives data transmitted from a game-supplying server connected to a public circuit network, and supplies this to the bus of the CPU block 10 . The public circuit network includes, but is not limited to, a subscriber circuit and dedicated line, regardless of it being a wire system or a wireless system. The controller 2 periodically converts the operation situation of the operation button group 22 and cross-shaped key 23 into codes and transmits these codes to the game device body 1 . The operation signals from each of these controllers 2 are used to move the respective characters displayed in the game. The sub-unit 21 is structured as a computer device comprising an independent CPU and memory so as to be able to operate as independent game, end stores setting data including settings each as the game progress, game scores and operation methods arising during a game. Setting data transmitted from the game device body specifying the game processing situation may be stores in the sub-unit 21 . This setting data is transferred to the game device body as backup data for restarting the game from the condition prior to shutting down the power source when the power source is to be shut down. By exchanging the sub-unit, such exchanged sub-unit becomes the data reflecting the operation situation of another game device in the game devise concerned. (Operation) Next, the operation of the game device is explained. In this game, a moving monster is displayed as a character. When the monster's body collides with a building, which is a structural object, a part or whole of the building collapses. The player operates the movement of the monster and destroys the buildings one after another by making the monster's tail, head or body hit the building and by firing laser beams at the building. The game device evaluates the game by giving scores for the method of destruction. Collapse Processing The constitution of the structural object is the present embodiment is foremost explained with reference to FIG. 6 . FIG. 6 ( c ) is a plane view showing the relation of the object and viewpoint arranged in the virtual space. The object OBJ is formed in a shape simulating a building and comprises four walls A, B, C and D. View point VP is a viewpoint of a three-dimensional image for viewing this abject OBJ. FIG. 6 ( a ) is an example of the object OBJ actually being displayed on the monitor 11 . The walls A and B facing the viewpoint side have texture data mapped thereon to give a realistic image of a building. FIG. 6 ( b ) shows is dashed lines the display elements structuring this object OBJ. Wall A is structured of display elements 1 ˜ 13 and wall B is structured of display elements 20 ˜ 29 . Walls C and D, not displayed, are also respectively structured of an aggregate of display elements ( 30 ˜ 39 for Wall C and 40 ˜ 49 for Wall D). In the present embodiment, display elements are treated synonymously as a polygon, which is the minimum display wait. Display elements, however, may also be sat as a group of polygon data structured to be simultaneously movable by a plurality of polygons. In any case, unlike the ordinary simple triangular or quadrilateral polygons, a plurality of vertexes are establishes in order to realize a complex outline. The shape of the display elements is set to be as though a rugged broken surface to simulate block clods created upon the actual collapse of a building. A display of a collapsed building is obtained by merely separating the display elements. These display elements may also be divided into blocks per group of a plurality of adjacent display elements. The display elements divided into blocks are capable of moving without being separated per block The coordinate direction seen from the viewpoint, as coordinate axis X, Y and Z shown in FIG. 6, is set forth below. The CPU block 10 transfers to the video block 11 object designation data for designating the object OBJ, polygon designation data for designating polygons to be displayed, polygon position data for designating the position of sack polygon in a world-coordinate system, polygon direction data for designating the normal line direction of each polygon, and texture designation data for designating the viewpoint position data of the viewpoint VP and texture data to be mapped onto each polygon. The video block 11 specifies the polygon data group of the object OBJ to be displayed by the polygon designation data, and extracts polygon data to be displayed by the polygon designation data. And pursuant to the viewpoint position data and polygon. Position data, the video block 11 performs perspective conversion on the vertex coordinates of each polygon and performs mapping of texture data onto each polygon. By this as image of an object OBJ is displayed as though viewing an actual building from a specific viewpoint. When erasing a specific display element upon collapsing a building, the CPU block prohibits the transfer of polygon designation data for specifying the display element to be erased. When dropping a specific display element, the CPU block calculates the direction and rotation speed of the drop based on the intensity and direction of impact inflicted upon such display element. And by changing the polygon position data and polygon direction data of the display element per frame displaying period, the CPU block displays a display element as though it is falling while rotating. Next, the collapse processing method of the object is explained in detail with reference to the flowchart shown is FIG. 3 . This flowchart is the processing for a single display element or a block including such display element. The same display processing is performed with respect to the other display elements and blocks. The renewal of frame image data is conducted per frame displaying period. The CPU block 10 awaits this renewal timing (S 101 , NO), and performs collision judgment (S 102 ) when it is the timing of generating a new image (S 101 , YES). Known art is used for this collision judgment. In other words, a collision circle with a prescribed radius is established on each of the display elements of the structural object OBJ and/or the monster. And when the distance between the center of both collision circles come within the sum of the radius of both collision circles, judgment of collision is made. When a collision is confirmed as a result of the collision judgment (S 102 , YES), the CPU block performs erase processing to the display elements that have collided (S 103 ). Erase processing is completed when the CPU block prohibits the transfer of polygon designation data for designating the display elements. Situations of the display elements being erased are, for example, when the monster contacts the display element and when the falling display element lands on the ground. If colliding into a monster (S 104 , Monster), the CPU block generates the collision vector I for deciding the intensity of impact and direction thereof (S 103 ). The collision vector may be set optionally. For example, when the monster's tail or laser beam bits an object, the collision vector may be set in correspondence with the direction of incidence and the moving speed. A single collision vector common with such of the display elements structuring the object is set. In order to realize an atmosphere of an internal explosion of a building, a collision vector directed outward may be set to each of the walls A˜D of the object OBJ irrelevant to the collision of the monster. A separate collision vector may be set to each of the display elements. If the subject of collision is the ground (S 104 , Ground), it is necessary to suspend the movement of display elements that fell together with the erased display elements but are still displayed since they have not directly landed on the ground. Thus, the CPU block resets data of the falling speed and rotation speed set to the group of display elements in the midst of the tell (S 106 ). When landing on the ground, it is possible to set is advance the number of displayable display elements and, when a number of display elements exceeding such number lands on the ground, erase the display elements at random. Contrarily, if the display element did net collide with either the monster or the ground (S 102 , NO), the CPU block judges whether the moving speed and rotation speed have bees set (S 107 ). if some type of speed has been set (S 107 , YES), it means that the display element is falling and therefore the falling processing is performed (S 108 ). Details of the falling processing are explained at S 112 . If no speed has been set to the display element (S 107 , NO), this display element is considered to not have directly contacted the monster and therefore does not fall. In the present embodiment, however, to realize a realistic picture, when a certain display element is erased, a picture of the display element adjacent thereto scattering in accordance with the intensity of impact is displayed. Therefore, when a judgment is made of the display element to be erased (S 110 , YES), the CPU block refers to the size of the impact vector set at step S 105 and judges whether the intensity of impact is larger than the minimum value Pmin (S 111 ). If larger (S 111 , YES), the CPU black calculates the movement speed, movement direction, rotation direction, rotation speed, and so forth of the parameter for displaying an image of this display element falling while rotating (S 112 ). When a center portion of as object is destroyed, displayed is a large clod of the upper part being supported by a part of the display element. In the present embodiment, in order to reproduce a some of a building naturally collapsing upon becoming unbearable to the weight is such a case, the entire building collapses or remains in accordance with the number of display elements supporting the building. Thereby, eves if the intensity of impact of the monster is smaller than the minimum value Pmin (S 111 , NO), the aforementioned parameter calculation (S 112 ) is performed when the number of display elements supporting the object becomes less than a prescribed value min (S 113 , YES) with respect to the display elements on the same XY plane. This parameter is calculated respectively for the supporting display elements and the overall block of the remaining display elements collectively displayed thereabove. By this, it in possible to display an image of a building collapsing naturally in which only a small section of the blocks are remaining. The parameter group calculated at atop S 112 is used for the actual coordinate position calculation of the display elements at step S 108 . That is, the CPU block calculates a new falling position and rotation angle per image renewal period. The CPU block completes the bitmap data by mapping texture data with respect to the display elements decided by the vertex coordinates (S 114 ). FIG. 6 ( d ) shows an explanatory diagram of these parameters set for a single display element. For each display element, a normal line vector N is set. The movement direction of this display element is initially the direction of the collision vector X set for the display element, and speeds Vx, Vy and Vz corresponding to the respective coordinate components are set. A gravity speed component Vg is added to the Z axis component in order to reproduce a picture of the gravity working. By this setting, it is possible to display an image of a block falling is accordance with gravity. The speed setting, however, is optional. Even if setting the movement position in accordance with the acceleration speed, the collision vector may be irrelevantly set. If a block is structured from a plurality of display elements and the display elements within the block are intact, a single movement speed may be calculated for such block and the block may be dropped as one body. The rotation is set in accordance with the relation between the collision vector I and normal line vector N. Larger the angle θ of the normal line vector N and collision vector I, the faster the rotation speed set by the CPU block. If the blocks rotating are set to simultaneously move without separating, the rotation speed may be set in accordance with the number of display elements constituting the block. For example, by setting such that larger the block slower the rotation and smaller the block, faster the rotation, it is possible to express a realistic collapse conforming to physical laws. The rotation direction may be set to either positive or negative in the plane including the normal line vector N and collision vector I. It is also possible to set the rotation direction in owe direction irrelevant to the vector. It is further possible to set the rotation direction in accordance with the position relation of the display element and collision point. For example, the rotation direction of the display element on the collision point may be set opposite to the rotation direction of the display element thereunder. FIGS. 7 through 14 show display examples of the collapse of the structural object pursuant to the aforementioned processing. FIG. 7 in an image display example immediately after it has been judged at step S 102 that the tail T of the monster has collided with the structural object OBJ shown in FIG. 6 . An object E showing a flash and objects S 1 and S 2 showing powder smoke at the moment of collision are displayed. FIG. 8 is an image display example where directly colliding display elements at step S 103 are erased and the display elements adjacent thereto are starting to fall. Display elements 10 , 11 and 27 are being erased upon directly colliding with the monster. As the size of the collision vector is larger than the minimum value Pmin (S 110 , YES, S 111 , YES) regarding display elements 9 , 12 , 26 , 28 and 40 adjacent to the erased display elements upon collision, they are starting to move and rotate (S 108 ) as the display position is changed based on the calculated parameter. It is also possible to set the connection relationship of the display elements to move without separating as in display elements 9 and 12 and display elements 26 and 28 . FIG. 9 is an image display example of the display elements directly above and adjacent to the erased display elements collapsing. Display elements 1 , 12 , 26 , 28 and 40 which have fallen are erased at step S 103 since they have hit the ground. Display elements 7 , 8 , 24 and 25 are newly starting to fall based on the calculated parameter at step S 112 . Display elements which are no longer supported as the display elements directly therebelow have been erased may be set to fall irrelevant to the parameter calculation (S 112 ). FIG. 10 is an image display example where the entire structural object is starting to fall since the supporting display elements are few. In this object OBJ, the upper object is only supported by two display elements 30 and 41 , and it is judged at step S 113 that it will not hold and begins rotating and falling based on the parameter calculated at S 112 . With respect to display elements 30 and 41 , they are independently falling based on a separately calculated parameter since a display element group is not formed. A single parameter is calculated with the whole thereof considered as a single object regarding the display element group that was on these display elements and start falling pursuant thereto. Display elements 7 , 8 , 24 and 25 which fell first have been erased at step S 103 since they hit the ground. FIG. 11 is a final image display element of the upper object which collectively collapsed and landed on the ground. Display elements 30 and 41 which were supporting the upper object have hit the ground and disappeared. The upper objects which collectively collapsed have landed on the ground as well, but only display elements 21 , 23 and 25 that are in direct contact with the ground are erased at step S 103 . Although not erased, as the movement parameter has been reset at step S 106 with respect to the remaining display elements, a part of the collapsed object is still, and is displayed as the remains of the building which hit the ground. The first collapse is thus completed. FIG. 12 is an image display example when a second attack is made to a part of the collapsed object. In the present embodiment, an object is continuously displayed unless such object directly hits the ground or becomes a minimum unit, in other words an individual display element, which is completely separated and cannot be separated any further. Therefore, it is possible to attack or carry and throw a part of the object that fell and is on the ground due to the first attack. The laser beam L fired by the monster C is hitting a part of the collapsed object. In other words, the object expressing the laser beam L is colliding with the collapsed structural object. The image displaying device displays an object flash E at the collision point and erases the display element judged as colliding with the direct laser beam L. FIG. 13 is an image display element of a display element, which is adjacent to the display element erased due to the impact upon laser beam irradiation, being scattered. As the size of the collision vector set at step S 105 is larger than the minimum value Pmin (S 111 , YES), parameters for movement and rotation have been set at step S 112 . Here, display elements 7 , 8 , and 32 and display elements 3 and 6 are moving as a single clod of a display element group without being mutually separated. The block consisting of display elements 7 , 8 and 32 is colliding with display elements 29 and 42 which structure the basic portion of the building remaining without collapsing. Cases like this, where the display elements collide with each other and disappear, may also occur. FIG. 14 is an image display example of the completion of the second attack. Display elements 3 , 6 , 7 , 8 , 20 , 22 and 24 that have scattered and separated due to the impact of the laser beam fired from the monster are erased by hitting the ground or being separated into minimum units. Display elements 7 , 8 and 32 scattered as blocks are similarly erased by directly colliding with the basic portion of the building or being separated. The remaining display elements 39 , 42 structuring the basic portion of the building are also erased by the block directly colliding thereto. Like this, each of the display elements is erased under the condition of directly colliding with a character or ground or being separated. In comparison to crushing and erasing an object with only the first attack, it is possible to express a more realistic form of destruction. By employing this method, there is also an advantage that the burden on the CPU within a short period is decreased. FIG. 15 is a display example a structural object and monster character in which texture mapping has been performed. By the character C contacting the structural object OBJ 1 , a flash E occurs, and the structural object is broken down into a plurality of blocks and is starting to collapse. The elapsed time from the start of the game is displayed on the upper right-hand corner of the screen, and the ratio of the object destroyed in comparison to the overall object is displayed on the lower right-hand corner of the screen. FIG. 16 shows a display example of other structural objects and monster characters. The object OBJ 2 is being destroyed by the laser beam L fired from the character C. Objects OBJ 3 and OBJ 4 are intact. Area-Out Processing Next, the area-out processing in the present embodiment is explained. The present game device performs area-out processing when a monster exceeds a prescribed movable range. This is because if the monster may freely move without any restrictions, a prescribed number of objects will deviate from the set range. FIG. 17 shows a plane conceptual view in the virtual space for explaining this area-out processing. An area A with a radius r is set in the center position O of the game. The monster C 0 is within this area. Monsters C 1 and C 2 are out of this area. The viewpoint position within the virtual space capable of capturing the monster is set in a position relationship relative to the monster. The viewpoint is set in accordance with the position of the monster in the world-coordinate system. When the monster goes out of this area A, the viewpoint is set to a position to capture the monster from behind. This is in order to give an impression that the monster is receding from view. In such case, fog processing is performed in the present embodiment based on the flowchart of FIG. 4 . While the monster is receding from view, an impression of it disappearing into the fog is given. This is in order to hide the scenery outside the area because, if no objects are set and displayed as is, such scenery will be bleak and unnatural. First, the renewal timing is awaited (S 200 , NO), and when it is the renewal timing (S 200 , YES), judgment is made as to whether the character is inside or outside the area by referring to the center coordinates of the character. If the character is within the area (S 201 , NO) transition is made to another processing (S 208 ). A picture of a standard monster C 0 is displayed on the screen in such a case as shown in FIG. 18 ( a ). Contrarily, if the character is outside the area (S 202 , NO), transition is made to the area-out processing. If the time is not yet running (S 202 , NO), the CPU block turns on the internal timer (S 203 ). This timer is used for the countdown of the area-out. If the timer is running (S 202 , YES), judgment is made as to whether it is time out. If not time out (S 204 , NO), the distance between the boundary of area A and the character is calculated (S 206 ). Then, the degree of brightness and color to be added to the character's bitmap data in correspondence with the calculated distance is set, and addition of bitmap data is performed (S 207 ). It is preferable to also set and add the degree of brightness and color in correspondence with the distance from the area boundary with respect to objects other than characters outside the area. According to this processing, if the distance from the area A in FIG. 17 is d 1 , the image including the character C 1 is shown as in FIG. 18 ( b ). In comparison to FIG. 18 ( a ), the degree of brightness and color has been changed, and the character becomes dim and fades into the fog. The farther the distance between the area A and the character, the stronger the displayed dimness. Window W 1 on the screen displays the remaining time in correspondence with the timer value. Characters for notifying the area-out is displayed on window W 2 . When time out (S 204 , YES), game over processing is performed (S 205 ). For example, the picture when it becomes time over at the position of the character C 2 in FIG. 17 will be displayed as in FIG. 18 ( c ). The outline of the character is further dimmed. The remaining time displayed in window W 1 becomes zero, and a character display of time over is displayed on window W 2 . The processing for placing fog on the character may be set by, in addition to controlling the software, setting the overall degree of brightness and color to automatically increase in a density corresponding to the parameter provided by the hardware. Especially, if structured such that the synthesis of the bitmap is performed in accordance with the distance between the character and the viewpoint, a display wherein a distant character is completely hidden in the fog and a near character is dimmed in accordance with its distance is possible. Damage Processing Next, damage processing of the present embodiment is explained. In conventional games when the character was attacked, a picture of either the character suddenly collapsing or no change at all was displayed. When the character is a large monster as in the present embodiment, however, it is unnatural if such monster were to be easily defeated. The character being absolutely invulnerable will also lower the amusement of the game. The present game device therefore performs damage processing when the character is attacked and displays the injured character. A flowchart for explaining this damage processing is shown in FIG. 5 . The renewal timing of the image is foremost awaited (S 300 , NO), and when it is the renewal timing (S 300 , YES), judgment is made as to whether the character is damaged or not (S 301 ). Whether the character is damaged or not may be judged by the collision judgment between, for example, a bullet object and character. The damage flag is turned on (S 302 ) only when the character sustains a new damage (S 301 , YES). A message indicating the damage, and position data showing the damaged portion or polygon specifying data are stored in the damage flag. A damage flag is generated for each new damage. When a cannonball hits the abdominal region 201 of the character 200 , for example, a flash E is displayed as shown in FIG. 19 . The CPU block then sets the character's posture in accordance with the existence of the damage flag. If the damage flag is no on (S 303 , NO), set is the posture which is ordinarily set (S 304 ). Contrarily, if the damage flag is on (S 303 , YES), the CPU block displays the character's posture according to the damaged portion (S 305 ). As shown in FIG. 20, for example, displayed in an object 202 with blood dripping from the abdominal region 201 . The position of each of the polygons structuring the character 200 is adjusted such that the character is in a posture of protecting such abdominal region. The CPU block further judges whether a recovery condition has been fulfilled (S 306 ). Recovery conditions are optionally set conditions. Specifically, when a character conducts a prescribed act, the act of “regaining energy by eating” for example, the recovery condition is fulfilled. A recovery condition may also be fulfilled upon a prescribed period of time elapsing from the time of sustaining damage. In other words, an image of a creature recovering from the damage is displayed. If the recovery condition is not fulfilled (S 306 , NO), transition is made to another processing (S 308 ) and an image of the posture of the damaged character is continued to be displayed. On the other hand, if the recovery condition is fulfilled (S 306 , YES), the CPU block resets the damage flag (S 307 ). The character is then displayed in the standard posture from the next image renewal period. If sustaining a plurality of damages, however, and a damage flag is remaining, an image of the posture of the damaged character is maintained. Evaluation Processing When it is game over, the CPU block displays a screen as shown in FIG. 21 and evaluates the game content. In window W 3 , a plurality of indicators IND for evaluating the player's operation technique are displayed classified by categories. Window W 4 is a column for displaying characters representing the character's title given as the overall evaluation. With respect to the evaluation per category in Window W 3 , the “DESTROY” column displays the percentage with index M of the number of polygons destroyed in consideration of the destructible number of polygons of the object set at 100. The “SPEED” column displays the percentage in index M of the ratio of the time required to clear the game in consideration of the time limit in the game (5 minutes for example) set at 100. The “SHOOT” column displays the percentage in index M of the number of enemies destroyed upon clearing the game in consideration of the number of enemies appearing during the game (fighter planes for example) set at 100. The “POWER” column displays the percentage in index M of the power value upon clearing the game in consideration of the maximum power of the monster character set at 100. The “COMBO” column evaluates the consecutive attacks made by the player. That is, the display elements constituting the structural object are divided into a certain number of blocks. When an attack is made to the object, these blocks are erased and dropped in block units. When a block starts falling due to the first attack, it is possible to conduct a second attack to such block. The “COMBO” column displays the percentage in index M of the number of blocks destroyed by consecutive attacks in consideration of the number of overall blocks set at 100. The “BALANCE” column evaluates the maneuver balance of the character. That is, upon attacking the blocks constituting the structural object, the CPU block records the “maneuver” required for the destruction thereof. Examples of “maneuvers” include tail attack, hand attack, laser beams, etc. With a premise that it is preferable to destroy the object with well-balanced “maneuvers,” the CPU block records the destruction number of the block per maneuver. The “BALANCE” column displays the percentage in index M of the balance evaluation upon clearing the game by comparing the difference in the destruction ratio of the blocks destroyed pursuant to each of the maneuvers and the standard value. The title in window W 4 is determined pursuant to the overall ratio of the evaluation of the six categories upon respectively evaluating and obtaining the results of the aforementioned six categories. Several titles are predetermined corresponding thereto in the order from a high evaluation to a low evaluation. The CPU block obtains the overall percentage based on these six categories, reads a title corresponding thereto, and displays the same on window W 4 . (Advantages) There are the following advantages according to the present embodiment as mentioned above: 1) According to the present embodiment, as the structural object is constituted of block-shaped display elements after a collapse, a display of a realistic collapse of a building is possible by merely separating the object per display element. 2) According to the present embodiment, as the outline of each display element is set to simulate a block clod created upon an actual collapse of a building, a display of a realistic collapse of a building is possible. 3) According to the present embodiment, as a display element is erased upon colliding with a character or the ground, it is possible to display a realistic scene of a part of the building being destroyed or the crushed block disappearing. 4) According to the present embodiment, as a display element directly above the erased display element is dropped, it is possible to display a realistic collapse of a building with a time lag as when a building is destroyed in a monster movie. 5) According to the present embodiment, when a display element is erased, a display element adjacent thereto is moved at a speed according to the intensity of impact and a display of an image where a display element is scattered far in accordance with the intensity of impact is possible. 6) According to the present embodiment, when a display element is erased, a display element adjacent thereto is moved toward a direction according to the direction of impact and a display of an image where a display element is scattered in a direction in accordance with the direction of impact is possible. 7) According to the present embodiment, when a display element is erased, a display element adjacent thereto is rotated at a rotation speed according to the size of the display element and a display simulating a rotation of the block conforming to the laws of nature is possible. 8) According to the present embodiment, when the intensity of impact exceeding a prescribed value is inflicted upon an object, the display position of an adjacent display element is changed. Thus, it is possible to realistically display a building immediately before collapsing wherein such building is barely supported by a partial pillar. 9) According to the present embodiment, when a display element is erased and the remaining display elements are barely being supported, the blocks on top of the supporting display elements are collectively dropped when the number of such supporting display elements is less than a prescribed number. It is therefore possible to display a realistic picture of the building collapsing. 10) According to the present embodiment, as the remaining object after the collapse is also structured to be destructible as another separate object, a further realistic image is provided. For example, it is possible to provide a realistic image where a monster further tramples over a part of a collapsed building just like in a monster movie. Another advantage is that less burden is placed on processing in comparison to a building being crushed with only the first collapse. 11) According to the present embodiment, the blocks after a collapse may be erased naturally as the display elements separated in minimum units are erased. In other words, the blocks erased from the screen are inconspicuous if they are in minimum units, and an unnaturalness of an object suddenly disappearing will not be conveyed to the player. A character may also use a part of the object not separated into minimum units after a collapse as a weapon (stone-throwing for example). A part of the object which became this weapon will collide with other characters, be separated into minimum units, and disappear. A new game processing method is provided wherein a character may be supplied with a weapon without unnecessarily increasing the number of usable weapons in the game. 12) According to the present embodiment, when a character goes out of the area, an image of a fog is displayed, and an unnecessary display outside the area may be naturally avoided. By gradually displaying the character such that it recedes from view, it is possible to naturally inform the player of the movable range of the character. 13) According to the present embodiment, as the density of the fog is changed in accordance with the distance between the character and the area boundary, it is possible to display a natural image of the fog becoming denser while the character is receding from view. 14) According to the present embodiment, as time out processing is performed while the character is outside the area, it is possible to end the game naturally in the fog. 15) According to the present embodiment, when it is judged that a character collided with another object, the character's posture is changed until the recovery condition is fulfilled, and it is therefore possible to naturally display an image of a character as though it has sustained damage. 16) According to the present embodiment, as the posture is set such that the character protects the place of collision, it is possible to display a creature's instinctive actions. 17) According to the present embodiment, as a character is made to recover by conducting predetermined movements, it is possible to display a creature's instinctive actions such as recovering by supplementing energy. 18) According to the present embodiment, as a character is made to recover by a predetermined period of time elapsing, it is possible to display a creature's instinctive actions such as recovering with the lapse in time. 19) According to the present embodiment, as consecutive attacks are evaluated in COMBO, it is possible to provide a worthy game to advanced players who are capable of conducting consecutive attacks. 20) According to the present embodiment, as maneuver balance is evaluated in BALANCE, it is possible to provide a worthy game to advanced players who are capable of combining several maneuvers. 21) According to the present embodiment, as a title is given as the overall evaluation, it is possible to provide a continuously appealing game by showing a target evaluation (title) to the player. (Other Examples) The present invention is not limited to the embodiment above but may also be employed upon being changed within the scope of the purport of the present invention. Display elements of the present invention, for example, may also be employed to objects other than structural objects. For example, display elements may also be employed to objects representing characters or natural objects such as mountains. The method of erasing and dropping the display elements is not limited to the above, and is employable upon various changes in planning. The combination of blocks as display element groups can also be set optionally. According to the present invention, it is possible to realistically collapse a building by structuring objects such as buildings with blocks to be collapsed. According to the present invention, it is possible to naturally restrict the movable range of the character by displaying a picture where the character is covered with fog in accordance with the moving position. According to the present invention, it is possible to realistically represent the degree of damage to the character by structuring the posture of the damaged character to be changeable.

A realistic image of buildings collapsing, as in a monster movie, is displayed. Each of the display blocks to be scattered after the collapse is previously set as collective movable display elements ( 1~29), and objects (OBJ) simulating buildings and the like composed of display elements are structured and displayed. By separating the display elements, it is possible to create an image similar to concrete blocks after as actual collapse. Further realism is provided by changing the way the blocks fall upon a collapse of a building.

BACKGROUND OF THE INVENTION This invention relates to winged implements in which the wings are biased by a hydraulic downpressure circuit to pivot toward the ground during operation to provide force onto the ground working tools so that they better penetrate hard ground to the set working depth. An earlier form of downpressure system shown in Flexi-coil's U.S. Pat. No. 5,687,798 uses PRRV (pressure reducing-relieving valve) as controls in the downpressure circuit. A related system is shown in Flexi-coil's patent application (U.S. Ser. No. 08/891,204, corresponding to Canadian 2,210,238. Recent tractor designs include hydraulic systems on the tractors that are CCLS (closed center load sensing) systems. These systems attempt to maintain a set flow volume through each of the tractor valves, when open. This volume can be set by the operator. The tractor hydraulic pump is controlled such that it will increase the system pressure until the flow volume at each of the open valves is satisfied. This system allows for efficiency to be gained from previous systems in which the pump volume output was reduced only after full pressure capability had been reached. Circuits connected to the tractor that have PRRV controls, will only accept flow when the PRRV senses a requirement for flow in the circuit connected downstream of the valve. A tractor having CCLS controls will attempt to deliver flow in any case, and the tractor pump will raise the pressure to the system maximum. This not only diminishes the efficiency of downpressure circuit which is causing the problem, but also diminishes the efficiency of any of the circuits being operated because the tractor control system introduces pressure drops at each valve to maintain only the set flow. SUMMARY OF THE INVENTION It is an object of the invention to provide a downpressure circuit for an agricultural implement having ground working devices mounted thereon. It is another object of this invention to reduce negative effects caused by agricultural implements having downpressure circuits on CCLS tractor hydraulic systems. It is a feature of this invention that the efficiency losses on CCLS tractor hydraulic systems that may be introduced by connecting other downpressure circuits are reduced. This invention relates to an agricultural implement including a frame having a pair of tool-carrying wings pivotally mounted thereon for pivotal movement between raised transport positions and lowered ground-working positions, each said wing having a hydraulic wing actuator connected thereto which is extendable and retractable for effecting said pivotal motion, and a hydraulic wing actuator circuit connected to each of said wing actuators, which circuit, when connected to a tractor hydraulic system, enables said wing actuators to apply down pressure to said wings when the wings are in the lowered working positions, and hydraulic pressure control valve means for controlling the down pressure exerted by said wing actuators. In one preferred feature of the invention said pressure control valve means comprises at least one pressure relief valve. In one form of the invention a hydraulic top link actuator is secured to said implement frame and adapted to be interposed between said implement frame and another vehicle to apply down pressure to the implement frame. As a further feature of the invention said hydraulic top link actuator is preferably connected to a portion of the wing actuator circuit. In another form of the invention a pair of said relief valves are provided to enable the down pressures exerted by said wing actuators and top link actuator to be controlled separately. The agricultural implement typically includes an implement lift hydraulic circuit adapted to be connected to a lifting system for the implement. Advantageously, the system may include a valve to disable the down pressure action of the top link actuator when the implement lift circuit is activated to raise the implement. The agricultural implement may preferably include a valve responsive to wing position to disable the pressure relief valve associated with the wing actuators when the wings are raised upwardly beyond the working positions. As a further preferred feature the agricultural implement includes a flow divider in said wing actuator circuit to allow the connection of another branch circuit to the same tractor control to maintain constant flow to each branch regardless of varying pressure in either branch or between branches. These and other objects, features and advantages are accomplished according to the invention by providing an agricultural implement including a frame having a pair of tool-carrying wings pivotally mounted thereon for pivotal movement between raised transport positions and lowered ground-working positions. Each wing has a hydraulic wing actuator connected thereto which is extendable and retractible for effecting the pivotal motion. A hydraulic wing actuator circuit is connected to each of the wing actuators, which circuit, when connected to a tractor hydraulic system, enables the wing actuators to apply down pressure to said wings when the wings are in the lowered working positions. A hydraulic pressure control valve system controls the down pressure exerted by the wing actuators. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a perspective view of a winged implement in which the actuator and downpressure system are incorporated; FIGS. 1A and 1B show in diagrammatic fashion the manner in which the implement is attached to the three point hitch of an aircart; FIG. 2 shows a simple wing lift circuit, i.e. without down pressure capability, with the actuator connected to the implement lift circuit; FIG. 3 shows a wing lift circuit with down pressure control in combination with the actuator system; and FIG. 4 shows a further hydraulic circuit with additional top link down pressure and wherein the wing down pressure and top link down pressure are controlled separately. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIG. 1, a first embodiment of the implement has wing sections 10 and 12 pivotally attached via joints 14 and 16 to a frame middle section 18 for carrying suitable ground working tools (not shown), which joints each have an axis that is oriented generally horizontal in the working position so that the wing sections are allowed pivotal movement over uneven ground. In the headland position shown in FIG. 1, the wing sections 10 and 12 are supported generally horizontally over the ground, suspended from the middle section 18 by their joints and by hydraulic wing actuators 20 . No other means is supporting the wings in this position. When lowered to a working position, gauge wheels 22 support each wing above the ground. The gauge wheels 22 can be adjusted to set the working height above the ground for each wing section. The wing can thereby float (pivot freely) to follow ground contours, or it may be biased toward the ground, and the gauge wheel 22 will limit the downward motion. Downward biasing may be required in soil conditions in which ground engaging tools do not penetrate to the desired depth as set by the gauge wheel and the gauge wheel and wing section is suspended off the ground by the ground tools. Points 24 and 26 for attachment to a three-point hitch are provided on the middle section 18 for towing and for controlling the height of the middle section. (Alternately the invention would work on implements having ground wheel means to support the middle section, with a floating or fixed hitch for towing). The hitch of the implement shown is particularly suited for connection to the three-point hitch of an aircart having double acting lower link actuators. Most three-point hitches on tractors or other implements provide only lifting action by the lower links and allow free upward movement of the links. The lower links of the aircart can be maintained in a fixed position. The implement middle section 18 is pivotally attached to the aircart lower links by connections at points 24 and 26 allowing the implement movement about a horizontal transverse axis 28 . A hydraulic top link 30 is pivotally connected at one end to the aircart (offset from the axis of the lower links), and at the second end is pivotally connected to the implement middle section 18 at a point offset from the horizontal axis 28 . An intermediate link 32 , is connected between the second end of the top link and the implement middle section by pivotal connections on both ends. The implement is allowed free downward pivotal movement about the horizontal axis 28 (limited by the length of the actuator and link 32 , and by rear support assembly 40 ) but upward pivotal movement is limited by an abutment 36 along the intermediate link 32 . The implement middle section 18 abuts the intermediate link at abutment 36 and the top link 30 reacts to the upward pivotal movement. FIGS. 1A and 1B help to illustrate the above and they show the implement connected to an aircart by the preferred 3 point hitch with hydraulic top link 30 and intermediate link 32 in both working and raised positions. This shows how there is freedom of pivoting in the raised position, even though the top link 30 may be locked out, and therefore rigid. The intermediate link 32 is drawn away from the abutment 36 , not by the top link but by the system geometry and during the raising action from the lower links 38 and rear support assembly 40 . Rear support assembly 40 is well known per se and each includes a castored ground wheel 42 connected by linkages 44 to frame middle section 18 . Actuator 46 effects movement of the linkages 44 during raising and lowering in a well known fashion. Alternately a rigid top link (not shown) may be connected directly between the aircart and the implement, as in a conventional three point hitch. This is used on implements not having rear support assembly 40 , so the rotation of the frame middle section 18 about the horizontal axis 28 is controlled, maintaining a generally constant relative orientation between the implement and the aircart as the implement is raised or lowered. When a rear lift support assembly 40 is provided on the implement, a compressible top link is required so that the implement is allowed pivotal movement about axis 28 . This may be a spring connected directly to the implement or via an abutting intermediate link 32 . In the preferred embodiment the required compressible link is a hydraulic top link operated by a biasing pressure and an intermediate link is also provided to create freedom to pivot in the transport position when hydraulic flow to the top link is blocked. The top link 30 is locked out of the circuit by valve 48 (FIG. 4) when the implement is raised (by rear lift means and lower arms of hitch) and the link 32 pivots away from the frame middle section so it no longer abuts the frame. The geometry between the lower links 38 and top link 30 causes this action. This allows pivoting of the implement relative to the aircart about horizontal axis 28 when in transit over uneven ground. Referring further to the embodiment of FIG. 1, the headland actuator system includes a headlands cylinder 50 , having its opposite ends pivotally attached to elongated center links 52 and 54 . The outer ends of links 52 and 54 are secured by pins 56 , 58 to the inner ends of the wing actuators 20 and these pins are disposed for movement in slots 60 and 62 formed in the upper ends of spaced towers 64 , 66 fixed to the frame middle section 18 . The headlands cylinder 50 is stabilized by means of stabilizing links 68 , 70 having upper ends connected at opposing ends of the cylinder 50 and their lower ends pivoted to the middle section 18 of the implement frame. Thus, as cylinder 50 is extended and retracted, the inner ends of the wing actuators 20 are caused to travel along the paths defined by slots 60 , 62 between the inner and outer extremities of these slots. (In an alternative arrangement an extra long headlands actuator could be used with its opposing ends being directly connected to the inner ends of the wing actuators 20 and eliminating the need for links 52 to 70 described above). In operation without down pressure, (FIG. 2) the wing lift circuit CD can be set to float mode in the tractor when the implement wings 10 and 12 have been lowered from their transport position. After the implement is lowered to the ground, continued flow into line B builds pressure to further operate the implement lift actuators until the depth stop (not shown) is reached. During this period pressure in line B causes pilot-to-open check valve 72 to open to allow flow from the rod end of the cylinder 50 , and the headlands system is extended by pressure in line B. This forces the ends of the wing actuators 20 to the outer ends of slots 60 and 62 for extra downward pivotal range of the wings 10 and 12 . The actuators 20 are held at the outer ends of slots 60 and 62 during operation in the working position. When raising the implement at headlands the cylinder 50 is retracted. This limits droop of the wings when the middle section 18 is raised by applying pressure to line A. The implement is typically raised just enough for working tools to clear the ground for turning at the field headlands. The pilot-to-open check 72 prevents fluid from escaping from the cylinder 50 to the rear or front lift actuators which may be extended only to an intermediate position at headlands. The check valve 72 also limits the droop of the wings 10 and 12 until the implement is lowered to the ground and line B is pressurized, repeating the cycle above. To raise the wings to transport position, the implement is first raised. Pressure is applied to line A, retracting the cylinder 50 and at the same time operating the three point hitch actuators (and rear lift actuators if present) which raise the middle section 18 . After the middle section 18 is raised, pressure is applied to line D and the wing actuators 20 rotate wings 10 and 12 to a generally vertical position for transport. The ends of the wing actuators 20 are held at the inner ends of slots 60 and 62 by the cylinder 50 . In this held position the headlands actuator motion is completely restricted so that motion of one wing may not be transmitted to the opposite wing through the linkage system when the wings are being raised. Otherwise the wings could freely toggle side to side in the vertical position until they came to rest against some other abutment. Alternately the slots 60 and 62 could be replaced by links pivotally connected to the middle section 18 and end of the wing actuator providing the link's rotation is limited by stops corresponding to the inner ends of the slots of the present embodiment. In operation with down pressure, (see the hydraulic circuits of FIGS. 3 or 4 ) the operation of the headlands system is the same. The wing lift circuit may be set to down pressure mode by setting the valve in the tractor to pressurize line C. The down pressure circuit to the wings may be connected in combination with the hydraulic top link 30 , or may act alone as in the case of a rigid top link. A hydraulic top link not connected to a down pressure circuit is known in the prior art for adjusting the angle of an implement relative to a tractor, and remains fixed as a rigid link during operation. Ball valve 74 (FIGS. 3 or 4 ) is closed when wings 10 and 12 are raised to the transport position. This allows full tractor pressure to be applied to wing actuators 20 to lower the wings which generally rest past an overcenter position in transport (generally vertical). The ball valve 74 is controlled by a cam or link mechanism so that it is open when the wing position is lower than about 15 degrees up from horizontal as described in the above-noted U. S. patent. Referring to FIGS. 3 and 4, wing down pressure is controlled by relief valve 76 , which limits the pressure in line C 2 . This relief valve allows fluid to return through line D when pressure in line C 2 exceeds the setting. An optional top link actuator may also be connected to line C 2 via line C′, and pressure to both the wing actuators and the top link actuator may be controlled by valve 76 . With particular reference to FIG. 4, valve 80 is provided when connecting a hydraulic biasing top link to lockout the top link biasing function when the implement is being raised. When the implement is lowered to the set working height there is no pressure in line A or to pilot A′, and valve 80 will open with any pressure at C 4 or C 1 to allow the top link to extend or retract with the biasing function. A second relief valve 82 (FIG. 4) may be added to the circuit to control the top link pressure separately. This valve may be set at pressures greater than that of relief valve 76 to create a differential pressure between lines C 2 and C′. The valve 82 allows pressure in C′ to build higher, before continuing into line C 2 , where relief valve 76 will control the pressure in that part of the circuit. This type of down pressure circuit described above which uses relief valves or pressure regulating valves rather than PRRV (pressure reducing-relieving valve) controls is preferred when connecting to tractors having CCLS (closed center-load sensing) controls. The tractor valve controlling this circuit is preferably set to deliver 3 gpm, which generally satisfies the rate at which the various actuators respond to uneven ground. This set flow will continuously pass through circuit CD during operation of down pressure, and be used as required by the actuators when they extend or retract as they provide bias to force the middle section 18 and/or wing sections 10 and 12 toward the ground. A flow divider 84 can be used to separate equal portions of flow when a second circuit is connected to the same control valve. In this case the tractor valve may be set to 6 gpm. A 50/50 divider will split 3 gpm to each circuit regardless of the pressure at which either circuit is operation. In the embodiment shown in FIG. 4, the second circuit operates hydraulic drives for metering seed or other materials for planting. A check valve 86 in the second circuit blocks reverse flow to the second circuit so that full pressure may be applied to the wing actuators when raising the wings. Depending on the ratio of flow required by the branch circuits, a flow divider with a different split ratio could be used. Or a priority flow divider could be used which sets a fixed flow to one branch and delivers any excess flow to the other. Other multiple number of branch circuits is conceivable by using primary and secondary flow dividers and so on. Preferred embodiments of the invention have been described and illustrated by way of example. Those skilled in the art will realize that various modifications and changes may be made while still remaining within the spirit and scope of the invention. Hence the invention is not to be limited to the embodiments as described but, rather, the invention encompasses the full range of equivalencies as defined by the appended claims.

An agricultural implement includes a frame having a pair of tool-carrying wings pivotally mounted thereon for pivotal movement between raised transport positions and lowered ground-working positions. Each wing has a hydraulic wing actuator connected thereto which is extendable and retractible for effecting the pivotal motion. A hydraulic wing actuator circuit is connected to each of the wing actuators, which circuit, when connected to a tractor hydraulic system, enables the wing actuators to apply down pressure to said wings when the wings are in the lowered working positions. A hydraulic pressure control valve system controls the down pressure exerted by the wing actuators.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The invention concerns an endoscopy capsule of the type having at least one magnetic element interacting with an external magnetic field for magnetic navigation of the endoscopy capsule. [0003] 2. Description of the Prior Art [0004] For examination of the gastrointestinal tract a flexible catheter endoscope is typically used that is inserted orally or rectally and is advanced. A disadvantage of this technique is that the catheter is relatively stiff since the feed force must be passed along it. Such a forward shifting of the catheter tip means that regions further removed from the body orifice can be difficult to reach or, respectively, cannot be reached at all. Catheter endoscopy is relatively uncomfortable for the patient, it can lead to complications such as an organ perforation (when it is pressed too strongly against an organ wall), and the manual operation for the physician is also relatively elaborate and complicated. [0005] As an alternative to this, the use of an endoscopy capsule is known that moves actively by means of an integrated magnetic element that interacts with a magnetic field (generated external to the patient) acting on the capsule, and with which the magnetic element is moved through the examination subject, meaning that the magnetic capsule navigation ensues by remote control, for example by actuation of a joystick or a mouse or the like. It is advantageous that an extensive automation of the medical procedure is possible. The automation capability has essentially two bases: the magnetic force effect ensues directly on the capsule; the perforation danger thereby drops drastically, and the control or the force no longer ensues directly manually, but rather indirectly via the control of the coil currents of the external magnetic system. The endoscopy capsule thus can be designed differently. It can be purely a video capsule that exhibits an image acquisition device with which images of the inside of the hollow organ can be acquired and transferred via radio to an external acquisition or control device. For example, a biopsy forceps or another mechanical instrument can be provided at the capsule, with the biopsy forceps or another mechanical instrument being externally controlled via radio in order to extract tissue samples or the like. In each case images and other measurement values or operations can be acquired or made at arbitrary locations in the gastrointestinal tract in this manner. [0006] A disadvantage of catheter-free capsule endoscopy is that only limited resources for working or operating means or electrical energy can be carried by the capsule. A small battery that delivers only limited power is integrated therein for operating electrical loads such as an image acquisition device or the biopsy forceps or an electrical valve that connects a gas reservoir in the capsule with a balloon. If used, a gas quantity for inflation of the balloon (which, for example, serves for vessel widening or for setting a stent) as well as a possible fluid quantity (that, for example, is necessary for lavaging the intestinal wall or the like) as well as the quantity of a medicine that is to be applied on site, can be provided only in small quantities. SUMMARY OF THE INVENTION [0007] An object of the present invention is to provide an endoscopy capsule that is no longer subject to the limitations described above that result from the limited carrying capability of working or operating means or from the limited power supply capacity. [0008] This object is achieved in accordance with the invention by an endoscopy capsule of the aforementioned type equipped with a tube composed of a flexible and material, via which tube one or more fluid or gaseous operating or working agents can be supplied to the capsule, and/or in which at least one conductor serving for the signal and/or power line is directed to the capsule. As used herein, “non-rigid” means a rigidity that is insufficient to permit feed of the capsule to be done using the aforementioned tube. [0009] The capsule is connected with external supply or feed devices via the thin, highly flexible supply tube, such that a continuous feed of necessary operating or working agents or a power feed is possible. The excellent navigability of the capsule with all of its advantages is retained; the capsule merely pulls the thin non-feed rigid tube behind it, which does not affect the mobility via the external magnetic field navigation device since the thin, highly flexible tube slides along the organ walls without further measures and can be pulled along through corresponding intestinal coils or the like without further measures. The tube, which preferably is formed of an inelastic (i.e. bendable but not expandable) material such as polypropylene or polytetrafluorethylene so that it does not elastically expand (for example given feed of a gaseous operating or working means) can be executed with very thin walls and very small in terms of diameter; a feed or, respectively, supply or, respectively, communication is nevertheless possible without further measures. The wall thickness of the tube can be between 0.1-0.5 mm (preferably 0.2 mm) while the outer diameter of the tube can be between 2-6 mm (in particular 3-4 mm). The own weight of the tube is extremely low and lies in the range of a few grams, even when the tube is executed very long. Lengths of more than 2 m are realizable without further measures; a length of up to 8 m is also conceivable, such that the tube can be drawn through the length of the entire gastrointestinal tract. [0010] Two or more separate channels sealed off from one another are advantageously fashioned in the tube (which should have a sufficient tensile strength so that it, together with the endoscopy capsule, can be pulled out from the gastrointestinal tract undamaged as needed), via which separate channels the various operating or working means can even be supplied simultaneously if needed. The corresponding channels are naturally directed at the capsule to the corresponding function devices of the capsule that should be supplied with the respective operating or working means, whereby the channels or continuation lines can be opened and closed as needed via corresponding electrical valves controllable via a capsule-side control device. For example, it is possible to feed a gas via a first channel, by means of which gas a balloon arranged at the capsule is inflated. By means of this balloon the capsule size (thus the capsule diameter) can be adapted to the size of the surrounding hollow organ for a sliding-contacting [sic] movement of the capsule along the organ wall, is fed, or via which a stent or a tamponade or the like can be placed, for example. Via the second channel a ravaging fluid that exits at a capsule-side exit opening (in order, for example, to clean the intestinal wall or the viewing window of an optical sensor in the capsule) can be fed, for example. [0011] The at least one (but typically more) electrical conductor is appropriately set in the tube wall, but can also be directed on the tube wall. In the case of a power supply, only very slight currents are to be conducted via these conductors. The communication between the external operating or control device and the capsule-side control device can also ensue via these same conductors, i.e. the image and other measurement data that are acquired at the capsule can be transferred to the external operating or control device, or control commands can be provided from the outside to capsule-internal function devices. [0012] As stated, at least one outlet opening for a supplied working or operating agent can be provided at the capsule, this outlet opening being advantageously positioned adjacent to an image acquisition device integrated into the capsule. For example, for an improved image acquisition a cleaning fluid can thus be supplied from outside and can be emitted via the outlet opening directly at the location of the Office Action. A number of such outlet openings can naturally also be provided. The tube-side channel opening at the capsule would then be coupled with the respective outlet openings via a corresponding connection channel system. Here as well a closing and opening of the respective channels or outlet openings via electrically controlled valves is naturally appropriate. The cleaning openings can also be combined with other sensors or probes on the capsule surface, for example a conductivity sensor or a bipolar probe for thermal coagulation. [0013] In the event a working or operating agent cannot be supplied via the very thin tube with the sufficient pressure that would be required for a sufficient washing of the intestinal wall or for a sufficiently strong inflation of a balloon or the like, in an embodiment of the invention a reservoir is provided for the supplied working or operating agent in the capsule, from which reservoir the working or operating agent can be removed via a pump or the like for output to a function device of the capsule or into the capsule environment. The reservoir can thus be continuously filled from the outside, while via the pump sufficient pressure can be developed so that the working or operating agent can perform its function. [0014] In addition to the extraction of tissue samples via a biopsy device, it is also sometimes appropriate to acquire liquid or gas samples from the examination location, for example. For this purpose, a suction device for suction of fluid or gas from the capsule environment via a capsule-side inlet opening and for feeding the fluid or gas into the tube (possibly the reservoir) is appropriately provided. The corresponding inlet opening (which, as described, can be opened and closed via an electrically controllable valve) thus enables the immediate acquisition of local fluid or local gas that can then be transported out with the capsule. The same acquisition can naturally ensue via an outlet opening provided anyway, which outlet opening is, for example, coupled with the pump already described, this pump can then be operated in reverse as a suction device. [0015] As described above, the opening and closing of the outlet and inlet openings or of connection lines leading to function devices ensues via corresponding valves that are electrically controllable via a control device integrated into the capsule. Insofar as no electrical communication line to an external operating device is provided, this control device can also communicate wirelessly via radio with the external operating or control device (alternatively via the tube-side signal lines, naturally). The control device (a small microprocessor) controls all electrically controllable or operating functions or operating elements that are integrated into the capsule. [0016] Because the capsule sometimes rotates around its own axis during the magnetic navigation, it is appropriate when a coupling element at which the tube is attached is arranged at or in the capsule, and said coupling element enables a rotation of the capsule relative to the tube. The capsule can thus rotate freely relative to the tube, which does not have to track the capsule rotation movement; it thus does not twist. The coupling element is designed such that naturally the corresponding conductor connections from the tube to the capsule are also not interrupted upon rotation. The coupling element itself does not necessarily have to be arranged at the point at which the tube discharges into the capsule; rather, the coupling can also be provided at an arbitrary point along the tube, preferably close to the capsule, naturally. [0017] Furthermore, it is sometimes appropriate to be able to decouple the tube from the capsule as needed, which can possibly ensue via the coupling element. For example, this can ensue via an electrical signal given by the capsule-side control device, which electrical signal specifically opens a mounting at the coupling element or at the connection of the tube with the capsule, or, for example, by defined mechanical pull on the tube, such that a connection mechanism between tube and capsule is hereby opened in a defined manner. The tube can then be drawn out while the capsule (which, for example, requires no further supply with working or operating means or the like) can be further directed through the intestine or the like via external control. Alternatively, the tube can also remain in the body in order to be used as a feeding or drainage tube while the endoscopy capsule is no longer needed. In this case the capsule can then be magnetically navigated further and secured. Here the accessibility of the entire intestine via the navigable capsule proves to be particularly advantageous, such that in the case of ileus (for example) a discharge sample can be placed very far aboral (for example in the jejunum or ileum) or a feeding tube can be introduced through the colon into the small intestine given a failing continuity of the oral sections of the gastrointestinal tract. [0018] Given use of tubes that are shorter than the entire length of the gastrointestinal tract, given oral examinations (gastroscopies) the decoupling capability offers the possibility to remove the tube without pain via mouth or nose after decoupling while the capsule is navigated further or moves via natural peristalsis and is secured anally. It is also sometimes possible to leave the capsule inside the gastrointestinal tract (possibly locally fixed) for further gastroenterological examination or treatment, however to already remove the tube because no further working or operating means or, respectively, energy supply is required. [0019] In a further embodiment of the invention the magnetic element is arranged in a housing section that can be decoupled from the remaining capsule housing as needed. This enables the magnetic element to be retrieved via the tube after the positioning of the endoscopy capsule in a target region, meaning that the decoupling-capable housing section is connected with the tube and can be drawn out with this. This enables the patient to be examined in a magnetic resonance system after the positioning of the endoscopy capsule since, given corresponding design, after removal of the magnetic element the endoscopy capsule no longer contains components that would react to the magnetic fields predominating during the magnetic resonance examination. It is also conceivable to direct a further magnetic endoscopy capsule via magnetic control to the same location, whereby the already-positioned capsule no longer interacts with the navigation field, i.e. is no longer displaced into movement with the navigation field. The detaching of the housing section from the remaining housing can ensue in manner described above as with the tube decoupling. [0020] Furthermore, an insertion element (for example a tube or the like) to be inserted into a body orifice of an examination subject (for example the rectum) can be associated with the endoscopy capsule, via which insertion element the capsule can be inserted into the examination subject, and the insertion element exhibits an arresting and/or advancement and retraction device for the tube. By means of the arrest the capsule can “dangle” on the tube in an intestinal section directed downwards; a magnetic levitation is not necessary. Particularly given the retrograde capsule movement, the pulling device in the insertion element can support the magnetic capsule navigation when both “movement types” (magnetic force on the capsule and drawing on the tube) are exerted with adjustment to one another. [0021] An easier capsule navigation is thus possible via the insertion element. The arresting and/or advancement and retraction device can be manually or mechanically actuated, however can also be controlled automatically and electrically. [0022] The insertion element itself can be executed gastight in order to enable a filling of the colon with gas to enlarge the same. BRIEF DESCRIPTION OF THE DRAWINGS [0023] FIG. 1 is a schematic block diagram of an endoscopy capsule in accordance with the present invention. [0024] FIG. 2 is a section through the flexible, non-rigid feed tube of the endoscopy capsule shown in FIG. 1 . DESCRIPTION OF THE PREFERRED EMBODIMENTS [0025] FIG. 1 shows an inventive endoscopy capsule 1 with a capsule housing 2 in which is integrated a magnetic element 3 , which can be a permanent magnet, a weakly magnetic element that can be magnetized in a magnetic field, or an electronic coil. This magnetic element 3 interacts with navigation magnetic fields that are generated via an external navigation device (not shown) so that the endoscopy capsule 1 accommodated in the patient body can be actively directed and moved via external control. [0026] A control device 5 in the form of a microcontroller is integrated into the oblong, cylindrical capsule exhibiting a diameter of, for example, 10 mm, which control device 5 takes over all control tasks concerning the function devices of the capsule (which are subsequently described in detail). An image acquisition device 6 is also provided, comprising a camera (for example a CCD camera 7 with which two illumination devices are associated in the form of two LEDs 8 ). Via the image acquisition device 6 (that is arranged behind a transparent capsule window covering 9 ) it is possible to acquire images of the examination volume that is illuminated via the LEDs 8 . The image signals are passed to the control device 5 which transfers these outward via a conductor connection to an external control or operating device (as is described further in the following). [0027] The detection of the position of the capsule inside the examination subject ensues in connection with a position sensor 10 provided at the capsule, which position sensor 10 interacts with a magnetic position detection system (not shown in detail). Also provided in the shown example is a function device in the form of a biopsy pincer 11 that can be controlled via the control device 5 in order to extract tissue samples. Finally a balloon or cuff 12 that can be reversibly inflated (which is discussed further in the following) is arranged at the capsule housing 2 . The outside of the capsule can be adapted or altered via this cuff 12 in order to adapt to changing diameters of the hollow organ examined or to be examined. [0028] The endoscopy capsule 1 also has or is also connected with a highly flexible, non-feed rigid tube 13 via a coupling element 14 . This tube comprises polypropylene (PP) or polytetrafluorethylene (PTFE), thus an inelastic material that does not expand given internal pressurization, and is also extremely thin in diameter with regard to the wall thickness. The latter is preferably approximately 0.2 mm; the diameter is preferably 3-4 mm. This tube 13 , which can be two or more meters long, is inserted into the patient together with the endoscopy capsule. The endoscopy capsule, as it is actively moved forward, draws the tube after it. The tube itself is extremely smooth on the outside, thus in practice slides along the organ wall without resistance and follows any curve without further measures because as executed it is extremely thin-walled and highly flexible. [0029] Inside the tube (see FIG. 2 ) three different lumens or channels 15 a , 15 b and 15 c are demarcated from one another via corresponding dividing walls 16 . Via these channels 15 a - 15 c it is possible to direct different working or operating means from the outside to the endoscopy capsule 1 which requires these in some form, thus requires these for internal operation or would like to emit them externally into the examination organ. For example, a CO 2 gas can hereby be fed as a washing gas that is emitted at the capsule into the intestine via an outlet opening. Water can also be supplied as a washing solution, or a medicinal substance that is emitted externally. Furthermore, the gas needed to inflate the balloon 12 can hereby be supplied. For this one the channel or channels are coupled with corresponding lines inside the capsule that lead to the function devices or outlets where the working or operating means are required (which is discussed further). [0030] Furthermore, a number of electrical conductors 17 a , 17 b , 17 c are shown that, in the shown example, are directly attached to the inner wall 18 of the tube 13 as thin-film conductors and that, in the shown example, are sealed off from the channel 15 a with a thin membrane 19 . Via these electrical conductors it is possible on the one hand to ensure the power supply of the electrical loads inside the capsule. For example, the conductor 17 a serves for this, which conductor 17 a is correspondingly looped further inside the capsule and is connected with the corresponding loads such as the control device 5 , the image acquisition device 6 with its components or the biopsy pincer 11 , but also a pump integrated into the capsule (which is subsequently discussed further). For example, the conductor 17 b serves for bidirectional signal or data transfer. For example, the communication between an external control or operating device and the control device 5 can thus ensue via the conductor 17 b . The conductor 17 c is, for example, a common neutral conductor for the conductors 17 a and 17 b . Image signals acquired via the image acquisition device 6 can be transferred from the control device 5 (for example via the conductor 17 b ) to the external control or operating device that processes and prepares the image signals and outputs them onto an associated monitor. [0031] The inventive endoscopy capsule 1 is thus clearly not autarkic, meaning it does not carry the necessary working or operating means with it; rather, in the shown example it is supplied from the outside with all required working or operating means including the necessary electrical current. This supply occurs via the highly flexible, extremely thin tube (serving exclusively as a connection element) that is drawn behind the capsule and that otherwise has no function whatsoever with regard to the mechanical capsule movement. Rather, the capsule movement ensues exclusively via the magnetic navigation. [0032] As stated, a pump 20 is integrated inside the capsule, upstream from which pump 20 is a reservoir 21 that is coupled via a line connection section 22 with the tube 13 that leads to the coupling element 14 . In the shown example the reservoir 21 exhibits three separate chambers 21 a , 21 b and 21 c into which a channel 15 a , 15 b or 15 c respectively leads. The supplied working or operating means (thus for example a flushing gas or a cleaning fluid or the like) can be cached [buffered] in said reservoir 21 and be removed as needed via the pump 20 , upstream from which is a multi-path valve 23 that can be correspondingly switched via the control device 5 . The pump 20 can generate the higher (compared with the feed pressure possible due to the extremely low channel diameter) pressure sometimes required, which is required for example in order to enable a sufficient washing or to inflate the cuff 12 . At this point it is noted that the reservoir 21 can naturally also be omitted if, for example, the feed should be possible with sufficiently high pressure when, for example, only one channel is provided at the tube and different working or operating agents are supplied via this, for example sequentially. [0033] In the shown example diverse lines exit from the pump 20 to different function devices. A first line 24 with integrated valve 25 that can be controlled via the control device 5 opens below the balloon 12 . If this should be inflated, the pump 20 pumps the corresponding gas supplied via the tube 13 (possibly after preceding extraction from the reservoir 21 ) into the balloon and inflates this. [0034] Two further lines 26 with associated valves 27 switchable via the control device 5 open at the capsule housing 2 in the openings 28 just before the image acquisition device 6 . They serve for the deployment of washing gas or washing fluid that is conveyed via the pump 20 with relatively high pressure. Given reverse operation of the pump it is also possible when this thus acts as a suction pump to draw liquid or gas from the capsule environment (thus from the hollow organ) into the capsule and, for example, to store it in the reservoir 21 from where it can be extracted and examined when the capsule is secured. [0035] At this point it is noted that the pump 20 , like the reservoir 21 , is naturally only optional. If, as stated, a feed of the working or operating means with sufficient pressure should be possible, these elements are not required; rather, the required CO 2 gas for inflation of the balloon can be supplied directed by a corresponding external feed controller and be conducted into the balloon, or, respectively, the flushing gas can then be directed directly to the openings 28 (that, as stated, can serve as outlet or inlet openings). [0036] The coupling element 14 is fashioned such that a rotation of the capsule 1 around its longitudinal axis relative to the stationary tube is possible, meaning that it is a swivel coupling (as is shown by the arrow). This enables the tube 13 to not have to follow possible capsule rotations around the capsule longitudinal axis (not drawn). This embodiment is particularly suitable when the tube 13 has only one channel. Otherwise it must be ensured that, in spite of capsule rotation, the connection of the tube-side channels with the corresponding connections inside the capsule is maintained. The electrical connection can be realized by slip ring connections or the like in the coupling element 14 . [0037] In order to enable the detachability of the tube 13 from the endoscopy capsule as needed, the coupling element 14 can be controlled via the control device 5 so that an opening mechanism (not shown in detail) integrated into the coupling element is activated and the tube 13 is decoupled. This can hereby be a simply fashioned, electrically controllable mechanism. This enables the tube to be detached from the capsule as needed, the tube to be withdrawn and the capsule to be directed further etc. Additionally or alternatively, it is also conceivable to separate the upper capsule housing 2 a which directly connects to the coupling element 14 and which is connected with the lower capsule housing 2 b via a sealed dividing wall 29 (shown here only dashed). Exclusively the magnetic element 3 is arranged in the upper capsule housing 2 a . Thus upper capsule part together with the magnetic element 3 can thus be removed as needed so that only the lower capsule part 2 b remains in the body. The remainder can be withdrawn with the tube 13 . This offers the possibility to leave the capsule in the body during a magnetic resonance examination. [0038] In order to generally maintain the operation of the capsule even when the tube 13 is decoupled, it is moreover conceivable to integrate an auxiliary energy supply 30 into the capsule so that it is ensured that, for example, the image acquisition device can also still operate after the decoupling. The radio transmitter/receiver 31 , which wirelessly transmits the image signals outside to the operating or control device and/or receives control signals for opening or closing of the valves 23 , 25 , 27 , then serves, for example, to transfer the acquired images and receive external control signals. It is also possible to optionally provide one or more storages 32 for gas or liquid or the like from which a certain albeit small quantity can be removed and employed in case of need given a decoupled tube. This in particular lends itself when the optional reservoir 21 is not provided. The storage or storages 32 are naturally connected with the remaining line system via corresponding lines (not shown in detail). [0039] As FIG. 1 also shows, the tube 13 is connected at its external end with a plurality of external supply or operating or control devices. In the shown example, for example, the supply devices A, B and C are connected with the channels 15 a , 15 b and 15 c via which a corresponding working or operating means can be supplied in a gaseous or liquid form. D exemplarily identifies the external control or operating device via which the entire capsule operation can be controlled (i.e. the electrical current feed and the data exchange can ensue) and that is connected with the capsule via the conductors 17 a, b, c. [0040] Although modifications and changes may be suggested by those skilled in the art, it is the intention of the inventors to embody within the patent warranted heron all changes and modifications as reasonably and properly come within the scope of their contribution to the art.

An endoscopy capsule has a capsule housing containing at least one magnetic element that interacts with an extracorporeally applied magnetic field to magnetically navigate the endoscopy capsule within a body lumen of a patient. The capsule housing has a tube connected thereto that is composed of a flexible, non-rigid material, i.e., of insufficient rigidity to feed the capsule housing in the body lumen. The tube is provided with a feed path for providing any of a liquid agent, a gaseous agent, electrical power and data between the capsule housing an extracorporeal source.

CROSS-REFERENCE TO PRIOR APPLICATIONS [0001] This is a Non Provisional U.S. Application of three provisional applications, claiming the benefit of U.S. Provisional Application No. 60/984,898, filed Nov. 2, 2007; U.S. Provisional Application No. 61/020,108 filed on Jan. 9, 2008; and US Provisional Application No. 61/083,566 filed on Jul. 25, 2008. FIELD OF THE INVENTION [0002] The present invention relates generally to methods of treating vitamin B 12 deficiency and pharmaceutical compositions for such treatment. BACKGROUND OF THE INVENTION [0003] Vitamin B 12 is important for the normal functioning of the brain and nervous system and for the formation of blood. It is involved in the metabolism of every cell of the body, especially affecting the DNA synthesis and regulation but also fatty acid synthesis and energy production. Its effects are still not completely known. [0004] Cyanocobalamin is the most stable and widely used form of vitamin B 12 . It is bound to plasma proteins and stored in the liver. Vitamin B 12 is excreted in the bile and undergoes some enterohepatic recycling. Absorbed vitamin B 12 is transported via specific B 12 binding proteins, transcobalamin I and II, to the various tissues. The liver is the main organ for vitamin B 12 storage. [0005] Vitamin B 12 deficiency can potentially cause severe and irreversible damage, especially to the brain and nervous system. Oral tablets containing vitamin B 12 have been developed to treat vitamin B 12 deficiency. However, many patients with vitamin B 12 deficiency do not respond to oral vitamin B 12 treatment. There is a need to develop a treatment for these patients. BRIEF SUMMARY OF THE INVENTION [0006] One aspect of the invention is directed to a method for treating vitamin B 12 deficiency in a subject, comprising the steps of (a) preparing a pharmaceutical composition for oral administration containing (1) vitamin B 12 and (2) at least one substance selected from the group consisting of N-[8-(2-hydroxybenzoyl)amino]caprylic acid and its pharmaceutically acceptable salts; and (b) administering the pharmaceutical composition to the subject to effectively treat said vitamin B 12 deficiency. [0007] Another aspect of the invention is directed to a pharmaceutical composition for treating vitamin B 12 deficiency in a subject, comprising (1) vitamin B 12 and (2) at least one substance selected from the group consisting of N-[8-(2-hydroxybenzoyl)amino]caprylic acid and its pharmaceutically acceptable salts; wherein said subject had failed to respond to existing oral vitamin B 12 treatment. [0008] The contents of the patents and publications cited herein and the contents of these documents cited in these patents and publications are hereby incorporated herein by reference to the extent permitted. BRIEF DESCRIPTION OF THE DRAWINGS [0009] FIG. 1 is a graph of serum vitamin B 12 concentration as a function of time. DETAILED DESCRIPTION [0010] As used herein, the term “SNAC” means Sodium-N-salicyloyl-8-aminocaprylate, Monosodium 8-(N-salicyloylamino) octanoate, N-(salicyloyl)-8-aminooctanoic acid monosodium salt, monosodium N-{8-(2phenoxybenzoyl)amino}octanoate, E414 monosodium salt or sodium 8-[(2-hydroxybenzoyl)amino]octanoate. It has the structure [0000] [0000] “N-[8-(2-hydroxybenzoyl) amino]caprylic acid” has an empirical formula C 15 H 21 NO 4 [0011] The term “Vitamin B 12 ” means any member of a group of cobalt-containing compounds known as cobalamins which include, but is not limited to cyanocobalamin, hydroxocobalamin, methylcobalamin, and 5-deoxyadenosylcobalamin. [0012] The term “treatment” or “treating” means any treatment of a disease or disorder in a mammal, including: preventing or protecting against the disease or disorder, that is, causing the clinical symptoms not to develop; inhibiting the disease or disorder, that is, arresting or suppressing the development of clinical symptoms; and/or relieving the disease or disorder, that is, causing the regression of clinical symptoms. The term “mammal” include human subjects. [0013] The terms “carrier, excipient, emulsifier, stabilizer, sweetener, flavoring agent, diluent, coloring agent, solubilizing agent” are as defined in the Handbook of Pharmaceutical Excipients (fourth edition) by Raymond C. Rowe, Paul J. Sheskey and Paul J. Weller, the content of which is herein incorporated by reference. [0014] The term “intrinsic factor protein” means is a glycoprotein produced by the parietal cells of the stomach. It is necessary for the absorption of vitamin B 12 later on in the terminal ileum. [0015] In a preferred embodiment, the treatment is directed to subjects that had failed to respond to existing oral vitamin B 12 treatment. Preferably, tablets are used for the treatment. Such tablets contain from about 0.01 mg to about 25 mg of vitamin B 12 and from about 1 mg to about 600 mg of SNAC each, preferably from about 0.02 mg to about 25 mg of vitamin B 12 and more preferably from about 0.1 mg to about 20 mg of vitamin B 12 and the most preferably from about 0.5 mg to 10 mg of vitamin B 12 and from about 10 mg to about 200 mg of SNAC in each tablet. [0016] The preferred weight ratio of vitamin B 12 and SNAC in the tablet is from about 2:1 to about 1:700, more preferably from about 1:2 to about 1:600 or from about 1:3 to about 1:20 and the most preferably from about 1:4 to about 1:10. [0017] In a preferred embodiment, the pharmaceutical composition is in the form of tablets. Preferrably, each tablet contains from about 0.01 mg to about 25 mg of vitamin B 12 and from about 50 mg to about 600 mg of SNAC. More preferably, each tablet contains from about 0.02 mg to about 20 mg of vitamin B 12 . More preferably, each tablet contains from about 0.1 mg to about 10 mg of vitamin B 12 . The most preferably, each tablet contains about 15 to 20 mg of vitamin B 12 and about 50 to 100 mg of SNAC, or about 0.1 to 1.5 mg of vitamin B 12 and about 25 to 150 mg of SNAC. [0018] In another preferred embodiment, the tablet further contains at least one of a carrier, excipient, emulsifier, stabilizer, sweetener, flavoring agent, diluent, coloring agent, solubilizing agent or combinations thereof. [0019] In another preferred embodiment, the tablet optionally contains from about 1 to 25 mg of Capmul PG-8 and optionally contains from about 0.5 to 10 mg of providone. Preferably, Capmul PG-8 is in an amount from about 2 to 20 mg and Providone is in an amount from about 1 to 8 mg. Preferably, Capmul PG-8 is in an amount from about 5 to 15 mg and the Providone is in an amount from about 1.5 to 5 mg. More preferably, Capmul PG-8 is in an amount from about 5 to 10 mg and Providone is in an amount from about 1.5 to 5 mg. [0020] Without intending to be bound by any particular theory of operation, it is believed that gastrointestinal absorption of vitamin B 12 depends on the presence of sufficient intrinsic factor protein, secreted from gastric parietal cells. The average diet supplies about 10 mcg/day of vitamin B 12 in a protein-bound form that is available for absorption after normal digestion. Vitamin B 12 is bound to intrinsic factor during transit through the stomach; separation occurs in the terminal ileum, and vitamin B 12 enters the mucosal cell for absorption via a receptor mediated process. It is then transported by the transcobalamin binding proteins. A small amount (approximately 1% of the total amount ingested) is absorbed by simple diffusion, but this mechanism is adequate only with very large doses. It is also believed that SNAC will allow B 12 to bypass its usual receptor mediated process. [0021] The following examples are given as specific illustrations of the invention. It should be understood, however, that the invention is not limited to the specific details set forth in the examples. All parts and percentages in the examples, as well as in the remainder of the specification, are by weight unless otherwise specified. [0022] Further, any range of numbers recited in the specification or paragraphs hereinafter describing or claiming various aspects of the invention, such as that representing a particular set of properties, units of measure, conditions, physical states or percentages, is intended to literally incorporate expressly herein by reference or otherwise, any number falling within such range, including any subset of numbers or ranges subsumed within any range so recited. The term “about” when used as a modifier for, or in conjunction with, a variable, is intended to convey that the numbers and ranges disclosed herein are flexible and that practice of the present invention by those skilled in the art using concentrations, amounts, contents, carbon numbers, and properties that are outside of the range or different from a single value, will achieve the desired result, namely, effective treatment of a subject with vitamin B 12 deficiency which failed to respond to existing oral vitamin B 12 tablets as well as pharmaceutical compositions for such treatment. EXAMPLE 1 [0023] Preparation of N-[8-(2-hydroxybenzoyl)amino]caprylic Acid and SNAC [0024] The preparation method for N-[8-(2-hydroxybenzoyl) amino]caprylic acid and SNAC involves the following steps: The starting material is salicylamide, which is converted to form Carsalam. The second step involves the alkylation of Carsalam. The penultimate step is a hydrolysis to cleave the ethyl protection group at the end of the alkyl chain and spring open the heterocyclic ring forming the free acid of SNAC. In the final step, the sodium salt of the SNAC free acid is formed by reaction with a 1% excess stoichiometric amount of sodium hydroxide base. Upon cooling the precipitated product is isolated by centrifugation and vacuum dried prior to packaging. The in-process controls for the synthetic scheme are given in Table I. [0000] TABLE I In-process controls for SNAC Manufacturing Process. Desired In-Process Step Reaction Product Specification Control 1 Carsalam Carsalam <10% salicylamide HPLC 2 Alkylation Alkylated <8% Carsalam HPLC Carsalam 3 Hydrolysis SNAC Free <0.5% LOD acid 4 Sodium Salt SNAC Sodium 95-105% HPLC salt EXAMPLE 2 Preparation of Vitamin B 12 Tablets. [0025] The tablet die and punches are checked to ensure that they are clean and that their surfaces are dusted with magnesium stearate powder. Vitamin B 12 , SNAC, carrier, excipient, emulsifier, stabilizer, sweetener, flavoring agent, diluent, coloring agent, solubilizing agent are screened through a #35 sieve and transferred into a sealed containers. 50 mg of Vitamin B 12 is weighed and mixed thoroughly with 11 grams of a carrier, excipient, emulsifier, stabilizer, sweetener, flavoring agent, diluent, coloring agent and/or solubilizing agent. 100 vitamin B 12 tablets are made, with each tablet containing 0.5 mg of Vitamin B 12 and 110 mg of a carrier, excipient, emulsifier, stabilizer, sweetener, flavoring agent, diluent, coloring agent and/or solubilizing agent. These tablets are used as a control. EXAMPLE 3 Preparation of Vitamin B 12 and SNAC Tablets [0026] 50 mg of Vitamin B 12 , 1 gram of SNAC are weighed and thoroughly mixed with 10 grams of a carrier, excipient, emulsifier, stabilizer, sweetener, flavoring agent, diluent, coloring agent and/or solubilizing agent. 100 vitamin B 12 tablets are made, with each tablet containing 0.5 mg of Vitamin B 12 . 10 mg of SNAC and 100 mg of a carrier, excipient, emulsifier, stabilizer, sweetener, flavoring agent, diluent, coloring agent and/or solubilizing agent. The process is repeated to make tablet batches containing 1.0 mg, 0.8 mg, 0.6 mg, 0.4 mg and 0.2 of Vitamin B 12 , respectively. These tablets have the following specifications for release of SNAC component: [0000] Analytical Tests Specification Method Appearance White to light-tan powder with AM001 pink hue Identification Test for Sodium Confirms presence of Sodium USP <191> FTIR Conforms to reference standard USP <197K> Melting Range/ 193-203° C. with a range not to USP <741> Temperature exceed 5° C. Water Content NMT 3.0% USP <921> Method I Heavy Metals <20 ppm USP <231> Method II Sodium Content 6.9 to 8.4% AM017 Residual Solvents Ethanol Less than 4000 ppm AM008 Heptane Less than 500 ppm AM008 Assay as SNAC 90.0-110.0% w/w AM016 Sodium salt (As Is) Example 4 Preparation of Tablets for Testing on Rats [0027] Tablets with four types of different ingredients were made as follows: (1) 8.8 mg of vitamin B 12 , 35 mg of SNAC were weighed, thoroughly mixed and made into a tablet for dosing on rat; (2) 8.8 mg of vitamin B 12 , 35 mg of SNAC and 5 mg of Capmul PG-8 were weighed, thoroughly mixed and made into a tablet; (3) 8.8 mg of vitamin B 12 , 35 mg of SNAC and 0.9 mg of Providone were weighed, thoroughly mixed and made into a tablet. Each of the four processes was repeated to produce more tablets. EXAMPLE 5 Dosing Sprague-Dawley Rats [0028] Male Sprague-Dawley rats (325-350g) were dosed with vitamin B 12 intravenously (0.5 mg/kg) alone, or orally with the tablets made in Example 4 at a dose of 50 mg/kg vitamin B 12 alone or in combination with SNAC at 200 mg/kg. Blood samples were collected at 0, 3, 10, 20, 30, 60, 120, 240 and 360 minutes post dosing. Plasma samples were analyzed for B12 by RIA. The model independent PK metrics obtained following B12-SNAC combination were compared to those obtained following B12 alone. The testing results are shown in Table 1. [0000] TABLE 1 Comparative Testing Results for Vitamin B 12 Absorption Cmax Tmax AUC Mean (ug/mL) (min) (ug * min/mL) Bio- Group (N = 5) Mean S.D Mean S.D Mean S.D availability % 0.5 mg/kg Vitamin B 12 2.15 0.64 4.4 3.13 65.84 11 (IV)  50 mg/kg Vitamin B 12 0.14 0.07 52 17.9 28.72 13 0.42 alone (PO)  50 mg/kg Vitamin B 12 + 7.99 2.41 24 5.48 522.37 179 7.93 200 mg/kg SNAC (PO) EXAMPLE 6 Preparation of Tablets for Testing on Human Subjects [0029] Tablets were made from Cyanocobalamin, SNAC, Kollidon 90F, Anhydrous Emcompress USP/EP and Magnesium Stearate, NF/BP/EP/JP. Each tablet contains the followings: [0000] Ingredients mg/tablet Cyanocobalamin, USP (Intragranular) 5.00 SNAC (Intragranular) 100.00 Kollidon 90F, NF/EP/JP 2.00 (Providone K90; Intragranular) Anhydrous Emcompress USP/EP (Diabasic 70.00 Calcium Phosphate, Anhydrous; Intragranular) Anhydrous Emcompress USP/EP (Diabasic 21.00 Calcium Phosphate, Anhydrous; Extragranular) Magnesium Stearate, NF/BP/EP/JP 2.00 (extragranular) Total Weight 200.0 EXAMPLE 7 Dosing Human Subjects [0030] Sixteen healthy male subjects were randomized to receive one of the following treatments: [0031] (1) Treatment B: a single oral dose of cyanocobalamin/SNAC (5 mg cyanocobalamin/100 mg SNAC) administered in the fasted state as a tablet. (6 subjects); [0032] (2) Treatment C: a single oral dose of cyanocobalamin alone (5 mg cyanocobalamin, VitaLabs, commercial) administered in the fasted state as a tablet. (6 subjects). [0033] (3) Treatment D: a single intravenous dose of cyanocobalamin (1 mg cyanocobalamin) administered in the fasted state. (4 subjects). Each subject received a 1 mL intravenous injection of a 1 mg/mL (1000 μg/mL) solution resulting in a total dose of 1 mg cyanocobalamin. [0034] The subjects were fasted overnight prior to dosing and had no liquids (including water) consumption for at least one hour before and after dosing. The oral forms of cyanocobalamin/SNAC tablets were administered in a single dose as tablets with 50 mL of plain water. Twenty-five blood samples were drawn for cyanocobalamin analyses at the following time points: within 30 minutes pre-dose and at Minutes 2, 5, 10, 20, 30, 40, 50, and at Hours 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20 and 24 post-dose. [0035] Pharmacokinetic metrics was obtained following a model independent pharmacokinetic analysis of individual cyanocobalamin concentrations. Descriptive statistics was used to summarize the results. [0036] Following 1 tablet of 5 mg B12/100 mg SNAC mean B12 peak concentration is 12847±6613 μg/mL and occur within 1 hour post dose (mean tmax of 0.50±0.21 hours). Mean AUClast (0-24) value is 54618±16392 hr*pg/mL. The percent coefficient of variation (% CV) is 51.5% for Cmax and 30.0% for AUC. [0037] Following a single oral dose of cyanocobalamin alone (5 mg cyanocobalamin, VitaLabs, commercial) mean B12 peak concentration is 1239±450 μg/mL and occur between 3 to 10 hours post-dose (mean tmax of 6.8±3.2 hours). Mean AUClast (0-24) value is 23131±8343 hr*pg/mL. The percent coefficient of variation (% CV) is 36.3% for Cmax and 36.1% for AUC. [0038] Following a single intravenous dose of cyanocobalamin (1 mg cyanocobalamin) administered in the fasted state (4 subjects). Mean B12 peak concentration is 221287±80248 pg/mL and mean AUClast (0-24) value is 215391±44602 hr*pg/mL. The percent coefficient of variation (% CV) is 36.3% for Cmax and 20.7% for AUC. [0039] The mean bioavailability of 1 tablet of 5 mg vitamin B12 alone, 1 tablet of 5 mg vitamin B12/100 mg SNAC, and 2 tablets of 5 mg vitamin B12/100 mg SNAC are 2.15±0.77%, 5.07±1.52, and 5.92±3.05%, respectively. (Note: 2 tablets of 5 mg vitamin B12/100 mg SNAC were dosed previously in a pilot arm are designated Treatment A). [0040] The mean tmax of 1 tablet of 5 mg vitamin B12 alone, 1 tablet of 5 mg vitamin B12/100 mg SNAC, and 2 tablets of 5 mg vitamin B12/100 mg SNAC are 6.8±3.2 hours, 0.50±0.21 hours, and 0.54±0.32 hours, respectively. [0041] No adverse events were observed during the given treatments. All formulations appear to be safe and well tolerated. [0042] It was found surprisingly that the extent of B12 absorption, measured as Cmax and AUC, was significantly enhanced by the administration of the cyanocobalamin/SNAC combination. Vitamin B12 bioavailability was —240% greater for the 1 tablet of 5 mg B12/100 mg SNAC compared to 5 mg B12 commercial formulation. Mean peak B12 concentrations following B12 commercial oral formulation occurred significantly later compared to that following the B12/SNAC combinations likely due to a different site of absorption between the two oral formulations. This is consistent with literature data describing intestinal absorption of B12 occurring in the distal section of the gastrointestinal tract in the absence of the carrier. [0043] The principles, preferred embodiments, and modes of operation of the present invention have been described in the foregoing specification. The invention which is intended to be protected herein, however, is not to be construed as limited to the particular forms disclosed, since these are to be regarded as illustrative rather than restrictive. Variations and changes may be made by those skilled in the art, without departing from the spirit of the invention.

A novel method and composition for treating vitamin B 12 deficiency mammals that fail to respond to oral vitamin B 12 therapy.

This is a continuation-in-part of commonly assigned, U.S. application Ser. No. 10/057,293, filed Oct. 19, 2001, now U.S. Pat. No. 6,551,200 and entitled Improved Golf Club Head. BACKGROUND OF THE INVENTION The present invention relates generally to iron-type golf clubs and, more particularly, to golf club heads configured to impart improved feel to the golfer and improved transfer of energy to a golf ball. After the initial drive from a tee, a golfer usually relies upon his or her set of irons to reach the green, where one or more putts typically finish the hole. A set of irons typically includes irons having loft angles ranging from about 17° for low numbered or long irons, through about 50° for higher numbered or short irons, and typically also includes at least a pitching wedge. The increasing loft angles generally cause the golf ball to have a higher launch angle and a higher spin rate. These irons are used primarily for distance down the fairway, as contrasted for example with lob or sand wedges, and therefore are typically designed differently from the higher lofted wedges, which typically have loft angles in the range of about 52 to 60°. Traditional iron-type golf club heads typically have blade-like shapes, often of a forged steel. This style of head typically includes an upper part that is blade-like and a lower part that is uniformly triangular in cross-section at the rear of the head. The resulting lower mass concentration combines with the loft angle to aid the golfer in getting the club head under the golf ball, particularly in sand or tall grass areas. However, the overall mass distribution can result in a hard feeling upon contact with a golf ball, which is unpleasant to many golfers. Generally, golfers prefer irons having a relatively “soft” feel. They also prefer irons that provide feel feedback on the appropriate swing and contact with the ball, in order to achieve the desired ball travel distance. Another prior iron-type golf club head design removes some mass from the rear of the head, at both the toe area and the heel area, to create two pockets or recesses. This forms a center peak at the rear of the club head. In one such design, the toe and heel end masses and the center peak extend to an upper position, toward the topline, at the rear of the club head. The increase in thickness of the center peak relative to the upper part of the club head is limited in order not to substantially increase the head's weight. Another prior iron-type golf club design has minimal amounts of mass removed from the toe and/or heel areas, so as to form a cosmetic feature that does not differ substantially from the previous, conventional design. In both recess designs, the higher positioned mass at the rear tends to stiffen the club head. A currently popular style is a perimeter-weighted, cavity-back iron, which often is made of a cast steel alloy. The perimeter weighting results in a more forgiving structure for mis-hits, and it is preferred by many golfers. Again, however, the perimeter mass can cause sufficient rigidity to result in undesired vibration being felt by the golfer. Such undesired vibrations also can occur even in head designs having a thickened portion at the rear of the head, behind the impact area. Thus, one undesirable characteristic that is common both to forged, blade-like iron heads and to cast, cavity-back iron heads is a harsh vibration of the head. This vibration also is indicative of uncontrolled energy transfer upon impact with the golf ball. It should, therefore, be appreciated that there is a need for an improved golf club iron head that reduces such undesired vibrations. The present invention fulfills this need. SUMMARY OF THE INVENTION The present invention provides an iron-type golf club head providing enhanced flexibility and selectively increased stiffness, for improved performance and feel. That is, the relative stiffness in the lower portion of the club head, varying from heel to toe, is designed in conjunction with a reduced top stiffness that results in improved vibration characteristics. The vibration is an indication of the energy transmission through the club head upon impact with a golf ball. Thus, the present invention optimizes the channeling of the energy that is felt as vibration, or heard as sound, by the golfer by configuring the club head to have discrete stiffened portions. This effect of these discrete stiffened portions has been found to be of greater significance than is the effect of forming the club head of a forged material or a cast material. A preferred embodiment of a golf club head of the present invention comprises a body having an upper portion and a rearwardly extending lower portion. The upper portion has a top edge, and the lower portion has a bottom edge. The striking face has a length, and a rear side of the lower portion has at least a first recess adjacent a toe end and at least a second recess adjacent a heel end of the head. The loft angle of the club head is between about 17° and 50°. Preferably, the upper portion of the body tapers such that a first stiffness at its upper end provides a maximum stiffness for the upper portion. A second stiffness at its lower end provides a minimum stiffness for the upper portion. A lateral axis is defined at the junction between the upper and lower portions of the body, extending from the toe end to the heel end. A reference point is defined at a mid portion of the lateral axis, between about 55% and about 75% of the height of the striking face, as measured from the bottom edge to the top edge. A central axis is defined substantially parallel to the lateral axis, at approximately 50% of the face height. The first recess comprises a first volume and the second recess comprises a second volume, and the first and second recesses extend at least to the central axis. The portions of the body that define the first and second recesses preferably each have a stiffness no more than 90% greater than a minimum stiffness of the upper portion. The remainder of the lower portion preferably has a stiffness at least 230% greater than the stiffness of at least one of the first and second recesses. In the preferred embodiment, the central region of the lower portion, located below the reference point, has a maximum stiffness that is at least about 30 times a maximum stiffness of the upper portion. The regions below the first and second recesses each have a maximum stiffness at least about 20 times the maximum stiffness of the upper portion. A stiffness zone is defined within the central region, at the central axis, and it extends halfway toward the lateral axis, between the first and second recesses. The zone extends at least about 20% of the length of the striking face, such that a relative stiffness is established between the central region and the upper portion and between the central region and the first and second recesses. Other features and advantages of the present invention should become apparent from the following description of the preferred embodiment, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side elevational view of a golf club head of a preferred embodiment of the invention, taken from the toe end. FIG. 2 is a front elevational view of the golf club head of FIG. 1, showing a striking face having scorelines. FIG. 3 is a side elevational view of the golf club head of FIG. 1, taken from the heel end. FIG. 4 is a rear elevational view of the golf club head of FIG. 1 . FIG. 5 is a rear view of the golf club head of FIG. 1, taken in a direction substantially perpendicular to the club head's rear face and showing regions of enhanced flexibility and regions of increased stiffness. FIG. 6 is the same as FIG. 5, but show the locations of detailed cross-sections. FIG. 7 is a cross-sectional view of the golf club head of FIG. 6, taken at line VII—VII, in the heel region. FIG. 8 is a cross-sectional view of the golf club head of FIG. 6, taken at line VIII—VIII, in the central region. FIG. 9 is a cross-sectional view of the golf club head of FIG. 6, taken at line IX—IX, in the toe region. FIG. 10 is a cross-sectional view of the golf club head of FIG. 6, taken at line X—X, in the lower portion of the club head containing the lower ends of the recesses. FIG. 11 is a cross-sectional view of the golf club head of FIG. 6, taken at line XI—XI, in the lower portion containing the recesses. FIG. 12 is a cross-sectional view of the golf club head of FIG. 6, taken at line XII—XII, at about the junction of the upper and lower portions. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS With reference now to the illustrative drawings, and particularly to FIGS. 1-5, there is shown an iron-type golf club head 10 having a cast metal body with a top edge 12 and a bottom edge 14 at its front wall 16 . A scoreline pattern 18 at a front striking face 20 of the front wall may have the form of U-shaped grooves or any other groove shape desired to obtain a preferred spin rate for a golf ball (not shown) upon impact with the striking face. The striking face has a length L F , measured from a point of intersection of a shaft axis 22 with a plane supporting the club head to the widest point at the club head's toe end 24 . The present invention can be embodied in long and mid irons (e.g., #1-4 and #5-7) having loft angles θ ranging from about 17° to about 38°, as well as in short irons (e.g., #8-9) having loft angles θ ranging to about 45°, and also in wedges having loft angles up to about 50°. A sole 26 may have one or more bounce angles γ i , as desired, to effect ground interaction during a stroke. The golf club iron preferably is part of a set including at least two clubs, and more preferably including at least a #3 iron through a pitching wedge. FIGS. 2 and 4 show how the flexibility of the club head 10 is enhanced by configuring it to have a relatively thin upper portion 30 and a relatively thick lower portion 32 , with recesses 34 , 36 positioned on opposite sides of a central region 38 . Generally, the rear mass of the club head is specifically located to obtain discrete stiffened portions across a toe region 40 , the central region 38 , and a heel region 42 . In the first embodiment described below, these discrete stiffness regions are achieved using specific tailored thicknesses. In contrast, prior art iron designs typically have been configured to have either a blade-like shape or a cavity-back, perimeter-weighted shape. The present invention optimizes the channeling of the energy that is sensed as vibration or sound by the golfer by use of the discrete stiffened portions. This effect of these discrete stiffened portions has been found to be of greater significance than is the effect of forming the club head of a forged material or a cast material. As shown in FIG. 5, a face axis FA is defined at the middle of the central region 38 , within about 10-15% of the midpoint of the length of the face L F . The region immediately adjacent to the face axis generally corresponds to the “sweet spot” of the club head 10 . A lateral axis LA is defined to be substantially tangent to, or linearly overlaying, the junction between the club head's upper and lower portions 30 , 32 . This junction is depicted in FIG. 5 to curve downwardly, but it can alternatively curve upwardly or form a straight line. A reference point R is defined where the face axis FA intersects the lateral axis LA. A reference face height FH is measured along the face axis FA, from the bottom edge 14 to the top edge 12 of the club head 10 , generally parallel to the plane formed by the front striking face 20 . A central axis CA is defined at the middle of the face height FH, parallel with the lateral axis LA. The reference point R preferably is located at a point between 55% and 75%, and more preferably between about 60% and 70%, of the way from the bottom edge to the top edge. Table I sets forth the loft angle and height of R for an exemplary set of irons of the first preferred embodiment. TABLE I First Preferred Embodiment Loft vs. R Values Iron No. 3 4 5 6 7 8 9 PW Loft (deg) 21 24 28 32 36 40 44 48 Ht of R 64 65 65 67 69 61 64 66 (% FH) The recesses 34 , 36 are configured to provide significantly improved flexibility in the respective toe and heel regions 40 , 42 , by their specific location and size at the rear of the club head 10 . A top end 44 of the central region 38 has a width l c , as measured along the lateral axis LA, that is between about 5% and 45% of the face length L F , or more preferably between about 25% and 35% of L F . The recesses 34 , 36 preferably are bound laterally at the toe and heel ends by ribs 46 , 48 that extend beneath the recesses, above the sole 26 . The upper ends 50 , 52 of the ribs 46 , 48 may lie generally along the lateral axis LA. Alternatively, one or both of the upper ends of the ribs may lie below or above the lateral axis, LA. Preferably, neither rib extends beyond about 75% of the face height FH at the toe and heel ends, and both ribs have a height measured above the sole that is at least 10% of the face height FH. With continued reference to FIG. 5, a stiffness zone S is defined in a section of the central region 38 , extending in a vertical direction from the central axis CA about midway to the lateral axis LA. In a substantially normal direction, the stiffness zone S preferably extends a distance of at least 10%, and more preferably at least 20%, of the face length L F , as measured from the face axis FA toward the toe and heel ends. As shown, the stiffness zone S is rectangular and does not include any portion of either recess. The stiffness zone S provides substantially increased stiffness relative to the upper portion 30 . In alternative embodiments of the invention (not shown in the drawings), the top end 44 of the central region 38 , with the reference point R, is curved above the stiffness zone S. Alternatively, the top end can extend toward the toe and heel regions 40 , 42 , over the recesses 34 , 36 . In other embodiments, multiple recesses can be formed at the toe and heel regions. In these latter embodiments, the overall lateral extent of the recesses is greater than it is in the earlier described embodiment, while the central region 38 has a narrower lateral extent l c at the junction of the upper and lower portions 30 , 32 . The volumes of the recesses 34 , 36 can be measured in terms of the material removed from an equivalent body without such recesses. In the present invention, the recesses extend downwardly from approximately the junction of the upper and lower portions 30 , 32 to at least the central axis CA. The shape of the recesses can vary from that depicted in FIG. 4, and can be, for example, rectangular, circular, triangular, or oval. Elaborating now on the stiffness characteristics of the present invention, a point on a wall of the club head 10 may be considered beam-like in cross-section, and its bending stiffness at that point can be calculated as a cubed function of its thickness, h 3 . That is, EI=ƒ(h 3 ), where E is the Young's Modulus and I is the inertia of the cross-section. Thus, for a body of uniform material, if a first point on the body has a thickness of 4.5 mm and a second point has a thickness of 5 mm, then the second point is 11% thicker and has a stiffness that is about 37% greater than that of the first point: (5) 3 /(45) 3 =(1.11) 3 =1.37 Referring now to FIGS. 4-6, a small stepped increase in thickness from the upper portion 30 is present at the lower portion 32 , including the recesses 34 , 36 . This increase does not increase the stiffness at the recesses by more than about 90% compared to the stiffness at the upper portion. The recesses are open toward the upper portion, because there is no wall bounding either recess at the junction of the upper and lower portions of the club head where the stepped increase occurs. FIGS. 7-9 are cross-sectional views of the club head 10 taken generally vertically at the heel region 42 , the central region 38 , and the toe region 40 , respectively. FIGS. 10-12 are cross-sectional views of the club head taken generally horizontally at three distinct horizontal positions. These views show the changes in thickness, and thus indicate the changes in stiffness, from top to bottom and from heel to toe. A thickness T TU at an upper end of the club head's upper portion 30 preferably is in the range of about 3 mm to about 6 mm, and more preferably is in the range of 4 mm to 5 mm, and most preferably is about 4.5 mm. In addition, the thickness T TU preferably is constant for all of the irons in the set. The upper portion 30 preferably tapers downwardly toward the lower portion 32 , from a thickness T TU at its upper end to a thickness T TB at its lower end. Preferably, the thickness T TU is less than about 10% greater than the thickness T TB . Because the head height increases heel to toe, the thickness T TB at the lower end of the upper portion 30 has decreasing values from heel to toe. In alternative embodiments, the thickness T TU could vary through the set. In the present invention, the thickness of the front wall 16 at the location of the recesses 34 , 36 is slightly increased from the upper end of the upper portion 30 of the club head 10 . In this first embodiment, the recess wall thickness T R at the heel and toe is the same and is about 5 mm, or less than about 12% greater than the upper end thickness T TU . Neither recess 34 , 36 should have a wall thickness that is more than about 25% greater than either the thickness T TU or the thickness T TB . The remainder of the lower portion 32 of the club head 10 preferably has a thickness that is at least 25% greater than the thickness T TU This corresponds to a stiffness increase at least 95%. Preferably, the thickness of this remainder of the lower portion is at least 50% greater than the thickness T TU , which corresponds to stiffness increase of at least 230%. In addition, a point of maximum thickness T C,MAX in the central region 38 (see FIG. 8) is at least 3 times thicker than the thickness T TU . This increases the stiffness by a factor of at least 27. More preferably, the maximum thickness T C,MAX is selected to increase the stiffness by a factor of at least 30 times. Similarly, points of maximum thickness T T,MAX , T H,MAX in the respective toe and heel regions 40 , 42 are at least 2.5 times thicker than the thickness T TU , providing a stiffness increase by a factor of at least 15 times. Preferably, the central, toe and heel regions all are at least 20 times stiffer than the upper portion 30 . The preferred thickness values for a 6-iron of this embodiment are shown in Table II. TABLE II First Preferred Embodiment Thickness/Stiffness Values for 6 Iron UPPER PORTION RECESS TOE CENTRAL HEEL REGION T TU, T TB,MIN T R T T,MAX T C,MAX T H,MAX Thickness 4.5, 4.1  5 16.3 15.4 13.6 (mm) Relative 91.1, 68.9 125 4331 3652 2515 Stiffness (T 3 ) Δ Stiffness — +37, +81 +4654, +3909, +2661, (%) +6186  +5200  +3550  A preferred material for the club head 10 of the present invention is steel, and more preferably a carbon steel such as 8620 or 1025. Alternative materials also could be used, including other metals and alloys, composites, and hybrid constructions utilizing, for example, laminations of metal and composite materials. If the club head is cast of a metal material such as steel, the recesses can be formed by milling. Alternatively, the front wall 16 and front striking face can be a separate portion that is welded or otherwise attached to the remainder of the club head in a manner known to those skilled in the art. The lower rear portion of the club head can include one or more separately formed pieces that are attached to the front in any manner known to those skilled in the art. Although the invention has been disclosed in detail with reference only to the preferred embodiments, those skilled in the art will appreciate that additional golf club heads can be made without departing from the scope of the invention. Accordingly, the invention is defined only by the claims set forth below.

A set of iron golf clubs is disclosed, each golf club having a head configured to provide enhanced flexibility for launching a golf ball. An upper portion of the body of each head has a reduced stiffness, while a lower portion of the body is configured with recesses that provide reduced stiffness toward the heel and the toe. A low central region supports the head at impact with the golf ball. The relative stiffness in the lower portion of the club head, varying from heel to toe, is designed in conjunction with a top to bottom difference in stiffness. Thus, the golf club head has enhanced flexibility and selectively increased stiffness, for improved performance and feel.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Patent Application Serial Number 60/380,589 to Summerfield filed on May 15, 2002, entitled “Hockey Puck With Visual Temperature Sensitivity,” incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention generally relates to a sporting object that undergoes a visible change with a change in temperature, and the method of making the sporting object. More particularly, the invention relates to a sporting object, such as a disk or a ball that comprises a temperature sensitive composition that undergoes a change in color or opaqueness upon a particular change in the object's temperature. The temperature sensitive paint or ink can be, for example, applied to the exterior of the sporting object or blended with the material of which the sporting object is made. BACKGROUND OF THE INVENTION [0003] Various activities require the use of a sporting object, such as a disk or a ball, to engage in the activity. The physical properties of the sporting object can be of significance in effectively playing the activity. An ice hockey puck is of particular interest, where the hardness of the puck can affect the character of play. The use of a hockey puck on ice has been in existence for well over 100 years. Other sports based on objects such as balls, pucks and the like may experience temperature dependent performance of the object. [0004] Today, ice hockey is played both at indoor and outdoor rinks. The outside conditions at which hockey is practiced or played vary a great deal in temperature and other conditions. Indoor conditions can vary also, but not generally to the degree that outside conditions vary. Outside rink conditions are obviously not controlled but the condition of indoor ice can be more controllable. [0005] Two of the main factors that affect the performance and use of a hockey puck are the temperature of the ice and the temperature of the puck. The temperature of the puck is controlled in some cases by the procedure of placing the puck(s) in an “ice box” to prepare a cold puck. This procedure of cold storage of the pucks is almost always the practice at the professional and college level of hockey and, in many cases, is practiced at the high school and other lower levels of hockey. However, it would be useful in the play of hockey to know the general temperature of the hockey puck, as the temperature of the puck can affect the play of the game. SUMMARY OF THE INVENTION [0006] In a first aspect, the invention pertains to a puck comprising a structural material in the general shape of a disk and a first thermochromic visualization agent associated with the disk. Generally, at least a portion of the thermochromic visualization agent is visually observable. [0007] In a further aspect, the invention pertains to a method for forming a puck with a temperature dependent visual appearance. The method comprises associating a thermochromic visualization agent with a generally disk shaped structural material. [0008] In another aspect, the invention pertains to a method for playing a sporting activity with an object comprising a thermochromic visualization agent. The method comprises evaluating the object by visual inspection to determine if the object is at a suitable temperature for playing. BRIEF DESCRIPTION OF THE DRAWINGS [0009] [0009]FIG. 1 is a plot of the shore hardness of seven commercially available ice hockey pucks as it varies with temperature. [0010] [0010]FIG. 2 is a plot of the percent of full scale shore hardness of seven commercially available pucks as it varies with temperature. DETAILED DESCRIPTION OF THE INVENTION [0011] Improved embodiments of a sporting object change color or opaqueness dependent upon the temperature to which the sporting object is subjected. The sporting object can be, for example, a disk, a ball (which may or may not be generally spherical) or the like. The visualization of a change in temperature of the sporting object can allow the player(s) to determine if the sporting object is ready for play or, alternatively, if play needs to be adjusted to compensate for the change in performance of the sporting object due to the temperature of the sporting object. The adjustment in play can take the form of, for example, changing the strength involved to strike the sporting object, changing the angle of lift when striking the sporting object, replacing the sporting object with another that is at an appropriate temperature and/or the like. Herein, the reference to temperature dependent color changing also includes differences in opaqueness that can occur at different temperatures. [0012] Temperature sensitive materials (i.e., thermochromic materials) that have different colors at different temperatures have been used in toys for amusement purposes. However, temperature dependent color or opaqueness-changing materials have not been suggested for use in evaluating the readiness for use or evaluating potential performance of a sporting object. The sporting object may be made from one or more materials such as rubber, synthetic polymers, fabric, animal products, such as leather or bone, stones, wood and the like. Although the following description focuses on the use of temperature sensitive materials associated with hockey pucks, other sporting objects can effectively use temperature sensitive color changing materials for the evaluation of the performance of the object. [0013] Many ice hockey players and coaches keep the hockey gear inside during the winter months, at room temperature. This is typically done to keep the clothing warm in the winter months of the Northern Hemisphere. Because the hockey pucks may be kept in the same bag as the other gear, the pucks are inadvertently kept warm also. Because of this, the hockey pucks can be much warmer than an appropriate temperature for desired performance during their use. During the spring and summer months of the Northern Hemisphere, the pucks will remain warm even if they are kept outside. [0014] In some embodiments, the desired performance of a hockey puck is obtained when the puck is cold. In particular, the performance of the puck is within a desired range when the puck has a temperature within a particular range. Since ice hockey pucks are used on ice, the desired temperature ranges generally are relatively cold. Thus, pucks can be stored in an “ice box” prior to use. The hardness of a puck can be significant with respect to both shooting the puck and in passing the puck along the ice. It is desired to have a puck that is hard when shooting so that the puck is not particularly elastic. A warm puck bounces more. It is not desirable to have the puck bounce significantly, for example, after striking the boards. Furthermore, if the puck has undesirable bounce, the puck may be more likely to bounce into the crowd, which can decrease the safety of viewers of a hockey game. Thus, the temperature of the puck can be significant to the game of ice hockey. For pucks and balls used for in-line skate hockey, street hockey and the like, the desired temperature of the puck/ball may be different, and the thermochromic ink can be accordingly selected. [0015] The temperature of the hockey puck relates directly to many of its physical properties, such as but not limited to hardness and coefficient of friction. This relationship of puck hardness and temperature is demonstrated for seven different commercially available hockey pucks in FIG. 1 and FIG. 2. The graphs show how the hardness of the puck varies with the temperature of the puck. The pucks were tested for hardness using a type D Durometer at various temperatures. The graphs can be used to select the temperature ranges where the pucks' hardness would provide for a desired level of hardness and therefore improved play as related to shooting and passing the puck and rebounding the puck off the boards. [0016] Thus, having a hockey puck in which the temperature can be determined by visual observation can greatly facilitate evaluation of puck temperature and corresponding desired puck performance. This visible manifestation can give an indication of the temperature of the hockey puck to the user of the puck. This visible change can then provide to the user of the puck an indication as to whether or not the puck is “ready” to be played with; i.e. the puck has its desired physical characteristics due to its temperature. [0017] In contrast, an alternative approach to determine the readiness of the puck is to touch the puck to determine the temperature of the puck. This method of indicating readiness is not very reliable and can vary from person to person with respect to accuracy. Also, in using a touch indication of temperature, one would have to physically pick-up the puck, as opposed to simply looking at it. [0018] As described herein, an improved puck provides a correlation of a visual manifestation in a sporting object, for example, a hockey puck, to sporting object's temperature. Generally, this correlation would be one physical appearance above a certain temperature and a second visible appearance below a certain temperature, although more than two manifestations of physical appearance can correlate with a corresponding plurality of ranges in temperature as well as a continuous change in visual manifestation with changes in the temperature. In various embodiments, the visual change between different temperatures in respective temperature ranges can be accomplished in many ways, such as a color change (e.g., yellow to red), a change from no color (e. g., black, white or clear) to a color, a change from a color to no color (e. g., black, white or clear) or a change in opaqueness. The color change can be reversible, such that the puck can be reused and can continue to provide the evaluative temperature dependent color change in the desired temperature range. In some embodiments, multiple colors can be used such that the colors or opaqueness may or may not change at the same temperature ranges. [0019] While the thermochromic material can be applied to cause a visual change of the entire surface of the object, in some embodiments, only a portion of the objects surface may undergo a visual manifestation that is temperature dependent. In particular, it may be desirable for the temperature dependent visual manifestation to be in the form of a design. In some embodiments, the design can form a word or familiar pattern. Similarly, the use of multiple colors can allow different patterns or designs to appear on the surface of the hockey puck, dependent upon temperature. For example, at different temperature ranges different portions of a design or logo can appear, or alternatively, the entire design can appear over one temperature range. Other visual changes are also possible, and the visual change can be over the whole puck or any portion thereof. [0020] In some embodiments, the hockey puck or a portion of the puck (or other sporting object) can be coated so that it changes in visual appearance at different temperatures. For example, a thermochromic polymer/ink can be used to generate the visual temperature sensitivity. Suitable thermochromic polymer/ink products include, for example, Chromicolor® products from Matsui International Co. Inc., Gardena, Calif. Suitable inks, paints and polymers are available in a range of standard colors as well as custom colors. In addition, the Chromicolor® inks are available in water-based inks, solvent-based self-curing inks, UV curable inks and epoxy two component inks. The epoxy inks and the UV curable inks are particularly durable. The screen printable commercial inks provide vivid colors. Stock versions of the inks have color transitions at particular temperatures, but custom versions of the commercial inks can have other selected temperatures for the color transition. Thermochromic compositions are described further, for example, in U.S. Pat. No. 4,717,710 to Shimizu et al., entitled “Thermochromic Compositions,” incorporated herein by reference. Examples of other applications of thermochromic inks are described further, for example, in U.S. Pat. No. 5,085,607 to Shibahashi et al., entitled “Toy That Stably Exhibits Different Colors With Indicator For Proper Temperature Application,” incorporated herein by reference. [0021] In some embodiments, a base coat, such as a white layer, can be applied to the object's surface prior to the application of the thermochromic polymer/ink. The base coat can provide improved adhesion to the puck surface. Additionally, or alternatively, the base coat may also provide a contrasting color base onto which the thermochromic polymer/ink can be applied. The contrasting color can add to the design and/or improve visibility of the thermochromic color. Also, the base coat can provide improved durability such that the thermochromic polymer/ink does not separate as readily from the puck substrate. Suitable base coat ink products include, for example, products in the Nazdar 9600 series screen inks from Nazdar, Shawnee, KS, which are available in durable epoxy-based or UV curable forms. [0022] In another embodiment, the puck, with or without a base coat, can be coated with a thermochromic polymer/ink and then a translucent or effectively transparent topcoat can be applied on top of the thermochromic polymer/ink. The topcoat can provide improved durability to the thermochromic polymer/ink coating. It may be advantageous to add such a topcoat, due to the rough treatment the thermochromic composition may encounter as part of a sporting object such as a hockey puck. In a further embodiment, the thermochromic polymer/ink can be pre-applied onto a transparent film thus creating a decal or sticker and, subsequently, the decal or sticker can be applied to the hockey puck surface, for example with an adhesive, other curable polymer or the like. Additionally, after the decal has been applied to the surface of the puck/object, a translucent topcoat can be applied to protect the thermochromic polymer/ink. [0023] In additional embodiments, the object can be formed from a thermochromic composition, or similarly the thermochromic composition can be blended with the material comprising all or a portion of the sporting object. A resulting thermochromic polymer can be used as part or all of the ingredients, for example, when the hockey puck or other sporting object is manufactured. [0024] The thermochromic compositions can have different colors in a variety of temperature ranges. The surface of a hockey puck or other sports object can display one message or design in one temperature range and another in a different temperature range due to the different visual appearance of the thermochromic material at different temperatures. For example, the puck surface can display the word “bad” or an frowning face at one temperature range, and display “good” or “Cool Puck”™ or a smiling face in a different temperature range, generally a desired range for performing the sporting activity with the object. For example, a thermochromic ink can be white at a warmer temperature and blue or other color at a lower temperature, such that the appropriately cool puck has a visual design when ready for use in ice hockey. [0025] In some embodiments, more than one thermochromic polymer/ink can be used on the surface of the hockey puck such that each thermochromic polymer/ink changes color at a different temperature transition. Both thermochromic polymers/inks can be present simultaneously on the same surface. In another embodiment, the thermochromic polymers/inks can change color in similar temperature ranges or alternatively, only one thermochromic polymer/ink can be used. In this embodiment, the thermochromic polymer/ink can be used, for example, to display a multi-color or single-color design or logo that appears in one temperature range. [0026] The temperature range that the thermochromic polymer/ink changes color may be dependent on the use of the sporting object. In the example of a hockey puck, the thermochromic polymer/ink can be selected to change color in a temperature range below 30 degrees F. (−1.1 degree C.), in an additional embodiment the thermochromic polymer/ink changes color below 35 degrees F. (1.7 degrees C.), in another embodiment the thermochromic polymer/ink changes color below 40 degrees F. (4.4 degrees C.), and in a further embodiment the thermochromic polymer/ink changes color below 59 degrees F. (15 degrees C.). In further embodiments, the thermochromic polymer/ink may change color at temperature ranges above 70 degrees F. (21.1 degrees C.), in other embodiments the thermochromic polymer/ink changes color above 80 degrees F. (26.7 degrees C.), and in additional embodiments the thermochromic polymer/ink changes color above 87.8 degrees F. (31.0 degrees C.). A person of ordinary skill in the art will recognize that additional values of temperature for the color transition between these explicit values are contemplated and are within the present disclosure. To specify ranges for the particular visual transition, the visual appearance at one temperature can be references to a reference temperature, such as room temperature or other convenient temperature) different from the transition temperature. [0027] A hockey puck generally has a disk shape with an outer diameter of about 3 inches (76.2 millimeters) and a height of about 1 inch (25.4 millimeters), although the dimensions can be varied as desired. The shape of the edge of the disk can be selected as desired, although for some uses the edge has a medium sharp knurl. A standard puck has a weight from about 155 grams to about 170 grams. A puck can be formed from hard rubber, such as vulcanized natural rubber or latex. Alternatively, a puck can be formed from synthetic polymers, such as polyvinyl chloride, polyisoprene, styrene-butadiene copolymers, arylonitrile-butadiene-styrene copolymer and the like, or mixtures thereof or from mixtures of natural rubber and synthetic polymers. Similarly, the thermochromic materials can be used with alternatively designed pucks, for example, as described in U.S. Pat. No. 5,695,420 to Bellehumeur, entitled “Hockey Puck,” and U.S. Pat. No. 3,704,891 to Chiarelli, entitled “Puck For Ice Hockey,” both of which are incorporated herein by reference. Variations in the puck shape with effectively the same performance properties of a hockey puck can be considered a generally disk shape. [0028] The thermochromic polymer/ink can be mixed with the puck material during formation of the puck, such as molding or extrusion of the puck. Suitable molding approaches include, for example, compression molding, injection molding and blow molding, with compression molding and injection molding being of particular commercial interest. In compression molding, a charge of raw material can be put into a mold and then cured generally under pressure with heat applied. Once the item (e.g. a puck) is removed from the mold, any excess material can be trimmed, and then the item is ready for use. In injection molding, the raw material is forced through a runner via a screw conveyor and into the mold. After the material is cured, the molded item is removed, and any excess material is trimmed. Regardless which method is used, the amount of thermochromic material can be adjusted to yield the desired visual effect. [0029] Alternatively or additionally, the thermochromic material can be coated or printed onto the exterior of the puck. Generally, a smaller amount of the thermochromic material can be used when applying the material as a coating rather than incorporating the thermochromic composition within the puck. Thus, an appropriate coating approach may be particularly cost effective while being effective to product visually pleasing designs. Convenient approaches for applying a thermochromic design, for example, involves screen-printing of a thermochromic ink onto the puck, which can be placed onto a background ink. The desired pattern can be created in a layer over the screen such that the screen forms the desired image. A plurality of screens can be used to form a plurality of ink patterns, which may or may not be overlapping and with one or more involving a thermochromic material. Alternatively, the thermochromic polymer/ink may be applied via other means of painting or imprinting or via a pre-manufactured decal, for example, using approaches known in the art. [0030] In use, the changing color of the puck can indicate to the player the readiness and relative hardness of the puck due to the temperature being within a desired range. For some sporting activities, the temperature dependent physical properties are a significant characteristic for the sporting activity. The visual change can be designed such that the player, referee and/or coach can readily see the visual appearance to evaluate the object, such as a puck. [0031] The present invention has been described in terms of use with a hockey puck, however the invention is not restricted to this use. The invention may be embodied in other materials and forms (e.g. a ball) without departing from the spirit of any of the essential attributes of the invention. Additional uses for the invention will be recognized by those with skill in the art. [0032] The embodiments described above are intended to be illustrative and not limiting. Additional embodiments are within the claims. Although the present invention has been described with reference to particular 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.

An improved puck has a structural material in the general shape of a disk and a thermochromic visualization agent associated with the disk. Generally, at least a portion of the visualization agent is visually observable. The visualization agent generally can be, for example, incorporated into the material of the puck or applied as a coating onto the surface of the puck. Methods for playing a sporting activity can comprise evaluating an object used in the sporting activity to determine if the object is at a suitable temperature for playing.

FIELD OF THE INVENTION [0001] The invention relates to methods for acute treatment of trauma victims, including the prevention of, or minimizing severity of, late complications in trauma patients. BACKGROUND OF THE INVENTION [0002] Haemostasis is a complex physiological process which ultimately results in the arrest of bleeding. This is dependent on the proper function of three main components: blood vessels (especially the endothelial lining), coagulation factors, and platelets. Once a haemostatic plug is formed, the timely activation of the fibrinolytic system is equally important to prevent further unnecessary haemostatic activation. Any malfunction of this system (due to a reduced number, or molecular dysfunction, of the haemostatic components or increased activation of the fibrinolytic components) may lead to clinical bleeding such as, e.g., haemorrhagic diathesis of varying severity. [0003] In most physiological situations, haemostasis is triggered by the interaction of circulating activated coagulation factor VII (FVIIa) with tissue factor (TF) subsequent to exposure of TF at the site of an injury. Endogenous FVIIa becomes proteolytically active only after forming a complex with TF. Normally, TF is expressed in the deep layers of the vessel wall and is exposed following injury. This ensures a highly localized activation of coagulation and prevents disseminated coagulation. TF also seems to exist in a non-active form, so-called encrypted TF. The regulation of encrypted versus active TF is still unknown. [0004] TF has in recent years been demonstrated in the circulating blood in a variety of situations such as trauma, sepsis, abdominal surgery. These studies used immunochemically-based methods for the determination of TF (ELISA). Such methods determine both active and inactive TF as well as TF in complex with any other proteins, (such as FVIIa, TFPI, etc.) and thus do not indicate whether the TF found is active or not. The respective subjects were undergoing surgery for idiopathic thoracic scoliosis, an extensive surgical trauma associated with significant tissue injury. Another study failed to demonstrate any TF in the circulation following major orthopaedic surgery (total hip replacement and knee replacement) known to be associated with a high frequency of postoperative deep venous thrombosis (DVT). [0005] Activated recombinant human factor VII (rFVIIa) is indicated for the treatment of bleeding episodes in haemophilia A or B subjects with inhibitors to Factor VIII or Factor IX. When given in high (pharmacological) doses, rFVIIa can bind independently of TF to activated platelets and initiate local thrombin generation which is important for the formation of the initial haemostatic plug. [0006] Uncontrolled bleeding is the major cause of death (39%) in civilian trauma victims. Sixty-five percent (65%) of deaths occur after admission to the hospital and exsanguination is responsible for between 15-40% of hospital deaths in trauma subjects. In subjects with complex liver injuries, the mortality exceeds 40%. There is a correlation between transfusion with blood products and mortality. Many critically ill trauma subjects have profound coagulopathy which correlates to the severity of injury. [0007] The uncontrolled life threatening bleeding and acquired coagulopathy secondary to transfusion, hypothermia and other related causes faced by these subjects may further lead to so-called late complications including pulmonary embolism, Disseminated Intravascular Coagulation (DIC), Acute Myocardial infarction, Cerebral Thrombosis, Multiple organ Failure (MOF), systemic inflammatory response syndrome (SIRS), and Acute Respiratory Distress Syndrome (ARDS), which complications contribute significantly to later deaths of trauma victims. [0008] Thus, there is a need in the art for improved methods and compositions for acute treatment of trauma, as well as for prevention and attenuation of late complications that result from trauma itself and from conventional modalities that are used to treat trauma victims. SUMMARY OF THE INVENTION [0009] The invention provides the use of Factor VIIa or a Factor VIIa equivalent for the manufacture of a medicament for treatment of trauma. Typical patients for whom the medicament is used are those suffering from coagulopathic bleedings, including, without limitation, patients who have experienced blunt or penetrating trauma. [0010] The invention also provides methods for treating trauma, which are carried out by administering to a patient an effective amount for said preventing or attenuating of Factor VIIa or a Factor VIIa equivalent. Typical patients have experienced blunt trauma or penetrating trauma. [0011] In some embodiments, the initial administering step is carried out within 5 hours of the occurrence of the traumatic injury. In some embodiments, the effective amount comprises at least about 150 μg/kg of Factor VIIa or a corresponding amount of a Factor VIIa equivalent. In some embodiments, a first amount of at least about 200 ug/kg Factor VIIa or a corresponding amount of a Factor VIIa equivalent is administered at the start of treatment, and a second amount of about 100 μg/kg of Factor VIIa or a corresponding amount of a Factor VIIa equivalent is administered to the patient one or more hours after the start of treatment. In some embodiments, a third amount of about 100 μg/kg of Factor VIIa or a corresponding Factor VIIa equivalent is administered at a later time, such as, e.g., at three hours after the start of treatment. [0012] In some embodiments, the method further comprises administering to the patient a second coagulation agent in an amount that augments the treatment by said Factor VIIa or Factor VIIa equivalent. Preferably, the second coagulation agent is a coagulation factor (including, without limitation, Factor VIII, Factor IX, Factor V, Factor XI, Factor XIII, and any combination thereof) or an antifibrinolytic agent (including, without limitation, PAI-1, aprotinin, ε-aminocaproic acid, tranexamic acid, or any combination thereof). [0013] The invention also provides methods for treating trauma in a majority of trauma patients, which are carried out by: (i) administering to a group of trauma patients an amount effective for treatment of Factor VIIa or a Factor VIIa equivalent; and (ii) observing a reduction in of trauma among the group of patients who received Factor VIIa or a Factor VIIa equivalent relative to the frequency of occurrence of said late complications that would have been expected in the same group of patients who had not received said Factor VIIa or Factor VIIa equivalent. LIST OF FIGURES [0014] FIG. 1 shows the distribution of RBC requirements within the 48-hour observation period following first dose of trial product. [0015] FIG. 2 shows the percentage of patients alive at 48 hours receiving >12 units of RBC within 48 hours of first dose, which equals >20 units of RBC inclusive of the 8 pre-dose units [0016] FIG. 3 shows survival curves for blunt and penetrating trauma populations. DETAILED DESCRIPTION OF THE INVENTION [0017] The present invention provides methods and compositions that can be used advantageously to treat trauma patients. The methods are carried out by administering to a trauma patient Factor VIIa or a Factor VIIa equivalent, in a manner that is effective for treatment. A manner effective for treatment may comprise administering a predetermined amount of Factor VIIa or a Factor VIIa equivalent, and/or utilizing a particular dosage regimen, formulation, mode of administration, combination with other treatments, and the like. The efficacy of the methods of the invention in treating trauma may be assessed using one or more conventionally used parameters of the immediate consequences of injury and/or late complications (see below). Immediate consequences include, e.g., blood loss and symptoms of shock; while late complications, include, without limitation, Pulmonary embolism (PE), Acute Respiratory Distress Syndrome (ARDS), Disseminated Intravascular Coagulation (DIC), Acute Myocardial Infarction (AMI), Cerebral Thrombosis (CT), Systemic Inflammatory Response Syndrome (SIRS), infections, Multiple Organ Failure (MOF), and Acute Lung Injury (ALI), including death caused by one or more of these syndromes. [0000] Patient Selection: [0018] Patients who may benefit by use of the methods of the present invention include, without limitation, patients who have suffered from blunt trauma and/or penetrating trauma. Blunt trauma includes blunt injuries, such as, e.g., those caused by traffic accidents or falls, which could result in one or more of liver injuries, multiple fractures, brain contusions, as well as lacerations of the spleen, lungs, or diaphragm. Blunt trauma is generally accompanied by more extensive tissue damage as compared to penetrating trauma and, consequently, more small vessel bleeding. Penetrating trauma includes penetrating injuries, such as, e.g., those caused by gun shot wounds or stab wounds, which could result in penetration of the inferior vena cava, liver damage, lung injury, injury to prostate, urinary bladder, thorax and liver lacerations, and wounds to the pelvis or chest. [0019] Trauma may cause injury to, and subsequent bleeding from, both larger and smaller vessels. Excessive or massive bleeding in most trauma cases presents a combination of bleeding from vessels needing surgical treatment (“surgical bleeding”) and diffuse uncontrolled bleeding from small vessels (“coagulopathic bleeding”). Furthermore, trauma subjects who receive massive transfusions often suffer from coagulopathy and continue to bleed profusely despite intervention with surgical procedures, packing, and embolization of larger vessels. [0020] Bleeding refers to extravasation of blood from any component of the circulatory system and encompasses any bleeding (including, without limitation, excessive, uncontrolled bleeding, i.e., haemorrhaging) in connection with trauma. In one series of embodiments, the excessive bleeding is caused by blunt injury; in another it is caused by penetrating injury. In one series of embodiment, the injury(ies) is/are to the liver, spleen, lungs, diaphragm, head, including the brain. In another series of embodiments, the injury(ies) is/are to the inferior vena cava, liver damage, lung injury, injury to prostate, urinary bladder, thorax and liver lacerations, pelvis or chest, or head, including the brain. [0021] Coagulopathy in trauma is multifactorial, encompassing coagulation abnormalities resembling DIC, caused by systemic activation of coagulation and fibrinolysis; excessive fibrinolysis, which can be evident on the first day in some trauma subjects; and dilutional coagulopathy, which is caused by excessive fluid administration. Some fluids such as hydroxyethyl starch (HES) preparations may directly compromise coagulation. Massive transfusion syndrome results in depletion of coagulation factors and impairment of platelet function. Hypothermia causes a slower enzyme activity of the coagulation cascade and dysfunctional platelets. Metabolic abnormalities, such as acidosis, also compromise coagulation especially when associated with hypothermia. [0022] Non-limiting examples of patients in need of treatment according to the invention include those who exhibit one or more of the following: Coagulation abnormalities resembling DIC, caused by systemic activation of coagulation and fibrinolysis Excessive fibrinolysis Dilutional coagulopathy caused by excessive fluid treatment, including, without limitation, a limited number of platelets and/or an impaired platelet function compared to the platelet count and platelet activity of normal pooled blood Receipt of hydroxyethyl starch (HES) preparations Hypothermia, a including having body temperature below about 37° C., such as, e.g., below about 36° C., below about 35° C., or below about 34° C. At least one indication of metabolic abnormalities, including, without limitation, acidosis having a blood pH below about 7.5, such as, e.g., below about 7.4, below about 7.3, below about 7.2, or below about 7.1. [0029] The methods of the present invention can be applied advantageously to any patient who has suffered blunt and/or penetrating trauma that, if left untreated, would result in a significant loss of blood, such as, e.g., over 10% of the patient's total blood volume (loss of over 40% of blood volume is immediately life-threatening.) A normal blood volume represents about 7% of an adult's ideal body weight and about 8-9% of a child's ideal body weight. [0030] In one series of embodiments, patients treated according to the invention are those who have received less than about 10 units of whole blood (WB), packed red blood cells (pRBC), or fresh frozen plasma (FFP) between the time of their traumatic injury and the time of administration of Factor VIIa or Factor VIIa equivalent. A unit of WB typically contains about 450 ml blood and 63 ml of conventional anticoagulant/preservative (having a haematocrit of 36-44%). A unit of pRBC typically contains 200-250 ml of red blood cells, plasma, and conventional anticoagulant/preservative (having a haematocrit of 70-80%). In other embodiments, patients treated according to the invention have received less than about 8 units of WB, pRBC, or FFP, such as, e.g., less than about 5 units, or less than about 2 units, or have not received any blood products and/or volume replacement products prior to administration of Factor VIIa or Factor VIIa equivalent. [0031] In one series of embodiments, patients treated according to the invention do not suffer from a bleeding disorder, whether congenital or acquired, such as, e.g., Haemophilia A, B. or C. [0032] In different embodiments of the invention, patients may be excluded from treatment if they have received transfusion of 10 units or more of PRBC, such as, e.g., more than 15, 20, 25, or 30 units, or if they have been diagnosed with a congenital bleeding disorder. [0000] Factor VIIa and Factor VIIa Equivalents: [0033] In practicing the present invention, any Factor VIIa or Factor VIIa equivalent may be used that is effective in treating trauma. In some embodiments, the Factor VIIa is human Factor VIIa, as disclosed, e.g., in U.S. Pat. No. 4,784,950 (wild-type Factor VII). The term “Factor VII” is intended to encompass Factor VII polypeptides in their uncleaved (zymogen) form, as well as those that have been proteolytically processed to yield their respective bioactive forms, which may be designated Factor VIIa. Typically, Factor VII is cleaved between residues 152 and 153 to yield Factor VIIa. [0034] Factor VIIa equivalents include, without limitation, Factor VII polypeptides that have either been chemically modified relative to human Factor VIIa and/or contain one or more amino acid sequence alterations relative to human Factor VIIa. Such equivalents may exhibit different properties relative to human Factor VIIa, including stability, phospholipid binding, altered specific activity, and the like. [0035] In one series of embodiments, a Factor VIIa equivalent includes polypeptides that exhibit at least about 10%, preferably at least about 30%, more preferably at least about 50%, and most preferably at least about 70%, of the specific biological activity of human Factor VIIa. For purposes of the invention, Factor VIIa biological activity may be quantified by measuring the ability of a preparation to promote blood clotting using Factor VII-deficient plasma and thromboplastin, as described, e.g., in U.S. Pat. No. 5,997,864. In this assay, biological activity is expressed as the reduction in clotting time relative to a control sample and is converted to “Factor VII units” by comparison with a pooled human serum standard containing 1 unit/ml Factor VII activity. Alternatively, Factor VIIa biological activity may be quantified by (i) measuring the ability of Factor VIIa or a Factor VIIa equivalent to produce of Factor Xa in a system comprising TF embedded in a lipid membrane and Factor X. (Persson et al., J. Biol. Chem. 272:19919-19924, 1997); (ii) measuring Factor X hydrolysis in an aqueous system (see, Example 5 below); (iii) measuring the physical binding of Factor VIIa or a Factor VIIa equivalent to TF using an instrument based on surface plasmon resonance (Persson, FEBS Letts. 413:359-363, 1997) and (iv) measuring hydrolysis of a synthetic substrate by Factor VIIa and/or a Factor VIIa equivalent. [0036] Examples of factor VII equivalents include, without limitation, wild-type Factor VII, L305V-FVII, L305V/M306D/D309S-FVII, L305I-FVII, L305T-FVII, F374P-FVII, V158T/M298Q-FVII, V158D/E296V/M298Q-FVII, K337A-FVII, M298Q-FVII, V158D/M298Q-FVII, L305V/K337A-FVII, V158D/E296V/M298Q/L305V-FVII, V158D/E296V/M298Q/K337A-FVII, V158D/E296V/M298Q/L305V/K337A-FVII, K157A-FVII, E296V-FVII, E296V/M298Q-FVII, V158D/E296V-FVII, V158D/M298K-FVII, and S336G-FVII, L305V/K337A-FVII, L305V/V158D-FVII, L305V/E296V-FVII, L305V/M298Q-FVII, L305V/V158T-FVII, L305V/K337A/V158T-FVII, L305V/K337A/M298Q-FVII, L305V/K337A/E296V-FVII, L305V/K337A/V158D-FVII, L305V/V158D/M298Q-FVII, L305V/V158D/E296V-FVII, L305V/V158T/M298Q-FVII, L305V/V158T/E296V-FVII, L305V/E296V/M298Q-FVII, L305V/V158D/E296V/M298Q-FVII, L305V/V158T/E296V/M298Q-FVII, L305V/V158T/K337A/M298Q-FVII, L305V/V158T/E296V/K337A-FVII, L305V/V158D/K337A/M298Q-FVII, L305V/V158D/E296V/K337A-FVII, L305V/V158D/E296V/M298Q/K337A-FVII, L305V/V158T/E296V/M298Q/K337A-FVII, S314E/K316H-FVII, S314E/K316Q-FVII, S314E/L305V-FVII, S314E/K337A-FVII, S314E/V158D-FVII, S314E/E296V-FVII, S314E/M298Q-FVII, S314E/V158T-FVII, K316H/L305V-FVII, K316H/K337A-FVII, K316H/V158D-FVII, K316H/E296V-FVII, K316H/M298Q-FVII, K316H/V158T-FVII, K316Q/L305V-FVII, K316Q/K337A-FVII, K316Q/V158D-FVII, K316Q/E296V-FVII, K316Q/M298Q-FVII, K316Q/V158T-FVII, S314E/L305V/K337A-FVII, S314E/L305V/V158D-FVII, S314E/L305V/E296V-FVII, S314E/L305V/M298Q-FVII, S314E/L305V/V158T-FVII, S314E/L305V/K337A/V158T-FVII, S314E/L305V/K337A/M298Q-FVII, S314E/L305V/K337A/E296V-FVII, S314E/L305V/K337A/V158D-FVII, S314E/L305V/V158D/M 298Q-FVII, S314E/L305V/V158D/E296V-FVII, S314E/L305V/V158T/M298Q-FVII, S314E/L305V/V158T/E296V-FVII, S314E/L305V/E296V/M298Q-FVII, S314E/L305V/V158D/E296V/M298Q-FVII, S314E/L305V/V158T/E296V/M298Q-FVII, S314E/L305V/V158T/K337A/M298Q-FVII, S314E/L305V/V158T/E296V/K337A-FVII, S314E/L305V/V158D/K337A/M298Q-FVII, S314E/L305V/V158D/E296V/K337A -FVII, S314E/L305V/V158D/E296V/M298Q/K337A-FVII, S314E/L305V/V158T/E296V/M298Q/K337A-FVII, K316H/L305V/K337A-FVII, K316H/L305V/V158D-FVII, K316H/L305V/E296V-FVII, K316H/L305V/M298Q-FVII, K316H/L305V/V158T-FVII, K316H/L305V/K337A/V158T-FVII, K316H/L305V/K337A/M298Q-FVII, K316H/L305V/K337A/E296V-FVII, K316H/L305V/K337A/V158D-FVII, K316H/L305V/V158D/M298Q-FVII, K316H/L305V/V158D/E296V-FVII, K316H/L305V/V158T/M298Q-FVII, K316H/L305V/V158T/E296V-FVII, K316H/L305V/E296V/M298Q-FVII, K316H/L305V/V158D/E296V/M298Q-FVII, K316H/L305V/V158T/E296V/M298Q-FVII, K316H/L305V/V158T/K337A/M298Q-FVII, K316H/L305V/V158T/E296V/K337A-FVII, K316H/L305V/V158D/K337A/M298Q-FVII, K316H/L305V/V158D/E296V/K337A -FVII, K316H/L305V/V158D/E296V/M298Q/K337A-FVII, K316H/L305V/V158T/E296V/M298Q/K337A-FVII, K316Q/L305V/K337A-FVII, K316Q/L305V/V158D-FVII, K316Q/L305V/E296V-FVII, K316Q/L305V/M298Q-FVII, K316Q/L305V/V158T-FVII, K316Q/L305V/K337A/V158T-FVII, K316Q/L305V/K337A/M298Q-FVII, K316Q/L305V/K337A/E296V-FVII, K316Q/L305V/K337A/V158D-FVII, K316Q/L305V/V158D/M298Q-FVII, K316Q/L305V/V158D/E296V-FVII, K316Q/L305V/V158T/M298Q-FVII, K316Q/L305V/V158T/E296V-FVII, K316Q/L305V/E296V/M298Q-FVII, K316Q/L305V/V158D/E296V/M298Q-FVII, K316Q/L305V/V158T/E296V/M298Q-FVII, K316Q/L305V/V158T/K337A/M298Q-FVII, K316Q/L305V/V158T/E296V/K337A-FVII, K316Q/L305V/V158D/K337A/M298Q-FVII, K316Q/L305V/V158D/E296V/K337A-FVII, K316Q/L305V/V158D/E296V/M298Q/K337A-FVII, and K316Q/L305V/V158T/E296V/M298Q/K337A-FVII. [0000] In some embodiments, the factor VII equivalent is V158D/E296V/M298Q-FVII. [0000] Preparations and Formulations: [0037] The present invention encompasses therapeutic administration of Factor VIIa or Factor VIIa equivalents, which is achieved using formulations that comprise Factor VIIa preparations. As used herein, a “Factor VII preparation” refers to a plurality of Factor VIIa polypeptides or Factor VIIa equivalent polypeptides, including variants and chemically modified forms, that have been separated from the cell in which they were synthesized, whether a cell of origin or a recombinant cell that has been programmed to synthesize Factor VIIa or a Factor VIIa equivalent. [0038] Separation of polypeptides from their cell of origin may be achieved by any method known in the art, including, without limitation, removal of cell culture medium containing the desired product from an adherent cell culture; centrifugation or filtration to remove non-adherent cells; and the like. [0039] Optionally, Factor VII polypeptides may be further purified. Purification may be achieved using any method known in the art, including, without limitation, affinity chromatography, such as, e.g., on an anti-Factor VII antibody column (see, e.g., Wakabayashi et al., J. Biol. Chem. 261:11097, 1986; and Thim et al., Biochem. 27:7785, 1988); hydrophobic interaction chromatography; ion-exchange chromatography; size exclusion chromatography; electrophoretic procedures (e.g., preparative isoelectric focusing (IEF), differential solubility (e.g., ammonium sulfate precipitation), or extraction and the like. See, generally, Scopes, Protein Purification, Springer-Verlag, New York, 1982; and Protein Purification, J.-C. Janson and Lars Ryden, editors, VCH Publishers, New York, 1989. Following purification, the preparation preferably contains less than about 10% by weight, more preferably less than about 5% and most preferably less than about 1%, of non-Factor VII proteins derived from the host cell. [0040] Factor VII and Factor VII-related polypeptides may be activated by proteolytic cleavage, using Factor XIIa or other proteases having trypsin-like specificity, such as, e.g., Factor IXa, kallikrein, Factor Xa, and thrombin. See, e.g., Osterud et al., Biochem. 11:2853 (1972); Thomas, U.S. Pat. No. 4,456,591; and Hedner et al., J. Clin. Invest. 71:1836 (1983). Alternatively, Factor VII may be activated by passing it through an ion-exchange chromatography column, such as Mono Q® (Pharmacia) or the like. The resulting activated Factor VII may then be formulated and administered as described below. [0041] Pharmaceutical compositions or formulations for use in the present invention comprise a Factor VIIa preparation in combination with, preferably dissolved in, a pharmaceutically acceptable carrier, preferably an aqueous carrier or diluent. A variety of aqueous carriers may be used, such as water, buffered water, 0.4% saline, 0.3% glycine and the like. The preparations of the invention can also be formulated into liposome preparations for delivery or targeting to the sites of injury. Liposome preparations are generally described in, e.g., U.S. Pat. Nos. 4,837,028, 4,501,728, and 4,975,282. The compositions may be sterilised by conventional, well-known sterilisation techniques. The resulting aqueous solutions may be packaged for use or filtered under aseptic conditions and lyophilised, the lyophilised preparation being combined with a sterile aqueous solution prior to administration. [0042] The compositions may contain pharmaceutically acceptable auxiliary substances or adjuvants, including, without limitation, pH adjusting and buffering agents and/or tonicity adjusting agents, such as, for example, sodium acetate, sodium lactate, sodium chloride, potassium chloride, calcium chloride, etc. [0000] Treatment Regimen: [0043] In practicing the present invention, Factor VIIa or the Factor VIIa equivalent may be administered to a patient as a single dose comprising a single-dose-effective amount for treating trauma, or in a staged series of doses which together comprise an effective amount for treating trauma. An effective amount of Factor VIIa or the Factor VIIa equivalent (see below) refers to the amount of Factor VIIa or equivalent which, when administered in a single dose or in the aggregate of multiple doses, or as part of any other type of defined treatment regimen, produces a measurable improvement in at least one clinical parameter associated with trauma (see below). When Factor VIIa equivalents are administered, an effective amount may be determined by comparing the coagulant activity of the Factor VIIa equivalent with that of Factor VIIa and adjusting the amount to be administered proportionately to the predetermined effective dose of Factor VIIa. [0044] Administration of Factor VIIa or a Factor VIIa equivalent according to the present invention is preferably initiated within about 6 hours after occurrence of the traumatic injury, such as, e.g., within about 4 hours, within about 2 hours, or within about 1 hour. [0045] Administration of a single dose refers to administration of an entire dose of Factor VIIa or the Factor VIIa equivalent as a bolus over a period of less than about 5 minutes. In some embodiments, the administration occurs over a period of less than about 2.5 minutes, and, in some, over less than about 1 min. Typically, a single-dose effective amount comprises at least about 40 ug/kg human Factor VIIa or a corresponding amount of a Factor VIIa equivalent, such as, at least about 50 ug/kg, 75 ug/kg, or 90 ug/kg, or at least 150 ug/kg Factor VIIa. [0046] In some embodiments, following administration of a single dose of Factor VIIa or a Factor VIIa equivalent according to the invention, the patient receives no further Factor VIIa or Factor VIIa equivalent for an interval of at least about 15 minutes. In some embodiments the post-administration interval is at least about 30 minutes, such as at least about 45 minutes, at least about 1 hour, at least about 1.5 hours, or at least about 2 hours. [0047] In other embodiments, the patient receives Factor VIIa or Factor VIIa equivalent according to the following regimen: (i) The patient receives a first amount of Factor VIIa or Factor VIIa equivalent comprising at least about 40 ug/kg; (ii) after a period of at least about 30 minutes, a second amount of Factor VIIa or Factor VIIa equivalent is administered, the amount comprising at least about 40 ug/kg; and (iii) after a period of at least about 30 minutes from administration of the second dose, a third amount of Factor VIIa or Factor VIIa equivalent is administered, the amount comprising at least about 40 ug/kg. After a period of at least about 30 minutes following the administration of the third amount, the patient may then receive a further (fourth) amount of Factor VIIa or Factor VIIa equivalent comprising at least about 40 ug/kg. [0048] In other embodiments, the first amount of Factor VIIa or Factor VIIa equivalent comprises at least about 100 ug/kg, such as at least about 150 ug/kg or at least about 200 ug/kg; in other embodiments, the second amount of Factor VIIa or Factor VIIa equivalent comprises at least about 75 ug/kg, such as at least about 90 ug/kg; in other embodiments, the third (and optionally fourth) amount of Factor VIIa or Factor VIIa equivalent comprises at least about 75 ug/kg, such as at least about 90 ug/kg. [0049] In one embodiment, the first dose comprises about 200 ug/kg, the second dose about 100 ug/kg, and the third (and optionally fourth) dose about 100 ug/kg. [0050] In other embodiments, the patient receives the second amount of Factor VIIa or Factor VIIa equivalent after a period of at least about 45 minutes from the first administration, such as at least about 1 hour, at least about 1.5 hours, at least about 2 hours, at least about 2.5 hours, or at least about 3 hours. [0051] In other embodiments, the patient receives the third (and optionally fourth) amount of Factor VIIa or Factor VIIa equivalent after a period of at least about 45 minutes from the previous administration, such as at least about 1 hour, at least about 1.5 hours, at least about 2 hours, at least about 2.5 hours, or at least about 3 hours. [0052] In one embodiment, the patient receives a first dose comprising about 200 ug/kg; after a period of about 1 hour, the patient receives a second dose comprising about 100 ug/kg, and after a period of about 3 hours from the first dose, the patient receives a third dose comprising about 100 ug/kg. [0053] The following table illustrates different non-limiting embodiments of the invention: Time post- Time to 2 nd Dose Time to 3 rd Dose Additional injury 1 st Dose 2 nd dose (optional) 3 rd dose (optional) Doses  0-≦1 h >40 mcg/kg 0-1 h >40 mcg/kg 0-1 h >40 mcg/kg As needed 1-2 h 1-2 h ≧3 h ≧3 h 100 mcg/kg 0-1 h 50-100 mcg/kg 0-1 h 50-100 mcg/kg 1-2 h 1-2 h ≧3 h ≧3 h ≧150 mcg/kg 0-1 h 50-100 mcg/kg 0-1 h 50-100 mcg/kg 1-2 h 1-2 h ≧3 h ≧3 h >1-≦3 h >40 mcg/kg 0-1 h >40 mcg/kg 0-1 h >40 mcg/kg As needed 1-2 h 1-2 h ≧3 h ≧3 h 100 mcg/kg 0-1 h 50-100 mcg/kg 0-1 h 50-100 mcg/kg 1-2 h 1-2 h ≧3 h ≧3 h ≧150 mcg/kg 0-1 h 50-100 mcg/kg 0-1 h 50-100 mcg/kg 1-2 h 1-2 h ≧3 h ≧3 h >3-<6 h >50 mcg/kg 0-1 h >50 mcg/kg 0-1 h >50 mcg/kg As needed 1-2 h 1-2 h ≧3 h ≧3 h 100 mcg/kg 0-1 h 50-100 mcg/kg 0-1 h 50-100 mcg/kg 1-2 h 1-2 h ≧3 h ≧3 h ≧150 mcg/kg 0-1 h 50-100 mcg/kg 0-1 h 50-100 mcg/kg 1-2 h 1-2 h ≧3 h ≧3 h  >6-<12 h >50 mcg/kg 0-1 h >50 mcg/kg 0-1 h >50 mcg/kg As needed 1-2 h 1-2 h ≧3 h ≧3 h 100 mcg/kg 0-1 h 50-100 mcg/kg 0-1 h 50-100 mcg/kg 1-2 h 1-2 h ≧3 h ≧3 h ≧150 mcg/kg 0-1 h 50-100 mcg/kg 0-1 h 50-100 mcg/kg 1-2 h 1-2 h ≧3 h ≧3 h >12 h >50 mcg/kg 0-1 h >50 mcg/kg 0-1 h >50 mcg/kg As needed 1-2 h 1-2 h ≧3 h ≧3 h 100 mcg/kg 0-1 h 50-100 mcg/kg 0-1 h 50-100 mcg/kg 1-2 h 1-2 h ≧3 h ≧3 h ≧150 mcg/kg 0-1 h 50-100 mcg/kg 0-1 h 50-100 mcg/kg 1-2 h 1-2 h ≧3 h ≧3 h [0054] It will be understood that the effective amount of Factor VIIa or Factor VIIa equivalent, as well as the overall dosage regimen, may vary according to the patient's haemostatic status, which, in turn, may be reflected in one or more clinical parameters, including, e.g., relative levels of circulating coagulation factors; amount of blood lost; rate of bleeding; haematocrit, and the like. It will be further understood that the effective amount may be determined by those of ordinary skill in the art by routine experimentation, by constructing a matrix of values and testing different points in the matrix. [0055] For example, in one series of embodiments, the invention encompasses (i) administering a first dose of Factor VIIa or a Factor VIIa equivalent; (ii) assessing the patient's coagulation status after a predetermined time; and (iii) based on the assessment, administering a further dose of Factor VIIa or Factor VIIa equivalent if necessary. Steps (ii) and (iii) may be repeated until satisfactory haemostasis is achieved. [0056] According to the invention, Factor VIIa or a Factor VIIa equivalent may be administered by any effective route, including, without limitation, intravenous, intramuscular, subcutaneous, mucosal, and pulmonary routes of administration. Preferably, administration is by an intravenous route. [0000] Combination Treatments: [0057] The present invention encompasses combined administration of an additional agent in concert with Factor VIIa or a Factor VIIa equivalent. In some embodiments, the additional agent comprises a coagulant, including, without limitation, a coagulation factor such as, e.g., Factor VIII, Factor IX, Factor V, Factor XI, or Factor XIII; or an inhibitor of the fibrinolytic system, such as, e.g., PAI-1, aprotinin, ε-aminocaproic acid or tranexamic acid. [0058] It will be understood that, in embodiments comprising administration of combinations of Factor VIIa with other agents, the dosage of Factor VIIa or Factor VIIa equivalent may on its own comprise an effective amount and additional agent(s) may further augment the therapeutic benefit to the patient. Alternatively, the combination of Factor VIIa or equivalent and the second agent may together comprise an effective amount for treating trauma. It will also be understood that effective amounts may be defined in the context of particular treatment regimens, including, e.g., timing and number of administrations, modes of administrations, formulations, etc. [0000] Treatment Outcomes: [0059] The present invention provides methods and compositions for treating trauma. Treatment encompasses any measurable improvement or amelioration of any parameter that is indicative of the degree of trauma. Non-limiting examples of such parameters include: Coagulation status, as reflected, e.g. in abnormalities resembling DIC; excessive fibrinolysis; dilutional coagulopathy, including, without limitation, a limited number of platelets and/or an impaired platelet function compared to the platelet count and platelet activity of normal pooled blood Hypothermia, a including having body temperature below about 37° C., such as, e.g., below about 36° C., below about 35° C., or below about 34° C. Indicators of metabolic abnormalities, including, without limitation, acidosis having a blood pH below about 7.5, such as, e.g., below about 7.4, below about 7.3, below about 7.2, or below about 7.1. Blood loss [0064] Efficacy of the methods of the present invention in treating trauma may also be measured by assessing a statistical decrease in late complications, including, without limitation, Pulmonary embolism (PE), Acute Respiratory Distress Syndrome (ARDS), Disseminated Intravascular Coagulation (DIC), Acute Myocardial Infarction (AMI), Cerebral Thrombosis (CT), Systemic Inflammatory Response Syndrome (SIRS), infections, Multiple Organ Failure (MOF), and Acute Lung Injury (ALI), including death caused by one or more of these syndromes. [0065] In practicing the present invention, late complications may be assessed using conventional methods, such as, e.g., the Scores described in Tables 1 to 5 herein. Assessments may be performed at least about 20 days from the start of treatment according to the invention, such as, e.g., at least about 30 days, at least about 35 days, or at least about 40 days from the start of treatment. [0066] Organ damage or organ failure encompass, without limitation, damage to the structure and/or damage to the functioning of the organ in kidney, lung, adrenal, liver, bowel, cardiovascular system, and/or haemostatic system. Examples of organ damage include, but are not limited to, morphological/structural damage and/or damage to the functioning of the organ such as, for example accumulation of proteins (for example surfactant) or fluids due to pulmonary clearance impairment or damage to the pulmonary change mechanisms or alveolo-capillary membrane damage. The terms “organ injury”, “organ damage” and “organ failure” may be used interchangeably. Normally, organ damage results in organ failure. By organ failure is meant a decrease in organ function compared to the mean, normal functioning of a corresponding organ in a normal, healthy person. The organ failure may be a minor decrease in function (e.g., 80-90% of normal) or it may be a major decrease in function (e.g., 10-20% of normal); the decrease may also be a complete failure of organ function. Organ failure includes, without limitation, decreased biological functioning (e.g., urine output), e.g., due to tissue necrosis, loss of glomeruli (kidney), fibrin deposition, haemorrhage, oedema, or inflammation. Organ damage includes, without limitation, tissue necrosis, loss of glomeruli (kidney), fibrin deposition, haemorrhage, oedema, or inflammation. [0067] Lung damage encompasses, but is not limited to, morphological/structural damage and/or damage to the functioning of the lung such as, for example accumulation of proteins (for example surfactant) or fluids due to pulmonary clearance impairment or damage to the pulmonary change mechanisms or alveolo-capillary membrane damage. The terms “lung injury”, “lung damage” and “lung failure” may be used interchangeably. [0068] Methods for testing organ function and efficiency, and suitable biochemical or clinical parameters for such testing, are well known to the skilled clinician. [0069] Such markers, or biochemical parameters of organ function are, for example: [0070] Respiration: PaO2/FiO2 ratio [0071] Coagulation: Platelets [0072] Liver: Bilirubin [0073] Cardiovascular: Blood pressure and need for vasopressor treatment [0074] Renal: Creatinine and urine output [0075] Other clinical assessments comprise ventilator free days, organ failure free days, vasopressor treatment free days, SOFA score and Lung Injury Score evaluation as well as vital signs. [0076] Methods for testing for coagulophathy or inflammation are also well known to the skilled clinician. Such markers of coagulatory or inflammatory state are, for example, PTT, Fibrinogen depletion, elevation in TAT complexes, ATIII activity, IL-6, IL-8, or TNFR-1. [0077] Chronic organ damage encompasses, but is not limited to, the long-term damage that may result from ARDS. This residual impairment, in particular of pulmonary mechanics, may include, without restriction, mild restriction, obstruction, impairment of the diffusing capacity for carbon monoxide, or gas-exchange abnormalities with exercise, fibrosing alveolitis with persistent hypoxemia, increased alveolar dead space, and a further decrease in alveolar or pulmonary compliance. Pulmonary hypertension, owing to obliteration of the pulmonary-capillary bed, may be severe and lead to right ventricular failure. [0078] In the present context, prevention includes, without limitation, the attenuation, elimination, minimization, alleviation or amelioration of one or more symptoms or conditions associated with late complications associated with trauma, including, but not limited to, the prevention of further damage to and/or failure of organs already subject to some degree of organ failure and/or damage, as well as the prevention of damage and/or failure of further organs not yet subject to organ failure and/or damage. Examples of such symptoms or conditions include, but are not limited to, morphological/structural damage and/or damage to the functioning of organs such as, but not limited to, lung, kidney, adrenal, liver, bowel, cardiovascular system, and/or haemostatic system. Examples of such symptoms or conditions include, but are not limited to, morphological/structural damage and/or damage to the functioning of the organs such as, for example, accumulation of proteins (for example surfactant) or fluids due to pulmonary clearance impairment or damage to the pulmonary exchange mechanisms or damage to the alveolo-capillary membrane, decreased urine output (kidney), tissue necrosis, loss of glomeruli (kidney), fibrin deposition, haemorrhage, oedema, or inflammation. [0079] Attenuation of organ failure or damage encompasses any improvement in organ function as measured by at least one of the well known markers of function of said organs (see Tables 1 to 4) compared to the corresponding value(s) found in trauma patients not being treated in accordance with the present invention. [0080] Prevention also includes preventing the development of Acute Lung Injury (ALI) into ARDS. ALI is defined by the following criteria (Bernard et al., Am. J. Respir. Crit. Care Med 149: 818-24, 1994): acute onset; bilateral infiltrates on chest radiography; pulmonary-artery wedge pressure of ≦18 mm Hg or the absence of clinical evidence of left atrial hypertension; and PaO 2 :FiO 2 of ≦300. ARDS is defined by the following criteria (Bernard et al., Am. J. Respir. Crit. Care Med 149: 818-24, 1994): acute onset; bilateral infiltrates on chest radiography; pulmonary-artery wedge pressure of ≦18 mm Hg or the absence of clinical evidence of left atrial hypertension, and PaO 2 :FiO 2 of ≦200. (PaO 2 denotes partial pressure of arterial oxygen, and FiO 2 fraction of inspired oxygen). [0000] Measurement of Late Complications: [0081] Following are non-limiting examples of methods for assessing the incidence and severity of late complications of trauma. [0082] 1. The Glasgow Coma Score is determined as follows Glasgow Coma Scale Eye Opening Motor Response (E) Verbal Response (V) (M) 4 = Spontaneous 5 = Normal conversation 6 = Normal 3 = To voice 4 = Disoriented 5 = Localizes to pain 2 = To pain conversation 4 = Withdraws to 1 = None 3 = Words, but not pain coherent 3 = Decorticate 2 = No words . . . only posture sounds 2 = Decerebrate 1 = None 1 = None Total = E + V + M Normal = 15 Vegetative = 0 [0083] 2. The Multiple Organ Failure (MOF) score is determined as follows: Multiple Organ Failure Score Multiple Organ Failure An MOF score of 4 or more Grade 1 Grade 2 Grade 3 Grade 0 Dysfunction Dysfunction Dysfunction Pulmonary a Normal ARDS score >5 ADRS score >9 ARDS score >13 Renal Normal Creatinine >1.8 mg/dL Creatinine >2.5 mg/dL Creatinine >5 mg/dL Hepatic b Normal Bilirubin >2 mg/dL Bilirubin >4 mg/dL Bilirubin >8 mg/dL Cardiac c Normal Minimal inotropes Moderate inotropes High inotropes a ARDS score = A + B + C + D + E, PCWP ≦18 cm H 2 0, or clinical setting where high PCWP is not anticipated. b Biliary obstruction and resolving haematoma excluded. c Cardiac index <3.0 L/min/m2 requiring inotropic support. Minimal dose, dopamine or dobutamine <5 μg/kg/min; moderate dose, dopamine or dobutamine 5-15 μg/kg/min; high dose, greater than moderate doses of above agents. Healthy = 0 Severe = 15 [0084] 3. The ARDS Score is determined as follows: ARDS Score A. Pulmonary findings by plain chest radiography 0 = Normal 1 = Diffuse, mild interstitial marking/opacities 3 = Diffuse, moderate airspace consolidation 4 = Diffuse, severe airspace consolidation B. Hypoxemia - Pao 2 /Fio 2 (mmHg) 0 = Normal 1 = 175-250 2 = 125-174 3 = 80-124 4 = <80 C. Minute ventilation (L/min) 0 = <11 1 = <11-13 2 = <14-16 3 = <17-20 4 = >20 D. Positive and expiratory pressure (cm H 2 0) 0 = <6 1 = 6-9 2 = 30-39 3 = 14-17 4 = >17 E. Static compliance (mL/cmH 2 0) 0 = >50 1 = 40-50 2 = 30-39 3 = 20-29 4 = <20 Normal = 0 Severe = 20 [0085] 4. The SIRS Score is determined as follows: Systemic Inflammatory Response Syndrome Score A SIRS score (1 to 4) calculated for each subject. One point for each component present: fever or hypothermia tachypnea tachycardia leukocytosis SIRS is present when two or more of the following criteria are met: temperature greater than 38° C. or less than 36° C. heart rate greater than 90 beats per minute respiratory rate greater than 20 breaths per minute or PaCO 2 less than 32 white blood cell count greater than 12,000/mm 3 or less than 4,000/,mm 3 or presence of 10% bands Normal = 0 Severe = 4 [0086] 5. DIC is measured as follows: DIC Term: Definition: Disseminated Clinical history of: an intense clotting stimulus and Intravascular shock (infection, trauma, tissue damage, surgery) Coagulation followed by bleeding. Blood tests: fibrinogen ≦150 mg/dL platelet count <150,000//mm 3 or drop of 100,000/mm 3 from last valve D-dimer >500 μg/L [0087] In one series of embodiments, the practice of the present invention results in one or more of the following clinical outcomes: A decrease in blood loss, including a complete cessation of blood loss An improvement in one or more parameters of shock, including, e.g., hypothermia and blood pH. [0090] In one series of embodiments, the practice of the present invention results in one or more of the following clinical outcomes: A Glasgow Coma Score of greater than about 9 when measured 20 days after start of treatment; A Glasgow Coma Score of greater than about 11 when measured 30 days after start of treatment; A Glasgow Coma Score of greater than about 13 when measured 40 days after start of treatment; An MOF Score of less than about 4 when measured 20 days after start of treatment; An MOF Score of less than about 3 when measured 30 days after start of treatment; An MOF Score of less than about 2 when measured 40 days after start of treatment; An ARDS Score of less than about 8 when measured 20 days after start of treatment; An ARDS Score of less than about 6 when measured 30 days after start of treatment; An ARDS Score of less than about 4 when measured 40 days after start of treatment; An SIRS Score of less than about 3 when measured 20 days after start of treatment; An SIRS Score of less than about 2 when measured 30 days after start of treatment; An SIRS Score of less than about 1 when measured 40 days after start of treatment: [0103] a Any combination of any of the above Glasgow Coma Scores, MOF Scores, ARDS Scores, and/or SIR Scores. [0000] Other Indices of Treatment: [0104] The efficacy of the methods of the present invention may also be assessed using other clinical parameters, including, without limitation, reduction in any one or more of the following parameters relative to a similar patient who has not been administered Factor VIIa or a Factor VIIa equivalent according to the invention: a reduction in units of blood, plasma, red blood cells, packed red blood cells, or volume replacement products that need to be administered; a decrease in the number of days of hospitalization after suffering a trauma, including a decrease in the number of days that a patient may spend in an intensive care unit (ICU) and a decrease in the number of days in which certain interventions (such as, e.g., a ventilator) are required. Non-limiting examples of outcomes include: (i) a reduction in the units of blood, plasma, red blood cells, packed red blood cells, or volume replacement products that need to be administered by at least about 2 units, 4 units, or 6 units; (ii) a decrease in ICU days by 1 day, 2 days, or 4 days; (iii) a reduction on the number of days on a ventilator by 1 day, 2 days, or 4 days; (iv) a reduction in the total days of hospitalization by 2 days, 4 days, or 8 days. [0105] The following examples are intended as non-limiting illustrations of the present invention. EXAMPLE 1 Factor VIIa Administration to Trauma Victims [0106] The following study was performed in order to assess efficacy and safety of recombinant activated coagulation factor VII (rFVIIa, NovoSeven®) as adjunctive therapy for bleeding control in severe trauma [0107] Methods A multicenter, randomized, double-blind trial compared rFVIIa with placebo. Study product was administered as 3 i.v. injections (200, 100 and 100 μg/kg) at time 0, 1 and 3 h after transfusion of 8 units of red blood cells (RBC). Patients were monitored for 48 hours after dosing with 30-day follow-up. Standard local hospital treatment was given throughout. Blunt and penetrating groups were separately analysed. [0000] Results [0108] In total, 143 blunt and 134 penetrating patients were analyzed. In patients with blunt trauma (Injury Severity Score mean±SD: 33±13), there was a trend to decreased RBC transfusion within 48h of dosing (primary endpoint) in the rFVIIa group vs placebo when adjusting for patients who died within 48 h (p=0.07). Excluding deceased patients, the reduction in RBC was significant (p=0.02). In particular, fewer patients in the rFVIIa group received massive transfusion (>20 RBC units). Fewer patients with predefined critical complications were observed with rFVIIa in blunt trauma (Table). For patients with penetrating trauma, transfusion results were similar but not statistically significant. The number of thromboembolic events was similar between treatment groups. [0000] Conclusions [0109] rFVIIa showed a good safety profile in this high-risk trauma population. RBC requirements were significantly reduced with rFVIIa in blunt trauma. Trends to reduced complications warrant further investigation. TABLE Patients with critical events within 30 days (blunt group) Placebo rFVIIa (N = 74) (N = 69) Multiple Organ Failure  7 (9%)  3 (4%) Acute Respiratory Distress 12 (16%)  3 (4%) Syndrome Death 22 (30%) 17 (25%) ICU-free time Mean 10.5 d Mean 12.6 d Ventilator-free time Mean 13.7 d Mean 15.4 d Results from blunt trauma indicate that patients treated with NovoSeven® have fewer complications and spend less time in intensive care units than patients receiving conventional treatment and also that overall mortality was lower in the group treated with NovoSeven®. EXAMPLE 2 Efficacy of Factor VIIa Given in Conjunction with Standard Therapy in the Treatment of Trauma [0000] Trial Design: [0110] A multi-centre, randomised, double-blind, parallel group, placebo-controlled trial was conducted in subjects with severe blunt and/or penetrating trauma injuries. Subjects were recruited for screening upon admittance to the trauma centre. In conjunction with the trial product, they received standard treatments for injuries and bleeding and any other procedures deemed necessary by the physician in charge of coordinating the trauma team. The trial is comprised of two treatments arms. Eligible subjects, upon receiving 6 units of PRBC within a 4-hour period, will be equally allocated to one of the following arms: Standard therapy in conjunction with three single doses (volume equal to 200 μg/kg+100 μg/kg+100 μg/kg) of placebo administered over a 3 hour period Standard therapy in conjunction with three single doses (200 μg/kg+100 μg/kg+100 μg/kg) of rFVIIa administered over a 3 hour period [0113] The first dose of rFVIIa or placebo (trial product) were administered once the subject had received 8 units of PRBC and followed 1 hour later by the second dose and an additional 2 hours later by the third and final dose of trial product. The trial drug were given to subjects who in the opinion of the attending surgeon required more transfusion than 8 units of PRBC. A 48-hour observation period, starting upon administration of the first dose, as well as a 30-day follow-up assessment, were conducted. The trial product was administered intravenously as a slow bolus injection. Specific procedures such as physical examination, laboratory assessment and adverse event evaluation were conducted throughout the trial. The subjects were monitored throughout the study for several endpoints including number of PRBC units required, adverse events, survival, and changes in coagulation related parameters. [0114] In order to evaluate the mortality due to haemorrhage, a sequential analysis of every set of 20 subjects treated was performed starting when mortality data from first 100 subjects were available. Safety was monitored and evaluated continuously taking into account all SAEs as they were reported during the trial. [0000] Trial Products: [0115] Activated recombinant human FVII (rFVIIa) and placebo will be supplied as freeze-dried powder in single use vial of 2.4 mg to be reconstituted with sterile water for Ph.Eur. injection. [0000] Trial Population: [0116] Approximately 280 subjects (140 per treatment arm), 16 years or older, with severe blunt and/or penetrating trauma injuries were enrolled. [0000] Inclusion Criteria [0117] Subjects entering the trial met the following inclusion criteria: 1. Injury(ies) due to a blunt and or penetrating trauma. 2. Receipt of 6 units of PRBC within a 4 hour period following admittance to the trauma centre 3. Receipt of 8 units of PRBC upon administration of trial drug. 4. Known age of ≧16 or legally of age according to local law and ≦65. Exclusion Criteria: [0122] Subjects meeting the following criteria were excluded from the study: 1. Prehospital cardiac arrest. 2. Cardiac arrest in the ER or OR. 3. Gunshot wound to the head. 4. Glasgow Coma Scale<8. 5 . Base deficit of >15 mEq/l or severe acidosis (pH<7.0.). 6. Transfusion of 8 units or more of PRBC prior to arrival in trauma centre. 7. Known congenital bleeding disorder. 8. Currently participating or has participated in another investigational drug trial within the last 30 days. 9. Known pregnancy or positive pregnancy test at enrolment. 10. Previous participation in this trial. 11. Known treatment with vitamin K antagonist, low-dose heparin before trial drug is given. 12. Injury sustained ≧12 hours prior to randomisation. 13. Estimated weight >130kg. Assessments: [0136] Treatment efficacy is based on the evaluation of the following variables for the period from SOT to 48 hours: Timing and number of deaths due to bleeding and all other causes. Timing and number of transfusion units of the following blood products administered: PRBC (timing) FFP Platelets Cryoprecipitate Number of times subject is taken to surgery due to bleeding. Time interval between first dose of study drug and reaching normal range of coagulation PT, normal temperature, and acid base status. Pharmacokinetic evaluations and population pharmacokinetic evaluation Overall survival at Day 30 Timing and number of complications including MOF, ARDS, and infections occurring from SOT to Day 30. Number of days of hospitalisation including days in the Intensive Care Unit (ICU), bed confinement and/or on a ventilator in the period from SOT to Day 30. Prior to Onset of Treatment (Treatment Period 0) Blood Sampling was Performed for: [0149] FVII:C (cf. below) [0150] Coagulation related parameters and haematology (cf. below) [0151] PT (cf. below) [0152] Blood chemistry (cf.below) [0000] After First Trial Product Administration and the Following 24 Hours. [0000] The Following was Recorded and/or Investigated: [0153] Mortality and time of death [0154] Vital signs at 30 min, 1, 2, 4, 6, 8, 12, 18 and 24 hours (cf. below). Glasgow Coma [0155] Score only at 24 hours. [0156] Number of transfusion product units required. (cf. below). [0157] I.V. fluid including the composition, e.g., colloid, crystalloids (cf. below). [0158] Number of times subject is taken to surgery and reason for surgery (cf.below). [0159] Adverse events). [0160] ARDS, infection, MOF. [0000] Blood Sampling was Performed for: [0161] Coagulation related parameters at 1, 4, 8, 12, and 24 hours (cf below). [0162] Haematology at 1, 4, 8, 12 and 24 hours (cf. below). [0163] FVII:C 2 to 4 samples, one in each of the following time intervals: 0-1 hour, 1-3 hours, 3-8 hours, and 8-12 hours (cf. below). [0164] Frequent sampling: FVII:C at 30 mins, 1, 2, 3, 4, 6, 8, and 12 hours (cf. below). [0165] PT at 1, 4, 8, 12, and 24 hours.(cf. below) Frequent sampling: 30 min and 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours. (cf. below) Blood chemistry at 24 hours (cf. below). [0000] From 24 to 48 Hours [0166] Mortality and time of death. [0167] Vital signs every 6 hours. [0168] Number of transfusion product units required. [0169] I.V. fluid volume including composition, e.g., colloid, crystalloid Physical examination changes from baseline. [0170] Number of times subject is taken into surgery and reason for surgery. [0171] ECG at 48 hours ARDS, infections, MOF Adverse events [0000] Blood Sampling will be Performed at 36 and 48 Hours for the Following: [0172] Coagulation related parameters [0173] Haematology [0174] PT [0175] Blood chemistry—only at 48 hours [0000] Follow-Up Visit—Day 30 [0176] Mortality and date and time of death [0177] Days of hospitalisation including number of days in Intensive Care Unit and of bed confinement. [0178] Days on Ventilator [0179] Serious Adverse Events [0180] ARDS, infection, MOF [0000] Analyses [0000] Coagulation-Related Parameters and Haematology [0181] Blood was drawn at the following time points: immediately prior to first treatment and at 1, 4, 8, 12, 24, 36, 48 hours after first treatment for the analysis of: [0182] Coagulation-Related Parameters [0183] APTT, Fibrinogen, D-dimers, Anti thrombin-III, F1+2, TAT [0184] Haematology [0185] Platelets, Haematocrit, Haemoglobin and White Blood Cells [0186] Blood Chemistry [0187] Blood was drawn at the following time points: prior to the first treatment and at 24, 48 hours after the first treatment for the analysis of: [0188] S-Bilirubin, S-albumin, S-creatinine, S-potassium, S-sodium, S-alanine aminotransferase. [0189] FVII:C (Pharmacokinetics) [0190] Fifty subjects was frequently sampled for FVII:C, and blood was be drawn at the following time points: immediately prior to first treatment and at 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours for the analysis of FVII:C. [0191] All other subjects had blood drawn 2-4 times, one sample in 2 to 4 of the following time intervals: 0-1 hour (immediately after first dose and before next dose is given), 1-3 hours (immediately after second dose and before next dose is given), 3-8 hours (immediately after third dose), and 8-12 hours. The samples can be taken any time in the time interval. Exact time of sampling was recorded. [0000] Prothrombin Time [0192] For the 50 subjects having frequent FVII:C sampling, blood was be drawn at the following time points: immediately prior to first treatment and at 30 minutes, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 hours for the analysis of Prothrombin time (PT). [0193] All other subjects had blood drawn at the following time points: immediately prior to first treatment and at 1, 4, 8, 12, 24, 36, and 48 hours. [0000] Vital Signs [0194] Vital signs was recorded prior to treatment and at 30 min, 1, 2, 4, 6, 8, 12, 16, 18 and then every 6 hours until 48 hours from first dose upon administration of the first dose of the study drug (otherwise as the condition of the subject demanded). [0000] The following was recorded: [0195] Body temperature (C [rectal, oral or ear]) [0196] Blood pressure (mm Hg) (systolic/diastolic) will in addition be recorded at scene of accident during pre-hospital phase. [0197] Pulse (beats/min) will in addition be recorded at scene of accident during pre-hospital phase. [0198] pH [0199] Respiration rate (only when off ventilator) will in addition be recorded at scene of accident during pre-hospital phase. [0200] Respiratory PaO2/FiO2, PaCO2 [0201] Positive end expiratory pressure (cm H20) [0202] Glasgow coma score (cf. the present specification) was recorded at scene of accident during pre-hospital phase at trauma centre: before treatment, 24 and 48 hours from first dose of study drug. If the patient was on ventilator, the GCS was not be recorded. EXAMPLE 3 In Vitro Evaluation of the Impact of Colloid Haemodilution, Acidosis, and Hypothermia on the Effect of Recombinant Factor VIIa [0203] The following experiments were performed to assess the effect on clot formation of Factor VIIa under physiological conditions that are clinically relevant in trauma, ie., low pH (acidosis), low temperature (hypothermia), and colloid haemodilution. [0000] 1. Methods [0204] Blood Collection: WB was obtained using a 21-gauge needle from six healthy volunteers. Samples were drawn into tubes containing citrate, mixing one part of citrate with nine parts of blood. The first tube of collected blood from each participant was discarded. After the blood samples had rested for 30 minutes at room temperature, they were manipulated to mimic one specific clinical situation, as outlined below. [0205] To stimulate acidosis, WB (2 mL) was made acidic (pH 7) by the addition of 140 μL of N-2-hydroxyethylpiperazine-N′-2-ethanesulfonic acid (HEPES) 1 M buffer, adjusted to pH 7. To simulate hypothermia, the temperature of the blood samples was lowered to 32° C. To simulate haemodilution, all solutions were mixed with citrate (10% v/v) to ensure adequate anticoagulation of the haemodiluted WB. WB was then diluted by 20%, 40%, and 60% (V/V) with one of three different colloid solutions: Human serum albumin 5%, MW=68 000; Hetastarch 6% (Hespan®, duPont Merck, Wilmington, Del., USA), MW=450 000; or Hydroxyethyl starch (HES) 130/0.4 (Voluven®, Fresenius Kabi, Bad Homburg, Germany), MW=130 000. [0206] Thromboelastography Whole Blood Coagulation Analysis: Coagulation was initiated by adding tissue factor 1:50 000 (Innovin®, Dade Behring, Deerfield, Ill., USA) to WB and recalcifying with 15 mM calcium chloride (free CaCl 2 ˜2-3 mM). The final concentration of tissue factor in WB corresponded to 0.12 pM. Experiments were performed in the absence or presence of 25 nM rFVIIa (25 nM 90 μg/kg). The haemostatic process was recorded by use of a TEG coagulation analyzer (5000 series TEG analyzer, Haemoscope Corporation). [0207] The clot formation rate (CFR) was recorded as the TEG α-angle (Figure); a greater CFR value is indicative of a more robust clot formation. [0208] Statistical Analysis: Pharmacodynamic parameters were summarized as means and standard deviations (SD). The student's t-test was performed on averaged data, with two-sided a set at 0.05. [0000] 2. Results [0209] Acidosis: Lowering the pH to 7.0 significantly decreased the CFR. Addition of rFVIIa resulted in a significant increase in the CFR. [0210] Hypothermia: Lowering the WB temperature to 32° C. resulted in a trend toward a modest decrease of the CFR. Addition of 25 nM rFVIIa significantly increased the CFR. [0000] Haemodilution: [0000] Albumin: Haemodilution with albumin was not associated with impairment of clot formation (Table). For the 20% and 40% dilutions, but not the 60% dilution, addition of rFVIIa significantly increased the CFR. Hetastarch: Haemodilution with hetastarch was associated with impaired clot formation at 40% and 60% only (Table). For the 20%, but not the 40% and 60% dilutions, addition of rFVIIa significantly increased the CFR. At 60% dilution, the CFR following addition of rFVIIa remained significantly reduced compared to the CFR in normal WB. HES: All dilutions of WB with HES were associated with reduced CFRs relative to normal WB (Table). The addition of rFVIIa improved the CFR only at the 20% dilution level. At 40% and 60% dilution, the CFR following addition of rFVIIa remained significantly reduced compared with the CFR in normal WB. Of note, increasing the rFVIIa concentration to 200 nM (corresponding to the plasma concentration following administration of 720 μg/kg) significantly improved the CFR at 40% dilution (48±3) but failed to improve the CFR at 60% dilution, which remained significantly reduced compared with the CFR in normal WB. 3. Conclusions [0214] The in vitro clot-promoting effects of rFVIIa were not adversely affected by acidosis, hypothermia, or haemodilution below 40%. However, more severe degrees of colloid haemodilution with 6% hetastarch and HES130/0.4 impaired the effect of rFVIIa on clot formation, as measured in vitro by TEG. CFR rFVIIa No addition (25 nM) Normal WB 52 ± 8 Acidosis (pH 7.0) 44 ± 7 58 ± 6 Hypothermia (32° C.) 51 ± 9 59 ± 9 Haemodilution albumin 20% 54 ± 8 65 ± 4 Haemodilution albumin 40% 55 ± 8 63 ± 4 Haemodilution albumin 60% 49 ± 7 49 ± 7 Haemodilution hetastarch 20% 51 ±± 5 58 ± 6 Haemodilution hetastarch 40% 46 ± 4 49 ± 8 Haemodilution hetastarch 60% 35 ± 5  36 ± 19 Haemodilution HES 130/0.4 20% 35 ± 4 49 ± 6 Haemodilution HES 130/0.4 40% 39 ± 6 38 ± 7 Haemodilution HES 130/0.4 60% 32 ± 6 31 ± 4 EXAMPLE 4 Efficacy of Factor VIIa Given in Conjunction with Standard Therapy in the Treatment of Trauma [0215] The following study was performed in order to assess efficacy and safety of recombinant activated coagulation factor VII (rFVIIa, NovoSeven®) as adjunctive therapy for bleeding control in severe trauma [0000] 1. Methods [0216] Severely bleeding patients with severe blunt and/or penetrating trauma injury were randomized to rFVIIa (200+100+100 μg/kg) or placebo in addition to standard treatment. The first dose followed the 8th RBC (red blood cell) unit, with additional doses 1 and 3 hours later. [0217] Patients were monitored closely during the 48-hour period following the first dose of trial product. This included recording transfusion and infusion requirements, adverse events and surgical procedures. Blood was drawn at frequent intervals to evaluate changes in coagulation and blood biochemistry parameters. Mortality, time on ventilator, hospitalization data, and serious adverse events including pre-defined critical complications (MOF and acute respiratory distress syndrome (ARDS)) as reported by the trial sites were recorded until day 30. [0218] Endpoints [0219] To assess the haemostatic effect, the primary endpoint was the number of RBC units (allogeneic RBC, autologous RBC and whole blood) transfused during the 48-hour period following first dose of trial product. Outcome of therapy was further assessed through requirement for other transfusion products, mortality, days on the ventilator, and hospitalization data. Safety outcomes comprised frequency and timing of adverse events, and changes in coagulation-related laboratory variables (activated partial thromboplastin time (aPTT), platelets, fibrinogen, D-dimer, antithrombin III, prothrombin fragments 1+2, and thrombin-antithrombin complex). Because mortality is not a sensitive variable in a trauma population, we studied a composite endpoint that comprised death, MOF, and ARDS. Safety reporting on MOF and ARDS was based on pre-specified definitions provided in the study protocol. [0220] Statistical Analysis [0221] We calculated sample size according to the transfusion data of a retrospective study in a severe blunt trauma patient population.14 In patients with an initial GCS≧8, a 0-48 h RBC transfusion requirement of 12.4 (SD: 6.2) units was found. We estimated that 70 patients in each treatment group would be required to detect a 60% reduction in 0-48 h RBC requirement from 4.4 units to 1.8 units in addition to the 8 pre-dose units, with 80% power and a 5% Type 1 error. As the trial involved two trauma populations and two treatment groups, a total sample size of 280 patients was planned for. Blunt and penetrating trauma populations were analyzed separately. Results pertain to all consented and randomized patients who received trial drug. The type 1 error was set to 5%. All analyses were defined a priori, unless otherwise stated. [0222] The total number of RBC units transfused within 48 hours from start of trial product treatment (the primary endpoint) was compared between treatment groups by use of one-sided Wilcoxon-Mann-Whitney rank test. A one-sided test was selected as it was not expected that administration of rFVIIa would increase transfusion requirements. Separate analyses were performed where patients who died within 48 hours were either excluded or assigned to the worst outcome. Priority was given to the analysis where patients who died within 48 hours were excluded because 1) in a large proportion of these patients, care was futile 2) 48-hour transfusion requirements could not be objectively assessed for patients who were alive for only a few hours. The Hodges-Lehman estimate was used to estimate the difference in RBC transfusions. Total RBC were calculated as the sum of autologous RBC, allogeneic RBC and whole blood, with each component normalized to standard units of RBC (equal to a volume of 295 mL with a haematocrit of 63%, as this was the average across all sites). [0223] The Fisher's exact test was used for comparing the number of patients requiring massive transfusion (defined post hoc as >20 units of RBC inclusive of the 8 pre-dose units) and number of patients experiencing MOF, ARDS, and/or death within 30 days. The relative risk reduction of massive reduction and its 95% confidence interval (CI) were calculated. Effects on 48-hour mortality were analyzed using chi-square testing. [0000] 2. Results [0224] Among 301 patients randomized, 143 blunt trauma patients and 134 penetrating trauma patients were eligible for analysis. Treatment groups were well matched in terms of baseline characteristics within each of the trauma populations (Table 1). Patients were predominantly young males and were characterized by being coagulopathic, acidotic and hypothermic. Causes of penetrating trauma were primarily gunshots (68%) and stab wounds (30%), whereas 75% of blunt trauma was due to traffic-related injury. [0225] Bleeding Control [0226] The primary endpoint, RBC requirements during the 48-hour observation period following the initial dose of trial product, is shown for patients alive at 48 hours in FIG. 1 . In patients with blunt trauma, rFVIIa significantly reduced 48-hour RBC requirements by 2.6 units compared with placebo (p=0.02). The need for massive transfusion was reduced from 20/61 (33%) patients in the placebo group to 8/56 (14%) in the rFVIIa group, which represents a relative risk reduction of 56% (95% CI: [9%; 79%]; p=0.03) ( FIG. 2 ). In patients with penetrating trauma, no significant effect of rFVIIa was observed with respect to 48-hour RBC requirements with an RBC reduction of 1.0 unit (p=0.10). The need for massive transfusion in penetrating trauma was reduced from 10/54 (19%) patients in the placebo group to 4/58 (7%) in the rFVIIa group, which represents a relative risk reduction of 63% (95% CI: [-12%; 88%]; p=0.08) ( FIG. 2 ). When assigning worst outcome to deceased patients, statistical significance was not reached in either trauma population (Table 2). [0227] No significant differences between treatment groups were observed in either trauma population with respect to administration of fresh frozen plasma, platelets, cryoprecipitate, crystalloids or colloids (data not shown). [0228] Clinical Outcome and Safety [0229] Results for adverse events, mortality, ventilator-free days and ICU-free days are summarized in Table 3. Positive trends in favour of rFVIIa were observed for these endpoints, especially those concerning critical complications (ARDS, MOF and/or death). Survival curves are depicted in FIG. 3 . [0230] Adverse events occurred at similar frequency and severity between treatment groups. Overall, the adverse event profile was similar between rFVIIa-treated and placebo-treated patients, and there were no apparent treatment-dependent patterns in the types of adverse events reported. As can be expected in this severely injured patient population, the three most frequently reported serious adverse events were ARDS, MOF, and sepsis. [0231] A total of 12 thromboembolic adverse events were reported by the investigators during the trial period; 6 in rFVIIa-dosed patients and 6 in placebo-dosed patients. In patients with blunt trauma, two incidences of pulmonary embolism and a subclavian vein thrombosis (after central line) were recorded in the placebo group, whereas one jugular vein thrombosis (after central line) and one arterial limb thrombosis were recorded in rFVIIa-treated patients. In patients with penetrating trauma, one cerebral infarction and one DVT was noted in each treatment group. In addition, a mesenteric vein thrombosis was recorded in the placebo group and an intestinal infarction (at the site of operation) and an event of phlebothrombosis was noted in the rFVIIa group. All 12 thromboembolic events were reported as serious adverse events. [0000] 3. Conclusions [0232] rFVIIa assisted in the control of bleeding in severe blunt trauma and resulted in a significant reduction in RBC transfusion. Similar trends were observed in penetrating trauma. The safety of rFVIIa was established in this trauma population within the investigated dose range TABLE 1 Baseline Characteristics Blunt trauma Penetrating trauma Placebo rFVIIa Placebo rFVIIa Variable (N = 74) (N = 69) (N = 64) (N = 70) Male sex 52 (70%) 48 (70%) 60 (94%) 66 (94%) Age (years) 35 ± 13 33 ± 13 32 ± 10 29 ± 10 ISS 32 ± 13 34 ± 12 26 ± 11 26 ± 15 Number of ISS body regions injured* 1 4 (5%) 6 (9%) 25 (39%) 21 (30%) 2-3 36 (49%) 29 (42%) 36 (56%) 43 (61%) >3 32 (43%) 33 (48%) 3 (5%) 6 (9%) Glasgow Coma Score ≦8  8 (11%)  8 (12%) 5 (8%) 3 (4%) 9-12 18 (24%) 11 (16%)  8 (13%) 6 (9%) 13-15 48 (65%) 47 (68%) 51 (80%) 60 (86%) Time from injury to hospitalization 0-1 hours 27 (36%) 21 (30%) 40 (63%) 41 (59%) 1-2 hours 23 (31%) 23 (33%) 10 (16%)  8 (11%) 2-4 hours 10 (14%) 11 (16%) 3 (5%) 3 (4%) >4 hours 7 (9%) 3 (4%) 1 (2%) 5 (7%) Unknown 7 (9%) 11 (16%) 10 (16%) 13 (19%) Time from hospitalization to trial product dosing 0-2 hours 15 (20%) 19 (28%)  8 (13%) 11 (16%) 2-4 hours 24 (32%) 18 (26%) 23 (36%) 25 (36%) 4-6 hours 17 (23%) 12 (17%) 16 (25%) 15 (21%) >6 hours 17 (23%) 18 (26%) 17 (27%) 19 (27%) Unknown 1 (1%) 2 (3%) 0 (0%) 0 (0%) Vital signs Systolic arterial blood 111 ± 27  102 ± 24  114 ± 25  111 ± 24  pressure (mmHg) Body temperature 35.3 ± 1.6  35.2 ± 1.6  35.2 ± 1.2  35.3 ± 1.3  (° C.) Biological variables Hemoglobin (g/dL) 9.1 ± 2.8 9.3 ± 2.5 8.8 ± 3.0 8.5 ± 2.8 pH 7.26 ± 0.11 7.24 ± 0.13 7.28 ± 0.11 7.27 ± 0.09 aPTT (seconds) 51 ± 28 49 ± 24 54 ± 26 49 ± 27 PT (seconds) 19 ± 6  20 ± 8  22 ± 6  18 ± 5  Data intervals refer to means ± SD. Other data refer to number (and percentage) of patients. *Body regions as defined for the Injury Severity Scale. No significant differences between rFVIIa and placebo groups were observed. aPTT: activated partial thromboplastin time; PT: prothrombin time [0233] TABLE 2 Total RBC transfusions (units) during 48 hours after first dose of trial drug Placebo rFVIIa Estimated Median Median RBC n (range) n (range) reduction* p Blunt N = 74 N = 69 All patients 72 7.2 (0-35) 64 7.8 (0-48) 2.00 ♯ 0.07 ♯ Alive at 48 h 59 7.5 (0-35) 52 7.0 (0-29) 2.60 0.02 Penetrating N = 64 N = 70 All patients 61 4.8 (0-41) 69 4.0 (0-37) 0.20 ♯ 0.24 ♯ Alive at 48 h 52 4.2 (0-41) 57 3.9 (0-30) 1.00 0.10 *Hodges-Lehman point estimate of the shift in transfusion amount from placebo to active group. ♯ Patients who died within 48 hours were assigned the highest rank. [0234] TABLE 3 Adverse events and clinical outcomes Blunt trauma Penetrating trauma Placebo rFVIIa Placebo rFVIIa (N = 74) (N = 69) (N = 64) (N = 70) Serious adverse events Patients with events 49 (66%) 44 (64%) 36 (56%) 36 (51%) Number of events 109 91 76 59 Thromboembolic adverse events Patients with events  3 (4%)  2 (3%)  3 (5%)  4 (60%) Number of events  3  2  3  4 48-hour mortality 13 (18%) 13 (19%) p = 0.84 10 (16%) 12 (17%) p = 0.85 Patients wth critical complications within 30 days ♯ ARDS 12 (16%)  3 (4%) p = 0.03  5 (8%)  4 (6%) p = 0.74 MOF  9 (12%)  5 (7%) p = 0.41  7 (11%)  2 (3%) p = 0.09 Death 22 (30%) 17 (25%) p = 0.58 18 (29%) 17 (25%) p = 0.69 Patients with ARDS, 31 (42%) 20 (29%) p = 0.16 22 (34%) 20 (29%) p = 0.57 MOF, and/or death Ventilator-free days 14 (0-30) 17 (0-30) p = 0.53 21 (0-30) 26 (0-30) p = 0.18 (median and range) ICU-free days  8 (0-29) 13 (0-30) p = 0.22 19 (0-30) 23 (0-30) p = 0.28 (median and range) MOF: Multiple organ failure; ARDS: Acute respiratory distress syndrome; ICU: Intensive care unit [0235] All patents, patent applications, and literature references referred to herein are hereby incorporated by reference in their entirety. [0236] Many variations of the present invention will suggest themselves to those skilled in the art in light of the above detailed description. Such obvious variations are within the full intended scope of the appended claims.

The invention relates to the use of Factor VIIa or a Factor VIIa equivalent for the manufacture of a medicament for treatment of trauma.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to and is a continuation in part of International Application No. PCT/US2016/054475, filed Sep. 29, 2016, entitled “Methods and Articles of Manufacture for the Treatment of Animals,” which claims priority to and benefit of U.S. Provisional Patent Application No. 62/234,354, filed Sep. 29, 2015, of the same title. The contents of these applications are incorporated herein by reference in their entirety. STATEMENT REGARDING FEDERAL SPONSORSHIP [0002] Inventions described herein were not conceived or reduced to practice with Federal sponsorship. FIELD OF THE INVENTION [0003] The present disclosure provides processed fetal tissues and cells suitable for reducing the effects of aging seen on skin and methods of using these fetal tissues and cells to promote a cosmetically appealing aspect to skin. BACKGROUND OF THE INVENTION [0004] The effects of aging on the human skin produce cosmetically undesirable appearance. These effects include wrinkles, creases, sags, hair loss, spots, loss of flexibility, thinning, loss of color and others. These effects are often addressed with surgical intervention such as face lifts, dermal fillers, onabutulinumtoxinA (sold under the tradename BOTOX®, Allergan, Inc., Irvine, Calif.). However, these interventions subject the subject receiving the intervention with risks and the effects may be of short duration, incomplete or produce unsatisfactory results. [0005] It would be useful to have methods and articles of manufacture that reduce the undesirable effects of aging on skin. As used herein, unless the context requires otherwise, the term “subject” encompasses and includes humans and animals receiving intervention for the effects of aging on skin. SUMMARY OF THE INVENTION [0006] Embodiments of the present invention feature methods and articles of manufacture that reduce the effects of aging on skin in humans and in animals. [0007] The fetal tissue and cellular compositions disclosed herein have many advantages for use in intervening with normal aging processes including promoting healing of injuries, immune privilege, an absence of associated ethical issues, and no requirement of invasive procedures for harvesting the cells and tissues. In addition, the treatment regimen disclosed herein is remarkably effective at promoting the rapid healing of open wounds within one to two weeks. [0008] One embodiment is directed to an article of manufacture. The article comprises aesthetic modifier comprising a dried particulate mixture of mechanically decellularized amnion obtained from one or more animals compatible with a subject animal. The dried particulate mixture is capable of reconstitution to form a reconstituted aesthetic modifier for administration to the subject animal to produce a cosmetic result. [0009] By way of example, without limitation, a cosmetically effective amount of the reconstituted medicament is applied by injecting at or around the periphery of or under or into wrinkles, creases, sags, hair loss, spots, loss of flexibility, thinning, loss of color and others, or applied to a subject by way of dropper or spray, cream, ointment, slurry, paste, wash, mask, dermal patch, powder, solution or suspension to the skin of a subject or into a dermal layer of the skin of a subject, or the like to a cosmetic result. As used herein, the term “cosmetic result” means a aesthetically pleasing result suggesting a more youthful or healthy appearance. Such appearance can mean one or more of the following including fuller skin, decreased appearance of wrinkles, creases, sagging, hair loss and spots, greater flexibility, healthier color, hair regeneration and the like. As used herein, the term “subject” refers to the person or animal receiving the aesthetic modifier. [0010] In one aspect, one milliliter of reconstituted aesthetic modifier is the amount of particulate matter obtained from the mechanically decellularized amnion of about 1.5 10 −2 cm 3 to 5 10 −2 cm 3 of amnion. In one aspect, the mechanically decellularized amnion is filtered to contain particles of less than about 100 microns in diameter. [0011] Embodiments of the present invention feature a particulate mixture comprising particles. The particles have an approximate diameter of less than 500μ, or less than 400μ, or less than 300μ, or less than 200μ, or less than 150μ, or less than 100μ, or less 90μ, or less than 80μ, or less than 70μ, or less than 60μ, or less than 50μ, or less than 40μ, or less than 30μ, or less than 20μ, or less than 10μ. In other embodiments, the particles have a diameter of more than 10μ, or more than 20μ, or more than 30μ, or more than 40μ, or more than 50μ, or more than 60μ, or more than 70μ, or more than 80μ, or more than 90μ, or more than 100μ, or more than 200μ, or more than 300μ, or more than 400μ, or more than 500μ. In other embodiments, the particles have an approximate diameter of about 500μ, or about 400μ, or about 300μ, or about 200μ, or about 150μ, or about 100μ, or about 50μ, or about 25μ. [0012] In certain embodiments, the article comprises a dried particulate mixture of mechanically decellularized amnion obtained from one or more animals compatible with a subject, and fetal cells obtained from one or more animals compatible with a subject to form a particulate cellular suspension. The particulate cellular suspension is administered to a subject to produce a cosmetic result. [0013] By way of example, without limitation, a cosmetically effective amount of the aesthetic modifier comprising a particulate cellular suspension medicament can be injected around the periphery of or under or into wrinkles, creases, sags, hair loss, spots, loss of flexibility, thinning, loss of color and others, or applied to a subject by way of dropper or spray, cream, ointment, slurry, paste, wash, mask, dermal patch, powder, solution or suspension to the skin of a subject or into a dermal layer of the skin of a subject, or the like to a cosmetic result. [0014] A cosmetically effective amount of the particulate cellular suspension medicament comprises about 10 1 to 10 20 cells per mL. Other embodiments feature about 10 3 to about 10 7 cells per mL. [0015] A further embodiment of the article further comprises a fetal tissue wrap. The tissue wrap can comprise amnion tissue obtained from one or more animals compatible with a subject. The wrap is constructed and arranged for placement in juxtaposition with a site of wrinkles, creases, sags, hair loss, spots, loss of flexibility, thinning, loss of color to promote a cosmetic result. For facial applications, the wrap is shaped or contoured to the shape and contour of the face. [0016] The wrap, comprising fetal tissue, can be air-dried for about 1 minute to about 48 or more. In another embodiment, the wrap is air-dried for about 1 hour to about 12 hours. In another embodiment, the wrap is air-dried for about 1 hour to about 6 hours. In another embodiment, the wrap is air-dried for about 1 hour to about 3 hours. In another embodiment, the wrap is air-dried for about 1 hour to about 2 hours. [0017] In another aspect of the invention, one embodiment features a kit for producing a cosmetic result in a subject. One kit comprises aesthetic modifier comprising a dried particulate mixture of mechanically decellularized amnion obtained from one or more animals compatible with a subject. The aesthetic modifier is directly applied or incorporated in one or more of the carriers such as a spray, cream, ointment, slurry, paste, wash, mask, dermal patch, powder, solution or suspension. The dried particulate mixture may be held as a powder that can be capable of reconstitution to form a reconstituted aesthetic modifier. [0018] A further embodiment of the kit comprises fetal cells obtained from one or more animals compatible with a subject that are compatible with a particulate mixture obtained from the mechanical decellularization of amnion isolated from one or more animals. The fetal cells are applied in cooperation or concurrently with the reconstituted aesthetic modifier or form a combined aesthetic modifier comprising a particulate cellular suspension and/or amniotic liquid for administration to the subject to produce a cosmetic result. [0019] A further embodiment of the kit comprises a tissue wrap obtained from one or more animals compatible with a subject. The tissue wrap comprises amnion tissue constructed and arranged for placement in juxtaposition with the site of wrinkles, creases, sags, hair loss, spots, loss of flexibility, thinning, loss of color to promote a cosmetic result. The tissue wrap is applied in cooperation or concurrently with the reconstituted aesthetic modifier or a combined medicament comprising a particulate cellular or acellular suspension medicament with or without mechanically decellularized amnion and/or amniotic liquid for administration to the subject to produce a cosmetic result. [0020] A further embodiment of the present invention features an inflammation inducing means selected from the group comprising keratolytics, irritants, rubefacients, abrasives, phototherapy, dermal microneedle devices for application prior to or during administration of the aesthetic modifier. For example, without limitation, one or more keratolytics, irritants, rubefacients, or abrasives are carried in a spray, cream, ointment, slurry, paste, wash, mask, dermal patch, powder, solution or suspension for application before or carried with with the aesthetic modifier and applied with the aesthetic modifier. [0021] A further embodiment of the present invention is directed to a method of producing a cosmetic result in a subject. One embodiment of the present method features the steps of administering to the site of wrinkles, creases, sags, hair loss, spots, loss of flexibility, thinning, loss of color an injury at least one of the group consisting of a reconstituted aesthetic modifier, a reconstituted amnion suspension with or without cells and a tissue wrap all of which have been previously described. [0022] For example, without limitation, in one embodiment, a method comprises the step of applying a reconstituted aesthetic modifier. The reconstituted aesthetic modifier is made from a dried particulate mixture of mechanically decellularized amnion obtained from one or more animals compatible with a subject. [0023] Another method features the step of applying, by way of injection, an aesthetic modifier comprising a particulate cellular suspension medicament to the periphery or under or into the site of wrinkles, creases, sags, hair loss, spots, loss of flexibility, thinning, loss of color to promote a cosmetic result. The particulate cellular suspension comprises particles derived from the mechanical decellularization of amnion obtained from one or more animals compatible with the subject animal, and isolated amniotic fluid cells obtained from the one or more animals compatible with the subject. [0024] In one aspect, the method further comprises the step of applying a tissue wrap to the site wrinkles, creases, sags, hair loss, spots, loss of flexibility, thinning, loss of color to promote a cosmetic result. The wrap comprises amnion tissue compatible with the subject constructed and arranged for placement in juxtaposition with the site of wrinkles, creases, sags, hair loss, spots, loss of flexibility, thinning, loss of color. The amnion tissue is air-dried for about 1 minute to about 48 hours or more. In another embodiment the amnion tissue is air-dried for about 1 hour to about 12 hours. In another embodiment, the amnion tissue is air-dried for about 1 hour to about 6 hours. In another embodiment, the amnion tissue is air-dried for about 1 hour to about 3 hours. In another embodiment, the amnion tissue is air-dried for about 1 hour to about 2 hours. One embodiment features a wrap shaped to the contours of the face for facial application in the nature of a mask. [0025] In one aspect of the method, the site of wrinkles, creases, sags, hair loss, spots, loss of flexibility, thinning, loss of color to promote a cosmetic result is prepared prior to or with the applying of one or more of the group consisting of a cellular reconstituted suspension, or a reconstituted acellular suspension medicament and a tissue wrap. The preparation creates an inflammation response which improves the effectiveness of the aesthetic modifier. For example without limitation, an inflammation inducing means selected from the group comprising keratolytics, irritants, rubefacients, abrasives, phototherapy, dermal microneedle devices is applied prior to or during administration of the aesthetic modifier. The one or more keratolytics, irritants, rubefacients, or abrasives are carried in a spray, cream, ointment, slurry, paste, wash, mask, dermal patch, powder, solution or suspension for application before or carried with with the aesthetic modifier and applied with the aesthetic modifier. [0026] A further embodiment is directed to a method of making a dried particulate mixture of mechanically decellularized fetal tissue obtained from one or more animals compatible with a subject. The dried particulate mixture is capable of reconstitution to form a reconstituted medicament for administration to the subject to produce a cosmetic result. The method comprises the step of mechanically decellularizing amnion tissue to form particles capable of reconstitution. [0027] A further embodiment is directed to a method of making a aesthetic modifier comprising a particulate cellular suspension. The method comprises the steps of providing a dried particulate mixture of mechanically decellularized amnion obtained from one or more animals compatible with a subject, and fetal cells obtained from one or more animals compatible with a subject animal and forming a particulate cellular suspension. The aesthetic modifier comprising a particulate cellular suspension is administered to a subject to produce a cosmetic result. [0028] A further embodiment of the present invention features methods of making a tissue wrap, a particulate mixture medicament and a particulate cellular suspension medicament. One embodiment of the method of making the tissue wrap comprises the steps of applying amnion tissue to a support to form a supported amnion. The supported amnion is next air dried to form the tissue wrap which is placed in a suitable containment means until applied. One embodiment features a mask. The mask is formed by shaping the wrap to the contours of the face. [0029] A further embodiment is directed to a method of making an aesthetic modifier for effecting a cosmetic result comprising the steps of mechanically decellularizing fetal tissue obtained from one or more animals compatible with a subject animal and drying the decellularized fetal tissue to form a dried particulate mixture for reconstitution and administration. [0030] These and other features and advantages will be apparent upon viewing the Figures that are briefly described below and upon reading the detailed description that follows. BRIEF DESCRIPTION OF THE FIGURES [0031] FIG. 1 depicts a kit embodying features of the present invention; [0032] FIG. 2 depicts a tissue wrap embodying features of the present invention; [0033] FIG. 3 shows a tissue wrap embodying features of the present invention in a container; and, [0034] FIG. 4 depicts a tissue wrap having facial contours and shape embodying features of the present invention. DETAILED DESCRIPTION [0035] Unless otherwise defined herein, scientific and technical terms used herein have the meanings that are commonly understood by those of ordinary skill in the art. In the event of any latent ambiguity, definitions provided herein take precedence over any dictionary or extrinsic definition. Unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular. The use of “or” means “and/or” unless stated otherwise. The use of the term “including”, as well as other forms, such as “includes” and “included”, is not limiting. [0036] It is noted here that as used in this specification and the appended claims, the singular forms “a”, “an”, and “the” also include plural reference, unless the context clearly dictates otherwise. [0037] The term “about” or “approximately” means within 10%, and more preferably within 5% (or 1% or less) of a given value or range. [0038] As used herein, the term “isolated cell” refers to a cell that has been removed from its in-vivo location. [0039] As used herein, the term “decellularization” refers to a process that removes cells from a tissue while preserving the native ultrastructure and composition of the extracellular matrix (ECM). For example, an amnion particulate mixture can be obtained by decellularizing a fetal tissue comprising amnion. [0040] There are a number of methods of decellularization of tissue known in the art, including, but not limited to, chemical agents, hypotonic and hypertonic solutions, detergents (e.g., Triton-X), alcohols, solvents (e.g., tributyl phosphate (TBP), biologic agents (e.g., collagenase, trypsin, lipase, nucleases, α-galactosidase), non-enzymatic agents (e.g., chelating agents such as EDTA or EGTA), physical agents (e.g., temperature, force and pressure, non-thermal irreversible, mechanical, electroporation (NTIRE) (see, for example, Crapo et al., Biomaterials. 2011; 32(12): 3233-3243). In certain embodiments, one or a combination of the aforementioned methods may be used to decellularize a tissue. However, methods that preserve the complex composition and three-dimensional ultrastructure of the extracellular matrix (ECM) are preferred. [0041] In one embodiment, a tissue is mechanically decellularized, e.g., by cryofractionation, a procedure in which a tissue is frozen and ground in a cryomill to produce a mixture of particles. Such particles are obtained from the cryofractionation of about 0.5 cm 2 , or about 1 cm 2 , or about 1.5 cm 2 , or about 2 cm 2 , or about 2.5 cm 2 , or about 3 cm 2 , or about 3.5 cm 2 or about 4 cm 2 , or about 4.5 cm 2 to about 5 cm 2 of amnion or more. The amnion can have a thickness of from about 500 to 50 or from 400 to about 50 , or from about 300 to 50 or from about 200 to about 50 or from about 150 to about 50 from about 100 to about 50 or from about 50 to about 25 or less. n another embodiment the amnion has a thickness of about 500 or about 400 or about 300 or about 200 or about 150 or about 100 or about 50 or about 25 or less. [0042] The term “amnion” refers to a thin, cellular, extra-embryonic membrane that forms the inner membrane of a closed sac surrounding and protecting an embryo in reptiles, birds, and mammals. The sac contains the fetus and amniotic fluid, in which the embryo is immersed, nourished and protected. Typically, the amnion is a tough, transparent, nerve-free, and nonvascular membrane consisting of two layers of cells: an inner, single-cell-thick layer of ectodermal epithelium and an outer covering of mesodermal, connective, and specialized smooth muscular tissue. In the later stages of pregnancy, the amnion expands to come in contact with the inner wall of the chorion creating the appearance of a thin wall of the sac extending from the margin of the placenta. The amnion and chorion are closely applied, though not fused, to one another and to the wall of the uterus. Thus, at the later stage of gestation, the fetal membranes are composed of two principal layers: the outer chorion that is in contact with maternal cells and the inner amnion that is bathed by amniotic fluid. The amnion has multiple functions, e.g., as a covering epithelium, as an active secretary epithelium, and for intense intercellular and transcellular transport. [0043] As used herein, the term “tissue” refers to an aggregate of similar cells and associated extracellular matrix (ECM) forming a definite kind of organized material with a specific function, in a multicellular organism. [0044] As used herein, an “amnion tissue” refers to the isolated cellular, extra-embryonic amnion membrane that is detached from the chorion. In one embodiment, the amnion tissue is air-dried. In another embodiment, the amnion is air-dried for about 60 to about 90 minutes or more at ambient temperature (i.e. about 18 to 24° C.). [0045] As used herein, a “particulate mixture” refers to the powder or particles obtained from the cryofractionation of amnion. [0046] As used herein, the term “fetal tissue” refers to extra-embryonic tissues including, but not limited to, amnion, chorion, yolk sac, the allantois, umbilical cord and/or fetal placenta (villous chorion). [0047] As used herein, the term “fetal cells” refers to cells resident in the extra-embryonic tissues including, but not limited to, amnion, chorion, yolk sac, the allantois, umbilical cord, fetal placenta (villous chorion) and/or amniotic fluid. In certain embodiments, the term “fetal cells” refer to isolated fetal cells. [0048] In certain embodiments, the term “fetal cells” refers to unfractionated cells of the amniotic fluid including epithelial and/or amniotic fluid or membrane-derived mesenchymal stem cells (see U.S. Patent Publication No. US 2013/0230924, which is incorporated by reference herein in its entirety). [0049] The term “injury” means a pathological condition, such as, by way of example, without limitation, a wound, incision, a break in the skin, bone, tendon, ligament, muscle, neoplasia, eye, and soft tissues, an inflammation, infection, or other disease condition. [0050] The term “promoting healing” refers to causing a favorable result compared to no treatment. The favorable result comprises any one or more of the following such as reduction of scarring, reduction of inflammation, regrowth of normal tissue or growth of scar tissue, improved load bearing on a limb movement, closure of wound, reduction in infection and reduction in mortality associated with the underlying pathology. [0051] The term “aesthetic modifier” refers to a material that produces a cosmetic effect on skin. This effect is not clearly a healing of an injury but is in the nature of ordinary and common aging, or exposure to long-term environmental conditions such as light. As used herein, the term “cosmetic effect” refers to a more pleasing younger appearance, in the nature of fewer or shallower wrinkles or creases, less sagging, less hair loss, hair regeneration, tighter fuller skin, thicker and more flexible skin, improved coloring, fewer or smaller or lighter spots. [0052] The term “compatible with a subject” denotes the origin of the tissue as being from the same species or closely related species or a species that does not elicit a strong immune response. [0053] In other embodiments, the term “compatible with a subject” refers to an xenograft, i.e., a tissue graft from different species. [0054] In another embodiment, the term “compatible with a subject” refers to allografts, i.e., a tissue from one individual to another of the same species with a different genotype. [0055] As used herein, an “animal” refers to living multi-cellular vertebrate organisms, a category that includes, for example, mammals, birds, reptiles, and amphibians. The term mammal includes both human and non-human mammals. Similarly, the term “subject” includes both human and non-human subjects. In a cosmetic sense, the term “subject” refers to an individual human which has a site having wrinkles, creases, sags, hair loss, spots, loss of flexibility, thinning, loss of color or other effects of aging. [0056] As used herein, a non-human animal can refer to a mammal including, but not limited to, a domesticated animal such as a dog, a racing dog, sheep, a pig, a goat, cattle, a zebu, a cat, a guinea pig, a donkey, water buffalo, including “river buffalo” and “swamp buffalo”, a horse, a racing horse, a dromedary camel, a yak, a bactrian camel, a llama, an alpaca, a ferret, a mouse, a bali cattle, a gayal, a rabbit, a rat and a lab rat, a silver fox or a hedgehog. [0057] In certain embodiments, a non-human animal can refer to mammals kept in zoos including, but not limited to, zebra, gazelle, wolves, wild swine (pigs & hogs), wild cattle, warthogs, vervet monkeys, two-toed sloths, tree pangolins, tigers, tapirs, tamandua or lesser anteaters, takins, sun bears, striped hyena, spotted hyena, spiral-horned antelope, somali wild ass, snow leopards, small cats, sloth bears, singing dogs, siamang, serval, sea lions, rock hyrax, rhinoceros, reindeer, red pandas, pygmy marmosets, pygmy hippopotamus, przewalski's horses, pronghorns, prairie dogs, porcupines, polar bears, painted dogs, otters, oryx, orangutan, okapi, ocelot, nubian ibex, nile lechwe, naked mole-rats, mountain lions (puma, cougar), monkeys, meerkat, mangabey, mandrill, lynx and bobcats, lions, leopards, lemur, jaguars, honey badgers (ratel), hippos, hamadryas baboons, guenon, guanaco, gorillas, giraffe, giant pandas, giant anteaters, gelada baboons, fossa, fishing cats, elephants, echidna, dhole, coquerel's sifaka, clouded leopards, chimpanzees, cheetahs, tigers, caracals, capybara, camels, brown bears, bonobos, binturongs, bat-eared fox, bats, armadillos, antelope, andean (spectacled) bears, birds and agouti. [0058] In certain other embodiments, a non-human animal can refer to mammals considered by the World Wildlife Fund to be endangered including, but not limited to, the amur leopard, black rhino, cross river gorilla, javan rhino, mountain gorilla, pangolin, saola, south china tiger, sumatran elephant, sumatran orangutan, sumatran rhino, sumatran tiger, vaquita, western lowland gorilla, yangtze finless porpoise, african wild dog, amur tiger, asian elephant, bengal tiger, black spider monkey, black-footed ferret, blue whale, bonobo, bornean orangutan, borneo pygmy elephant, chimpanzee, eastern lowland gorilla, fin whale, ganges river dolphin, giant panda, hector's dolphin, indian elephant, indochinese tiger, indus river dolphin, malayan tiger, north atlantic right whale, orangutan, sea lions, sei whale, snow leopard, Sri Lankan elephant, tigers and whales. [0059] In certain embodiments, a non-human animal can refer to marsupials, including, but not limited to, wallabies, koalas, possums, opossums, kangaroos, bandicoots, wombats, bettongs, bilbys, quolls, quokkas and the Tasmanian devil. [0060] The term “reconstituted” means that that an aqueous liquid is added to make the material. A liquid for reconstitution comprises a biocompatible solution such as normal saline, e.g. phosphate buffered saline (PBS) or amniotic fluid. A preferred liquid for reconstitution is calcium-free sterile, non-pyrogenic isotonic solution suitable for intravenous administration. For example, without limitation, one such liquid is sold under the trademark PlasmaLyte A™ in a single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C 6 H 11 NaO 7 ); 368 mg of Sodium Acetate Trihydrate, USP (C 2 H 3 NaO 2 .3H 2 O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl 2 .6H 2 O). It contains no antimicrobial agents. The pH is 7.4. [0061] The term “administering” means applying or injecting or ingesting the material. The term “applying” is used broadly and includes uses such as washes, placing and massaging into the skin as performed with conventional creams, ointments lotions and pastes and implantation. [0062] Connective soft tissue defects or injuries often occur by damage to the extra-cellular matrix (ECM) that forms muscles, ligaments or tendons in mammals. Collagen is the most abundant structural protein in the connective tissue (ECM) and acts as a natural scaffold for cellular attachment in the body. [0063] Amnion is an abundant source of collagen, as well as the other proteins, carbohydrates, lipids, hyaluronic acid, laminin, fibronectin, pluripotent mesenchymal stem cells (MSC) and other complex growth factors that are essential for fetal growth and development. In particular, amnion has a complete lack of surface antigens, thus it does not induce an immune response when implanted into a ‘foreign’ body, which is in contrast to most other allograft implants. Amnion also markedly suppresses the expression of the pro-inflammatory cytokines, IL-1α and IL-1β (Solomon et al., 2001, Br. J. Ophthalmol. 85 (4):444-9) and produces natural inhibitors of matrix metalloproteases (MMPs) expressed by infiltrating polymorphonuclear cells and macrophages (Hao et al., 2000, Cornea, 19 (3):348-52; Kim et al., 2000, Exp. Eye Res. 70 (3):329-37). Amnion also down-regulates TGF-β and its receptor expression by fibroblasts leading to the ability to modulate the healing of a wound by promoting tissue reconstruction. Furthermore, amnion has a broad spectrum of antimicrobial activity against bacteria, fungi, protozoa, and viruses for reduced risk of post-operative infection. [0064] Amnion derived tissues are therefore immune-privileged and ideally suited for cosmetic purposes. [0065] A “kit” is an assembly of parts, materials, and compositions of matter packaged together to facilitate a procedure. Kits commonly comprise instructions for the use of the parts, materials and compositions. [0066] Turning now to FIG. 1 , a kit embodying features of the present invention, generally designated by the numeral 11 is depicted. Kit 11 has the following major elements: a first vial 15 , a second vial 17 , a container for a tissue wrap 21 , a syringe 23 , and instructions 25 . The kit 11 is held in suitable packaging, as depicted, a box 27 . Suitable packaging may comprise any means for holding the collection of parts, materials and compositions. For example, without limitation, bags, wraps, containers, ties and the like. [0067] The first vial 15 contains a aesthetic modifier comprising a dried particulate mixture of mechanically decellularized amnion obtained from one or more animals compatible with a subject. Upon reconstitution, the aesthetic modifier forms a reconstituted aesthetic modifier. The kit 11 may contain a vial containing such liquid for reconstitution [not shown] or the liquid for reconstitution may be derived from other sources. [0068] The second vial contains fetal cells obtained from one or more animals compatible with a subject and compatible with a particulate mixture in the first vial 15 . The fetal cells are applied in cooperation or concurrently with the reconstituted aesthetic modifier or form a combined aesthetic modifier comprising a particulate cellular suspension and fetal cells for application to the subject to produce a cosmetic effect. In forming a combined aesthetic modifier, the dried particulate mixture of the first vial 15 is reconstituted with or combined with the fetal cells of the second vial 17 , supplemented as needed with further liquid for reconstitution. For example, the dried particulate mixture can be reconstituted by suspension in a solution of 50% solution for reconstitution, such as PlasmaLyte A′, and 50% amniotic fluid containing fetal cells. [0069] The combined aesthetic modifier is injected into or around the site of at least one of the group of sites comprising creases, wrinkles, inconsistent pigment, sags, hair loss, spots, loss of flexibility, thinning, and voids injury with syringe 23 . [0070] The kit 11 may also contain cream or ointment or lotion or paste bases in a third vial or jar [not shown] to which the combined aesthetic modifier and/or the aesthetic modifier comprising the dried particulate cellular and/or the reconstituted aesthetic modifier is incorporated by agitation and or levigation. Cream and lotion bases are sold under a variety of tradenames such as Eucerin® and Nivea® (Beiersdorf, Inc., Hamburg, Germany). Ointment bases are sold under a number of tradenames and comprise white petrolatum as a major constituent. Pastes can be made readily by adjusting the water content of the fluids used for reconstitution or by adding inert builders such as carboxymethycellulose. The cream, lotion, ointment or paste can be made just prior to application or premade. Although reference is made to commercially available cream and ointment bases, the aesthetic modifier, reconstituted aesthetic modifier and combined aesthetic modifier may be incorporated in similar creams, ointments, lotion and pastes during the manufacture of the base. [0071] The kit 11 may also contain an inflammation inducing means {not shown]. Inflammation inducing means creates an inflammation creates an inflammation response which improves the effectiveness of the aesthetic modifier. For example without limitation, a inflammation inducing means selected from the group comprising keratolytics, irritants, rubefacients, abrasives, phototherapy, dermal microneedle devices is applied prior to or during administration of the aesthetic modifier. The one or more keratolytics, irritants, rubefacients, or abrasives are carried in a spray, cream, ointment, slurry, paste, wash, mask, dermal patch, powder, solution or suspension held in a vial [not shown] similar to the vials depicted or in a jar. The one or more keratolytics, irritants, rubefacients, or abrasives are applied before or carried with the aesthetic modifier and applied with the aesthetic modifier. Irritants, rubefacients and vesicants are know in the art and include, by way of example, without limitation, anthralin, camphor, cantharidin, capsicum , coal tar, ichthammol, juniper tar, menthol, Peruvian balsam, and pine tar. Keratolytics are known in the art and include by way of example, without limitation, benzoyl peroxide, salicylic acid, retinoic acid and other vitamin A derivatives. Keratolytic compounds are commonly found in acne treatment products. The kit 11 may also comprise photo or light devices to create an inflammatory response. Photo or light devices are known in the art as sun lamps and tuned lazer devices. [0072] The container for a tissue wrap 21 contains a tissue wrap derived from amnion tissue obtained from one or more animals compatible with a subject. The tissue wrap comprises amnion tissue constructed and arranged for placement in juxtaposition with at least one of the group of sites comprising creases, wrinkles, inconsistent pigment, sags, hair loss, spots, loss of flexibility, thinning, and voids. The tissue wrap is applied in cooperation or concurrently with the aesthetic modifier, reconstituted aesthetic modifer or a combined aesthetic modifier to create a cosmetic result. [0073] Turning now to FIG. 2 the container for tissue wrap 21 is depicted as a transparent bag through which the tissue wrap designated by numeral 31 can be seen. As seen in FIG. 3 , tissue wrap 31 is formed by affixing amnion tissue to a first support 33 on one side of the amnion and a second support on the other side of the amnion [not shown] and air drying the tissue for thirty minutes to three hours or more, based on humidity, and, most preferably, for about one hour. The supports, of which first support 33 is depicted, maintain the shape of the tissue during the drying process. The supports are preferably removed prior to placement of the tissue in container 21 . One embodiment of the present invention features a first support 33 and second support constructed and arranged to have facial features [not shown]. The first support 33 and the second support are sculpted to resemble a human face in shape and contour such that the tissue wrap 21 , when placed on the face of a subject will readily conform to the shape and contours of the subject's face as best seen in FIG. 4 . [0074] FIG. 4 depicts a subject 23 to which a tissue wrap 21 in the form of a mask 25 is being applied. Mask 25 has openings 27 (only one is visable) for the eyes and openings 31 (only one is visable) for nasal passages and an opening 35 for the mouth. Mask 25 is removed from the container and placed over the face to create a cosmetic result. [0075] Returning now to FIG. 1 , the dried particulate mixture is obtained from the mechanical decellularization or cryofractionation of about 1.5 10 −2 cm 3 to 5 10 −2 cm 3 of amnion/mL of reconstituted medicament and include particles greater than 20-100 microns in diameter. Upon reconstitution of the dried particulate mixture by suspension in a solution of amniotic fluid and/or PlasmaLyte A™, the reconstituted medicament can be administered to the subject animal to promote the healing of superficial wounds. [0076] The dried particulate mixture obtained from the cryofractionation comprises about 1.5×10 −2 cm 3 to about 5×10 −2 cm 3 of amnion/mL of reconstituted medicament. [0077] The fetal cells can comprise amniotic fluid cells and the particulate matter can be filtered to contain particles that are less than 100 microns in diameter. The fetal cells can have a concentration from 10 3 to 10 20 /mL mesyschimal and/or epithelial stem cells. In another embodiment, fetal cells can have a concentration of 10 3 to 10 12 /mL. In another embodiment, fetal cells can have a concentration of 10 4 to 10 12 /mL. In another embodiment, fetal cells can have a concentration of 10 4 to 10 11 /mL. In another embodiment, fetal cells can have a concentration of 10 4 to 10 10 /mL. In another embodiment, fetal cells can have a concentration of 10 4 to 10 9 /mL. In another embodiment, fetal cells can have a concentration of 10 4 to 10 8 /mL. In another embodiment, fetal cells can have a concentration of 10 4 to 10 7 /mL. In another embodiment, fetal cells can have a concentration of 10 4 to 10 6 /mL. In another embodiment, fetal cells can have a concentration of 10 3 to 10 6 /mL. In another embodiment, fetal cells can have a concentration of 10 3 to 10 7 /mL. [0078] In one example, the fetal cells can have a concentration of about 0.8×10 6 to 1.2×10 6 cells/mL of the particulate cellular suspension. The dried particulate mixture can contain particles obtained from the cryofractionation of from about 1.5×10 −2 cm 3 to about 5×10 −2 cm 3 amnion per mL of the particulate cellular suspension. In one example, the particulate cellular suspension comprises a particulate matter obtained from the cryofractionation about 1.5×10 −2 cm 3 to about 5×10 −2 cm 3 amnion for every 10 6 plus or minus 2×10 5 amnion fluid cells. [0079] Features of the present invention are further described with respect to the following Examples. These examples feature equine subjects and materials. However, materials derived from other animals species, for example, without limitation, canine, feline, bovine, porcine and other animal species materials and subjects can be prepared in a similar manner as outlined below. The equine materials have been utilized with avian, reptilian and other animal groups. EXAMPLES Example 1: Amniotic Material Processing [0080] This procedure defines the aseptic collection of amniotic material (amnion and amniotic fluid) for injection at the site of an injury. [0081] Amnion Tissue [0082] The amnion container was picked up and sampled for Bioburden. The amnion was aseptically transferred into the sterile field (laminar flow hood). The amnion transport packaging (previously disinfected, i.e. with 70% ETOH) was opened. [0083] A 50 mL sample of the Amnion Transport Solution was aseptically transferred into a 30 to 60 mL conical tube for pre-processing bioburden testing. The vial was labeled with sample description, batch number, date and time and placed in a designated refrigerator. [0084] (1) Amnion Preparation [0085] The amnion from the incoming container was transferred into approximately 200 mL of Plasma Lyte-A in a sterile bioassay dish where it was gently rinsed. A piece of amnion was then spread evenly on a sterile cutting board carefully avoiding any overlaps. A record was made of the amnion preparation start time. Sterile gauze or laps were used to remove any remaining debris/blood from the surface of the amnion. The amnion was inverted and the surface of the opposite site was similarly washed. Any chorion was removed by blunt dissection to separate it from the amnion. After washing and cleaning, the amnion pieces were returned to the bioassay dish containing Plasma Lyte-A. Using a sterile scissors/scalpel, the amnion was cut into 2 to 10 sections. The approximate area of each piece (50-450 cm 2 ) was measured and recorded using a sterile stainless steel ruler. [0086] The cleaned pieces of the amnion were placed back on the sterile cutting board and the amnion was spread out on the board taking care to not overlap. A sterile nylon mesh was placed over the surface of the amnion again taking care to overlap them. The amnion and mesh were then placed onto a sterile drying rack and allowed to air dry for a minimum of one hour. Start and stop times for drying were recorded. [0087] (2) Amniotic Fluid [0088] (a) Amnion Fluid Preparation [0089] A large sterile pan was first placed into the sterile field (laminar flow hood) and filled with cold packs from a −80° C. freezer. The aspiration containers with the amniotic fluid were disinfected with 70% ethanol (ETOH), inspected for integrity and placed on the cold packs in the laminar flow hood. The source of the amniotic fluid was confirmed by looking at the Donor animal ID number. The 2.0 mL of amniotic fluid was then aseptically pipeted into a 2 mL sterile microcentrifuge tube for bioburden testing. The vial was labeled with the sample number, batch number, date and time and placed in the designated refrigerator. [0090] Using a 50 mL sterile disposable serological pipette all the remaining amniotic fluid was transferred into 1 liter sterile disposable bottles and placed on the cold pack. The total volume of the amniotic fluid and the color were recorded. [0091] (3) Amniotic Fluid Cell Count and Determination of the Number of Viable Cells [0092] Each amniotic fluid bottle was gently mixed and 1.0 mL of the fluid was collected using a 1 mL micropipette and transferred into a 2 mL Eppendorf microcentrifuge tube. A total of 50 of cell suspension was then added to 50 μL of trypan blue (0.4%) in an Eppendorf microcentrifuge tube and vortexed for 5 seconds. The sample was placed on a rack for 5 minutes. [0093] A Neubauer chamber (hemocytometer) was rinsed with distilled water, and then sprayed with ETOH 70% and wiped clean and dried with paper towels. A cover slip was placed on the top of the micro-grids of the chamber. The trypan blue-cell suspension was gently mixed and used to fill both sides of the hemocytometer with 10 μL by capillary action. The cells were allowed to settle down for at least 30 seconds. The hemocytometer was placed under the microscope and all cells in the four 1 mm corner squares and one 1 mm center square were counted. For accuracy the total number of cells counted was greater than 100. The cells were re-counted if >10% of the cells appeared clustered, by vigorously pipetting in the original cell suspension as well as in the trypan blue cell suspension mixture. Using a double cell counter, the number of viable and non-viable cells was determined. The cells in both chambers were counted and an average was calculated. For the trypan blue test, live cells did not take up the dye, whereas dead (non-viable) cells did. Thus non-viable cells stained blue and viable cells remained opaque. “Ghost” cells, which appeared as flattened pale blue cells were not counted. [0094] The number of cells was determined as follows: Each square represented a total volume of 0.1 mm 3 or 1×10 −4 mL (0.1 mm depth×1 mm width×1 mm height=0.1 mm 3 ). The number of cells per mL was then deduced from the average viable cell count per 1 mm square×2×10 4 . The total cell number was therefore equal to the number of cells per mL multiplied by the original volume of sample fluid. The cells were then diluted to the desired concentration. Example 2: Aseptic Processing of the Amniotic Material [0095] (1) Aseptic Cryofractionation of Amnion [0096] After at least one hour, the amnion was removed from the drying rack and transferred into the milling chambers having an impactor. The milling chambers were placed into the Cryomill and cryofractionated using the following settings: [0097] Number of Cycles: 4 [0098] Frequency 1/s: 10 CPS — [0099] Precooling Time: 10 minutes [0100] Grinding Time: 4 minutes [0101] Intermediate Cooling: 3 minutes [0102] Once grinding was complete, the milling chambers were allowed to warm to room temperature for approximately two hours. The start and stop times were recorded. [0103] Approximately 50 mL of the amnion suspension solution was dispensed into each milling chamber. The inside milling chamber and the impactor were rinsed with the solution multiple times until the ground amnion (dried particulate mixture) was re-suspended and collected in the bottom of the chamber. The impactor was removed using the magnet pen. The cryofractionated amnion solution was then transferred to the amnion suspension container and placed on cold packs in the sterile field and diluted to the desired amount. [0104] (2) Aseptic Processing of Amniotic Fluid [0105] The amniotic fluid was aliquoted evenly into 50 mL sterile centrifuge tubes and centrifuged at 200-400×g (1100-1600 rpm) for approximately 5-10 minutes at room temperature. The supernatant was then removed from each tube using a 25 mL sterile serological pipette. The amniotic liquid was kept in new container and the pellet was re-suspended in Plasma Lyte-A™ to a total volume of 25 mL in each tube. The re-suspended cells in any two different tubes were vortexed for approximately 3 to 5 sec and consolidated into a single tube prior to centrifugation at 200-400×g (1100-1600 rpm) for approximately 5-10 minutes at ambient temperature. The preceding steps were repeated as necessary. [0106] The supernatant from each tube was removed using a sterile pipette and the pellet was again re-suspended in a cell suspension solution (amniotic fluid and/or an isotononic solution, e.g., PlasmaLyte A™) to bring the volume in each tube to about 10 mL and vortexed for approximately 3 to 5 seconds. A 1 mL aliquot was removed and the cell count and viability was determined using the above-described trypan blue test. [0107] If red blood cells were present in the amniotic fluid cell suspension, they were removed using a RBC Lysing Solution. A 10× concentration was prepared as follows: NH 4 Cl (ammonium chloride)=8.02 gm+NaHCO 3 (sodium bicarbonate)=0.84 gm adjusted to a total volume of 100 mL with Millipore filtered water. 10 mL of the 10× concentrate was added to 90 mL Millipore filtered water and refrigerated until use. The amount needed of Erythrolysis solution (15 mL per tube centrifuged) was removed from the refrigerator and kept for a period of 0.5 hours in the stabilization incubator. After centrifuging the amniotic fluid at 400×g for 10 minutes, the supernatant was removed and the pellet was re-suspended in Erythrolysis solution (minimum of 50 mL per tube). The contents of all the tubes were consolidated into one tube that was rocked for ˜10 minutes at room temperature until the liquid was clear red. The cells were again centrifuged for 5 minutes at 250 to 400×g. The supernatant was decanted. The pellet was washed with 50 mL of PBS or PlasmaLyte A™ before centrifugation again for 10 minutes at 250 to 400×g. The washing of the pellet was repeated as needed. The amniotic fluid cells were then filtered through a 100 μm cell strainer, and re-suspended in PBS or PlasmaLyte A™. The cells were again centrifuged for 10 minutes at 250 to 400×g. The supernatant was decanted and the pellet was left in the 50 mL conical centrifuge tube. [0108] (3) Procedure for Cryopreservation of Cryofractionated Amnion with Amnion Fluid Cells [0109] Appropriate size cryovials that were previously labeled and their corresponding size of CoolCell™ freezer (CCF) racks were placed in the hood. CryoStor 10™, the Cell Suspension Solution and the Amnion Suspension Solution were also placed on cold packs in the hood. Cryostor 10™ is commercially available from Biolife Solutions. [0110] The cell suspension solution and the amnion suspension solution were then combined into the cell suspension solution container. Using 50 mL serological pipettes, the solutions were homogenized several times. The container was again placed on the cold packs on the sterile field. Empty cryovials were placed in the CCF racks on cold packs and their caps were removed inside the hood (sterile field). The mix of cell/amnion suspension solution was pipeted into an empty Amnion Suspension container and a same volume of CryoStor 10™ was added and homogenized before being placed on the cold packs. A 50 mL pipette Combitip was fitted on to a repeat pipetor set to dispensing mode. The fill volume was adjusted and 50 mL of the Cell/Amnion solution was aspirated and then adjusted to the desired dispense volume (1 or 2 mL). The cryovials in the CCF were then filled and the vial caps were replaced securely and the rack of filled vials was placed on cold packs for QC inspection. [0111] Cell freezing was achieved by cooling the cells at a cooling rate of 1° C. per minute from 4° C. to −80° C., using a passive cooling controlled-rate freezer CoolCell™ (commercially available from Biocision.) [0112] The cell suspension in cryoprotective freezing medium was aliquoted into each of the cryovials and the cells were gently mixed to maintain a homogeneous cell suspension. The solid core of the CoolCell (black ring) at room temperature was seated in the bottom of the central cavity and the vials containing the cell suspension were placed in each well. The lid of the CoolCell™ was fully sealed and the Coolcell™ was placed into a −80° C. freezer for at least 4 hours prior to transfer on dry ice to long term storage. Cell viability and QA/QC were evaluated by thawing one vial after short term storage. Example 3: Amniotic Tissue Wrap Preparation [0113] After confirming the amniotic tissue source and donor mare ID and recording the time of receipt, the amnion transport packaging (previously disinfected, i.e. with 70% ethanol, methanol, etc.) was aseptically transferred into the sterile field (a laminar flow hood). A sample of the Amnion Transport Solution was first transferred into a 50 mL conical tube for Bioburden testing. The vial was then labeled with sample description, batch number, date and time and placed in designated refrigerator. [0114] (1) Amniotic Membrane Wrap Preparation [0115] Saline was aseptically added into a second receiving pan in the sterile field (i.e. laminar flow hood) and the amnion tissue was taken from incoming receiving pan to the second receiving pan containing the sterile saline. Any remaining blood was rinsed with sterile saline. After documenting the amnion preparation start time, sterile gauze or laps was used to remove any remaining debris/blood from the surface of the amnion. The amnion was then inverted and the other side was rinsed and washed. Any remaining chorion was removed by blunt dissection to separate it from the amnion. The amnion was kept wet with sterile saline. The tissue was blocked off by cutting away any stringy ends and checked for holes or tears. After repositioning the amnion on the cutting board with the chorion side up, the approximate area of each piece of amnion was measured and recorded in cm 2 using a sterile stainless steel ruler. [0116] The amnion (chorion side up) was covered with a sterile mesh (e.g., a nylon mesh) wetted with sterile saline. For the purpose of this discussion, there is a first steel mesh which is denoted by a first visible indicia, the color white, and a second steel mesh, to be discussed below, which is denoted by a second visible indicia, the color blue. Any reference to the colors white or blue are directed to these visible indicia. Those skilled in the art will recognize that such visible indicia is matter of choice. The mesh was cut to size and was allowed to slightly overlap the amnion. The mesh-covered amnion was then gently lifted, turned over and placed back on the cutting board. Caution was used as to not disturb the mesh/amnion interface. The newly exposed side of the amnion was wiped with sterile wipes or gauze pads to remove any remaining blood or small tissue particles. The newly exposed side of the amnion was covered with a second steel mesh, BLUE sterile mesh (e.g., a nylon mesh) wetted with sterile saline. The mesh was cut to size and was allowed to slightly overlap the amnion. [0117] The amnion tissue sandwiched between the white and blue mesh was placed on the drying rack where the amnion tissue was allowed to dry for 60 to 90 minutes at ambient temperature (65° to 70° F.). Caution was used as to not disturb the mesh/amnion interface. The amnion was kept unfolded and as flat as possible during this step. Additional drying racks were used as needed. The total drying time was recorded. The dried tissue was then removed from the rack(s) and laid flat on the cutting board, WHITE side up. The WHITE mesh was carefully removed from the entire sheet of amnion which was checked for holes or tears. With the BLUE mesh side up on the cutting board, each section was cut using a scalpel or rotary cutting blade and the sizes and surface areas were recorded as 5×5 cm, 10×10 cm, round 15 mm diameter and round 22 mm diameter. Those skilled in the art will recognize that the sections can be cut and sized to fit particular needs and these sizes and shapes are only exemplary. For example, the supports may be constructed and arranged to resemble facival features to produce a mask as previously described. [0118] (2) Amniotic Membrane Wrap Pre-Packing Pouches, Sealing Test and Labeling [0119] The sterile field was set up for packaging including a sealer for packing pouches (Sealer settings: Temperature=177±9° C. (350±15° F.)). Three (3) empty pouches were sealed for visual inspection and retention and then labeled. Packing pouches are available from numerous vendors. One suitable pouch is sold under the trademark KAPAK™. Amniotic Membrane Wrap Packing [0120] Pouches were transferred onto the sterile field (previously disinfected laminar flow hood). Using sterile forceps, each individual tissue membrane was inserted into the inner pouch. Large membranes were folded if necessary. The pouches were sealed with the dried amnion tissue on a mesh (see, for example, FIGS. 2 and 3 ) and inspected for a broken seal, impurities, and defects. Upon passing the inspection, the pouches were labeled with date and packaged in large pouches according to size and stored in the refrigerator or at room temperature. The donor ID, size, date, time, and initials were documented. Example 4: Implantation of Cryofractionated Amnion and Isolated Amniotic Fluid Cells [0121] (1) Thawing Vials [0122] A container was ¾ filled with hot tap water with a thermometer and cold water was added until a temperature of 37° C. was reached. A vial of cryofractionated amnion with amniotic fluid cells was taken from the −80° C. freezer. Holding the cap, the vial was partial immersed in the water bath for approximately 2 to 3 minutes with gentle agitation until the contents were melted. The vial was removed from the water bath and the exterior was wiped with sterile gauze saturated with 70% ethanol. The thawed contents were then ready for immediate use. [0123] (2) Implantation Procedure [0124] The site for the product implantation would be processed as a surgically prepared area. After cleaning or clipping of any gross contamination, the complete the area would be scrubbed with chlorhexidine for 5 to 7 minutes and then wiped down with alcohol swabs. Before proceeding, the area would be cleaned until the alcohol swabs used on the scrubbed area were dirt-free. Antibiotics would be administered prior to starting the procedure, if needed. [0125] The contents of the 2 mL vial would be split into multiple doses (0.50 to 0.67 mL) and loaded into syringes (for example, 1 mL syringes) with sterile hypodermic needles (for example 22 gauge, 1.5 inch needles). The sites comprising creases, wrinkles, inconsistent pigment, sags, hair loss, spots, loss of flexibility, thinning, and voids are injected with small volumes of combined aesthetic modifier. After injection, the site was bandaged with sterile swabs and adhesive bandage, if needed. Example 5: Implantation of Cryofractionated Amnion and Isolated Amniotic Fluid Cells in Combination with the Amnion Tissue Wrap [0126] (1) Materials [0127] A kit comprising sterile hypodermic needles (18 and 23 gauge), syringes (3 to 5 mL), vials of thawed cryofractionated amnion and amniotic fetal cells as well as packaged amnion tissue wrap of the appropriate size were assembled (see FIG. 1 ) together with sterile gloves, 1% lidocaine, saline and sedatives and/or anesthetics. [0128] (2) Surface Preparation [0129] The site would be initially pre-cleaned to remove dirt, scrubbed with chlorhexidine for 5 to 7 minutes and then wiped down with alcohol swabs. [0130] (3) Inflammation: [0131] A subject would create a mild inflammatory response by applying one or more inflammation means comprising keratolytics, irritants, rubefacients, abrasives, phototherapy, dermal microneedle devices prior to or during administration of the aesthetic modifier. The one or more keratolytics, irritants, rubefacients, or abrasives are carried in a spray, cream, ointment, slurry, paste, wash, mask, dermal patch, powder, solution or suspension. The one or more keratolytics, irritants, rubefacients, or abrasives are applied before or carried with with the aesthetic modifier and applied with the aesthetic modifier. Irritants, rubefacients and vesicants are know in the art and include, by way of example, without limitation, anthralin, camphor, cantharidin, capsicum , coal tar, ichthammol, juniper tar, menthol, Peruvian balsam, and pine tar. Keratolytics are known in the art and include by way of example, without limitation, benzoyl peroxide, salicylic acid, retinoic acid and other vitamin A derivatives. Keratolytic compounds are commonly found in acne treatment products. The kit 11 may also comprise photo or light devices to create an inflammatory response. Photo or light devices are known in the art as sun lamps and tuned lazer devices. [0132] This step created a relatively clean wound bed and generated an inflammatory signal that induced the migration and proliferation of stem cells and growth factors (from the amniotic material and subject's own immune system). Systemic antibiotics were administered prior to starting the procedure. [0133] (4) Application of Amniotic Tissue Wrap [0134] Amniotic tissue wrap shaped as a mask for facial application would be applied to the face of the subject. [0135] After the application of the amnion tissue wrap as described above, the approximate volume of the would be estimated and the amount of cryofractionated amnion and isolated amnion fluid cells to be injected were determined in accordance with guidelines shown in Table 3. [0000] TABLE 3 Amount of cryofractionated amnion and isolated amnion fluid cells to be injected as a function of volume crease or voids or wrinkles. Amount of cryofractionated amnion/ Area amnion fluid cell suspension to use <12.5 cm 2 1.0 mL >12.5 cm 2 but <25 cm 2 1.5 mL   >25 cm 2 2.0 mL [0136] After application of the inflammation means, the cryofractionated amnion/amnion fluid cell suspension would be injected into the skin below the features which modifiecation is desired. [0137] To minimize discomfort and to ensure an adequate spread of the amniotic material, the cryofractionated amnion/amnion fluid cell suspension would be mixed with 1% plain lidocaine in a 1:1 ratio. After the completion of the procedure, the site was dressed with a nonporous dressing followed by application of a nonstick dressing and a dry sterile dressing of gauze. Five to seven days after implant of the amnion allograft, the area would be redressed, and standard wound care consisting of saline wet to dry sterile gauze dressing would be resumed. [0138] Any patent, patent application, publication, or other disclosure material identified in the specification is hereby incorporated by reference in its entirety and for all purposes to the same extent as if each such individual reference (e.g., patent, patent application, publication, or other disclosure material) was specifically and individually indicated to be incorporated by reference in its entirety for all purposes. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein, is only incorporated by reference to the extent that no conflict arises between that incorporated by reference material and the present disclosure material. [0139] Other embodiments are within the following claims.

Methods are disclosed for the collection and processing of amniotic material in animals. These methods involve collection of amniotic material directly during parturition or cesariean section in animals for the processing of regenerative wound treatments and tissue repairs without culturing or utilization of any excess manipulation of tissue. These materials are used to effect a cosmetic result.

FIELD OF THE INVENTION [0001] The present invention to a grill for cooking food that is equipped with top and bottom cooking elements movable toward and from one another for cooking food through both sides to reduce cooking time. BACKGROUND OF THE INVENTION [0002] Some grills are equipped with top and bottom-heating surfaces so that meat placed between the heating surfaces is cooked from both the top and bottom sides of the meat simultaneously to reduce cooking time. Unfortunately, the cooked meat is often tough because fat contained in the meat has insufficient time to dissolve meat fibers to tenderize the meat. Fat also imports flavor to meat and, when meat is cooked very rapidly, the liquefied fat does not have sufficient time to permeate the meat to develop the full flavor. When these grills cook meat such as hamburger, pork chops, and chicken fillets, they are usually cooked done yielding dry meat, which is tough to chew. Sauces are sometimes applied to the meat after cooking to add moisture and enhance flavor. Unfortunately, applying sauces on top of the meat does not enhance flavor throughout the meat adds very little moisture. It is desirable to have a grill that can cook foods quickly without destroying the flavor or drying out the meat. [0003] Some grills drain fat to a dish to keep it away from the meat during cooking. As the fat is removed from the meat during cooking, the meat dries and flavor is lost. To combat this tendency, meat is sometimes marinated in a mixture of vegetable oil and seasonings that are somewhat absorbed by the meat prior to the cooking which may increase the moisture content and flavor of the cooked meat. Vegetable oil tends to stay on the surface of the meat where it is removed during the cooking process even before the animal fat is rendered liquid and drained from the meat. Marinade is therefore ineffective in reducing the fat content of the cooked meat. The marinade, however, can enhance the flavor of the meat because the spices and other liquids in the marinade are absorbed deeper into the meat than the oil to enhance flavor. [0004] While the marinade can improve the flavor of the cooked meat, its effectiveness is dependent on the liquid in the marinade displacing the liquid in the meat prior to cooking. The displacement process proceeds very slowly at refrigerator temperatures and may take several days for maximum displacement which is impractical in a restaurant setting because of the extra refrigerator space required. The process can be carried out faster at room temperature, but leaving meat at room temperature for the time required for the marinade to be effective gives harmful bacteria a chance to multiply. It is desirable to have a grill that can decrease the fat content of the cooked meat while retaining moisture and flavor without increasing refrigerator space required. [0005] In prior grills the marinade emanates from a cup located in the center of the bottom cooking surface. The marinade flows through the grooves and migrates upward as it evaporates. Moisture from the food vaporizes during cooking and that moisture vaporized by the top cooking surface has a tendency to be forced downward through the food which helps tenderize and flavor the food. Unfortunately, the downward vaporized moisture retards upward movement of the vaporized marinade resulting in less than through penetration of the marinade. It is therefore desirable to have a way to for the marinade to completely penetrate the cooking food to impart uniform flavor and moisture. [0006] When meat is cooked by heating it from the top and bottom simultaneously, rendered fat accumulates on the cooking surfaces of the grill because less evaporates due to the top heating surface. Some grills remove the rendered fat by providing grooves in the cooking surfaces so that the fat can drain into a dish. The grooves in the cooking surface are slanted so that the grease flows by gravity for collection. While this process does remove and capture the rendered fat, it is not practical in a restaurant setting because the rendered fat is hot and therefore hazardous. There is an opportunity for the rendered fat to spill or splatter on a worker and there is the possibility that a worker could be injured by steam exiting through the grooves from the cooking process. It is therefore desirable to have grill where grease is easily captured and removed without exposing workers to it while the meat is cooking. Accordingly, it would be appreciated, that it would be highly desirable to have a grill that captures rendered fat for safe and easy removal. [0007] A problem with grills is that during the cooking process, in addition to fat collecting on the grill, scraps of meat or other cooking debris also accumulate on the cooking surface and must be removed. When left on the cooking surface, the cooking debris will bum importing undesirable flavors to the food that is cooking. It is therefore desirable to have a simple method of removing cooking debris from the surface of the grill after each use. [0008] Another problem with grills is that cleaning the cooking surfaces is difficult. The bottom cooking surface is a horizontal plane at a fixed height that is not comfortable for all workers, while the top cooking surface must be raised over the heads of some workers for cleaning. It is desirable to have cooking surfaces that are easily accessible for all workers. [0009] Still another problem with grills is that vapors and smoke from cooking permeate the air with odors and grease. Vapors and smoke escape from the space existing between the top and bottom cooking surfaces. Even though the top surface overlaps the bottom surface, there is space existing between the two where vapors and smoke escape. It is desirable to have a venting system that discourages smoke and vapors from leaving the grill to permeate the air in the cooking room. SUMMARY OF THE INVENTION [0010] According to the present invention, a grill has top and bottom cooking surfaces with the top cooking surface movable upward to load the grill with food and movable downward onto the food and bottom surface to cook the food. Different surface cooking zones may be heated individually to accommodate the amount and type of food. The top surface is lowered and pressed onto the food at a preselected pressure to provide positive contact with the food. Heated marinade and marinade vapor flow through openings or grooves in the cooking surfaces to steam the food and render fat for removal to a grease trough. [0011] It is an object of the invention to provide a grill that can cook foods quickly without destroying the flavor or drying out the meat. This object is achieved by top and bottom cooking surfaces that heat food from the top and bottom simultaneously while steaming the food with its own juices or with a marinade to keep the food moist. It is a feature of the invention that the top and bottom cooking surfaces move, one relative to the other, to contact the food to directly heat the food. [0012] It is an object of the invention to provide a grill that decreases the fat content of the cooked meat while retaining moisture and flavor without increasing refrigerator space required. This object is achieved by forcing steam or marinade through the meat to render the fat and drain the rendered fat as the meat cooks. It is feature of the invention that marinade is added at the time of cooking thereby eliminating the need marinating the meat in a refrigerator. Another feature of the invention is that meat can be cooked from a frozen state without thawing prior to placing it on the grill thereby reducing the need for refrigeration. [0013] Another object of the invention is provide a way to for the marinade to completely penetrate the cooking food to impart uniform flavor and moisture. This object is achieved by introducing the marinade through openings in the top cooking surface. A feature of the invention is a series of passageways and openings in the top member for dispersing the marinade. An advantage of the openings in the top member is that steaming marinade is forced through the meat from both the top and bottom for thorough flavoring and cooking. [0014] Another object of the invention provide a grill that captures rendered fat for safe and easy removal. This object is achieved by a trough along the front edge of the bottom member. A feature of the trough is that it is large enough for collecting cooking debris. An advantage of the trough is that it can be outfitted with a drain to removed grease and debris as it is generated thereby providing a clean working environment at all times and greatly reducing hazards associated with hot grease. [0015] Still another object of the invention provide a simple method of removing cooking debris from the surface of the grill after each use. This object is achieved with tiltable top and bottom cooking surfaces. The rear of the bottom cooking surface can be raised to allow debris and cleaning solution to quickly drain. The top cooking surface pivots from a horizontal position for cooking to a vertical position for cleaning. [0016] Yet another object of the invention is top provide a venting system that discourages smoke and vapors from leaving the grill to permeate the air in the cooking room. This object is achieved by several vent tubes placed about the periphery of the top member of the grill. Individual vent tubes on each side of the grill feed into a larger tube. The four larger tubes feed into a main exhaust tube that has a fan inside to create suction in the several vent tubes. The tubes has some flexibility so that they can flex when the top member moves up and down, and when the top member is tilted for cleaning. A feature of the vent system is that the main exhaust tube can be vented to the outside or vented inside through an activated charcoal filter. [0017] These and other aspect, objects, features and advantages of the present invention will become more apparent from a study of the detailed description of the invention and by reference to the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS [0018] [0018]FIG. 1 is a diagrammatic front view of a preferred embodiment of a grill according to the present invention. [0019] [0019]FIG. 2 is a diagrammatic right side view of the grill of FIG. 1 with the grill open to receive food to be cooked. [0020] [0020]FIG. 3 is a diagrammatic right side view of the bottom portion of the grill with the bottom cooking surface tilted. [0021] [0021]FIG. 4 is a diagrammatic right side view of the bottom portion of the grill illustrating the marinade cup and grease through. [0022] [0022]FIG. 5 is a diagrammatic top view of the top portion of the grill illustrating the pivot bar. [0023] [0023]FIG. 6 is a diagrammatic top view of the bottom cooking surface illustrating the embedded cooking elements. [0024] [0024]FIG. 7 is a diagrammatic bottom view of the top cooking surface illustrating the embedded cooking elements. [0025] [0025]FIG. 9 illustrates the control panel for the grill. [0026] [0026]FIG. 10 is a diagram of a ventilation system for the top member of the grill. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0027] Referring to FIGS. 1 - 3 , a grill 10 for cooking food contains a frame which supports a bottom member 12 and top member 14 each of which contains a cooking surface. The frame preferably has a set of legs 16 for supporting the bottom member 12 and a set of vertically extending, telescoping posts 18 for supporting the top member 14 . Preferably, the posts have lockable wheels 20 for moving the grill about, and also have height adjustment and leveling devices. A hood or canopy 15 may be attached at the top of posts 18 . Stainless steel is preferred for construction of the grill but other metals can be used that are corrosion resistant and have a clean appearance. [0028] One or more jacks 22 have one end attached to the legs or to a cross member attached to the legs, and has the other end attached to the bottom cooking surface or to a brace or bracket attached to the bottom cooking surface. The jacks 22 operate to raise the back edge of the bottom cooking surface relative to the front edge to cause grease and liquid to drain from the bottom cooking surface. The jacks 22 may be hydraulic with the cylinder end attached to the legs and the piston end attached to the bottom cooking surface. Alternatively, jacks 22 cam be solenoids or electric motors that raise and lower the rear edge of the bottom cooking surface relative to the front edge of the bottom cooking surface. An electric motor could work in conjunction with a gear rack that raises and lowers to operate the bottom cooking surface. Power controls 24 for the jacks 22 a may be located on the frame below the bottom member 12 . In the case of hydraulic jacks, controls 24 would include a pump and hoses for supplying pressurized fluid to the jacks along with appropriate manual switches and controls for an operator to turn the pump on or off and to raise or lower the bottom member. A manual control panel 26 for the grill may be located on the frame below the bottom member 12 above the power controls 24 on the left side of the grill. Along its front edge, bottom member 12 is preferably hingedly connected to the frame so that bottom member 12 pivots or partially rotates about the hinged connection point. For efficient cleaning, the rear of the bottom member is raised to encourage grease runoff and to make the rear more accessible to the operator. [0029] Referring to FIGS. 1 - 6 , the bottom member 12 has a bottom periphery bounding the bottom cooking surface 28 that is slightly upturned to prevent liquids on the cooking surface 28 from spilling over the edge of the bottom member. Preferably, bottom cooing surface has a larger area than top cooking surface 30 which allows vapors from cooking escaping from between the cooking surfaces to naturally turn upward instead of being forced outward into the path of an operator. [0030] Bottom cooking surface 28 preferably has a cylindrical marinade cup 32 formed therein for holding a marinade used to moisturize and flavor the food that is cooking. The marinade cup preferably extends below the bottom member 12 , has a bottom cap that is removable and has its own heating element 34 . It may be fitted with a tube for the introduction of the marinade allowing easy measuring and changing of the mixture according to the food to be cooked. The removable cap can be removed to form a drain that is useful for directing debris and cleaning solutions to a collection station when the bottom surface is cleaned. [0031] The marinade cup 32 maybe a separate cup member positioned in a depression or opening in the bottom cooking surface or it maybe formed from a depression formed in the bottom cooking surface. Preferably, the cup 32 is a threaded member that screws into a threaded opening in the bottom member or screws onto a threaded tail pipe that opens to the bottom cooking surface. The idea is to have a cup that is removable for cleaning and to have a bottom member that is relatively easy to manufacture. As an alternative to threaded members, other methods for coupling members together may be used, such as the couplings used for hydraulic and pneumatic lines which are easy to connect without leaks. [0032] Referring to FIG. 6, the bottom cooking surface 28 contain a plurality of grooves 36 that terminate at a grease collection trough 38 . The grooves 36 preferably run laterally from back to front with a varying depth slanting bottom that acts a drain for directing grease collecting in the grooves 36 to the grease collection trough 38 . The grease collection trough 38 preferably borders the front of the cooking surface so that grease drains from the cooking surface to the through 38 and is direct ed to a drain 40 that directs the collected grease into a container or grease trap in the plumbing system for the building for appropriate disposal or recycling. [0033] Both the top and bottom cooking surfaces may be heated with heating elements 42 , 44 imbedded beneath the cooking surfaces. Such heating elements may be strips of nichrome heater wire or other electrical heating element, or heat tubes for distributing steam, water, air or other fluid for heating. Nichrome wire could be embedded in the channels in the top and bottom members or attached to the rear of the cooking surfaces. Similarly, conduits for fluid could be embedded in the channels in the top and bottom members or attached to the rear of the cooking surfaces. The preferred arrangement for cooking with a filled grill is to have the heaters 42 , 44 (FIGS. 6 - 7 ) spaced to uniformly heat the entire cooking surface so that food cooks uniformly. To make a single grill more versatile, the cooking surface can be divided into zones with each zone having a heating element 42 , 44 to heat a portion of the cooking surface as needed for the particular items to be cooked. [0034] The heaters may be arranged to heat the cooking surface uniformly, and may be controlled from control panel 26 to heat only specific portions or zones of the cooking surface as desired depending on the variety and amount of food to be cooked, or to heat different portions or zones of the grill at different temperatures to cook more than one food at a time. The control panel 26 regulates the temperatures by controlling electric current or heating fluid flow to the top and bottom members. To heat in zones, the wiring or tubing is laid in zones and controlled from control panel 26 accordingly. In the case of heated fluid, a manifold attached to or near the top member with a tube for each zone controlled by a solenoid would effectively control flow to regulate the temperature. While such laying in zones is a more expensive manufacturing process, it is desirable where the grill will be called upon to provide a variety of foods in small servings. Not only may the top and bottom cooking surfaces operate at different temperatures, but different portions of each can be operated at differing desired temperatures for different periods of time. Varying the cooking time by zones or portions of the grill cooking surfaces allows foods to be cooked as desired and takes into account the time required to load and unload the grill so that foods are not inadvertently overcooked. [0035] Referring to FIG. 8, to solve the problem of uneven dispersement of the marinade, the top member is outfitted with a number of jets 46 to spray or drip marinade from the top onto the cooking food. The jets are arranged in zones or other pattern to compliment the heating pattern, and are controlled by a solenoid manifold in similar manner to the heating fluid. The marinade is pumped to the manifold by a pump from a reservoir 65 (FIG. 5) with sufficient pressure for the jets to provide a drip or spray as desired. An inlet tube 48 delivers marinade to the jets, or manifold where a manifold is used, while an outlet tube 50 discharges unused marinade. Outlet tube 50 is preferably fitted with a one way valve 52 to prevent fluid from back flowing. Fluid flows from inlet tube 48 through tubing for jets 46 and on to outlet tube 50 . To help build pressure to operate the jets, the one way valve 52 may be a solenoid operated valve. The jets and associated tubing are preferably embedded in the top member. Inlet tube 48 is removably connected to the embedded tubing. One way valve 52 and outlet tube 50 are also removably connected to the embedded tubing. The embedded tubing is easily cleaned by replacing the marinade with a cleaning solution followed by a rinsing solution. [0036] Referring to FIG. 9, while the prior method of introducing marinade through grooves in the bottom member was superior to previous methods of cooking for speed and flavor, it produced a cooked product which was cooked and flavored more on the bottom than throughout the product because of the cooking occurring while loading and unloading the grill. The present method of introducing marinade from both the top and bottom produces a more uniformly flavored product, while the zone, temperature and time controls produce more uniform cooking to compensate for time spent loading and unloading the grill. The control panel 26 contains push buttons or other control mechanisms for opening 54 the grill and for closing 56 the grill. Push buttons 54 and 56 open and close the grill by energizing jack 58 to raise and lower top member 14 . Alternatively, the bottom member 12 may be raised to close the grill and lowered to open the grill, but moving the top member up or down is preferred because moving the bottom member would cause the bottom member to be at an inconvenient height when either open or closed thereby increasing operating complexity requiring a worker with increased skill to operate the grill. As the top member is raised and lowered, its telescoping legs extend and retract. [0037] Control panel 26 also has a number of preset buttons 60 which can be programmed for temperature using keypad 62 , for pressure using keypad 64 , for cooking time using timer keypad 66 , and for cooking zone using heat zone keypad 68 . Lights 70 , 72 illuminate to indicate that the top and bottom cooking surfaces, respectively, are at the desired temperature. Gauges 74 and 76 show top and bottom cooking surface temperatures in actual degrees referenced against the desired temperature. Each preset button 60 has an indicator light associated with it to indicate that the preset is being used. Temperature can be controlled by varying the time the heating elements are energized during the cooking cycle time. Cooking cycle time begins after the desired temperature is initially reach and when the desired pressure is obtained after moving the cooking surfaces towards one another. Cooking time for each particular food requires only a few trials. Cooking times for various foods are provided with instructions for the grill. To prevent over cooking, cooling tubes or passageways can run through the top and bottom members to quickly cool the cooking surfaces using water or a recyclable coolant. While artificially cooling the cooking surfaces increases energy demand, it allows food to remain on the grill while a dish is assembled thereby reducing the total area required to prepare a meal. [0038] Referring to FIG. 5, the top member 14 is pivotally connected to its posts so that it can pivot from a horizontal position for cooking to a vertical or nearly vertical position for cleaning. Such pivotal movement may be facilitated by mounting the top member on a pivot rod 60 or pivot pins. Such a pivot rod 60 could extend through top member 14 and terminate in a bracket 61 on either side of the top member. A locking pin 63 fits through openings in the rod 60 and bracket 61 to lock top member in a horizontal position for cooking, or a vertical position for cleaning. With pin 63 removed, top member 14 can be pivoted manually. Brackets 61 are attached to the telescoping posts. Jacks to raise and lower top member 14 can also be attached to the brackets 61 and to the lower portion of the frame. [0039] As an alternative to jacks, stepping motors may be used to raise and lower the top member. The stepping motors could be mounted on the stationary portion of the posts with gear teeth to engage teeth on the telescoping portion of the posts. Or, stepping motors could be mounted on the brackets supporting the top member and used with stationary posts to raise and lower the top member. Stepping motors have the advantage of being able to control the pressure exerted by the top member on the food. Such pressure could be controlled using the motor torque of motor current which indicates the pressure exerted. [0040] Referring to FIG. 10, an exhaust system 77 is attached about the perimeter of the top member to exhaust smoke and cooking fumes. A series of vent tube 78 are detachably attached to the skirt of the top member 14 . Top member 14 is smaller in area than bottom member 12 so that smoke and fumes tend to rise about the periphery of top member 14 . The individual vent tubes 78 on each side of the top member connect to larger tubes 80 , 81 , 83 , and a similar tube on the rear (not shown). The larger tubes 80 , 81 , 83 connect to an exhaust tube 82 that has a fan 84 inside to create suction in vent tubes 78 . Tube 82 is preferably vented to the outside but may exhaust into an activated charcoal filter or the like and then recirculated in the room. Tube 80 is flexible to accommodate the up and down motion of top member 14 , and to accommodate the pivoting motion of top member 14 . Alternatively, or in addition, vent tubes can be added to the bottom member 12 , however, top venting is preferred as it takes advantage of the natural tendency of smoke and fumes to rise. [0041] Operation of the present invention results in meat that is moist and tasty. To cook, the top cooking surface is raised, and selections for cooking zone, temperature, pressure and cooking time are selected using the keypads on the control panel. Marinade is added to the reservoir if marinade is to be used. The cooking surfaces and cup are brought to cooking temperature and the meat or other food is placed on the bottom cooking surface. Pushing the “down” button lowers the top surface. Pressure is increased to press the top surface against the food with a preselected pressure. Cooking is accomplished with heat from the top and bottom surfaces and from the heated marinade, marinade vapor and water vapor from the food. After cooking for a prelecteded length of time, the “up” button is pushed to raise the top surface and stop the heating. The food is ready and can be removed from the grill. Where the grill is equipped with a cool down cycle, the food can remain on the grill as platters of food are prepared. [0042] The meat may be seasoned prior to cooking, seasoned with the marinade during cooking, or season as desired after cooking. The vapor injected into the meat during cooking liquefies the fat and replaces the fat which drains away to the collection trough. Meat is placed on the heated grill, and the top cooking surface is lowered and presses on the meat so that the vapor can tenderize it while flavoring it. After a predetermined cooking time, the top cooking surface is raised and the cooked meat is removed. Depending on the particular combination, different meats can be cooked together and vegetables can also be cooked at the same time. Meats using the same marinade can be cooked together although their cooking times may vary. Their cooking temperatures can be varied so that both cook in the same amount of time. [0043] It can now be appreciated that an apparatus and method for cooking food quickly while keeping meat moist and tender has been presented. The apparatus includes a bottom member having a bottom member with a bottom cooking surface, means for controllably heating the bottom cooking surface, a top member with a top cooking surface. The top cooking surface is vertically movable relative to the bottom cooking surface between an open position for loading the apparatus with food to be cooked and a closed position for cooking the food. [0044] The method for cooking food comprises heating the bottom cooking surface of the bottom grill member to a first predetermined temperature and heating a top cooking surface of the top grill member to a predetermined temperature. The temperatures may be the same or different, and different zones of the cooking surfaces may attain different preselected temperatures. If not already raised, the next step is raising the top surface vertically to the open position and loading the bottom cooking surface with food. The food may be pre-seasoned with spices and seasonings, but it is not necessary to do so. The step of adding a marinade of spices, seasonings and juices to the marinade reservoir will cause sufficient seasoning of the food. After loading the grill with food, the top cooking surface is vertically lowered to the closed position. Press cooking requires forcing the top surface down into contact with the food at a pressure sufficient to confine the food between the cooking surfaces so that the fat can be rendered and the marinade permeated throughout the food. [0045] The method includes heating the marinade creating a marinade vapor, driving the marinade and marinade vapor into the food for rupturing bonds between food fibers and permeating the food replacing fat and juices with the marinade, and draining the fat and juices to the grease collection trough. After cooking the food for a predetermined length of time, the top surface is raised to the open position, and the food is removed. [0046] While the invention has been described with particular reference to the preferred embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements of the preferred embodiments without departing from invention. For example, pivot pin for the top member that extends the length of the top member can be replaced by a pair of short pins, one on each end. In addition, many modifications may be made to adapt a particular situation and material to a teaching of the invention without departing from the essential teachings of the present invention. As is evident from the foregoing description, certain aspects of the invention are not limited to the particular details of the examples illustrated, and it is therefore contemplated that other modifications and applications will occur to those skilled in the art. For example, the bottom grill member may be movable while the top grill member remains stationary, and the bottom member may be equipped with an exhaust system. It is accordingly intended that the claims shall cover all such modifications and applications as do not depart from the true spirit and scope of the invention.

A grill has top and bottom cooking surfaces with the top cooking surface movable upward to load the grill with food and movable downward onto the food and bottom surface to cook the food. Different surface cooking zones may be heated individually to accommodate the amount and type of food. The top surface is lowered and pressed onto the food at a preselected pressure to provide positive contact with the food. Heated marinade and marinade vapor flow through openings or grooves in the cooking surfaces to steam the food and drive fat out for removal to a grease trough. The marinade replaces fat and natural juices producing a relatively low fat cooked meat.

BACKGROUND OF THE INVENTION The present invention relates to a utility stand. More particularly to a utility stand for users requiring a portable work/utility stand. The utility stand incorporates the basic equipment a musician, surveyor, artist, or any user that requires a complete platform for work, practice or performing into a single structure that is easily disassembled or collapsed for storage and transport between uses. Prior art includes examples of a Portable Workstation, U.S. Pat. No. 6,068,355, a Portable Music Stand, U.S. Pat. No. 6,264,161. Other Portable equipment used by musicians, surveyors, and artists among others include portable footrests, portable instrument support stands, and portable reference tables and portable microphone stands. While having some utility these separate components have several major drawbacks. First, as individual pieces of equipment they lack stability and are easily knocked over because of their small support bases. Because they are separate pieces they are cumbersome to transport and setup. Also, the separate pieces of equipment require a larger total floor area than a single integrated utility stand. This is because the separate pieces of equipment require an extended base around each piece of equipment to achieve stability. Moreover, these separate pieces of equipment duplicate functions of the individual pieces and therefore more parts are fabricated than necessary. Another problem with portable work stations and music stands is the lack of convenient storage for tools, reference material, sheet music, and accessories, e.g. tools, paint brushes, pencils, guitar strings, markers, tuning devices to name a few which a user may require for work, study, or practice. Another problem is the lack of comfortable seating that can be adjusted to the user needs and workstation level. Accordingly, it is an object or the present invention to provide a portable utility stand that combines the separate components into a single utility stand configured for specific or multiple applications. This invention is focused toward the musician, but can be tailored for aforementioned users. Another object is to minimize the number of components and complexity by combining functions of support, seating, and storage. Yet another object is to provide an improved process for collapsing and setting up the portable utility stand for transport or storage requiring fewer set up steps. Yet another object of this invention is to configure mating parts such that the assembly cannot be setup in a manner that makes it unsafe for use. Yet another object of this invention is to provide a compact portable stand that is more resistant to tipping over when jostled or bumped than the individual pieces of equipment it replaces Yet another object of this invention is to provide convenient storage for the users reference material and accessories. Yet another object of this invention is to minimize the required floor area. Yet another object of this invention to provide for additional auxiliary equipment to be attached such as a microphone, instrument tuning device, artists easel, or an umbrella to name but a few. BRIEF SUMMARY OF THE INVENTION To achieve these and other objects, there is provided a portable utility stand with a substantially horizontal base frame supporting universal mounting receptacles that accept a broad range of components thereby enabling the base frame to integrate components such as: 1. a seating/storage unit, 2. a sheet music support or work platform, 3. a microphone/ancillary equipment support, 3. a foot rest, 4. an instrument or tool rest and a reference table to name but a few into a single unit. This single unit requires less floor area than the total floor area required by the same separate components; but has a larger stabilizing floor footprint than each separate component. This larger footprint provides more resistance to being tipped over than the separate units provide and achieves this with fewer parts. The base with universal mounting receptacles allows right hand or left-hand users to set up the components, as they prefer. In addition, a user could use the same utility stand for multiple uses by using for example the artist's easel in place of the sheet music support platform. At one end of the base frame a vertically adjustable member supports a padded seating bench with backrest. The bench provides both seating and storage. The storage unit is substantially below the seat with shelves and drawers that allow easy access without getting up from the seating bench. At the other end of the base frame is a rotatable and telescoping post supporting a rotatable platform. The platform thus mounted is adjustable by the user to provide a comfortable viewing distance and angle. Also attached to the base frame and in close proximity to the seat is an adjustable foot support that can be raised or lowered vertically, shifted left or right horizontally, tilted up or down, and support either foot or both feet simultaneously. Also attached to the base frame is an instrument support. The instrument support is rotatable about the vertical support axis and the user may install it any of the universal mounts on the left, right or behind. Also, attached to the frame is a rotatable horizontal/table platform close to hand for easy access and storage of the user's accessories. As with all the components configured for this utility stand they can be mounted in any receptacle In a preferred embodiment the utility stand is comprised of a tubular structure which is collapsible to a configuration suitable for transport or storage. In conjunction with the portable stand, another aspect of the present invention is a process for stowing the stand, including: a. a means for disconnecting/collapsing the seating bench storage unit. b. a means for rotating the sheet music platform support to be substantially parallel with the base. c. a means for disconnecting/collapsing the instrument support. d. a means for removing/collapsing the accessory shelf. e. a means for disconnecting/collapsing the auxiliary equipment supports. Thus in accordance with the present invention, a stable portable utility stand that supports user requirements for comfortable seating, displaying sheet music or other work in progress, storing accessories and reference material, supporting auxiliary equipment such as a microphone and providing a reference table is easily collapsed and setup. BRIEF DESCRIPTION OF THE DRAWINGS For a further appreciation of the above and other features and advantages, reference is made to the following detailed description of this invention and to the drawings, in which: FIG. 1A is a left-side frontal prospective view of a portable utility stand constructed in accordance with an exemplary embodiment of the present invention. A mounted musical instrument is shown for clarity; FIG. 1B is a right-side frontal prospective view of the utility stand. A mounted musical instrument is also shown for clarity; FIG. 1C is a frontal view showing the seating bench/storage assembly height adjustment means; FIG. 2 is a right-side rear prospective view of the utility stand with a rotatable extension arm for the instrument support; FIG. 3A is a collapsed left-side frontal prospective view of the utility stand; FIG. 3B is a collapsed right-side frontal prospective view of the utility stand; FIG. 4 is a left-side frontal prospective view of the base frame subassembly; FIG. 5A is a right-side frontal prospective view of the seating bench/storage subassembly; FIG. 5B is an exploded right-side frontal prospective view of the seating bench subassembly; FIG. 5C is a right-side, rear bottom prospective view of the seating bench subassembly; FIG. 6 A and is a left-side prospective view of the foot rest subassembly; FIG. 6B is a partial frontal view of the footrest mounting; FIG. 7A is a right-side prospective view of the instrument support subassembly; FIG. 7B is an exploded right-side prospective view of the instrument support subassembly; FIG. 8 is right-side rear view of the sheet music support post subassembly with extension arm FIG. 9 is an upper prospective view of the accessory shelf subassembly; FIG. 10 is prospective view of the auxiliary equipment support subassembly with an exemplary microphone; FIG. 11A is a left-side rear prospective view of the utility stand adapted for an artist; FIG. 11B is a right-side rear prospective view of the portable utility stand adapted for an artist; FIG. 12A is a left-side frontal prospective view of a compact version of the portable utility stand; FIG. 12B is a right-side frontal prospective view of the compact version of the portable utility stand; FIG. 12C is right-side rear prospective view of the compact version of the portable utility stand; FIG. 13 is a left-side frontal prospective view of the frame configuration for the compact version of the portable utility stand frame; FIG. 14A is left-side frontal prospective view of the compact version of the portable utility stand collapsed inside a standard guitar case; FIG. 14B is left-side frontal prospective view of the compact version of the portable utility stand collapsed with the guitar case removed for clarity; FIG. 14C is right-side frontal prospective view of the compact version of the portable utility stand collapsed with the guitar case removed for clarity; FIG. 15A is a side elevation view of a horizontal version of footrest 99 showing the height adjustment means for the compact portable utility stand. FIG. 15B is a side elevation view of a tilted version of footrest 99 showing the height adjustment means for the compact portable utility stand DETAILED DESCRIPTION OF THE INVENTION The utility stand top assembly 16 is shown in FIG. 1 A and FIG. 1 B. The eight subassemblies that comprise the utility stand 16 include: 1. A base frame subassembly 17 , see FIG. 4 2. A seating bench/storage subassembly 18 , see FIG. 5A , FIG. 5B , and FIG. 5C 3. A sheet music support subassembly 19 , see FIG. 8 4. A rotatable instrument support subassembly 20 , see FIGS. 7A and 7B 5. An auxiliary equipment support subassembly 21 , see FIG. 10 6. A foot rest subassembly 10 , see FIGS. 6A and 6B 7. An auxiliary shelf subassembly 23 , see FIG. 9 8. An extension arm subassembly 43 , see FIGS. 2 , 7 A and 7 B FIGS. 1A and 1B show the utility stand top assembly 16 . The adjustable seating bench/storage subassembly 18 is shown with the drawer 24 open. The sheet music support subassembly 19 is shown with the platform 25 facing the seating bench/storage unit 18 where the user would be seated. The rotatable instrument support subassembly 20 is shown supporting an instrument 22 (a guitar in this case) on the rotatable instrument support stalk 26 . The footrest subassembly 10 is shown with the foot platform 27 in the level position. The auxiliary equipment support subassembly 21 is shown supporting a microphone 89 in this particular case. Two auxiliary shelf subassemblies 23 are shown along side the storage unit seating bench/storage assembly 18 . The equipment is mounted on frame subassembly 17 , seating bench/storage subassembly 18 is shown installed in seat receptacle 35 . The rotatable instrument support subassembly 20 is shown installed in receptacle 31 . The auxiliary shelf subassembly 23 is shown installed receptacle 34 in FIG. 1 A. The auxiliary shelf subassembly 23 is shown installed in receptacle 33 in FIG. 1 B. The auxiliary equipment support subassembly 21 is shown installed in receptacle 32 . The footrest subassembly 10 is shown mounted to the frame subassembly 17 on support receptacles 88 and support receptacle 36 . Support receptacle 88 supports foot support bracket 57 on pin 58 . Support receptacle 36 supports foot support bracket 56 on pin 59 . Height and tilt adjustment of footrest subassembly 10 is achieved by adjusting pins 58 and 59 . FIGS. 1A and 1B also show the upper seat cushion 41 and the lower seat cushion 42 . Storage shelf 44 shown in FIG. 1B is a part of the seating bench storage subassembly 18 shown in FIGS. 5A , 5 B, and 5 C. The drawer 24 (shown open) and the shelf 44 are reversible. The sheet music subassembly 19 is tilted forward. The auxiliary equipment support 21 is shown with a microphone adjusted forward on the gooseneck 68 . FIG. 1C shows an exemplary method of adjusting the seat bench/storage subassembly 18 height. Support bracket 48 is supported by pin 45 in hole 53 . The seating bench/storage subassembly 18 is supported by pin 45 . Moving pin 45 to hole 52 raises the seating bench/storage subassembly 18 . Clamping means 16 two places are tightened to eliminate clearance between receptacle 35 seat support 48 . FIG. 2 shows the rotating extensions arm 43 installed over receptacle 31 . The extension arm 43 supports the rotatable instrument subassembly 20 . The extension arm 43 rotates about receptacle 31 in this case This allows the instrument 22 to be positioned closer to the user. In addition the instrument 22 , can be rotated out of the way on 43 to a protected position between the seating bench/storage subassembly 18 and the sheet music support subassembly 19 FIG. 3A shows a left-hand frontal prospective view of the utility stand collapsed for transport or storage. The sheet music support assembly 19 rotates to a substantially horizontal position. The remaining component parts lift out of their respective receptacles 31 , 32 , 33 , 34 , and 35 . They are then packed substantially horizontal in a transport case. The Transport case is not shown for clarity. FIG. 3B shows a right-hand frontal prospective view of the utility stand collapsed for transport or storage. The Transport case is not shown for clarity. FIG. 4 shows the base frame subassembly 17 is comprised of a center member 28 , a front member 29 and a rear member 30 substantially attached to the center member 28 . At each end of the front member 29 are receptacles 31 and 32 . At each end of the rear member 30 are receptacles 33 and 34 . Seat receptacle 35 , footrest support 36 , and lower footrest support 88 are attached to center member 28 . Footrest support 36 has pinholes 91 , 92 , and 93 used to adjust the footrest support subassembly 10 height. Footrest support 88 has pinholes 94 , 95 , and 96 to adjust the height or tilt of footrest subassembly 10 . Floor glides 37 and 38 are adjustably fastened to the lower side of front member 29 . Floor glides 39 and 40 are adjustably fastened to the lower side of rear member 30 . Pinhole 52 and pinhole 53 are shown in seat receptacle 35 . The use of these pinholes to adjust the height of the seating bench/storage subassembly 18 is shown in FIG. 1 C. FIG. 5A , FIG. 5B , and FIG. 5C show the seating bench/storage assembly 18 . The seat back rest 46 is slightly curved to conform to the users back and fastened to back support 47 . The back support 47 is inserted into the backrest support bracket 49 and secured with a clamping means 50 . The backrest support bracket 49 is secured to the bench/drawer structure 51 . The support bracket 48 is also secured to the bench/drawer tubular structure 51 . The support bracket 48 is inserted into the seat receptacle 35 attached to the base frame assembly 17 shown in FIG. 4 . FIG. 5B an exploded view provides a better understanding of the basic components of the seating bench/storage unit 18 . The drawer 24 slides on commonly used drawer slides 52 . FIG. 5C shows a bottom right rear view of the bench/storage assembly 18 . Finger griping recess 53 allows the drawer to be pulled open and facilitates reference material removal from storage 44 . FIG. 6A shows the footrest subassembly 10 is comprised of the footrest platform 27 , forward support bracket 56 , and rear support bracket 57 . The forward support bracket 56 is engaged in a slot 89 . The rear support bracket 57 supports footrest platform 27 on flat 90 . FIG. 1 A and FIG. 1B show the support means: support bracket 56 is supported by pin 59 engaged in 36 and support bracket 57 is supported by pin 58 engaged in 88 . FIG. 6B shows the support and adjustment means the footrest subassembly 10 . Pin 59 is shown installed in pinhole 91 . Footrest subassembly 10 height and tilt adjustment is achieved by moving pin 59 shown in hole 91 to holes 92 or 93 in cooperation with pin 58 and holes 94 , 95 , or 96 . FIG. 7A shows the rotatable support unit 20 installed in extension arm 43 . FIG. 7B shows an exploded view of the rotatable support assembly 20 with extension arm 43 . The rotatable instrument support stalk 26 is substantially fastened to tilted post 60 . The upper fork rest 61 cradles the instrument fingerboard. The upper fork rest 61 is substantially fastened to the tilted post 60 . The upper fork rest 61 is preferably round stock, covered with a soft material covering 64 . The soft material covering 64 preferably conforms to the fork rest 61 and is split to allow assembly over the upper fork rest 61 . The instrument is vertical support fork 62 is preferably round stock and configured to support the instrument vertically and horizontally with three legs of the upper vertical support fork 62 . The three legs are covered with a soft material covers 65 , 66 , and 67 . The fourth leg of the vertical support fork 62 attaches to the tilted post 69 . The extension arm unit 43 is composed of a horizontal beam 68 , with receptacle 60 and receptacle 71 . Stiffening member 72 substantially joined to the horizontal beam 69 , and receptacles 69 , and 71 . The instrument support stalk 26 is inserted inside receptacle 69 . The extension arm 43 is shown installed on the base frame unit 17 over receptacle 31 however, it could be installed over receptacles 32 , 33 , or 34 depending on user preference. FIG. 8 shows the sheet music support 19 . The sheet music support subassembly 19 consists of a lower column section 73 and a telescoping section 74 . Mounted on top of the telescoping section 74 is a bracket 75 that pivotably supports the sheet music support 76 . As indicated in FIG. 1 the sheet music support subassembly 19 is rotationally coupled to footrest support 36 through bracket 77 and secure with clamping means 45 . The telescoping section 74 is held in position with clamping means 82 . The sheet music support 25 is formed with a protruding ledge 76 to support reference material and illuminated with lamps 83 and 84 . FIG. 9 shows the auxiliary shelf unit 23 . The auxiliary shelf 23 is composed of a preferably round support member 54 , and shelf 55 . The support member 54 is rotationally coupled to the shelf 55 . FIG. 10 shows the auxiliary equipment support unit 21 that is composed of three components: a lower support member 63 , a flexible gooseneck 68 , and receptacle 70 . A microphone 89 is shown installed in receptacle 70 . However the receptacle 70 is removably mounted to the gooseneck 68 . A receptacle suitable for mounting an instrument tuning device, telephone, or other device could be installed on the gooseneck 68 . The auxiliary equipment support subassembly 21 is shown rotationally mounted to the base frame subassembly 17 on receptacle 32 in FIG. 1A and 1B but could be installed on any receptacle as discussed earlier. FIGS. 11A and 11B shows the portable utility stand adapted for an artist or surveyor. The easel 86 is shown supporting art 87 . The easel 86 replaces platform 25 on the music sheet support subassembly 19 . The frame subassembly 17 is unaltered. An auxiliary shelf subassembly 23 is installed in receptacle 33 and receptacle 34 . Umbrella 85 is shown installed in receptacle 32 . FIGS. 12A , 12 B, and 12 C show a compact version of the portable utility stand. This version, with integrated components easily fits into a guitar case as shown in FIG. 14 A. In this version the portable utility stand is supported on three floor guides 96 , 97 and 98 . Stand stability is achieved by supporting the footrest 99 on forward brace 100 and rear brace 101 . Forward brace 100 and rear brace 101 are slidably fitted to guides 102 and 103 in the frame assembly 105 . Guide 102 and floor guide 106 support forward brace 100 . Guide 103 and floor guide 107 support brace 101 . Slidably mounted braces 100 and 101 take the load directly to the floor and prevent utility stand from tipping over should the user stand on the footrest 99 . The instrument support subassembly 20 is supported on stalk support brace 108 slidably fitted to guide 109 and supported by floor guide 110 . Seat cushion 111 mounted to seat bracket 112 (see FIG. 13 ) is supported by seat post 113 mounted frame assembly 105 in seat receptacle 114 . FIG. 13 shows an exploded view of the seat cushion 111 , the seat bracket 112 and the seat post 113 is shown installed in the seat receptacle 114 . The rear seat legs 115 are rigidly attached to the seat receptacle 114 . Floor guides 90 and 91 are installed in seat legs 115 . Beam member 116 is rigidly attached to seat receptacle 114 . Guides 103 , 102 , and 109 provide receptacles for the rear brace 101 , forward brace 100 and stalk support brace 108 . Post 117 provides for pivotably mounting the instrument support subassembly 20 . FIG. 14A shows the condensed version of the portable utility stand collapsed into guitar case 118 . FIG. 14B shows the condensed version of the portable utility stand with guitar case 118 removed for clarity. The instrument support subassembly 20 is rotated horizontally with the sheet music support 25 notch straddling the seat receptacle 114 . Channel shaped footrest 99 straddles the instrument support subassembly 20 . FIG. 15A shows the footrest 99 for the condensed version of the portable utility stand. Footrest height adjustment is achieved by simply moving footrest 99 forward or backward to a different set of notches that rest on the forward brace 100 and the rear brace 101 . A 1 , A 2 , and A 3 show the height progression for each position. FIG. 15 shows the footrest 99 with a tilt for the condensed version of the portable utility stand. Footrest height adjustment is achieved by simply moving footrest 99 forward or backward to a different set of notches that rest on the forward brace 100 and the rear brace 101 , B 1 , B 2 , and B 3 show the height progression for each position. All of the embodiments disclosed here provide a portable utility stands easily set up for supporting music or other uses, and easily collapsed into a compact configuration for convenient storage or transport. When set up the user has a stable platform to work, practice, or perform. The user has the option of arranging the equipment, as he requires using the universal mounting receptacles. The user tools, and accessories are within easy reach. Expensive instruments or equipment can be rotated to a protected out of the way position between the sheet music support and the seating bench/storage area. Having described exemplary embodiments of the present invention with reference to the accompanying drawings, it will be appreciated that the present invention is not limited to those precise embodiments, and the various changes and modifications can be effected therein by one of ordinary skill in the art without departing from the scope and spirit of the invention as defined by the appended claims.

A portable utility stand that integrates the equipment required by users such as musicians, artists, and surveyors. These users generally require a lighted work platform, a tool or instrument support, a comfortable adjustable seat, a storage area for equipment such as tools, an adjustable footrest, shelf to temporarily place equipment, a means to support equipment such as, microphones, tuning devices or a telephone. The equipment is mounted to a base platform equipped with mounting receptacles that allow the user to arrange, adjust, and select suitable equipment for a particular application and in a preferred arrangement. The base platform is essentially a single member with receptacles for equipment mounting. A seating bench with storage unit is centrally located with respect to the mounting receptacles. Floor glides are mounted on bottom extreme ends. Disassembly simply requires removing the receptacle mounted equipment.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates to a toy or an amusing ornament wherein a doll, a model of a fish, or another figure, is caused to move or dance in a clear liquid inside a transparent container, and wherein that movement can be enjoyed. [0003] 2. Description of the Related Art [0004] If a figure is caused to move inside a liquid, then the movement thereof will be a comparatively leisurely, wavering movement, compared to movement over the ground or in the air. A toy of this kind is one that can be enjoyed simply by watching the wavering motion. [0005] A toy wherein a figure is caused to move in a liquid is described, for example, in the Japanese Utility Model Application No. S59-124909 (Utility Model Laid-open No. S61-39597). In this toy, a fish-shaped object is disposed floatingly in a container filled with water and tied up through a fine string with a weight having a permanent magnet attached thereto. The weight is rotatably set on the bottom of the container filled with water. A coil, which generates alternating lines of magnetic force, is arranged under the bottom on the outer side of the container. Swimming actions are caused to the fish-shaped object by the alternating magnetic force generated by the coil. [0006] However, the expression of this toy is poor, since it merely causes the weight to rotate in a circle, and it does not provide satisfactory entertainment as a toy. SUMMARY OF THE INVENTION [0007] It is an object of the present invention to provide a toy which is able to create varied and entertaining movements by means of a simple mechanism. [0008] In order to achieve the aforementioned object, the toy of the present invention comprises: a liquid container section containing a liquid therein; a figure of specific gravity lower than that of the liquid, accommodated inside the liquid container section; a magnetic body accommodated inside the liquid container section and arranged movably in a vertical direction; a line member extended between the figure and the magnetic body; and an electromagnetic mechanism that acts on the magnetic body. Without a magnetic field the magnetic body is pulled up by a buoyant force caused to the figure. Then a descent movement is caused to the figure so as to move against the buoyancy force of the figure by the descent movement of the magnetic body when an electric current is applied through the electromagnetic mechanism. The figure and the magnetic body are caused to return to their original positions by the buoyancy force of the figure, by releasing the passage of current through the electromagnetic mechanism. Thereby, the figure can be caused to make upward and downward movement, and since it returns to its original position by means of the buoyancy force, a natural movement is achieved. [0009] In the toy described above, desirably, a control device for passing a pulse current through the electromagnetic mechanism is provided. Since the movement of the figure is created by a pulse current, power consumption is reduced and varied movement can be achieved by combining pulse currents or changing periods of pulses. [0010] In the toy described above, desirably, plural line members and magnetic bodies may be connected to a plurality of positions on the figure, and the plural magnetic bodies can be arranged so as to move at different timings. By causing the magnetic bodies to move simultaneously, or by causing one only to move, or causing each to move alternately, it can provide a more varied movement. [0011] In the toy described above, desirably, the interval between the line members is greater in the vicinity of the figure than in the vicinity of the magnetic bodies. Thereby, it is possible to cause the figure to move in a horizontal direction, rather than simply the vertical direction, by causing the magnetic body connected to one of the line member to move, or by causing both of the magnetic bodies to move in alternating fashion. [0012] According to the present invention, it is possible to provide a toy which is able to create varied and entertaining movements by means of a simple mechanism and arrangement. BRIEF DESCRIPTION OF THE DRAWINGS [0013] [0013]FIG. 1 is a conceptual diagram showing an example of a toy according to an embodiment of the present invention; and [0014] [0014]FIG. 2 is a perspective view showing an aspect of the assembly of the toy shown in FIG. 1. [0015] [0015]FIG. 3 is a conceptual diagram depicting another variation of a toy according to the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0016] Below, an embodiment of the present invention is described with reference to the drawings. [0017] (1. Composition of the Toy) [0018] [0018]FIG. 1 is a conceptual diagram showing an example of the composition of a toy according to an embodiment of the present invention. FIG. 2 is a perspective diagram showing the aspect of the assembly of this toy. This toy comprises a container main body 11 which accommodates a figure object 2 , magnetic members 31 , 32 , and fine line or string members 41 , 42 , and comprises a base section 12 which accommodates coils 51 , 52 forming electromagnetic mechanisms and a drive unit 6 , and the like. The liquid container section according to the present invention is constituted by the container main body 11 and the upper face of the base section 12 . [0019] (1-1. Liquid Container Section) [0020] The container main body 11 has a cylindrical shape, one end of which is closed. More specifically, the upper end as illustrated in the diagram is closed in a domed shape, and the lower end as illustrated in the diagram is open. The upper face of the base section 12 is fixed in a watertight fashion, via an O-ring 8 (FIG. 2) to the open end. [0021] The container main body 11 has a transparent section in such a manner that the movement of the figure object 2 contained therein can be seen, and desirably the whole body thereof is transparent. Desirably, the transparent section has colourless transparency or coloured transparency. [0022] The liquid accommodated in the liquid accommodating section is desirably a colourless transparent liquid or a coloured transparent liquid, and desirably, it should be chemically stable and not liable to decomposition, such as water containing a preservative, or ethanol, or the like. [0023] (1-2. Figure Object) [0024] A figure object 2 may be a doll or an object of adorable characters as depicted in FIG. 1 or a body simulating a fish, or dolphin, or other aquatic creature, or a diver, or the like, is accommodated inside the liquid container section. Desirably, the figure object 2 has a lower specific gravity than the liquid contained in the liquid container section, and is made, for example, from foamed styrene or is made of a hollow figure of an ABS (Acrylonitrile Butadiene Styrene) plastic material. The hollow may be filled with foamed styrene. The figure object 2 may be immersed completely in the liquid, or if it is accommodated inside the liquid container section together with a material of lighter specific gravity (air, or the like,) then it may float on the surface of the liquid. [0025] The figure object 2 may be provided with a part simulating a tail, fin, or the like, swingably on a main part or on a central body. Even if it is not driven in particular, a tail or fin of this kind can be caused to flutter from side to side, by the movement of the main part through the liquid. [0026] (1-3. Magnetic Member) [0027] Swinging plates 33 , 34 are provided on the upper face of the base section 12 , in other words, at the bottom of the liquid container section. The swinging plates 33 , 34 are both flat in shape, and are rotatably supported in the region of one end thereof on the upper face of the base section 12 , in such a manner that they can swing upwards and downwards. Magnetic members 31 , 32 are fixed respectively to the other ends of the swinging plates 33 , 34 , in the vicinity of the free ends thereof, in such a manner that they can move upwards and downwards with the swinging motion of the swinging plates 33 , 34 . [0028] Desirably, the magnetic members 31 , 32 are flat in shape, and they may be members which are inherently magnetic (for example, permanent magnets), or they may be members which are not inherently magnetic but which are induced to be magnetic (for example, a magnetic metal such as iron, or the like). [0029] The magnetic members 31 , 32 and the swinging plates 33 , 34 may themselves have a specific gravity that is greater than that of the contained liquid. In this case, when no current is passed through the coils 51 , 52 , the magnetic members 31 , 32 and the swinging plates 33 , 34 can be pulled and raised to a prescribed position, by the buoyancy force caused to the figure object 2 . [0030] A blind plate 7 is fixed to the base section 12 above the magnetic members 31 , 32 and the swinging plates 33 , 34 . The purpose of the blind plate 7 is to hide the magnetic members 31 , 32 and the swinging plates 33 , 34 , from external view, but desirably, it is provided with gaps or holes in order to pass the line members 41 , 42 . Alternatively, the blind plate 7 itself may be made of a plate-shaped net. [0031] Although the swinging plates 33 , 34 are able to swing upwards and downwards, the downward movement thereof is restricted by the upper face of th base section 12 , and the upward movement thereof is restricted by the blind plate 7 . The method for limiting the range of swing of the swinging plates 33 , 34 is not limited to this, and it is also possible to provide stoppers on the aforementioned support sections for the base section 12 of the swinging plates. [0032] (1-4. Fine Line Members) [0033] The figure object 2 is linked to the magnetic members 31 , 32 by means of respective threads 41 , 42 forming line members. More specifically, it is linked respectively to the aforementioned other end or the movable end of the swinging plate 33 on which the magnetic member 31 is fixed, and the aforementioned other end of the swinging plate 34 on which the magnetic member 32 is fixed. The threads 41 , 42 are connected to different positions on the figure object 2 in particular, if it is possible to define the right-hand side and left-hand side, or the front and back, of the figure object 2 (for example, if the object is simulating a fish, or the like), then the threads 41 , 42 are fixed to approximately symmetrical positions on the right and left-hand sides of the figure object 2 . [0034] The interval between the threads 41 , 42 is greater in the vicinity of the magnetic members 31 , 32 than in the vicinity of the figure object 2 . [0035] Desirably, the threads 41 , 42 are made of a material that does not visually stand out in the liquid, such as a transparent material, thin material, or the like, but th material should not be limited in particular, and any material, such as fishing line, or the like, may be used. Here, a material of low expandability is used, but an expandable material may also be used. [0036] (1-5. Coils) [0037] Electromagnetic coils 51 , 52 are provided on the inner side of the base section 12 , in other words, on the outer side of the liquid container section. These coils 51 , 52 are able respectively to exercise a magnetic action in the range of movement of the magnetic members 31 , 32 in the liquid container section. For this purpose, desirably, the coils 51 , 52 are fixed to the walls of the liquid container section, from the outer side. In the present embodiment, they are fixed to the upper end of the base section 12 , from the inner side of the base section. The upper face of the base section 12 is made front a non-magnetic material, in such a manner that it does not shield the magnetic force. [0038] In the present embodiment, the coils 51 , 52 are provided on the outer side of the liquid container section in order to avoid problems of liquid leakage or current leakage, but it is also possible to provide them inside the liquid container section, provided that these problems are prevented. Moreover, the invention is not limited to using coils 51 , 52 , and another magnetic mechanism, such as magnets, with associated moving mechanism which cause the magnets to move for example upwards and downwards so that they engage and disengage with the corresponding magnet members in the liquid container, may also be used. [0039] The coils 51 , 52 are connected to a control circuit 6 which controls the current flowing through the coils. The control circuit 6 according to the present embodiment is able to pass a pulse current through the coils 51 and 52 , respectively, at any desired timing. In particular, desirably, by means of the control implemented by the control circuit 6 , it is possible to pass pulse currents through the coils 51 and 52 , at separate timings, and it is also possible to pass pulse currents through the coils 51 and 52 , simultaneously. Desirably, a spacer 61 is disposed between the control circuit 6 and the coils 51 , 52 and, in order to maintain a uniform distance of separation of the control circuit 6 from the coils, and to shield out electrical and magnetic effects. Desirably, the spacer 61 is made from an insulating material, such as hardened rubber, for example. [0040] The control circuit 6 is connected to a power supply, such as a dry cell battery 62 , for example. [0041] In the present embodiment, the number of magnetic members 31 , 32 , threads 41 , 42 and coils 51 , 52 provided was respectively two each, but the invention is not limited to this, and for example, three or more of each member may be provided. If three of each member is provided, then the position at which the third thread is fixed to the figure object 2 is desirably displaced towards the front or the rear, with respect to the threads 41 and 42 . [0042] (2. Operation of the Toy) [0043] Next, the basic operation of the toy shall be described. [0044] (2-1. When a Pulse Current is Not Supplied) [0045] If no current is supplied to the coils 51 and 52 , then neither of the coils 51 and 52 is magnetized and hence there is no action on the magnetic bodies 31 , 32 . In this case, the figure object 2 is pushed upwards by the buoyancy force, and the magnetic bodies 31 , 32 and the swinging plates 33 , 34 are pulled and raised to their limit position as determined by the blind plate 7 . [0046] (2-2. When Pulse Currents are Supplied Simultaneously) [0047] When currents of the same magnitude are supplied simultaneously to the coils 51 and 52 , then the coils 51 and 52 will be magnetized simultaneously, and the magnetic bodies 31 and 32 will be drawn downwards simultaneously, and with the same degree of force. Thereby, a pulling force is transmitted to the figure object 2 by means of the threads 41 and 42 , and hence the figure object 2 is drawn downwards against the buoyancy force. [0048] Here, if the pulse width (the length of the time period for which current is passed) is large enough, then the magnetic bodies 31 , 32 and the swinging plates 33 , 34 will be able to move until they reach the lower limit position, as determined by the upper face of the base section 12 . Consequently, the figure object 2 reaches a bottommost point in its range of movement. When the current is released, the figure object 2 returns to its original position, together with the magnetic bodies 31 , 32 , due to the buoyancy force. [0049] If the pulse width is small, then a magnetizing force of the coils 51 , 52 will attenuate before the magnetic bodies 31 , 32 and the swinging plates 33 , 34 reach their lower limit position, and the figure object 2 will return to its original position, together with the magnetic bodies 31 , 32 , due to the buoyancy force, after having been pulled down to an intermediate position. [0050] The size of the pulse width required in order for the magnetic bodies 31 , 32 and the swinging plates 33 , 34 to reach their lower limit position varies depending on the resistance of the figure object 2 and the swinging plates 33 , 34 , in the liquid, the buoyancy force of the figure object 2 , and the strength of the coils 51 , 52 , and so on. [0051] If a current having a short pulse width is passed repeatedly, in a consecutive fashion, then the figure object 2 will move reciprocally, up and down, in short and sharp movements. If the resistance of the figure object 2 in the vertical direction with respect to the liquid differs between the region to the front of the installation positions of the threads 41 , 42 on the figure object 2 and the region to the rear of these positions, then the region where the resistance is lower will perform greater upward and downward movement consequently, for example, if the resistance on the front side is made lower than that on the rear side, by, for instance, making the surface area to the front of the installation positions of the threads 41 , 42 a smaller area, then the front side will move upwards and downwards to a greater degree than the rear side, and hence the whole body of the figure object 2 will oscillate in the vertical direction, and the figure object 2 will appear as if it were nodding up and down. If the interval between pulses is short, then the subsequent pulse will arrive before the figure object 2 has returned to its original position due to the buoyancy force, and it will move further downwards, thus appearing as if it were moving downwards in stages. [0052] (2-3. When Pulse Currents are Supplied at Different Timings) [0053] If a pulse current is supplied to one of the coils 51 and 52 only, then only one of the magnetic bodies will be drawn downwards. Accordingly, only one of the left-hand and right-hand threads attached to the figure object 2 will be pulled, whilst the other one of the threads will not be pulled. Here, since the interval between the threads 41 , 42 becomes greater as they proceed in the downward direction, then if, for example, only the right-hand thread is pulled, this will result in the figure object being pulled not only downwards, but also towards the right-hand side. Therefore, the figure object 2 moves in a rightward and downward direction. Moreover, since the threads 41 , 42 are installed in symmetrical positions on the right-hand and left-hand sides of the figure object 2 , and then if only the right-hand thread is pulled, for example, this will also result in the figure object 2 being inclined towards the right-hand side. [0054] When short pulse currents are supplied alternately to each one of the coils 51 and 52 , then the figure object 2 will repeat a motion of: (1) moving down to the right; (2) returning to its original position; (3) moving down to the left; (4) returning to its original position; and so on. If the interval between pulses is made short, then the figure object 2 will repeat a motion of: (1) moving down to the right; (2) pulled to left whilst returning to original position; (3) pulled to right whilst returning to original position; and so on. In either of these cases, the figure object 2 will perform a rightward and leftward movement. Therefore, it is possible to cause the figure object 2 to perform a movement wherein the whole body thereof. Oscillates towards the right and left, as if it were refusing something. [0055] Moreover, if a plurality of short pulse currents are supplied repeatedly and consecutively to one of the coils 51 and 52 , whereby only the right-hand thread is pulled a plurality of times, for example, then the figure object 2 will move upwards and downwards, in a state where it moves towards the right and is inclined towards the right-hand side. If the interval between pulses is short, then the subsequent pulse will arrive before the figure object 2 has returned to its original position due to the buoyancy force, and it will move further downwards, thus appearing as it if were moving downwards in stages, in a state where it moves towards the right and is inclined towards the right-hand side. [0056] (2-4. When the Foregoing Operations are Combined) [0057] When the operations described above are combined, then it is possible to achieve a rich variety of different movements control of the pulse currents of this kind can be achieved by means of a control device 6 . [0058] On the toy explained herein above switches operable by a user or watcher, sensors detecting surrounding sounds and lights or other input devices. One example is shown in FIG. 3, The toy shown in FIG. 3 is provided with a pair of switches 71 and 72 each operable by a user. When one of the switches is pressed, the control circuit 6 is triggered starting operation and the figure object 2 starts dancing in accordance with a preset dancing pattern together with a music output from a small speaker 73 installed inside of the base body 12 . Another switch may provide another dancing pattern with another music. [0059] The toy in FIG. 3 is further provided with a sound sensor which may detect a voice of a user. When the sensor detects a voice or a certain sound, the control circuit 6 starts generating the pulse current and the figure object 2 starts dancing in accordance with a preset moving pattern and outputs music or may be an imitated voice of the figure object 2 from the speaker 73 .

A floating toy is provided which can achieve varied and entertaining movements by means of a simple composition. The floating toy comprises: a liquid container section ( 11, 12) containing liquid therein; a figure ( 2) of lower specific gravity than the liquid, accommodated inside the liquid container section; magnetic bodies ( 31, 32) accommodated movably inside the liquid container section; line members ( 41, 42) extended between the figure and the magnetic bodies; and electromagnetic mechanisms ( 51, 52) that act on the magnetic bodies. The magnetic bodies and the figure are caused to move against the buoyancy force of the figure, by passing current through the electromagnetic mechanisms, and are caused to return to their original positions by the buoyancy force of the figure, by releasing the passage of current through the electromagnetic mechanisms.

BACKGROUND OF THE INVENTION This invention relates to brushing, scrubbing and general cleaning, and specifically to a hand-held machine for power scrubbing. To replace tedious manual scrubbing which is common in household cleaning, several forms of power scrubbers have been developed. These power scrubbers have had electric motors within sturdy housings to rotate a scrubbing brush mounted on the shaft of the motor. In some cases the motors have been battery-powered, enabling the scrubber to be used anywhere without a bothersome cord. The rotary brushes usually have had a generally circular shape. Although these previous scrubbers have been small, lightweight and easily handled, they have had many disadvantages. The rotary scrubbing motion is not as effective as the traditional manual scrubbing motion. A person manually scrubbing a surface uses a back-and-forth movement which is not effectively simulated by the rotary motion of prior art scrubbers. Also, the circular brush of these previous scrubbers cannot fit into corners or other tight spots. Thus, the user was forced to rely on manual scrubbing to finish the job. SUMMARY OF THE INVENTION The scrubber of the present invention overcomes the disadvantages of the prior art by providing a hand-held electrically powered scrubber which simulates the back-and-forth movement of manual scrubbing and which has a triangular brush which fits into corners. It is an object of the present invention to provide an improved electrically powered hand-held scrubber. Another object is to provide a scrubber which produces a reversing back-and-forth movement which breaks through the dirt surface quicker than a constant rotary motion. Still another object is to provide an electric power scrubber which has a generally triangular-shaped brush capable of fitting easily into corners and other tight spots into which a conventional circular brush cannot fit. Yet another object is to provide a power scrubber which can thoroughly clean irregular shapes and texturized surfaces. Another object is to provide a power scrubber which produces a concentrated cleaning motion, enabling the scrubber to be used in cramped areas such as the bottom of garbage cans and wastebaskets. Another object is to provide a lightweight all-purpose hand-held power scrubber which can be used dry to dust or used wet with cleansers to scrub. Another object is to provide an electrically powered scrubber which has a hand grip and an oscillatory back-and-forth motion which simulates as closely as possible the user's established habits of cleaning. Another object is to provide an electrically powered scrubber which can receive an interchangeable variety of attachments best suited to different cleaning tasks. These and other objects are accomplished by the scrubber according to the present invention in which a generally triangular-shaped brush is attached to a sealed housing which has a configuration to be easily gripped by hand. Within the housing is an electric motor which drives an eccentric. Around the eccentric is a yoke formed around a hole in a plate. The plate turns an attached oscillatory shaft in a reciprocating rotary back-and-forth motion. The generally triangular-shaped brush is removably mounted on the oscillatory shaft. Alternatively, the yoke can be formed around a hole in the body of the brush so that the wheel oscillates the brush when the brush is mounted on the shaft. Preferably, the motor is powered by a rechargeable battery contained in the housing, enabling the scrubber to be used anywhere without the restriction of an electric cord. Also, a switch is preferably provided on the handle of the housing to enable the user to turn the scrubber on and off easily. The preferred embodiment of the present scrubber can be provided with a variety of different brushes. Depending upon the type of cleaning or dusting to be accomplished, the proper brush can be removably mounted on the oscillating shaft. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side elevational view of the scrubber of the present invention; FIG. 2 is a bottom view taken along the line 2--2 of FIG. 1 showing a preferred scrubbing brush; FIG. 3 is a sectional view of the scrubber interior taken along the line 3--3 of FIG. 2; FIG. 4 is a bottom view of the oscillating mechanism of the scrubber taken along the line 4--4 of FIG. 3; FIG. 5 is another view of the mechanism of FIG. 4 showing the oscillation motion in broken and solid lines; FIG. 6 is a sectional view similar to FIG. 3 showing an alternative embodiment of the scrubber of the present invention; and FIG. 7 is a plan view of the brush mount taken along the line 7--7 of FIG. 6. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring more particularly to the drawings and initially to FIG. 1, there is shown an electric power scrubber according to the present invention having a sealed housing 10. The housing 10 is sealed to be as waterproof as possible to protect the power means inside against damage from water associated with scrubbing tasks. Preferably, the housing 10 is made from a sturdy molded plastic material such as ABS polymers, acetal copolymers and homopolymers, high density polyethylenes and the like. The housing 10 has a generally flat bottom 11 and an upper portion designed to be easily gripped by hand. The upper portion of the housing 10 includes a handle portion 12 and a recessed portion 13, which together provide a comfortable hand-grip shape. The hand-grip configuration allows the user of the scrubber to grip the scrubber in the same way that the user would grip a sponge, rag or ordinary scrub brush. Protruding from the forward end of the handle portion 12 is a switch button 14. By pushing in the switch button 14, the user can start and stop the power means within the housing. As shown in FIG. 3, the button 14 is operatively connected to a switch 16 mounted on a bracket 17 which is secured to a mounting plate 18. The switch 16 is connected to the power means of the scrubber which includes a motor 19 mounted on the bracket 17. The motor 19 is a conventional electric small-appliance or power-tool motor having adequate power to drive the scrub brush when pressed against a dirty surface. A variable-speed motor may be used, in which case the switch 16 may be a speed control switch. The motor 19 is connected to a supply of electric power. Preferably, the electric power supply comprises nickel cadmium storage cells 22 mounted within the housing 10. While electric power could also be supplied from an ordinary electric outlet via a plugged-in cord, the storage cells 22 allow the scrubber to be used anywhere without the restrictions of a cord. A nickel cadmium battery, or other rechargeable battery, is preferred so that the scrubber can be easily recharged from ordinary house current when not in use and the expense of replaceable batteries is avoided. The rechargeable battery 22 is connected to a socket 26 into which a plug can be inserted when the scrubber is not in use, enabling the battery 22 to be recharged. The rechargeable batteries may also be designed as a unit that could be slipped in and out of the scrubber and charged separately. A rotating shaft 28 emerges from the motor 19 and provides the motor power to the oscillating means below. Preferably, a reduction gearing means 30 is provided to reduce the speed of the oscillating brush from that of the rotating motor and to increase the power of the oscillating brush. The slower, more powerful oscillating movement is preferred since it allows the user to apply greater pressure to the scrubbed surface without stalling the motor and without excessive reaction forces produced by higher oscillating speeds. The gearing means 30 comprises a gear 32 mounted on the shaft 28 and a larger gear 34 mounted on a shaft 35 driven thereby. Preferably, the gears 32 and 34 are made from nylon such as nylon 66 or an equivalent material. Mounted on the shaft 35 coaxially with the larger gear 34 is a cam or eccentric 36. The eccentric 36 fits within a yoke 38 formed around a hole in a plate 40. The yoke 38 is preferably made from acetal homopolymer (Delrin) or an equivalent material. The plate 40 is parallel to and just above the housing bottom 11. Attached to the plate 40 is a shaft 42 which is pivotally mounted through a flange 43 attached to the mounting plate 18. The shaft 42 provides a pivot for the movement of the plate 40. The movement of the oscillating means can be seen by comparing the solid and broken lines of FIG. 5. As the smaller gear 32 rotates the larger gear 34, it turns the eccentric 36. The yoke 38 around the eccentric 36 oscillates, swinging the plate 40 in an arcuate to-and-fro oscillatory motion. At the shaft 42, the motion becomes a purely oscillating rotary motion in which the shaft 42 rotates back-and-forth in a reciprocatory or oscillatory manner. By this means the rotary motion of the motor shaft 28 is converted into the oscillating motion of the shaft 42. The shaft 42 extends through an opening in the bottom 11 of the housing. Mounted on the shaft 42 is any one of a number of different preferred scrubbing brushes, such as a brush 50 shown in FIG. 2. The brush 50 has a generally triangular-shaped body 52 which has a hole 54 for mounting the brush on the oscillatory shaft 42. Attached to the body 52 is an inner set of bristles 56 having a generally triangular shape. Surrounding the inner bristles is a periphery of outer bristles which includes two sets of bristles 58 on each side of the brush and a forward set of bristles 60 on the nose of the brush. Each set of outer bristles 58 and 60 are mounted to the brush body 52 to extend outwardly at an angle. The outer bristles 58 and 60 enable the user to clean corners and crevices easily while the inner bristles 56 provide ability to scrub flat surfaces. Thus, the brush 50 is able to clean irregular shapes and texturized surfaces. Alternative brushes includes those in which the inner bristles 56 are replaced by a scrub pad material (nylon with abrasive filler), such as Scotchbrite, or a sponge material or a dusting or polishing material. In addition, the inner or outer bristles may be made to any desired length or stiffness. An alternative embodiment of the scrubber of the present invention is shown in FIGS. 6 and 7. In this embodiment the yoke 38 and the plate 40 of the previous embodiment are combined with the body 52 of the brush. The housing 10 of the scrubber has the same general configuration with an internal battery and a motor 19. A reduction gearing means 30 comprising a gear 32 on the motor shaft 28 and a larger gear 34 on the shaft 35 is provided as before. A cam or eccentric 66 is mounted coaxially with larger gear 34 on the shaft 35. Unlike the previous embodiment, the eccentric 66 extends below the bottom 11 of the housing of the scrubber. Also extending below the housing bottom 11 is a shaft 72. The shaft 72 is pivotally mounted through the flange 43 attached to the mounting plate 18. A brush 80 is mounted on the shaft 72. The body 82 of the brush has an opening around which is formed a yoke 83 to fit over the eccentric 66. The body 82 of the brush also has a hole 84 for mounting the brush on the shaft 72. As the eccentric 66 turns, it oscillates the brush back-and-forth in an arcuate manner about the pivot formed by the shaft 72. This scrubber produces the same general movement as the scrubber of the previous embodiment, but the yoke 38 and the plate 40 have been combined with the body 52 of the brush in a single element. The principal advantage of this form of the invention is that the configuration of the yoke opening 83 can be modified from brush to brush and thus provide varying amplitudes and speeds of oscillation by merely changing brushes. A longer yoke opening provides a larger, slower oscillation and a shorter one a smaller, faster oscillation. No other changes or adjustments are required to achieve this effect. The scrubber of the present invention can also be provided with a storage stand having a built-in recharger which can be conveniently mounted in a kitchen near the sink. When the scrubber is mounted in the stand, the socket 26 is mounted in a plug in the storage stand which is directly connected to a recharger current. Through this means the batteries 22 are recharged whenever the scrubber is stored in the stand, enabling it to always be ready for use. While the invention has been shown and described with respect to specific embodiments thereof, these are intended for the purpose of illustration rather than limitation. Other modifications and variations in the specific scrubber herein shown and described will be apparent to those skilled in the art, all within the intended scope and spirit of the invention. Accordingly, the invention is not to be limited to the specific embodiment herein shown and described nor in any other way that is inconsistent with the extent to which the progress in the art has been advanced by this invention.

An electrically powered hand-held scrubber is disclosed which comprises a scrubbing brush removably attached to a sealed housing having a configuration adapted for a hand grip. Within the housing is a motor, preferably powered by rechargeable nickel cadmium storage cells which drives an eccentric. The eccentric produces an oscillating rotary motion which is communicated to the brush. The brush is moved in an oscillating back-and-forth rotary motion rather than a constant rotary motion, resulting in a more effective cleansing action. The brush has a generally triangular shape enabling it to fit into corners and other tight spots into which a circular brush cannot fit.

CROSS REFERENCE TO RELATED APPLICATION This application is a continuation-in-part application of my co-pending U.S. patent application Ser. No. 07/616,543, filed Nov. 21, 1990, now abandoned. FIELD OF THE INVENTION The present invention relates to a method and apparatus for stimulating the growth and healing of living mammalian, especially human, tissues, promoting the healing of wounds and skeletal fractures, and more particularly to electrical apparatus and methods for stimulating the scalp of a human being. The invention is applicable to both cosmetic and medical treatment of tissue. BACKGROUND OF THE INVENTION It has been shown that such exogenous electrical stimulation will stimulate growth of skeletal tissue in non-united fractures, as well as speeding healing in soft tissue wounds (see Becker and Selden, The Body Electric Electromagnetism; New York; Quill; 1985; pages 163-180). These researchers demonstrated that electrical current directly stimulates cell dedifferentiation of red cells and that these then redifferentiated as cartilage, which continue on to become bone cells. Pulsed electrical stimulation has been found to promote the healing of wounds with high current densities and without tissue irritation or burning. Types of wounds responsive to electrical stimulation include burn wounds, lacerations and abrasions. Electrical stimulation accelerates the healing process, and it is believed to also reduce the incidence of infection, decrease scarring, reduce trauma from injury, as well as trauma following surgery. It is especially useful in healing of skin grafts. Electrical stimulation can relieve muscle spasms, help activate atrophied muscles, and assist in reeducation of spastic muscles. Electrical stimulation has the potential of decreasing headache pain, and other head pain, regardless of the source of pain, such as improper blood circulation, neuromuscular problems or a combination thereof. It can also promote mental relaxation, in a manner similar to biofeedback treatments. In 1983, Dr. William Bauer, of the Veterans Administration Medical Center in Cleveland, Ohio, reported success with head and neck pain by treatment with transcutaneous electrical nerve stimulation (TENS). Electrical stimulation of the epidermis can reduce the incidence of dry scalp, psoriasis, and dandruff. It has also been used to treat ulcers and skin infections. Masaki U.S. Pat. No. 4,841,972, entitled LOW-FREQUENCY TREATMENT DEVICE DIRECTED TO USE IN BATH, teaches a low frequency treatment for use in a bath, such as a bathtub, including means for oscillating a surged treatment wave and vibrating means for massaging the epidermis. Masaki British Patent Publication GB 2160426A, entitled ELECTROTHERAPEUTIC APPARATUS, teaches an electrotherapeutic apparatus including a low frequency generator which is worn on the head as a part of the apparatus, and has a frontal electrode for engaging the user's brow, and an upper central electrode for engaging the top of the user's scalp, both electrodes being provided with an absorbent material cover, such as sponge. The patents which employ one or more vibration units create so much weight, which are so heavy on the head of a user, that continued use is unlikely. I have invented an apparatus which avoids the heavy weight of such units, and requires neither vibrational massage nor medication to effectively promote growth and healing of living tissue. The invented device may be used in conjunction with existing neuro-stimulation and muscle stimulation devices, as well as DC electrical skin care units operated by batteries. SUMMARY OF THE INVENTION The invented apparatus consists of a baseplate, such as a headpiece, for encompassing all or a portion of a body member, such as a scalp. The baseplate preferably is made of plastic or other lightweight non-conductive material. A multiplicity of generally evenly spaced holes are provided in the baseplate and each hole receives a probe adapter having a hole therethrough. A probe having an electrically conductive outer skin is provided within each of the probe adapters. An electric wire or electric contact connects the interior of each adapter to a terminal on the baseplate. Each probe is individually adjustable to contact the wearer's body part within the base member regardless of the configuration of the body part. Thus, by causing the probe to make contact or removing the probe from contact with the wearer's body, treatment of an entire body part, such as a scalp, or only a small area can be effected. The present invention is useful for cosmetic purposes and for medical purposes, including promoting healing and growth of both skeletal and soft tissues. Stimulation of human tissues by electrical means has been shown to be effective in promoting healing and in skin care. OBJECTS OF THE INVENTION The principal object of the present invention is to provide an improved device for promoting healing of both skeletal tissue and soft tissue of a mammal. Another object of the invention is to provide electrical apparatus for promoting healing of human tissue without further injury or burning of tissue. Another object of the invention is to provide apparatus for decreasing headache pain. BRIEF DESCRIPTION OF THE DRAWINGS The foregoing and other objects will become more readily apparent by referring to the following detailed description and the appended drawings in which: FIG. 1 is an isometric view of the outside of one embodiment of the invented device for use on a human head. FIG. 2 is an isometric view of the embodiment of FIG. 1 showing a portion of the interior. FIG. 3 is a cross-sectional view of a portion of the oval-shaped headpiece of FIG. 1 taken through a probe and probe adapter, showing the probe contacting the scalp of a user. FIG. 4 is a side view of a probe. FIG. 5 is a top view of a probe adapter. FIG. 6 is a side view of the probe adapter of FIG. 5. FIG. 7 is a cross-sectional view of the oval shaped base headpiece of FIG. 1. FIG. 8 is an isometric view of the exterior of the oval-shaped headpiece of FIGS. 1 and 7 showing the placement of the holes for accommodating the probe adapters. FIG. 9 is an isometric view of the exterior of an alternative elongated base member showing the placement of the holes for receiving probe adapters. FIG. 10 is a partial isometric view of a portion of the exterior of the elongated base member of FIG. 9 showing alternative electrical connections. DETAILED DESCRIPTION Referring now to the drawings, and particularly to FIG. 1, the invented device includes a baseplate member, such as oval-shaped hood or headpiece 10 having a multiplicity of holes 12 therethrough at regularly spaced intervals, as shown in FIG. 7. Any number of holes 12 can be provided in the base plate, but preferably they should be about 2 to 3 centimeters apart and should cover substantially all of the base plate. The oval-shaped hood can have a downwardly extending portion 14 adapted to cover the rear of a head. Situated in each hole 12 is a removable probe adapter or electrode socket 16 having an electrical contact 18 communicating with its center and having a central elongated opening 22 within which the electrical contact is situated. Positionable within the central elongated opening 22 of probe adapter 16 is a probe 24, having a shank 25, and preferably having a rounded end 26, and either being made of an electrically conductive material or having an electrically conductive skin. A pair of electric contacts 28, 30 are situated in the head piece for connection to a low voltage power source. The probe adapter 16, as shown in FIGS. 3, 5 and 6, can be as simple as a plastic insert having a base 32, a central elongated portion 34 upstanding from the base 32 and tapered or partially tapered retaining flanges 36 for wedging into the hole 12. The probe adapter is inserted into the baseplate 10 from the interior, with the base 32 mating against the inside of the baseplate 10 as shown in FIGS. 3 and 6. A contact wire 40 passes down through the inside of the elongated hole 22 wherein it is situated for making contact with the probe 24. Alternatively, the interior of the central elongated opening 22 can be lined with an electrical contact or partially lined with a thin electrical contact embedded in the sidewall of the central elongated opening 22, or even a printed circuit on the sidewall. The four flanges 36 or protrusions fill the hole diameter and create a gripping mechanism with the sides of hole 12. The elongated end of the probe adapter 16 which extends outwardly through the base plate opposite the base 32 preferably is provided with one or more elongated slots 44 (two are shown), and with a tapered interior of the central hole 22. The elongated slots in the adapter effect a spring action against side of the probe shank 25 when the probe is inserted into the probe adapter 16. Advantageously, a funnel-shaped bevel or chamfer 48 is provided at the upper end of the probe adapter for easy positioning of a probe into the adapter. Likewise, a similar funnel-shaped bevel or chamfer 50 is provided at the lower end of the probe adapter to facilitate withdrawal of a probe through the adapter. The contact 28 communicates with approximately one half of the probe adapter holes 12 through circuits A, A1, A2, A3, etc., while contact 30 communicates with the remaining probe adapter holes 12 through circuits B, B1, B2,, B3, etc., as best shown in FIG. 8. Printed circuits can be provided in place of wires, and such printed circuits can be positioned on either the exterior or interior of the baseplate 10. The baseplate 60 shown in FIGS. 9 and 10 is preferably made of a flexible plastic, or other non-conductive material, so it can be spread to accommodate a limb of the user, or it could even be sufficiently large to encompass the torso of a user in special situations. FIG. 10 shows an alternative electrical contact 62 for receiving a probe 24, the contact 62 being made of a conductive material, containing a conductive material, or being at least partially covered and lined with a printed circuit. In operation, probe adapters 16 are inserted into the adapter holes 12 from the inside of the baseplate 10, with the flange or base 32 of each adapter mated against the baseplate. Probes 24 are dampened with water to enhance conductivity, and are inserted shank first from the inside of the baseplate 10 into each elongated hole 44 in each adapter 16 to a depth sufficient that the end 26 will contact the subject's head 66 in those areas of the head to be treated. The oval-shaped hood is placed on the head of a human being for the purpose of electrical stimulation. Low voltage power is connected to the contacts 28, 30 and power is supplied to the apparatus, passing through the probe 24 and stimulating the scalp. Only small amounts of energy are transmitted, in the range of microamperes or milliamperes. There is no feeling of vibration or other discomfort to the wearer of the headpiece during treatment. The only feeling observed by the user is the light weight of the headpiece, which is distributed evenly by the many probes which contact the scalp, and the dampness of the probes from use of water to transmit the variations of current and waveform. Vibration, oscillation or other similar types of discomforting energy are avoided. In treating the scalp, probes in alternating holes are connected to different electrical poles, i.e., having alternating positive and negative polarity. In other treatments, it may be desirable for all probes to have the same polarity, for instance to attract oxygen to the probe for the purpose of healing a wound. It has been found that vibration, medication, or massage is unnecessary to achieve the desired result. The probes are soft tipped, and disposable, so the device is easy to clean, and to use on multiple patients. The probes are not invasive, so do not physically damage sensitive tissues. Because the entire apparatus is light in weight, the scalp treatment version usually weighing about 8 ounces, the device is portable, and can be carried conveniently for treatment anywhere. The probes may be dampened with water either prior to insertion in the probe adapter, or after insertion but before placement in contact with the body part to be treated. Any convenient means of dampening the probes may be used, including spraying water directly on them, and immersing the probes in water. The invented device can be utilized on a human head to reduce headache pain. In this case, the probes are brought into contact with the scalp selectively in the areas where such pain is noted by the user. Although the foregoing discussion has related principally to scalp treatment, by utilizing a base member having a configuration shown in FIG. 9, a broken or burned limb can be treated in generally the same manner as described above. Probe adapters are inserted from the inside of the baseplate, and the baseplate is placed around the limb to be treated. Probes are inserted into the probe adapter from the interior of the device to a depth to make contact with the exterior of the limb, current flow is begun, and continued for a predetermined period, generally for from 5 to 15 minutes per treatment. The invented method for stimulating the growth and healing of living tissues comprises at least partially encompassing a body part, such as an arm or even a torso, with a base member having a multiplicity of electrically conductive adjustable probes, each probe being adapted for selectively engaging the body part by the amount of protrusion of each probe being adjusted as appropriate to contact the desired body part; bringing the desired number of probes into engagement with the body part; then passing low voltage power through the probe, stimulating the growth or healing of tissue encompassed by the base member. The probe is preferably wetted with an electrolyte before contacting the body part, the preferred electrolyte being water in the form of ordinary tap water. The method can be utilized to promote healing of animals, by providing a good electrical contact with the epidermis of the animal, which may involve shaving of the contact area to achieve good contact. The probes are moveable and independently adjustable within each socket, and the source of power is both low voltage and low frequency (low amperage). A user of the invention does not feel the electrical voltage or impulses, as the voltage, wattage, and current are so low as to prevent such sensation. Low voltage, which is a common term used with many electrical devices today, means that a device operates at twelve volts or less. This can be done by utilizing a transformer to step down the voltage or by utilizing batteries as the source of power. In an article published in the International Journal of Dermatology, vol. 29, pages 446-450, July-August, 1990, entitled "The Biological Effects of a Pulsed Electrostatic Field with Specific Reference to Hair" the authors discuss the use of low voltage and low amperage in their experiment. It was stated that a dangerous power level corresponds to 300 million volts per meter (v/m) and that a test was performed on mice at a level of 190,000 v/m in a 60 Hertz field for 1,500 hours, over the course of ten and a half months, with no detected adverse health effects. Further it was stated that the human subjects of the experiment were exposed at a level of less than 4,000 v/m for a shorter period of time. Medical literature contains many references to the use of low voltage, low amperage devices in the treatment of patients. An article published in Osteopathic Medical News, date unknown, pages 34 and 35 describes the use a "Microelectrical Neuromuscular Stimulation" device referred to as (MENS). That device has an amperage current range of 10 μA to 600 μA and frequencies ranging from 0.1 Hz to 990 Hz, which are the same as those useful in the present invention. Advantageously, the amperage used with the invented apparatus is 80 μA at frequencies of 0.3, 0.7, 30 and 50 Hz, all well within the range reported in the above mentioned article. The article entitled "Electrotherapy for Acceleration of Wound Healing; Low Intensity Direct Current" in Arch Phys Med Rehabil Vol 54, July 1985, describes standardizing a protocol for using the low intensity direct current (LIDC) of 200 μA to 400 μA for normally innervated skin and 400 μA to 800 μA for denervated or decentralized skin applied at the wound site. The result was healing rates of 2 to 3.5 times faster than those of the control subjects. An article entitled "EMR . . . The Electronic Answer to Resistant Muscular Problems" (Wing, EMR . . . The Electronic Answer to Resistant Muscular Problems, Digest of Chiropractic Economics, 118-126, November-December (1982)), includes a discussion of treating a patient with between 40 μA and 600 μA of current. Again, these values are within the useful range of the present invention. These articles indicate that the range of current, voltage and waveform are readily determinable by one of ordinary skill in the art. The invented apparatus is preferably powered by a device which is capable of providing: waveform; polarity; frequency; and current, and is preferably powered by eight (8) D-Cell batteries, of 1.5 volts each. These types of machines are commercially available. With such a control device, the voltage can be regulated in the very low voltage range, i.e., the milliamp, millivolt ranges, and even into microvolt and microamp ranges. Each electrical stimulation treatments should last about 15 minutes, and preferably not more than one to three times per week. Individual settings must be determined in accordance with the health and physiological differences of each user. SUMMARY OF THE ACHIEVEMENT OF THE OBJECTS OF THE INVENTION From the foregoing, it is readily apparent that I have invented an improved method and apparatus for promoting healing of both skeletal tissue and soft tissue of a mammal, and for reducing pain, including headache pain. Further, the invented apparatus promotes healing of damaged human tissue without further injury or burning of tissue. It is to be understood that the foregoing description and specific embodiments are merely illustrative of the best mode of the invention and the principles thereof, and that various modifications and additions may be made to the apparatus by those skilled in the art, without departing from the spirit and scope of this invention, which is therefore understood to be limited only by the scope of the appended claims.

An improved method and apparatus for stimulating the growth and healing of living, especially human, tissues, promoting the healing of wounds and skeletal fractures. An electrical apparatus consists of a baseplate, made of lightweight nonconductive material, for encompassing all or a portion of a body member. A multiplicity of generally evenly spaced holes are provided in the baseplate and a probe adapter including a moveable electrically conductive probe is situated within the holes, as desired. An electric contact connects the interior of each adapter and the probe situated therein to a terminal on the baseplate. Each probe is individually adjustable to contact the wearer's body part within the base member regardless configuration of the body part, thus allowing treatment of all or a selected portion of the body part.

CROSS-REFERENCE TO RELATED APPLICATIONS Not Applicable. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not Applicable. BACKGROUND OF THE INVENTION Millions of surgeries are performed each year under local anesthesia and/or intravenous (IV) sedation in freestanding ambulatory surgery centers. In any procedure, the patient is often faced with significant distress and anxiety which can lead to many problems. In addition to the physiologic changes caused by anxiety and pre-procedural stress, the patient's ability to follow pre-op instructions is often compromised. This can be of a particular problem in patients such as diabetics who are often confused about which medicines and how much of each they should or should not take in the pre-op period. This, coupled with the fact that patients often need to refrain from eating or drinking (nothing by mouth or Latin: Nil Per Os or NPO) for an extended period of time prior to the procedure, can lead to problems such as significant and symptomatic hypoglycemic episodes. Minor medical emergencies in a non-hospital, office-based environment can pose challenges. Often, in the stable and fully conscious patient with mild hypoglycemia, a glucose-rich Per Os (by mouth, Latin: Per Os or PO) drink is administered. Such intervention is practical in these mildly affected patients where a more acute intervention is not necessary. In a more acute situation where quick reversal of hypoglycemia is required, dextrose may be administered via IV access. However, the option of IV administration would take some time to prepare and push even in the event that an IV is already in place. Intervention with IV dextrose alone would likely be slower than optimal or desirable in those patients who do not already have IV access. Intervention in the form of the application of a sugar-rich substance such as cake icing to the buccal or sublingual mucosa is often advocated and a possible option in the event that an IV is not accessible or if dextrose infusion is not immediately available. This option, in addition to having no data supporting its efficacy, has other problems as well. Application should only be used in a fully conscious and alert patient due to the risk of pulmonary aspiration. There is also a dependence on patient compliance even in the conscious persons. If the sugar is swallowed, there would be a significant delay in the effects on blood glucose levels. Another problem is the delay necessary for the sugar, in the form of sucrose, to be broken down by sucrase in the oral cavity prior to being able to be transported transmucosally as glucose. If the above treatments are not administered without delay, a patient, particularly those with brittle (labile) diabetes, may become comatose due to hypoglycemic brain injury. In certain situations this can lead to a persistent vegetative state without any expected neurologic improvement. Quick and acutely effective sources of glucose, administered expeditiously during crashing could be the difference between life and death. Of additional importance, the dose of dextrose required to effect a change in the blood glucose of an individual is approximately 5 to 15 grams—necessitating the ability to deliver a large dextrose payload. The problem and risk of hypoglycemic episodes for the diabetic is not limited to the medical or dental office, however, and constant access to a source of rescue glucose is crucial. It is not uncommon for physicians to recommend that these individuals keep a tube of cake icing or other glucose rich substance on their person for quick application in such events. As enumerated earlier, the use of either cake icing or PO forms of rescue glucose pose significant problems and are suboptimal for these same reasons. Hypoglycemia of the newborn and hypoglycemia associated with severe systemic illness is a significant health problem worldwide, particularly in the undeveloped world. Hypoglycemia can be closely linked to a significant proportion of the two hundred and twenty-five thousand (225,000) yearly malarial deaths in African children under the age of five (5) years. The preferred treatment in most cases is correction via IV dextrose infusions. Problems with this treatment are plentiful in the undeveloped areas that are poor both in terms of monetary and human capital. Delay to infusion can be caused by many reasons. Most health care facilities do not have the supplies. Families of the sick are given prescriptions for needed supplies/medications and they must go and find not only the money to buy these supplies but a pharmacy that has the supplies available prior to returning to the hospital for initiation of treatment. Additionally, it can be hard to obtain IV access in a small, acutely ill (dehydration, shock, unconscious) child. IV access carries other risks, including pain, risk of blood-borne pathogen transmission, and possible local or systemic infection associated with venous catheterization. The correction of hypoglycemia by placing a spoon full of granulated table sugar (sucrose) under the tongue has been studied in this population by the medical community and the results were promising when compared to IV dextrose infusion. Problems with this very basic method, however, included early swallowing of the loose, granulated sugar by the children which resulted in treatment failure. Additionally, table sugar is sucrose and must be broken down to glucose and fructose by sucrase in the oral cavity prior to transport transmucosally. Hypoglycemia is of immediate concern in the person found by healthcare workers to be unconscious due to an unknown cause. Classically, such a patient is always treated, immediately on arrival in the emergency department, with an intravenous administration of a three drug combination including dextrose, thiamine, and naloxone. The decision to administer these drugs is a reflexive decision (i.e. all unconscious patients with a significantly and abnormally depressed mental status, without a clear or known cause for such, are reflexively administered this “coma cocktail.”) If such a transmucosal dosage-form were possible, under the reflexive direction of a proper protocol, it would allow for the administration of the classic cocktail constituents by emergency medical services providers immediately upon arrival to the scene and long before IV access or reaching the hospital emergency department. Long-distance athletes have a need to obtain hydration, electrolytes, and carbohydrates during the episodes of intense and prolonged exertion that they often put themselves through. Many different carbohydrate formulations, predominantly meant to be consumed orally, have been developed to target this population. A popular embodiment involves a gel-type formulation that is stored in a small pouch and meant to be consumed at some time period during the extended physical exertion. Targeting the PO route with these carbohydrate loads have multiple unwanted side effects—all of which have to do with the normal gastrointestinal physiology. Stimulation of the gastrointestinal tract with a load of carbohydrate, causes increased neuronal activity to the area leading to increased peristalsis which combined with the decreased blood supply to the bowels during strenuous exertion produces the common sensation of gastrointestinal uneasiness or queasiness after consuming the product. The next step in physiology is an increased shunting of blood away from the muscles needing this perfusion to the splachnic circulation towards the bowels. Athletes also describe the subjective feeling of a vague central heaviness. Prior art, with regard to oral, transmucosal drug delivery does not describe a method by which large payloads of active pharmaceutical agent, on the order of grams, can be delivered systemically. The prior art of dosage form fabrication for oral transmucosal drug delivery describes gels, tabs, patches, sprays. It lacks in having not described a form by which large payloads (on the order of multiple grams) can be delivered systemically through the mucosa of the oral cavity. It has also not described anatomic delivery forms for oral application. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates the parts of the oral cavity (prior art). FIG. 2 illustrates a three-dimensional anatomic form of the bilateral lingual vestibular space in accordance with an exemplary embodiment of the invention. FIGS. 3A and 3B illustrate cross-sectional areas of a pharmaceutical dosage-form molded in a three-dimensional anatomic form of the bilateral lingual vestibules in accordance with an exemplary embodiment of the invention. FIG. 4A through 4D illustrates handles and supportive substrates for use in bilateral lingual vestibular transmucosal pharmaceutical dosage-form and delivery systems in accordance with an exemplary embodiment of the invention. FIG. 5A through 5C illustrates embedded supportive substrates in molded bilateral lingual vestibular transmucosal pharmaceutical dosage-form and delivery systems in accordance with an exemplary embodiment of the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Described herein is a transmucosal dosage-form for delivery to the oral cavity substances in a large payload, on the order of 5+ grams, in order to deliver therapeutic amounts of substances systemically. Substances may be, but are not limited to pharmaceuticals and other active agents. A transmucosal dosage-form for delivery of dextrose, thiamine, and naloxone (i.e. the “coma cocktail”), would allow for immediate administration by a health care worker upon encountering an unconscious patient without the delay of starting an IV. The problem is that there was previously no method of such a transmucosal dosage-form of any one of these drugs, much less all three in a dosage adequate to accommodate the amount of pharmaceutical payload necessary to deliver therapeutic amounts of these drugs systemically. Further, by the description herein, we describe a transmucosal dosage-form for delivery to the oral cavity of agents which may be used for delivery of dextrose for treatment of hypoglycemia without fear of aspiration. A bilateral lingual vestibular mucoadhesive, transmucosal dosage-form and delivery system for pharmaceutical payload delivery can provide a quick, easy, and safe means of treatment, even in patients whose consciousness is questionable, with the capacity to deliver large pharmaceutical payloads. In one embodiment pharmaceutical payloads of 5 to 10 grams could be delivered by the system. A polymeric mucoadhesive carrier matrix, serving as one possible type of a supportive substrate, binds the pharmaceutical payload to the mucosal tissue in the lingual vestibules to overcome the displacing forces created by salivary flow in the area and combat the risk of treatment failure due to premature patient swallowing or patient aspiration. By using a general or anatomical shape, the dosage-form is also physically secured in the lingual vestibular region by the lingual frenulum and the tongue to hold it against the thin mucosa overlying the dense vasculature of the floor of the mouth and ventral tongue, preventing it from migrating. The retention of the dosage-form can be further enhanced by the addition of a handle, its purpose serving both to aid insertion and allowing for external control of the dosage-form position once placed. The pharmaceutical payload may be an active pharmaceutical agent, a medicament, and/or other active or passive substances. In one embodiment, there is an embedded supportive substrate to which a pharmaceutical payload is molded or otherwise adhered. In such an embodiment the supportive substrate may be partially or substantially enclosed within the pharmaceutical payload. The pharmaceutical payload may be molded, formed, or otherwise shaped into either a general or a specific anatomical shape to fit the lingual vestibular space. In one embodiment, the shape is anatomical to fit the potential space formed by the bilateral lingual vestibules. In another embodiment the dosage-form payload is formed into a generally cylindrical or rectangular shape which is curved along the center so that the ends are substantially parallel forming a “U” like shape. In another embodiment, the dosage-form is shaped to fit a unilateral lingual vestibular space of either the left or right side. Such a dosage-form could be used alone, in pairs, or in conjunction with another dosage-form containing a different combination of active pharmaceuticals. One skilled in the art would appreciate that other forms could be utilized in accordance with the teachings herein. In another embodiment the supportive substrate forms the structure of at least a generally anatomical shape designed in a manner to fit into the lingual vestibule. In such an embodiment the supportive substrate may be semi-permeable and impregnated with a pharmaceutical payload. As an alternative, in such an embodiment, the supportive substrate may be coated in a pharmaceutical payload. One skilled in the arts would appreciate other configurations for mating the pharmaceutical payload to the supportive substrate in a manner consistent with an exemplary embodiment of the invention. A pharmaceutical dosage-form may be comprised of any active pharmaceutical agent which may be administered in a transmucosal manner. Many such pharmaceutical agents benefit from avoidance of the degradation, delay, and/or unpredictability of passing through the gastrointestinal track before finding its way into other of the body systems. Examples of such pharmaceutical agents include, but are not limited to: Dextrose, Thiamine, Naloxone, Alanine, Terbutaline, and Arginine. A pharmaceutical dosage-form may further be comprised of agents that enhance the transmucosal transportation of an active agent (permeation enhancers). Examples of such permeation enhancers include, but are not limited to: bile salts such as sodium cholate, sodium glycocholate, sodium glycodeoxycholate, taurodeoxycholate, sodium deoxycholate, sodium lithocholate chenocholate, chenodexoycholate, ursocholate, ursodeoxy-cholate, hyodeoxycholate, dehydrocholate, glycochenocholate, taurochenocholate, taurochenodeoxycholate. Others include sodium dodecyl sulfate (“SDS”), dimethyl sulfoxide (“DMSO”), sodium lauryl sulfate, salts and other derivatives of saturated and unsaturated fatty acids, surfactants, bile salt analogs, derivatives of bile salts, capsaicin, histamine, or any other additives which may positively augment the transmucosal absorption of the active pharmaceutical payload. Once skilled in the art would appreciate that different permeation enhancers would be used depending on the active agents used in a particular dosage-form and a particular patient target. A pharmaceutical dosage-form may further be comprised of components which aid in binding the payload to the mucosal tissue in an effort to avoid migration and maximize transmucosal transportation. These mucoadhesives or mucoretentive polymers or compounds may serve to form the supportive substrate of the dosage-form or may serve as a component of the substance payload itself. Such mucoadhesives may be natural, and/or synthetic in the form of polymers and/or reservoirs with tissue adhesives. Examples include, but are not limited to: chitosan, mucilage, hydrogel, sodium alginate, sodium carboxymethylcellulose, guar gum, xanthum gum, hydroxyethylcellulose, karya gum, methylcellulose, polyethylene glycol (PEG), retene, tragacanth, Poly(acrylic acid), Polycarbophil, carbopol, polyox, chitosan-cysteine, chitosan-thiobutylamidine, chitosan-thioglycolic acid, poly (acrylic acid)-cysteine, poly (acrylic acid)-cysteamine, carboxymethylcellulose-cysteine, alginate-cysteine, polaxamer. In an alternative embodiment, a plurality of active pharmaceutical agents, payload enhancers, and/or flavor enhancers may be combined in the dosage-form to act synergistically. One skilled in the art would appreciate that the composition of the dosage-form may contain various permutations of the above in varying percentages depending on the intended treatment, the targeted patient type, and the specific condition. The preferred embodiment is a bilaterial lingual vestibular dosage-form and delivery system comprised of an anatomic three-dimensional matrix formed by the combination, in solutions, of a mucoadhesive compound, active substance/agent payload(s), and any additional modifying compounds such as permeation enhancers which is formed to the approximate anatomical shape of the bilateral lingual vestibules. The achievable payload allowed by fabricating a dosage-form and delivery system that targets the bilateral lingual vestibules can be as high as 5-10 grams in an average patient Further, fabricating the dosage-form in an anatomic shape of the lingual vestibule aids in maximizing the mucosal surface area engaged by active pharmaceutical agent thereby optimizing speed and amount of transmucosal payload transportation. The bilateral lingual vestibular delivery system may further comprise a fixed or detachable handle apparatus which could be used to place and secure the device in the oral cavity, specifically the lingual vestibule of a patient experiencing a hypoglycemic episode, particularly in a situation where altered conscious makes normal PO delivery unsafe due to the danger of aspiration; or where timing, lack of equipment, or lack of expertise makes the use of IV delivery unviable; and other methods would not yield delivery of a sufficient sized payload for transmucosal uptake into the systemic circulation. Through an indirect impression technique, it is possible to model an anatomic negative representation of the bilateral lingual vestibules. This is best achieved through the proper use of an elastomeric impression material, such as a polyvinyl siloxane rubber base. This negative representation of the bilateral lingual vestibules is then used to create the reciprocal positive form which can be accomplished using a material, such as die stone, which has a working state that is fluid and a final, set state that is solid and stable. From this solid positive representation of the bilateral lingual vestibules, a mold, for subsequent dosage-form production, can then be fabricated using a material of choice. With this exact negative mold of the targeted lingual vestibule, an anatomic lingual vestibular dosage-form can be fabricated. In one embodiment, the dosage-form of the delivery system is comprised of an active pharmaceutical agent(s) and permeation enhancer(s) combined within a polymeric, mucoadhesive matrix which is produced in the form of the bilateral lingual vestibules via the fabrication processes enumerated above. Additionally, it is possible to commercialize an anatomically-shaped dosage-form by generalizing the dosage-form size in production so that the dosage-forms are subsequently applied to patients based on the patient's sex and/or size, and/or other physical attributes. Averages of the general anatomic curvatures of the bilateral lingual vestibules, obtained via the above enumerated impression procedures, can guide scaling of the dosage-forms in production to fit differing sized individuals. One skilled in the art would appreciate that such a shape may be approximated by several other methods which would suit the requirements embodied within this disclosure. Employing an alternative embodiment, athletes having a need to obtain hydration, electrolytes, and carbohydrates during the episodes of intense and prolonged exertion may avoid the gastrointestinal uneasiness, queasiness, and vague central heaviness that accompany normal PO route carbohydrate loads. The ability to transport sufficiently larger payloads of dextrose, for instance, transmucosally in the oral cavity via a mucoadhesive delivery form/device allows for systemic effects without stimulating the unwanted gastrointestinal physiology. The primary payload (ie dextrose) could additionally be accompanied by adjunct constituents to maximize athletic performance (ie alanine, arginine, electrolytes, etc.) As a matter of definition with respect to the descriptions within this document, the lingual vestibules are bordered: superiorly by the ventral surface of the tongue, laterally by the mucosa covering the mandible, inferiorly by the floor of the mouth, and medially by the root of the tongue posteriorly. Anteromedially, at the midline of the mouth, the right and left lingual vestibules are continuous. Posteriorly the lingual vestibule is bordered by the oropharynx. Referring to FIG. 1 , one finds an illustration of the parts of the oral cavity ( 100 ) illustrated to aid one in understanding the descriptions given herein. Shown are the familiar parts of the mouth, specifically the lips ( 110 ), the teeth ( 120 ), and the tongue ( 130 ). The parts of the tongue ( 130 ) are the body of the tongue ( 131 ), the apex of the tongue ( 132 ), the dorsum of the tongue ( 133 ), the ventral of the tongue ( 134 ) and the deep lingual vasculature ( 137 ). One can clearly see that the body of the tongue ( 131 ) is rooted to the floor of the oral cavity by the lingual frenulum ( 140 ) between the sublingual papilla ( 150 ), in line with the apex of the tongue ( 132 ). Sublingual glands and a dense array of superficial vasculature (not illustrated) are covered by the sublingual mucosal covering ( 160 ). FIG. 2 illustrates a three-dimensional anatomic form of the bilateral lingual vestibules in accordance with an exemplary embodiment of the invention. This three-dimensional anatomic mold of the lingular vestibular shape ( 200 ) has an anterior ( 210 ) and a posterior ( 220 ). The anatomical lingular vestibular mold's ( 200 ) shape is substantially mirrored along a midline plane which runs from the anterior ( 210 ) to the posterior ( 220 ) and extends from the superior ( 230 ) of the mold ( 200 ), which approximates the ventral surface of the tongue ( 134 ) to inferior ( 240 ), which approximates the floor of the mouth, where the sublingual mucosal covering ( 160 ) and sublingual papilla ( 150 ) are located. A left lingual vestibular flange ( 260 ) is shaped to occupy the space of the lingual vestibular region to the left of the lingual frenulum ( 140 ) and extending to the posterior of the oral cavity. A right lingual vestibular flange ( 250 ) is shaped to occupy the space of the lingual vestibular region to the right of the lingual frenulum ( 140 ) and extending to the posterior of the oral cavity. The left lingual vestibular flange ( 260 ) and the right lingual vestibular flange ( 250 ) are continuous at the midline on the anterior side ( 210 ) creating a void along the posterior ( 220 ). When the anatomical mold of the lingual vestibular shape ( 200 ) is placed in the oral cavity ( 100 ), the void will be occupied by the lingual frenulum ( 140 ) and the root of the tongue, and thus the mold will be held to the floor of the mouth by the body of the tongue ( 131 ), thus preventing slippage. Also illustrated is the location of the cross section ( 3 A, 3 B) from which FIGS. 3A and 3B were derived. FIG. 3A illustrates a cross-sectional area of a bilateral lingual vestibular dosage-form molded in a three-dimensional anatomic form of the bilateral lingual vestibules in accordance with an exemplary embodiment of the invention. For reference, the superior/ventral tongue ( 230 ) and the inferior/floor of the mouth ( 240 ) are indicated. From the area shown, a cross section of the left lingual vestibular flange ( 260 ) is seen on the left of the figure, and a cross section of the right lingual vestibular flange ( 250 ) is seen on the right of the figure. The embodiment illustrated is constructed from a semi-permeable substrate structure ( 270 ), such as a mucoadhesive polymeric matrix, which is impregnated with a active substance/agent payload (not illustrated) which may be liquid, gaseous, or semi-solid in form. Such a payload would migrate from the supportive substrate ( 270 ) across the mucosal coverings into the vasculature and thus enter the patient's system. FIG. 3B illustrates a cross-sectional area of a hollow supportive substrate filled with a pharmaceutical payload and mucoadhesive polymer formed in a three-dimensional anatomic form of the lingual vestibular space in accordance with an exemplary embodiment of the invention. One skilled in the arts would appreciate that a pharmaceutical payload which possesses mucoadhesive properties may not require the addition of mucoadhesive polymer to serve the same purpose. For reference, the superior/ventral tongue ( 230 ) and the inferior/floor of the mouth ( 240 ) positions are indicated. From the area shown, a cross-section of the left lingual vestibular flange ( 260 ) is seen on the left of the figure, and a cross-section of the right lingual vestibular flange ( 250 ) is seen on the right of the figure. The embodiment illustrated is constructed from a hollow supportive substrate ( 280 ) which contains a pharmaceutical payload ( 290 ) which may be solid, or semi-solid in form. Such a payload would dissolve, melt, or in some other manner break-down or degrade to release at least the active pharmaceutical agents across the mucosal coverings into the vasculature and thus enter the patient's system. In this embodiment the bottom of the supportive substrate ( 280 ) is shown as open to the sublingual mucosal covering ( 160 , not illustrated). In other embodiments the supportive substrate ( 280 ) may be more substantially closed with only minor openings to allow the pharmaceutical payload ( 290 ) to be released. In other embodiments the supportive substrate ( 280 ) may be open in other areas to direct the pharmaceutical payload to other parts of the oral cavity ( 110 ). FIG. 4A illustrates a handle attached to a three-dimensional anatomic form of the lingual vestibular space in accordance with an exemplary embodiment of the invention. The handle ( 400 ) is attached to a pharmaceutical delivery form which is an anatomic representation of the potential space formed by the bilateral lingual vestibules ( 200 ). In this embodiment, the handle is a flat tab-like structure which is affixed by a clip or band connected to the anterior joint between the left and right lingual vestibular flanges ( 260 and 250 , not indicated) FIG. 4B illustrates a handle connected to an embedded supportive substrate in a three-dimensional anatomic form of the lingual vestibular space in accordance with an exemplary embodiment of the invention. The handle ( 410 ) is attached to a pharmaceutical delivery form which is an anatomic representation of the potential space formed by the bilateral lingual vestibules ( 200 ). In this embodiment the handle ( 410 ) is a string or band-like structure which is attached to more string or band like material ( 420 ) which is embedded in a moldable pharmaceutical payload ( 450 ). The pharmaceutical payload ( 450 ) illustrated is a three-dimensional shape formed to the potential space of the bilateral lingual vestibular shape. Other shapes could be used to produce other embodiments. FIG. 4C illustrates a supportive substrate with attached handle for use in a lingual vestibular pharmaceutical delivery system in accordance with an exemplary embodiment of the invention. In the embodiment shown, a handle ( 410 ) is a string or band-like material which is attached to a U shaped flexible rod ( 430 ) which forms an internal structural support for the pharmaceutical delivery system. In the embodiment shown the U-shaped flexible rod is formed from a sheet material which has been gathered and twisted. The material from the handle ( 410 ) has been tied to the approximate middle of the rod ( 430 ). The two ends of the rod ( 430 ) are then bent such that the first end and the distal end are approximately parallel to one another. FIG. 4D illustrates a supportive substrate with attached handle for use in a lingual vestibular pharmaceutical delivery system in accordance with an exemplary embodiment of the invention. The molded supportive substrate ( 440 ) is formed from a substantially flat material formed into a “U” shape. The material may be further comprised of a surface texture which enhances the bonding of the pharmaceutical payload to the supportive substrate. The material has a plurality of openings ( 443 ) passing through the main body in several locations so that the formed pharmaceutical payload ( 290 , not illustrated) can be attached above and below and joined through the openings to secure it to the supportive substrate ( 440 ). A rounded ridge, bead, or lip ( 445 ) is formed at the edge of the body. This helps to further secure the pharmaceutical payload ( 290 , not illustrated) to the supportive substrate ( 440 ) and prevents sharp edges which may harm a patient's delicate oral tissue. A handle ( 400 ′) is formed form the same material as the supportive substrate and is angled to be offset from the main body such that the main body may be situated in the lingual vestibule of a patient, and the handle may protrude from the oral cavity through the mouth. In the illustration, the handle is joined to the base of the “U” shape so that it would project directly from the front of the face. One skilled in the art would appreciate that such a handle could be of varying shapes and attached in varying ways to the main body. Further a handle could be angled to project from the side of the mouth at varying angles and still be in accordance with the teaching herein. FIG. 5A illustrates an embedded supportive substrate in a molded pharmaceutical payload system in a three-dimensional general form of the bilateral lingual vestibular space in accordance with an exemplary embodiment of the invention. Illustrated is a handle ( 400 ′) attached to a supportive substrate ( 440 , not visible) which is embedded in a moldable pharmaceutical payload ( 460 ). The pharmaceutical payload ( 460 ) in this embodiment has a general shape of a long cylinder which is curved near the middle into a general “U” shape to fit into the bilateral lingual vestibules. FIG. 5B illustrates an embedded supportive substrate in a molded pharmaceutical payload system in a three-dimensional general form of the bilateral lingual vestibules in accordance with an exemplary embodiment of the invention. Illustrated is a handle ( 400 ′) attached to a supportive substrate ( 440 , not visible) which is embedded in an anatomically moldable pharmaceutical payload ( 470 ). The pharmaceutical payload ( 470 ) in this embodiment has a semi- anatomical shape to fit into the bilateral lingual vestibules. One skilled in the art would appreciate that a perfect fit or custom mold, while an option, is not absolutely necessary due to the pliable nature of the oral tissue. Therefore several general sizes could be used to fit patients with different characteristics. FIG. 5C illustrates an embedded supportive substrate in a molded pharmaceutical payload system in a three-dimensional general form of the lingual vestibular space in accordance with an exemplary embodiment of the invention. Illustrated is a handle ( 410 ) formed from a string or band type material and attached to a supportive substrate ( 430 , not visible) which is embedded in a moldable pharmaceutical payload ( 460 ). The pharmaceutical payload ( 460 ) in this embodiment has a general shape of a long cylinder which is curved near the middle into a general “U” shape to fit into the lingual vestibule. One skilled in the art would appreciate that other shapes for the cross-sectional areas of the pharmaceutical payload ( 460 ) could be used in accordance with the teachings herein. The diagrams in accordance with exemplary embodiments of the present invention are provided as examples and should not be construed to limit other embodiments within the scope of the invention. For instance, heights, widths, and thicknesses may not be to scale and should not be construed to limit the invention to the particular proportions illustrated. Additionally some elements illustrated in the singularity may actually be implemented in a plurality. Further, some element illustrated in the plurality could actually vary in count. Further, some elements illustrated in one form could actually vary in detail. Further yet, specific numerical data values (such as specific quantities, numbers, categories, etc.) or other specific information should be interpreted as illustrative for discussing exemplary embodiments. Such specific information is not provided to limit the invention. The above discussion is meant to be illustrative of the principles and various embodiments of the present invention. Numerous variations and modifications will become apparent to those skilled in the art once the above disclosure is fully appreciated. It is intended that the following claims be interpreted to embrace all such variations and modifications.

A pharmaceutical delivery system enabling the oral transmucosal administration of active pharmaceutical agents in a situation where rapid transmucosal administration is preferred to prevent the delay and decomposition of the agents in passing through the intestinal tract. The delivery system comprises a supportive substrate with bilateral lingual vestibular flanges connected at the anterior midline to form a 'U' like shape for fitting in the potential space of the bilateral lingual vestibules, and further comprising a handle or tab for holding the device in the mouth of a patient with altered consciousness to prevent aspiration or premature swallowing. The pharmaceutical dosage-form is formulated and shaped to contact the mucosal tissues and may include mucoadhesive compounds, retentive compounds, and/or additional payload enhancers, such as permeation enhancers and flavor enhancers.

RELATED PATENTS AND APPLICATIONS U.S. Patent Documents 6,355,865 March 2002 Elmstrom 2003/0121075 June 2003 Barham, Warren S. 2003/0163852 August 2003 Barham, Robert; et al. 6,759,576 July 2004 Zhang, et al. 2006/0137044 June 2006 Lanini; Brenda; et al. OTHER REFERENCES American Diabetes Association website—accessed Mar. 17, 2008 Bassett, Mark J. (editor), 1986, Breeding Vegetable Crops, AVI Publishing Company, Inc. Central Intelligence Agency website—accessed Mar. 17, 2008 Florida Cooperative Extension Service, Institute of Food and Agricultural Sciences, University of Florida, HS1079, January 2007 Glich et al., (Eds), 1993, Methods in Plant Molecular Biology & Biotechnology, CRC Press Harvard School of Public Health website—accessed Mar. 17, 2008 Maynard, D. N. (editor), 2001, Watermelon Characteristics, Production and Marketing, ASHS Press National Agricultural Statistics Service of USDA—January 2006 Rhodes & Dane, 1999, Gene List for Watermelon, Cucurbit Genetics Cooperative Report 22:71-77 University of Sydney—Glycemic Index and GI database—accessed Mar. 17, 2008 Zhang, Xing-ping & Jiang, Yi, 1990, Edible Seed Watermelons ( Citrullus lanatus (Thunb. Matsum. Nakai) in Northwest China, Northwestern Agricultural University, China. FIELD OF THE INVENTION This invention is in the field of watermelon breeding, specifically relating to diploid watermelon plants producing fruit with reduced sugar content, and also serving the function of pollinating triploid watermelon plants for the commercial production of seedless watermelon fruit. BACKGROUND OF THE INVENTION Watermelon is an important horticultural crop with over 137,000 acres grown in the United States in 2005. The leading watermelon producing states are Florida, Georgia, Texas, and California with a combined total of 86,300 acres. (National Agricultural Statistics Service of USDA—January 2006) The popularity of seedless (triploid) watermelon has increased over the last decade. During peak watermelon production in the U.S. market in 2005 and 2006, seeded watermelons only comprised 22% of the market and averaged four to five cents less per pound (Florida Cooperative Extension Service, Institute of Food and Agricultural Sciences, University of Florida, HS1079, January 2007). Population of the United States is estimated at over 300 million as of July 2007 (Central Intelligence Agency website). Of the 20.8 million Americans with diabetes, 90 to 95 percent have type 2 diabetes. (American Diabetes Association website). This amounts to 7% of the total population of the United States. The glycemic index (GI) is a ranking of foods on a scale from 0 to 100 according to the extent to which they raise blood sugar levels after eating. Foods with a GI of 70 or above are considered high GI foods. Watermelon is rated at 72 which is considered a high GI. (University of Sydney Glycemic Index and GI database) Glycemic index in watermelon can be lowered by decreasing its sugar content. Lower GI foods have been shown to help control type 2 diabetes and improve weight loss. (Harvard School of Public Health—website) The goal of plant breeding is to combine in a single variety or hybrid various desirable traits. Desirable traits may include resistance to diseases and insects, tolerance to heat and drought, reducing the time to crop maturity, greater yield, and better agronomic quality. Other desired traits may include particular nutrient content, color, fruit shape, as well as taste characteristics. As with many different plants, watermelon contains a fruit part and a plant part. Each part contains different traits that are desired by consumers and/or growers, including such traits as flavor, texture, disease resistance, and appearance traits such as shape and color. Reduced sugar is a highly desirable trait for consumers with type 2 diabetes. The seedless trait in the watermelon fruit is also highly desired by consumers. Extended flowering in diploid watermelon plants is a trait sought after by growers of seedless watermelon. Seeded watermelon plants are diploid and can be self-pollinated either by bees or by hand. Seedless watermelon plants are triploid and must be pollinated by the pollen of diploid watermelon plants. The two primary methods currently in practice to pollinate seedless watermelon plants are; 1) planting traditional hybrid diploid varieties (e.g. Sangria produced by Syngenta, Inc.) in dedicated rows and harvesting and selling both the diploid fruit and the seedless fruit, or 2) inter planting between triploid watermelon plants within rows of triploid plants special pollenizer plants (e.g. SP-1 produced by Syngenta, Inc.), with plant characteristics especially favorable for pollination, which produce non-marketable fruit due their poor fruit quality, in particular a thin explosive rind making it difficult to harvest and transport the fruit. Due to the non-marketable fruit that these special pollenizer plants produce, they are generally referred to as “Non-Harvestable Pollenizers”. The present invention recognizes the need to provide consumers with type 2 diabetes a watermelon with reduced sugar and therefore with less total carbohydrates, and a lower glycemic index. The present invention also recognizes that a method of producing reduced sugar watermelons is needed that reduces the economic risk of producing this product which has a relatively limited market (less than 7% of the total market). BRIEF SUMMARY OF THE INVENTION The present invention uses a novel diploid watermelon to provide a product to the consumer segment, which includes those suffering from type 2 diabetes in an economical manner. According to the invention, there is provided a novel reduced sugar watermelon (hereinafter referred to as “dual purpose reduced sugar watermelon”) and a method for producing it in an economical manner by using it as a pollenizer for seedless watermelon production. In other words, it will be produced as a byproduct of seedless watermelon production. In addition to reduced sugar, the present invention includes a dual purpose reduced sugar watermelon with the following additional fruit traits enabling the successful production and marketing of this watermelon; 1) relatively firm flesh desired by consumers, 2) tough rind thereby reducing breakage of fruit during harvesting and transport, 3) rind color distinguishable from other watermelon fruit currently in the market in the United States, and 4) small fruit enabling consumers to purchase a “single portion”. The small fruit also helps to increase flowering, which contributes to the invention's second purpose as a pollenizer for seedless watermelon production. The present invention further includes a dual purpose reduced sugar watermelon comprising a plant with the following characteristics favorable for its second purpose as a pollenizer for seedless watermelon production; 1) extended flowering duration providing pollen to seedless watermelon plants over an extended time period, 2) thin leaves thereby shading seedless watermelon plants located in close proximity to a lesser degree, and 3) long thin sprawling vines providing pollen over a larger surface area. Also included in this present invention is a method of producing reduced sugar watermelons as a byproduct making the reduced sugar watermelon crop more economically feasible. This is accomplished by using the reduced sugar watermelon plant as a pollenizer for seedless watermelon production. The reduced sugar watermelon plants can be planted within seedless watermelon fields as a pollenizer in any of the currently practiced manners, and the fruit of the reduced sugar watermelon can be harvested and sold. The dual purpose reduced sugar watermelon of the invention is further enhanced by including resistance to various pests and herbicides via conventional plant breeding methods or genetic transformation. The dual purpose reduced sugar watermelon of the invention is further enhanced by various flesh colors including orange or yellow or white or red via conventional plant breeding methods or genetic transformation. DETAILED DESCRIPTION OF THE INVENTION Development of Dual Purpose Reduced Sugar Watermelon According to the present invention, a watermelon OW824 is selected having the characteristics of an extended flowering duration, small leaves with deep, non-overlapping leaf lobes, a long sprawling vine, firm flesh, tough rind, and low sugar content. In this example, the fruit of OW824 is relatively large, the rind and flesh are very firm, the seed size is very big, and the flesh is white. OW824 is a publicly available edible seed watermelon variety generally referred to as Xinjiang Edible Seed Watermelon. Also according to the invention, a watermelon Mickylee (PI 601307) is selected for its rind color which is distinguishable from other watermelon fruit on the market in the United States. In this example, Mickylee has a firm red flesh, light green rind, and weighs 4 to 5 Kg. Mickylee is publically available from the USDA—AMS National Genetic Resources Program. Also according to the invention, diploid inbred watermelon line GSX-26, a proprietary Gold Seed Co. breeding line is selected for its small size (average weight of 1.5 Kg.). In this example, GSX-26 has fruit with the following characteristics; jubilee type striped rind pattern, thin rind, sweet red flesh, oval shape with small seeds. The plant is of medium vigor, high fruit set, and with very early maturity. The first step was to cross Mickylee to GSX-26, and then hybrid progeny were crossed to OW824 to form a three way cross. This three way cross generated progeny having the characteristics of the dual purpose reduced sugar watermelon of the present invention as described in more detail below. The initial cross of Mickylee X GSX-26 was made during the spring of 2005 in Israel. This hybrid was further crossed with OW824 in Summer 2005 in Israel. The three-way cross produced was self-pollinated in spring 2006 in Israel. The F2 generation was grown in the summer of 2006. Individuals with the set of traits required for the dual purpose reduced sugar watermelon were successfully identified and self-pollinated in the F2 population. A total of 4 selections were made. The 4 F3 lines were grown in Israel in Spring 2007 for further selection and evaluation. 1 F3 line was identified to best meet our breeding goals and advanced to the F4 generation. This one line, Escort-4, called 121-14, is fixed for every trait concerned. Escort-4 contains the traits that are illustrative of the traits of the dual purpose reduced sugar watermelon of the invention. Other examples of dual purpose reduced sugar watermelon lines with similar characteristics were 121-5 with yellow/pink flesh, 121-7 with white flesh, and 121-11 with slightly larger fruits and a different rind color. Fruit: The fruit of the dual purpose reduced sugar watermelon, e.g. of Escort-4, has approximately ⅓ less sugar content compared to the most popular diploid varieties currently marketed. Fruit of Escort-4 and the most popular diploid variety currently on the market called Sangria (Syngenta, Inc.) were harvested at full maturity on May 7, 2008, and tested for Total Soluble Sugars (TSS) for comparison purposes as shown in Table 1 below. In this comparison, fruit of Escort-4 had an average TSS content of 32% less than Sangria. TABLE 1 Escort-4 % TSS Sangria % TSS Fruit #1 9.5 Fruit #1 12.8 Fruit #2 9.1 Fruit #2 13.4 Fruit #3 8.6 Fruit #3 12.7 Fruit #4 8.8 Fruit #4 13.6 Fruit #5 8.5 Fruit #5 12.6 Fruit #6 8.6 Fruit #6 13.7 Fruit #7 8.9 Fruit #7 13 Fruit #8 8.3 Fruit #8 12.7 Fruit #9 10.1 Fruit #9 12.5 Fruit #10 8.4 Fruit #10 14 Average 8.9 Average 13.1 The flesh of the dual purpose reduced sugar watermelon, e.g. of Escort-4, is relatively firm. The flesh pressure when measured by a penetrometer (Model No. FT011 of Wagner Instruments, Greenwich, Conn. 06836) is in the range of approximately 2 lbs./inch to approximately 4 lbs./inch. The average flesh pressure is approximately 3 lbs./inch. In addition, the fruit of the dual purpose reduced sugar watermelon, e.g. of Escort-4, compared to one of the more popular “non-harvestable” diploid pollenizers on the market called SP-1 (Syngenta, Inc.), has a much tougher rind, which resists breakage as opposed to the brittle fruit rind of SP-1 that splits easily and therefore can not be shipped easily if desired. Brittleness is conferred by a gene e (explosive rind, thin, and tender rind, bursting when cut (Rhodes & Dane, 1999, Gene List for Watermelon, Cucurbit Genetics Cooperative Report 22:71-77). The fruit of this invention does not contain this e gene and therefore has the ability to be harvested and transported long distances with minimal damage. For comparison purposes, fully mature fruit of Escort-4 and SP-1 were harvested on May 7, 2008 and measured for rind breakage pressure by a penetrometer (Model No. FT327 with a tip FT516— 5/16 diameter of Wagner Instruments, Greenwich, Conn. 06836). The Escort-4 fruit broke at 16-22 lbs./in., whereas fruit of SP-1 broke at 7-10 lbs./in. The rind of Escort-4 resists more than double the pressure as compared to SP-1. See TABLE 2 below. TABLE 2 Breakage Breakage Pressure Pressure Escort-4 (Lbs./Inch) SP-1 (Lbs./Inch) Fruit #1 22.5 Fruit #1 9.5 Fruit #2 16 Fruit #2 8.5 Fruit #3 17 Fruit #3 7.5 Fruit #4 21 Fruit #4 10 Fruit #5 19.5 Fruit #5 7 Fruit #6 21 Fruit #6 8 Fruit #7 18.5 Fruit #7 7.5 Fruit #8 17.5 Fruit #8 7.5 Fruit #9 18 Fruit #9 8.5 Fruit #10 17 Fruit #10 9.5 Average 18.8 Average 8.3 The fruit of the dual purpose reduced sugar watermelon of the invention, e.g. of Escort-4, can be distinguished from the fruit of all of the most popular commercially available seedless watermelon varieties marketed in the United States. The rind color of the dual purpose reduced sugar watermelon is preferably light green with slightly noticeable very thin medium green lines. Preferably, the fruit size of the dual purpose reduced sugar watermelon, e.g. of Escort-4, is small being approximately in the range of about 5 to about 7 inches long, and in the range of about 4 to about 5 inches wide. Small fruit size was selected to decrease the load on the plant, thereby extending the duration of plant growth and flower production. Another advantage of the small fruit size is that it can be marketed as a single serving fruit providing an option for individuals wanting to enjoy watermelon without having the excess from a typically large fruit. The fruit of the dual purpose reduced sugar watermelon weighs approximately in the range of about 2 to about 7 lbs, preferably about 2 to about 6 lbs. The average weight for the fruits of the dual purpose reduced sugar watermelon is preferably about 4.0 lbs. Flowering: The plants of the dual purpose reduced sugar watermelon, e.g. of Escort-4, are very vigorous and continue flowering over a relatively long period. The plant of this invention begins flowering approximately 7 days earlier than diploid reference variety Sangria. It continues to flower for approximately 7 weeks, which is when the most common seedless watermelon varieties finish harvesting. It therefore flowers during the entire flowering period of seedless watermelons currently in the market, thereby providing a continuous supply of diploid watermelon pollen to seedless watermelon plants during the critical time period. Leaf: The leaves of the dual purpose reduced sugar watermelon, e.g. of Escort-4, are similar to the Xinjiang Edible Seed Watermelon. The leaves of the dual purpose reduced sugar watermelon preferably have a surface area approximately in the range of about 20 to about 70 cm 2 , preferably about 22.5 to about 50 cm 2 . The leaves of the dual purpose reduced sugar watermelon preferably have deep, non-overlapping leaf lobes. These thin leaves shade seedless watermelon plants located in close proximity to a lesser degree than diploid watermelon Sangria, which is a variety favored by many growers. Vine: The vines of the dual purpose reduced sugar watermelon, e.g. of Escort-4, are long, thin, and sprawling similar to the Xinjiang Edible Seed Watermelon. Length of vine at first harvest is approximately 1.7 to 2.3 meters. Diameter of the vine is approximately 4 to 6 mm at the second node. The long sprawling vine provides pollen to seedless watermelon plants over an extended surface area. Other Traits: The dual purpose reduced sugar watermelon, e.g. Escort-4, can be used either as donor of the set of traits disclosed above, or as the recurrent parent to develop additional dual purpose reduced sugar watermelon lines. In accordance with the invention, the dual purpose reduced sugar watermelon contains traits of disease resistance (e.g. Fusarium wilt , Anthracnose, Gummy Stem Blight, Powdery Mildew, and Bacterial Fruit Blotch), insect resistance (e.g. cucumber beetle, aphids, white flies and mites), salt tolerance, cold tolerance, and/or herbicide resistance added. In addition, the dual purpose reduced sugar watermelon contains various flesh colors (e.g. orange or white or yellow or red). These traits can be added to existing lines by using either the conventional backcrossing method, pedigree breeding method or genetic transformation. The methods of conventional watermelon breeding are taught in several reference books, e.g. Maynard, D. N. (editor), 2001, Watermelon Characteristics, Production and Marketing, ASHS Press; and Bassett, Mark J. (editor), 1986, Breeding Vegetable Crops, AVI Publishing Company, Inc. General methods of genetic transformation can be learned from published references, e.g. Glich et al., (Eds.), 1993, Methods in Plant Molecular Biology & Biotechnology, CRC Press. Forms of the Dual Purpose Reduced Sugar Watermelon: Once the dual purpose reduced sugar watermelon lines are developed, several forms of dual purpose reduced sugar watermelon varieties can be used in commercial watermelon production. Specifically, these forms of dual purpose reduced sugar watermelon varieties include: (1) Open Pollinated Variety: The stable lines of the dual purpose reduced sugar watermelon are grown in isolated fields, at least 2,000 meters from other watermelon varieties. Pollination is conducted in the open fields by bees. Seeds are harvested from the seed production field when the fruit and seeds are fully developed. The seeds are dried and processed according to standard watermelon seed handling procedures. (2) Hybrid Variety: Two dual purpose reduced sugar watermelon lines, the male and female parents, are planted in the same field. Hand pollination is conducted. Only the seed from the female parent line is harvested and sold to the commercial grower for use. Method of producing reduced sugar watermelons as a byproduct: In order to produce the reduced sugar watermelons in an economical manner the dual purpose reduced sugar watermelon can be used as a pollenizer for seedless watermelon production. It can be planted as a pollenizer in both of the most common currently practiced methods, which are; 1) planting the dual purpose reduced sugar watermelon in separate dedicated rows before and after every 2nd row of seedless watermelon plants, and the seedless watermelon fruit and the reduced sugar watermelon fruit would then be harvested and sold, or 2) inter planting between triploid watermelon plants with no dedicated space for the dual purpose reduced sugar watermelon plants within the same rows as the seedless watermelon plants between every 2nd or 3rd or 4th or 5th plant. Both the seedless watermelon fruit and the reduced sugar watermelon fruit would then be harvested and sold. Therefore, a dedicated field for production of reduced sugar watermelons is not necessary. Deposit Applicant has made a deposit of at least 2500 seeds of the Dual Purpose Reduced Sugar Watermelon line Escort-4 at The National Collections of Industrial and Marine Bacteria Limited (NCIMB), Ferguson Building, Craibstone Estate, Bucksburn, Aberdeen AB21 9YA, Scotland, UK under number NCIMB 41542 in order to illustrate the invention. This deposit of the Dual Purpose Reduced Sugar Watermelon line Escort-4 will be maintained in the NCIMB depository, which is a public depository, for a period of 30 years, or 5 years after the most recent request, or for the effective life of the patent, whichever is longer, and will be replaced if it becomes nonviable during that period. Additionally, applicant has satisfied all the requirements of 37 C.F.R. sections 1.801-1.809, including providing an indication of the viability of the sample. Applicant imposes no restrictions on the availability of the deposited material from the NCIMB; however, applicant has no authority to waive any restrictions imposed by law on the transfer of biological material or its transportation in commerce. Applicant does not waive any infringement of its rights granted under this patent. The foregoing invention has been described in detail for purposes of clarity and understanding. However, it will be obvious that certain changes and modifications such as single gene modifications and mutations, somaclonal variants, variant individuals selected from large populations of the plants of the instant inbred and the like may be practiced within the scope of the invention, as limited only by the scope of the appended claims. Thus, although the foregoing invention has been described in some detail in this document, it will be obvious that changes and modifications may be practiced within the scope of the invention, as limited only by the scope of the appended claims.

The invention relates to a diploid watermelon having fruit with approximately 1/3 lower sugar content than common watermelons found in the market place, and plant characteristics favorable for use as a pollenizer for commercial production of seedless watermelons. In addition to reduced sugar, fruit characteristics of the invention include a tough rind, firm flesh, distinct rind color, and small fruit. The watermelon plant of the invention has the characteristics of extended flowering duration, thin leaves, and long sprawling vines. The invention combining the above mentioned fruit and plant characteristics can serve the dual purpose of producing reduced sugar watermelon fruit, and pollinating seedless watermelons. This will in effect produce reduced sugar watermelons which are beneficial for consumers with type 2 diabetes as a byproduct of commercial seedless watermelon production making the product more economically feasible.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application is a continuation-in-part of the pending U.S. patent application Ser. No. 13/485,247, filed May 31, 2012, which application claims priority from German patent application No. 11 168 177.1 filed on May 31, 2011. The content of all prior applications is incorporated herein by reference. FIELD OF THE INVENTION [0002] The invention relates to a trocar sleeve for minimally invasive surgery, having a first sleeve part that essentially has the form of a straight tubular piece with a longitudinal axis, and having a second sleeve part that at least partly surrounds the first sleeve part in close contiguity with it and is movable during use in relation to the first sleeve part. BACKGROUND OF THE INVENTION [0003] A trocar sleeve of this type is known from patent WO 2010/136805 A1, although the two sleeve parts are two telescope-type straight tubular pieces that can slide into and out of one another and whose relative sliding either follows a straight line or moves along a helical spiral. The radial outer sleeve part is connected on its proximal end with a head piece that comprises an insulation for gas-tight insertion of an instrument into the trocar sleeve and a fluid connection support, and the radially inner sleeve part has a flexible ring-shaped flange on its distal end. [0004] A trocar sleeve is a medical instrument that is used in minimally invasive surgery for inserting instruments into the human or animal body. In a minimally invasive surgical procedure, a trocar, which consists of a trocar sleeve and a trocar mandrel that is enclosed in the trocar sleeve, is used, first, to provide access to a body cavity. For this purpose the tip of the trocar mandrel is applied on an incision on the skin and is then pushed through the epithelium. Then the trocar mandrel is withdrawn from the trocar sleeve; the trocar sleeve remains inserted in the body. Through the trocar sleeve it is then possible to insert, in alternation, instruments such as endoscopes, forceps, scissors, sewing instruments and the like into the body cavity to perform surgical procedures. [0005] The flexible flange on the distal end of a trocar sleeve unfolds below the perforated epithelium and can then be secured with a corresponding additional flange from outside in order to ensure secure anchoring on the epithelium. To make it possible for the flange to unfold below the epithelium, the trocar sleeve must be slid relatively deeply into the body, and in addition a flexible flange made of rubber or the like must be relatively thick to allow it to be effectively secured from outside, so that the flange, even during an intervention, takes up relatively much space below the epithelium. In addition, most trocar sleeves are designed for a certain minimum thickness of the epithelium. For these reasons the known trocar sleeves are not suited for some operations, for instance operations on small children or on the thyroid. [0006] The documents US 2008/0242930 A1, DE 10 2009 014 525 A1 and US 2002/0042606 A1 each disclose an instrument for providing access for surgical interventions, said access comprising two elements that can pivot around an axis running perpendicular to the instrument longitudinal axis and that can be unfolded below the epithelium to form a type of flange, likewise requiring relatively a great deal of space below the epithelium. SUMMARY OF THE INVENTION [0007] It is the object of the invention to provide a trocar sleeve that requires a very small insertion depth and no minimum thickness of the epithelium and that is also simple to produce, easy to install and can be cleaned well. [0008] This object is achieved by means of a trocar sleeve with the characteristics of claim 1 . Advantageous refinements of the invention are indicated in the dependent claims. [0009] According to the invention, the two sleeve parts each comprise on their distal axial ends a flange part that extends outward at an angle of less than 180 degrees from the respective sleeve part. If the sleeve parts are turned into a relative position in which both flange parts point in the same direction and essentially are situated one above the other congruently, the two flange parts together can be slid through and below the epithelium without needing to be flexible, because the elasticity of the epithelium is sufficient in itself. This is particularly true when the flange parts, as preferred, have approximately U-shaped contours, as seen in a plane perpendicular to the longitudinal axis, such that the distance of the two legs of the U-shape is approximately equal to the diameter of the first or preferably of the second sleeve part. [0010] After insertion, the sleeve parts can easily be turned by hand into a relative position in which the two flange parts point in contrary directions to one another and are situated in a plane perpendicular to the longitudinal axis, so that the trocar sleeve is anchored on the perforated epithelium. [0011] Because the flange parts are not required to be flexible, they can be made of a stable material just like the sleeve parts and thus are preferably of one-piece construction. Flange parts of this type can be substantially thinner than a flexible flange, for example approximately 1 mm thick. In the insertion position in which the two flange parts are situated directly one above the other, their total thickness is then equal to 2 mm, which is still comparatively little, so that the trocar sleeve has a very small insertion depth in a body. [0012] According to the invention, the mobility of the second sleeve part in relation to the first sleeve part consists essentially only in an ability of the second sleeve part to rotate around the first sleeve part. With respect to the foregoing, this should be understood as indicating that it is harmless to have an axial mobility that serves in the course of the rotation to bring only one of the two flange parts, which are situated in insertion position one above the other, into the working position, in precisely the same plane as that of the other flange part, in order to produce a plane anchoring surface below the epithelium. In the cited example of flange parts 1 mm thick, a sliding of this type would be equal to 1 mm. It is likewise harmless when, in the course of a rotation, between the insertion position and the working position, there is a particular installation position in which the second sleeve part can be slid in the axial direction in order to be able to release it easily from the first sleeve part and the head part. It is useful to provide an installation position of this type in order to allow the trocar sleeve to be assembled easily and dismantled again quickly for cleaning. [0013] In theory, each of the two sleeve parts can comprise essentially, that is as one base body, a straight full tube. In this case the first, inner sleeve part must be detachably fastened on the body part, for example by means of cap nuts and positioning pins so that the second sleeve part can be installed and dismantled. [0014] In an alternative embodiment, the portion of the second sleeve part that is contiguous with the first sleeve part is essentially in the form of a half of a lengthwise two-part tube. In this case the second sleeve part can simply be slid axially over the first sleeve part and along the longitudinal axis in the direction toward the head part of the trocar sleeve and then allowed to engage in the guide and locking means configured in the head part. [0015] The cross-section of the second sleeve part perpendicular to the longitudinal axis can be, for example, simply a semicircle. [0016] It is better for the cross-section of the second sleeve part perpendicular to the longitudinal axis to be a circular arc, which comprises a few more degrees than a semicircle. In this case the second sleeve part surrounds the first sleeve part at an angle of something more than 180 degrees and is thereby held firmly in form-locked manner on the first sleeve part along its entire length, also ensuring good cohesion of the two sleeve parts during use. To facilitate the axial sliding of the second sleeve part onto the first sleeve part, the flange part of the first sleeve part can be provided with small indentations at the point where it makes a transition into the first sleeve part. [0017] Optimal gas-proof insulation between the trocar sleeve and the body opening held open by it, can be achieved with an embodiment in which each of the two sleeve parts has essentially the shape of a straight full tube, such that the first, inner sleeve part is detachably fastened on the head part and the second sleeve part can be assembled on and disassembled from the first sleeve part when the first sleeve part is separated from the head part. [0018] In this case the second sleeve part is preferably guided in such a way that it can be rotated between two end positions that are situated about 180 degrees apart with respect to the longitudinal axis, such that the one end position corresponds to an insertion position in which the flange parts of the first and second sleeve parts point in the same direction and are situated precisely in a plane perpendicular to the longitudinal axis, and such that the other end position corresponds to a working position in which the flange parts of the first and second sleeve parts point in approximately opposite directions to one another and likewise are situated in a plane precisely perpendicular to the longitudinal axis. Here the flange parts of the first and second sleeve parts have, preferably together, a U-shaped radial contour as seen in a plane perpendicular to the longitudinal axis. [0019] The detachable fastening of the first sleeve part on the head part can include a screw-in lock or a type of bayonet lock. [0020] A trocar mandrel especially suitable for the invention has a blunt distal end whose contour concludes essentially flush with the contour of the distal end of the trocar sleeve when the trocar mandrel is inserted completely into the trocar sleeve. [0021] To secure the flange parts on the outside of the epithelium, it is possible in principle to use any disc-shaped element, in particular a two-part element, that can be installed around the sleeve parts after assembly of the second sleeve part. [0022] Especially useful for the invention, however, is a securing element in the form of a one-piece, rubber disc, with gap, which can be slid laterally over the sleeve parts of the trocar sleeve with the gap stretched wide and then closes more or less firmly around the sleeve parts because of its own elasticity. After the trocar sleeve has been anchored in the epithelium, the rubber disc is simply slid along the longitudinal axis in the direction toward the epithelium in order to protect the flange part from outside the epithelium. The rubber disc then remains in this position simply by static friction. [0023] Even more useful, because it attaches with particular reliability on the sleeve parts, is a securing element made of a rigid element with a gap that fits with the outer diameter of the outer sleeve part and with an elastic element that can be detached from the rigid element, or alternatively made only of rigid elements, namely a plate with a gap that fits with the outer diameter of the outer sleeve part, a clamping element for the outer sleeve part that can be slid onto the plate, and an actuation element mounted on the plate for the slidable clamping element. Securing elements of this type are also useful for other trocar sleeves and trocars as described herein. [0024] Because it is possible to dismantle the trocar sleeve, and the additional parts that form a trocar, easily and rapidly into their components, said parts are also easy to clean, so that the trocar sleeve or the trocar constructed with it meets stringent hygienic requirements. BRIEF DESCRIPTION OF THE DRAWINGS [0025] There follows a description of embodiments with reference to the drawings. The drawings are as follows: [0026] FIG. 1 shows a perspective view of a trocar sleeve whose outer sleeve part is separated from it and is in a position before assembly. [0027] FIG. 2 shows a perspective view of the trocar sleeve of FIG. 1 in an assembly position, that is, in a phase shortly before it is completely assembled. [0028] FIG. 3 shows a perspective view of the assembled trocar sleeve with the outer sleeve part in an insertion position in which the trocar sleeve can be inserted into an opening produced in an epithelium. [0029] FIG. 4 shows a perspective view of the assembled trocar sleeve with the external sleeve part in a working position, in which the trocar sleeve can be anchored behind an opening produced in an epithelium. [0030] FIG. 5 shows a perspective view of the trocar sleeve from FIG. 4 with a superimposed rubber disc as securing element. [0031] FIG. 6 shows a side view of the trocar sleeve from FIG. 5 as it is anchored and secured in an epithelium. [0032] FIG. 7 shows a perspective view of an embodiment for a trocar sleeve in which each of the two sleeve parts has essentially the shape of a straight full tube, in an assembled condition, whereby the outer sleeve part is in an insertion position in which the trocar sleeve can be inserted into an opening produced in an epithelium. [0033] FIG. 8 shows another perspective view of the trocar sleeve from FIG. 7 , on which a securing element is additionally installed. [0034] FIG. 9 shows an enlarged perspective view of the distal end of the trocar sleeve from FIG. 7 in the insertion position. [0035] FIG. 10 shows an enlarged perspective view of the distal end of the trocar sleeve from FIG. 7 in a working position in which the trocar sleeve can be anchored behind an opening produced in an epithelium. [0036] FIG. 11 shows an enlarged perspective view of the distal end of the inner sleeve part of the trocar sleeve from FIG. 7 . [0037] FIG. 12 shows an enlarged perspective view of the distal end of the outer sleeve part of the trocar sleeve from FIG. 7 . [0038] FIG. 13 shows an enlarged perspective view of the distal end of the trocar sleeve from FIG. 7 in the course of a rotation of the outer sleeve part from the insertion position into the working position. [0039] FIG. 14 shows an interrupted longitudinal sectional view of the two sleeve parts of the trocar sleeve in the position from FIGS. 7 and 9 . [0040] FIG. 15 shows an explosion perspective view of the trocar sleeve from FIG. 7 in the area of the fastening of the inner sleeve part on the head part. [0041] FIG. 16 shows an enlarged perspective view of the cap nut from FIG. 15 . [0042] FIG. 17 shows an enlarged perspective view of the spring packet from FIG. 15 . [0043] FIG. 18 shows a longitudinal sectional view of the trocar sleeve from FIG. 7 in the area of the fastening of the inner sleeve part on the head part. [0044] FIG. 19 shows a side view of a proximal resistance path in an inner sleeve part for a fastening on the head part by means of a type of bayonet lock. [0045] FIG. 20 shows an unfolding of the resistance path of the inner sleeve part from FIG. 19 into the plane. [0046] FIG. 21 shows a sectional view of the inner sleeve part from FIG. 19 and of a head part suited to it, which are connected with one another by a type of bayonet lock. [0047] FIG. 22 shows a perspective view of the trocar sleeve portion shown in FIG. 18 . [0048] FIG. 23 shows a perspective view of a trocar mandrel for insertion into the shown trocar sleeve. [0049] FIG. 24 shows a securing element consisting only partly of an elastic material, in a perspective view. [0050] FIG. 25 shows another securing element consisting only partly of an elastic material, in a perspective view. [0051] FIG. 26 shows a securing element consisting only of rigid parts, in a sectional view. DETAILED DESCRIPTION OF THE INVENTION [0052] The trocar sleeve shown in FIGS. 1 through 6 consists of a head part 2 , a first, inner sleeve part 4 and a second, outer sleeve part 6 . [0053] The head part 2 is an approximately rotation-symmetrical housing that contains an axial clearance hole. Situated in a proximal end of the head part 2 , shown in the upper part of FIGS. 3 through 6 , is a flexible insulation 8 for gas-tight insertion of an instrument in and through the clearance hole in the head part 2 . In addition, the head part 2 has a fluid connection support 10 with a valve 12 . Carbon dioxide or flushing liquid, for example, can be supplied by way of the fluid connection support 10 . [0054] Attached to the distal end of the head part 2 is a proximal end of the inner sleeve part 4 , which consists mainly of a piece of tube that extends in the axial extension of the clearance hole in the head part 2 to a distal end. [0055] All the way at the distal end of the inner sleeve part 4 , a first flange part 14 is shaped that has approximately the form of a spatula. In particular, the flange part 14 has a U-shaped contour, as seen in a plane perpendicular to the longitudinal axis of the inner sleeve part 4 , such that the distance between the two legs of the U-shape is equal to or somewhat smaller than the diameter of the inner sleeve part 4 . In the embodiment the first flange part 14 consists of the same material as the inner sleeve part 4 and is, for example, 1 mm thick. [0056] The outer sleeve part 6 consists mainly of a lengthwise halved piece of tube of about the same length and of the same material as the inner sleeve part 4 . The cross-section of the outer sleeve part 6 perpendicular to the longitudinal axis is a circular arc, which is a few degrees greater than a half-circle. The inner diameter of the outer sleeve part 6 is equal to the outer diameter of the inner sleeve part 4 . [0057] On the distal end of the outer sleeve part 6 , a second flange part 16 is shaped, which has practically the same contour and the same thickness as the first flange part 14 and, in the same manner that the first flange part 14 forms a right-angle deviating continuation of the inner sleeve part 4 , it forms a radially outward running and thus right-angle deviating continuation of the outer sleeve part 6 . [0058] In the vicinity of the proximal end of the outer sleeve part 6 , a gripping member 18 is shaped on it and, similarly as the second flange part 16 , forms a radially outward running continuation of the outer sleeve part 6 , but is thicker and wider. Somewhat closer to the proximal end of the outer sleeve part 6 , a small, round stud 20 is formed on it and extends a few millimeters axially from the outer sleeve part 6 . [0059] The head part 2 on its distal end has a ring 22 , with gap, that extends radially around the inner sleeve part 4 at a distance that is somewhat greater than the thickness of the outer sleeve part 6 . Interacting with the stud 20 on the outer sleeve part 6 , the ring 22 with gap forms guide and locking elements for the outer sleeve part 6 in the manner of a bayonet lock, as is described in greater detail below. [0060] As shown in FIGS. 1 and 2 , the trocar sleeve is installed by sliding the outer sleeve part 6 in the indicated direction of the arrow onto the inner sleeve part 4 , so that both flange parts 14 , 16 point in directions approximately opposite to one another. [0061] To facilitate this pushing motion, the first flange part 14 has two small indentations 24 in its edges, specifically located where it is connected with the first sleeve part 4 . The indentations 24 also allow rotation of the outer sleeve part 6 by a few degrees when it is seated on the inner sleeve part 4 . In particular, the outer sleeve part 6 can be rotated into the position shown in FIG. 2 , in which both flange parts 14 , 16 point in directions about 160 degrees apart, and then the outer sleeve part 6 can be pushed completely onto the inner sleeve part 4 . [0062] When the outer sleeve part 6 has been pushed completely onto the inner sleeve part 4 , the outer sleeve part 6 is rotated around the inner sleeve part 4 into the position shown in FIG. 3 , in which the two flange parts 14 and 16 are situated congruently one over the other. During the rotation, whose rotating direction is indicated in FIG. 3 with an arrow, the stud 20 glides within the ring 22 with gap and is guided thereby. [0063] In the position shown in FIG. 3 , the two flange parts 14 and 16 of the trocar sleeve can easily be inserted into an opening produced in an epithelium without penetrating deep therein, while the trocar sleeve is held more or less perpendicular over the epithelium and is moved somewhat downward and to the side so that the two flange parts 14 and 16 together glide below the epithelium. [0064] After the trocar sleeve has reached its end position in and above the body opening, the outer sleeve part 6 is rotated back, with the assistance of the gripping member 18 , around the inner sleeve part 4 , namely into the position shown in FIG. 4 in which the two flange parts 14 and 16 are pointing in directions exactly opposite to one another and are situated precisely in a plane perpendicular to the longitudinal axis of the sleeve parts 4 and 6 . The rotation direction is indicated with an arrow in FIG. 4 . In this position the stud 20 is held firmly on the first sleeve part 4 by an indentation in the ring 22 with gap, so that the second sleeve part 6 is locked on the trocar sleeve. Within the boundaries dictated by its own elasticity, the second sleeve part 6 is also locked along its length, because the outer sleeve part 6 encloses the inner sleeve part 4 by more than 180 degrees. [0065] The guiding effect of the ring 22 with gap on the head part is either purely rotational or it also causes a slight longitudinal sliding by the thickness of the flange parts 14 and 16 , so that the second flange part 16 is automatically moved from the position shown in FIG. 3 , in which it is situated congruently over the first flange part 14 , into the position shown in FIG. 4 , in which it is situated precisely in a plane with the first flange part 14 . A displacement of this type can also be achieved by corresponding configuration of the section of the ring 22 , with gap, in which the stud 20 is locked by an indentation in the ring 22 with gap. [0066] As shown in FIG. 5 , after anchoring the trocar sleeve in a body opening, a with gap, rubber disc 26 , in the form of a so-called optic stopper for instance, which can be stretched by hand, is pushed from the side over both sleeve parts 4 and 6 of the trocar sleeve. When the rubber disc 26 contracts again, it surrounds the sleeve parts 4 and 6 with a certain force. The rubber disc 26 can then be pushed by hand in the direction toward the flange parts 14 and 16 until an epithelium 28 , indicated schematically in a sectional view in FIG. 6 , is contiguous with the flange parts 14 , 16 below and with the rubber disc 26 above, so that the trocar sleeve is securely anchored on the epithelium 28 . [0067] Instead of the rubber disc 26 , any other suitable securing element can be used, for example a two-part securing element, which can be installed around the sleeve parts 4 and 6 . [0068] In the illustrated embodiment, the flange parts 14 and 16 are spatula-shaped or U-shaped. Although this special configuration is particularly advantageous in terms of sparing tissue and avoiding great insertion depth in the epithelium, other contour shapes are also possible. For example, the flange parts 14 and 16 can be of any leaf shape, as occurs with plant leaves, but their contours should be rounded. It is essential that each flange part 14 , 16 extends radially outward at an angle of less than 180 degrees from the respective sleeve part 4 or 6 . [0069] In the illustrated embodiment, the flange parts 14 and 16 are in addition level and situated always parallel to one another. They could also, for example, form conical parts or spherical parts, which could be advantageous for operations on more convex or concave body parts. [0070] An additional embodiment is distinguished from the embodiment in FIGS. 1 through 6 essentially in that the base body of the outer sleeve part does not have a semicircular cross-section, as in the outer sleeve part 6 , but instead, as with the inner sleeve part 4 , is a full tube. To be able to assemble and dismantle the outer sleeve part in this case, the distal end of the inner sleeve part must be detachably fastened on the head part, for example by means of cap nuts and positioning pins. [0071] This embodiment, which is distinguished in further details from the embodiment in FIGS. 1 through 6 , is described in greater detail hereinafter with reference to FIGS. 7 through 26 . [0072] The trocar sleeve with two full tubes as sleeve parts contains a head part 32 , a first, inner sleeve part 34 and a second, outer sleeve part 36 . The head part 32 is similar to the head part 2 of the foregoing embodiment, except that the inner sleeve part 34 , which consists principally of a piece of tube that extends in the axial extension of the clearance hole in the head part 32 all the way to a distal end, is detachably assembled on the distal end of the head part 2 . The outer sleeve part 36 , like the inner sleeve part 34 , has the form of a full tube, and the inner sleeve part 34 , beginning with its distal end, can be inserted into the outer sleeve part 36 , such that the outer sleeve part 36 encloses the inner sleeve part 34 with little play. [0073] A first flange part 44 is formed on the distal end of the inner sleeve part 34 , said flange part having approximately the shape of a spatula longitudinally cut in half and forming a continuation of the inner sleeve part 34 that runs radially outward and thus protrudes at a right angle. A second flange part 46 is formed on the distal end of the outer sleeve part 36 , said flange part having the shape of the other half of the spatula longitudinally cut in half and forming a continuation of the outer sleeve part 36 that runs radially outward and thus protrudes at a right angle. [0074] When the inner sleeve part 34 and the outer sleeve part 36 are completely pushed together lengthwise, as shown in FIGS. 7 through 10 , 13 and 14 , both flange parts 44 and 46 extend precisely in a plane perpendicular to the longitudinal axis of the sleeve parts 34 and 36 . [0075] In the insertion position shown in FIGS. 7 , 8 , 9 and 14 , the two flange parts 44 and 46 supplement one another to form the (halved) spatula, in that they together have a U-shaped contour, as seen in a plane perpendicular to the longitudinal axis of the sleeve parts 34 and 36 , such that the distance between the two legs of the U-shape is approximately equal to, or somewhat smaller than, the diameter of the inner sleeve part 34 . [0076] The side of the inner sleeve part 34 that is opposite the flange part 44 has a protruding nose 38 , which fits into a groove 40 open to the distal end, which is configured in the side of the outer sleeve part 36 opposite the flange part 44 . The groove 40 merges into a radially surrounding indentation 42 in the inner circumference of the outer sleeve part 36 . [0077] In the relative angular position shown in FIGS. 7 through 10 , 13 and 14 , the inner sleeve part 34 and the outer sleeve part 36 can be completely pushed together lengthwise, such that the nose 38 slides into the groove 40 and makes contact with its base. At the same time, the plane surface on the flange part 44 of the inner sleeve part 34 that points in the proximal direction makes contact with a distal front end of the outer sleeve part 36 . Both flange parts 44 and 46 are then situated in the same plane perpendicular to the longitudinal axis of the sleeve parts 34 and 36 . [0078] If now the outer sleeve part 36 is rotated somewhat around the inner sleeve part 34 as shown in FIG. 13 , the nose 38 on the inner sleeve part 34 enters into the indentation 42 in the outer sleeve part 36 , so that the inner sleeve part 34 and the outer sleeve part 36 can no longer be pushed axially toward one another. The outer sleeve part 36 can then be rotated further around the inner sleeve part 34 until the two flange parts 44 and 46 are situated in a working position or operating position, in which they point in directions contrary to one another as shown in FIG. 10 , in order to anchor the trocar sleeve below an epithelium. During the entire rotation process, both flange parts 44 and 46 remain in the same plane perpendicular to the sleeve longitudinal axis. [0079] When the inner sleeve part 34 is fastened on the head part 32 , then in the insertion position in which the nose 38 does not yet engage in the indentation 42 , an axial sliding of the outer sleeve part 36 in the proximal direction is restricted by the head part 32 . [0080] As shown in FIG. 14 , there is, situated on the proximal end of the outer sleeve part 36 , a radially surrounding cuff 48 into which an O-ring 50 fits that insulates the outer sleeve part 36 from the longer inner sleeve part 34 . Also fastened on the cuff 48 is an actuation lever to turn the external sleeve part 36 . Said actuation lever consists of a metallic spring 52 that springs in the sleeve longitudinal direction, with a round plastic cap 54 whose function is explained further below. [0081] There are several possibilities for fastening the inner sleeve part 34 , on which the outer sleeve part 36 is mounted, on the head part 32 . Described below with reference to FIGS. 15 through 18 is an example for fastening the inner sleeve part 34 on the head part 32 by means of a screw-in lock. [0082] The proximal end of the inner sleeve part 34 with the outer sleeve part 36 assembled on it can be recognized in FIG. 15 . The proximal end of the inner sleeve part 34 has a double-V-shaped contour 56 with two locking holes 58 in the peaks of the double-V-shaped contour 56 . A cap nut 60 , in whose smallest diameter the inner sleeve part 34 fits precisely, has on its inside two pins 62 ( FIG. 16 ) that protrude radially inward beyond the smallest diameter. The indents in the double-V-shaped contour 56 are rounded with the same radius as the pins 62 . [0083] When the proximal end of the inner sleeve part 34 on the side with the smallest diameter is pushed into the cap nut 60 , then the pins 62 of the cap nut 60 touch the diagonal sides of the double-V-shaped contour 56 . When the inner sleeve part 34 is pushed farther into the cap nut 60 , the cap nut 60 is thereby rotated until the pins 62 are situated precisely in the indents of the double-V-shaped contour 56 . The inner sleeve part 34 thereby assumes a firm position in the cap nut 60 both radially and axially. [0084] Inside the cap nut 60 are situated two recesses 64 , which extend perpendicular to the axis of the pins 62 . One segment of one of two groove stones 66 , which are fastened on opposite points on an oval spring 68 , fits into each of the recesses 64 in order to form a spring packet as shown in FIG. 17 . The oval spring 68 exerts a pretension force radially outward onto the groove stones 66 when the spring packet is seated in the cap nut 60 , as shown in FIG. 18 . [0085] The groove stones 66 each bear a bolt extension 70 , which fits precisely into a locking hole 56 of the inner sleeve part 34 and is flush with it when the pins 62 of the cap nut 60 are situated precisely in the indents of the double-V-shaped contour of the inner sleeve part 34 . In addition, diagonally outward-pointing conical surfaces 72 are configured on the groove stones 66 . [0086] The screw-in portion 74 of the head part 32 shown in FIGS. 15 and 18 bears an outer thread 76 that matches an inner thread 78 in the cap nut 60 . When the screw-in portion 74 is rotated into the cap nut 60 while the inner sleeve part 34 and the spring packet are situated in it, then a conical portion 80 on the screw-in portion 74 presses against the conical surfaces 72 of the groove stones 66 . The groove stones 66 are thereby moved inward against the spring force of the oval spring 68 , so that the bolt extensions 70 engage in the locking holes 56 in the inner sleeve part 34 and thus lock the inner sleeve part 34 on the head part 32 . [0087] On releasing the threads 76 and 78 from one another, the groove stones 66 move outward so that the bolt extensions emerge from the locking holes 56 and the inner sleeve part 34 , together with the outer sleeve part 36 , can be withdrawn from the head part 32 . Then the sleeve parts 34 and 36 can be separated from one another. [0088] As can be recognized in FIG. 18 , two O-rings insulate the cap nuts 60 from the inner sleeve part 34 or from the screw-in portion 74 of the head part 32 . [0089] With reference to FIGS. 19 through 21 , an example for a fastening of an inner sleeve part 34 ′ on a head part 32 ′ by means of a type of bayonet lock is now described, however with a distinction from a conventional bayonet lock in that the lock cannot be released by simple rotation of the connected parts in relation to one another. [0090] The inner sleeve part 34 ′ and the head part 32 ′ are distinguished from the previously described inner sleeve part 34 and head part 32 only in the area of the fastening with one another. That is, in the area of the proximal end of the inner sleeve part 34 ′ a resistance path 82 is hollowed out in its outer circumference, which seen from the side resembles FIG. 19 and appears unfolded into a plane as shown in FIG. 20 . Protruding radially inward from the inner circumference of the head part 32 ′ is a bayonet pin 84 ( FIG. 21 ) that fits into the resistance path 82 . [0091] To fasten the inner sleeve part 34 ′ on the head part 32 ′, the head part 32 ′ is pushed onto the inner sleeve part 34 ′ in such a way that the bayonet pin 84 engages in the resistance path 82 and then is guided by it. If the head part 32 ′ is then further pushed onto the inner sleeve part 34 ′ and turned, then the head part 32 ′ at first moves further in the distal direction by the inner sleeve part 34 ′ until it is contiguous with the distally furthermost point of the resistance path 82 . If the head part 32 ′ is rotated further, then it moves again a short distance in the proximal direction. In this position the inner sleeve part 34 ′ is fixed on the head part 32 ′, in that a distancing sleeve 86 is inserted into the head part 32 ′ starting from the proximal end of the head part 32 ′ until it is contiguous with the inner sleeve part 34 ′. This is possible because the head parts 32 and 32 ′ each comprise an unscrewable cap 30 (see FIG. 8 ) on the proximal end. By screwing the cap 30 back onto the head part 32 ′ after inserting an insulation in the head part 32 ′, the distancing sleeve 86 and thus the inner sleeve part 34 ′ are fastened on the head part 32 ′. Because in this condition axial and radial movements overlap, no radial movement is possible between the inner sleeve part 34 ′ and the head part 32 ′ by the axial fastening. [0092] In addition, in the area between maximum axial relative sliding and axial relative sliding in the assembled condition, as shown in FIG. 21 , the metallic spring 52 of the actuation lever is elastically reshaped on the outer sleeve part 36 . This provides a haptic feedback by the catch-locking of the bayonet lock. [0093] Likewise as in the previously described embodiment, in the embodiment in FIGS. 7 through 21 as well, the trocar sleeve can be broken down easily and quickly into several components, facilitating their sterilization. [0094] Characteristics of the embodiment in FIGS. 7 through 21 can also be combined with characteristics of the embodiment in FIGS. 1 through 6 . [0095] There follows a description of additional details and additional parts of the embodiment in FIGS. 7 through 21 , which can also be applied in FIGS. 1 through 6 . [0096] To indicate to the user the position in which the instrument is found, that is, the insertion position, in which the flange parts 44 , 46 of the two sleeve parts 34 , 36 point in the same direction, or the working position, in which the flange parts 44 , 46 point in approximately contrary positions to one another, two partially cylindrical indentations, which are displaced from one another by 180 degrees, are foreseen on a distal plane surface of the head part 32 or 32 ′ or of the cap nut 60 . In FIG. 22 , which gives a perspective view of the trocar sleeve portion shown in FIG. 18 , these are two cylindrical indentations 88 for the insertion position or the working position, only one of which is visible in the drawing, on the cap nut 60 . As long as the synthetic cap 54 of the actuation lever is situated in one of these indentations 88 , its metallic spring 52 is not impacted. If the outer sleeve part 36 is rotated by means of the actuation lever, the actuation lever must overcome the rim of the corresponding indentation 88 . Thus the axial distance between the head part 32 and the outer sleeve part 36 changes, and the metallic spring 52 is pretensed. As soon as the actuation lever moves over one of the indentations 88 , it catches easily therein, as the metallic spring 52 is relaxed. [0097] FIG. 23 shows a trocar mandrel 90 , which is especially suited for inserting the described trocar sleeves in a body. The trocar mandrel 90 has, instead of the otherwise customary sharp point, a blunt distal end 92 with a slightly curved front surface with small fibers or roundings in the transition to the cylindrical shaft of the trocar mandrel 90 . The contour of the distal end 92 of the trocar mandrel 90 ends essentially flush with the contour of the distal end of the trocar sleeve, which can be recognized more precisely in FIG. 14 , when the trocar mandrel 90 is completely inserted in the trocar sleeve, as can be seen in FIG. 7 . This condition can be recognized by an operator from the fact that the proximal end 94 of the trocar mandrel 90 ends flush with the proximal end of the trocar head 32 , as can be seen in FIG. 8 . [0098] To be used, the trocar mandrel 90 is inserted from the proximal end through the trocar sleeve in order thereby to close its distal end. The spatula formed by the flange parts 44 and 46 (or 14 and 16 ) is inserted in a scalpel cut, while the trocar is held diagonally above the epithelium. The trocar is pivoted into perpendicular position, and the sleeve parts 34 and 36 and thus the flange parts 44 and 46 are rotated with respect to one another by means of the actuation lever, so that the trocar is inserted atraumatically in the body opening. Then the trocar mandrel 90 can be withdrawn from the trocar sleeve. The trocar sleeve is now open in order to perform a minimally invasive procedure through the trocar sleeve. [0099] Then the flange parts 44 and 46 are secured on the outside of the epithelium with a securing element that surrounds the outer sleeve part 36 and can be slid axially along the outer sleeve part 36 by overcoming or switching off its clamping force. Even better suited for this purpose than the previously described one-piece rubber disc with gap are securing elements, as are described below. [0100] The securing element shown in FIG. 24 can be broken down into two parts, namely a disc-shaped part 100 , with gap, of an elastic material such as silicon that has a somewhat smaller inner diameter than the outer diameter of the outer sleeve part 36 , and a support plate 102 , with gap, of a rigid material such as steel. Protruding at a right angle from the support plate 102 are extensions 104 that fit in matching recesses in the elastic part 100 . Said extensions 104 hold the elastic part 100 firmly to the rigid support plate 102 and stabilize it in order achieve sufficient clamping force. The elastic part 100 and the support plate 102 have sufficiently extensive gaps so that they can be separately pushed laterally onto the outer sleeve part 36 and then connected together in the axial direction. [0101] The securing element shown in FIG. 25 can also be broken down into two parts, namely a ring-shaped enclosure 110 of a rigid material such as steel with a U-shaped gap 112 , and an insert 114 of an elastic material such as silicon that is inside the gap 112 and can be fixed somewhat in the gap 112 by form-locking or force-locking but is removable. The enclosure 110 stabilizes the insert 114 in order to produce sufficient clamping force. The enclosure 110 and insert 114 can be pushed simultaneously or sequentially onto the outer sleeve part 36 and then axially slid along on it into the desired position as illustrated in FIG. 8 . [0102] The securing element shown in FIG. 26 cannot be dismantled and consists of an approximately rigid plate 120 with a radial gap 122 , a clamping element 124 that can be slid in the direction toward the inner end of the gap 122 , and an actuation lever 126 , which is mounted to pivot on the plate 120 and comprises at its base a cam 128 that grips on the clamping element 124 . After this securing element has been pushed laterally onto the outer sleeve part 36 , the clamping element 124 is pressed against the outer sleeve part 36 by pivoting the actuation lever 126 and remains in this position by gripping action of the cam 128 on the clamping element 124 .

A trocar sleeve for minimally invasive surgery, having a first sleeve part, which has essentially the shape of a straight tubular piece with a longitudinal axis, and having a second sleeve part, which at least partly surrounds the first sleeve part in close contiguity and is movable during use with respect to the first sleeve part. The mobility of the second sleeve part in relation to the first sleeve part consists essentially only in rotatability of the second sleeve part around the first sleeve part, and in addition the first sleeve part and the second sleeve part each comprise on their distal axial ends a flange part that extends radially outward at an angle of less than 180 degrees from the respective sleeve part.